Medical devices and methods to prevent bile reflux after bariatric procedures

• US 9,579,186 B2
• Filed: 06/24/2015
• Issued: 02/28/2017
• 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 J
• Application Number:
  US14/749,221
• Publication Number:
  US 20150374484A1
• Time in Patent Office: 615 Days
• Field of Search: 623/1.24, 623/1.26, 623/2.14, 623/2.18, 623/23.65, 623/1.23, 623/23.64, 604/8, 604/9, 604/103
• US Class Current: 1/1
• 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. An endoscopic stent for implantation in portions of a patient'"'"'s esophagus, stomach, and duodenum after sleeve gastrectomy or biliopancreatic diversion with duodenal switch or biliopancreatic diversion with duodenal switch, the endoscopic stent comprising:

a stent portion, the stent portion comprising 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 is defined by a length of about 50 mm to about 200 mm, wherein the enlarged middle portion is defined by a length of about 20 mm to about 80 mm, and 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 the stent portion and extending distally beyond the distal end portion forming a polymeric sleeve portion, the polymeric sleeve portion devoid of stent material;

wherein the endoscopic stent is constructed and arranged for implantation such that the proximal end portion extends into a distal portion of the esophagus, the enlarged middle portion is disposed with a central portion of the stomach, the distal end portion terminates in the stomach, and only the polymeric sleeve portion extends into the duodenum.

2. The endoscopic stent of claim 1, wherein the distal end portion is defined by a length of 0 mm to about 100 mm.

3. The endoscopic stent of claim 2, wherein the distal end portion of the stent is about 50 mm to about 100 mm.

4. The endoscopic stent of claim 1, wherein a proximal end of the proximal end portion, the distal end portion, or both, comprises a flare.

5. The endoscopic stent of claim 1, wherein the polymeric sleeve portion is defined by a length of about 200 mm to about 350 mm.

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

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

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

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

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

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

12. An endoscopic stent for implantation in a patient after sleeve gastrectomy or biliopancreatic diversion with duodenal switch, the endoscopic stent comprising:

a stent portion, the stent portion comprising a proximal end portion, the proximal end portion defined by a length of about 100 mm to about 200 mm, an enlarged middle portion, the enlarged middle portion having an enlarged diameter and defined by a length of about 40 mm to about 80 mm, and a distal end portion, the distal end portion defined by a length of about 50 mm to about 100 mm; and

wherein at least a portion of the distal end portion of the stent comprises reduced radial strength and is configured to extend across the pyloric valve and allow the pyloric valve to open and close;

wherein at least a portion of the distal end portion comprises a reduced wire diameter compared to the proximal end portion and middle portion, a lower braid angle compared to the proximal end portion and middle portion, or a reduced number of wires compared to the proximal end portion and middle portion, thereby achieving the reduced radial strength.

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

14. The endoscopic stent of claim 12, wherein the endoscopic stent is woven, braided or laser cut.

15. The endoscopic stent of claim 12, wherein the distal end portion of the endoscopic stent comprises a continuous wall configuration.

16. An endoscopic stent for implantation in a patient after sleeve gastrectomy or biliopancreatic diversion with duodenal switch, the endoscopic stent comprising:

a stent portion, the stent portion comprising a proximal end portion, the proximal end portion defined by a length of about 100 mm to about 200 mm, an enlarged middle portion, the enlarged middle portion having an enlarged diameter and defined by a length of about 40 mm to about 80 mm, and a distal end portion, the distal end portion defined by a length of about 50 mm to about 100 mm; and

an elastomeric band surrounding the distal end portion, the elastomeric band configured to apply an inward pressure to close a lumen extending through the stent porion;

wherein at least a portion of the distal end portion of the stent comprises reduced radial strength and is configured to extend across the pyloric valve and allow the pyloric valve to open and close.