Delivery systems with telescoping capsules for deploying prosthetic heart valve devices and associated methods

Patent metadata

Field	Value
Publication number	US-11559398-B2
Application number	US-202016870012-A
Country	US
Kind code	B2
Filing date	May 8, 2020
Priority date	Jun 2, 2017
Publication date	Jan 24, 2023
Grant date	Jan 24, 2023

Abstract

Delivery systems with telescoping capsules for delivering prosthetic heart valve devices and associated methods are disclosed herein. A delivery system configured in accordance with embodiments of the present technology can include, for example, a delivery capsule having a first housing, a second housing slidably disposed within a portion of the first housing, and a prosthetic device constrained within the first and second housings. The delivery capsule can further include first and second chamber defined in part by the first and second housings. During deployment, fluid is delivered to the first chamber to move the first housing distally over the second housing, thereby releasing a portion of the prosthetic device. Subsequently, fluid is delivered to the second chamber such that the first and second housings move together in the distal direction to release a second portion of the prosthetic device.

First claim

We claim:

1. A method for delivering a prosthetic heart valve device to a native valve of a heart of a human patient, the method comprising:
positioning a delivery capsule at a distal portion of an elongated catheter body within the heart, the delivery capsule carrying the prosthetic heart valve device, wherein the delivery capsule comprises a first housing configured to contain at least a first portion of the prosthetic heart valve device and a second housing slidably associated with a portion of the first housing, wherein the second housing is configured to contain a second portion of the prosthetic heart valve device;
moving the first housing in a distal direction with respect to the second housing to release the first portion of the prosthetic heart valve device from the delivery capsule; and
moving the second housing and the first housing together in a distal direction to release the second portion of the prosthetic heart valve device from the delivery capsule.

2. The method of claim 1 , wherein the delivery capsule further comprises:
a first sealing member between a distal portion of the first housing and the second housing, wherein the first sealing member is slidable along the second housing;
a second sealing member between a proximal portion of the second housing and the first housing;
a first fluid chamber between the first and second sealing members; and
a second fluid chamber defined at least in part by an inner surface of the second housing,
wherein moving the first housing in a distal direction with respect to the second housing comprises delivering a fluid to the first chamber to slide the first sealing member in the distal direction over the second housing, and
wherein moving the second housing and the first housing together in a distal direction fluid comprises delivering fluid to the second chamber such that the first and second housings move together in the distal direction.

3. The method of claim 2 , wherein the delivery capsule further comprises a platform extending from the elongated catheter body into the second housing, wherein the platform includes a distal end portion slidably sealed against an inner wall of the second housing and defines a proximal end of the second fluid chamber.

4. The method of claim 2 , wherein the first sealing member is a first sleeve extending inwardly from the first housing, and wherein the second sealing member is a second sleeve extending outwardly from the second housing.

5. The method of claim 2 , further comprising evacuating the first fluid from the first fluid chamber while the second fluid chamber remains pressurized with fluid such that the first housing moves in a proximal direction.

6. The method of claim 2 , wherein a first fluid lumen extends through the elongated catheter body and is in fluid communication with the first fluid chamber; and wherein a second fluid lumen extends through the elongated catheter body and is in fluid communication with the second fluid chamber.

7. The method of claim 6 , wherein the first fluid lumen passes through the second housing and into a port in the first housing, and wherein the port is in fluid communication with the first fluid chamber.

8. The method of claim 6 , wherein the second housing comprises an inner channel in a wall of the second housing, and wherein the inner channel is in fluid communication with the first fluid chamber and defines a portion of the first fluid lumen.

9. The method of claim 1 , wherein the delivery capsule has an overall length of at most 50 mm.

10. The method of claim 1 , wherein the delivery capsule has an overall length of at most 40 mm.

11. The method of claim 1 , wherein the first housing and the second housing each have a length of at most 30 mm.

12. The method of claim 1 , wherein a first spring biases the first housing toward a delivery state, and wherein a second spring biases the second housing toward the delivery state.

13. The method of claim 1 , wherein the second housing includes an arched feature on an outer surface of the second housing and positioned between the first and second housings, wherein a first tether element attaches to a first portion of the first housing, wherein the first tether element extends from the first housing, over a distal end portion of the second housing, into the second housing, and through the elongated catheter body, wherein a second tether element attached to a second portion of the first housing, wherein the second tether element extends in a proximal direction around the arched feature, over the distal end portion of the second housing, into the second housing, and through the elongated catheter body, the method further comprising:
proximally retracting of the first tether element to slide the first housing over the second housing in the distal direction to unsheathe at least a portion of the prosthetic heart valve device from the delivery capsule, and
proximally retracting of the second tether element to slide the first housing over the second housing in a proximal direction to resheathe the prosthetic heart valve device.

14. A method for delivering a prosthetic heart valve device to a native valve of a heart of a human patient, the method comprising:
positioning a delivery capsule at a distal portion of an elongated catheter body within the heart, the delivery capsule carrying the prosthetic heart valve device;
delivering fluid to a first fluid chamber of the delivery capsule to slide a first housing in a distal direction over a portion of a second housing so that a first portion of the prosthetic heart valve device is released from the delivery capsule; and
delivering fluid to a second fluid chamber of the delivery capsule to move the second housing together with the first housing in the distal direction to release a second portion of the prosthetic heart valve device from the delivery capsule.

15. The method of claim 14 , further comprising evacuating fluid from the first fluid chamber while the second fluid chamber remains pressurized with fluid such that the first housing slides in a proximal direction over the second housing.

16. The method of claim 14 , wherein positioning the delivery capsule within the heart comprises delivering the delivery capsule across an atrial septum of the heart to a left atrium.

17. The method of claim 14 , wherein a first sealing member is between a distal portion of the first housing and the second housing, wherein the first sealing member is slidable along the second housing, wherein a second sealing member is between a proximal portion of the first housing and the second housing, and wherein the first fluid chamber extends between the first and second sealing members.

18. The method of claim 14 , wherein the first and second housings each have a length of 20-30 mm.

19. The method of claim 14 , wherein a first spring is configured to urge the first housing toward a delivery state when the first fluid chamber is evacuated of fluid, and wherein a second spring configured to urge the second housing toward the delivery state when the second fluid chamber is evacuated of fluid.

20. A method for delivering a prosthetic heart valve device to a native mitral valve of a heart of a human patient, the method comprising:
delivering a delivery capsule at a distal portion of an elongated catheter body across an atrial septum of the heart to a left atrium of the heart, the delivery capsule having a first housing and a second housing slidably disposed within at least a portion of the first housing, wherein the first

Assignees

• Twelve Inc

Inventors

• Mauch Kevin
• Dwork Joshua

Classifications

• A61F2/2436 Primary

  Deployment by retracting a sheath · CPC title

• A61F2/844

  folded prior to deployment · CPC title

• A61F2/243 Primary

  Deployment by mechanical expansion · CPC title

• A61B2017/00243

  cardiac · CPC title

• A61F2/2427

  Devices for manipulating or deploying heart valves during implantation · CPC title