HARD TISSUE ANCHORS AND DELIVERY DEVICES

• US 20110257693A1
• Filed: 07/01/2011
• Published: 10/20/2011
• Est. Priority Date: 12/06/2006
• Status: Active Grant

• Current Assignee: TC1 LLC (Abbott Laboratories Incorporated)
• Original Assignee: Spinal Modulation, Inc. (Abbott Laboratories Incorporated)
• Inventors: Burdulis, Albert G.
• Granted Patent: US 8,518,092 B2
• Time in Patent Office: Days
• US Class Current: 606/86.A
• CPC Class Codes: A61B 17/0642 for bones, e.g. for osteosynthesis or connecting tendon to bone
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 17/86 Pins or screws or threaded wires; nuts therefor A61B17/72 take precedence
• CPC Class Codes: A61B 17/861 specially shaped for gripping driver
• CPC Class Codes: A61B 17/864 hollow, e.g. with socket or cannulated
• CPC Class Codes: A61B 17/8875 Screwdrivers, spanners or wrenches
• CPC Class Codes: A61B 17/8883 the driver bit acting on the periphery of the screw head
• CPC Class Codes: A61B 17/8886 holding the screw head
• CPC Class Codes: A61B 17/8891 at its periphery
• CPC Class Codes: A61B 17/92 Impactors or extractors, e.g. for removing intramedullary devices insertion or extraction of artificial joints A61F2/4603
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0648 threaded, e.g. tacks with a screw thread
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

The present invention provides devices, systems and methods for anchoring medical devices to hard tissues, such as bones or bony structures, particularly vertebrae. By anchoring these medical devices directly to the surrounding hard tissue, the devices are anchored closer to the source of treatment. This provides additional stability and reduces migration of the device at the treatment site. Also, by attaching to hard tissue rather than soft tissue, a stronger attachment is often able to be made.

Claims

1. A method for anchoring an element within the body, the method comprising:

positioning the element so that a portion resides within the epidural space and portion resides outside of the epidural space;

driving a penetrating end of a hard tissue anchor into a surface of a vertebrae; and

fixing the portion of the element residing outside of the epidural space to the head of the hard tissue anchor so as to substantially maintain the position of the element.

2. A method as in claim 1, wherein driving comprises driving the penetrating end of the hard tissue anchor into the vertebrae adjacent a point of entry of the element into the epidural space.

3. A method as in claim 1, wherein driving comprises driving the penetrating end of the hard tissue anchor into a spinous process of the vertebrae.

4. A method as in claim 1, wherein driving comprises driving the penetrating end of the hard tissue anchor into a foramen of the vertebrae.

5. A method as in claim 1, wherein the element comprises a lead having at least one electrode and positioning comprises positioning the at least one electrode within the epidural space.

6. A method as in claim 5, wherein positioning comprises positioning at least one of the at least one electrodes so as to selectively stimulate a dorsal root ganglion.

7. A method as in claim 1, wherein positioning comprises positioning the element so that at least a portion of the element resides within a foramen.

8. A method as in claim 1, wherein fixing comprises applying pressure to the head so as to secure the element within the aperture.

9. A method as in claim 8, wherein applying pressure comprises deforming the head so as to secure the element within the aperture due to friction.

10. A method as in claim 1, wherein the driving and fixing steps occur at least partially simultaneously.

11. A method as in claim 1, wherein the anchor includes a channel connected to the aperture and further comprising passing a portion of the element through the channel to the aperture.

12. A method as in claim 11, wherein fixing comprises deforming the head so as to at least partially close the channel.

13. A method as in claim 12, wherein driving comprises advancing a distal end of an applicator having the hard tissue anchor mounted thereon so as to drive the penetrating end into the surface of the vertebrae.

14. A method as in claim 13, further comprising advancing the distal end of the applicator through a percutaneous access opening.

15. A system comprising:

a lead comprising an elongate body having at least one electrode, wherein the elongate body is configured for positioning at least one of the at least one electrodes within stimulating range of a dorsal root ganglion;

a hard tissue anchor having a penetrating end configured for penetrating a vertebrae and a head having an aperture, wherein the aperture is configured to receive the elongate body and secure at least one of the at least one electrodes in relation to the dorsal root ganglion while the penetrating end is anchored to the vertebrae.

16. A system as in claim 15, wherein the elongate body is configured for positioning at least partially within a foramen.

17. A system as in claim 15, wherein the head includes a channel connected to the aperture, wherein the channel is configured to allow passage of the lead from outside of the head to the aperture.

18. A system as in claim 17, wherein the head is adjustable to close the channel.

19. A system as in claim 18, wherein the head is adjustable by deformation of the head.

20. A system as in claim 19, wherein deformation of the head secures the lead in relation to the hard tissue anchor.

21. A system as in claim 19, wherein the hard tissue anchor further comprises a grommet disposed within the aperture, and wherein deformation of the head fixes the lead within the grommet.

22. A system as in claim 15, wherein the hard tissue anchor is bioresorbable.

23. A system as in claim 15, wherein the penetrating end has a tapered, conical, notched, barbed, serrated or threaded shape.

24. A system as in claim 23, wherein the penetrating end has a threaded shape wherein the thread is configured for penetrating cortical bone.

25. A system comprising:

a lead comprising an elongate body having at least one electrode, wherein the elongate body is configured for positioning at least partially within a foramen; and

a hard tissue anchor having a penetrating end configured for penetrating a vertebrae and a head having an aperture, wherein the aperture is configured to receive the elongate body and secure the elongate body in relation to the foramen while the penetrating end is anchored to the vertebrae.

26. A system comprising:

a hard tissue anchor having a penetrating end configured for penetrating a vertebrae and a head having an aperture, wherein the aperture is configured to receive and secure a lead while the penetrating end is anchored to the vertebrae; and

an applicator configured for delivering the hard tissue anchor, wherein the applicator comprises a distal end for receiving the head of the hard tissue anchor and a proximal end having a handle thereattached so that force applied to the handle is translatable to the head of the hard tissue anchor.

27. A system as in claim 26, wherein the distal end of the applicator is shaped for passage through a percutaneous access opening.

28. A system as in claim 26, wherein applicator is configured so that the force comprises longitudinal force which is translatable to a downward force on the head of the hard tissue anchor.

29. A system as in claim 26, wherein the applicator is configured so that the force comprises rotational force which is translatable to rotation of the head of the hard tissue anchor.

30. A system as in claim 29, wherein the distal end comprises a rotatable member joinable with the head, wherein the rotation force rotates the rotatable member.