Tissue anchor for securing tissue layers

• US 10,076,330 B2
• Filed: 05/13/2013
• Issued: 09/18/2018
• Est. Priority Date: 05/12/2008
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Xlumena, Inc. (Boston Scientific Corporation)
• Inventors: Sander, Fiona M, Allen, Michael P., Yurek, Matthew, Binmoeller, Kenneth F.
• Primary Examiner(s): MCEVOY, THOMAS M
• Application Number:
  US13/892,958
• Publication Number:
  US 20130253546A1
• Time in Patent Office: 1,954 Days
• Field of Search: 606139, 606151, 606153-158, 606213, 606215, 606216
• 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 17/12009 Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• 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 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61B 2017/3486 Balloon
• 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: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/09125 Device for locking a guide wire in a fixed position with respect to the catheter or the human body
• CPC Class Codes: A61M 2025/1059 having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties with different compartments A61M2025/1072
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

Tissue anchors comprise a woven filament braid body having an elongated tubular configuration and a foreshortened configuration where proximal and distal ends of the body expand radially into double-walled flange structures while leaving a cylindrical saddle region therebetween. The tissue anchors are deployed through penetrations between adjacent tissue layers, where the flanges engage the outer surfaces of the tissue layers and the saddle region resides within the tissue penetrations.

Claims

1. A tissue anchor to appose adjacent tissue layers of a first luminal body and a second body in a patient, comprising a body formed of a woven filament braid, said body having an elongated tubular configuration and a foreshortened configuration where a proximal end of the body radially expands into only one proximal flange structure and a distal end of the body radially expands into only one distal flange structure leaving a cylindrical saddle region therebetween, wherein the adjacent tissue layers are apposed between the radially expanded proximal and distal ends and along the cylindrical saddle region, wherein a diameter of the cylindrical saddle region is greater than a diameter of the body in the elongated tubular configuration, wherein the proximal and distal flange structures have a diameter that is at least substantially twice the diameter of the cylindrical saddle region, wherein an opening of the proximal flange structure and an opening of the distal flange structure include a diameter that is greater than a diameter of the body in the elongated tubular configuration, wherein the tissue anchor is configured in the foreshortened configuration to allow fluid flow through the cylindrical saddle region, and an elastomeric membrane is formed over an entire length of the tissue anchor so that the membrane conforms to the tissue anchor in both the elongated tubular configuration and the foreshortened configuration.

2. A tissue anchor as in claim 1, wherein the radially expanded proximal and distal flange structures have preselected bending stiffnesses in the range from 1 g/mm to 100 g/mm.

3. A tissue anchor as in claim 2, wherein the radially expanded proximal and distal flange structures have preselected bending stiffnesses in the range from 4 g/mm to 40 g/mm.

4. A tissue anchor as in claim 1, wherein the body in the elongated tubular configuration has a diameter in the range from 7 mm to 100 mm.

5. A tissue anchor as in claim 4, wherein the proximal and distal flange structures have diameters in the range from 3 mm to 70 mm and the cylindrical saddle region has a diameter in the range from 1 mm to 40 mm in the foreshortened configuration.

6. A tissue anchor as in claim 1, wherein the proximal and distal flange structures are self-expanding when the body is released from constraint.

7. A tissue anchor as in claim 6, wherein the proximal and distal flange structures expand to a pre-shaped body configuration.

8. A tissue anchor as in claim 1, wherein the tissue anchor has a length of from 3 mm to 40 mm in the foreshortened configuration.

9. A tissue anchor as in claim 1, wherein the proximal and distal flange structures are double-walled flange structures.

10. A tissue anchor as in claim 1, wherein the tissue anchor in the foreshortened configuration is capable of maintaining the fluid flow through the cylindrical saddle region for a week or more.

11. A tissue anchor comprising a body formed of a woven filament braid, said body having an elongated tubular configuration and a foreshortened configuration, where proximal and distal ends of the body expand radially into respective proximal and distal flange structures leaving a cylindrical saddle region therebetween, the cylindrical saddle region having a longitudinal axis, wherein a length of the cylindrical saddle region is at least 40% less than a length of the body in the elongated configuration, wherein the proximal and distal flange structures have a diameter that is at least substantially twice the diameter of the cylindrical saddle region, wherein an opening of the proximal flange structure and an opening of the distal flange structure include a diameter that is greater than a diameter of the body in the elongated tubular configuration, wherein the proximal flange structure includes a single tissue apposing surface adjacent to the cylindrical saddle region and the distal flange structure includes a single tissue apposing surface adjacent to the cylindrical saddle region to appose adjacent tissue layers along the cylindrical saddle, wherein the tissue anchor is configured in the foreshortened configuration to allow fluid flow through an interior of the cylindrical saddle region, and an elastomeric membrane is formed over an entire length of the tissue anchor so that the membrane conforms to the tissue anchor in both the elongated tubular configuration and the foreshortened configuration.

12. A tissue anchor as in claim 11, wherein the body defines an open passage along a central axis in the elongated tubular configuration.

13. A tissue anchor as in claim 11, wherein the proximal and distal flange structures have preselected bending stiffnesses in the range from 1 g/mm to 100 g/mm.

14. A tissue anchor as in claim 13, wherein the proximal and distal flange structures have preselected bending stiffnesses in the range from 4 g/mm to 40 g/mm.

15. A tissue anchor as in claim 11, wherein the body in the elongated tubular configuration has a diameter in the range from 7 mm to 100 mm.

16. A tissue anchor as in claim 15, wherein the proximal and distal flange structures have diameters in the range from 3 mm to 70 mm and the saddle region has a diameter in the range from 1 mm to 40 mm in the foreshortened configuration.

17. A tissue anchor as in claim 11, wherein the proximal and distal flange structures are self-expanding when the body is released from constraint.

18. A tissue anchor as in claim 11, wherein the tissue anchor is configured to be removable during or after implantation.

19. A tissue anchor as in claim 11, wherein the tissue anchor has a length of from 3 mm to 40 mm in the foreshortened configuration.

20. A tissue anchor as in claim 11, wherein the cylindrical saddle region includes a longitudinal axis, and wherein the proximal and distal flange structures each expand into a double-walled flange structure.

21. A tissue anchor as in claim 20, wherein each of the double-walled flange structures includes a pair of walls, wherein each of the pair of walls are aligned substantially perpendicular to the longitudinal axis of the cylindrical saddle region when in the foreshortened configuration.

22. A tissue anchor as in claim 11, wherein the tissue anchor in the foreshortened configuration is capable of maintaining the fluid flow through the cylindrical saddle region for a week or more.

23. A tissue anchor to appose adjacent tissue layers of a first luminal body and a second body in a patient, comprising a body formed of a woven filament braid, said body having an elongated tubular configuration and a foreshortened configuration where proximal and distal ends of the body expand radially into respective proximal and distal flange structures leaving a cylindrical saddle region therebetween, wherein the proximal flange structure includes a single tissue opposing surface adjacent to the cylindrical saddle region and the distal flange structure includes a single tissue opposing surface adjacent to the cylindrical saddle region to appose the adjacent tissue layers along the cylindrical saddle region, wherein a diameter of the cylindrical saddle region is greater than a diameter of the body in the elongated tubular configuration, wherein the proximal and distal flange structures have a diameter that is at least substantially twice the diameter of the cylindrical saddle region, wherein an opening of the proximal flange structure and an opening of the distal flange structure include a diameter that is greater than a diameter of the body in the elongated tubular configuration, wherein the tissue anchor is configured in the foreshortened configuration to allow fluid flow through the cylindrical saddle region, and an elastomeric membrane is formed over an entire length of the tissue anchor so that the membrane conforms to the tissue anchor in both the elongated tubular configuration and the foreshortened configuration.

24. A tissue anchor as in claim 23, wherein the proximal and distal flange structures are double-walled flange structures.

25. A tissue anchor as in claim 23, wherein the tissue anchor in the foreshortened configuration is capable of maintaining the fluid flow through the cylindrical saddle region for a week or more.