Fixation device for implantable microdevices

• US 7,054,692 B1
• Filed: 05/15/2002
• Issued: 05/30/2006
• Est. Priority Date: 06/22/2001
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: Whitehurst, Todd K, McGivern, James P
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US10/146,332
• Time in Patent Office: 1,476 Days
• Field of Search: 607 1- 3, 607/36, 607/46, 607/118, 607/120, 607/125, 607/126, 607/149, 607/116, 600/386, 128/898, 606/151, 606/152, 606/154, 224/200
• US Class Current: 607/149
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37518 Anchoring of the implants, e.g. fixation
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

A fixation device fixes the position of an implantable microminiature device residing proximally to a target site such as a nerve or a muscle. In one embodiment, the device comprises a sheath and a means for attaching the device to adjacent tissue. The means for attaching may be any one of several embodiments including one or more grasping members, a combination of grasping members and one or more helices, or an extension adapted to accept a suture. In another embodiment, the fixation device comprises an assembly residing in the implantation pathway, behind the stimulation device, thus preventing retreat of the stimulation device in the pathway. In a preferred use, the fixation device fixes the position of a microstimulator component of a Peripheral Nerve Stimulation (PNS) system.

Claims

1. An implantable device including a fixation device with an implantable microdevice for stimulating tissue, said microdevice comprising a case, comprising:

a flexible, arced grasping member comprising a sheet of material having a first edge and a second edge, said sheet being curved into an unclosed cylindrical shape with said first and second edges being separated by an open space running a full length of said cylindrical shape;

a holder configured to hold said microdevice, said holder being disposed along a length of said first edge of said sheet; and

said implantable microdevice in said holder configured to deliver a stimulus to said tissue, said microdevice being secured in position relative to said tissue by said grasping member and said holder.

2. The device of claim 1 wherein the flexible, arced grasping member comprises at least two fingers.

3. The device of claim 1 wherein the holder comprises at least two loops.

4. The device of claim 1 wherein the holder comprises a sheath.

5. The device of claim 1 wherein the flexible arced member is configured to reach substantially around the body tissue.

6. The device of claim 5 wherein the holder resides substantially within the arc of the arced member.

7. The device of claim 5 wherein the holder resides substantially outside the arc of the arced member.

8. The device of claim 5 wherein the arced member comprises at least two arced members spaced along a length of the microdevice.

9. The device of claim 8 wherein the arced members are uniform in size.

10. The device of claim 8 wherein the arced members vary in size.

11. The system of claim 1 wherein the flexible arced member comprises at least one electrode configured to provide stimulation to the body tissue, and wherein the holder includes at least one contact configured to electrically cooperate with the microdevice to electrically connect the microdevice to the electrode.

12. The device of claim 1 wherein the fixation device is configured to elute at least one medication.

13. The device of claim 1 wherein at least one of the set consisting of the holder and the arced member is made from a resorbable material.

14. The device of claim 1 wherein the microdevice is a microstimulator element of a Peripheral Nerve Stimulation (PNS) system.

15. The device of claim 1 wherein the arced member comprises silicone, polyimide, or polyurethane.

16. The device of claim 1 further comprising at least one helical member connected to the holder for engaging the body tissue along with the flexible arced member.

17. The device of claim 1, wherein said sheet is substantially rectangular in shape.

18. A method of using an implantable microdevice with a fixation device comprising a holder for the microdevice disposed on a flexible arced member having an opening along a length thereof for engaging body tissue, comprising;

placing the body tissue in a space within and defined by the arced member by passing the body tissue through the opening running along the length of the arced member such that the arced member is placed around the body tissue; and

placing the microdevice in the holder,

wherein the arced member is placed on the body tissue before the microdevice is placed in the holder.

19. A system for an implantable microdevice, comprising:

means for grasping an elongated body tissue, the means having an opening along a length thereof so that the means for grasping can be slipped around the elongated body tissue by passing the tissue through the opening such that the means for grasping curls around the tissue; and

means for holding the microdevice disposed on the means for grasping.

20. The system of claim 19 wherein the means for grasping comprises at least two arced members spaced along a length of the microdevice.

21. The system of claim 19 wherein the means for grasping further comprising at least one electrode for providing stimulation to the body tissue by connecting with the microdevice.

22. The system of claim 19 wherein the system is configured to elute at least one medication.