초록 ▼

An implantable lead for electrical stimulation of tissue has wire-like extendable members whose tips curl back upon themselves in open tissue spaces to form 2- or 3-dimensional electrodes. The electrodes may be positioned axially or in other directions from the lead body. Traction on the lead body o

An implantable lead for electrical stimulation of tissue has wire-like extendable members whose tips curl back upon themselves in open tissue spaces to form 2- or 3-dimensional electrodes. The electrodes may be positioned axially or in other directions from the lead body. Traction on the lead body or extendable members allows easy withdrawal as the member tip electrodes uncurl, allowing removal without major surgery. This apparatus and method is useful for minimally invasive insertion of electrodes or electrode arrays, especially through a narrow body lumen or Tuohy needle, providing therapeutic stimulation of nervous tissue, muscle or organs.

대표청구항 ▼

1. An implantable lead for stimulation of nerve tissue muscle or organs, the lead comprising: an elongate lead body having an axis and a tip; and at least one extendable member having a distal portion adapted to curl upon itself when not-constrained, a proximal portion, and an intermediate port

1. An implantable lead for stimulation of nerve tissue muscle or organs, the lead comprising: an elongate lead body having an axis and a tip; and at least one extendable member having a distal portion adapted to curl upon itself when not-constrained, a proximal portion, and an intermediate portion between the distal and proximal portion, the distal portion forming an electrode, the extendable member received at least in part within the lead body for axial movement between: a retracted position in which the distal and proximal portions are constrained within the lead body; andan extended position in which the proximal portion is retained within the lead body and the distal portion is deployed out the tip of the lead body such that the distal portion curls upon itself, the intermediate portion being deployed out of the lead body when the extendable member is in the extended position; wherein the intermediate portion is adapted to curl as it is deployed out the tip of the lead body less tightly than the distal portion curls upon itself. 2. The implantable lead of claim 1 in which the intermediate portion comprises an insulated wire allowing current to flow between the proximal portion and the distal portion.3. The implantable lead of claim 1 in which the distal portion is formed such that it tends to curl upon itself in two dimensions in the extended position.4. The implantable lead of claim 1 in which the distal portion is formed such that it tends to curl upon itself in three dimensions in the extended position.5. The implantable lead according to claim 4, wherein the extendable member comprises wire, and the distal portion comprises one or more external coiled conductors.6. The implantable lead according to claim 5, wherein the one or more external coiled conductors comprises a plurality of external coiled conductors having dissimilar properties.7. The implantable lead according to claim 1, wherein the distal portion of the extendable member has preset elastic properties that tend to cause the distal portion to curl into an electrode.8. The implantable lead according to claim 1, wherein the distal portion of the extendable member is formed of bimetallic metals or nitinol material that change shape due to temperature changes.9. The implantable lead according to claim 1, wherein the distal portion of the extendable member will uncurl if the extendable member is retracted into the lead body.10. The implantable lead according to claim 1, wherein the extendable member has a preset curve so that as it is extended axially beyond the lead body, it will move also in directions laterally to the axis of the lead body.11. The implantable lead according to claim 10, wherein the extendable member has a preset curve over the distal portion.12. The implantable lead according to claim 10, wherein the extendable member has an elasticity that allows it to be held straight by the lead body but allows the extendable member to resume its preset curve when it is extended beyond the tip of the lead body.13. The implantable lead according to claim 10, wherein the extendable member has a preset curvature such that, when deployed out of the lead body, the extendable member moves in axial directions and lateral directions.14. The implantable lead according to claim 10, wherein the extendable member has a preset curve so that as it is extended beyond the lead body, it will move also in directions perpendicular to the axis of the lead body.15. The implantable lead according to claim 1, wherein the extendable member is held by the lead body against rotation relative to the lead body.16. The implantable lead according to claim 1, wherein the extendable member comprises a plurality of extendable members, each of which can be independently extended to deploy a distal portion beyond the tip of the lead body.17. The implantable lead according to claim 1, wherein the lead body has a central portion movable axially within the lead body to move the at least one extendable member between the retracted and extended positions.18. The implantable lead according to claim 1, in which the extendable member comprises a plurality of extendable members, wherein the distal portions of the extendable members can be selectively deployed such that the electrodes fit a surface of tissue or achieve a desired distribution of current.19. The implantable lead according to claim 1, wherein the distal tip of the extendable member has a material coating adapted to keep the distal tip straight after deployment past the tip of the lead body, wherein the material will dissolve over time inside the body.20. The implantable lead of claim 19, wherein the material coating will dissolve by application of electrical current through the distal portion of the extendable members.21. The implantable lead according to claim 1, wherein the extendable member is small enough to pass through a small body lumen, the distal portion being adapted to be advanced through the small body lumen and to curl into an electrode after being advanced through the small body lumen.22. An implantable lead for stimulation of nerve tissue, muscle or organs, the lead comprising: an elongate lead body having an axis and a tip; and at least one extendable member having a distal portion adapted to curl upon itself when not-constrained and a proximal portion, the extendable member received at least in part within the lead body for axial movement between: a retracted position in which the distal and proximal portion are constrained within the lead body; andan extended position in which the proximal portion is retained within the lead body and the distal portion is deployed out the tip of the lead body such that the distal portion curls upon itself; wherein the distal portion of the extendable member is sufficiently flexible that the distal portion will uncurl if the entire lead body is pulled through tissue, thereby reducing trauma to the tissue if excessive forces are applied to the lead. 23. The implantable lead of claim 22 in which the distal portion forms an electrode.24. The implantable lead of claim 23 which the extendable member further comprises an intermediate portion between the distal and proximal portions.25. The implantable lead of claim 24 in which the intermediate portion is deployed out of the lead body when the extendable member is in the extended position.26. The implantable lead of claim 25 in which the intermediate portion comprises an insulated wire allowing current to flow between the proximal portion and the distal portion.27. The implantable lead of claim 22 in which the distal portion is formed such that it tends to curl upon itself in two dimensions in the extended position.28. The implantable lead of claim 22 in which the distal portion is formed such that it tends to curl upon itself in three dimensions in the extended position.29. The implantable lead according to claim 22, wherein the extendable member comprises wire, and the distal portion comprises one or more external coiled conductors.30. The implantable lead according to claim 29, wherein the one or more external coiled conductors comprises a plurality of external coiled conductors having dissimilar properties.31. The implantable lead according to claim 22, wherein the distal portion of the extendable member has preset elastic properties that tend to cause the distal portion to curl into an electrode.32. The implantable lead according to claim 22, wherein the distal portion of the extendable member is formed of bimetallic metals or nitinol material that change shape due to temperature changes.33. The implantable lead according to claim 22, wherein the distal portion of the extendable member will uncurl if the extendable member is retracted into the lead body.34. The implantable lead according to claim 22, wherein the extend able member has a preset curve so that as it is extended axially beyond the lead body, it will move also in directions laterally to the axis of the lead body.35. The implantable lead according to claim 34, wherein the extendable member has a preset curve over the distal portion.36. The implantable lead according to claim 34, wherein the extendable member has an elasticity that allows it to be held straight by the lead body but allows the extendable member to resume its preset curve when it is extended beyond the tip of the lead body.37. The implantable lead according to claim 34, wherein the extendable member has a preset curvature such that, when deployed out of the lead body, the extendable member moves in axial directions and lateral directions.38. The implantable lead according to claim 34, wherein the extendable member has a preset curve so that as it is extended beyond the lead body, it will move also in directions perpendicular to the axis of the lead body.39. The implantable lead according to claim 22, wherein the extendable member is held by the lead body against rotation relative to the lead body.40. The implantable lead according to claim 22, wherein the extendable member comprises a plurality of extendable members, each of which can be independently extended to deploy a distal portion beyond the tip of the lead body.41. The implantable lead according to claim 22, wherein the lead body has a central portion movable axiaily within the lead body to move the at least one extendable member between the retracted and extended positions.42. The implantable lead according to claim 22, in which the extendable member comprises a plurality of extendable members, wherein the distal portions of the extendable members can be selectively deployed such that the electrodes fit a surface of tissue or achieve a desired distribution of current.43. The implantable lead according to claim 22, wherein the distal tip of the extendable member has a material coating adapted to keep the distal tip straight after deployment past the tip of the lead body, wherein the material will dissolve over time inside the body.44. The implantable lead of claim 43, wherein the material coating will dissolve by application of electrical current through the distal portion of the extendable members.45. The implantable lead according to claim 22, wherein the extendable member is small enough to pass through a small body lumen, the distal portion being adapted to be advanced through the small body lumen and to curl into an electrode after being advanced through the small body lumen.46. An implantable lead for stimulation of nerve tissue, muscle or organs, the lead comprising: an elongate lead body having an axis and a tip; and at least one extendable member having a distal portion adapted to curl upon itself when not-constrained and a proximal portion, the extendable member received at least in part within the lead body for axial movement between: a retracted position in which the distal and proximal portions are constrained within the lead body; andan extended position in which the proximal portion is retained within the lead body and the distal portion is deployed out the tip of the lead body such that the distal portion curls upon itself; wherein the extendable member is held by the lead body against rotation relative to the lead body, the extendable member having an asymmetric cross section along at least a portion of the proximal portion thereof, the lead body having a channel receiving at least the proximal portion, the channel having an asymmetric cross section that engages the asymmetric cross section of the extendable member to hold the extendable member against rotation relative to the lead body. 47. The implantable lead of claim 46 in which the distal portion forms an electrode.48. The implantable lead of claim 47 in which the extendable member further comprises an intermediate portion between the distal and proximal portions.49. The implantable lead of claim 48, in which the intermediate portion is deployed out of the lead body when the extendable member is in the ext ended position.50. The implantable lead of claim 46 in which the intermediate portion comprises an insulated wire allowing current to flow between the proximal portion and the distal portion.51. The implantable lead of claim 46 in which the distal portion is formed such that it tends to curl upon itself in two dimensions in the extended position.52. The implantable lead of claim 46 in which the distal portion is formed such that it tends to curl upon itself in three dimensions in the extended position.53. The implantable lead according to claim 46, wherein the extendable member comprises wire, and the distal portion comprises one or more external coiled conductors.54. The implantable lead according to claim 53, wherein the one or more external coiled conductors comprises a plurality of extemai coiled conductors having dissimilar properties.55. The implantable lead according to claim 46, wherein the distal portion of the extendable member has preset elastic properties that tend to cause the distal portion to curl into an electrode.56. The implantable lead according to claim 46, wherein the distal portion of the extendable member is formed of bimetallic metals or nitinol material that change shape due to temperature changes.57. The implantable lead according to claim 46, wherein the distal portion of the extendable member will uncurl if the extendable member is retracted into the lead body.58. The implantable lead according to claim 46, wherein the extendable member has a preset curve so that as it is extended axially beyond the lead body, it will move also in directions laterally to the axis of the lead body.59. The implantable lead according to claim 58, wherein the extendable member has a preset curve over the distal portion.60. The implantable lead according to claim 58, wherein the extendable member has an elasticity that allows it to be held straight by the lead body but allows the extendable member to resume its preset curve when it is extended beyond the tip of the lead body.61. The implantable lead according to claim 58, wherein the extendable member has a preset curvature such that, when deployed out of the lead body, the extendable member moves in axial directions and lateral directions.62. The implantable lead according to claim 58, wherein the extendable member has a preset curve so that as it is extended beyond the lead body, it will move also in directions perpendicular to the axis of the lead body.63. The implantable lead according to claim 46, wherein the extendable member comprises a plurality of extendable members, each of which can be independently extended to deploy a distal portion beyond the tip of the lead body.64. The implantable lead according to claim 46, wherein the lead body has a central portion movable axially within the lead body to move the at least one extendable member between the retracted and extended positions.65. The implantable lead according to claim 46, in which the extendable member comprises a plurality of extendable members, wherein the distal portions of the extendable members can be selectively deployed such that the electrodes fit a surface of tissue or achieve a desired distribution of current.66. The implantable lead according to claim 46, wherein the distal tip of the extendable member has a material coating adapted to keep the distal tip straight after deployment past the tip of the lead body, wherein the material will dissolve over time inside the body.67. The implantable lead of claim 66, wherein the material coating will dissolve by application of electrical current through the distal portion of the extendable members.68. The implantable lead according to claim 46, wherein the extendable member is small enough to pass through a small body lumen, the distal portion being adapted to be advanced through the small body lumen and to curl into an electrode after being advanced through the small body lumen.69. An implantable lead for stimulation of nerve tissue, muscle or organs, t he lead comprising: an elongate lead body having an axis and a tip; and at least one extendable member having a distal portion adapted to curl upon itself when not-constrained to form an electrode and a proximal portion, the extendable member received at least in part within the lead body for axial movement between: a retracted position in which the distal and proximal portions are constrained within the lead body; andan extended position in which the proximal portion is retained within the lead body and the distal portion is deployed out the tip of the lead body such that the distal portion curls upon itself; wherein the lead body has a diameter, and the electrode formed by curling of the distal portion has a 2- or 3-dimensional shape in which one or more of the dimensions is larger than the diameter of the lead body. 70. The implantable lead of claim 69 in which the distal portion forms an electrode.71. The implantable lead of claim 70 in which the extendable member further comprises an intermediate portion between the distal and proximal portions.72. The implantable lead of claim 71 in which the intermediate portion is deployed out of the lead body when the extendable member is in the extended position.73. The implantable lead of claim 69 in which the intermediate portion comprises an insulated wire allowing current to flow between the proximal portion and the distal portion.74. The implantable lead of claim 69 in which the distal portion is formed such that it tends to curl upon itself in two dimensions in the extended position.75. The implantable lead of claim 69 in which the distal portion is formed such that it tends to curl upon itself in three dimensions in the extended position.76. The implantable lead according to claim 69, wherein the extendable member comprises wire, and the distal portion comprises one or more external coiled conductors.77. The implantable lead according to claim 76, wherein the one or more external coiled conductors comprises a plurality of external coiled conductors having dissimilar properties.78. The implantable lead according to claim 69, wherein the distal portion of the extendable member has preset elastic properties that tend to cause the distal portion to curl into an electrode.79. The implantable lead according to claim 69, wherein the distal portion of the extendable member is formed of bimetallic metals or nitinol material that change shape due to temperature changes.80. The implantable lead according to claim 69, wherein the distal portion of the extendable member will uncurl if the extendable member is retracted into the lead body.81. The implantable lead according to claim 69, wherein the extendable member has a preset curve so that as it is extended axially beyond the lead body, it will move also in directions laterally to the axis of the lead body.82. The implantable lead according to claim 81, wherein the extendable member has a preset curve over the distal portion.83. The implantable lead according to claim 81, wherein the extendable member has an elasticity that allows it to be held straight by the lead body but allows the extendable member to resume its preset curve when it is extended beyond the tip of the lead body.84. The implantable lead according to claim 81, wherein the extendable member has a preset curvature such that, when deployed out of the lead body, the extendable member moves in axial directions and lateral directions.85. The implantable lead according to claim 81, wherein the extendable member has a preset curve so that as it is extended beyond the lead body, it will move also in directions perpendicular to the axis of the lead body.86. The implantable lead according to claim 69, wherein the extendable member is held by the lead body against rotation relative to the lead body.87. The implantable lead according to claim 69, wherein the extendable member comprises a plurality of extendable members, each of which can be independently extended to deploy a d istal portion beyond the tip of the lead body.88. The implantable lead according to claim 69, wherein the lead body has a central portion movable axially within the lead body to move the at least one extendable member between the retracted and extended positions.89. The implantable lead according to claim 69, in which the extendable member comprises a plurality of extendable members, wherein the distal portions of the extendable members can be selectively deployed such that the electrodes fit a surface of tissue or achieve a desired distribution of current.90. The implantable lead according to claim 69, wherein the distal tip of the extendable member has a material coating adapted to keep the distal tip straight after deployment past the tip of the lead body, wherein the material will dissolve over time inside the body.91. The ixnplantable lead of claim 90 wherein the material coating will dissolve by application of electrical current through the distal portion of the extendable members.92. The implantable lead according to claim 69, wherein the extendable member is small enough to pass through a small body lumen, the distal portion being adapted to be advanced through the small body lumen and to curl into an electrode after being advanced through the small body lumen.93. A method of implanting an implantable lead into a patient comprising: prodding an implantable lead having: an elongate lead body having an axis and a tip; andat least one extendable member having a distal portion adapted to curl upon itself when not-constrained; a proximal portion and an intermediate portion between the distal and proximal portions the extendable member received at least in part within the lead body for axial movement between:a retracted position in which the distal and proximal portions are constrained within the lead body andan extended position in which proximal portion is retained within the lead body and the distal portion is deployed out the tip of the lead body such that the distal portion curls upon itself: inserting the implantable lead into a desired location within a patient's body; and extending the distal tip portion of the extendable member out the tip of the lead body to allow the distal tip portion to curl upon itself to form an electrode; deploying the intermediate portion out of the lead body when the extendable member is in the extended position wherein the intermediate portion of the extendable member is adapted to curl less tightly than the distal portion curls upon itself, the step of deploying the extendable member out of the tip of the load body includes: allowing the intermediate portion of the extendable portion to curl to position the distal portion.94. The method of claim 93 in which the intermediate portion comprises an insulated wire allowing current to flow between the proximal portion and the distal portion.95. A method of implanting an implantable lead for spinal cord or sacral nerve stimulation, the method comprising: providing an implantable lead having: an elongate lead body having an axis and a tip; andat least one extendable member having a distal portion adapted to curl upon itself when not-constrained and a proximal portion, the extendable member received at least in part within the lead body for axial movement between:a retracted position in which the distal and proximal portions are constrained within the lead body andan extended position in which proximal portion is retained within the lead body and the distal portion is deployed out the tip of the lead body such that the distal portion curls upon itself;inserting the implantable lead adjacent a foramen or bony canal; andextending the distal portion of the extendable member out the tip of the lead body to advance the distal portion through the foramen and to allow the distal portion to curl upon itself to form an electrode on other side of the foramen from the lead body.96. The method of claim 95 in which the foramen is an intervertebra l foramen.97. The method of claim 95, wherein the foramen is a sacral foramen.98. The method of claim 95, wherein the foramen is the foramen rotundum.99. A method of implanting an implantable lead, the method comprising: providing an implantable lead having: an elongate lead body having an axis and a tip; andat least one extendable member having a distal portion adapted to curl upon itself when not-constrained, a proximal portion, and an intermediate portion between the distal and proximal portions, the extendable member received at least in part within the lead body for axial movement between:a retracted position in which the distal and proximal portions are constrained within the lead body andan extended position in which proximal portion is retained within the lead body and the distal portion and intermediate portions are deployed out the tip of the lead body such that the distal portion curls upon itself and the intermediate portion curls less tightly than the distal portion curls upon itself; inserting the implantable lead adjacent a narrow lumen with a space on the distal end of the lumen having a greater cross sectional area than the lumen; extending the distal portion of the extendable member out the tip of the lead body to advance the distal portion through the lumen and to allow the distal portion to curl upon itself to form an electrode within the space; and deploying the intermediate portion out of the lead body to allow the intermediate portion of the extendable portion to curl to position the distal portion. 100. A method of implanting an implantable lead, the method comprising: providing an implantable lead having: an elongate lead body having an axis and a tip; andat least one extendable member having a distal portion adapted to curl upon itself when not-constrained and a proximal portion, the extendable member received at least in part within the lead body for axial movement between:a retracted position in which the distal and proximal portions are constrained within the lead body andan extended position in which proximal portion is retained within the lead body and the distal portion is deployed out the tip of the lead body such that the distal portion curls upon itself; inserting the implantable lead adjacent a narrow lumen with a space on the distal end of the lumen having a greater cross sectional area than the lumen, wherein the narrow lumen is an aqueduct in the brain; and extending the distal portion of the extendable member out the tip of the lead body to advance the distal portion through the lumen and to allow the distal portion to curl upon itself to form an electrode within the space. 101. A method of implanting an implantable lead, the method comprising: providing an implantable lead having: an elongate lead body having an axis and a tip; andat least one extendable member having a distal portion adapted to curl upon itself when not-constrained and a proximal portion, the extendable member received at least in part within the lead body for axial movement between:a retracted position in which the distal and proximal portions are constrained within the lead body andan extended position in which proximal portion is retained within the lead body and the distal portion is deployed out the tip of the lead body such that the distal portion curls upon itself; inserting the implantable lead adjacent a narrow lumen with a space on the distal end of the lumen having a greater cross sectional area than the lumen, wherein the narrow lumen is created by puncture of the dun mater; and extending the distal portion of the extendable member out the tip of the lead body to advance the distal portion through the lumen and to allow the distal portion to curl upon itself to form an electrode within the space. 102. A method of implanting an implantable lead, the method comprising: providing an implantable lead having: an elongate lead body having an axis and a tip; andat least one extendable member having a distal portion adapted to curl upon itself when not-constrained and a proximal portion, the extendable member received at least in art within the lead body for axial movement between:a retracted position in which the distal and proximal portions are constrained within the lead body andan extended position in which proximal portion is retained within the lead body and the distal portion is deployed out the tip of the lead body such that the distal portion curls upon itself; inserting the implantable lead adjacent a narrow lumen with a space on the distal end of the lumen having a greater cross sectional area than the lumen, wherein the narrow lumen is created by puncture of a body membrane with a needle; and extending the distal portion of the extendable member out the tip of the lead body to advance the distal portion through the lumen and to allow the distal portion to curl upon itself to form an electrode within the space. 103. The method of claim 102, wherein the body membrane is dura mater or arachnoid membrane or pia mater.104. A method of implanting an implantable lead, the method comprising: providing an implantable lead having: an elongate lead body having an axis and a tip; andat least one extendable member having a distal portion adapted to curl upon itself when not-constrained and a proximal portion, the extendable member received at least in part within the lead body for axial movement between:a retracted position in which the distal and proximal portions are constrained within the lead body andan extended position in which proximal portion is retained within the lead body and the distal portion is deployed out the tin of the lead body such that the distal portion curia upon itself: inserting the implantable lead adjacent a narrow lumen with a space on the distal end of the lumen having a greater cross sectional area than the lumen, wherein the narrow lumen is created by puncture of a body membrane with the tip of the distal portion, prior to the curling of its ending; and extending the distal portion of the extendable member out the tip of the lead body to advance the distal portion through the lumen and to allow the distal portion to curl upon itself to form an electrode within the space. 105. The method of claim 104, wherein the body membrane is dura mater or arachnoid membrane or pia mater.106. An implantable lead for electrical communication with an implantable medical device, the lead comprising: an elongate lead body having an axis and a tip; and at least one extendable member having a distal portion adapted to curl upon itself when not constrained to form an electrode, a proximal portion adapted to be in electrical communication with the implantable medical device, and an intermediate portion between the distal and proximal portions providing electrical communication between the distal and proximal portions, the extendable member received at least in part within the lead body for axial movement between: a retracted position in which the distal, intermediate and proximal portions are constrained within the lead body; andan extended position in which the proximal portion is retained within the lead body and the intermediate and distal portions are deployed out the tip of the lead body such that the distal portion curls upon itself and the intermediate portion curls less tightly than the distal portion curls upon itself.107. The implantable lead of claim 106 in which the intermediate portion comprises an insulated wire allowing current to flow between the proximal portion and the distal portion.108. An implantable lead for stimulation of nerve tissue, muscle or organs, the lead comprising: an elongate lead body having an axis and a tip; and at least one extendable member having a distal portion adapted to curl upon itself when not-constrained, proximal portion, and an intermediate portion between the distal and proximal portion, the extendable member received at least i n part within the lead body for axial movement between: a retracted position in which the distal and proximal portions are constrained within the lead body: andan extended position in which the proximal portion is retained within the lead body and the distal portion is deployed out the tip of the lead body such that the distal portion tightly curls upon itself to form a compact conductive electrode, the intermediate portion being deployed out of the lead body when the extendable member is in the extended position;wherein the intermediate portion is adapted to curl as it is deployed out the tin of the lead body less tightly than the distal portion curls upon itself.