Abstract: A catheter apparatus for assessing denervation comprises: an elongated catheter body; a deployable structure coupled to the catheter body, the deployable structure being deployable outwardly from and contractible inwardly toward the longitudinal axis of the catheter body; one or more ablation elements disposed on the deployable structure to move outwardly and inwardly with the deployable structure; one or more stimulation elements spaced from each other and disposed on the deployable structure to move with the deployable structure, the stimulation elements being powered to supply nerve stimulating signals to the vessel; and one or more recording elements spaced from each other and from the stimulation elements, the recording elements being disposed on the deployable structure to move with the deployable structure, the recording elements configured to record response of the vessel to the nerve stimulating signals.

Abstract: A catheter apparatus for assessing denervation comprises: an elongated catheter body; a deployable structure coupled to the catheter body, the deployable structure being deployable outwardly from and contractible inwardly toward the longitudinal axis of the catheter body; one or more ablation elements disposed on the deployable structure to move outwardly and inwardly with the deployable structure; one or more stimulation elements spaced from each other and disposed on the deployable structure to move with the deployable structure, the stimulation elements being powered to supply nerve stimulating signals to the vessel; and one or more recording elements spaced from each other and from the stimulation elements, the recording elements being disposed on the deployable structure to move with the deployable structure, the recording elements configured to record response of the vessel to the nerve stimulating signals.

Abstract: Methods, systems, and apparatus for signal detection are described. In one example, a detection assembly includes a signal detector. The signal detector is configured to receive a sensor signal having a peak magnitude and a first frequency and generate an output signal having a magnitude proportional to the peak magnitude of the sensor signal and having a second frequency less than the first frequency of the sensor signal.

Abstract: A catheter apparatus for assessing denervation comprises: an elongated catheter body; a deployable structure coupled to the catheter body, the deployable structure being deployable outwardly from and contractible inwardly toward the longitudinal axis of the catheter body; one or more ablation elements disposed on the deployable structure to move outwardly and inwardly with the deployable structure; one or more stimulation elements spaced from each other and disposed on the deployable structure to move with the deployable structure, the stimulation elements being powered to supply nerve stimulating signals to the vessel; and one or more recording elements spaced from each other and from the stimulation elements, the recording elements being disposed on the deployable structure to move with the deployable structure, the recording elements configured to record response of the vessel to the nerve stimulating signals.

Abstract: An adjustable prosthetic anatomical holder system may include an adjustable annuloplasty ring, a ring holder, and a positioning handle. The adjustable annuloplasty ring holder facilitates placement and adjustment of the annuloplasty ring during a cardiac surgical procedure. An optional positioning handle holds the adjustable annuloplasty ring during placement and suturing of the ring. The ring holder is constructed from two members that are slidably fit together in telescopic arrangement to accommodate adjustment of the ring size.

Abstract: A device and method for repairing a mitral valve leaflet 2, 3. The device 10 includes a body 16 having an annular wall 18 and at least one aperture 22 through the annular wall 18. A deployment assembly 24 mounted on the body includes at least one grasping wire 28 arranged for sliding movement in the aperture 22. Movement of the deployment assembly 24 to a deployed position relative to the body causes a free end of the grasping wire 28 to project out from the annular wall 18 through the aperture 22, and movement of the deployment assembly to a retracted position relative to the body causes the free end of the grasping wire 28 to not project out from the annular wall 18. In the deployed position, the grasping wire 28 may grasp and gather tissue of the leaflet 2,3.

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: Apparatus for use with a prosthetic heart valve includes a holder, to which the heart valve is releasably attached, and an elongated handle. The handle can be connected to the holder simply by pushing a distal end of the handle straight into a recess in the holder. After this has been done, the holder preferably releasable latches onto the handle, and the handle can also be rotated about its longitudinal axis to transmit torque to the holder (e.g., a rotatable portion of the holder). Rotation of such a rotatable portion of the holder can be used to deflect portions of the valve radially inward. This operation of a rotatable portion of the holder is preferably one-way only. The handle can be released from the holder at any time, and it can similarly be reconnected to the holder at any time.

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 ablation catheter comprises: an elongated catheter body extending longitudinally between a proximal end and a distal end along a longitudinal axis; a distal member disposed adjacent the distal end, the distal member including an ablation element to ablate a biological member; one or more acoustic transducers disposed in the distal member and each configured to direct an acoustic signal toward a respective target ablation region and receive reflection echoes therefrom; and an acoustic redirection member disposed in the distal member to at least partially redirect the acoustic signal from at least one of the acoustic transducers toward a tissue target. The distal member includes a most-distal portion, a proximal portion, and a deflectable portion between the most-distal portion and proximal portion to permit deflection between the most-distal portion and proximal portion of the distal member. The transducers and redirection member are mounted on opposite sides of the deflectable portion.

Abstract: A delivery system for delivering a collapsible prosthetic heart valve includes a valve support structure for supporting a collapsible prosthetic heart valve, and a distal sheath movable in a longitudinal direction relative to the valve support structure between a first position in which the distal sheath is adapted to surround a collapsible prosthetic heart valve supported on the valve support structure, and a second position in which the distal sheath is adapted to expose the collapsible prosthetic heart valve for deployment. The distal sheath is at least partially formed of an inner polymer layer, an outer polymer layer, and a tubular supporting member sandwiched between the inner polymer layer and the outer polymer layer.

Abstract: A stent for use in a prosthetic heart valve has a plurality of expandable and collapsible closed cells, a portion of which form an annulus section adapted for placement within the annulus of the native heart valve. Anchor features of the stent residing within at least some closed cells are adapted to engage tissue of the heart, including native valve leaflets, the sinotubular junction, or another implanted device when the prosthetic valve is implanted in the heart. The anchor features may help to retain the prosthetic valve in position, without interfering with the opening and closing of the valve leaflets. Furthermore, the anchor features may be configured to allow the stent to be resheathed into a delivery device after the portion of the stent with the anchor feature has expanded out of the delivery device.

Abstract: A prosthetic heart valve includes an annularly collapsible and re-expandable supporting structure extending between an inflow end and an outflow end and including a plurality of struts and a plurality of posts, each post having an elongated opening, a plurality of leaflets disposed inside the supporting structure and operative to allow flow in a first direction from the inflow end to the outflow end and to substantially block flow in an opposite direction from the outflow end to the inflow end, each of the plurality of leaflets including flaps, and a first patch covering the opening of a first post, the first patch being attached to a first flap of a first leaflet.

Abstract: A cardiovascular valve assembly is disclosed including a housing assembly comprising a first portion and a second portion removably attached to the first portion. A valve may be positioned within the housing assembly. The valve, which may be a mechanical valve, a biological tissue valve, or a polymeric valve, may be structured to allow fluid to flow through the housing assembly in a single direction. In certain embodiments, the valve assembly may further include at least one coupling structure provided on the second portion and at least one aperture defined in the first portion, with the aperture structured to receive the coupling structure to couple the first portion to the second portion. Corresponding systems incorporating cardiovascular valve assemblies are also disclosed.

Abstract: A mandrel for molding polymer valve leaflets for heart valve prostheses is disclosed, including a body portion including an outer surface with ridges and contoured surfaces corresponding to the leaflets, the upper edge of the contoured surfaces corresponding to the free upper edge of the leaflets, and the mandrel including a mandrel extension above the body portion, and a gap extending around the mandrel between the upper edge of the contoured surface and the mandrel extension. A process for producing these polymer valve leaflets is also disclosed by dip coating with this mandrel and removing the polymer film created at the gap, preferably by applying suction or blowing thereto.

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: 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 device 10 for gathering tissue in a patient includes an elongated catheter 14 and a capture assembly 13 at a distal portion of the catheter. The capture assembly has a closed side 18 and a door 20 rotatable between an open condition and a closed condition. The closed side 18 of the capture assembly 13 and the door 20 in the closed condition may collectively define a tissue capturing compartment 19. Movement of the door 20 from the open condition to the closed condition adjacent the tissue may capture a portion 44 of the tissue in the tissue capturing compartment 19. A clip may then be applied from the capture assembly 13 to the captured tissue 44 to hold the tissue substantially in a gathered configuration.

Abstract: Prosthetic heart valve apparatus is adapted for delivery into a patient in a circumferentially collapsed condition, followed by circumferential re-expansion at the implant site in the patient. The apparatus includes an annular anchoring structure that can be implanted in the patient first. The apparatus further includes an annular valve support structure, which supports a flexible leaflet structure of the valve. The support and leaflet structures are initially separate from the anchoring structure, but they can be implanted in the patient by interengagement of the support structure with the already-implanted anchoring structure.

Abstract: A mandrel (5) for molding polymer valve leaflets for heart valve prostheses is disclosed, including a body portion (52) including an outer surface with ridges (60) and contoured surfaces (64) corresponding to the leaflets, the upper edge of the contoured surfaces corresponding to the free upper edge of the leaflets, and the mandrel including a mandrel extension (54) above the body portion, and a gap (68) extending around the mandrel between the upper edge of the contoured surface and the mandrel extension. A process for producing these polymer valve leaflets is also disclosed by dip coating with this mandrel and removing the polymer film created at the gap, preferably by applying suction or blowing thereto.