Anastomosis device and related methods

• US 20040087995A1
• Filed: 08/21/2003
• Published: 05/06/2004
• Est. Priority Date: 08/22/2002
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Copa, Vincent G., Hauschild, Sidney F., Hamel, Kory P.
• Granted Patent: US 8,551,126 B2
• Time in Patent Office: Days
• US Class Current: 606/192
• 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 the urethra and bladder after a radical prostatectomy, wherein the devices incorporate tissue approximating structure to maintain contact between 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,

an inflatable balloon at the distal end,

a drainage lumen connected to the distal end, and

tissue approximating structure on the catheter body on a proximal side of the balloon at a location to contact severed tissue during an anastomosis procedure.

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 comprises movable elongate structure selected from a tine, a probe, a prod, and a needle.

4. The device of claim 3 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.

5. The device of claim 1 comprising

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

an inflatable balloon at the distal end and an inflation lumen extending from the proximal end to the balloon,

a drainage lumen extending from a 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.

6. The device of claim 1 comprising

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

an inflatable balloon at the distal end and an inflation lumen extending from the proximal end to the balloon,

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

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.

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

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

9. An anastomosis device comprising

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

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

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

tissue approximating means on the catheter body on the proximal side of the balloon for holding severed tissue in contact for healing.

10. The device of claim 9 wherein the tissue approximating means are located on the distal end.

11. The device of claim 9 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 9 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 9 wherein the tissue approximating structure comprises a movable tine.

14. The device of claim 9 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 tine can be extended to contact tissue selected from the group consisting of bladder tissue, urethral tissue, urethral stump tissue, and perineal wall tissue.

15. A method of performing urethral anastomosis, the method comprising

inserting a portion of an anastomosis device into the urethra, the anastomosis device comprising

tissue approximating structure and

a distal end comprising a balloon,

inflating the balloon in the bladder, and

using the tissue approximating structure to hold severed tissue together.

16. The method of claim 15 comprising vesico-urethral anastomosis, the method comprising

removing a prostate to leave a urethral stump and a bladder neck on a bladder,

inserting a portion of an anastomosis device through the urethral stump and through the bladder neck into the bladder, the anastomosis device comprising

tissue approximating structure and

a distal end comprising a balloon,

inflating the balloon inside the bladder,

moving the bladder neck to contact the urethral stump, and

using the tissue approximating structure to hold the urethral stump against the bladder neck to allow healing of the urethral stump to the bladder neck.

17. The method of claim 16 comprising using the tissue approximating structure to hold the urethral stump in contact with the bladder neck for a time sufficient to allow the urethral stump and the bladder neck to heal together.

18. The method of claim 15 comprising end-to-end urethral anastomosis, the method comprising

severing a urethra to produce two opposing severed urethral portions,

inserting a portion of an anastomosis device into the urethra, the anastomosis device comprising

tissue approximating structure and

a distal end comprising a balloon,

inflating the balloon in the bladder,

moving the two opposing severed urethral portions into contact, and

using the tissue approximating structure to hold the two opposing severed urethral portions in contact to allow the tissue portions to heal together.

19. The method of claim 18 comprising using the tissue approximating structure to hold the opposing severed urethral portions together for a time sufficient to allow the severed urethral portions to heal together.

20. The method of claim 15 wherein the tissue approximating structure comprises multiple tines.

21. A method of performing a urethral anastomosis, the method comprising

severing a urethra to leave opposing severed urethral tissues,

inserting a distal end of an anastomosis device through the urethra and into the bladder, the anastomosis device comprising

tissue approximating structure and

a balloon,

inflating the balloon inside of the bladder,

holding the opposing severed urethral tissues together in healing contact using the tissue approximating structure.

22. The method of claim 21 comprising performing a radical prostatectomy, the method comprising

removing a prostate to leave a urethral stump and a bladder neck,

inserting an anastomosis device through the urethral stump and through the bladder neck, the anastomosis device comprising a balloon and tissue approximating structure,

inflating the balloon inside of the bladder,

holding the urethral stump and the bladder neck together in healing contact using the tissue approximating structure.

23. The method of claim 22 wherein the anastomosis device remains in place for a time to effect healing of the urethra stump to the bladder neck.

24. The method of claim 21 comprising filling the bladder using a drainage port on the distal end and checking for leaks at the anastomosis site.

25. The method of claim 22 wherein the urethral anastomosis is an end-to-end urethral anastomosis comprising severing the urethra below a perineal wall and reconnecting the severed tissue.