Anastomosis devices

• US 9,993,251 B2
• Filed: 04/30/2015
• Issued: 06/12/2018
• Est. Priority Date: 05/02/2014
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Todd, Daniel H., Sambandam, Sakthi
• Primary Examiner(s): Lynch, Robert
• Application Number:
  US14/700,505
• Publication Number:
  US 20150313598A1
• Time in Patent Office: 1,139 Days
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• 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 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/1103 Approximator
• CPC Class Codes: A61B 2017/1107 for blood vessels
• 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
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/077 having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve

Abstract

Implantable medical devices for connecting tissue layers, such as for connecting a gallbladder and a portion of a gastrointestinal tract to create an anastomosis, include a tubular structure having a plurality of apposition portions, a central region, and a covering material. The devices are endoscopically deployable and may include open cells or undulating edges that facilitate a secure connection between the tissue structures.

Claims

1. An implantable medical device for creating an anastomosis between a gallbladder and a portion of a gastrointestinal tract, the device comprising:

a tubular structure comprising at least one elongate member forming a framework of interconnected struts, the tubular structure including;

a central portion having a first end and a second end, defining a longitudinal axis, and including a plurality of central portion cells defined by the at least one elongate member, the central portion formed of a plurality of body struts each including a plurality of longitudinally-extending portions interconnected with a plurality of angled portions, each of the body struts being separate and not interconnected with adjacent body struts between the first end and the second end of the central portion such that the plurality of central portion cells are open to longitudinally-adjacent central portion cells of the plurality of central portion cells and are closed to circumferentially-adjacent central portion cells of the plurality of central portion cells to define a plurality of central portion cell columns that are each open at one of the first end and the second end of the central portion and closed at the other of the first end and the second end of the central portion;

a first apposition portion at the first end of the central portion, the first apposition portion comprising a plurality of first flange cells defined by the at least one elongate member; and

a second apposition portion at the second end of the central portion, the second apposition portion comprising a plurality of second flange cells defined by the at least one elongate member, wherein at least some of the second flange cells are closed at a first end of the second flange cells by an undulating portion of the at least one elongate member and opened at a second end of the second flange cells to the central portion.

2. The device of claim 1, wherein the at least one elongate member forms (1) a first pattern extending longitudinally along the central portion, (2) a first flange cell of the plurality of first flange cells, (3) a second pattern extending longitudinally along the central portion, the second pattern opposing the first pattern, (4) a second flange cell of the plurality of second flange cells.

3. The device of claim 2, wherein the at least one elongate member comprises a single elongate member that forms the central portion, the first apposition portion, and the second apposition portion.

4. The device of claim 1, wherein the at least one elongate member forms a pattern so as to first define a first flange cell of the plurality of first flange cells, the elongate member second traverses the central portion, the elongate member third defines a second flange cell of the plurality of second flange cells, the elongate member fourth traverses the central portion, and thereafter the elongate member repeats the pattern to form additional flange cells of the first and second plurality of flange cells while traversing the central portion in between.

5. The device of claim 4, wherein each successive flange cell of the first and second plurality of flange cells is out of phase with directly preceding flange cells of the first and second plurality of flange cells.

6. The device of claim 1, wherein each first flange cell of the plurality of first flange cells is open to a respective central portion cell of the plurality of central portion cells, and wherein each second flange cell of the plurality of second flange cells is open to another respective central portion cell of the plurality of central portion cells.

7. The device of claim 1, wherein each of the plurality of second flange cells is open to one or more of the central portion cells of the plurality of central portion cells.

8. The device of claim 1, wherein the undulating portion is sinusoidal.

9. The device of claim 1, wherein each of the first and second apposition portions comprises circumferential rings that undulate substantially sinusoidally along edges thereof.

10. The device of claim 1, wherein the central portion cells are open to a gap between struts of at least one of the first and second apposition portions.

11. The device of claim 1, wherein the plurality of longitudinally-extending portions interconnected with the plurality of angled portions combine to define the plurality of central portion cells without interconnecting adjacent body struts across the central portion cells along the length of the body struts.

12. An implantable medical device for creating an anastomosis between a gallbladder and a portion of a gastrointestinal tract, the device comprising:

a tubular structure comprising at least one elongate member forming a framework of interconnected struts, the tubular structure defining;

a central portion having a first end and a second end and comprising a plurality of body cells defined by the at least one elongate member, the central portion formed of a plurality of body struts each including a plurality of longitudinally-extending portions interconnected with a plurality of angled portions, each of the body struts being entirely separate from adjacent body struts between the first end and the second end of the central portion such that the plurality of body cells are open to longitudinally-adjacent body cells of the plurality of body cells and are closed to circumferentially-adjacent body cells of the plurality of body cells to define a plurality of body cell columns that are each open at one of the first end and the second end of the central portion and closed at the other of the first end and the second end of the central portion;

a first apposition portion at a first end of the central portion having a plurality of first flange cells defined by the at least one elongate member such that the plurality of first flange cells are open to the central portion; and

a second apposition portion at a second end of the central portion comprising a plurality of second flange cells defined by the at least one elongate member such that the plurality of second flange cells are open to the central portion.

13. The device of claim 12, wherein the at least one elongate member is formed such that (1) the at least one elongate member forms a first pattern traversing the central portion along a longitudinal axis, (2) the elongate member defines a first flange cell of the plurality of first flange cells, (3) the elongate member traverses the central portion along the longitudinal axis in a second pattern opposing said first pattern, (4) the elongate member defines a second flange cell of the plurality of second flange cells.

14. The device of claim 12, wherein the at least one elongate member is formed in a pattern so as to first define a first flange cell of the plurality of first flange cells, the elongate member second traverses the central portion, the elongate member third defines a second flange cell of the plurality of second flange cells, the elongate member fourth traverses the central portion, and thereafter the elongate member repeats the pattern to form additional flange cells of the first and second plurality of flange cells while traversing the central portion in between.

15. The device of claim 12, wherein each of the first and second apposition portions comprises circumferential rings that undulate substantially sinusoidally along edges thereof.

16. The device of claim 12, wherein the plurality of axially-extending portions interconnected with the plurality of angled portions combine to define the plurality of body cells without interconnecting adjacent body struts across the body cells along the length of the body struts.

17. An implantable medical device for creating an anastomosis between a gallbladder and a portion of a gastrointestinal tract, the device comprising:

a tubular structure comprising at least one elongate member forming a framework of interconnected struts, the tubular structure defining;

a central portion having a first end, a second end, and a plurality of body cells defined by the at least one elongate member, the central portion formed of a plurality of body struts each including a plurality of longitudinally-extending portions interconnected with a plurality of angled portions, each of the body struts extending separately from adjacent body struts between the first end and the second end of the central portion such that the plurality of body cells are open to longitudinally-adjacent body cells of the plurality of body cells and are closed to circumferentially-adjacent body cells of the plurality of body cells to define a plurality of body cell columns that are each open at one of the first end and the second end of the central portion and closed at the other of the first end and the second end of the central portion;

a first apposition portion at a first end of the central portion having a plurality of first flange cells defined by the at least one elongate member; and

a second apposition portion at a second end of the central portion having a plurality of second flange cells defined by the at least one elongate member, wherein the at least one elongate member is formed such that (1) the at least one elongate member forms a first pattern traversing the central portion along a longitudinal axis, (2) the elongate member defines a first flange cell of the first plurality of flange cells, (3) the elongate member traverses the central portion along the longitudinal axis in a second pattern opposing said first pattern, (4) the elongate member defines a second flange cell of the second plurality of flange cells.

18. The device of claim 17, wherein each successive flange cell of the first and second plurality of flange cells is out of phase with directly preceding flange cells of the first and second plurality of flange cells.

19. A method of implanting an anastomosis device in a patient:

navigating a delivery sheath containing the anastomosis device to a target location within the patient, wherein the anastomosis device comprises;

a tubular structure comprising at least one elongate member forming a framework of interconnected struts, the tubular structure defining;

a central portion having a first end and a second end and comprising a plurality of body cells defined by the at least one elongate member, the central portion formed of a plurality of body struts each including a plurality of longitudinally-extending portions interconnected with a plurality of angled portions, each of the body struts being separate and not interconnected with adjacent body struts between the first end and the second end of the central portion such that the plurality of body cells are open to longitudinally-adjacent body cells of the plurality of body cells and are closed to circumferentially-adjacent body cells of the plurality of body cells to define a plurality of body cell columns that are each open at one of the first end and the second end of the central portion and closed at the other of the first end and the second end of the central portion;

a first apposition portion at a first end of the central portion having a plurality of first flange cells defined by the at least one elongate member such that the plurality of first flange cells are open to the central portion; and

a second apposition portion at a second end of the central portion comprising a plurality of second flange cells defined by the at least one elongate member such that the plurality of second flange cells are open to the central portion; and

deploying the anastomosis device out from the delivery sheath such that at least one layer of tissue is between the first apposition portion and the second apposition portion.