Abstract: Delivery devices and methods for delivering a prosthetic heart valve. The delivery device includes an inner shaft assembly with a valve retainer, an outer shaft assembly, a handle assembly and an axial force adjustment assembly. The outer shaft assembly includes a capsule containing the prosthetic valve in a loaded state. The handle assembly is coupled to a proximal region of the outer shaft assembly. The axial force adjustment assembly connects a proximal section of the inner shaft assembly to the handle assembly, and is configured to selectively move the proximal section relative to the handle assembly. The axial force adjustment assembly can include an actuator member and a driver member. The driver member directly interfaces with the inner shaft assembly, and a force applied to the actuator member is transferred onto the proximal section via the driver member. A sensor for sensing tension and/or compression in the inner shaft assembly can be provided.

Abstract: Aspects of the disclosure relate to “wet” transcatheter prosthetic heart valve or other implant packaging and assemblies in which a prosthetic heart valve or other implant is loaded into a first portion of a delivery device and positioned within a container in which sterilizing fluid is retained to sterilize interior portions of the container as well as provide moisture to prevent the implant from drying out. The disclosure also relates to methods of sterilizing the disclosed assemblies. Some disclosed methods include at least two sterilizing steps and adjustment of a mechanical seal member or formation of multiple seals so that areas proximate the seals are also sterilized during the sterilization process.

Abstract: A balloon catheter configured for delivery of a prosthetic heart valve is provided. The balloon catheter is configured to deploy a prosthetic heart valve through inflation. The balloon catheter is provided with a reinforcing member configured to increase the rigidity of the balloon catheter over an operational portion of the device. The increased rigidity serves to prevent damage to an introducer sheath, patient anatomy, or the prosthetic heart valve during delivery of the prosthetic heart valve.

Abstract: Techniques of this disclosure relate to delivery devices for use in delivering a prosthesis via percutaneous transcatheter (or transluminal) techniques. Embodiments achieve variable tensile and bending resistance of a transcatheter delivery device, which improves trackability and positioning accuracy of the system while maintaining the tensile characteristics of the transcatheter delivery device required for recapture and deployment of the prosthesis. Other embodiments relate to other components of a transcatheter delivery device that can be torqueable to assist in rotational positioning of the prosthesis. Other embodiments relate to the capsule of the transcatheter delivery device outer sheath member and/or the prosthesis retention member of the transcatheter delivery device that can passively or otherwise rotate about their respective central axis to prevent built-up torque during delivery of a prosthesis. The capsule can include an echogenic marker.

Abstract: Aspects of the disclosure relate to “wet” transcatheter prosthetic heart valve or other implant packaging and assemblies in which a prosthetic heart valve or other implant is loaded into a first portion of a delivery device and positioned within a container in which sterilizing fluid is retained to sterilize inside of the container as well as provide moisture to prevent the implant from drying out. The disclosure also relates to methods of sterilizing the disclosed assemblies. Some disclosed methods include at least two sterilizing steps and adjustment of a shaft seal or formation of multiple seals maintaining sterilizing fluid within the container so that areas underneath the shaft seal(s) can also be sterilized.

Abstract: A delivery device includes a control release shaft and a pusher shaft disposed within the control release shaft. A distal end of the control release shaft includes a collar having a sloped distal edge. The control release shaft is rotatable in order to rotate the collar. The pusher shaft has a distal end having a spindle coupled thereto. The spindle is configured to receive at least one connector extending from at least one endmost crown of the self-expanding prosthesis in order to releasably attach the self-expanding prosthesis to the pusher shaft. When disposed over an end of the self-expanding prosthesis, the collar is configured to radially restrain the endmost crowns and the connector of the self-expanding prosthesis. Actuation of an actuator of the delivery device rotates and proximally retracts the collar relative to the spindle to achieve incremental release of the endmost crowns and the connector of the self-expanding prosthesis.

Abstract: A system including a self-expanding prosthesis configured to foreshorten during deployment thereof and a delivery device configured to percutaneously deliver the self-expanding prosthesis. The delivery device includes a handle having an actuator thereon, an outer sheath including a proximal end coupled to the handle and a pusher shaft slidingly disposed within the outer sheath. The pusher shaft has a proximal end coupled to the handle and a distal end configured to releasably couple to the self-expanding prosthesis such that the self-expanding prosthesis axially moves therewith. The inner shaft has a distal portion of the inner shaft that is configured to receive a self-expanding prosthesis thereon. The outer sheath and the pusher shaft are configured to simultaneously move in opposing axial directions via actuation of the actuator on the handle to compensate for the foreshortening of the self-expanding prosthesis during deployment.

Abstract: The disclosure relates to transcatheter stented prosthesis delivery devices including transition elements that route, constrain, support and reduce damage to tension member wear as tension in the tension members is varied to adjust the compression of a stented prosthesis loaded onto the delivery device. Various disclosed tension elements include inserts, edge treatments and guides proximate a distal portion of the delivery device upon which the stented prosthesis is loaded. In some embodiments, the transition feature is positioned proximate a location where at least one tension member transitions from a first orientation that is not parallel to the distal portion to a second orientation that is generally parallel to the distal portion. Further embodiments disclose configurations and methods of selectively locking and unlocking a longitudinal and/or rotational position of the stent frame with respect to the distal portion of the delivery device.

Abstract: A system including a self-expanding prosthesis configured to foreshorten during deployment thereof and a delivery device configured to percutaneously deliver the self-expanding prosthesis. The delivery device includes a handle having an actuator thereon, an outer sheath including a proximal end coupled to the handle and a pusher shaft slidingly disposed within the outer sheath. The pusher shaft has a proximal end coupled to the handle and a distal end configured to releasably couple to the self-expanding prosthesis such that the self-expanding prosthesis axially moves therewith. The inner shaft has a distal portion of the inner shaft that is configured to receive a self-expanding prosthesis thereon. The outer sheath and the pusher shaft are configured to simultaneously move in opposing axial directions via actuation of the actuator on the handle to compensate for the foreshortening of the self-expanding prosthesis during deployment.

Abstract: The disclosure relates to transcatheter stented prosthesis delivery devices including transition elements that route, constrain, support and reduce damage to tension member wear as tension in the tension members is varied to adjust the compression of a stented prosthesis loaded onto the delivery device. Various disclosed tension elements include inserts, edge treatments and guides proximate a distal portion of the delivery device upon which the stented prosthesis is loaded. In some embodiments, the transition feature is positioned proximate a location where at least one tension member transitions from a first orientation that is not parallel to the distal portion to a second orientation that is generally parallel to the distal portion. Further embodiments disclose configurations and methods of selectively locking and unlocking a longitudinal and/or rotational position of the stent frame with respect to the distal portion of the delivery device.

Abstract: Aspects of the present disclosure provide a delivery device including a tubular outer jacket having a distal end and a tyne assembly including a shaft supporting at least one tyne. In some aspects, an inner jacket is positioned within the outer jacket, wherein the tyne assembly is positioned between the outer jacket and the inner jacket. The delivery device has a delivery configuration in which the tynes are maintained within the outer jacket and a deployed configuration in which the tynes extend from a distal end of the tubular outer jacket. Aspects of the disclosure also provide methods of conducting a percutaneous coronary intervention including utilizing one or more tyne assemblies to engage the tynes of each tyne assembly with the frame to maintain the position of the delivery device.

Abstract: The disclosure relates to transcatheter stented prosthesis delivery devices including a handle assembly connected to a shaft assembly on which a stented prosthesis is loaded and compressively retained with a plurality of elongate tension members. The delivery devices include a cutting assembly that can sever the elongate tension members after the stented prosthesis is expanded at a target site so that the delivery device can be withdrawn from the patient. Certain embodiments position the cutting assembly at least within the shaft assembly and others position the cutting assembly over the shaft assembly. Various disclosed cutting assemblies are actuated with the handle assembly or the like, which draw the tension members across the blade or vice versa.

Abstract: The disclosure relates to transcatheter stented prosthesis delivery devices including a handle assembly connected to a shaft assembly on which a stented prosthesis is loaded and compressively retained with a plurality of elongate tension members. The delivery devices include a cutting assembly that can sever the elongate tension members after the stented prosthesis is expanded at a target site so that the delivery device can be withdrawn from the patient. Certain embodiments position the cutting assembly at least within the shaft assembly and others position the cutting assembly over the shaft assembly. Various disclosed cutting assemblies are actuated with the handle assembly or the like, which draw the tension members across the blade or vice versa.

Abstract: Aspects of the disclosure relate to “wet” transcatheter prosthetic heart valve or other implant packaging and assemblies in which a prosthetic heart valve or other implant is loaded into a first portion of a delivery device and positioned within a container in which sterilizing fluid is retained to sterilize interior portions of the container as well as provide moisture to prevent the implant from drying out. The disclosure also relates to methods of sterilizing the disclosed assemblies. Some disclosed methods include at least two sterilizing steps and adjustment of a mechanical seal member or formation of multiple seals so that areas proximate the seals are also sterilized during the sterilization process.

Abstract: Aspects of the disclosure relate to “wet” transcatheter prosthetic heart valve or other implant packaging and assemblies in which a prosthetic heart valve or other implant is loaded into a first portion of a delivery device and positioned within a container in which sterilizing fluid is retained to sterilize inside of the container as well as provide moisture to prevent the implant from drying out. The disclosure also relates to methods of sterilizing the disclosed assemblies. Some disclosed methods include at least two sterilizing steps and adjustment of a shaft seal or formation of multiple seals maintaining sterilizing fluid within the container so that areas underneath the shaft seal(s) can also be sterilized.

Abstract: Aspects of the disclosure relate to “wet” transcatheter prosthetic heart valve or other implant packaging and assemblies in which a prosthetic heart valve or other implant is loaded into a first portion of a delivery device and positioned within a container in which sterilizing fluid is retained to sterilize inside of the container as well as provide moisture to prevent the implant from drying out. The disclosure also relates to methods of sterilizing the disclosed assemblies. Some disclosed methods include at least two sterilizing steps and adjustment of a shaft seal or formation of multiple seals maintaining sterilizing fluid within the container so that areas underneath the shaft seal(s) can also be sterilized.

Abstract: The disclosure generally relates to delivery devices for transcatheter delivery of a prosthesis. The delivery device includes a hollow shaft on which the prosthesis is supported. A handle assembly maintains the shaft. The delivery device further includes a guide wire that is selectively directed through the handle assembly and shaft. The guide wire directs the shaft to a target site at which the prosthesis is to be deployed. In practice, an operator managing the inner catheter controls the prosthesis positioning. The delivery devices disclosed herein are configured to ergonomically also allow the operator to control the position of the guide wire as the position of the guide wire influences the deployment position of the prosthesis. In this way, a second operator for positioning the guide wire can be omitted. Embodiments of the disclosure are believed to improve positioning predictability and ease of use.

Abstract: Aspects of the disclosure relate to “wet” transcatheter prosthetic heart valve or other implant packaging and assemblies in which a prosthetic heart valve or other implant is loaded into a first portion of a delivery device and positioned within a container in which sterilizing fluid is retained to sterilize interior portions of the container as well as provide moisture to prevent the implant from drying out. The disclosure also relates to methods of sterilizing the disclosed assemblies. Some disclosed methods include at least two sterilizing steps and adjustment of a mechanical seal member or formation of multiple seals so that areas proximate the seals are also sterilized during the sterilization process.

Abstract: Provided here are, inter alia, methods of estimating a genetic predisposition of an individual subject developing a phenotype by identifying a plurality of different rare genetic variant in a population of subjects and estimating the genetic predisposition of the individual subject developing the phenotype based at least in part on the presence of the plurality of different rare genetic variants within the genome of the individual.

Abstract: A system including a self-expanding prosthesis configured to foreshorten during deployment thereof and a delivery device configured to percutaneously deliver the self-expanding prosthesis. The delivery device includes a handle having an actuator thereon, an outer sheath including a proximal end coupled to the handle and a pusher shaft slidingly disposed within the outer sheath. The pusher shaft has a proximal end coupled to the handle and a distal end configured to releasably couple to the self-expanding prosthesis such that the self-expanding prosthesis axially moves therewith. The inner shaft has a distal portion of the inner shaft that is configured to receive a self-expanding prosthesis thereon. The outer sheath and the pusher shaft are configured to simultaneously move in opposing axial directions via actuation of the actuator on the handle to compensate for the foreshortening of the self-expanding prosthesis during deployment.