| EDWARDS LIFESCIENCES CORPORATION Patent applications |
| Patent application number | Title | Published |
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| 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 |
| 20110147251 | PROSTHETIC HEART VALVE PACKAGING AND DEPLOYMENT SYSTEM - 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. The packaging system facilitates attachment of the valve delivery tube for use in a quick-connect valve implant procedure. | 06-23-2011 |
| 20110146361 | Method of Peening Metal Heart Valve Stents - Medical devices, such as percutaneous prosthetic heart valves can include a stent or frame structure component. The stent can be shot peened, laser peened, and/or ultrasonically peened, thereby reducing surface abnormalities, improving surface appearance, and/or increasing fatigue life of the device. | 06-23-2011 |
| 20110144742 | Expansion Device for Treatment of Vascular Passageways - A delivery system 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. The expandable member is moveable between a collapsed configuration and an expanded configuration, and has an inner expandable member and a plurality of outer expandable members that at least partially surround the inner expandable member. | 06-16-2011 |
| 20110137409 | PROSTHETIC HEART VALVE HAVING FLARED OUTFLOW SECTION - 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 outward 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. | 06-09-2011 |
| 20110137397 | PROSTHETIC VALVE FOR REPLACING MITRAL VALVE - Embodiments of prosthetic valves for implantation within a native mitral valve are provided. A preferred embodiment of a prosthetic valve includes a radially compressible main body and a one-way valve portion. The prosthetic valve further comprises at least one ventricular anchor coupled to the main body and disposed outside of the main body. A space is provided between an outer surface of the main body and the ventricular anchor for receiving a native mitral valve leaflet. The prosthetic valve preferably includes an atrial sealing member adapted for placement above the annulus of the mitral valve. Methods and devices for delivering and implanting the prosthetic valve are also described. | 06-09-2011 |
| 20110137326 | Single Catheter Mitral Valve Repair Device and Method for Use - A single catheter mitral valve repair device for stabilizing a tissue portion and selectively applying a tissue fastener thereto. The single catheter mitral 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. | 06-09-2011 |
| 20110112632 | METHOD OF IMPLANTING A PROSTHETIC VALVE IN A MITRAL VALVE WITH PULMONARY VEIN ANCHORING - A method of implanting a prosthetic mitral valve assembly is disclosed. The prosthetic mitral valve assembly includes a stent and valve combination. The prosthetic mitral valve assembly is provided with an anchoring portion adapted to be positioned in the left atrium. In one embodiment, the anchoring portion includes at least one anchoring arm sized for placement in a pulmonary vein. The stent is radially expandable so that it can expand into position against the walls of the left atrium and accommodate a wide range of anatomies. Contact between the stent and the native tissue in the left atrium reduces paravalvular leakage and prevents migration of the stent once in place. | 05-12-2011 |
| 20110098602 | Apparatus and Method 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. | 04-28-2011 |
| 20110093065 | Mitral and Tricuspid Annuloplasty Rings - A mitral annuloplasty ring with an inner core and an outer band located therearound. The ring has an anterior region, a posterior region opposite the anterior region, and two side regions therebetween. A cross-sectional width dimension of the outer band is greater in the posterior region of the ring than in the anterior region. A cross-sectional width dimension of a semi-flexible core is thinner in the anterior and posterior regions than in the side regions so that the mitral ring is more rigid in bending in the anterior-posterior direction. A tricuspid annuloplasty ring of the invention has an inner core and an outer band located therearound. The inner core has an anterior region separated across a gap from a septal region, and a posterior region. A cross-sectional width dimension of the outer band is greater in the septal region than either the anterior or posterior regions. | 04-21-2011 |
| 20110093063 | Sequential Heart Valve Leaflet Repair Device - A heart valve and tissue repair device for independently, selectively and sequentially grasping heart valve leaflets and independently, selectively and sequentially applying one or more fasteners thereto is disclosed. The device includes a leaflet engaging tip having one or more graspers capable of individually and sequentially grasping leaflets, and one or more deployable fasteners capable of fastening the leaflets. An actuation system for the device individually and selectively controls the graspers and deploys the one or more fasteners. Vacuum pressure from an external vacuum source can be used to grasp the leaflets via a selector system that controls the actuation system so as to individually and sequentially apply vacuum force to the graspers. | 04-21-2011 |
| 20110077733 | LEAFLET CONTACTING APPARATUS AND METHOD - A prosthesis can include a leaflet contacting member and an anchoring member. The leaflet contacting member can have an outer surface and an aperture that extends through at least a portion of the leaflet contacting member. The outer surface of the leaflet contacting member can be configured to contact one or more leaflets of the heart valve during coaptation of the leaflets, and the contact of the leaflets with the outer surface can prevent the leaflets from contacting one or more wires that extend through the aperture of the leaflet contacting member. | 03-31-2011 |
| 20110071546 | SHAFTED SURGICAL INSTRUMENT FOR REMOTE ACCESS SURGICAL PROCEDURES - An instrument for use in minimally-invasive procedures generally including a pair of coaxially arranged shafts, an end-effector at the distal ends of the shafts, and an actuator at the proximal ends of the shafts. The end-effector is in the form of a suture holder which includes a first, fixed arm at a distal end of a first, fixed outer shaft, and a second, movable arm at a distal end of a second, movable inner shaft. The fixed arm includes a u-shaped end, which defines an opening adapted to receive a portion of an elongate flexible suture material. A closure pin fixed at an end of the movable arm moves back and forth, opening and closing the opening in the u-shaped end of the fixed arm. The closure pin extends from the movable arm into a pin guide opening through one leg of the u-shaped end of the fixed arm. | 03-24-2011 |
| 20110054598 | Contoured Sewing Ring for a Prosthetic Mitral Heart Valve - A prosthetic mitral heart valve including a contoured sewing ring that better matches the mitral valve annulus. The sewing ring includes an inflow end and an outflow end, the outflow and having at least one raised portion. There may be two raised portions located approximately 120° apart from each other and designed to register with two anterior trigones of the mitral valve annulus. The sewing ring may be formed by a suture-permeable annular member surrounded by a fabric covering, the annular member desirably being molded of silicone. The raised portion(s) may gently curve upward to a height of about 2 mm above the adjacent portions of the outflow end of the sewing ring. The sewing ring may also be constructed so as to be more flexible around a posterior aspect than around an anterior aspect to accommodate calcified tissue more commonly found around the posterior annulus. The contoured sewing ring can be combined with various types of heart valve including bioprosthetic and mechanical valves. A bioprosthetic heart valve of the present invention may include a support stent having three outflow commissures alternating with three inflow cusps, with two of the commissures being located at the same place as two raised portions of the sewing ring. A method of implant includes tilting the prosthetic heart valve in the mitral annulus so that a posterior commissure angles away from the ventricular wall and reduces the chance of contact therebetween. | 03-03-2011 |
| 20110054596 | Method of Delivering a Prosthetic Heart Valve - A method of delivering a prosthetic heart valve to a native valve site within the human vasculature. The prosthetic valve is disposed on a balloon at the end of a balloon catheter. The balloon catheter passes through a delivery sleeve assembly. A pull wire travels from the handle to a distal end of the delivery sleeve assembly. Actuation of the handle pulls on the pull wire, which causes the delivery sleeve assembly to bend for facilitating navigation through a patient's vasculature. A stretchable cover is preferably placed over the slotted tube for biasing the steerable catheter toward a straight position. Once advanced to the vicinity of the native valve site, the prosthetic valve may be accurately positioned by advancing the balloon catheter relative to the delivery sleeve assembly and then deployed within the native valve site by inflating the balloon. In an alternative embodiment, the delivery sleeve assembly may be used to advance a self-expanding prosthetic heart valve through a patient's vasculature and a pusher member may be used to eject the prosthetic valve at the native valve site. | 03-03-2011 |
| 20110054284 | Anti-Coagulant Calibrant Infusion Fluid Source - Methods and systems for preventing or eliminating thrombus during use of a sensor are disclosed. The method comprises providing a calibrant infusion fluid source comprising a predetermined amount of a calibrant and adding a predetermined amount of a non-heparin anti-thrombotic agent into the calibrant infusion fluid source. A system and method is disclosed that includes an infusion calibrant source comprising a predetermined amount of a calibrant and a predetermined amount of a non-heparin anti-thrombotic agent with a glucose sensor. | 03-03-2011 |
| 20110034999 | 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. | 02-10-2011 |
| 20110028995 | Surgical Puncture Cinch and Closure System - A system for forming a purse string suture, including a suture applicator having a proximal handle having a suture spool mounted thereon or in an internal chamber. A length of suture is partly wound on the spool, and a hollow suture needle extends from a distal end of the handle and contains a free end of the length of suture. The suture needle projects distally from the handle in a helical shape and terminates in a sharp distal tip with an opening in one side close to the distal tip. The free end of the length of suture may extend out of the distal tip and back into the hollow suture needle through the opening. The suture needle may have a deflection segment adjacent the distal tip that is more flexible than the rest of the helical distal portion of the suture needle. A linear hollow pivot shaft extends from a distal end of the handle substantially along an axis of the helical distal portion of the suture needle. The pivot shaft has a blunt tip with a substantially larger radial profile than the shaft to prevent puncturing tissue. | 02-03-2011 |
| 20110028797 | INTRACARDIAC SHEATH STABILIZER - A surgical stabilizer for use with a surgical site retractor has a base, a bendable arm, and a distal cuff adapted to resiliently hold a tube of an elongated port-access device. The cuff may have a body defining a partial enclosure within which is held a highly flexible gasket having a slit for resiliently receiving the tube. The surgical site retractor may have a collapsible ring and a flexible outer portion attached thereto, the ring being sized to pass through an intercostal incision and expand therein under adjacent ribs to prevent removal, and the flexible outer portion extending out of the incision and drawing over the stabilizer base to mutually secure the retractor and base. The port-access tube may be for a heart valve delivery system using an elongated port-access device for transapically delivering a prosthetic heart valve to the aortic valve annulus. A method involves partly installing the surgical site retractor, anchoring the base of the stabilizer with the flexible outer portion, deploying the port-access tube from outside the body through the incision and through a puncture in the heart wall, and resiliently capturing a tube of the port-access within the partial enclosure of the stabilizer cuff. A second bendable arm on the base having a clip may be used to hold still a proximal end of the port-access device. | 02-03-2011 |
| 20110022165 | INTRODUCER FOR PROSTHETIC HEART VALVE - The present disclosure concerns embodiments of an introducer that is adapted to facilitate insertion of a prosthetic device, such as a prosthetic heart valve, into a patient's vasculature. In one embodiment, the introducer comprises an elongated body defining a central lumen extending between distal and proximal ends of the body. The introducer body can also have a longitudinally extending gap extending along the length of the body between the distal end proximal ends. The gap in the introducer allows a user to place the introducer around implant sutures by passing the sutures through the gap and into the central lumen. Similarly, the gap allows the introducer to be easily removed from the sutures and/or a delivery device by passing them outwardly through the gap. | 01-27-2011 |
| 20110017594 | ANALYTE SENSOR FABRICATION - A biosensor fabrication process comprising transferring one or more layers (e.g., conductive ink and/or membrane layers) from a surface to the biosensor substrate and biosensors produced therefrom. Layers are transferred from the surface to the biosensor substrate using a deposition device, such as a pick and place machine or a printing pad/plate. | 01-27-2011 |
| 20110015731 | Anatomically Approximate Prosthetic Mitral Valve - 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. For example, the flow orifice may be elliptical. A relatively wide sewing ring has a contoured inflow end and is attached to the base structure in such a way that the valve can be implanted in an intra-atrial position and the taller commissures do not extend too far into the left ventricle, therefore avoiding injury to the ventricle. | 01-20-2011 |
| 20110015729 | TRANSAPICAL DELIVERY SYSTEM FOR HEART VALVES - 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. | 01-20-2011 |
| 20110015728 | TRANSAPICAL DELIVERY SYSTEM FOR HEART VALVES - 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. | 01-20-2011 |
| 20110015727 | Annuloplasty Ring and Holder Combination - An annuloplasty ring holder includes an angled post for improved visibility and access by the surgeon. The post may be configured to be adjusted in angle and rotation. The ring holder can include a relatively open lower template, including relatively narrow extending radial arms with short, generally arcuate ring-retaining distal portions. The invention includes placements of suture holes and cutting wells which, in combination with improved suture routing, afford the user improved access to cutting the suture that is used to retain the annuloplasty ring to the holder. Another annuloplasty ring and ring holder combination disclosed includes a generally triangular-shaped ring and a generally T-shaped holder. The ring holder has a base portion forming the top of the T shape and engaging against a first segment of the ring, with a radial arm extending from the base portion and forming the post of the T. The radial arm engages against a junction between two segments of the ring. | 01-20-2011 |
| 20110015722 | DEVICE AND METHOD FOR RESHAPING MITRAL VALVE ANNULUS - Devices and methods for reshaping a mitral valve annulus are provided. One preferred device is configured for deployment in the right atrium and is shaped to apply a force along the atrial septum. The device causes the atrial septum to deform and push the anterior leaflet of the mitral valve in a posterior direction for reducing mitral valve regurgitation. Another preferred device is deployed in the left ventricular outflow tract at a location adjacent the aortic valve. The device is expandable for urging the anterior leaflet toward the posterior leaflet. Another preferred device comprises a tether configured to be attached to opposing regions of the mitral valve annulus. | 01-20-2011 |
| 20100331972 | Unitary Quick Connect Prosthetic Heart Valve and 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. | 12-30-2010 |
| 20100331708 | 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. | 12-30-2010 |
| 20100312334 | HOLDERS FOR PROSTHETIC AORTIC HEART VALVES - A holder for a flexible leaflet prosthetic aortic heart valve that is less bulky than earlier holders and minimizes obstructions to vision and working space around the valve to facilitate implantation thereof. The holder may have a central hub and three outwardly extending legs that connect directly and exclusively to tips of the commissures of the aortic heart valve for better tactile feedback when parachuting and seating the valve in the annulus. The legs are sized so that they do not overlap the commissure tips and therefore afford a better view of the sewing ring adjacent the commissures. The legs may be narrow in the midsection or split into two rails to increase visibility of the valve leaflets. The hub may be vaulted axially upward relative to the outer ends of the legs to further increase visibility of the valve. A more secure engagement between the central hub and a delivery handle is also provided to ensure the holder/handle connection does not become loose during suture placement through the sewing ring and fewer handle revolutions are required to screw in and unscrew the handle from the holder. | 12-09-2010 |
| 20100305432 | System and Method for Locating Medical Devices in Vivo Using Ultrasound Doppler Mode - A system for locating a medical device in vivo includes an ultrasound scanner having a scan head and being capable of operating in a 3D Doppler mode, a medical device having a distal end configured to be inserted in vivo, and a vibratory element coupled to the medical device to induce vibrations in the first distal end. When the scan head is positioned over the distal end inserted in vivo to obtain scan data of the tissue volume, the ultrasound scanner is configured to generate 3D Doppler data in the form of a plurality of slices from the scan data and to identify a location of the distal end within the slices based upon localized data within one of the slices meeting predetermined criteria. | 12-02-2010 |
| 20100305420 | FLEXIBLE CIRCUIT AND METHOD FOR FORMING THE SAME - A flexible circuit is provided herein that includes conductive material on the top and bottom planar surfaces of a dielectric substrate. The flexible circuit can be used in various applications, including use as a sensor. A via is used to provide electrical communication between the top and bottom surface of the flexible circuit. A method of preparing a flexible circuit and a medical instrument including the flexible circuit are also provided. | 12-02-2010 |
| 20100293892 | Method of Packaging and Package for Sensors - There are provided methods of packaging and packages that prevent damage of the package contents while maintaining sterility and that limit the negative effects of sterilization on sensors such as enzyme sensors. A method of packaging an enzyme sensor includes providing an enzyme sensor such as a glucose oxidase sensor in a gas impermeable package comprising one or more of oxygen and water, removing a significant portion of the oxygen and water present in the package, and sealing the package. The resulting package comprises the enzyme sensor in an atmosphere that is substantially free of oxygen and water. The package can also include a pressure indicator that indicates when the package has exceeded a predetermined pressure. | 11-25-2010 |
| 20100274098 | Patient Monitoring System - A patient monitoring system is disclosed having a central configuration management system in communication with a plurality of medical monitors via a communication system. The central communication management system allows users to create a plurality of use-specific monitor configurations, such as physician-specific and location-specific monitor configurations. The plurality of use-specific monitor configurations are stored on the central communication management system until a use-specific monitor configuration is selected for a particular monitor. The communication system is then used to transmit the selected use-specific monitor configuration from the central configuration management system to the particular monitor. A use-specific configuration can be selected for a monitor based on, for example, a selection made by a user of the monitor or automatically based on an RFID tag associated with a particular physician or location proximate to the monitor. | 10-28-2010 |
| 20100268097 | Monitoring Peripheral Decoupling - Methods for monitoring central-to-peripheral arterial pressure decoupling, i.e., hyperdynamic conditions, are described. These methods involve the comparison of parameters calculated from multivariate statistical models established for both subjects experiencing normal hemodynamic conditions and subjects experiencing hyperdynamic conditions, in which central- to peripheral decoupling may occur. The difference or ratio between the parameters calculated using the two multivariate statistical models provides a continual indication of the level of decoupling as well as indicating peripheral decoupling when a threshold value is exceeded. These methods can be used to both alert a user to the fact that a subject is experiencing peripheral decoupling and provide accurate arterial tone measurements, which enable the calculation of accurate values for other parameters, such as stroke volume and cardiac output. | 10-21-2010 |
| 20100257735 | METHODS FOR ASSEMBLING COMPONENTS OF A FABRIC-COVERED PROSTHETIC HEART VALVE - A system and method for assembling a prosthetic heart valve, including a procedure for tightly wrapping fabric around a heart valve support stent. The support stent typically includes alternating cusps and commissures that create a highly contoured undulating outflow edge. The system includes a mandrel for retaining tension without manual assistance in a tubular length of fabric wrapped over the support stent. The mandrel may include an inner clamping mechanism for holding the first end of the fabric tube, a pedestal tube on which the support stent rests and through which the fabric tube passes, and an outer clamping mechanism for holding the free end of the fabric tube. The inner and outer clamping mechanisms include discrete clamps spaced apart 120° from each other that pull the fabric only in the cusps of the support stent. The inner clamping mechanism, outer clamping mechanism, and pedestal are relatively axially movable. Once the fabric is retained over the support stent, the mandrel may be placed in a chuck of a sewing machine system for automatically forming the seam. A small shuttle with bobbin thread reciprocates within a channel inside of the support stent and cooperates with the sewing machine needle to form a lock-stitch in the fabric tube. The mechanization of the fabric covering procedure greatly enhances manufacturing throughput and reduces ergonomic strain on workers. | 10-14-2010 |
| 20100249908 | PROSTHETIC HEART VALVE SYSTEM WITH POSITIONING MARKERS - An exemplary two-stage prosthetic heart valve system has a radially expandable base stent implanted within a native valve annulus. The base stent desirably has three position markers projecting in the axial direction from the outflow end of the base stent to assist in aligning the stent with respect to the commissures of the native valve. The two-stage heart valve system also has a valve component that is delivered to and mounted within the base stent in a separate or sequential operation after the base stent has been anchored within the annulus. The valve component in certain embodiments comprises a hybrid valve component that includes a conventional, non-expandable surgical valve that is modified to include an expandable coupling stent that can be expanded to engage the inner surface of the base stent, thereby anchoring the valve component to the base stent. | 09-30-2010 |
| 20100249894 | PROSTHETIC HEART VALVE SYSTEM - An exemplary two-stage prosthetic heart valve system has a radially expandable base stent implanted within a native valve annulus. The two-stage heart valve system also has a valve component that is delivered to and mounted within the base stent in a separate or sequential operation after the base stent has been anchored within the annulus. The valve component in certain embodiments comprises a hybrid valve component that includes a conventional, non-expandable surgical valve that is modified to include an expandable coupling stent that can be expanded to engage the inner surface of the base stent, thereby anchoring the valve component to the base stent. In its expanded configuration, the outflow end portion base stent has tri-lobular shape that closely conforms to the shape of the aortic root and a support ring of the prosthetic valve that is mounted within the base stent. | 09-30-2010 |
| 20100243477 | 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. | 09-30-2010 |
| 20100241013 | Direct Measurements of Arterial Pressure Decoupling - Methods for monitoring central-to-peripheral arterial pressure decoupling, i.e., hyperdynamic or vasodilation conditions are described. These methods involve the comparison of parameters such as impedance, compliance, and pressure that can be determined from flow and pressure measurements at central aortic and peripheral arterial locations. The relationship between the parameters at the central aortic and peripheral arterial locations provides an indication of central-to-peripheral arterial pressure decoupling. These methods can be alert a user that a subject is experiencing central-to-peripheral arterial pressure decoupling, which can enable a clinician to appropriately provide treatment to the subject. | 09-23-2010 |
| 20100236923 | 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. | 09-23-2010 |
| 20100219085 | Analyte Sensor Offset Normalization - Measurements of current from a working electrode and current from a blank electrode are received and a ratio corresponding to the ratio of surface areas of the working electrode and the blank electrode is determined. This ratio is used to correct any differential current offset between an analyte (working) electrode and a control (blank) electrode to yield a more accurate net current output. Systems, methods and computer program products are further described for measuring an analyte concentration disclosed are for calculating the amount of an analyte in a fluid using a biosensor. | 09-02-2010 |
| 20100204592 | 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. | 08-12-2010 |
| 20100204591 | Calculating Cardiovascular Parameters - Methods for measuring a cardiovascular parameter in a subject regardless of whether the subject is experiencing normal hemodynamic or abnormal hemodynamic conditions are described. These methods involve the determination of whether a subject is experiencing normal hemodynamic conditions or abnormal hemodynamic conditions, then applying an appropriate model to subject data to determine a cardiovascular parameter for the subject. Multivariate Boolean models are used to establish if the subject is experiencing normal hemodynamic or abnormal hemodynamic conditions, then multivariate statistical models are used to calculate the appropriate cardiovascular parameter. Having correct cardiovascular parameters for a subject experiencing abnormal hemodynamic conditions, for example, enables the calculation of accurate values for treatment relevant parameters, such as, cardiac output and stroke volume. | 08-12-2010 |
| 20100204590 | Detection of Vascular Conditions Using Arterial Pressure Waveform Data - Multivariate statistical models for the detection of vascular conditions, methods for creating such multivariate statistical models, and methods for the detection of vascular condition in a subject using the multivariate statistical models are described. The models are created based on arterial pressure waveform data from a first group of subjects that were experiencing a particular vascular condition and a second group of subjects that were not experiencing the same vascular condition. The multivariate statistical models are set up to provide different output values for each set of input data. Thus, when data from a subject under observation is input into the model, the relationship of the model output value to the established output values for the two groups upon which the model was established will indicate whether the subject is experiencing the vascular condition. | 08-12-2010 |
| 20100200538 | 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. | 08-12-2010 |
| 20100161046 | HOLDER FOR FLEXIBLE HEART VALVE - A holder for a highly flexible tissue-type heart valve is disclosed that maintains an implant shape to the valve. The holder may have cusp and commissure contacting supports, and may be attached at all six such supports, or only three. The holder may be flexible to permit inward flexing of the heart valve during implant for greater visibility when implanting using a running suture method. The holder may be formed of flexible wires such as Nitinol, and shaped to resist excessive axial and torsional deformation of the valve. A short handle connector suitable for manual grasping may be attached and stored with the valve, with the handle connector having a coupling for receiving a longer delivery handle. A two stage holder may be utilized to accommodate different implant methods. | 06-24-2010 |
| 20100161036 | 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 to 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. A catheter-based system and method for deployment is provided. | 06-24-2010 |
| 20100160756 | Membrane Layer for Electrochemical Biosensor and Method of Accommodating Electromagnetic and Radiofrequency Fields - A method comprising providing an in vivo electrochemical biosensor, the biosensor comprising an electrode surface, a flux-limiting layer covering at least a portion of the electrode surface, covering at least a portion of the flux-limiting layer with a hydrophilic polymer membrane, and preventing or eliminating disruption of the output signal of the electrochemical biosensor by an external EMF or external RF source during in vivo use of the biosensor in a subject. | 06-24-2010 |
| 20100160755 | Polyelectrolytes as Sublayers on Electrochemical Sensors - Disclosed herein is an electrochemical sensor for measuring an analyte in a subject. More particularly, sensors comprising a polyelectrolyte layer at least partially covering the electroactive surface of an electrode are disclosed. | 06-24-2010 |
| 20100152592 | Assessment of Preload Dependence and Fluid Responsiveness - Methods for determining a cardiovascular parameter reflecting fluid or volume changes and for detecting arrhythmia are disclosed. These methods involve receiving a waveform dataset corresponding to an arterial blood pressure, pulseox, Doppler ultrasound or bioimpedance signal and analyzing the waveform to detect irregular cardiac cycles. Irregular cardiac cycles are detected, for example, by comparing parameters of individual cardiac cycles to the parameters of other or average cardiac cycles. If any irregular cardiac cycles are present, their effect is compensated for to form a modified waveform dataset. Once any irregular cardiac cycles are compensated for, a cardiovascular parameter reflecting fluid or volume changes using the modified waveform dataset is calculated. In the method for determining arrhythmia, if the number of irregular cardiac cycles exceeds a predetermined arrhythmia threshold, a user such as a medical professional is notified. | 06-17-2010 |
| 20100137980 | Annular Prosthesis for a Mitral Valve - An annular prosthesis for a mitral valve that may include 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. The ratio between the distance between the anterior half-ring and the posterior half-ring, as measured along a second plane, perpendicular to the first plane and equidistant to the couplings, and the maximum width of the prosthesis is lower than ¾. | 06-03-2010 |
| 20100131039 | APPARATUS AND METHOD FOR IN SITU EXPANSION OF PROSTHETIC DEVICE - 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. | 05-27-2010 |
| 20100108509 | Analyte Sensor with Non-Working Electrode Layer - Disclosed is an electrochemical sensors for measuring an analyte in a subject. More particularly, the sensor comprises a non-working electrode, the non-working electrode comprising a non-working electroactive surface, and a layer covering at least a portion of the non-working electroactive surface, the layer configured to prevent or reduce endogenous or exogenous components from contacting the non-working electrode surface. | 05-06-2010 |
| 20100098380 | Releasably Locking Auto-Aligning Fiber Optic Connector - A connector assembly couples signal lines for an optical catheter by providing a guided releasable latching mechanism that ensures optimal alignment with only a single vertical dimension under control. A receptacle carrying a first signal line defines a channel for receiving a plug carrying a second signal line. A spring-loaded pawl on the receptacle locks to a retaining bracket on the plug when the plug slides into the channel, imparting a retaining force on the plug, the force having a first component normal to channel and a second component parallel to the channel to maintain the first and second signal lines in optimal alignment. The retaining bracket may include a sloped edge to allow for easy release of the pawl in the presence of a release force. The release force may be set to allow disconnection of the assembly without affecting catheter installation or causing patient discomfort. | 04-22-2010 |
| 20100094392 | 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 tissue 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 comprise a sheath with inner and outer tubular layers, and an intermediate tubular layer comprising a shape memory alloy. Other embodiments comprise one or more layers having one or more longitudinal notches or cuts to facilitate expansion of the sheath. 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. | 04-15-2010 |
| 20100094077 | Method for substantially non-delaminable smooth ventricular assist device conduit and product from same - A method of non-delaminably bonding a non-porous thermoplastic elastomer to a substrate by heating a bilayer of the elastomer and the substrate for a predetermined time and a product obtained by the method. Methods for producing non-delaminable conduits and non-delaminable kink-resistant conduits constructed of biocompatible elastomers and substrates, and products produced by these methods are taught. Methods, products, and articles of manufacture relating to non-delaminable monofilament supported kink-resistive conduits that may be used as inflow conduits in left ventricular assist devices for treatment of heart failure are also provided. | 04-15-2010 |
| 20100087743 | Pulse Contour Method and Apparatus for Continuous Assessment of a Cardiovascular Parameter - A cardiovascular parameter such as cardiac output is estimated from a current pressure waveform data set without needing to directly measure blood flow or arterial compliance. The general shape of an input flow waveform over one beat-to-beat cycle is assumed (or computed), and then the parameters of a flow-to-pressure model, if not pre-determined, are determined using system identification techniques. In one embodiment, the parameters thus determined are used to estimate a current peripheral resistance, which is used not only to compute an estimate of the cardiovascular parameter, but also to adjust the shape of the input flow waveform assumed during at least one subsequent beat-to-beat cycle. Another embodiment does not require computation of the peripheral resistance and still another embodiment computes a flow estimate from an optimized identification of the parameters defining the assumed input flow waveform. | 04-08-2010 |
| 20100076549 | Annuloplasty Ring Configured to Receive a Percutaneous Prosthetic Heart Valve Implantation - The invention is an annuloplasty ring, and associated methods therefore, configured to reshape a native heart valve annulus to correct heart valve function, and also configured to be reshaped into a generally circular form in order to receive and/or support a prosthetic heart valve. The annuloplasty ring may be configured to have a generally D-shaped configuration when initially implanted to correct native valve function, but to assume a generally circular form when subjected to an outward force such as that provided by a dilation balloon. | 03-25-2010 |
| 20100076548 | Prosthetic Heart Valve Configured to Receive a Percutaneous Prosthetic Heart Valve Implantation - The invention 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 may be configured to have a generally rigid and/or expansion-resistant configuration when initially implanted to replace 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. | 03-25-2010 |
| 20100072062 | Membrane For Use With Amperometric Sensors - Membranes useful for amperometric sensors are described. The membranes allow continuous and real time in vivo measurements of a variety of redox active chemical species present in a fluid sample. In some embodiments, the membrane comprises a redox mediator, a redox reactive species, and conductive nano structures, such as carbon nanotubes. The membrane can be provided on a working electrode of the sensor. Amperometric sensors incorporating the membranes and methods of treatment using the sensors are also described. | 03-25-2010 |
| 20100057193 | FLEXIBLE HEART VALVE AND ASSOCIATED CONNECTING BAND - 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. | 03-04-2010 |
| 20100056932 | 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. | 03-04-2010 |
| 20100042147 | METHOD AND APPARATUS FOR REPAIRING OR REPLACING CHORDAE TENDINAE - A method and apparatus for performing mitral valve chordal repair on a patient include attaching at least one filament to a mitral valve leaflet and to a papillary muscle. A first end of a filament can be attached to the mitral valve leaflet and the length of the filament can be adjusted by adjusting the tension of the filament in a catheter. The second end of the filament can be attached to an attachment site. | 02-18-2010 |
| 20100030330 | Device and method for mitral valve repair - Devices and methods for reshaping a mitral valve annulus are provided. One device according to the invention is configured for deployment in the right atrium and is shaped to apply a force along the atrial septum. The device causes the atrial septum to deform and push the anterior leaflet of the mitral valve in a posterior direction for reducing mitral valve regurgitation. Another embodiment of a device is deployed in the left ventricular outflow tract at a location adjacent the aortic valve. The device may be expandable for urging the anterior leaflet toward the posterior leaflet. Another embodiment of the device includes a first anchor, a second anchor, and a bridge, with the bridge having sufficient length to reach from the coronary sinus to the right atrium and/or superior or inferior vena cava. In a further embodiment a device includes a middle anchor positioned on the bridge between the distal and proximal anchors. | 02-04-2010 |
| 20100023118 | METHOD AND APPARATUS FOR REPAIRING OR REPLACING CHORDAE TENDINAE - A method and apparatus for performing mitral valve chordal repair on a patient include attaching at least one filament to a mitral valve leaflet and to a papillary muscle. The length of filaments can be adjusted by adjusting tension in a filament or by altering the effective length of a filament by cutting filament strands or by moving an adjustment member along the length of the filaments. | 01-28-2010 |
| 20100010625 | MITRAL VALVE ANNULOPLASTY RING HAVING AN OFFSET POSTERIOR BOW - A mitral heart valve annuloplasty ring having a posterior bow that conforms to an abnormal posterior aspect of the mitral annulus. The ring may be generally oval having a major axis and a minor axis, wherein the posterior bow may be centered along the minor axis or offset in a posterior section. The ring may be substantially planar, or may include upward bows on either side of the posterior bow. The ring may include a ring body surrounded by a suture-permeable fabric sheath formed of a plurality of concentric ring elements or bands. The posterior bow is stiff enough to withstand deformation once implanted and subjected to normal physiologic stresses. A method of repairing an abnormal mitral heart valve annulus having a depressed posterior aspect includes providing a ring with a posterior bow and implanting the ring to support the annulus without unduly stressing the attachment sutures. | 01-14-2010 |
| 20100004677 | SHAFTED SURGICAL INSTRUMENTS FOR REMOTE ACCESS SURGICAL PROCEDURES - An instrument for endoscopic minimally invasive procedures has a shaft with a working end, such as a clamp, scissors, forceps, or the like. Handle portions extend in an opposed relationship and pivot relative to the shaft. When the handle portions are moved about respective pivot points, the working end of the surgical instrument is actuated. The first and second handle portions each have an indented grasping segment in which a surgeon's finger or thumb may rest. The grasping segments have rounded cross-sections to facilitate a surgeon rotating the handle with a finger and another finger or thumb. The indented portions form a narrow portion when the handle is in a closed configuration. There may be a 1:1 ratio between handle movement and that of the working end, and the balance point of the instrument may be at the distal end of the handle. | 01-07-2010 |
| 20090319037 | 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 stent is delivered to a position on the surface of the outflow side of a native heart valve of a patient, the support stent defining a support-stent interior. An expandable prosthetic heart valve is delivered into the native heart valve from the inflow side of the native heart valve and into the support-stent interior. The expandable prosthetic heart valve is expanded while the expandable prosthetic valve is in the support-stent interior and while the support stent is at the position on the surface of the outflow side of the heart valve, thereby causing one or more of the native leaflets of the native heart valve to be frictionally secured between the support stent and the expanded prosthetic heart valve. | 12-24-2009 |
| 20090318871 | MITRAL VALVE REPAIR SYSTEM AND METHOD FOR USE - The present invention is directed to various systems for repairing tissue within the heart of a patient. The mitral valve repair system of the present invention comprises a guide catheter having a proximal end, a distal end, and at least one internal lumen formed therein, a therapy catheter capable of applying a suture to the tissue, and a fastener catheter capable of attaching a fastener to the suture. The therapy catheter and the fastener catheter are capable of traversing the internal lumen of the guide catheter. In addition, the present invention discloses various methods for repairing tissue within the heart of a patient. In one embodiment, the method of repairing heart valve tissue includes advancing a guide catheter through a circulatory pathway to a location in the heart proximate to a heart valve, advancing a therapy catheter through the guide catheter to the heart valve, stabilizing a first leaflet with the therapy catheter, deploying a first suture into the stabilized first leaflet, disengaging the first leaflet from the therapy catheter while leaving the first suture attached thereto, stabilizing a second leaflet with the therapy catheter, deploying a second suture into the second leaflet, disengaging the second leaflet from the therapy catheter while leaving the second suture attached thereto, and joining the first and second leaflets by reducing the distance between the first and second sutures. | 12-24-2009 |
| 20090299470 | Quick-Release Annuloplasty Ring Holder - 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. The annuloplasty ring may have a relatively rigid inner core surrounded by a suture-permeable cover, and the peripheral edge may be formed by a lower axial wall and an upper radial ledge that projects outward from the rigid inner core but not quite as far as a sewing margin of the ring. The ring and holder may be for mitral annuloplasty rings and generally have a D shape in plan view, and may be three-dimensional with upward anterior and posterior bows. | 12-03-2009 |
| 20090292160 | Electromagnetic Cardiac Assist Device and Method - Embodiments of the present invention provide systems and methods for assisting with contraction of the heart muscle. For example, in one embodiment of the invention, one or more flexible strips are attached to the surface of the heart, each strip having a plurality of electromagnets alternating with a plurality of permanent magnets. The electromagnets are electrically coupled to a control device and a power supply for generating current in the electromagnets. The control device controls the current in the electromagnets in such a way that the electromagnets are periodically activated to attract the adjacent permanent magnets to assist with contraction of the heart muscle. In some embodiments a sensor is provided for sensing the sinus rhythm so that the control device can activate the electromagnets based on the sensed sinus rhythm. | 11-26-2009 |
| 20090291555 | Method and Apparatus for Using Flex Circuit Technology to Create a Reference Electrode Channel - A method of creating a sensor that may include applying a first conductive material on a first portion of a substrate to form a reference electrode and depositing a first mask over the substrate, the first mask having an opening that exposes the reference electrode and a second portion of the substrate. The method may also include depositing a second conductive material into the opening in the first mask, the second conductive material being in direct contact with the reference electrode and depositing a second mask over the second conductive material, the second mask having an opening over the second portion of the substrate, the opening exposing a portion of the second conductive material which forms a working surface to receive a fluid of interest. | 11-26-2009 |
| 20090287303 | PHYSIOLOGICALLY HARMONIZED TRICUSPID ANNULOPLASTY RING - A prosthetic 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 desirably 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 tricuspid 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 commissure 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, so as to adapt or harmonize its 3-dimensional shape to each individual patient and, therefore, to significantly reduce the constraints on the annulus and adjacent structures, particularly the leaflets and the conduction tissue. | 11-19-2009 |
| 20090281619 | Low Profile Delivery System for Transcatheter Heart Valve - A heart valve delivery apparatus includes a valve carrying member. A prosthetic valve is crimped onto the valve carrying member at a location that is distal or proximal to the balloon member, thereby providing a smaller profile delivery apparatus. | 11-12-2009 |
| 20090276040 | DEVICE AND METHOD FOR REPLACING MITRAL VALVE - A prosthetic mitral valve assembly and method of inserting the same is disclosed. In certain disclosed embodiments, the prosthetic mitral valve assembly has a flared upper end and a tapered portion to fit the contours of the native mitral valve. The prosthetic mitral valve assembly can include a stent or outer support frame with a valve mounted therein, The assembly can be adapted to expand radially outwardly and into contact with the native tissue to create a pressure fit. One embodiment of a method includes positioning the mitral valve assembly below the annulus such that the annulus itself can restrict the assembly from moving in an upward direction towards the left atrium. The mitral valve assembly is also positioned so that the leaflets of the mitral valve hold the assembly to prevent downward movement of the assembly towards the left ventricle. | 11-05-2009 |
| 20090275919 | Balloon Deployment Device and Method - Embodiments of the present invention provide systems and methods for deploying and/or retrieving a balloon configured to at least partially occlude a vessel, such as the coronary sinus. More particularly, embodiments of the present invention provide a stylet and a balloon catheter configured such that the stylet can be inserted into a lumen in the catheter and used to exert a force against an interior portion of the balloon in order to stretch the balloon and reduce the diameter of the balloon. In one embodiment, the stylet and the balloon both have specialty-configured tips that work together to prevent tearing of the balloon when the stylet is exerting a force against the interior of the balloon's tip. | 11-05-2009 |
| 20090270739 | REAL-TIME DETECTION OF VASCULAR CONDITIONS OF A SUBJECT USING ARTERIAL PRESSURE WAVEFORM ANALYSIS - Methods for the detection of vascular conditions such as vasodilation in a subject are described. The methods involve receiving a signal corresponding to an arterial blood pressure and calculating one or more cardiovascular parameters from the arterial blood pressure. The cardiovascular parameters are calculated using factors impacted by vascular conditions such as vasodilation. Factors impacted by these vascular conditions include the area under the systolic portion of the arterial blood pressure signal, the duration of systole, and the ratio of the duration of the systole to the duration of the diastole. By monitoring cardiovascular parameters that are calculated using factors impacted by vascular conditions such as vasodilation for changes indicating the vascular conditions, such vascular conditions can be detected. | 10-29-2009 |
| 20090259306 | TRANSCATHETER HEART VALVE WITH MICRO-ANCHORS - Various embodiments of methods and apparatus for treating defective heart valve are disclosed herein. In one exemplary embodiment, a transcatheter heart valve is disclosed that includes an expandable shape memory stent and a valve member supported by the stent. A plurality of micro-anchors can be disposed along an outer surface of the stent for engaging native tissue. The transcatheter heart valve can be configured to be advanced into a dilated valve annulus via a balloon catheter. The balloon can be inflated to expand the transcatheter heart valve from a collapsed diameter to an over-expanded diameter such that the micro-anchors engage tissue along the surrounding valve annulus. After engaging the tissue, the balloon can be deflated and the shape memory stent can retract or recoil toward its predetermined recoil diameter. As the stent recoils, the surrounding tissue is pulled inward by the stent such that the diameter of the valve annulus is reduced. | 10-15-2009 |
| 20090254177 | Method 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 head 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. | 10-08-2009 |
| 20090234291 | CANNULA - A cannula assembly including a cannula body having a perfusion lumen extending therethrough; a removable introducer to be carried in the perfusion lumen, the removable introducer including a first hole, a second hole and a central lumen extending therebetween to allow fluid entering the first hole to flow through the central lumen and exit the second hole into the perfusion lumen; and a cap member including at least one venting means that allows air displaced by the fluid entering the first hole to be vented from the cannula body. | 09-17-2009 |
| 20090222084 | SUTURELESS HEART VALVE ATTACHMENT - A prosthetic heart valve having spaced apart anchoring flanges that change shape when the valve is implanted and contact the surrounding annulus to prevent migration of the valve. The heart valve may be non-expandable and the anchoring flanges may provide the primary anchoring structure of the valve. Alternatively, the valve may be expandable wherein the anchoring flanges supplement the inherent anchoring capacity of the valve structure. The anchoring flanges are at least partly made of a material that increases in size, i.e., swells, due to absorption of body fluids. For instance, the anchoring flanges may be formed of an inner material that swells upon contact with body fluids enclosed by a cover. The anchoring flanges may be provided on an anchoring sleeve that changes shape to provide the spaced apart annular flanges for securing the valve around a fibrous annulus. An anchoring sleeve for a prosthetic heart valve having an expandable frame surrounds a majority of the frame and may define an external hourglass configuration. | 09-03-2009 |
| 20090188811 | 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. | 07-30-2009 |
| 20090177276 | 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. | 07-09-2009 |
| 20090157175 | LEAFLET ATTACHMENT FRAME FOR A PROSTHETIC VALVE - An implantable prosthetic valve has an upper frame section and a lower frame section. The upper frame section has a plurality of struts and a first leaflet receiving surface at a lower portion of the upper frame section. The lower frame section has a second leaflet receiving surface at an upper portion of the lower frame section. An edge of a flexible leaflet is disposed between the first and second leaflet receiving surfaces to attach the leaflet to the upper and lower frame sections. | 06-18-2009 |
| 20090157161 | Percutaneous Nitinol Stent 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. | 06-18-2009 |
| 20090152200 | Optimizing Clearance for Protein-Bound Molecules Using Cascade Filtration Therapy - A hemofiltration system or method removes unwanted molecules from a flow of blood using cascaded first and second hemofilters. Filtration of the blood in first hemofilter raises hemoconcentration of unwanted protein-bound molecules. Combination of a substitution fluid with outflow from the first hemofilter creates a concentration differential between bound and unbound molecules that frees unwanted molecules from protein bonds. Filtration of the combined fluids in a second hemofilter removes the unwanted free molecules. A second substitution fluid may be added to the twice filtered blood fluid for return to a patient. Removal of inflammatory mediators, apoptotic mediators, and certain electrolytes may be effected, and the removal may be optimized by controlling fluid flows and transmembrane pressures. | 06-18-2009 |
| 20090143658 | ANALYTE SENSOR - Electrochemical sensors for measuring an analyte in a subject are described. More particularly, devices for measurement of an analyte are disclosed incorporating a sensor comprising an enzyme layer in contact with an interference layer and a membrane comprising vinyl ester monomeric units covering at least a portion of the enzyme layer and at least a portion of the interference layer, the devices providing rapid and accurate analyte levels upon deployment. | 06-04-2009 |
| 20090120810 | ANALYTE MONITORING SYSTEM CAPABLE OF DETECTING AND PROVIDING PROTECTION AGAINST SIGNAL NOISE GENERATED BY EXTERNAL SYSTEMS THAT MAY AFFECT THE MONITORING SYSTEM - An analyte monitoring system includes a biosensor for detecting an analyte concentration in blood. The monitoring system includes a sensor for sensing whether tool or other piece of equipment is producing electrical noise that may affect operation of the biosensor. If such electrical noise is detected, the system isolates the biosensor during the period of detected operation of the other tool or equipment. In some embodiments, the system measure both signal noise in and temperature of the environment surrounding the biosensor to determine whether another tool or other piece of equipment is currently in operation. The system may also include an auxiliary power source to maintain the biosensor in a biased state during the period when the biosensor is placed in isolation. | 05-14-2009 |
| 20090118604 | ANALYTE MONITORING SYSTEM HAVING BACK-UP POWER SOURCE FOR USE IN EITHER TRANSPORT OF THE SYSTEM OR PRIMARY POWER LOSS - An analyte monitoring system includes a biosensor for detecting an analyte concentration in blood. The monitoring system includes first and second power sources, each selectively couplable to the biosensor for providing power to the biosensors. A sensor may be associated with the first power source and senses the output thereof. A selector is coupled to both the first and second power sources and the biosensor, such that it may selectively couple an output or outputs of either the first or second power sources to the biosensor. In operation, the first power source is coupled to the biosensor to thereby bias the sensor. If the sensor indicates that the first power source is not providing power to the biosensor, the selector decouples the first power source from the biosensor and couples the second power source to the biosensor to thereby maintain the biosensor in a biased state. | 05-07-2009 |
| 20090076586 | Device and Method for ReShaping Mitral Valve Annulus - Devices and methods for reshaping a mitral valve annulus are provided. One preferred device is configured for deployment in the right atrium and is shaped to apply a force along the atrial septum. The device causes the atrial septum to deform and push the anterior leaflet of the mitral valve in a posterior direction for reducing mitral valve regurgitation. Another preferred device is deployed in the left ventricular outflow tract at a location adjacent the aortic valve. The device is expandable for urging the anterior leaflet toward the posterior leaflet. Another preferred device comprises a tether configured to be attached to opposing regions of the mitral valve annulus. | 03-19-2009 |
| 20090062666 | 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. | 03-05-2009 |
| 20090054973 | Four-leaflet stented mitral heart valve - A prosthetic mitral heart valve having four separate flexible leaflets. The heart valve includes a support frame that may be non-circular, for example elliptical or “D-shaped”. The support frame may have an undulating outflow edge defined by four inflow cusps and four outflow commissures to which each of the flexible leaflets attaches. The support frame may comprise an undulating wireform and a surrounding stent defining a structure having four cantilevered posts projecting in the outflow direction to support the four leaflets. The heart valve is designed to be secured in the annulus and function as a standalone unit without papillary muscle connections to the leaflets. The four leaflets may be arranged in two opposed pairs, one pair being smaller than the other pair. The larger pair of leaflets may be identical, or differently sized. Existing sizes of heart valve leaflets may be utilized with the smaller leaflets being at least two leaflet sizes smaller than the larger leaflets in odd millimeter increments. | 02-26-2009 |
| 20090048527 | ASSESSMENT OF PRELOAD DEPENDENCE AND FLUID RESPONSIVENESS - Methods for determining a cardiovascular parameter reflecting fluid or volume changes and for detecting arrhythmia are disclosed. These methods involve receiving a waveform dataset corresponding to an arterial blood pressure, pulseox, Doppler ultrasound or bioimpedance signal and analyzing the waveform to detect premature ventrical or atrial contractions. Premature ventrical or atrial contractions are detected, for example, by comparing parameters of individual cardiac cycles to the parameters of other or average cardiac cycles. If any premature ventrical or atrial contractions are present, they are removed from the waveform dataset. Once any the premature ventrical or atrial contractions are removed, a cardiovascular parameter reflecting fluid or volume changes using the modified waveform dataset is calculated. In the method for determining arrhythmia, if the number of premature ventrical or atrial contractions exceeds a predetermined arrhythmia threshold, a user such as a medical professional is notified. | 02-19-2009 |
| 20090043184 | CATHETER AND PROBE FOR MEASURING ANALYTES OR OTHER PARAMETERS - A medical sensing system including an access tube with a fluid infusate lumen and a sensing probe that can be passed through a second lumen in the access tube and extended into the vasculature for sensing a blood parameter. The sensing probe has a sensor on a distal end thereof and a shape that permits it to extend from the access tube such that the sensor is displaced laterally from the access tube, and out of the infusate flow. If the sensing probe passes through the lumen opening at the distal tip of the catheter, the distal end of the probe bends or otherwise deflects laterally so that the sensor is displaced laterally from the infusate flow path. Alternatively, the probe may exit a side port of the access tube upstream of an infusate side port. The deflectable probe is particularly useful for sensing glucose in blood through any number of conventional, off-the-shelf catheters. | 02-12-2009 |
| 20090043153 | Apparatus, system, and method for applying and adjusting a tensioning element to a hollow body organ - An adjustable support pad for adjustably holding a tensioning line used to apply tension to a body organ. The adjustable support pad can include a locking mechanism for preventing slidable movement of the tensioning element in one or both directions. The locking mechanism may include spring-loaded locks, rotatable cam-like structures, and/or rotatable spool structures. The adjustable support pad may be formed from rigid, semi-rigid, and/or flexible materials, and may be formed to conform to the outer surface of a body organ. The adjustable support pad can be configured to adjustably hold one or more separate tensioning lines, and to provide for independent adjustment of one or more tensioning lines or groups thereof. | 02-12-2009 |
| 20090030641 | MONITORING AND COMPENSATING FOR TEMPERATURE-RELATED ERROR IN AN ELECTROCHEMICAL SENSOR - A method for compensating for a temperature-related error in an electrochemical sensor without using separate sources of temperature measurement by measuring sensor current, temporarily lowering sensor voltage to a first level below a reaction-sustaining threshold, measuring a first offset current, adjusting sensor voltage to a second level below the threshold, measuring a second offset current, calculating a difference between the offset currents, deriving a temperature compensation value from the difference based on empirical data, and adding the value to the measured sensor current. A computer system may execute the method as an algorithm stored in memory, provide automatic control of the sensor, and provide continuous display of corrected output values. | 01-29-2009 |
| 20090024146 | System, apparatus, and method for repairing septal defects - An apparatus and method for repairing 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, and tightening the suture lines. The catheter can include one or more vacuum ports, with the vacuum ports being sized and configured to grasp opposing edges of the defect when vacuum is applied thereto. The vacuum ports may be positioned longitudinally distant from each other along the catheter, and may also be on different sides of the catheter. The vacuum ports may have vacuum applied via independent control. The catheter can also include suture deploying structure that prevents the suture line from becoming entangled in the catheter. | 01-22-2009 |
| 20090024015 | 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. | 01-22-2009 |
| 20090005663 | NON-INVASIVE MEASUREMENT OF BLOOD ANALYTES - An apparatus for the measurement of at least one analyte in the blood of a patient, which includes a light source generating broadband light and a light-transmission arrangement having a plurality of transmitting fibers is positioned for simultaneously transmitting multiple wavelengths of the broadband light from the light source to the blood of the patient. The measurement apparatus further includes an optical fiber arrangement having a plurality of light detector fibers for leading multi-wavelength light, in spectrally unseparated form, transmitted through, or reflected from, the blood and a light detection arrangement for receiving the multi-wavelength light in its spectrally unseparated form from the optical fiber arrangement, for spectrally decomposing the received light, and for determining amplitudes of selected wavelengths of the decomposed light. The measurement apparatus utilizes a non-pulsatile element of the patient's blood for determining the measurement of at least one analyte in the blood as a function of the amplitudes of the selected wavelengths. | 01-01-2009 |
| 20080302372 | METHODS FOR PRE-STRESSING AND CAPPING BIOPROSTHETIC TISSUE - A treatment for bioprosthetic tissue used in implants or for assembled bioprosthetic heart valves to reduce in vivo calcification is disclosed. The method includes preconditioning, pre-stressing, or pre-damaging fixed bioprosthetic tissue in a manner that mimics the damage associated with post-implant use, while, and/or subsequently applying a calcification mitigant such as a capping agent or a linking agent to the damaged tissue. The capping agent suppresses the formation of binding sites in the tissue that are exposed or generated by the damage process (service stress) and otherwise would, upon implant, attract calcium, phosphate, immunogenic factors, or other precursors to calcification. The linking agent will act as an elastic reinforcement or shock-absorbing spring element in the tissue structure at the site of damage from the pre-stressing. In one method, tissue leaflets in assembled bioprosthetic heart valves are preconditioned by simulating actual flow conditions for a predetermined number of cycles, during or after which the valve is exposed to the capping agent. | 12-11-2008 |
| 20080300494 | REAL-TIME MEASUREMENT OF VENTRICULAR STROKE VOLUME VARIATIONS BY CONTINUOUS ARTERIAL PULSE CONTOUR ANALYSIS - Ventricular stroke volume variation (SVV) is estimated as a function of the standard deviation of arterial blood pressure value measured over each of at least two cardiac cycles, preferably over each of the cardiac cycles in a computation interval covering a full respiratory cycle. In one embodiment, maximum and minimum standard deviation values are determined over the computation interval. SVV is then estimated proportional to the ratio of the difference between the maximum and minimum standard deviation values and the mean of the standard deviation values. In another embodiment, SVV is then estimated proportional to the ratio of the standard deviation of the standard deviation values and the mean standard deviation over the entire computation interval. A pre-processing arrangement for improving reliability of estimates of more general cardiac or hemodynamic parameters is also disclosed and involves smoothing with an approximating function, and sampling and low-pass filtering at an adjustable rate. | 12-04-2008 |
| 20080275551 | INWARDLY-BOWED TRICUSPID ANNULOPLASTY RING - A prosthetic tricuspid remodeling annuloplasty ring having two free ends and at least one inward bow to help reduce chordal tethering. The ring may have segments corresponding to the anterior, posterior and septal leaflets, with inward bows located adjacent one, two or all leaflets. Convex corners separate the concave inward bows, with inflection points therebetween. The ring has a semi-rigid inner body covered by fabric or a suture interface such as silicone and fabric. | 11-06-2008 |
| 20080269878 | MINIMALLY-INVASIVE HEART VALVE WITH CUSP POSITIONERS - A prosthetic heart valve having an internal support frame with a continuous, undulating leaflet frame defined therein. The leaflet frame has three cusp regions positioned at an inflow end intermediate three commissure regions positioned at an outflow end thereof. The leaflet frame may be cloth covered and flexible leaflets attached thereto form occluding surfaces of the valve. The support frame further includes three cusp positioners rigidly fixed with respect to the leaflet frame and located at the outflow end of the support frame intermediate each pair of adjacent commissure regions. The valve is desirably compressible so as to be delivered in a minimally invasive manner through a catheter to the site of implantation. Upon expulsion from catheter, the valve expands into contact with the surrounding native valve annulus and is anchored in place without the use of sutures. In the aortic valve position, the cusp positioners angle outward into contact with the sinus cavities, and compress the native leaflets if they are not excised, or the aortic wall if they are. The support frame may be formed from a flat sheet of Nitinol that is bent into a three-dimensional configuration and heat set. A holder having spring-like arms connected to inflow projections of the valve may be used to deliver, reposition and re-collapse the valve, if necessary. | 10-30-2008 |
| 20080228201 | MITRAL VALVE REPAIR SYSTEM AND METHOD FOR USE - The present invention is directed to various systems for repairing tissue within the heart of a patient. The mitral valve repair system of the present invention comprises a guide catheter having a proximal end, a distal end, and at least one internal lumen formed therein, a therapy catheter capable of applying a suture to the tissue, and a fastener catheter capable of attaching a fastener to the suture. The therapy catheter and the fastener catheter are capable of traversing the internal lumen of the guide catheter. In addition, the present invention discloses various methods for repairing tissue within the heart of a patient. In one embodiment, the method of repairing heart valve tissue includes advancing a guide catheter through a circulatory pathway to a location in the heart proximate to a heart valve, advancing a therapy catheter through the guide catheter to the heart valve, stabilizing a first leaflet with the therapy catheter, deploying a first suture into the stabilized first leaflet, disengaging the first leaflet from the therapy catheter while leaving the first suture attached thereto, stabilizing a second leaflet with the therapy catheter, deploying a second suture into the second leaflet, disengaging the second leaflet from the therapy catheter while leaving the second suture attached thereto, and joining the first and second leaflets by reducing the distance between the first and second sutures. | 09-18-2008 |
| 20080208331 | ANNULOPLASTY RING WITH OFFSET FREE ENDS - 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. A deliver template having a mounting ring with about the same shape as the ring facilitates implant, and may be releasably attached to a delivery handle. The deliver template may include a plurality of cutting guides for releasably attaching the annuloplasty ring thereto while presenting maximum outer surface area of the ring. The template may have an outwardly-facing groove to receive and retain the ring. | 08-28-2008 |
