Implantable medical device with lubricious material

• US 20070074732A1
• Filed: 09/25/2006
• Published: 04/05/2007
• Est. Priority Date: 04/30/2004
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Singhal, Ruchika, Wahlstrand, Carl, Scott, Erik, Skime, Robert, Randall, James, Olson, Paulette, Janzig, Darren
• Granted Patent: US 9,162,072 B2
• Time in Patent Office: Days
• US Class Current: 128/899
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61N 1/0526 Head electrodes A61N1/0551 takes precedence
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: A61N 1/37514 Brain implants

Abstract

An implantable medical device with lubricious material permits implantable medical devices to have a reduced friction between the device and at least a portion of the surrounding tissue. The implantable medical device may have a housing or it may have a housing and a member for providing a smooth interface between the device and the tissue. The lubricious material may be provided on or impregnated in the housing or the member. In some embodiments, the device is configured for implantation in the head of a human body. In other embodiments, the device is configured for implantation between the cranium and the scalp. In some embodiments, the device includes a single module while in other embodiments a plurality of modules are coupled together to provide a smaller profile.

Claims

1. An implantable medical device for implantation within a human body, the implantable medical device comprising:

a first module comprising a first housing, wherein the first housing contains at least a portion of the electronics for providing monitoring of or therapy to a patient;

a member coupled to the first module, wherein the member provides a smooth interface between at least a portion of the first housing and a tissue of the human body; and

a lubricious material on or impregnated in at least a portion of the member for reducing the friction between the member and a tissue of the human body.

2. The implantable medical device of claim 1, wherein the lubricous material is only on or impregnated in one side of the member.

3. The implantable medical device of claim 1, wherein the implantable medical device is configured for implantation in a head of the human body.

4. The implantable medical device of claim 3, wherein the implantable medical device is configured for implantation between a scalp and a cranium of the human body.

5. The implantable medical device of claim 4, wherein a side of the member facing the scalp is substantially convex as viewed from the scalp.

6. The implantable medical device of claim 5, wherein the lubricious material is only on or impregnated in the substantially convex side of the member.

7. The implantable medical device of claim 1, wherein the member is flexible.

8. The implantable medical device of claim 1, wherein the member comprises an elastomeric material.

9. The implantable medical device of claim 8, wherein the elastomeric material is silicone.

10. The implantable medical device of claim 1, wherein the member comprises a non-elastomeric material.

11. The implantable medical device of claim 10, wherein the non-elastomeric material is one of a polysulfone and a polyurethane.

12. The implantable medical device of claim 1, further comprising a lead connection module within the member for connecting an external lead to electronics within the first module.

13. The implantable medical device of claim 1, wherein an edge of the member provides a sloped interface with a surface of a patient, and an angle between the edge and the surface of the patient is greater than 90 degrees.

14. The implantable medical device of claim 13, wherein the angle is within a range from 120 to 150 degrees.

15. The implantable medical device of claim 14, wherein the angle is approximately equal to 135 degrees.

16. The implantable medical device of claim 1, wherein the member comprises a material having a high thermal conductivity to act as a heat sink for thermal energy generated within the first module.

17. The implantable medical device of claim 1, wherein the member comprises a material having a low thermal conductivity to act as a shield of thermal energy generated within the first module.

18. The implantable medical device of claim 1, wherein the member includes a groove to hold external lead material.

19. The implantable medical device of claim 1, wherein the member includes a pouch to hold external lead material.

20. The implantable medical device of claim 1, wherein the member includes a through-hole to receive an attachment mechanism for attaching the implantable medical device to a patient.

21. The implantable medical device of claim 1, further comprising a second module coupled to the member, the second module comprising a second housing, wherein the member provides a smooth interface between the first and second housings and a tissue of the human body.

22. The implantable medical device of claim 21, wherein the lubricous material is only on or impregnated in one side of the member.

23. The implantable medical device of claim 21, wherein the implantable medical device is configured for implantation in a head of the human body.

24. The implantable medical device of claim 23, wherein the implantable medical device is configured for implantation between a scalp and a cranium of the human body.

25. The implantable medical device of claim 24, wherein a side of the member facing the scalp is substantially convex as viewed from the scalp.

26. The implantable medical device of claim 25, wherein the lubricious material is only on or impregnated in the substantially convex side of the member.

27. The implantable medical device of claim 21, wherein the member is flexible.

28. The implantable medical device of claim 21, wherein the member comprises an elastomeric material.

29. The implantable medical device of claim 28, wherein the elastomeric material is silicone.

30. The implantable medical device of claim 21, wherein the member comprises a non-elastomeric material.

31. The implantable medical device of claim 30, wherein the non-elastomeric material is one of a polysulfone and a polyurethane.

32. The implantable medical device of claim 21, further comprising a lead connection module within the member for connecting an external lead to electronics within the first module.

33. The implantable medical device of claim 21, wherein an edge of the member provides a sloped interface with a surface of a patient, and an angle between the edge and the surface of the patient is greater than 90 degrees.

34. The implantable medical device of claim 33, wherein the angle is within a range from 120 to 150 degrees.

35. The implantable medical device of claim 34, wherein the angle is approximately equal to 135 degrees.

36. The implantable medical device of claim 1, wherein the lubricious material is at least one of polyvinyl pyrrolidone (PVP) hydrogel, fluoroethylpolymer, polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), ethylene tetrafluoroethylene (ETFT), paralene, or a hydrophilic polymer.

37. An implantable medical device for implantation within a human body, the implantable medical device comprising:

a first module comprising a first housing, wherein the first housing contains at least a portion of the electronics for providing monitoring of or therapy to a patient;

a member coupled to the first module, wherein the member provides a smooth interface between at least a portion of the first housing and a tissue of the human body; and

lubricating means on or impregnated in at least a portion of the member for reducing the friction between the member and the tissue of the human body.

38. An implantable medical device for implantation within a head of a human body, the implantable medical device comprising:

a plurality of modules, the plurality of modules comprising a plurality of housings, wherein the plurality of housings contains at least a portion of the electronics for providing monitoring of or therapy to a patient;

means for integrating the modules into a single structure that at least partially encapsulates each of the housings, whereby the means for integrating the modules provides a smooth interface between the plurality of housings and a tissue of the human body; and

lubricating means on or impregnated in at least a portion of the means for integrating for reducing the friction between the means for integrating and the tissue of the human body.

39. The implantable medical device of claim 38, wherein the means for integrating is flexible.

40. The implantable medical device of claim 38, wherein the means for integrating provides a sloped interface with a surface of a patient.

41. A method for fabricating an implantable medical device, the method comprising:

fabricating a member configured to provide a smooth interface between the implantable medical device and a tissue of a human body;

fabricating a first module;

combining the member and the first module to construct the implantable medical device; and

applying a lubricious material to the member for reducing friction between the member and the tissue.

42. The method of claim 41, wherein the lubricious material is at least one of polyvinyl pyrrolidone (PVP) hydrogel, fluoroethylpolymer, polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), ethylene tetrafluoroethylene (ETFT), paralene, or a hydrophilic polymer.

43. The method according to claim 41, wherein the member comprises a solid biocompatible elastomeric material that is flexible.

44. The method according to claim 41, wherein applying the lubricious material to the member comprises spraying the lubricious material onto the member.

45. The method according to claim 41, wherein applying the lubricious material to the member comprises placing the member into the lubricious material.

46. The method according to claim 41, wherein the implantable medical device is configured for implantation within a head of a patient.

47. The method according to claim 41, wherein the implantable medical device is configured for implantation between a scalp and a cranium of the patient.