Anastomosis device and related methods

• US 8,551,126 B2
• Filed: 08/21/2003
• Issued: 10/08/2013
• Est. Priority Date: 08/22/2002
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Copa, Vincent G., Hamel, Kory P., Hauschild, Sidney F.
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): YABUT, DIANE D
• Application Number:
  US10/646,383
• Publication Number:
  US 20040087995A1
• Time in Patent Office: 3,701 Days
• Field of Search: 606/153, 606/151, 606/139, 606/148, 606/213, 606/104, 606/144, 606192-194, 600 29- 31, 604/22, 604/96.01, 604/96.02, 604540-544
• US Class Current: 606/153
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections

Abstract

Described are methods and devices relating to reconnecting tissue of the urethra, e.g., connecting the urethra and bladder after a radical prostatectomy, wherein the devices incorporate tissue approximating structure such as tines to maintain contact between severed tissue, such as a severed bladder neck tissue and a severed urethral stump tissue, preferably without the use of sutures.

Claims

1. An anastomosis device comprising

a hollow, elongate, flexible catheter body having a proximal end and a distal end, the distal end comprising a catheter body wall,

an inflatable balloon at the distal end,

a drainage aperture at the distal end, and

elongate tissue approximating structure that can be extended and retracted from the catheter body wall at the distal end of the catheter body on a proximal side of the inflatable balloon,

wherein the inflatable balloon is on a proximal side of the drainage aperture, and

wherein the tissue approximating structure comprises movable elongate structure selected from a tine, a probe, a prod, and a needle.

2. The device of claim 1 wherein, when the device is installed in a body having a prostate removed, with the balloon in a bladder, the tissue approximating structure is capable of contacting tissue selected from tissue of a bladder, tissue of a perineal wall, urethral tissue, and combinations of these.

3. The device of claim 1 wherein the tissue approximating structure can be extended and retracted from apertures in the catheter body using an actuating mechanism that extends through a lumen along a portion of the length of the device to the proximal end.

4. The device of claim 1, comprising

an inflation lumen extending from the proximal end to the balloon,

a drainage lumen extending from the drainage aperture at the distal end to a port at the proximal end, and

wherein the tissue approximating structure comprises

distal tissue approximating structure comprising movable elongate tines positioned to extend through apertures in the hollow catheter body on the proximal side of the balloon, and

proximal tissue approximating structure comprising movable elongate tines positioned to extend through apertures in the hollow catheter body on the proximal side of the distal tissue approximating structure.

5. The device of claim 1 wherein the tissue approximating structure comprises multiple tines.

6. The device of claim 1 wherein the tissue approximating structure comprises multiple opposing tines.

7. The device of claim 1 wherein tissue approximating structure can be extended and retracted from the catheter body wall at a fixed location on the catheter body, the fixed location being fixed relative to the distal end of the catheter body and relative to the proximal end of the catheter body, and wherein

the balloon can be extended and retracted from the catheter body wall at a fixed location on the catheter body, the fixed location being fixed relative to the distal end of the catheter body and relative to the proximal end of the catheter body.

8. The device of claim 7 wherein the tissue approximating structure comprises multiple tines.

9. An anastomosis device comprising

a hollow, elongate, flexible catheter body having a proximal end and a distal end, the distal end comprising a catheter body wall,

an inflatable balloon at the distal end,

a drainage aperture at the distal end, and

elongate tissue approximating structure that can be extended and retracted from the catheter body wall at the distal end of the catheter body on a proximal side of the inflatable balloon,

an inflation lumen extending from the proximal end to the balloon,

a drainage lumen extending from the drainage aperture at the distal end to a port at the proximal end, and

movable elongate tissue approximating structure positioned to extend through apertures in the hollow catheter body at the distal end,

wherein the inflatable balloon is on a proximal side of the drainage aperture.

10. An anastomosis device comprising

a hollow elongate flexible catheter body having proximal end and a distal end, the distal end comprising a catheter body wall,

an inflatable balloon at the distal end and inflation means to inflate the balloon,

a drainage aperture and drainage means connected to the drainage aperture for draining urine from a bladder, and

elongate tissue approximating means on the proximal side of the balloon for holding severed tissue in contact for healing

wherein the inflatable balloon is on a proximal side of the drainage aperture and the tissue approximating means can be extended and retracted from the catheter body wall at a location along the distal end of the catheter body, and

wherein the tissue approximating means comprises a movable tine.

11. The device of claim 10 further comprising actuating means for actuating the tissue approximating means, the actuating means connected to the tissue approximating means and extending from the tissue approximating means to the proximal end.

12. The device of claim 10 wherein the tissue approximating structure is selected from the group consisting of an inflatable balloon, a movable elongate structure, and a combination thereof.

13. The device of claim 10 wherein, with the device positioned to place the at least a portion of the catheter body inside the urethra and the inflated balloon in the bladder, the tissue approximating means can be extended to contact tissue selected from the group consisting of bladder tissue, urethral tissue, urethral stump tissue, and perineal wall tissue.

14. The device of claim 10 wherein tissue approximating means can be extended and retracted from the catheter body wall at a fixed location along the distal end of the catheter body, the fixed location being fixed relative to the distal end of the catheter body and relative to the proximal end of the catheter body.

15. The device of claim 14 wherein the tissue approximating means comprises multiple tines.

16. An anastomosis device comprising

a hollow, elongate, flexible catheter body having a proximal end and a distal end, the distal end comprising a catheter body wall,

a drainage aperture at the distal end, and

tissue approximating structure at the distal end of the catheter body, the tissue approximating structure comprising first tissue approximating structure and second tissue approximating structure, the first and second tissue approximating structure located on a proximal side of the drainage aperture, wherein each of the first and second tissue approximating structure can be extended and retracted from the catheter body wall, and the second tissue approximating structure comprises elongate structure

wherein, when the device is positioned to place a distal portion of the catheter body inside the urethra, the first tissue approximating structure can be located to contact tissue of the bladder and the second tissue approximating structure is located to contact tissue selected from tissue of a bladder, tissue of a perineal wall, urethral stump tissue, tissue inside a urethra, and combinations of these, and

wherein the second tissue approximating structure is located on a proximal side of the first tissue approximating structure, and the second tissue approximating structure comprises movable elongate structure selected from a tine, a probe, a prod, and a needle.

17. The device of claim 16 wherein the first tissue approximating structure is selected from the group consisting of a balloon and a balloon-like structure.

18. The device of claim 17 wherein the first tissue approximating structure, when placed inside of the bladder, is capable of expanding within the bladder to prevent urine from passing through the bladder neck and urethra to an anastomosis site.

19. The device of claim 16 wherein the second tissue approximating structure comprises multiple opposing tines.

20. An anastomosis device comprising

a hollow, elongate, flexible catheter body having a proximal end and a distal end, the distal end comprising a catheter body wall,

a drainage aperture at the distal end,

an inflatable balloon at the distal end on a proximal side of the drainage aperture,

tissue approximating structure that can be extended through apertures in the catheter body wall, at the distal end of the catheter body on a proximal side of the inflatable balloon, the tissue approximating structure comprising movable elongate structure selected from a tine, a probe, a prod, and a needle.

21. The device of claim 20 wherein the tissue approximating structure can be extended and retracted through the apertures in the catheter body using an actuating mechanism that extends through a lumen along a portion of the length of the device to the proximal end.

22. The device of claim 20 comprising

distal tissue approximating structure comprising movable elongate tines positioned to extend through apertures in the hollow catheter body on the proximal side of the balloon, and

proximal tissue approximating structure comprising movable elongate tines positioned to extend through apertures in the hollow catheter body on the proximal side of the distal tissue approximating structure,

wherein the distal tissue approximating structure can be extended and retracted through the apertures in the catheter body using an actuating mechanism that extends through a lumen along a portion of the length of the device to the proximal end, and

wherein the proximal tissue approximating structure can be extended and retracted through the apertures in the catheter body using an actuating mechanism that extends through a lumen along a portion of the length of the device to the proximal end.

23. An anastomosis device comprising

a hollow, elongate, flexible catheter body having a proximal end and a distal end, the distal end comprising a catheter body wall,

an inflatable balloon at the distal end,

a drainage aperture at the distal end, and

elongate tissue approximating structure that can be extended and retracted from the catheter body wall at the distal end of the catheter body on a proximal side of the inflatable balloon,

wherein the inflatable balloon is on a proximal side of the drainage aperture, and

wherein the tissue approximating structure comprises

distal tissue approximating structure comprising multiple tines, and

proximal tissue approximating structure comprising multiple tines that oppose the multiple tines of the distal tissue approximating structure,

wherein the distal tissue approximating structure can be extended and retracted from the catheter body wall at a fixed location on the catheter body, the fixed location being fixed relative to the distal end of the catheter body and relative to the proximal end of the catheter body, and

the proximal tissue approximating structure can be extended and retracted from the catheter body wall at a fixed location on the catheter body, the fixed location being fixed relative to the distal end of the catheter body and relative to the proximal end of the catheter body.

24. The device of claim 23 wherein the position of the balloon on the catheter body is fixed relative to the distal end of the catheter body and relative to the proximal end of the catheter body.

25. An anastomosis device comprising

a hollow elongate flexible catheter body having a proximal end and a distal end, the distal end comprising a catheter body wall,

an inflatable balloon at the distal end and inflation means to inflate the balloon,

a drainage aperture and drainage means connected to the drainage aperture for draining urine from a bladder, and

elongate tissue approximating means on the proximal side of the balloon for holding severed tissue in contact for healing

wherein the inflatable balloon is on a proximal side of the drainage aperture and the tissue approximating means can be extended and retracted from the catheter body wall at a location along the distal end of the catheter body,

wherein tissue approximating means comprises

distal tissue approximating means comprising multiple tines, and

proximal tissue approximating means comprising multiple tines that oppose the multiple tines of the distal tissue approximating means,

wherein the distal tissue approximating structure can be extended and retracted from the catheter body wall at a fixed location on the catheter body, the fixed location being fixed relative to the distal end of the catheter body and relative to the proximal end of the catheter body, and

the proximal tissue approximating structure can be extended and retracted from the catheter body wall at a fixed location on the catheter body, the fixed location being fixed relative to the distal end of the catheter body and relative to the proximal end of the catheter body.

26. The device of claim 25 wherein the position of the balloon on the catheter body is fixed relative to the distal end of the catheter body and relative to the proximal end of the catheter body.

27. An anastomosis device comprising

a hollow, elongate, flexible catheter body having a proximal end and a distal end, the distal end comprising a catheter body wall,

a drainage aperture at the distal end, and

tissue approximating structure at the distal end of the catheter body, the tissue approximating structure comprising first tissue approximating structure and second tissue approximating structure, the first and second tissue approximating structure located on a proximal side of the drainage aperture, wherein each of the first and second tissue approximating structure can be extended and retracted from the catheter body wall, and the second tissue approximating structure comprises elongate structure,

wherein the first approximating structure can be extended and retracted from the catheter body wall at a fixed location on the catheter body, the fixed location being fixed relative to the distal end of the catheter body and relative to the proximal end of the catheter body, and

the second tissue approximating structure can be extended and retracted from the catheter body wall at a fixed location on the catheter body, the fixed location being fixed relative to the distal end of the catheter body and relative to the proximal end of the catheter body.

28. The device of claim 27 wherein the first tissue approximating structure comprises an inflatable balloon and the second tissue approximating structure comprises multiple tines.