Protective apparatus for use in gastrointestinal tract

• US 10,568,754 B2
• Filed: 05/12/2017
• Issued: 02/25/2020
• Est. Priority Date: 05/13/2016
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Valdes, Caleb A., Slater, Nigel, Modlish, John, Hirte, Thomas G., Tessier, Cristina, Pherwani, Sweta, Mannion, Paul
• Primary Examiner(s): Deak, Leslie R
• Application Number:
  US15/594,470
• Publication Number:
  US 20170325983A1
• Time in Patent Office: 1,019 Days
• 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 2/07 Stent-grafts
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 5/0036 Intragastrical devices

Abstract

An apparatus may be used after a surgical procedure to protect against leaks and to separate healing tissue from foreign materials such as nutritional contents. In some cases the apparatus may be easily delivered to a surgical site before, during or after a surgical procedure such as gastric bypass surgery, but this is only an example. The apparatus may include expandable anchors at either end and a collapsible central portion extending between the two expandable anchors.

Claims

1. An apparatus for protecting against leaks after a surgical procedure on a stomach, the apparatus configured to extend through the stomach once implanted, the apparatus comprising:

an elongate collapsible tubular member having a proximal region and a distal region and a collapsible lumen extending therethrough;

an expandable proximal anchor including only a single wide proximal tissue engagement portion connected to a single narrow distal portion, the narrow distal portion secured to the proximal region of the elongate collapsible tubular member, the expandable proximal anchor configured to anchor at a first position above a lower esophageal sphincter;

an expandable distal anchor secured to the distal region of the elongate collapsible tubular member, the expandable distal anchor including a wide tissue engagement portion and a narrow portion, the expandable distal anchor configured to anchor at a second position below a pylorus sphincter;

a proximal end of the elongate collapsible tubular member extending proximally only over the narrow portion of the expandable proximal anchor such that the proximal end of the elongate collapsible member is located distal of the wide tissue engagement portion of the expandable proximal anchor and a distal end of the elongate collapsible tubular member extending distally only over the narrow portion of the expandable distal anchor such that the distal end of the elongate collapsible member is located proximal of the wide tissue engagement portion of the expandable distal anchor.

2. The apparatus of claim 1, wherein the expandable proximal anchor comprises a braided stent and a covering disposed over at least part of the braided stent.

3. The apparatus of claim 1, wherein the expandable distal anchor comprises a braided stent and a covering disposed over at least a part of the braided stent.

4. The apparatus of claim 1, further comprising a removal tether extending around a circumference of the expandable proximal anchor.

5. The apparatus of claim 1, further comprising a removal tether extending around a circumference of the expandable distal anchor.

6. The apparatus of claim 1, wherein the apparatus is bio-absorbable.

7. The apparatus of claim 1, further comprising a wire support extending at least partially along the elongate collapsible tubular member.

8. The apparatus of claim 7, wherein the wire support extends from the expandable proximal anchor to the expandable distal anchor.

9. The apparatus of claim 7, wherein the wire support is embedded in the elongate collapsible tubular member.

10. The apparatus of claim 7, wherein the wire support extends helically along the elongate collapsible tubular member.

11. The apparatus of claim 1, wherein the elongate collapsible tubular member is formed of a polymer having a Shore durometer hardness of 60 A or less.

12. The apparatus of claim 1, wherein the expandable proximal and distal anchors each comprise a braided stent, wherein the elongate collapsible tubular member defines a collapsing region between a distal end of the expandable proximal anchor and a proximal end of the expandable distal anchor that is devoid of the braided stent of first and second anchors.

13. The apparatus of claim 12, wherein the collapsing region of the elongate collapsible tubular member collapses under its own weight to close off the collapsible lumen whenever nutritional contents are not moving through the collapsible lumen.

14. The apparatus of claim 13, wherein the elongate tubular member has a length of between 15 cm to 25 cm.

15. An apparatus for protecting against leaks within a portion of a gastrointestinal tract, the gastrointestinal tract including a sphincter that is configured to reversibly close the gastrointestinal tract proximate the sphincter, the apparatus comprising:

an elongate collapsible tubular member having a first end and a second end and a collapsible lumen extending therethrough;

a first anchor secured near the first end of the elongate collapsible tubular member, the first anchor configured to anchor at a position upstream from the sphincter;

a second anchor secured near the second end of the elongate collapsible tubular member, the second anchor configured to anchor at a position downstream from the sphincter;

wherein the elongate collapsible tubular member is biased in a collapsed configuration such that the elongate collapsible tubular member collapses under its own weight to close off the collapsible lumen.

16. The apparatus of claim 15, wherein the first anchor is self-expandable from a collapsed delivery configuration to an expanded anchoring configuration.

17. The apparatus of claim 15, wherein the second anchor is self-expandable from a collapsed delivery configuration to an expanded anchoring configuration.

18. The apparatus of claim 15, wherein the elongate collapsible tubular member is axially collapsible to move the first anchor toward the second anchor.

19. An apparatus for protecting against leaks within a portion of a gastrointestinal tract, the gastrointestinal tract including a sphincter that is configured to reversibly close the gastrointestinal tract proximate the sphincter, the apparatus having an upstream end and a downstream end, the apparatus comprising:

an upstream anchor disposed relative to the upstream end of the apparatus and configured to secure the apparatus within the gastrointestinal tract with the upstream anchor disposed at a position upstream from the sphincter;

a downstream anchor disposed relative to the downstream end of the apparatus and configured to secure the apparatus within the gastrointestinal tract with the downstream anchor disposed at a position downstream from the sphincter; and

an elongate collapsible tubular member extending from the upstream anchor to the downstream anchor and thus extending through the sphincter, the elongate collapsible tubular member including a collapsible lumen extending therethrough such that the sphincter can close the elongate collapsible tubular member proximate the sphincter by collapsing the collapsible lumen, the elongate collapsible tubular member having a length of between 15 cm to 25 cm;

wherein the elongate collapsible tubular member has an outermost diameter less than an outermost diameter of the upstream anchor and less than an outermost diameter of the downstream anchor.

20. The apparatus of claim 19, wherein the elongate collapsible tubular member comprises a silicone tube having a collapsing region defined between the upstream anchor and the downstream anchor, wherein the collapsing region of the elongate collapsible tubular member collapses under its own weight to close off the collapsible lumen whenever nutritional contents are not moving through the collapsible lumen.