An implantable seal assembly and an implantable medical device

Abstract

The utility model discloses an implantable sealing assembly and implantable medical instrument, wherein, implantable sealing assembly is used to install in implantable medical instrument to seal and separate the inside of implantable medical instrument with outside, implantable sealing assembly is provided with the cutout of through, the cutout is used to be opened up when cooperation with adjusting tool and resets when separating with adjusting tool, implantable sealing assembly includes sealing main part and the temperature sensing restraint of installing in sealing main part, the cutout is provided on sealing main part, and the temperature sensing restraint is arranged in the outer periphery of cutout and contracts or relaxes according to temperature change to press fit or release cutout. The utility model discloses implantable sealing assembly and implantable medical instrument are used to improve the sealing effect of sealing assembly, reduce the risk or degree of patient body fluid through sealing assembly and infiltrate implantable medical instrument.

Description

Technical Field

[0001] This utility model relates to the field of implantable medical device technology, and in particular to an implantable sealing component and an implantable medical device. Background Technology

[0002] In treating conditions with lesions within the body, implantable medical devices are used to apply corresponding effects to the lesions to alleviate symptoms or treat the underlying condition. For example, in treating 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, a combined approach of deep brain stimulation (DBS) and medication is employed. DBS involves inserting electrode leads into the lesion within the patient's body to deliver electrical stimulation.

[0003] Deep brain stimulation (DBS) involves an implantable medical device comprising a stimulator, extension leads, and electrode leads. The stimulator transmits electrical signals to the electrode leads via the extension leads, allowing the electrode leads to apply electrical stimulation to the patient's lesion. The connection between the extension leads and electrode leads is secured with fasteners. Notches are provided at the fastener locations on the extension leads for adjusting the fasteners. Adjustment fixtures are used to adjust the fasteners, allowing for fixation or loosening of the electrode leads. Because the extension leads and electrode leads are implanted in the patient's body, there is a risk that bodily fluids may seep into the extension leads through the notches. This fluid may affect the electrical connection between the extension leads and electrode leads, thus impacting the effectiveness of the electrical stimulation.

[0004] In related technologies, a slit-shaped seal is used to seal the opening and prevent bodily fluids from seeping in. An adjustment fixture opens the slit of the seal to engage with a fastener, and after the fastener is adjusted and separated from the seal, the seal elastically returns to its original position, closing the slit. Electrode leads and extension leads are then implanted into the patient, and the seal prevents bodily fluids from entering the extension leads.

[0005] After the extension lead is implanted in the patient's body, the patient's daily activities will come into contact with the seal on the extension lead and may squeeze the seal. After the seal is deformed by pressure, the incision may be slightly opened and a channel may be formed. Body fluid may seep into the extension lead from the channel and affect the electrical connection between the extension lead and the electrode lead. Summary of the Invention

[0006] The purpose of this invention is to provide an implantable sealing component and an implantable medical device to improve the sealing effect of the sealing component and reduce the risk or extent of the patient's body fluid passing through the sealing component and seeping into the implantable medical device.

[0007] The objective of this utility model is achieved through the following technical solution: An implantable sealing assembly is provided for installation in an implantable medical device to seal and separate the interior of the implantable medical device from the outside. The implantable sealing assembly has a through incision for being opened when engaged with an adjustment fixture and repositioned when separated from the adjustment fixture. The implantable sealing assembly includes a sealing body and a temperature-sensitive restraint mounted on the sealing body. The sealing body has the incision, and the temperature-sensitive restraint is disposed on the outer periphery of the incision and contracts or relaxes according to temperature changes to press or release the incision.

[0008] Preferably, the temperature-sensitive constraint is made of shape memory alloy material; when the temperature of the implantable sealing component is greater than or equal to a certain threshold, the temperature-sensitive constraint contracts and presses against the incision; when the temperature of the implantable sealing component is less than a certain threshold, the temperature-sensitive constraint relaxes to release the incision.

[0009] Preferably, the temperature-sensing constraint is disposed around the outer periphery of the cut; The temperature-sensing constraint element is ring-shaped, mesh-shaped, or spiral-shaped; The temperature of the implantable sealing component has a certain threshold that is greater than room temperature and less than or equal to the internal temperature of the human body.

[0010] Preferably, the outer wall of the sealing body is provided with a recess, the recess is located on the outer periphery of the cut, and the recess direction of the recess intersects with the depth direction of the cut, and the temperature-sensing constraint is disposed in the recess; Alternatively, the temperature-sensing constraint is embedded within the sealing body and is covered by the sealing body.

[0011] Preferably, the aspect ratio of the cut is greater than 2.

[0012] Preferably, the cut extends vertically through the sealing body, and the temperature-sensitive constraint is horizontally arranged and includes a first part and a second part. The first part and the second part are distributed on opposite sides of the cut along the width direction of the cut. The first part and the second part contract and move closer together to press the cut or expand and relax to release the cut according to temperature changes.

[0013] Preferably, the material of the temperature-sensing constraint is a Ni-Ti-based, Ag-based, Au-based, or Co-based shape memory alloy; or, the material of the temperature-sensing constraint is a polyurethane polymer or an epoxy resin polymer. The sealing body is made of elastic sealing material.

[0014] Preferably, a fixing layer is provided on the side wall of the sealing body, and the implantable sealing assembly is sealed to the implantable medical device through the fixing layer.

[0015] An implantable medical device, comprising: An extension wire is provided with a notch extending from the outer wall into the interior of the extension wire; Any of the above-mentioned implantable sealing components is sealed and installed at the notch of the extension wire to separate the outside from the inside of the extension wire.

[0016] Preferably, one end of the extension wire is provided with a connector, the inside of the connector is for inserting an electrode wire, the connector is provided with a notch communicating with the outside of the connector, and a fastening screw is provided at the notch, the fastening screw is used to pass through the connector to fix the electrode wire. The fastening screw is located inside the implanted sealing assembly.

[0017] Preferably, the connector includes an insulating shell with the notch provided, the fastening screw and the connector are disposed inside the insulating shell, and the implanted sealing assembly is sealed to the insulating shell through a fixing layer.

[0018] Compared with the prior art, the beneficial effects of this utility model include at least the following: By incorporating a temperature-sensitive restraint to constrain the incision, the restraint can relax to release the incision when the implantable sealing component is not implanted in the patient's body. This allows for easy adjustment of the jig through the incision to regulate the internal components of the implantable medical device. When the implantable sealing component is implanted in the patient's body, the restraint can contract and compress the incision. The restraining effect of the temperature-sensitive restraint prevents the incision from deforming and opening. During the patient's daily activities, the restraint can prevent the incision from deforming and expanding, thereby ensuring the long-term reliability of the seal of the implantable sealing component, ensuring its sealing effect, and reducing the risk or extent of the patient's bodily fluids passing through the sealing component and seeping into the implantable medical device. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of the structure of the implantable sealing component of this utility model when it is installed in an implantable medical device; Figure 2 This is a cross-sectional view of the implantable sealing component of this utility model when it is installed in an implantable medical device. Figure 3 This is a cross-sectional view of the implantable medical device according to an embodiment of the present invention when the implantable sealing component is not installed; Figure 4 This is a schematic diagram of the structure of the implantable sealing component according to an embodiment of the present invention; Figure 5 This is a cross-sectional view of the implantable sealing component according to an embodiment of the present invention; Figure 6 This is a cross-sectional view of the implantable sealing component according to an embodiment of the present invention, taken from another cutting plane; Figure 7 This is a schematic diagram of the structure of an implantable sealing component according to another embodiment of the present invention; Figure 8 This is a cross-sectional view of an implantable sealing component according to another embodiment of the present invention.

[0020] In the diagram: 100, Implantable sealing assembly; 1, Sealing body; 11, Cutout; 12, Recess; 2, Temperature-sensitive restraint; 21, First part; 22, Second part; 200, Extension wire; 201, Connector; 202, Notch; 203, Fastening screw; 204, Mounting channel; 205, Insulating shell; 206, Spring seat; 207, Sealing ring; 208, Connecting block. Detailed Implementation

[0021] Exemplary embodiments will now be described more fully with reference to the accompanying drawings. However, these exemplary embodiments can be implemented in many forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided to make the present invention more comprehensive and complete, and to fully convey the concept of the exemplary embodiments to those skilled in the art. The same reference numerals in the drawings denote the same or similar structures, and therefore repeated descriptions of them will be omitted.

[0022] The terms used to describe position and direction in this utility model are illustrated with the accompanying drawings, but changes can be made as needed, and all such changes are included within the scope of protection of this utility model.

[0023] like Figures 1 to 8 As shown, this utility model provides an implantable sealing component 100, which can be installed in an implantable medical device, specifically in the portion of the implantable medical device intended for implantation into a patient's body. The implantable sealing component 100 separates the interior of the implantable medical device from the outside environment. When the implantable medical device is implanted into the patient's body, the implantable sealing component 100 prevents bodily fluids from seeping into the implantable medical device. The implantable sealing component 100 includes a sealing body 1 and a temperature-sensitive restraint member 2.

[0024] Reference Figure 2 and Figure 4The sealing body 1 can be made of a sealing material, specifically an elastic sealing material, and has a through incision 11. Under normal conditions, the incision 11 of the sealing body 1 is closed, preventing or hindering the passage of bodily fluids and other substances. When adjustments are needed to internal components of the implantable medical device, such as adjusting the fastening screw 203 used to fix the electrode wires, a corresponding adjustment fixture can be inserted into the incision 11 of the sealing body 1. The incision 11 is opened by the pressure of the adjustment fixture, allowing the fixture to pass through the sealing body 1 to adjust the fastening screw 203. After adjustment, the adjustment fixture is removed, and the sealing body 1 elastically resets, causing the incision 11 to close again. Specifically, the sealing body 1 can be made of silicone.

[0025] A temperature-sensitive restraint element 2 is installed on the sealing body 1 and positioned on the outer periphery of the incision 11. The temperature-sensitive restraint element 2 can contract or relax according to temperature changes. Specifically, when the temperature of the implantable sealing component 100 is below a certain threshold, the temperature-sensitive restraint element 2 can relax; when the temperature of the implantable sealing component 100 is greater than or equal to a certain threshold, the temperature-sensitive restraint element 2 can contract. In actual treatment, the implantable sealing component 100 is installed outside the patient's body within the implantable medical device, at which time the implantable sealing component 100 is located in a room temperature environment. After the implantable sealing component 100 is implanted into the human body, there will be a temperature difference between the internal temperature of the human body and the room temperature, resulting in two different states for the implantable sealing component 100 before and after implantation. Specifically, the internal temperature of the human body is greater than or equal to a certain threshold, while the room temperature is less than a certain threshold.

[0026] Specifically, before the implantable sealing component 100 is implanted into the patient's body, the temperature-sensitive restraint 2 is relaxed and exerts virtually no restraining force on the incision 11, i.e., the temperature-sensitive restraint 2 releases the notch 202. At this time, the adjusting fixture can open the incision 11 and adjust the fastening screw 203. After the implantable sealing component 100 is implanted into the patient's body, the temperature-sensitive restraint 2 contracts due to temperature changes. After contraction, the temperature-sensitive restraint 2 restrains the incision 11 located inside the temperature-sensitive restraint 2, thereby causing the incision 11 to close, i.e., the temperature-sensitive restraint 2 presses the incision 11. When the patient is active, even if the implantable sealing component 100 comes into contact with and is squeezed, the restraining effect of the temperature-sensitive restraint 2 can prevent the incision 11 from deforming and opening, thereby ensuring the sealing effect of the implantable sealing component 100 and reducing the risk or extent of the patient's body fluid passing through the sealing component and seeping into the implantable medical device.

[0027] The temperature-sensitive restraint component 2 can be made of shape memory alloy. Shape memory alloys have a memory effect; that is, after the shape of the alloy is changed, it will return to its original shape once heated to a certain temperature threshold. The temperature-sensitive restraint component 2 can restrain the incision 11 and drive it to close within the body's internal temperature environment. When the temperature-sensitive restraint component 2 is at room temperature, i.e., outside the patient's body, it can be in a relaxed state. Even if adjusting the fixture to open the opening causes a change in the shape of the temperature-sensitive restraint component 2, it can still return to its original shape after implantation, i.e., return to restraining the incision 11 and driving it to close.

[0028] The material of the temperature-sensitive restraint component 2 can be any one of Ni-Ti-based, Ag-based, Au-based, or Co-based shape memory alloy materials. The temperature-sensitive restraint component 2 can be made by winding, weaving, laser cutting, or CNC forming of metal round or flat wires. Alternatively, the material of the temperature-sensitive restraint component 2 can also be a polymer material, such as polyurethane polymer or epoxy resin polymer, which can be injection molded. The jump temperature of the temperature-sensitive restraint component 2 is greater than room temperature and less than or equal to the internal body temperature, so that the temperature-sensitive restraint component 2 relaxes at room temperature. When the temperature-sensitive restraint component 2 is implanted into the patient's body, its temperature reaches the jump temperature and returns to a contracted state to drive the incision 11 to close. The jump temperature is the required temperature for the temperature-sensitive restraint component 2 to return to its original state. The jump temperature of the temperature-sensitive restraint component 2 is also a certain threshold temperature that the implantable sealing component 100 needs to reach when the temperature-sensitive restraint component 2 contracts.

[0029] A temperature-sensitive constraint member 2 is disposed around the outer periphery of the cut 11. The direction of the temperature-sensitive constraint member 2 intersects the depth direction of the cut 11, preferably perpendicular to the depth direction of the cut 11. Specifically, the temperature-sensitive constraint member 2 is placed horizontally, that is, the extension axis of the temperature-sensitive constraint member 2 is located in a horizontal plane, and the cut 11 extends vertically to penetrate the sealing body 1. At this time, the width direction of the cut 11 is horizontal. The aspect ratio of the cut 11 is greater than 2. In the preferred embodiment, the cut is a long and narrow slit. Referring to... Figure 6The temperature-sensitive restraint 2 includes a first part 21 and a second part 22, which can be distributed on opposite sides of the incision 11 along the width direction of the incision 11. When the temperature-sensitive restraint 2 is at room temperature, the first part 21 and the second part 22 are in a relaxed state and release the opening to reduce the restraining force of the temperature-sensitive restraint 2 on the incision 11, thereby facilitating the adjustment of the fixture on the fastening screw 203. After the temperature-sensitive restraint 2 is implanted into the patient's body, the first part 21 and the second part 22 of the temperature-sensitive restraint 2 contract, and the first part 21 and the second part 22 tend to move closer to each other. The first part 21 and the second part 22 apply a clamping force to the sealing body 1 along the width direction of the incision 11, and the width of the incision 11 shrinks to 0 or close to 0 under the action of the clamping force. At this time, the incision 11 is in a sealed state. Furthermore, this clamping force can counteract the force exerted on the incision 11 during patient movement, causing the incision 11 to deform. This ensures that the incision 11 remains sealed during patient movement, guaranteeing the sealing effect of the implantable sealing component 100 and reducing the risk or extent of patient bodily fluids passing through the sealing component and seeping into the implantable medical device. The first part 21 and the second part 22 can be an integrally connected structure. The first part 21 and the second part 22 are symmetrical to each other.

[0030] The temperature-sensing constraint 2 is a ring-shaped structure, which is arranged around the outer periphery of the cut 11; or, the temperature-sensing constraint 2 can be a mesh structure, which extends along a circular path around the cut 11 so that the temperature-sensing constraint 2 can surround the outer periphery of the cut 11; or, the temperature-sensing constraint 2 can be a spiral structure, which extends along a circular path around the cut 11 so that the temperature-sensing constraint 2 can surround the outer periphery of the cut 11.

[0031] Reference Figure 4 and Figure 5 In some specific embodiments, the outer wall of the sealing body 1 may be provided with a recess 12, which is located on the outer periphery of the cut 11, and the recess direction of the recess 12 intersects the depth direction of the notch 202. For example, the recess 12 is recessed into the sealing body 1 in a horizontal direction. The temperature-sensing restraint 2 is disposed in the recess 12 to realize the connection between the temperature-sensing restraint 2 and the sealing body 1. When preparing the implantable sealing assembly 100, the temperature-sensing restraint 2 and the sealing body 1 can be prepared in advance. The sealing body 1 is cut to form the cut 11, and then the temperature-sensing restraint 2 is installed in the recess 12 of the sealing body 1 at room temperature.

[0032] Reference Figure 7 and Figure 8In some other embodiments, the temperature-sensing constraint 2 can be embedded within the sealing body 1, that is, the temperature-sensing constraint 2 is covered by the sealing body 1. When preparing the implantable sealing assembly 100, the temperature-sensing constraint 2 can be prepared in advance, and then the sealing body 1 covering the temperature-sensing constraint 2 can be formed by overmolding, and the sealing body 1 can be cut to form a cut 11.

[0033] In some specific embodiments, a fixing layer is provided on the side wall of the sealing body 1. When the implantable sealing assembly 100 is installed in the implantable medical device, the sealing body 1 of the implantable sealing assembly 100 is sealed and fixedly connected to the implantable medical device through the fixing layer. The fixing layer can be an adhesive layer coated on the side wall of the sealing body 1. After the side wall of the sealing body 1 is coated with adhesive and installed in the implantable medical device, the sealing body 1 can be sealed and fixedly connected to the implantable medical device after the adhesive has cured.

[0034] Reference Figures 1 to 3 The present invention also provides an implantable medical device, including an extension lead 200, the aforementioned implantable sealing assembly 100, and may further include a stimulator and electrode leads.

[0035] The extension lead 200 is connected to both the stimulator and the electrode lead, allowing the stimulator to transmit electrical signals to the electrode lead via the extension lead 200, thereby enabling the electrode lead to apply stimulation to the lesion site within the patient's body. One end of the extension lead 200 is provided with a connector 201 for connection to the electrode lead.

[0036] The connector 201 may have a notch 202, and the connector 201 internally has an installation channel 204 for accommodating electrode wires. The notch 202 extends from the outer wall of the connector 201 extending the wire 200 into the interior of the connector 201, so that the notch 202 can connect the installation channel 204 to the outside. A fastening screw 203 can be installed at the notch 202. Specifically, the connector 201 may include a connecting block 208, which has a channel for accommodating part of the electrode wires. The connecting block 208 is located below the notch 202 and has a threaded channel that mates with the fastening screw 203. The threaded channel communicates with the notch 201 and can be part of the installation channel 204. The fastening screw 203 is screwed into the connecting block 208 through the threaded channel to press and fix the electrode wires.

[0037] A portion of the electrode lead can be inserted into the mounting channel 204 of the connector 201. The fastening screw 203 can be tightened into the mounting channel 204 to press and secure the electrode lead to the connector 208, or it can be unscrewed out of the mounting channel 204 to release the electrode lead. The notch 202, which communicates with the outside, allows an adjustment fixture for turning the fastening screw 203 to engage with it, facilitating adjustment of the fastening screw 203.

[0038] In some specific embodiments, an insulating shell 205 and a connecting assembly may also be disposed within the connector 201. A notch 202 is formed on the insulating shell 205. The insulating shell 205 is made of insulating material, and components such as the connecting assembly, connector 201, and fastening screws 203 are all installed within the insulating shell 205. The connecting assembly includes multiple spring seats 206 and multiple sealing rings 207. The spring seats 206 and sealing rings 207 are alternately spaced, such that each spring seat 206 has a sealing ring 207 on both sides. The sealing rings 207 are made of insulating material, and adjacent spring seats 206 are separated by the sealing rings 207. The interiors of the spring seats 206 and sealing rings 207 are hollow and can accommodate electrode wires. When the electrode wire is inserted into the connector 201, multiple contacts on the electrode wire can be connected one-to-one with the multiple spring seats 206 to achieve electrical connection between the electrode wire and the extension wire 200. The connector 201 is located on one side of the connecting assembly and can abut against the sealing ring 207 at one end of the connecting assembly.

[0039] An implantable sealing component 100 is installed at the notch 202, and the implantable sealing component 100 can be located outside the fastening screw 203. The fastening screw 203, connector 201, and other components located inside the notch 202, as well as the installation channel 204, are sealed and separated from the outside environment by the implantable sealing component 100. The implantable sealing component 100 can be embedded within the notch 202, and the upper surface of the implantable sealing component 100 can be flush with the outer wall of the connector 201. The implantable sealing component 100 is sealed and fixedly attached to the wall forming the notch 202 by a fixing layer.

[0040] During the assembly of the implantable medical device, the electrode lead is inserted into the connector 201 of the extension lead 200, and the contacts of the electrode lead are aligned with the spring seat 206 within the connector 201. The fastening screw 203 and the implantable sealing assembly 100 are then installed on the connector 201. An adjustment fixture, which mates with the fastening screw 203, is used to open and pass through the incision 11 of the implantable sealing assembly 100 to adjust the fastening screw 203, causing it to extend into the connector block 208 and press and secure the electrode lead. The adjustment fixture is then removed. The electrode lead and extension lead 200 are implanted into the patient's body. The temperature-sensitive restraint 2 of the implantable sealing assembly 100 heats up and contracts to apply a force that tends to close the incision 11. During the patient's daily activities, the temperature-sensitive restraint 2 prevents the incision 11 from deforming and expanding, thereby ensuring the long-term reliability of the seal of the implantable sealing assembly 100.

[0041] Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those skilled in the art can make changes, modifications, substitutions and alterations to the above embodiments within the scope of the present invention without departing from the principles and spirit of the present invention, and all such changes should fall within the protection scope of the claims of the present invention.

Claims

1. An implantable sealing assembly for installation in an implantable medical device to seal and separate the interior of the implantable medical device from the outside, the implantable sealing assembly (100) having a through incision (11) for being opened when engaged with an adjustment fixture and repositioned when separated from the adjustment fixture, characterized in that, The implantable sealing assembly (100) includes a sealing body (1) and a temperature-sensitive restraint (2) installed on the sealing body (1). The sealing body (1) has the incision (11). The temperature-sensitive restraint (2) is located on the outer periphery of the incision (11) and contracts or relaxes according to temperature changes to press or release the incision (11).

2. The implantable sealing assembly according to claim 1, characterized in that, The temperature-sensitive restraint (2) is made of shape memory alloy material; when the temperature of the implantable sealing assembly (100) is greater than or equal to a certain threshold, the temperature-sensitive restraint (2) contracts and presses the incision (11); when the temperature of the implantable sealing assembly (100) is less than a certain threshold, the temperature-sensitive restraint (2) relaxes to release the incision (11).

3. The implantable sealing assembly according to claim 2, characterized in that, The temperature-sensitive constraint (2) is arranged around the outer periphery of the cut (11); The temperature-sensing constraint (2) is ring-shaped, mesh-shaped, or spiral-shaped; The temperature of the implantable sealing component (100) has a certain threshold greater than room temperature and less than or equal to the internal temperature of the human body.

4. The implantable sealing assembly according to claim 1, characterized in that, The outer wall of the sealing body (1) is provided with a recess (12), the recess (12) is located on the outer periphery of the cut (11), and the recess direction of the recess (12) intersects with the depth direction of the cut (11), and the temperature sensing constraint (2) is disposed in the recess (12). Alternatively, the temperature-sensing constraint (2) is embedded in the sealing body (1) and covered by the sealing body (1).

5. The implantable sealing assembly according to claim 1, characterized in that, The aspect ratio of the cut (11) is greater than 2.

6. The implantable sealing assembly according to claim 1, characterized in that, The cut (11) extends vertically through the sealing body (1). The temperature-sensitive constraint (2) is horizontally arranged and includes a first part (21) and a second part (22). The first part (21) and the second part (22) are distributed on opposite sides of the cut (11) along the width direction of the cut (11). The first part (21) and the second part (22) shrink and move closer together to press the cut (11) or expand and relax to release the cut (11) according to temperature changes.

7. The implantable sealing assembly according to claim 1, characterized in that, The material of the temperature-sensitive constraint (2) is a Ni-Ti based, Ag based, Au based or Co based shape memory alloy material; or, the material of the temperature-sensitive constraint (2) is a polyurethane polymer or an epoxy resin polymer. The sealing body (1) is an elastic sealing material.

8. The implantable sealing assembly according to claim 1, characterized in that, A fixing layer is provided on the side wall of the sealing body (1), and the implantable sealing assembly (100) is sealed to the implantable medical device through the fixing layer.

9. An implantable medical device, characterized in that, include: The extension wire (200) is provided with a notch (202) extending from the outer wall into the interior of the extension wire (200). The implantable sealing assembly (100) as described in any one of claims 1 to 8 is sealed at the notch (202) of the extension wire (200) to separate the outside from the inside of the extension wire (200).

10. The implantable medical device according to claim 9, characterized in that, One end of the extension wire (200) is provided with a connector (201). The connector (201) is used for inserting an electrode wire. The connector (201) is provided with a notch (202) that connects the inside of the connector (201) to the outside. A fastening screw (203) is provided at the notch (202). The fastening screw (203) is used to pass through the connector (201) to fix the electrode wire. The fastening screw (203) is located inside the implanted sealing assembly (100).

11. The implantable medical device according to claim 10, characterized in that, The connector (201) includes an insulating shell (205) with the notch (202) provided, the fastening screw (203) and the connector (201) are disposed in the insulating shell (205), and the implanted sealing assembly (100) is sealed to the insulating shell (205) through a fixing layer.

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