Peripheral nerve stimulation system

Abstract

The present invention provides a peripheral nerve stimulation system, comprising: a stimulation portion, a release portion, wires, and a base. The stimulation portion and the release portion are configured to be implanted into a body, and the stimulation portion is configured to be connected to a target nerve; the base is configured to be arranged outside the body; two ends of each wire are respectively connected to the base and the stimulation portion; the base is configured to deliver stimulation energy to the stimulation portion through the wires; the stimulation portion is configured to be degradable; the release portion is configured to drive the wires to be detached from the stimulation portion when receiving release energy from the base; and once the wires have been detached from the stimulation portion, the wires are configured to be removed from the body. By means of such a configuration, both the precision and efficacy of intraoperative electrical stimulation treatment and the convenience of percutaneous electrical stimulation treatment are achieved, and the need for a second surgery can be eliminated upon the completion of treatment.

Description

Peripheral nerve stimulation system Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a peripheral nerve stimulation system. Background Technology

[0002] Neurostimulation therapy is widely used in the rehabilitation of peripheral nerve injuries. Currently, there are several types of neurostimulation therapy: intraoperative electrical stimulation therapy, transcutaneous electrical stimulation therapy, and fully implantable electrical stimulation therapy.

[0003] Intraoperative electrical stimulation (IOS) typically involves surgically exposing the diseased nerve, treating the target nerve, and then using the IOS function of a nerve monitor to directly stimulate the target nerve. This stimulation method offers excellent therapeutic effects, but its application is limited; it can only be used during nerve exposure in the middle of surgery, and the duration of effective treatment is also limited.

[0004] Transcutaneous electrical stimulation (TES) is a commonly used postoperative neurological rehabilitation method. After surgery, there is a treatment window of several weeks to months for the affected nerve. During this period, electrical stimulation can be induced to improve the degree and rate of target nerve recovery. Transcutaneous TES is a commonly used stimulation method during this time. TES typically involves placing positive and negative electrode patches on the skin surface near the target nerve. The electrical stimulation is delivered to the target nerve through the skin, tissue, and muscle via the electrode patches. This stimulation method is convenient and widely used, but because it involves the skin, tissue, and muscle, its stimulation precision is poor, its effectiveness is low, and it has many adverse reactions (such as muscle fatigue and muscle injury). Furthermore, to achieve sufficient stimulation of the target nerve, high-intensity TES is required, which often leads to severe pain for the patient. Prolonged high-intensity TES can cause the patient's skin to become hot and swollen. Additionally, this postoperative rehabilitation often requires the guidance of a doctor, necessitating regular hospital visits, which is time-consuming and laborious, affecting patient adherence to treatment.

[0005] While fully implantable electrical stimulation therapy (PES) offers direct stimulation of target nerves through implantation and is highly convenient, the entire device is implanted within the body, making it difficult to adjust stimulation parameters and tailor the treatment to the different injury sites of various patients. Furthermore, the entire PES device requires a second surgery for removal after treatment, causing secondary harm to the patient.

[0006] These different methods of nerve electrical stimulation therapy each have their own shortcomings and are difficult to meet the needs. Summary of the Invention

[0007] The purpose of this invention is to provide a peripheral nerve stimulation system to solve the problems existing in current nerve electrical stimulation therapy methods.

[0008] To solve the above-mentioned technical problems, the present invention provides a peripheral nerve stimulation system, which includes: a stimulation part, a release part, a lead wire, and a base;

[0009] The stimulation part and the release part are for implantation in the body, the stimulation part is for connection with the target nerve; the base is for placement outside the body; the two ends of the wire are respectively connected to the base and the stimulation part; the base is configured to send stimulation energy to the stimulation part through the wire;

[0010] The stimulating part is configured to be biodegradable, and the detaching part is configured to drive the wire to detach from the stimulating part when it receives detachment energy from the base; after the wire is detached from the stimulating part, the wire is configured to be removed from the body.

[0011] Optionally, the base includes a wire retrieval mechanism having a docking structure adapted to an external drive mechanism, the wire retrieval mechanism being used to remove the wire from the body under the drive of the drive mechanism.

[0012] Optionally, the base is used to attach to the body surface along the axial direction, and the wire retrieval mechanism is rotatably disposed on the base about the rotation axis; the wire retrieval mechanism removes the wire from the body by rotating about the rotation axis.

[0013] Optionally, the release part uses a physical release method to drive the lead wire to detach from the stimulation part; the peripheral nerve stimulation system also includes a cannula, which is sleeved on the release part and the lead wire.

[0014] Optionally, the stimulation portion is flexible and is used to wrap around part or all of the target nerve.

[0015] Optionally, the peripheral nerve stimulation system further includes an electrical stimulation module, which is detachably connected to the base;

[0016] The base includes a first electrical connection structure, and the electrical stimulation module includes a power supply unit and a second electrical connection structure. When the electrical stimulation module is connected to the base, the first electrical connection structure and the second electrical connection structure are connected, and the power supply unit supplies power to the base through the first electrical connection structure and the second electrical connection structure.

[0017] Optionally, the peripheral nerve stimulation system further includes a tuning module, which is detachably connected to the base; the tuning module is used to adjust the stimulation parameters of the stimulation energy.

[0018] The base includes a first electrical connection structure, and the debugging module includes a third electrical connection structure;

[0019] When the debugging module is connected to the base, the first electrical connection structure and the third electrical connection structure are connected. The first electrical connection structure and the third electrical connection structure are used to realize power transmission and communication transmission between the debugging module and the base.

[0020] Optionally, the base includes a fourth electrical connection structure, which is connected to the release part, and the debugging module further includes a release unit and a fifth connection structure;

[0021] When the debugging module is connected to the base, the fourth electrical connection structure and the fifth electrical connection structure are connected, and the release unit sends release energy to the base through the fourth electrical connection structure and the fifth electrical connection structure.

[0022] Optionally, the debugging module further includes a drive mechanism for driving the wire retraction mechanism of the base to drive the wire to be removed from the body.

[0023] Optionally, the peripheral nerve stimulation system further includes a control module, which is connected to the debugging module;

[0024] The control module is used to supply power to the debugging module and communicate with the debugging module to adjust the parameters of the stimulation energy.

[0025] In summary, the peripheral nerve stimulation system provided by the present invention includes: a stimulation part, a release part, a lead wire, and a base; the stimulation part and the release part are for implantation in the body, and the stimulation part is for connection with a target nerve; the base is for placement outside the body; the two ends of the lead wire are respectively connected to the base and the stimulation part; the base is configured to send stimulation energy to the stimulation part through the lead wire; wherein, the stimulation part is configured to be biodegradable, and the release part is configured to drive the lead wire to detach from the stimulation part when receiving release energy from the base; after the lead wire detaches from the stimulation part, the lead wire is configured to be removed from the body.

[0026] This configuration allows the stimulation unit to be implanted and connected to the target nerve, directly delivering stimulation energy to the nerve, reducing energy attenuation, minimizing adverse reactions, and improving treatment precision and effectiveness. Furthermore, after a period of time, the lead wire can be detached from the stimulation unit via a release mechanism, allowing for wire removal. The stimulation unit itself degrades, eliminating the need for a second surgery. Therefore, the peripheral nerve stimulation system provided by this invention combines the precision and effectiveness of intraoperative electrical stimulation with the convenience of percutaneous electrical stimulation, eliminating the need for a second surgery after treatment and effectively solving the problems associated with existing nerve stimulation methods. Attached Figure Description

[0027] Those skilled in the art will understand that the accompanying drawings are provided to better understand the invention and do not constitute any limitation on the scope of the invention.

[0028] Figure 1 is a schematic diagram of the peripheral nerve stimulation system according to an embodiment of the present invention.

[0029] Figure 2 is a schematic diagram of the stimulation part according to an embodiment of the present invention.

[0030] Figure 3 is a schematic diagram of the release section according to an embodiment of the present invention.

[0031] Figure 4 is a schematic diagram of the sleeve according to an embodiment of the present invention.

[0032] Figure 5 is a schematic diagram of the base according to an embodiment of the present invention.

[0033] Figure 6 is a schematic diagram of the electrical stimulation module according to an embodiment of the present invention.

[0034] Figure 7 is a schematic diagram of the adjustment module according to an embodiment of the present invention.

[0035] Figure 8 is a schematic diagram of the control module according to an embodiment of the present invention.

[0036] In the attached diagram: 1-stimulation part; 11-substrate; 111-insulating layer; 112-suture hole; 12-electrode; 2-release part; 21-high resistance device; 3-lead wire; 4-base; 41-patch; 42-lead retrieval mechanism; 421-connection structure; 43-first electrical connection structure; 44-fourth electrical connection structure; 5-sleeve; 6-electrical stimulation module; 61-power supply unit; 62-second electrical connection structure; 7-adjustment module; 71-third electrical connection structure; 72-fifth connection structure; 73-drive mechanism; 731-drive shaft; 8-control module; 81-cable; 82-display screen; 83-button; 84-knob; 85-power input interface. Detailed Implementation

[0037] To make the objectives, advantages, and features of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to facilitate and clarify the explanation of the embodiments of this invention. Furthermore, the structures shown in the drawings are often part of the actual structures. In particular, different figures may emphasize different aspects and may sometimes use different scales.

[0038] As used herein, the singular forms “a,” “an,” “one,” and “the” include plural objects; the term “or” is generally used to mean “and / or”; the term “a number” is generally used to mean “at least one”; and the term “at least two” is generally used to mean “two or more”. Furthermore, the terms “first,” “second,” and “third” are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined as “first,” “second,” or “third” may explicitly or implicitly include one or at least two of that feature; “one end” and “the other end,” and “proximal” and “distal” generally refer to two corresponding parts, which include not only the endpoints. The terms “proximal” and “distal” are defined herein with respect to a peripheral nerve stimulation system having an end (stimulation part) for intervention in the human body and a control end (base, etc.) extending outside the body. The term "proximal" refers to the location closer to the control end of the peripheral nerve stimulation system extending outside the body, and the term "distal" refers to the location closer to the end of the peripheral nerve stimulation system inserted into the body and therefore further away from the control end of the peripheral nerve stimulation system. Optionally, in manual or hand-operated applications, the terms "proximal" and "distal" are defined herein in relation to the operator, such as a surgeon or clinician. The term "proximal" refers to the location closer to the operator, and the term "distal" refers to the location closer to the peripheral nerve stimulation system and therefore further away from the operator. Furthermore, as used in this invention, "installed," "connected," "attached," and "set" of one element on another should be interpreted broadly, generally indicating only a connection, coupling, cooperation, or transmission relationship between the two elements, which can be direct or indirect through an intermediate element, and should not be construed as indicating or implying a spatial positional relationship between the two elements, i.e., one element can be located inside, outside, above, below, or to one side of the other element, unless otherwise explicitly stated. For those skilled in the art, the specific meaning of the above terms in this invention can be understood according to the specific circumstances. Furthermore, directional terms such as above, below, up, down, upward, downward, left, right, etc., are used relative to exemplary embodiments as shown in the figures, with upward or up direction pointing towards the top of the corresponding figure, and downward or down direction pointing towards the bottom of the corresponding figure.

[0039] The purpose of this invention is to provide a peripheral nerve stimulation system to address the problems existing in current nerve electrical stimulation therapy methods. The following description refers to the accompanying drawings.

[0040] Please refer to Figure 1. An embodiment of the present invention provides a peripheral nerve stimulation system, comprising: a stimulation part 1, a release part 2, a lead wire 3, and a base 4; the stimulation part 1 and the release part 2 are for implantation in the body, the stimulation part 1 being used to connect to a target nerve; the base 4 is for placement outside the body; both ends of the lead wire 3 are connected to the base 4 and the stimulation part 1, respectively; the base 4 is configured to send stimulation energy to the stimulation part 1 through the lead wire 3; wherein, the stimulation part 1 is configured to be biodegradable, and the release part 2 is configured to, upon receiving release energy from the base 4, drive the lead wire 3 to detach from the stimulation part 1; after the lead wire 3 detaches from the stimulation part 1, the lead wire 3 is configured to be removed from the body.

[0041] The peripheral nerve stimulation system provided in this invention can be applied to nerves such as the carpal tunnel, sciatic nerve, and ulnar nerve, especially to the frequently moved limbs. Target nerves vary in type and individual, and different patients have different tolerances to nerve stimulation. Different target nerves also require different stimulation intensities and durations for regeneration. Therefore, different nerve stimulation needs are proposed for different patients and different injury sites.

[0042] Therefore, the peripheral nerve stimulation system of this embodiment has a base 4 located externally, which extends to the stimulation unit 1 inside the body via a wire 3, making it a semi-implantable system. The external base 4 allows for convenient adjustment of stimulation parameters, enabling differentiated stimulation therapy for different patients and different injuries. Furthermore, as the patient gradually recovers, the required stimulation intensity and duration will change; at this time, the stimulation parameters can be adjusted solely through the external base 4, achieving customized treatment plans. The semi-implantable system is also easy to remove after treatment.

[0043] For semi-implantable systems, it's understandable that if the stimulation part 1 is linear (like a needle) and freely positioned near the target nerve, it can be easily withdrawn from the body along with the lead wire 3. However, this arrangement presents two problems. First, the nerve or other tissues can easily come into contact with the tip of the linear stimulation part 1, causing a foreign body sensation or pain, especially for nerves in frequently moving limb areas where movement is common near the target nerve region. Second, the linear stimulation part 1 struggles to form an effective connection with the target nerve, leading to energy attenuation, adverse reactions, and a decreased therapeutic effect.

[0044] Therefore, to improve the reliability of electrical stimulation, the stimulation part 1 needs to maintain a relatively firm connection with the target nerve. Optionally, the stimulation part 1 can be placed against the target nerve and have a certain contact area. For example, in an alternative example, the stimulation part 1 is flexible and is used to wrap around a portion of the target nerve, or even the entire target nerve. However, such a firm connection can lead to the disadvantage that the stimulation part 1 is difficult to remove, potentially requiring a secondary surgery.

[0045] The inventors discovered that if the stimulation part 1 is not removed after implantation, it means that after the nerve stimulation window period, the stimulation part 1 will no longer function, or its function will be extremely limited. Furthermore, permanent implants are expensive and have a low yield rate. Further research revealed that after a period of time, the stimulation part 1 gradually becomes entangled with scar tissue, making it difficult to remove. In mouse experiments, approximately four weeks after the stimulation part 1 was implanted, opening the wound revealed obvious scar tissue wrapped around the stimulation part 1, firmly binding it to the nerve; removal would mean causing secondary nerve damage.

[0046] Therefore, in this embodiment, the stimulation part 1 is configured to be biodegradable, and the material of the stimulation part 1 can be selected from biodegradable materials with excellent biocompatibility. It does not need to be removed after implantation and can degrade and dissipate over time without causing further harm to the human body. However, the biodegradable stimulation part 1 brings a new problem: once implanted, its degradation process begins irreversibly. During the treatment window period (e.g., several weeks to several months), it is necessary to ensure the effectiveness of the stimulation part 1 and prevent it from being excessively degraded and becoming ineffective. After the treatment window period ends, it is desirable to remove the lead 3 from the body as soon as possible to avoid the adverse effects of long-term implantation. If the stimulation part 1 degrades to structural failure and breaks off from the lead 3 at the end of the treatment window period, it is possible to remove the lead 3 as early as possible. However, considering various factors, this is practically difficult to achieve. In particular, to ensure the functional integrity of the stimulation part 1 during the treatment window period, the time for the stimulation part 1 to degrade to failure generally needs to be configured to be longer than the treatment window period. That is, the stimulation part 1 can be adjusted to maintain its effective maintenance period at least as long as the treatment window period, and the complete degradation period should be longer than the treatment window period. This results in the lead wire 3 still being reliably connected to the stimulation part 1 at the end of the treatment window, making it difficult to separate from the stimulation part 1 and remove it from the body.

[0047] The provision of the release section 2 allows the lead wire 3 to actively disengage from the stimulation section 1 at the end of the treatment window, enabling the lead wire 3 to be removed from the body as soon as possible after the treatment window ends. Those skilled in the art know that in the field of vascular interventional therapy, such as in intracranial vessels, there is the application of electrically detachable coils. These can utilize bodily fluids (such as blood) to chemically or corrode the release point. However, in the peripheral nerve field where this invention is applied, which is located outside blood vessels, bodily fluids are relatively scarce, making it difficult to chemically or corrode the release point using bodily fluids. Therefore, this embodiment requires the additional provision of the release section 2, which primarily employs physical release methods to disengage the lead wire 3 from the stimulation section 1. Specific release methods include, for example, thermal release using resistance differences or cutting / trimming release using shearing action.

[0048] This configuration allows the stimulation unit 1 to be implanted in the body and connected to the target nerve, directly transmitting stimulation energy to the target nerve, reducing energy attenuation, minimizing adverse reactions, and improving treatment precision and effectiveness. Furthermore, after a period of time, the lead wire 3 can be detached from the stimulation unit 1 via the release unit 2, allowing for removal of the lead wire 3. The stimulation unit 1 is also biodegradable, eliminating the need for a second surgery. Therefore, the peripheral nerve stimulation system provided by this invention combines the precision and effectiveness of intraoperative electrical stimulation with the convenience of percutaneous electrical stimulation, eliminating the need for a second surgery after treatment and effectively solving the problems existing in current nerve electrical stimulation methods.

[0049] Referring to Figure 2, in one embodiment, the stimulation part 1 includes a base 11 and an electrode 12. The base 11 may contain several insulating layers 111, whose main function is to provide insulation protection for the circuit. The electrode 12 may be sandwiched within several insulating layers 111 of the base 11. The electrode 12 is connected to the wire 3, and the side of the electrode 12 facing the target nerve is exposed. For example, several holes may be made in the base 11 to expose at least a portion of the electrode 12. The material of the base 11 may be a flexible material with excellent biocompatibility and high resistivity. Depending on the degradation requirements, it may be polylactic acid or polyurethane. The material of the electrode 12 is a flexible material with low resistivity. Depending on the degradation requirements, it may be a magnesium-based alloy. During use, the operator can bend the stimulation part 1 into a ring shape and wrap it around at least a portion of the periphery of the target nerve. Furthermore, several suture holes 112 may be made in the base 11. After the stimulation part 1 is bent and wrapped around the target nerve, sutures can be used to fix it through the suture holes 112.

[0050] Please refer to Figure 3, which exemplarily illustrates a release part 2 for electrothermal release, which includes a high-resistance device 21. The high-resistance device 21 may optionally be adjacent to the wire 3 and may optionally be insulated from it. The high-resistance device 21 is also connected to the base 4 via a release wire. Understandably, the release energy is, for example, electrical energy. When current is applied to the high-resistance device 21, it heats up, thereby melting the surrounding wire 3, disrupting the continuity of the wire 3, and achieving release separation from the stimulation part 1. The materials and structures of the wire 3 and the high-resistance device 21 are not limited. In some embodiments, the high-resistance device 21 may also be part of the release wire 3, i.e., a section of the wire 3 is specially processed to create a difference in resistivity between that section and the rest.

[0051] It should be noted that the release section 2 of the electrothermal release shown in Figure 3 is merely an example of the release section 2 and not a limitation thereof. In other embodiments, the release section 2 may also be a cutting release achieved by shearing action. In this case, the release energy is, for example, mechanical driving energy. The release section 2 includes, for example, a shearing part and a driving wire, the driving wire extending proximally to the base 4. By manipulating the driving wire through the base 4, the shearing part can be driven to physically cut the wire 3.

[0052] To minimize the time that residual components remain in the body after release and reduce their impact on tissues, the residual components should be as small as possible. Therefore, the release point should be as distal as possible to the stimulation site 1 to achieve the minimum residual amount after release. However, the release point generates thermal or mechanical effects during the release process. If the release point is too close to the stimulation site 1, it may damage the nerve during release, causing injury. Therefore, the release point should not be too close to the stimulation site 1. In practice, the location of the release point can be set according to the specific structure of the release site 2 and the specific condition of the target nerve to achieve a balance.

[0053] Furthermore, since the release part 2 uses a physical release method to disengage the lead wire 3 from the stimulation part 1, referring to Figure 4, the peripheral nerve stimulation system of this embodiment may also include a cannula 5, which is sleeved on the release part 2 and the lead wire 3. Based on the above analysis of minimum residual amount, it is known that the release point should be as close as possible to the stimulation part 1. However, such an arrangement is prone to causing damage to the target nerve during release. The cannula 5 can enclose the release part 2. The cannula 5 has the following multiple effects:

[0054] First, the release part 2 is physically blocked to reduce or avoid damage and impact on human tissue during the release process. With the sleeve 5 in place, the release part 2 can be positioned relatively more distally closer to the stimulation part 1, allowing the release point to move distally closer to the stimulation part 1, thus reducing the number of residual parts after release.

[0055] Secondly, physical barriers are applied to the conductor 3 to reduce the impact of human tissue on the integrity of the internal structures of the conductor 3 and the release part 2. At the same time, this can reduce or prevent the stimulating energy from dissipating into the surrounding human tissue during the transmission of stimulating energy, thereby reducing or avoiding adverse reactions such as electric shock.

[0056] Thirdly, it reduces the removal resistance of components such as the lead wire 3 or the release part 2. In some embodiments, the release part 2 is designed so that the lead wire 3 has irregularities in the axial direction. In some embodiments, the release part 2 also needs to be removed, especially after implantation for a period of time. The uneven and irregular structure makes it easy for tissue to climb and adhere, making it difficult to remove. The cannula 5 can wrap around components such as the lead wire 3 and the release part 2, reducing or preventing tissue from adhering to the lead wire 3 and the release part 2, and reducing the removal resistance of components such as the lead wire 3 or the release part 2.

[0057] Fourth, it provides certain physical support for components such as lead wire 3 and release part 2, improves the reliability of lead wire 3 and release part 2 during implantation, and reduces or avoids problems such as bending, breakage, detachment, and displacement caused by movement.

[0058] The structure of the sleeve 5 is not limited; for example, in one example, it is cylindrical, with its distal end configured to be open and its proximal end extending to connect with the base 4. Optionally, the distal end of the sleeve 5 axially covers at least a portion of the release portion 2, or optionally completely covers the release portion 2, thereby completely enclosing the release portion 2.

[0059] In some embodiments, the cannula 5 can be removed after the treatment window period. Optionally, the cannula 5 is made of a flexible polymer material with high resistivity, and its outer surface may be smooth to reduce adhesion to tissue. Furthermore, to reduce cell climbing and blood clotting on the outer surface of the cannula 5, an anticoagulant and lubricating coating may be provided on the outer surface of the cannula 5.

[0060] In other embodiments, the cannula 5 is configured to be biodegradable, and its material may be, for example, polylactic acid or other biodegradable materials. It can be left in the body after the treatment window period ends, gradually degrading to allow tissue healing. In embodiments where the cannula 5 is not removed, the outer surface of the cannula 5 is not required to be smooth, but the inner surface of the cannula 5 may be smooth to reduce the frictional resistance between the lead wire 3 and the release part 2 and the inner surface of the cannula 5, facilitating the removal of the lead wire 3 and the release part 2. Optionally, in embodiments where the cannula 5 is not removed, regeneration factors may be mixed into the material of the cannula 5 to further promote tissue regeneration and growth.

[0061] Please refer to Figure 5, which exemplarily shows an example of a base 4. The base 4 is for axial attachment to a body surface. Optionally, the side of the base 4 facing the body surface has a patch 41 for attachment to the body surface, such as the skin. An electrical stimulation driving circuit may be disposed within the base 4, with the proximal end of a wire 3 extending into the base 4 and electrically connected to the electrical stimulation driving circuit.

[0062] Optionally, the base 4 includes a lead wire retrieval mechanism 42, which has a docking structure 421 adapted to an external drive mechanism. The lead wire retrieval mechanism 42 is used to remove the lead wire 3 from within the body under the drive of the drive mechanism. It is understood that the removal of the lead wire 3 is a one-time step that occurs only after treatment, and the lead wire 3 does not need to be driven during the entire treatment window. To improve portability and ease of use, it is desirable to minimize the volume of the base 4 during the treatment window. Therefore, the drive mechanism for removing the lead wire 3 can be externally mounted, and only the corresponding lead wire retrieval mechanism 42 is provided on the base 4 to minimize the volume of the base 4.

[0063] In one embodiment, the wire retrieval mechanism 42 is rotatably disposed on the base 4 about a rotation axis; the wire retrieval mechanism 42 removes the wire 3 from its body by rotating about the rotation axis. Optionally, after the proximal end of the wire 3 extends into the base 4, it can be fixed to the outer periphery of the wire retrieval mechanism 42, so that when the wire retrieval mechanism 42 rotates, it can wind the wire 3, thereby retrieving the wire 3. The external drive mechanism can be a manual tool (such as a screwdriver or hand crank) or a power tool, for example, it can be integrated into the debugging module 7 (see the following description). This embodiment is not limited to this. In some embodiments, the rotation axis of the wire retrieval mechanism 42 is parallel to the axial direction of the base 4. The rotation method parallel to the axial direction facilitates docking and driving of the external drive mechanism, which is beneficial to reducing the product size. Of course, in other embodiments, the rotation axis of the wire retrieval mechanism 42 can also be perpendicular to the axial direction of the base 4. This reduces the shear force on lead 3 during retraction, lowers the probability of lead 3 breaking during retraction, increases the reliability of lead 3 retraction using lead retrieval mechanism 42, and reduces the overall risk of the peripheral nerve stimulation system.

[0064] Please refer to Figure 6. Optionally, the peripheral nerve stimulation system further includes an electrical stimulation module 6, which is detachably connected to the base 4. The electrical stimulation module 6 includes a power supply unit 61 and a second electrical connection structure 62. When the electrical stimulation module 6 is connected to the base 4, the first electrical connection structure 43 of the base 4 is connected to the second electrical connection structure 62, and the power supply unit 61 supplies power to the base 4 through the first electrical connection structure 43 and the second electrical connection structure 62.

[0065] The power supply unit 61 is housed within the removable electrical stimulation module 6, facilitating its replacement. In some cases, if the power supply unit 61 runs out of power or fails for other reasons, the problem can be easily solved by replacing the electrical stimulation module 6, without needing to disassemble the base 4 itself, thus reducing adverse effects on implanted components such as the lead wire 3.

[0066] In an alternative example, the electrical stimulation module 6 and the base 4 have matching concave-convex shapes, allowing them to be snapped together for assembly. Furthermore, the electrical stimulation module 6 and the base 4 may have matching mechanical locking structures (such as snap-fit ​​mechanisms) to improve the reliability of the mechanical connection between them. Optionally, the first electrical connection structure 43 and the second electrical connection structure 62 are a set of corresponding electrode contacts; when the electrical stimulation module 6 and the base 4 are assembled, the electrode contacts of the first electrical connection structure 43 and the second electrical connection structure 62 abut against each other to achieve electrical conductivity. The power supply unit 61 may include a button battery or other energy storage unit, which provides electrical power to the electrical stimulation drive circuit.

[0067] In some embodiments, the electrical stimulation driving circuit is disposed within the base 4, and the electrical stimulation module 6 is used only to supply power to the base 4. In this case, the first electrical connection structure 43 and the second electrical connection structure 62 are used only to realize power transmission.

[0068] In other embodiments, the electrical stimulation driving circuit may be partially or entirely disposed in the electrical stimulation module 6. In this case, the first electrical connection structure 43 and the second electrical connection structure 62 are used not only for power transmission but also for communication transmission or transmission of stimulation energy. In one embodiment, the entire electrical stimulation driving circuit is disposed in the electrical stimulation module 6. In this case, the base 4 is equivalent to serving only as an intermediate electrical transmission device. The stimulation energy generated by the electrical stimulation driving circuit is transmitted to the base 4 via the first electrical connection structure 43 and the second electrical connection structure 62, and further transmitted to the stimulation part 1 via the wire 3.

[0069] In an optional example, the electrical stimulation driving circuit includes a first part and a second part, wherein the first part is disposed within the base 4 and the second part is disposed within the electrical stimulation module 6. The second part, which may have pre-stored specific stimulation parameters, communicates with the first part through a first electrical connection structure 43 and a second electrical connection structure 62. The first part delivers stimulation energy to the stimulation unit 1 based on the stimulation parameters from the second part. Optionally, in this case, the first electrical connection structure 43 and the second electrical connection structure 62, in addition to facilitating communication between the first and second parts, also facilitate power transmission between the power supply unit 61 and the first part. It is understood that, since the electrical stimulation module 6 and the base 4 are detachably connected, multiple electrical stimulation modules 6 can be configured with different pre-stored stimulation parameters in practice. Thus, the surgeon only needs to select an electrical stimulation module 6 with suitable pre-stored stimulation parameters, assemble it with the base 4, and complete the setting of the stimulation parameters, facilitating operation and use. Furthermore, as the patient gradually recovers and their need for stimulation parameters changes, the operator can adjust the stimulation parameters by replacing the electrical stimulation module 6 with one that has different pre-stored stimulation parameters and assembling it with the base 4.

[0070] Referring to Figure 7, optionally, the peripheral nerve stimulation system further includes a tuning module 7, which is detachably connected to the base 4; the tuning module 7 is used to adjust the stimulation parameters of the stimulation energy; the tuning module 7 includes a third electrical connection structure 71; when the tuning module 7 is connected to the base 4, the first electrical connection structure 43 and the third electrical connection structure 71 are connected, and the first electrical connection structure 43 and the third electrical connection structure 71 are used to realize power transmission and communication transmission between the tuning module 7 and the base 4.

[0071] Optionally, the debugging module 7 and the base 4 have matching concave-convex shapes, allowing them to be interlocked and assembled. Further, the debugging module 7 and the base 4 may have matching mechanical locking structures (such as snap-fit ​​devices) to improve the reliability of the mechanical connection between them. The third electrical connection structure 71 consists of electrode contacts that match the first electrical connection structure 43. Optionally, the electrical stimulation module 6 and the debugging module 7 have similar concave-convex shapes, allowing the debugging module 7 to be assembled and connected to the base 4 when the electrical stimulation module 6 is not mounted on the base 4.

[0072] In some embodiments, the electrical stimulation driving circuit is disposed in the base 4 and stores stimulation parameters. The adjustment module 7 includes a parameter adjustment circuit. When the adjustment module 7 is connected to the base 4, the parameter adjustment circuit is connected to the electrical stimulation driving circuit through the first electrical connection structure 43 and the third electrical connection structure 71, thereby adjusting the stimulation parameters in the electrical stimulation driving circuit. Furthermore, the electrical stimulation driving circuit can also acquire feedback signals from the stimulation unit 1. The parameter adjustment circuit can acquire feedback signals through the first electrical connection structure 43 and the third electrical connection structure 71 to assist in the adjustment of stimulation parameters. That is, the first electrical connection structure 43 and the third electrical connection structure 71 can be a bidirectional communication connection. In addition, during the parameter adjustment process, the adjustment module 7 can also supply power to the electrical stimulation driving circuit through the first electrical connection structure 43 and the third electrical connection structure 71. Furthermore, after the adjustment module 7 completes the adjustment steps of the stimulation parameters in the electrical stimulation drive circuit, the adjustment module 7 can be detached from the base 4, and then the electrical stimulation module 6 can be installed on the base 4. At this time, the electrical stimulation module 6 supplies power to the electrical stimulation drive circuit on the base 4 to achieve normal stimulation therapy.

[0073] Optionally, the base 4 includes a fourth electrical connection structure 44, which is connected to the release part 2. The debugging module 7 further includes a release unit and a fifth connection structure 72. When the debugging module 7 is connected to the base 4, the fourth electrical connection structure 44 and the fifth electrical connection structure 72 are connected, and the release unit sends release energy to the base 4 through the fourth electrical connection structure 44 and the fifth electrical connection structure 72. Optionally, the fourth electrical connection structure 44 and the fifth electrical connection structure 72 are a set of corresponding electrode contacts. When the debugging module 7 is assembled and connected to the base 4, the electrode contacts of the fourth electrical connection structure 44 and the fifth electrical connection structure 72 abut against each other and become connected.

[0074] In an optional example, the adjustment module 7 is used not only for parameter adjustment but also for controlling the release. Taking the release section 2 of the electrothermal release as an example, its release wire is connected to the fourth electrical connection structure 44. If the release unit includes a release circuit, it can emit release energy (such as electrical energy). After the treatment window period ends, the electrical stimulation module 6 can be detached from the base 4, and then the adjustment module 7 can be installed on the base 4. At this time, the fourth electrical connection structure 44 and the fifth electrical connection structure 72 are connected. The release unit can then emit release energy to the release section 2 through the fourth electrical connection structure 44 and the fifth electrical connection structure 72, thereby causing the release section 2 to heat up and melt the wire 3.

[0075] Optionally, the debugging module 7 further includes a drive mechanism 73 for driving the wire retraction mechanism 42 of the base 4 to remove the wire 3 from its body. In an alternative example, the drive mechanism 73 may include a motor and a drive shaft 731, which may be coaxially connected to the wire retraction mechanism 42 and has features that match the docking structure 421 of the wire retraction mechanism 42. For example, in one example, the docking structure 421 and the drive shaft 731 have matching grooves and teeth that can engage and transmit torque.

[0076] Therefore, the debugging module 7 can be used not only for controlling the release but also for retrieving the drive wire 3, serving multiple purposes. Of course, in some other embodiments, the functions of controlling the release and / or retrieving the drive wire 3 can be set separately from the debugging module 7. For example, the debugging module 7 can be used only for parameter adjustment, while the control of the release and / or retrieval of the drive wire 3 after the treatment is completed can be achieved by another module. This invention is not limited to this.

[0077] Referring to Figure 8, optionally, the peripheral nerve stimulation system further includes a control module 8, which is connected to the adjustment module 7. The control module 8 supplies power to the adjustment module 7 and communicates with it to adjust the parameters of the stimulation energy. The connection between the control module 8 and the adjustment module 7 can optionally be achieved via a cable 81, which enables both communication and power supply. Of course, this embodiment is not limited to the connection method between the control module 8 and the adjustment module 7; in some embodiments, they can also be connected wirelessly, such as via Bluetooth. The wireless connection between the control module 8 and the adjustment module 7 may only include wireless communication, in which case the adjustment module 7 may have its own battery. The wireless connection between the control module 8 and the adjustment module 7 can also simultaneously achieve wireless communication and wireless power supply; its implementation can refer to existing technologies, which will not be elaborated upon in this embodiment.

[0078] Furthermore, when the debugging module 7 also includes a release unit and / or a drive mechanism 73, the control module 8 may optionally also be used to control the release unit and / or drive mechanism 73, that is, the control module 8 can manipulate the action of the release unit and / or drive mechanism 73. Optionally, the control module 8 can also supply power to the release unit and / or drive mechanism 73 to reduce the size of the debugging module 7. In an alternative example, the control module 8 includes components such as a display screen 82, buttons 83, knobs 84, and a power input interface 85. The control module 8 can realize visual parameter adjustment and control functions through the display screen 82, buttons 83, and knobs 84.

[0079] In summary, the peripheral nerve stimulation system provided by the present invention includes: a stimulation part, a release part, a lead wire, and a base; the stimulation part and the release part are for implantation in the body, and the stimulation part is for connection with a target nerve; the base is for placement outside the body; the two ends of the lead wire are respectively connected to the base and the stimulation part; the base is configured to send stimulation energy to the stimulation part through the lead wire; wherein, the stimulation part is configured to be biodegradable, and the release part is configured to drive the lead wire to detach from the stimulation part when receiving release energy from the base; after the lead wire detaches from the stimulation part, the lead wire is configured to be removed from the body.

[0080] This configuration allows the stimulation unit to be implanted and connected to the target nerve, directly delivering stimulation energy to the nerve, reducing energy attenuation, minimizing adverse reactions, and improving treatment precision and effectiveness. Furthermore, after a period of time, the lead wire can be detached from the stimulation unit via a release mechanism, allowing for wire removal. The stimulation unit itself degrades, eliminating the need for a second surgery. Therefore, the peripheral nerve stimulation system provided by this invention combines the precision and effectiveness of intraoperative electrical stimulation with the convenience of percutaneous electrical stimulation, eliminating the need for a second surgery after treatment and effectively solving the problems associated with existing nerve stimulation methods.

[0081] It should be noted that the above embodiments can be combined with each other. The above description is only a description of preferred embodiments of the present invention and is not intended to limit the scope of the present invention in any way. Any changes or modifications made by those skilled in the art based on the above disclosure shall fall within the protection scope of the present invention.

Claims

1. A peripheral nerve stimulation system, characterized in that, include: Stimulation part, release part, wire, and base; The stimulation part and the release part are for implantation in the body, the stimulation part is for connection with the target nerve; the base is for placement outside the body; the two ends of the wire are respectively connected to the base and the stimulation part; the base is configured to send stimulation energy to the stimulation part through the wire; The stimulating part is configured to be degradable, and the detaching part is configured to drive the wire to detach from the stimulating part when it receives detaching energy from the base. After the lead wire is detached from the stimulation site, the lead wire is configured for self-removal within the body.

2. The peripheral nerve stimulation system according to claim 1, characterized in that, The base includes a wire retrieval mechanism, which has a docking structure adapted to an external drive mechanism. The wire retrieval mechanism is used to remove the wire from the body under the drive of the drive mechanism.

3. The peripheral nerve stimulation system according to claim 2, characterized in that, The base is used to attach to the body surface along the axial direction, and the wire retrieval mechanism is rotatably disposed on the base about the rotation axis; the wire retrieval mechanism removes the wire from the body by rotating about the rotation axis.

4. The peripheral nerve stimulation system according to claim 1, characterized in that, The release mechanism uses a physical release method to disengage the lead wire from the stimulation part; the peripheral nerve stimulation system also includes a cannula, which is fitted over the release mechanism and the lead wire.

5. The peripheral nerve stimulation system according to claim 1, characterized in that, The stimulation portion is flexible and is used to wrap around part or all of the target nerve.

6. The peripheral nerve stimulation system according to claim 1, characterized in that, The peripheral nerve stimulation system also includes an electrical stimulation module, which is detachably connected to the base; The base includes a first electrical connection structure, and the electrical stimulation module includes a power supply unit and a second electrical connection structure. When the electrical stimulation module is connected to the base, the first electrical connection structure and the second electrical connection structure are connected, and the power supply unit supplies power to the base through the first electrical connection structure and the second electrical connection structure.

7. The peripheral nerve stimulation system according to claim 1, characterized in that, The peripheral nerve stimulation system also includes a tuning module, which is detachably connected to the base; the tuning module is used to adjust the stimulation parameters of the stimulation energy. The base includes a first electrical connection structure, and the debugging module includes a third electrical connection structure. When the debugging module is connected to the base, the first electrical connection structure and the third electrical connection structure are connected. The first electrical connection structure and the third electrical connection structure are used to realize power transmission and communication transmission between the debugging module and the base.

8. The peripheral nerve stimulation system according to claim 7, characterized in that, The base includes a fourth electrical connection structure, which is connected to the release part; the debugging module also includes a release unit and a fifth connection structure. When the debugging module is connected to the base, the fourth electrical connection structure and the fifth electrical connection structure are connected, and the release unit sends release energy to the base through the fourth electrical connection structure and the fifth electrical connection structure.

9. The peripheral nerve stimulation system according to claim 7, characterized in that, The debugging module also includes a drive mechanism for driving the wire retrieval mechanism of the base to remove the wire from the body.

10. The peripheral nerve stimulation system according to claim 7, characterized in that, The peripheral nerve stimulation system also includes a control module, which is connected to the debugging module; The control module is used to supply power to the debugging module and communicate with the debugging module to adjust the parameters of the stimulation energy.

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