Implantable tissue fastener and system for treating gastroesophageal reflux disease

• US 6,447,533 B1
• Filed: 04/18/2000
• Issued: 09/10/2002
• Est. Priority Date: 05/26/1998
• Status: Expired due to Term

• Current Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Adams, Ronald
• Primary Examiner(s): Reip, David O.
• Assistant Examiner(s): Woo, Julian W.
• Application Number:
  US09/551,754
• Time in Patent Office: 875 Days
• Field of Search: 606/213-217, 606/153, 606/151, 606/72, 606/73, 600/30, 600/31, 600/499, 623/23, 623/67, 128/898
• US Class Current: 606/213
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61M 2025/0233 specifically adapted for attaching to a body wall by means which are on both sides of the wall, e.g. for attaching to an abdominal wall
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

A system including an implantable fastener for fastening layers of tissue is disclosed. In one embodiment, the fastener includes a proximal anchor member and a distal anchor member each being movable from a reduced profile position to a deployed position. The anchor members are mesh structures capable of moving to the deployed position by reducing the axial spacing between opposite ends of the anchor members. Methods of treating gastroesophageal reflux disease (GERD) are also disclosed. One of the methods includes placing the distal anchor member through a hole formed in the wall of the esophagus and through a hole formed in the gastric wall. The distal anchor member and the proximal anchor member are then placed in their deployed positions to fasten the wall of the esophagus and the gastric wall together between the anchor members.

Claims

1. An implantable fastener for fastening layers of tissue together, comprising:

an elongated body having a lumen and at least one aperture in a distal end portion of the body;

a balloon on the distal end portion of the body, an interior of the balloon being flow connected to the lumen of the body via the aperture so that the balloon is capable of being inflatable from a reduced profile position to an inflatable position;

a seal on the body to maintain inflating fluid in the balloon;

a cap member configured to be positioned on a proximal end of the body; and

at least one retainer on the proximal end portion of the body for retaining the cap member on the body when the tissue layers are between the balloon and the cap member.

2. The fastener of claim 1, wherein the seal is configured to permit passage of an inflating tube through the seal.

3. The fastener of claim 1, wherein the balloon has a low profile, generally disc shape when the balloon is in the inflated position.

4. The fastener of claim 1, wherein the cap member has an opening permitting sliding of the cap member on the proximal end portion of the fastener.

5. A system for fastening layers of tissue together, comprising:

the fastener of claim 1; and

an inflating tube for passing inflating fluid into the balloon.

6. The system of claim 5, further comprising a pushing member for pushing the cap member on the proximal end portion of the body.

7. The system of claim 1, further comprising an introducer tube having a sharp end configured to pierce the tissue layers.

8. A method of treating gastroesophageal reflux disease using at least one implantable fastener including a distal anchor member configured to be movable from a reduced profile position to a deployed position, and a proximal anchor member configured to be movable from a reduced profile position to a deployed position, comprising:

passing the implantable fastener transorally through the esophagus to a position near the junction between the esophagus and the stomach;

inserting the distal anchor member through a hole formed in the wall of the esophagus and through a hole formed in the gastric wall while the distal anchor member is in the reduced profile position;

placing the distal anchor member in the deployed position; and

placing the proximal anchor member in the deployed position to fasten the wall of the esophagus and the gastric wall together between the deployed distal anchor member and the deployed proximal anchor member.

9. The method of claim 8, further comprising forming the hole in the wall of the esophagus and forming the hole in the gastric wall by piercing the wall of the esophagus and the gastric wall.

10. The method of claim 8, further comprising introducing an adhesion inducing agent between the wall of the esophagus and the gastric wall.

11. The method of claim 8, wherein the distal anchor member is configured to be placed in the deployed position by reducing a spacing between proximal and distal end portions of the distal anchor member and wherein the proximal anchor member is configured to be placed in the deployed by reducing a spacing between proximal and distal end portions of the proximal anchor member, the placing of the distal anchor member in the deployed position including reducing the spacing between the proximal and distal end portions of the distal anchor member, and the placing of the proximal anchor member in the deployed position including reducing the spacing between the proximal and distal end portions of the proximal anchor member.

12. The method of claim 8, further comprising retaining the distal anchor member and the proximal anchor member in the deployed positions while the wall of the esophagus and the gastric wall are between the deployed distal anchor member and the deployed proximal anchor member.

13. The method of claim 8, wherein the placing of the distal anchor member in the deployed position and the placing of the proximal anchor in the deployed position include placing a pushing member against a proximal end of the implantable fastener and pulling an actuator proximally to move a distal end of the fastener toward a proximal end of the fastener.

14. The method of claim 8, wherein the placing of the distal anchor member in the deployed position includes pushing a proximal end portion of the distal anchor member toward a distal end portion of the distal anchor member.

15. The method of claim 8, wherein the placing of the distal anchor member in the deployed position includes pulling a distal end portion of the distal anchor member toward a proximal end of the distal anchor member.

16. The method of claim 8, wherein the placing of the proximal anchor member in the deployed position includes moving proximal and distal end portions of the proximal anchor member toward the wall of the esophagus.

17. A method of treating gastroesophageal reflux disease using a fastener including an elongated body, a balloon on the body, and a cap member, the method comprising:

passing the fastener transorally through the esophagus to a position near the junction between the esophagus and the stomach;

inserting the balloon through a hole formed in the wall of the esophagus and a hole formed in the gastric wall while the balloon is in a reduced profile position;

inflating the balloon; and

retaining the cap member on the body of the fastener to fasten the wall of the esophagus and the gastric wall together between the cap member and the inflated balloon.

18. The method of claim 17, further comprising forming the hole in the wall of the esophagus and forming the hole in the gastric wall by piercing the wall of the esophagus and the gastric wall.

19. The method of fastening at least two layers of tissue together, comprising:

introducing an adhesion inducing agent between first and second tissue layers in a body, wherein the first layer of tissue is the wall of the esophagus and the second layer of tissue is the gastric wall;

inserting an implantable fastener in the body; and

holding the first and second layers together with the implantable fastener while the adhesion inducing agent is between the first and second tissue layers.

20. The method of claim 19, further comprising:

forming a first hole in the first tissue layer and a second hole in the second tissue layer, and passing the fastener through the first and second holes.

21. The method of claim 20, wherein the implantable fastener includes a proximal anchor member and a distal anchor member, and wherein the holding includes placing the anchor members in a deployed position to sandwich the tissue layers between the anchor members.