IP Library Granted Patent US 10,543,087
Granted Patent B2
US 10,543,087 · App. 15/730,080 · Granted Jan 28, 2020

Device and method for delivery of an implant through a catheter

Inventors: Nadav Yellin (Ramat Gan, IL); Samuel M. Shaolian (Newport Beach, CA); Matan Gedulter (Givat Ella, IL); Boaz Schwarz (Tel Aviv, IL); Tsahi Grimberg (Kfar Saba, IL); Viktoria Protsenko (Bat Yam, IL); Daniel Rapoport (Kfar Menahem, IL)
Assignee: VALCARE, INC.
A61F2/2436A61B17/3468A61F2/2466A61F2/95
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Quick Facts
Patent No.
US 10,543,087
App. No.
15/730,080
Granted
Jan 28, 2020
Kind
B2
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 (37)

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.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 8, 2023
From: VALCARE, INC.
To: VALCARE MEDICAL, INC.
Reel/Frame 065835/0401 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 4, 2019
From: YELLIN, NADAV; SHAOLIAN, SAMUEL M.; GEDULTER, MATAN; SCHWARZ, BOAZ; GRIMBERG, TSAHI; PROTSENKO, VIKTORIA; RAPOPORT, DANIEL
To: VALCARE, INC.
Reel/Frame 051194/0730 →
Continuity (2)
Provisional Application 62406765 · Oct 11, 2016
Related Publication 20180098849A1 · Apr 12, 2018
Cited By (6)
US 12,279,955 US 12,396,853 US 12,409,034 US 12,642,654 US 12,648,850 US 12,661,228