Abstract: A compliance restoration device includes a compliance balloon lumen, a chamber support structure disposed in the compliance balloon lumen and configured to expand to support an expanded volume of the compliance balloon lumen, and a spring assembly configured to cause the chamber support structure to expand by applying a force on a first end of the chamber support structure.

Abstract: The invention is a cardiac implant, and associated methods therefore, configured to repair and/or replace a native heart valve, and having a support frame configured to be reshaped into an expanded/changed form in order to receive and/or support an expandable prosthetic heart valve therein. The implant may be configured to have a generally rigid and/or expansion-resistant configuration when initially implanted to replace/repair a native valve (or other prosthetic heart valve), but to assume a generally non-rigid and/or expanded/expandable form when subjected to an outward force such as that provided by a dilation balloon. The implant may be configured to have a generally D-shaped configuration when initially implanted, but to assume a generally circular form when subjected to an outward force such as that provided by a dilation balloon.

Abstract: A device useful for accessing the left atrium is provided. The device comprises an elongated tubular body and a dilating tip. The tubular body has an axis, a proximal end, a distal end and a lumen longitudinally extending therethrough. The dilating tip is slidably mounted on the distal end of the tubular body. The dilating tip comprises a segmented surface that is generally transverse to the axis of the tubular body, and a generally rigid tube extending distally from the segmented surface and having a sharp distal end. Distal movement of the tubular body relative to the dilating tip exerts a force on the segmented surface to thereby open the segmented surface.

Abstract: A two-stage or component-based valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve comprises a support structure that is deployed at a treatment site. The prosthetic valve further comprises a valve member configured to be quickly connected to the support structure. The support structure may take the form of a stent that is expanded at the site of a native valve. If desired, the native leaflets may remain and the stent may be used to hold the native valve open. In this case, the stent may be balloon expandable and configured to resist the powerful recoil force of the native leaflets. The support structure is provided with a coupling means for attachment to the valve member, thereby fixing the position of the valve member in the body. The valve member may be a non-expandable type, or may be expandable from a compressed state to an expanded state.

Abstract: The invention is a cardiac implant, and associated methods therefore, configured to repair and/or replace a native heart valve, and having a support frame configured to be reshaped into an expanded/changed form in order to receive and/or support an expandable prosthetic heart valve therein. The implant may be configured to have a generally rigid and/or expansion-resistant configuration when initially implanted to replace/repair a native valve (or other prosthetic heart valve), but to assume a generally non-rigid and/or expanded/expandable form when subjected to an outward force such as that provided by a dilation balloon. The implant may be configured to have a generally D-shaped configuration when initially implanted, but to assume a generally circular form when subjected to an outward force such as that provided by a dilation balloon.

Abstract: A heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve comprises a support structure that is deployed at a treatment site. The prosthetic valve further comprises a valve member configured to be quickly connected to the support structure. The support structure may take the form of a stent that is expanded at the site of a native valve. If desired, the native leaflets may remain and the stent may be used to hold the native valve open. In this case, the stent may be balloon expandable and configured to resist the powerful recoil force of the native leaflets. The support structure is provided with a coupling means for attachment to the valve member, thereby fixing the position of the valve member in the body. The valve member may be expandable or a non-expandable type.

Abstract: In one representative embodiment, a prosthetic valve assembly comprises a valve component comprising a radially compressible and expandable frame and a valve structure supported inside of the frame. The valve structure is configured to allow blood to flow through the valve component in one direction and block the flow of blood in the opposite direction. The assembly further comprises a radially compressible and expandable anchor comprising an annular base and a plurality of cantilevered fixation members extending from the base. The fixation members are configured to pivot inwardly toward the valve component when the valve component is radially expanded within the anchor.

Abstract: In one representative embodiment, a prosthetic valve assembly comprises a valve component comprising a radially compressible and expandable frame and a valve structure supported inside of the frame. The valve structure is configured to allow blood to flow through the valve component in one direction and block the flow of blood in the opposite direction. The assembly further comprises a radially compressible and expandable anchor comprising an annular base and a plurality of cantilevered fixation members extending from the base. The fixation members are configured to pivot inwardly toward the valve component when the valve component is radially expanded within the anchor.

Abstract: A low profile transseptal catheter and implant system is disclosed. Access to the mitral valve can be obtained using femoral catheterization with a fluoroscopically guided, low-profile catheter. For example, the right atrium is accessed and the interatrial septum punctured to access the left atrium, and the mitral valve is approached through the left atrium. Advantageously, this approach avoids contact with the left ventricular outflow tract and the chordae tendinae. Two leaflet braces are extended over guide wires to form semicircular loops that circumnavigate the anterior and posterior mitral valve leaflets. Tension is applied to the catheter from the atrial direction to keep the leaflet braces tightly wedged under the leaflets for the remainder of the procedure. A fastener joins the ends of each loop to create one annular ring encircling the valve under the anterior and posterior leaflets.

Abstract: A device useful for accessing the left atrium is provided. The device comprises an elongated tubular body and a dilating tip. The tubular body has an axis, a proximal end, a distal end and a lumen longitudinally extending therethrough. The dilating tip is slidably mounted on the distal end of the tubular body. The dilating tip comprises a segmented surface that is generally transverse to the axis of the tubular body, and a generally rigid tube extending distally from the segmented surface and having a sharp distal end. Distal movement of the tubular body relative to the dilating tip exerts a force on the segmented surface to thereby open the segmented surface.

Abstract: An active annuloplasty ring holder having a template that can be folded or pivoted to the side allowing the template to align longitudinally with the handle and enter the patient's chest through a small incision. The holder may include a mechanism to remotely detach sutures fastening the ring to the holder, thereby detaching the ring while avoiding the risk associated with introducing a scalpel into the operating field. A detachment mechanism may include a movable pin actuated by a pull wire that releases a plurality of holding sutures, or a hot wire, knives, or pull wire that severs the sutures. The holder may have a built-in light source for better visualization of the ring inside the heart. The holder may also have an optical means of visualizing the inside of the heart from the proximal end of the handle.

Abstract: Apparatus and methods for monitoring and indexing glucose consumption are disclosed. Embodiments of the present invention provide for accurate measurement of small differences in blood glucose values at various points in the body. These accurate measurements can be used to monitor glucose uptake in specific organs of the body such as the brain or heart. The apparatus includes an upstream intravascular glucose sensor and a downstream intravascular glucose sensor. In some embodiments, substantially simultaneous fluid communication of a calibration fluid to both glucose sensors reduces bias between the sensors. A processor is used to calculate and optionally display blood glucose consumption. Oxygen consumption can also be determined and used to determine and display an index value that is indicative of any mismatch between the two. In some embodiments, insulin and/or glucose infusion can be controlled by the system.

Abstract: A device useful for accessing the left atrium is provided. The device comprises an elongated tubular body and a dilating tip. The tubular body has an axis, a proximal end, a distal end and a lumen longitudinally extending therethrough. The dilating tip is slidably mounted on the distal end of the tubular body. The dilating tip comprises a segmented surface that is generally transverse to the axis of the tubular body, and a generally rigid tube extending distally from the segmented surface and having a sharp distal end. Distal movement of the tubular body relative to the dilating tip exerts a force on the segmented surface to thereby open the segmented surface.

Abstract: An active annuloplasty ring holder having a template that can be folded or pivoted to the side allowing the template to align longitudinally with the handle and enter the patient's chest through a small incision. The holder may include a mechanism to remotely detach sutures fastening the ring to the holder, thereby detaching the ring while avoiding the risk associated with introducing a scalpel into the operating field. A detachment mechanism may include a movable pin actuated by a pull wire that releases a plurality of holding sutures, or a hot wire, knives, or pull wire that severs the sutures. The holder may have a built-in light source for better visualization of the ring inside the heart. The holder may also have an optical means of visualizing the inside of the heart from the proximal end of the handle.

Abstract: A heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve comprises a support structure that is deployed at a treatment site. The prosthetic valve further comprises a valve member configured to be quickly connected to the support structure. The support structure may take the form of a stent that is expanded at the site of a native valve. If desired, the native leaflets may remain and the stent may be used to hold the native valve open. In this case, the stent may be balloon expandable and configured to resist the powerful recoil force of the native leaflets. The support structure is provided with a coupling means for attachment to the valve member, thereby fixing the position of the valve member in the body. The valve member may be expandable or a non-expandable type.

Abstract: A heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve comprises a support structure that is deployed at a treatment site. The prosthetic valve further comprises a valve member configured to be quickly connected to the support structure. The support structure may take the form of a stent that is expanded at the site of a native valve. If desired, the native leaflets may remain and the stent may be used to hold the native valve open. In this case, the stent may be balloon expandable and configured to resist the powerful recoil force of the native leaflets. The support structure is provided with a coupling means for attachment to the valve member, thereby fixing the position of the valve member in the body. The valve member may be expandable or a non-expandable type.

Abstract: A valve loading apparatus is provided for loading a crimped prosthetic valve into a lumen of a delivery system. The valve recoil adapter can counteract recoil of a compressed prosthetic valve, and maintain the valve at its desired crimp diameter. An integrated bioprosthesis/delivery system is provided for delivering a bioprosthesis to a target area within a body lumen is provided. The delivery system includes a valve covering member and a compressing member, which compresses the valve covering member to surround, hold, and/or compress the valve during delivery to the target area.

Abstract: The invention is a cardiac implant, and associated methods therefore, configured to repair and/or replace a native heart valve, and having a support frame configured to be reshaped into an expanded/changed form in order to receive and/or support an expandable prosthetic heart valve therein. The implant may be configured to have a generally rigid and/or expansion-resistant configuration when initially implanted to replace/repair a native valve (or other prosthetic heart valve), but to assume a generally non-rigid and/or expanded/expandable form when subjected to an outward force such as that provided by a dilation balloon. The implant may be configured to have a generally D-shaped configuration when initially implanted, but to assume a generally circular form when subjected to an outward force such as that provided by a dilation balloon.

Abstract: A heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve comprises a support structure that is deployed at a treatment site. The prosthetic valve further comprises a valve member configured to be quickly connected to the support structure. The support structure may take the form of a stent that is expanded at the site of a native valve. If desired, the native leaflets may remain and the stent may be used to hold the native valve open. In this case, the stent may be balloon expandable and configured to resist the powerful recoil force of the native leaflets. The support structure is provided with a coupling means for attachment to the valve member, thereby fixing the position of the valve member in the body. The valve member may be expandable or a non-expandable type.

Abstract: A valve loading apparatus is provided for loading a crimped prosthetic valve into a lumen of a delivery system. The valve recoil adapter can counteract recoil of a compressed prosthetic valve, and maintain the valve at its desired crimp diameter. An integrated bioprosthesis/delivery system is provided for delivering a bioprosthesis to a target area within a body lumen is provided. The delivery system includes a valve covering member and a compressing member, which compresses the valve covering member to surround, hold, and/or compress the valve during delivery to the target area.