IP Library › Granted Patent US 12,156,644
Granted Patent B2
US 12,156,644 · App. 18/517,764 · Granted Dec 3, 2024

Suture closure devices

Inventors: Meni Iamberger (Kfar Saba, IL); Nir Lilach (Kfar Yehoshua, IL); Amit Segal (Afula, IL); Eliahu Eliachar (Haifa, IL); Ohad Yehoshua Henn (Ramat Gan, IL); Oded Aldaag (Motza Ilit, IL)
Assignee: THE GLOBAL HEART VALVE INNOVATION CENTER (ISRAEL) LTD.
A61B17/0057A61B17/0469A61B2017/00663A61B2017/0472
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Quick Facts
Patent No.
US 12,156,644
App. No.
18/517,764
Granted
Dec 3, 2024
Kind
B2
Abstract

A closure device ( 320 ) is provided for suturing a puncture. The closure device ( 320 ) includes a suture ( 322, 822 ), an elongate support ( 328 ), a suture-positioning support ( 330 ), and an elongate dilator ( 344 ). The suture-positioning support ( 330 ) is coupled to a distal end portion ( 332 ) of the elongate support ( 328 ), laterally extendable with respect to the distal end portion ( 332 ) of the elongate support ( 328 ), and configured to removably receive the suture ( 322, 822 ). The dilator ( 344 ) is configured to be inserted through the puncture, and has a proximal end ( 348 ) that is coupled to the distal end portion ( 332 ) of the elongate support ( 328 ). The closure device ( 320 ) is configured to allow movement of the distal end portion ( 332 ) of the elongate support ( 328 ) with respect to the proximal end ( 348 ) of the dilator ( 344 ) with at least two degrees of freedom. Other embodiments are also described.

Claims (67)

1. A closure device for suturing a puncture, the closure device comprising:

a suture;

an elongate support, which comprises one or more shafts, including (a) an outer tubular shaft and (b) an inner shaft, nested within the outer tubular shaft;

a control handle, which is coupled to a proximal end portion of the elongate support, and which comprises one or more user controls, wherein the outer tubular shaft is fixed with respect to the control handle;

a suture-positioning support, which is (a) coupled to the inner shaft of the elongate support at a distal end portion of the elongate support, (b) laterally extendable with respect to the distal end portion of the elongate support, and (c) configured to removably receive the suture; and

an elongate dilator, which j is configured to be inserted through the puncture, (b) has a proximal end that is coupled to the distal end portion of the elongate support, and (c) is shaped so as to define a guidewire channel,

wherein the closure device is configured to:

allow movement of the distal end portion of the elongate support with respect to the proximal end of the dilator with at least two degrees of freedom, and

rotate the suture-positioning support about a distal-support central longitudinal axis defined by the distal end portion of the elongate support, by rotating the inner shaft while the closure device holds the outer tubular shaft fixed with respect to the control handle.

2. The closure device according to claim 1 , wherein the at least two degrees of freedom include at least one rotational degree of freedom.

3. The closure device according to claim 2 , wherein the at least two degrees of freedom include at least two rotational degrees of freedom.

4. The closure device according to claim 3 , wherein the at least two degrees of freedom include three rotational degrees of freedom.

5. The closure device according to claim 1 , wherein the closure device is configured to allow the movement without requiring the distal end portion of the elongate support to directly or indirectly apply a force to the proximal end of the dilator.

6. The closure device according to claim 1 , wherein the closure device is configured to allow the movement without requiring bending of the dilator.

7. The closure device according to claim 1 , wherein the closure device is configured to allow the movement without requiring deformation of the dilator.

8. The closure device according to claim 1 , further comprising an elongate flexible dilator connector, which couples the proximal end of the dilator to the distal end portion of the elongate support so as to allow the movement.

9. The closure device according to claim 8 , wherein an average outer diameter of the dilator connector is less than 20% of a greatest outer diameter of the dilator.

10. The closure device according to claim 8 , wherein the dilator connector comprises an element selected from the group of elements consisting of a cable, a cord, a wire, and a string.

11. The closure device according to claim 8 , wherein the dilator connector comprises a tube.

12. The closure device according to claim 1 , wherein the dilator is shaped so as to define an atraumatic proximal tip that is tapered.

13. The closure device according to claim 1 ,

wherein the closure device further comprises:

a ferrule, which is coupled to a distal end portion of the suture; and

a suturing needle, which is removably couplable to the ferrule,

wherein the suture-positioning support is shaped so as to define a ferrule receptacle, which is configured to removably receive the ferrule, such that the suture-positioning support is configured to removably receive the suture, and

wherein the closure device is configured to direct the ferrule into the ferrule receptacle during distal advancement of the suturing needle removably coupled to the ferrule.

14. The closure device according to claim 1 ,

wherein the outer tubular shaft of the elongate support has a distal end,

wherein the suture-positioning support has proximal and distal end portions at opposite ends of the suture-positioning support,

wherein the proximal end portion of the suture-positioning support is coupled to the elongate support, and

wherein the distal end portion of the suture-positioning support is disposed distally to the distal end of the outer tubular shaft.

15. The closure device according to claim 14 , wherein the suture-positioning support is coupled to the inner shaft of the elongate support.

16. The closure device according to claim 1 , wherein the suture-positioning support is configured to assume:

a delivery position, in which a suture-positioning support axis of the suture-positioning support (a) forms a first angle of less than 45 degrees with a distal-support central longitudinal axis of the distal end portion of the elongate support, or (b) is parallel with the distal-support central longitudinal axis, and

one or more deployed positions, in which the suture-positioning support is laterally extended with respect to the distal end portion of the elongate support such that the suture-positioning support axis forms a second angle of at least 60 degrees with the distal-support central longitudinal axis.

17. The closure device according to claim 16 , wherein the second angle is at least 75 degrees.

18. The closure device according to claim 1 , wherein an external portion of the suture-positioning support that interfaces with the distal end portion of the elongate support is shaped so as to define one or more partial spherical surfaces.

19. A closure device for suturing a puncture, the closure device comprising:

a suture;

an elongate support, which comprises one or more shafts, including (a) an outer tubular shaft and (b) an inner shaft, nested within the outer tubular shaft;

a control handle, which is coupled to a proximal end portion of the elongate support, and which comprises one or more user controls, wherein the outer tubular shaft is fixed with respect to the control handle;

a suture-positioning support, which is (a) coupled to the inner shaft of the elongate support at a distal end portion of the elongate support, (b) laterally extendable with respect to the distal end portion of the elongate support, and (c) configured to removably receive the suture; and

an elongate dilator, which O is configured to be inserted through the puncture, (b) has a proximal end that is coupled to the distal end portion of the elongate support, and (c) is shaped so as to define a guidewire channel,

wherein the closure device is configured to:

allow movement of the distal end portion of the elongate support with respect to the proximal end of the dilator with at least one translational degree of freedom, and

rotate the suture-positioning support about a distal-support central longitudinal axis defined by the distal end portion of the elongate support, by rotating the inner shaft while the closure device holds the outer tubular shaft fixed with respect to the control handle.

20. The closure device according to claim 19 , wherein the at least one translational degree of freedom includes a translational degree of freedom along a distal-support central longitudinal axis of the distal end portion of the elongate support.

21. The closure device according to claim 19 , wherein the at least one translational degree of freedom includes at least two translational degrees of freedom.

22. The closure device according to claim 21 , wherein the at least two translational degrees of freedom includes three translational degrees of freedom.

23. The closure device according to claim 19 , further comprising an elongate flexible dilator connector, which couples the proximal end of the dilator to the distal end portion of the elongate support so as to allow the movement.

24. The closure device according to claim 23 , wherein an average outer diameter of the dilator connector is less than 20% of a greatest outer diameter of the dilator.

25. The closure device according to claim 23 , wherein the dilator connector comprises an element selected from the group of elements consisting of a cable, a cord, a wire, and a string.

26. The closure device according to claim 23 , wherein the dilator connector comprises a tube.

27. The closure device according to claim 19 , wherein the dilator is shaped so as to define an atraumatic proximal tip that is tapered.

28. The closure device according to claim 19 , wherein the closure device is configured to allow the movement without requiring bending of the dilator and without requiring deformation of the dilator.

29. The closure device according to claim 19 , wherein the suture-positioning support is configured to assume:

a delivery position, in which a suture-positioning support axis of the suture-positioning support (a) forms a first angle of less than 45 degrees with a distal-support central longitudinal axis of the distal end portion of the elongate support, or (b) is parallel with the distal-support central longitudinal axis, and

one or more deployed positions, in which the suture-positioning support is laterally extended with respect to the distal end portion of the elongate support such that the suture-positioning support axis forms a second angle of at least 75 degrees with the distal-support central longitudinal axis.

30. A closure device for suturing a puncture, the closure device comprising:

a suture;

an elongate support, which comprises one or more shafts;

a suture-positioning support, which is (a) coupled to a distal end portion of the elongate support, (b) laterally extendable with respect to the distal end portion of the elongate support, and (c) configured to removably receive the suture; and

an elongate dilator, which is configured to be inserted through the puncture, which has a proximal end that is coupled to the distal end portion of the elongate support, and which is shaped so as to define a guidewire channel,

wherein the distal end portion of the elongate support defines a distal-support central longitudinal axis, and a proximal end portion of the dilator, which includes the proximal end of the dilator, defines a proximal-dilator central longitudinal axis, and

wherein the closure device is configured to allow the distal end portion of the elongate support to move with respect to the proximal end of the dilator from defining a first dilator-to-elongate-support angle to defining a second dilator-to-elongate-support angle between the distal-support central longitudinal axis and the proximal-dilator central longitudinal axis while a suture-positioning-support-to-elongate-support angle remains constant,

wherein the second dilator-to-elongate-support angle is at least 15 degrees greater than the first dilator-to-elongate-support angle, and

wherein the suture-positioning-support-to-elongate-support angle is defined between (a) a suture-positioning support axis of the suture-positioning support and (b) the distal-support central longitudinal axis.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 24, 2024
From: THE GLOBAL HEART VALVE INNOVATION CENTER LTD.
To: THE GLOBAL HEART VALVE INNOVATION CENTER (ISRAEL) LTD.
Reel/Frame 067518/0054 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 31, 2024
From: IAMBERGER, MENI; LILACH, NIR; SEGAL, AMIT; ELIACHAR, ELIAHU; HENN, OHAD YEHOSHUA; ALDAAG, ODED
To: THE GLOBAL HEART VALVE INNOVATION CENTER LTD
Reel/Frame 066311/0612 →
Continuity (4)
Continuation PCTIL2023050966 · Sep 7, 2023
Provisional Application 63526765 · Jul 14, 2023
Provisional Application 63404630 · Sep 8, 2022
Related Publication 20240081800A1 · Mar 14, 2024