Multi-channel balloon electrode, method for preparing same, and use thereof

Abstract

Disclosed are a multi-channel balloon electrode, a method for preparing same, and use thereof. The method comprises the following steps: preparing a balloon with a thermoplastic polyurethane rubber, and using a hot melt adhesive to seal the two ends of the balloon; conformally attaching a patterned mask to the outer surface of the balloon; depositing a multi-channel conductive electrode on the balloon by means of vacuum magnetron sputtering deposition or vapor deposition; and packaging the multi-channel conductive electrode. The balloon electrode prepared in the present invention solves the problems in the prior art such as complicated electrode preparation procedures, limited electrode functionality, poor electrode precision and electrode stability, low scalability and the like, and is suitable for mass production. The balloon electrode can be used for mapping and electrical stimulation, and has potential application prospects in the medical field.

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] Balloon electrodes, as a tool for neural stimulation and recording, have been widely used in biomedical research and clinical practice, including in fields such as neuroscience, cardiology, and myopathy. Therefore, their performance and technology require continuous improvement and innovation. In neurology, balloon electrodes are primarily used for recording and stimulating neural signals, helping researchers gain a deeper understanding of the structure and function of the nervous system and develop more effective neurotherapy methods. In intraoperative monitoring, balloon electrodes can be used to monitor neural function, such as neuronal activity and conduction velocity, to help surgeons avoid nerve tissue damage. During brain surgery, balloon electrodes can be used to monitor localized EEG activity, helping to define the surgical area and predict postoperative neurological recovery. In electrophysiological monitoring, balloon electrodes can also be used to monitor patient electrophysiological parameters, such as heart rhythm, muscle activity, and respiratory function. This is extremely helpful for monitoring the patient's physiological status and adjusting anesthetic dosage during surgery.

[0003] Although balloon electrodes have great potential in neuroscience research and clinical applications, some problems and challenges remain. For example, the preparation method of balloons with multi-channel electrodes is complex and costly, making it impossible to prepare them according to actual needs. Secondly, the electrode positioning accuracy of balloon electrodes is critical to research and treatment effectiveness. Currently, there are still some difficult problems to solve, such as how to ensure the accurate positioning of balloon electrodes and how to prevent displacement. Another issue is stability. During long-term use, balloon electrodes may become loose or fall off due to friction with tissue and other factors, thereby affecting recording or stimulation effects. In addition, there are certain issues with scalability. Currently, most balloon electrode designs are based on the needs of specific fields, such as EEG recording and neural stimulation. However, the needs and designs of balloon electrodes will vary in different fields, so how to meet these different needs is another challenge facing balloon electrodes.

[0004] Summary of the Invention

[0005] The present invention addresses the following technical issues: The present invention addresses the complex preparation methods, poor electrode precision, poor electrode stability, and potential for improved scalability of balloon electrodes. By providing a multi-channel balloon electrode, its preparation method, and application, the present invention utilizes flexible mask transfer, magnetron sputtering, and other techniques to fabricate the multi-channel balloon electrode, particularly for intraoperative mapping.

[0006] The technical solutions of the present invention are as follows:

[0007] In one aspect, the present invention provides a method for preparing a multi-channel balloon electrode, comprising the following steps:

[0008] (1) preparing a balloon made of thermoplastic polyurethane rubber (TPU), and sealing both ends of the balloon with hot melt adhesive;

[0009] (2) conformally attaching the patterned mask to the outer surface of the balloon;

[0010] (3) depositing a multi-channel conductive electrode on the balloon obtained in step (2) by vacuum magnetron sputtering deposition or evaporation;

[0011] (4) Encapsulating the multi-channel conductive electrode.

[0012] In the technical solution of the present invention, the number of channels of the multi-channel is 1 to 100, preferably 2 to 50.

[0013] As a preferred embodiment, in step (1), the wall thickness of the balloon is 500 nm to 200 μm;

[0014] Preferably, the method of preparing the thermoplastic polyurethane rubber (TPU) into the balloon is a hot melt method;

[0015] Preferably, after both ends of the balloon are sealed with hot melt adhesive, the interior is in a filled state;

[0016] In the technical solution of the present invention, the size of the balloon is customized according to the application scenario; by using hot melt adhesive to seal both ends of the balloon, the interior of the balloon can be filled with gas and prevent gas leakage, thereby ensuring the conformality and accuracy of subsequent mask attachment.

[0017] As a preferred embodiment, in step (2), the mask is made of a highly adhesive flexible material, such as polyimide. In the technical solution of the present invention, the mask made of a highly adhesive flexible material has the characteristics of being soft, highly adhesive, and easy to remove, has good adhesion to the TPU material, and is easy to process.

[0018] Preferably, the thickness of the mask is 1 μm to 1000 μm, and the size is customized according to the application scenario.

[0019] Preferably, the patterning process is performed using an ultraviolet laser or an infrared laser; in the technical solution of the present invention, the precision of the ultraviolet laser or the infrared laser must ensure the accuracy and precision of the patterning.

[0020] As a preferred embodiment, the material of the multi-channel conductive electrode is selected from at least one of gold, platinum and iridium; in the technical solution of the present invention, gold, platinum and iridium have good biocompatibility;

[0021] In certain specific embodiments, for vacuum magnetron sputtering deposition, gold target, platinum target, or iridium target is used to deposit the electrode; for evaporation deposition, gold particles, platinum particles, or iridium particles are used to deposit the electrode;

[0022] Preferably, the deposition is uniform deposition; in some specific embodiments, the balloon rotates at a constant speed during the deposition process, which can ensure the integrity and uniformity of the deposition;

[0023] Preferably, the thickness of the multi-channel conductive electrode is 100 nm to 1000 nm;

[0024] Preferably, the width of the multi-channel conductive electrode is 10 μm to 5000 μm;

[0025] In the technical solution of the present invention, the specific thickness and width of the multi-channel conductive electrode are customized according to the application scenario.

[0026] As a preferred embodiment, in step (4), the packaging is performed using a polymer material; the thickness of the packaging is 1 to 1000 nm; the packaging can avoid the risk of leakage when the electrode is used;

[0027] Preferably, the polymer material is an adhesive polymer material, such as SEBS.

[0028] In another aspect, the present invention provides a multi-channel balloon electrode obtained by the above preparation method.

[0029] In yet another aspect, the present invention provides use of the multi-channel balloon electrode described above in mapping and electrical stimulation.

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

[0031] (1) The present invention prepares a multi-channel balloon electrode by mask transfer, magnetron sputtering and other methods, giving full play to the advantages of various materials and methods, and realizing the preparation of a multifunctional, multi-channel balloon electrode.

[0032] (2) The preparation method provided by the present invention is simple in process and reduces the cost of raw materials. This preparation method solves the problems of the existing balloon electrode preparation method, such as complex electrode preparation method, minimal electrode functionality, poor electrode precision, poor electrode stability and low scalability, and is suitable for large-scale production.

[0033] (3) The multi-channel balloon electrode provided by the present invention can be used for mapping and electrical stimulation, and has potential application value in the medical field. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] FIG1 is a schematic structural diagram of a flexible polyimide mask prepared in Example 1 of the present invention.

[0035] FIG2 is a physical picture of the patterned multi-channel balloon electrode prepared in Example 1 of the present invention.

[0036] FIG3 is a schematic diagram of the structure of the patterned multi-channel balloon electrode prepared in Example 2 of the present invention

[0037] FIG4 is a physical picture of the patterned multi-channel balloon electrode prepared in Example 2 of the present invention.

[0038] FIG5 is a statistical graph of the average resistance values ​​of 10 balloon electrode samples prepared in Example 1 of the present invention before and after friction.

[0039] FIG6 is a stretching-resistance curve of the balloon electrode prepared in Example 1 of the present invention.

[0040] FIG7 is an impedance diagram of the balloon electrode prepared in Example 1 of the present invention.

[0041] FIG8 is a diagram of nerve electrical signals of the tibial nerve of a rat monitored by the balloon electrode prepared in Example 1 of the present invention under stimulation currents of different intensities.

[0042] FIG9 is a diagram of the myoelectric signals of the human body surface monitored by the balloon electrode prepared in Example 1 of the present invention. DETAILED DESCRIPTION

[0043] 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.

[0044] 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.

[0045] Example 1:

[0046] This embodiment provides a patterned four-channel balloon electrode with an interface, and the preparation process includes the following steps:

[0047] (1) Thermoplastic polyurethane rubber (TPU) was prepared into a balloon structure by a hot melt method, and then both ends of the balloon were sealed with hot melt adhesive to ensure that the balloon was filled with gas; the wall thickness of the balloon was 200 μm;

[0048] (2) A patterned flexible polyimide mask was prepared by UV laser cutting, the structure of which is shown in FIG1 and has a thickness of 30 μm;

[0049] (3) conformally attaching the patterned polyimide mask to the outer surface of the balloon;

[0050] (4) The balloon with the mask attached was rotated at a constant speed, and then vacuum magnetron sputtering deposition (argon atmosphere, pressure 3×10 -3 Pa) depositing multi-channel gold electrodes on the balloon surface; the electrode thickness is 150 nm, the electrode width is 1.2 mm, the width of the electrode interface is 0.6 mm, and the number of channels is 4;

[0051] (5) The electrodes were encapsulated with SEBS, and the thickness of the encapsulation layer was 100 nm.

[0052] A physical picture of the four-channel balloon electrode prepared in this example is shown in FIG2 .

[0053] Ten balloon electrode samples prepared in this example were tested for their average resistance. A nitrile glove with a 500g weight was then rubbed against the balloon electrodes 100 times to measure their average resistance. The test results are shown in Figure 5. As can be seen from Figure 5, the balloon electrode samples prepared in this example exhibit low resistance and good conductivity. The friction test also demonstrated the stability and friction resistance of the balloon electrodes.

[0054] The balloon electrode prepared in this example was subjected to a stretching-resistance test, and the test results are shown in Figure 6. As can be seen from Figure 6, the balloon electrode has excellent stretchability and stretching conductivity.

[0055] The balloon electrode prepared in this embodiment was subjected to impedance testing, and the test results are shown in Figure 7. As can be seen from Figure 7, the balloon electrode has good electrical performance below 1000 Hz, and this excellent electrical performance is suitable for collecting physiological electrical signals of different frequencies.

[0056] The balloon electrode prepared in this example was used to collect signals from the rat tibial nerve in vivo, and the test results are shown in Figure 8. As can be seen from Figure 8, evoked nerve signals can be collected in all comparative experiments using microcurrents of different intensities to stimulate the rat tibial nerve.

[0057] The balloon electrode prepared in this embodiment was tested for collecting electromyographic signals from the human body surface, and the test results are shown in Figure 9. As can be seen from Figure 9, the balloon electrode prepared in this embodiment has the ability to collect electromyographic signals from the human body surface.

[0058] Example 2:

[0059] This embodiment provides a patterned four-channel balloon electrode without an interface, and the preparation method includes the following steps:

[0060] (1) Thermoplastic polyurethane rubber (TPU) was prepared into a balloon structure by a hot melt method, and then both ends of the balloon were sealed with hot melt adhesive to ensure that the balloon was filled with gas; the wall thickness of the balloon was 200 μm;

[0061] (2) UV laser cutting was used to prepare a patterned flexible polyimide mask with a thickness of 30 μm;

[0062] (3) conformally attaching the patterned polyimide mask to the outer surface of the balloon;

[0063] (4) The balloon with the mask attached was rotated at a constant speed, and then vacuum magnetron sputtering deposition (argon atmosphere, pressure 3×10 -3 Pa) depositing multi-channel gold electrodes on the balloon surface; the electrode thickness is 150 nm, the width is 1 mm, and the number of channels is 4;

[0064] (5) The electrodes were encapsulated with SEBS, and the thickness of the encapsulation layer was 100 nm.

[0065] The structural diagram and actual image of the balloon electrode prepared in this embodiment are shown in Figures 3-4.

[0066] 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. A preparation method of a multi-channel balloon electrode, characterized in that, it includes the following steps: (1) Prepare a balloon from thermoplastic polyurethane rubber, and seal both ends of the balloon with hot melt adhesive; (2) Conformally attach a patterned mask plate to the outer surface of the balloon; (3) Deposit a multi-channel conductive electrode on the balloon obtained in step (2) by vacuum magnetron sputtering deposition or evaporation; (4) Package the multi-channel conductive electrode.

2. The preparation method according to claim 1, characterized in that, in step (1), the wall thickness of the balloon is 500 nm to 200 μm; the method of preparing the balloon from thermoplastic polyurethane rubber is the hot melting method; after both ends of the balloon are sealed with hot melt adhesive, the inside is in a filled state.

3. The preparation method according to claim 1, characterized in that, in step (2), the thickness of the mask plate is 1 μm to 1000 μm.

4. The preparation method according to claim 1, characterized in that, in step (2), the patterning treatment is performed by ultraviolet laser or infrared laser.

5. The preparation method according to claim 1, characterized in that, in step (3), the material of the multi-channel conductive electrode is selected from at least one of gold, platinum and iridium.

6. The preparation method according to claim 1, characterized in that, in step (3), the deposition is uniform deposition.

7. The preparation method according to claim 1, characterized in that, in step (3), the thickness of the multi-channel conductive electrode is 100 nm to 1000 nm; the width of the multi-channel conductive electrode is 10 μm to 5000 μm.

8. The preparation method according to claim 1, characterized in that, in step (4), the packaging is performed with a polymer material; the thickness of the packaging is 1 to 1000 nm.

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 mapping and electrical stimulation.

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