Multi-channel balloon electrode, preparation method therefor, and use thereof

Abstract

Disclosed in the present invention are a multi-channel balloon electrode, a preparation method therefor, and use thereof. The preparation method comprises the following steps: taking a thermoplastic polyurethane elastomer thin film as a substrate material, and preparing a patterned metal layer on a surface of the thermoplastic polyurethane elastomer thin film; packaging a part of an electrode except an effective functional area to obtain a thin film electrode; and curling the thin film electrode and then packaging to obtain the balloon electrode. According to the multi-channel balloon electrode provided by the present invention, the TPU thin film is used as the substrate to first prepare the two-dimensional patterned thin film electrode which is then curled to prepare the three-dimensional balloon electrode, thereby achieving surface patterning on the three-dimensional balloon electrode. The balloon electrode provided by the present invention has the advantages of adjustable channel number and density of the electrode, controllable preparation process, diverse functionalities, and scalable production, so that the precision and anti-interference capability of the electrode can be comprehensively improved by improving the electrode density and improving the electrode material and the electrode stretchability.

Description

A multi-channel balloon electrode and its preparation method and application Technical Field

[0001] The present invention relates to the technical field of balloon electrodes, and in particular to a multi-channel balloon electrode and a preparation method and application thereof. Background Art

[0002] With the advancement of electrophysiological and catheter-based technologies, renal sympathetic denervation (RDN) has become a new interventional treatment for hypertension. RDN can significantly lower blood pressure, with particularly significant results for refractory hypertension. This procedure ablates the sympathetic nerves lining the renal artery, thereby reducing the sympathetic nervous system's control over blood pressure and lowering blood pressure. A balloon electrode is a surgical tool used for sympathetic nerve ablation of the renal artery wall. During RDN, surgeons insert a balloon electrode into the renal artery wall, using the electrode to measure nerve electrical activity and precisely ablate the sympathetic nerves. Compared to traditional medications and surgical treatments, balloon electrode ablation offers advantages such as long-lasting efficacy, safety, reliability, and minimal invasiveness. It can also reduce patients' dependence on medication and improve their quality of life. Furthermore, balloon electrode ablation technology can monitor nerve electrical signals in real time, providing guidance to physicians and ensuring accurate and lasting surgical results. Balloon electrode ablation is currently a commonly used procedure in RDN surgery, offering patients an efficient and safe treatment option. For example, the Symplicity Spyral balloon electrode is used in renal sympathetic nerve ablation procedures. It accurately measures nerve electrical activity within the inner wall of the renal artery to guide sympathetic nerve ablation. Although balloon electrodes with certain limitations are currently available, achieving customized channel count and density within the balloon electrode to improve the accuracy of physiological electrical activity monitoring remains a significant challenge in terms of material selection and fabrication processes.

[0003] Summary of the Invention

[0004] The present invention addresses the problems of complex balloon electrode preparation process, the inability to customize the number of electrode channels and density according to actual needs, and the low accuracy of physiological electrical activity monitored by electrodes. A multi-channel balloon electrode, its preparation method and application are provided.

[0005] To achieve the above object, the technical solution adopted by the present invention is:

[0006] In one aspect, the present invention provides a method for preparing a multi-channel balloon electrode, comprising the following steps:

[0007] (1) A thermoplastic polyurethane (TPU) film is used as a substrate material, and a patterned metal layer is prepared on its surface;

[0008] (2) Encapsulating the portion outside the effective functional area of ​​the electrode to obtain a thin film electrode;

[0009] (3) The thin film electrode is rolled up and then packaged to obtain the balloon electrode.

[0010] In the technical solution of the present invention, the number of channels of the multi-channel is 1 to 100, preferably 2 to 50.

[0011] As a preferred embodiment, in step (1), the thickness of the thermoplastic polyurethane elastomer (TPU) film is 0.01 to 1 mm, preferably 0.05 to 0.5 mm;

[0012] In certain specific embodiments, the planar dimensions of the thermoplastic polyurethane elastomer (TPU) film are 1-10 cm×0.5-10 cm, preferably 3-7 cm×1-7 cm;

[0013] In certain specific embodiments, the thermoplastic polyurethane elastomer (TPU) film may be 90A type TPU or 95A type TPU;

[0014] In some specific embodiments, the thermoplastic polyurethane elastomer (TPU) film is prepared by a hot melt extrusion flattening method; preferably, the film prepared by the hot melt extrusion flattening method needs to be cleaned and dried; the cleaning is preferably cleaning with ethanol solution and deionized water; the drying is preferably oven drying, and further preferably oven drying at 60°C.

[0015] As a preferred embodiment, in step (1), the method for preparing the patterned metal layer is vacuum magnetron sputtering or vacuum thermal evaporation;

[0016] Preferably, the material for preparing the patterned metal layer is a metal conductive material, specifically gold, silver, platinum, iridium, etc.;

[0017] Preferably, the thickness of the patterned metal layer is 1 to 1000 nm, for example, 1 nm, 50 nm, 100 nm, 150 nm, 200 nm, 250 nm, 300 nm, 350 nm, 400 nm, 450 nm, 500 nm, 550 nm, 600 nm, 650 nm, 700 nm, 750 nm, 800 nm, 850 nm, 900 nm, 950 nm, or 1000 nm.

[0018] In some specific embodiments, the patterned metal layer is prepared using a mask plate, and the pattern of the mask plate can be designed and produced according to parameters such as different electrode channels, electrode size and density; the mask plate is produced by an ultraviolet laser cutting machine, and the working power and other parameters of the ultraviolet laser cutting machine are set according to actual needs.

[0019] As a preferred embodiment, in step (2), the encapsulation is performed using an ultra-thin SEBS film; the ultra-thin film has a thickness of 1 to 100 nm;

[0020] Preferably, the ultra-thin SEBS film is prepared by spin coating or drop coating.

[0021] As a preferred embodiment, in step (3), the curling is mechanical curling or mechanical curling under heating conditions;

[0022] Preferably, the curling is performed with the patterned metal layer as the outer layer;

[0023] Preferably, the mechanical curling is end-to-end or end-to-end partially overlapped;

[0024] In some specific embodiments, the mechanical curling uses an adhesive to fix the shape;

[0025] In certain specific embodiments, in step (3), the encapsulation is performed using a polymer solution, and the polymer solution may include an N,N-dimethylformamide solution of polyurethane; and the encapsulation is performed on the parts that are connected end to end or overlap end to end.

[0026] In another aspect, the present invention provides a multi-channel balloon electrode obtained by the above preparation method.

[0027] In yet another aspect, the present invention provides use of the multi-channel balloon electrode in electrophysiological signal monitoring.

[0028] The above technical solution has the following advantages or beneficial effects:

[0029] The multi-channel balloon electrode provided by the present invention is first fabricated as a two-dimensional patterned thin-film electrode using a TPU film as a substrate. This is then rolled to form a three-dimensional balloon electrode, achieving surface patterning. The balloon electrode provided by the present invention offers advantages such as adjustable channel number and density, a controllable preparation process, diverse functionality, and scalable production. By increasing electrode density, improving electrode materials, and enhancing stretchability, it can comprehensively enhance electrode precision and anti-interference capabilities.

[0030] Compared with the prior art, the present invention has the following advantages:

[0031] (1) This invention uses a patterned two-dimensional thin film electrode to form a patterned three-dimensional balloon electrode by rolling it. Compared with the method of first preparing a three-dimensional substrate and then preparing the patterned electrode, the preparation process is controllable and the number of channels and density of the electrode can be adjusted. In addition, TPU with excellent flexibility and biocompatibility has good competitiveness in the preparation of biofunctional materials.

[0032] (2) The preparation method provided by the present invention is simple in process, reduces production costs, and is easy to scale up production.

[0033] (3) The balloon electrode provided by the present invention can realize multi-channel, real-time stimulation and recording of physiological electrical signals, and has great application value for monitoring physiological electrical signals. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] FIG1 is a schematic diagram of a preparation process of a multi-channel balloon electrode according to an embodiment of the present invention.

[0035] FIG2 is a graph showing myoelectric signals collected by the four-channel balloon electrode prepared in Example 4 of the present invention in the tibialis anterior muscle of a rat leg. DETAILED DESCRIPTION

[0036] The following embodiments are merely some of the embodiments of the present invention, rather than all of them. Therefore, the detailed description of the embodiments of the present invention provided below is not intended to limit the scope of the claimed invention, but rather merely represents selected embodiments of the present invention. All other embodiments derived by those skilled in the art based on the embodiments of the present invention without creative effort are intended to fall within the scope of protection of the present invention.

[0037] In the present invention, unless otherwise specified, all equipment and raw materials can be purchased from the market or are commonly used in the industry. The methods in the following embodiments, unless otherwise specified, are all conventional methods in the art.

[0038] Example 1:

[0039] The method for preparing a multi-channel balloon electrode provided in this embodiment is shown in FIG1 , and includes the following steps:

[0040] (1) 90A TPU was prepared by hot melt extrusion flattening method with a thickness of 0.05 mm and a plane size of 3×1 cm 2 The film was washed with 75% ethanol solution and deionized water; and dried at 60°C to obtain a substrate;

[0041] (2) A patterned gold conductive layer is prepared on the substrate using a vacuum magnetron sputtering deposition method using a mask. The thickness of the gold conductive layer is 100 nm. In this embodiment, the mask is designed based on 30 electrode channels.

[0042] (3) Using an ultra-thin SEBS film with a thickness of 100 nm to encapsulate the portion outside the effective functional area of ​​the electrode to obtain a thin film electrode;

[0043] (4) Curling the thin film electrode with the electrode pattern facing outward and bonding the end-to-end joints with an adhesive;

[0044] (5) Encapsulate with polyurethane N,N-dimethylformamide solution and heat cure.

[0045] Example 2:

[0046] The method for preparing a multi-channel balloon electrode provided in this embodiment is shown in FIG1 , and includes the following steps:

[0047] (1) 90A TPU was prepared by hot melt extrusion flattening method with a thickness of 0.3 mm and a plane size of 4×5 cm 2 The film was washed with 75% ethanol solution and deionized water; and dried at 60°C to obtain a substrate;

[0048] (2) A patterned gold conductive layer is prepared on the substrate using a vacuum magnetron sputtering deposition method using a mask. The thickness of the gold conductive layer is 500 nm. In this embodiment, the mask is designed based on 30 electrode channels.

[0049] (3) Using an ultra-thin SEBS film with a thickness of 100 nm to encapsulate the portion outside the effective functional area of ​​the electrode to obtain a thin film electrode;

[0050] (4) Curling the thin film electrode with the electrode pattern facing outward and bonding the end-to-end joints with an adhesive;

[0051] (5) Encapsulate with polyurethane N,N-dimethylformamide solution and heat cure.

[0052] Example 3:

[0053] The method for preparing a multi-channel balloon electrode provided in this embodiment is shown in FIG1 , and includes the following steps:

[0054] (1) 90A TPU was prepared by hot melt extrusion flattening method with a thickness of 0.05 mm and a plane size of 7×7 cm 2 The film was washed with 75% ethanol solution and deionized water; and dried at 60°C to obtain a substrate;

[0055] (2) A patterned gold conductive layer is prepared on the substrate using a vacuum magnetron sputtering deposition method using a mask. The thickness of the gold conductive layer is 1000 nm. In this embodiment, the mask is designed based on 30 electrode channels.

[0056] (3) Using an ultra-thin SEBS film with a thickness of 100 nm to encapsulate the portion outside the effective functional area of ​​the electrode to obtain a thin film electrode;

[0057] (4) Curling the thin film electrode with the electrode pattern facing outward and bonding the end-to-end joints with an adhesive;

[0058] (5) Encapsulate with polyurethane N,N-dimethylformamide solution and heat cure.

[0059] Example 4

[0060] The method for preparing a multi-channel balloon electrode provided in this embodiment is shown in FIG1 , and includes the following steps:

[0061] (1) 90A TPU was prepared by hot melt extrusion flattening method with a thickness of 0.05 mm and a plane size of 7×7 cm 2 The film was washed with 75% ethanol solution and deionized water; and dried at 60°C to obtain a substrate;

[0062] (2) A patterned gold conductive layer is prepared on the substrate using a vacuum magnetron sputtering deposition method using a mask. The thickness of the gold conductive layer is 1000 nm. In this embodiment, the mask is designed based on the number of electrode channels being 4.

[0063] (3) Using an ultra-thin SEBS film with a thickness of 100 nm to encapsulate the portion outside the effective functional area of ​​the electrode to obtain a thin film electrode;

[0064] (4) Curling the thin film electrode with the electrode pattern facing outward and bonding the end-to-end joints with an adhesive;

[0065] (5) Encapsulate with polyurethane N,N-dimethylformamide solution and heat cure.

[0066] The electromyographic signals collected by the four-channel balloon electrode prepared in this embodiment on the tibialis anterior muscle of the rat leg are shown in Figure 2. As can be seen from the figure, the balloon electrode prepared in this embodiment can effectively collect electrophysiological signals.

[0067] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. Preparation method of a multi-channel balloon electrode, characterized in that, it includes the following steps: (1) Using a thermoplastic polyurethane elastomer film as the base material, preparing a patterned metal layer on its surface; (2) Encapsulating the part outside the effective functional area of the electrode to obtain a thin film electrode; (3) After curling the thin film electrode, encapsulating it to obtain the said balloon electrode.

2. The preparation method according to claim 1, characterized in that, the number of channels of the multi-channel is 1 to 100.

3. The preparation method according to claim 1, characterized in that, in step (1), the thickness of the thermoplastic polyurethane elastomer film is 0.01 to 1 mm.

4. The preparation method according to claim 1, characterized in that, the thermoplastic polyurethane elastomer film is prepared by a hot melt extrusion and flattening method; the film prepared by the hot melt extrusion and flattening method needs to be cleaned and dried; the cleaning is with an ethanol solution and deionized water; the drying is drying at 60 °C.

5. The preparation method according to claim 1, characterized in that, in step (1), the method for preparing the patterned metal layer is vacuum magnetron sputtering or vacuum thermal evaporation; the material for preparing the patterned metal layer is a metal conductive material; the thickness of the patterned metal layer is 1 to 1000 nm.

6. The preparation method according to claim 1, characterized in that, in step (2), the encapsulation is carried out using an ultra-thin SEBS film; the ultra-thin means a thickness of 1 to 100 nm; the ultra-thin SEBS film is prepared by a spin coating method or a drop coating method.

7. The preparation method according to claim 1, characterized in that, in step (3), the curling is mechanical curling or mechanical curling under heating conditions; the curling is with the patterned metal layer as the outer layer for curling; the mechanical curling is end-to-end connection or partial overlap of the head and tail.

8. The preparation method according to claim 1, characterized in that, in step (3), the encapsulation is carried out using a polymer solution; the encapsulation is for the part of end-to-end connection or overlap of the head and tail.

9. A multi-channel balloon electrode, characterized in that, it is prepared by the preparation method according to any one of claims 1-8.

10. Use of the multi-channel balloon electrode according to claim 9 in electrophysiological signal monitoring.

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