Systems and method for bypassing an anastomosis site

• US 9,511,208 B2
• Filed: 02/19/2014
• Issued: 12/06/2016
• Est. Priority Date: 12/15/2010
• Status: Active Grant

• Current Assignee: Colospan Ltd.
• Original Assignee: ColoGuard LTD
• Inventors: Assaf, Boaz, Teichman, Eyal
• Primary Examiner(s): Zalukaeva, Tatyana
• Assistant Examiner(s): Zimbouski, Ariana
• Application Number:
  US14/184,534
• Publication Number:
  US 20140188029A1
• Time in Patent Office: 1,021 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 17/1155 Circular staplers comprising a plurality of staples
• CPC Class Codes: A61B 2017/00473 Distal part, e.g. tip or head A61B2017/00464 takes precedence
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/1103 Approximator
• CPC Class Codes: A61B 2017/1132 End-to-end connections
• CPC Class Codes: A61B 2017/1142 Purse-string sutures
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202

Abstract

A system for bypassing an anastomosis site in a hollow organ is provided. The system includes a sleeve configured for spanning the anastomosis site at an internal surface of the hollow organ and a band configured for attachment to an external surface of the hollow organ and limiting migration of the sleeve beyond the anastomosis site.

Claims

1. A system for bypassing an anastomosis site in a colon, the system comprising:

a band, configured for positioning around an external surface region of the colon;

a tubular sleeve having a portion configured for spanning the anastomosis site at an internal surface of the colon, the tubular sleeve including a first tubular region extending to a contiguous second tubular region, the first tubular region including an inflatable structure having;

an outer diameter that, when inflated, is greater than an outer diameter of the contiguous second tubular region;

a first, proximal-most portion that, when inflated, is configured to cooperate with the band to limit movement of the tubular sleeve in a downstream direction of the colon while enabling migration of the tubular sleeve in an upstream direction of the colon;

a second portion distal to the first proximal-most portion, the second portion being configured to stabilize the tubular sleeve within the colon; and

a distance from a proximal edge of the first, proximal-most portion to a distal edge of the second portion that, when the inflatable structure is inflated, is greater than the outer diameter of the first tubular region and less than or equal to twice said outer diameter of the first tubular region.

2. The system of claim 1, wherein the inflatable structure includes at least a first, proximal balloon, constituting the first, proximal-most portion and a second, distal balloon constituting the second portion.

3. The system of claim 1, wherein an internal diameter of the band is equal to, or greater than, an external diameter of the colon and less than the outer diameter of the inflatable structure of the first tubular region.

4. The system of claim 1, wherein the band is configured to extend through an abdominal wall when the band is positioned around the external surface region of the colon.

5. The system of claim 1, wherein the first tubular region is more rigid than the second tubular region.

6. The system of claim 5, wherein the first tubular region includes elements for increasing a longitudinal rigidity thereof.

7. The system of claim 6, wherein the elements are longitudinal struts.

8. The system of claim 1, wherein the tubular sleeve includes a fluid conduit for dispensing a fluid into the colon.

9. The system of claim 1, wherein an internal surface of the band is fabricated from a polymer having a Shore A value of between approximately 40 and 60.

10. The system of claim 1, wherein the band is fabricated from a biodegradable material.

11. The system of claim 1, wherein the second portion is configured to inhibit yaw of the first tubular region when the inflatable structure is inflated.

12. The system of claim 1, wherein the band is configured for anchoring to the external surface region of the colon.

13. The system of claim 12, wherein the band is configured for anchoring to a serosa or a mesentery of the colon.

14. A method of internally shielding an anastomosis site in a colon of a subject, the method comprising:

positioning within the colon a tubular sleeve having a first tubular region extending to a contiguous second tubular region, the first tubular region including an inflatable structure having an outer diameter that, when inflated, is greater than an outer diameter of the contiguous second tubular region, wherein the inflatable structure includes a first, proximal-most portion that, when inflated, is configured to cooperate with a band to limit movement of the tubular sleeve in a downstream direction of the colon while enabling migration of the tubular sleeve in an upstream direction of the colon, wherein a second portion of the inflatable structure, distal to the proximal-most portion of the inflatable structure, when inflated, is configured to stabilize the tubular sleeve within the colon, and wherein a distance from a proximal edge of the first, proximal-most portion to a distal edge of the second portion, when inflated, is greater than the outer diameter of the first tubular region and less than or equal to twice said outer diameter of the first tubular region;

positioning the band around an external surface region of the colon upstream of the anastomosis site and downstream of the inflatable structure; and

inflating the inflatable structure thereby restricting downstream migration of the tubular sleeve and shielding the anastomosis site in the colon.

15. The method of claim 14, wherein the inflatable structure includes at least a first, proximal-most balloon, which, when inflated, is configured to cooperate with the band to limit movement of the tubular sleeve in a downstream direction of the colon while enabling migration of the tubular sleeve in an upstream direction of the colon, and at least a second balloon, which, when inflated, is configured to stabilize the tubular sleeve within the colon.

16. The method of claim 14, wherein positioning the tubular sleeve includes delivering the tubular sleeve through an anal orifice.

17. The method of claim 14, wherein positioning the band includes forming a portion of a linear strip into a loop around the external surface region of the colon.

18. The method of claim 14, further comprising delivering the band through an abdominal wall of the subject.

19. The method of claim 17, wherein following positioning of the band, a portion of the linear strip extends through an abdominal wall.

20. The method of claim 14, wherein positioning the tubular sleeve includes inflating the inflatable structure within the colon.

21. The method of claim 20, wherein the tubular sleeve further includes at least one inflation conduit and inflating the inflatable structure includes delivering fluid from an inflation port positioned outside a body of the subject to the inflation conduit.

22. The method of claim 21, wherein the fluid delivered from the inflation port to the inflation conduit is a liquid.

23. The method of claim 21, wherein the fluid delivered from the inflation port to the inflation conduit is a gas.

24. The method of claim 14, wherein the band is anchored to a serosa or a mesentery of the colon.