Nerve stimulation electrode based on shape memory material and preparation method thereof

Abstract

The invention relates to the technical field of medical instruments, in particular to a nerve stimulation electrode based on a shape memory material. The nerve stimulation electrode comprises a flexible packaging electrode body and a substrate crease layer arranged on the surface of the flexible packaging electrode body. The material of the substrate crease layer comprises a shape memory polymer and a nano ferromagnetic material; the substrate crease layer comprises a first bending part which is used for enabling the flexible packaging electrode body to be folded along the length direction of the flexible packaging electrode body. The nerve stimulation electrode can solve the problems that an existing nerve stimulation electrode is hard in appearance, large in overall mass, poor in flexibility and complex in implantation operation.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a nerve stimulation electrode based on shape memory material and a preparation method thereof. Background Art

[0002] Neuroelectrical stimulation is a treatment method that stimulates nerves by implanting electrodes into the spinal cord or brain to transmit stimulation pulses to the injured area. Currently, the commonly used implantable electrical stimulation electrodes are linear electrodes and flat electrodes. Linear electrodes are characterized by being slender and soft, and can flexibly adapt to the anatomical structure around the spinal cord, but there is a risk of displacement, they are easily affected by body movement, and their coverage is relatively limited, making it difficult to handle large-scale treatments.

[0003] Compared with linear electrodes, flat electrodes are flatter, have a larger contact arrangement, cover a wide range, are highly stable, and are not easily displaced, making them suitable for treating complex pain areas. However, flat electrodes have a hard appearance, large overall mass, poor flexibility, and require open surgery for implantation, which makes the surgery highly invasive, traumatic, and requires a long recovery time, with relatively high risks and complications. Summary of the invention

[0004] In order to solve the problems of existing neural stimulation electrodes such as hard appearance, large overall mass, poor flexibility and complicated implantation surgery, the present invention provides a neural stimulation electrode based on shape memory material and a preparation method thereof.

[0005] In a first aspect, the present invention provides a shape memory material-based neural stimulation electrode, comprising a flexible packaged electrode body and a base folding layer disposed on the surface of the flexible packaged electrode body;

[0006] The material of the base crease layer includes shape memory polymer and nano ferromagnetic material;

[0007] The base folding layer includes a first bending portion for folding the flexible package electrode body along a length direction thereof.

[0008] Optionally, the nerve stimulation electrode further comprises wings, and the wings are distributed on both sides of the flexible package electrode body along the width direction;

[0009] The material of the wing includes shape memory polymer and nano ferromagnetic material;

[0010] Optionally, the wing includes a second bending portion for folding the wing along its length direction.

[0011] Optionally, the neural stimulation electrode further comprises a drug administration capsule, the material of which comprises a shape memory polymer and a nano-ferromagnetic material, and the drug administration capsule is disposed on the flexible packaged electrode body or the base fold layer.

[0012] Optionally, there are multiple first bending portions, and the multiple first bending portions are distributed at intervals on the same surface of the flexible package electrode body along the length direction of the flexible package electrode body;

[0013] The wing sheet and the drug delivery capsule are respectively connected to the flexible package electrode body;

[0014] The wing piece and the medication capsule are both distributed between two adjacent base fold layers.

[0015] Optionally, the number of the base folding layers is two, and the two base folding layers are arranged on two surfaces of the flexible package electrode body;

[0016] Each of the base folding layers comprises a plurality of the first bending portions, and the plurality of the first bending portions of the two base folding layers are alternately and spacedly distributed on the two surfaces of the flexible package electrode body;

[0017] The wing sheet and the drug delivery capsule are respectively connected to the flexible package electrode body;

[0018] The wing piece and the medication capsule are both distributed between the first bending portion of the upper surface of the flexible package electrode body and the first bending portion of the adjacent lower surface.

[0019] Optionally, the base fold layer includes a plurality of first bending portions connected to each other;

[0020] A plurality of the first bending portions are distributed at intervals along the length direction of the flexible package electrode body;

[0021] The wing sheet and the medication capsule are respectively connected to the base fold layer;

[0022] The wing piece and the medication capsule are both distributed between two adjacent first bending portions of the base fold layer.

[0023] Optionally, the drug delivery capsule comprises a plurality of leaflets, and the plurality of leaflets can gather or unfold at corresponding temperatures to store or release the drug.

[0024] Optionally, in the base fold layer, the wing sheet and the drug delivery capsule, the mass ratio of the shape memory polymer to the nano-ferromagnetic material is (1-4): 1;

[0025] The shape memory polymer includes one or more of epoxy shape memory polymer, polyimide shape memory polymer, cyanate shape memory polymer, polyimide shape memory polymer, polyurethane shape memory polymer and polylactic acid shape memory polymer.

[0026] In a second aspect, the present invention provides a method for preparing the above-mentioned shape memory material-based neural stimulation electrode, comprising:

[0027] After mixing the shape memory polymer and nano-ferromagnetic material, the base crease layer, wing sheet and drug delivery capsule were prepared by 3D printing technology.

[0028] The base fold layer and the drug-delivery capsule are adhered to the surface of the flexible package electrode body and then cured, and the wing sheets are adhered to both sides of the flexible package electrode body along the width direction and then cured;

[0029] Or, the preparation method comprises:

[0030] After mixing the shape memory polymer and nano-ferromagnetic material, the base crease layer, wing sheet and drug delivery capsule are formed into an integral part by 3D printing technology;

[0031] The one-piece molded part is adhered to the surface of the flexible package electrode body and cured.

[0032] Compared with the prior art, the present invention has the following beneficial effects:

[0033] The present invention provides a base crease layer on the surface of the flexible package electrode body, and the first bend on the base crease layer is used to fold the flexible package electrode body along the length direction, so as to shorten the overall length of the flexible package electrode body. The material of the base crease layer is a shape memory polymer doped with nano ferromagnetic particles. The flexible package electrode body is folded into a desired shape in vitro through the first bend, that is, before being inserted into the body, the base crease layer is folded according to the first bend, thereby driving the flexible package electrode body to fold, so as to reduce the volume of the entire neural stimulation electrode. When the neural stimulation electrode is inserted into the body, by applying a high-frequency variable magnetic field, the nano ferromagnetic particles generate heat to heat the shape memory polymer, so that the shape memory polymer reaches the film glass transition temperature, and the shape memory polymer will return to its desired initial set shape, driving the neural stimulation electrode to rapidly unfold in vivo according to the crease shape. The embodiment of the present invention utilizes the properties of the shape memory polymer itself to unfold the stimulation electrode in vivo, and the unfolding drive mechanism is simple. The shape memory polymer material is light in weight, easy to fold, has a large storage ratio, reduces the wound surface during implantation, and reduces the surgical risk. Moreover, shape memory polymer materials can adapt to the in vivo environment, are non-biotoxic, degradable in the body, and can be heated through wireless magnetic drive without the need for an external heat source. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 is a schematic diagram of the structure of the nerve stimulation electrode when it is fully deployed in Example 1 of the present invention;

[0035] Figure 2 is a schematic diagram of the structure of the neural stimulation electrode when part of the neural stimulation electrode is unfolded in Example 1 of the present invention;

[0036] Figure 3 is a schematic diagram of the distribution of the base crease layer on the surface of the flexible package electrode body in Example 1 of the present invention;

[0037] Figure 4 is a schematic diagram of the structure of the drug delivery capsule when it is fully unfolded in Example 1 of the present invention;

[0038] Figure 5 is a schematic diagram of the distribution of the base crease layer on the surface of the flexible package electrode body in Example 2 of the present invention;

[0039] Figure 6 It is a schematic diagram of the distribution of the base crease layer on the surface of the flexible packaging electrode body in Example 3 of the present invention.

[0040] Description of reference numerals:

[0041] 1. Flexible package electrode body; 11. Electrode; 12. Flexible package layer; 2. Base crease layer; 21. First bending portion; 211. Groove; 212. Protrusion; 3. Wing; 31. Second bending portion; 4. Drug delivery capsule; 41. Leaflet; 411. Channel. DETAILED DESCRIPTION

[0042] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the specific embodiments of the present invention are described in detail below in conjunction with the accompanying drawings. Although certain embodiments of the present invention are shown in the accompanying drawings, it should be understood that the present invention can be implemented in various forms and should not be interpreted as being limited to the embodiments described herein. On the contrary, these embodiments are provided to provide a more thorough and complete understanding of the present invention. It should be understood that the drawings and embodiments of the present invention are only for exemplary purposes and are not intended to limit the scope of protection of the present invention.

[0043] Unless otherwise defined, all technical and scientific terms used in this application have the same meanings as those commonly understood by those skilled in the art to which this application belongs; the terms used in the specification of this application are only for the purpose of describing specific implementation methods and are not intended to limit this application;

[0044] The term "including" and its variations used in this article are open inclusions, that is, "including but not limited to"; the term "based on" is "based at least in part on"; the term "one embodiment" means "at least one embodiment"; the term "another embodiment" means "at least one other embodiment"; the term "some embodiments" means "at least some embodiments"; the term "optionally" means "optional embodiments". The relevant definitions of other terms will be given in the following description. It should be noted that the concepts of "first" and "second" mentioned in the present invention are used to distinguish different objects, rather than to describe a specific order or a primary and secondary relationship. In addition, the terms "first" and "second" are only used for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of this application, unless otherwise specified, the meaning of "multiple" is two or more.

[0045] Shape memory polymer is a very important smart material, which can obtain its initial shape through the conventional preparation method of polymer. Under external stimulus conditions (such as temperature), it can change its shape accordingly, and after removing the stimulus, its deformed state can be fixed. If the external environment changes again in a specific way and law, they can reversibly recover to the initial state. This material has a two-phase structure, namely a stationary phase and a reversible phase. The stationary phase refers to the component in the material structure that can remember the initial shape of the material and is not affected by temperature; while the reversible phase refers to the component in the structure that reversibly softens and hardens with changes in temperature. When the temperature is below the transition temperature, the molecular chain segments are in a frozen state and the shape of the material is fixed; when the temperature is above the transition temperature, the molecular chain segments are in a highly elastic state and can be stretched under the action of external force, or restored to a curled state under the action of the stationary phase, and the material undergoes shape recovery behavior on a macro scale.

[0046] In order to expand the electrode coverage area in the brain and spinal cord during neurological treatment, a craniotomy or laminectomy must usually be performed to place large flat electrodes to cover the brain or spine. Since shape memory polymers have low stiffness and high biomechanical compatibility, the present invention combines the geometric shape of biocompatible shape memory polymers with electrode arrays, inserts them in a minimally invasive manner through a needle or a small window in the spine or skull, and then uses the shape memory response function of the shape memory polymer to transform the electrode shape into a shape that covers a more desired area of ​​the brain or spinal cord. The present invention is described in detail below in conjunction with specific embodiments.

[0047] Example 1

[0048] In a first aspect, this embodiment provides a neural stimulation electrode based on shape memory material. Figure 1 and Figure 2As shown, the neural stimulation electrode comprises a flexible package electrode body 1 and a base fold layer 2 arranged on the surface of the flexible package electrode body 1, and the material of the base fold layer 2 comprises a shape memory polymer and a nano ferromagnetic material. Figure 3 As shown, the base folding layer 2 includes a first bending portion 21 for folding the flexible package electrode body 1 along its length direction.

[0049] It should be noted that the flexible packaged electrode body 1 in the embodiment of the present invention includes an electrode 11 and a flexible packaging layer 12. Specifically, the electrode 11 is first prepared by existing technologies such as coating, deposition, printing, micro-nano laser processing, and then encapsulated in the flexible packaging layer 12 by any existing technology such as transfer printing and thermal curing to prepare a flexible flexible packaged electrode body 1. Among them, the material of the flexible packaging layer 12 includes one or more of polyimide, polydimethylsiloxane, polyethylene terephthalate and polyethylene naphthalate. Since the preparation and packaging process of the electrode 11 belongs to the existing technology, it will not be repeated here. The base crease layer 2 in the embodiment of the present invention is arranged on the surface of the flexible packaging layer 12.

[0050] The present invention sets a base crease layer 2 on the surface of the flexible package electrode body 1, and the first bend 21 on the base crease layer 2 is used to fold the flexible package electrode body 1 along the length direction, so as to shorten the overall length of the flexible package electrode body 1. The material of the base crease layer 2 is a shape memory polymer doped with nano ferromagnetic particles. The flexible package electrode body 1 is folded into a desired shape in vitro through the first bend 21, that is, before being inserted into the body, the base crease layer 2 is folded according to the first bend 21, thereby driving the flexible package electrode body 1 to fold, so as to reduce the volume of the entire neural stimulation electrode. When the neural stimulation electrode is inserted into the body, by applying a high-frequency variable magnetic field, the nano ferromagnetic particles generate heat to heat the shape memory polymer, so that the shape memory polymer reaches the film glass transition temperature, and the shape memory polymer will return to its desired initial set shape, driving the neural stimulation electrode to rapidly unfold in vivo according to the crease shape. The embodiment of the present invention utilizes the properties of the shape memory polymer itself to unfold the neural stimulation electrode in vivo, and the unfolding drive mechanism is simple. The shape memory polymer material is light in weight, easy to fold, has a large storage ratio, reduces the trauma surface during implantation, and reduces the surgical risk. Moreover, shape memory polymer materials can adapt to the in vivo environment, are non-biotoxic, degradable in the body, and can be heated through wireless magnetic drive without the need for an external heat source.

[0051] Optionally, as one implementation method, refer to Figure 1-Figure 4 As shown, the base fold layer 2 includes a plurality of first bending portions 21 , and the plurality of first bending portions 21 are distributed at intervals on the same surface of the flexible package electrode body 1 along the length direction of the flexible package electrode body 1 .

[0052] It should be understood that the base crease layer 2 can be a layer structure composed of a plurality of first bending portions 21 arranged at intervals, or the base crease layer 2 can be a continuous layer structure, and the first bending portions 21 are arranged at intervals on the continuous layer structure, and a similar crease structure is provided at the first bending portion 21 to facilitate bending at this location.

[0053] In an alternative embodiment, referring to Figure 3 As shown, all first bending portions 21 are distributed on one surface, specifically the upper surface, of the flexible package electrode body 1. The distance between each two first bending portions 21 is the length of the folding unit, ie, the minimum length unit of the folded neural stimulation electrode.

[0054] Reference Figure 3 In this embodiment, in order to form a fold, each first bending portion 21 is provided with a groove 211 or a protrusion 212. The groove 211 represents that the folding direction here is upward, and the protrusion 212 represents that the folding direction here is downward. In this optional embodiment, the base folding layer 2 provided with the groove 211 and the base folding layer 2 provided with the protrusion 212 are alternately distributed, so that the folded neural stimulation electrode is wavy, which can reduce the space required for the neural stimulation electrode to be unfolded, which is conducive to the smooth unfolding of the neural stimulation electrode in the body. Alternatively, the upper surface of the flexible packaged electrode body 1 is a first bending portion 21 provided with a groove 211 or a first bending portion 21 provided with a protrusion 212, so that the folded neural stimulation electrode is rolled, which can also achieve the effect of reducing the volume of the neural stimulation electrode. As a schematic, Figure 1-Figure 2 The first bending portion 21 in the figure is linear in shape as a whole. It should be understood that the first bending portion 21 actually has a certain width and thickness. Figure 3 shown.

[0055] Optionally, refer to Figure 1 and Figure 2 As shown, the nerve stimulation electrode in the embodiment of the present invention further includes wings 3 distributed on both sides of the flexible package electrode body 1 along the width direction, and the material of the wings 3 also includes shape memory polymer and nano ferromagnetic material.

[0056] Specifically, refer to Figure 1 and Figure 2As shown, the wing 3 also includes a plurality of second bending portions 31 distributed along its length direction. The second bending portions 31 have similar structures to the first bending portions 21 and will not be described in detail here. Similar to the first bending portion 21, under the action of the second bending portion 31, the wing 3 can be folded along its length direction to achieve the purpose of reducing the volume of the wing 3. The wing 3 is connected to the side of the flexible package electrode body 1 along the width direction, and the end of the wing 3 close to the flexible package electrode body 1 is located between two adjacent base crease layers 2, so that the flexible package electrode body 1 will not cause deformation of the wing 3 when folded. The wing 3 can be folded and gathered along the crease, and then the flexible package electrode body 1 can be folded into a minimum length unit.

[0057] The present invention further arranges wings 3 made of shape memory polymer on both sides of the flexible package electrode body 1, and the wings 3 do not occupy extra space after being folded. The wings 3 of the present invention increase the surface area of ​​the nerve stimulation electrode in contact with the surrounding tissue. When the nerve stimulation electrode is folded, the wings 3 are also folded. After the nerve stimulation electrode is unfolded, the wings 3 are unfolded and bent, and can clamp the ligament or bone tissue next to the spine, playing a stabilizing role. This makes the working state of the nerve stimulation electrode after unfolding very stable and not prone to failure.

[0058] Optionally, when preparing the multifunctional electrode surface and the multifunctional support structure, the overall stiffness of the nerve stimulation electrode can be changed by adjusting the thickness of the base fold layer 2 and the wing 3. The thickness of the base fold layer 2 and the wing 3 in the embodiment of the present invention ranges from 1 to 2 mm to adapt to the narrow space of the spine in the human body.

[0059] Optionally, refer to Figure 1 and Figure 2 As shown, the neural stimulation electrode in the embodiment of the present invention further includes a drug administration capsule 4, and the material of the drug administration capsule 4 also includes a shape memory polymer and a nano-ferromagnetic material. The drug administration capsule 4 is arranged on the surface of the flexible package electrode body 1 and is distributed between two adjacent base fold layers 2. Different drugs are contained in the drug administration capsule 4. By adjusting the deformation temperature of different drug administration capsules 4, different drug administration capsules 4 will be unfolded at different time points as the high-frequency magnetic field is applied for different times, thereby achieving the release of specific drugs at different set times, and achieving the purpose of auxiliary treatment at different stages.

[0060] Specifically, refer to Figure 4 As shown, the drug-delivery capsule 4 is in the shape of a bud composed of a plurality of petals 41. By using a shape memory polymer, the plurality of petals 41 can gather or unfold at a corresponding temperature, thereby storing or releasing drugs. Figure 4As shown, the upper and lower surfaces of each leaflet 41 are provided with a plurality of grooves 411 spaced apart along the length direction of the leaflet 41, so that the thickness of each position on the leaflet 41 is different, and the thickness range is preferably 0.5-1.5 mm. Positions with different thicknesses have different rigidity, which is conducive to the bending of the bud-shaped drug-delivery capsule 4 according to the layout of the grooves 411, completing the process of inward folding and outward expansion.

[0061] Optionally, in the base fold layer 2, the wing sheet 3 and the drug delivery capsule 4, the mass ratio of the shape memory polymer to the nano ferromagnetic material is (1-4): 1. The shape memory polymer includes one or more of epoxy shape memory polymer, polyimide shape memory polymer, cyanate shape memory polymer, polyimide shape memory polymer, polyurethane shape memory polymer and polylactic acid shape memory polymer, and the nano ferromagnetic material is preferably ferrosoferric oxide.

[0062] In a second aspect, an embodiment of the present invention further provides a method for preparing the above-mentioned neural stimulation electrode, comprising:

[0063] S1: One or more of gold, silver, copper, molybdenum, conductive nano-ink, liquid metal eutectic gallium indium, copper nanowire, carbon nanotube, carbon black, graphene, graphite, carbon fiber, activated carbon are used as conductive materials to prepare a stretchable linear electrode 11. The prepared electrode 11 is then encapsulated with one or more of polyimide, polydimethylsiloxane, polyethylene terephthalate, and polyethylene naphthalate.

[0064] Specifically, the preparation of the electrode 11 and its packaging process are prior art. As an example, in an embodiment of the present invention, the preparation process of the electrode 11 includes: using grayscale resin to manufacture a stamp with the desired electrode 11 pattern by 3D printing technology. Then, liquid metal eutectic gallium indium containing 75.5wt% gallium and 24.5wt% indium is spread on the surface of the stamp and transferred to the surface of the polydimethylsiloxane film. In order to form a pattern by screen printing, a polydimethylsiloxane mask is placed on the polydimethylsiloxane film, liquid metal eutectic gallium indium is dripped, and then screen printing is performed.

[0065] S2: After the shape memory polymer and the nano-ferromagnetic material are mixed, the first bending portion 21, the wing 3 and the drug-delivery capsule 4 are prepared respectively by 3D printing technology. Specifically, as an example, 30% by mass of ferroferric oxide is added to polylactic acid, and then the temperature of the 3D printing wire extruder is adjusted to 200°C, and the extrusion speed is adjusted to 3mm / s to prepare the 3D printing wire. Then, the model drawing software is used to draw the model of the base crease layer 2, the wing 3 and the drug-delivery capsule 4, and the model is imported into the slicing software, and the 3D printing wire is used as the raw material for 3D printing.

[0066] S3: Paste the first bending portion 21 and the drug-administering capsule 4 on the surface of the flexible packaged electrode body 1 and solidify them, and paste the wing 3 on both sides of the flexible packaged electrode body 1 and solidify them. Specifically, first use 704 silicone rubber or 705 silicone rubber to paste the base crease layer 2 on the upper surface of the flexible packaged electrode body 1 in turn and laterally, and make the grooves 211 and the protrusions 212 on the first bending portion 21 alternately arranged. Then paste the drug-administering capsule 4 between each two adjacent base crease layers 2, and finally paste the wing 3 on both sides of the flexible packaged electrode body 1, and the end of the wing 3 is located between the two adjacent base crease layers 2. Finally, the flexible packaged electrode body 1 with the base crease layer 2, the drug-administering capsule 4 and the wing 3 is left to stand for 48 hours to complete the curing.

[0067] The neural stimulation electrode in the embodiment of the present invention is structurally designed based on the characteristics of shape memory materials and origami structures. Before being implanted in the body, the shape memory polymer material is softened by heating to facilitate folding. The material is folded according to the designed first bend 21 to obtain the folded shape of the neural stimulation electrode. It is then immediately cooled to below the glass transition temperature to allow the material to set. After the folded neural stimulation electrode is implanted into the human body, the shape memory polymer is heated by wireless magnetic drive using nano-ferromagnetic particles to a temperature higher than the glass transition temperature, and the neural stimulation electrode is restored to the state as shown in the figure. Figure 2 After the heating source is removed, the structural rigidity of the shape memory polymer increases rapidly, and the nerve stimulation electrode is fixed in this shape. At this time, the discharge end of the nerve stimulation electrode can reach the required electrical stimulation site.

[0068] Example 2

[0069] The difference between this embodiment and embodiment 1 is that, referring to Figure 5 As shown, in this embodiment, the number of the base folding layers 2 is two, and the two base folding layers 2 are arranged on the two surfaces of the flexible package electrode body 1. Each base folding layer 2 includes a plurality of first bending portions 21, and the plurality of first bending portions 21 of the two base folding layers 2 are alternately distributed on the two surfaces of the flexible package electrode body 1. The medication capsule 4 and the wing 3 (not shown in the figure) are respectively connected to the flexible package electrode body 1, and the wing 3 and the medication capsule 4 are distributed between the first bending portion 21 on the upper surface of the flexible package electrode body 1 and the first bending portion 21 on the adjacent lower surface.

[0070] It should be understood that in this embodiment, the distance between two adjacent base crease layers 2 on the same surface of the flexible package electrode body 1 is the length of two folding units. When the base crease layers 2 are arranged in the manner of this embodiment, both surfaces of the flexible package electrode body 1 can be folded under force, so that the folded shape is more stable.

[0071] Example 3

[0072] The difference between this embodiment and embodiment 1 is that the base fold layer 2, the wing sheet 3 and the drug delivery capsule 4 in this embodiment are integrally formed. Figure 6 As shown, the number of the base fold layer 2 is one and covers one surface of the flexible package electrode body 1. The base fold layer 2 includes a plurality of first bends 21 connected to each other. The plurality of first bends 21 are spaced apart along the length direction of the flexible package electrode body 1, and the distance between each two adjacent first bends 21 is the distance of the folding unit. In addition, the wing 3 (not shown in the figure) is connected to both sides of the base fold layer 2 along the width direction, and the drug capsule 4 is arranged on the surface of the base fold layer 2, and the wing 3 and the drug capsule 4 are both distributed between two adjacent first bends 21 of the base fold layer 2.

[0073] In this embodiment, the method for preparing the nerve stimulation electrode is different from that in Embodiment 1 in that:

[0074] In step S2, after the shape memory polymer and the nano-ferromagnetic material are mixed, a 3D printing technology is used to prepare an integrally formed part of the base fold layer 2, the wing 3 and the drug delivery capsule 4.

[0075] In step S3, the integrally formed part is adhered to the surface of the flexible package electrode body 1 and cured.

[0076] In this embodiment, the base fold layer 2, the wing piece 3 and the drug-delivery capsule 4 are integrally formed and printed, and then the integrally formed part is assembled to the surface of the flexible package electrode body 1, thereby improving the assembly efficiency.

[0077] Although the present invention is disclosed as above, the protection scope of the present invention is not limited thereto. Those skilled in the art may make various changes and modifications without departing from the spirit and scope of the present invention, and these changes and modifications will fall within the protection scope of the present invention.

Claims

1. A neural stimulation electrode based on shape memory material, characterized in that: It comprises a flexible package electrode body (1) and a base fold layer (2) arranged on the surface of the flexible package electrode body (1); The material of the base fold layer (2) includes shape memory polymer and nano ferromagnetic material; The base folding layer (2) comprises a first bending portion (21) for folding the flexible package electrode body along its length direction.

2. The neural stimulation electrode according to claim 1, characterized in that: It also includes fins (3), and the fins (3) are distributed at both ends of the flexible package electrode body (1) along the width direction; The material of the wing (3) includes shape memory polymer and nano ferromagnetic material.

3. The neural stimulation electrode according to claim 2, characterized in that: The wing (3) comprises a second bending portion (31) for folding the wing (3) along its length direction.

4. The neural stimulation electrode according to claim 2, characterized in that: Also included is a drug administration capsule (4), wherein the material of the drug administration capsule (4) includes a shape memory polymer and a nano ferromagnetic material; The drug delivery capsule (4) is arranged on the flexible package electrode body (1) or the base fold layer (2).

5. The neural stimulation electrode according to claim 4, characterized in that: The number of the first bending portions (21) is plural, and the plurality of the first bending portions (21) are distributed at intervals on the same surface of the flexible packaging electrode body (1) along the length direction of the flexible packaging electrode body (1); The wing sheet (3) and the drug delivery capsule (4) are respectively connected to the flexible package electrode body (1); The wing piece (3) and the medication capsule (4) are both distributed between two adjacent first bending portions (21).

6. The neural stimulation electrode according to claim 4, characterized in that: The number of the base folding layers (2) is two, and the two base folding layers (2) are arranged on two surfaces of the flexible package electrode body (1); Each of the base folding layers (2) comprises a plurality of the first bending portions (21), and the plurality of the first bending portions (21) of the two base folding layers (2) are alternately and spacedly distributed along the length direction of the flexible package electrode body (1); The wing sheet (3) and the drug delivery capsule (4) are respectively connected to the flexible package electrode body (1); The wing (3) and the medication capsule (4) are both distributed between the first bent portion (21) on the upper surface of the flexible package electrode body (1) and the first bent portion (21) on the adjacent lower surface.

7. The neural stimulation electrode according to claim 4, characterized in that: The base fold layer (2) comprises a plurality of first fold portions (21) connected to each other; A plurality of the first bent portions (21) are distributed at intervals along the length direction of the flexible package electrode body (1); The wing sheet (3) and the medication capsule (4) are respectively connected to the base fold layer (2); The wing piece (3) and the medication capsule (4) are both distributed between two adjacent first bending portions (21) of the base fold layer (2).

8. The neural stimulation electrode according to claim 4, characterized in that: The medication capsule (4) comprises a plurality of leaflets (41), each of the leaflets (41) being provided with a plurality of grooves (411) spaced apart along the length direction of the leaflet (41); The plurality of leaflets (41) can gather or expand at corresponding temperatures to store or release drugs.

9. The neural stimulation electrode according to claim 4, characterized in that: In the base fold layer (2), the wing sheet (3) and the drug delivery capsule (4), the mass ratio of the shape memory polymer to the nano-ferromagnetic material is (1-4):1; The shape memory polymer includes one or more of epoxy shape memory polymer, polyimide shape memory polymer, cyanate shape memory polymer, polyimide shape memory polymer, polyurethane shape memory polymer and polylactic acid shape memory polymer.

10. A method for preparing a neural stimulation electrode according to any one of claims 1 to 9, characterized in that: include: After the shape memory polymer and the nano-ferromagnetic material are mixed, a base fold layer (2), a wing sheet (3) and a drug delivery capsule (4) are respectively prepared by using 3D printing technology; The base fold layer (2) and the drug administration capsule (4) are adhered to the surface of the flexible package electrode body (1) and then cured, and the wing sheet (3) is adhered to both ends of the flexible package electrode body in the width direction and then cured; Or, the preparation method comprises: After mixing the shape memory polymer and the nano-ferromagnetic material, a 3D printing technology is used to prepare an integrally formed part of a base fold layer (2), a wing sheet (3) and a drug delivery capsule (4); The integrally formed part is adhered to the surface of the flexible package electrode body (1) and cured.

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