Nerve stimulator assembly implanted into skull

Abstract

The invention discloses a nerve stimulator assembly implanted into a skull, and belongs to the technical field of medical instruments. Comprising a base installed on a skull, a pulse generator and a fixing part, the pulse generator is arranged on the base to form a combined part, and the fixing part penetrates through the pulse generator and is connected with the base, so that the pulse generator is fixed to the base. According to the nerve stimulator assembly implanted into the skull, through skull implantation, subcutaneous puncture is reduced, interface and electrode stress is reduced, and it is guaranteed that the nerve stimulator assembly implanted into the skull is relatively fixed to the skull.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to a neurostimulator component implanted in the skull. Background Art

[0002] At present, some neurological diseases such as Parkinson's disease and epilepsy are treated by deep brain stimulation therapy to stimulate the corresponding nuclei. Among the existing products, deep brain stimulators usually use a pulse generator implanted in the chest to output stimulation to the brain through extended wires and electrode wires. Therefore, a long subcutaneous tunnel needs to be created, and the wires are subjected to long-term soft tissue traction, which increases the risk of trauma recovery, postoperative infection and electrode damage. Summary of the invention

[0003] The purpose of the present application is to provide a neurostimulator component implanted in the skull, which can reduce subcutaneous punctures, reduce the stress on the interface and electrodes, and ensure the relative fixation of the neurostimulator component implanted in the skull and the skull.

[0004] To achieve this goal, this application adopts the following technical solutions:

[0005] A neurostimulator component implanted in the skull comprises a base mounted on the skull, a pulse generator and a fixing member, wherein the pulse generator is arranged on the base to form an assembly, and the fixing member passes through the pulse generator and is connected to the base to fix the pulse generator to the base.

[0006] In some possible implementations, the fixing member is provided with a first limiting portion, and the assembly is provided with a second limiting portion, and the first limiting portion and the second limiting portion can cooperate in a limiting manner to limit the axial movement of the fixing member.

[0007] In some possible implementations, the fixing member includes a connecting cap and a connecting column rotatably connected to the connecting cap, the connecting column is limited to the connecting cap along its extension direction, and the connecting column is threadedly connected to the base.

[0008] In some possible embodiments, the connecting column includes a column portion and an end cap portion, the connecting cap is provided with a receiving cavity and an avoidance hole, the end cap portion is rotatably connected to the receiving cavity, and the end cap portion is limited in the receiving cavity along the extension direction of the column portion, and the side of the end cap portion facing away from the column portion is exposed to the outside through the avoidance hole.

[0009] In some possible embodiments, an annular groove is provided on the outer periphery of the end cap portion, the fixing member further includes a pin, the connecting cap is provided with a mounting hole connected to the accommodating cavity, the pin is passed through the mounting hole and part of the pin is passed through the annular groove, so that the connecting column is limited in its extension direction.

[0010] In some possible implementations, an annular groove is formed on the outer periphery of the end cap portion, and an annular protrusion is formed on the side wall of the receiving cavity. The annular protrusion is received in the annular groove, so that the connecting column is limited in its extension direction.

[0011] In some possible implementations, the connecting cap is provided with a first limiting portion, the pulse generator is provided with a second limiting portion, and the connecting cap can be rotated to enable the first limiting portion and the second limiting portion to cooperate in circumferential limiting manner.

[0012] In some possible implementations, the pulse generator is provided with a sink hole, the sink hole includes a sink and a through hole, the connecting column is passed through the through hole, and the connecting cap can abut against the bottom of the sink.

[0013] In some possible implementations, the side walls of the sink are provided with notches and limiting holes at intervals, and the outer periphery of the connecting cap is provided with limiting protrusions, and the connecting cap can be rotated so that the limiting protrusion rotates from the notch to the limiting hole.

[0014] In some possible embodiments, the base is provided with a column, and the column is passed through the pulse generator. One of the column and the fixing member is provided with an external thread, and the other is provided with a pipe thread that can be threadedly connected to the external thread, so that the fixing member and the column are threadedly connected.

[0015] In some possible implementations, the fixing member is provided with a first limiting portion at one end facing the base, and the column is provided with a second limiting portion, and the fixing member can move toward the base so that the first limiting portion and the second limiting portion are axially limited and matched.

[0016] In some possible embodiments, the external thread provided on the column is a first external thread, the fixing member is provided with a pipe thread, the end of the fixing member is provided with at least two first extension portions spaced apart along the circumferential direction, the first limiting portion is a first hook provided at the end of the first extension portion, and the second limiting portion is a first ridge protruding from the outer side of the column, and the first hook can be engaged with the first ridge.

[0017] In some possible embodiments, the column is provided with a pipe thread, the external thread provided on the fixing piece is a second external thread, the end of the column is provided with at least two second extension portions spaced apart along the circumferential direction, the first limiting portion is a second convex ridge protruding from the outside of the fixing piece, and the second limiting portion is a second hook provided at the end of the second extension portion, and the second hook can be engaged with the second convex ridge.

[0018] In some possible implementations, one of the pulse generator and the base is provided with a slot, and the other is provided with a buckle, and the buckle can be snapped into the slot.

[0019] Beneficial effects of this application:

[0020] The present application provides a neurostimulator assembly implanted in the skull, in which a pulse generator and a base are fixed by a fixing part, and the base is fixed to the skull, thereby ensuring the relative fixation of the neurostimulator assembly implanted in the skull and the skull, and preventing the neurostimulator assembly implanted in the skull from being subjected to random vibration or impact force during the patient's daily life such as walking or running after the neurostimulator assembly is implanted in the skull, causing the pulse generator to become detached and fail on the base, or the base to become detached and fail on the skull due to random vibration or impact force. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 is a schematic diagram of a neurostimulator assembly implanted in the skull provided in Example 1 of the present application;

[0022] Figure 2 is an exploded view of a neurostimulator assembly implanted in the skull provided in Example 1 of the present application;

[0023] Figure 3 yes Figure 2 The enlarged view of X;

[0024] Figure 4 is an exploded view of the fixing member provided in the first embodiment of the present application;

[0025] Figure 5 is a cross-sectional view of a fixing member provided in Embodiment 1 of the present application;

[0026] Figure 6 is an exploded view of a fixing member provided in Embodiment 2 of the present application;

[0027] Figure 7 is a cross-sectional view of a fixing member provided in Embodiment 2 of the present application;

[0028] Figure 8 is a partial schematic diagram of an exploded view of a neurostimulator assembly implanted in the skull provided in Example 3 of the present application;

[0029] Fig. 9 It is a partial schematic diagram of an exploded view of a neurostimulator assembly implanted in the skull provided in Example 4 of the present application.

[0030] In the figure:

[0031] 100, assembly; 101, base; 1011, column; 10111, first external thread; 1012, first ridge; 1013, second extension; 1014, second hook; 1015, second groove; 1016, buckle; 1017, enclosure; 1018, fixing portion; 1019, base plate;

[0032] 102, pulse generator; 1021, sink hole; 10211, sink; 10212, through hole; 1022, notch; 1023, limit hole; 1024, slot; 200, fixing piece; 201, connecting cap; 2011, receiving cavity; 2012, avoidance hole; 2013, mounting hole; 2014, annular protrusion; 2015, limit protrusion; 202, connecting column; 2021, column part; 2022, end cap part; 20221, annular groove; 203, pin; 204, first extension part; 205, first hook; 206, second convex ridge; 207, first groove; 208, second external thread. DETAILED DESCRIPTION

[0033] In order to make the technical problems solved by this application, the technical solutions adopted, and the technical effects achieved more clearly, the technical solutions of the embodiments of this application will be further described in detail below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of this application, not all of them. Based on the embodiments in this application, all other embodiments obtained by those skilled in the art without making creative efforts are within the scope of protection of this application.

[0034] In the description of this application, unless otherwise clearly specified and limited, the terms "connected", "connected", and "fixed" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0035] In the present application, unless otherwise clearly specified and limited, a first feature being "above" or "below" a second feature may include that the first and second features are in direct contact, or may include that the first and second features are not in direct contact but are in contact through another feature between them. Moreover, a first feature being "above", "above" and "above" a second feature includes that the first feature is directly above and obliquely above the second feature, or simply indicates that the first feature is higher in level than the second feature. A first feature being "below", "below" and "below" a second feature includes that the first feature is directly below and obliquely below the second feature, or simply indicates that the first feature is lower in level than the second feature.

[0036] Embodiment 1

[0037] The following is a brief description of the technical field and related terms of the embodiments of the present application.

[0038] Implantable medical systems include implantable neural stimulation systems, implantable cardiac stimulation systems (also known as pacemakers), implantable drug delivery systems (IDDS), and lead switching systems. Examples of implantable neural stimulation systems include deep brain stimulation (DBS), implantable cortical nerve stimulation (CNS), implantable spinal cord stimulation (SCS), implantable sacral nerve stimulation (SNS), and implantable vagus nerve stimulation (VNS).

[0039] The implantable neural electrical stimulation system includes a stimulator implanted in the patient's body (i.e., an implantable neural stimulator) and a programmable device disposed outside the patient's body. In other words, the stimulator is a medical device, or in other words, the medical device includes the stimulator. The relevant neural regulation technology mainly implants electrodes (electrodes, for example, in the form of electrode wires) in specific parts of the tissues of the organism (i.e., target points) through stereotactic surgery, and emits discharge pulses to the target points through the electrodes to regulate the electrical activity and function of the corresponding neural structures and networks, thereby improving symptoms and relieving pain.

[0040] As an example, DBS includes an IPG (Implantable Pulse Generator), an extension wire and an electrode wire, and the IPG is connected to the electrode wire via the extension wire. The IPG is implanted in the patient's body, for example, in the patient's chest or other body parts.

[0041] As another example, DBS includes an IPG and an electrode lead, and the IPG is directly connected to the electrode lead. The IPG is implanted in the patient's head, for example, a groove is made in the patient's skull, and then the IPG is installed in the groove of the skull. In this case, the IPG may not protrude from the outer surface of the skull, or may partially protrude from the outer surface of the skull.

[0042] The IPG responds to the program-controlled instructions sent by the program-controlled device, and relies on sealed batteries and circuits to provide controllable electrical stimulation therapy (or electrical stimulation energy) to the tissues in the body. The IPG delivers one or more controllable specific electrical stimulations to specific areas of the tissues in the body through electrode wires.

[0043] In some embodiments, the extension lead is used in conjunction with the IPG as a transmission medium for electrical stimulation, and transmits the electrical stimulation generated by the IPG to the electrode lead.

[0044] In some embodiments, the electrical stimulation may be delivered in the form of a pulse signal or in the form of a non-pulse signal. For example, the electrical stimulation may be delivered as a signal having various waveform shapes, frequencies, and amplitudes. Thus, the electrical stimulation in the form of a non-pulse signal may be a continuous signal, which may have a sinusoidal waveform or other continuous waveform.

[0045] After receiving the electrical stimulation transmitted by the IPG or the extension wire, the electrode wire delivers the electrical stimulation to a specific area of ​​the tissue in the body through a plurality of electrode contacts. The stimulator is provided with, for example, 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 circumferential direction 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 circumferential direction of the electrode wire. The electrode contacts can include stimulation electrode contacts and / or collection electrode contacts. The electrode contacts can be in the shape of sheets, rings, dots, etc., for example.

[0046] In some embodiments, the stimulated in vivo tissue may be the patient's brain tissue, and the stimulated site may 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), the use of one or more (single channel or multiple channels) of specific electrical stimulation, and the stimulation parameters (values) are also different.

[0047] The embodiments of the present application do not limit the types of diseases that can be used, and they can be the types of diseases that deep brain stimulation (DBS), spinal cord stimulation (SCS), sacral nerve stimulation, gastric stimulation, peripheral nerve stimulation, and functional electrical stimulation can be used for. Among them, the types of diseases that DBS can be used to treat or manage include, but are not limited to: spastic diseases (e.g., epilepsy), pain, migraine, mental illness (e.g., major depressive disorder (MDD)), bipolar disorder, anxiety, post-traumatic stress disorder, mild 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.

[0048] In the embodiment of the present 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, different stimulation parameters correspond to different electrical stimulations), and the stimulator can also sense the patient's electrophysiological activities to collect electrophysiological signals, and the collected electrophysiological signals can be used to continue to adjust the stimulation parameters of the stimulator, thereby realizing closed-loop control (or adaptive adjustment) of the stimulation parameters.

[0049] The stimulation parameters may include at least one of the following: the electrode contact identification used to deliver electrical stimulation (for example, electrode contact #2 and electrode contact #3), frequency (for example, the number of electrical stimulation pulse signals within a unit time of 1s, in Hz), pulse width (the duration of each pulse, in μs), amplitude (generally expressed in voltage, that is, the intensity of each pulse, in V), timing (for example, it can be continuous or burst, and burst refers to discontinuous timing behavior composed of multiple processes), stimulation mode (including one or more of current mode, voltage mode, timed stimulation mode and cyclic stimulation mode), upper and lower limits controlled by the doctor (the range that can be adjusted by the doctor) and upper and lower limits controlled by the patient (the range that can be adjusted autonomously by the patient).

[0050] In some embodiments, various stimulation parameters of the stimulator can be adjusted in current mode or voltage mode.

[0051] Programmable devices may include doctor programmable devices (i.e. programmable devices used by doctors) and / or patient programmable devices (i.e. programmable devices used by patients). Doctor programmable devices are, for example, tablet computers, laptop computers, desktop computers, mobile phones and other intelligent terminal devices equipped with programmable software. Patient programmable devices are, for example, tablet computers, laptop computers, desktop computers, mobile phones and other intelligent terminal devices equipped with programmable software. Patient programmable devices may also be other electronic devices with programmable functions (e.g., chargers with programmable functions, electrophysiological acquisition devices, etc.).

[0052] like Figures 1 to 5As shown, this embodiment provides a neurostimulator assembly implanted in the skull, comprising a base 101 mounted on the skull, a pulse generator 102 and a fixing member 200. The pulse generator 102 is arranged on the base 101 to form an assembly 100. The fixing member 200 passes through the pulse generator 102 and is connected to the base 101, so that the pulse generator 102 is fixed to the fixing member 200 and the base 101. By implanting in the skull, subcutaneous puncture is reduced, and the stress on the interface and the electrode is reduced. The pulse generator 102 and the base 101 are fixed by the fixing part 200, and the base 101 is fixed to the skull, so as to ensure the relative fixation of the neurostimulator component implanted in the skull and the skull, and prevent the pulse generator 102 from being subjected to random vibration force or impact force during the patient's daily life such as walking and running after the neurostimulator component implanted in the skull is implanted, causing the pulse generator 102 to be detached from the base 101 and fail, or the base 101 to be subjected to random vibration force or impact force, causing it to be detached from the skull and fail.

[0053] In one embodiment, the fixing member 200 is provided with a first limiting portion, and the assembly 100 is provided with a second limiting portion, and the first limiting portion and the second limiting portion can cooperate in limiting position to limit the axial movement of the fixing member 200. Through the limiting position cooperation of the first limiting portion and the second limiting portion, the axial movement of the fixing member 200 is limited, and the pulse generator 102 and the base 101 are prevented from loosening and falling off, and the stability of locking by the fixing member 200 under the force conditions of random vibration and impact after surgery is ensured, thereby increasing the implant safety guarantee.

[0054] In one embodiment, the fixing member 200 is threadedly connected to the base 101. During the operation, the fixing member 200 and the base 101 are threadedly connected to fix the pulse generator 102 and the base 101. The first limiting portion and the second limiting portion do not cooperate, which is convenient for repeatedly installing and removing the pulse generator 102 from the base 101 during the operation, meeting the doctor's needs for debugging output, and will not cause the locking feature between the pulse generator 102 and the base 101 to be damaged and invalid due to repeated operations. When the pulse generator 102 needs to be fixed and no longer repeatedly installed and removed, the first limiting portion and the second limiting portion cooperate again in a limiting manner, so that the threads of the fixing member 200 and the base 101 are prevented from loosening and falling off, ensuring the stability of the thread locking method under the force conditions of random vibration and impact after the operation, and increasing the safety guarantee of implantation.

[0055] The fixing member 200 includes a connection cap 201 and a connection column 202 rotatably connected to the connection cap 201. The connection column 202 is limited to the connection cap 201 along its extension direction, and the connection column 202 is threadedly connected to the base 101. During the installation process, the fixing member 200 is passed through the pulse generator 102, the connection column 202 is screwed to be threadedly connected to the base 101, and the connection cap 201 abuts against the pulse generator 102, so that the pulse generator 102 is sandwiched between the connection cap 201 and the base 101.

[0056] The first limiting part is provided on the connecting cap 201, and the second limiting part is provided on the pulse generator 102. The connecting cap 201 can be rotated so that the first limiting part and the second limiting part cooperate in circumferential limiting. When the pulse generator 102 needs to be fixed and no longer disassembled and assembled repeatedly, the connecting cap 201 is screwed to make the first limiting part and the second limiting part cooperate. The connecting cap 201 and the connecting column 202 are rotatably connected and can be screwed independently without affecting each other. The connecting column 202 is limited to the connecting cap 201 along its extension direction, and the connecting column 202 is fixed to the pulse generator 102 through the connecting cap 201.

[0057] The pulse generator 102 is provided with a groove hole 1021, and the groove hole 1021 includes a groove 10211 and a through hole 10212. The connecting column 202 is passed through the through hole 10212. The connecting cap 201 can abut against the bottom of the groove 10211 to achieve axial positioning and prevent the connecting cap 201 from protruding from the surface of the pulse generator 102. The structure is compact, and the shape of the top of the connecting cap 201 is adapted to the shape of the top of the pulse generator 102, so that the surface of the structure is smooth.

[0058] The side wall of the sink 10211 is provided with a notch 1022 and a limiting hole 1023 at intervals. The first limiting part is a limiting protrusion 2015 provided on the outer periphery of the connecting cap 201, and the second limiting part is the limiting hole 1023. The connecting cap 201 can rotate to rotate the limiting protrusion 2015 from the notch 1022 to the limiting hole 1023. When the fixing member 200 is initially installed in the assembly 100, the limiting protrusion 2015 is placed toward the notch 1022 to avoid structural interference. The limiting protrusion 2015 is screwed into the limiting hole 1023 by strong screwing. The limiting hole 1023 restricts the limiting protrusion 2015 in the screwing direction and the vertical direction, which indirectly restricts the rotation and vertical movement of the fixing member 200, so as to further ensure the locking effect.

[0059] The connecting column 202 includes a column portion 2021 and an end cap portion 2022. The connecting cap 201 is provided with a receiving cavity 2011 and an avoidance hole 2012. The end cap portion 2022 is rotatably connected to the receiving cavity 2011, and the end cap portion 2022 is limited to the receiving cavity 2011 along the extension direction of the column portion 2021. The two can rotate relative to each other, but the axial direction is relatively fixed. The side of the end cap portion 2022 away from the column portion 2021 is exposed to the outside through the avoidance hole 2012. Optionally, the end cap portion 2022 is provided with a hexagonal slot. A hexagonal wrench is used to pass through the avoidance hole 2012 and inserted into the hexagonal slot to screw the connecting column 202 to make it threadedly connected with the base 101. The connecting cap 201 moves downward as the connecting column 202 is screwed until the connecting cap 201 abuts against the pulse generator 102. A cross slot is provided on the top of the connecting cap 201. The cross wrench cooperates with the cross slot to screw the connecting cap 201 so that the first limiting part and the second limiting part cooperate. By providing the hexagonal slot and the cross slot, it is convenient to use a tool to screw and operate conveniently.

[0060] An annular groove 20221 is formed on the outer periphery of the end cap 2022, the fixing member 200 further includes a pin 203, the connecting cap 201 is formed with a mounting hole 2013 communicating with the receiving cavity 2011, the pin 203 is passed through the mounting hole 2013 and part of the pin 203 is passed through the annular groove 20221, so that the connecting column 202 is limited in its extending direction. Part of the pin 203 is located in the annular groove 20221 and the mounting hole 2013 at the same time, so that the connecting column 202 and the connecting cap 201 are relatively fixed along the axial direction.

[0061] In one embodiment, the connection cap 201 is made of metal material or polymer material, and the connection column 202 is made of metal material.

[0062] The base 101 is provided with a column 1011, and the column 1011 is penetrated in the pulse generator 102. For example, the column 1011 is penetrated in the through hole 10212 of the countersunk hole 1021. One of the column 1011 and the fixing member 200 is provided with an external thread, and the other is provided with a pipe thread that can be threadedly connected with the external thread, so that the fixing member 200 and the column 1011 are connected. By providing the column 1011, the threaded connection area between the fixing member 200 and the column 1011 is increased, the reliability is good, and the column 1011 is penetrated in the through hole 10212, making the structure more compact. In one embodiment, the connecting column 202 is a screw with an annular groove 20221, which is threadedly connected to the column 1011 with a pipe thread.

[0063] The base 101 is used to be fixed to the skull. Specifically, the base 101 includes a substrate 1019 and a baffle 1017 that matches the shape of the pulse generator 102. The baffle 1017 further prevents the pulse generator 102 from moving relative to the base 101, thereby improving the connection reliability. One of the pulse generator 102 and the base 101 is provided with a slot 1024, and the other is provided with a buckle 1016. The buckle 1016 can be snapped into the slot 1024, thereby further improving the connection stability and reliability. In this embodiment, the baffle 1017 is connected with two buckles 1016, and the pulse generator 102 is provided with two slots 1024. The two buckles 1016 are correspondingly snapped into the two slots 1024. Optionally, the projection shape of the pulse generator 102 is a rectangle, the two slots 1024 are provided on the same side, and the sink hole 1021 is provided on the other side. The enclosure 1017 is also connected to a fixing portion 1018, and the titanium nail passes through the through hole of the fixing portion 1018 to connect with the skull, so that the base 101 is installed in the bone groove. Optionally, three fixing portions 1018 are correspondingly provided on three sides of the enclosure 1017 to improve the reliability of the connection with the skull. Optionally, a hollow hole is provided in the middle of the base plate 1019 to achieve lightweight.

[0064] During installation, the first step is to install the base 101 on the skull; the second step is to install the pulse generator 102 on the base 101, with the enclosure 1017 surrounding the pulse generator 102, the column 1011 passing through the slot hole 1021, and the buckle 1016 being snapped into the slot 1024; the third step is to pass the fixing piece 200 through the slot hole 1021, with the limiting boss facing the notch 1022; the fourth step is to screw the connecting column 202 to make it threadedly connected with the column 1011 until the connecting cap 201 abuts against the bottom of the slot 10211; the fifth step is to screw the connecting cap 201 vigorously to make the limiting protrusion 2015 cooperate with the limiting hole 1023.

[0065] Embodiment 2

[0066] This embodiment provides a neural stimulator, which has a structure substantially the same as that of the first embodiment, and the similarities are not repeated here. The difference is that Figure 6 and Figure 7 As shown, an annular groove 20221 is formed on the outer periphery of the end cap 2022, and an annular protrusion 2014 is formed on the side wall of the receiving cavity 2011. The annular protrusion 2014 is received in the annular groove 20221, so that the connecting column 202 is limited in its extension direction, and the connecting column 202 and the connecting cap 201 are relatively fixed along the axial direction. Specifically, the end cap 2022 and the connecting column 202 are formed by hot pressing.

[0067] In other embodiments, an annular baffle may be provided at the notch of the receiving cavity 2011 , the annular baffle abuts against one end of the end cap portion 2022 facing the column portion 2021 , and the annular baffle may be connected to the notch of the receiving cavity 2011 by a fastener.

[0068] Embodiment 3

[0069] This embodiment provides a neural stimulator, which has a structure substantially the same as that of the first embodiment, and the similarities are not repeated here. The difference is that Figure 8 As shown, the first limiting part is provided at one end of the fixing member 200 facing the base 101, and the column 1011 is provided with a second limiting part. The fixing member 200 can move toward the base 101 so that the first limiting part and the second limiting part cooperate in axial limiting. The fixing member 200 is screwed to firstly make the fixing member 200 and the column 1011 threadedly connected. When the pulse generator 102 needs to be fixed and no longer repeatedly disassembled, the first limiting part and the second limiting part are screwed to cooperate. When the fixing member 200 is loose, in addition to overcoming the pre-tightening force, it is also necessary to overcome the force of the axial cooperation of the first limiting part and the second limiting part, so as to ensure the locking effect.

[0070] The column 1011 is provided with an external thread, i.e., a first external thread 10111, and the fixing member 200 is provided with a pipe thread. At least two first extensions 204 are provided at intervals along the circumferential direction at the end of the fixing member 200. The first limiting portion is a first hook 205 provided at the end of the first extension 204, and the second limiting portion is a first convex ridge 1012 convexly provided on the outer side of the column 1011. The first hook 205 can be engaged with the first convex ridge 1012. A hexagonal slot is provided at the top of the fixing member 200. A hexagonal wrench is inserted into the hexagonal slot, and the fixing member 200 is screwed to connect with the first external thread 10111 of the column 1011. As the fixing member 200 is screwed, the first hook 205 is squeezed and deformed by the first convex ridge 1012, and then the first convex ridge 1012 enters the side of the first hook 205 facing the pipe thread, i.e., the first hook 205 is engaged with the first convex ridge 1012. When the fixing member 200 is loosened, in addition to overcoming the pre-tightening force, it is also necessary to overcome the force of the first convex edge 1012 coming off the first hook 205, thereby ensuring the locking effect.

[0071] Two adjacent first extension parts 204 form a first groove 207 , which provides deformation space for the first extension part 204 . The first hook 205 is squeezed by the first ridge 1012 to easily deform the first extension part 204 , thereby facilitating the clamping of the first hook 205 and the first ridge 1012 .

[0072] Optionally, the column 1011 having the first external thread 10111 is a threaded column, and the fixing member 200 includes an end cap and a connecting pipe with a pipe thread, and the end cap is arranged in the groove 10211 of the groove hole 1021, and the top of the end cap is adapted to the shape of the pulse generator 102, and the structure is compact and the structural surface is smooth.

[0073] Embodiment 4

[0074] This embodiment provides a neural stimulator, which has a structure substantially the same as that of the third embodiment, and the similarities are not repeated here. The difference is that: Fig. 9 As shown, the column 1011 is provided with a pipe thread, the fixing member 200 is provided with an external thread, i.e., a second external thread 208, and at least two spaced second extensions 1013 are provided at the end of the column 1011 along the circumferential direction, the first limiting portion is a second convex ridge 206 convexly provided on the outside of the fixing member 200, and the second limiting portion is a second hook 1014 provided at the end of the second extension 1013, and the second hook 1014 can be engaged with the second convex ridge 206. A hexagonal slot is provided at the top of the fixing member 200, and a hexagonal wrench is inserted into the hexagonal slot, and the fixing member 200 is screwed to be connected with the pipe thread of the column 1011. As the fixing member 200 is screwed, the second hook 1014 is squeezed and deformed by the second convex ridge 206, and then the second convex ridge 206 enters the side of the second hook 1014 facing the pipe thread, that is, the second hook 1014 is engaged with the second convex ridge 206. When the fixing member 200 is loosened, in addition to overcoming the pre-tightening force, it is also necessary to overcome the force of the second convex edge 206 coming off the second hook 1014, thereby ensuring the locking effect.

[0075] Two adjacent second extension parts 1013 form a second groove 1015. By setting the second groove 1015, the second extension part 1013 is given deformation space. The second hook 1014 is squeezed by the second ridge 206 to easily realize the deformation of the second extension part 1013, thereby facilitating the clamping of the second hook 1014 and the second ridge 206.

[0076] Optionally, the fixing member 200 can be a screw, the screw cap is arranged in the recessed groove 10211 of the recessed groove hole 1021, the top shape of the screw cap is adapted to the surface shape of the pulse generator 102, the structure is compact, and the surface of the structure is smooth. The side of the threaded column of the screw is provided with a second ridge 206.

[0077] Obviously, the above embodiments of the present application are only examples for clearly illustrating the present application, and are not intended to limit the implementation methods of the present application. For those of ordinary skill in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all implementation methods here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present application should be included in the protection scope of the claims of the present application.

Claims

1. A neurostimulator assembly implanted in the skull, characterized in that: The invention comprises a base (101) mounted on a skull, a pulse generator (102) and a fixing member (200); the pulse generator (102) is arranged on the base (101) to form an assembly (100); the fixing member (200) passes through the pulse generator (102) and is connected to the base (101), so that the pulse generator (102) is fixed to the base (101).

2. The neurostimulator assembly implanted in the skull according to claim 1, characterized in that: The fixing member (200) is provided with a first limiting portion, and the assembly (100) is provided with a second limiting portion, and the first limiting portion and the second limiting portion can cooperate in a limiting manner to limit the axial movement of the fixing member (200).

3. The neurostimulator assembly implanted in the skull according to claim 1, characterized in that: The fixing member (200) comprises a connecting cap (201) and a connecting column (202) rotatably connected to the connecting cap (201); the connecting column (202) is limited to the connecting cap (201) along its extension direction; and the connecting column (202) and the base (101) are threadedly connected.

4. The neurostimulator assembly implanted in the skull according to claim 3, characterized in that: The connecting column (202) comprises a column portion (2021) and an end cap portion (2022); the connecting cap (201) is provided with a receiving cavity (2011) and an avoidance hole (2012); the end cap portion (2022) is rotatably connected to the receiving cavity (2011), and the end cap portion (2022) is limited in the receiving cavity (2011) along the extension direction of the column portion (2021); and a side of the end cap portion (2022) facing away from the column portion (2021) is exposed to the outside through the avoidance hole (2012).

5. The neurostimulator assembly implanted in the skull according to claim 4, characterized in that: The end cap portion (2022) is provided with an annular groove (20221) on its outer periphery, the fixing member (200) further comprises a pin (203), the connecting cap (201) is provided with a mounting hole (2013) connected to the receiving cavity (2011), the pin (203) is passed through the mounting hole (2013) and part of the pin (203) is passed through the annular groove (20221), so that the connecting column (202) is limited in its extension direction.

6. The neurostimulator assembly implanted in the skull according to claim 4, characterized in that: An annular groove (20221) is provided on the outer periphery of the end cap portion (2022), and an annular protrusion (2014) is provided on the side wall of the receiving cavity (2011). The annular protrusion (2014) is received in the annular groove (20221), so that the connecting column (202) is limited in its extension direction.

7. The neurostimulator assembly implanted in the skull according to claim 3, characterized in that: The connecting cap (201) is provided with a first limiting portion, the pulse generator (102) is provided with a second limiting portion, and the connecting cap (201) is capable of rotating so that the first limiting portion and the second limiting portion are circumferentially limited and matched.

8. The neurostimulator assembly implanted in the skull according to claim 3, characterized in that: The pulse generator (102) is provided with a sink hole (1021), the sink hole (1021) comprises a sink groove (10211) and a through hole (10212), the connecting column (202) is passed through the through hole (10212), and the connecting cap (201) can abut against the bottom of the sink groove (10211).

9. The neurostimulator assembly implanted in the skull according to claim 8, characterized in that: The side wall of the sink (10211) is provided with a notch (1022) and a limiting hole (1023) at intervals, and the outer periphery of the connecting cap (201) is provided with a limiting protrusion (2015), and the connecting cap (201) can be rotated so that the limiting protrusion (2015) rotates from the notch (1022) to the limiting hole (1023).

10. The neurostimulator assembly implanted in the skull according to claim 1, characterized in that: The base (101) is provided with a column (1011), and the column (1011) is inserted into the pulse generator (102). One of the column (1011) and the fixing member (200) is provided with an external thread, and the other is provided with a pipe thread that can be threadedly connected to the external thread, so that the fixing member (200) and the column (1011) are threadedly connected.

11. The neurostimulator assembly implanted in the skull according to claim 10, characterized in that: The fixing member (200) is provided with a first limiting portion at one end facing the base (101), and the column (1011) is provided with a second limiting portion, and the fixing member (200) can move toward the base (101) so that the first limiting portion and the second limiting portion are axially limited and matched.

12. The neurostimulator assembly implanted in the skull according to claim 11, characterized in that: The external thread provided on the column (1011) is a first external thread (10111), the fixing member (200) is provided with a pipe thread, the end of the fixing member (200) is provided with at least two first extension portions (204) spaced apart along the circumferential direction, the first limiting portion is a first hook (205) provided at the end of the first extension portion (204), the second limiting portion is a first convex ridge (1012) convexly provided on the outer side of the column (1011), and the first hook (205) can be engaged with the first convex ridge (1012).

13. The neurostimulator assembly implanted in the skull according to claim 11, characterized in that: The column (1011) is provided with a pipe thread, the external thread provided on the fixing member (200) is a second external thread (208), the end of the column (1011) is provided with at least two second extension portions (1013) spaced apart along the circumferential direction, the first limiting portion is a second convex ridge (206) convexly provided on the outside of the fixing member (200), the second limiting portion is a second hook (1014) provided at the end of the second extension portion (1013), and the second hook (1014) can be engaged with the second convex ridge (206).

14. The neurostimulator assembly implanted in the skull according to any one of claims 1 to 13, characterized in that: One of the pulse generator (102) and the base (101) is provided with a slot (1024), and the other is provided with a buckle (1016), and the buckle (1016) can be buckled into the slot (1024).

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