Abstract: A crimping tool for use with a collapsible prosthetic valve having a stent frame with a plurality of cell openings, and a valve structure assembled in the stent frame. The crimping tool includes a plurality of resilient tines defining an array around a longitudinal axis of the crimping tool. The array has a first cross-section in an expanded state and a second cross-section less than the first cross-section in a collapsed state. The plurality of tines are adapted to intersect the plurality of cell openings in an assembled position of the crimping tool on the prosthetic valve to prevent pinching of the valve structure by the stent frame as the prosthetic valve is collapsed.

Abstract: A crimping tool for use with a collapsible prosthetic valve having a stent frame with a plurality of cell openings, and a valve structure assembled in the stent frame. The crimping tool includes a plurality of resilient tines defining an array around a longitudinal axis of the crimping tool. The array has a first cross-section in an expanded state and a second cross-section less than the first cross-section in a collapsed state. The plurality of tines are adapted to intersect the plurality of cell openings in an assembled position of the crimping tool on the prosthetic valve to prevent pinching of the valve structure by the stent frame as the prosthetic valve is collapsed.

Abstract: A device for transcatheter gathering of tissue of a heart valve leaflet may include an elongated tube extending in a longitudinal direction and a capture tool moveable in the elongated tube between a retracted position and an extended position. The elongated tube may have at least one slot extending generally in the longitudinal direction from a distal end of the elongated tube. The at least one slot may have an open end at the distal end of the elongated tube and a closed end remote therefrom. The capture tool may be operable to gather tissue of the heart valve leaflet into the at least one slot. The gathered tissue may have a pleated configuration.

Abstract: The present invention relates to a medical device comprising both pyrolytic carbon and an NO generator, methods of making same, and methods of using same.

Abstract: A method of making a prosthetic heart valve may include providing an annular stent having a plurality of annularly spaced commissure portions having tips, covering each of the tips with a first fabric cover, covering the first fabric covers and the remainder of the stent with a second fabric cover, covering the second fabric cover with a first tissue membrane, and covering the outside of the first tissue membrane with a second tissue membrane, the second tissue membrane forming leaflet portions that extend inwardly between the commissure portions.

Abstract: Prosthetic heart valves, which are collapsible to a relatively small circumferential size for less invasive delivery into a patient and which then re-expand to operating size at an implant site in the patient, include a collapsible/expandable stent-like supporting structure and various components of flexible, sheet-like material that are attached to the supporting structure. For example, these sheet-like other components may include prosthetic valve leaflets, layers of buffering material, cuff material, etc. Improved structures and techniques are provided for securing such other components to the stent-like supporting structure of the valve.

Abstract: A stent (10) for use in a prosthetic heart valve has an annulus section (12) adapted for placement within the ? leaflets and annulus of the native heart valve. The annulus section has latch members (50) adapted to engage the leaflets of the native heart valve when prosthetic valve is implanted in the native valve. The latch members may hold the leaflets in engagement with the annulus section, and help to retain the prosthetic valve in position. The annulus section may have a non-circular cross-sectional shape.

Abstract: A prosthetic heart valve includes an annular frame that is adapted for (1) delivery into a patient's native heart valve annulus in a circumferentially collapsed condition, and (2) circumferential re-expansion when in the annulus, the frame, in an expanded condition. The frame having a longitudinal axis, an inflow end and an outflow end, a first portion of the frame adjacent the inflow end inclining radially outwardly in a direction toward the inflow end, and a second portion of the frame between the first portion and the outflow end bulging radially outwardly, the second portion of the frame being positioned between a first axial distance from the inflow end and a second axial distance from the inflow end. The frame also includes a plurality of commissure members. The heart valve further includes a flexible leaflet structure disposed in the frame.

Abstract: A prosthetic heart valve is provided with a cuff having features which promote sealing with the native tissues even where the native tissues are irregular. The cuff may include a portion adapted to bear on the LVOT when the valve is implanted in a native aortic valve. The valve may include elements for biasing the cuff outwardly with respect to the stent body when the stent body is in an expanded condition. The cuff may have portions of different thickness distributed around the circumference of the valve in a pattern matching the shape of the opening defined by the native tissue. All or part of the cuff may be movable relative to the stent during implantation.

Abstract: A signal interrogation system comprises an optical coupler to split input laser beam into a first laser beam as a power reference and a second laser beam, the optical coupler being coupled to a first path for the first laser beam and a second path for the second laser beam; an optical circulator disposed in the second path; a bi-directional optical switch disposed in the second path and having on one side a single channel end oriented toward the optical circulator and on another side multiple channel ends with multiple switchable channels; a plurality of optical fibers coupled to the multiple channel ends of the bi-directional optical switch; an interference optical signals path coupled to the optical circulator to receive the interference optical signals from the bi-directional switch; and a balanced photo detector to measure a power difference between the interference optical signals and the power reference.

Abstract: A prosthetic heart valve is circumferentially collapsible for less invasive delivery into a patient. The valve re-expands to operating size at the implant site in the patient. A frame structure of the valve includes restraining structure that can help to push one or more of the patient's native heart valve leaflets radially outwardly so that this native leaflet tissue does not interfere with the operation or service life of the prosthetic valve.

Abstract: A method of making a prosthetic heart valve may include providing an annular stent having a plurality of annularly spaced commissure portions having tips, covering each of the tips with a first fabric cover, covering the first fabric covers and the remainder of the stent with a second fabric cover, covering the second fabric cover with a first tissue membrane, and covering the outside of the first tissue membrane with a second tissue membrane, the second tissue membrane forming leaflet portions that extend inwardly between the commissure portions.

Abstract: A closure device includes a delivery member, a sealing material applicator, and an expandable member. The delivery member is insertable through a tissue tract to a vessel puncture. The sealing material applicator is configured to supply a volume of sealing material to the delivery member and includes first and second multi-chamber devices and a valve assembly. Each chamber of the first and second multi-chamber devices holds a component of the sealing material, and operating the valve assembly permits mixing of at least some of the components prior to connecting the sealing material applicator to the delivery member. The expandable member is positionable within the vessel to temporarily seal closed the vessel puncture from within the vessel. The closure device is operable to deliver the sealing material from the sealing material applicator, through the delivery member, and to the tissue tract to seal closed the vessel puncture from outside the vessel.

Abstract: A system for delivering a collapsible and re-expandable prosthetic heart valve into a patient includes a valve support structure (140) around which the valve (10) is disposed in a collapsed condition. A sheath structure (110) surrounds the collapsed valve, but can be moved relative to the valve to uncover it for expansion at the desired implant site in the patient. The sheath structure may be variously mounted and moved to deploy the valve in various ways. For example, the sheath structure may include multiple parts, each of which can be moved separately to separately deploy various parts of the valve. The apparatus may have other aspects, such as the ability to reverse deployment of the valve, the ability to pass other instrumentation through the valve delivery apparatus, the ability to be smoothly withdrawn from the patient after deployment of the valve, etc.

Abstract: A method for performing elastographic deformation mapping of tissues and plaques comprises: introducing a distal portion of a catheter to an interior of an interior body of a patient; applying, from a palpator in the distal portion, one of a directed fluid or a mechanical indenter to produce a surface-applied palpation force to a target area of the interior body to mechanically displace the interior body and cause elastographic deformation of the target area of one or more surface and subsurface tissues and plaques; and directing and delivering an OCT (optical coherence tomography) beam, from an OCT imaging sensor in the distal portion, for OCT deformation detection including elastographic deformation measurement to provide elastographic mapping of the target area.

Abstract: An adjustment tool enables manipulation of a prosthetic anatomical device such as an annuloplasty ring. The tool includes a compression member which is operative for retarding rotation of the adjustment shaft to preclude inadvertent rotation thereof during use of the tool by the surgeon. A locking device is associated with the adjustment tool to enable the releasable attachment of the tool to the anatomical device during its adjustment by manipulation of the tool. The locking device is oriented into operative and inoperative positions by the engagement and disengagement of locking elements. A scale may be provided on the adjustment tool to assist a surgeon in determining the size or amount of adjustment to the size of the anatomical device during its adjustment.

Abstract: An optical coherence tomography rotation catheter comprises a catheter body and a tubular member that rotates around a longitudinal axis in the catheter body. An optical fiber extends along an interior of the tubular member and has an optical fiber distal end. A light reflecting member is distal of the optical fiber distal end and rotates around the longitudinal axis with the tubular member. The light reflecting member includes a light reflecting surface which is spaced from and faces the optical fiber distal end and which is inclined to reflect the light from the optical fiber in a radial direction at an angle with respect to the longitudinal axis. The light reflecting member has a diameter of at most about 0.25 mm. The light reflecting surface is polished and coated with a light reflecting film.

Abstract: A system for delivering a medical implant includes an expandable member at least partially positioned inside the medical implant and operable to radially expand at least a portion of the medical implant to an expanded condition, first and second grasping mechanisms each adapted to grasp a portion of the medical implant, and a displacement mechanism operatively coupled to the first and second grasping mechanisms and configured to move the first and second grasping mechanisms between an inner position in which the first and second grasping mechanisms are relatively close to one another, and an outer position in which the first and second grasping mechanisms are relatively distant to one another. The movement of the first and second grasping mechanisms from the outer position to the inner position at least partially collapses the medical implant from the expanded condition to enable the medical implant to be repositioned if necessary.

Abstract: A delivery device for an implantable medical device having at least one retention member at an end thereof includes a shaft extending in a longitudinal direction, an elongated sheath surrounding a longitudinal portion of the shaft, a compartment defined inside of the sheath and adapted to receive the medical device in an assembled condition, a retainer positioned at one end of the compartment, and at least one acceptance in the retainer adapted to receive the retention member of the medical device in the assembled condition. The sheath is slidable relative to the shaft in the longitudinal direction to uncover and deploy the medical device. The retainer may be rotatable relative to the shaft to reduce torsional forces in the medical device during delivery and deployment. The retainer may have at least one recess facing the compartment for receiving a strut at an end of a stent of the medical device.

Abstract: A prosthetic heart valve is designed to be circumferentially collapsible for less invasive delivery into the patient. At the implant site the valve re-expands to a larger circumferential size, i.e., the size that it has for operation as a replacement for one of the patient's native heart valves. The valve includes structures that, at the implant site, extend radially outwardly to engage tissue structures above and below the native heart valve annulus. These radially outwardly extending structures clamp the native tissue between them and thereby help to anchor the prosthetic valve at the desired location in the patient.