Peripheral nerve stimulation system

Abstract

The utility model provides a peripheral nerve stimulation system. The peripheral nerve stimulation system comprises a stimulation front end, a release part, a wire and a base, the stimulation front end and the release part are used for being implanted into a body, and the stimulation front end is used for being connected with a target nerve; the base is used for being arranged outside a body; the two ends of the wire are connected with the base and the stimulation front end respectively. The base is configured to send stimulation energy to the stimulation front end through the wire; wherein the stimulation front end is configured to be degradable, and the release part is configured to drive the wire to be released and separated from the stimulation front end when receiving release energy from the base; after the lead is disengaged from the stimulation front end, the lead is configured to be removed from the body. By means of the configuration, the precision and effectiveness of intraoperative electrical stimulation treatment and the convenience of percutaneous electrical stimulation treatment are achieved at the same time, and a secondary operation can be omitted after treatment is completed.

Description

TECHNICAL FIELD

[0001] The utility model relates to medical equipment technical field, especially a peripheral nerve stimulation system. BACKGROUND

[0002] The nerve electric stimulation treatment is widely applied in the peripheral nerve injury rehabilitation, and the nerve electric stimulation treatment mainly has several at present: intraoperative electric stimulation treatment, percutaneous electric stimulation treatment and whole implantation electric stimulation treatment.

[0003] The intraoperative electric stimulation treatment generally exposes the lesion nerve through surgical operation, and after completing the target nerve treatment, the intraoperative electric stimulation function of the nerve monitor is used to carry out direct contact electric stimulation to the target nerve. This stimulation mode has excellent treatment effect, but the application range is limited, can only be used when the nerve is exposed in the middle of operation, and the treatment effective duration is limited.

[0004] The percutaneous electric stimulation treatment is a common postoperative nerve rehabilitation means. After the surgical operation is completed, the lesion nerve has a treatment window of several weeks to several months, and during the period, the electric stimulation induction can be carried out to the nerve, so that the target nerve rehabilitation degree and the rehabilitation rate can be improved. The common stimulation means during this period is percutaneous electric stimulation. The percutaneous electric stimulation is usually through the positive and negative electrode patches to the skin surface near the target nerve, and the electric stimulation is delivered to the target nerve through the electrode patch, the skin, the tissue and the muscle, so that the electric stimulation to the target nerve is realized. This stimulation mode is convenient to use and is widely applied, but because the skin, the tissue and the muscle of the human body are in between, the stimulation precision is poor, the effectiveness is low, and the adverse reactions are many (for example, muscle fatigue and muscle injury). In addition, in order to achieve sufficient stimulation of the target nerve, high-intensity percutaneous electric stimulation is needed, which often causes unbearable pain of the patient. Long-time high-intensity percutaneous electric stimulation can cause the skin of the patient to be hot and swollen. At the same time, this postoperative rehabilitation often needs to be carried out under the guidance of the doctor, and the patient needs to go to the hospital regularly, which is time-consuming and laborious, and affects the treatment compliance of the patient.

[0005] The whole implantation electric stimulation treatment can realize direct stimulation treatment to the target nerve through the implantation mode, and has high convenience, but because the whole device is implanted in the body, the stimulation parameters are difficult to adjust, and it is difficult to match the needs of different injury sites of different patients. In addition, the whole implantation electric stimulation treatment device needs to be removed through secondary surgery after completing the treatment, which causes secondary injury to the patient.

[0006] These several nerve electric stimulation treatment modes all have respective defects and are difficult to meet the needs. UTILITY MODEL CONTENTS

[0007] The utility model aims at providing a peripheral nerve stimulation system to solve the problems existing in the current nerve electric stimulation treatment mode.

[0008] To solve the above technical problems, the utility model provides a kind of peripheral nerve stimulation system, it includes: stimulation front end, release part, lead and base;

[0009] The stimulation front end and the release part are used to be implanted in vivo, and the stimulation front end is used to be connected with target nerve;The base is used to be set in vitro;Two ends of the lead are connected with the base and the stimulation front end respectively;The base is configured to send stimulation energy to the stimulation front end through the lead;

[0010] Wherein, the stimulation front end is configured to be degradable, and the release part is configured to drive the lead to be released from the stimulation front end when receiving release energy from the base;After the lead is released from the stimulation front end, the lead is configured to be removed from the body.

[0011] Optionally, the base includes a lead recovery mechanism, the lead recovery mechanism has a docking structure matched with an external driving mechanism, and the lead recovery mechanism is used to drive the lead to be removed from the body under the driving of the driving mechanism.

[0012] Optionally, the base is used to be attached to the body surface along the axial direction, and the lead recovery mechanism is rotatably arranged on the base around a rotation axis;The lead recovery mechanism drives the lead to be removed from the body by rotating around the rotation axis.

[0013] Optionally, the release part uses a physical release mode to drive the lead to be released from the stimulation front end;The peripheral nerve stimulation system further includes a sleeve, and the sleeve is sleeved on the release part and the outer periphery of the lead.

[0014] Optionally, the stimulation front end has flexibility, and the stimulation front end is used to wrap a part or all of the outer periphery of the target nerve.

[0015] Optionally, the peripheral nerve stimulation system further includes an electrical stimulation module, and the electrical stimulation module is detachably connected with the base.

[0016] The base includes a first electrical connection structure, the electrical stimulation module includes an energy supply unit and a second electrical connection structure, when the electrical stimulation module is connected with the base, the first electrical connection structure and the second electrical connection structure are conductive, and the energy supply unit supplies energy 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 debugging module, and the debugging module is detachably connected with the base;The debugging module is used to adjust the stimulation parameters of the stimulation energy.

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

[0019] When the debugging module is connected with the base, the first electrical connection structure and the third electrical connection structure are in conduction, and the first electrical connection structure and the third electrical connection structure are used for realizing energy supply transmission and communication transmission between the debugging module and the base.

[0020] Optionally, the base comprises a fourth electrical connection structure, the fourth electrical connection structure is connected with the release part, and the debugging module further comprises a release unit and a fifth electrical connection structure.

[0021] When the debugging module is connected with the base, the fourth electrical connection structure and the fifth electrical connection structure are in conduction, 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 comprises a driving mechanism, and the driving mechanism is used for driving a wire recovery mechanism of the base to drive the wire to be withdrawn from the body.

[0023] Optionally, the peripheral nerve stimulation system further comprises a control module, and the control module is connected with the debugging module.

[0024] The control module is used for supplying energy to the debugging module and communicating with the debugging module to realize adjustment of parameters of the stimulation energy.

[0025] In summary, the peripheral nerve stimulation system provided by the utility model comprises a stimulation front end, a release part, a wire and a base; the stimulation front end and the release part are used for being implanted in the body, and the stimulation front end is used for being connected with a target nerve; the base is used for being arranged outside the body; two ends of the wire are connected with the base and the stimulation front end respectively; the base is configured to send stimulation energy to the stimulation front end through the wire; wherein the stimulation front end is configured to be degradable, and the release part is configured to drive the wire and the stimulation front end to be released and separated when receiving release energy from the base; after the wire and the stimulation front end are released and separated, the wire is configured to be withdrawn from the body.

[0026] In this way, on one hand, the stimulation front end can be implanted in the body and connected with the target nerve, and can directly transmit stimulation energy to the target nerve, reduce the attenuation of the stimulation energy, reduce the generation of adverse reactions, and improve the treatment accuracy and effectiveness. On the other hand, after a period of time, the lead can be separated from the stimulation front end through the release part, and the lead is removed, and the stimulation front end can be degraded, so that secondary surgery is avoided. Therefore, the peripheral nerve stimulation system provided by the utility model has both the accuracy and effectiveness of intraoperative electrical stimulation treatment and the convenience of transcutaneous electrical stimulation treatment, and can avoid secondary surgery after treatment, and effectively solves the problems existing in the prior art of nerve electrical stimulation treatment. BRIEF DESCRIPTION OF DRAWINGS

[0027] Those skilled in the art will understand that the drawings provided are for a better understanding of the utility model, and do not constitute any limitation on the scope of the utility model.

[0028] Figure 1 is a schematic view of the peripheral nerve stimulation system of the utility model embodiment.

[0029] Figure 2 is a schematic view of the stimulation front end of the utility model embodiment.

[0030] Figure 3 is a schematic view of the release part of the utility model embodiment.

[0031] Figure 4 is a schematic view of the sleeve of the utility model embodiment.

[0032] Figure 5 is a schematic view of the base of the utility model embodiment.

[0033] Figure 6 is a schematic view of the electrical stimulation module of the utility model embodiment.

[0034] Figure 7 is a schematic view of the adjustment module of the utility model embodiment.

[0035] Figure 8 is a schematic view of the control module of the utility model embodiment.

[0036] In the drawings: 1 - stimulation tip; 11 - base; 111 - insulation layer; 112 - suture hole; 12 - electrode; 2 - release part; 21 - high resistance device; 3 - lead wire; 4 - base; 41 - patch; 42 - lead wire recovery mechanism; 421 - docking structure; 43 - first electrical connection structure; 44 - fourth electrical connection structure; 5 - sleeve; 6 - electrical stimulation module; 61 - energy supply unit; 62 - second electrical connection structure; 7 - debugging module; 71 - third electrical connection structure; 72 - fifth electrical connection structure; 73 - driving mechanism; 731 - driving shaft; 8 - control module; 81 - cable; 82 - display screen; 83 - button; 84 - knob; 85 - power input interface. DETAILED DESCRIPTION

[0037] In order to make the purpose, advantages and characteristics of the present application more clear, the present application will be further described in detail below in combination with the drawings and specific embodiments. It should be noted that the drawings are all very simplified and not drawn in proportion, and are only used to facilitate and clarify the purpose of assisting the description of the embodiments of the present application. In addition, the structures shown in the drawings are often part of the actual structures. In particular, the emphasis of each drawing needs to be different, and sometimes different scales are used.

[0038] As used in the present utility model, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. The term "or" is generally employed in its sense including "and / or" unless the context clearly dictates otherwise. The term "at least one" is generally employed in its sense including "one or more" unless the context clearly dictates otherwise. The term "at least two" is generally employed in its sense including "two or more" unless the context clearly dictates otherwise. In addition, the terms "first," "second," "third," etc. are used only to describe a particular one of various features and do not imply a relative importance or an ordering of the features so described unless the context clearly dictates otherwise. Thus, features identified as "first," "second," "third," etc. can include one or at least two such features, either explicitly or implicitly. The terms "proximal" and "distal" generally refer to two portions that are opposite each other, and they include not only the end points. The terms "proximal" and "distal" are defined herein with respect to a peripheral nerve stimulation system having one end for insertion into a human body (a stimulation front end) and a control end (a base or the like) extending out of the body. The term "proximal" refers to a location closer to the control end of the peripheral nerve stimulation system extending out of the body, and the term "distal" refers to a location closer to the one end of the peripheral nerve stimulation system for insertion into the human body and thus further away from the control end of the peripheral nerve stimulation system. Alternatively, in a manual or hand-operated application scenario, the terms "proximal" and "distal" are defined herein with respect to an operator such as a surgeon or a clinician. The term "proximal" refers to a location closer to the operator, and the term "distal" refers to a location closer to the peripheral nerve stimulation system and thus further away from the operator. In addition, as used in the present utility model, "mounting", "connection", "connecting", one element "provided" in another element should be understood broadly, and generally only indicates that there is a connection, coupling, cooperation or transmission relationship between the two elements, and the connection, coupling, cooperation or transmission between the two elements can be direct or indirect through intermediate elements, and cannot be understood as indicating or implying the spatial positional relationship between the two elements, i.e. one element can be in any orientation inside, outside, above, below or one side of another element, unless the content is otherwise clearly indicated. For those of ordinary skill in the art, the specific meanings of the above terms in the present utility model can be understood according to the specific circumstances. In addition, directional terms such as above, below, up, down, upward, downward, left, right, etc. are used with respect to the exemplary embodiments as they are shown in the figures, upward or upward direction is toward the top of the corresponding drawing, and downward or downward direction is toward the bottom of the corresponding drawing.

[0039] The utility model aims at providing a peripheral nerve stimulation system to solve the problems existing in the current nerve electric stimulation treatment mode. The following is described with reference to the drawings.

[0040] Please refer to Figure 1The utility model embodiment provides a kind of peripheral nerve stimulation system, it includes: stimulating front end 1, release part 2, wire 3 and base 4;The stimulating front end 1 and the release part 2 are used to be implanted in vivo, the stimulating front end 1 is used to be connected with target nerve;The base 4 is used to be set in vitro;Two ends of the wire 3 are connected with the base 4 and the stimulating front end 1 respectively;The base 4 is configured to send stimulation energy to the stimulating front end 1 by the wire 3;Wherein, the stimulating front end 1 is configured to be degradable, the release part 2 is configured to when receiving release energy from the base 4, drive the wire 3 and the stimulating front end 1 release separation;After the wire 3 and the stimulating front end 1 release separation, the wire 3 is configured to be removed from in vivo.

[0041] The peripheral nerve stimulation system provided by the utility model embodiment can be applied to carpal tunnel nerve, sciatic nerve, ulnar nerve and the like, and is particularly applied to frequently moving limb regions. Target nerves have different types and individual differences, different patients have different tolerances to nerve stimulation, and different target nerves have different stimulation intensities and stimulation times required for regeneration. Therefore, different nerve stimulation requirements are proposed for different patients and different injury sites.

[0042] Therefore, the peripheral nerve stimulation system of the embodiment sets the base 4 in vitro, which is connected to the stimulating front end 1 in vivo through the wire 3, and is a semi-implanted system. The stimulating parameters can be conveniently adjusted through the base 4 in vitro to realize differential stimulation treatment for different patients and different injury conditions. In addition, as the patient gradually recovers, the requirements for stimulation intensity and stimulation time will change, at which time the stimulation parameters can be adjusted through the base 4 in vitro to realize customized treatment programs. Moreover, the semi-implanted system is also convenient to remove after treatment.

[0043] For the semi-implanted system, it can be understood that if the stimulating front end 1 is linear (such as a needle shape) and approaches the target nerve in a free state, it can be more conveniently withdrawn from the body with the wire 3. However, such an arrangement has the following problems. On the one hand, the nerve or other tissues are likely to contact the head end of the linear stimulating front end 1, thereby causing a foreign body sensation or pain, especially for the nerves in the frequently moving limb regions, the target nerve region is often moved, and this situation is more significant. On the other hand, the linear stimulating front end 1 is difficult to form an effective connection with the target nerve, resulting in attenuation of stimulation energy, some adverse reactions, and poor treatment effect.

[0044] Therefore, in order to improve the reliability of the electrical stimulation, the stimulation front end 1 needs to be firmly connected with the target nerve, preferably the stimulation front end 1 abuts against the target nerve and has a certain abutting area. For example, in an alternative example, the stimulation front end 1 is flexible, and the stimulation front end 1 is used to wrap a part of the target nerve, or even the entire periphery of the target nerve. However, such a firm connection will bring the disadvantage that the stimulation front end 1 is difficult to remove, and a second surgery may be required.

[0045] The inventors have found that, assuming that the stimulation front end 1 is not removed after implantation, it means that after the nerve stimulation window period, the stimulation front end 1 can no longer play any role or has extremely limited role. Moreover, permanent implants are expensive and have low yield. Further research has found that the stimulation front end 1 will be gradually wrapped by scar tissue after being implanted for a period of time, so that it is eventually difficult to remove. In experiments on mice, after the stimulation front end 1 is implanted, the wound is opened about 4 weeks later, and it can be seen that the scar tissue is wrapped around the stimulation front end 1, tightly binding the stimulation front end 1 and the nerve together, and removal means that the nerve will be damaged again.

[0046] Therefore, the stimulation front end 1 of the present embodiment is configured to be degradable, and the material of the stimulation front end 1 can be selected to be a biocompatible degradable material. After being implanted in the human body, it can be degraded and dispersed over time without causing harm to the human body again. However, the degradable stimulation front end 1 brings a new problem, once the stimulation front end 1 is implanted, the degradation process starts irreversibly, and during the treatment window period (such as several weeks to several months), the effectiveness of the stimulation front end 1 needs to be ensured, so as not to be excessively degraded and fail. After the treatment window period ends, it is expected that the lead 3 can be removed from the body as soon as possible to avoid the adverse effects of long-term implantation. If the stimulation front end 1 happens to degrade to structural failure and the lead 3 is disconnected at the end of the treatment window period, the lead 3 can be removed as soon as possible. However, considering various factors, this is actually difficult to achieve. In particular, in order to ensure the integrity of the function of the stimulation front end 1 during the treatment window period, the degradation time of the stimulation front end 1 to failure generally needs to be configured to be longer than the treatment window period, that is, the stimulation front end 1 can adjust the degradation rate to keep its effective maintenance period not shorter than the treatment window period, and the complete degradation period is longer than the treatment window period. This results in that at the end of the treatment window period, the lead 3 and the stimulation front end 1 are still in a reliable connection state, and it is difficult to separate from the stimulation front end 1 and be removed from the body.

[0047] The setting of the release part 2 can actively drive the lead wire 3 to be released from the stimulation front end 1 at the end of the treatment window period, so that the lead wire 3 can be withdrawn out of the body as soon as possible after the end of the treatment window period. Those skilled in the art know that the prior art exists in the field of vascular intervention treatment, such as intracranial blood vessels, electrolytic release of spring rings. It can be chemically or corrosively released by means of a body fluid (such as blood) medium. However, the environment applied by the utility model is the peripheral nerve field, which is located outside the blood vessel and has relatively less body fluid, so it is difficult to chemically or corrosively release the release point by means of the body fluid medium. Therefore, the embodiment needs to additionally set the release part 2, and the release part 2 mainly adopts a physical release mode to drive the lead wire 3 to be released from the stimulation front end 1. The specific release mode is, for example, thermal release achieved by utilizing resistance difference or cutting / cropping release achieved by utilizing shearing action.

[0048] In this way, on the one hand, the stimulation front end 1 can be implanted in the body and connected with the target nerve, and can directly transmit stimulation energy to the target nerve, reduce the attenuation of stimulation energy, reduce the generation of adverse reactions, and improve the treatment accuracy and effectiveness. On the other hand, after a period of time, the lead wire 3 can be released from the stimulation front end 1 by the release part 2, and the lead wire 3 is removed, and the stimulation front end 1 can be degraded, eliminating the second operation. Therefore, the peripheral nerve stimulation system provided by the utility model has both the accuracy and effectiveness of intraoperative electrical stimulation treatment and the convenience of percutaneous electrical stimulation treatment, and can eliminate the second operation after treatment, effectively solving the problems existing in the prior art of nerve electrical stimulation treatment.

[0049] Please refer to Figure 2 In one embodiment, the stimulation front end 1 comprises a base 11 and an electrode 12. The base 11 can include a plurality of insulating layers 111, which mainly serve to provide insulation protection for the circuit. The electrode 12 is preferably clamped between the plurality of insulating layers 111 of the base 11. The electrode 12 is connected with the lead wire 3, and the side of the electrode 12 facing the target nerve is exposed, for example, a plurality of holes can be formed on the base 11 to expose at least a part of the electrode 12. The material of the base 11 is preferably a flexible material with good biocompatibility and high resistivity, and according to the degradation requirement, for example, polylactic acid or polyurethane can be used. The material of the electrode 12 is selected from a flexible material with low resistivity, and according to the degradation requirement, for example, magnesium-based alloy can be used. During use, the operator can bend the stimulation front end 1 into a ring shape and wrap it around at least a part of the periphery of the target nerve. Further, a plurality of suture holes 112 can be formed on the base 11, and after the stimulation front end 1 is bent and wrapped around the target nerve, a suture can be used to pass through the suture holes 112 for fixation.

[0050] Please refer to Figure 3Fig. 1 shows a peripheral nerve stimulation system according to an embodiment of the present application. The peripheral nerve stimulation system comprises a stimulation lead 1, a base 4, and a detachment portion 2. The stimulation lead 1 comprises a proximal end 10 and a distal end 11. The stimulation lead 1 further comprises a lead wire 3 and a stimulation tip 12. The stimulation tip 12 is connected to the lead wire 3. The stimulation tip 12 is configured to stimulate a target nerve. The stimulation tip 12 is located at the distal end 11 of the stimulation lead 1. The base 4 is connected to the proximal end 10 of the stimulation lead 1. The base 4 is configured to be implanted in a patient. The detachment portion 2 is connected to the stimulation lead 1. The detachment portion 2 is configured to detach the stimulation lead 1 from the stimulation tip 12. The detachment portion 2 comprises a high resistance device 21. The high resistance device 21 is preferably in contact with the lead wire 3 and is preferably electrically insulated. The high resistance device 21 is further connected to the base 4 by the lead wire. It is understood that the detachment energy is for example electrical energy. When the high resistance device 21 is energized, the high resistance device 21 generates heat, which melts the lead wire 3 around the high resistance device 21, and breaks the continuity of the lead wire 3, and detaches the stimulation lead 1 from the stimulation tip 12. The materials and structure of the lead wire 3 and the high resistance device 21 are not limited. In some embodiments, the high resistance device 21 can also be a part of the lead wire 3. That is, a section of the lead wire 3 is specially processed so that the electrical resistivity of the section is different from the rest of the lead wire 3.

[0051] It is to be noted that Figure 3 The detachment portion 2 shown is only an example of the detachment portion 2 and is not a limitation of the detachment portion 2. In other embodiments, the detachment portion 2 can also be a cutting detachment that uses a shearing action. The detachment energy is for example mechanical driving energy. The detachment portion 2 comprises for example a shearing portion and a driving wire. The driving wire extends proximally to the base 4. The shearing portion is driven by the driving wire to physically cut the lead wire 3.

[0052] In order to make the residual components after detachment remain in the body for a shorter time and have less impact on the tissue, it is necessary to make the residual components after detachment as small as possible. Therefore, the detachment point is required to be as close as possible to the stimulation tip 12. However, the detachment point generates a thermal effect or a force effect during the detachment process. If the detachment point is too close to the stimulation tip 12, the nerve can be damaged during the detachment, causing injury. Therefore, the detachment point cannot be too close to the stimulation tip 12. In practice, the position of the detachment point can be set according to the specific structure of the detachment portion 2 and the specific circumstances of the target nerve, in order to achieve a balance.

[0053] Further, since the detachment portion 2 uses a physical detachment method to drive the lead wire 3 to detach from the stimulation tip 12, please refer to Figure 4 The peripheral nerve stimulation system of the present embodiment preferably further comprises a sleeve 5, which is sleeved on the detachment portion 2 and the lead wire 3. Based on the above analysis of the minimum residual amount, it is desirable for the detachment point to be as close as possible to the stimulation tip 12. However, such an arrangement is prone to damage to the target nerve during detachment. The sleeve 5 is arranged to wrap the detachment portion 2. The sleeve 5 has the following effects:

[0054] The first is to physically block the release portion 2, to reduce or avoid the release portion 2 from causing damage and impact to the human tissue during the release. In the case of the sleeve 5, the release portion 2 can be arranged relatively closer to the stimulation tip 1 towards the distal end, so that the release point can be moved closer to the stimulation tip 1 towards the distal end, reducing the remaining components after the release.

[0055] The second is to physically block the lead 3, to reduce the impact of the human tissue to the integrity of the lead 3 and the release portion 2, and to reduce or prevent the stimulation energy from escaping to the surrounding human tissue during the transmission of the stimulation energy, reducing or avoiding the adverse reactions such as electric shock.

[0056] The third is to reduce the removal resistance of the lead 3 or the release portion 2. In some embodiments, the release portion 2 is arranged so that the lead 3 has a concave-convex structure in the axial direction, and in some embodiments, the release portion 2 also needs to be removed, especially after being implanted for a period of time. The rough concave-convex structure makes it easy for the tissue to climb and combine, and difficult to remove. The sleeve 5 can wrap the lead 3 and the release portion 2, reducing or avoiding the combination of the tissue and the lead 3 and the release portion 2, and reducing the removal resistance of the lead 3 or the release portion 2.

[0057] The fourth is to provide certain physical support performance to the lead 3 and the release portion 2, to improve the reliability of the lead 3 and the release portion 2 during the implantation and application, and to reduce or avoid the problems such as bending, breaking, falling off, and displacement caused by movement.

[0058] The structure of the sleeve 5 is not limited, for example, in one exemplary embodiment, it is in the form of a cylinder, and the distal end can be configured to be open, and the proximal end can be extended to be connected to the base 4. Alternatively, the distal end of the sleeve 5 at least covers a part of the release portion 2 in the axial direction, and preferably completely covers the release portion 2, so as to completely wrap the release portion 2.

[0059] In some embodiments, the sleeve 5 can be removed after the end of the treatment window period. Alternatively, the material of the sleeve 5 is a flexible high polymer material with high electrical resistivity, and the outer surface is preferably smooth to reduce the combination with the tissue. Further, in order to reduce the cell climbing and the blood coagulation on the outer surface of the sleeve 5, an anticoagulant and lubricating coating can be provided on the outer surface of the sleeve 5.

[0060] In some other embodiments, the sleeve 5 is configured to be degradable, for example, made of biodegradable material such as polylactic acid. The sleeve 5 can be left in the body after the treatment window period and gradually degraded to allow tissue healing. In the case where the sleeve 5 is not removed, the outer surface of the sleeve 5 is not necessarily smooth, but the inner surface of the sleeve 5 is preferably smooth to reduce the frictional resistance between the lead 3 and the dislodging portion 2 and the inner surface of the sleeve 5, facilitating the removal of the lead 3 and the dislodging portion 2. Optionally, in the case where the sleeve 5 is not removed, a regenerative factor can be mixed in the material of the sleeve 5 to further promote tissue regeneration and growth.

[0061] Reference is made to Figure 5 which exemplarily shows an example of the base 4. The base 4 is configured to be attached to the body surface in the axial direction. The side of the base 4 facing the body surface preferably has a patch 41 for attachment to the body surface, such as the skin. The base 4 can be provided with an electrical stimulation driving circuit, and the proximal end of the lead 3 extends to the base 4 and is electrically connected to the electrical stimulation driving circuit.

[0062] Optionally, the base 4 includes a lead recovery mechanism 42 having a docking structure 421 adapted to an external driving mechanism. The lead recovery mechanism 42 is configured to be driven by the driving mechanism to remove the lead 3 from the body. It can be understood that the removal of the lead 3 is a one-time step only after the treatment is completed, and during the entire treatment window period, the lead 3 does not need to be driven. In order to improve portability and application convenience, it is desirable to minimize the volume of the base 4 during the treatment window period, and therefore the driving mechanism for driving the lead 3 to be removed can be external, and the base 4 is only provided with the corresponding lead recovery mechanism 42 to minimize the volume of the base 4.

[0063] In one embodiment, the lead retraction mechanism 42 is rotatably arranged around a rotation axis of the base 4; the lead retraction mechanism 42 is configured to retract the lead 3 from the body by rotating around the rotation axis. Optionally, the proximal end of the lead 3 is fixed to the outer periphery of the lead retraction mechanism 42 after extending into the base 4, so that the lead retraction mechanism 42 can wind the lead 3 when rotating, thereby retracting the lead 3. The external driving mechanism can be a manual tool (such as a screwdriver or a hand-operated mechanism, etc.), or an electric tool, which can be integrated in the adjustment module 7 (to be described later). The present embodiment is not limited thereto. In some embodiments, the rotation axis of the lead retraction mechanism 42 is parallel to the axial direction of the base 4. The parallel rotation facilitates the docking and driving of the external driving mechanism, and is conducive to reducing the size of the product. Of course, in other embodiments, the rotation axis of the lead retraction mechanism 42 can also be perpendicular to the axial direction of the base 4. In this way, the shearing force on the lead 3 during retraction is reduced, the probability of lead 3 breakage during retraction is lower, the reliability of the lead retraction mechanism 42 for retracting the lead 3 is higher, and the risk of the entire peripheral nerve stimulation system is lower.

[0064] Please refer to Figure 6 Optionally, the peripheral nerve stimulation system further comprises an electrical stimulation module 6, the electrical stimulation module 6 is detachably connected with the base 4; the electrical stimulation module 6 comprises a power supply unit 61 and a second electrical connection structure 62, when the electrical stimulation module 6 is connected with the base 4, the first electrical connection structure 43 of the base 4 is in conduction with 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 arranged in the detachable electrical stimulation module 6, which is conducive to replacing it. In some cases, if the power supply unit 61 is exhausted or fails due to other reasons, it can be easily solved by replacing the electrical stimulation module 6, without the need to disassemble the base 4 itself, thereby reducing the adverse effects on the implanted components such as the lead 3.

[0066] In an alternative example, the electrical stimulation module 6 and the base 4 have a matching concave-convex shape, and the two can be assembled and connected by clamping each other. Further, the electrical stimulation module 6 and the base 4 can have a matching mechanical locking structure (such as a buckle, etc.), to improve the mechanical connection reliability of the electrical stimulation module 6 and the base 4. Optionally, the first electrical connection structure 43 and the second electrical connection structure 62 are a set of corresponding electrode contacts, and when the electrical stimulation module 6 and the base 4 are assembled and connected, the electrode contacts of the first electrical connection structure 43 and the second electrical connection structure 62 are in contact with each other to conduct. The power supply unit 61, such as a button cell or other energy storage unit, is used to provide power for the electrical stimulation driving circuit.

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

[0068] In other embodiments, the electric stimulation driving circuit can also be partially or entirely arranged in the electric stimulation module 6. In this case, the first electric connection structure 43 and the second electric connection structure 62 are used to realize not only energy supply transmission but also communication transmission or stimulation energy transmission. In one embodiment, the electric stimulation driving circuit is entirely arranged in the electric stimulation module 6. In this case, the base 4 is equivalent to only an electric intermediate transmission member, and the stimulation energy generated by the electric stimulation driving circuit is transmitted to the base 4 through the first electric connection structure 43 and the second electric connection structure 62 and further transmitted to the stimulation front end 1 through the lead 3.

[0069] In one preferred example, the electric stimulation driving circuit comprises a first part and a second part, wherein the first part is arranged in the base 4 and the second part is arranged in the electric stimulation module 6. The second part can pre-store specific stimulation parameters, and the stimulation parameters are communicated with the first part through the first electric connection structure 43 and the second electric connection structure 62. The first part delivers stimulation energy to the stimulation front end 1 based on the stimulation parameters from the second part. Optionally, the first electric connection structure 43 and the second electric connection structure 62 realize not only communication transmission between the first part and the second part but also energy supply transmission between the energy supply unit 61 and the first part. It can be understood that, since the electric stimulation module 6 and the base 4 are detachably connected, in practice, a plurality of electric stimulation modules 6 can be configured with different pre-stored stimulation parameters, so that the operator only needs to select the electric stimulation module 6 with appropriate pre-stored stimulation parameters to assemble with the base 4, so as to complete the setting of the stimulation parameters, which is convenient for operation and use. Further, when the stimulation parameters need to be adjusted as the patient gradually recovers, the operator can also replace the electric stimulation module 6 with different pre-stored stimulation parameters to assemble with the base 4, so as to complete the adjustment of the stimulation parameters.

[0070] Please refer to Figure 7 Optionally, the peripheral nerve stimulation system further comprises a debugging module 7, the debugging module 7 is detachably connected with the base 4; the debugging module 7 is used to adjust the stimulation parameters of the stimulation energy; the debugging module 7 comprises a third electric connection structure 71; when the debugging module 7 is connected with the base 4, the first electric connection structure 43 and the third electric connection structure 71 are in conduction, and the first electric connection structure 43 and the third electric connection structure 71 are used to realize energy supply transmission and communication transmission between the debugging module 7 and the base 4.

[0071] Optionally, the debugging module 7 and the base 4 have matching concave-convex shapes, and the two can be assembled and connected with each other. Further, the debugging module 7 and the base 4 can have matching mechanical locking structures (such as buckles, etc.), so as to improve the mechanical connection reliability of the debugging module 7 and the base 4. The third electric connection structure 71 is an electrode contact point matched with the first electric connection structure 43. Preferably, the electric stimulation module 6 and the debugging module 7 have similar concave-convex shapes, and when the electric stimulation module 6 is not installed on the base 4, the debugging module 7 can be assembled and connected with the base 4.

[0072] In some embodiments, the electric stimulation driving circuit is arranged in the base 4, and the stimulation parameters are stored in the base 4. The debugging module 7 includes a parameter adjustment circuit, and when the debugging module 7 is connected with the base 4, the parameter adjustment circuit is turned on with the electric stimulation driving circuit through the first electric connection structure 43 and the third electric connection structure 71, so as to adjust the stimulation parameters in the electric stimulation driving circuit. Further, the electric stimulation driving circuit can also obtain the feedback signal from the stimulation front end 1, and the parameter adjustment circuit can obtain the feedback signal through the first electric connection structure 43 and the third electric connection structure 71, so as to assist the adjustment of the stimulation parameters. That is, the first electric connection structure 43 and the third electric connection structure 71 can be bidirectional communication connection. In addition, the debugging module 7 can also supply power to the electric stimulation driving circuit through the first electric connection structure 43 and the third electric connection structure 71 during the parameter adjustment process of the parameter adjustment circuit. Further, after the debugging module 7 completes the adjustment of the stimulation parameters in the electric stimulation driving circuit, the debugging module 7 can be detached from the base 4, and then the electric stimulation module 6 is installed on the base 4. At this time, the electric stimulation module 6 supplies power to the electric stimulation driving circuit on the base 4, and normal stimulation treatment is realized.

[0073] Optionally, the base 4 includes a fourth electric connection structure 44, the fourth electric connection structure 44 is connected with the release part 2, the debugging module 7 further includes a release unit and a fifth electric connection structure 72; when the debugging module 7 is connected with the base 4, the fourth electric connection structure 44 and the fifth electric connection structure 72 are turned on, and the release unit sends release energy to the base 4 through the fourth electric connection structure 44 and the fifth electric connection structure 72. Optionally, the fourth electric connection structure 44 and the fifth electric connection structure 72 are a group of corresponding electrode contact points, and when the debugging module 7 is assembled and connected with the base 4, the electrode contact points of the fourth electric connection structure 44 and the fifth electric connection structure 72 are in contact with each other and are turned on.

[0074] In a preferred example, the debugging module 7 is used not only for parameter adjustment, but also for control of disengagement. Taking the disengagement unit 2 of the electrothermal disengagement as an example, the disengagement lead wire is connected to the fourth electrical connection structure 44. The disengagement unit, for example, contains a disengagement circuit, which can externally emit disengagement energy (such as electrical energy). After the end of the treatment window, the electrical stimulation module 6 can be detached from the base 4, and then the debugging module 7 is installed on the base 4, at which time the fourth electrical connection structure 44 is in conduction with the fifth electrical connection structure 72. The disengagement unit can then emit disengagement energy to the disengagement unit 2 through the fourth electrical connection structure 44 and the fifth electrical connection structure 72, so that the disengagement unit 2 generates heat and melts the lead wire 3.

[0075] Optionally, the debugging module 7 further comprises a driving mechanism 73 for driving the lead wire recovery mechanism 42 of the base 4 to drive the lead wire 3 to be withdrawn from the body. In an alternative example, the driving mechanism 73, for example, contains a motor and a driving shaft 731, which is preferably coaxially connected to the lead wire recovery mechanism 42, and the driving shaft 731 has features that match the connection structure 421 of the lead wire recovery mechanism 42, for example, in an example, the connection structure 421 and the driving shaft 731 have matching grooves and teeth, which can be engaged and transmit torque.

[0076] Thus, the debugging module 7 is not only used for control of disengagement, but also for driving the recovery of the lead wire 3, which is multi-purpose. Of course, in other embodiments, the functions of controlling disengagement and / or driving the recovery of the lead wire 3 can be provided separately from the debugging module 7, for example, the debugging module 7 can be used only for parameter adjustment, and the control of disengagement and / or the driving of the recovery of the lead wire 3 after the completion of treatment can be achieved by another module, which is not limited by the present application.

[0077] Please refer to Figure 8 Optionally, the peripheral nerve stimulation system further comprises a control module 8 connected to the debugging module 7; the control module 8 is used to supply energy to the debugging module 7 and communicate with the debugging module 7 to adjust the parameters of the stimulation energy. The connection between the control module 8 and the debugging module 7 is preferably connected by a cable 81, which can not only realize communication, but also realize energy supply. Of course, the connection mode between the control module 8 and the debugging module 7 is not limited in the present embodiment, and in some embodiments, the two can also be connected wirelessly, such as Bluetooth connection. The wireless connection between the control module 8 and the debugging module 7 can only contain wireless communication connection, at which time the debugging module 7 can be self-powered. The wireless connection between the control module 8 and the debugging module 7 can also realize wireless communication connection and wireless energy supply connection at the same time, which can be realized by referring to the prior art, and this embodiment will not be described.

[0078] Further, when the debugging module 7 further comprises a release unit and / or a driving mechanism 73, the control module 8 is further used for controlling the release unit and / or the driving mechanism 73, that is, the control module 8 can control the action of the release unit and / or the driving mechanism 73. Preferably, the control module 8 can further supply energy to the release unit and / or the driving mechanism 73, so as to reduce the volume of the debugging module 7. In an alternative example, the control module 8 comprises a display screen 82, a button 83, a knob 84 and a power input interface 85, and the control module 8 can realize visual parameter adjustment and control functions through the display screen 82, the button 83 and the knob 84.

[0079] In summary, the peripheral nerve stimulation system provided by the utility model comprises a stimulation front end, a release part, a lead and a base, the stimulation front end and the release part are used for implanting in the body, the stimulation front end is used for connecting with a target nerve, the base is used for being arranged outside the body, two ends of the lead are connected with the base and the stimulation front end respectively, the base is configured to send stimulation energy to the stimulation front end through the lead, wherein the stimulation front end is configured to be degradable, the release part is configured to drive the lead and the stimulation front end to release and separate when receiving release energy from the base, after the lead and the stimulation front end release and separate, the lead is configured to be removed from the body.

[0080] In this way, on the one hand, the stimulation front end can be implanted in the body and connected with the target nerve, can directly transmit the stimulation energy to the target nerve, reduces the attenuation of the stimulation energy, reduces the generation of adverse reactions, improves the treatment accuracy and effectiveness. On the other hand, after a period of time, the lead and the stimulation front end can be released and separated through the release part, and the lead is removed, and the stimulation front end can be degraded, so that secondary surgery is avoided. Therefore, the peripheral nerve stimulation system provided by the utility model has both the accuracy and effectiveness of intraoperative electrical stimulation treatment and the convenience of transcutaneous electrical stimulation treatment, and can avoid secondary surgery after treatment, effectively solving the problems existing in the existing nerve electrical stimulation treatment mode.

[0081] It should be noted that the above several embodiments can be combined with each other. The above description is only a description of the preferred embodiments of the utility model, and does not limit the scope of the utility model in any way. Any modification or modification of the utility model made by a person skilled in the art based on the above disclosure is within the protection scope of the utility model.

Claims

1. A peripheral nerve stimulation system, characterized by, The peripheral nerve stimulation system comprises a stimulation front end, a release part, a lead wire and a base; The stimulation front end and the release part are configured to be implanted in a body, and the stimulation front end is configured to be connected with a target nerve; The base is configured to be arranged outside the body, and two ends of the lead wire are connected with the base and the stimulation front end respectively; the base is configured to send stimulation energy to the stimulation front end through the lead wire; The stimulation front end is configured to be degradable, and the release part is configured to drive the lead wire to be released from the stimulation front end when receiving release energy from the base; After the lead wire is released from the stimulation front end, the lead wire is configured to be removed from the body.

2. The peripheral nerve stimulation system of claim 1, wherein, The base comprises a lead wire recovery mechanism, the lead wire recovery mechanism has a docking structure matched with an external driving mechanism, and the lead wire recovery mechanism is configured to drive the lead wire to be removed from the body under the driving of the driving mechanism.

3. The peripheral nerve stimulation system of claim 2, wherein, The base is configured to be attached to a body surface along an axial direction, and the lead wire recovery mechanism is rotatably arranged on the base around a rotation axis; the lead wire recovery mechanism drives the lead wire to be removed from the body by rotating around the rotation axis.

4. The peripheral nerve stimulation system of claim 1, wherein, The release part adopts a physical release mode to drive the lead wire to be released from the stimulation front end; the peripheral nerve stimulation system further comprises a sleeve, and the sleeve is arranged on the release part and the lead wire.

5. The peripheral nerve stimulation system of claim 1, wherein, The stimulation front end has flexibility, and the stimulation front end is configured to wrap a part or all of the periphery of the target nerve.

6. The peripheral nerve stimulation system of claim 1, wherein, The peripheral nerve stimulation system further comprises an electric stimulation module, and the electric stimulation module is detachably connected with the base; The base comprises a first electric connection structure, the electric stimulation module comprises an energy supply unit and a second electric connection structure, the first electric connection structure is in conduction with the second electric connection structure when the electric stimulation module is connected with the base, and the energy supply unit supplies energy to the base through the first electric connection structure and the second electric connection structure.

7. The peripheral nerve stimulation system of claim 1, wherein, The peripheral nerve stimulation system further comprises a debugging module, and the debugging module is detachably connected with the base; the debugging module is configured to adjust stimulation parameters of the stimulation energy; The base comprises a first electric connection structure, and the debugging module comprises a third electric connection structure; The first electric connection structure is in conduction with the third electric connection structure when the debugging module is connected with the base, and the first electric connection structure and the third electric connection structure are configured to realize energy supply transmission and communication transmission between the debugging module and the base.

8. The peripheral nerve stimulation system of claim 7, wherein, The base comprises a fourth electric connection structure, the fourth electric connection structure is connected with the release part, the debugging module further comprises a release unit and a fifth electric connection structure; The fourth electric connection structure is in conduction with the fifth electric connection structure when the debugging module is connected with the base, and the release unit sends release energy to the base through the fourth electric connection structure and the fifth electric connection structure.

9. The peripheral nerve stimulation system of claim 7, wherein, The debugging module further comprises a driving mechanism, and the driving mechanism is configured to drive the lead wire recovery mechanism of the base to drive the lead wire to be removed from the body.

10. The peripheral nerve stimulation system of claim 7, wherein, The peripheral nerve stimulation system further comprises a control module, and the control module is connected with the debugging module; The control module is used to supply power to the debugging module and communicate with the debugging module to realize the adjustment of the parameters of the stimulation energy.

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