TISSUE ANCHOR FOR SECURING TISSUE LAYERS

• US 20090281557A1
• Filed: 04/21/2009
• Published: 11/12/2009
• 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., Yurek, Matthew, Allen, Michael P.
• Granted Patent: US 8,454,632 B2
• Time in Patent Office: Days
• US Class Current: 606/151
• 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 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 double-walled flange structures leaving a cylindrical saddle region therebetween.

2. A tissue anchor as in claim 1, wherein the tubular body defines an open passage along a central axis in the elongated tubular configuration.

3. A tissue anchor as in claim 1, wherein the tubular body is closed along a central axis in the elongated tubular configuration.

4. A tissue anchor as in claim 1, further comprising a membrane over at least a portion of the body.

5. A tissue anchor as in claim 4, wherein the sheath comprises an elastomeric membrane which conforms to the body in both the elongated and foreshortened configurations.

6. A tissue anchor as in claim 1, wherein the double-walled flange structures have preselected bending stiffnesses in the range from 1 g/mm to 100 g/mm.

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

8. A tissue anchor as in claim 7, wherein the double-walled 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.

9. A tissue anchor as in claim 1, wherein the flanges on the body are self-expanding when the body is released from constraint.

10. A tissue anchor as in claim 9, wherein the flanges expand to a pre-shaped body configuration.

11. A tissue anchor as in claim 9, further comprising an elastic tether joining the ends of the body, wherein the elastic tether applies an axial tension which foreshortens the body and expands the flanges.

12. A tissue anchor as in claim 9, further comprising a lock which maintains the body in the foreshortened configuration.

13. A tissue anchor as in claim 12, wherein the lock comprises a rod or cylinder within the body which latches to both ends of the body when the body is foreshortened.

14. A tissue anchor as in claim 9, further comprising a sleeve disposed over the cylindrical saddle region.

15. A tissue anchor as in claim 1, wherein the flanges on the body are expanded by applying an axial tension to the ends of the body.

16. A tissue anchor as in claim 15, further comprising at least one axial member attached to one end of the body, wherein said axial member can be pulled to foreshorten the body.

17. A tissue anchor as in claim 16, wherein the axial member comprises a plurality of tethers.

18. A tissue anchor as in claim 17, wherein the tethers lie over the saddle region of the body and within a lumen of the flange regions of the body.

19. A tissue anchor as in claim 16, wherein the axial member comprises a rod or cylinder within a lumen of the body.

20. A tissue anchor as in claim 16, wherein the axial member locks the body in the foreshortened configuration.

21. A system for delivering a tissue anchor, said system comprising:

a tissue anchor as in claim 9; and

a delivery catheter comprising a sheath which causes the tissue anchor body in its elongated tubular configuration and which is retracted relative to the anchor to release the body and allow the flanges to radially expand.

22. A system for delivering a tissue anchor, said system comprising:

a tissue anchor as in claim 16; and

a delivery catheter comprising an actuator which releasably holds the tissue anchor and which includes an actuator for engaging and pulling the axial member to expand the flanges and deploy the anchor.

23. A method for approximating tissue, said method comprising:

forming aligned penetrations in two adjacent tissue layers;

advancing a tissue anchor comprising a body formed of a woven filament braid through said aligned penetrations, wherein said body is in an elongated tubular configuration while being advanced, and

foreshortening the body to cause a distal end and a proximal end of the body to each deform into a double-walled flange structure leaving a cylindrical saddle region therebetween, wherein the flange structures press against the tissue layers with the saddle region disposed in the penetrations.

24. A method as in claim 23, wherein the body is foreshortened to apply sufficient pressure to the tissues to hold them together without causing significant tissue necrosis or adhesion.

25. A method as in claim 24, wherein the applied pressure is in the range from 0.025 psi to 2.5 psi.

26. A method as in claim 23, wherein the adjacent tissue layers are selected from tissues of the esophagus, stomach, duodenum, small intestine, large intestine, bile duct, pancreatic duct, gallbladder, pancreas, pancreatic pseudocyst, liver, diaphragm, and curs.

27. A method as in claim 23, wherein forming and advancing comprise positioning a catheter near a target location on a tissue wall within a body lumen, advancing a penetrating element from the catheter to form the penetrations, and advancing the catheter through the penetrations to position the tissue anchor therethrough prior to foreshortening.

28. A method as in claim 23, wherein foreshortening comprises releasing the elongated tubular body from constraint so that the flanges self-expand.

29. A method as in claim 23, wherein foreshortening comprises applying an axial tension to the body to draw the ends closer.