Implantable medical device with anti-infection agent

• US 7,596,408 B2
• Filed: 04/30/2004
• Issued: 09/29/2009
• Est. Priority Date: 12/09/2002
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Singhal, Ruchika, Skime, Robert M., Janzig, Darren A., Scott, Erik R., Wahlstrand, Carl D., Olson, Paulette C., Randall, James E.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Reidel; Jessica
• Application Number:
  US10/837,319
• Publication Number:
  US 20050004620A1
• Time in Patent Office: 1,978 Days
• Field of Search: 607 55- 57, 607136-139, 607 36- 37, 607/45, 427/2.24, 427386-387, 623/10, 600544-545, 600372-373, 600/377, 600/383, 600/25, 604/890.1, 604/891.1, 604/502, 606/108, 606129-130
• US Class Current: 607/3
• 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 with 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 for implantation within the head of 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 electronics for providing monitoring of or therapy to a brain of a patient;

a lead connection module configured to accept an external lead and electrically couple the external lead to the electronics, wherein the external lead is separable from the lead connection module;

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

a lubricious material coated on or impregnated in at least a second portion of the first housing, wherein the first and second portions are different.

2. The implantable medical device of claim 1, wherein the implantable medical device is configured for implantation between a scalp and a cranium of the human body.

3. The implantable medical device of claim 2, wherein a side of the first housing facing the cranium of the human body is substantially concave as viewed from the cranium and the anti-infection agent is on or impregnated in the substantially concave side of the first housing.

4. The implantable medical device of claim 1 further comprising a second module, the 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.

5. The implantable medical device of claim 1, wherein the anti-infection agent is absent from at least one side of the first housing.

6. The implantable medical device of claim 5, wherein the anti-infection agent is only coated on or impregnated in one side of the first housing.

7. The implantable medical device of claim 1, wherein the first housing is metal.

8. The implantable medical device of claim 7, wherein the first housing is titanium.

9. The implantable medical device of claim 1, wherein the first housing is ceramic.

10. The implantable medical device of claim 1, wherein the anti-infection agent is an antimicrobial agent.

11. The implantable medical device of claim 10, wherein the antimicrobial agent is one of an antibiotic and an antiseptic.

12. The implantable medical device of claim 10, wherein the antimicrobial agent comprises the combination of rifampin and minocycline.

13. 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 first housing.

14. The implantable medical device of claim 1, wherein the lead connection module includes a mechanical lead securing mechanism.

15. The implantable medical device of claim 14, wherein the mechanical lead securing mechanism comprises a tool-less mechanical lead securing mechanism.

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

17. 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 electronics for providing monitoring of or therapy to a patient;

a member at least partially encapsulating 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;

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 are different.

18. The implantable medical device of claim 17, wherein the anti-infection agent is only coated on or impregnated in one side of the member.

19. The implantable medical device of claim 17, wherein the implantable medical device is configured for implantation in the head of the human body.

20. The implantable medical device of claim 19, wherein the implantable medical device is configured for implantation between the scalp and the cranium.

21. The implantable medical device of claim 20, wherein a first side of the member facing the scalp is substantially convex as viewed from the scalp.

22. The implantable medical device of claim 21, wherein the anti-infection agent is only coated on or impregnated in a substantially concave side of the member that is substantially opposite the first side.

23. The implantable medical device of claim 21, wherein the lubricious material is only disposed on the first side of the member.

24. The implantable medical device of claim 17, wherein the member is flexible.

25. The implantable medical device of claim 17, wherein the member comprises an elastomeric material.

26. The implantable medical device of claim 25, wherein the elastomeric material is silicone.

27. The implantable medical device of claim 17, wherein the member comprises a non-elastomeric material.

28. The implantable medical device of claim 27, wherein the non-elastomeric material is one of a polysulfone and a polyurethane.

29. The implantable medical device of claim 17, further comprising a lead connection module within the member for connecting an external lead to electronics within the first module, wherein the external lead is separable from the lead connection module.

30. The implantable medical device of claim 17, 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.

31. The implantable medical device of claim 30, wherein the angle is within a range from 120 and 150 degrees.

32. The implantable medical device of claim 31, wherein the angle is approximately equal to 135 degrees.

33. The implantable medical device of claim 17, 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.

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

35. The implantable medical device of claim 17, wherein the member includes a groove to hold external lead material.

36. The implantable medical device of claim 17, wherein the member includes a pouch to hold external lead material.

37. The implantable medical device of claim 17, wherein the member includes a through-hole to receive an attachment mechanism for attaching the implantable medical device to a patient.

38. The implantable medical device of claim 17, 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.

39. The implantable medical device of claim 38, wherein the anti-infection material is only coated on or impregnated in one side of the member.

40. The implantable medical device of claim 38, wherein the implantable medical device is configured for implantation in the head of the human body.

41. The implantable medical device of claim 40, wherein the implantable medical device is configured for implantation between the scalp and the cranium.

42. The implantable medical device of claim 41, wherein the side of the member facing the scalp is substantially convex as viewed from the scalp.

43. The implantable medical device of claim 42, wherein the anti-infection agent is only coated on or impregnated in the substantially convex side of the member.

44. The implantable medical device of claim 38, wherein the member is flexible.

45. The implantable medical device of claim 38, wherein the member comprises an elastomeric material.

46. The implantable medical device of claim 45, wherein the elastomeric material is silicone.

47. The implantable medical device of claim 38, wherein the member comprises a non-elastomeric material.

48. The implantable medical device of claim 47, wherein the non-elastomeric material is one of a polysulfone and a polyurethane.

49. The implantable medical device of claim 38, further comprising a lead connection module within the member for connecting an external lead to electronics within the first module, wherein the external lead is separable from the lead connection module.

50. The implantable medical device of claim 38, 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.

51. The implantable medical device of claim 50, wherein the angle is within a range from 120 and 150 degrees.

52. The implantable medical device of claim 51, wherein the angle is approximately equal to 135 degrees.

53. The implantable medical device of claim 17, wherein the anti-infection agent is an antimicrobial agent.

54. The implantable medical device of claim 53, wherein the antimicrobial agent is one of an antibiotic and an antiseptic.

55. The implantable medical device of claim 53, wherein the antimicrobial agent comprises the combination of rifampin and minocycline.

56. The implantable medical device of claim 17, wherein the anti-infection agent is impregnated in a polymer layer and the polymer layer is attached to the first portion of the member.

57. The implantable medical device of claim 17, wherein the anti-infection agent and the lubricious material are impregnated in the member.

58. 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 electronics for providing monitoring of or therapy to a patient;

a lead connection module configured to accept an external lead and electrically couple the external lead to the electronics, wherein the external lead is separable from the lead connection module;

anti-infection means coated on or impregnated in at least a first portion of the first housing for reducing the likelihood of infection to the body; and

lubricious means coated on or impregnated in at least a second portion of the first housing, wherein the first and second portions are different.

59. The implantable medical device of claim 58, wherein the lubricious means is electrically conductive.

60. 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 electronics for providing monitoring of or therapy to a patient;

a lead connection module configured to accept an external lead and electrically couple the external lead to the electronics, wherein the external lead is separable from the lead connection module;

a member at least partially encapsulating the first module and the lead connection module, wherein the member provides a smooth interface between at least a portion of the first housing and a tissue of the human body;

anti-infection means coated on or impregnated in at least a first portion of the member for reducing the likelihood of infection to the body; and

lubricious means coated on or impregnated in at least a second portion of the member, wherein the first and second portions are different.

61. An implantable medical device for implantation within the 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 electronics for providing monitoring of or therapy to a patient, and wherein the plurality of housings comprises a lead connection module configured to accept an external lead and electrically couple the external lead to the electronics, wherein the external lead is separable from the lead connection module;

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;

anti-infection means coated on or impregnated in at least a first portion of the means for integrating for reducing the likelihood of infection to the body; and

lubricious means coated on or impregnated in at least a second portion of the means for integrating for reducing the likelihood of infection to the body, wherein the first and second portions are different.

62. The implantable medical device of claim 61, wherein the means for integrating is flexible.

63. The implantable medical device of claim 61, wherein the means for integrating provides a sloped interface with a surface of a patient.

64. A method for fabricating an implantable medical device configured for implantation in a head of a human body, the method comprising:

fabricating a first module, the 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 the brain;

fabricating a lead connection module, wherein the lead connection module is configured to accept an external lead that is separable from the lead connection module and electrically couple the external lead to the electronics;

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

applying a lubricious material to at least a second portion of the first housing, wherein the first and second portions are different.

65. The method according to claim 64, wherein the anti-infection agent comprises an antimicrobial agent.

66. The implantable medical device of claim 65, wherein the antimicrobial agent is one of an antibiotic and an antiseptic.

67. The method according to claim 65, wherein the antimicrobial agent comprises the combination of rifampin and minocycline.

68. The method according to claim 64, wherein the step of applying an anti-infection agent to the first housing comprises spraying an anti-infection agent onto the first housing.

69. The method according to claim 64, wherein the step of applying an anti-infection agent to the first housing comprises placing the first housing into the anti-infection agent.

70. The method according to claim 64 further comprising fabricating a second module comprising a second housing, connecting the first and second modules, and applying an anti-infection agent to the second housing.

71. The method according to claim 64, wherein the implantable medical device is configured for implantation between a scalp and a cranium of the patient.

72. The method according to claim 64, wherein the step of applying an anti-infection agent comprises incorporating the anti-infection agent into a polymer layer and attaching the polymer layer to the first housing.

73. The method according to claim 72, wherein the polymer layer comprises the lubricious material.

74. The method of claim 64, wherein the lubricious material is electrically conductive.

75. 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;

at least partially encapsulating the first module with the member to construct the implantable medical device;

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

applying an anti-infection agent to a second portion of the member for reducing the likelihood of infection to the body, wherein the first and second portions are different.

76. The method of claim 75, wherein the anti-infection agent is an antimicrobial agent.

77. The implantable medical device of claim 76, wherein the antimicrobial agent is one of an antibiotic and an antiseptic.

78. The method according to claim 75, wherein the member comprises a solid biocompatible elastomeric material that is flexible.

79. The method according to claim 75, wherein the step of applying an anti-infection agent to the member comprises spraying an anti-infection agent onto the member.

80. The method according to claim 75, wherein the step of applying an anti-infection agent to the member comprises placing the member into the anti-infection agent.

81. The method according to claim 75, wherein the implantable medical device is configured for implantation within a head of a patient.

82. The method according to claim 75, wherein the implantable medical device is configured for implantation between a scalp and a cranium of the patient.

83. The method according to claim 75, wherein the step of applying an anti-infection agent comprises incorporating the anti-infection agent into a polymer layer and attaching the polymer layer to the member.

84. The method according to claim 83, wherein the polymer layer comprises a lubricious material.

85. The method according to claim 75, wherein the step of applying the anti-infection agent comprises compounding the anti-infection agent with the member.