Self-assembling magnetic anastomosis device having an exoskeleton

• US 8,870,898 B2
• Filed: 05/17/2013
• Issued: 10/28/2014
• Est. Priority Date: 01/05/2010
• Status: Active Grant

• Current Assignee: G.I. Windows, Inc.
• Original Assignee: G.I. Windows, Inc.
• Inventors: Beisel, Robert F., Lukin, Peter, McWeeney, John, Ryou, Marvin, Thompson, Christopher, Winkler, Josef K.
• Primary Examiner(s): ANDERSON, GREGORY A
• Application Number:
  US13/896,670
• Publication Number:
  US 20130253550A1
• Time in Patent Office: 529 Days
• Field of Search: 606/151, 606/153, 600/30, 600/37, 600/101, 600/104, 623/23.64
• US Class Current: 606/153
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 2017/00809 Lung operations
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/1117 adapted for discharge after necrotisation, e.g. by evacuation, expulsion or excretion
• CPC Class Codes: A61B 2017/1132 End-to-end connections
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections

Abstract

The invention is an implantable magnetic anastomosis device having an exoskeleton that directs self-assembly. The design allows the device to be delivered in a linear configuration using a minimally-invasive technique, such as endoscopy or laparoscopy, whereupon the device self-assembles into, e.g., a polygon. A coupled set of polygons define a circumscribed tissue that can be perforated, or the tissue can be allowed to naturally necrose and perforate. The device can be used to create anastomoses in a variety of tissues, such as tissues found in the gastrointestinal, renal/urinary, and reproductive tracts. New procedures for using anastomoses, e.g., surgical bypass are also disclosed.

Claims

1. A method of creating an anastomosis in a tissue comprising:

mating a first and a second implantable device to the tissue,

wherein each implantable device comprises a plurality of magnetic segments and an exoskeleton that covers a portion of the exterior of each of the magnetic segments,

wherein the exoskeleton is adapted to direct the magnetic segments to self-assemble into a geometric shape.

2. The method of claim 1, wherein the first or the second implantable device is delivered to the tissue with an endoscope, laparoscope, catheter, or needle.

3. The method of claim 2, wherein the first or the second implantable device comprises four or more magnetic segments and self-assembles into a polygon.

4. The method of claim 3, wherein both the first and second implantable devices form polygons, and the mated polygons circumscribe a portion of the tissue.

5. The method of claim 4, further comprising perforating the circumscribed tissue.

6. The method of claim 3, wherein the first or the second implantable device is delivered in a linear or angular configuration and self-assembles into the polygon.

7. The method of claim 1, wherein the tissue comprises a portion of the stomach, gallbladder, pancreas, duodenum, small intestine, large intestine, or bowel.

8. The method of claim 1, wherein the magnetic segments have a rectangular or square cross section and the exoskeleton covers three of the four sides.

9. The implantable device of claim 1, wherein the exoskeleton provides a substantially continuous smooth surface on the annular face of the geometric shape.

10. The implantable device of claim 1, wherein the exoskeleton limits the magnetic segments to moving in a plane defined by the geometric shape.

11. A method for creating an anastomosis between proximal and distal bowel, comprising:

forming an anastomosis between a proximal portion and a distal portion of a bowel with a first and a second implantable device, wherein each implantable device comprises a plurality of magnetic segments and an exoskeleton that covers a portion of the exterior of each of the magnetic segments, wherein the exoskeleton is adapted to direct the magnetic segments to self-assemble into a geometric shape, thereby creating a portion of partially bypassed bowel; and

leaving the partially bypassed bowel unobstructed so that the partially bypassed bowel can continue its native physiological function.

12. The method of claim 11, wherein the anastomosis causes nutrients to be rapidly delivered from the proximal bowel to the distal bowel.

13. The method of claim 12, wherein the method is intended to induce weight loss in a subject, improvement in Type II diabetes in a subject, or improvement in a lipid profile of a subject.

14. The method of claim 11, wherein the partially bypassed bowel lessens a risk of a complication selected from malnutrition, diarrhea, excessive weight loss, bacterial overgrowth, or vitamin deficiency.

15. The method of claim 11, further comprising selecting a size of the anastomosis to determine a ratio of:

nutrients moving from the proximal bowel to the distal bowel via the anastomosis and nutrients moving from the proximal bowel to the distal bowel via the partially bypassed bowel.

16. The method of claim 11, further comprising forming a plurality of anastomoses to determine a ratio of:

nutrients moving from the proximal bowel to the distal bowel via the anastomoses and nutrients moving from the proximal bowel to the distal bowel via the partially bypassed bowel.