Bone growth stimulator

• US 4,333,469 A
• Filed: 07/20/1979
• Issued: 06/08/1982
• Est. Priority Date: 07/20/1979
• Status: Expired due to Term

• Current Assignee: Electro-Biology Incorporated (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Telectronics Incorporated
• Inventors: Jeffcoat, Keith W., Wickham, Geoffrey G.
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US06/059,443
• Time in Patent Office: 1,054 Days
• Field of Search: 128/419 F, 128/419 B, 128/419 C, 128/419 P, 128/419 R, 128/82.1, 128/784-786, 174/117 F, 174/110 PM
• US Class Current: 607/5
• CPC Class Codes: A61B 17/58 for osteosynthesis, e.g. bone plates, screws , setting implements or the like A61B17/14, A61B17/16 take precedence
• CPC Class Codes: A61N 1/20 continuous direct currents
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings

Abstract

There is disclosed an improved implantable bone growth stimulator having a titanium, bullet-shaped case and pre-stretched helical electrode leads. The leads are sheathed, and the circuitry in the case is potted in silicone elastomer. The shape of the case lends itself to long-bone applications. The potting material is ideal for preventing ionic contamination of the circuit, while the metal case offers the requisite mechanical strength. The shape of the case facilitates removal during an explant procedure, and the pre-stretching of the leads prevents tissue damage at this time. The electrical circuit is a stacked assembly of components without a circuit board, which gives rise to the desired bullet shape of the case.

Claims

1. An implantable bone growth stimulator comprising a case made of at least 90% titanium, a current source in said case, and anode and at least one cathode leads electrically connected to said current source and exiting said case;

characterized by said case having a cylindrical cross-section and a length which is at least two times greater than its diameter, said anode lead being made of platinum, being bent back where it exits said case, and being electrically connected to said case.

2. An implantable bone growth stimulator comprising a case, a current source in said case, and anode and at least one cathode leads electrically connected to said current source and exiting said case;

characterized by said case being made of metal, and having a cylindrical cross-section and a length which is at least two times greater than its diameter, said current source being a boardless circuit whose components are stacked along the length of said case, said circuit including at least one transistor and at least one battery having a seal therearound, the leads of said at least one transistor and the seal of said at least one battery being disposed at and facing opposite ends of said case, said at least one battery being oriented with its axis co-extensive with the axis of said case, with the largest diametrical dimension of said stacked circuit being essentially that of said at least one battery, said stacked circuit being potted within a silicone elastomer which fills said case, said silicone elastomer potting consisting of a first pot completely enclosing said stacked circuit and a second pot completely filling the space between said first pot and said case.

3. An implantable bone growth stimulator in accordance with claim 2 wherein said first pot includes a plurality of ribs along the exterior thereof for facilitating the formation of said second pot within said case.

4. An implantable bone growth stimulator in accordance with claim 3 wherein said stacked circuit includes at least one wire connected to a battery terminal and being partially disposed in one of said ribs.

5. An implantable bone growth stimulator comprising a case, a current source in said case, and anode and at least one cathode leads electrically connected to said current source and exiting said case;

characterized by said case being made of metal, and having a cylindrical cross-section and a length which is at least two times greater than its diameter, said current source being a boardless circuit whose components are stacked along the length of said case, said circuit including at least one transistor and at least one battery having a seal therearound, the leads of said at least one transistor and the seal of said at least one battery being disposed at and facing opposite ends of said case, said at least one battery being oriented with its axis co-extensive with the axis of said case, with the largest diametrical dimension of said stacked circuit being essentially that of said at least one battery, said stacked circuit being potted within a silicone elastomer which fills said case, said at least one cathode lead being sheathed in polyethylene, and further including silicone elastomer tubing covering that end of the polyethylene sheath which is adjacent to said case, extending into said case, and being bonded to the surrounding silicone elastomer pot which fills said case.

6. An implantable bone growth stimulator in accordance with claim 5 wherein said at least one cathode lead is coated with silicone elastomer within said tubing adjacent to said end of said polyethylene sheath.

7. An implantable bone growth stimulator in accordance with claim 6 wherein said at least one cathode lead stretches by no more than 5% when it is pulled before it breaks.

8. An implantable bone growth stimulator in accordance with claim 7 wherein said at least one cathode lead is in the shape of a pre-stretched helix.

9. An implantable bone growth stimulator comprising a case having a screwthreaded cap, a current source in said case, and anode and at least one cathode leads electrically connected to said current source and exiting said case;

characterized by said case being made of metal, and having a cylindrical cross-section and a length which is at least two times greater than its diameter, said current source being potted in silicone elastomer material within said case, some of said material being disposed in the thread of said cap.

10. An implantable bone growth stimulator comprising a case, a current source in said case, and anode and at least one cathode leads electrically connected to said current source and exiting said case;

characterized by said case being made of metal, and having a cylindrical cross-section and a length which is at least two times greater than its diameter, said current source being potted in silicone elastomer material within said case, with at least one centimeter of said material separating every electrical component in said current source from the points at which said leads exit said case.

13. An implantable bone growth stimulator in accordance with claim 10 wherein said first pot includes a plurality of ribs along the exterior thereof for facilitating the formation of said second pot within said case.

14. An implantable bone growth stimulator in accordance with claim 13 wherein said current source includes at least one wire connected to a battery terminal and being partially disposed in one of said ribs.

11. An implantable bone growth stimulator comprising a case, a current source in said case, and anode and at least one cathode leads electrically connected to said current source and exiting said case;

characterized by said case being made of metal, and having a cylindrical cross-section and a length which is at least two times greater than its diameter, said current source being potted in a material which adheres to the inside wall of said case, allows out-gasing and is impervious to liquids and ionic and polar molecules, with at least one centimeter of said material separating every electrical component in said current source from the points at which said leads exit said case.

12. An implantable bone growth stimulator comprising a case, a current source in said case, and anode and at least one cathode leads electrically connected to said current source and exiting said case;

characterized by said case being made of metal, and having a cylindrical cross-section and a length which is at least two times greater than its diameter, said current source being potted within a silicone elastomer which fills said case, said silicone elastomer potting consisting of a first pot completely enclosing said current source and a second pot completely filling the space between said first pot and said case.

15. An implantable bone growth stimulator comprising a case, a current source in said case, and anode and at least one cathode leads electrically connected to said current source and exiting said case;

characterized by said case being made of metal, and having a cylindrical cross-section and a length which is at least two times greater than its diameter, said current source being potted within a silicone elastomer which fills said case, said at least one cathode lead being sheathed in polyethylene, and further including silicone elastomer tubing covering that end of the polyethylene sheath which is adjacent to said case, extending into said case, and being bonded to the surrounding silicone elastomer pot which fills said case.

16. An implantable bone growth stimulator in accordance with claim 15 wherein said at least one cathode lead is coated with silicone elastomer within said tubing adjacent to said end of said polyethylene sheath.

17. An implantable bone growth stimulator in accordance with claim 16 wherein said at least one cathode lead stretches by no more than 5% when it is pulled before it breaks.

18. An implantable bone growth stimulator in accordance with claim 17 wherein said at least one cathode lead is in the shape of a pre-stretched helix.

19. An implantable bone growth stimulator comprising a case, a current source in said case, and anode and at least one cathode leads electrically connected to said current source and exiting said case;

characterized by said case being made of metal, and having a cylindrical cross-section and a length which is at least two times greater than its diameter, said at least one cathode lead being covered with a plastic sheath, and said at least one cathode lead stretching by no more than 5% when it is pulled before it breaks.

20. An implantable bone growth stimulator in accordance with claim 19 wherein said at least one cathode lead is in the shape of a pre-stretched helix.

21. An implantable bone growth stimulator in accordance with claim 20 wherein said plastic sheath is made of polyethylene.

22. An implantable bone growth stimulator in accordance with claim 19 wherein said plastic sheath is made of polyethylene.

23. An implantable bone growth stimulator comprising a case, a current source in said case, and anode and at least one cathode leads electrically connected to said current source with at least said one cathode lead exiting said case;

characterized by said case being made of a material which is at least 90% titanium, said anode lead being electrically attached to said case and said case having platinum on the exterior thereof.

24. An implantable bone growth stimulator comprising a case, a current source in said case, and anode and at least one cathode leads electrically connected to said current source with at least said one cathode lead exiting said case;

characterized by said cathode lead and said case being made of materials which are at least 90% titanium, said anode lead being made of platinum, and said anode lead being electrically attached to said case, said current source being potted within a silicone elastomer which fills said case, said silicone elastomer potting consisting of a first pot completely enclosing said current source and a second pot completely filling the space between said first pot and said case.

25. An implantable bone growth stimulator comprising a case, a current source in said case, and anode and at least one cathode leads electrically connected to said current source with at least said one cathode lead exiting said case;

characterized by said cathode lead and said case being made of materials which are at least 90% titanium, said anode lead being made of platinum, and said anode lead being electrically attached to said case, said current source being potted within a silicone elastomer which fills said case, said at least one cathode lead being sheathed in polyethylene and further including silicone elastomer tubing covering that end of the polyethylene sheath which is adjacent to said case, extending into said case, and being bonded to the surrounding silicone elastomer pot which fills said case.

26. An implantable bone growth stimulator in accordance with claim 25 wherein said at least one cathode lead is coated with silicone elastomer within said tubing adjacent to said end of said polyethylene sheath.

27. An implantable bone growth stimulator in accordance with claim 26 wherein said at least one cathode lead stretches by no more than 5% when it is pulled before it breaks.

28. An implantable bone growth stimulator in accordance with claim 27 wherein said at least one cathode lead is in the shape of a pre-stretched helix.

29. An implantable bone growth stimulator comprising a case, a current source in said case, and anode and at least one cathode leads electrically connected to said current source with at least said one cathode lead exiting said case;

characterized by said cathode lead and said case being made of materials which are at least 90% titanium, said anode lead being made of platinum, and said anode lead being electrically attached to said case, said at least one cathode lead being covered with a plastic sheath, and said at least one cathode lead stretching by no more than 5% when it is pulled before it breaks.

30. An implantable bone growth stimulator in accordance with claim 29 wherein said at least one cathode lead is in the shape of a pre-stretched helix.

31. An implantable bone growth stimulator in accordance with claim 30 wherein said plastic sheath is made of polyethylene.

32. An implantable bone growth stimulator comprising a case, a current source in said case, and anode and at least one cathode leads electrically connected to said current source with at least said one cathode lead exiting said case;

characterized by said cathode lead and said case being made of materials which are at least 90% titanium, said anode lead being made of platinum, and said anode lead being electrically attached to said case, said anode lead exiting said case, being bent back, and being attached to the outside of said case.

33. An implantable bone growth stimulator comprising a case;

a current source in said case;

said current source being potted in a material which adheres to the inside wall of said case, allows out-gasing and is impervious to liquids and ionic and polar molecules; and

anode and at least one cathode leads electrically connected to said current source and exiting said case;

characterized by said current source including at least one transistor and at least one battery having a seal therearound, with the leads of said at least one transistor and the seal of said at least one battery being disposed at and facing opposite ends of said case, said current source being potted in silicone elastomer material, with at least one centimeter of said material separating every electrical component in said current source from the points at which said leads exit the case.

34. An implantable bone growth stimulator comprising a case;

a current source in said case;

said current source being potted in a material which adheres to the inside wall of said case, allows out-gasing and is impervious to liquids and ionic and polar molecules; and

anode and at least one cathode leads electrically connected to said current source and exiting said case;

characterized by said current source including at least one transistor and at least one battery having a seal therearound, with the leads of said at least one transistor and the seal of said at least one battery being disposed at and facing opposite ends of said case, said current source being potted within a silicone elastomer which fills said case, said silicone elastomer potting consisting of a bubble-free first pot completely enclosing said current source and a second pot completely filling the space between said first pot and said case.

42. An implantable bone growth stimulator in accordance with claim 34 wherein said plastic sheath is made of polyethylene.

35. An implantable bone growth stimulator comprising a case;

a current source in said case;

said current source being potted in a material which adheres to the inside wall of said case, allows out-gasing and is impervious to liquids and ionic and polar molecules; and

anode and at least one cathode leads electrically connected to said current source and exiting said case;

characterized by said current source including at least one transistor and at least one battery having a seal therearound, with the leads of said at least one transistor and the seal of said at least one battery being disposed at and facing opposite ends of said case, said current source being potted within a silicone elastomer which fills said case, said at least one cathode lead being sheathed in polyethylene, and further including silicone elastomer tubing covering that end of the polyethylene sheath which is adjacent to said case, extending into said case, and being bonded to the surrounding silicone elastomer pot which fills said case.

36. An implantable bone growth stimulator in accordance with claim 35 wherein said at least one cathode lead is coated with silicone elastomer within said tubing adjacent to said end of said polyethylene sheath.

37. An implantable bone growth stimulator in accordance with claim 36 wherein said at least one cathode lead stretches by no more than 5% when it is pulled before it breaks.

38. An implantable bone growth stimulator in accordance with claim 37 wherein said at least one cathode lead is in the shape of a pre-stretched helix.

39. An implantable bone growth stimulator comprising a case;

a current source in said case;

said current source being potted in a material which adheres to the inside wall of said case, allows out-gasing and is impervious to liquids and ionic and polar molecules; and

anode and at least one cathode leads electrically connected to said current source and exiting said case;

characterized by said current source including at least one transistor and at least one battery having a seal therearound, with the leads of said at least one transistor and the seal of said at least one battery being disposed at and facing opposite ends of said case, said at least one cathode lead being covered with a plastic sheath, and said at least one cathode lead stretching by no more than 5% when it is pulled before it breaks.

40. An implantable bone growth stimulator in accordance with claim 39 wherein said at least one cathode leads is in the shape of a pre-stretched helix.

41. An implantable bone growth stimulator in accordance with claim 40 wherein said plastic sheath is made of polyethylene.

43. An implantable bone growth stimulator comprising a case, a current source in said case, and anode and at least one cathode leads electrically connected to said current source and exiting said case;

characterized by said current source being completely encapsulated by a bubble-free first pot, with a second pot completely filling the space between said first pot and said case.

44. An implantable bone growth stimulator in accordance with claim 43 wherein said first pot includes a plurality of ribs along the exterior thereof for facilitating the formation of said second pot within said case.

45. An implantable bone growth stimulator in accordance with claim 43 wherein said at least one cathode lead is sheathed in plastic, and further including tubing covering that end of the sheath which is adjacent to said case, extending into said case, and being bonded to the surrounding second pot which fills said case.

46. An implantable bone growth stimulator in accordance with claim 45 wherein said second pot material is a silicone elastomer and said at least one cathode lead is coated with silicone elastomer within said tubing adjacent to said end of said plastic sheath.

47. An implantable bone growth stimulator in accordance with claim 43 wherein said at least one cathode lead stretches by no more than 5% when it is pulled before it breaks.

48. An implantable bone growth stimulator in accordance with claim 47 wherein said at least one cathode lead is in the shape of a pre-stretched helix.

49. An implantable bone growth stimulator in accordance with claim 43 wherein at least one centimeter of potting material separates every electrical component in said current source from the points at which said leads exit said case.

50. An implantable bone growth stimulator comprising a case, a current source in said case, and anode and at least one cathode leads electrically connected to said current source and exiting said case;

characterized by said at least one cathode lead being covered with a plastic sheath and stretching by no more than 5% when it is pulled before it breaks.

51. An implantable bone growth stimulator in accordance with claim 50 wherein said at least one cathode lead is in the shape of a pre-stretched helix.

52. An implantable bone growth stimulator in accordance with claim 50 wherein said current source is potted in silicone elastomer material within said case, and at least one centimeter of said material separates every electrical component in said current source from the points at which said leads exit the case.

53. An implantable bone growth stimulator in accordance with claim 50 wherein said current source is potted within a silicone elastomer which fills said case.

54. An implantable bone growth stimulator in accordance with claim 53 wherein the silicone elastomer potting consists of a first pot completely enclosing said current source and a second pot completely filling the space between said first pot and said case.

55. An implantable bone growth stimulator in accordance with claim 53 wherein said at least one cathode lead is sheathed in polyethylene, and further including silicone elastomer tubing covering that end of the polyethylene sheath which is adjacent to said case, extending into said case, and being bonded to the surrounding silicone elastomer pot which fills said case.

56. An implantable bone growth stimulator in accordance with claim 50 wherein said at least one cathode lead is made of a material which is at least 90% titanium by weight.

57. An implantable bone growth stimulator comprising a metal case, a potted current source in said case, and anode and at least one cathode leads electrically connected to said current source and exiting said case;

characterized by said case having a cylindrical cross-section and a screw-threaded cap, said cap having a hole through which said leads exit, said case having an end opposite said cap which is rounded, said current source being potted within a first pot of silicone elastomer which completely encloses said current source, and a second pot of silicone elastomer completely filling the space between said first pot and said case.

58. An implantable bone growth stimulator comprising a metal case, a potted current source in said case, and anode and at least one cathode leads electrically connected to said current source and exiting said case;

characterized by said case having a cylindrical cross-section and a screw-threaded cap, said cap having a hole through which said leads exit, and said current source being potted in silicone elastomer material within said case, with at least one centimeter of said material separating every electrical component in said current source from the points at which said leads exit the case.

59. An implantable bone growth stimulator comprising a metal case, a potted current source in said case, and anode and at least one cathode leads electrically connected to said current source and exiting said case;

characterized by said case having a cylindrical cross-section and a screw-threaded cap, said cap having a hole through which said leads exit, and said current source being potted in a material which adheres to the inside wall of said case, allows out-gasing and is impervious to liquids and ionic and polar molecules, with at least one centimeter of said material separating every electrical component in said current source from the points at which said leads exit the case.

60. An implantable bone growth stimulator comprising a metal case, a potted current source in said case, and anode and at least one cathode leads electrically connected to said current source and exiting said case;

characterized by said case having a cylindrical cross-section and a screw-threaded cap, said cap having a hole through which said leads exit, and said at least one cathode lead is covered with a plastic sheath, said at least one cathode lead stretching by no more than five percent when it is pulled before it breaks.

61. An implantable bone growth stimulator in accordance with claim 60 wherein said at least one cathode lead is in the shape of a pre-stretched helix.

62. An implantable bone growth stimulator in accordance with claim 61 wherein said plastic sheath is made of polyethylene.

63. An implantable bone growth stimulator in accordance with claim 60 wherein said plastic sheath is made of polyethylene.

64. An electrode for an implantable bone growth stimulator comprising an electrically conductive lead encased in a plastic sheath, said lead stretching by no more than five percent before it breaks and being implantable in a human body for use with said implantable bone growth stimulator.

65. An electrode in accordance with claim 64 wherein said plastic sheath is made of polyethylene.

66. An electrode in accordance with claim 64 further including a piece of silicone elastomer tubing partially contained on one end of said plastic sheath with said lead extending through said tubing, and silicone elastomer adhesive contained within said tubing around that portion of said lead which extends therethrough.

67. An electrode in accordance with claim 64 wherein said lead is made of a material which is at least ninety percent titanium by weight.

68. An electrode lead for an implantable bone growth stimulator comprising a pre-stretched helical coil encased in a plastic sheath, said coil stretching further by no more than 5% before it breaks.

69. An electrode lead in accordance with claim 68 wherein said plastic sheath is made of polyethylene.

70. An electrode lead in accordance with claim 68 further including silicone elastomer tubing being partially contained on one end of said plastic sheath with said coil extending through said tubing, and silicone elastomer adhesive contained within said tubing around that portion of said coil which extends therethrough.

71. An electrode lead in accordance with claim 68 wherein said helical coil is made of a material which is at least 90% titanium by weight.

72. A method of making an implantable bone growth stimulator comprising the steps of assembling a current source with anode and at least one cathode leads electrically connected thereto, potting said current source so that it is completely encapsulated except for said leads, placing the potted current source in a case with said leads exiting the case and with there being free space between the potted current source and the case, and potting the encapsulated current source with a material which completely fills the free space in said case.

73. A method of making an implantable bone growth stimulator in accordance with claim 72 wherein said case is made of metal and the materials used in both potting steps are silicone elastomers.

74. A method of making an implantable bone growth stimulator in accordance with claim 73 wherein said case has a cylindrical shape, and said current source is assembled as a boardless circuit whose components are stacked so as to fit within said case.

75. A method of making an implantable bone growth stimulator in accordance with claim 74 wherein the encapsulated current source is made with a plurality of ribs along its exterior surface for facilitating the potting thereof in said case.

76. A method of making an implantable bone growth stimulator in accordance with claim 75 wherein prior to at least the last potting step the ends of said leads which are connected to said current source are sheathed in silicone elastomer tubing, and silicone elastomer adhesive is placed around said lead ends within said tubing, the ends of said tubing being potted during at least one of said potting steps.

77. A method of making an implantable bone growth stimulator in accordance with claim 76 wherein said case is at least 90% titanium, and the silicone elastomer used in the last potting step adheres to the inside wall of said case.

78. A method of making an implantable bone growth stimulator in accordance with claim 73 wherein prior to at least the last potting step the ends of said leads which are connected to said current source are sheathed in silicone elastomer tubing, and silicone elastomer adhesive is placed around said lead ends within said tubing, the ends of said tubing being potted during at least one of said potting steps.

79. A method of making an implantable bone growth stimulator in accordance with claim 73 wherein said case is at least 90% titanium, and the silicone elastomer used in the last potting step adheres to the inside wall of said case.

80. A method of making an implantable bone growth stimulator in accordance with claim 72 wherein said case has a cylindrical shape, and said current source is assembled as a boardless circuit whose components are stacked so as to fit within said case.

81. A method of making an implantable bone growth stimulator in accordance with claim 80 wherein the encapsulated current source is made with a plurality of ribs along its exterior surface for facilitating the potting thereof in said case.

82. A method of making an implantable bone growth stimulator in accordance with claim 72 wherein the material used in the last potting step is a silicone elastomer, and prior to at least the last potting step the ends of said leads which are connected to said current source are sheathed in silicone elastomer tubing, and silicone elastomer adhesive is placed around said lead ends within said tubing, the ends of said tubing being potted during at least one of said potting steps.

83. A method of making an implantable bone growth stimulator in accordance with claim 82 wherein said case is at least 90% titanium, and the silicone elastomer used in the last potting step adheres to the inside wall of said case.