Device and method for delivery of an implant through a catheter

• US 10,543,087 B2
• Filed: 10/11/2017
• Issued: 01/28/2020
• Est. Priority Date: 10/11/2016
• Status: Active Grant

• Current Assignee: ValCare Medical, Inc.
• Original Assignee: ValCare, Inc.
• Inventors: Yellin, Nadav, Shaolian, Samuel M., Gedulter, Matan, Schwarz, Boaz, Grimberg, Tsahi, Protsenko, Viktoria, Rapoport, Daniel
• Primary Examiner(s): Tyson, Melanie R
• Application Number:
  US15/730,080
• Publication Number:
  US 20180098849A1
• Time in Patent Office: 839 Days
• 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: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor

Abstract

Disclosed herein is a delivery system for percutaneous heart valve repair, the delivery system including a steerable sheath configured to provide percutaneous access into a heart and to deliver an implant. The system may also have a steering mechanism configured to manipulate and orient the implant, a ball joint mechanism configured to connect the steerable sheath to the steering mechanism, a main knob assembly configured to advance and retract a multilumen shaft assembly, a stabilizing tool including a plurality of prongs configured to engage the implant within the heart to make an intimate contact with the heart tissue using a stabilizer and a tongue assembly, and a back assembly including: the actuation mechanism, a suture routing mechanism, a tip lock mechanism, and a back cover configured to protect all sutures being cut by mistake.

Claims

1. A delivery system for percutaneous heart valve repair, the delivery system comprising:

a steerable sheath configured to provide percutaneous access into a heart and to deliver an implant;

a steering mechanism configured to manipulate and orient the implant;

a ball joint mechanism configured to connect the steerable sheath to the steering mechanism;

wherein the steering mechanism is further configured to pull a steering cable by rotating a steering wheel in order to steer the steerable sheath, the steering mechanism comprising;

one or more steering modules, and

a steering shaft comprising a plurality of flat surfaces configured to connect the one or more steering modules and to ensure a rotational alignment;

a main knob assembly configured to advance and retract a multilumen shaft assembly, wherein the multilumen shaft assembly comprises a multilumen shaft configured to connect to the implant on a distal end and to an actuation mechanism on a proximal end;

a stabilizing tool comprising a plurality of prongs configured to engage the implant within the heart to make an intimate contact with the heart tissue using a stabilizer and a tongue assembly, wherein the stabilizing tool is configured to be controlled by a multilumen cart, wherein the multilumen cart is configured to enable sealing and flushing of the multilumen shaft; and

a back assembly comprising;

the actuation mechanism;

a suture routing mechanism;

a tip lock mechanism; and

a back cover configured to protect all sutures being cut by mistake.

2. The delivery system of claim 1, wherein the steerable sheath comprises a rigid element braided with a specifically patterned metal wire.

3. The delivery system of claim 1, wherein the steerable sheath comprises a wire coiled around the steerable sheath.

4. The delivery system of claim 1, wherein the steerable sheath comprises a hypotube on an outer surface of the sheath.

5. The delivery system of claim 1, wherein the steerable sheath comprises a heat shrink and a pull ring.

6. The delivery system of claim 1, wherein the steerable sheath is connected to a multilumen base comprising a flushing port configured to be attached to a hemostat.

7. The delivery system of claim 1, wherein the steerable sheath has a sheer strength of about 1,000 newtons (N).

8. The delivery system of claim 1, wherein the multilumen shaft comprises a multilumen extrusion, a metallic backbone, an interface assembly, the stabilizer, the tongue assembly, and the stabilizing tool.

9. The delivery system of claim 1, wherein the steering shaft comprises a plurality of flat surfaces, wherein a distance between adjacent flat surfaces is in a range from about 30 mm to about 150 mm.

10. The delivery system of claim 1, wherein the steering shaft comprises a flat surface configured to determine a steering stroke and a steering direction.

11. The delivery system of claim 1, wherein the stabilizing tool comprises a flexible segment configured to steer the multilumen shaft.

12. The delivery system of claim 1, wherein the ball joint mechanism comprises:

a handle; and

a ball joint plate comprising a conical surface.

13. The delivery system of claim 1, wherein the main knob assembly is in a normally closed configuration.

14. The delivery system of claim 1, wherein the tongue assembly comprises one or more tongues.

15. The delivery system of claim 1, wherein the multilumen cart comprises a bipod cover with a corresponding pattern with respect to a pattern of the stabilizing tool.

16. The delivery system of claim 1, wherein the multilumen cart comprises a sealing mechanism, a stabilizing tool handle, a stabilizing tool lock rail, and one or more multilumen cart rails.

17. The delivery system of claim 16, wherein the multilumen cart further comprises an actuation knob configured to open and lock the stabilizing tool handle to the multilumen cart.

18. The delivery system of claim 1, wherein the actuation mechanism of the back assembly comprises:

a plurality of actuation knobs configured to move along one or more channels; and

one or more springs configured to maintain tension to the sutures.

19. The delivery system of claim 1, wherein the suture routing mechanism of the back assembly comprises a suture cut configured to separate the sutures.

20. The delivery system of claim 1, wherein the tip lock mechanism is configured to connect to a flushing port to flush a tip lumen and to provide a passage to a guide wire.