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1. WO2020060881 - MONOLITHIC LEAD ASSEMBLY AND METHODS OF MICROFABRICATING A MONOLITHIC LEAD ASSEMBLY

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[ EN ]

WHAT IS CLAIMED IS:

1. A monolithic thin-film cable assembly comprising:

a proximal end;

a distal end;

a supporting structure that extends from the proximal end to the distal end, wherein the supporting structure is comprised of one or more layers of dielectric material; and

a plurality of conductive traces formed on a portion of the supporting structure, wherein the portion of the supporting structure has a spiral shape comprising two or more turns.

2. The monolithic thin-film cable assembly of claim 1 , wherein the plurality of conductive traces extend from the proximal end to the distal end.

3. The monolithic thin-film cable assembly of claim 1 or 2, wherein the dielectric material is polyimide, liquid crystal polymer, parylene, polyether ether ketone, or a combination thereof.

4. The monolithic thin-film cable assembly of claim 1, 2, or 3, wherein the plurality of conductive traces are comprised of one or more layers of conductive material, and the conductive material is copper (Cu), gold (Au), silver (Ag), gold/chromium (Au/Cr), platinum (Pt), platinum/ iridium (Pt/Ir), titanium (Ti), gold/titanium (Au/Ti), or any alloy thereof.

5. The monolithic thin-film cable assembly of claim 4, wherein a coefficient of thermal expansion for the plurality of conductive traces is approximately equal to a coefficient of thermal expansion for the supporting structure.

6. A monolithic thin-film lead assembly comprising:

a cable comprising a proximal end, a distal end, a supporting structure that extends from the proximal end to the distal end, and a plurality of conductive traces formed on a portion of the supporting structure, wherein the supporting structure is comprised of one or more layers of dielectric material; and

an electrode assembly formed on the supporting structure at the distal end of the cable, wherein the electrode assembly comprises one or more electrodes in electrical connection with one or more conductive traces of the plurality of conductive traces.

7. The monolithic thin-film lead assembly of claim 6, wherein the portion of the supporting structure is a helical portion comprising two or more turns.

8. The monolithic thin-film lead assembly of claim 6 or 7, wherein the dielectric material is polyimide, liquid crystal polymer, parylene, polyether ether ketone, or a combination thereof.

9. The monolithic thin-film lead assembly of claim 6, 7, or 8, wherein the plurality of conductive traces are comprised of one or more layers of conductive material, and the conductive material is copper (Cu), gold (Au), silver (Ag), gold/chromium (Au/Cr), platinum (Pt), platinum/ iridium (Pt/Ir), titanium (Ti), gold/titanium (Au/Ti), or any alloy thereof.

10. The monolithic thin-film lead assembly of claim 9, wherein a coefficient of thermal expansion for the plurality of conductive traces is approximately equal to a coefficient of thermal expansion for the supporting structure.

11. The monolithic thin-film lead assembly of any one of claims 6-10, further comprising a connector formed on the supporting structure at the proximal end of the cable and in electrical connection with the one or more conductive traces of the plurality of conductive traces.

12. The monolithic thin-film lead assembly of claim 11, wherein the connector comprises one or more bond or contact pads.

13. The monolithic thin-film lead assembly of claim 7, wherein the helical portion comprises a pitch from 100 pm to 2 mm.

14. The monolithic thin-film lead assembly of claim 7, wherein the helical portion comprises a pitch from 200 pm to 400 pm.

15. The monolithic thin-film lead assembly of claim 7, wherein the helical portion comprises a pitch from 600 pm to 1600 pm.

16. The monolithic thin-film lead assembly of claim 7, wherein the helical portion comprises a helix angle from 10° to 85°.

17. The monolithic thin-film lead assembly of claim 7, wherein the helical portion comprises a helix angle from 40° to 65°.

18. The monolithic thin-film lead assembly of claim 7, wherein the helical portion is wound in a clockwise direction or an anti-clockwise direction.

19. The monolithic thin-film lead assembly of any of claims 6- 18, further comprising a housing encasing the helical portion.

20. The monolithic thin-film lead assembly of claim 19, wherein the housing is comprised of a medical grade polymer material.

21 The monolithic thin-film lead assembly of claim 20, wherein the medical grade polymer material is silicone, a polymer dispersion, parylene, or a polyurethane.

22. A neuromodulation system comprising:

a neurostimulator comprising an electronics module;

a cable comprising a supporting structure and a plurality of conductive traces formed on a portion of the supporting structure, wherein the supporting structure is comprised of one or more layers of dielectric material;

an electrode assembly formed on the supporting structure, wherein the electrode assembly comprises one or more electrodes in electrical connection with one or more conductive traces of the plurality of conductive traces; and

a connector formed on the supporting structure and in electrical connection with the one or more conductive traces of the plurality of conductive traces,

wherein the connector electrically connects the one or more conductive traces of the plurality of conductive traces to the electronics module.

23. The neuromodulation system of claim 22, wherein a portion of the cable is helical.

24. The neuromodulation system of claim 23, wherein the helical portion of the cable comprises a pitch from 100 pm to 2 mm.

25. The neuromodulation system of claim 23 or 24, wherein the helical portion of the cable comprises a helix angle from 10° to 85°.

26. The neuromodulation system of claim 23, 24, or 25, further comprising a housing encasing the helical portion of the cable.

27. The neuromodulation system of claim 26, wherein the housing is comprised of a medical grade polymer material.

28. The neuromodulation system of claim 27, wherein the medical grade polymer material is silicone, a polymer dispersion, parylene, or a polyurethane.

29. A monolithic thin-film lead assembly comprising:

a cable comprising:

a first helical portion at a proximal end of the cable, the first helical portion having a first pitch,

a second helical portion at a distal end of the cable, the second helical portion having the first pitch,

a third helical portion that extends between the first helical portion and the second helical portion, the middle portion being a third helical portion with a second pitch greater than the first pitch,

a supporting structure that extends from the proximal end to the distal end, and a plurality of conductive traces formed on a portion of the supporting structure; and

an electrode assembly formed on the supporting structure at the distal end of the cable, wherein the electrode assembly comprises one or more electrodes in electrical connection with one or more conductive traces of the plurality of conductive traces.

30. The monolithic thin-film lead assembly of claim 29, further comprising a first portion of a housing formed coplanar with the first helical portion.

31. The monolithic thin-film lead assembly of claim 30, wherein the first portion of the housing is comprised of a thermoplastic or thermosetting polymer.

32. The monolithic thin-film lead assembly of claim 30, further comprising a second portion of the housing formed coplanar with the second helical portion.

33. The monolithic thin-film lead assembly of claim 32, wherein the second portion of the housing is comprised of a thermoplastic or thermosetting polymer.

34. The monolithic thin-film lead assembly of claim 32, further comprising a third portion of the housing completely encasing the third helical portion.

35. The monolithic thin-film lead assembly of claim 34, wherein the third portion of the housing is comprised of silicone.

36. The monolithic thin-film lead assembly of claim 29, further comprising a multiplexer chip formed on the supporting structure at the proximal end or the distal end, the multiplexer chip in electrical connection with the one or more electrodes via the one or more conductive traces of the plurality of conductive traces.

37. The monolithic thin-film lead assembly of claim 29, wherein the supporting structure is comprised of one or more layers of dielectric material that is polyimide, liquid crystal polymer, parylene, polyether ether ketone, or a combination thereof.

38. The monolithic thin-film lead assembly of claim 29, wherein the plurality of conductive traces are comprised of one or more layers of conductive material, and the conductive material is copper (Cu), gold (Au), silver (Ag), gold/chromium (Au/Cr), platinum (Pt), platinum/ iridium (Pt/Ir), titanium (Ti), gold/titanium (Au/Ti), or any alloy thereof.

39. A method of manufacturing a monolithic thin-film lead assembly, comprising:

forming a first polymer layer on a wafer or panel of substrate;

forming a plurality of conductive traces on a first portion of the first polymer layer, wherein the forming the plurality of conductive traces comprises depositing a conductive material in a spiral pattern with two or more turns on the first portion of the first polymer layer; forming a wiring layer on a second portion of the first polymer layer, wherein the forming the wiring layer comprises depositing the conductive material in electrical contact with the plurality of conductive traces;

depositing a second polymer layer on the wiring layer and the second portion of the first polymer layer;

forming at least one electrode on the second polymer layer such that the at least one electrode is in electrical contact with at least a portion of a top surface of the wiring layer; and cutting the monolithic thin-film lead assembly from the first polymer layer, wherein the monolithic thin-film lead assembly comprises the plurality of conductive traces in the spiral pattern on the first polymer layer and the at least one electrode on the second polymer layer electrically connected to the plurality of conductive traces.

40. The method of claim 39, wherein the first polymer layer comprises one or more layers of dielectric material.

41. The method of claim 40, wherein the dielectric material is polyimide, liquid crystal polymer, parylene, polyether ether ketone, or a combination thereof.

42. The method of claim 39, 40, or 41, wherein the second polymer layer comprises one or more layers of dielectric material.

43. The method of claim 42, wherein the dielectric material is polyimide, liquid crystal polymer, parylene, polyether ether ketone, or a combination thereof.

44. The method of claim 39, 40, or 42, further comprising forming contact vias in the second polymer layer to the wiring layer, wherein the forming the at least one electrode comprises: depositing a conductive material in the contact via and on a top surface of the second polymer layer, and patterning the conductive material to form: (i) a first electrode over a first region of the second polymer layer such that the first electrode is in contact with a first portion of the top surface of the wiring layer, and (ii) a second electrode over a second region of the second polymer layer such that the second electrode is in contact with a second portion of the top surface of the wiring layer.

45. The method of claim 44, wherein the first region and the second region of the second polymer layer are separated from one another by a third region of the second polymer layer that does include at least a portion of the wiring layer but does not include an electrode.

46. The method of claim 44 or 45, further comprising depositing the second polymer layer on the plurality of conductive traces and the first portion of the first polymer layer.

47. The method of claim 39, further comprising detaching the monolithic thin-film lead assembly from the wafer or panel of substrate.

48. A method of manufacturing a monolithic thin-film lead assembly, comprising:

obtaining an initial structure comprising: (i) a cable comprising: a proximal end, a distal end, a supporting structure that extends from the proximal end to the distal end, and a plurality of conductive traces formed on a portion of the supporting structure; and (ii) an electrode assembly formed on the supporting structure at the distal end of the cable, wherein the electrode assembly comprises one or more electrodes in electrical connection with one or more conductive traces of the plurality of conductive traces;

winding the portion of the supporting structure in a helical pattern on a mandrel; and heating the initial structure with the portion of the supporting structure wound in the helical pattern on the mandrel to form the monolithic thin-film lead assembly.

49. The method of claim 48, wherein the winding is controlled such that the helical pattern has a helix angle from 10° to 85° and a pitch from 100 pm to 2 mm.

50. The method of claim 48, wherein the obtaining the initial structure comprises:

forming the supporting structure on a wafer or panel of substrate;

forming the plurality of conductive traces on a first portion of the supporting structure; forming a wiring layer on a second portion of the supporting structure;

depositing a polymer layer on the wiring layer and the second portion of the supporting structure;

forming at least one electrode on the polymer layer such that the at least one electrode is in electrical contact with at least a portion of a top surface of the wiring layer;

removing the wafer or panel of substrate from the supporting structure; and

cutting the initial structure from the first polymer layer.

51. A method of manufacturing a monolithic thin-film lead assembly, comprising:

obtaining an initial structure comprising: (i) a cable comprising: a proximal end, a distal end, a supporting structure that extends from the proximal end to the distal end, and a plurality of conductive traces formed on a portion of the supporting structure; and (ii) an electrode assembly formed on the supporting structure at the distal end of the cable, wherein the electrode assembly comprises one or more electrodes in electrical connection with one or more conductive traces of the plurality of conductive traces;

winding the portion of the supporting structure in a helical pattern on a mandrel;

inserting the mandrel with the portion of the supporting structure into a polymer tube to form an intermediate structure;

heating the intermediate structure with the portion of the supporting structure wound in the helical pattern on the mandrel to form the monolithic thin-film lead assembly; and

removing the mandrel from the monolithic thin-film lead assembly,

wherein the polymer tube completely encases the portion of the supporting structure wound in the helical pattern.

52. The method of claim 51, wherein the polymer tube is comprised of silicone, a polymer dispersion, parylene, or a polyurethane.

53. The method of claim 52, wherein an inner diameter of the polymer tube is less than an outer diameter of the portion of the supporting structure wound in the helical pattern.

54. The method of claim 53, further comprising soaking the polymer tube in a solution to swell the polymer tube prior to the insertion of the mandrel with the portion of the supporting structure wound in the helical pattern into the polymer tube.

55. The method of claim 54, wherein the solution comprises heptane.

56. The method of claim 53, wherein the heating process results in at least a portion of the portion of the supporting structure wound in the helical pattern embedding into a wall of the polymer tube since the inner diameter of the polymer tube is less than the outer diameter of the portion of the supporting structure wound in the helical pattern.

57. The method of claim 51, further comprising treating the monolithic thin-film lead assembly with oxygen plasma.

58. The method of claim 51, further comprising sealing ends of the polymer tube in the monolithic thin-film lead assembly.

59. A method of manufacturing a monolithic thin-film lead assembly, comprising:

obtaining an initial structure comprising: (i) a cable comprising: a proximal end, a distal end, a supporting structure that extends from the proximal end to the distal end, and a plurality of conductive traces formed on a portion of the supporting structure; and (ii) an electrode assembly formed on the supporting structure at the distal end of the cable, wherein the electrode assembly comprises one or more electrodes in electrical connection with one or more conductive traces of the plurality of conductive traces;

winding the portion of the supporting structure in a helical pattern on a mandrel;

heating the initial structure with the portion of the supporting structure wound in the helical pattern on the mandrel to form a first intermediate structure;

removing the mandrel from the intermediate structure;

inserting the mandrel into a polymer tube;

winding the portion of the supporting structure in the helical pattern on the polymer tube and the mandrel to form a second intermediate structure;

inserting the second intermediate structure into a heat shrink tube;

heating the second intermediate structure with the heat shrink tube to form the monolithic thin-film lead assembly; and

removing the heat shrink tube and the mandrel from the monolithic thin-film lead assembly,

wherein the heating embeds the supporting structure wound in the helical pattern into the polymer tube.

60. The method of claim 59, wherein the polymer tube is comprised of silicone, a polymer dispersion, parylene, or a polyurethane.

61. The method of claim 59, wherein the polymer tube is comprised of polyurethane.

62. A neuromodulation system comprising:

a neurostimulator comprising an electronics module;

a cable comprising:

a first helical portion at a proximal end of the cable, the first helical portion having a first pitch,

a second helical portion at a distal end of the cable, the second helical portion having the first pitch,

a third helical portion that extends between the first helical portion and the second helical portion, the middle portion being a third helical portion with a second pitch greater than the first pitch,

a supporting structure that extends from the proximal end to the distal end, and a plurality of conductive traces formed on a portion of the supporting structure; an electrode assembly formed on the supporting structure at the distal end of the cable, wherein the electrode assembly comprises one or more electrodes in electrical connection with one or more conductive traces of the plurality of conductive traces; and

a connector formed on the supporting structure at the proximal end and in electrical connection with the one or more conductive traces of the plurality of conductive traces,

wherein the connector electrically connects the one or more conductive traces of the plurality of conductive traces to the electronics module.

63. A method of manufacturing a monolithic thin-film lead assembly, comprising:

obtaining an initial structure comprising: (i) a cable comprising: a proximal end, a distal end, a supporting structure that extends from the proximal end to the distal end, and a plurality of conductive traces formed on a portion of the supporting structure; and (ii) an electrode assembly formed on the supporting structure at the distal end of the cable, wherein the electrode assembly comprises one or more electrodes in electrical connection with one or more conductive traces of the plurality of conductive traces;

winding the portion of the supporting structure in a helical pattern on a mandrel;

inserting the mandrel with the portion of the supporting structure into a heat shrink tube to form an intermediate structure;

heating the first intermediate structure with the portion of the supporting structure wound in the helical pattern on the mandrel to form a second intermediate structure;

removing the mandrel from the second intermediate structure such that the second intermediate structure is left with a lumen;

injecting the lumen of the second intermediate structure with a polymer to form a third intermediate structure,

heating the third intermediate structure with the heat shrink tube to form the monolithic thin-film lead assembly; and

removing the heat shrink tube from the monolithic thin-film lead assembly,

wherein the heating embeds the supporting structure wound in the helical pattern into the polymer.

64. The method of claim 63, wherein the heat shrink tube is comprised of a

fluoropolymer.

65. The method of claim 63, wherein the polymer is comprised of silicone, a

polyurethane, a copolymer thereof, or a blend thereof.

66. The method of claim 65, wherein the polymer has a Shore durometer measured on a Shore 00 Scale of less than 50.

67. The method of claim 63, wherein the plurality of conductive traces and the supporting structure wound in the helical pattern are coplanar with the polymer in the monolithic thin-film lead assembly.

68. A method of manufacturing a monolithic thin-film lead assembly, comprising:

obtaining an initial structure comprising: (i) a cable comprising: a proximal end, a distal end, a supporting structure that extends from the proximal end to the distal end, and a plurality of conductive traces formed on a portion of the supporting structure; and (ii) an electrode assembly formed on the supporting structure at the distal end of the cable, wherein the electrode assembly comprises one or more electrodes in electrical connection with one or more conductive traces of the plurality of conductive traces;

winding the portion of the supporting structure in a helical pattern on a mandrel;

cutting a slit into a polymer tube such that a lumen of the polymer tube is exposed along an entire length of the polymer tube;

inserting the mandrel with the portion of the supporting structure into the lumen of the polymer tube through the slit to form a first intermediate structure;

removing the mandrel from the first intermediate structure such that the first intermediate structure is left with the lumen;

sealing ends of the polymer tube in the first intermediate structure to form a second intermediate structure; and

heating the second intermediate structure to form the monolithic thin-film lead assembly, wherein the polymer tube encases the portion of the supporting structure wound in the helical pattern.

69. The method of claim 68, wherein the polymer tube is comprised of silicone, a polymer dispersion, parylene, a polyurethane.

70. The method of claim 68, wherein an inner diameter of the polymer tube is greater than an outer diameter of the portion of the supporting structure wound in the helical pattern.

71. A method of manufacturing a monolithic thin-film lead assembly, comprising:

obtaining an initial structure comprising: (i) a cable comprising: a proximal end, a distal end, a supporting structure that extends from the proximal end to the distal end, and a plurality of conductive traces formed on a portion of the supporting structure; and (ii) an electrode assembly formed on the supporting structure at the distal end of the cable, wherein the electrode assembly comprises one or more electrodes in electrical connection with one or more conductive traces of the plurality of conductive traces;

winding the portion of the supporting structure in a helical pattern on a mandrel;

removing the mandrel from the portion of the supporting structure;

treating the portion of the supporting structure with oxygen plasma;

diluting a liquid prepolymer or polymer with a solvent to form a solution;

applying the solution on the supporting structure to form an intermediate structure comprising one or more coats of polymer; and

heating the intermediate structure to form the monolithic thin-film lead assembly, wherein the polymer encases the portion of the supporting structure wound in the helical pattern.

72. The method of claim 71, wherein the polymer is comprised of silicone, a polymer dispersion, parylene, or a polyurethane.

73. The method of claim 71, wherein the applying the solution comprises applying the solution using a dip coating process, spin coating process, or spray coating process.