Anastomosis device and related methods

• US 20050070938A1
• Filed: 08/16/2004
• Published: 03/31/2005
• Est. Priority Date: 08/22/2002
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Hamel, Kory P., Copa, Vincent G.
• Granted Patent: US 9,307,991 B2
• Time in Patent Office: Days
• US Class Current: 606/153
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/1103 Approximator
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61F 2002/047 Urethrae

Abstract

Described are methods and devices relating to anastomosis procedures, including those that reconnect the urethra and bladder after a radical prostatectomy, wherein the devices incorporate tissue approximating structure to maintain contact between tissues for healing the tissues together.

Claims

1. An anastomosis device comprising:

an elongate body comprising an open drainage lumen extending through at least a portion of a length of the elongate body,

a drainage aperture at a distal end of the elongate body for communication with a proximal end of the elongate body through the drainage lumen,

a balloon spaced from the drainage aperture along the length of the elongate body, and

tissue approximating structure extendable from the elongate body and spaced proximally from the balloon along the length of the elongate body.

2. The device of claim 1, wherein the tissue approximating structure is a proximal balloon.

3. The device of claim 1 wherein the open drainage lumen comprises an unobstructed passage from the proximal end to the drainage aperture.

4. The device of claim 1 wherein the tissue approximating structure comprises elongate tissue approximating structure and an actuating mechanism.

5. The device of claim 4, wherein the actuating mechanism comprises a wire.

6. The device of claim 1, wherein the elongate body comprises a body wall comprising an inflation lumen extending along at least a portion of the length of the elongate body and connecting the balloon to the proximal end of the elongate body, wherein the device is installable in a body with the balloon positionable in a bladder so that the tissue approximating structure is capable of contacting at least one tissue structure adjacent to the bladder.

7. The device of claim 1 wherein the tissue approximating structure comprises elongate structure selected from a tine, a probe, a prod, and a needle.

8. The device of claim 1, comprising a tine support comprising a tine support body that includes a hollow channel and a tine deflector, wherein the tissue approximating structure comprises:

a tine frame slidably supported by a drainage lumen connector that extends along at least a portion of the length of the elongate body,

at least one tine extending from the tine frame, each tine supported by an aperture of the tine deflector, and

an actuating mechanism operably connecting the tine frame to the proximal end of the device through an actuating lumen that extends along at least a portion of the length of the elongate body.

9. The device of claim 1, wherein the elongate body further comprises a body wall comprising an inflation lumen extending along the length of the elongate body from the proximal end to the balloon, wherein the drainage lumen comprises an unobstructed passage from the proximal end to the drainage aperture, and wherein the tissue approximating structure comprises extendable tines.

10. The device of claim 9 wherein the tissue approximating structure further comprises:

distal tissue approximating structure comprising at least one distal elongate tine positioned to extend from the elongate body on the proximal side of the distal balloon, and

proximal tissue approximating structure comprising at least one proximal elongate tine positioned to extend from the elongate body on a proximal side of the distal tissue approximating structure.

11. The device of claim 10 comprising

a proximal tine deflector comprising a body that includes at least one arcuate aperture,

a distal tine deflector comprising a body that includes at least one aperture,

wherein the distal tissue approximating structure comprises:

a distal tine frame slidably supported by a drainage lumen connector, wherein the at least one distal elongate tine extends from the distal tine frame, each distal tine movably supported by the at least one aperture of the distal tine deflector,

a distal actuating mechanism operably connecting the distal tine frame to the proximal end of the device through an actuating lumen that extends along at least a portion of the elongate body, and wherein

the proximal tissue approximating structure comprises

a proximal tine frame slidably supported by a drainage lumen connector wherein the at least one proximal tine extends from the proximal tine frame, each proximal tine movably supported by the at least one aperture of the proximal tine deflector,

a proximal actuating mechanism operably connecting the proximal tine frame to the proximal end of the device through the actuating lumen.

12. The device of claim 11, wherein the distal and proximal tissue approximating structures are positionable within a body for contacting adjacent tissue structures.

13. An anastomosis device comprising

an elongate body having a body wall, a proximal end, and a distal end,

a drainage aperture at the distal end,

a drainage lumen extending along at least a portion of a length of the elongate body and connecting the drainage aperture to the proximal end,

an inflatable balloon spaced proximally from the drainage aperture along the length of the elongate body,

an inflation lumen extending within a length of the body wall, connecting the balloon to the proximal end,

distal tissue approximating structure comprising at least one distal tine connected to a distal frame, each distal tine extendably supported within an aperture of a distal tine deflector,

a distal actuating mechanism operably connecting the distal frame to the proximal end of the device, through an actuating lumen extending along a length of the elongate body in the body wall,

proximal tissue approximating structure comprising at least one proximal tine connected to a proximal frame, each proximal tine extendably supported within an aperture of a proximal tine deflector,

a proximal actuating mechanism operably connecting the proximal frame to the proximal end of the device, through the actuating lumen.

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

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

an elongate body comprising an open drainage lumen extending through at least a portion of a length of the elongate body,

a drainage aperture at a distal end of the elongate body for communication with a proximal end of the elongate body through the open drainage lumen,

a balloon spaced from the drainage aperture along the length of the elongate body, and

tissue approximating structure extendable from the elongate body by use of an actuating mechanism,

positioning the device so that the balloon is at least partially inserted into a bladder,

inflating the balloon in the bladder, and

extending the tissue approximating structure with the actuating mechanism to hold adjacent tissues together.

15. The method of claim 14 comprising vesico-urethral anastomosis, the method comprising

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

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

moving the bladder neck to contact the urethral stump,

wherein the step of extending the tissue approximating structure includes 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.

16. The method of claim 15 wherein the step of using the tissue approximating structure to hold the urethral stump in contact with the bladder neck includes maintaining the position of the tissue approximating structure for a time sufficient to allow the urethral stump and the bladder neck to heal together.

17. The method of claim 14 comprising end-to-end urethral anastomosis, the method comprising

severing the urethra to produce two opposing severed urethral portions,

moving the two opposing severed urethral portions into contact with each other, and

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

18. The method of claim 17 wherein the step of using the tissue approximating structure to hold the opposing severed urethral portions together includes maintaining the position of the tissue approximating structure for a time sufficient to allow the severed urethral portions to heal together.