Sealing assembly and pulse generator

Abstract

A sealing assembly and a pulse generator. The sealing assembly is configured to seal a channel (10) of the pulse generator. An inner hole (100) is formed in the sealing assembly and communicated with the channel (10); the inner hole (100) is configured to allow for insertion of an electrode wire; at least one sealing step portion (200) is provided on the hole wall of the inner hole (100) and protrudes from the hole wall of the inner hole; the side of the sealing step portion (200) close to the channel (10) and the hole wall of the inner hole (100) define a groove (300); the side of the sealing step portion (200) away from the channel (10) and the hole wall of the inner hole (10) define a notch (400); when the electrode wire is inserted into the inner hole (100), the electrode wire is in interference fit with the sealing step portion (200).

Description

Sealing components and pulse generators

[0001] This application claims priority to the Chinese patent application filed with the China Patent Office on June 29, 2023, with application number 202310787697.0, the entire contents of which are incorporated by reference into this application. Technical Field

[0002] The present application relates to the technical field of medical devices, for example, to a sealing assembly and a pulse generator. Background Art

[0003] Neuroelectrical stimulation is a commonly used treatment for neurological disorders and rehabilitation of nerve injuries. Neuroelectrical stimulation systems deliver electrical stimulation to the relevant areas of the brain through an implanted pulse generator and electrodes. The pulse generator is primarily configured to generate electrical stimulation, which is then released into the patient's brain via the stimulation electrodes to aid recovery.

[0004] The pulse generator's channel is configured to receive an electrode lead. A sealing assembly is located at the open end of the channel. The electrode lead is inserted through the open end into the pulse generator's channel and connects to the contact spring inside the channel. The sealing assembly provides a seal, preventing bodily fluids from entering the channel and affecting the normal operation of the pulse generator.

[0005] In related technologies, when the electrode wire is inserted into the channel of the pulse generator, it may not be inserted smoothly or may not be properly inserted; or the electrode wire may easily fall out of the channel, resulting in the risk of electrode wire dislocation or loosening, requiring further surgical correction, which increases the patient's pain.

[0006] Summary of the Invention

[0007] The present application provides a sealing assembly that enables an electrode wire to be easily inserted into an inner hole but difficult to be pulled out of the inner hole.

[0008] The present application provides a sealing assembly configured to seal a channel of a pulse generator, wherein an inner hole is provided in the sealing assembly, the inner hole being in communication with the channel and configured to insert an electrode wire;

[0009] A sealing step portion is protruding from the wall of the inner hole, and the sealing step portion defines a groove with the inner hole on the side close to the channel, and forms a notch with the wall of the inner hole on the side away from the channel. When the electrode wire is inserted into the inner hole, the electrode wire and the sealing step portion have an interference fit.

[0010] In one or more embodiments, the sealing step portion includes a first portion, a second portion, and a third portion, wherein the second portion is disposed between the first portion and the third portion, one side of the second portion is connected to the first portion, and the other side of the second portion is connected to the third portion;

[0011] The first portion and the inner hole define the groove, the second portion and the electrode wire are interference fit, and the third portion and the hole wall of the inner hole form the notch.

[0012] In one or more embodiments, the sealing step, the groove and the notch are all arranged in an annular shape.

[0013] In one or more embodiments, the notch has an inclined surface, and the inclined surface forms a first inclined angle R with the plane where the hole wall of the inner hole is located, and the first inclined angle R is greater than 90°.

[0014] In one or more embodiments, the bottom wall of the groove forms a second inclination angle Q with the plane where the hole wall of the inner hole is located, and the second inclination angle Q is less than 90°.

[0015] In one or more embodiments, the inner hole is coaxially arranged with the channel.

[0016] In one or more embodiments, a plurality of sealing step portions are protruding from the hole wall of the inner hole, and the plurality of sealing step portions are arranged at equal intervals along the axial direction thereof.

[0017] In one or more embodiments, the width A of the groove closest to the channel is smaller than the width B of the remaining grooves.

[0018] As an optional technical solution for a sealing component, the sealing component is a silicone component.

[0019] The present application also provides a pulse generator, which has high safety and can achieve the technical effect of making it easy to insert the electrode wire into the inner hole and difficult to pull it out of the inner hole, thereby saving costs.

[0020] The present application also provides a pulse generator, which includes a head and the sealing assembly described above, wherein the channel is provided in the head, a finger contact spring is provided in the channel, the sealing assembly is sealed at the port of the channel, and the finger contact spring is configured to be in conduction with the electrode wire.

[0021] In one or more embodiments, the pulse generator further includes a shell, which is sealed to the head, a battery and a circuit board are disposed in the shell, the battery is configured to power the circuit board, and the circuit board is electrically connected to the contact spring. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] FIG1 is a schematic structural diagram of a sealing assembly provided in an embodiment of the present application;

[0023] FIG2 is a cross-sectional view of a sealing assembly provided in an embodiment of the present application;

[0024] FIG3 is a schematic structural diagram of a pulse generator provided in an embodiment of the present application;

[0025] FIG4 is a cross-sectional view of a pulse generator provided in an embodiment of the present application.

[0026] Reference numerals 100 , inner hole; 200 , sealing step portion; 210 , first portion; 220 , second portion; 230 , third portion; 300 , groove; 400 , notch; 10 , channel; 11 , finger spring; 20 , head; 30 , housing; 31 , battery. DETAILED DESCRIPTION

[0027] The technical solution of the present application will be described below with reference to the accompanying drawings and through implementation methods.

[0028] In the description of this application, unless otherwise specified or limited, the terms "connected," "connected," and "fixed" should be understood in a broad sense. For example, they can refer to fixed connections, detachable connections, or integration; mechanical connections, electrical connections; direct connections, indirect connections through an intermediate medium, and internal connections between two components or interactions between two components. The meanings of the above terms in this application can be understood based on actual circumstances.

[0029] In this application, unless otherwise specified or limited, a first feature being "above" or "below" a second feature may include the first feature being in direct contact with the second feature, or may include the first feature being in contact with the second feature through another feature between them instead of being in direct contact. Moreover, a first feature being "above," "above," and "above" a second feature may include the first feature being directly above or obliquely above the second feature, or may simply mean that the first feature is higher in level than the second feature. A first feature being "below," "below," and "below" a second feature may include the first feature being directly below or obliquely below the second feature, or may simply mean that the first feature is lower in level than the second feature.

[0030] In the description of this embodiment, the terms "upper," "lower," "left," and "right," etc., regarding orientations or positions, are based on the orientations or positions shown in the accompanying drawings and are intended solely for ease of description and simplified operation. They do not indicate or imply that the devices or components referred to must have, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on this application. Furthermore, the terms "first" and "second" are used solely for descriptive purposes and have no special meanings.

[0031] Typically, implantable medical systems include implantable neurostimulation systems, implantable cardiac stimulation systems (also known as pacemakers), implantable drug delivery systems (IDDS), and lead switching systems. Examples of implantable neurostimulation systems include deep brain stimulation (DBS) systems, implantable cortical nerve stimulation (CNS) systems, implantable spinal cord stimulation (SCS) systems, implantable sacral nerve stimulation (SNS) systems, and implantable vagus nerve stimulation (VNS) systems.

[0032] An implantable neurostimulation system includes a stimulator (i.e., an implantable neurostimulator, a type of neurostimulation device) implanted in the patient's body and a programmable device located outside the patient's body. In other words, the stimulator is an implant, or in other words, the implant includes the stimulator. Related neuromodulation technologies primarily involve implanting electrodes (e.g., in the form of electrode wires) at specific locations (i.e., target sites) in the tissues of a living organism through stereotactic surgery. The electrodes then emit electrical pulses to the target sites, regulating the electrical activity and function of the corresponding neural structures and networks, thereby improving symptoms and alleviating pain. The stimulator may include an implantable pulse generator (IPG), extension wires, and electrode wires. The IPG is located within the patient's body and, in response to programmable instructions sent by the programmable device, relies on sealed batteries and circuits to provide controllable electrical stimulation energy to the tissues within the body. The IPG delivers one or more controllable, specific electrical stimulations to specific areas of the tissue within the body via the extension wires and electrode wires. The extension wires, used in conjunction with the IPG, serve as a transmission medium for the electrical stimulation signals, transmitting the electrical stimulation signals generated by the IPG to the electrode wires. The electrode wire delivers electrical stimulation to a specific area of ​​tissue in the body through a plurality of electrode contacts. The stimulator is provided with one or more electrode wires on one side or both sides, and a plurality of electrode contacts are provided on the electrode wire, and the electrode contacts can be arranged uniformly or non-uniformly in the circumference of the electrode wire. As an example, the electrode contacts can be arranged in an array of 4 rows and 3 columns (a total of 12 electrode contacts) in the circumference of the electrode wire. The electrode contacts may include stimulation electrode contacts and / or collection electrode contacts. The electrode contacts may, for example, be in the shape of a sheet, a ring, a point, or the like.

[0033] In some embodiments, the stimulated body tissue can be the patient's brain tissue, and the stimulated site can be a specific site of the brain tissue. When the patient's disease type is different, the stimulated site is generally different, and the number of stimulation contacts (single source or multiple sources) used, the use of one or more (single channel or multiple channels) specific electrical stimulation signals, and the stimulation parameter data are also different. The embodiments of the present application do not limit the applicable disease types, and can be disease types applicable to DBS, SCS, pelvic stimulation, gastric stimulation, peripheral nerve stimulation, and functional electrical stimulation. Among them, the types of diseases that DBS can be used to treat or manage include, but are not limited to: spastic disorders (e.g., epilepsy), pain, migraine, psychiatric disorders (e.g., Major Depressive Disorder (MDD)), bipolar disorder, anxiety disorders, post-traumatic stress disorder, hypoactive depression, obsessive-compulsive disorder (OCD), behavioral disorders, mood disorders, memory disorders, mental state disorders, movement 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 injuries.

[0034] As shown in Figures 1 to 4, this embodiment provides a sealing assembly configured to seal the channel 10 of the pulse generator. An inner hole 100 is provided in the sealing assembly, and the inner hole 100 is connected to the channel 10, and the inner hole 100 is configured to insert an electrode wire (not shown in the figure). At least one sealing step 200 is convexly provided on the hole wall of the inner hole 100. The side of the sealing step 200 close to the channel 10 defines a groove 300 with the hole wall of the inner hole 100, and the side of the sealing step 200 away from the channel 10 forms a notch 400 with the hole wall of the inner hole 100. When the electrode wire is inserted into the inner hole 100, the electrode wire and the sealing step 200 have an interference fit, that is, the electrode wire and the sealing step 200 have a certain friction force.

[0035] Based on the above design, in this embodiment, the sealing component is configured as a silicone component, that is, the sealing component is made of silicone or rubber material, has a certain elasticity, and has a good sealing effect. As shown in Figure 2, in this embodiment, the sealing step portion 200 includes a first portion 210, a second portion 220, and a third portion 230. The second portion 220 is arranged between the first portion 210 and the third portion 230, one side of the second portion 220 is connected to the first portion 210, and the other side of the second portion 220 is connected to the third portion 230. The first portion 210 and the hole wall of the inner hole 100 define a groove 300. In one or more embodiments, the first portion 210, the second portion 220, and the third portion 230 are integrally formed, thereby improving the processing and manufacturing efficiency of the sealing component and improving the sealing performance. The first portion 210 and the inner hole 100 define a groove 300, the second portion 220 has an interference fit with the electrode wire, and the third portion 230 forms a notch 400 with the hole wall of the inner hole 100.

[0036] When the electrode wire is inserted into the inner hole 100 of the sealing assembly, the outer peripheral wall of the electrode wire is connected with the second part 220 by interference fit. During the process of inserting the electrode wire into the inner hole 100, the first part 210 can be deformed toward the groove 300 under the action of the friction between the electrode wire and the second part 220, thereby reducing the difficulty of inserting the electrode wire, allowing the electrode wire to be smoothly inserted into the inner hole 100, reducing the difficulty of operation during surgery and saving time. When the electrode wire tends to be pulled out of the inner hole 100 of the sealing assembly, the notch 400 can block the displacement of the sealing step portion 200 and play a certain limiting role on the sealing step portion 200, thereby increasing the difficulty of pulling out the electrode wire, preventing the risk of the electrode wire being dislocated or loosened when the patient moves after surgery, and improving reliability and safety.

[0037] Compared with the related art, the sealing assembly provided in this embodiment has a simple structure. By setting the groove 300 and the notch 400, the difficulty of inserting the electrode wire into the inner hole 100 of the sealing assembly can be reduced, making it easy for the electrode wire to be inserted into the inner hole 100, reducing the difficulty of operation during surgery and saving time; at the same time, it can also increase the difficulty of pulling the electrode wire out of the inner hole 100 of the sealing assembly, preventing the risk of dislocation or loosening of the electrode wire when the patient moves after surgery, thereby improving reliability and safety performance.

[0038] In some optional embodiments, the sealing step 200, the groove 300, and the notch 400 are all annularly arranged, thereby improving the sealing performance of the sealing assembly while making it easy to insert the electrode wire into the inner hole 100 and difficult to remove the electrode wire from the inner hole 100. The shapes of the sealing step 200, the groove 300, and the notch 400 can also be set to other shapes, which will not be detailed here.

[0039] As shown in FIG2 , in this embodiment, the notch 400 has an inclined surface, and the inclined surface forms a first inclination angle R with the plane where the hole wall of the inner hole 100 is located, and the first inclination angle R is greater than 90°. Exemplarily, the first inclination angle R is set to 100° to 160°. For example, the first inclination angle R can be set to angle values ​​such as 100°, 110°, 120°, 130°, 140°, 150°, and 160°, thereby improving the limiting blocking effect of the notch 400 on the sealing step 200 when the electrode wire is pulled out of the inner hole 100.

[0040] As shown in FIG2 , in this embodiment, the bottom wall of the groove 300 forms a second inclination angle Q with the plane of the hole wall of the inner hole 100, and the second inclination angle Q is less than 90°. For example, the second inclination angle Q can be set to 45°, 50°, 60°, 70°, etc., that is, the bottom wall of the groove 300 is in an inclined state.

[0041] In this embodiment, the width A or the width B of the groove 300 can be set to between 1 mm and 5 mm. For example, the width A or the width B of the groove 300 can be set to values ​​such as 1 mm, 2 mm, 3 mm, 4 mm, and 5 mm.

[0042] In some optional embodiments, the inner hole 100 is coaxially arranged with the channel 10, which can improve the efficiency of inserting the electrode wire into the channel 10 of the pulse generator, thereby reducing the difficulty of the operation, saving operation time, and improving the reliability of the conduction between the electrode wire and the finger spring 11 in the channel 10.

[0043] In some optional embodiments, a plurality of sealing steps 200 are provided, and the plurality of sealing steps 200 are evenly spaced along the axial direction. Multiple sealing steps 200 are protruding from the wall of the inner hole 100. For example, the operator can provide one, two, three, or other sealing steps 200 according to actual needs, and the plurality of sealing steps 200 are coaxially arranged.

[0044] As shown in FIG2 , the width A of the groove 300 closest to the channel 10 is smaller than the width B of the remaining grooves 300. That is, along the central axis of the grooves 300, the cross-sectional area of ​​the groove 300 closest to the channel 10 is smaller than the cross-sectional area of ​​the remaining grooves 300. For example, the width A of the groove 300 closest to the channel 10 can be set to 1 mm, while the widths B of the remaining grooves 300 can all be set to 3 mm. This facilitates demolding during the molding of the sealing assembly, thereby preventing damage to the sealing assembly during the demolding process and saving costs.

[0045] As shown in Figures 3 and 4, this embodiment also provides a pulse generator, which includes a head 20, a shell 30, and the above-mentioned sealing assembly. A channel 10 is provided in the head 20, and a finger spring 11 is provided in the channel 10. The sealing assembly is sealed at the end of the channel 10, and the finger spring 11 is configured to be in electrical communication with the electrode wire. The shell 30 is sealed and connected to the head 20. A battery 31 and a circuit board are provided in the shell 30. The battery 31 is configured to supply power to the circuit board. The circuit board is electrically connected to the finger spring 11, so that an electrical stimulation signal can be generated between the electrode wire and the finger spring 11. The electrical stimulation signal is released to the patient's brain through the electrode wire to help the patient recover. Because the pulse generator has the above-mentioned sealing assembly, the pulse generator is highly safe and can achieve the technical effect that the electrode wire is easy to insert into the inner hole 100 and difficult to pull out of the inner hole 100, thereby saving costs.

[0046] Optionally, the head 20 can be made of a biocompatible material, and the shell 30 can be made of a titanium alloy. The head 20 is made by a casting process.

[0047] Throughout this specification, references to terms such as "some embodiments" and "other embodiments" indicate that the features, structures, materials, or characteristics described in conjunction with such embodiments or examples are included in at least one embodiment or example of the present application. In this specification, schematic representations of such terms do not necessarily refer to the same embodiment or example. Furthermore, the described features, structures, materials, or characteristics may be combined in any suitable manner in any one or more embodiments or examples.

Claims

1. A sealing assembly configured to seal a channel (10) of a pulse generator, wherein: An inner hole (100) is provided in the sealing component, the inner hole (100) is communicated with the channel (10), and the inner hole (100) is configured to insert an electrode wire; At least one sealing step portion (200) is protrudingly provided on the hole wall of the inner hole (100); a side of the sealing step portion (200) close to the channel (10) defines a groove (300) with the hole wall of the inner hole (100); a side of the sealing step portion (200) away from the channel (10) forms a notch (400) with the hole wall of the inner hole (100); when the electrode wire is inserted into the inner hole (100), the electrode wire and the sealing step portion (200) are interference fit.

2. The sealing assembly according to claim 1, wherein: The sealing step portion (200) comprises a first portion (210), a second portion (220) and a third portion (230), wherein the second portion (220) is arranged between the first portion (210) and the third portion (230), one side of the second portion (220) is connected to the first portion (210), and the other side of the second portion (220) is connected to the third portion (230); The first part (210) and the hole wall of the inner hole (100) define the groove (300), the second part (220) and the electrode wire are interference fit, and the third part (230) and the hole wall of the inner hole (100) form the notch (400).

3. The sealing assembly according to claim 1, wherein: The sealing step portion (200), the groove (300) and the notch (400) are all arranged in an annular shape.

4. The sealing assembly according to claim 1, wherein: The notch (400) has an inclined surface, and the inclined surface forms a first inclined angle (R) with the plane where the hole wall of the inner hole (100) is located, and the first inclined angle (R) is greater than 90°.

5. The sealing assembly according to claim 1, wherein: The bottom wall of the groove (300) and the plane where the hole wall of the inner hole (100) is located form a second inclination angle (Q), and the second inclination angle (Q) is less than 90°.

6. The sealing assembly according to claim 1, wherein: The inner hole (100) is coaxially arranged with the channel (10).

7. The seal assembly according to claim 1, wherein: A plurality of sealing step portions (200) are convexly provided on the hole wall of the inner hole (100), and the plurality of sealing step portions (200) are arranged at equal intervals along the axial direction of the plurality of sealing step portions (200).

8. The sealing assembly according to claim 7, wherein: The width A of the groove (300) closest to the channel (10) is smaller than the width B of the remaining grooves (300).

9. The seal assembly according to claim 1, wherein: The sealing component is a silicone piece.

10. A pulse generator, wherein: The pulse generator comprises a head (20) and a sealing assembly according to any one of claims 1 to 9, wherein the channel (10) is arranged in the head (20), a finger contact spring (11) is arranged in the channel (10), the sealing assembly is sealed at the port of the channel (10), and the finger contact spring (11) is configured to be in conduction with the electrode wire.

11. The pulse generator according to claim 10, wherein: The pulse generator further comprises a shell (30), wherein the shell (30) is sealedly connected to the head (20), a battery (31) and a circuit board are arranged in the shell (30), the battery (31) is configured to supply power to the circuit board, and the circuit board is electrically connected to the finger contact spring (11).

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