Implantation of low-profile implantable medical device

• US 20040173221A1
• Filed: 12/09/2003
• Published: 09/09/2004
• 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.
• Granted Patent: US 8,397,732 B2
• Time in Patent Office: Days
• 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 the scalp of a head of a patient to create a scalp flap;

creating a pocket between the scalp and a skull; and

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

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 a lead to the low-profile implantable medical device.

8. The method of claim 6, further comprising:

drilling a burr hole through the skull; and

inserting a portion of the lead through the burr hole.

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

10. The method of claim 9, 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.

11. The method of claim 1, further comprising:

covering at least a portion of the low-profile implantable medical device with the scalp flap; and

suturing the scalp flap to close the incision.

12. The method of claim 1, further comprising creating a recess in the skull.

13. 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.

14. The method of claim 13, 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.

15. 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.

16. 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.

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

18. A method comprising:

in a first surgical procedure,

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 dummy low-profile implantable medical device in the pocket;

covering at least a portion of the dummy low-profile implantable medical device with the scalp flap;

suturing the scalp flap to close the incision; and

in a second surgical procedure, removing the dummy low-profile implantable medical device and implanting a working low-profile implantable medical device in place of the dummy low-profile implantable medical device.

19. The method of claim 18, further comprising adjusting a contour of the working low-profile implantable medical device as a function of the shape of the dummy low-profile implantable medical device.

20. The method of claim 18, wherein the dummy low-profile implantable medical device has a first volume prior to suturing, the method further comprising expanding the dummy low-profile implantable medical device to a second volume following suturing.

21. The method of claim 20, wherein expanding the dummy low-profile implantable medical device to a second volume comprises injecting fluid into the dummy low-profile implantable medical device.