Implantable medical device with anti-infection agent

• US 8,086,313 B2
• Filed: 08/05/2009
• Issued: 12/27/2011
• Est. Priority Date: 12/09/2002
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Singhal, Ruchika, Janzig, Darren A., Wahlstrand, Carl D., Skime, Robert M., Olson, Paulette C., Scott, Erik R., Randall, James E.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Sarcione, Jessica
• Application Number:
  US12/536,258
• Publication Number:
  US 20090292327A1
• Time in Patent Office: 874 Days
• Field of Search: 607 1- 3, 607 36- 37, 607/45, 607 55- 57, 607136-137, 607/139, 604/890.1, 604/891.1, 604/502, 606/108, 606129-130
• US Class Current: 607/36
• CPC Class Codes: A61B 2560/04 Constructional details of apparatus
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 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
• CPC Class Codes: A61N 1/37518 Anchoring of the implants, e.g. fixation
• CPC Class Codes: A61N 1/3754 Feedthroughs

Abstract

An implantable medical device comprises an anti-infection agent. The implantable medical device may be configured for placement in the head of a patient and for monitoring or treatment of the brain. 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 adjacent tissue. The anti-infection agent may be provided on or impregnated in the housing or the member. In some embodiments, the device includes a single module while in other embodiments a plurality of modules are coupled to provide a smaller profile. In some embodiments the implantable medical device may include both anti-infection and lubricious materials.

Claims

1. An implantable medical device comprising:

a module comprising a housing that contains at least a portion of electronics for providing monitoring of or therapy to a brain of a patient;

an anti-infection agent coated on or impregnated in at least a first portion of the housing; and

a lubricious material coated on or impregnated in at least a second portion of the housing, wherein the first and second portions of the housing are different sides, and wherein at least one of the anti-infection agent or the lubricious material is only coated on or impregnated in one side of the housing.

2. The implantable medical device of claim 1, wherein the module comprises a first module and the housing comprises a first housing, wherein the medical device further comprising a second module comprising a second housing, wherein the first and second modules are connected, and wherein the anti-infection agent is coated on or impregnated in the second housing.

3. The implantable medical device of claim 1, wherein the anti-infection agent is only coated on or impregnated in one side of the housing.

4. The implantable medical device of claim 1, wherein the housing comprises ceramic.

5. The implantable medical device of claim 1, wherein the housing defines a substantially concave side that includes the first portion of the housing.

6. The implantable medical device of claim 5, wherein the housing defines a substantially convex surface that includes the second portion of the housing.

7. The implantable medical device of claim 1, wherein the lubricious material comprises a polymer layer and wherein the anti-infection agent is impregnated in the polymer layer and the polymer layer is attached to the at least the second portion of the housing.

8. The implantable medical device of claim 1, wherein the lubricious material is electrically conductive.

9. An implantable medical device comprising:

a module comprising a housing that contains at least a portion of electronics for providing monitoring of or therapy to a patient;

a member at least partially encapsulating the module, wherein the member provides a smooth interface between at least a portion of the housing and tissue of a patient;

an anti-infection agent coated on or impregnated in a first portion of the member; and

a lubricious material coated on or impregnated in at least a second portion of the member, wherein the first and second portions of the member are different sides, and wherein at least one of the anti-infection agent or the lubricious material is only coated on or impregnated in one side of the housing.

10. The implantable medical device of claim 9, wherein the anti-infection agent is only coated on or impregnated in one side of the member.

11. The implantable medical device of claim 10, wherein the member defines a substantially concave side comprising the first portion of the member.

12. The implantable medical device of claim 11, wherein the anti-infection agent is only coated on or impregnated in the substantially concave side of the member.

13. The implantable medical device of claim 10, wherein the member defines a substantially convex side comprising the second portion of the member.

14. The implantable medical device of claim 13, wherein the lubricious material is only on the substantially convex side of the member.

15. The implantable medical device of claim 9, wherein the member is flexible.

16. The implantable medical device of claim 9, further comprising a lead connection module within the member for connecting an external lead to electronics within the module, wherein the external lead is separable from the lead connection module.

17. The implantable medical device of claim 9, wherein an edge of the member provides a sloped interface with a surface of the patient, and an angle between the edge and the surface of the patient is greater than 90 degrees.

18. The implantable medical device of claim 9, wherein the lubricious material is electrically conductive.

19. An implantable medical device comprising:

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

anti-infection means coated on or impregnated in at least a first portion of the housing; and

lubricious means coated on or impregnated in at least a second portion of the housing, wherein the first and second portions of the housing are different sides, and wherein at least one of the anti-infection means or the lubricious means is only coated on or impregnated in one side of the housing.

20. The implantable medical device of claim 19, wherein the anti-infection agent is absent from at least one side of the housing.

21. An implantable medical device comprising:

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

means for at least partially encapsulating the module, wherein the means for at least partially encapsulating the module provides a smooth interface between at least a portion of the housing and tissue of a patient;

anti-infection means coated on or impregnated in at least a first portion of the means for at least partially encapsulating the module; and

lubricious means coated on or impregnated in at least a second portion of the means for at least partially encapsulating the module, wherein the first and second portions of the means for at least partially encapsulating the module are different sides, and wherein at least one of the anti-infection means or the lubricious means is only coated on or impregnated in one side of the means for at least partially encapsulating the module.

22. The implantable medical device of claim 21, wherein the means for at least partially encapsulating the module includes a substantially concave side comprising the first portion and a substantially convex side comprising the second portion.

23. The implantable medical device of claim 22, wherein the anti-infection agent is only coated on or impregnated in the substantially concave side of the means for at least partially encapsulating the module.

24. The implantable medical device of claim 22, wherein the lubricious material is only on the substantially convex side of the means for at least partially encapsulating the module.

25. The implantable medical device of claim 21, wherein the module comprises a first module comprising a first housing, the implantable medical device further comprising a second module comprising a second housing, wherein the means for at least partially encapsulating the first module integrates the first and second module into a single structure and provides a smooth interface between the first and second housings and tissue of the patient.

26. A method comprising:

fabricating a module comprising a housing containing at least a portion of the electronics for providing monitoring of or therapy to a patient;

applying an anti-infection agent to at least a first portion of the housing; and

applying a lubricious material to at least a second portion of the housing, wherein the first and second portions of the housing are different sides, and wherein at least one of the anti-infection agent or the lubricious material is only applied to one side of the housing.

27. The method of claim 26, wherein applying an anti-infection agent to the at least the first portion of the housing comprises spraying an anti-infection agent onto the at least the first portion of the housing.

28. The method of claim 26, wherein applying an anti-infection agent to the at least the first portion of the housing comprises placing the at least the first portion of the housing into the anti-infection agent.

29. The method of claim 26, wherein applying an anti-infection agent to the at least the first portion of the housing comprises incorporating the anti-infection agent into a polymer layer and attaching the polymer layer to the at least the first portion of the housing.

30. The method of claim 26, wherein applying an anti-infection agent to the at least the first portion of the housing comprises applying the anti-infection agent to only one side of the housing.

31. A method comprising:

fabricating a member configured to provide a smooth interface between an implantable medical device and tissue of a patient;

fabricating a module containing at least a portion of the electronics for providing monitoring of or therapy to the patient;

at least partially encapsulating the module with the member;

applying a lubricious coating to at least a first portion of the member; and

applying an anti-infection agent to at least a second portion of the member, wherein the first and second portions of the member are different sides, and wherein at least one of the anti-infection agent or the lubricious material is only applied to one side of the member.

32. The method of claim 31, wherein applying an anti-infection agent to the at least the first portion of the member comprises spraying an anti-infection agent onto the at least the first portion of the member.

33. The method of claim 31, wherein applying an anti-infection agent to the at least the first portion of the member comprises placing the at least the first portion of the member into the anti-infection agent.

34. The method of claim 31, wherein applying an anti-infection agent to the at least the first portion of the member comprises incorporating the anti-infection agent into a polymer layer and attaching the polymer layer to the at least the first portion of the member.

35. The method of claim 34, wherein the polymer layer comprises the lubricious material.

36. The method of claim 31, wherein applying an anti-infection agent to the at least the first portion of the member comprises compounding the anti-infection agent with the at least the first portion of the member.

37. The method of claim 31, wherein applying an anti-infection agent to the at least the first portion of the housing comprises applying the anti-infection agent to only one side of the member.

38. The method of claim 31, wherein applying a lubricious material to the at least the second portion of the housing comprises applying the lubricious material to only one side of the member.