IMPLANTABLE MEDICAL IMPLANTS HAVING FASTENERS AND METHODS OF FASTENING

• US 20100049214A1
• Filed: 10/28/2009
• Published: 02/25/2010
• Est. Priority Date: 09/15/2003
• Status: Active Grant

• Current Assignee: ReShape LifeSciences, Inc.
• Original Assignee: Allergan Incorporated (Abbvie Incorporated)
• Inventors: BIRK, Janel, Coe, Frederick L., Hoyt, Robert E. JR.
• Granted Patent: US 8,409,203 B2
• Time in Patent Office: Days
• US Class Current: 606/139
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• 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 17/0684 having a forming anvil staying above the tissue during stapling
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61M 2039/0223 having means for anchoring the subcutaneous access site
• CPC Class Codes: A61M 2039/0229 having means for facilitating assembling, e.g. snap-fit housing or modular design
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 39/04 having pierceable self-sealing members
• CPC Class Codes: A61M 5/1415 Stands, brackets or the like for supporting infusion accessories

Abstract

A surgical fastening system for implantable devices such as injection port systems. The implantable device may contain a plurality of fasteners in pre-deployment position, may have a housing fitted over or around it which contains a plurality of fasteners in pre-deployment position, or may be a part of a two-part system into which it fits. Accordingly, the present invention also encompasses a deployment system or tool that optionally positions the implantable device, and which causes the fasteners to move into post-deployment position. The fasteners may be staples, metal loops, coils, springs or hooks formed of biocompatible materials, including shape memory alloys such as NiTi.

Claims

1. A surgically implantable device:

(a) a medical implant for performing a therapeutic function;

(b) an attachment mechanism comprising at least one fastener integral to the implant for attaching the implant to a body, the fastener having a deployed position that extends from a distal end of the implant, and an undeployed position proximal to the distal end of the implant; and

(c) a safety member covering the fastener and removably attached to the distal end of the implant.

2. The device of claim 1, wherein the safety member comprises an annular recess which defines an internal cavity for receiving the implant.

3. The device of claim 1, wherein the safety member comprises at least one grasping tab extending therefrom.

4. The device of claim 1, wherein the safety member resiliently attaches to the implant with tabs that engage the distal end of the implant.

5. The device of claim 4, wherein the tabs have ribs that engage complementary features on the distal end of the implant.

6. The device of claim 1, wherein the implant and safety member snap together.

7. The device of claim 1, wherein the implant comprises an injection port having a proximal septum capable of penetration by a needle along a vertical axis, the injection port further including a space below the septum defining a fluid reservoir, the therapeutic function including injecting fluid into the reservoir through the septum.

8. The device of claim 7, wherein the safety member includes an annular wall that surrounds the implant and is interrupted by a passageway therein to accommodate a reservoir outlet conduit extending from the implant.

9. The device of claim 1, wherein the fastener pivotally rotates in the implant from the undeployed position to the deployed position.

10. The device of claim 9, wherein the fastener comprises a curved hook that pivots from the undeployed position to the deployed position.

11. The device of claim 10, wherein a sharp tip of the curved hook rotates through an arc and is received back in or near the distal end of the implant at the end of its travel.

12. A method of surgically implanting/positioning a medical implant for performing a therapeutic function, the method comprising the steps of:

(a) providing an applier for attaching the medical implant to body tissue, the medical implant having a deployed and an undeployed state;

(b) attaching the medical implant to the applier, the medical implant comprising at least one fastener integral to the implant for attaching the implant to a body, the fastener having a deployed position that extends from a distal end of the implant, and an undeployed position proximal to the distal end of the implant, the medical implant further having a safety member removably attached to the distal end of the implant and covering the fastener;

(c) removing the safety member from the medical implant;

(d) locating the medical implant at a first location; and

(e) moving the fastener from the undeployed position to the deployed position, thereby attaching the medical implant to the body tissue at the first location.

13. The method of claim 12, further comprising the step of moving the fastener from the deployed position to the undeployed position, thereby detaching the medical implant from the body tissue.

14. The method of claim 13, further comprising the steps of:

(a) disposing the medical implant at a second location adjacent body tissue; and

(b) moving the fastener from the undeployed position to the deployed position, thereby attaching medical implant to the body tissue at the second location.

15. The method of claim 12, wherein the safety member resiliently attaches to the distal end of the implant with tabs.

16. The method of claim 14, wherein the tabs have ribs that engage complementary features on the distal end of the implant.

17. The method of claim 12, wherein the distal end of the implant and safety member snap together.

18. The method of claim 12, wherein the safety member includes a main portion that snaps to the distal end of the implant and at least one grasping tab extending radially therefrom to facilitate removal of the safety member from the implant.

19. The method of claim 12, wherein the safety member comprises an annular recess which defines an internal cavity for receiving the implant.

20. The method of claim 12, wherein the implant comprises an injection port having a proximal septum capable of penetration by a needle along a vertical axis, the injection port further including a space below the septum defining a fluid reservoir, the therapeutic function including injecting fluid into the reservoir through the septum.

21. The method of claim 20, wherein the safety member includes an annular wall that surrounds the implant and is interrupted by a passageway therein to accommodate a reservoir outlet conduit extending from the implant.

22. The method of claim 12, wherein the fastener pivotally rotates in the implant from the undeployed position to the deployed position.

23. The method of claim 22, wherein the fastener comprises a curved hook that pivots from the undeployed position to the deployed position.

24. The method of claim 23, wherein a sharp tip of the curved hook rotates through an arc and is received back in or near the distal end of the implant at the end of its travel.

25. The method of claim 12, wherein the fastener pivotally rotates in the implant from the undeployed position to the deployed position, and the implant further comprises a rotating disc for rotating the fastener from its undeployed position to its deployed position, and wherein the method includes rotating the rotating disc with the applier.