Systems and method for bypassing an anastomosis site

• US 8,690,817 B2
• Filed: 02/17/2013
• Issued: 04/08/2014
• Est. Priority Date: 12/15/2010
• Status: Active Grant

• Current Assignee: Colospan Ltd.
• Original Assignee: ColoGuard LTD
• Inventors: Teichman, Eyal, Assaf, Boaz
• Primary Examiner(s): Wiest, Philip R.
• Assistant Examiner(s): Zimbouski, Ariana
• Application Number:
  US13/769,338
• Publication Number:
  US 20130158463A1
• Time in Patent Office: 415 Days
• Field of Search: 604/8, 606/153, 623/23.64, 623/23.65, 623/23.67, 623/1.13, 623/1.14
• US Class Current: 604/8
• 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 for prostheses A61F2210/0014
• 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) a band, configured for positioning around an external surface region of the colon;

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

(i) a diameter, when expanded, greater than a diameter of said contiguous second tubular region;

(ii) at least three balloons, wherein a first, proximal-most balloon is configured to cooperate with the band in a manner limiting movement of the tubular sleeve in a downstream direction of the colon and enabling migration of the tubular sleeve in an upstream direction in the colon, and wherein a second intermediate balloon and a third distal-most balloon are configured to stabilize the tubular sleeve within the colon when the second and third balloon are inflated; and

(iii) a distance from a proximal edge of the first balloon to a distal edge of the third balloon is greater than the diameter of the first tubular region, when expanded.

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

3. The system of claim 1, wherein said band is capable of extending through an abdominal wall when said band is positioned around said external surface region of the hollow organ.

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

5. The system of claim 4, wherein said first tubular region includes elements for increasing a longitudinal rigidity thereof.

6. The system of claim 5, wherein said elements are longitudinal struts.

7. The system of claim 1, wherein said tubular sleeve includes a fluid conduit for injecting a fluid into the colon.

8. The system of claim 1, wherein an internal surface of said band is fabricated from a polymer having a Shore A value of 40-60.

9. The system of claim 1, wherein said band is fabricated from a biodegradable material.

17. The system of claim 1, wherein said band is anchored to said external surface region.

18. The system of claim 17, wherein said band is anchored to a serosa or mesentery of said colon.

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

(a) positioning within the colon a tubular sleeve having a first tubular region extending to a contiguous second tubular region, said first tubular region including an expandable structure having a diameter, when expanded, greater than a diameter of the contiguous second tubular region, and at least three balloons, wherein a first, proximal-most balloon is configured to cooperate with a band in a manner limiting movement of the tubular sleeve in a downstream direction of the colon and enabling migration of the tubular sleeve in an upstream in the colon wherein, a second intermediate balloon and a third distal-most balloon are configured to stabilize the tubular sleeve within the colon when the second and third balloon are inflated, and wherein a distance from a proximal edge of the first balloon to a distal edge of the third balloon is greater than the diameter of the first tubular region, when expanded;

(b) positioning the band around an external surface region of the colon upstream of the anastomosis site and downstream of said first tubular region of said tubular sleeve; and

(c) expanding said expandable structure thereby restricting downstream migration of the tubular sleeve and internally shielding the anastomosis site in the colon.

11. The method of claim 10, wherein positioning the tubular sleeve is effected by delivering said tubular sleeve through an anal orifice.

12. The method of claim 10, wherein positioning the band is effected by closing a linear strip into said band around said external surface region of the colon.

13. The method of claim 10, wherein said band is delivered through an abdominal wall of the subject.

14. The method of claim 12, wherein following positioning of the band, a portion of said linear strip extends through an abdominal wall.

15. The method of claim 11, wherein positioning the tubular sleeve includes inflating said at least three balloons within the colon.

16. The method of claim 15, wherein said inflating is effected via an inflation conduit having an inflation port positioned outside a body of the subject.

19. The method of claim 11, wherein said band is anchored to a serosa or mesentery of said colon.