METHOD TO MANUFACTURE CUFF LEADS

Abstract

A method of manufacturing an implantable lead including a cuff is disclosed. The method includes partially curing a first silicone electrode cover, embedding electrodes within the first silicone electrode cover, partially curing a second silicone electrode cover, placing the first silicone electrode in a face-to-face relationship with the second silicone electrode cover to form an assembly, forming the assembly into a desired shape against a shim, placing an assembly within a canister to control an outer expansion, and curing the assembly.

Claims

1. A method of manufacturing an implantable lead including a cuff comprising: partially curing a first silicone electrode cover; embedding electrodes within the first silicone electrode cover; partially curing a second silicone electrode cover; placing the first silicone electrode in a face-to-face relationship with the second silicone electrode cover to form an assembly; forming the assembly into a desire shape against a shim; placing the assembly within a canister to control an outer expansion; and curing the assembly.

2. The method of claim 1, wherein the first silicone electrode cover and the second silicone electrode cover include a platinum-cured elastomer.

3. The method of claim 1, wherein the partial curing is between 2 and 15 seconds inclusive.

4. The method of claim 1, wherein the partial curing is between 120° and 180° Centigrade inclusive.

5. The method of claim 1, wherein the assembly curing is between 120 and 240 minutes inclusive.

6. The method of claim 1, wherein the assembly curing is above 180 degrees Centigrade inclusive.

7. The method of claim 1, further comprising covering at least a portion of the embedded electrodes with a third semi-cured platinum-cured elastomer silicone cover.

8. The method of claim 1, wherein at least a portion of the embedded electrodes are not covered by the at least one of the silicone covers.

9. The method of claim 1, further comprising placing the first silicone cover or the second silicone against a shim in a face-to-face relationship.

10. The method of claim 1, wherein the desired shape includes at least one roll or coil.

11. The method of claim 10, wherein the desired shape defines a greater than a 360-degree coil.

12. The method of claim 1, further comprising flowing air over the assembly.

13. The method of claim 12, wherein airflow is between 80 and 110 liters per minute inclusive.

14. The method of claim 1, further comprising removing from the assembly from the canister when fully cured.

15. The method of claim 1, wherein the shim includes stainless steel or nitinol shims.

16. An implantable lead comprising a cuff adapted to be wound around a nerve comprising: a first silicone layer defining a coil including a plurality of electrodes embedded within the silicone; a second silicone layer cured to the first silicone layer defining an assembly; and a gap defining at least a partial space between the first silicone layer and the second silicone layer.

17. The implantable lead of claim 16, wherein the electrodes are stamped platinum electrodes.

18. The implantable lead of claim 16, wherein the electrodes are arranged in an array within the first silicone layer.

19. The implantable lead of claim 16, wherein a portion of each of the electrodes is uncovered.

20. The implantable lead of claim 19, wherein a portion of each of the electrodes is flush with or raised above an outer surface of one of the covers.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] So that those skilled in the art to which the subject invention appertains will readily understand how to make and use the devices and methods of the subject invention without undue experimentation, preferred embodiments thereof will be described in detail herein below with reference to certain figures, wherein:

[0012] FIG. 1 is a perspective view of a cuff lead according to this disclosure;

[0013] FIG. 2a is a top view of an uncured bottom cover of the cuff lead;

[0014] FIG. 2b is a side view of an uncured bottom cover of the cuff lead;

[0015] FIG. 3a is a top view of an uncured top cover of the cuff lead;

[0016] FIG. 3b is a side view of an uncured top cover of the cuff lead;

[0017] FIG. 4 is a perspective view of an assembly step of the cuff lead of FIG. 1, showing the placement of the electrodes.

[0018] FIG. 5 is a perspective view of the partially cured top and bottom covers of FIG. 4, showing the implanted electrodes;

[0019] FIG. 6 is a perspective view of the partially cured top and bottom covers of FIG. 2, being coiled with the assembly of a shim; and

[0020] FIG. 7 is a perspective view of the partially cured top and bottom covers of FIG. 6, being inserted into a final curing mold.

DETAILED DESCRIPTION

[0021] Reference will now be made to the drawings wherein like reference numerals identify similar structural features or aspects of the subject invention. For purposes of explanation and illustration, and not limitation, a partial view of an exemplary embodiment of a cuff lead is shown in FIG. 1, which can be made using the manufacturing method shown in FIGS. 2-7. The methods and systems of the invention can be used to form a custom shaped implantable lead assembly.

[0022] FIG. 1 shows an implantable cuff lead 100. The cuff lead includes a top silicone electrode cover 202 and a bottom cover 204. Along with a plurality of electrodes 206 embedded therein. In order to produce an intricate shape as the one shown in the FIG. 1 a series of steps as shown in FIGS. 2-7 have to be performed.

[0023] FIG. 2a is a top view of an uncured bottom cover 204 of the cuff lead 100 and FIG. 2b is a side view of an uncured bottom cover 204. The bottom cover 204 can be flat a shape without electrode receptacles. FIG. 3a is a top view of an uncured top silicone electrode cover 202 of the cuff lead 100 and FIG. 3b is a side view of an uncured top silicone electrode cover 202. The top silicone electrode cover 202 can include a plurality of electrode receptacles 201. The receptacles can include a step 201a to ensure retention of the electrodes. Each of the covers 202/204 include a platinum-cured elastomer. Thermoplastics such as Pellethane or Polyurethane can also be used. The covers 202/204, originally, in liquid form are placed within molds. Each of the covers 202/204 are then partially cured. Afterwards each cover 202/204 is ejected from the mold as quickly as it can while still maintaining its shape. Partial curing requires between 2 and 15 seconds at a temperature between 120° and 180° Centigrade. Each of the covers 202/204 are set aside to cool to room temperature. After each of the covers 202/204 is partially cured, electrodes 206 are embedded into assembly 208 in an array within the top silicone electrode cover 202 as shown in FIG. 4. The electrodes 206 can be stamped platinum electrodes. Each of the electrodes 206 is connected to a wire 203, which is placed in a gap 205, by laser welding, resistance welding, or soldering.

[0024] The bottom silicone electrode cover 204 is then placed on top of or in a face-to-face relationship with the top silicone electrode cover 202, covering up the electrodes 206 and forming an assembly 208 as shown in FIG. 5. A third semi-cured platinum-cured elastomer silicone cover can be used before the first and second covers are placed face-to-face in order to cover the electrodes. Some of the electrodes 206 can be left partially uncovered and expose a portion of the electrode 207 through the top cover 202.

[0025] The resultant assembly 208 is then placed against a flexible metal shim 210 and together with the shim 210, the assembly 208 carefully curled into a shape spanning more than 360 degrees where the electrode assembly is now in a spiral shape as shown in in FIG. 6. In FIG. 6 a coil is formed. In the particular case, the coil spans more than 450 degrees. The shim, which can be stainless steel or nitinol shim. The complete assembly 208 along with the shim 210 is then placed into an encasing canister 212, as shown in FIG. 7, that constrains the assembly to the desired outer diameter or thickness. The assembly 208, shim 210, and canister 212 are then placed into a curing oven. This oven is set with the appropriate curing temperature and airflow for the appropriate curing time according to the Liquid Silicone specification. The assembly 208 requires curing for 120 to 240 minutes at a temperature above 180 degrees Centigrade. The assembly 208 is then removed from the canister 212 when fully cured producing a final manufactured shape for implantable cuff leads, which can be used for electrical stimulation of nerves, muscles, veins or arteries.

[0026] The methods and systems of the present disclosure, as described above and shown in the drawings provide for a manufacturing method with superior properties including increased complexity. While the apparatus and methods of the subject disclosure have been showing and described with reference to embodiments, those skilled in the art will readily appreciate that changes and/or modifications may be made thereto without departing from the spirit and score of the subject disclosure.