Implantable tissue fastener and system for treating gastroesophageal reflux disease

• US 6,113,609 A
• Filed: 05/26/1998
• Issued: 09/05/2000
• Est. Priority Date: 05/26/1998
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Adams, Ronald
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Shai, Daphna
• Application Number:
  US09/084,001
• Time in Patent Office: 833 Days
• Field of Search: 606/72, 606/193, 606/195, 606/198, 606/213, 606/215, 606/216, 606/217
• US Class Current: 606/139
• 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 support;

a distal anchor member having a first end portion connected to the support and a second end portion movable on the support, the distal anchor member being configured to be movable from a reduced profile position to a deployed position when a spacing between the first and second end portions is reduced;

a proximal anchor member having first and second end portions movable on the support, the proximal anchor member being configured to be movable from a reduced profile position to a deployed position when a spacing between the first and second end portions of the proximal anchor member is reduced, the proximal anchor member being spaced from the distal anchor member a distance sufficient to position the layers of tissue together between the proximal and distal anchor members; and

at least one retainer on a proximal end portion of the support, the retainer engaging one of the end portions of the proximal anchor member when at least the proximal anchor member is in the deployed position so that at least the proximal anchor member is retained in the deployed position.

2. The implantable fastener of claim 1, wherein each of the distal and proximal anchor members includes an expandable mesh structure having a generally cylindrical shape in the reduced profile position and a generally disk shape in the deployed position.

3. The implantable fastener of claim 1, wherein the first end portion of the distal anchor member is a distal end portion and wherein the implantable fastener further includes a connecting section connecting a proximal end of the distal anchor member to a distal end of the proximal anchor member, the connecting section being movable on the elongated support and having a length sufficient to place the layers of tissue together between the proximal and distal anchor members.

4. The implantable fastener of claim 3, wherein the retainer is located on the support so that the retainer engages a proximal end portion of the proximal anchor member to retain the proximal anchor member and the distal anchor member in the deployed positions.

5. The implantable fastener of claim 1, wherein the first end portion of the distal anchor member is a distal end portion and wherein the second end portion of the distal anchor member is slidably mounted on the support.

6. The implantable fastener of claim 1, wherein the first end portion of the distal anchor member is a proximal end portion and wherein the second portion of the distal anchor member is slidably mounted on the support.

7. The implantable fastener of claim 1, wherein the first and second end portions of the proximal anchor member are slidably mounted on the support, and wherein the retainer is located on the support so that the retainer engages a proximal end portion of the proximal anchor member to retain the proximal anchor member in the deployed position.

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

the implantable fastener of claim 5, the fastener further including a lumen in the support; and

a pushing member extending in the lumen of the support, a distal end of the pushing member being configured to contact the second end portion of the distal anchor member so that distal movement of the pushing member slides the second end portion of the distal anchor member toward the first end portion of the distal anchor member to place the distal anchor member in the deployed position.

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

the implantable fastener of claim 6, the fastener further including a lumen in the support; and

an actuator extending in the lumen of the support, the actuator being coupled to the second end portion of the distal anchor member so that proximal movement of the actuator slides the second end portion of the distal anchor member toward the first end portion of the distal anchor member to place the distal anchor member in the deployed position.

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

the implantable fastener of claim 7; and

a pushing member having a distal end configured to contact the proximal end portion of the proximal anchor member so that distal movement of the pushing member slides the proximal end portion of the proximal anchor member toward a distal end portion of the proximal anchor member to place the proximal anchor member in the deployed position.

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

a first anchor member having a distal end portion and a proximal end portion, the first anchor member being configured to be movable from a reduced profile position to a deployed position when a spacing between the proximal and distal end portions is reduced;

a second anchor member having a proximal end portion and a distal end portion, the second anchor member being configured to be movable from a reduced profile position to a deployed position when a spacing between the proximal and distal end portions of the second anchor member is reduced;

a connecting section connecting the proximal end portion of the first anchor member to the distal end portion of the second anchor member, the connecting section having a length sufficient to position the layers of tissue together between the first and second anchor members;

an elongated support connected to the distal end portion of the first anchor member, the support being movable proximally in the proximal end portion of the first anchor member, in the connecting section, and in the second anchor member to place the first and second anchor members in the deployed positions; and

at least one retainer on a proximal end portion of the support, the retainer engaging the proximal end portion of the second anchor member when the first and second anchor members are in the deployed positions.

12. The implantable fastener of claim 11, wherein each of the first and second anchor members includes an expandable mesh structure having a generally cylindrical shape in the reduced profile position and a generally disk shape in the deployed position.

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

the implantable fastener of claim 11;

an introducer tube having a lumen, the implantable fastener being capable of being placed in the lumen of the introducer tube when the first and second anchor members are in the reduced profile position;

a pushing member extending in the lumen of the introducer tube, a distal end of the pushing member being configured to contact a proximal end of the fastener; and

an actuator extending through the introducer tube, the actuator being coupled to the elongated support so that proximal movement of the actuator moves the support proximally in the proximal end portion of the first anchor member, in the connecting section, and in the second anchor member when the distal end of the pushing member contacts the proximal end of the fastener.

14. The system of claim 13, wherein the pushing member includes a lumen and wherein the actuator passes through the lumen of the pushing member.

15. The system of claim 13, wherein the actuator includes a thread removably coupled to the elongated support.

16. The system of claim 13, further comprising a first connector on a proximal end of the introducer and a second connector on a proximal end of the pushing member, the first connector being adapted to be connected to the second connector.

17. The system of claim 13, wherein a distal end of the introducer has a sharp tip capable of piercing the layers of tissue.

18. The system of claim 13, wherein a distal end portion of the introducer has at least one outlet for permitting an adhesion inducing agent to be introduced between the layers of tissue.

19. The system of claim 13, further comprising a piercing member configured to pierce the tissue layers.

20. The system of claim 19, wherein the piercing member includes at least one outlet for permitting an adhesion inducing agent to be introduced between the tissue layers.