Implantable device fastening system and methods of use

• US 7,901,381 B2
• Filed: 01/21/2005
• Issued: 03/08/2011
• Est. Priority Date: 09/15/2003
• Status: Active Grant

• Current Assignee: Apollo Endosurgery US, Inc. (Boston Scientific Corporation)
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Hoyt, Robert E. Jr., Birk, Janel, Coe, Frederick L.
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): FISHER, ELANA BETH
• Application Number:
  US10/562,954
• Publication Number:
  US 20060235445A1
• Time in Patent Office: 2,237 Days
• Field of Search: 606/151, 606/219, 604/174, 604/175
• US Class Current: 604/175
• 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 for prostheses A61F2210/0014
• 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 is disclosed. 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 method of securing a device to bodily tissue comprising:

providing a device having associated tissue attaching fasteners, wherein the device comprises a housing that comprises a plurality of the tissue attaching fasteners pivotally mounted thereto and acted on by a rotating disc in the device to displace each fastener from a first position above a lower surface of the device to a second position below the lower surface;

positioning the lower surface of the device on the bodily tissue;

covering the device with a delivery system;

activating the delivery system to rotate the disc such that the attaching fasteners are each pivotally rotated from the first position to the second position to secure the device in bodily tissue; and

,

removing the delivery system from the secured device.

2. The method of claim 1, wherein the attaching fasteners comprise curved hooks distributed evenly around the device, the method further including piercing the bodily tissue with the curved hooks.

3. The method of claim 2, wherein sharp tips of the curved hooks rotate through an arc and are received back in or near a lower face of the device in their second positions.

4. The method of claim 1, wherein the delivery system comprises a proximal handle and a distal cover sized to substantially surround and act on the device, the delivery system further including a transmission that converts linear motion of a plunger in the handle into rotational motion of the disc in the device, the method further including actuating the plunger.

5. The method of claim 4, wherein the distal cover of the delivery system defines a recess that receives the device therein such that the lower face of the device is exposed, the cover and recess being oriented to extend down over the device generally vertically, the delivery system further including a shaft extending upward at an angle to the vertical from the distal cover to the proximal handle, the method further including inserting the cover and device through an incision with the proximal handle extending out of the incision at an angle.

6. The method of claim 5, wherein the proximal handle of the delivery system has a palm-grip actuator angled with respect to the shaft, the palm-grip actuator including a lever connected to the transmission and pivotally mounted with respect to a housing portion, the method further including squeezing the lever and housing portion together to pivot the attaching fasteners.

7. The method of claim 1, wherein the device further includes a safety member removably attached over the lower surface and covering the attaching fasteners, the method further including removing the safety member from the device prior to positioning the lower surface of the device on the bodily tissue.

8. The method of claim 7, wherein the safety member resiliently attaches to the lower surface of the device with tabs.

9. The method of claim 7, wherein the lower surface of the device and safety member snap together.

10. The method of claim 7, wherein the safety member includes a main portion that snaps to the lower surface of the device and at least one grasping tab extending radially therefrom to facilitate removal of the safety member from the device.

11. The method of claim 1, further comprising the step of pivoting the fasteners from the second positions to the first positions, thereby detaching the device from the bodily tissue.

12. The method of claim 11, further comprising the steps of:

disposing the device at a second location on bodily tissue; and

again pivoting the fasteners from the first positions to the second positions, thereby attaching device to the bodily tissue at the second location.

13. The method of claim 1, wherein the disc rotates about a central axis of the device.

14. The method of claim 13, wherein the disc includes lever arms that push against and pivot the attaching fasteners.

15. The method of claim 1, wherein the device is an implantable injection port including a fluid reservoir, an upwardly-facing needle-puncturable septum over the reservoir in the housing, and an outlet conduit extending through a side wall of the housing from the reservoir, the method further including connecting tubing to the outlet conduit.

16. The method of claim 1, wherein the method includes locking the attaching fasteners into the second position.

17. The method of claim 1, wherein the housing is integral with the device.

18. The method of claim 1, wherein the housing is detachable and surrounds the outside of the device, such that the device is securely contained within the housing after said activating step.

19. A method of securing a device to bodily tissue comprising:

providing a device having associated tissue attaching fasteners, wherein the device comprises a housing that comprises a plurality of the tissue attaching fasteners pivotally mounted thereto and acted on by a rotating disc in the device to displace each fastener from a first position above a lower surface of the device to a second position below the lower surface, wherein each fastener has a sharp tip for piercing tissue, and wherein in the first position the sharp tips of the fasteners are located above a bottom surface of the housing and in the second position the fasteners rotate so that the sharp tips pass through tissue below the housing and nest against the bottom surface of the housing;

positioning the lower surface of the device on the bodily tissue;

covering the device with a delivery system;

activating the delivery system to rotate the disc such that the attaching fasteners are each pivotally rotated from the first position to the second position to secure the device in bodily tissue; and

,

removing the delivery system from the secured device.

20. The method of claim 19, wherein the attaching fasteners comprise curved hooks distributed evenly around the device.

21. The method of claim 19, wherein the delivery system comprises a proximal handle and a distal cover sized to substantially surround and act on the device, the delivery system further including a transmission that converts linear motion of a plunger in the handle into rotational motion of the disc in the device, the method further including actuating the plunger.

22. The method of claim 21, wherein the distal cover of the delivery system defines a recess that receives the device therein such that the lower face of the device is exposed, the cover and recess being oriented to extend down over the device generally vertically, the delivery system further including a shaft extending upward at an angle to the vertical from the distal cover to the proximal handle, the method further including inserting the cover and device through an incision with the proximal handle extending out of the incision at an angle.

23. The method of claim 22, wherein the proximal handle of the delivery system has a palm-grip actuator angled with respect to the shaft, the palm-grip actuator including a lever connected to the transmission and pivotally mounted with respect to a housing portion, the method further including squeezing the lever and housing portion together to pivot the attaching fasteners.

24. The method of claim 19, wherein the device further includes a safety member removably attached over the lower surface and covering the attaching fasteners, the method further including removing the safety member from the device prior to positioning the lower surface of the device on the bodily tissue.

25. The method of claim 24, wherein the safety member includes a main portion that snaps to the lower surface of the device and at least one grasping tab extending radially therefrom to facilitate removal of the safety member from the device.

26. The method of claim 19, further comprising the step of pivoting the fasteners from the second positions to the first positions, thereby detaching the device from the bodily tissue.

27. The method of claim 26, further comprising the steps of:

disposing the device at a second location on bodily tissue; and

again pivoting the fasteners from the first positions to the second positions, thereby attaching device to the bodily tissue at the second location.

28. The method of claim 19, wherein the disc rotates about a central axis of the device.

29. The method of claim 28, wherein the disc includes lever arms that push against and pivot the attaching fasteners.

30. The method of claim 19, wherein the device is an implantable injection port including a fluid reservoir, an upwardly-facing needle-puncturable septum over the reservoir in the housing, and an outlet conduit extending through a side wall of the housing from the reservoir, the method further including connecting tubing to the outlet conduit.

31. The method of claim 19, wherein the method includes locking the attaching fasteners into the second position.

32. The method of claim 19, wherein the housing is integral with the device.

33. The method of claim 19, wherein the housing is detachable and surrounds the outside of the device, such that the device is securely contained within the housing after said activating step.

34. A method of securing a device to bodily tissue comprising:

providing a device having associated tissue attaching fasteners, wherein the device comprises a housing integral with the device that comprises a plurality of the tissue attaching fasteners pivotally mounted thereto and acted on by a rotating disc in the device to displace each fastener from a first position above a lower surface of the device to a second position below the lower surface;

positioning the lower surface of the device on the bodily tissue;

covering the device with a delivery system;

activating the delivery system to rotate the disc such that the attaching fasteners are each pivotally rotated from the first position to the second position to secure the device in bodily tissue; and

,

removing the delivery system from the secured device.

35. The method of claim 34, wherein the attaching fasteners comprise curved hooks distributed evenly around the device.

36. The method of claim 34, wherein the delivery system comprises a proximal handle and a distal cover sized to substantially surround and act on the device, the delivery system further including a transmission that converts linear motion of a plunger in the handle into rotational motion of the disc in the device, the method further including actuating the plunger.

37. The method of claim 36, wherein the distal cover of the delivery system defines a recess that receives the device therein such that the lower face of the device is exposed, the cover and recess being oriented to extend down over the device generally vertically, the delivery system further including a shaft extending upward at an angle to the vertical from the distal cover to the proximal handle, the method further including inserting the cover and device through an incision with the proximal handle extending out of the incision at an angle.

38. The method of claim 37, wherein the proximal handle of the delivery system has a palm-grip actuator angled with respect to the shaft, the palm-grip actuator including a lever connected to the transmission and pivotally mounted with respect to a housing portion, the method further including squeezing the lever and housing portion together to pivot the attaching fasteners.

39. The method of claim 34, wherein the device further includes a safety member removably attached over the lower surface and covering the attaching fasteners, the method further including removing the safety member from the device prior to positioning the lower surface of the device on the bodily tissue.

40. The method of claim 39, wherein the safety member includes a main portion that snaps to the lower surface of the device and at least one grasping tab extending radially therefrom to facilitate removal of the safety member from the device.

41. The method of claim 34, further comprising the step of pivoting the fasteners from the second positions to the first positions, thereby detaching the device from the bodily tissue.

42. The method of claim 41, further comprising the steps of:

disposing the device at a second location on bodily tissue; and

again pivoting the fasteners from the first positions to the second positions, thereby attaching device to the bodily tissue at the second location.

43. The method of claim 34, wherein the disc rotates about a central axis of the device.

44. The method of claim 43, wherein the disc includes lever arms that push against and pivot the attaching fasteners.

45. The method of claim 34, wherein the device is an implantable injection port including a fluid reservoir, an upwardly-facing needle-puncturable septum over the reservoir in the housing, and an outlet conduit extending through a side wall of the housing from the reservoir, the method further including connecting tubing to the outlet conduit.

46. The method of claim 34, wherein the method includes locking the attaching fasteners into the second position.