Abstract: A tray and packaging system for a prosthetic valve delivery system permits conversion from a storage and/or shipping configuration to a set up and preparation configuration. In a first configuration, a delivery system can be supported by first and second main trays with the elongate catheter of the delivery system arranged to extend linearly from the first main tray to the second main tray, and in a second configuration, the delivery system can be supported by the first and second main trays with the elongate catheter of the delivery system turned back in a U-shaped manner with the deployment portion of the delivery system positioned to the side of the control handle portion of the delivery system.

Abstract: Medical device delivery assemblies are disclosed. The assembly may include a catheter-based delivery system. The assembly may include a pacing element to pace a patient's heart before, during, or after a procedure. The pacing element may be a detachable, implanting pacing element. The pacing element may be an implantable pacemaker and the implantable pacemaker may be disposed on a catheter-based delivery system. The assembly may include a prosthetic heart valve with one or more pacing elements on it. The pacing element may include a pacing strip or strips. These strips may be conductive or insulative. These strips may prevent, treat, or correct abnormal electrical communication in a heart.

Abstract: Medical device delivery assemblies are disclosed. The assembly may include a catheter-based delivery system. The assembly may include a pacing element to pace a patient's heart before, during, or after a procedure. The pacing element may be a detachable, implanting pacing element. The pacing element may be an implantable pacemaker and the implantable pacemaker may be disposed on a catheter-based delivery system. The assembly may include a prosthetic heart valve with one or more pacing elements on it. The pacing element may include a pacing strip or strips. These strips may be conductive or insulative. These strips may prevent, treat, or correct abnormal electrical communication in a heart.

Abstract: A method for loading a prosthesis onto a delivery system includes passing a distal end of a delivery system through a first open end and a second open end of a reducing member. The method includes seating the prosthesis in a piston member of a cap by contacting a first end of the prosthesis with a first surface of the piston member and by contacting a portion of a side of the prosthesis with at least one side wall extending from the periphery of the first surface. Additionally, the method includes inserting the distal end of the delivery system into a center of the prosthesis and an opening defined by the piston member. And the method includes advancing the cap towards a reducing member such that a portion of the prosthesis seated in the piston member advances along an inner surface of the conical wall of the reducing member.

Abstract: A prosthetic valve delivery system that is improved in controllability by way of a proximal handle system. Such a handle system of the present invention advantageously permits a controlled fine or micro movement or adjustment of a distal sheath for uncovering a plunger that is to be loaded with a prosthetic valve for deployment thereof. The delivery system of the present invention permits a trigger-release for a gross or macro movement to the sheath relative to the plunger. Also, the control handle of the delivery system is shaped and contoured for ease in manipulation of the micro-control actuator.

Abstract: Medical device delivery assemblies are disclosed. The assembly may include a catheter-based delivery system. The assembly may include a pacing element to pace a patient's heart before, during, or after a procedure. The pacing element may be a detachable, implanting pacing element. The pacing element may be an implantable pacemaker and the implantable pacemaker may be disposed on a catheter-based delivery system. The assembly may include a prosthetic heart valve with one or more pacing elements on it. The pacing element may include a pacing strip or strips. These strips may be conductive or insulative. These strips may prevent, treat, or correct abnormal electrical communication in a heart.

Abstract: A system includes a medical device for implanting in a valve of a subject, the implantable medical device having a self-expanding frame; and a holder configured to retain the frame of the implantable medical device in a constricted configuration and to control expansion of the frame. The holder has a controllably constrictable and expandable loop, wherein the loop is disposed about at least a portion of the self-expanding frame such that constriction or expansion of the first loop controls constriction or expansion of the frame.

Abstract: A method for loading a prosthesis onto a delivery system includes passing a distal end of a delivery system through a first open end and a second open end of a reducing member. The method includes seating the prosthesis in a piston member of a cap by contacting a first end of the prosthesis with a first surface of the piston member and by contacting a portion of a side of the prosthesis with at least one side wall extending from the periphery of the first surface. Additionally, the method includes inserting the distal end of the delivery system into a center of the prosthesis and an opening defined by the piston member. And the method includes advancing the cap towards a reducing member such that a portion of the prosthesis seated in the piston member advances along an inner surface of the conical wall of the reducing member.

Abstract: Valve delivery catheter assemblies including components that limit trauma to the expanded prosthetic valve and body channels as the distal tip of the catheter is withdrawn through the expanded valve and thereafter from the body. In one embodiment, a catheter assembly according to the present invention includes a handle assembly, an introducer sheath, and a distal tip assembly. The handle assembly cap include a fixed main handle and two or more rotating handles that allow a user to control the distal tip assembly of the catheter. A valve retaining mechanism ears be included to assist in retaining the prosthetic valve prior to deployment. Each control knob on the handle assembly controls a portion of the components on the distal tip of the catheter by allowing for precise manipulation of various delivery shafts. Each delivery shaft extends from the handle assembly to respective positions towards the distal end of the catheter.

Abstract: In an embodiment, a device for loading a prosthesis onto a delivery system comprises a cap and a reducing member. The cap has a piston member that seats a prosthesis. The piston member has at least one side wall configured to contact a portion of the side of the prosthesis seated therein. The reducing member has a conical wall, a first open end, and a second open end. The first open end is configured to receive the piston member. The reducing member reduces an external dimension of at least a portion of the prosthesis seated in the piston member as the prosthesis is moved along an inner surface of the conical wall.

Abstract: Valve delivery catheter assemblies including components that limit trauma to the expanded prosthetic valve and body channels as the distal tip of the catheter is withdrawn through the expanded valve and thereafter from the body. In one embodiment, a catheter assembly according to the present invention includes a handle assembly, an introducer sheath, and a distal tip assembly. The handle assembly can include a fixed main handle and two or more rotating handles that allow a user to control the distal tip assembly of the catheter. A valve retaining mechanism can be included to assist in retaining the prosthetic valve prior to deployment. Each control knob on the handle assembly controls a portion of the components on the distal tip of the catheter by allowing for precise manipulation of various delivery shafts. Each delivery shaft extends from the handle assembly to respective positions towards the distal end of the catheter.

Abstract: A prosthetic valve delivery system that is improved in controllability by way of a proximal handle system. Such a handle system of the present invention advantageously permits a controlled fine or micro movement or adjustment of a distal sheath for uncovering a plunger that is to be loaded with a prosthetic valve for deployment thereof. The delivery system of the present invention permits a trigger-release for a gross or macro movement to the sheath relative to the plunger. Also, the control handle of the delivery system is shaped and contoured for ease in manipulation of the micro-control actuator.

Abstract: A tray and packaging system for a prosthetic valve delivery system permits conversion from a storage and/or shipping configuration to a set up and preparation configuration. In a first configuration, a delivery system can be supported by first and second main trays with the elongate catheter of the delivery system arranged to extend linearly from the first main tray to the second main tray, and in a second configuration, the delivery system can be supported by the first and second main trays with the elongate catheter of the delivery system turned back in a U-shaped manner with the deployment portion of the delivery system positioned to the side of the control handle portion of the delivery system.

Abstract: In an embodiment, a device for loading a prosthesis onto a delivery system comprises a cap and a reducing member. The cap has a piston member that seats a prosthesis. The piston member has at least one side wall configured to contact a portion of the side of the prosthesis seated therein. The reducing member has a conical wall, a first open end, and a second open end. The first open end is configured to receive the piston member. The reducing member reduces an external dimension of at least a portion of the prosthesis seated in the piston member as the prosthesis is moved along an inner surface of the conical wall.

Abstract: A catheter and guide wire exchange system including a catheter that has a guide wire lumen with a guide way extending along a length of the proximal shaft. A guide member is slidably disposed about the proximal shaft for directing a guide wire into or out of the guide way and the guide wire lumen. A transition section joins the bilumen proximal shaft to a coaxial distal shaft.

Abstract: A catheter and guide wire exchange system including a catheter that has a guide wire lumen with a guide way extending along a length of the proximal shaft. A guide member is slidably disposed about the proximal shaft for directing a guide wire into or out of the guide way and the guide wire lumen. A transition section joins the trilumen proximal shaft to a coaxial distal shaft.

Abstract: A catheter and guide wire exchange system including a catheter having a guide wire lumen with a guide way extending along the length of a stiffened proximal shaft portion, and a guide member slidably disposed about the proximal shaft for directing a guide wire into or out of the guide way and the guide wire lumen. The proximal shaft may be slid through the guide member so that the guide wire is contained within the guide wire lumen distal to the guide member and with the guide wire and catheter being separated proximal of the guide member. The guide member has a decoupled body, that allows it to be rotated without affecting the guidewire direction through the guidemember.

Abstract: A catheter and guide wire exchange system including a catheter that has a guide wire lumen with a guide way extending along a length of the proximal shaft. A guide member is slidably disposed about the proximal shaft for directing a guide wire into or out of the guide way and the guide wire lumen. A transition section joins the trilumen proximal shaft to a coaxial distal shaft.

Abstract: A catheter and guide wire exchange system including a catheter that has a guide wire lumen with a guide way extending along a length of the proximal shaft. A guide member is slidably disposed about the proximal shaft for directing a guide wire into or out of the guide way and the guide wire lumen. A transition section joins the bitumen proximal shaft to a coaxial distal shaft.