Medical devices and methods to prevent bile reflux after bariatric procedures

• US 10,016,268 B2
• Filed: 01/17/2017
• Issued: 07/10/2018
• Est. Priority Date: 06/26/2014
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Hingston, John A., Clerc, Claude O., Root, Jonathan, Shah, Vishal
• Primary Examiner(s): Stewart, Alvin
• Application Number:
  US15/407,896
• Publication Number:
  US 20170119520A1
• Time in Patent Office: 539 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 2/2475 Venous valves
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2002/041 Bile ducts
• CPC Class Codes: A61F 2002/044 Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61M 2039/2433 Valve comprising a resilient or deformable element, e.g. flap valve, deformable disc
• CPC Class Codes: A61M 39/24 Check- or non-return valves

Abstract

An endoscopic stent for implantation in a patient after sleeve gastrectomy or biliopancreatic diversion with duodenal switch or biliopancreatic diversion with duodenal switch comprising a stent portion, the stent portion comprising a proximal end portion, the proximal end portion defined by a length of about 50 mm to about 200 mm, an enlarged middle portion, a middle portion having an enlarged diameter relative to the proximal end portion and the distal end portion and defined by a length of about 20 mm to about 80 mm, and a distal end portion and a polymeric sleeve portion engaged to and extending distally from the distal end portion of the stent.

Claims

1. A stent for implantation in portions of a patient'"'"'s esophagus, stomach, and duodenum after a bariatric surgery, the endoscopic stent comprising:

a stent portion, the stent portion including stent material forming a proximal end portion, a distal end portion, and an enlarged middle portion located between the proximal and distal end portions, wherein the proximal end portion has a proximal flared end having a diameter 2 mm to 10 mm larger than a diameter of the remaining proximal end portion, wherein the proximal end portion, the enlarged middle portion and the distal end portion are sized such that when the proximal flared end is positioned within the esophagus, the proximal end portion has a length extending into the stomach, the enlarged middle portion resides within an antrum region of the stomach, and the distal end portion has a length extending into and residing within the duodenum, wherein the enlarged middle portion has an enlarged diameter relative to both the proximal end portion and the distal end portion; and

a polymeric cover disposed over at least a portion of the stent portion and extending distally beyond the distal end portion forming a polymeric sleeve portion, the polymeric sleeve portion devoid of the stent material.

2. The stent of claim 1, wherein the proximal end portion has a length of about 50 mm to about 200 mm, the enlarged middle portion has a length of about 20 mm to about 80 mm, and the polymeric sleeve portion has a length of about 200 mm to about 350 mm.

3. The stent of claim 2, wherein the distal end portion has a length of 0 mm to about 100 mm.

4. The stent of claim 2, wherein the distal end portion has a length of about 50 mm to about 100 mm.

5. The stent of claim 1, wherein the polymeric sleeve portion is configured to collapse upon itself.

6. The stent of claim 1, further comprising a valve positioned in the distal end portion.

7. The stent of claim 1, wherein the polymeric sleeve portion is elastomeric.

8. The stent of claim 1, wherein the polymeric sleeve portion comprises silicone.

9. The stent of claim 1, wherein the stent portion is braided, woven or laser cut.

10. The stent of claim 1, wherein the stent portion comprises nickel-titanium alloy, cobalt-chromium-nickel alloy, cobalt-chromium alloy, or stainless steel.

11. A stent for implantation in a patient after a bariatric surgery, the endoscopic stent comprising:

a stent portion having a distal end and a proximal end, the stent portion defining a proximal end portion, an enlarged middle portion, and a distal end portion, the enlarged middle portion having a diameter larger than the proximal end portion and the distal end portion; and

wherein at least a portion of the distal end portion comprises a construction configured to open and close,

wherein the stent portion is continuously braided or woven from the proximal end to the distal end; and

wherein the proximal end portion has a length of about 100 mm to about 200 mm, the enlarged middle portion has an enlarged diameter and a length of about 40 mm to about 80 mm, and the distal end portion has a length of about 50 mm to about 100 mm.

12. The stent of claim 11, wherein the proximal end portion, the distal end portion, or both, comprises a flare.

13. The stent of claim 11, wherein the construction includes a one-way valve disposed within the distal end portion between the enlarged middle portion and the distal end of the stent portion.

14. The stent of claim 13, wherein the one-way valve is a single cusp or multiple cusp valve.

15. The stent of claim 13, wherein the one-way valve is a tricuspid valve.

16. The stent of claim 11, wherein the construction is an elastomeric band disposed on an outer surface of the distal end portion at a distal end of the enlarged middle portion.

17. A stent for implantation in a patient after a bariatric surgery, the endoscopic stent comprising:

a stent portion having a distal end and a proximal end, the stent portion defining a proximal end portion, an enlarged middle portion, and a distal end portion, the enlarged middle portion having a diameter larger than the proximal end portion and the distal end portion; and

wherein at least a portion of the distal end portion comprises a construction configured to open and close,

wherein the stent portion is continuously braided or woven from the proximal end to the distal end; and

wherein the construction includes the distal end portion having a region of radial strength lower than the enlarged middle portion and the proximal end portion, the distal end portion configured to extend across a patient'"'"'s pyloric valve and allow a patient'"'"'s pyloric valve to open and close.

18. The stent of claim 17, wherein the proximal end portion has a length of about 100 mm to about 200 mm, the enlarged middle portion has an enlarged diameter and a length of about 40 mm to about 80 mm, and the distal end portion has a length of about 50 mm to about 100 mm.

19. The stent of claim 17, wherein the reduced radial strength is caused by at least a portion of the distal end portion comprising a reduced wire diameter compared to the proximal end portion and the middle portion, a lower braid angle compared to the proximal end portion and the middle portion, or a reduced number of wires compared to the proximal end portion and the middle portion.

20. The stent of claim 17, wherein the region of lower radial strength is disposed adjacent the enlarged middle portion.