Devices and methods for forming an anastomosis

• US 10,052,106 B2
• Filed: 10/21/2016
• Issued: 08/21/2018
• Est. Priority Date: 05/17/2012
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Xlumena, Inc. (Boston Scientific Corporation)
• Inventors: Binmoeller, Kenneth F., Brown, Peter, Lepulu, Keke, Donovan, Ryan
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US15/331,285
• Publication Number:
  US 20170035428A1
• Time in Patent Office: 669 Days
• Field of Search: 604 8, 604 9
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00278 Transorgan operations, e.g. transgastric
• CPC Class Codes: A61B 2017/0034 adapted to be inserted through a working channel of an endoscope
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/1132 End-to-end connections
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections Y-shaped blood vessel prostheses A61F2002/065
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61B 2090/306 using optical fibres
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61F 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves

Abstract

Devices and methods for deploying an anastomotic stent between portions of the gastrointestinal (GI) tract are disclosed. The anastomotic stents are configured to atraumatically engage the tissue walls and to permit the flow of fluid, partially digested food, and food. The stents can be deployed using endoscopic catheter devices, laparoscopic tools, and combinations of both endoscopic tools and laparoscopic tools. Examples of anastomoses include anastomoses between the stomach and a portion of the intestines such as the jejunum. Anastomoses can also be formed between two closed ends of the intestines, such as two closed ends of the colon formed during a colon resection procedure. Anastomoses can also be formed between a fundal pouch formed during a gastric bypass procedure and the jejunum. Laparoscopic tools are disclosed to deploy a stent by selectively removing a radial restraint on a self expanding stent with the restraint removed through the laparoscopic access points.

Claims

1. A device having a self-expanding body that comprises:

a cylindrical middle region having a lumen and defining a longitudinal axis and a center plane perpendicular to the longitudinal axis;

a proximal end region and a distal end region that flare away from the longitudinal axis into flange configurations on opposite ends and around a full circumference of the cylindrical middle region when expanded;

each flange configuration comprising at least first and second points of inflection that define first and second segments of the flange;

the first segment extending from the first inflection point toward the center plane, the second segment extending from the second inflection point away from the center plane; and

wherein an angle of the first inflection point defined by the first segment and the cylindrical middle region is at least as great as an opposing angle of the second inflection point defined by the first segment and the second segment.

2. The device of claim 1, wherein the first and second segments are curved along a portion of the length of each segment.

3. The device of claim 1, wherein the first and second inflection points have a curved surface.

4. The device of claim 3, wherein the curved surfaces of the first inflection points of each flange face away from the center plane and the curved surfaces of the second inflection points of each flange face toward the center plane.

5. The device of claim 1, wherein a line passing through at least a portion of each flange configuration along a plane perpendicular to the longitudinal axis will intersect the flange configuration at four discrete points.

6. The device of claim 1, wherein the first and second inflection points and first and second segments of each flange configuration above or below the longitudinal axis form an S-shape or Z-shape.

7. A drainage stent having a self-expanding stent body that comprises:

a cylindrical middle region having a lumen and defining a longitudinal axis;

proximal and distal end regions that extend radially from the longitudinal axis into flared flange configurations on opposite ends and around a full circumference of the cylindrical middle region when expanded, each flared flange configuration defining at least first and second segment lengths of the stent body, the first segment lengths of the proximal and distal end regions extending in a direction toward each other along the longitudinal axis, and the second segment lengths of the proximal and distal end regions extending in a direction different than their respective first segment lengths;

wherein the first segment lengths of each flange configuration extend from the cylindrical middle region and the second segment lengths of each flange configuration extend from respective first segment lengths;

wherein the intersection of the cylindrical middle region and the first segment lengths defines a first inflection point and the intersection of the first segment lengths and second segment lengths defines a second inflection point; and

wherein an angle of the first inflection point defined by the first segment length and the cylindrical middle region is 90 degrees or less, and an opposing angle of the second inflection point defined by the first segment length and the second segment length is 90 degrees or less.

8. The drainage stent of claim 7, wherein the second segment lengths are shorter than the first segment lengths.

9. The drainage stent of claim 7, wherein the first and second inflection points and first and second segment lengths of each flange above or below the longitudinal axis form an S-shape or Z-shape.

10. The drainage stent of claim 7, wherein an end of the first segment length of each flange that is furthest from the longitudinal axis terminates at a distance along the longitudinal axis that is closer to a center plane of the cylindrical middle region than the first inflection point.

11. A drainage device having a device body that comprises:

a cylindrical middle region having a lumen and defining a longitudinal axis and a center plane perpendicular to the longitudinal axis;

proximal and distal end regions that flare radially from the longitudinal axis into flanges on opposite ends and around a full circumference of the cylindrical middle region when expanded, each flange comprising at least first and second points of inflection that define first and second segments of the flange, the second points of inflection being further spaced radially from the longitudinal axis than the first points of inflection, and the second points of inflection closer than the first points of inflection to the center plane along the longitudinal axis; and

wherein the flanges on the opposite ends of the cylindrical middle region touch planes that are parallel to the longitudinal axis, at least one plane each above and below the longitudinal axis, at at least two separate points along the parallel planes.

12. The device of claim 11, wherein the device body is self-expanding and comprises a woven nitinol filament braid of a shape memory material.

13. The device of claim 12, wherein the woven nitinol filament braid comprises multiple filaments or a single filament.

14. The device of claim 11, further comprising an elastomeric material covering at least the cylindrical middle region of the device body.

15. The device of claim 11, wherein the first and second inflection points have curved surfaces that face in different directions with respect to the center plane.