IMPLANT SYSTEM AND METHOD FOR BULKING TISSUE

• US 20020052653A1
• Filed: 07/06/1998
• Published: 05/02/2002
• Est. Priority Date: 07/06/1998
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: DURGIN, RUSSELL
• Granted Patent: US 6,591,838 B2
• Time in Patent Office: Days
• US Class Current: 623/11.11
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• 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 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2/20 Epiglottis; Larynxes; Tracheae combined with larynxes or for use therewith tracheae, bronchi per se A61F2/04 ; tracheostomy tubes A61M16/0465
• CPC Class Codes: A61F 5/0079 Pyloric or esophageal obstructions
• CPC Class Codes: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

A system for placing an implant in the body includes an elongated member having at least one inner lumen extending from a proximal end portion of the member to an opening in a distal end portion of the member. At least one compressible implant is in the inner lumen of the member. The implant optionally includes anchor members projecting from its outer surface to limit migration of the implant in the body. Structure is provided to push the implant through the opening in the distal end portion of the member.

The implant is placed between layers of body tissue to bulk the tissue. In one of the disclosed methods, the system is used to treat gastroesophageal reflux disease (GERD) by placing the implant between layers of body tissue at or near the gastro-esophageal junction.

Claims

1. A system for placing an implant in the body, comprising:

an elongated member having a proximal end portion, a distal end portion, at least one opening in the distal end portion, and at least one inner lumen extending from the proximal end portion to the opening in the distal end portion;

at least one compressible implant in the inner lumen of the elongated member, the implant being configured to be implanted in body tissue to bulk the tissue; and

means for pushing the implant through the opening in the distal end portion of the elongated member.

2. The system of claim 1, wherein the pushing means comprises a pushing member movable in the inner lumen of the elongated member.

3. The system of claim 1, wherein the pushing means comprises a source of fluid in fluid communication with the inner lumen, the source of fluid pressurizing the inner lumen to force the implant through the opening in the distal end portion of the elongated member.

4. The system of claim 1, wherein the elongated member is a needle having a distal end configured to pierce through tissue.

5. The system of claim 1, wherein the member comprises a first inner lumen and a second inner lumen, the implant being in the first inner lumen and the second inner lumen being in fluid communication with a source of fluid, fluid flowing through the second inner lumen being capable of separating layers of body tissue.

6. The system of claim 5, wherein the first inner lumen and the second inner lumen each extend from the proximal portion to a respective opening in a distal end of the elongated member.

7. The system of claim 1, wherein a plurality of the implants are in the inner lumen.

8. The system of claim 1, wherein the implant is formed of material including at least one of the group consisting of open cell foam and closed cell foam.

9. The system of claim 1, wherein the implant includes a hollow cavity and wherein the implant is formed of an elastomeric material.

10. The system of claim 1, wherein the implant is expandable from a compressed configuration to an expanded configuration, the implant being in the compressed configuration when the implant is in the inner lumen and the implant expanding to the expanded configuration when the implant passes through the opening in the distal end portion of the elongated member.

11. The system of claim 1, wherein an outer surface of the implant includes means for limiting migration of the implant in the body.

12. The system of claim 11, wherein the migration limiting means comprises anchor members extending from the outer surface of the implant.

13. The system of claim 12, wherein the anchor members are configured to interconnect with anchor members on another implant implanted in the body.

14. The system of claim 11, wherein the migration limiting means comprises a coating on the outer surface of the implant for limiting sliding of the implant in the body.

15. The system of claim 11, wherein the migration limiting means comprises at least one of the group consisting of ridges and grooves formed on the outer surface of the implant.

16. The system of claim 1, wherein the implant comprises radiopaque material.

18. The method of claim 17, wherein the applying of the pushing force includes moving a pushing member in the inner lumen toward the distal end portion to push the implant through the opening.

19. The method of claim 17, further comprising retracting the elongated member while the pushing force is applied to the implant.

20. The method of claim 17, wherein the applying of the pushing force includes pressurizing the inner lumen to force the implant through the opening.

21. The method of claim 17, further comprising piercing the body tissue with a distal end of the elongated member.

22. The method of claim 17, further comprising placing fluid between the layers of body tissue to separate the layers of body tissue.

23. The method of claim 22, wherein the placing of fluid includes flowing the fluid from the elongated member into an area between the layers of body tissue.

24. The method of claim 22, wherein the placing of fluid includes flowing the fluid from a needle into an area between the layers of body tissue.

25. The method of claim 17, wherein the implant is expandable from a compressed configuration to an expanded configuration, and wherein the method further comprises allowing the implant to expand to the expanded configuration when the implant passes through the opening in the elongated member.

26. The method of claim 17, wherein a plurality of compressible implants are in the inner lumen of the elongated member, and wherein the method further comprises placing more than one of the compressible implants between the layers of tissue.

27. The method of claim 26, wherein the implants include anchor members capable of interconnecting with one another, and wherein the method further comprises interconnecting at least one of the anchor members on one of the implants with at least one of the anchor members on another of the implants to limit migration of the implants in the body.

28. The method of claim 17, wherein the implant is placed between layers of body tissue at or near the gastro-esophageal junction to treat gastroesophageal reflux disease.

29. The method of claim 28, wherein the implant is elongated and has a longitudinal axis, and wherein the method further comprises positioning the implant between the tissue layers so that the longitudinal axis of the implant is substantially parallel to the longitudinal axis of the esophagus.

30. The method of claim 28, wherein the implant is elongated and has a longitudinal axis, and wherein the method further comprises positioning the implant between the tissue layers so that the longitudinal axis of the implant is in a plane perpendicular to the longitudinal axis of the esophagus.

31. The method of claim 28, further comprising placing the implant between a mucosa layer and an outer surface of a muscularis layer located at or near the gastro-esophageal junction.

32. The method of claim 28, wherein the introducing of the elongated member comprises passing the elongated member transorally through the esophagus.

33. The method of claim 17, wherein the implant is placed between layers of tissue along the urinary tract to treat urinary incontinence.

35. The implant of claim 34, wherein the implant is formed of material including at least one of the group consisting of open cell foam and closed cell foam.

36. The implant of claim 34, further comprising a coating on the outer surface of the implant for limiting sliding of the implant in the body.

37. The implant of claim 34, wherein the implant comprises radiopaque material.

38. The implant of claim 34, wherein the implant comprises longitudinal grooves and ridges.

39. The implant of claim 34, wherein the implant comprises transverse grooves and ridges.

40. The implant of claim 34, wherein the implant has a shape consisting of one of:

a substantially cylindrical shape and a substantially spherical shape.

17. A method of bulking tissue using an elongated member and at least one compressible implant in an inner lumen of the elongated member, comprising:

introducing the elongated member in the body;

positioning a distal end portion of the elongated member between layers of body tissue; and

applying a pushing force to the implant to move the implant through an opening in the distal end portion and between the layers of body tissue.

34. An implant configured to be implanted in the body to bulk tissue, the implant comprising compressible material allowing the implant to expand from a compressed configuration to an expanded configuration, the implant further comprising a plurality of anchor members extending from the outer surface of the implant, the anchor members being configured to interconnect with anchor members on another implant implanted in the body.