Anastomosis Device and Method

• US 20080200935A1
• Filed: 11/14/2007
• Published: 08/21/2008
• Est. Priority Date: 11/14/2006
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Hamel, Kory P., Copa, Vincent G.
• Granted Patent: US 8,277,466 B2
• Time in Patent Office: Days
• US Class Current: 606/153
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/1103 Approximator
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections Y-shaped blood vessel prostheses A61F2002/065
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22055 with three or more balloons

Abstract

An apparatus and method for using an anastomosis device to repair severed tissues resulting from a surgical medical procedure such as a radical prostatectomy, ilio-orthotopic neobladder construction, cystoprostatectomy, cystectomy, urethral anastomosis, or ureteral anastomosis.

Claims

1. A method for performing a ureter-to-ureter anastomosis procedure comprising:

providing an anastomosis device including a distalmost pair of tines and a medial inflation balloon;

advancing a distal end of the anastomosis device through a urinary tract and into a severed ureteral member such that a first tine set is positioned within a distal severed portion and a second tine set is positioned within a proximal severed portion;

extending the first tine set to grasp the distal severed portion;

inflating a medial inflation balloon within a bladder such that the medial inflation balloon is proximate the proximal severed portion;

pushing on the bladder with the medial inflation balloon to direct the proximal severed portion into contact with the distal severed portion; and

extending the second tine set to grasp the proximal severed portion and retain the proximal severed portion and the distal severed portion in approximation.

2. The method of claim 1, further comprising:

draining fluid in the distal severed portion through a drainage aperture at the distal end of the anastomosis device.

3. The method of claim 1, further comprising

maintaining approximation of the proximal severed portion and the distal severed portion throughout a healing period.

4. A method for performing a ureter-to-bladder anastomosis procedure comprising:

providing an anastomosis device including a distalmost pair of tines and a medial inflation balloon;

advancing a distal end of the anastomosis device through a urinary tract and into a severed ureteral member such that a first tine set is positioned within a distal severed portion and a second tine set is positioned within a bladder neck;

extending the first tine set to grasp the distal severed portion;

inflating a medial inflation balloon within the bladder such that the medial inflation balloon is proximate the bladder neck;

pushing on the bladder with the medial inflation balloon to direct the bladder neck into contact with the distal severed portion; and

extending the second tine set to grasp the bladder neck and retain the bladder neck and the distal severed portion in approximation.

5. The method of claim 4, further comprising:

draining fluid in the distal severed portion through a drainage aperture at the distal end of the anastomosis device.

6. The method of claim 4, further comprising

maintaining approximation of the bladder neck and the distal severed portion throughout a healing period.

7. A method for performing a bladder replacement procedure comprising:

providing an anastomosis device including a distalmost pair of tines, a proximalmost pair of tines, a medial inflation balloon and a proximal inflation balloon;

advancing a distal end of the anastomosis device through a urinary tract and into a severed ureteral member such that a first tine set is positioned within a distal severed portion and a second tine set is positioned within a ureteral bladder neck;

extending the first tine set to grasp the distal severed portion;

inflating the medial inflation balloon within the bladder such that the medial inflation balloon is proximate the ureteral bladder neck;

pushing on the bladder with the medial inflation balloon to direct the ureteral bladder neck into contact with the distal severed portion;

extending the second tine set to grasp the ureteral bladder neck and retain the ureteral bladder neck and the distal severed portion in approximation;

extending a third tine set within the bladder to grasp a urethral bladder neck;

inflating the proximal inflation balloon within the bladder such that the proximal inflation balloon is proximate the urethral bladder neck;

pulling on the bladder with the proximal inflation balloon to direct the urethral bladder neck into contact with a severed urethral member; and

extending a fourth tine set within the severed urethral member to grasp the severed urethral member and retain the severed urethral member and the urethral bladder neck in approximation.

8. The method of claim 7, further comprising:

draining fluid in the distal severed portion through a drainage aperture at the distal end of the anastomosis device.

9. The method of claim 7, further comprising

maintaining approximation of the ureteral bladder neck and the distal severed portion throughout a healing period;

and

maintaining approximation of the urethral bladder neck and the urethral member throughout the healing period.

10. The method of claim 7, wherein the bladder replacement procedure comprises a cystectomy procedure, a cystoprostatectomy procedure or an ilio-orthotopic neobladder procedure.

11. An anastomosis device for performing a variety of anastomosis procedure comprising:

an elongate body having a central lumen extending between a distal end and a proximal end, the distal end including a drainage aperture connected to a drainage lumen within the central lumen, the elongate body including a distal inflation balloon, a medial inflation balloon and a proximal inflation balloon, wherein each balloon is individually connected to an inflation lumen within the central lumen, the elongate body further including a distalmost pair of retention members positioned between the distal inflation balloon and the medial inflation balloon and a proximalmost pair of retention members positioned between the medial inflation balloon and the proximal inflation balloon.

12. The anastomosis device of claim 11, wherein the retention members comprise extendible tines.

13. The anastomosis device of claim 11, wherein the distalmost pair of retention members comprises a first set of tine members and a second set of tine members, wherein the first and second sets of tine members are independently deployable.

14. The anastomosis device of claim 13, wherein the proximalmost pair of retention members comprises a third set of tine members and a fourth set of tine members, wherein the third and fourth sets of tine members are independently deployable.

15. The anastomosis device of claim 11, wherein the anastomosis procedure comprises a radical prostatectomy procedure, a urethral anastomosis procedure, a cystectomy procedure, a cystoprostatectomy procedure or an ilio-orthotopic neobladder procedure.