阅读说明：本技术 包括电极阵列的刺激装置 (Stimulation device comprising an electrode array ) 是由 A·C·约翰逊 L·N·斯特罗特曼 于 2020-04-03 设计创作，主要内容包括：刺激装置包括用于产生电信号的刺激器和用于将电信号传输到目标的电极阵列。所述电极阵列包括限定开孔的基底以及由基底支撑的至少一个电极。所述刺激装置还包括连接器,该连接器从刺激器延伸,并且至少部分地设置在基底的开孔中以限定位于连接器和基底之间的空间。所述连接器被构造为在刺激器和电极阵列之间建立电连接。所述导电弹性油墨至少部分地设置在限定于连接器和基底之间的空间内,以将连接器固定到基底。(The stimulation device includes a stimulator for generating electrical signals and an electrode array for transmitting the electrical signals to a target. The electrode array includes a substrate defining an aperture and at least one electrode supported by the substrate. The stimulation device also includes a connector extending from the stimulator and at least partially disposed in the aperture of the substrate to define a space between the connector and the substrate. The connector is configured to establish an electrical connection between the stimulator and the electrode array. The conductive elastomeric ink is at least partially disposed within a space defined between the connector and the substrate to secure the connector to the substrate.)

1. A stimulation device, comprising:

a stimulator for generating an electrical signal;

an electrode array for transmitting the electrical signal to a target, and the electrode array comprising a substrate defining an aperture and at least one electrode supported by the substrate;

a connector extending from the stimulator and disposed at least partially in the aperture of the substrate and defining a space between the connector and the substrate, wherein the connector is configured to establish an electrical connection between the stimulator and the electrode array; and

a conductive elastomeric ink disposed at least partially within the space to secure the connector in the opening.

2. The stimulation device as recited in claim 1, wherein said substrate has an electrode area and an interconnect area, wherein said at least one electrode is supported by said substrate at said electrode area, and said substrate defines said aperture at said interconnect area.

3. The stimulation device as recited in claim 2, wherein said substrate has a width and said aperture is defined at least partially through said width of said substrate.

4. A stimulation device as set forth in claim 3, wherein said connector is further defined as a connector pin and said connector pin is at least partially disposed in said aperture and secured to the substrate by the conductive elastomeric ink.

5. A stimulation device as recited in claim 3, wherein the aperture is defined completely through the width of the substrate.

6. The stimulation device as recited in claim 5, wherein the connector further comprises opposing first and second ends, wherein the first end is attached to the stimulator and the second end defines a hook that abuts the base to further secure the connector to the base.

7. The stimulation device as recited in claim 1, wherein said opening is one of a plurality of openings defined in said substrate, wherein said plurality of openings define a pitch between adjacent openings of from about 50 μ ι η to about 1500 μ ι η.

8. The stimulation device as recited in claim 1, wherein said at least one electrode is formed from said conductive elastomeric ink.

9. The stimulation device as recited in claim 1, wherein said conductive elastic ink comprises conductive particles and silicone, wherein said silicone imparts elasticity to said electrode array.

10. The stimulation device as recited in claim 9, wherein said conductive particles are selected from the group consisting of platinum particles, silver particles, copper particles, gold particles, chromium particles, titanium particles, iridium particles, stainless steel particles, conductive polymer particles, carbon nanotubes, and combinations thereof.

11. The stimulation device as recited in claim 9, wherein said conductive elastomeric ink further comprises a silicone selected from the group consisting of cyclosiloxanes, linear siloxanes, and combinations thereof.

12. A stimulation device as recited in claim 9, wherein the conductive particles have an effective particle size of less than 1 μ ι η.

13. The stimulation device as recited in claim 1, wherein said substrate is formed of a non-conductive material selected from the group consisting of silicone, fluoropolymers, oxides, pre-stretched elastomers, poly (p-xylylene), polyimide, polyurethane, and combinations thereof.

14. The stimulation device as recited in claim 1, wherein said substrate is formed from one or more silicones.

15. The stimulation device as recited in claim 1, wherein said at least one electrode in said electrode array is stretchable up to an elongation of about 140% while remaining electrically conductive.

16. A stimulation device as set forth in claim 1 wherein said stimulation device is further defined as a neuroprosthetic device.

17. An electrode array, comprising:

a substrate; and

at least one electrode supported by the substrate;

wherein the substrate defines an aperture for receiving a connector for establishing an electrical connection between a stimulator and the electrode array.

18. An electrode array according to claim 17, further comprising conductive elastomeric ink disposed within the aperture for securing the connector in the aperture.

19. The electrode array of claim 17, wherein the at least one electrode is formed from a conductive elastic ink comprising conductive particles and silicone, wherein the silicone imparts elasticity to the at least one electrode.

20. The electrode array of claim 19, wherein the conductive particles are selected from the group consisting of platinum particles, silver particles, copper particles, gold particles, chromium particles, titanium particles, iridium particles, stainless steel particles, conductive polymer particles, carbon nanotubes, and combinations thereof.

21. The electrode array of claim 19, wherein the conductive elastomeric ink further comprises a siloxane selected from the group consisting of cyclosiloxanes, linear siloxanes, and combinations thereof.

22. The electrode array of claim 17, wherein the at least one electrode is stretchable to an elongation of up to about 140% while remaining electrically conductive.

Technical Field

The present disclosure relates generally to stimulation devices that include an electrode array.

Background

Neuroprosthetic devices are stimulation devices that are commonly used to treat neurological diseases and disorders such as parkinson's disease, deafness, epilepsy, chronic pain, paralysis, and blindness. One example of a neuroprosthetic device is a cochlear implant, a medical device implanted in the cochlea of an organism. A cochlear implant includes a stimulator that generates electrical signals and an electrode array that provides electrical signals to nerve fibers in the cochlea to improve hearing. Electrical connections are typically established between the stimulator and the electrode array through connectors or feedthrough pins that connect to wiring harnesses soldered to the electrodes of the stimulator and the electrode array. While suitable for establishing electrical connections, soldering is often a complex manufacturing process. The wiring harness is prone to breakage, resulting in a greater number of revision surgeries. Furthermore, the wiring harness is also difficult to assemble, which limits the miniaturization of the stimulator and/or the electrode array. The present disclosure is directed to solving these problems.

Disclosure of Invention

Embodiments of a stimulation device are provided. The stimulation device comprises: a stimulator for generating an electrical signal; an electrode array for transmitting electrical signals to a target, and the electrode array comprising a substrate defining an aperture and at least one electrode supported by the substrate; a connector extending from the stimulator and disposed at least partially in the aperture of the substrate and defining a space between the connector and the substrate, wherein the connector is configured to establish an electrical connection between the stimulator and the electrode array; and a conductive elastomeric ink disposed at least partially within the space to secure the connector within the opening.

Embodiments of an electrode array are also provided. The electrode array includes a substrate; and at least one electrode supported by the substrate, wherein the substrate defines an aperture for receiving a connector for establishing an electrical connection between a stimulator and the electrode array.

Drawings

Advantages of the invention will be readily appreciated as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings.

Fig. 1 is a semi-schematic partial cross-sectional perspective view of a portion of an auditory system of a biological object and a stimulation device implanted in a cochlea of the biological object.

Fig. 2 is a schematic perspective view of a section of an electrode array for a stimulation device.

Fig. 3 is an exploded semi-schematic perspective view of a stimulation device according to an embodiment of the present disclosure.

Fig. 4 is a cross-sectional view of a section of the stimulation device taken along line 4-4 of fig. 3.

Fig. 5 is a cross-sectional view of a section of a stimulation device according to another embodiment of the present disclosure.

Fig. 6 is a cross-sectional view of a section of a stimulation device according to yet another embodiment of the present disclosure.

Detailed Description

Referring now to the drawings, in which like reference numerals designate like or corresponding parts throughout the several views, embodiments of a stimulation device and an electrode array 102 for the stimulation device are shown throughout the drawings and described in detail below. In the embodiments described below, the stimulation device is a neuroprosthetic device adapted to replace or supplement an input and/or output of the nervous system of an organism, such as an animal or human. Neuroprosthetic devices are commonly used to treat a variety of neurological diseases and disorders. Non-limiting examples of neuroprosthetic devices include deep brain stimulators, spinal cord stimulators, retinal prostheses, and cochlear prostheses. For example, and as shown in fig. 1, the stimulation device may be a cochlear prosthesis 100, a device that may be implanted in the cochlea 12 of an organism 10 for treating hearing loss. Due at least in part to the presence of flexible materials such as silicone in the various material layers, the electrode array 102 of the stimulation device is flexible and resilient and can be easily implanted in small curved spaces such as the cochlea 12 of the living being 10. It should be understood that the stimulation device is not limited to cochlear prostheses. Applications other than medical devices are also contemplated.

With continued reference to fig. 1, the stimulation apparatus includes a stimulator 104 for generating electrical signals and an electrode array 102 for transmitting the electrical signals to a target (e.g., cochlea 12 of the living organism 10). The stimulation device also includes a connector 108, such as a connector pin or feedthrough pin schematically represented in fig. 3-6, that extends from the stimulator 104. As described in detail below, the connector 108 is received and secured within an aperture 118 defined in the substrate 110 of the electrode array 102 to establish an electrical connection between the electrode array 102 and the stimulator 104.

As used herein, stimulator 104 is or includes any device (of any suitable design or construction) that operates to effect stimulation or produce stimulation. For example, the stimulator 104 is a device that operates to generate an electrical signal. In medical applications, the signals are used as stimuli for treating various medical diseases or disorders. For example, the signals generated by the stimulator 104 may be used to stimulate nerves of the organism 10 to mask pain, treat hearing loss, control organ function, and the like. Further, for medical applications, the stimulator 104 may or may not be implanted in the living being 10. In the case where the stimulator 104 is not implantable in the living being 10 (such as shown in fig. 1), the stimulator 104 may be referred to as an external device.

The electrode array 102 is electrically connected (via connector 108 as described above) to the stimulator 104 and, in medical applications, is typically implanted in the living being 10. The electrode array 102 is desirably formed of a biocompatible material, i.e., a material that is friendly and harmless to living tissue. The electrode array 102 includes a configuration or array of electrodes 116 adapted to transmit or transmit electrical signals generated by the stimulator 104 to a target (e.g., a nerve or neuron in the cochlea 12 of the organism 10). In alternative embodiments, a single electrode 116 may be used to deliver the electrical signal to the target. In this alternative embodiment, the electrode array 102 would simply be one electrode.

Fig. 2 is a schematic diagram of a stimulation device (e.g., prosthesis 100) including an electrode array 102. Referring to fig. 1-3, electrode array 102 has an interconnect region 112 and an electrode region 114. As shown in fig. 1 and 3, the interconnect region 112 allows the electrode array 102 to be electrically connected to the stimulator 104. The electrode area 114 includes a substrate 110 supporting a plurality of electrodes 116 of the electrode array 102, as best shown in fig. 2. Although four electrodes 116 are shown in fig. 2, it should be understood that the electrode array 102 may have any number of electrodes 116, such as one, two, three, four, or more electrodes 116. The interconnect region 112 and the electrode region 114 may be as small or as large as desired and/or required. In general, the size and/or configuration of the electrode region 114 depends on the shape of the area in which the electrode array 102 is to be implanted and/or the number of electrodes 116 of the electrode array 102. Other factors may affect the size and/or configuration of the electrode region 114. As described above, the stimulator 104 and the electrode array 102 are connected by the connector 108. The connector 108 is connected to the electrodes 116 of the electrode array 102 via, for example, wires embedded in the substrate 110.

The substrate 110 of the electrode array 102 is formed of a non-conductive material. In one embodiment, the non-conductive material is both an electrically insulating material and a biocompatible material. In one embodiment, the non-conductive material has at least 1x10¹¹Resistivity of ohm m. Non-limiting examples of biocompatible non-conductive materials for substrate 110 include silicone, fluoropolymers (e.g., polytetrafluoroethylene), oxides, pre-stretched elastomers, poly (p-xylene), polyimide, polyurethane, and combinations thereof. In certain embodiments, the non-conductive material is a silicone or a combination of silicones. In an alternative embodiment, the non-conductive material may be one or more silicones combined with another biocompatible non-conductive material. It is also contemplated that biocompatible non-conductive materials other than silicone may be used for substrate 110.

Substrate 110 may have any suitable configuration and/or dimensions. In the embodiment shown in FIG. 2, substrate 110 has a generally rectangular configuration and has a length L₁₁₀(Luo) and width W₁₁₀(WHO). Alternatively, the substrate 110 may have an oval or other suitable configuration. Where the substrate 110 has a generally rectangular configuration, the corners of the substrate 110 are generally rounded. Length L of substrate 110₁₁₀At least in part, the length of the area in which the electrode array 102 is to be implanted and/or the length suitable to support the desired number of electrodes 116. For example, for an electrode array 102 having six electrodes 116, the length L of the substrate 110 is compared to an electrode array 102 having two electrodes 116₁₁₀It can be longer. In another example, for an electrode array 102 to be implanted in a long channel (e.g., cochlea 12), the length L of the substrate 110 is compared to the electrode array 102 to be implanted or used in a more open area₁₁₀It can be longer. For cochlear prosthesis 100, length L of base 110₁₁₀And may be about 90 to about 110 mm. Further, the substrate 110 may have any width W₁₁₀So long as electrode array 102 can be suitably implanted and/or support the desired configuration of electrodes 116. For cochlear implant 100, width W₁₁₀Typically less than 1 mm. Longer, shorter, wider, or narrower substrates 110 than the ranges provided above are also contemplated.

As described above, the substrate 110 includes an interconnect region 112 that allows the electrode array 102 to be electrically connected to the stimulator 104. As shown in fig. 3-6, the substrate 110 defines an opening 118 at the interconnect region 112. In the embodiment shown in fig. 3, substrate 110 defines a bond pad 120 at interconnect region 112, and bond pad 120 defines an opening 118. In the illustrated embodiment, four bond pads 120 are shown, wherein each bond pad 120 defines an opening 118. Although four bond pads are shown in fig. 3, it is understood that the substrate 110 may define more or fewer bond pads 120. The aperture 118 is configured to receive the connector 108 for electrically connecting the electrode array 102 to the stimulator 104.

In the illustrated embodiment, each bond pad 120 defines an opening 118, the opening 118 being adapted to receive a respective connector 108 for establishing an electrical connection between a particular electrode 116 of the electrode array 102 and the stimulator 104. As shown, each bond pad 120 defines a single opening 118, the opening 118 being configured to receive a connector 108 for electrically connecting a plurality (e.g., four as shown in fig. 3) of electrodes 116 to stimulator 104. Alternatively, each bond pad 120 may define two or more apertures 118. In another alternative configuration, the substrate 118 may define a single bond pad 120, and the single bond pad 120 may define all of the apertures 118. It should also be understood that the substrate 110 may support any number of electrodes 116 and the interconnect region 112 may define any number of apertures 118, wherein each aperture 118 is adapted to receive the connector 108 to electrically connect a respective one of the electrodes 116 in the electrode array 102 to the stimulator 104.

As also shown in fig. 3, each of the bond pads 120 are spaced apart from one another. Further, each of the apertures 118 is spaced apart from one another. The apertures 118 define a pitch P between adjacent apertures 118₁₁₈(Pus), the pitch being measured from the center of one aperture 118 to the center of an adjacent aperture 118. Pitch P between adjacent openings 118₁₁₈And may be of any suitable length. In one embodiment, the pitch P between adjacent apertures 118₁₁₈From about 50 to about 1500 μm (pm). In another embodiment, the pitch P between adjacent apertures 118₁₁₈From about 80 to about 120 μm. In yet another embodiment, the pitch P between adjacent apertures 118₁₁₈From about 90 to about 110 μm.

As best shown in fig. 4-6, the aperture(s) 118 may have any suitable configuration, such as a circular configuration, a square configuration, or the like. In one embodiment, the aperture(s) 118 have a diameter D₁₁₈A circular configuration of about 20 to about 330 μm. In another embodiment, the aperture(s) 118 have a diameter D₁₁₈A circular configuration of about 30 to about 200 μm. In yet another embodiment, the aperture(s) 118 have a diameter D₁₁₈A circular configuration of about 30 to about 150 μm. In yet another embodiment, the opening(s) 118 have a diameter D₁₁₈A circular configuration of about 40 to about 70 μm. It should be appreciated that the size of the aperture 118 is at least partially dependent upon the size of the connector 108 to be partially received in the aperture 118. Is described belowIn an embodiment of (a), the aperture(s) 118 are larger than the connector 118 such that at least a portion of the connector 108 can be easily placed and/or received within the aperture 118 and a space 140 is formed between the connector 108 and the substrate 110. The space 140 is described in further detail below.

The opening(s) 118 are defined at least partially through the width W of the substrate 110 (or bond pad 120)₁₁₀. In one embodiment and as shown in fig. 4 and 5, the opening(s) 118 are defined through the entire width W of the substrate 110 (or bond pad 120)₁₁₀. For example, the substrate 110 has opposing first and second sides 122, 124, and the aperture(s) 118 are defined through both sides 122, 124 of the substrate 110.

Referring to fig. 3 and 4, the connector 108 has a first end 109 and a second end 111, wherein the first end 109 is attached to the stimulator 104 and the second end 111 is spaced apart from the stimulator 104. In the illustrated embodiment, the first end 109 of the connector 108 is embedded in, and thus extends into, the stimulator 104. Alternatively, the first end 109 of the connector 108 may be attached (e.g., welded, etc.) to the surface 105 of the stimulator 104. The connector 108 extends from the stimulator 104, through a first side 122 of the substrate 110, through the aperture 118, and through a second side 124 of the substrate 110. The second end 111 of the connector 108 protrudes above the second side 124 of the substrate 110 or beyond the second side 124 of the substrate 110. As best shown in fig. 4, a space 140 is defined between the connector 108 and the substrate 110 when the connector 108 extends through the aperture 118. More specifically, a space 140 is defined between at least one side 142 of the connector 108 and the substrate 110.

The stimulation device 100 also includes a conductive elastomeric ink 146 disposed at least partially in the space 140 to secure the connector 108 in the opening 118. The conductive elastomeric ink 146 may be the same material used to form the electrodes 116 of the electrode array 102. In this embodiment, the conductive elastomeric ink 146 may be disposed within the space 140 during formation of the electrode array 102. Alternatively, and due at least in part to the elastic properties of the conductive elastomeric ink (which is described in further detail below), the electrodes 116 formed from the conductive elastomeric ink may be stretched over the connectors 108 to secure the connectors 108 within the apertures 118. In another embodiment, such as shown in fig. 5, the second end 111 of the connector 108 is bent to form a hook that engages the second side 124 of the base 110 to secure the connector 108 in the aperture 118.

The connector 108 is connected to the electrodes 116 of the electrode array 102 via, for example, wires embedded in the substrate 110. The conductive elastomeric ink securing the connector 108 in the opening 118 also serves to establish or complete an electrical connection between the electrode array 102 and the stimulator 104. Additional layers of conductive ink may also be added to further ensure electrical connection.

In another embodiment and as shown in fig. 6, the opening(s) 118 are defined partially through the width W of the substrate 110 (or bond pad 124)₁₁₀. For example, the aperture(s) 118 are defined through the first side 122 of the substrate 110, but do not extend through the entire width W of the substrate 110 (or the bond pad 120)₁₁₀. The openings 118 may have any suitable depth d₁₁₈(due) as long as the opening 118 is not formed throughout the entire width W of the substrate 110₁₁₀And (4) finishing. In one embodiment, the depth d of the opening 118₁₁₈At least about 5 μm. It should be understood that the depth d₁₁₈May be less than 5 μm such that the aperture 118 is substantially flush with the first side 122 of the substrate 110. As shown in fig. 6, only a portion of connector 108 including second end 111 is received in aperture 118.

When the portion of the connector 108 is disposed within the aperture 118, a space 140 is defined between the connector 108 and the substrate 110. In this embodiment, a space 140 is defined between at least one side 142 of the connector 108 and the substrate 110. A space 140 is also defined between the second end 111 of the connector 108 and the substrate 110. Conductive elastomeric ink 146 is disposed in the space 140 to secure the connector 108 in the opening 118. The conductive elastomeric ink 146 may be disposed within the space 140 during formation of the electrode array 102. The conductive elastomeric ink 146 disposed within the space 140 in electrical connection with the electrodes 116 of the electrode array 102 is also used to establish or complete an electrical connection between the electrode array 102 and the stimulator 104.

The opening(s) 118 may be formed during formation of the substrate 110 or after formation of the substrate 110 using any suitable subtractive manufacturing technique. Alternatively, the aperture(s) 118 may be formed when the connector 108 is disposed (e.g., stamped) through the substrate 110. In this alternative embodiment, the aperture(s) 118 have substantially the same configuration as the connector 108.

The substrate 110 may be formed by depositing a non-conductive material into a mold using any suitable additive manufacturing process (process) or technique. In one embodiment, the non-conductive material, which may be in the form of a non-conductive ink, is deposited using a printing technique such as pressure driven extrusion printing. This technique may utilize techniques such as those available from nScrypt Inc. (Orlando, FL)The appropriate pressure for the 3Dn printer drives the extrusion printer to perform. Alternatively, the substrate 110 may be formed using other manufacturing processes, such as by chemical and/or physical deposition processes. More details of the process for forming the substrate 110 can be found in co-pending patent application No. __ (Attorney Docket No.264.0002PC1/Attorney Docket No.264.0002PC1), the contents of which are incorporated herein in their entirety as a non-limiting example.

The non-conductive ink used to form the substrate includes a non-conductive material and a curing agent. In one embodiment, the non-conductive ink further comprises a solvent such as, but not limited to, xylene, toluene, ligroin, mineral spirits, chlorinated hydrocarbons, and combinations thereof. The non-conductor may also include one or more additives.

In one embodiment, the substrate 110 includes one or more three-dimensional (3D) features, such as one or more channels or one or more other structures, to facilitate surgical placement or implantation of the electrode array 102 into the organism 10. In addition, the first side 122 and/or the second side 124 of the substrate 110 may be roughened to improve adhesion to subsequently formed components of the electrode array 102 (e.g., the electrodes 116). Other features may include undulating surface contours to enhance the ability of the electrode array 102 to stretch without adversely affecting the performance of the conductive features (e.g., electrodes 116) and/or the substrate 110 may be pre-stretched to enhance the elasticity of the electrode array 102. One or more of these features may be obtained during 3D printing to form the substrate 110.

Referring again to fig. 2, the electrode array 102 includes a plurality of electrodes 116 supported by the substrate 110. As previously described, the electrode 116 is supported by the substrate 110 at the electrode region 114. The electrodes 116 may have any desired configuration on the substrate 110. For example, the electrodes 116 may be arranged in a single row, multiple rows, according to a pattern, randomly, or according to a combination thereof. Further, the electrodes 116 are spaced apart from each other. The electrodes 116 are kept electrically isolated from each other by means of a non-conductive substrate material surrounding the electrodes 116.

The electrodes 116 are formed from conductive elastomeric ink. The conductive elastomeric ink includes conductive particles and a carrier (vehicle) comprising silicone, such as polydimethylsiloxane, that imparts elasticity to the conductive elastomeric ink, thereby enabling the electrode array 102 to flex while the electrodes 116 remain conductive. Silicone resins are commonly used with curing agents. In one embodiment, the conductive elastomeric ink further comprises a siloxane and optionally one or more solvents, for example, conventional solvents such as toluene, heptane, and the like. Silicones are used to reduce the viscosity of conductive elastomeric inks and tend to evaporate slowly compared to traditional solvents, thereby maintaining ink consistency during printing. Non-limiting examples of suitable siloxanes for use in the conductive ink include cyclosiloxanes (e.g., hexamethylcyclotrisiloxane, octamethylcyclotetrasiloxane, etc.), linear siloxanes (e.g., hexamethylcyclotrisiloxane, octamethyltrisiloxane, etc.), and combinations thereof. One or more additives (e.g., surfactants, etc.) may also be used in the conductive elastomeric ink.

The conductive particles of the conductive elastomeric ink are biocompatible and typically have a particle size of less than 1x10^-7Resistivity of ohm m. Non-limiting examples of conductive particles for use in the ink include medical grade platinum particles, silver particles, copper particles, gold particles, chromium particles, titanium particles, iridium particles, stainless steel particles, conductive polymer particles, carbon nanotubes, and combinations thereof. In generalThe conductive particles have an effective particle size of less than 1 μm and may be referred to as nanoparticles. In one embodiment, the particles have an effective particle size of about 50nm to about 1 μm. Alternatively, the particles may have an effective particle size of up to about 10 μm. In a particular embodiment, the conductive elastic ink includes platinum particles as the conductive particles, and the conductive elastic ink may be referred to as a platinum ink. In another embodiment, the platinum particles may be optimized for superior electrical properties, such as charge storage capacity, resistance, etc., by including conductive particles having different shapes, sizes, and/or concentrations.

The conductive elastomeric ink may be formed by combining conductive particles, silicone, siloxane, and optionally one or more additives. For example, the combination can be accomplished by mixing the conductive particles, silicone, siloxane, and optional additives using sonication (sonication), planetary centrifugal mixing, roll-to-roll milling, and the like. Other methods of combining the components of the conductive elastomeric inks known in the art are also contemplated.

The electrodes 116 are formed by depositing a conductive elastomeric ink onto the substrate 110 using any suitable additive manufacturing process, such as by pressure driven extrusion printing. In one embodiment, the conductive elastomeric ink is applied using a printer (e.g., for depositing non-conductive material to form the substrate 110 described above)Printer) to deposit. Further details of the process for forming the electrodes 116, and thus the entire electrode array 102, can be found in the above-mentioned co-pending patent application No. __ (Attorney Docket No. 264.0002PC1/264.0002US1). Other additive manufacturing processes for forming the electrode 116 are also contemplated herein.

The electrode array 102 of the present disclosure is advantageously flexible and resilient, such that the electrode array 102 may be used with a stimulation device, such as a neuroprosthetic device, to be implanted or used in a curved region or space. In one embodiment, the electrode array 102 may stretch up to approximately 140% elongation while remaining electrically conductive. The stretchability of the electrode array 102 was measured using a tensile test in which the electrode array 102 was immersed in saline at 37 ℃ for 10 days and removed, subjected to percent (%) elongation at 1mm/s, and then held for 1 minute before returning to a relaxed state. The electrode array 102 is stretched until no resistance can be recorded. Electrode array 102 also passed a 15 degree flex test (where array 102 was bent 15 degrees around a 2 millimeter rod at 2Hz while being subjected to a force of 0.03N for 100,000 cycles), a 90 degree bend test (where array 102 was bent 90 degrees around a 5 millimeter rod at 1mm/s for 10 cycles), and a 360 degree twist test (where array 102 was twisted 360 degrees forward at 1mm/s and then inverted 360 degrees for 50 cycles). Based at least on these results, the electrode array 102 conforms to european standard EN45502 parts 1 and 2 and the us national standard ANSI/AAMI C186:2017 for cochlear implant systems.

Furthermore, the electrodes 116 of the electrode array 102 exhibit about 30 to about 200mC/cm at 1kHz for line thicknesses of about 25 to about 300 μm²And an Electrochemical Impedance Spectrum (EIS) of about 100 to about 5000' omega. Electrode 116 (formed from first and second conductive inks including at least conductive particles and silicone) exhibits lower polarization than a platinum foil electrode. This lower voltage potential indicates that a higher charge density can be input without causing tissue damage to the organism.

The disclosure has been described in an illustrative manner, and it is to be understood that the terminology which has been used is intended to be in the nature of words of description rather than of limitation. It will be apparent to those skilled in the art that many modifications and variations of the present disclosure are possible in light of the above teachings. For example, the electrode array 102 may have electrodes 116 stacked in a vertical direction. In this example, one side 122 of the substrate 110 may serve as a surface on which the additional electrode 116 is built up in a vertical direction. Furthermore, several layers of electrodes 116 separated by substrate layers 110 may be formed on top of each other, for example, by pressure driven extrusion printing, to produce high density electrodes, thereby minimizing the footprint of electrode array 102 while maximizing functionality. It is, therefore, to be understood that the disclosure may be practiced otherwise than as specifically described.