Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: The invention is directed a delivery system for implantation a self-expanding medical device in a body which includes a control handle and a catheter portion. The catheter portion includes an outer restraining member which covers the collapsed, medical device, an inner catheter member having a distal end including a region upon which the medical device is mounted, and an outer sheath which is removably attached to the control handle. The outer sheath creates a conduit for the catheter portion to prevent the inner catheter member from moving axially when the outer restraining member is retracted. The control handle has a rotatable thumbwheel to actuate a retraction mechanism attached to the proximal end of the outer restraining member which moves the restraining member in a proximal direction to deploy the medical device.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: A delivery system for implantation a self-expanding medical device in a body includes a control handle and a catheter portion. The catheter portion includes an outer restraining member which covers the collapsed, medical device, an inner catheter member having a distal end including a region upon which the medical device is mounted, and an outer sheath removably attached to the control handle. The outer sheath creates a conduit for the catheter portion to prevent the inner catheter member from moving axially when the outer restraining member is retracted. The control handle has a rotatable thumbwheel to actuate a retraction mechanism attached to the proximal end of the outer restraining member which moves the restraining member in a proximal direction to deploy the medical device.

Abstract: 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.

Abstract: The invention is directed a delivery system for implantation a self-expanding medical device in a body which includes a control handle and a catheter portion. The catheter portion includes an outer restraining member which covers the collapsed, medical device, an inner catheter member having a distal end including a region upon which the medical device is mounted, and an outer sheath which is removably attached to the control handle. The outer sheath creates a conduit for the catheter portion to prevent the inner catheter member from moving axially when the outer restraining member is retracted. The control handle has a rotatable thumbwheel to actuate a retraction mechanism attached to the proximal end of the outer restraining member which moves the restraining member in a proximal direction to deploy the medical device.

Abstract: 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.

Abstract: The invention is directed a delivery system for implantation a self-expanding medical device in a body which includes a control handle and a catheter portion. The catheter portion includes an outer restraining member which covers the collapsed, medical device, an inner catheter member having a distal end including a region upon which the medical device is mounted, and an outer sheath which is removably attached to the control handle. The outer sheath creates a conduit for the catheter portion to prevent the inner catheter member from moving axially when the outer restraining member is retracted. The control handle has a rotatable thumbwheel to actuate a retraction mechanism attached to the proximal end of the outer restraining member which moves the restraining member in a proximal direction to deploy the medical device.

Abstract: The invention is directed a delivery system for implantation a self-expanding medical device in a body which includes a control handle and a catheter portion. The catheter portion includes an outer restraining member which covers the collapsed, medical device, an inner catheter member having a distal end including a region upon which the medical device is mounted, and an outer sheath which is removably attached to the control handle. The outer sheath creates a conduit for the catheter portion to prevent the inner catheter member from moving axially when the outer restraining member is retracted. The control handle has a rotatable thumbwheel to actuate a retraction mechanism attached to the proximal end of the outer restraining member which moves the restraining member in a proximal direction to deploy the medical device.

Abstract: A controlled volume inflation-deflation device to inflate a balloon to occlude a blood vessel by dialing a knob that locks at rotational positions to locate a plunger at equally spaced locations within a syringe of the inflation-deflation device. The inflation-deflation device includes a releasable latch to lock the proximal and distal housings together to hold the plunger forward for occlusion, and to separate and hold the proximal and distal housings to retract the plunger for perfusion. When the inflation-deflation device is returned to the-latched position, the balloon is re-inflated to its previous occlusive diameter. Also, an extension tube made of a lower modulus outer material co-extruded over and miscible with a higher modulus inner material may be used to produce a suitably low compliance extension tube for the inflation-deflation device.

Abstract: The invention is directed a delivery system for implantation a self-expanding medical device in a body which includes a control handle and a catheter portion. The catheter portion includes an outer restraining member which covers the collapsed, medical device, an inner catheter member having a distal end including a region upon which the medical device is mounted, and an outer sheath which is removably attached to the control handle. The outer sheath creates a conduit for the catheter portion to prevent the inner catheter member from moving axially when the outer restraining member is retracted. The control handle has a rotatable thumbwheel to actuate a retraction mechanism attached to the proximal end of the outer restraining member which moves the restraining member in a proximal direction to deploy the medical device.

Abstract: The invention is directed a delivery system for implantation a self-expanding medical device in a body which includes a control handle and a catheter portion. The catheter portion includes an outer restraining member which covers the collapsed, medical device, an inner catheter member having a distal end including a region upon which the medical device is mounted, and an outer sheath which is removably attached to the control handle. The outer sheath creates a conduit for the catheter portion to prevent the inner catheter member from moving axially when the outer restraining member is retracted. The control handle has a rotatable thumbwheel to actuate a retraction mechanism attached to the proximal end of the outer restraining member which moves the restraining member in a proximal direction to deploy the medical device.

Abstract: A deflectable catheter assembly is disclosed. The assembly comprises a catheter shaft having a catheter proximal section and a catheter distal section, and at least one lumen extending therethrough. The catheter distal section is more flexible than the catheter proximal section. A tendon is disposed within a first lumen of said catheter shaft. The first lumen is approximately centrally located within the catheter shaft at the catheter proximal section. The first lumen is located off-center of the catheter shaft at the catheter distal section. The tendon is able to deflect the catheter distal section when being pulled on. A catheter handle is coupled to the catheter shaft at the catheter proximal section, the catheter handle includes a control mechanism to control the tendon.

Abstract: The invention is directed a delivery system for implantation a self-expanding medical device in a body which includes a control handle and a catheter portion. The catheter portion includes an outer restraining member which covers the collapsed, medical device, an inner catheter member having a distal end including a region upon which the medical device is mounted, and an outer sheath which is removably attached to the control handle. The outer sheath creates a conduit for the catheter portion to prevent the inner catheter member from moving axially when the outer restraining member is retracted. The control handle has a rotatable thumbwheel to actuate a retraction mechanism attached to the proximal end of the outer restraining member which moves the restraining member in a proximal direction to deploy the medical device.