A semi-embedded housing and stimulator

Abstract

The present invention relates to a semi-embedded housing and a stimulator, belonging to the technical field of full-head active implantable medical devices, and solves the problem that the implantation method of the stimulator in the prior art is highly traumatic and increases the risk of infection. The semi-embedded housing of the present invention comprises an upper shell and a lower shell, wherein the upper shell is fixedly connected to the lower shell to form a sealed or semi-sealed accommodating cavity, and the lower shell is stepped. The semi-embedded housing of the present invention enables the stimulator to be semi-embedded in the countersunk hole of the skull, thereby reducing surgical trauma and lowering surgical risks.

Description

Technical Field

[0001] The present invention relates to the technical field of full-head active implantable medical devices, and in particular to a semi-embedded housing and a stimulator. Background Art

[0002] Implantable active medical devices are now widely used to treat a variety of diseases. One type of implantable active medical device is a neurostimulator, which transmits pulse signals to nerve tissue through electrodes to improve the normal functioning of the human body. For example, the more common one is DBS (Deep Brain Stimulation), which can effectively improve the limb control and coordination ability of patients with neurological diseases. This deep brain nerve stimulation technique has become the preferred treatment option besides drugs because it is minimally invasive, safe and effective. Therefore, the research on implantable brain stimulators has also received more and more attention.

[0003] The existing stimulator installation method is to first find a suitable implantation site on the skull, and after determining the site, cut the scalp, cut through the skull to cut off the skull that is the same size as the stimulator, directly expose the dura mater part of the brain, and fix the stimulator to the skull through the 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 function of the tray is to fix the stimulator on the one hand, and on the other hand, it can prevent the stimulator from damaging the dura mater when it is impacted by the outside world, and reduce the risk of the stimulator accidentally entering the skull and damaging brain tissue.

[0004] However, the existing stimulator installation method has a relatively complicated surgical process and is relatively harmful to people. After the skull is removed, the repair period is relatively long. If the patient's craniotomy causes a skull defect of 3 cm or more, a part of the skull is missing, the intracranial environment will change dramatically, the intracranial pressure will become unstable, the cerebrospinal fluid circulation and cerebral blood flow circulation in the skull may be affected, and the neurological function in the skull may be obstructed, resulting in a series of skull defect syndromes, affecting the physical and mental health of the whole person. In addition, the bottom of the existing stimulator is in direct contact with the dura mater. If it encounters an impact, it may directly damage the dura mater. At the same time, this direct contact method, if there is brain fluid leakage, will further reduce the service life of the stimulator and increase the risk of infection for the patient. Furthermore, the existing installation method between the stimulator and the skull also uses skull nails, which expands the skull damage, increases the risk of secondary infection of the patient's head, prolongs the operation time, increases the cost of consumables, and increases the economic burden on the patient. Summary of the invention

[0005] In view of the above analysis, an embodiment of the present invention aims to provide a semi-embedded housing and a stimulator to solve the problem that the implantation method of the existing stimulator is highly invasive and increases the risk of infection.

[0006] On the one hand, the present invention provides a semi-embedded housing, comprising an upper shell and a lower shell, wherein the upper shell is fixedly connected to the lower shell to form a sealed or semi-sealed accommodating cavity, and the lower shell is stepped.

[0007] Further, the lower shell includes an embedded portion, and the bottom wall and side walls of the embedded portion define a second accommodating space;

[0008] A limiting portion extending outward from the top edge of the side wall is formed on the side wall of the embedded portion.

[0009] Furthermore, the top surface and the side surfaces of the upper shell define a first accommodating space.

[0010] Furthermore, at least a first step and a second step are provided on the top of the side surface of the upper shell; the edge of the limiting portion abuts against the step surface of the second step, and the top surface of the limiting portion is flush with the step surface of the first step.

[0011] Furthermore, the top surface of the limiting portion is a curved surface with a certain curvature.

[0012] Furthermore, the embedding portion is arranged in a countersunk hole of the skull, and the limiting portion is located outside the countersunk hole.

[0013] Furthermore, it is characterized in that the projection of the limiting portion toward the embedding portion can cover the end surface of the embedding portion.

[0014] On the other hand, the present invention provides a stimulator, which includes the semi-embedded housing described above.

[0015] Furthermore, the stimulator also includes a second shell fixedly connected to the semi-embedded shell; the second shell is a sealed or semi-sealed shell; the second shell and the upper shell form a cylinder.

[0016] Furthermore, the semi-embedded shell is made of a first material, and the second shell is made of a second material.

[0017] Furthermore, an anti-loosening component is provided at the bottom of the semi-embedded housing.

[0018] Furthermore, a battery and a PCB board connected to each other are provided in the semi-embedded housing, the battery is provided in the embedded portion of the lower housing, and the PCB board is provided in the upper housing.

[0019] Furthermore, the second shell is configured as a coil assembly, and the coil assembly includes a charging coil and a sealing shell; the sealing shell wraps the charging coil and is arranged on the side of the upper shell.

[0020] Compared with the prior art, the present invention can achieve at least one of the following beneficial effects:

[0021] (1) The semi-embedded housing of the present invention has a stepped lower shell, which is arranged in a countersunk hole on the skull. The lower shell is fixed to the skull by cooperating with the countersunk hole. Due to the structural characteristics of the stepped lower shell, some medical devices can be fixed on the human skull in a semi-embedded installation manner, avoiding drilling holes in the skull, further reducing surgical trauma, and reducing the risk of infection caused by the internalization of medical devices.

[0022] (2) The semi-embedded housing of the present invention is stepped as a whole and can serve as the housing of medical devices such as a neurostimulator or a cochlear implant. It has a wide range of applications, and one housing structure can be adapted to the housings of multiple different medical devices, thereby reducing production costs. When the semi-embedded housing is used as the housing of a neurostimulator, the fixation between the neurostimulator and the skull eliminates the need for consumables such as a stimulator tray and skull nails, greatly reducing the economic burden on the patient. At the same time, the operation time is shortened and the probability of surgical infection is reduced.

[0023] (3) The fixation of the semi-embedded shell to the skull countersunk hole can be that the embedded part is directly fixedly connected to the skull countersunk hole through interference fit; the outer surface of the embedded part can be provided with an external thread, which is threadedly connected to the skull countersunk hole; a connecting piece can be provided on the side surface of the embedded part, and the friction between the connecting piece and the countersunk hole is increased to achieve a fixed connection between the two; a reinforcing piece can be provided on the side surface of the embedded part, and the contact force with the skull countersunk hole is enhanced by the reinforcing piece to achieve a fixed connection between the two; or a reinforcing piece can be provided on the side surface of the embedded part, and a connecting piece can be provided on the outer surface of the reinforcing piece, and the contact force is increased by the reinforcing piece and the friction is increased by the connecting piece to achieve a fixed connection between the two. The above connection methods do not require skull nails, which reduces damage to the skull, simplifies the surgical procedure, and can achieve a stable connection between the lower shell and the countersunk hole.

[0024] (4) The stimulator is semi-embedded in the countersunk hole of the skull, and the lower shell is fixed by cooperating with the countersunk hole, avoiding drilling holes in the skull and using skull nails to fix the shell, reducing surgical trauma and avoiding the risk of infection caused by the shell sinking. At the same time, the charging coil is confined to the side of the upper shell by the sealing shell, and forms a complete arc shape with the upper shell, avoiding the need to set up a separate circular shell for the charging coil, thereby reducing surgical trauma.

[0025] (5) The electrode fixing assembly includes an expansion shell and a fixing inner plug that fit each other in a conical shape, so that the expansion shell can be firmly connected to the through hole on the skull without using skull nails, thereby avoiding trauma caused by using skull nails.

[0026] In the present invention, the above-mentioned technical solutions can also be combined with each other to achieve more preferred combination solutions. Other features and advantages of the present invention will be described in the subsequent description, and some advantages can become obvious from the description, or can be understood by practicing the present invention. The purpose and other advantages of the present invention can be realized and obtained through the contents particularly pointed out in the description and the drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The drawings are only for the purpose of illustrating particular embodiments and are not to be considered limiting of the present invention. Like reference symbols denote like components throughout the drawings.

[0028] Figure 1 It is a structural schematic diagram of a semi-embedded housing of a specific embodiment;

[0029] Figure 2 is a schematic diagram of the lower housing structure of a specific embodiment;

[0030] Figure 3 It is a schematic diagram of the structure of a lower housing provided with a spherical connector in a specific embodiment;

[0031] Figure 4 It is a schematic diagram of the structure of the lower shell provided with a protective diamond-patterned connector according to a specific embodiment (I);

[0032] Figure 5 It is a schematic diagram of the structure of the lower shell provided with a protective diamond-patterned connector according to a specific embodiment (II);

[0033] Figure 6 It is a schematic diagram of the structure of the lower shell provided with a protective diamond-patterned connector according to a specific embodiment (III);

[0034] Figure 7 It is a schematic diagram of the structure of a lower shell provided with a reinforcement member in a specific embodiment;

[0035] Figure 8 It is a schematic diagram of a semi-embedded housing structure provided with a reinforcement member in a specific embodiment;

[0036] Fig. 9 is a schematic structural diagram of a stimulator according to a specific embodiment (I);

[0037] Fig.10 It is a partial structural exploded view of a stimulator of a specific embodiment (I);

[0038] Fig.11It is a partial structural exploded view of a stimulator of a specific embodiment (II);

[0039] Fig.12 It is a partial structural exploded view of a stimulator of a specific embodiment (III);

[0040] Fig.13 is a structural schematic diagram of a stimulator of a specific embodiment (II);

[0041] Fig.14 For a specific embodiment Fig.13 AA section view;

[0042] Fig.15 is a schematic diagram of the installation of a stimulator in a specific embodiment;

[0043] Fig.16 It is a schematic diagram of the expansion shell structure of a specific embodiment;

[0044] Fig.17 It is a schematic diagram of the fixed inner plug structure of a specific embodiment.

[0045] Reference numerals:

[0046] 1-stimulator; 2-scalp; 3-skull; 4-lower shell; 5-battery; 6-PCB board; 7-second feedthrough; 8-upper shell; 81-first step; 82-second step; 9-electrode adapter; 10-electrode connector; 11-electrode fixing seat; 12-locking screw; 13-electrode; 14-first feedthrough; 15-charging coil; 16-winding seat; 17-sealed shell; 18-connecting wire; 19-upper cover; 20-transmitting antenna; 21-marker; 22-electrode adapter wire ; 23-second plane portion; 241-expansion shell; 2411-conical hole; 2412-threaded hole; 2413-strip groove; 2414-flange; 242-fixed inner plug; 2421-first cylindrical portion; 2422-conical portion; 2423-second cylindrical portion; 41-embedded portion; 411-connecting piece; 412-reinforcement piece; 4121-connecting plate; 4122-elastic component; 4123-limiting and anti-loosening spring sheet; 42-limiting portion; 421-first plane portion; 43-battery accommodating cavity. DETAILED DESCRIPTION

[0047] The preferred embodiments of the present invention will be described in detail below in conjunction with the accompanying drawings, wherein the accompanying drawings constitute a part of the present invention and are used together with the embodiments of the present invention to illustrate the principles of the present invention, but are not used to limit the scope of the present invention.

[0048] In the description of the embodiments of the present invention, it should be noted that, unless otherwise clearly specified and limited, the term "connected" 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, it can be an electrical connection, it can be a direct connection, or it can be indirectly connected through an intermediate medium. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0049] The terms "top", "bottom", "above", "lower", and "on" used throughout the description are relative to the relative positions of components of a device, such as the relative positions of the top and bottom substrates within a device. It is understood that devices are multifunctional regardless of their orientation in space.

[0050] Example 1

[0051] A specific embodiment of the present invention, as Figure 1 As shown, a semi-embedded housing is disclosed, comprising an upper shell 8 and a lower shell 4, wherein the lower shell 4 is covered on the upper shell 8 and sealed to form a sealed or semi-sealed accommodating cavity, and the lower shell 4 is a stepped structure. Further, the upper shell 8 and / or the lower shell 4 are provided with an accommodating portion, and the accommodating portion and / or the accommodating cavity can hold a medical device body, such as a neural stimulator, a cochlear implant chip, etc.

[0052] Please also read Fig.10 , Fig.11 and Fig.14 In a preferred embodiment of the present invention, the upper shell 8 has a first accommodating space, the lower shell 4 has a second accommodating space, and the upper shell 8 and the lower shell 4 are sealed and connected to form an accommodating cavity (not shown in the figure). More specifically, Figure 2 As shown, the stepped lower shell 4 includes an embedded portion 41. The bottom wall and side walls of the embedded portion 41 define a second accommodation space, and the bent portion formed on the side wall and extending outward from the top edge of the side wall is the limiting portion 42. The top surface and side surface of the upper shell 8 define a first accommodation space, and the top of the side surface of the upper shell 8 is provided with at least 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 shell 4 is covered on the upper shell 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 limiting portion 42 increases from the inside to the outside (from the top edge of the side wall to the outer edge of the limiting portion 42); further, the top wall of the limiting portion 42 is designed to be a curved surface with a certain curvature so that the semi-embedded shell fits the human skull better and avoids subcutaneous bulges.

[0053] Please also read Fig.15 When the semi-embedded housing is used on a human skull, a countersink is first ground on the human skull. Preferably, the volume of the countersink matches the embedding portion 41. The bottom of the lower shell 4 (i.e., the embedding portion 41) is embedded in the countersink, and the top outer edge of the lower shell 4 (i.e., the limiting portion 42) protrudes out of the countersink to directly contact the upper surface of the skull. The semi-embedded housing relies on the cooperation between the bottom of the lower shell 4 and the countersink to limit the rotation and axial movement of the lower shell 4 in the countersink.

[0054] Compared with the prior art, the semi-embedded shell provided in this embodiment has a stepped lower shell, the bottom of which is arranged in a countersunk hole on the skull, and the semi-embedded shell is directly fixedly connected to the skull by cooperating with the countersunk hole, replacing the traditional surgical solution of drilling a hole in the skull and fixing the shell with skull nails, preserving the integrity of the skull as much as possible, and greatly reducing the trauma of the surgery. The surgical time is shortened while avoiding the risk of infection caused by the shell sinking.

[0055] Furthermore, the embedded portion 41 is disposed in the countersunk hole of the skull, and the limiting portion 42 is located outside the countersunk hole and is integrally formed with the embedded portion 41. Since the housing can be a medical device body implanted subcutaneously, in order to reduce the subcutaneous protrusion, the limiting portion 42 is a disc-shaped structure, and the embedded portion 41 is a protrusion disposed in the middle of one side of the limiting portion 42, and the projection of the limiting portion 42 toward the embedded portion 41 can cover the end surface of the embedded portion 41.

[0056] Furthermore, the bottom wall of the embedded portion 41 may be in a rectangular, square, triangular, circular, elliptical, polygonal, quasi-circular or oblong shape. Considering the complexity, safety and operability of opening a hole in the skull, in order to facilitate opening a countersink in the skull, preferably, the bottom wall of the embedded portion 41 is in an oblong shape, and the limiting portion 42 is in a disc shape.

[0057] Example 2

[0058] This embodiment 2 is a preferred embodiment of the semi-embedded housing in embodiment 1 applied to a neurostimulator product. When the semi-embedded housing is used as the main body of the neurostimulator, the semi-embedded housing is fine-tuned on the basis of embodiment 1, and the following will be described in detail using the neurostimulator as an example.

[0059] like Fig. 9 , Fig.10 and Fig.11As shown, a first plane portion 421 is provided on one side of the position-limiting portion 42; a second plane portion 23 is provided on one side of the upper shell 8. That is, the top surface, the side surface and the second plane portion 23 of the upper shell 8 together define the first accommodation space; the shape of the upper shell 8 is adapted to the shape of the position-limiting portion 42. When the upper shell 8 is sealed and connected to the lower shell 4, the first plane portion 421 and the second plane portion 23 are aligned to form a sealed accommodation cavity.

[0060] like Fig.10 As shown, in order to further reduce the volume of the stimulator 1, reduce subcutaneous trauma and the area of ​​the skull countersink, the structural characteristics of the semi-embedded shell are utilized to assemble a highly integrated compact neurostimulator. Generally, the upper shell 8 is used to place the electronic components of the stimulator 1, and the second accommodation space formed by the embedded portion 41 is used as a battery accommodating chamber 43, and the battery 5 is arranged in the battery accommodating chamber 43. This arrangement not only fully utilizes the space of the skull countersink, but also avoids arranging the battery 5 in the upper shell 8, thereby increasing the volume of the upper shell 8, and the space utilization rate is high.

[0061] The neurostimulator provided in this embodiment has a half embedded housing, and the housing has a stepped structure (i.e., the lower housing 4). Fig.15 As shown, when in use, a countersunk hole is made on the patient's skull 3 (i.e., the skull is not pierced or part of the skull does not need to be removed), and the neurostimulator and the skull 3 are fixed by the cooperation of the embedded portion 41 and the countersunk hole. After the operation, the scalp 2 is covered and sutured. Since the skull is not pierced, the problem of the traditional stimulator being sunken due to accidental collision and damaging the dura mater will not occur, thereby avoiding the risk of infection of the implanted device. In addition, since the shell of this embodiment is semi-embedded, the shell is positioned and limited by the cooperation of the lower shell and the countersunk hole, and there is no need to use skull nails for positioning, which further reduces the trauma of the operation and the difficulty of the operation.

[0062] It is worth noting that the semi-embedded housing provided in this embodiment does not require skull pins during installation, and there is no need to preset skull pin holes on the limiting portion 42 of the lower shell 4. Compared with the housing of the stimulator that needs to be installed with skull pins, the neurostimulator described in this embodiment simplifies the installation process of the stimulator and shortens the operation time. At the same time, since the skull pin is a relatively small component, it is difficult to find it if it is lost during the operation. If it accidentally falls into the surgical wound, it will cause a medical accident. The semi-embedded housing provided in this embodiment does not need to be fixed with a small component such as a skull pin, thereby avoiding the increase in surgical risks caused by the loss of the skull pin.

[0063] Specifically, the detailed arrangement of the neurostimulator in this embodiment 2 is as follows.

[0064] like Fig.14 As shown, a neurostimulator is disclosed, which includes a first shell and a second shell. The first shell is the semi-embedded shell (i.e., the neurostimulator body) described in Example 2, and the first shell is made of a first material (such as a titanium alloy); the second shell is made of a second material (such as silicone, rubber, etc.), and the second shell is sealed and connected to the first shell. Preferably, both the first material and the second material are materials that can meet biocompatibility. The second shell is a sealed or semi-sealed shell.

[0065] For further information, please also refer to Fig.10 , Fig.11 , Fig.12 and Fig.13 . The second shell is configured as a coil assembly. The coil assembly includes a charging coil 15, a winding seat 16 and a sealing shell 17. The charging coil 15 is wound on the winding seat 16, and the charging coil 15 and the winding seat 16 are wrapped in the sealing shell 17. Further, the sealing shell 17 is arranged on the side of the main body of the neurostimulator. Preferably, the sealing shell 17 is arranged on one side of the upper shell 8, and then the sealing shell 17 and the upper shell 8 form a cylinder. Compared with the prior art, the stimulator provided in this embodiment is a compact stimulator with a high degree of integration. The charging coil is limited to the side of the upper shell by a sealing shell, and forms a complete cylindrical shape with the upper shell, avoiding the need to set a separate circular shell for the charging coil, thereby reducing surgical trauma. At the same time, the problem of temperature rise of the stimulator shell caused by the charging coil being arranged inside the shell of the stimulator in the prior art is avoided; compared with the prior art, the present invention further ensures higher charging efficiency, normal operation and service life of the stimulator.

[0066] Further, such as Fig.10 , Fig.13 As shown, the plane side of the sealing shell 17 is preferably 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 surface of the upper shell 8 and the limiting portion 42 to form a complete cylindrical surface.

[0067] It should be noted that the sealing shell 17 is formed by vulcanization of silicone.

[0068] like Fig.11 , Fig.12 As shown, the winding seat 16 is also provided with a transmitting antenna 20 and a mark 21, and the transmitting antenna 20 and the two ends of the charging coil 15 are welded on the first feedthrough 14 (preferably a 3-pin feedthrough) to achieve communication and charging functions. Fig.14As shown, the middle part of the first feedthrough 14 is disposed in the upper housing 8 and connected to the PCB board 6. One end of the first feedthrough 14 passes through the lower housing 4, and the other end passes through the second plane portion 23 and is connected to the transmitting antenna 20 and the charging coil 15.

[0069] In this embodiment, the sealing shell 17 wraps and fixes the winding seat 16, the transmitting antenna 20, the marker 21, and the charging coil 15 on the second planar portion 23 of the upper shell 8, and forms a complete cylindrical surface with the upper shell 8. Compared with a stimulator that requires an additional shell for the charging coil, the overall volume of the stimulation is reduced, thereby reducing the trauma of the operation.

[0070] In this embodiment, the arrangement space of the battery 5 is placed on the lower side of the PCB board 6 and connected to the PCB board 6 through the connecting wire 18. At the same time, the protruding part in the thickness direction of the stimulator 1 (the embedded part 41 of this embodiment) is used as a surgical implant to be embedded in the countersunk hole of the skull 3, which can save the overall plane space of the product.

[0071] like Fig.11 As shown, the stimulator 1 further includes a second feedthrough 7 (preferably an 8-pin feedthrough) and an electrode assembly, wherein the electrode assembly includes an electrode adapter 9 and an electrode 13, wherein the second feedthrough 7 is disposed in the upper housing 8 and connected to the PCB board 6, and is located on the opposite side of the first feedthrough 14. One end of the electrode adapter 9 passes through the upper housing 8 and is fixedly connected to the second feedthrough 7 in a non-detachable manner (such as welding), and the other end is connected to the electrode 13 in a detachable manner.

[0072] Specifically, in order to facilitate the connection between the electrode adapter 9 and the second feedthrough 7, a slot is provided on the end surface of the upper shell 8 to expose the second feedthrough 7, and the electrode adapter 9 is connected to the second feedthrough 7 through the electrode adapter wire 22. The slot cover is provided with an upper cover 19, which is well sealed. Furthermore, the connection between the second feedthrough 7 and the electrode adapter wire 22 is a non-detachable connection, such as welding.

[0073] It should be noted that, in one preferred embodiment of the present invention, the connection relationship between the various parts inside the stimulator housing and between the stimulator housing and external components is preferably a non-detachable connection form such as welding. In particular, the connection between the feedthrough (e.g., 8-pin feedthrough) in the stimulator housing and the electrode assembly is preferably a non-detachable connection method such as welding. The advantages of such a design are: 1. The stimulator will be implanted in the patient's head as a medical device, so the reliability and service life of the internal connection of the stimulator must be guaranteed, while the connection between the electrode and the feedthrough in the existing stimulator is a detachable connection, first, there is a risk of poor sealing, second, when the connection is poor, the relevant workers cannot quickly and without damaging the housing for inspection, and third, the service life of the stimulator is reduced; 2. The use of welding and other forms avoids complex detachable connection structures, greatly reduces the volume of the stimulator, and ensures the reliability of the internal connection.

[0074] In addition, if Fig.11 As shown, in order to ensure the reliable connection between the electrode adapter 9 and the electrode 13, the other end of the electrode adapter 9 is provided with an electrode connector 10, an electrode fixing seat 11 and a locking screw 12. The electrode 13 passes through the electrode fixing seat 11 and is connected to the electrode connector 10. The locking screw 12 tightens the electrode fixing seat 11 and presses the electrode 13 to prevent the electrode 13 from falling out. That is, compared with the prior art, the stimulator of the present invention places the detachable connection form between the stimulator housing and the electrode outside the housing (for example, the detachable connection between the electrode 13 and the electrode adapter 9), which avoids the normal operation and stability of the stimulator affected by multiple plugging and unplugging of electrodes, and is also convenient for relevant staff to flexibly adjust and inspect the stimulator equipment.

[0075] Example 3

[0076] This embodiment is an optimized design based on the embodiment 2, and the optimization part mainly lies in the electrode fixing assembly. The optimization is described below.

[0077] After the electrode 13 is inserted into the brain, it needs to be fixed to the skull through an electrode fixing assembly to prevent the electrode from deviating from the target point and affecting the treatment effect. Therefore, the neurostimulator also includes an electrode fixing assembly. Fig.16 and Fig.17 As shown, the electrode fixing assembly includes an expansion shell 241 and a fixing inner plug 242 inserted into the expansion shell 241. The expansion shell 241 is preferably conical (the expansion shell 241 can also be cylindrical). One end of the expansion shell 241 has a conical hole 2411, and the other end ( Fig.16 A threaded hole 2412 is formed at the bottom of the expansion shell 241, and the threaded hole 2412 is connected to and coaxially arranged with the tapered hole 2411. Preferably, the electrode fixing assembly is made of a biocompatible material.

[0078] A plurality of strip grooves 2413 are evenly arranged along the circumference of the shell side wall where the tapered hole 2411 is located to increase the expansion force of the expansion shell 241. These strip grooves 2413 play a role in limiting and fastening the expansion shell 241 during installation of the skull through hole, thereby solving the problem of the expansion shell 241 rotating or failing to fasten.

[0079] Furthermore, in order to prevent the expansion shell 241 from falling into the through hole of the skull 3, the end of the tapered hole 2411 ( Fig.16 The top of the expansion shell 241 is shown in FIG. Fig.16 The left end of the expansion shell 241 in the figure is provided with a flange 2414. A first electrode placement groove (not shown in the figure) matching with the electrode 13 is provided on the radial surface of the flange 2414, and the electrode 13 can be pressed in the first electrode placement groove to fix the electrode line.

[0080] Please also read Fig.17 , a through hole is provided at the axis center of the fixed inner plug 242. One end of the fixed inner plug 242 is a first cylindrical portion 2421 with an external thread; the middle is a conical portion 2422; and the other end is a second cylindrical portion 2423. Further, the first cylindrical portion 2421 cooperates with the threaded hole 2412; the conical portion 2422 and the second cylindrical portion 2423 are integrally arranged and arranged in the conical hole 2411. Further, the conical portion 2422 and the second cylindrical portion 2423 are connected in a smooth transition, and the diameter of the small end of the conical portion 2422 is slightly smaller than the opening diameter of the conical hole 2411, so that the fixed inner plug 242 can be screwed into the expansion shell 241. The diameter of the second cylindrical portion 2423 is equal to the bottom diameter of the tapered hole 2411, so that when the first cylindrical portion 2421 is screwed into the threaded hole 2412, the expansion shell 241 is cylindrical and matches the through hole on the skull 3, that is, the expansion shell 241 can be fixed on the through hole in a well-sealed manner.

[0081] In order to place the electrode 13, a second electrode placement groove (not shown in the figure) matching the electrode 13 is provided along the radial surface of the end of the second cylindrical portion 2423. Preferably, the notch of the first electrode placement groove and the notch of the second electrode placement groove are arranged to butt against each other; more preferably, the notch diameter of the first electrode placement groove and the notch diameter of the second electrode placement groove are as small as possible or less than or equal to the outer diameter of the electrode wire, so that the electrode wire can be securely buckled in the first electrode placement groove and the second electrode placement groove. In order to facilitate the screwing of the fixed inner plug 242, at least two grooves (not shown in the figure) are symmetrically provided at the end of the second cylindrical portion 2423. The opening position and shape of the grooves can be designed with reference to the structure of the surgical instrument actually used, so as to better enable the fixed inner plug 242 to be sealed and screwed into the expansion shell 241. The opening of the notches mentioned above is all prior art and will not be repeated here.

[0082] In this embodiment, by cooperating with the fixed inner plug 242 and the expansion outer shell 241, the expansion outer shell 241 expands outward under the action of the fixed inner plug 242 and is clamped in the through hole of the skull, thereby achieving a stable connection between the expansion outer shell 241 and the through hole. Compared with the prior art, the electrode fixing assembly of the present invention can achieve electrode fixation without the use of skull nails, further reducing patient damage and reducing the use of medical consumables.

[0083] Furthermore, a skull nail hole may also be provided on the flange 2414 of the expansion shell 241, and the expansion shell may be fixed by the cooperation of the skull nail hole and the skull nail.

[0084] It should be noted that the electrode 13 of this embodiment can also be fixed by using an electrode fixing device in the prior art, which will not be described in detail here.

[0085] Example 4

[0086] The above Example 3 introduces the fixation of the electrode on the skull. This Example 4 will focus on the direct fixation of the neurostimulator to the skull. In order to ensure good fixation of the neurostimulator to the skull, the neurostimulator is also provided with an anti-loosening component. The preferred implementation of the anti-loosening component is described below.

[0087] Optimal design scheme 1 for anti-loosening components:

[0088] Since the neurostimulator in the above-mentioned embodiment 2 adopts the cooperation between the lower shell 4 and the countersunk hole on the skull, and does not adopt the installation method of fixing with skull nails, in order to further strengthen the fixing effect between the lower shell 4 and the countersunk hole, a connecting piece 411 is provided on the side wall surface of the embedded part 41. The connecting piece 411 is used to increase the friction between the embedded part 41 and the countersunk hole. Preferably, the connecting piece 411 is a spherical protrusion or anti-slip diamond pattern provided on the side surface of the embedded part 41.

[0089] like Figure 3 As shown, when the connecting member 411 is a spherical protrusion, the spherical protrusion is no larger than half of the sphere, and the spherical protrusion is evenly arranged on the side wall surface of the embedded portion 41. Figure 4 As shown, when the connecting member 411 is a non-slip diamond pattern, the non-slip diamond pattern is evenly arranged on the side wall surface of the embedded portion 41.

[0090] Alternatively, if Figure 5 As shown, the axis of the anti-slip rib is arranged parallel to the central axis of the embedding portion 41 in the height direction. Optionally, the axis of the anti-slip rib is arranged at a certain angle to the central axis of the embedding portion 41 in the height direction. Optionally, the anti-slip ribs arranged at an angle to the central axis of the embedding portion 41 in the height direction may be arranged at the same angle, at different angles, or in a grid structure. Optionally, as Figure 6 As shown, the cylindrical surface of the embedded portion 41 is provided with both the anti-skid ribs parallel to the central axis of the embedded portion 41 in the height direction and the anti-skid ribs perpendicular to the central axis of the embedded portion 41 in the height direction, that is, the anti-skid ribs are arranged in a grid structure. The arrangement of the spherical protrusions and the anti-skid ribs can be flexibly set according to actual needs, which will not be described in detail here.

[0091] Optimal design scheme 2 for anti-loosening components:

[0092] The anti-loosening component may also be a reinforcement member 412 .

[0093] like Figure 7 As shown, the reinforcing member 412 includes a connecting plate 4121 and an elastic component 4122. One end of the elastic component 4122 is connected to the side surface of the embedding portion 41, and the other end is connected to the connecting plate 4121. Preferably, the elastic component 4122 is a compression spring.

[0094] The shape and number of the connecting plates 4121 are determined according to the shape of the countersunk hole opened on the skull 3. For example, when the countersunk hole is a rectangular hole, the shape of the connecting plates 4121 is a long strip, and the number of the connecting plates 4121 is a multiple of 4; when the countersunk hole is circular, the shape of the connecting plates 4121 is an arc-shaped plate, and the number of the connecting plates 4121 is at least 3; when the countersunk hole is an oblong, the shape of the connecting plates 4121 includes an arc-shaped plate and a rectangular plate to adapt to the shape of the countersunk hole, wherein the number of the connecting plates 4121 in the shape of an arc plate is a multiple of 2, and the number of the connecting plates 4121 in the shape of a rectangular plate is also a multiple of 2.

[0095] The following is an example of an oblong countersunk hole:

[0096] Specifically, a plurality of rows of mounting holes are arranged on the side wall surface of the embedding portion 41 in parallel along the axial direction of the embedding portion 41, and each row includes a plurality of mounting holes. Figure 7 As shown, each row includes three mounting holes, and the mounting holes do not penetrate the side wall surface of the embedding portion 41. One end of the elastic component 4122 is fixed in the mounting hole, and the other end of the elastic component 4122 is fixedly connected to the inner wall of the connecting plate 4121.

[0097] Further, the connecting plate 4121 includes two arc-shaped plates and two long strip plates, and the thickness of the connecting plate 4121 is equal to the thickness of the embedding portion 41. The two arc-shaped plates are respectively arranged on the curved surface side of the countersunk hole, and the two long strip plates are respectively arranged on the flat surface side of the countersunk hole.

[0098] In the solution of this embodiment, when the embedded part 41 is arranged in the countersunk hole, the elastic component is in a compressed state and has a tendency to stretch and restore the original length. The connecting plate 4121 is expanded outward under the action of the elastic component and fits with the inner wall of the countersunk hole. Under the action of the elastic component 4122, the embedded part 41 is in close contact with the countersunk hole, thereby limiting the movement of the neurostimulator.

[0099] Optimal design scheme 3 for anti-loosening components:

[0100] As an optional solution of this embodiment, Figure 8As shown, the anti-loosening component is a limiting anti-loosening spring piece 4123, and a plurality of the limiting anti-loosening spring pieces 4123 are arranged at intervals on the embedded portion 41. Preferably, the limiting anti-loosening spring piece 4123 is in an "L" shape, which includes a connecting portion and a supporting portion. The connecting portion is connected to the bottom of the embedded portion 41; the supporting portion is located on the side periphery of the embedded portion 41 and away from the side wall surface of the embedded portion 41 (that is, there is a certain gap between the supporting portion and the side wall surface of the embedded portion 41). The connection portion of the limiting anti-loosening spring piece 4123 and the connection portion of the supporting portion have a smooth transition. The limiting anti-loosening spring piece 4123 can be a leaf spring.

[0101] When the embedding portion 41 is disposed in the countersunk hole of the skull 3, the outer contour formed by the plurality of support portions is larger than the countersunk hole, and the position-limiting anti-loosening spring sheet 4123 is elastic. Therefore, when the support portion contacts the inner wall of the countersunk hole, the support portion is compressed under the action of the countersunk hole and shrinks toward the side wall of the embedding portion 41. Since the position-limiting anti-loosening spring sheet 4123 has a certain rigidity, the support portion has a tendency to return to its original state when compressed, thereby enabling the neurostimulator to achieve a stable connection with the countersunk hole with the cooperation of the position-limiting anti-loosening spring sheet 4123.

[0102] As an optional solution of this embodiment, since the semi-embedded shell of this embodiment adopts the cooperation between the lower shell 4 and the countersunk hole on the skull, and does not adopt the method of skull nail fixation, in order to further strengthen the fixing effect of the lower shell 4 and the countersunk hole, the embedding part 41 of the lower shell 4 is provided with an external thread, and correspondingly, the countersunk hole on the skull is provided with an internal thread, and the embedding part 41 and the countersunk hole are threadedly connected.

[0103] The semi-embedded shell provided in the present embodiment may be an embedded part 41 directly fixedly connected to the countersunk hole on the skull through an interference fit; the outer surface of the embedded part 41 may be provided with an external thread, which is threadedly connected to the countersunk hole on the skull; a connecting piece may be provided on the side surface of the embedded part 41, and the friction force with the countersunk hole is increased by the connecting piece to achieve a fixed connection between the two; a reinforcing piece may be provided on the side surface of the embedded part 41, and the contact force with the countersunk hole on the skull is enhanced by the reinforcing piece to achieve a fixed connection between the two; or a reinforcing piece may be provided on the side surface of the embedded part 41, and a connecting piece is provided on the contact surface between the reinforcing piece and the countersunk hole, and the fixed connection between the two is achieved by increasing the contact force by the reinforcing piece and increasing the friction by the connecting piece. The above connection methods do not require skull nails, which reduces damage to the skull, simplifies the surgical procedure, and can achieve a stable connection between the lower shell and the countersunk hole.

[0104] The above description is only a preferred specific implementation manner of the present invention, but the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily conceived by any technician familiar with the technical field within the technical scope disclosed by the present invention should be covered within the protection scope of the present invention.

Claims

1. A stimulator, characterized in that: A semi-embedded housing and an electrode fixing assembly, wherein the semi-embedded housing comprises an upper housing (8) and a lower housing (4), wherein the upper housing (8) and the lower housing (4) are fixedly connected to form a sealed or semi-sealed accommodating cavity, and the lower housing (4) is stepped; The electrode fixing assembly comprises an expansion shell (241) and a fixed inner plug (242) inserted into the expansion shell (241); the expansion shell (241) expands outwards under the action of the fixed inner plug (242) so as to be clamped in the through hole of the skull; a first electrode placement groove is provided on the expansion shell (241); a second electrode placement groove is provided on the fixed inner plug (242); the groove diameter of the first electrode placement groove and the groove diameter of the second electrode placement groove are less than or equal to the outer diameter of the electrode wire, and the electrode wire is clamped in the first electrode placement groove and the second electrode placement groove; a tapered hole (2411) is opened at one end of the expansion shell (241), and a plurality of strip grooves (2413) are evenly arranged along the circumference on the side wall of the shell where the tapered hole (2411) is located; The lower shell (4) comprises an embedded portion (41); an anti-loosening component is provided at the bottom of the semi-embedded shell; the anti-loosening component is a connecting piece (411) provided on the side wall surface of the embedded portion (41); the connecting piece (411) is a spherical protrusion or anti-slip diamond pattern provided on the side wall surface of the embedded portion (41); or the anti-loosening component is a reinforcing piece (412); the reinforcing piece (412) comprises a connecting plate (4121) and an elastic component (4122); one end of the elastic component (4122) is connected to the embedded portion (411). The anti-loosening component is connected to the side wall of the embedded part (41), and the other end is connected to the connecting plate (4121); or, the anti-loosening component is a position-limiting anti-loosening spring sheet (4123), and a plurality of the position-limiting anti-loosening spring sheets (4123) are arranged at intervals on the embedded part (41), and the position-limiting anti-loosening spring sheet (4123) is "L"-shaped, comprising a connecting portion and a supporting portion, the connecting portion is connected to the bottom of the embedded part (41), and the supporting portion is located on the side wall of the embedded part (41), and the connection between the connecting portion and the supporting portion is smoothly transitioned.

2. The stimulator according to claim 1, characterized in that The bottom wall and side walls of the embedded portion (41) define a second accommodating space; A limiting portion (42) extending outward from the top edge of the side wall is formed on the side wall of the embedded portion (41).

3. The stimulator according to claim 1, characterized in that The top surface and side surfaces of the upper shell (8) define a first accommodating space.

4. The stimulator according to claim 2, characterized in that The top of the side surface of the upper shell (8) is provided with at least a first step (81) and a second step (82); 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).

5. The stimulator according to claim 2, characterized in that The top surface of the limiting portion (42) is a curved surface with a certain curvature.

6. The stimulator according to claim 2, characterized in that The embedding portion (41) is arranged in the countersunk hole of the skull, and the limiting portion (42) is located outside the countersunk hole.

7. The stimulator according to any one of claims 2, 4-6, characterized in that: The projection of the limiting portion (42) toward the embedding portion (41) can cover the end surface of the embedding portion (41).

8. The stimulator according to claim 1, characterized in that The stimulator also comprises a second shell fixedly connected to the semi-embedded shell; the second shell is a sealed or semi-sealed shell; the second shell and the upper shell (8) form a cylinder.

9. The stimulator according to claim 8, characterized in that The semi-embedded housing is made of a first material, and the second housing is made of a second material.

10. The stimulator according to claim 1, characterized in that The semi-embedded housing is provided with a battery (5) and a PCB board (6) connected to each other; the battery (5) is arranged in the embedding portion (41) of the lower housing (4), and the PCB board (6) is arranged in the upper housing (8).

11. The stimulator according to any one of claims 8 to 9, characterized in that: The second housing is configured as a coil assembly, which includes a charging coil (15) and a sealing shell (17); the sealing shell (17) wraps the charging coil (15) and is arranged on the side of the upper housing (8).

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