Abstract: An assembly includes a medical device having a stent and a prosthetic valve connected to the stent. The prosthetic valve includes valve leaflets. The assembly further includes a buffer piece having a leaflet cover and a removable attaching structure. The leaflet cover protects the valve leaflets and the removable attaching structure removably attaches the buffer piece to the medical device. The buffer piece prevents contact, imprinting, abrasion, and/or damage to the valve leaflets.

Abstract: Methods for purging a balloon catheter of air. An inflation fluid is inserted into a balloon and an inflation lumen of a balloon catheter. The inflation lumen is in fluid communication with the balloon. The balloon catheter is positioned in an inverted orientation with a distal end thereof disposed below a proximal end thereof. The distal end of the balloon catheter includes a balloon. A vibration source is positioned in direct contact with an outer surface of the balloon catheter. The balloon catheter is vibrated via the vibration source. A vacuum is applied or pulled on the inflation lumen of the balloon catheter. The steps of vibrating the balloon catheter and applying the vacuum are performed simultaneously.

Abstract: A crimper for altering an implantable medical device from an uncompressed state to a compressed state. The crimper includes a plurality of crimper elements that define a crimper channel, each of the crimper elements including a non-planar surface that forms a portion of the crimper channel. Each non-planar surface is configured to apply non-uniform radial compression along a length of the implantable medical device during operation of the crimper when altering the implantable medical device from the uncompressed state to the compressed state. The crimper also includes handle configured to operate the crimper. Actuation of the handle decreases a volume of the crimper chamber to transition the implantable medical device from the uncompressed state to the compressed state.

Abstract: Methods for purging a balloon catheter of air. An inflation fluid is inserted into a balloon and an inflation lumen of a balloon catheter. The inflation lumen is in fluid communication with the balloon. The balloon catheter is positioned in an inverted orientation with a distal end thereof disposed below a proximal end thereof. The distal end of the balloon catheter includes a balloon. A vibration source is positioned in direct contact with an outer surface of the balloon catheter. The balloon catheter is vibrated via the vibration source. A vacuum is applied or pulled on the inflation lumen of the balloon catheter. The steps of vibrating the balloon catheter and applying the vacuum are performed simultaneously.

Abstract: An assembly includes a medical device having a stent and a prosthetic valve connected to the stent. The prosthetic valve includes valve leaflets. The assembly further includes a buffer piece having a leaflet cover and a removable attaching structure. The leaflet cover protects the valve leaflets and the removable attaching structure removably attaches the buffer piece to the medical device. The buffer piece prevents contact, imprinting, abrasion, and/or damage to the valve leaflets.

Abstract: A leaflet folding accessory or tool configured for use with a crimper when radially compressing a transcatheter valve prosthesis into a crimped configuration for delivery within a vasculature. The crimping accessory is configured to apply or remove fluid to or from the at least one leaflet of the transcatheter valve prosthesis during the crimping process to prevent protrusion of the leaflets into the frame of the transcatheter valve prosthesis that may cause leaflet pinching and damage.

Abstract: An assembly including a transcatheter valve prosthesis and a leaflet folding accessory configured for use when compressing the transcatheter valve prosthesis into the crimped configuration. The transcatheter valve prosthesis includes a frame and a prosthetic valve component including at least one leaflet disposed within and secured to the frame. The leaflet folding accessory includes a plurality of guide fingers. A leaflet contact portion of each guide finger is configured to be disposed radially within the frame and contact an inner surface of a leaflet of the at least one leaflet. During crimping of the transcatheter valve prosthesis, the plurality of guide fingers remain disposed radially within the frame such that the at least one leaflet preferentially folds around the plurality of guide fingers.

Abstract: A catheter includes a handle with torqueing and steering mechanisms. The torqueing mechanism includes a rotatable nosecone and a bearing coupled to the nosecone to be rotatable therewith. The bearing is concentrically disposed over a shaft of the catheter. The steering mechanism includes a rack coupled to the bearing to be slideable therewith and a pull wire having a proximal end attached to the bearing and a distal end attached to a distal portion of the shaft. Rotation of the nosecone causes an entire length of the shaft to rotate and axial movement of the rack tensions the pull wire to bend the distal portion of the shaft. A valve relief component is slidingly disposed over the shaft and is configured to dock onto the handle when not in use.

Abstract: A catheter includes a handle with torqueing and steering mechanisms. The torqueing mechanism includes a rotatable nosecone and a bearing coupled to the nosecone to be rotatable therewith. The bearing is concentrically disposed over a shaft of the catheter. The steering mechanism includes a rack coupled to the bearing to be slideable therewith and a pull wire having a proximal end attached to the bearing and a distal end attached to a distal portion of the shaft. Rotation of the nosecone causes an entire length of the shaft to rotate and axial movement of the rack tensions the pull wire to bend the distal portion of the shaft. A valve relief component is slidingly disposed over the shaft and is configured to dock onto the handle when not in use.

Abstract: A catheter includes a handle with torqueing and steering mechanisms. The torqueing mechanism includes a rotatable nosecone and a bearing coupled to the nosecone to be rotatable therewith. The bearing is concentrically disposed over a shaft of the catheter. The steering mechanism includes a rack coupled to the bearing to be slideable therewith and a pull wire having a proximal end attached to the bearing and a distal end attached to a distal portion of the shaft. Rotation of the nosecone causes an entire length of the shaft to rotate and axial movement of the rack tensions the pull wire to bend the distal portion of the shaft. A valve relief component is slidingly disposed over the shaft and is configured to dock onto the handle when not in use.

Abstract: Novel tools and techniques are provided for implementing protection of at least one tissue layer of a medical device or implant during crimping of the medical device or implant. In various embodiments, an implant tissue protection tool may include an outer portion configured to surround one or more outer segments of at least one tissue layer of a medical device to be implanted into a body of a subject and at least one protrusion (which may be affixed to a surface of the outer portion) configured to minimize or prevent occurrence (or likelihood of occurrence) of the at least one tissue layer (in some cases, leaflet material, or the like) of the medical device passing through at least one opening defined by a frame structure of the medical device during crimping of the medical device by a crimping device in preparation for implantation into the body of the subject.

Abstract: A system for assisting in loading an implantable medical device onto a delivery system includes a body having a first end, a second end, and a conduit extending from the first end to the second end. The body has an inner diameter that allows a distal portion of the delivery system to slidably move through the conduit. The body has an outer diameter that allows the body to be inserted into a central lumen of the implantable medical device.

Abstract: Balloon catheters for delivery of prosthetic hear valves is provided. The balloon catheters are configured to deploy a prosthetic heart valve through inflation. The balloon catheters are further configured with one or more retention bumpers to reduce or prevent migration of the prosthetic heart valve during delivery. Balloon catheters described herein are configured with substantially incompressible retention bumpers that promote longitudinal inflation fluid flow.

Abstract: A crimper for altering an implantable medical device from an uncompressed state to a compressed state. The crimper includes a plurality of crimper elements that define a crimper channel, each of the crimper elements including a non-planar surface that forms a portion of the crimper channel. Each non-planar surface is configured to apply non-uniform radial compression along a length of the implantable medical device during operation of the crimper when altering the implantable medical device from the uncompressed state to the compressed state. The crimper also includes handle configured to operate the crimper. Actuation of the handle decreases a volume of the crimper chamber to transition the implantable medical device from the uncompressed state to the compressed state.

Abstract: A transcatheter valve prosthesis includes a stent having a crimped configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve. The stent includes at least one axial frame member. The transcatheter valve prosthesis includes at least one outflow marker positioned on the at least one axial frame member. The transcatheter heart valve prosthesis may include inflow markers positioned within the inflow portion of the stent. The transcatheter heart valve prosthesis may include two outflow markers disposed on axial frame members and being circumferentially and longtiduinally offset from each other. The markers are configured to aid in axial and circumferential aligned of the transcatheter heart valve prosthesis within a native heart valve.

Abstract: Methods for purging a balloon catheter of air. An inflation fluid is inserted into a balloon and an inflation lumen of a balloon catheter. The inflation lumen is in fluid communication with the balloon. The balloon catheter is positioned in an inverted orientation with a distal end thereof disposed below a proximal end thereof. The distal end of the balloon catheter includes a balloon. A vibration source is positioned in direct contact with an outer surface of the balloon catheter. The balloon catheter is vibrated via the vibration source. A vacuum is applied or pulled on the inflation lumen of the balloon catheter. The steps of vibrating the balloon catheter and applying the vacuum are performed simultaneously.

Abstract: A catheter includes a handle with torquing and steering mechanisms. The torquing mechanism includes a rotatable nosecone and a bearing coupled to the nosecone to be rotatable therewith. The bearing is concentrically disposed over a shaft of the catheter and is configured to transmit a torque from the nosecone to the shaft when the nosecone is rotated. The steering mechanism includes a rack coupled to the bearing to be slideable therewith and a pull wire having a proximal end attached to the bearing and a distal end attached to a distal portion of the shaft. Rotation of the nosecone causes an entire length of the shaft to rotate and axial movement of the rack tensions the pull wire to bend the distal portion of the shaft. A valve relief component is slidingly disposed over the shaft and is configured to dock onto the handle when not in use.