Transcatheter valve delivery system with septum hole closure tip assembly

• US 10,449,044 B2
• Filed: 05/31/2017
• Issued: 10/22/2019
• Est. Priority Date: 06/02/2016
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Anderson, Marc
• Primary Examiner(s): Severson, Ryan J.
• Application Number:
  US15/609,203
• Publication Number:
  US 20170348096A1
• Time in Patent Office: 874 Days
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00588 Rigid or stiff implements, e.g. made of several rigid parts linked by hinges
• CPC Class Codes: A61B 2017/0061 Implements located only on one side of the opening
• CPC Class Codes: A61B 2017/00619 Locking means for locking the implement in expanded state
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

Transcatheter heart valve delivery systems having a tip assembly configured to close the hole or perforation made in a patient'"'"'s septal wall after transseptal delivery of a stented prosthetic heart valve to a defective heart valve (e.g., a mitral valve). The delivery device is configured to permit in vivo release of the tip assembly immediately after deployment of the stented prosthetic heart valve to implant the tip assembly into the septal wall proximate the hole through which the stented prosthetic heart valve is delivered. Methods of treating the defective heart valve, including closing the hole made during transseptal delivery of the stented prosthetic heart valve with the tip assembly of the delivery device are also disclosed.

Claims

1. A delivery device for implanting a stented prosthetic heart valve, the device comprising:

a support shaft having a distal region;

a retention assembly associated with the support shaft and configured to retain the stented prosthetic heart valve; and

a tip assembly releasably coupled to the distal region of the support shaft distal to the retention assembly;

wherein the delivery device is configured to permit in vivo release of the stented prosthetic heart valve and, in a separate action, actuate in vivo release of the tip assembly from a remainder of the delivery device.

2. The delivery device of claim 1, wherein the tip assembly is configured to transition from a delivery state to a deployed state, and further wherein a maximum outer diameter of the tip assembly in the deployed state is greater than the maximum outer diameter in the delivery state.

3. The delivery device of claim 2, wherein the tip assembly is configured to engage tissue in the deployed state.

4. The delivery device of claim 2, wherein the tip assembly is configured for implantation over a hole in a septum of a heart when in the deployed state and released from a remainder of the delivery device.

5. The delivery device of claim 1, wherein the tip assembly includes:

a housing defining a proximal side, a distal side, and a cavity; and

an arm assembly slidably connected to the housing;

wherein the tip assembly is configured to transition from a delivery state to a deployed state, and further wherein the delivery state includes at least a majority of a length of the arm assembly disposed within the cavity, and the deployed state includes at least a majority of the length of the arm assembly projecting from the housing outside of the cavity.

6. The delivery device of claim 5, wherein the housing defines a maximum outer diameter of the tip assembly in the delivery state and the arm assembly defines a maximum outer diameter of the tip assembly in the deployed state, and further wherein the maximum outer diameter of the tip assembly in the deployed state is greater than the maximum outer diameter of the tip assembly in the delivery state.

7. The delivery device of claim 5, wherein the arm assembly includes a plurality of arms, and further wherein the arms are longitudinally arranged in the delivery state, and even further wherein the arms are transversely arranged in the deployed state.

8. The delivery device of claim 5, wherein the arm assembly includes a plurality of arms and a plurality of barbs, and further wherein at least one of the barbs is attached to and extends from a respective one of the arms.

9. The delivery device of claim 8, wherein the delivery state includes the barbs disposed within the cavity, and further wherein the deployed state includes the barbs located outside of the cavity for engaging tissue.

10. The delivery device of claim 5, wherein the arm assembly includes a plurality of arms maintaining a skirt.

11. The delivery device of claim 10, wherein the tip assembly further includes a seal carried by the housing.

12. The delivery device of claim 1, wherein the tip assembly includes a housing that is generally conically-shaped.

13. A system for treating a defective heart valve via a trans-septal approach, the system comprising:

a delivery device including;

a support shaft having a distal region,

a retention assembly associated with the support shaft, and

a tip assembly releasably coupled to the distal region of the support shaft; and

a stented prosthetic heart valve compressed over the support shaft and retained by the retention assembly in a loaded arrangement of the delivery device;

wherein the delivery device is configured to permit in vivo release of the stented prosthetic heart valve and the tip assembly from a remainder of the delivery device.

14. The system of claim 13, wherein the delivery device includes an outer sheath;

further wherein the delivery device transitions from the loaded arrangement in which a distal end of the outer sheath is proximal to the tip assembly and over the stented prosthetic heart valve to a valve deployment arrangement in which a distal end of the outer sheath is proximal the stented prosthetic heart valve to permit deployment of the prosthetic heart valve from the delivery device.

15. The system of claim 14, wherein the tip assembly is configured to transition from a delivery state to a deployed state, and further wherein a maximum outer diameter of the tip assembly in the deployed state is greater than the maximum outer diameter in the delivery state, and even further wherein the tip assembly is in the delivery state in both the loaded arrangement and the valve deployment arrangement.

16. The system of claim 15, wherein the tip assembly is configured for implantation over a hole in a septal of a heart when in the deployed state and released from a remainder of the delivery device.

17. The system of claim 13, wherein the tip assembly includes:

a housing defining a proximal side, a distal side, and a cavity; and

an arm assembly slidably connected to the housing;

wherein the tip assembly is configured to transition from a delivery state to a deployed state, and further wherein the delivery state includes at least a majority of a length of the arm assembly disposed within the cavity, and the deployed state includes at least a majority of a length of the arm assembly projecting from the housing outside of the cavity.

18. A method of treating a defective heart valve of a patient, the method comprising:

providing a delivery device including a support shaft maintaining a stented prosthetic heart valve and having a tip assembly adjacent and distal to the prosthetic heart valve;

forming a hole in a septum of a heart of the patient;

directing the tip assembly and the stented prosthetic heart valve through the hole;

deploying the prosthetic heart valve from the delivery device to implant the prosthetic heart valve at the defective heart valve; and

implanting the tip assembly at the hole in the septum.

19. The method of claim 18, wherein the step of implanting the tip assembly includes transitioning the tip assembly from a delivery state to a deployed state, a maximum outer diameter of the tip assembly in the delivery state being less than a diameter of the hole and a maximum outer diameter of the tip assembly in the deployed state being greater than the diameter of the hole.

20. The method of claim 18, further comprising the step of releasing the tip assembly from the support shaft after implanting the tip assembly.