A protective sleeve

Abstract

The utility model discloses a protective sleeve belongs to medical instrument technical field. Protective sleeve is used for connecting extension wire and electrode wire, and the protective sleeve includes sleeve body and holds tightly spare, and the sleeve body includes the first body part and the second body part of being arranged at both ends, and the first body part is connected to the extension wire, and the second body part is sleeved in electrode wire, and the holding tightly spare is arranged in the sleeve body, and the holding tightly spare is shape memory spare, and when temperature is less than preset temperature, the holding tightly spare is in relaxed state, and at least part sleeve body and extension wire and / or electrode wire clearance fit, and when temperature is greater than or equal to preset temperature, the holding tightly spare is in contraction state, and makes at least part sleeve body and extension wire and / or electrode wire close adhesion. The protective sleeve of the utility model is used for realizing the sealing of extension wire and / or electrode wire, and reduces the dependence of the doctor's threading technique.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a protective cover. Background Technology

[0002] In recent years, deep brain stimulation (DBS) combined with medication has been a common clinical treatment strategy for motor dysfunction disorders such as Parkinson's disease, epilepsy, dystonia, and spinal cord pain, as well as mental illnesses such as depression, drug addiction, and obsessive-compulsive disorder. In most current DBS systems, signal transmission is achieved by connecting an IPG (Implantable Pulse Generator) and electrode leads via extension wires. For example... Figure 1 As shown, in related technologies, the extension lead 1000 and the electrode lead 2000 are typically sealed and waterproofed by a protective sleeve 3000. Specifically, for one end of the extension lead 1000, a ligature 4000 is used to secure the protective sleeve 300 to the extension lead 1000, achieving a seal. However, the sealing method of the ligature 4000 is highly dependent on the doctor's ligation technique. If the ligature 4000 is not tightened, the seal of the protective sleeve 3000 may fail, leading to poor insulation at the contacts after the electrode lead 2000 and the extension lead 1000 are connected, thus affecting product functionality. Utility Model Content

[0003] The purpose of this invention is to provide a protective sleeve that achieves a seal and reduces reliance on the doctor's suture techniques.

[0004] To achieve this objective, the present invention adopts the following technical solution:

[0005] A protective sleeve for connecting extension wires and electrode wires, the protective sleeve comprising:

[0006] The body includes a first body portion and a second body portion disposed at both ends, the first body portion being sleeved and connected to the extension wire, and the second body portion being sleeved on the electrode wire;

[0007] A clamping element is provided on the sleeve body. The clamping element is a shape memory element. When the temperature is lower than a preset temperature, the clamping element is in a relaxed state, and at least a portion of the sleeve body is in clearance fit with the extension wire and / or the electrode wire. When the temperature is greater than or equal to the preset temperature, the clamping element is in a contracted state, so that at least a portion of the sleeve body is in close contact with the extension wire and / or the electrode wire.

[0008] In some embodiments, the sleeve body further includes an intermediate body portion disposed between the first body portion and the second body portion, the intermediate body portion being sleeved at the connection between the extension wire and the electrode wire; the clamping member includes a first portion disposed on the outer periphery of the first body portion and a second portion disposed on the outer periphery of the intermediate body portion.

[0009] In some embodiments, the extension wire includes a connecting portion, the connecting portion including a receiving channel for receiving the electrode wire, and a plurality of sealing structures and mating structures are alternately arranged in sequence along the length direction in the receiving channel. The connector of the electrode wire extends into the receiving channel and is electrically connected to the mating structure; the sealing structure is elastic.

[0010] In some embodiments, the clamping member further includes a third portion disposed on the second body portion.

[0011] In some embodiments, the first part, the second part, and the third part are an integral structure or a separate structure.

[0012] In some embodiments, the second body portion is interference-fitted with the electrode wire.

[0013] In some embodiments, the inner side of the second body portion is provided with a sealing rib, and the sealing rib is interference-fitted with the electrode wire.

[0014] In some embodiments, the sleeve body is a shape memory polymer component, and / or the clamping component is a shape memory alloy component or a shape memory polymer component.

[0015] In some embodiments, the clamping member is embedded in the sleeve body, or the clamping member is sleeved on the outside of the sleeve body.

[0016] In some embodiments, the inner surface of the sleeve body is provided with a coating for adsorption to the outer surface of the extension wire; and / or, the inner surface of the sleeve body is a nano-etched structure for mating with the outer surface of the extension wire, so that a concave-convex mating structure is formed between the two.

[0017] In some embodiments, the clamping element is spiral, mesh, or ring-shaped.

[0018] The beneficial effects of this utility model are:

[0019] This utility model provides a protective sleeve, in which an extension wire is connected to a first body portion at one end of the sleeve body, and an electrode wire is connected to a second body portion at the other end of the sleeve body. The connection between the electrode wire and the extension wire is covered within the sleeve body. For the extension wire end, when the temperature is below a preset temperature, the clamping member remains relaxed, and the protective sleeve and extension wire are fitted with a gap for easy installation. When the protective sleeve is implanted into the human body along with the extension wire, and the temperature exceeds the preset temperature due to the influence of the human body's ambient temperature, the clamping member contracts inward, squeezing and pressing against the sleeve body, thus tightly fitting the sleeve body and the extension wire together to achieve a sealed connection. This reduces reliance on the doctor's suture technique and allows the protective sleeve to effectively seal the extension wire.

[0020] For one end of the electrode lead, when the temperature is below the preset temperature, the clamping member remains loose, and the protective sleeve and electrode lead are fitted with a gap for easy installation. When the protective sleeve is implanted into the human body along with the electrode lead, it is affected by the ambient temperature and when the temperature exceeds the preset temperature, the clamping member contracts inward, squeezing the sleeve body and tightly fitting it to the electrode lead, thus achieving a sealed connection. This reduces reliance on the doctor's suture technique, effectively seals the electrode lead, ensures the contact connection effect after the electrode lead and extension lead are connected, and thus ensures product functionality. Attached Figure Description

[0021] Figure 1 This is a schematic diagram of the protective sleeve connecting the extension wire and the electrode wire in the prior art;

[0022] Figure 2 This is a schematic diagram of the protective sleeve provided in a specific embodiment of this utility model;

[0023] Figure 3 This is a schematic diagram of a protective sleeve with a light-transmitting structure provided in a specific embodiment of this utility model;

[0024] Figure 4 This is a cross-sectional view of the protective sleeve provided in a specific embodiment of this utility model;

[0025] Figure 5 This is a schematic diagram of the protective sleeve connecting the extension wire and the electrode wire provided in a specific embodiment of this utility model;

[0026] Figure 6 yes Figure 5 AA sectional view.

[0027] In the picture:

[0028] 1000, extension wire; 2000, electrode wire; 3000, protective sleeve; 4000, wire;

[0029] 100. Extension wire; 110. Sealing structure; 120. Butt joint structure; 130. Reception channel; 200. Electrode wire; 210. Connector; 300. Protective sleeve; 410. First sealing area; 420. Second sealing area;

[0030] 310. Body assembly; 311. First body assembly; 312. Second body assembly; 313. Intermediate body assembly; 314. Sealing rib;

[0031] 320. Clamping component; 321. First part; 322. Second part. Detailed Implementation

[0032] To make the technical problems solved by this utility model, the technical solutions adopted, and the technical effects achieved clearer, the technical solutions of the embodiments of this utility model will be further described in detail below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this utility model, and not all embodiments. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the protection scope of this utility model.

[0033] In the description of this utility model, unless otherwise explicitly specified and limited, the terms "connected," "linked," and "fixed" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0034] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0035] The technical field and related terms of the embodiments of this application are briefly described below.

[0036] Implantable medical systems include implantable neurostimulation systems, implantable cardiac stimulation systems (also known as pacemakers), implantable drug delivery systems (IDDS), and lead transfer systems. Examples of implantable neurostimulation systems include deep brain stimulation (DBS), cortical nerve stimulation (CNS), spinal cord stimulation (SCS), sacral nerve stimulation (SNS), and vagus nerve stimulation (VNS).

[0037] Implantable neurostimulation systems consist of a stimulator implanted in the patient's body (i.e., an implantable neurostimulator) and a programmed device placed outside the patient's body. In other words, the stimulator is a medical device, or medical devices include stimulators. Related neuromodulation techniques primarily involve stereotactic surgery to implant electrodes (e.g., electrode wires) at specific sites (target points) in the body's tissues. Discharge pulses are then delivered through these electrodes to the target points, modulating the electrical activity and function of corresponding neural structures and networks, thereby improving symptoms and alleviating pain.

[0038] As an example, a DBS includes an IPG (Implantable Pulse Generator), extension leads, and electrode leads. The IPG is connected to the electrode leads via the extension leads. The IPG is implanted in the patient's body, for example, in the chest or other internal locations.

[0039] As another example, DBS includes an IPG and electrode leads, with the IPG directly connected to the electrode leads. The IPG is implanted in the patient's head, for example, by creating a groove in the patient's skull and then placing the IPG in the groove. In this case, the IPG may not protrude from the outer surface of the skull, or it may protrude partially from the outer surface of the skull.

[0040] In this system, the IPG responds to programmed commands sent by a programmable device, using a sealed battery and circuitry to deliver controllable electrical stimulation (or electrical stimulation energy) to tissues within the body. The IPG delivers one or more controllable electrical stimuli to specific areas of tissue via electrode leads.

[0041] In some embodiments, the extension wire is used in conjunction with the IPG as a medium for transmitting electrical stimulation, thereby transmitting the electrical stimulation generated by the IPG to the electrode wire.

[0042] In some embodiments, electrical stimulation can be delivered in the form of a pulsed signal or a non-pulsed signal. For example, electrical stimulation can be delivered as a signal with various waveform shapes, frequencies, and amplitudes. Therefore, non-pulsed signal electrical stimulation can be a continuous signal, which can have a sinusoidal waveform or other continuous waveforms.

[0043] After receiving electrical stimulation from the IPG or extension leads, the electrode leads deliver the stimulation to specific areas of tissue within the body via multiple electrode contacts. The stimulator may have one or more electrode leads on one or both sides, with multiple electrode contacts on each lead. These contacts may be evenly or non-uniformly arranged circumferentially on the electrode leads. As an example, the electrode contacts may be arranged in a 4x3 array (a total of 12 electrode contacts) circumferentially on the electrode leads. The electrode contacts may include stimulating electrode contacts and / or collecting electrode contacts. The electrode contacts may be in shapes such as sheet-like, ring-like, or dot-like.

[0044] In some embodiments, the stimulated tissue may be the patient's brain tissue, and the stimulated site may be a specific location within the brain tissue. Generally, the stimulated site differs depending on the patient's disease type, and the number of stimulation contacts (single-source or multi-source), the application of one or more specific electrical stimulation pathways (single-channel or multi-channel), and the stimulation parameters (values) also vary.

[0045] This application does not limit the applicable disease types, but can be any disease type applicable to deep brain stimulation (DBS), spinal cord stimulation (SCS), sacral nerve stimulation, gastric stimulation, peripheral nerve stimulation, or functional electrical stimulation. Among these, DBS can be used to treat or manage diseases including, but not limited to: spastic disorders (e.g., epilepsy), pain, migraines, mental illnesses (e.g., major depressive disorder (MDD)), bipolar disorder, anxiety disorders, post-traumatic stress disorder, mild depression, obsessive-compulsive disorder (OCD), behavioral disorders, mood disorders, memory disorders, mental state disorders, mobility disorders (e.g., essential tremor or Parkinson's disease), Huntington's disease, Alzheimer's disease, drug addiction, autism, or other neurological or psychiatric diseases and impairments.

[0046] In this embodiment of the application, when the programmable device and the stimulator establish a programmable connection, the programmable device can be used to adjust one or more stimulation parameters of the stimulator (or one or more stimulation parameters of the pulse generator, with different stimulation parameters corresponding to different electrical stimuli). Alternatively, the stimulator can sense the patient's electrophysiological activity to collect electrophysiological signals, and the collected electrophysiological signals can be used to continue adjusting the stimulation parameters of the stimulator to achieve closed-loop control (or adaptive adjustment) of the stimulation parameters.

[0047] Stimulation parameters may include at least one of the following: electrode contact identification for delivering electrical stimulation (e.g., electrode contact #2 and electrode contact #3), frequency (e.g., the number of electrical stimulation pulse signals per second, in Hz), pulse width (duration of each pulse, in μs), amplitude (generally expressed as voltage, i.e., the intensity of each pulse, in V), timing (e.g., continuous or bursty, bursty refers to discontinuous temporal behavior composed of multiple processes), stimulation mode (including one or more of current mode, voltage mode, timed stimulation mode, and cyclic stimulation mode), physician control upper and lower limits (the range that the physician can adjust), and patient control upper and lower limits (the range that the patient can adjust independently).

[0048] In some embodiments, the stimulation parameters of the stimulator can be adjusted in current mode or voltage mode.

[0049] Programmable devices can include physician-controlled devices (i.e., devices used by physicians) and / or patient-controlled devices (i.e., devices used by patients). Physician-controlled devices are, for example, smart terminal devices such as tablets, laptops, desktop computers, and mobile phones equipped with programming software. Patient-controlled devices are, for example, smart terminal devices such as tablets, laptops, desktop computers, and mobile phones equipped with programming software; patient-controlled devices can also be other electronic devices with programming functions (e.g., chargers with programming functions, electrophysiological acquisition devices, etc.).

[0050] like Figures 2-6 As shown, this embodiment provides a protective sleeve for connecting the extension wire 100 and the electrode wire 200. The protective sleeve 300 includes a sleeve body 310 and a clamping member 320. The sleeve body 310 includes a first body portion 311 and a second body portion 312 disposed at both ends. The first body portion 311 is sleeved and connected to the extension wire 100, and the second body portion 312 is sleeved on the electrode wire 200. The clamping member 320 is annular and disposed on the sleeve body 310. The clamping member 320 is a shape memory member. When the temperature is lower than a preset temperature, the clamping member 320 is in a relaxed state, and at least a portion of the sleeve body 310 is in a clearance fit with the extension wire 100 and / or the electrode wire 200. When the temperature is greater than or equal to the preset temperature, the clamping member 320 is in a contracted state, and at least a portion of the sleeve body 310 is in a tight fit with the extension wire 100 and / or the electrode wire 200.

[0051] For example, the preset temperature is about 35°C. At normal temperature (such as the temperature of the use environment is about 25°C), which is lower than the preset temperature, the clamping member 320 remains in a relaxed state. When the protective cover 300 is implanted into the human body along with the extension wire 100, it is affected by the human body ambient temperature (generally the human body ambient temperature is above 36°C). When the human body ambient temperature is higher than the preset temperature, the clamping member 320 reaches a contracted state.

[0052] When the clamping member 320 is used to make at least a portion of the sleeve body 310 and the extension wire 100 either in a clearance fit or a tight fit, that is, when the clamping member 320 is in a relaxed state, at least a portion of the sleeve body 310 and the extension wire 100 are in a clearance fit, which facilitates their installation; when the clamping member 320 is in a contracted state, it contracts and squeezes inward, thereby squeezing the sleeve body 310 and tightly fitting at least a portion of the sleeve body 310 and the extension wire 100 to form a first sealing area 410, thereby achieving a sealed connection between the sleeve body 310 and the extension wire 100. The extension wire 100 is connected to the first body part 311 at one end of the sleeve body 310, and the electrode wire 200 is connected to the second body part 312 at the other end of the sleeve body 310. The connection between the electrode wire 200 and the extension wire 100 is covered inside the sleeve body 310. For the extension wire 100 end, the reliance on the doctor's suture technique is reduced, and the protective sleeve 300 effectively seals the extension wire 100, ensuring the contact connection effect after the electrode wire 200 and the extension wire 100 are connected, thereby ensuring the product function. When removal is required, after removal from the human body, the retaining member 320 returns to a relaxed state, facilitating the removal of the extension wire 100 from the protective sleeve 300. The specific preset temperature is adaptively set according to experiments and usage conditions.

[0053] When the clamping member 320 is used to allow at least a portion of the sleeve body 310 to have a clearance fit or a tight fit with the electrode lead 200, i.e., when the clamping member 320 is in a relaxed state, at least a portion of the sleeve body 310 and the electrode lead 200 have a clearance fit, facilitating their installation. When the clamping member 320 is in a contracted state, it contracts inward and compresses, thereby compressing the sleeve body 310 and tightly fitting at least a portion of the sleeve body 310 with the electrode lead 200, thus achieving a sealed connection between the sleeve body 310 and the electrode lead 200. For one end of the electrode lead 200, the reliance on the doctor's ligation technique is reduced, allowing the protective sleeve 300 to effectively seal the extension lead 100, ensuring the contact connection effect after the electrode lead 200 and the extension lead 100 are connected, thereby ensuring product functionality. When removal is required, after removal from the body, the clamping member 320 returns to a relaxed state, facilitating the removal of the electrode lead 200 from the protective sleeve 300.

[0054] like Figure 6As shown, the sleeve body 310 also includes an intermediate body part 313 disposed between the first body part 311 and the second body part 312, and the intermediate body part 313 is sleeved at the connection between the extension wire 100 and the electrode wire 200; the clamping member 320 includes a first part 321 and a second part 322, the first part 321 is disposed in the first body part 311, and the second part 322 is disposed in the intermediate body part 313. In the relaxed state, both the first body part 311 and the intermediate body part 313 are in clearance fit with the extension wire 100. In the contracted state, the clamping member 320 compresses the first body part. The first part 321 and the middle body part 313 are fitted to the extension wire 100. The clamping member 320 can squeeze the first body part 311 to achieve a seal by clamping the extension wire 100 by providing the first part 321. By providing the second part 322, it can squeeze the middle body part 313 to achieve a seal by clamping the connection between the electrode wire 200 and the extension wire 100. The length of the clamping member 320 is increased, which increases the length of the compression protective sleeve 300, thereby increasing the sealing area between the protective sleeve 300 and the extension wire 100 and further improving the sealing effect.

[0055] Continue to refer to Figure 6 The extension wire 100 includes a connecting portion, which includes a receiving channel 130 for receiving the electrode wire 200. Multiple sealing structures 110 and mating structures 120 are alternately arranged along the length of the receiving channel 130. The connector 210 of the electrode wire 200 extends into the receiving channel 130 to form a connection between the extension wire 100 and the electrode wire 200. The mating structure 120 is electrically connected to the electrode wire 200. Specific details can be found in existing technology and will not be elaborated further. The sealing structure 110 is elastic, like a sealing ring, and has high elasticity. Under the compression of the clamping member 320 and the intermediate body portion 313, the sealing structure 110 can undergo elastic deformation. The sealing effect of the intermediate body portion 313 and the sealing structure 110 is better than that of the intermediate body portion 313 and the mating structure 120, causing the second part 322 to compress the intermediate body portion 313 and the sealing structure 110 to form a second sealing area 420.

[0056] like Figure 6As shown, from left to right, the body 310 is divided into a first body part 311, a middle body part 313, and a second body part 312. The first body part 311 is the leftmost dashed frame portion, which forms the first sealing area 410. The middle body part 313 is the large dashed frame portion, in which multiple sealing structures 110 are located. The second part 322 is sealed to the multiple sealing structures 110 to form multiple second sealing areas 420. The contacts are located between the two second sealing areas 420, which realizes the individual sealing of multiple contacts. The first sealing area 410 and the second sealing area 420 insulate the portion of the extension wire 100 outside the contacts and the channels between each contact, further improving the contact connection effect after the electrode wire 200 and the extension wire 100 are connected.

[0057] Optionally, the clamping member 320 further includes a third part disposed on the second body portion 312. In the relaxed state, the second body portion 312 is in clearance fit with the electrode wire 200. In the contracted state, the clamping member 320 squeezes the second body portion 312 to fit against the electrode wire 200. By providing the third part, the clamping member 320 can squeeze the second body portion 312 to clamp and seal the electrode wire 200.

[0058] The first part 321, the second part 322, and the third part can be an integral structure or a separate structure. The clamping member 320 with an integral structure is easier to manufacture. The clamping member 320 with a separate structure can be adapted to the specific sealing connection position as needed. For example, only one of the first part 321, the second part 322, and the third part can be set, or only two of them can be set, or all three can be set at the same time. Furthermore, for the second part 322, it can be divided into multiple segments. The segments of the second part 322 are set only on the middle body part 313 at the position corresponding to the sealing structure 110. This provides good flexibility, reduces the arrangement of shape memory parts, and saves materials.

[0059] The clamping component 320 is a shape memory alloy or shape memory polymer component. Specifically, the material of the clamping component 320 can be a Ni-Ti based, Ag-based, Au-based, Co-based, or other shape memory alloy material, or it can be a polyurethane polymer or epoxy resin polymer or other shape memory polymer material. The sleeve body 310 is a shape memory polymer component, such as a polyurethane polymer or epoxy resin polymer.

[0060] The clamping member 320 is embedded within the sleeve body 310, either in the middle layer or on the outer surface of the sleeve body 310. It is sufficient that the clamping member 320, in both relaxed and contracted states, can compress the protective sleeve 300, causing deformation and thus compressing the extension wire 100. The clamping member 320 should not be completely located on the inner surface of the sleeve body 310 to prevent separation from the sleeve body 310 in the contracted state, which would prevent a proper seal between the clamping member 320 and the sleeve body 310, thus affecting the sealing effect on the extension wire 100. When the first part 321, the second part 322 and the third part are separate structures, they can be partially embedded in the middle layer of the sleeve body 310, and the other part can be sleeved outside the sleeve body 310. For example, the first part 321 and the third part are set outside the sleeve body 310, and the second part 322 is embedded in the middle layer of the sleeve body 310. Alternatively, the first part 321 and the second part 322 are an integral structure, both embedded in the middle layer of the sleeve body 310, while the third part is sleeved outside the sleeve body 310.

[0061] The protective sleeve 300 and the clamping component 320 are easy to manufacture, including: first, prefabricating the clamping component 320 by winding, weaving, laser cutting, or CNC forming metal round or flat wires to make the clamping component 320 spiral, mesh, or ring-shaped. Then, the clamping component 320 is embedded into the sleeve body 310 material through secondary molding, such as by overmolding, injection molding, compression molding, remolding, or 3D printing. The above molding methods are all existing technologies and will not be described in detail.

[0062] Optionally, the inner surface of the sleeve body 310 is provided with a coating for adsorption with the outer surface of the extension wire 100. Optionally, the coating is an anaerobic adhesive coating. After the anaerobic adhesive and the extension wire 100 come into contact, they are cured and connected to achieve sealing and insulation between the extension wire 100 and the sleeve body 310.

[0063] Optionally, the inner surface of the sleeve body 310 has a nano-etched structure for mating with the outer surface of the extension wire 100, so that the two form a concave-convex mating structure. When the sleeve body 310 and the extension wire 100 are mated, one surface has a protrusion and the other forms a groove. The groove and the protrusion can be nested in each other and tightly connected to achieve a seal.

[0064] Optionally, by controlling the fit gap between the sleeve body 310 and the extension wire 100, a vacuum adsorption effect can be formed after installation to achieve sealing and insulation between the contacts.

[0065] The second body part 312 is interference-fitted with the electrode lead 200, achieving a sealed connection between the electrode lead 200 and the protective sleeve 300. This eliminates the need for the wire binding method used in existing technologies, further reducing reliance on the doctor's technique. The electrode lead 200 is interference-fitted to the second body part 312, achieving a sealed connection between the electrode lead 200 and the second body part 312. The extension lead 100 is sealed to the first body part 311 via the clamping member 320, achieving a sealed connection between the extension lead 100 and the first body part 311. This creates a sealed cavity formed by the electrode lead 200, the extension lead 100, and the sleeve body 310. The connection point between the electrode lead 200 and the extension lead 100 is located within this sealed cavity, achieving a sealed and insulating performance at the connection point. This ensures the contact insulation effect after the electrode lead 200 and the extension lead 100 are connected, thereby ensuring product functionality.

[0066] Optionally, the inner side of the second body 312 is provided with a sealing rib 314, which is interference-fitted with the electrode wire 200, thereby achieving a sealed connection between the second body 312 and the electrode wire 200 through the sealing rib 314. This interference-fit sealing connection relies on the dimensional interference of the parts themselves, reducing reliance on the doctor's technique. It eliminates the need for additional sealing elements such as sealing rings or sealant structures, simplifying the number of parts and assembly process, and preventing seal failure due to aging, deformation, or detachment of sealing elements. The interference-fit mating surface has high friction due to radial pressure, effectively resisting dynamic loads such as vibration and impact, resulting in high reliability.

[0067] Optionally, two or more sealing ribs 314 are provided. By increasing the number of sealing ribs 314, the sealing connection effect between the sealing ribs 314 and the electrode wire 200 is improved.

[0068] like Figure 3 As shown, optionally, the protective sleeve 300 adopts a light-transmitting structure, which allows for real-time observation of the installation status of the extension wire 100 and the electrode wire 200 during the installation process. This facilitates identification of whether the extension wire 100 and the electrode wire 200 are installed in place, further ensuring the contact insulation effect after the electrode wire 200 and the extension wire 100 are connected.

[0069] This embodiment also provides an implantable electrical stimulation system, including a protective sleeve 300 as described above. By providing a clamping member 320 with shape memory function on the sleeve body 310, the clamping member 320 squeezes the sleeve body 310 in the contracted state, so that the sleeve body 310 fits tightly against the extension wire 100, thereby achieving a seal on the extension wire 100 and reducing the dependence on the doctor's technique.

[0070] Obviously, the above embodiments of this utility model are merely examples for clearly illustrating the present utility model, and are not intended to limit the implementation of the present utility model. Those skilled in the art can make other variations or modifications based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of this utility model should be included within the protection scope of the claims of this utility model.

Claims

1. A protective sleeve for connecting an extension wire (100) and an electrode wire (200), characterized in that, The protective case includes: The body (310) includes a first body part (311) and a second body part (312) disposed at both ends. The first body part (311) is sleeved and connected to the extension wire (100), and the second body part (312) is sleeved on the electrode wire (200). A clamping member (320) is provided on the sleeve body (310); the clamping member (320) is a shape memory member. When the temperature is lower than the preset temperature, the clamping member (320) is in a relaxed state, and at least part of the sleeve body (310) is in clearance fit with the extension wire (100) and / or the electrode wire (200); when the temperature is greater than or equal to the preset temperature, the clamping member (320) is in a contracted state, so that at least part of the sleeve body (310) is in close contact with the extension wire (100) and / or the electrode wire (200).

2. The protective sleeve according to claim 1, characterized in that, The sleeve body (310) further includes an intermediate body part (313) disposed between the first body part (311) and the second body part (312), the intermediate body part (313) being sleeved at the connection between the extension wire (100) and the electrode wire (200); the clamping member (320) includes a first part (321) disposed on the outer periphery of the first body part (311) and a second part (322) disposed on the outer periphery of the intermediate body part (313).

3. The protective sleeve according to claim 2, characterized in that, The extension wire (100) includes a connecting portion, which includes a receiving channel (130) for receiving the electrode wire (200). Multiple sealing structures (110) and docking structures (120) are alternately arranged along the length direction in the receiving channel (130). The connector (210) of the electrode wire (200) extends into the receiving channel (130) and is electrically connected to the docking structure (120). The sealing structure (110) is elastic.

4. The protective sleeve according to claim 2, characterized in that, The clamping member (320) also includes a third part disposed on the second body part (312).

5. The protective sleeve according to claim 4, characterized in that, The first part (321), the second part (322) and the third part are either an integral structure or a separate structure.

6. The protective sleeve according to claim 2, characterized in that, The second body part (312) is interference-fitted with the electrode wire (200).

7. The protective sleeve according to claim 6, characterized in that, The inner side of the second body part (312) is provided with a sealing rib (314), and the sealing rib (314) is interference-fitted with the electrode wire (200).

8. The protective sleeve according to claim 1, characterized in that, The sleeve body (310) is a shape memory polymer component, and / or the clamping component (320) is a shape memory alloy component or a shape memory polymer component.

9. The protective sleeve according to claim 1, characterized in that, The clamping member (320) is embedded inside the sleeve body (310), or the clamping member (320) is sleeved outside the sleeve body (310).

10. The protective sleeve according to claim 1, characterized in that, The inner surface of the sleeve body (310) is provided with a coating, which is used to adhere to the outer surface of the extension wire (100); and / or, the inner surface of the sleeve body (310) is a nano-etched structure, which is used to cooperate with the outer surface of the extension wire (100) to form a concave-convex fit structure between the two.

11. The protective sleeve according to claim 1, characterized in that, The clamping element (320) is spiral, mesh, or ring-shaped.

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