阅读说明：本技术 一种半嵌入式外壳及刺激器 (Semi-embedded shell and stimulator ) 是由 陈新蕾 崔贺强 姚松林 冯方 曲啸 于 2021-08-06 设计创作，主要内容包括：本发明涉及一种半嵌入式外壳及刺激器,属于全头部有源植入类医疗器械技术领域,解决了现有技术中刺激器的植入方式创伤大、增加感染风险的问题。本发明的半嵌入式外壳,包括上壳体和下壳体,所述上壳体与所述下壳体固定连接形成密封或半密封的容置腔体,所述下壳体为阶梯状。本发明半嵌入式外壳使得刺激器能够半嵌入式嵌入颅骨的沉孔中,减小了手术创伤,降低了手术风险。(The invention relates to a semi-embedded shell and a stimulator, belongs to the technical field of full-head active implantation medical instruments, and solves the problems that the implantation mode of the stimulator in the prior art has large wound and increases infection risk. The semi-embedded shell comprises an upper shell and a lower shell, wherein the upper shell and the lower shell are fixedly connected to form a sealed or semi-sealed accommodating cavity, and the lower shell is in a step shape. The semi-embedded shell enables the stimulator to be embedded into the counter bore of the skull in a semi-embedded mode, so that the surgical trauma is reduced, and the surgical risk is reduced.)

1. The semi-embedded shell is characterized by comprising an upper shell (8) and a lower shell (4), wherein the upper shell (8) and the lower shell (4) are fixedly connected to form a sealed or semi-sealed accommodating cavity, and the lower shell (4) is in a step shape.

2. The half-embedded casing according to claim 1, characterized in that the lower shell (4) comprises an embedding portion (41), the bottom wall and the side walls of the embedding portion (41) defining a second housing space;

a limiting part (42) extending outwards from the top edge of the side wall is formed on the side wall of the embedding part (41).

3. Semi-embedded shell according to claim 1, characterized in that the top and side faces of the upper shell (8) define a first housing space.

4. The half-embedded shell according to claim 2, characterized in that the top of the side of the upper shell (8) is provided with at least a first step (81) and a second step (82); the edge of the limiting part (42) abuts against the step surface of the second step (82), and the top surface of the limiting part (42) is flush with the step surface of the first step (81).

5. The semi-embedded shell according to claim 2, wherein the top surface of the limiting portion (42) is a curved surface with a certain radian.

6. A semi-embedded housing according to claim 2, wherein the embedded portion (41) is provided in a counter bore of the skull, and the stopper portion (42) is located outside the counter bore.

7. Semi-embedded shell according to any one of claims 2, 4 to 6, characterized in that the projection of the limit stop (42) towards the embedding part (41) can cover the end face of the embedding part (41).

8. A stimulator comprising a semi-recessed housing according to any one of claims 1 to 7.

9. The stimulator of claim 8, further comprising a second housing fixedly coupled to the semi-recessed housing; the second shell is a sealed or semi-sealed shell; the second housing forms a cylinder with the upper shell (8).

10. The stimulator of claim 9, wherein the semi-embedded shell is made of a first material and the second shell is made of a second material.

11. The stimulator according to any one of claims 9 to 10, wherein the bottom of the semi-embedded shell is provided with a locking feature.

12. Stimulator according to claim 8, characterized in that the semi-embedded casing is provided with a battery (5) and a PCB board (6) connected to each other, the battery (5) is arranged in the embedded portion (41) of the lower shell (4), and the PCB board (6) is arranged in the upper shell (8).

13. The stimulator according to any of claims 9 to 10, wherein the second housing is configured as a coil assembly comprising a charging coil (15) and a sealing housing (17); the sealing shell (17) is arranged on the side surface of the upper shell (8) in a wrapping mode and wraps the charging coil (15).

Technical Field

The invention relates to the technical field of full-head active implantation medical instruments, in particular to a semi-embedded shell and a stimulator.

Background

Implantable active medical devices are widely used to treat a variety of conditions, one of which is a nerve electrical stimulator that delivers a pulse signal to nerve tissue via electrodes to improve the normal skill of the human body. For example, DBS (Deep Brain Stimulation) is a common type of implanted Deep Brain nerve Stimulation electrode, and is effective in improving limb control and coordination ability of patients with nervous system diseases. This deep brain nerve electrical stimulation is a preferred treatment regimen in addition to drugs because of its microtrauma, safety and efficacy. Therefore, the research on the implantable brain stimulator is receiving more and more attention.

The existing stimulator mounting mode is that a part suitable for implantation is found on the skull, the scalp is cut after the part is determined, the skull with the size consistent with that of the stimulator is cut off in a mode of cutting through the skull, the dura mater part of the brain is directly exposed, and the stimulator is fixed on the skull through a stimulator tray. Specifically, the tray is embedded and fixed at the incision of the skull, the bottom of the tray is in direct contact with the dura mater, and then the stimulator is placed in the tray. The effect of tray is fixed the stimulator on the one hand, and on the other hand can avoid the stimulator to damage the dura mater when receiving external impact, reduces the unexpected risk that gets into the inside brain tissue that destroys of skull of stimulator.

However, the existing stimulator installation mode has a complex operation process and great harm to people. After the skull is removed, the repair period is long, if the skull defect of a patient reaches 3cm or more due to craniotomy, a part of the skull is lacked, the intracranial environment is changed rapidly, the intracranial pressure is unstable, the intracranial cerebrospinal fluid circulation and cerebral blood circulation can be influenced, the intracranial nerve function operation can be possibly obstructed, a series of skull defect syndromes are generated, and the physical and mental health of the whole person is influenced. In addition, the bottom of the existing stimulator is in direct contact with the dural part, and if an impact is encountered, the dural part may be directly damaged. At the same time, this direct contact, if cerebral fluid seeps out, further reduces the life of the stimulator and increases the risk of infection for the patient. In addition, the existing mounting mode between the stimulator and the skull is also provided with skull nails, skull injuries are enlarged, the risk of secondary infection of the skull of a patient is increased, operation time is prolonged, material consumption cost is increased, and the economic burden of the patient is increased.

Disclosure of Invention

In view of the above analysis, the present invention provides a semi-embedded housing and a stimulator, so as to solve the problems of great trauma and increased infection risk in the implantation manner of the existing stimulator.

In one aspect, the invention provides a semi-embedded shell, which comprises an upper shell and a lower shell, wherein the upper shell and the lower shell are fixedly connected to form a sealed or semi-sealed accommodating cavity, and the lower shell is in a step shape.

Further, the lower shell comprises an embedded part, and a second accommodating space is defined by the bottom wall and the side wall of the embedded part;

and a limiting part extending outwards from the top edge of the side wall is formed on the side wall of the embedding part.

Further, the top surface and the side surface of the upper shell define a first accommodating space.

Furthermore, the top of the side surface of the upper shell is at least provided with a first step and a second step; the edge of the limiting part is abutted against the step surface of the second step, and the top surface of the limiting part is flush with the step surface of the first step.

Furthermore, the top surface of the limiting part is a curved surface with a certain radian.

Further, the embedding part is arranged in a counter bore of the skull, and the limiting part is positioned outside the counter bore.

Further, the projection of the stopper portion toward the insertion portion may cover an end surface of the insertion portion.

In another aspect, the present invention provides a stimulator including the above-described semi-embedded housing.

Further, the stimulator further comprises a second housing fixedly connected with the semi-embedded housing; the second shell is a sealed or semi-sealed shell; the second housing and the upper case form a cylinder.

Furthermore, the semi-embedded shell is made of a first material, and the second shell is made of a second material.

Further, the bottom of the semi-embedded shell is provided with an anti-loosening part.

Furthermore, a battery and a PCB which are connected with each other are arranged in the semi-embedded shell, the battery is arranged in the embedded part of the lower shell, and the PCB is arranged in the upper shell.

Further, the second housing is configured as a coil assembly comprising a charging coil and a sealed housing; the sealing shell is wrapped on the charging coil and arranged on the side face of the upper shell.

Compared with the prior art, the invention can realize at least one of the following beneficial effects:

(1) the semi-embedded shell is provided with a stepped lower shell, the lower shell is arranged in a counter bore on a skull, and the lower shell is matched with the counter bore to realize the fixation of the lower shell and the skull. By means of the structural characteristics of the stepped lower shell, partial medical instruments are fixed on the human skull in a semi-embedded mounting mode, through holes are prevented from being punched on the skull, operative wounds are further reduced, and the infection risk caused by invagination of the medical instruments is reduced.

(2) The semi-embedded shell is integrally in a step shape, can serve as shells of medical instruments such as a nerve stimulator or a cochlear implant and the like, has wide application fields, can be suitable for shells of a plurality of different medical instruments, and reduces production cost. When the semi-embedded shell is used as the shell of the nerve stimulator, consumables such as a stimulator tray, skull nails and the like are omitted due to the fixation between the nerve stimulator and the skull, and the economic burden of a patient is greatly relieved. Meanwhile, the operation time is shortened, and the operation infection probability is reduced.

(3) The semi-embedded shell is fixed with the skull counter bore, and the embedded part can be directly fixedly connected with the counter bore on the skull through interference fit; the outer surface of the embedded part can be provided with external threads which are connected with counter bores on the skull in a threaded manner; the side surface of the embedded part can be provided with a connecting piece, and the connecting piece is used for increasing the friction force with the counter bore to realize the fixed connection of the embedded part and the counter bore; the side surface of the embedded part can be provided with a reinforcing part, and the reinforcing part is used for enhancing the contact force with the counter bore on the skull so as to realize the fixed connection of the embedded part and the skull; the side surface of the embedded part can be provided with a reinforcing part, the outer surface of the reinforcing part is provided with a connecting part, and the reinforcing part and the connecting part are fixedly connected by increasing contact force and friction force. The above connection modes do not need skull nails, thus reducing the damage to the skull, simplifying the operation process and realizing the stable connection of the lower shell and the counter bore.

(4) The stimulator is embedded into the counter bore of the skull in a semi-embedded mode, and the lower shell is fixed by means of matching with the counter bore, so that through holes are prevented from being drilled on the skull, skull nails are used for fixing the shell, operative wounds are reduced, and infection risks caused by the fact that the shell is sunken inwards are avoided. Simultaneously, inject the charging coil in the side of last casing through sealed shell to form complete arc with last casing, avoided setting up a circular shell again alone for the charging coil, and then reduced the operation wound.

(5) The electrode fixing assembly comprises an expansion shell and a fixed inner plug which are in mutual conical fit, so that the expansion shell can be stably connected with a through hole in a skull under the condition that no skull nail is used, and the trauma caused by the skull nail is avoided.

In the invention, the technical schemes can be combined with each other to realize more preferable combination schemes. Additional features and advantages of the invention will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The objectives and other advantages of the invention will be realized and attained by the structure particularly pointed out in the written description and drawings.

Drawings

The drawings are only for purposes of illustrating particular embodiments and are not to be construed as limiting the invention, wherein like reference numerals are used to designate like parts throughout.

FIG. 1 is a schematic diagram of a semi-embedded enclosure according to an embodiment;

FIG. 2 is a schematic view of a lower housing construction of an exemplary embodiment;

FIG. 3 is a schematic view of a lower housing with a ball joint according to an exemplary embodiment;

FIG. 4 is a schematic structural diagram of a lower shell provided with a protective diamond-grain connecting piece according to an embodiment (I);

FIG. 5 is a schematic structural diagram of a lower housing with a protective diamond-grain connector according to an embodiment;

FIG. 6 is a schematic structural view (III) of a lower shell provided with a protective diamond-grain connecting piece according to an embodiment;

FIG. 7 is a schematic view of a lower housing with a stiffener according to an exemplary embodiment;

FIG. 8 is a schematic structural view of a semi-embedded enclosure with stiffeners according to an embodiment;

FIG. 9 is a schematic structural diagram of a stimulator according to an exemplary embodiment;

FIG. 10 is an exploded view (one) of a portion of the structure of the stimulator according to an embodiment;

FIG. 11 is an exploded view (two) of a portion of the structure of the stimulator according to an embodiment;

FIG. 12 is an exploded view (III) of a portion of the structure of the stimulator according to an embodiment;

FIG. 13 is a schematic structural diagram of a stimulator according to an embodiment (II);

FIG. 14 is a cross-sectional view A-A of FIG. 13 in accordance with an exemplary embodiment;

FIG. 15 is a schematic view of the installation of a stimulator according to an embodiment;

FIG. 16 is a schematic view of an embodiment of an expansion shell configuration;

fig. 17 is a schematic view of a fixed inner plug structure according to an embodiment.

Reference numerals:

1-a stimulator; 2-scalp; 3-the skull; 4-a lower shell; 5-a battery; 6-PCB board; 7-a second feedthrough; 8-an upper shell; 81-a first step; 82-a second step; 9-electrode patch cord; 10-an electrode connector; 11-electrode holder; 12-a locking screw; 13-an electrode; 14-a first feedthrough; 15-a charging coil; 16-a winding seat; 17-sealing the shell; 18-a connecting line; 19-upper sealing cover; 20-a transmitting antenna; 21-label; 22-electrode patch cord wire; 23-a second planar section; 241-an expansion shell; 2411-taper hole; 2412-threaded holes; 2413-a strip groove; 2414-flanging; 242-fixed inner plug; 2421-a first cylindrical portion; 2422-conical section; 2423-a second cylindrical portion; 41-an insert part; 411-connecting piece; 412-a reinforcement; 4121-connecting plate; 4122-a resilient component; 4123-spacing anti-loose spring plate; 42-a limiting part; 421-a first planar portion; 43-Battery receiving Cavity.

Detailed Description

The preferred embodiments of the present invention will now be described in detail with reference to the accompanying drawings, which form a part hereof, and which together with the embodiments of the invention serve to explain the principles of the invention and not to limit its scope.

In the description of the embodiments of the present invention, it should be noted that the term "connected" is to be understood broadly, and may be, for example, fixed, detachable, or integrally connected, and may be mechanically or electrically connected, and may be directly or indirectly connected through an intermediate medium, unless otherwise specifically stated or limited. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

The terms "top," "bottom," "above … …," "below," and "on … …" as used throughout the description are relative positions with respect to components of the device, such as the relative positions of the top and bottom substrates inside the device. It will be appreciated that the devices are multifunctional, regardless of their orientation in space.

Example 1

One embodiment of the present invention, as shown in fig. 1, discloses a semi-embedded shell, which includes an upper shell 8 and a lower shell 4, wherein the lower shell 4 is covered on the upper shell 8 and hermetically connected to form a sealed or semi-sealed accommodating cavity, and the lower shell 4 is in a step-shaped structure. Further, the upper shell 8 and/or the lower shell 4 are provided with accommodating portions, and the accommodating portions and/or the accommodating cavities can accommodate medical device bodies, such as a nerve stimulator, a cochlear implant chip and the like.

Referring to fig. 10, 11 and 14, in a preferred embodiment of the present invention, the upper housing 8 has a first receiving space, the lower housing 4 has a second receiving space, and the upper housing 8 and the lower housing 4 are hermetically connected to form a receiving cavity (not shown). More specifically, as shown in fig. 2, the stepped lower case 4 includes an insertion portion 41. The bottom wall and the side wall of the embedding portion 41 define a second accommodating space, and a bent portion formed on the side wall and extending outward from the top edge of the side wall is a limiting portion 42. The top surface and the side surface of the upper housing 8 define a first accommodating space, the top of the side surface of the upper housing 8 is at least provided with a first step 81 and a second step 82, and preferably, the step surface of the first step 81 is higher than the step surface of the second step 82. Further, when the lower housing 4 is covered on the upper housing 8, the edge of the limiting portion 42 abuts against the step surface of the second step 82, and the top surface of the limiting portion 42 is flush with the step surface of the first step 81. Preferably, the thickness of the position-limiting portion 42 increases from inside to outside (from the top edge of the side wall to the outer edge of the position-limiting portion 42); furthermore, the top wall of the limiting part 42 is designed to be a curved surface with a certain radian, so that the semi-embedded shell is more attached to the skull of a human body, and subcutaneous bulge is avoided.

Referring also to fig. 15, when the semi-embedded shell is used on a human skull, a counter bore is milled into the human skull. Preferably, the volume of the counterbore matches the volume of the insert 41. The bottom of the lower shell 4 (i.e. the embedding part 41) is embedded in the counter bore, and the outer edge of the top of the lower shell 4 (i.e. the limiting part 42) protrudes out of the counter bore and is directly contacted with the upper surface of the skull. The semi-embedded shell relies on the bottom of the lower shell 4 cooperating with a counterbore to limit the rotation and axial movement of the lower shell 4 within the counterbore.

Compared with the prior art, the lower shell of the semi-embedded shell provided by the embodiment is in a step shape, the bottom of the lower shell is arranged in the counter bore on the skull, and the semi-embedded shell is directly and fixedly connected with the skull by matching with the counter bore, so that the traditional operation scheme of punching a through hole on the skull and fixing the shell by adopting skull nails is replaced, the integrity of the skull is kept as much as possible, and the operation trauma is greatly reduced. The operation time is shortened, and meanwhile, the infection risk caused by the invagination of the shell can be avoided.

Further, the embedding part 41 is arranged in a counter bore of the skull, and the limiting part 42 is positioned outside the counter bore and is integrally formed with the embedding part 41. Since the housing can be a main body of a medical device implanted under the skin, in order to reduce subcutaneous protrusion, the position-limiting part 42 is a disk-shaped structure, the embedding part 41 is a protrusion arranged in the middle of one side of the position-limiting part 42, and the projection of the position-limiting part 42 toward the embedding part 41 can cover the end face of the embedding part 41.

Further, the bottom wall shape of the insertion portion 41 may be one of rectangular, square, triangular, circular, oval, polygonal, quasi-circular, or oblong. In view of the complexity, safety and ease of operation of opening the hole in the skull, it is preferable that the bottom wall of the insertion portion 41 is oblong and the stopper portion 42 is disc-shaped in order to facilitate the opening of the counter bore in the skull.

Example 2

This embodiment 2 is a preferred embodiment of the semi-embedded shell in embodiment 1 applied to a neurostimulator product. When the semi-embedded shell is used as a main body of the nerve stimulator, the semi-embedded shell is finely adjusted on the basis of embodiment 1, and the details are described below by taking the nerve stimulator as an example.

As shown in fig. 9, 10 and 11, a first plane 421 is disposed on one side of the position-limiting part 42; a second flat portion 23 is provided at one side of the upper case 8. That is, the top surface, the side surface and the second plane portion 23 of the upper housing 8 jointly define the first accommodating space; the shape of the upper case 8 is adapted to the shape of the stopper 42. After the upper housing 8 and the lower housing 4 are connected in a sealing manner, the first plane portion 421 and the second plane portion 23 are aligned to form a sealed accommodating cavity.

In order to further reduce the volume of the stimulator 1 and reduce the subcutaneous trauma and the area of skull countersinking, a highly integrated compact nerve stimulator will be assembled by utilizing the structural characteristics of the semi-embedded shell, as shown in fig. 10. Generally, the upper case 8 is used for placing the electronic components of the stimulator 1, the second accommodating space formed by the embedded portion 41 serves as a battery accommodating cavity 43, and the battery 5 is disposed in the battery accommodating cavity 43. The arrangement not only makes full use of the space of the counter bore on the skull, but also avoids arranging the battery 5 in the upper shell 8, thereby increasing the volume of the upper shell 8 and having high space utilization rate.

The present embodiment provides a neurostimulator having a half-embedded housing with a stepped structure (i.e., the lower housing 4). As shown in fig. 15, in use, a countersink is punched on the skull 3 of a patient (namely, the skull is not punched through or a part of the skull is not cut), the nerve stimulator and the skull 3 are fixed through the matching of the embedding part 41 and the countersink, and the scalp 2 is covered and sutured after the operation is finished. Because the skull is not punctured, the problem that the dura mater is damaged due to the fact that the traditional stimulator is sunk in the skull caused by accidental collision can be avoided, and the infection risk of the implantation instrument is avoided. In addition, because the shell of this embodiment adopts half embedded installation, rely on the cooperation of casing and counter bore down to fix a position and spacing the shell, need not to adopt the skull nail to fix a position, further reduced the wound of operation and the degree of difficulty of operation.

It should be noted that the semi-embedded shell provided by this embodiment does not need a skull nail during the installation process, and does not need to preset a skull nail hole on the limiting portion 42 of the lower shell 4, and compared with a shell of a stimulator which needs to be installed by a skull nail, the neurostimulator of this embodiment simplifies the installation process of the stimulator and shortens the operation time. Meanwhile, as the skull nail is a small part, the problem that the skull nail is lost and not easy to find exists in the operation process, medical accidents can be caused if the skull nail carelessly falls into an operation wound, and the semi-embedded shell provided by the embodiment does not need to be fixed by a small part of the skull nail, so that the increase of operation risks caused by the loss of the skull nail is avoided.

Specifically, the detailed arrangement of the neurostimulator in this embodiment 2 is as follows.

As shown in fig. 14, a neural stimulator is disclosed that includes a first housing and a second housing. The first housing is the semi-embedded housing (i.e., the neurostimulator body) described in embodiment 2, and is made of a first material (e.g., a titanium alloy material); the second shell is made of a second material (such as silica gel, rubber and the like), and the second shell is connected with the first shell in a sealing mode. Preferably, the first material and the second material are both materials capable of meeting biocompatibility. The second shell is a sealed or semi-sealed shell.

Further, please refer to fig. 10, fig. 11, fig. 12 and fig. 13. The second housing is configured as a coil assembly. Coil assembly includes charging coil 15, winding seat 16 and sealed shell 17, and charging coil 15 coiling is on winding seat 16, is wrapping up charging coil 15 and winding seat 16 in the sealed shell 17. Further, the sealing shell 17 is disposed on a side surface of the neurostimulator main body, preferably, the sealing shell 17 is disposed on one side of the upper shell 8, and further, the sealing shell 17 and the upper shell 8 form a cylinder. Compared with the prior art, the stimulator that this embodiment provided is a compact stimulator with high integrated level, and it is injectd the side at last casing with the charging coil through sealed shell to form complete cylindricality with last casing, avoided setting up a circular shell again alone for the charging coil, and then reduced the operation wound. Meanwhile, the problem of temperature rise of the stimulator shell caused by the fact that the charging coil is arranged inside the shell of the stimulator in the prior art in a charging state is solved; compared with the prior art, the invention further ensures higher charging efficiency, normal operation and service life of the stimulator.

Further, as shown in fig. 10 and 13, the plane side of the sealing shell 17 is preferentially arranged on the plane formed by the first plane portion 421 and the second plane portion 23, so that the arc surface of the sealing shell 17 is spliced with the arc surfaces of the upper housing 8 and the limiting portion 42 to form a complete cylindrical surface.

Note that the sealing case 17 is formed by vulcanization of silicone rubber.

As shown in fig. 11 and 12, the winding base 16 is further provided with a transmitting antenna 20 and a mark 21, and both ends of the transmitting antenna 20 and the charging coil 15 are welded on the first feed-through 14 (preferably 3-pin feed-through) to realize communication and charging functions. As shown in fig. 14, the first feedthrough 14 is disposed in the upper case 8 at a middle portion thereof and connected to the PCB board 6. One end of the first feed-through 14 passes through the lower housing 4, and the other end passes through the second plane portion 23 to be connected with the transmitting antenna 20 and the charging coil 15.

In this embodiment, the seal shell 17 will wind the seat 16, transmitting antenna 20, mark 21, charging coil 15 parcel is fixed on the second plane portion 23 of upper housing 8 to form complete face of cylinder with upper housing 8, compare with the stimulator that needs additionally to configure a shell for the charging coil, reduced amazing whole volume, and then reduced the wound of operation.

In this embodiment, the arrangement space of the battery 5 is placed on the lower side of the PCB 6, and is connected to the PCB 6 through the connecting wire 18, and the protrusion (the embedding part 41 in this embodiment) of the stimulator 1 in the thickness direction is used as an implant to be embedded into the counter bore of the skull 3, so that the overall planar space of the product can be saved.

As shown in fig. 11, the stimulator 1 further comprises a second feedthrough 7 (preferably an 8-pin feedthrough) and an electrode assembly comprising an electrode patch 9 and an electrode 13, said second feedthrough 7 being provided in the upper casing 8 in connection with the PCB board 6 and being located on the opposite side of said first feedthrough 14. One end of the electrode patch 9 passes through the upper shell 8 and is fixedly connected with the second feed-through 7 in a non-detachable mode (such as welding), and the other end of the electrode patch is connected with the electrode 13 in a detachable mode.

Specifically, in order to facilitate the connection of the electrode patch 9 to the second feedthrough 7, the end face of the upper case 8 is provided with a slot hole exposing the second feedthrough 7, and the electrode patch 9 is connected to the second feedthrough 7 through the electrode patch lead 22. The upper cover of the slotted hole is provided with an upper cover 19, and the sealing is good. Furthermore, the second feedthrough 7 is connected to the electrode patch wire 22 in a non-detachable manner, for example by welding.

In a preferred embodiment of the present invention, the connection relationship between the parts inside the stimulator housing and the connection relationship between the stimulator housing and the external component are preferably non-detachable, such as welding. In particular, the connection between the feedthrough (e.g., an 8-pin feedthrough) in the stimulator housing and the electrode assembly is preferably a non-detachable connection such as a weld. The advantage of so designing lies in: firstly, the stimulator is used as a medical instrument to be implanted into the head of a patient, so that the reliability and the service life of the internal connection of the stimulator must be ensured, and the connection between an electrode and a feed-through piece in the existing stimulator is detachable, so that firstly, the risk of poor sealing exists, secondly, when the connection is poor, related workers cannot quickly check without damaging a shell, and thirdly, the service life of the stimulator is reduced; secondly, the welding and other forms are adopted, so that a complex detachable connecting structure is avoided, the size of the stimulator is greatly reduced, and the reliability of internal connection is ensured.

In addition, as shown in fig. 11, in order to ensure reliable connection between the electrode patch cord 9 and the electrode 13, an electrode connector 10, an electrode holder 11 and a locking screw 12 are arranged in the other end of the electrode patch cord 9, the electrode 13 passes through the electrode holder 11 to be connected with the electrode connector 10, and the locking screw 12 screws the electrode holder 11 and presses the electrode 13, so as to prevent the electrode 13 from being removed. Compared with the prior art, the stimulator has the advantages that the shell of the stimulator is detachably connected with the electrodes outside the shell (for example, the electrodes 13 are detachably connected with the electrode patch cord 9), so that the influence on the normal operation and stability of the stimulator caused by the fact that the electrodes are plugged and pulled for many times is avoided, and the stimulator equipment can be flexibly adjusted and checked by related workers.

Example 3

This embodiment is an optimized design based on embodiment 2, and the optimization mainly consists in the electrode fixing assembly, and the optimization will be described below.

After the electrode 13 is inserted into the brain, the electrode needs to be fixed on the skull through an electrode fixing assembly so as to avoid the electrode from deviating from the target point and affecting the treatment effect. The neurostimulator therefore further comprises an electrode mounting assembly. As shown in fig. 16 and 17, the electrode fixing assembly includes an expansion housing 241 and a fixing inner plug 242 inserted into the expansion housing 241. Wherein the expansion shell 241 is preferably conical (the expansion shell 241 may also be cylindrical). One end of the expansion shell 241 is provided with a taper hole 2411, the other end (the bottom of the expansion shell 241 in fig. 16) is provided with a threaded hole 2412, and the threaded hole 2412 is communicated with the taper hole 2411 and is coaxially arranged. Preferably, the electrode fixing components are made of biocompatible materials.

A plurality of strip-shaped grooves 2413 are uniformly arranged on the side wall of the shell where the taper hole 2411 is arranged along the circumference so as to increase the expansion force of the expansion shell 241. The strip-shaped grooves 2413 play a role in limiting and fastening the expansion shell 241 in the installation of the skull through hole, so that the problem that the shell of the expansion shell 241 rotates along with the skull or cannot be fastened is solved.

Further, in order to prevent the expansion shell 241 from falling into the through hole of the skull 3, the end of the taper hole 2411 (the top of the expansion shell 241 in fig. 16, that is, the left end of the expansion shell 241 in fig. 16) is provided with a flange 2414. A first electrode placing groove (not shown in the figure) matched with the electrode 13 is formed in the radial surface of the turned-over edge 2414, and the electrode 13 can be pressed and buckled in the first electrode placing groove to fix the electrode wire.

Referring to fig. 17, a through hole is formed at the axial center of the fixed inner plug 242. One end of the fixed inner plug 242 is a first cylindrical part 2421 provided with an external thread; a conical part 2422 is arranged in the middle; the other end is a second cylindrical portion 2423. Further, the first cylindrical portion 2421 is matched with the threaded hole 2412; the conical part 2422 and the second cylindrical part 2423 are integrally arranged and arranged in the conical hole 2411. Further, the conical part 2422 is in smooth transition connection with the second cylindrical part 2423, and the diameter of the small end of the conical part 2422 is slightly smaller than the opening diameter of the conical hole 2411, so that the fixing inner plug 242 can be screwed into the expansion shell 241. The diameter of the second cylindrical part 2423 is equal to the diameter of the bottom of the taper hole 2411, so that when the first cylindrical part 2421 is screwed into the threaded hole 2412, the expansion shell 241 is in a cylindrical shape matched with the through hole on the skull 3, that is, the expansion shell 241 can be fixed on the through hole in a good sealing manner.

In order to receive the electrode 13, a second electrode receiving groove (not shown) is provided along a radial surface of the end portion of the second cylindrical portion 2423 to engage with the electrode 13. Preferably, the notch of the first electrode placing groove and the notch of the second electrode placing groove are in butt joint with each other; more preferably, the caliber of the notch of the first electrode placing groove and the caliber of the notch of the second electrode placing groove are as smaller or equal to the outer diameter of the electrode wire as possible, so that the electrode wire can be firmly fastened in the first electrode placing groove and the second electrode placing groove. In order to facilitate the screwing of the fixed inner plug 242, the end of the second cylindrical portion 2423 is symmetrically provided with at least two grooves (not shown), and the opening positions and shapes of the grooves can be designed according to the structure of the surgical instrument actually used, so as to better enable the fixed inner plug 242 to be screwed into the expansion shell 241 in a sealing manner. The above-mentioned opening of the notch is the prior art, and is not described herein.

In this embodiment, the expansion shell 241 is expanded outwards under the action of the fixed inner plug 242 by matching the fixed inner plug 242 with the expansion shell 241 so as to be clamped in the through hole of the skull, and the expansion shell 241 is firmly connected with the through hole. Compared with the prior art, the electrode fixing assembly can realize the fixation of the electrode without using skull nails, further reduces the damage of patients and reduces the use of medical consumables.

Further, the flange 2414 of the expansion shell 241 may also be provided with a skull nail hole, and the expansion shell may be fixed by the cooperation of the skull nail hole and the skull nail.

It should be noted that the electrode 13 of the present embodiment may also be fixed by using an electrode fixing device in the prior art, which is not described herein again.

Example 4

In the above embodiment 3, the fixation of the electrode on the skull is described, and in the embodiment 4, the direct fixation of the neurostimulator on the skull is described with emphasis. In order to ensure good fixation of the nerve stimulator and the skull, the nerve stimulator is also provided with an anti-loosening part. Preferred embodiments of the anti-loosening element are described below.

The first preferred design of the anti-loosening component is as follows:

since the nerve stimulator in embodiment 2 described above uses the lower shell 4 to match with the counter bore on the skull, and does not use the skull nail fixing method, in order to further enhance the fixing effect of the lower shell 4 and the counter bore, the side wall surface of the embedding portion 41 is provided with the connecting piece 411. The connector 411 is used to increase the friction between the insert 41 and the counterbore. Preferably, the connecting member 411 is a spherical protrusion or an anti-slip diamond pattern provided on the side surface of the insertion portion 41.

As shown in fig. 3, when the connecting member 411 is a spherical projection, the spherical projection is not more than half of a sphere, and the spherical projection is uniformly provided on the side wall surface of the insertion portion 41. As shown in fig. 4, when the connecting member 411 is an anti-slip rib, the anti-slip rib is uniformly arranged on the side wall surface of the embedding portion 41.

Alternatively, as shown in fig. 5, the axis of the anti-slip rib is arranged parallel to the central axis in the height direction of the embedded portion 41. Alternatively, the axis of the non-slip rib is disposed at an angle to the central axis in the height direction of the insert portion 41. Alternatively, the plurality of anti-slip ribs arranged at an angle with respect to the central axis of the embedded portion 41 in the height direction may be arranged at the same angle, may be arranged at different angles, or may be arranged to form a mesh structure. Alternatively, as shown in fig. 6, the cylindrical surface of the embedded portion 41 is provided with the anti-slip ribs parallel to the central axis of the embedded portion 41 in the height direction, and is also provided with the anti-slip ribs perpendicular to the central axis of the embedded portion 41 in the height direction, that is, the anti-slip ribs form an arrangement manner of the grid structure. The arrangement mode of the spherical protrusions and the anti-skid ribs can be flexibly set according to actual needs, and further description is omitted here.

The second preferable design of the anti-loosening component is as follows:

the anti-loosening element may also be a reinforcement 412.

As shown in fig. 7, the reinforcement member 412 includes a connecting plate 4121 and a resilient member 4122. One end of the elastic member 4122 is connected to a side surface of the insertion portion 41, and the other end is connected to the connection plate 4121. Preferably, the resilient member 4122 is a compression spring.

The shape and number of the connecting plates 4121 are determined according to the shape of the counter bore arranged on the skull 3. Illustratively, when the counter bores are rectangular holes, the connecting plates 4121 are in the shape of long strips, and the number of the connecting plates 4121 is a multiple of 4; when the counter bores are circular, the connecting plates 4121 are arc-shaped plates, and the number of the connecting plates 4121 is at least 3; when the counter bores are oblong, the connecting plates 4121 are shaped like arcs and also like rectangular plates to fit the shape of the counter bores, wherein the number of the connecting plates 4121 like arcs is a multiple of 2 and the number of the connecting plates 4121 like rectangular plates is a multiple of 2.

The oblong counter bores are illustrated below as an example:

specifically, a plurality of rows of mounting holes are provided in parallel along the axial direction of the insertion portion 41 on the side wall surface of the insertion portion 41, and each row includes a plurality of mounting holes. Preferably, as shown in fig. 7, each row includes 3 of the mounting holes, which do not penetrate through the side wall surface of the embedding portion 41. One end of the elastic component 4122 is fixedly arranged in the mounting hole, and the other end of the elastic component 4122 is fixedly connected with the inner side wall of the connecting plate 4121.

Further, the connecting plate 4121 includes 2 arc-shaped plates and 2 elongated plates, and the thickness of the connecting plate 4121 is equal to that of the embedded portion 41. 2 arc-shaped plates are respectively arranged on the curved surface side of the counter bore, and 2 strip-shaped plates are respectively arranged on the plane side of the counter bore.

In the embodiment, after the embedded portion 41 is disposed in the counter bore, the elastic member is in a compressed state, and tends to extend and return to its original length. The connecting plate 4121 is expanded outward by the elastic member to be attached to the inner wall of the counterbore, and the embedded portion 41 is in close contact with the counterbore by the elastic member 4122, thereby restricting the movement of the nerve stimulator.

The preferable design scheme of the anti-loosening part is as follows:

as an optional solution in this embodiment, as shown in fig. 8, the anti-loosening component is a limiting anti-loosening elastic sheet 4123, and the limiting anti-loosening elastic sheets 4123 are arranged on the embedding portion 41 at intervals. Preferably, the limiting anti-loose elastic piece 4123 is in an L shape and comprises a connecting part and a supporting part. The connecting part is connected with the bottom of the embedding part 41; the support portion is located on the outer periphery of the side surface of the fitting portion 41 and is away from the side wall surface of the fitting portion 41 (i.e., the support portion has a certain gap from the side wall surface of the fitting portion 41). The connecting part of the limiting anti-loosening elastic sheet 4123 and the connecting part of the supporting part are in smooth transition. The limiting anti-loosening elastic sheet 4123 can be a plate spring.

When the embedded part 41 is arranged in the counter bore of the skull 3, the outer contour formed by the plurality of supporting parts is larger than the counter bore, and the limiting anti-loosening elastic sheet 4123 has elasticity. Therefore, when the supporting portion contacts with the inner wall of the counterbore, the supporting portion is compressed under the action of the counterbore and shrinks towards the direction of the side wall surface of the embedding portion 41, and the limiting anti-loosening elastic sheet 4123 has certain rigidity, so that the supporting portion has the tendency of recovering to the original shape when being compressed, and the nerve stimulator is stably connected with the counterbore under the matching of the limiting anti-loosening elastic sheet 4123.

As an optional scheme of this embodiment, because the semi-embedded housing of this embodiment adopts the way that lower housing 4 is matched with the counter bore on the skull, and does not adopt the way of skull nail fixation, in order to further strengthen the fixed effect of lower housing 4 and counter bore, embedding portion 41 of lower housing 4 is equipped with the external screw thread, and correspondingly, the counter bore on the skull is equipped with the internal screw thread, and embedding portion 41 and counter bore threaded connection.

The semi-embedded shell provided by the embodiment can be fixedly connected with the counter bore on the skull by the embedded part 41 through interference fit; the outer surface of the embedding part 41 can be provided with external threads which are connected with counter bores on the skull in a threaded manner; the side surface of the embedded part 41 can be provided with a connecting piece, and the connecting piece can increase the friction force with the counter bore to realize the fixed connection of the embedded part and the counter bore; the side surface of the embedded part 41 can be provided with a reinforcing part, and the reinforcing part is used for enhancing the contact force with a counter bore on the skull so as to realize the fixed connection of the embedded part and the skull; the lateral surface of the embedding part 41 can be provided with a reinforcing part, the contact surface of the reinforcing part and the counter bore is provided with a connecting part, the reinforcing part increases the contact force, the connecting part increases the friction force to realize the fixed connection of the reinforcing part and the counter bore, the skull nail is not needed in the above connection mode, the damage to the skull is reduced, the operation process is simplified, and the stable connection of the lower shell and the counter bore can be realized.

The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention are included in the scope of the present invention.