EDWARDS LIFESCIENCES CORPORATION Patent applications |
Patent application number | Title | Published |
20160121079 | BI-DIRECTIONAL CANNULA - A bi-directional cannula for perfusing blood in two directions. The cannula has a distal opening in fluid communication with a cannula first lumen. The cannula has a secondary opening proximal of the distal opening, and may include a movable tubular extension selectively extendable from the cannula via the secondary opening. The tubular extension may be in fluid connection with the cannula first lumen and/or a cannula second lumen. The tubular extension may have distal and/or side openings, with the openings providing antegrade fluid perfusion. The cannula second lumen may be separate from the first lumen, so that perfusion can be selectively provided to just the cannula distal opening, just the secondary opening/tubular extension, or simultaneously to both the distal opening and secondary opening/tubular extension. | 05-05-2016 |
20160121078 | COMPRESSION RESISTANT HOSE - Described herein is a hose, wherein the hose has a length having a distal end and a proximal end, and an inner diameter and an outer diameter. The hose is comprised of a first layer; and a second layer, wherein the first layer and the second layer extend along at least a portion of the length and wherein a longitudinal compressive force applied to either the distal end or the proximal end of the hose causes the first layer to lock against the second layer. | 05-05-2016 |
20160081680 | BIO-ABSORBABLE WOUND CLOSURE DEVICE AND METHOD - A wound closure device comprises a first frame and a flexible tubular section connected to the first frame, the first frame implantable through a wound in a patient's skin into a lumen of a blood vessel with a portion of the tubular section extending out through the skin. The tubular section has a first portion and a second portion, a wall of the tubular section defining a coaxial inner bore. Twisting the first portion relative to the second portion of the tubular section closes the bore is closed in an area of the tubular section between the first and second portions, thereby closing the wound. Also disclosed is an embodiment for closing an opening in a heart, as well as a delivery device, systems, and methods. | 03-24-2016 |
20160074163 | METHODS AND APPARATUSES FOR DEPLOYING MINIMALLY-INVASIVE HEART VALVES - A system for delivering and deploying a self-expandable heart valve to a site of implantation such as the aortic annulus includes a deployment mechanism that engages the valve and regulates the rate of expansion of both the proximal and distal ends thereof. The heart valve may be a rolled-type valve and the deployment mechanism may include a plurality of distal fingers and a plurality of proximal fingers that engage the outer layer of the heart valve. Controlled radial movement of the fingers regulates the unwinding of the rolled heart valve. The fingers may be removed prior to inflation of a balloon to fully expand the valve, or the fingers may be repositioned to the inside of the valve for this purpose. The deployment mechanism may include an umbrella structure that forces the rolled valve outward into its fully expanded configuration. Alternatively, a gear shaft that engages one or more gear tracks on the valve may be utilized to regulate expansion of the valve. A stabilization balloon may be used to axially and radially locate the deployment mechanism relative to the site of implantation. Methods of operation of the delivery and deployment mechanism include regulating the rate of self-expansion of the valve and forcing the valve outward into its fully expanded configuration utilizing the same or different means. | 03-17-2016 |
20160074157 | METHODS AND APPARATUSES FOR DEPLOYING MINIMALLY-INVASIVE HEART VALVES - A medical assembly for replacing a native heart valve of a patient can include a deployment mechanism and a radially expandable and contractable prosthetic heart valve coupled to the deployment mechanism. The prosthetic heart valve can comprise a self-expandable stent body and a plurality of leaflet-forming membranes. The assembly can further include a storage container, wherein the prosthetic heart valve and the deployment mechanism are disposed in the storage container. | 03-17-2016 |
20160067042 | VALVED AORTIC CONDUITS - A valved conduit including a bioprosthetic aortic heart valve connected to a tubular conduit graft forming an ascending aorta. The conduit graft may attach to the heart valve in a manner that facilitates a redo operation in which the valve is replaced with another valve. A sewing ring may be pre-attached to the inflow end of the graft, and then the valve connected to a delivery holder advanced into the graft and secured to the sewing ring. Dry bioprosthetic valves coupled with conduit grafts sealed with a bioresorbable medium can be stored with the delivery holder. | 03-10-2016 |
20160066903 | Finger-Mounted Surgical Instruments and Methods of Use - A device is described which has an instrument portion secured to a sleeve/cuff portion, where the sleeve/cuff portion is configured to receive a portion of user's finger therein and to radially compress onto the user's finger to hold the instrument portion thereon. The present invention is particularly well suited for use in minimally invasive surgical procedures. The present invention also teaches a method of forming a knot in suture material as well as other techniques for treating patients. | 03-10-2016 |
20160038097 | DETERMINATION OF A HEMODYNAMIC PARAMETER - Embodiments of the disclosure are directed to methods, apparatuses, and computer program products for determining a hemodynamic parameter. An exemplary method comprises: receiving data associated with at least one heart beat; calculating a first standard deviation for at least a portion of the data; interpolating a second standard deviation for at least a second portion of the data; and determining the hemodynamic parameter based on the first standard deviation and the second standard deviation. | 02-11-2016 |
20150351904 | PROSTHETIC VALVE FOR REPLACING A MITRAL VALVE - Embodiments of a prosthetic heart valve comprise an annular main body, an atrial cap extending radially outwardly from the atrial end of the main body, and a plurality of ventricular anchors extending outwardly from the ventricular end of the main body. Each ventricular anchor can have a proximal end portion connected to the ventricular end, an intermediate portion extending away from the atrial end and then back toward the atrial so as to define a first bend, and a free distal end portion that extends from the intermediate portion. The distal end portion can comprise a first section, a second section, and a second bend between the first and second sections, the first section extending from the intermediate portion in a direction toward the atrial end and radially away from the main body. | 12-10-2015 |
20150336150 | CRIMPING APPARATUS FOR CRIMPING PROSTHETIC VALVE WITH PROTRUDING ANCHORS - Embodiments of an apparatus, and a method for crimping expandable stents or prosthetic valves having a radially expandable and compressible annular body and one or more protruding anchors extending from the body using the apparatus, where the apparatus comprise a housing, a plurality of circumferentially arranged nesting jaws, and an actuator configured to move the jaws radially inwardly to reduce the size of the crimping aperture, thereby radially compressing the annular body of the prosthetic valve or stent. In particular embodiments, a selected set of the jaws, each having a front side and a recessed portion in its front side adjacent to its inner end. The recessed portions of the selected jaws collectively are sized and shaped to receive the one or more anchors of the prosthetic valve when the annular body is positioned within the crimping aperture. | 11-26-2015 |
20150313526 | SYSTEM AND METHOD FOR BLOOD SAMPLING FAILURE ANALYSIS AND CORRECTION - Disclosed herein are systems and methods for analyzing failed bodily fluid sampling. The systems and methods include providing a system having a sampling line and an access device, the access device having an inner space, wherein the sampling line is positioned in the inner space; performing a sampling event; obtaining one or more status values of the sampling event; comparing the one or more status values with at least one predetermined value corresponding to a failed sampling event; and determining whether the sampling event failed based on the comparing step. In the event of sampling failure, the systems and methods provide flushing the sampling line or a portion of the inner space of the access device via the flow controller; detecting pressure; and determining one or more possible root causes for the failure of the sampling event based on the detected pressure. | 11-05-2015 |
20150282931 | RETAINING MECHANISMS FOR PROSTHETIC HEART VALVES - According to one representative embodiment, a method of treating aortic insufficiency comprises delivering a support structure to a position around the leaflets of a native heart valve. The support structure comprises an annular body defining an interior and at least one projection extending radially inwardly from the annular body. An expandable prosthetic heart valve can be advanced into the native heart valve and into the interior of the annular body. The prosthetic heart valve can be expanded into contact with the leaflets of the native valve, thereby causing the leaflets of the native valve to be frictionally secured between an inner surface of the annular body and an outer surface of the prosthetic heart valve and causing the at least one projection and a portion of one of the leaflets contacted by the at least one projection to extend into an opening of the frame of the prosthetic valve. | 10-08-2015 |
20150282751 | SENSOR SYSTEMS AND METHODS OF USING THE SAME - Provided are sensor systems and methods for detecting analytes of bodily fluids. The systems can be used to reduce the administration volume of certain compounds and/or fluids during medical monitoring or other procedures by providing a calibration path configured to receive a first fluid, a sample path isolated from the calibration path, the sample path configured to receive a bodily fluid from a subject, and a sensor apparatus comprising at least one sensor selectively positionable between the calibration path and the sample path. | 10-08-2015 |
20150276651 | ANALYTE SENSOR AND FABRICATION METHODS - Methods for fabricating analyte sensor components using IC- or MEMs-based fabrication techniques and sensors prepared therefrom. Fabrication of the analyte sensor component comprises providing an inorganic substrate having deposited thereon a release layer, a first flexible dielectric layer and a second flexible dielectric layer insulating there between electrodes, contact pads and traces connecting the electrodes and the contact pads of a plurality of sensors. Openings are provided in one of the dielectric layers over one or more of the electrodes to receive an analyte sensing membrane for the detection of an analyte of interest and for electrical connection with external electronics. The plurality of fabricated sensor components are lifted off the inorganic substrate. Methods of improving sensor performance by solution based and non-solution based etching are provided. | 10-01-2015 |
20150258321 | SEALING CONNECTOR ASSEMBLY - The present disclosure provides a sensor system that includes a fluid supply, one or more supply lines, a monitor, communication lines, a sensor, a catheter and a connector assembly. The connector assembly includes a housing and a tube extending out of a distal end of the housing wherein the tube is compressed against a luer connector of the catheter to form a seal between the catheter and connector assembly. | 09-17-2015 |
20150250588 | METHODS FOR DEPLOYING SELF-EXPANDING HEART VALVES - A system for delivering and deploying a self-expandable heart valve to a site of implantation such as the aortic annulus includes a deployment mechanism that engages the valve and regulates the rate of expansion of both the proximal and distal ends thereof. The heart valve may be a rolled-type valve and the deployment mechanism may include a plurality of distal fingers and a plurality of proximal fingers that engage the outer layer of the heart valve. Controlled radial movement of the fingers regulates the unwinding of the rolled heart valve. The fingers may be removed prior to inflation of a balloon to fully expand the valve, or the fingers may be repositioned to the inside of the valve for this purpose. The deployment mechanism may include an umbrella structure that forces the rolled valve outward into its fully expanded configuration. Alternatively, a gear shaft that engages one or more gear tracks on the valve may be utilized to regulate expansion of the valve. A stabilization balloon may be used to axially and radially locate the deployment mechanism relative to the site of implantation. Methods of operation of the delivery and deployment mechanism include regulating the rate of self-expansion of the valve and forcing the valve outward into its fully expanded configuration utilizing the same or different means. | 09-10-2015 |
20150230919 | PERCUTANEOUS LEAFLET AUGMENTATION - In a representative embodiment, an implantable prosthetic heart valve device comprises an elongated body having first and second end portions, the body being configured to be implanted around a native leaflet of a heart valve such that the first end portion is on an atrial side of the leaflet and the second end portion is on a ventricular side of the leaflet and such that the body can coapt with and move away from an opposing native leaflet during operation of the heart valve. The device can further comprises a fastener configured to be mounted on a suture that extends from one of the first or second end portions, through the native leaflet and through the other of the first or second end portions such that the body is secured to the native leaflet. | 08-20-2015 |
20150190225 | SYSTEM AND METHOD FOR CRIMPING A PROSTHETIC HEART VALVE - A device for crimping a radially expandable and collapsible prosthetic valve comprises a coiled wire frame having a longitudinal opening extending from a proximal end to a distal end thereof The opening has a first state and a second state, the opening in the first state having a first diameter dimensioned to receive the prosthetic valve in an expanded or partially crimped configuration therein, and the opening in the second state having a second diameter dimensioned to receive the prosthetic valve in a crimped configuration. The coiled wire frame has a first end coupled to a first member and a second end coupled to a second member. The first member is movable relative to the second member to convert the coiled wire frame from the first state to the second state. | 07-09-2015 |
20150182217 | SUTURE CLIP DEPLOYMENT DEVICES - Suture clip deployment devices for applying suture clips to sutures are described. Some embodiments can include a generally tubular main body and a vacuum port located at the distal end, a hollow inner body longitudinally slidable within the main body and extending from the main body at its distal end, and a suture recess located in the generally tubular main body. At least one suture clip configured to frictionally fit on an outer surface of the inner body is deployed during use. Clip deployment can occur after a vacuum source is applied to the device so as to draw the suture into the device. The suture lines can be retrieved through the suture recess, and the device can be actuated so as to deliver the suture clip off the delivery device and onto the suture, locking the suture in place. | 07-02-2015 |
20150157455 | PROSTHETIC HEART VALVE AND DELIVERY APPARATUS - The present disclosure is directed to embodiments of catheter-based prosthetic heart valves, and in particular, prosthetic heart valves having sealing members configured to seal the interface between the prosthetic valve and the surrounding tissue of the native annulus in which the prosthetic valve is implanted. The present disclosure also discloses new methods of making an introducer sheath with an inner liner for percutaneous insertion of a medical device into a patient. | 06-11-2015 |
20150148896 | AORTIC INSUFFICIENCY REPAIR DEVICE AND METHOD - This application relates to methods, systems, and apparatus for replacing native heart valves with prosthetic heart valves and treating valvular insufficiency. In a representative embodiment, a support frame configured to be implanted in a heart valve comprises an annular main body formed by a plurality of angled struts, the main body including a plurality of peaks formed by the intersection of respective adjacent struts. The support frame further comprises one or more leaflet-engaging mechanisms configured to engage leaflets of the heart valve. The support frame can be radially expandable and collapsible. | 05-28-2015 |
20150142049 | SEALING DEVICES, RELATED DELIVERY APPARATUSES, AND USES THEREOF - Embodiments of the present disclosure are directed to implantable sealing devices, delivery apparatuses, and methods of their use, for closing surgical openings or defects in a sidewall of a vessel in a subject. In several embodiments, the disclosed implantable sealing devices, delivery apparatuses, and methods can be used to close a surgical opening in a sidewall of the heart. | 05-21-2015 |
20150134052 | LOW PROFILE TRANSCATHETER HEART VALVE - An implantable prosthetic valve, according to one embodiment, comprises a frame, a leaflet structure, and a skirt member. The frame can have a plurality of axial struts interconnected by a plurality of circumferential struts. The leaflet structure comprises a plurality of leaflets (e.g., three leaflets arrange to form a tricuspid valve). The leaflet structure has a scalloped lower edge portion secured to the frame. The skirt member can be disposed between the leaflet structure and the frame. | 05-14-2015 |
20150127096 | METHOD FOR REPLACING MITRAL VALVE - A method of implanting a prosthetic mitral valve assembly using a transapical procedure is disclosed. An incision is formed in the chest in the apex of the patient's heart. A delivery catheter containing the prosthetic mitral valve assembly is advanced over a guidewire into the patient's heart. The prosthetic mitral valve assembly is deployed from the delivery catheter into the native mitral valve. The prosthetic mitral valve assembly comprises a stent having a lower portion for placement between the leaflets of a native mitral valve and an upper portion having a flared end for placement above the annulus. The prosthetic mitral valve includes a valve portion having leaflets formed of pericardial tissue. A plurality of upwardly bent prongs are provided along an outer surface of the stent for preventing upward migration of the prosthetic mitral valve assembly after deployment. | 05-07-2015 |
20150127093 | MAGNETIC RETAINING MECHANISMS FOR PROSTHETIC VALVES - Disclosed herein are representative embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve to a deficient valve. In one embodiment, for instance, a support member is positioned to at least partially surround the native chordae tendineae and/or leaflets of a valve. The support member can comprise a flexible, distensible material to reduce abrasion and other mechanical damage to surrounding structures. A locking member may be used to couple both ends of the support member, forming a support ring. The support member may have two magnetic end portions which can be magnetically coupled to form a support ring. An expandable prosthetic heart valve can be delivered into the native heart valve and expanded within the support band, thereby causing one or more of the native chordae tendineae and/or leaflets of the native heart valve to be frictionally secured between the support ring and the expanded prosthetic heart valve. | 05-07-2015 |
20150105634 | Monitoring Cardiovascular Conditions Using Signal Transit Times - Methods for monitoring cardiovascular conditions, i.e., hyperdynamic circulation, vasodilation, vasoconstriction, or central-to-peripheral arterial pressure decoupling conditions are described. These methods involve measuring a central signal proportional to or a function of the subject's heart activity and a peripheral signal proportional to or a function of a signal related to the central signal. Then calculating a time difference between features in the central and peripheral signals representing the same heart event. The cardiovascular condition is indicated if the time difference is greater or lower than a threshold value, if the time difference is greater or lower than a threshold value over a specified period of time, or if there is a significant statistical change in the times over the specified time period. These methods can alert a user that a subject is experiencing the cardiovascular condition, which can enable a clinician to appropriately provide treatment to the subject. | 04-16-2015 |
20150065828 | METHOD AND APPARATUS FOR CONTINUOUS ASSESSMENT OF A CARDIOVASCULAR PARAMETER USING THE ARTERIAL PULSE PRESSURE PROPAGATION TIME AND WAVEFORM - A method and apparatus for determining a cardiovascular parameter including receiving an input signal corresponding to an arterial blood pressure measurement over an interval that covers at least one cardiac cycle, determining a propagation time of the input signal, determining at least one statistical moment of the input signal, and determining an estimate of the cardiovascular parameter using the propagation time and the at least one statistical moment. | 03-05-2015 |
20150045878 | METHOD AND APPARATUS FOR RESHAPING A VENTRICLE - Methods are provided for reshaping the left ventricle to a more conical shape to counter the effects of dilation, thereby improving pumping efficiency. In an exemplary embodiment, a reshaping apparatus comprises an implantable body that can be delivered to a dilated left ventricle via the patient's vasculature in a minimally-invasive procedure. When deployed inside the left ventricle, the implantable body applies a longitudinal (downward) force against the inner surface of the left ventricle, thereby causing the left ventricle to distend or elongate downwardly. The implantable body preferably includes an anchor which is deployed adjacent the mitral valve for maintaining the longitudinal force against the inner surface of the left ventricle. | 02-12-2015 |
20150018696 | DISPOSABLE BLOOD PRESSURE TRANSDUCER AND MONITOR INTERFACE - A medical blood pressure transducer that provides an identifier to a monitor that conveys characteristics of the transducer. The monitor can use the information to decide whether to function, or in calibration of the system. The transducer may be part of a disposable blood pressure monitoring system, and may include two transducers closely-spaced to provide two separate but identical outputs. In this way, the transducer may be connected to both a patient monitor and a cardiac output monitor at the same time measurements from a single line can be simultaneously supplied to two separate monitoring devices (for example a patient monitor and a cardiac output monitor). The identifier for the transducer may be circuitry, specifically a resistance/capacitance (RC) combination that possesses a characteristic time constant. | 01-15-2015 |
20150007630 | SYSTEM AND METHOD FOR CRIMPING A PROSTHETIC VALVE - An exemplary system for crimping a prosthetic valve comprises a radially expandable and compressible prosthetic valve, a crimping device positioned around the valve and configured to reduce the diameter of the valve to a delivery configuration, and a sterile package enclosing the valve and the crimping device. The valve can be pre-assembled in a partially crimped configuration within the crimping device. After removing the sterile packaging, the crimping device can be used to crimp the valve from the partially crimped configuration to the delivery configuration, such as by twisting a knob on the crimping device. The system can further comprise at least a portion of a delivery catheter within the sterile package, wherein the valve is pre-mounted on or adjacent to an inflatable balloon of the delivery catheter, such that the valve can be crimped onto the delivery catheter using the crimping device. | 01-08-2015 |
20140379067 | EXPANDABLE SHEATH FOR INTRODUCING AN ENDOVASCULAR DELIVERY DEVICE INTO A BODY - Embodiments of an expandable sheath can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. Such embodiments can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Some embodiments can include a sheath with inner and outer layers, where a folded portion of the inner layer extends through a slit in the outer layer and a portion of the outer layer overlaps the folded portion of the inner layer. Some embodiments include an elastic outer cover positioned outside the outer layer. Embodiments of the present expandable sheath can avoid the need for multiple insertions for the dilation of the vessel, thus offering advantages over prior art introducer sheaths. | 12-25-2014 |
20140371847 | EXPANSION DEVICE AND METHOD FOR TREATING VASCULAR PASSAGEWAYS - Method for delivering an expandable member to a treatment location includes an elongate shaft and an expandable member coupled to a distal end of the elongate shaft. Embodiments of the expandable member are moveable between a collapsed configuration and an expanded configuration, and have an inner expandable member and a plurality of outer expandable members that at least partially surround the inner expandable member, and are suitable for delivering prosthetic heart valves and performing vavuloplasties. | 12-18-2014 |
20140364943 | METHODS OF DELIVERY OF FLEXIBLE HEART VALVES - A prosthetic heart valve can include a valve frame having a wireform portion and a stent portion. The wireform and stent portions can be undetachably coupled together via a plurality of upright struts so as to form a one-piece prosthetic heart valve frame. Alternatively, a self-expanding wireform portion and a balloon-expandable stent portion can be coupled together via one or more leaflets and a subassembly having a flexible leaflet support stent and a sealing ring. The wireform portion can include cusps and commissures configured to support a plurality of leaflets. The prosthetic valve can be radially collapsible for minimally invasive and/or transcatheter delivery techniques. Disclosed embodiments can also provide flexion of the wireform portion (e.g., of the commissures) in response to physiologic pulsatile loading when the valve is implanted in a patient's native valve annulus. Methods of making and using prosthetic heart valves are also disclosed. | 12-11-2014 |
20140353153 | Preparation and Maintenance of Sensors - Apparatus and methods are described for preparing, maintaining, and stabilizing sensors. The apparatus and methods for preparing sensors for use are utilized in advance of the sensor being removed from a sealed, sterilized package. The apparatus include packaging materials having electrical circuits capable of stabilizing a sensor to prepare the sensor for use. The methods for preparing a sensor for use includes methods of providing a solution to a sterilized packaging that contains a sensor connected to a sensor activating circuit, activating the circuit, and allowing the sensor to stabilize. These methods can be performed without compromising the packaging. The apparatus for stabilizing a sensor that is in use include a circuit connectable to the sensor that provides a signal to the sensor that prevents the sensor from becoming destabilized when disconnected from a monitoring device. | 12-04-2014 |
20140343671 | PERIVALVULAR SEALING FOR TRANSCATHETER HEART VALVE - The present disclosure is directed to embodiments of catheter-based prosthetic heart valves, and in particular, prosthetic heart valves having sealing devices configured to seal the interface between the prosthetic valve and the surrounding tissue of the native annulus in which the prosthetic valve is implanted. In one embodiment, a prosthetic heart valve includes an annular sealing member that can be placed in a delivery orientation extending axially away from one end of the valve when the valve is in a radially compressed state. When the valve is expanded, the expansion of the frame causes the sealing member to be pulled to an operative orientation covering a portion of the frame. The present disclosure also discloses new mechanisms and techniques for mounting valve leaflets to a frame of a prosthetic heart valve. | 11-20-2014 |
20140343670 | PROSTHETIC HEART VALVE DELIVERY APPARATUS - Certain embodiments of the present disclosure provide a prosthetic valve (e.g., prosthetic heart valve) and a valve delivery apparatus for delivery of the prosthetic valve to a native valve site via the human vasculature. The delivery apparatus is particularly suited for advancing a prosthetic heart valve through the aorta (i.e., in a retrograde approach) for replacing a diseased native aortic valve. The delivery apparatus in particular embodiments is configured to deploy a prosthetic valve from a delivery sheath in a precise and controlled manner at the target location within the body. | 11-20-2014 |
20140336753 | EXPANDABLE MEMBER FOR DEPLOYING A PROSTHETIC DEVICE - An apparatus and method for delivering a prosthetic device through the vasculature of a patient includes a radially expandable member coupled to the distal end of an elongate shaft. The expandable member has an open frame configuration and an outer mounting surface for mounting the prosthetic device in a collapsed state thereon. The expandable member expands radially outwards from a first configuration to a second configuration to expand a prosthetic device mounted thereon. | 11-13-2014 |
20140336702 | EXPANDABLE CLIP FOR TISSUE REPAIR - An apparatus, system, and method for repairing openings such as septal defects includes advancing a catheter to the site of the defect, grasping opposing edges of the defect, passing one or more suture lines through the opposing edges, tightening the suture lines, and deploying and expanding a fastener to secure the suture lines and close the defect. The fastener can include tissue-growth-inducing materials to encourage tissue growth onto or into the fastener and/or suture. The fastener includes a locking clip portion and a plug portion, which may be an expandable portion and/or tissue-growth-inducing portion. | 11-13-2014 |
20140330366 | SYSTEM AND METHOD FOR TRANSAORTIC DELIVERY OF A PROSTHETIC HEART VALVE - A delivery system and method for delivering a prosthetic heart valve to the aortic valve annulus via a transaortic approach. The system includes a balloon catheter for delivering a balloon-expandable prosthetic heart valve through an introducer from an approach from outside the patient, through a minimally-invasive opening in the chest cavity through an incision in the aorta, and into the aorta and aortic annulus. The balloon catheter includes a flexible, tapered tip just distal of the balloon to facilitate positioning of the prosthetic heart valve in the proper orientation within the aortic annulus. The prosthetic heart valve may be installed over the existing calcified leaflets, and a pre-dilation valvuloplasty procedure may also be utilized. | 11-06-2014 |
20140324160 | LOW-PROFILE HEART VALVE AND DELIVERY SYSTEM - Disclosed replacement heart valves can be designed to be delivered to a native valve site while crimped on a delivery catheter. The crimped profile of the replacement valve can be minimized by, for example, separating a frame or stent structure from a leaflet structure, along the axial direction. Disclosed replacement valves can be transitioned from a delivery configuration, in which the crimped profile can be minimized, to an operating configuration. The replacement valve can be fully assembled in both the delivery and operating configurations. In some embodiments, the leaflets can be positioned outside of the stent in the delivery configuration, and positioned inside of the stent lumen in the operating configuration. Disclosed replacement valves can include a flexible sleeve coupling the leaflets to the stent and facilitating the transition to the operating configuration. Methods of implanting said replacement valves are also disclosed. | 10-30-2014 |
20140309732 | BLOOD FLOW CONTROLLING APPARATUS - A method for reducing regurgitation in a mitral valve using a blood flow controlling apparatus. The blood flow controlling apparatus comprises a leaflet coaptation member, a connecting member, and an anchor suitable for anchoring the apparatus to the interventricular septum. The leaflet coaptation member coapts with the native mitral valve leaflets during systole when disposed therebetween, thereby reducing mitral valve regurgitation. During diastole, the native leaflets release coaptation with the leaflet coaptation member, permitting blood flow from the left atrium into the left ventricle. | 10-16-2014 |
20140309728 | TRANSAPICAL METHOD OF DELIVERING PROSTHETIC HEART VALVE - A method of delivering a prosthetic heart valve to the aortic valve annulus while a patient's heart is beating. The method includes accessing the left ventricle through an intercostal incision and forming a puncture in the left ventricle. A guidewire is advanced into the left ventricle and through the native aortic valve. An introducer sheath is passed over the guidewire and into the left ventricle. A prosthetic heart valve is advanced over the guidewire and through the introducer sheath using a delivery catheter. After positioning the prosthetic heart valve in the native aortic valve, the prosthetic heart valve is radially expanded in the aortic valve annulus for replacing the function of the native aortic valve. | 10-16-2014 |
20140303652 | SUTURE CLIP DEPLOYMENT DEVICES - Suture clip deployment devices for applying suture clips to sutures are described. Some embodiments can include a generally tubular main body and a vacuum port located at the distal end, a hollow inner body longitudinally slidable within the main body and extending from the main body at its distal end, and a suture recess located in the generally tubular main body. At least one suture clip configured to frictionally fit on an outer surface of the inner body is deployed during use. Clip deployment can occur after a vacuum source is applied to the device so as to draw the suture into the device. The suture lines can be retrieved through the suture recess, and the device can be actuated so as to deliver the suture clip off the delivery device and onto the suture, locking the suture in place. | 10-09-2014 |
20140296727 | Detection of Parameters in Cardiac Output Related Waveforms - Methods for detecting parameters in cardiac output related waveforms are described. The methods include methods for detecting individual heart beat cycles in a cardiac output related waveform, methods for detecting an error in an assigned starting point for an individual heart beat cycle in a cardiac output related waveform, methods for detecting a dichrotic notch for an individual heart beat cycle in a cardiac output related waveform, and methods for detecting an error in an assigned dichrotic notch for an individual heart beat cycle in a cardiac output related waveform. The identification of these parameters is important for a clinician as these parameters form the basis for the calculation of many other cardiac output related parameters. | 10-02-2014 |
20140288480 | DEVICE AND METHOD FOR INCREASING FLOW THROUGH THE LEFT ATRIAL APPENDAGE - Methods and devices for increasing flow in the left atrial appendage (LAA) include a conduit directing blood flow from a pulmonary artery into the LAA and/or a conduit drawing blood from the LAA by a Bernoulli effect. In one embodiment, a method comprises implanting a conduit in a pulmonary vein, expanding an inlet portion such that the conduit becomes anchored within the vein and directs blood through an outlet portion of the conduit into or toward the left atrial appendage. | 09-25-2014 |
20140277421 | DYNAMIC ANNULOPLASTY RING SIZER - A dynamic, adjustable annuloplasty ring sizer can include an adjustable ring replica, which can be adjusted through a range of sizes corresponding to available prosthetic annuloplasty repair ring sizes. Actuation of an adjustment trigger on a handle portion of the ring sizer can displace tension wires that extend through a malleable shaft and through a plurality of articulating segments that form the ring replica. Displacement of the tension wires causes flexion of the joints between adjacent articulating segments, thereby reducing the overall size of the ring replica. Releasing the tension wires can allow an elastic extension wire to act on the ring replica, enlarging the ring replica to its maximum, at-rest size. In this manner, the appropriate size of annuloplasty ring prosthesis can be determined with a single device, without requiring a plurality of static ring sizers that require individual insertion and placement for the conventional trial-and-error sizing methods. | 09-18-2014 |
20140277420 | MULTI-STRANDED HEAT SET ANNULOPLASTY RINGS - An annuloplasty repair segment for heart valve annulus repair. In one embodiment a multi-stranded cable replaces solid core wire for both the tricuspid and mitral valves. Cable allows for greater deployment flexibility for minimally-invasive surgical (MIS) implant, while still maintaining the required strength and similar tensile properties of solid-core wire. Stranded cable provides a MIS annuloplasty ring with sufficient flexibility in the x-y plane to allow a surgeon to squeeze the ring into a small incision, such as being able to pass through an 18Fr or smaller catheter, while maintaining structural rigidity under forces exerted on the implanted ring by the cardiac cycle. The particular shape of the annuloplasty ring is fixed using a heat setting process. | 09-18-2014 |
20140260097 | AUTOMATED CRIMPING OF TRANSCATHETER HEART VALVES - The present disclosure is directed to embodiments of automated crimping systems, methods of crimping prosthetic valves, and methods of using automated crimping systems to crimp prosthetic valves. In some embodiments, an automated crimping system includes a crimper controller, a rotary actuator, an outer crimper housing, and a crimper mechanism mounted within the outer crimper housing. In some embodiments, an automated method of crimping a prosthetic valve includes inserting a prosthetic valve into an automated crimping system, activating the automated crimping system, and removing the crimped prosthetic valve from the automated crimping system. In some embodiments, a method of crimping a prosthetic valve comprises partially crimping the prosthetic valve at a first speed to a partially crimped configuration and further crimping the prosthetic valve at a second speed. | 09-18-2014 |
20140243958 | METHOD FOR TREATING AN AORTIC VALVE - A method for replacing a native heart valve with a prosthetic heart valve comprises moving a first portion of a prosthetic heart valve towards a second portion of the prosthetic heart valve along a plurality of guide wires, and lock the first portion to the second portion in a final, radially expanded configuration. The prosthetic heart valve is radially contractible and expandable, and in some embodiments, is self-expanding. Embodiments of the method are minimally invasive. | 08-28-2014 |
20140235984 | SYSTEM FOR A BLOOD ANALYTE SENSOR - The present invention provides a blood parameter sensing system that may include a sensor, a blood access system, a flow controller and a monitor system. The blood access system may include a blood draw member having an internal configuration adapted to avoid clotting without the use of anticoagulants and under a range of flow profiles, including small volume blood draws. The flow controller may be configured to adapt to a range of access devices by using feedback from the sensor and monitor to customize flow profiles. The monitor system is configured to reduce parameter measurement error by modeling sensitivity change during system startup or reconnect. | 08-21-2014 |
20140235971 | DETECTING A VASOACTIVE AGENT IN THE BLOODSTREAM - A system and method are disclosed for detecting a vasoactive agent in patient's bloodstream. In one embodiment, an input signal is received that is associated with arterial blood pressure. A change of an arterial blood pressure parameter over time is determined. A vasoactive agent is then automatically detected using the determined change. In another embodiment, a waveform associated with an arterial blood pressure signal can be received. A parameter associated with the received waveform is calculate. Then the calculated parameter can be used to determine the presence of a vasoactive agent. In yet another embodiment, detection of a vasoactive agent in any of the other embodiments can be used in a calculation of a hemodynamic parameter, such as cardiac output, stroke volume, systemic vascular resistance, stroke volume variation, cardiac index, stroke volume index, systemic vascular resistance index, vascular compliance, and vascular tone. | 08-21-2014 |
20140222141 | PROSTHETIC MITRAL VALVE - A prosthetic mitral valve with a compressible and expandable stent that, when expanded, is circumferentially oval, elliptical, or D-shaped, with a major axis and a minor axis ratio of from about 3:4 to about 4:5. Embodiments of the stent comprise three commissure posts disposed towards an outflow end and three curved cusp regions between adjacent commissure posts. Three flexible leaflets are attached to the commissure posts in a tri-foil configuration. Embodiments of the prosthetic mitral valve include an atrial ring disposed at the inflow end of the stent. | 08-07-2014 |
20140222140 | METHODS OF IMPLANTING MINIMALLY-INVASIVE PROSTHETIC HEART VALVES - Expandable prosthetic heart valves for minimally invasive valve replacement are disclosed. In one preferred embodiment, an expandable prosthetic heart valve includes a support stent comprising an expandable tubular base along an inflow end and three upstanding commissure posts along an outflow end. The three commissure posts are spaced at 120 degree intervals with gaps therebetween. The prosthetic heart valve further includes a tubular flexible member having a prosthetic section and a fabric section. The prosthetic section is connected to the three commissure posts and defines three leaflets, preferably formed of pericardial tissue. The fabric section is sutured to the expandable tubular base. The tubular base may be formed with a shape memory material and is sized for deployment with an annulus of a native aortic valve. After deployment, the three commissure posts support the leaflets above the tubular base for replacing the function of the native aortic valve. In one variation, flanges may be provided on the support stent for improving attachment of the support stent to the host tissue. | 08-07-2014 |
20140222139 | EXPANDABLE INTRODUCER SHEATH - An introducer sheath has a radially unexpanded and a radially expanded configuration, where the sheath locally expands from the unexpanded configuration to the expanded configuration when a device is advanced through a lumen thereof, and locally contracts back to the unexpanded configuration after the device advances past that location. Embodiments of the introducer sheath include an outer tubular layer comprising a longitudinal cut therethrough, and an inner tubular layer comprising at least one pleat extending through the longitudinal cut to an outside surface of the outer tubular layer. Embodiments of the inner tubular layer are adhered to an inner surface of the outer tubular layer, with the pleat not adhered to an outer surface of the outer tubular layer. | 08-07-2014 |
20140222136 | PROSTHETIC VALVE FOR REPLACING MITRAL VALVE - Embodiments of prosthetic valves for implantation within a native mitral valve are provided. One embodiment of a prosthetic valve includes a radially compressible main body and a one-way valve member. In some cases, the prosthetic valves also include ventricular anchors and/or an atrial portion coupled to and disposed outside of the main body. Methods, devices, and systems for delivering such prosthetic valves to the native mitral valve and implanting them therein are also provided. | 08-07-2014 |
20140221911 | CLOT DETECTION BASED ON SIGNAL-TIME HISTORY DIAGNOSTICS - The present disclosure provides a sensor system that includes a blood access device, a flow controller, and an analyte sensor. The system is configured to flush or draw a volume of fluid through the blood access device at least once; determine a signal-time history corresponding to signals received from the sensor; determine a duration of a portion of the signal-time history; determine whether the duration is greater than a predetermined threshold value; and detect the occlusion in the blood access device when the duration is greater than the predetermined threshold value. | 08-07-2014 |
20140214069 | Inflatable Embolic Deflector - The present disclosure concerns embodiments of an expandable and collapsible embolic deflector that can be collapsed to a very small profile for insertion through a patient's vasculature and then expanded once inside the body. The embolic deflector comprises a flexible, inflatable frame that supports a blood-permeable membrane that prevents emboli above a predetermined size from entering vasculature that is blocked by the membrane. The frame comprises an inflatable body made of a soft polymeric material, such as urethane, Pebax, or nylon, similar to a balloon of a balloon catheter. In particular embodiments, the frame does not include any metal components. In certain embodiments, the frame can include one or more radiopaque markers, which can be made of a metal or metal alloy. In either case, the risk of potential trauma to the patient can be reduced since the amount of hard metal components is significantly reduced or completely eliminated. | 07-31-2014 |
20140214068 | CATHETER BALLOON AND FORMATION THEREOF - A process for forming a catheter balloon includes subjecting a tubular parison in a mold to molding fluid pressure. The resulting catheter balloon includes a balloon portion having two ends and tubular leg portions extending from either end. The ends of the balloon portion are tapered to the tubular leg portions. While in the mold, the tubular leg portions are drawn axially sufficiently to form permanent creases in the tapered ends. This drawing may be sufficient to cause the material of the tapered ends to exceed the yield strength, particularly with the balloon material in a malleable state. Anomalies on tapered parts of the mold may include ribs or spiral ribs to assist in the creasing process. | 07-31-2014 |
20140213970 | CATHETER BALLOON AND METHOD OF FABRICATION - A process for forming a catheter balloon includes subjecting a tubular parison in a mold to molding fluid pressure. The resulting catheter balloon includes a balloon portion having two ends and tubular leg portions extending from either end. The ends of the balloon portion are tapered to the tubular leg portions. The tapered ends have alternating elongate areas of greater and lesser resistance to deformation displaced circumferentially about the tapered ends. The elongate areas of greater and lesser resistance to deformation can include ridges which are either longitudinal or spiraled or rods imbedded in the body of the balloon. While in the mold, the tubular legs are drawn axially sufficiently to form permanent creases in the tapered ends. This drawing may be sufficient to cause the material of the tapered ends to exceed the yield strength, particularly with the balloon material in a malleable state. | 07-31-2014 |
20140213914 | ARTERIAL PRESSURE-BASED, AUTOMATIC DETERMINATION OF A CARDIOVASCULAR PARAMETER - One or more cardiovascular parameters is estimated as a function of the arterial pressure waveform, in particular, using at least one statistical moment of a discrete representation pressure waveform having an order greater than one. Arterial compliance, the exponential pressure decay constant, vascular resistance, cardiac output, and stroke volume are examples of cardiovascular parameters that can be estimated using various aspects of the invention. In one embodiment of the invention, not only are the first four moments (mean, standard deviation, skewness, and kurtosis) of the pressure waveform used to estimate the cardiovascular parameter(s) of interest, but also heart rate, statistical moments of a set of pressure-weighted time values, and certain anthropometric patient measurements such as age, sex, body surface area, etc. | 07-31-2014 |
20140209459 | MEMBRANE SYSTEM WITH SUFFICIENT BUFFERING CAPACITY - Electrochemical sensors for measurement of an analyte comprising an analyte sensing membrane comprising at least one salt of acetate ion, carbonate ion, bicarbonate ion, or mixtures thereof. Sensor testing methods comprising contacting an electrochemical sensor with an aqueous solution comprising at least one salt of acetate ion, carbonate ion, bicarbonate ion, or mixtures thereof and contacting the electrochemical sensor with one or more concentrations of analyte, the one or more concentrations of analyte being in the clinical concentration range of the analyte. | 07-31-2014 |
20140209238 | METHODS OF MAKING ENCAPSULATED HEART VALVES - The present disclosure concerns embodiments of implantable prosthetic devices, and in particular, implantable prosthetic valves, and methods for making such devices. In one aspect, a prosthetic device includes encapsulating layers that extend over a fabric layer and secure the fabric layer to another component of the device. In particular embodiments, the prosthetic device comprises a prosthetic heart valve, and can be configured to be implanted in any of the native heart valves. In addition, the prosthetic heart valve can be, for example, a transcatheter heart valve, a surgical heart valve, or a minimally-invasive heart valve. | 07-31-2014 |
20140202908 | DRY PROSTHETIC HEART VALVE PACKAGING SYSTEM - Packaging for prosthetic heart valves including an assembly for stabilizing dry prosthetic tissue implants such as heart valves during storage. The packaging assembly includes a primary sterile barrier that permits gas sterilization of the tissue implant, and a secondary sterile barrier that prevents oxidation of the implant during storage. Tissue heart valves are placed inside an inner tray and sealed with a gas-permeable lid. The inner tray is placed within an outer sterile barrier and the assembly is sterilized. The outer sterile barrier may include a double seal so that a first gas-permeable seal can be closed for sterilization, after which a second gas-impermeable seal is closed to seal out any further oxygen contact with the tissue implant. Alternatively, the inner tray is placed within a sterile pouch and the assembly gas-sterilized, and then the entire assembly is placed within another pouch that provides an impermeable barrier. | 07-24-2014 |
20140200661 | RAPIDLY DEPLOYABLE SURGICAL HEART VALVES - A quick-connect heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The heart valve includes a substantially non-expandable, non-compressible prosthetic valve and a plastically-expandable frame, thereby enabling attachment to the annulus without sutures. A small number of guide sutures may be provided for aortic valve orientation. The prosthetic valve may be a commercially available valve with a sewing ring with the frame attached thereto. The frame may expand from a conical deployment shape to a conical expanded shape, and may include web-like struts connected between axially-extending posts. A system and method for deployment includes an integrated handle shaft and balloon catheter. A valve holder is stored with the heart valve and the handle shaft easily attaches thereto to improve valve preparation steps. | 07-17-2014 |
20140200659 | CAPPING BIOPROSTHETIC TISSUE TO REDUCE CALCIFICATION - A treatment for bioprosthetic tissue used in implants or for assembled bioprosthetic heart valves to reduce in vivo calcification. The method includes applying a calcification mitigant such as a capping agent or an antioxidant to the tissue to specifically inhibit oxidation in tissue. Also, the method can be used to inhibit oxidation in dehydrated tissue. The capping agent suppresses the formation of binding sites in the tissue that are exposed or generated by the oxidation and otherwise would, upon implant, attract calcium, phosphate, immunogenic factors, or other precursors to calcification. In one method, tissue leaflets in assembled bioprosthetic heart valves are pretreated with an aldehyde capping agent prior to dehydration and sterilization. | 07-17-2014 |
20140194977 | METHODS AND APPARATUSES FOR DEPLOYING MINIMALLY-INVASIVE HEART VALVES - Methods and systems for delivering and deploying a prosthetic heart valve include a deployment mechanism coupled to the prosthetic heart valve, the deployment mechanism comprising a longitudinal shaft that when rotated in a first direction, expands the prosthetic heart valve from a contracted state to an expanded state, and optionally, when rotated in a second direction opposite the first direction, re-contracts the prosthetic valve from the expanded state. Embodiments of the deployment mechanism comprise a pinion gear that engages a gear track on the prosthetic heart valve. | 07-10-2014 |
20140188219 | POST-IMPLANT EXPANDABLE SURGICAL HEART VALVE CONFIGURATIONS - Disclosed herein is a prosthetic heart valve, and associated methods therefore, configured to replace a native heart valve, and having a support frame configured to be reshaped into an expanded form in order to receive and/or support an expandable prosthetic heart valve therein. The prosthetic heart valve is configured to have an expansion-resistant configuration when initially implanted to replace a native valve (or other prosthetic heart valve), but to assume a generally expanded form when subjected to an outward force such as that provided by a dilation balloon or other mechanical expander. | 07-03-2014 |
20140180337 | SYSTEM FOR SECURING SUTURES - Described herein are systems and methods for securing sutures that obviate the need for tying knots. Instead of tying two ends of a suture or two sutures together with a knot, two or more suture portions can be fused or cauterized together using heat. A device can be applied to adjacent suture portions that heats the suture portions and causes the suture portions to fuse together, effectively securing the suture portions together without a knot. | 06-26-2014 |
20140166612 | ANALYTE SENSOR AND FABRICATION METHODS - Methods for fabricating analyte sensor components using IC- or MEMs-based fabrication techniques and sensors prepared therefrom. Fabrication of the analyte sensor component comprises providing an inorganic substrate having deposited thereon a release layer, a first flexible dielectric layer and a second flexible dielectric layer insulating there between electrodes, contact pads and traces connecting the electrodes and the contact pads of a plurality of sensors. Openings are provided in one of the dielectric layers over one or more of the electrodes to receive an analyte sensing membrane for the detection of an analyte of interest and for electrical connection with external electronics. The plurality of fabricated sensor components are lifted off the inorganic substrate. | 06-19-2014 |
20140163670 | PROSTHETIC HEART VALVE DELIVERY SYSTEM AND METHOD - A method for delivering a self-expanding prosthetic heart valve comprises positioning the prosthetic heart valve in an annulus of a native heart valve while mounted in a radially compressed state in a delivery cylinder, the delivery cylinder coupled to a distal end portion of the torque shaft, and rotating a torque shaft coupled to the delivery cylinder. Rotating the torque shaft retracts the delivery cylinder, thereby exposing the prosthetic heart valve, allowing the prosthetic heart valve to self-expand in the native valve annulus. In some embodiments, the torque shaft is rotated by a motor disposed in a handle at a proximal end of the delivery device. | 06-12-2014 |
20140135910 | DEVICE AND METHOD FOR RESHAPING TRICUSPID VALVE ANNULUS - A device for reshaping the tricuspid valve comprises a stent that is deployed in the right ventricular outflow tract (RVOT) adjacent to the tricuspid valve and expanded to a size sufficient to reduce the annular diameter or size of the tricuspid valve, thereby improving coaptation of the leaflets and reducing regurgitation. Embodiments of the device are deliverable percutaneously. | 05-15-2014 |
20140134594 | METHODS FOR CROSS-LINKING BIOPROSTHETIC TISSUE USING BIO-ORTHOGONAL BINDING PAIRS - Methods for treating a bioprosthetic tissue are described. The methods comprise contacting the biological tissue with an anchor compound, the anchor compound comprising first and second functional groups. The first functional group is reactive with and couples a tissue functional group associated with the biological tissue. The second functional group is one of a bio-orthogonal binding pair. The biological tissue coupled to the anchor compound is then exposed to a linking compound. The linking compound comprises at least two functional groups, each comprising the other one of the bio-orthogonal binding pair. In a preferred embodiment, the bio-orthogonal binding pair is an azide and an acetylene. The method can be performed in the presence of a catalyst, preferably a copper catalyst. Alternatively, the method can be performed in the absence of a catalyst, wherein the acetylene is incorporated in a ring-strained cyclic compound, such as cyclooctyne. | 05-15-2014 |
20140130456 | Treatment of Bioprosthetic Tissues to Mitigate Post Implantation Calcification - Bioprosthetic tissues are treated by immersing or otherwise contacting fixed, unfixed or partially fixed tissue with a glutaraldehyde solution that has previously been heat-treated or pH adjusted prior to its contact with the tissue. The prior heat treating or pH adjustment of the glutaraldehyde solution causes its free aldehyde concentration to decrease by about 25% or more, preferably by as much as 50%, and allows a “stabilized” glutaraldehyde solution to be obtained at the desired concentration and pH for an optimal fixation of the tissue at high or low temperature. This treatment results in a decrease in the tissue's propensity to calcify after being implanted within the body of a human or animal patient. | 05-15-2014 |
20140128968 | IMPLANTABLE PROSTHETIC VALVE ASSEMBLY AND METHOD FOR MAKING THE SAME - An implantable prosthetic valve assembly having a frame comprising a first frame portion and a second frame portion connected end-to-end exhibits enhanced rigidity. Each frame portion includes a plurality of circumferential struts formed with multiple bends, with the bends of the first frame portion having angles that are less than the bends of the second frame portion. Some embodiments of the frame have a semi-collapsed state in which the first frame portion is frustoconical and the second frame portion is generally cylindrical. A valve member is attached to the first frame portion. | 05-08-2014 |
20140127804 | METHODS FOR TREATING BIOPROSTHETIC TISSUE USING A NUCLEOPHILE/ELECTROPHILE IN A CATALYTIC SYSTEM - Methods for treating a bioprosthetic tissue are described herein. The methods comprise contacting the bioprosthetic tissue with at least one nucleophile and/or at least one electrophile in the presence of a catalytic system comprising at least one or a combination of a fluoride-based salt, a cesium-based salt, a potassium-based salt, a rubidium-based salt, or a carbonate-based salt. The methods may be used to alter functional groups on biological tissue which represent actual and potential calcium binding sites and also processes for cross-linking bioprosthetic tissue. Both processes may be used in conjunction with known fixative techniques, such as glutaraldehyde fixation, or may be used to replace known fixative techniques. | 05-08-2014 |
20140121764 | AORTIC VALVE AND CONDUIT GRAFT IMPLANT TOOL - A sizing tool for use in implanting a composite valved conduit having a prosthetic heart valve on a distal end attached to a conduit graft that extends to a proximal end. The tool includes a proximal handle and a distal shaft, a prosthetic heart valve sizer having an axis affixed to a distal end of the shaft, and a conduit graft replica having an axis mounted on the shaft proximal to the heart valve sizer. A method of securing a composite valved conduit includes introducing to an excised ascending aorta the sizing tool, measuring the aortic annulus with the prosthetic heart valve sizer, and determining whether the coronary arteries have sufficient length or whether an additional tubular coronary extension segment is required to add to one or both of the ends of the coronary arteries by extending the coronary arteries toward the conduit graft replica. | 05-01-2014 |
20140100420 | TRANSVENTRICULAR IMPLANT TOOLS AND DEVICES - A method and implantation tools for repairing a heart include a delivery catheter and implant. The method includes gaining access to the patient's heart and identifying implantation points for the implant. The method may include marking those locations and delivering implant, which may be a tension member. Anchors for the implant may also be delivered. The length of the tension member may be measured and the walls of the heart drawn together. Pads may be secured to the tension member and the tension member trimmed to length. The pads may be secured to the heart surface. | 04-10-2014 |
20140088694 | TWO-PART PROSTHETIC VALVE SYSTEM - A prosthetic valve system for replacing a native aortic valve exhibiting regurgitation comprises a support structure and a transcatheter heart valve (THV) that is separate from the support structure. The support structure is radially collapsible and expandable, and deployable on an outflow side of the native aortic valve, circumscribing the native leaflets of the aortic valve. The THV is radially collapsible and expandable, and deployable in an annulus of the native aortic valve to frictionally engage the native leaflets between an interior surface of the support structure and the THY. | 03-27-2014 |
20140088692 | SYSTEMS AND METHODS FOR REPLACING A NATIVE HEART VALVE AND AORTA WITH A PROSTHETIC HEART VALVE AND CONDUIT - A medical device includes an expandable conduit, a prosthetic heart valve and a delivery device, including a balloon catheter. The expandable conduit may include one or more inner or outer sleeves supported by a frame or stent. The sleeve(s) may be a bioprosthetic tissue wrapped, molded or sewn about the frame or stent. Coupled to an end of the expandable conduit is the prosthetic heart valve. The conduit and heart valve may be crimped on the balloon catheter for percutaneous deployment. The frame may be constructed of a balloon-expandable material for the conduit portion and a self-expandable material for the prosthetic heart valve portion. The prosthetic heart valve is anchored at the native heart valve and then the conduit to be expanded into place to protect the aorta. The self-expanding prosthetic heart valve avoids the need for balloon mounting. This provides for a smaller diameter and easier delivery. | 03-27-2014 |
20140081389 | CONFORMAL EXPANSION OF PROSTHETIC DEVICES TO ANATOMICAL SHAPES - A system for expanding a device in a conduit or orifice of a human body includes an expansion device that is movable from a first configuration to a second configuration. External surfaces of the expansion device can collectively have a non-cylindrical cross-section relative to a main axis of the expansion device, such that the external surfaces of the expansion device generally conform to the anatomical shape of the conduit or orifice when the expansion device is in the second configuration. | 03-20-2014 |
20140067054 | Heart Valve Sealing Devices - This disclosure pertains generally to prosthetic devices and related methods for helping to seal native heart valves and prevent or reduce regurgitation therethrough, as well as devices and related methods for implanting such prosthetic devices. In some cases, a spacer having a single anchor can be implanted within a native heart valve. In some cases, a spacer having dual anchors can be implanted within a native heart valve. In some cases, devices can be used to extend the effective length of a native heart valve leaflet. | 03-06-2014 |
20140067052 | Heart Valve Sealing Devices - This disclosure pertains generally to prosthetic devices and related methods for helping to seal native heart valves and prevent or reduce regurgitation therethrough, as well as devices and related methods for implanting such prosthetic devices. In some cases, a spacer having a single anchor can be implanted within a native heart valve. In some cases, a spacer having dual anchors can be implanted within a native heart valve. In some cases, devices can be used to extend the effective length of a native heart valve leaflet. | 03-06-2014 |
20140067048 | Heart Valve Sealing Devices - This disclosure pertains generally to prosthetic devices and related methods for helping to seal native heart valves and prevent or reduce regurgitation therethrough, as well as devices and related methods for implanting such prosthetic devices. In some cases, a spacer having a single anchor can be implanted within a native heart valve. In some cases, a spacer having dual anchors can be implanted within a native heart valve. In some cases, devices can be used to extend the effective length of a native heart valve leaflet. | 03-06-2014 |
20140058502 | INTEGRATED HEART VALVE DELIVERY SYSTEM - Embodiments of the present disclosure provide a delivery apparatus for delivering a prosthetic heart valve to a native valve site via the human vasculature without the need for a separate introducer sheath. The delivery apparatus is particularly well-suited for advancing a prosthetic valve through the aorta (i.e., in a retrograde approach) for replacing a stenotic aortic valve. | 02-27-2014 |
20140039609 | HOLDERS FOR PROSTHETIC HEART VALVES - An improved holder and storage system for prosthetic heart valves that pre-shields or pre-constricts the commissure posts of the valve to prevent suture looping. Pre-shielding and pre-constriction mean at the time of manufacture, so that the valves are stored with the commissure posts shielded and/or constricted. The holders may have solid legs that directly contact and constrict and hold the commissure posts without the use of sutures in tension that might creep over the time in storage. The holder may have a base in contact with the inflow end and a shaft portion that projects through the valve leaflets and cooperates with movable legs on the outflow end of the valve in contact with the commissure posts. The holders may, alternatively, have flexible leg members that extend through the valve and have distal end portions configured to extend over and shield the tips of commissure posts. | 02-06-2014 |
20140039380 | DIRECT ACCESS ATHERECTOMY DEVICES AND METHODS OF USE - An atherectomy device and method has cannula systems having lumens adapted for insertion of a blood filter and an atherectomy catheter useful for performing atherectomy directly on a patient's cardiovascular tissue. Other embodiments include a lumen for arterial perfusion useful in providing oxygenated blood to the aorta during cardiopulmonary bypass. The distal end of the atherectomy catheter includes an assembly that has a pincer, a loop with or without a mesh, laser, hydraulics, or other suitable mechanism adapted for removing atheroma from a cardiac or vascular tissue. Methods of using the systems for vascular atherectomy are also disclosed herein. | 02-06-2014 |
20140031930 | CARDIAC IMPLANT CONFIGURED TO RECEIVE A PERCUTANEOUS PROSTHETIC HEART VALVE IMPLANTATION - The invention is a cardiac implant, and associated methods therefore, configured to repair and/or replace a native heart valve, and having a support frame configured to be reshaped into an expanded/changed form in order to receive and/or support an expandable prosthetic heart valve therein. The implant may be configured to have a generally rigid and/or expansion-resistant configuration when initially implanted to replace/repair a native valve (or other prosthetic heart valve), but to assume a generally non-rigid and/or expanded/expandable form when subjected to an outward force such as that provided by a dilation balloon. The implant may be configured to have a generally D-shaped configuration when initially implanted, but to assume a generally circular form when subjected to an outward force such as that provided by a dilation balloon. | 01-30-2014 |
20140012373 | Method for Implanting a Prosthetic Mitral Valve - Embodiments of a method for implanting a prosthetic valve at the native mitral valve region of the heart, the prosthetic valve including a main body that is radially compressible to a radially compressed state and self-expandable from the compressed state to a radially expanded state. The prosthetic apparatus also comprises at least one ventricular anchor coupled to the main body and disposed outside of the main body with a leaflet-receiving space between the anchor and an outer surface of the main body to receive a native valve leaflet. Apparatus for delivering and implanting the prosthetic valve are also described. | 01-09-2014 |
20140012372 | Apparatus For Treating A Mitral Valve - Embodiments of an apparatus for treating a deficient mitral valve include an expandable spacer configured for placement between the native leaflets of the mitral valve, the spacer anchorable to a wall of the ventricle. Methods and apparatus for delivering and implanting the prosthetic are also described. | 01-09-2014 |
20130345801 | FORCE-BASED HEART VALVE SIZER - A valve sizer for determining an appropriate replacement valve size when performing a heart valve replacement procedure is provided. In one version the valve sizer has a hollow shaft with proximal and distal ends. A movable sizing element couples to the distal end of the shaft and is radially expandable between first, contracted and second, expanded positions. An actuator assembly on a handle includes an actuator coupled to a clutch member via a ball-spring-detent clutch. A rod extends through the shaft and maintains a fixed distance between the handle and a distal hub in the sizing element. Movement of the actuator causes axial movement of the shaft, thereby causing radial expansion of sizing petals relative to the hub. The clutch slips when a predetermined reaction force from the surrounding valve annulus is met by the petals. | 12-26-2013 |
20130345798 | METHODS OF VALVE DELIVERY ON A BEATING HEART - A delivery system and method for delivering a prosthetic heart valve to the aortic valve annulus. The system includes a delivery catheter having a steering mechanism thereon for delivering a balloon-expandable prosthetic heart valve to the aortic annulus in an antegrade fashion through an introducer passing into the left ventricle through its apex. The introducer may have a more floppy distal section than a proximal section to reduce trauma to the heart wall while preserving good operating field stability. The delivery catheter includes a deflecting segment just proximal to a distal balloon to facilitate positioning of the prosthetic heart valve in the proper orientation within the aortic annulus. A trigger in a catheter handle may be coupled to a deflection wire that actuates the deflecting segment, while a slider in the handle controls retraction of a valve pusher. The prosthetic heart valve may be installed over the existing calcified leaflets, and a pre-dilation valvuloplasty procedure may also be utilized. | 12-26-2013 |
20130338763 | DEVICES AND METHODS FOR REDUCING CARDIAC VALVE REGURGITATION - The present invention relates to devices and methods for improving the function of a defective heart valve, and particularly for reducing regurgitation through an atrioventricular heart valve—i.e., the mitral valve and the tricuspid valve. For a tricuspid repair, the device includes an anchor deployed in the tissue of the right ventricle, in an orifice opening to the right atrium, or anchored to the tricuspid valve. A flexible anchor rail connects to the anchor and a coaptation element on a catheter rides over the anchor rail. The catheter attaches to the proximal end of the coaptation element, and a locking mechanism fixes the position of the coaptation element relative to the anchor rail. Finally, there is a proximal anchoring feature to fix the proximal end of the coaptation catheter subcutaneously adjacent the subclavian vein. The coaptation element includes an inert covering and helps reduce regurgitation through contact with the valve leaflets. | 12-19-2013 |
20130325110 | SYSTEMS AND METHODS FOR PLACING A COAPTING MEMBER BETWEEN VALVULAR LEAFLETS - The present invention relates to devices and methods for improving the function of a defective heart valve, and particularly for reducing regurgitation through an atrioventricular heart valve—i.e., the mitral valve and the tricuspid valve. For a tricuspid repair, the device includes an anchor deployed in the tissue of the right ventricle, in an orifice opening to the right atrium, or anchored to the tricuspid valve. A flexible anchor rail connects to the anchor and a coaptation element on a catheter rides over the anchor rail. The catheter attaches to the proximal end of the coaptation element, and a locking mechanism fixes the position of the coaptation element relative to the anchor rail. Finally, there is a proximal anchoring feature to fix the proximal end of the coaptation catheter subcutaneously adjacent the subclavian vein. The coaptation element includes an inert covering and helps reduce regurgitation through contact with the valve leaflets. | 12-05-2013 |
20130325098 | PERCUTANEOUS IMPLANT EXTRACTION DEVICE - A minimally invasive catheter system and method for extraction of a shape memory device such as a nitinol stent, from inside a tubular organ, is provided. The catheter system comprises a multi-lumen tube with at least one expandable balloon and an extraction device. The multi-lumen tube has multiple ports, which are used for injecting fluid inside the tubular organ and the expandable balloon, and inserting the extraction device. The catheter system is inserted inside the lumen of the tubular organ percutaneously. A cold fluid is injected into the expandable balloon and the lumen of the tubular organ. This cold fluid converts the shape memory device from an expanded state to a collapsed state. The shape memory device in the collapsed state is then removed with the help of the extraction device. | 12-05-2013 |
20130324815 | CONTINUOUS MEASUREMENT OF TOTAL HEMOGLOBIN - The present application relates to continuous measurement of total hemoglobin (tHb) in whole blood. In one embodiment, different wavelengths are used for normalization of the spectral intensity and calculation of the total hemoglobin. In particular, for normalization, a first wavelength is used wherein the wavelength is substantially insensitive to changes in levels of hemoglobin and oxygen saturation. For calculation of the total hemoglobin, a second wavelength is used. The second wavelength is sensitive to changes in levels of hemoglobin, but substantially insensitive to changes in levels of oxygen saturation. In another embodiment, a continuous measurement can be made using two wavelengths that are both sensitive to oxygen saturation, but they both are equally sensitive. In other words, the normalized intensities associated with the two wavelengths change equal amounts with equal changes in oxygen saturation levels. | 12-05-2013 |
20130324804 | SYSTEMS AND METHODS FOR MONITORING AND DISPLAYING A PATIENT'S STATUS - The disclosure generally relates to a patient monitoring and display system. The system allows a clinician to trigger the occurrence of a clinical event, and record a patient's status following the clinical event. The system calculates and displays a change in a patient's status resulting from the clinical event. The system allows multiple parameters to be tracked and displayed on a single screen. The system can also display various animated organs, such as a heart or a lung, corresponding to an operation of the organs in the patient. | 12-05-2013 |
20130317598 | RAPID DEPLOYMENT PROSTHETIC HEART VALVES - A heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve comprises a support structure that is deployed at a treatment site. The prosthetic valve further comprises a valve member configured to be quickly connected to the support structure. The support structure may take the form of a stent that is expanded at the site of a native valve. If desired, the native leaflets may remain and the stent may be used to hold the native valve open. In this case, the stent may be balloon expandable and configured to resist the powerful recoil force of the native leaflets. The support structure is provided with a coupling means for attachment to the valve member, thereby fixing the position of the valve member in the body. The valve member may be expandable or a non-expandable type. | 11-28-2013 |
20130310929 | METHODS OF CONDITIONING SHEET BIOPROSTHETIC TISSUE - Methods for the conditioning of bioprosthetic material employ bovine pericardial membrane. A laser directed at the fibrous surface of the membrane and moved relative thereto reduces the thickness of the membrane to a specific uniform thickness and smoothes the surface. The wavelength, power and pulse rate of the laser are selected which will smooth the fibrous surface as well as ablate the surface to the appropriate thickness. Alternatively, a dermatome is used to remove a layer of material from the fibrous surface of the membrane. Thinning may also employ compression. Stepwise compression with cross-linking to stabilize the membrane is used to avoid damaging the membrane through inelastic compression. Rather, the membrane is bound in the elastic compressed state through addition cross-linking. The foregoing several thinning techniques may be employed together to achieve strong thin membranes. | 11-21-2013 |
20130310926 | LOW PROFILE TRANSCATHETER HEART VALVE - An implantable prosthetic valve, according to one embodiment, comprises a frame, a leaflet structure, and a skirt member. The frame can have a plurality of axial struts interconnected by a plurality of circumferential struts. The leaflet structure comprises a plurality of leaflets (e.g., three leaflets arrange to form a tricuspid valve). The leaflet structure has a scalloped lower edge portion secured to the frame. The skirt member can be disposed between the leaflet structure and the frame. | 11-21-2013 |
20130310668 | SYSTEM, METHOD AND COMPUTER PROGRAM PRODUCT FOR OPTICAL MEASUREMENT OF BLOOD PARAMETERS - A system for optically measuring blood parameters including a light source and light transmitter for transmitting light to the blood, a light remitter for capturing remitted light, a spectrometer breaking the remitted light into its spectral components and a processor for comparing a morphologically distinct portion of the remitted light to a database of known morphologies. Each of the known morphologies corresponds to a measurement value at least one parameter, such as an analyte. Advantageously, the determined morphologies can uniquely correspond to two or more blood parameters, such as O | 11-21-2013 |
20130253640 | RETAINING MECHANISMS FOR PROSTHETIC VALVES - Disclosed herein are representative embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve to a deficient valve. In one embodiment, for instance, a support member is positioned to at least partially surround the native leaflets of a valve. A locking member is used to couple both ends of the support member, forming a support band. An expandable prosthetic heart valve is delivered into the native heart valve and expanded while the expandable prosthetic valve is at least partially within the support band, thereby causing one or more of the native leaflets of the native heart valve to be frictionally secured between the support band and the expanded prosthetic heart valve. | 09-26-2013 |
20130238087 | METHOD OF DELIVERING A PROSTHETIC HEART VALVE - A method of delivering a prosthetic heart valve to a native aortic valve is disclosed. The prosthetic heart valve comprises a radially compressible and expandable metallic stent and a flexible valvular structure. A delivery system comprises a selectively steerable section and a pusher member extending through a central lumen of the steerable section. The prosthetic heart valve is compressed and inserted into a distal end portion of the delivery system. The delivery system and prosthetic heart valve are advanced through a femoral artery and around an aortic arch. A pull wire is actuated for selectively controlling a curvature of the steerable section during advancement around the aortic arch. The pusher member is advanced for ejecting the prosthetic heart valve from the delivery system into the native aortic valve, wherein the prosthetic valve self-expands after ejection. | 09-12-2013 |
20130228002 | CALIBRANT INFUSION FLUID SOURCE PREPARATION - Methods and systems for preparation of calibrant infusion fluid sources are disclosed. In one embodiment, a precise volume of glucose is injected into a saline-solution filled calibrant infusion fluid source proximate in time to conducting a calibration procedure. The glucose concentration in the calibrant infusion fluid source is subsequently calculated based on the measured weight of the saline-solution, as determined prior to glucose injection, and the volume of glucose injected. This method provides a highly accurate and convenient manner for use in a hospital environment, for example, with an intravenous blood glucose sensor system. In another embodiment, a premixed calibrant infusion fluid source is provided that includes saline solution and a predetermined concentration of glucose. In such embodiments, shelf life problems related to water evaporation are mitigated by hermetically covering or otherwise hermetically containing the calibrant infusion fluid source up until the point of use. | 09-05-2013 |
20130211512 | FLEXIBLE ANNULOPLASTY RING - An annuloplasty repair segment for heart valve annulus repair. In one embodiment a multi-stranded cable replaces solid core wire for both the tricuspid and mitral valves. Cable allows for greater deployment flexibility for minimally-invasive surgical (MIS) implant, while still maintaining the required strength and similar tensile properties of solid-core wire. In addition, selective placement of point-welds or other such control points locally control other parameters such as the amount and direction of displacement as the ring undergoes external loading. Cable with well-placed control points result in a MIS annuloplasty ring with sufficient flexibility in the x-y plane to allow a surgeon to squeeze the ring into a small incision, such as for example 1 cm×1 cm, while maintaining structural rigidity under forces exerted on the implanted ring by the cardiac cycle and allowing for asymmetrical deflection to be designed into the product. | 08-15-2013 |
20130199944 | ANALYTE SENSOR - The present disclosure relates generally to an electrochemical sensor comprising a membrane layer comprising one or both of an active enzymatic portion and an inactive-enzymatic or non-enzymatic portion, at least one electrode disposed beneath the membrane and either at least one pH sensor or a hematocrit sensor. The present disclosure also relates to methods of adjusting analyte concentration values using a correction factor based on measured pH values and/or measured hematocrit levels. | 08-08-2013 |
20130197333 | ANALYTE SENSOR - The present disclosure relates generally to an electrochemical sensor comprising a membrane layer comprising one or both of an active enzymatic portion and an inactive-enzymatic or non-enzymatic portion, at least one electrode disposed beneath the membrane and either at least one pH sensor or a hematocrit sensor. The present disclosure also relates to methods of adjusting analyte concentration values using a correction factor based on measured pH values and/or measured hematocrit levels. | 08-01-2013 |
20130197325 | ANTI-COAGULANT INFUSION FLUID SOURCE - Methods and systems for preventing or eliminating blood coagulation or thrombus during use of an intravenous anti-thrombotic sensor are disclosed. The method further comprises for providing antimicrobial into the infusion fluid source. An anti-thrombotic sensor is also disclosed that comprises a coating of a complex of a non-heparin anti-thrombotic agent and an alkylbenzyldimethyl ammonium cationic salt. | 08-01-2013 |
20130184814 | METHODS OF IMPLANT OF A HEART VALVE WITH A CONVERTIBLE SEWING RING - A sewing ring for prosthetic heart valves that is connected and configured to pivot outward. A biocompatible fabric covering surrounds at least a portion of the sewing ring, and the ring may be exclusively connected to a stent with the fabric. The sewing ring may be generally planar and of uniform thickness, or may be of varying thickness. The fabric may be used to encompass both the stent and the sewing ring, and may be a single piece. A seam may be provided in the fabric as a discrete pivoting line. The sewing ring may be convertible between bi-stable positions. The ring may extend outward in a frusto-conical shape so as to enable inversion between a position facing the inflow end of the valve and a position facing the outflow end of the valve. A method of implantation, and a method of assembly of the heart valve is also provided. | 07-18-2013 |
20130172989 | METHODS FOR MEASURING BODY ORIFICE - A device for measuring an expanded internal orifice of a patient includes an orifice-expanding device, a pressure measuring device, and a size-measuring device. The size-measuring device measures a dimension of the orifice after it has been expanded by the orifice-expanding device. | 07-04-2013 |
20130166022 | ANCHORING DEVICE AND METHOD FOR REPLACING OR REPAIRING A HEART VALVE - A device for anchoring a prosthetic heart valve or annuloplasty ring to a valve annulus in a heart and a method of implanting same is disclosed. The device can include a prosthetic valve or annuloplasty ring with one or more anchors configured to be threaded or otherwise passed underneath a native leaflet and/or subvalvular tissue to secure the device at the native annulus. | 06-27-2013 |
20130165953 | SUTURE CLIP DEPLOYMENT DEVICES - Suture clip deployment devices for applying suture clips to sutures are described. Some embodiments can include a generally tubular main body and a vacuum port located at the distal end, a hollow inner body longitudinally slidable within the main body and extending from the main body at its distal end, and a suture recess located in the generally tubular main body. At least one suture clip configured to frictionally fit on an outer surface of the inner body is deployed during use. Clip deployment can occur after a vacuum source is applied to the device so as to draw the suture into the device. The suture lines can be retrieved through the suture recess, and the device can be actuated so as to deliver the suture clip off the delivery device and onto the suture, locking the suture in place. | 06-27-2013 |
20130160512 | APPARATUS AND METHOD FOR STENT SHAPING - An apparatus for crimping a radially expandable stent includes a pressure vessel, shaping balloon, and mandrel. The mandrel is configured to slidingly receive a stent thereon, and to be slidingly advanced into the pressure vessel. The shaping balloon is inflated to radially compress the stent onto the form of the mandrel; such compression need not be uniform. Pressurization of the shaping balloon facilitates the expansion of the balloon to achieve compression of the stent, with depressurization of the shaping balloon causing the balloon to return to an unexpanded state. | 06-27-2013 |
20130158600 | KNOTLESS SUTURE ANCHORING DEVICES AND TOOLS FOR IMPLANTS - Devices for securing prostheses such as heart valves or annuloplasty rings with sutures and without using knots are disclosed. The devices are particularly well suited for traditional surgery or minimally invasive surgery, and improve the ease of implantation by eliminating surgical knots a clinician would normally tie in the limited space in and around the implant site. The devices have opposed the clamp halves surrounded by a coil spring. Sutures pass between the clamp halves and the coil spring has an inner coil diameter sufficient to compress the sutures between the clamp. A retention member positioned between the clamp halves maintains a minimum space and therebetween to enable the locking device to be slid along the sutures into position, and to adjust the tension of the sutures therethrough. A delivery tool may be used to deliver and deploy the locking devices. | 06-20-2013 |
20130152659 | SYSTEM AND METHOD FOR CRIMPING A PROSTHETIC VALVE - An exemplary system for crimping a prosthetic valve comprises a radially expandable and compressible prosthetic valve, a crimping device positioned around the valve and configured to reduce the diameter of the valve to a delivery configuration, and a sterile package enclosing the valve and the crimping device. The valve can be pre-assembled in a partially crimped configuration within the crimping device. After removing the sterile packaging, the crimping device can be used to crimp the valve from the partially crimped configuration to the delivery configuration, such as by twisting a knob on the crimping device. The system can further comprise at least a portion of a delivery catheter within the sterile package, wherein the valve is pre-mounted on or adjacent to an inflatable balloon of the delivery catheter, such that the valve can be crimped onto the delivery catheter using the crimping device. | 06-20-2013 |
20130150955 | ACTIVE HOLDER FOR ANNULOPLASTY RING DELIVERY - An active annuloplasty ring holder having a template that can be folded or pivoted to the side allowing the template to align longitudinally with the handle and enter the patient's chest through a small incision. The holder may include a mechanism to remotely detach sutures fastening the ring to the holder, thereby detaching the ring while avoiding the risk associated with introducing a scalpel into the operating field. A detachment mechanism may include a movable pin actuated by a pull wire that releases a plurality of holding sutures, or a hot wire, knives, or pull wire that severs the sutures. The holder may have a built-in light source for better visualization of the ring inside the heart. The holder may also have an optical means of visualizing the inside of the heart from the proximal end of the handle. | 06-13-2013 |
20130150954 | FORCE-BASED HEART VALVE SIZER - A valve sizer for determining an appropriate replacement valve size when performing a heart valve replacement procedure is provided. In one version the valve sizer has a hollow shaft with proximal and distal ends. A movable sizing element couples to the distal end of the shaft and is radially expandable between first, contracted and second, expanded positions. An actuator assembly on a handle includes an actuator coupled to a clutch member via a ball-spring-detent clutch. A rod extends through the shaft and maintains a fixed distance between the handle and a distal hub in the sizing element. Movement of the actuator causes axial movement of the shaft, thereby causing radial expansion of sizing petals relative to the hub. The clutch slips when a predetermined reaction force from the surrounding valve annulus is met by the petals. | 06-13-2013 |
20130150869 | SELF-CINCHING SURGICAL CLIPS AND DELIVERY SYSTEM - A device and method for deploying self-cinching surgical clips. The device accesses at least two layers of tissue or material from only one side of the tissue or material and punctures through the two layers of tissue or material. The various configurations of clips disclosed herein are made of a superelastic material such as Nitinol, and have a constrained and a relaxed state, and no sharp edges or tips so as to reduce tissue irritation following deployment. The clip is disposed within the housing of the delivery device and held in a constrained state by a tube assembly until deployment wherein the clip assumes its relaxed state, where the ends of the clip are brought into close approximation, thereby securing the layers of tissue or material together. | 06-13-2013 |
20130150690 | FLUX LIMITING MEMBRANE FOR INTRAVENOUS AMPEROMETRIC BIOSENSOR - A flux limiting layer for an intravenous amperometric biosensor is formed on a substrate to limit a diffusion rate of an analyte from blood to an enzyme electrode. The layer may be formed from ethylene vinylacetate (EVA) dissolved in a solvent such as paraxylene, spray-coated to cover a portion of the electrode, and cured to seal the electrode to the substrate. In a glucose sensor having glucose oxidase disposed on the electrode, thickness and concentration of the EVA layer are optimized to promote a linear output of electrode current as a function of blood glucose concentration. | 06-13-2013 |
20130138121 | MINIMALLY INVASIVE MITRAL VALVE REPAIR METHOD AND APPARATUS - The present invention is directed to an apparatus and method for the stabilization and fastening of two pieces of tissue. A single device may be used to both stabilize and fasten the two pieces of tissue, or a separate stabilizing device may be used in conjunction with a fastening device. After the pieces of tissue are stabilized, they are fastened together using sutures or clips. One exemplary embodiment of a suture-based fastener comprises a needle connected to a suture. The needle enters the blind side of the tissue and exits the front side. The suture is then tied in a knot to secure the pieces of tissue. One example of a clip-based fastener comprises a spring-loaded clip having two arms with tapered distal ends and barbs. The probe includes a deployment mechanism which causes the clip to pierce and lockingly secure the two pieces of tissue. | 05-30-2013 |
20130134064 | CAPPING BIOPROSTHETIC TISSUE TO REDUCE CALCIFICATION - A treatment for bioprosthetic tissue used in implants or for assembled bioprosthetic heart valves to reduce in vivo calcification. The method includes applying a calcification mitigant such as a capping agent or an antioxidant to the tissue to specifically inhibit oxidation in tissue. Also, the method can be used to inhibit oxidation in dehydrated tissue. The capping agent suppresses the formation of binding sites in the tissue that are exposed or generated by the oxidation and otherwise would, upon implant, attract calcium, phosphate, immunogenic factors, or other precursors to calcification. In one method, tissue leaflets in assembled bioprosthetic heart valves are pretreated with an aldehyde capping agent prior to dehydration and sterilization. | 05-30-2013 |
20130116777 | UNITARY QUICK-CONNECT PROSTHETIC HEART VALVEAND DEPLOYMENT SYSTEM AND METHODS - A quick-connect heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The heart valve includes a substantially non-expandable, non-compressible prosthetic valve and a plastically-expandable coupling stent, thereby enabling attachment to the annulus without sutures. A small number of guide sutures may be provided for aortic valve orientation. The prosthetic valve may be a commercially available valve with a sewing ring with the coupling stent attached thereto. The coupling stent may expand from a conical deployment shape to a conical expanded shape, and may include web-like struts connected between axially-extending posts. A system and method for deployment includes a hollow two-piece handle through which a balloon catheter passes. A valve holder is stored with the heart valve and the handle easily attaches thereto to improve valve preparation steps. | 05-09-2013 |
20130116676 | METHODS OF CONDITIONING SHEET BIOPROSTHETIC TISSUE - Methods for the conditioning of bioprosthetic material employ bovine pericardial membrane. A laser directed at the fibrous surface of the membrane and moved relative thereto reduces the thickness of the membrane to a specific uniform thickness and smoothes the surface. The wavelength, power and pulse rate of the laser are selected which will smooth the fibrous surface as well as ablate the surface to the appropriate thickness. Alternatively, a dermatome is used to remove a layer of material from the fibrous surface of the membrane. Thinning may also employ compression. Stepwise compression with cross-linking to stabilize the membrane is used to avoid damaging the membrane through inelastic compression. Rather, the membrane is bound in the elastic compressed state through addition cross-linking. The foregoing several thinning techniques may be employed together to achieve strong thin membranes. | 05-09-2013 |
20130110230 | SUTURE AND METHOD FOR REPAIRING A HEART | 05-02-2013 |
20130110097 | METHODS OF CONDITIONING SHEET BIOPROSTHETIC TISSUE | 05-02-2013 |
20130096674 | MINIMALLY-INVASIVE PROSTHETIC HEART VALVE METHOD - A method of implanting a collapsible prosthetic heart valve is disclosed. The prosthetic heart valve includes three biological leaflets mounted within a self-expanding tubular leaflet frame formed of nitinol. The method comprises loading a collapsed prosthetic heart valve into a distal end of a delivery tube. The distal end of the delivery tube is inserted into a vasculature of a patient and positioned proximal to an aortic valve. The prosthetic heart valve is expelled into an annulus of the aortic valve and expanded. The prosthetic heart valve includes cusp positioners that engage sinus cavities above the valve annulus and rotationally orient the prosthetic valve. Preferred embodiments of the cusp positioners do not occlude the coronary arteries. | 04-18-2013 |
20130096671 | METHOD OF IMPLANTING A SELF-EXPANDABLE PROSTHETIC HEART VALVE - A method of implanting a collapsible prosthetic heart valve is disclosed. The prosthetic heart valve includes three biological leaflets mounted within a self-expanding tubular leaflet frame formed of nitinol. The method comprises loading a collapsed prosthetic heart valve into a distal end of a delivery tube. The distal end of the delivery tube is inserted into a vasculature of a patient and positioned proximal to an aortic valve. The prosthetic heart valve is expelled into an annulus of the aortic valve and allowed to self-expand to a first diameter. A balloon is then inflated within the prosthetic heart valve for expanding the prosthetic heart valve to a second diameter, wherein the second diameter is larger than the first diameter, thereby securely implanting the prosthetic heart valve within the annulus of the aortic valve. | 04-18-2013 |
20130090726 | RETAINING MECHANISMS FOR PROSTHETIC VALVES - A method of treating a deficient mitral valve without open heart surgery is disclosed. A support band is advanced from a delivery catheter and positioned around native leaflets of the deficient mitral valve. The support band is preferably formed of a shape memory material and is configured to assume a curved shape upon advancement from the delivery catheter. While the support band is positioned around the native leaflets of the mitral valve, an expandable prosthetic heart valve is delivered through an apex of the left ventricle and into the mitral valve. The expandable prosthetic heart valve is then expanded within the mitral valve, thereby causing one or more of the native leaflets of the mitral valve to be frictionally secured between the support band and the prosthetic heart valve. | 04-11-2013 |
20130090725 | UNITARY QUICK-CONNECT PROSTHETIC HEART VALVE DEPLOYMENT METHODS - A quick-connect heart valve prosthesis that can be quickly and easily implanted is provided. The heart valve includes a substantially non-expandable, non-compressible prosthetic valve and a plastically-expandable coupling stent, thereby enabling attachment to the annulus without sutures. A small number of guide sutures may be provided for aortic valve orientation. The prosthetic valve may be a commercially available valve with a sewing ring with the coupling stent attached thereto. The coupling stent may expand from a conical deployment shape to a conical expanded shape, and may include web-like struts connected between axially-extending posts. A system and method for deployment includes a hollow two-piece handle through which a balloon catheter passes. A valve holder is stored with the heart valve and the handle easily attaches thereto to improve valve preparation steps. | 04-11-2013 |
20130079873 | PROSTHETIC MITRAL VALVE WITH VENTRICULAR TETHERS AND METHODS FOR IMPLANTING SAME - A prosthetic valve assembly and method of implanting same is disclosed. The prosthetic valve assembly includes a prosthetic valve formed by support frame and valve leaflets, with one or more tethers each having a first end secured to the support frame and the second end attached to, or configured for attachment to, to papillary muscles or other ventricular tissue. The tether is configured and positioned so as to avoid contact or other interference with movement of the valve leaflets, while at the same time providing a tethering action between the support frame and the ventricular tissue. The valve leaflets may be flexible (e.g., so-called tissue or synthetic leaflets) or mechanical. | 03-28-2013 |
20130075278 | Preparation and Maintenance of Sensors - Apparatus and methods are described for preparing, maintaining, and stabilizing sensors. The apparatus and methods for preparing sensors for use are utilized in advance of the sensor being removed from a sealed, sterilized package. The apparatus include packaging materials having electrical circuits capable of stabilizing a sensor to prepare the sensor for use. The methods for preparing a sensor for use includes methods of providing a solution to a sterilized packaging that contains a sensor connected to a sensor activating circuit, activating the circuit, and allowing the sensor to stabilize. These methods can be performed without compromising the packaging. The apparatus for stabilizing a sensor that is in use include a circuit connectable to the sensor that provides a signal to the sensor that prevents the sensor from becoming destabilized when disconnected from a monitoring device. | 03-28-2013 |
20130053950 | DEVICE AND METHOD FOR REPLACING MITRAL VALVE - A prosthetic mitral valve assembly is disclosed. The assembly comprises a radially-expandable stent including a lower portion sized for deployment between leaflets of a native mitral valve and an upper portion having a flared end. The upper portion is sized for deployment within the annulus of the mitral valve and the flared end is configured to extend above the annulus. The stent is formed with a substantially D-shape cross-section for conforming to the native mitral valve. The D-shape cross-section includes a substantially straight portion for extending along an anterior side of the native mitral valve and a substantially curved portion for extending along a posterior side of the native mitral valve. The assembly further includes a valve portion formed of pericardial tissue and mounted within an interior portion of the stent for occluding blood flow in one direction. | 02-28-2013 |
20130053949 | QUICK-CONNECT PROSTHETIC HEART VALVE AND METHODS - A heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve has a base stent that is deployed at a treatment site, and a valve component configured to quickly connect to the base stent. The base stent may take the form of a self- or balloon-expandable stent that expands outward against the native valve with or without leaflet excision. The valve component has a non-expandable prosthetic valve and a self- or balloon-expandable coupling stent for attachment to the base stent, thereby fixing the position of the valve component relative to the base stent. The prosthetic valve may be a commercially available valve with a sewing ring and the coupling stent attaches to the sewing ring. The system is particularly suited for rapid deployment of heart valves in a conventional open-heart surgical environment. | 02-28-2013 |
20130053664 | ELIMINATION OF THE EFFECTS OF IRREGULAR CARDIAC CYCLES IN THE DETERMINATION OF CARDIOVASCULAR PARAMETERS - Methods for determining a cardiovascular parameter, e.g., a parameter reflecting fluid or volume responsiveness, using a modified waveform dataset are described. The waveform dataset corresponds to a signal, for example, from an arterial blood pressure, or any signal proportional to, or derived from the arterial pressure signal. These methods involve identifying individual cardiac cycles in the waveform dataset, measuring the waveform characteristics for the individual cycles, then determining if the individual cardiac cycles are regular cardiac cycles or irregular cardiac cycles. Once any irregular cardiac cycles are detected, a respiratory parameter is measured. Next, a modified waveform dataset containing the waveform characteristics of the regular cardiac cycles and the waveform characteristics of the irregular cardiac cycles is created wherein the waveform characteristics of the irregular cardiac cycles are replaced with estimated waveform characteristics. Finally, a cardiovascular parameter is determined using the modified waveform dataset. | 02-28-2013 |
20130030519 | DELIVERY SYSTEMS FOR PROSTHETIC HEART VALVE - Described herein are systems and methods from delivering prosthetic devices, such as prosthetic heart valves, through the body and into the heart for implantation therein. The prosthetic devices delivered with the delivery systems disclosed herein are, for example, radially expandable from a radially compressed state mounted on the delivery system to a radially expanded state for implantation using an inflatable balloon of the delivery system. Exemplary delivery routes through the body and into the heart include transfemoral routes, transapical routes, and transaortic routes, among others. | 01-31-2013 |
20130030418 | CONICAL CRIMPER - Embodiments of crimping devices for crimping stented prosthetic valves and other medical devices from a larger, expanded diameter to a smaller, crimped diameter are disclosed. Some crimping devices utilize a conical surface extending out-of-plane from the direction of crimping, where motion of the conical surface in the out-of-plane direction causes in-plane radially crimping. Other crimping devices comprise a funnel-shaped rigid body having a tapered inner lumen that compresses a medical device moving therethrough. Some funnel-shaped embodiments have slotted sides that allow portions of the medical device to project therethrough. Other funnel-shaped embodiments are used with a tubular sock to pull the medical device through the tapered lumen. Other crimping devices utilize rotating rollers that compress a medical device while the medical device spins between the rollers. | 01-31-2013 |
20130023984 | COMMISSURE MODIFICATION OF PROSTHETIC HEART VALVE FRAME FOR IMPROVED LEAFLET ATTACHMENT - Embodiments of the present disclosure provide an improved support frame for a prosthetic heart valve. The support frame can include a plurality of diamond-shaped cells arranged in a plurality of circumferential rows. Three cells corresponding to the leaflet commissures can be configured as commissure tip cells, with elongated rounded portions rather than a diamond shape. The commissure tip cells can allow for insertion of leaflet tabs, thereby allowing the leaflets to be sutured outside of the valve. In this manner, the leaflet sutures can be removed from areas of high stress during physiologic loading. Thus, currently disclosed embodiments of a support frame can allow for use of thinner leaflet materials than possible with conventional prosthetic heart valves, without sacrificing valve durability in some embodiments. | 01-24-2013 |
20130023983 | METHOD FOR TREATING AN AORTIC VALVE - Expandable, percutaneously deployable, prosthetic heart valves and systems for minimally invasive replacement of damaged or diseased native aortic valves comprise an expandable, tubular stent body and a unidirectional valve assembly. Embodiments of the stent body comprise an annulus anchoring section, a sinus section, and an outflow section, with the outflow section flared outwardly from the sinus section in an expanded configuration. Embodiments of the stent body are self-expanding, comprising, for example nitinol. The valve assembly disposed within the sinus section of the stent body and sutured thereto. Embodiments of the valve assembly comprise three leaflets, each leaflet comprising a curved outer edge sutured to the sinus section of the stent body, and a coapting free edge. Embodiments of the valve leaflets comprise pericardium, for example, porcine pericardium. Embodiments of the prosthetic heart valve have a contracted configuration dimensioned for percutaneous delivery thereof. | 01-24-2013 |
20130018458 | PERIVALVULAR SEALING FOR TRANSCATHETER HEART VALVE - The present disclosure is directed to embodiments of catheter-based prosthetic heart valves, and in particular, prosthetic heart valves having sealing devices configured to seal the interface between the prosthetic valve and the surrounding tissue of the native annulus in which the prosthetic valve is implanted. In one embodiment, a prosthetic heart valve includes an annular sealing member that can be placed in a delivery orientation extending axially away from one end of the valve when the valve is in a radially compressed state. When the valve is expanded, the expansion of the frame causes the sealing member to be pulled to an operative orientation covering a portion of the frame. The present disclosure also discloses new mechanisms and techniques for mounting valve leaflets to a frame of a prosthetic heart valve. | 01-17-2013 |
20130012767 | SYSTEMS, DIES, AND METHODS FOR PROCESSING PERICARDIAL TISSUE - Systems, dies, and methods are provided for processing pericardial tissue. The method includes positioning a die-cut assembly over the pericardial tissue, the die-cut assembly including a die having a plate, a die pattern, and an opening, the die pattern attached to the plate, the opening formed in the plate to provide access to the pericardial tissue, and measuring a thickness of the tissue through the opening. The die-cut assembly may be mounted for automated vertical movement, and a platen on which the tissue is placed is capable of automated horizontal movement. Different target areas on the tissue can be assessed by measuring the thickness through the die, and when an area is deemed suitable the die pattern cuts a shape therefrom. The system is useful for cutting uniform thickness heart valve leaflets, and can be automated to speed up the process. | 01-10-2013 |
20120330412 | PHYSIOLOGICALLY HARMONIZED TRICUSPID ANNULOPLASTY RING - A tricuspid remodeling annuloplasty ring having two free ends that are upturned in the inflow direction to help avoid unnecessary leaflet abrasion. The free ends are separated across a gap that is large enough to reduce the risk of passing sutures through the conductive system of the heart, yet not too large that support of the septal leaflet of the tricuspid annulus is degraded. The ring may have four sequential segments looking from the inflow side and extending in a clockwise direction from a free end located adjacent the antero septal commis sure after implant. The ring may define an inflow bulge in the first segment and/or an inflow bulge in the fourth segment that help the ring conform to the natural bulges created by the adjacent aorta, thereby reducing stress and the potential for ring dehiscence. Desirably, the ring has variable flexibility, either gradual and/or between or within different segments. | 12-27-2012 |
20120323316 | PROSTHETIC APPARATUS FOR IMPLANTATION AT MITRAL VALVE - Embodiments of prosthetics configured for implanting in at the native mitral valve region of the heart include a main body that is radially compressible to a radially compressed state and self-expandable from the compressed state to a radially expanded state. The prosthetic apparatus also comprises at least one ventricular anchor coupled to the main body and disposed outside of the main body with a leaflet-receiving space between the anchor and an outer surface of the main body to receive a native valve leaflet. Methods and apparatus for delivering and implanting the prosthetic valve are also described. | 12-20-2012 |
20120310333 | SINGLE CATHETER MITRAL VALVE REPAIR DEVICE AND METHOD FOR USE - A single catheter valve repair device for stabilizing a tissue portion and selectively applying a tissue fastener thereto. The single catheter valve repair device of the present invention includes an extendable engagement tip having at least one vacuum port formed thereon, at least one deployable fastener in communication with the engagement tip, and at least one actuator member in communication with the port. The deployable fastener is capable of controllably engaging and fastening a tissue segment located proximal to the engagement tip. | 12-06-2012 |
20120310328 | SYSTEM AND METHOD FOR TREATING VALVE INSUFFICIENCY OR VESSEL DILATATION - A medical device for treating aortic insufficiency (and associated aneurysms or defects of any other vessel associated with a valve) includes a support structure, a stent, a prosthetic valve and a deflector. Generally, the support structure is configured to cooperate with the prosthetic valve to pinch the native valve therebetween and provide an anchor for the stent which extends into the aorta and supports the deflector which is positioned to abate blood flow against the aneurysm. | 12-06-2012 |
20120303113 | IMPLANTABLE PROSTHETIC VALVE ASSEMBLY AND METHOD FOR MAKING THE SAME - An implantable prosthetic valve assembly having a support stent, or frame, having circumferential struts with multiple bends forming obtuse angles when the valve assembly is expanded to its functional size. The frame can be manufactured with one or more of the circumferential struts in a partially collapsed state and a flexible valve member can be mounted to the partially collapsed frame. The partially collapsed struts can be formed with multiple bends having angles selected to facilitate crimping of the frame to a profile suitable for percutaneous delivery. When the frame is expanded, the bends can expand to form obtuse angles, thereby enhancing the rigidity of the frame to better resist closing forces exerted on the valve assembly. | 11-29-2012 |
20120296418 | ENCAPSULATED HEART VALVE - The present disclosure concerns embodiments of implantable prosthetic devices, and in particular, implantable prosthetic valves, and methods for making such devices. In one aspect, a prosthetic device includes encapsulating layers that extend over a fabric layer and secure the fabric layer to another component of the device. In particular embodiments, the prosthetic device comprises a prosthetic heart valve, and can be configured to be implanted in any of the native heart valves. In addition, the prosthetic heart valve can be, for example, a transcatheter heart valve, a surgical heart valve, or a minimally-invasive heart valve. | 11-22-2012 |
20120291943 | METHOD FOR PREPARING A CATHETER ASSEMBLY INCLUDING A SENSING ELEMENT HAVING AN ADHESIVE BACKING - The present invention is directed to a sensing element that comprises a flexible substrate having first and second opposite surfaces; at least one sensor disposed on the first surface of the flexible substrate; an adhesive layer substantially covering the second surface of the flexible substrate; and a release liner releasably adhered to the adhesive layer so that upon removal of the release liner the adhesive layer is exposed for securing the sensing element to the catheter. The release liner permits the sensing element to be positioned at a desired location within the catheter after which the release liner can be removed to expose the adhesive layer. The adhesive layer can then be used to attach and secure the sensing element at a desired location on the catheter. As a result, the need for additional adhesives can be reduced or eliminated. | 11-22-2012 |
20120290079 | MITRAL HEART VALVE HOLDER AND STORAGE SYSTEM - An improved holder and storage system for a tissue-type prosthetic mitral heart valve that constricts the commissure posts of the valve and prevents suture looping. A rod axially movable relative to the holder tensions lengths of attachment sutures that extend between the commissure post tips to create a tent and flex the tips inward, thus helping to prevent looping of any of an array of pre-implanted sutures around the leading tips during delivery of the valve. The holder has a safety mechanism that prevents valve delivery before the rod is deployed. One embodiment automatically deploys the rod upon opening a storage jar. One embodiment permits a delivery handle to directly deploy the rod, while another uses a separate worm screw and coupling. A holder clip that attaches to a packaging sleeve may be formed of flexible members meshed together from which the heart valve and holder are easily pulled free to eliminate a step of decoupling the clip from the sleeve. | 11-15-2012 |
20120290078 | HEART VALVE DELIVERY SYSTEM WITH VALVE CATHETER - A heart valve delivery system is provided wherein a prosthetic valve is carried on a valve catheter inside a tubular delivery sleeve. The valve catheter has a distal end coupled to a mop. The mop comprises a plurality of flexible extensions configured for releasable attachment to the prosthetic valve. A lead screw nut is coupled to a proximal end of the tubular delivery sleeve and a lead screw is coupled to the valve catheter. The lead screw engages the lead screw nut and rotation of the lead screw causes the delivery sleeve to retract relative to the valve catheter and the prosthetic valve for exposing the prosthetic valve. The flexible extensions of the mop allow expansion of the valve while maintaining the attachment during placement of the valve at a native valve site. | 11-15-2012 |
20120289977 | MITRAL VALVE REPAIR SYSTEM AND METHOD FOR USE - The present invention is directed to a method of securing suture within a patient. The method comprises advancing suture material into the patient, passing a portion of the suture material through tissue of the patient, and advancing a fastener catheter and a suture fastener along the suture material. The fastener catheter includes a catheter main body and a handle. The suture fastener has a generally cylindrical body formed of a shape memory material and a suture fastener inner lumen. The suture fastener has at least one engagement tab biased to extend at least partially into the suture fastener inner lumen to engage against and secure one or more lines of suture passing through the suture fastener. | 11-15-2012 |
20120271411 | DEVICES, SYSTEMS AND METHODS FOR ACCURATE POSITIONING OF A PROSTHETIC VALVE - The invention is a system and method for accurately positioning a prosthetic valve such as a prosthetic heart valve at a desired position for deployment. The invention includes extendable positioning elements which provide tactile feedback to a user to confirm proper positioning of the catheter with respect to the native valve annulus. During delivery, the extendable positioning elements lie against the catheter, over the prosthetic valve and expandable balloon, providing a low profile for advancing the catheter to the desired treatment location via small passages such as body lumens. Prior to valve deployment, the positioning elements are extended and brought into contact with tissue of the native annulus to confirm the proper positioning of the delivery system and prosthetic valve. | 10-25-2012 |
20120265225 | DIRECT ACCESS ATHERECTOMY DEVICES AND METHODS OF USE - An atherectomy device comprising cannula systems having lumens adapted for insertion of a blood filter and an atherectomy catheter useful for performing atherectomy directly on a patient's cardiovascular tissue. Other embodiments include alumen for arterial perfusion useful in providing oxygenated blood to the aorta during cardiopulmonary bypass. The distal end of the atherectomy catheter includes an assembly that comprises a pincer, a loop with or without a mesh, laser, hydraulics, or other suitable mechanism adapted for removing atheroma from a cardiac or vascular tissue. Methods of using the systems for vascular atherectomy are also disclosed herein. | 10-18-2012 |
20120253457 | COMPRESSIBLE HEART VALVE ANNULUS SIZING TEMPLATES - Compressible heart valve annulus sizing templates suitable for minimally-invasive or otherwise reduced accessibility surgeries. The sizing templates may be folded, rolled, or otherwise compressed into a reduced configuration for passage through an access tube or other such access channel. Once expelled from the access tube the sizing templates expand to their original shape for use in sizing the annulus. The templates may be formed of an elastomeric polymer material such as silicone, a highly elastic metal such as NITINOL, or both. Grasping tabs or connectors for handles permit manipulation from outside the body. A NITINOL wireform may be compressed for passage through an access tube and expelled from the distal end thereof into a cloth cover to assume a sizer shape. | 10-04-2012 |
20120253386 | APICAL PUNCTURE ACCESS AND CLOSURE SYSTEM - A device, system, and method for providing access to, and sealing of, a body organ includes an implant device. An implant device has a main body having an internal access lumen, with a plurality of prongs extending from a distal end of the main body. The main body can include two lumens, one slidable within the other, to form a single continuous lumen with an adjustable length. The main body has an expanded configuration with an expanded diameter, and an unexpanded configuration with an unexpanded diameter. The prongs have a generally straight configuration where they extend distally of the distal end of the main body, and a bent configuration where the prongs bend around so that their tips extend proximally of the distal end of the main body. The device may include a hemostatic barrier to prevent fluid leakage therethrough when the main body is in the unexpanded configuration. | 10-04-2012 |
20120215304 | DEGENERATIVE VALVULAR DISEASE SPECIFIC ANNULOPLASTY RING SETS - Annuloplasty rings optimally sized to take into account more of the common degenerative valve pathologies. Each ring has a structural ring body with a shape that complies with predicted shapes of degenerative valvular diseases. The predicted shapes are obtained through careful echocardiographic and intraoperative measurements, and often differ for different annulus orifice sizes. For instance, in mitral rings the larger rings have larger minor axis and oblique axis dimensions relative to their major axis dimensions, and are more circular as opposed to D-shaped. The rings may also be three-dimensional and the relative heights around the rings may change for different sized rings. A mitral ring may have a higher anterior saddle relative to a posterior saddle, with the relative heights varying across the ring sizes. The ring may have varying flexibility around the ring periphery which also changes for different ring sizes. | 08-23-2012 |
20120209376 | DEVICE AND METHOD FOR RESHAPING MITRAL VALVE ANNULUS - Methods for treating a defective mitral valve are provided. One preferred method comprises attaching opposing ends of a tether to opposing regions of the mitral valve annulus. The tether is advanced percutaneously into the left atrium by a therapy catheter. Vacuum ports may be provided on the therapy catheter for grasping tissue along the mitral valve annulus. The therapy catheter may also include advanceable needles for passing the tether through the tissue. Alternatively, the ends of the tether may be attached to fastener elements which are secured to the tissue. Tension in the tether pulls the opposing regions of the mitral valve annulus into closer proximity for improving mitral valve function. | 08-16-2012 |
20120191182 | PROSTHETIC INSERT FOR TREATING A MITRAL VALVE - A prosthetic insert member for improving the function of a mitral valve is disclosed. The insert member is configured for insertion between leaflets of mitral valve. The insert member has an elongated cross-sectional profile for conforming to the opening in the mitral valve. The device also includes an anchoring member for attachment to heart tissue for maintaining the insert member in the mitral valve. In operation, the insert member fills the opening between the leaflets of the mitral valve and reduces regurgitation while preferably allowing the leaflets to function in a substantially normal manner. In one embodiment, the insert member is formed with a valve member disposed in a passageway for allowing blood to pass through the insert member in one direction. | 07-26-2012 |
20120179245 | METHODS OF ASSEMBLING AND DELIVERING AN ANNULOPLASTY RING - A holder for an annuloplasty ring having a template defining a proximal face opposite the distal face, and a peripheral edge about which the annuloplasty ring conforms. The annuloplasty ring anchors to the template using one or more flexible filaments. The template includes a single cutting well on its proximal face over which the flexible filament is suspended. Desirably, the single cutting well is located adjacent the peripheral edge so as to be away from any handle connections for ease of access. The flexible filament emerges above the proximal face of the template at only one location at the cutting well, thus presenting a one cut quick-release structure that is highly visible to the surgeon. | 07-12-2012 |
20120179243 | METHODS AND APPARATUSES FOR DEPLOYING MINIMALLY-INVASIVE HEART VALVES - A method for replacing native valve function of a diseased aortic valve in a patient is provided. The method comprises: (a) guiding a catheter system having a balloon through the vasculature of the patient; (b) guiding an artificial heart valve assembly through the vasculature of the patient; (c) while the catheter system is in the patient's vasculature, positioning the artificial heart valve assembly about the balloon of the catheter system; (d) delivering the artificial heart valve assembly to the region of the diseased aortic valve; (e) while the patient's heart is beating, expanding the artificial heart valve assembly in the region of the diseased aortic valve; and (f) withdrawing the catheter system from the patient's vasculature. | 07-12-2012 |
20120172983 | METHODS OF REPAIRING AN ABNORMAL MITRAL VALVE - The present invention refers to an annular prosthesis for mitral valve. In one of its embodiments the annular prosthesis for mitral valve is made up of a posterior half-ring and an anterior half-ring coupled to each other on a first transverse plane which defines a maximum width section of the prosthesis, characterised in that the ratio between the distance between said anterior half-ring and said posterior half-ring, as measured along a second plane, perpendicular to said first plane and equidistant to said couplings, and said maximum width of the prosthesis is lower than 3/4. | 07-05-2012 |
20120158128 | PROSTHETIC HEART VALVE DELIVERY SYSTEMS AND PACKAGING - Packaging for dry prosthetic tissue heart valves and their delivery systems includes a primary sterile barrier that permits gas sterilization of the tissue implant, and a secondary sterile barrier that also prevents oxidation of the implant during long-term storage. Dry tissue heart valves and their delivery systems are placed within a primary container such as a rigid tray that limits movement of the components therein. The primary container is placed within a secondary container, and the assembly is then sterilized. The outer sterile barrier may include a double seal so that a first gas-permeable seal can be closed for sterilization, after which a second gas-impermeable seal can be closed to seal out any further oxygen contact with the tissue implant. A collapsible delivery handle for a surgical heart valve may be provided which reduces the size of the packaging. | 06-21-2012 |
20120158118 | IMPLANTABLE PROSTHETIC VALVE WITH NON-LAMINAR FLOW - A valve prosthesis device and methods for deployment is disclosed. The device comprises an expandable support stent and a valve assembly comprising a flexible conduit having an inlet end and an outlet, made of pliant material attached to the support beams providing collapsible slack portions of the conduit at the outlet. Flow is allowed to pass through the valve prosthesis device from the inlet to the outlet, but reverse flow is prevented as the collapsible slack portions of the valve assembly collapse inwardly. The device is configured so that retrograde flow will be altered from laminar flow and directed towards the leaflets to effect closing. The device can be deployed in a native heart valve position using a deployment catheter advanced through a body lumen such as a blood vessel, including an aorta. | 06-21-2012 |
20120150288 | PROSTHETIC HEART VALVE PACKAGING AND DEPLOYMENT METHODS - Packaging for prosthetic heart valves including an assembly for securely retaining a heart valve within a jar and facilitating retrieval therefrom. The assembly includes a packaging sleeve that fits closely within the jar and has a clip structure for securing a valve holder. Contrary to previous designs, in one embodiment the valve holder is directed downward into the jar, and the valve is retained with an inflow end upward. The valve may have flexible leaflets, and a leaflet parting member on the end of the shaft extends through the leaflets and couples with the valve holder. The assembly of the packaging sleeve, valve, and holder can then be removed from the jar and a valve delivery tube connected with the holder, or to the leaflet parting member. The packaging sleeve may be bifurcated into two halves connected at a living hinge to facilitate removal from around the valve/holder subassembly. | 06-14-2012 |
20120143322 | THREE-DIMENSIONAL ANNULOPLASTY RING - An annuloplasty ring having a three-dimensional discontinuous form generally arranged about an axis with two free ends that are axially offset. The ring is particularly suited for repair of the tricuspid valve, and more closely conforms to the annulus shape. The ring is more flexible in bending about radially extending axes than about the central axis. The ring may have an inner structural support covered by a pliable sleeve and/or a fabric tube. The structural support may have a varying cross-section, such as a C-shaped cross-section in a mid-section between two free ends and a rectangular cross-section at the free ends. | 06-07-2012 |
20120143321 | THREE-DIMENSIONAL ANNULOPLASTY RING - An annuloplasty ring having a three-dimensional discontinuous form generally arranged about an axis with two free ends that are axially offset. The ring is particularly suited for repair of the tricuspid valve, and more closely conforms to the annulus shape. The ring is more flexible in bending about radially extending axes than about the central axis. The ring may have an inner structural support covered by a pliable sleeve and/or a fabric tube. The structural support may have a varying cross-section, such as a C-shaped cross-section in a mid-section between two free ends and a rectangular cross-section at the free ends. | 06-07-2012 |
20120136435 | Reduced Dehiscence Annuloplasty Ring - A prosthetic remodeling annuloplasty ring for use in tricuspid or mitral valve repairs to provide support after annuloplasty surgery. The annuloplasty ring includes a relatively rigid core extending around an axis that is discontinuous to define two free ends. A suture-permeable interface surrounding the core includes floppy regions adjacent both free ends of the core. Sutures are used to attach the annuloplasty ring to the annulus, including at least one suture through each of the floppy regions to secure the free ends of the ring and minimize the risk of ring dehiscence, or pull through of the sutures through the annulus tissue. The floppy regions may project from each free end into the gap toward each other, be radially enlarged such as paddle-like extensions, or may comprise outwardly lateral extensions at the free ends of the core. | 05-31-2012 |
20120136434 | ERGONOMIC MITRAL HEART VALVE HOLDERS - A holder for a prosthetic mitral heart valve that attaches to an inflow end of the valve and includes a simple tensioning mechanism that flexes the heart valve commissure posts inward to help prevent suture looping. The tensioning mechanism may include relatively movable rings of the holder or a generally unitary holder with a tensor, or rotatable knob. Connecting sutures thread through internal passages in the holder and travel in the outflow direction along valve commissure posts, emerging at the post tips and mutually crossing over the outflow side of the valve. A handle attaches off-center on the holder to increase visualization of and access to the heart valve through a central window. The holder is constructed of non-metallic materials so as to avoid interfering with imaging devices, and the handle is ergonomically curved and shaped to facilitate manipulation. The holder may be shaped as a ring with an open inner diameter for enhanced access to the commissure posts and leaflets. | 05-31-2012 |
20120136200 | SURGICAL STABILIZER AND CLOSURE SYSTEM - A system for stabilizing the heart via a helical needle, providing access to the interior of the heart via an introducer sheath, and forming a purse string suture using suture delivered by the helical needle. A helical needle projects distally from the device and terminates in a sharp distal tip. The helical needle is advanced into the heart wall, and is used to stabilize the heart and to pass a purse string suture through the heart tissue. An access port provides access to the interior of the heart via an opening passing through the heart wall in an area circumscribed by the helical needle. The helical needle may have a deflection segment adjacent the distal tip that is more flexible than the rest of the helical distal portion of the helical needle. | 05-31-2012 |
20120130416 | LOW RESISTANCE DILATOR - A dilator for use in accessing a vessel or other hollow organ is provided. The dilator has an extruded shaft with a tip portion at the distal end. The tip portion is formed by inserting the distal end portion of an extruded shaft into a die. Typically, the tip portion is molded to be tapered, and has a matte finish on at least a portion of its surface. The non-tapered shaft portion of the dilator may also have a matte finish that is typically formed during the extrusion process. In one embodiment, the matte surface is imparted to the surface of the tip portion after the shaft of the dilator has been extruded, by molding the tip portion in a die that has a matte or unpolished surface. The surface of the molded tip portion is then the inverse of the pattern on the surface of the die. | 05-24-2012 |
20120123557 | DOUBLE CROSS-LINKAGE PROCESS TO ENHANCE POST-IMPLANTATION BIOPROSTHETIC TISSUE DURABILITY - Bioprosthetic tissues and methods for making same, comprising fixing bioprosthetic implant tissue by treatment with 0.1 to 10 wt. % glutaraldehyde at elevated temperature, capping said fixed tissue by treatment with a diamine crosslinking agent, and treating said capped tissue with about 0.6 wt. % glutaraldehyde. | 05-17-2012 |
20120123530 | PROSTHETIC HEART VALVE WITH DISSIMILAR LEAFLETS - An anatomically approximate prosthetic heart valve includes dissimilar flexible leaflets, dissimilar commissures and/or a non-circular flow orifice. The heart valve may be implanted in the mitral position and have one larger leaflet oriented along the anterior aspect so as to mimic the natural anterior leaflet. Two other smaller leaflets extend around the posterior aspect of the valve. A basic structure providing peripheral support for the leaflets includes two taller commissures on both sides of the larger leaflet, with a third, smaller commissure between the other two leaflets. The larger leaflet may be thicker and/or stronger than the other two leaflets. The base structure defines a flow orifice intended to simulate the shape of the mitral annulus during the systolic phase. | 05-17-2012 |
20120123529 | PROSTHETIC HEART VALVE - Embodiments of a radially collapsible and expandable prosthetic heart valve are disclosed. A valve frame can have a tapered profile when mounted on a delivery shaft, with an inflow end portion having a smaller diameter than an outflow end portion. The valve can comprise generally V-shaped leaflets, reducing material within the inflow end of the frame. An outer skirt can be secured to the outside of the inflow end portion of the frame, the outer skirt having longitudinal slack when the valve is expanded and lying flat against the frame when the valve is collapsed. A diagonally woven inner skirt can elongate axially with the frame. Side tabs of adjacent leaflets can extend through and be secured to window frame portions of the frame to form commissures. The window frame portions can be depressed radially inward relative to surrounding frame portions when the valve is crimped onto a delivery shaft. | 05-17-2012 |
20120123522 | METHOD OF TREATING A DILATED VENTRICLE - A method of reducing ventricular dilation comprises placing one or more cardiac bridges into vessels extending along a length of the ventricle. Each cardiac bridge preferably includes a pair of anchors and a bridge member secured therebetween. The tension in the bridge member compresses the ventricle and thereby reduces the dilation along the ventricle wall. In another embodiment, the bridge member is tensioned to reshape the left ventricle for reducing tension on the chordae tendinae in the heart for improving valve function. | 05-17-2012 |
20120117734 | TREATMENT OF BIOPROSTHETIC TISSUES TO MITIGATE POST IMPLANTANATION CALCIFICATION - Bioprosthetic tissues are treated by immersing or otherwise contacting fixed, unfixed or partially fixed tissue with a glutaraldehyde solution that has previously been heat-treated or pH adjusted prior to its contact with the tissue. The prior heat treating or pH adjustment of the glutaraldehyde solution causes its free aldehyde concentration to decrease by about 25% or more, preferably by as much as 50%, and allows a “stabilized” glutaraldehyde solution to be obtained at the desired concentration and pH for an optimal fixation of the tissue at high or low temperature. This treatment results in a decrease in the tissue's propensity to calcify after being implanted within the body of a human or animal patient. | 05-17-2012 |
20120089223 | BAR-LESS COMMISSURE ATTACHMENT FOR PROSTHETIC VALVE - An implantable prosthetic valve, according to one embodiment, comprises a radially collapsible and expandable frame and a leaflet structure supported within the frame. The leaflet structure can comprise a plurality of leaflets paired together at commissures. In one embodiment, the commissures can comprise leaflet tabs rolled into spirals around non-rigid reinforcing inserts. In another embodiment, the commissures can comprise a reinforcing sheet folded around leaflet tabs. | 04-12-2012 |
20120078357 | Prosthetic Heart Valve Frame With Flexible Commissures - A prosthetic heart valve can include a valve frame having a wireform portion and a stent portion. The wireform and stent portions can be undetachably coupled together via a plurality of upright struts so as to form a one-piece prosthetic heart valve frame. Alternatively, a self-expanding wireform portion and a balloon-expandable stent portion can be coupled together via one or more leaflets and a subassembly having a flexible leaflet support stent and a sealing ring. The wireform portion can include cusps and commissures configured to support a plurality of leaflets. The prosthetic valve can be radially collapsible for minimally invasive and/or transcatheter delivery techniques. Disclosed embodiments can also provide flexion of the wireform portion (e.g., of the commissures) in response to physiologic pulsatile loading when the valve is implanted in a patient's native valve annulus. Methods of making and using prosthetic heart valves are also disclosed. | 03-29-2012 |
20120071970 | PHYSIOLOGIC TRICUSPID ANNULOPLASTY RING - A prosthetic tricuspid remodeling annuloplasty ring for use in tricuspid valve repairs to provide annular support after reconstructive valve surgery. The ring maintains an optimal annular dimension to prevent excessive dilatation of the natural valve annulus while adapting to the dynamic motion of the tricuspid annulus during the cardiac cycle. An exemplary ring features a waveform contour and may be constructed of a titanium core having a varying cross-section for selective flexibility for good Z-axis or out-of plane movement. The “waveform” contour and selective flexibility of the different segments of this ring are designed to adapt to the complex motion of the annulus. This reduces the stress on the anatomical structures and therefore minimizes the risk of arrhythmia and ring dehiscence. | 03-22-2012 |
20120046738 | Color-Coded Prosthetic Valve System and Methods for Using the Same - A color-coded bioprosthetic valve system having a valve with an annular sewing ring, and a valve holder system with a holder sutured to the ring of the valve, a post operatively connected to the holder, and an adapter sutured to the post and having a color associated with the valve model and/or size. For example, the adapter may be blue to indicate that the valve of the system is a mitral valve of a particular type and/or size. The system may also include a flex handle that is configured to engage with the adapter. The handle has a color associated with the adapter such that a user is able to visually determine that the handle color matches the valve model. For example, the handle may have a grip that is colored blue to match the blue color of the adapter. Accordingly, the color-coded system enables users to confirm easily that the correct accessories such as the sizer or flex handle are being used with the correct valve. | 02-23-2012 |
20120037406 | METHOD AND APPARATUS FOR USING FLEX CIRCUIT TECHNOLOGY TO CREATE AN ELECTRODE - A method of creating an active electrode that may include providing a flex circuit having an electrode made of a first material and providing a first mask over the flex circuit, the first mask having an offset region and an opening that exposes the electrode. The method may also include depositing a second material over the offset region and the opening, the second material being different from the first material and providing a second mask over the second material, the second mask having an opening over a portion of the second material that is over the offset region. | 02-16-2012 |
20120029628 | METHOD OF RESHAPING A VENTRICLE - Methods for restoring the conical shape of a dilated heart ventricle, or at least reshaping the ventricle to a more conical shape to counter the effects of dilation, thereby improving pumping efficiency. In an exemplary embodiment, a reshaping apparatus comprises an implantable body that can be delivered to a dilated left ventricle via the patient's vasculature in a minimally-invasive procedure. When deployed inside the left ventricle, the body is adapted to apply a longitudinal (downward) force against the inner surface of the left ventricle that causes the ventricle to distend or elongate downwardly relative to the base of the heart so as to at least partially restore the conical shape of the heart. In other embodiments, one or more tension members can be secured to heart tissue inside a heart chamber or on the outside of the heart and placed in tension to reshape the geometry of the heart. | 02-02-2012 |
20120016408 | CANNULA WITH ASSOCIATED FILTER AND METHODS OF USE DURING CARDIAC SURGERY - Devices and methods for filtering blood. The devices generally comprise a mesh for filtering blood flowing within a blood vessel, particularly within an artery such as the aorta, a structure adapted to open and close the mesh within the blood vessel, and a means to actuate the structure. The methods generally include the steps of introducing a mesh into a blood vessel to entrap embolic material, and removing the mesh and the entrapped foreign matter from the blood vessel. | 01-19-2012 |
20110319991 | Low Profile Transcatheter Heart Valve - An implantable prosthetic valve, according to one embodiment, comprises a frame, a leaflet structure, and a skirt member. The frame can have a plurality of axial struts interconnected by a plurality of circumferential struts. The leaflet structure comprises a plurality of leaflets (e.g., three leaflets arrange to form a tricuspid valve). The leaflet structure has a scalloped lower edge portion secured to the frame. The skirt member can be disposed between the leaflet structure and the frame. | 12-29-2011 |
20110319728 | BLOOD PARAMETER SENSOR AND FLOW CONTROL SYSTEM, METHOD AND COMPUTER PROGRAM PRODUCT - A system is provided for sensing a blood parameter, such as an analyte, in a patient's vasculature. The system includes a vascular access device, a parameter sensor, a pressure sensor and a flow control device. The vascular access device supports the parameter sensor within the vasculature of the patient and includes an internal passageway for drawing samples onto and calibrating the parameter sensor. The pressure sensor is within the internal passageway. The flow control device modulates sample draw, calibration and flushing fluid flows to prevent or remove clots based on communication with the pressure sensor. Advantageously, the dynamic, adaptive modulation of flow reduces flushing and other cycle times while at the same time improving clot flushing. As another advantage, this enables reduction or elimination of the use of heparin and other anticoagulant components in the solution supplied for flushing and/or calibration. | 12-29-2011 |
20110301704 | Annuloplasty Rings for Repair of Abnormal Mitral Valves - A remodeling mitral annuloplasty ring with a reduced anterior-to-posterior dimension to restore coaptation between the mitral leaflets in mitral valve insufficiency (IMVI). The ring has a generally oval shaped body with a major axis perpendicular to a minor axis, both perpendicular to a blood flow axis. An anterior section lies between anteriolateral and posteriomedial trigones, while a posterior section defines the remaining ring body and is divided into P | 12-08-2011 |
20110282440 | Low Gradient Prosthetic Heart Valve - A low pressure gradient prosthetic heart valve for implant in a human. The valve includes a support frame with undulating inflow cusps and outflow commissure posts to which flexible leaflets attach and coapt in a flow area. The commissure posts angle outward in a neutral state to widen the outflow orifice area. Also, the leaflets are designed to fit within the support frame and expand outward in a valve open state without creating a shelf or belly that would restrict flow. | 11-17-2011 |
20110275943 | Arterial Pressure-Based, Automatic Determination of a Cardiovascular Parameter - One or more cardiovascular parameters is estimated as a function of the arterial pressure waveform, in particular, using at least one statistical moment of a discrete representation pressure waveform having an order greater than one. Arterial compliance, the exponential pressure decay constant, vascular resistance, cardiac output, and stroke volume are examples of cardiovascular parameters that can be estimated using various aspects of the invention. In one embodiment of the invention, not only are the first four moments (mean, standard deviation, skewness, and kurtosis) of the pressure waveform used to estimate the cardiovascular parameter(s) of interest, but also heart rate, statistical moments of a set of pressure-weighted time values, and certain anthropometric patient measurements such as age, sex, body surface area, etc. | 11-10-2011 |
20110271967 | TRANSVENTRICULAR IMPLANT TOOLS AND DEVICES - A method and implantation tools for placing a transventricular splint including a tension member. The method includes gaining access to the patient's hearts and identifying entry or exit points for the tension member, marking those locations and delivering the tension member. Anchors for the tension member are also delivered. The length of the tensions member is measured and the walls of the heart drawn together. The pads are secured to the tension member and the tension member is trimmed to length. The pads are secured to the heart surface. | 11-10-2011 |
20110257736 | Flexible Heart Valve and Holder Therefor - A highly flexible tissue-type heart valve is disclosed having a structural stent in a generally cylindrical configuration with cusps and commissures that are permitted to move radially. The stent commissures are constructed so that the cusps are pivotably or flexibly coupled together at the commissures to permit relative movement therebetween. The stent may be cloth-covered and may be a single element or may be made in three separate elements for a three cusp valve, each element having a cusp portion and two commissure portions; adjacent commissure portions for each pair of adjacent stent element combining to form the stent commissures. If the stent has separate elements their commissure portions may be pivotably or flexible coupled, or may be designed to completely separate into independent leaflets at bioresorbable couples. The cloth covering may have an outwardly projecting flap that mates with valve leaflets (e.g., pericardial leaflets) along the cusps and commissures. A connecting band may be provided that follows the cusps and commissures and extends outwardly. The valve is connected to the natural tissue along the undulating connecting band using conventional techniques, such as sutures. The connecting band may be a cloth-covered silicon member and attaches to the underside of the valve at the cusps to provide support to the stent and to the outer side of the valve at the commissures. The connecting band includes commissure portions defining generally axial gaps that help permit flexing of the valve. | 10-20-2011 |
20110224786 | Degenerative Valvular Disease Specific Annuloplasty Rings - Annuloplasty rings optimally sized to take into account more of the common degenerative valve pathologies. Each ring has a structural ring body with a shape that complies with predicted shapes of degenerative valvular diseases, such as fibroelastic deficiency (FED), Marfan's or Barlow's. The predicted shapes are obtained through careful echocardiographic and intraoperative measurements, and often differ for different annulus orifice sizes. For instance, in mitral rings the larger rings have larger minor axis and oblique axis dimensions relative to their major axis dimensions, and are more circular as opposed to D-shaped. The rings may also be three-dimensional and the relative heights around the rings may change for different sized rings. A mitral ring may have a higher anterior saddle relative to a posterior saddle, with the relative heights varying across the ring sizes. The ring may have varying flexibility around the ring periphery which also changes for different ring sizes. A bulge on the sewing cuff forms a step on the outflow side for ease of suturing, which may be indicated by a suture line. | 09-15-2011 |
20110218620 | Retaining Mechanisms for Prosthetic Valves - Disclosed herein are representative embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve to a deficient valve. In one embodiment, for instance, a support member is positioned to at least partially surround the native leaflets of a valve. A locking member is used to couple both ends of the support member, forming a support band. An expandable prosthetic heart valve is delivered into the native heart valve and expanded while the expandable prosthetic valve is at least partially within the support band, thereby causing one or more of the native leaflets of the native heart valve to be frictionally secured between the support band and the expanded prosthetic heart valve. | 09-08-2011 |
20110218619 | LOW-PROFILE HEART VALVE AND DELIVERY SYSTEM - Disclosed replacement heart valves can be designed to be delivered to a native valve site while crimped on a delivery catheter. The crimped profile of the replacement valve can be minimized by, for example, separating a frame or stent structure from a leaflet structure, along the axial direction. Disclosed replacement valves can be transitioned from a delivery configuration, in which the crimped profile can be minimized, to an operating configuration. The replacement valve can be fully assembled in both the delivery and operating configurations. In some embodiments, the leaflets can be positioned outside of the stent in the delivery configuration, and positioned inside of the stent lumen in the operating configuration. Disclosed replacement valves can include a flexible sleeve coupling the leaflets to the stent and facilitating the transition to the operating configuration. Methods of implanting said replacement valves are also disclosed. | 09-08-2011 |
20110214398 | Dry Prosthetic Heart Valve Packaging System - Packaging for prosthetic heart valves including an assembly for stabilizing dry prosthetic tissue implants such as heart valves during storage. The packaging assembly includes a primary sterile barrier that permits gas sterilization of the tissue implant, and a secondary sterile barrier that also prevents oxidation of the implant during long-term storage. Tissue heart valves may be placed or suspended within a cavity of an inner rigid tray with a gas-permeable lid sealed thereon, and a cap placed over the cavity to limit movement of the valve therein. The inner tray is placed within an outer sterile barrier, such as another rigid tray or a flexible pouch, and the assembly is then sterilized. The outer sterile barrier may include a double seal so that a first gas-permeable seal can be closed for sterilization, after which a second gas-impermeable seal can be closed to seal out any further oxygen contact with the tissue implant. Alternatively, the inner tray may be placed within a sterile pouch and the assembly gas-sterilized, and then the entire assembly is placed within another pouch that provides an impermeable barrier to the surrounding atmosphere to prevent oxidation of the tissue implant. | 09-08-2011 |
20110208013 | Body Parameter Sensor and Monitor Interface - A system for sensing a physiological parameter in a human or animal, and storing a processed sensing signal at a sensor with which the sensing was performed. The system includes a physiological sensor adapted to output a sensor signal representative of a sensed physiological parameter, for processing by a remote processor. A microcontroller has memory, and is located locally to the sensor and is fixedly attached to or housed together with the sensor. An authentication algorithm is stored in the memory and the microprocessor is configured to engage in an authentication process to authenticate the sensor when queried by a remote processor. The memory is configured to receive and store data representative of a sensed physiological parameter after data from the sensor has been processed by a remote processor. The microcontroller may be configured to communicate with a remote processor over a single wire by, for example, using a single wire protocol. | 08-25-2011 |
20110198244 | PROSTHETIC HEART VALVE PACKAGING SYSTEM - Packaging for prosthetic heart valves including an assembly for securely retaining a heart valve within a sterile jar and facilitating retrieval therefrom. The assembly includes a packaging sleeve that fits closely within the jar and has a clip structure for securing a valve holder. A delivery handle on the end of a shaft couples with the valve holder while the packaging sleeve engages the jar to prevent rotation. The assembly of the packaging sleeve, valve, and holder can then easily be removed from the jar. | 08-18-2011 |
20110190879 | Devices and Methods for Treating a Heart - Devices and related methods of use are provided for improving heart function. In one embodiment of the present disclosure, a device includes a ring-like structure configured to be secured to a heart valve; at least one elongate member extending from the ring-like structure, wherein an end of the elongate member is configured to be secured to heart geometry other than a heart valve; and an adjustment mechanism for simultaneously altering a dimension of the ring-like structure and a length of the elongate member. | 08-04-2011 |
20110186429 | ANALYTE SENSOR - Electrochemical sensors for measuring an analyte in a subject are described. More particularly, devices for measurement of an analyte incorporating a sensor comprising a hydrophilic polymer-enzyme composition covering an electroactive surface providing rapid and accurate analyte levels upon deployment are disclosed. | 08-04-2011 |
20110184511 | TRICUSPID RING - A prosthetic tricuspid remodeling annuloplasty ring having two free ends can be configured to be stiff in the XY plane and relatively flexible along the Z axis. A tricuspid ring can be provided with a substantially elliptical shape in the XY plane, and a saddle shape in the Z direction. Disclosed tricuspid rings can include an inner core, an elastomeric interface, and an outer fabric covering. In some embodiments, the inner core can include a plurality of stacked layers of different materials. In some embodiments, the inner core can be formed of a single material and sized specifically to create a tricuspid ring that has a greater stiffness in the XY plane than along the Z axis. | 07-28-2011 |
20110166636 | Method and Apparatus for Replacing a Prosthetic Valve - In one aspect, the present disclosure concerns a percutaneously delivered adapter stent that is deployed within a previously implanted prosthetic valve and serves as an anchor or platform for implanting a percutaneously delivered replacement valve within the previously implanted valve. The adapter stent can be delivered to the implantation site via the patient's vasculature and positioned within the previously implanted valve. The stent can then be deployed to cause the stent to expand and become anchored to the inner surface of the previously implanted valve. Subsequently, the replacement valve can be positioned within the adapter stent and deployed to cause the replacement valve to expand and become anchored to the adapter stent. The adapter stent and the replacement valve can be mounted on the same catheter for delivery to the implantation site. | 07-07-2011 |
20110165675 | CAPPING BIOPROSTHETIC TISSUE TO REDUCE CALCIFICATION - A treatment for bioprosthetic tissue used in implants or for assembled bioprosthetic heart valves to reduce in vivo calcification. The method includes applying a calcification mitigant such as a capping agent or an antioxidant to the tissue to specifically inhibit oxidation in tissue. Also, the method can be used to inhibit oxidation in dehydrated tissue. The capping agent suppresses the formation of binding sites in the tissue that are exposed or generated by the oxidation and otherwise would, upon implant, attract calcium, phosphate, immunogenic factors, or other precursors to calcification. In one method, tissue leaflets in assembled bioprosthetic heart valves are pretreated with an aldehyde capping agent prior to dehydration and sterilization. | 07-07-2011 |
20110160849 | BIMODAL TRICUSPID ANNULOPLASTY RING - A prosthetic remodeling tricuspid annuloplasty ring having two free ends can be configured to more accurately mimic native valve anatomy (e.g., shape) and movement during the cardiac cycle. A tricuspid ring can be provided with a substantially elliptical shape in the X-Y plane, and a bimodal saddle shape in the Z direction. The tricuspid ring can be configured to contract and expand during each cardiac cycle such that the area of the orifice and/or the diameter of the ring decrease with each contraction. Further, the elevation or non-planarity of the bimodal saddle shape can increase with each contraction. Movement of the tricuspid ring can vary in each different segment of the tricuspid ring. Tricuspid annuloplasty rings can be provided in a set, with changing ratios of diameter, changing out-of-plane static amplitudes, and changing amounts of dynamic movement in each different size of tricuspid ring. | 06-30-2011 |
20110154880 | CALIBRANT INFUSION FLUID SOURCE PREPARATION - Methods and systems for preparation of calibrant infusion fluid sources are disclosed. In one embodiment, a precise volume of glucose is injected into a saline-solution filled calibrant infusion fluid source proximate in time to conducting a calibration procedure. The glucose concentration in the calibrant infusion fluid source is subsequently calculated based on the measured weight of the saline-solution, as determined prior to glucose injection, and the volume of glucose injected. This method provides a highly accurate and convenient manner for use in a hospital environment, for example, with an intravenous blood glucose sensor system. In another embodiment, a premixed calibrant infusion fluid source is provided that includes saline solution and a predetermined concentration of glucose. In such embodiments, shelf life problems related to water evaporation are mitigated by hermetically covering or otherwise hermetically containing the calibrant infusion fluid source up until the point of use. | 06-30-2011 |