Method for producing implantable electrode device

Abstract

To provide a method for producing an implantable electrode device.SOLUTION: In a method for producing an implantable electrode device, an electrically insulating support 14 and at least one electrically conductive electrode element 12 are provided to attach the at least one electrode element 12 to the support 14. To attach the at least one electrode element 12 to the support 14, the at least one electrode element 12 and / or the support 14 are heated, and the at least one electrode element 12 is pressed against the support 14.SELECTED DRAWING: Figure 4B

Description

[Technical Field]

[0001] The present invention relates to a method for manufacturing an implantable electrode device according to the preamble of claim 1. [Background technology]

[0002] In such a method, an electrically insulating support and at least one electrically conductive electrode element are provided for attaching the at least one electrically conductive electrode element to the electrically insulating support.

[0003] Such electrode devices can emit stimulation signals when implanted in a patient, for example, to induce spinal nerve stimulation. For this purpose, electrode devices can be introduced into the epidural space near the spinal cord to achieve spinal nerve stimulation by introducing electrical stimulation energy. However, such electrode devices can also be used for cardiac stimulation, for example, in conjunction with pacemaker systems or defibrillation systems.

[0004] For example, electrode devices used for spinal nerve stimulation may be in the form of an isodiametric electrode formed with a roughly circular cross section and a diameter typically less than 2 mm, with a ring electrode disposed thereon, or in the form of a so-called paddle electrode with a flat end formed on the electrode body, typically with multiple electrode elements disposed thereon. While isodiametric electrodes can be easily implanted percutaneously and require a small implantation space, paddle electrodes may be more efficient because the electrode array formed on the flat end may have directional characteristics that allow for targeted delivery of stimulation energy.

[0005] However, a challenge with such paddle electrodes is to attach the electrode arrangement to the flat end of the paddle electrode in a simple, reproducible and accurately positionable manner, and preferably in a manner that can be easily automated.

[0006] Paddle electrode designs are known, for example, from US Pat. No. 6,895,283 and US Pat. No. 9,561,363. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] U.S. Patent No. 6,895,283 [Patent Document 2] U.S. Patent No. 9,561,363 Summary of the Invention [Problem to be solved by the invention]

[0008] It is an object of the present invention to provide an implantable electrode device and a method for manufacturing an implantable electrode device that allows for simple and automatable manufacturing with the possibility of accurate placement of one or more electrode elements. [Means for solving the problem]

[0009] This object is achieved by the subject matter having the features of claim 1.

[0010] Thus, in order to attach the at least one electrode element to the support, the at least one electrode element and / or the support are heated and the at least one electrode element is pressed against the support.

[0011] The attachment of the at least one electrode element to the support is carried out by heating the electrode element and / or the support. The support may, for example, be made of a thermoplastic material, such as polyurethane, so that the support softens when heated and the at least one electrode element can be at least partially pressed into the support, thereby forming an integrally bonded connection to the support. The attachment of the at least one electrode element can therefore be carried out in a method step that can be easily automated, without the need for additional adhesive bonding, for example by adhesive, to fix the at least one electrode element to the support.

[0012] The material of the support can be heated by heating the at least one electrode element before attaching the at least one electrode element to the support, and when the at least one electrode element is attached to the support, heat is transferred from the electrode element to the support, heating the support so that the support, which is preferably made of a thermoplastic material, softens and thus becomes integrally bonded to the at least one electrode element.

[0013] Additionally or alternatively, the support may also be heated such that the support is heated by a heat source in addition to or instead of heat transfer from the electrode element to the support in order to attach at least one electrode element to the support.

[0014] To attach the at least one electrode element, in one embodiment, the at least one electrode element and / or the support is heated to a temperature at or close to the melting temperature of the support material, for example above 100°C, preferably above 150°C, more preferably above 180°C, for example 190°C. Heating can be carried out, for example, in an oven in which the at least one electrode element and / or the support to be heated is arranged. Alternatively, a locally acting heat source can be used to heat the at least one electrode element or the support. The at least one electrode element can then be placed on the support, for example in an automated manner, for example using a robot, by pressing the at least one electrode element onto the support, thus without any further method steps for fixing the at least one electrode element to the support.

[0015] The support may be made of a thermoplastic material, for example a polyurethane material, with a film having a thickness between 0.1 mm and 0.5 mm, for example 0.2 mm, For example, the support may have a surface area between 4 mm x 20 mm and 10 mm x 100 mm.

[0016] Each electrode element may have a thickness of, for example, between 0.05 mm and 0.2 mm and be made of a metal material, for example a platinum material. For example, the electrode elements may have a surface area of ​​between 1 mm x 2 mm and 3 mm x 4 mm, for example 2 mm x 3 mm.

[0017] In one embodiment, the at least one electrode element is arranged with its lower surface in contact with the upper surface of the support. The at least one electrode element may be pressed against the support so that its upper surface is flush with the upper surface of the support. However, in another embodiment, the at least one electrode element can also be attached to the support so that it protrudes from the support and thus protrudes relative to the upper surface of the support. The depth to which the at least one electrode element is pressed into the support can, in principle, be selected depending on, for example, the desired radiation characteristics for delivering stimulation energy via the electrode element.

[0018] In one embodiment, the electrical supply lines are connected to the at least one electrode element before the at least one electrode element is attached to the support. In this embodiment of the method, the supply lines connected to the at least one electrode element are preferably placed on the support together with the at least one electrode element and are pressed into the support when the at least one electrode element and / or the support are heated, so that the supply lines connected to the at least one electrode element are embedded in the support at least in the region below the electrode element.

[0019] In one embodiment, a supply line connected to at least one electrode element is embedded in the support along the path of said line within the area of ​​the support.

[0020] In one embodiment, the electrical supply line is designed as a wire or cord.

[0021] In one embodiment, the at least one electrode element has at least one fixing element which is pressed into the support when the at least one electrode element is mounted, and which may for example protrude like a tab from the underside of the electrode element facing the support and which engages with the support when the at least one electrode element is positioned, so that an additional form-fit connection is formed between the at least one electrode element and the support via the at least one fixing element, improving the retention of the at least one electrode element on the support.

[0022] The at least one fixing element may, for example, have a hook shape, for example in the form of a barb, and additionally or alternatively, for example, openings may be formed in the at least one fixing element, by means of which the material of the support can engage when the at least one electrode element is positioned, thereby enabling the at least one electrode element to be firmly held on the support.

[0023] In one embodiment, at least one electrode element has a pin that protrudes from the underside of the electrode element facing the support and is pressed into the support when the at least one electrode element is positioned. When the at least one electrode element is positioned, the pin penetrates the support so as to be accessible on the underside of the support facing away from the upper side, thereby making it possible to connect an electrical supply line to the at least one electrode element via the pin after the at least one electrode element is positioned. The connection of the supply line can here be made in the area of ​​the underside of the support, so that the supply line is on the underside of the support and not on the side of the electrode device from which stimulation energy is emitted during operation.

[0024] In one embodiment, after attachment of the at least one electrode element, the support is at least partially surrounded by an encasement, for example by overmolding the support in some sections with the material of the encasement. The encasement may be made of, for example, a silicone material, and the support may be completely enclosed in the encasement, for example, except for the surfaces of the electrode elements attached to the support that are exposed to the outside for emitting stimulation energy during operation of the electrode device.

[0025] In one embodiment, a plurality of electrode elements are attached to a support. The electrode elements may be attached to the support in the form of a matrix, for example, with a number of rows of electrode elements possibly formed on the support to form a regular arrangement. For example, two rows of electrode elements may be attached to the support, with the rows having electrode elements arranged adjacent to each other.

[0026] The implantable electrode device has an electrode body connectable to a generator and an electrode end connected distally to the electrode body, the electrode end having a support and a plurality of electrode elements attached to the support by the method described above.

[0027] The advantages and advantageous embodiments described above for this method are equally applicable to the electrode device, and therefore full reference should be made to the above.

[0028] Such electrode devices provide paddle electrodes that can be implanted, for example, for spinal nerve stimulation in the region of the spine and thus in the epidural space adjacent to the spinal cord, in particular to provide nerve stimulation in a targeted manner in the region of the spinal cord.

[0029] The concepts underlying the invention are explained in more detail below with reference to the embodiments shown in the drawings. [Brief explanation of the drawings]

[0030] [Figure 1]FIG. 1 is a diagram of an electrode device implanted in the spinal region of a patient and connected to a generator. [Figure 2] FIG. 1 is a diagram of an electrode device in the epidural space in the region of the spine. [Figure 3] FIG. 1 is a view of the flat end of the electrode device. [Figure 4A] 1 is a schematic diagram of a process for attaching an electrode element to a support. [Figure 4B] FIG. 10 is a view of an electrode element in position to be attached to a support. [Figure 5] FIG. 10 is a diagram of another embodiment of an electrode element. [Figure 6] FIG. 10 is a diagram of another embodiment of an electrode element. [Figure 7] FIG. 10 is a diagram of another embodiment of an electrode element. [Figure 8] 8 is a view of the electrode element according to FIG. 7 in a position disposed on a support. [Figure 9] 4B with an additional enclosure for surrounding the support. FIG. DETAILED DESCRIPTION OF THE INVENTION

[0031] In one embodiment, the electrode device 1 shown in Figures 1 and 2 is realized as a so-called paddle electrode and has an electrode body 10 and an electrode end 11 connected to the electrode body 10, at which a number of electrode elements are attached for emitting stimulation energy in the region of the spine W of the patient P.

[0032] The electrode device 1 is connected by the proximal end of the electrode body 10 to the terminal block 20 of the generator 2, through which stimulation energy can be delivered to the electrode device 1 and emitted through an electrode arrangement located at the electrode end 11 to stimulate the spinal cord R in the region of the spine W.

[0033] As can be seen from the cross-sectional view of FIG. 2, in the illustrated embodiment, the electrode device 1 is implanted in the epidural space E in the region of the spine W of the patient P so that the electrode end 11 is located in the region of the spinal cord R and thus can introduce stimulation energy in a directed direction into the spinal cord R to cause neural stimulation in the region of the spinal cord R.

[0034] For example, while the electrode body 10 has a circular (equidistant) cross section, the electrode device 1 is flattened in the region of the electrode end 11 and, as can be seen in FIG. 3, carries thereon a plurality of electrode elements 12, which can be arranged in two rows adjacent to each other and are positioned relative to each other so that stimulation energy can be supplied in a directional manner, for example into the spinal cord R of the patient P.

[0035] 3, each electrode element 12 is connected to a supply line 13, and each electrode element 12 can be connected to the generator 2 via the associated supply line 13, and thus can be supplied with stimulation energy via the generator 2 to emit an electrical signal. The supply lines 13 are routed together to the generator 2 in a manner encapsulated as a cable harness within the electrode body 10.

[0036] The electrode elements 12 are disposed on a support 14 but are exposed with their surfaces facing outwards so that they can come into contact with the surrounding tissue when the electrode device 1 is implanted in a patient.

[0037] To secure the electrode element 12 to the support 14, a simple manufacturing process that can be automated and that allows for accurate placement of the electrode element 12 on the support 14 is desired.

[0038] For this purpose, it is proposed here to attach the electrode element 12 to the support 14 by heating the support 14 and / or the corresponding electrode element 12, so that the electrode element 12 can be pressed into the support 14 and form an integrally bonded connection to the support 14.

[0039] This is shown in Figures 4A and 4B. For example, the electrode element 12 connected to the support 14 can be heated to a temperature at or near the melting temperature of the material of the support 14, the support 14 being made of, for example, a thermoplastic material, such as a polyurethane material, so that when the electrode element 12 is placed, the support 14 is melted in some areas and can therefore be pressed into the support 14, resulting in an integral bond between the electrode element 12 and the support 14.

[0040] 4A and 4B, the electrode element 12 is arranged in the joining direction F relative to the upper side surface 140 of the support element 14, so that the upper side surface 123 of the electrode element 12 is flush with the upper side surface 140 of the support element 14, as can be seen in Fig. 4B. The pressing depth T to which the electrode element 12 is pressed into the support 14 therefore corresponds to the thickness of the electrode element 12.

[0041] It should be noted that the upper surface 123 of the electrode element 12 does not necessarily have to be flush with the upper surface 140 of the support 14. The electrode element 14 may also be arranged on the support 14 such that the upper surface 123 of the electrode element 12 protrudes, for example, relative to the upper surface 140 of the support 14. In general, the electrode element 12 may be arranged on the support 14 with respect to the indentation depth T such that the radiation characteristics for radiating an electrical signal via the electrode element 12 are optimized.

[0042] To attach the electrode element 12 to the support 14, the electrode element 12 may be heated, for example to a temperature at or near the melting temperature of the material of the support 14. Additionally or alternatively, the support 14 may also be heated. For example, to attach the electrode element 12 to the support 14, the electrode element 12 and / or the support 14 may be heated to a temperature above 100°C, such as above 150°C, more preferably above 180°C, for example 190°C.

[0043] 4A and 4B , the supply line 13 is connected to the electrode element 12 before the electrode element 12 is attached to the support 14. In the example shown here, the supply line 13 is connected to the underside 124 of the electrode element 12 facing away from the upper side 123, so that when the electrode element 12 is placed on the support 14, the supply line 13 is located in several sections below the electrode element 12 and is pressed into the material of the support 14 together with the electrode element 12. The supply line 13 is therefore embedded in the support 14 below the electrode element 12, so that the connection point of the supply line 13 to the electrode element 12 is encompassed by the support 14, thus ensuring an electrical connection between the supply line 13 and the electrode element 12.

[0044] In the embodiment shown in Figures 4A and 4B, the electrode element 12 forms a flat, e.g. rectangular or round, surface element which, with its upper surface 123 in the attached position, faces outwards and through which electrical signals can be emitted for stimulation, e.g. in the region of the spinal cord R of the patient P.

[0045] 5, the electrode element 12 can have a fixing element 120 in the form of a tab protruding from an underside 124, which serves to improve the mechanical connection of the electrode element 12 to the support 14. When the electrode element 12 is attached to the support 14, the fixing element 120 engages with the support 14 in a form-fitting manner, thus creating a form-fit between the electrode element 12 and the support 14, which results in an improved retention of the electrode element 12 on the support 14.

[0046] The plurality of fixing elements 120 may be formed, for example, along the outer periphery of the electrode element 12 at a distance from each other on the electrode element 12 .

[0047] The fixing element 120 can have, for example, a hook shape, for example in the form of barbs. Additionally or alternatively, openings may be formed on the fixing element 120, in which openings the material of the support 14 can engage when mounting takes place, so that the form-fit retention of the electrode element 12 on the support 14 is further improved.

[0048] In another embodiment shown in Figure 6, a pin 121 is formed on the underside 124 of the electrode element 12, which pin penetrates the support 14 when the electrode element 12 is positioned and is therefore accessible on the underside 141 of the support 14 facing away from the upper side 140, so that the supply line 13 may be connected to the pin 121.

[0049] In a more detailed embodiment shown in Figure 7, a head 122 can be formed on the pin 121, which head forms an undercut, so that a form fit with the support 14 is formed via the head 122, as shown in Figure 8, thereby also improving the mechanical retention of the electrode element 12 on the support 14 via the pin 121. The supply line 13 may also be connected to the head 122, as shown in Figure 8.

[0050] 6 and 7, the supply lines 13 may be connected after the electrode elements 12 have been mounted on the support 14. In this case, the supply lines 13 may be arranged in the region of the lower side 141 and thus on the rear surface of the support 14, which faces away from the face of the electrode device 1 from which energy is emitted during operation. This allows for a simple routing of the supply lines 13 to the different electrode elements 12.

[0051] After the (all) electrode elements 12 have been attached to the support 14, the support 14 may be surrounded by an enclosure 15, for example, by overmolding the support 14, as shown in Figure 9. The enclosure 15 may be made of, for example, a silicone material, and the support 14 may be completely surrounded by the material of the enclosure 15, while the electrode elements 12 attached to the support 14 are exposed to the outside. Thus, the electrode device 1 may be enclosed and encapsulated in the region of the electrode ends 11 by the enclosure.

[0052] The concept underlying the invention is not limited to the above example but can be implemented in other ways.

[0053] The electrode device can be used for spinal nerve stimulation, but also for other stimulation, for example cardiac stimulation.

[0054] One or more electrode elements may be arranged on the support and, if multiple electrode elements are used, the arrangement of the electrode elements can be configured to provide a desired directional characteristic. [Explanation of symbols]

[0055] 1. Implantable electrode devices 10 Electrode body 11 Electrode end 12 electrode element 120 Fixed Elements 121 pins 122 head 123 Top side 124 Lower side 13 Supply Line 14 Support 140 Top side 141 Lower side 15 Enclosure 2. Generator 20 Terminal block E epidural space F Joining direction O surface P patient R spinal cord T deep W Spine

Claims

1. A method for manufacturing an implantable electrode device (1), comprising: Providing an electrically insulating support (14); Providing at least one conductive electrode element (12); and attaching said at least one electrode element (12) to said support (14); 10. A method according to claim 9, wherein the at least one electrode element (12) and / or the support (14) are heated and the at least one electrode element (12) is pressed against the support (14) to attach the at least one electrode element (12) to the support (14).

2. 2. The method of claim 1, wherein the support (14) is made of a thermoplastic material.

3. 3. A method according to claim 1 or 2, characterized in that the support (14) is made of a material comprising polyurethane.

4. 4. The method according to any one of claims 1 to 3, characterized in that in order to attach the at least one electrode element (12) to the support (14), the at least one electrode element (12) and / or the support (14) are heated to a temperature above 100°C, preferably above 150°C, more preferably above 180°C.

5. 5. The method according to any one of claims 1 to 4, characterized in that the at least one electrode element (12) is arranged on an upper side (140) of the support (14).

6. 6. The method according to claim 5, characterized in that the at least one electrode element (12) is pressed against the support (14) so ​​that an upper side (123) of the at least one electrode element (12) is flush with the upper side (140) of the support (14).

7. 7. The method according to any one of claims 1 to 6, characterized in that an electrical supply line (13) is connected to the at least one electrode element (12) before the at least one electrode element (12) is attached to the support (14).

8. 8. The method according to claim 7, characterized in that the supply line (13) connected to the at least one electrode element (12) is attached to the support (14) together with the at least one electrode element (12).

9. 9. The method according to claim 1, wherein the at least one electrode element (12) has at least one fixing element (120) that is pressed into the support (14) when the at least one electrode element (12) is attached to the support (14).

10. 10. The method according to claim 1, wherein the at least one electrode element (12) has a pin (121) that is press-fit into the support (14) when the at least one electrode element (12) is attached to the support (14), so that the pin (121) penetrates a lower surface (141) of the support (14) facing away from the upper surface (140).

11. 11. A method according to claim 10, characterized in that after the at least one electrode element (12) has been attached to the support (14), an electrical supply line (13) is connected to the pin (121).

12. 12. The method according to any one of claims 1 to 11, characterized in that the support (14) is at least partially surrounded by an enclosure (15) after application of the at least one electrode element (12).

13. 13. The method according to claim 12, characterized in that the enclosure (15) is made of a silicone material.

14. 14. A method according to any one of claims 1 to 13, characterized in that a plurality of electrode elements (12) are attached to the support (14).

15. An implantable electrode device (1), comprising: an electrode body (10) connectable to a generator (2); an electrode end (11) connected distally to the electrode body (10); and An implantable electrode device (1), wherein the electrode end comprises a support (14) and a plurality of electrode elements (12) attached to the support (14), the electrode elements (12) being attached to the support by a method according to any one of claims 1 to 14.

Images