Implantation of low-profile implantable medical device

• US 8,397,732 B2
• Filed: 12/09/2003
• Issued: 03/19/2013
• Est. Priority Date: 12/09/2002
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Singhal, Ruchika, Skime, Robert M., Wahlstrand, Carl D.
• Primary Examiner(s): Matthews, William H.
• Application Number:
  US10/731,868
• Publication Number:
  US 20040173221A1
• Time in Patent Office: 3,388 Days
• Field of Search: 623/11, 623/15.11, 623/24, 607/36, 607/45, 607/116
• US Class Current: 128/898
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/37514 Brain implants
• CPC Class Codes: A61N 1/37518 Anchoring of the implants, e.g. fixation
• CPC Class Codes: A61N 1/3754 Feedthroughs
• CPC Class Codes: A61N 1/3758 Packaging of the components within the casing

Abstract

In general, the invention is directed to techniques for implantation of a low-profile implantable medical device (IMD) in the body of a patient. In an exemplary embodiment, the low-profile IMD is implanted under the scalp. When the treatment or monitoring site is in or on the head of the patient, the low-profile IMD can be implanted under the scalp proximate to the treatment or monitoring site. In one embodiment, the invention is directed to a method that includes making an incision in the scalp of a head of a patient to create a scalp flap, exposing a skull beneath the scalp flap, creating a pocket between the scalp and the skull, and placing at least a portion of a low-profile IMD in the pocket. The low-profile IMD may include a plurality of modules, covered in part by a flexible overmold.

Claims

1. A method comprising:

making an incision in a scalp of a head of a patient to create a scalp flap;

separating the scalp flap from a skull of the patient, wherein the separated scalp flap is attached to the remainder of the scalp by a fold;

after separating the scalp flap from the skull, separating a portion of the remainder of the scalp adjacent to the fold from the skull to create a pocket adjacent to the fold and between the scalp and the skull;

placing at least a portion of a low-profile implantable medical device in the pocket adjacent to the fold and underneath the scalp;

drilling one or more burr holes in a portion of the skull of the patient exposed by separating the scalp flap from the skull; and

inserting one or more leads through the burr holes and into a brain of the patient.

2. The method of claim 1, wherein the low-profile implantable medical device comprises:

a first module that includes control electronics within a first housing;

a second module that includes a second housing; and

a flexible overmold that at least partially covers the first and second housings.

3. The method of claim 1, wherein the low-profile implantable medical device has a maximum thickness of between approximately 4 millimeters and approximately 8 millimeters.

4. The method of claim 1, wherein the low-profile implantable medical device has a maximum thickness of approximately 6 millimeters.

5. The method of claim 1, wherein the low-profile implantable medical device has a periphery and wherein the angle between the periphery and the skull, is greater than ninety degrees.

6. The method of claim 5, wherein the angle is approximately 135 degrees.

7. The method of claim 1, further comprising connecting the one or more leads to the low-profile implantable medical device.

8. The method of claim 1, further comprising anchoring the low-profile implantable medical device to the skull.

9. The method of claim 8, wherein anchoring the low-profile implantable medical device to the skull comprises anchoring the low-profile implantable medical device to the skull with a bone screw.

10. The method of claim 1, further comprising:

covering an exposed portion of the low-profile implantable medical device with the scalp flap; and

suturing the scalp flap to close the incision.

11. The method of claim 1, further comprising:

creating a recess in the skull; and

placing the low-profile implantable medical device in the recess.

12. The method of claim 1, further comprising:

creating a second pocket between the scalp and the skull; and

placing at least a portion of a low-profile implantable medical device in the second pocket.

13. The method of claim 12, wherein the low-profile implantable medical device comprises:

a first module within a first housing;

a flexible overmold that at least partially covers the first housings;

a second module that includes a second housing; and

a flexible tether member that couples the second module to the first module,

wherein placing at least a portion of a low-profile implantable medical device in the second pocket comprises placing at least a portion of the second module in the second pocket.

14. The method of claim 1, wherein the low-profile implantable medical device is contoured in three dimensions to substantially conform to the shape of a skull.

15. The method of claim 1, further comprising adjusting the low-profile implantable medical device to cause a contour of the low-profile implantable medical device to more closely match a contour of the skull.

16. The method of claim 1, further comprising administering a local anesthetic to the patient prior to making the incision.

17. The method of claim 1, wherein the incision is made in a top of the head of the patient.

18. The method of claim 1, wherein placing at least a portion of the low-profile implantable medical device in the pocket comprises placing all of the low-profile implantable medical device in the pocket.

19. The method of claim 1, wherein the low-profile implantable medical device is a neurostimulator that provides deep brain stimulation.

20. The method of claim 1, wherein the incision is a C-flap incision.

21. A method comprising:

making an incision in a scalp at a top of a head of a patient to create a scalp flap at the to of the head of the patient;

separating the scalp flap from a skull of the patient, wherein the separated scalp flap is attached to the remainder of the scalp by a fold;

after separating the scalp flap from the skull, separating a portion of the remainder of the scalp adjacent to the fold from the skull to create a pocket adjacent to the fold and between the scalp and the skull;

placing at least a portion of a low-profile implantable medical device in the pocket adjacent to the fold and underneath the scalp;

drilling one or more burr holes in a portion of the skull of the patient exposed by separating the scalp flap from the skull;

inserting one or more leads through the burr holes and into a brain of the patient;

connecting the one or more leads to the low-profile implantable medical device;

covering the low-profile implantable medical device, leads and burr holes with the scalp flap; and

closing the incision.

22. The method of claim 21, further comprising:

creating a recess in the skull; and

placing the low-profile implantable medical device within the recess.

23. A method comprising:

making an incision in a scalp at a top of a head of a patient to create a scalp flap at the top of the head of the patient;

separating the scalp flap from a skull of the patient, wherein the separated scalp flap is attached to the remainder of the scalp by a fold;

after separating the scalp flap from the skull, separating a portion of the remainder of the scalp adjacent to the fold from the skull to create a pocket adjacent to the fold and between the scalp and the skull; and

placing at least a portion of a low-profile implantable medical device in the pocket adjacent to the fold and underneath the scalp.

24. The method of claim 23, wherein placing the portion of the low-profile implantable medical device in the pocket adjacent to the fold and underneath the scalp comprises placing all of the low-profile implantable medical device in the pocket adjacent to the fold and underneath the scalp.

25. The method of claim 23, wherein the low-profile implantable medical device is a neurostimulator that provides deep brain stimulation.