A multi-polar neuro-electrical stimulation electrode catheter
By combining a flexible conduit, an elastic element, and a rigid guide wire, the problems of reduced electrical stimulation efficiency and processing complexity caused by changes in electrode position are solved. This achieves stable electrode fixation and low-cost production, thereby improving the electrical stimulation effect.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- THE SECOND XIANGYA HOSPITAL OF CENT SOUTH UNIV
- Filing Date
- 2025-04-10
- Publication Date
- 2026-06-05
Smart Images

Figure CN224320738U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of medical device technology, and in particular to a multipolar nerve electrical stimulation electrode catheter. Background Technology
[0002] Neuromodulation can be applied to various types of pain, epilepsy, Parkinson's disease, mental illnesses, angina pectoris, irritable bowel syndrome, and peripheral neurovascular diseases. Peripheral nerve electrical stimulation is one type of neuromodulation technique. It utilizes implantable technology and electrical stimulation signals to alter peripheral nerve activity, thereby improving symptoms in patients with chronic pain.
[0003] Currently, peripheral nerve stimulation electrodes used in clinical practice are typically implanted via a puncture needle. The electrode tip is positioned close to the target nerve tissue. After adjusting the electrode position to achieve the best stimulation effect, the electrode is fixed in place. Electrodes are usually fixed by sutures to the skin surface or superficial subcutaneous fascia. When the patient moves their limbs or experiences repeated muscle contractions, the electrode position can easily change. Even slight positional changes can reduce the efficiency of electrical stimulation, while severe electrode displacement can directly lead to electrode dislodgement and complete ineffectiveness.
[0004] In addition, existing electrical stimulation electrodes are basically conductive metal ring structures, which require the use of multi-strand twisted metal wires to weld to the metal ring. During processing, it is necessary to consider whether the weld between the metal wire and the metal ring is strong, and also to treat the protruding weld points or burrs after welding to avoid damage to human tissue. Therefore, the processing procedures of existing electrical stimulation electrodes are more complicated and the manufacturing cost is higher. Utility Model Content
[0005] This invention aims to solve at least one of the technical problems existing in the prior art. To this end, this invention proposes a multipolar nerve electrical stimulation electrode catheter, which can increase the opportunity for the electrode to contact nerve tissue and is easy to fix the catheter position.
[0006] According to an embodiment of the present invention, a multipolar nerve electrical stimulation electrode catheter includes a flexible catheter body, the catheter body having a first end and a second end opposite to each other, the catheter body having a first channel extending from the first end to the second end, and the first channel having a closed structure at the port of the first end.
[0007] An elastic element, the elastic element including a shaping segment, the elastic element having an initial state, in which the shaping segment of the elastic element is bent in a plane, the elastic element being disposed in the first channel, and the shaping segment of the elastic element being located at the first end;
[0008] A rigid guide wire is movably inserted through the first channel. The guide wire can move within the first channel to a restricted position or an unrestricted position. In the restricted position, the guide wire can keep the catheter body in a straight line. In the unrestricted position, the elastic element can drive the first end to bend into a spiral shape in a plane.
[0009] An electrode assembly is disposed on the outer wall of the catheter body.
[0010] The multipolar nerve electrical stimulation electrode catheter according to the embodiments of this utility model has at least the following beneficial effects: the catheter body is a flexible structure, and the structure of the catheter body can be changed by the deformation of the elastic element; the elastic element is configured with a central axis in a spiral shape, that is, the elastic element can change the first end of the catheter body into a spiral structure. In the plane, the straight catheter body becomes a spiral shape, which increases the area of the projection in the plane, so the catheter body is more difficult to move in the tissue; the guide wire is rigid and is movably inserted in the first channel. When the guide wire is in the first channel, the guide wire can prevent the elastic element from deforming, that is, both the catheter body and the elastic element remain in a straight state, which facilitates the puncture and implantation of the catheter body into the target tissue area; the electrode assembly is used to contact the peripheral nerve and use electrical stimulation signals to change the activity of the peripheral nerve.
[0011] According to some embodiments of the present invention, the electrode assembly includes a first electrode body and a second electrode body, the first electrode body is disposed on the outer side wall of the first end, the second electrode body is disposed on the outer side wall of the second end, and the first electrode body and the second electrode body are electrically connected.
[0012] According to some embodiments of the present invention, the outer side wall of the first end is provided with a surrounding first electrode wire, which is wound into a spiral structure to form the first electrode body. The outer side wall of the second end is provided with a surrounding second electrode wire, which is wound into a spiral structure to form the second electrode body. The first electrode body and the second electrode body are an integral structure.
[0013] According to some embodiments of the present invention, the catheter body is provided with a second channel, and a conductive wire is provided inside the second channel. The conductive wire connects the first electrode body and the second electrode body, and the second channel is isolated from the first channel.
[0014] According to some embodiments of the present invention, the electrode assembly includes a plurality of first electrode bodies and a plurality of second electrode bodies, wherein the plurality of first electrode bodies are spaced apart along the length direction of the catheter body, and the plurality of second electrode bodies are spaced apart along the length direction of the catheter body.
[0015] According to some embodiments of the present invention, the catheter body is provided with a plurality of second channels, and each second channel is provided with a conductive wire, and the conductive wire is connected to the first electrode body and the second electrode body of the same electrode assembly.
[0016] According to some embodiments of the present invention, a plurality of second channels are evenly distributed around the first channel in the circumference.
[0017] According to some embodiments of the present invention, the catheter body is provided with multiple liquid outlet holes, all of which are connected to the first channel and penetrate the outer side wall of the first end.
[0018] According to some embodiments of the present invention, the catheter body is provided with a radiopaque portion, which is located at the port of the first end and constitutes the closed structure.
[0019] According to some embodiments of the present invention, the side of the developing section away from the second end is the head, and the head is arc-shaped.
[0020] According to some embodiments of the present invention, the shaping segment of the elastic member is bent into a spiral shape in the plane.
[0021] Additional aspects and advantages of this invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description
[0022] The present invention will be further described below with reference to the accompanying drawings and embodiments, wherein:
[0023] Figure 1 This is a schematic diagram of the structure of the multipolar nerve electrical stimulation electrode conduit according to an embodiment of the present invention;
[0024] Figure 2 This is a schematic diagram of the structure of the second end of the multipolar nerve electrical stimulation electrode conduit according to an embodiment of the present invention;
[0025] Figure 3 This is a schematic diagram of the structure of the first end of the multipolar nerve electrical stimulation electrode conduit according to an embodiment of the present invention;
[0026] Figure 4 This is a schematic diagram of a multipolar nerve electrical stimulation electrode conduit bent into a spiral structure according to an embodiment of the present invention.
[0027] Icon labels:
[0028] The catheter body 100, the first channel 110, the second channel 120, the imaging section 130, the elastic element 200, the guide wire 300, the electrode assembly 400, the first electrode body 410, and the second electrode body 420. Detailed Implementation
[0029] The embodiments of this utility model are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain this utility model, and should not be construed as limiting this utility model.
[0030] In the description of this utility model, it should be understood that the orientation descriptions, such as up, down, etc., are based on the orientation or positional relationship shown in the drawings. They are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model.
[0031] In the description of this utility model, "multiple" refers to two or more. The use of "first" and "second" is for distinguishing technical features only and should not be construed as indicating or implying relative importance, or implicitly indicating the number of technical features or their sequential relationship.
[0032] In the description of this utility model, unless otherwise explicitly defined, terms such as "setting," "installation," and "connection" should be interpreted broadly, and those skilled in the art can reasonably determine the specific meaning of the above terms in this utility model in conjunction with the specific content of the technical solution.
[0033] As described in the background section, even slight changes in electrode position can reduce the efficiency of electrical stimulation, while severe electrode displacement can directly lead to electrode detachment and complete failure. Therefore, some electrode structures incorporate barbed silicone structures to prevent electrode displacement and detachment. However, after electrical stimulation, these silicone structures can then hinder electrode removal.
[0034] Reference Figure 1 and Figure 2 As shown, a multipolar nerve electrical stimulation electrode conduit of one embodiment of the present invention includes a flexible conduit body 100, a pre-shaped elastic element 200, a rigid guide wire 300, and an electrode assembly 400.
[0035] The catheter body 100 has a first end and a second end, and it should be understood that, in Figure 1The portion between the first and second ends of the catheter body 100 is not shown. The catheter body 100 has a first channel 110 extending from the first end to the second end, and a closure structure is provided at the port of the first end of the catheter body 100. The catheter body 100 is made of a flexible material, making it easy to deform and bend. For example, the flexible catheter body 100 can be made using any of the following materials: silicone, polyurethane (PU), or thermoplastic polyurethane (TPU).
[0036] It is important to understand that the first end of the catheter body 100 is used for puncture and implantation into human tissue to reach the peripheral nerves, which include, but are not limited to, dorsal root ganglia, spinal nerve roots, peripheral nerve trunks, and peripheral nerve branches. The second end of the catheter body 100 is generally located on the outside of the human tissue and is used for connection to other devices or for the operator to hold.
[0037] It should be understood that the elastic element 200 can be made using a Bourdon tube with shape memory metal function, and the elastic element 200 undergoes pre-shaping treatment to form a shaped segment on the elastic element 200. The elastic element 200 is in its initial state after pre-shaping treatment. When the elastic element 200 is in its initial state, the shaped segment of the elastic element 200 is bent in the plane, which is also the initial state of the elastic element 200 after pre-shaping, that is, the state exhibited by the elastic element 200 when it is not subjected to external force or restriction. Preferably, the shaped segment of the elastic element 200 is bent in a spiral shape in the plane. When the elastic element 200 is subjected to external force, it deforms; after the external force is removed, the elastic element 200 will return to its initial state. In the embodiments of this application, under certain circumstances, it is necessary to restrict the elastic element 200 so that the elastic element 200 is in a straight line state.
[0038] The elastic element 200 is disposed within the first channel 110 of the catheter body 100, and the shaping section of the elastic element 200 is ensured to be located at the first end of the catheter body 100.
[0039] The guide wire 300 is movably inserted through the first channel 110. The guide wire 300 can move within the first channel 110 to a restricted position or an unrestricted position. In the restricted position, the guide wire 300 can keep the catheter body 100 in a straight line. In the unrestricted position, the elastic member 200 can drive the first end of the catheter body 100 to bend into a spiral shape in the plane. The electrode assembly 400 is disposed on the outer wall of the catheter body 100.
[0040] An elastic element 200 is disposed within the first channel 110, and a rigid guide wire 300 is inserted into the first channel 110. Since the straight guide wire 300 is rigid, it restricts the bending deformation of the catheter body 100. When the catheter body 100 cannot bend, the elastic element 200 within the first channel 110 also cannot bend and remains straight. In other words, the guide wire 300 also restricts the elastic element 200 within the first channel 110 to a straight state, maintaining it in a straight position. Furthermore, when the elastic element 200 is a spring tube or similar structure, the guide wire 300 can also be inserted into the center of the elastic element 200. In this assembly structure, the guide wire 300 is also disposed within the first channel 110. In this assembly structure, the guide wire 300 directly restricts the elastic element 200 to a straight state, thus maintaining the catheter body 100 in a straight state.
[0041] When the guide wire 300 is inserted into the first channel 110, the catheter body 100 is initially in a straight state under the constraint of the guide wire 300. At this time, the catheter body 100 can be manipulated to puncture into the human tissue until the electrode assembly 400 reaches the peripheral nerve.
[0042] It should be understood that the guide wire 300 can also be used as an auxiliary tool to guide the movement of the catheter body 100. The force applied to the guide wire 300 can be transmitted to the catheter body 100 through the closed structure located at the first end of the catheter body 100, thereby pushing the catheter body 100 forward.
[0043] After the catheter body 100 is implanted, the guide wire 300 is removed from the first channel 110. At this time, the elastic element 200 is no longer restricted by the guide wire 300, and the elastic element 200 begins to return to its initial state. That is, the elastic element 200 drives the catheter body 100 to form a spiral structure together, for example... Figure 4 The structure shown makes it easy to fix the catheter body 100 and the electrode assembly 400 in human tissue, reducing the risk of displacement of the electrode assembly 400.
[0044] The first end of the catheter body 100 is spiral-shaped. This spiral shape primarily refers to a spiral within a plane; for example, along the direction from the second end of the catheter body 100 towards the first end, the catheter body 100 gradually spirals inward. Within the plane, the straight catheter body 100 transforms into a spiral shape, increasing the area of its projection within the plane. Specifically, along the puncture direction, the first end of the catheter body 100 has more contact points with the tissue, making it more difficult for the catheter body 100 to shift or dislodge within the tissue, and easier to fix.
[0045] The electrode assembly 400 is connected to an external pulse generator, which can apply electrical stimulation to the peripheral nerves.
[0046] It is important to understand that after the electrical stimulation treatment is completed, when the guide wire 300 is inserted into the first channel 110, the catheter body 100 can return to a straight state, making it easier to remove the catheter body 100 from the human tissue.
[0047] It should be understood that even if the patient's local muscle tissue moves repeatedly, the spiral catheter body 100 has more room for extension and retraction, which plays a certain role in fixation.
[0048] It is understood that the electrode assembly 400 includes a first electrode body 410 and a second electrode body 420. The first electrode body 410 is disposed on the outer side wall of the first end, and the second electrode body 420 is disposed on the outer side wall of the second end. The first electrode body 410 and the second electrode body 420 are electrically connected.
[0049] The first electrode 410 is disposed at the first end of the catheter 100 and is implanted along with the first end into the peripheral nerve to generate electrical stimulation for the peripheral nerve. The second electrode 420 is disposed at the second end of the catheter 100, which is located on the outer side of the human tissue. The second electrode 420 is used to connect an external power supply device, such as a pulse generator. The second electrode 420 is disposed on the outer wall of the second end for easier connection to the pulse generator.
[0050] It is understood that the outer wall of the first end is provided with a first electrode wire that is wound around in a spiral structure to form the first electrode body 410, and the outer wall of the second end is provided with a second electrode wire that is wound around in a spiral structure to form the second electrode body 420. The first electrode wire and the second electrode wire are an integral structure.
[0051] The first electrode body 410 is formed by wrapping the first electrode wire around the outer wall of the first end. This structure is easier to manufacture and the manufacturing process is simpler. Compared with the traditional welding of metal rings and metal guide wires, directly wrapping the first electrode wire to form the first electrode body 410 eliminates the need for welding and the need to deal with protrusions or burrs generated after welding, thus saving processing steps and reducing manufacturing costs. Similarly, the second electrode body 420 is also formed by wrapping the second electrode wire around the outer wall of the second end. It should be understood that the first and second electrode wires are an integral structure, for example, a single metal wire, with one end called the first electrode wire and the other end called the second electrode wire. Generally, both the first and second electrode wires are made of platinum-iridium metal or other precious metals. The spiral structure formed by the above-mentioned wrapping can reduce manufacturing costs and increase the contact area between the first electrode body 410 and the peripheral nerve, thereby improving the electrical stimulation effect.
[0052] It is understood that the catheter body 100 is provided with a second channel 120, and a conductive wire is provided inside the second channel 120. The conductive wire connects the first electrode body 410 and the second electrode body 420. The second channel 120 is isolated from the first channel 110.
[0053] The conductive wire is disposed within the second channel 120 and is isolated from the first channel 110, reducing the risk of the elastic element 200 damaging the conductive wire during deformation. Similarly, it also reduces the risk of the guide wire 300 damaging the conductive wire during movement.
[0054] It should be understood that in the integrated structure of the first electrode wire and the second electrode wire, platinum-iridium metal is used. One end of the metal wire is called the first electrode wire, which is directly wound to form the first electrode body 410. The other end of the metal wire is called the second electrode wire, which is directly wound to form the second electrode body 420. The part between the first electrode wire and the second electrode wire is the conductive wire.
[0055] It is understood that the electrode assembly 400 includes a plurality of first electrode bodies 410 and a plurality of second electrode bodies 420. A first electrode body 410 and a second electrode body 420 that are connected to each other form a group. Typically, the electrode assembly 400 is provided with 2 to 16 groups of first electrode bodies 410 and second electrode bodies 420.
[0056] Preferably, the combination of the first electrode 410 and the second electrode 420 is provided in 4 or 8 groups. That is, there are 4 or 8 first electrode 410s and 4 or 8 second electrode 420s simultaneously, and the conductive wire between each group of first electrode 410 and second electrode 420 is independent of the conductive wires of other groups. Multiple first electrode 410s can increase the possibility of contact with peripheral nerves and make it easier to reach the position with the best electrical stimulation effect. It should be understood that after the conduit body 100 forms a spiral, the multiple first electrode 410s are more concentrated, and the probability of the first electrode 410 being in the position with the best electrical stimulation effect increases.
[0057] It is understood that multiple first electrode bodies 410 are spaced apart along the length of the conduit body 100, and multiple second electrode bodies 420 are spaced apart along the length of the conduit body 100.
[0058] The first electrode 410 and the second electrode 420 are both distributed at intervals along the length of the conduit 100, which facilitates control to prevent interference between each first electrode 410 and each second electrode 420, forming multiple independent electrode assemblies 400. It should be understood that the spacing between the multiple first electrode 410s should be reasonably adjusted so that after the conduit 100 forms a spiral, the first electrode 410s on adjacent inner and outer rings are staggered, minimizing contact and conduction between the first electrode 410s.
[0059] It is understood that the catheter body 100 is provided with multiple second channels 120, and each second channel 120 is provided with a conductive wire, which is connected to a set of first electrode bodies 410 and second electrode bodies 420.
[0060] Each conductive wire can also be separated by multiple second channels 120.
[0061] It is understandable that multiple second channels 120 are evenly distributed circumferentially around the first channel 110, ensuring that the bending section modulus of the catheter body 100 is similar in all directions. This prevents the elastic element 200 from deforming towards the side of the catheter body 100 with a lower bending section modulus during helical bending, thus avoiding uncontrollable bending of the catheter body 100. After pre-shaping treatment, the bending direction of the elastic element 200 can be determined. After the elastic element 200 is assembled with the catheter body 100, if the bending section modulus of the catheter body 100 is similar or the same in all directions, the bending direction driven by the elastic element 200 can be determined and marked. When the catheter body 100 enters the tissue, the bending direction of the catheter body 100 can be controlled according to the marking. It should be understood that similar bending section modulus means nearly equal. If the multiple second channels 120 are not evenly distributed around the first channel 110 in the circumferential direction, then the conduit body 100 will necessarily have a direction with a smaller bending section modulus. When the bending direction of the elastic element 200 is inconsistent with the direction with a smaller bending section modulus of the conduit body 100, the elastic element 200 will bend towards the direction with a smaller bending section modulus of the conduit body 100, and the degree of deflection will be inconsistent each time, making it uncontrollable to determine the bending direction of the conduit body 100 driven by the elastic element 200 according to the marking.
[0062] It is understandable that the catheter body 100 is provided with multiple liquid outlet holes, all of which are connected to the first channel 110 and all of which penetrate the outer side wall of the first end.
[0063] For patients with severe pain or those who do not respond well to electrical stimulation alone, peripheral nerve local injection therapy can be combined with electrical stimulation. The first channel 110 can also serve as the injection channel, delivering the medication to the peripheral nerve via the first channel 110 and the outlet orifice. This eliminates the need for a separate injection puncture, reducing surgical risks and medical expenses for the patient. It is important to understand that 3 to 6 outlet orifices can be provided, distributed non-coaxially on the outer wall of the first end, resulting in more uniform drug distribution. Furthermore, the outlet orifices can be designed with a microporous structure to reduce the rate at which the injected medication flows out. For example, the medication exits from the outlet orifice as droplets, avoiding the formation of a high-speed jet during injection, slowing drug diffusion, and maximizing drug retention time.
[0064] Reference Figure 3 As shown, it can be understood that the catheter body 100 is provided with a radiopaque section 130, which is located at the port of the first end and forms a closed structure.
[0065] The imaging unit 130 can indicate the position of the first end of the catheter body 100, i.e. the position of the electrode assembly 400 in the human tissue, when imaging observation is performed using relevant medical equipment, so as to adjust and move the electrode assembly 400 to the target position, i.e. the peripheral nerve that needs to be electrically stimulated.
[0066] It should be understood that, under normal circumstances, when human tissue is irradiated with X-rays, materials that are not X-rays can be developed. The developing section 130 is made of a material that is not X-rays.
[0067] Understandably, the side of the developing section 130 furthest from the second end is the head, and the head is arc-shaped.
[0068] Since the imaging section 130 is located at the first end, when the catheter body 100 is implanted into human tissue, the head of the imaging section 130 comes into contact with the human tissue first. The arc-shaped head can reduce the damage of the imaging section 130 to the patient's tissue and reduce the patient's pain.
[0069] The embodiments of the present utility model have been described in detail above with reference to the accompanying drawings. However, the present utility model is not limited to the above embodiments. Within the scope of knowledge possessed by those skilled in the art, various changes can be made without departing from the spirit of the present utility model.
Claims
1. A multipolar nerve electrical stimulation electrode catheter, characterized in that, include: A flexible catheter body (100) has a first end and a second end opposite to each other. The catheter body (100) is provided with a first channel (110) extending from the first end to the second end. The first channel (110) is provided with a closed structure at the port of the first end. An elastic element (200) includes a shaping segment, the elastic element (200) has an initial state in which the shaping segment of the elastic element (200) is bent in a plane, the elastic element (200) is disposed in the first channel (110), and the shaping segment of the elastic element (200) is located at the first end; A rigid guide wire (300) is movably inserted through the first channel (110). The guide wire (300) can move within the first channel (110) to a restricted position or an unrestricted position. In the restricted position, the guide wire (300) can hold the catheter body (100) in a straight line. In the unrestricted position, the elastic element (200) can drive the first end to bend into a spiral shape in a plane. Electrode assembly (400) is disposed on the outer side wall of the catheter body (100).
2. The multipolar nerve stimulation electrode catheter according to claim 1, characterized in that, The electrode assembly (400) includes a first electrode body (410) and a second electrode body (420). The first electrode body (410) is disposed on the outer side wall of the first end, and the second electrode body (420) is disposed on the outer side wall of the second end. The first electrode body (410) and the second electrode body (420) are electrically connected.
3. The multipolar nerve electrical stimulation electrode catheter according to claim 2, characterized in that, The outer wall of the first end is provided with a first electrode wire that is wound around in a spiral structure to form the first electrode body (410). The outer wall of the second end is provided with a second electrode wire that is wound around in a spiral structure to form the second electrode body (420). The first electrode wire and the second electrode wire are integral structures.
4. The multipolar nerve electrical stimulation electrode catheter according to claim 3, characterized in that, The catheter body (100) is provided with a second channel (120), and a conductive wire is provided inside the second channel (120). The conductive wire connects the first electrode body (410) and the second electrode body (420). The second channel (120) is isolated from the first channel (110).
5. The multipolar nerve stimulation electrode catheter according to claim 4, characterized in that, The electrode assembly (400) includes a plurality of first electrode bodies (410) and a plurality of second electrode bodies (420), wherein the plurality of first electrode bodies (410) are spaced apart along the length direction of the catheter body (100), and the plurality of second electrode bodies (420) are spaced apart along the length direction of the catheter body (100).
6. The multipolar nerve stimulation electrode catheter according to claim 5, characterized in that, The catheter body (100) is provided with a plurality of second channels (120), and each second channel (120) is provided with a conductive wire. The conductive wire is connected to the first electrode body (410) and the second electrode body (420) of the same electrode assembly (400).
7. The multipolar nerve stimulation electrode catheter according to claim 6, characterized in that, Multiple second channels (120) are evenly distributed around the first channel (110) in the circumference.
8. The multipolar nerve stimulation electrode catheter according to claim 1, characterized in that, The catheter body (100) is provided with multiple liquid outlet holes, all of which are connected to the first channel (110) and all of which penetrate the outer side wall of the first end.
9. The multipolar nerve stimulation electrode catheter according to claim 1, characterized in that, The catheter body (100) is provided with a radiopaque section (130), which is located at the port of the first end and constitutes the closed structure.
10. The multipolar nerve stimulation electrode catheter according to claim 1, characterized in that, The shaping segment of the elastic element (200) is bent into a spiral shape in the plane.