Anastomosis Device Having Improved Safety Features

• US 20080097493A1
• Filed: 10/17/2007
• Published: 04/24/2008
• Est. Priority Date: 10/17/2006
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Copa, Vincent, Rykhus, Robert, Hauschild, Sidney, Roychowdhury, Suranjan, Soderberg, Jay, Hamel, Kory
• Granted Patent: US 8,066,725 B2
• Time in Patent Office: Days
• US Class Current: 606/153
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• 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: A61B 2017/22069 Immobilising; Stabilising

Abstract

An anastomosis device providing increased functionality, reliability and safety through the use of designs addressing potential puncture of an inflation balloon being used to hold and approximate tissue. The anastomosis device can include bladder retention structures configured to engage and retain tissue without pointed or sharpened surfaces that can rupture the inflation balloon. The anastomosis device can include a reinforced or otherwise protected inflation balloon to resist puncturing by a bladder retention structure. The anastomosis device can include a catheter wall profile selected to physically prevent bladder retention structures from being forcibly bent back so as to avoid potential contact with and puncture of the inflation balloon. The anastomosis device can include a catheter funnel with an internal spring for preventing kinking of the catheter lumen while providing for flexibility and stretch of the funnel to absorb pulling or shock force which can rupture the inflation balloon.

Claims

1. An anastomosis device comprising:

a catheter body having a proximal connection portion, a distal end portion, an inflation balloon and a tissue approximating structure, the tissue approximating structure including a proximalmost approximating structure and a distalmost approximating structure wherein said proximalmost approximating structure has a puncture resistant configuration so as to avoid perforation of the inflation balloon when in an inflated configuration.

2. The device of claim 1, wherein the distalmost approximating structure comprises a loop structure having an arcuate tissue engagement portion.

3. The device of claim 1, wherein the distalmost approximating structure comprises a rounded structure having a leg portion and a ball tissue engagement portion.

4. The device of claim 1, wherein the distalmost approximating structure comprises a paddle structure having a leg portion and a flattened tissue engagement portion.

5. The device of claim 1, wherein the distalmost approximating structure comprises a preformed tine structure having a leg portion and an angled tissue engagement portion.

6. The device of claim 1, wherein the distalmost approximating structure comprises a coil structure having a leg portion and a twisted tissue engagement portion.

7. The device of claim 1, wherein the inflation balloon includes a protective element positioned proximate the distalmost approximating structure.

8. The device of claim 7, wherein the protective element includes a protective layer covering a proximalmost hemisphere of the inflation balloon.

9. The device of claim 7, wherein the protective element includes a plurality of spaced apart protective strips, wherein each protective strip is aligned with the distalmost approximating structure.

10. The device of claim 1, wherein the catheter body further comprises a raised profile portion between the inflation balloon and the distalmost approximating structure and wherein the raised profile portion prevents physical contact between the inflation balloon and the distalmost approximating structure.

11. The device of claim 1, further comprising an actuation body operably coupled to the proximal connection portion, the actuation body including a relief portion having an internal relief spring responding to external forces so as to prevent translation of said external forces to the catheter body.

12. A method for preventing puncture of an inflation balloon during a healing period resulting from an anastomosis procedure comprising:

selecting a puncture resistant configuration for a distalmost approximating structure;

providing a catheter body having a proximal connection portion, a distal end portion, an inflation balloon and a tissue approximating structure, the tissue approximating structure including a proximalmost approximating structure and the distalmost approximating structure;

inflating the inflation balloon so as to allow two tissue members to be approximated; and

actuating the tissue approximating structure to retain the two tissue members in approximation.

13. The method of claim 12, further comprising:

preventing the distalmost approximation structure from physically contacting the inflation balloon.

14. The method of claim 12, further comprising:

isolating the catheter body from external forces during the healing period.

15. The method of claim 12, further comprising:

reinforcing the inflation balloon with a protective element.