Methods allowing pyloric sphincter to normally function for bariatric stents

• US 9,801,749 B2
• Filed: 09/17/2015
• Issued: 10/31/2017
• Est. Priority Date: 09/18/2014
• 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): Deak, Leslie
• Application Number:
  US14/856,953
• Publication Number:
  US 20160081832A1
• Time in Patent Office: 775 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 2/82 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 2/844 folded prior to deployment
• 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 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61F 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves
• CPC Class Codes: A61F 5/0083 Reducing the size of the stomach, e.g. gastroplasty surgical interventions A61B17/00

Abstract

A prosthesis that when implanted in the gastrointestinal tract does not impede the normal function of the pyloric sphincter. In some instances, the prosthesis is implanted as part of, or after, a sleeve gastrectomy procedure. The prosthesis includes a stent with an outer surface and a polymeric cover fully covering the outer surface of the stent. The stent includes a proximal stent flange; a proximal stent segment extending distally from the proximal stent flange; and an enlarged stent segment extending distally from the proximal stent segment.

Claims

1. A prosthesis comprising:

a stent with an outer surface, the stent comprising;

a proximal stent flange;

a proximal stent segment extending distally from the proximal stent flange;

an enlarged stent segment extending distally from the proximal stent segment;

a polymeric cover fully covering the outer surface of the stent, the polymeric cover forming an outer surface of the prosthesis; and

a connecting segment formed by a tubular section of the polymeric cover extending distally from the enlarged stent segment, the connecting segment consisting of the polymeric cover.

2. The prosthesis of claim 1, the stent further comprising:

a distal stent flange extending distally from the connecting segment, the distal stent flange forming a distal stent end and the proximal stent flange forming a proximal stent end;

wherein the stent comprises stent filaments, the stent filaments being braided at a first braid angle to form the proximal stent flange, the proximal stent segment, the enlarged stent segment, and the distal stent flange.

3. The prosthesis of claim 2, wherein the first braid angle is about 120°

.

4. The prosthesis of claim 2, wherein the distal stent flange has a longitudinal length of about 20 mm to about 40 mm, and a diameter of about 20 mm to about 30 mm at its widest point.

5. The prosthesis of claim 1, wherein the connecting segment has a longitudinal length of about 30 mm to about 70 mm, and a diameter of about 15 mm to about 25 mm.

6. The prosthesis of claim 1, the stent further comprising a distal stent flange segment, the polymeric cover forming the tubular connecting segment engaging the enlarged stent segment to the distal stent flange, the proximal stent flange forming a proximal stent end and the distal stent flange forming a distal stent end.

7. The prosthesis of claim 1, wherein:

the proximal stent flange has a longitudinal length of about 20 mm to about 40 mm, and a diameter of about 20 mm to about 30 mm at its widest point;

the proximal stent segment has a longitudinal length of about 100 mm to about 200 mm;

a uniform diameter of about 10 mm to about 20 mm; and

the enlarged stent segment has a longitudinal length of about 40 mm to about 80 mm, and a diameter of about 30 mm to about 70 mm at its widest point.

8. The prosthesis of claim 7, wherein the connecting segment has a longitudinal length of about 30 mm to about 70 mm, and a diameter of about 15 mm to about 25 mm.

9. The prosthesis of claim 1, wherein the connecting segment is constructed and arranged to exert no or very little radial force when the prosthesis is implanted for normal functioning of a pyloric sphincter.

10. The prosthesis of claim 1, wherein the polymeric cover is a silicone cover.

11. The prosthesis of claim 1, wherein the prosthesis has a single stent layer formed by the stent.

12. The prosthesis of claim 1, further comprising a distal stent flange extending distally from the connecting segment, the distal stent flange forming a distal stent end and the proximal stent flange forming a proximal stent end.

13. The prosthesis of claim 12, wherein the connecting segment is constructed and arranged to exert no or very little radial force when the prosthesis is implanted for normal functioning of a pyloric sphincter.

14. The prosthesis of claim 13, wherein:

the proximal stent flange has a longitudinal length of about 20 mm to about 40 mm, and a diameter of about 20 mm to about 30 mm at its widest point;

the proximal stent segment has a longitudinal length of about 100 mm to about 200 mm;

a uniform diameter of about 10 mm to about 20 mm;

the enlarged stent segment has a longitudinal length of about 40 mm to about 80 mm, and a diameter of about 30 mm to about 70 mm at its widest point;

the connecting segment has a longitudinal length of about 30 mm to about 70 mm, and a diameter of about 15 mm to about 25 mm; and

the distal stent flange has a longitudinal length of about 20 mm to about 40 mm, and a diameter of about 20 mm to about 30 mm at its widest point.

15. A proximal bariatric prosthesis comprising a single stent layer forming an inner layer of the bariatric prosthesis and a polymeric cover forming an outer layer of the bariatric prosthesis,

the single stent layer comprising:

a proximal stent flange, the proximal stent flange forming a proximal end of the bariatric prosthesis;

a distal stent flange, the distal stent flange forming a distal end of the bariatric prosthesis;

a proximal cylindrical stent segment extending distally from the proximal stent flange;

an enlarged stent segment extending distally from the proximal cylindrical stent segment; and

a connecting segment extending distally from the enlarged stent segment to the distal stent flange, the connecting segment consisting of the polymeric cover;

wherein the polymeric cover is attached to an outer surface of the single stent layer.

16. The bariatric prosthesis of claim 15, wherein

the proximal stent flange has a longitudinal length of about 20 mm to about 40 mm, and a diameter of about 20 mm to about 30 mm at its widest point;

the proximal stent segment has a longitudinal length of about 100 mm to about 200 mm;

a uniform diameter of about 10 mm to about 20 mm;

the enlarged stent segment has a longitudinal length of about 40 mm to about 80 mm, and a diameter of about 30 mm to about 70 mm at its widest point;

the connecting segment has a longitudinal length of about 30 mm to about 70 mm, and a diameter of about 15 mm to about 25 mm; and

the distal stent flange has a longitudinal length of about 20 mm to about 40 mm, and a diameter of about 20 mm to about 30 mm at its widest point.

17. The bariatric prosthesis of claim 15, wherein the connecting segment is constructed and arranged to exert no or very little radial force when the bariatric prosthesis is implanted for normal functioning of a pyloric sphincter.

18. A bariatric prosthesis comprising a single stent layer and a polymeric cover,

the single stent layer comprising:

a proximal stent, the proximal stent consisting of;

a proximal stent flange having a variable diameter;

a proximal cylindrical stent segment extending distally from the proximal stent flange, the proximal cylindrical stent segment having a uniform diameter; and

an enlarged stent segment extending distally from the proximal cylindrical stent segment, the enlarged stent segment having a variable diameter; and

a distal stent consisting of a distal stent flange having a variable diameter, a proximal end of the distal stent spaced apart from a distal end of the proximal stent to define a gap therebetween;

wherein the polymeric cover is attached to an outer surface of the proximal stent;

is attached to an outer surface of the distal stent; and

interconnects the proximal and distal stents and spans the gap between the proximal end of the distal stent and the distal end of the proximal stent.

19. The bariatric prosthesis of claim 18, wherein the proximal and distal stents are interconnected only by the polymeric cover.