Cochlear implant electrode array

• US 7,272,449 B2
• Filed: 09/28/2001
• Issued: 09/18/2007
• Est. Priority Date: 10/04/2000
• Status: Expired due to Fees

• Current Assignee: Cochlear Limited
• Original Assignee: Cochlear Limited
• Inventors: Gibson, Peter, Treaba, Claudiu, Darley, Ian, Parker, John, Dadd, Fysh
• Primary Examiner(s): Layno; Carl
• Assistant Examiner(s): Reidel; Jessica L.
• Application Number:
  US10/149,642
• Publication Number:
  US 20040122501A1
• Time in Patent Office: 2,181 Days
• Field of Search: 607/137, 607 55- 57, 607/136, 623/10, 600/25
• US Class Current: 607/137
• CPC Class Codes: A61F 11/20 Ear surgery
• CPC Class Codes: A61N 1/0541 Cochlear electrodes

Abstract

A cochlear implant electrode assembly (10) comprising an elongate electrode carrier member (11), a bioresorbable stiffening element (15) and an outer layer (16) surrounding the stiffening element (15). The carrier member (11) is made of a resiliently flexible first material and has a plurality of electrodes (12) mounted thereon and has a first configuration selected to allow it to be inserted into an implantee'"'"'s cochlea, and at least a second configuration wherein it is curved to match a surface of the cochlea. The bioresorbable stiffening element (15) has a configuration selected for biassing the elongate member (11) into the first configuratin and is made of a second material relatively stiffer than the first material and which dissolves or softens on exposure to cochlear fluids to permit the elongate member (11) to at least approach or adopt the second configuration. The outer layer (16) surrounding the stiffening element (15) is made of a material sufficiently resiliently flexible to allow the elongate member (11) to at least approach or adopt the second configuration. The outer layer (16) has a first rate of cochlear fluid ingress therethrough and has at least one fluid ingress means (21) formed therein. The rate of cochlear fluid ingress through the fluid ingress means (21) is greater than the first rate of cochlear fluid ingress through the outer layer (16).

Claims

1. An implantable tissue-stimulating device comprising:

an elongate carrier member having at least one electrode mounted thereon and having a first insertion configuration selected to allow said elongate carrier member to be inserted into an implantee'"'"'s body and at least a second implanted configuration, wherein said elongate carrier member is made of a resiliently flexible first material;

a bioresorbable stiffening element disposed in a lumen of the elongate carrier member and the bioresorbable stiffening element having a configuration selected for biasing said elongate carrier member into said first insertion configuration, said bioresorbable stiffening element being made of a second material relatively stiffer than said first material wherein said second material dissolves on exposure to a fluid to permit said elongate carrier member to substantially adopt said second implanted configuration while in the implantee'"'"'s body; and

an outer layer surrounding the bioresorbable stiffening element and the elongate carrier member, the outer layer being made of a material sufficiently resiliently flexible to allow said elongate carrier member to substantially adopt said second implanted configuration, and wherein the outer layer has at least one fluid ingress means formed therein.

2. An implantable tissue-stimulating device of claim 1 wherein the second configuration of the elongate carrier member is curved.

3. An implantable tissue-stimulating device of claim 2 wherein the elongate carrier member adopts a spiral configuration when in the second configuration.

4. An implantable tissue-stimulating device of claim 1 wherein the fluid is a body fluid of the implantee.

5. An implantable tissue-stimulating device of claim 1 wherein the elongate carrier member is preformed from a plastics material with memory and is preformed in the second configuration.

6. An implantable tissue-stimulating device of claim 1 wherein the elongate carrier member has a first end that is firstly inserted into the implantee.

7. An implantable tissue-stimulating device of claim 1 wherein the first configuration is at least substantially straight.

8. An implantable tissue-stimulating device of claim 1 wherein the elongate carrier member is formed from a biocompatible material.

9. An implantable tissue-stimulating device of claim 1 wherein the bioresorbable material of the bioresorbable stiffening element is selected from the group comprising polyacrylic acid (PAA), polyvinyl alcohol (PVA), polylactic acid (PLA) and polyglycolic acid (PCA).

10. An implantable tissue-stimulating device of claim 1 wherein the outer layer is in turn surrounded by an additional layer formed from a material selected from the group comprising a lubricious material and a non-lubricious material.

11. An implantable tissue-stimulating device of claim 10 wherein the outer layer is formed from a biocompatible material.

12. An implantable tissue-stimulating device of claim 1 wherein the lumen has at least one opening at an end of the lumen distal the first end of the elongate carrier member, the opening being closable by a closure means.

13. An implantable tissue-stimulating device of claim 12 wherein the closure means comprises a plug or cap.

14. An implantable tissue-stimulating device of claim 12 wherein the closure means comprises a sealing layer bonded to the elongate carrier member.

15. An implantable tissue-stimulating device of claim 1 wherein a plurality of the fluid ingress means in the form of slits are provided in the outer layer.

16. An implantable tissue-stimulating device of claim 15 wherein the slits are sealable with a bioresorbable material.

17. An implantable tissue-stimulating device of claim 15 wherein the slits are formed so as to have substantially the same rate of ingress of the fluid through the outer layer.

18. An implantable tissue-stimulating device of claim 15 wherein at least one slit has a different rate of progress of the fluid through the outer layer compared to the other slits in the outer layer.

19. An implantable tissue-stimulating device of claim 18 wherein a distal slit most distal to a first end of the elongate carrier member allows a greater rate of fluid ingress through the outer layer than its adjacent proximal slit positioned closer to the first end, such that the bioresorbable material of the bioresorbable stiffening element beneath said distal slit preferably begins to dissolve before the remainder of the bioresorbable stiffening element so allowing the elongate carrier member to begin to firstly move from its first configuration to its second configuration at or adjacent the position of the distal slit.

20. An implantable tissue-stimulating device of claim 18 wherein the rate of ingress provided by each slit follows a pattern of a relatively lesser rate in the rate of ingress from a distal slit most distal to a first end of the elongate carrier member towards a proximal slit most proximal to the first end of the elongate carrier member.

21. An implantable tissue-stimulating device of claim 1 wherein a plurality of fluid ingress means are provided in the outer layer and each fluid ingress means comprise regions of silicone having a thickness less than that of the outer layer.

22. An implantable tissue-stimulating device of claim 1 wherein a resiliently flexible tip member extends forwardly from a first end of the elongate carrier member.

23. An implantable tissue-stimulating device of claim 22 wherein the resiliently flexible tip member has a plurality of metallic particles dispersed therethrough.

24. A cochlear implant electrode assembly comprising:

an elongate carrier member having at least one electrode mounted thereon and having a first insertion configuration selected to allow said elongate carrier member to be inserted into an implantee'"'"'s cochlea and at least a second implanted configuration to allow said elongate carrier member to substantially approximate a curve of said cochlea, wherein said elongate carrier member is made of a resiliently flexible first material;

a bioresorbable stiffening element disposed in a lumen of the elongate carrier member and the bioresorbable stiffening element having a configuration selected for biasing said elongate carrier member into said first insertion configuration, said bioresorbable stiffening element being made of a second material relatively stiffer than said first material, wherein said bioresorbable stiffening element dissolves on exposure to cochlear fluids to permit said elongate carrier member to substantially adopt said second implanted configuration; and

an outer layer surrounding the bioresorbable stiffening element and the elongate carrier member, the outer layer is made of a material sufficiently resiliently flexible to allow said elongate carrier member to substantially adopt said second implanted configuration, and wherein the outer layer includes at least one fluid ingress means formed therein.

25. A cochlear implant electrode assembly of claim 24 wherein the elongate carrier member is preformed from a plastics material with memory and is preformed in the second configuration.

26. A cochlear implant electrode assembly of claim 24 wherein the elongate carrier member has a first end that is firstly inserted into the implantee.

27. A cochlear implant electrode assembly of claim 24 wherein the first configuration is at least substantially straight.

28. A cochlear implant electrode assembly of claim 24 wherein the elongate carrier member is formed from a biocompatible material.

29. A cochlear implant electrode assembly of claim 24 wherein the bioresorbable material of the bioresorbable stiffening element is selected from the group comprising polyacrylic acid (PAA), polyvinyl alcohol (PVA), polylactic acid (PLA) and polyglycolic acid (PCA).

30. A cochlear implant electrode assembly of claim 24 wherein the outer layer is in turn surrounded by an additional layer formed from a material selected from the group comprising a lubricious material and a non-lubricious material.

31. A cochlear implant electrode assembly of claim 30 wherein the outer layer is formed from a biocompatible material.

32. A cochlear implant electrode assembly of claim 24 wherein the lumen has at least one opening at an end of the lumen distal the first end of the elongate carrier member, the opening being closable by a closure means.

33. A cochlear implant electrode assembly of claim 32 wherein the closure means comprises a plug or cap.

34. A cochlear implant electrode assembly of claim 32 wherein the closure means comprises a sealing layer bonded to the elongate carrier member.

35. A cochlear implant electrode assembly of claim 24 wherein a plurality of the fluid ingress means in the form of slits are provided in the outer layer.

36. A cochlear implant electrode assembly of claim 35 wherein the slits are formed so as to have substantially the same rate of ingress of the cochlear fluids through the outer layer.

37. A cochlear implant electrode assembly of claim 35 wherein at least one slit has a different rate of progress of the cochlear fluids through the outer layer compared to the other slits in the outer layer.

38. A cochlear implant electrode assembly of claim 37 wherein a distal slit most distal to a first end of the elongate carrier member allows a greater rate of fluid ingress through the outer layer than its adjacent proximal slit positioned closer to said first end, such that the bioresorbable material of the bioresorbable stiffening element beneath said distal slit preferably begins to dissolve before the remainder of the bioresorbable stiffening element so allowing the elongate carrier member to begin to firstly move from its first configuration to its second configuration at or adjacent the position of the distal slit.

39. A cochlear implant electrode assembly of claim 37 wherein the rate of ingress provided by each slit follows a pattern of a relatively lesser rate in the rate of ingress from a distal slit most distal to a first end of the elongate carrier member towards a proximal slit most proximal to the first end of the elongate carrier member.

40. A cochlear implant electrode assembly of claim 35 wherein the slits are sealable with a bioresorbable material.

41. A cochlear implant electrode assembly of claim 24 wherein a plurality of fluid ingress means are provided in the outer layer and each fluid ingress means comprise regions of silicone having a thickness less than that of the outer layer.

42. A cochlear implant electrode assembly of claim 24 wherein a resiliently flexible tip member extends forwardly from a first end of the elongate carrier member.

43. A cochlear implant electrode assembly of claim 42 wherein the resiliently flexible tip member has a plurality of metallic particles dispersed therethrough.

44. A cochlear implant electrode assembly of claim 24 wherein the second configuration of the elongate carrier member is curved.

45. A cochlear implant electrode assembly of claim 44 wherein the elongate carrier member adopts a spiral configuration when in the second configuration.

46. A cochlear implant electrode assembly comprising:

an elongate carrier member having at least one electrode mounted thereon and having a first insertion configuration selected to allow said elongate carrier member to be inserted into an implantee'"'"'s cochlea and at least a second implanted configuration to allow said elongate carrier member to substantially approximate a curve of said cochlea, wherein said elongate carrier member is made of a resiliently flexible first material;

a bioresorbable stiffening element disposed in a lumen of the carrier member and having a configuration selected for biasing said elongate carrier member into said first insertion configuration, said bioresorbable stiffening element being made of a second material relatively stiffer than said first material, wherein said bioresorbable stiffening element dissolves on exposure to cochlear fluids to permit said elongate carrier member to substantially adopt said second implanted configuration; and

an outer layer surrounding the bioresorbable stiffening element and the elongate carrier member, the outer layer is made of a material sufficiently resiliently flexible to allow said elongate carrier member to substantially adopt said second implanted configuration, and wherein the outer layer includes plurality of fluid ingress means and each fluid ingress means comprise regions of silicone having a thickness less than that of the outer layer.

47. An implantable tissue-stimulating device of claim 46 wherein the second implanted configuration of the elongate carrier member is curved.

48. An implantable tissue-stimulating device of claim 47 wherein the elongate carrier member adopts a spiral configuration when in the second implanted configuration.

49. A cochlear implant electrode assembly of claim 46 wherein the elongate carrier member is preformed from a plastics material with memory and is preformed in the second implanted configuration.

50. A cochlear implant electrode assembly of claim 46 wherein the elongate carrier member has a first end that is firstly inserted into the implantee.

51. A cochlear implant electrode assembly of claim 46 wherein the first configuration is at least substantially straight.

52. A cochlear implant electrode assembly of claim 46 wherein the elongate carrier member is formed from a biocompatible material.

53. A cochlear implant electrode assembly of claim 46 wherein the bioresorbable material of the bioresorbable stiffening element is selected from the group comprising polyacrylic acid (PAA), polyvinyl alcohol (PVA), polylactic acid (PLA) and polyglycolic acid (PCA).

54. A cochlear implant electrode assembly of claim 46 wherein the outer layer is in turn surrounded by an additional layer formed from a material selected from the group comprising a lubricious material and a non-lubricious material.

55. A cochlear implant electrode assembly of claim 54 wherein the outer layer is formed from a biocompatible material.

56. A cochlear implant electrode assembly of claim 46 wherein the bioresorbable stiffening element is positionable in a lumen extending within the elongate carrier member.

57. A cochlear implant electrode assembly of claim 56 wherein the lumen has at least one opening at an end of the lumen distal the first end of the elongate carrier member, the opening being closable by a closure means.

58. A cochlear implant electrode assembly of claim 57 wherein the closure means comprises a plug or cap.

59. A cochlear implant electrode assembly of claim 58 wherein the closure means comprises a sealing layer bonded to the elongate carrier member.

60. A cochlear implant electrode assembly of claim 46 wherein a plurality of the plurality of fluid ingress means in the form of slits are provided in the outer layer.

61. A cochlear implant electrode assembly of claim 60 wherein the slits are formed so as to have substantially the same rate of ingress of the cochlear fluids through the outer layer.

62. A cochlear implant electrode assembly of claim 60 wherein at least one slit has a different rate of progress of the cochlear fluids through the outer layer compared to the other slits in the outer layer.

63. A cochlear implant electrode assembly of claim 62 wherein a distal slit most distal to a first end of the elongate carrier member allows a greater rate of fluid ingress through the outer layer than its adjacent proximal slit positioned closer to said first end, such that the bioresorbable material of the bioresorbable stiffening element beneath said distal slit preferably begins to dissolve before the remainder of the bioresorbable stiffening element so allowing the elongate carrier member to begin to firstly move from its first configuration to its second configuration at or adjacent the position of the distal slit.

64. A cochlear implant electrode assembly of claim 62 wherein the rate of ingress provided by each slit follows a pattern of a relatively lesser rate in the rate of ingress from a distal slit most distal to a first end of the elongate carrier member towards a proximal slit most proximal to the first end of the elongate carrier member.

65. A cochlear implant electrode assembly of claim 60 wherein the slits are sealable with a bioresorbable material.

66. A cochlear implant electrode assembly of claim 46 wherein a resiliently flexible tip member extends forwardly from a first end of the elongate carrier member.

67. A cochlear implant electrode assembly of claim 66 wherein the resiliently flexible tip member has a plurality of metallic particles dispersed therethrough.

68. A cochlear implant electrode assembly of claim 46 wherein the second implanted configuration of the elongate carrier member is curved.

69. A cochlear implant electrode assembly of claim 68 wherein the elongate carrier member adopts a spiral configuration when in the second implanted configuration.

70. A cochlear implant electrode assembly comprising:

an elongate carrier member having at least one electrode mounted thereon and having a first insertion configuration selected to allow said elongate carrier member to be inserted into an implantee'"'"'s cochlea and at least a second implanted configuration to allow said elongate carrier member to substantially approximate a curve of said cochlea, wherein said elongate carrier member is made of a resiliently flexible first material;

a bioresorbable stiffening element stiffening element disposed in a lumen of the carrier member and having a configuration selected for biasing said elongate carrier member into said first insertion configuration, said bioresorbable stiffening element being made of a second material relatively stiffer than said first material, wherein said bioresorbable stiffening element dissolves on exposure to cochlear fluids to permit said elongate carrier member to substantially adopt said second implanted configuration; and

an outer layer surrounding the bioresorbable stiffening element and the elongate carrier member, the outer layer is made of a material sufficiently resiliently flexible to allow said elongate carrier member to substantially adopt said second implanted configuration, and wherein the outer layer includes a plurality of slits formed therein so as to have substantially the same rate of ingress of the cochlear fluids through the outer layer.

71. An implantable tissue-stimulating device of claim 70 wherein the second implanted configuration of the elongate carrier member is curved.

72. An implantable tissue-stimulating device of claim 71 wherein the elongate carrier member adopts a spiral configuration when in the second implanted configuration.

73. A cochlear implant electrode assembly of claim 70 wherein the elongate carrier member is preformed from a plastics material with memory and is preformed in the second implanted configuration.

74. A cochlear implant electrode assembly of claim 70 wherein the first configuration is at least substantially straight.

75. A cochlear implant electrode assembly of claim 70 wherein the elongate carrier member is formed from a biocompatible material.

76. A cochlear implant electrode assembly of claim 70 wherein the bioresorbable material of the bioresorbable stiffening element is selected from the group comprising polyacrylic acid (PAA), polyvinyl alcohol (PVA), polylactic acid (PLA) and polyglycolic acid (PCA).

77. A cochlear implant electrode assembly of claim 70 wherein the outer layer is in turn surrounded by an additional layer formed from a material selected from the group comprising a lubricious material and a non-lubricious material.

78. A cochlear implant electrode assembly of claim 77 wherein the outer layer is formed from a biocompatible material.

79. A cochlear implant electrode assembly of claim 70 wherein the lumen has at least one opening at an end of the lumen distal the first end of the elongate carrier member, the opening being closable by a closure means.

80. A cochlear implant electrode assembly of claim 79 wherein the closure means comprises a plug or cap.

81. A cochlear implant electrode assembly of claim 79 wherein the closure means comprises a sealing layer bonded to the elongate carrier member.

82. A cochlear implant electrode assembly of claim 70 wherein each of the plurality of slits are sealable with a bioresorbable material.

83. A cochlear implant electrode assembly of claim 70 wherein a resiliently flexible tip member extends forwardly from a first end of the elongate carrier member.

84. A cochlear implant electrode assembly of claim 83 wherein the resiliently flexible tip member has a plurality of metallic particles dispersed therethrough.

85. A cochlear implant electrode assembly of claim 70 wherein the second implanted configuration of the elongate carrier member is curved.

86. A cochlear implant electrode assembly of claim 85 wherein the elongate carrier member adopts a spiral configuration when in the second implanted configuration.

87. A cochlear implant electrode assembly comprising:

an elongate carrier member having at least one electrode mounted thereon and having a first insertion configuration selected to allow said elongate carrier member to be inserted into an implantee'"'"'s cochlea and at least a second implanted configuration to allow said elongate carrier member to substantially approximate a curve of said cochlea, wherein said elongate carrier member is made of a resiliently flexible first material;

a bioresorbable stiffening element having a configuration selected for biasing said elongate carrier member into said first insertion configuration, said bioresorbable stiffening element being made of a second material relatively stiffer than said first material, wherein said bioresorbable stiffening element dissolves on exposure to cochlear fluids to permit said elongate carrier member to substantially adopt said second implanted configuration; and

an outer layer surrounding the bioresorbable stiffening element and the elongate carrier member, the outer layer is made of a material sufficiently resiliently flexible to allow said elongate carrier member to substantially adopt said second implanted configuration, and wherein the outer layer includes a plurality of slits formed therein so at least one slit of the plurality of slits has a different rate of progress of the cochlear fluids through the outer layer compared to the other slits in the outer layer.

88. A cochlear implant electrode assembly of claim 87 wherein a distal slit most distal to a first end of the elongate carrier member allows a greater rate of fluid ingress through the outer layer than its adjacent proximal slit positioned closer to said first end, such that the bioresorbable material of the bioresorbable stiffening element beneath said distal slit preferably begins to dissolve before the remainder of the bioresorbable stiffening element so allowing the elongate carrier member to begin to firstly move from its first configuration to its second configuration at or adjacent the position of the distal slit.

89. A cochlear implant electrode assembly of claim 87 wherein the rate of ingress provided by each slit follows a pattern of a relatively lesser rate in the rate of ingress from a distal slit most distal to a first end of the elongate carrier member towards a proximal slit most proximal to the first end of the elongate carrier member.

90. An implantable tissue-stimulating device of claim 87 wherein the second implanted configuration of the elongate carrier member is curved.

91. An implantable tissue-stimulating device of claim 90 wherein the elongate carrier member adopts a spiral configuration when in the second implanted configuration.

92. A cochlear implant electrode assembly of claim 87 wherein the elongate carrier member is preformed from a plastics material with memory and is preformed in the second implanted configuration.

93. A cochlear implant electrode assembly of claim 87 wherein the elongate carrier member has a first end that is firstly inserted into the implantee.

94. A cochlear implant electrode assembly of claim 87 wherein the first configuration is at least substantially straight.

95. A cochlear implant electrode assembly of claim 87 wherein the elongate carrier member is formed from a biocompatible material.

96. A cochlear implant electrode assembly of claim 87 wherein the bioresorbable material of the bioresorbable stiffening element is selected from the group comprising polyacrylic acid (PAA), polyvinyl alcohol (PVA), polylactic acid (PLA) and polyglycolic acid (PCA).

97. A cochlear implant electrode assembly of claim 87 wherein the outer layer is in turn surrounded by an additional layer formed from a material selected from the group comprising a lubricious material and a non-lubricious material.

98. A cochlear implant electrode assembly of claim 97 wherein the outer layer is formed from a biocompatible material.

99. A cochlear implant electrode assembly of claim 87 wherein the bioresorbable stiffening element is positionable in a lumen extending within the elongate carrier member.

100. A cochlear implant electrode assembly of claim 99 wherein the lumen has at least one opening at an end of the lumen distal the first end of the elongate carrier member, the opening being closable by a closure means.

101. A cochlear implant electrode assembly of claim 100 wherein the closure means comprises a plug or cap.

102. A cochlear implant electrode assembly of claim 101 wherein the closure means comprises a sealing layer bonded to the elongate carrier member.

103. A cochlear implant electrode assembly of claim 87 wherein each of the plurality of slits are sealable with a bioresorbable material.

104. A cochlear implant electrode assembly of claim 87 wherein a resiliently flexible tip member extends forwardly from a first end of the elongate carrier member.

105. A cochlear implant electrode assembly of claim 104 wherein the resiliently flexible tip member has a plurality of metallic particles dispersed therethrough.

106. A cochlear implant electrode assembly of claim 87 wherein the second implanted configuration of the elongate carrier member is curved.

107. A cochlear implant electrode assembly of claim 106 wherein the elongate carrier member adopts a spiral configuration when in the second implanted configuration.