Tissue anchor for securing tissue layers

• US 8,454,632 B2
• Filed: 04/21/2009
• Issued: 06/04/2013
• 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: Binmoeller, Kenneth F., Sander, Fiona M., Allen, Michael P., Yurek, Matthew
• Primary Examiner(s): MCEVOY, THOMAS M
• Application Number:
  US12/427,215
• Publication Number:
  US 20090281557A1
• Time in Patent Office: 1,505 Days
• Field of Search: 606/139, 606/151, 606153-158, 606/213, 606/215, 606/216
• 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 method for approximating tissue and forming an anastomosis between a gallbladder and a duodenum or stomach, said method comprising:

forming aligned penetrations in two adjacent tissue layers of two anatomical lumens, a first of the two anatomical lumens being formed by the gallbladder and a second of the two anatomical lumens being formed by either the duodenum or the stomach;

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

allowing the body to foreshorten into a preformed shape by self-expansion 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, the saddle region having an open central lumen therethrough to provide a flow path through the adjacent tissue layers after the tissue anchor is in place, wherein the both walls of each flange structure lie perpendicular to the axis and the flange structures press against the tissue layers with the saddle region disposed in the penetrations, wherein the both walls of each flange structure and the cylindrical saddle region therebetween comprise a continuous woven filament braid having an elastomeric material formed over the braid such that the material conforms to the body in both the elongated and foreshortened configurations, the material being configured to prevent or inhibit tissue ingrowth, to minimize fluid leakage from the anatomical lumens and from the lumen of the saddle region, and to allow the anchor to be removed after having been implanted for weeks, months, or longer, the material being configured to allow fluid flow through each flange structure and the cylindrical saddle region between the anatomical lumens.

2. A method as in claim 1, wherein the body is foreshortened to apply sufficient pressure to the tissue layers to hold them together without causing significant tissue necrosis or adhesion.

3. A method as in claim 2, wherein the applied pressure is in the range from 0.025 psi to 2.5 psi.

4. A method as in claim 1, wherein forming and advancing comprise positioning a catheter near a target location on a tissue wall within one of said anatomical lumens, 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.

5. A method as in claim 1, wherein foreshortening comprises releasing the elongated tubular body from constraint so that the flanges self-expand.

6. A method as in claim 1, wherein a valve, interposed within the body, provides a one way flow control allowing flow from the gallbladder and into the duodenum or stomach without reflux.