Deep brain stimulators and stimulation systems

Abstract

The present invention relates to the field of medical devices, and in particular to a deep brain stimulator and a stimulation system. The deep brain stimulator comprises a wire and a shell. The shell is used to be fixed in a groove opened in the skull. A double-layer structure is arranged at the part where the wire is used to be connected with the shell. The outer layer is a sealing layer, and the inner layer is a supporting layer. The sealing layer is used to extrude and seal with a flange pipe fitting. When the sealing layer is squeezed by the flange pipe fitting, the squeezing force is transmitted to the supporting layer through the sealing layer. The supporting layer provides a reverse force to ensure the sealing of the connection between the wire and the shell, thereby improving the service life of the stimulator.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a deep brain stimulator and a stimulation system. Background Art

[0002] Usually in DBS (deep brain stimulation) systems, the pulse generator is implanted in the user's chest, and the extension wire passes through the subcutaneous tunnel of the neck from the chest to connect to the electrode under the head skin. The movement of the neck can easily cause the extension wire to be stressed, thus causing a series of problems such as connection failure, extension wire or electrode breakage, etc. Therefore, it is proposed to design the pulse generator into a modular connection composed of several parts, which are implanted in the skull separately, but the connection between the modules becomes crucial, both to ensure the reliability of the connection and to ensure good sealing. Summary of the invention

[0003] In view of this, the present invention provides a deep brain stimulator and a stimulation system, in which the sealing design between the wire and the shell improves the sealing of the connection between the wire and each module, thereby ensuring the service life of the stimulator.

[0004] In one aspect, the present invention provides a deep brain stimulator, comprising a housing and a wire, wherein the housing is used to be fixed in a groove formed in a skull;

[0005] The shell is installed with a flange pipe, and the flange pipe has a pipe hole communicating with the inside and outside of the shell;

[0006] The wire is provided with a connection end and a sealing layer and a supporting layer surrounding the connection end, wherein the sealing layer is provided on the outer side of the supporting layer;

[0007] The connecting end of the wire extends into the housing through the tube hole, the sealing layer is squeezed and sealed with the tube hole, and the supporting layer is used to provide support for the sealing layer.

[0008] Furthermore, the tube hole is conical, with the large end of the tube hole facing the outside of the shell, and the support layer is provided with a first conical surface for matching with the tube hole.

[0009] Furthermore, the support layer gradually becomes thinner from the middle to both ends in the axial direction of the wire, and the outer surface of the middle of the support layer away from the connecting end forms a second conical surface;

[0010] The wire is connected with a fixing cap for sealing connection with the flange pipe fitting, and the fixing cap is provided with a threading hole for the wire to pass through, and the threading hole is conical and matches with the second conical surface.

[0011] Furthermore, the sealing layer gradually becomes thinner from both ends to the middle in the axial direction of the wire, and the inner surface of the sealing layer is a conical surface and the outer surface is a cylindrical surface;

[0012] The outer diameter of the sealing layer is larger than the aperture of the tube hole, and the difference between the two is t. The thickness of the sealing layer is t1, and the relationship between t and t1 satisfies: 0.15t1≤0.5t≤0.3t1.

[0013] Furthermore, the wire is also provided with a flange ring for fitting on the outside of the housing;

[0014] The fixing cap is provided with a cap cavity for accommodating the flange ring, the depth of the cap cavity is less than the height of the flange ring protruding relative to the shell surface, and the fixing cap presses the flange ring and is sealed and connected to the shell.

[0015] Furthermore, the support layer is provided with at least one annular protrusion along the circumferential direction, the sealing layer reflects the annular protrusion, the inner wall of the tube hole is provided with an annular groove, and the annular groove is sealingly matched with the annular protrusion reflected by the sealing layer.

[0016] Furthermore, the conductor includes a metal tube, and the supporting layer includes a tube wall of the metal tube.

[0017] Furthermore, it also includes a stimulation module, which has the shell and a battery and a control mainboard located in the shell. The shell is connected to the wire, and the communication / charging module and the stimulation electrode are connected through the wire.

[0018] Furthermore, it also includes a battery module, a control module, a communication / charging module and at least one connector, and the battery module, the control module and the communication / charging module respectively have the housing;

[0019] The battery module and the control module, the communication / charging module and the control module, and the connector and the control module are connected respectively through the wires.

[0020] Another aspect of the present invention provides a deep brain stimulation system, comprising the above-mentioned deep brain stimulator.

[0021] The beneficial effects of a deep brain stimulator provided by the present invention include:

[0022] A double-layer structure is set at the part where the wire is used to connect with the shell. The outer sealing layer is used to extrude and seal with the flange fitting. When the sealing layer is squeezed by the flange fitting, the extrusion force is transmitted to the supporting layer through the sealing layer. The inner supporting layer provides a reverse force to ensure the compression force between the sealing layer and the flange fitting, improve the sealing of the connection between the wire and the shell, and ensure the service life of the stimulator. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The above and other objects, features and advantages of the present invention will become more apparent through the following description of the embodiments of the present invention with reference to the accompanying drawings, in which:

[0024] Figure 1 It is a partial schematic diagram of the first deep brain stimulator according to an embodiment of the present invention.

[0025] Figure 2 It is a partial schematic diagram of a second deep brain stimulator according to an embodiment of the present invention.

[0026] Figure 3 It is a partial schematic diagram of a third deep brain stimulator according to an embodiment of the present invention.

[0027] Figure 4 Embodiment of the present invention Figure 3 Schematic diagram of the transfer module.

[0028] Figure 5 It is a schematic diagram of the connection between the wire and the housing in an embodiment of the present invention.

[0029] Figure 6 Embodiment of the present invention Figure 5 A partial cross-sectional schematic diagram of .

[0030] Figure 7 It is another connection schematic diagram between the wire and the housing according to an embodiment of the present invention.

[0031] Figure 8 Embodiment of the present invention Figure 7 A partial cross-sectional schematic diagram of .

[0032] Fig. 9 It is another connection diagram between the wire and the housing according to an embodiment of the present invention.

[0033] Fig.10 Embodiment of the present invention Fig. 9 A partial cross-sectional schematic diagram of .

[0034] Fig.11 It is another connection schematic diagram between the wire and the housing according to an embodiment of the present invention.

[0035] Fig.12 It is a schematic diagram of a fixed cover according to an embodiment of the present invention.

[0036] Fig.13 2 is a schematic diagram of a fixed cover from another perspective of an embodiment of the present invention.

[0037] Fig.14 This is a schematic diagram of fixing part of a stimulator on a skull in a deep brain stimulation system according to an embodiment of the present invention.

[0038] Description of reference numerals:

[0039] 10-stimulation module; 20-communication / charging module; 30 (30a, 30b, 30c)-lead wire; 40a, 40b-connector; 50-adapter module; 60-fixing cover; 70-fixing plate;

[0040] 11-battery module; 12-control module;

[0041] 110-housing; 120a, 120b, 120c-flange pipe fittings; 121-buckle; 122-stopper; 123-annular groove; 124-expansion;

[0042] 310-connecting end; 320a, 320b, 320c-sealing layer; 321-flange ring; 322-convex rib; 330a, 330b, 330c-supporting layer; 340a, 340b-fixing cap; 350-first line segment; 360-second line segment; 370-third line segment; 380-fourth line segment; 390-third conductor;

[0043] 331-annular protrusion; 332-first cone surface; 333-second cone surface; 334-slot;

[0044] 341-cap cavity;

[0045] 510-insertion channel; 520-notch groove; 530-fixing convex bump; 540-sealing protrusion; 550-metal connector;

[0046] 61-export; 62-accommodating tank. DETAILED DESCRIPTION

[0047] The present invention is described below based on embodiments, but the present invention is not limited to these embodiments. In the detailed description of the present invention below, some specific details are described in detail. It is possible for a person skilled in the art to fully understand the present invention without the description of these details. In order to avoid confusing the essence of the present invention, known methods, processes, flows, components and circuits are not described in detail.

[0048] In addition, it should be understood by those skilled in the art that the figures provided herein are for illustrative purposes and are not necessarily drawn to scale. Unless the context clearly requires otherwise, the words "including", "comprising" and the like throughout the application document should be interpreted as including rather than exclusive or exhaustive; that is, "including but not limited to". In the description of the present invention, it should be understood that the terms "first", "second", etc. are used for descriptive purposes only and are not to be understood as indicating or implying relative importance. In addition, in the description of the present invention, unless otherwise specified, "plurality" means two or more.

[0049] Unless otherwise clearly defined and limited, the terms "installed", "connected", "connected", "fixed" and the like 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 directly connected or indirectly connected through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0050] For ease of explanation, spatially relative terms such as "inside", "outside", "below", "below", "lower", "above", "upper", etc. are used herein to describe the relationship of one element or feature illustrated in the figures to another element or feature. It will be understood that spatially relative terms may be intended to include different orientations of the device in use or operation other than the orientation depicted in the figures. For example, if the device in the figure is turned over, an element described as being "below" or "below" other elements or features will then be positioned as being "above" the other elements or features. Thus, the example term "below" can include both the orientations of above and below. The device may be oriented in other ways (rotated 90 degrees or in other orientations), and the spatially relative descriptors used herein should be interpreted accordingly.

[0051] The present invention provides a deep brain stimulator and a deep brain stimulation system. The stimulation system includes the deep brain stimulator. By designing the connection structure between the wire 30 and the shell 110, the sealing performance of the connection between the wire 30 and each module is improved, thereby ensuring the service life of the stimulator.

[0052] In the description of the present invention, it should be noted that the embodiments of the present invention and the features in the embodiments can be combined with each other without conflict.

[0053] Figure 1 It is a partial schematic diagram of the first deep brain stimulator according to an embodiment of the present invention.

[0054] like Figure 1The deep brain stimulator includes a battery module 11, a control module 12, a communication / charging module 20 and at least one connector 40a. The battery module 11, the control module 12 and the communication / charging module 20 respectively have a housing 110. The housing 110 is used to seal the electronic components related to the module to avoid being affected by body fluids after implantation. The battery module 11 is connected to the control module 12 through a wire 30a, the communication / charging module 20 is connected to the control module 12 through a wire 30b, and the connector 40a is connected to the control module 12 through a wire 30c. The connector 40a is used to connect to the stimulation electrode. In this example, the connection structure of the wires 30a, 30b, and 30c is the same as that of the housing 110. There are two connectors 40a, and the two connectors 40a are used to connect to the left brain stimulation electrode and the right brain stimulation electrode, respectively. Preferably, the connector 40a is a socket structure, and the stimulation electrode is plugged and sealed with the connector 40a.

[0055] Each module is connected by wires, and the implantation position in the skull is highly flexible, and different modules can be placed in different parts of the skull. The volume, area, and thickness of each module are much smaller than that of the integrated deep brain stimulator, which reduces the depth of skull cutting, reduces the height of the deep brain stimulator protruding from the skull surface after implantation, and reduces skin tension.

[0056] Figure 2 It is a partial schematic diagram of a second deep brain stimulator according to an embodiment of the present invention.

[0057] like Figure 2 As shown, the deep brain stimulator includes a stimulation module 10, a communication / charging module and two connectors. The stimulation module 10 includes a housing 110 and a battery and a control mainboard located in the housing 110. The stimulation module 10 is connected to one end of a wire 30, and the other end of the wire 30 is connected to a connector, and the wire 30 is sealed and connected to the housing 110. The housing 110 is connected to two wires 30, and each of the two wires is connected to a connector, namely, a connector 40a and a connector 40b. The stimulation module 10 can be connected to the stimulation electrode and the communication / charging module respectively through two connectors. This example removes the top cover design relative to the existing deep brain stimulator, and the communication / charging module is designed independently to reduce the size of the deep brain stimulator.

[0058] Figure 3 It is a partial schematic diagram of a third deep brain stimulator according to an embodiment of the present invention.

[0059] like Figure 3The deep brain stimulator includes a battery module 11, a control module 12, a communication / charging module 20 and an adapter module 50. A first wire is provided between the battery module 11 and the control module 12. The first wire includes a first wire segment 350 and a second wire segment 360. The two ends of the first wire segment 350 are respectively connected to the battery module 11 and the adapter module 50, and the two ends of the second wire segment 360 are respectively connected to the control module 12 and the adapter module 50. A second wire is provided between the communication / charging module 20 and the control module 12. The second wire includes a third wire segment 370 and a fourth wire segment 380. The two ends of the third wire segment 370 are respectively connected to the communication / charging module 20 and the adapter module 50 by plugging and unplugging, and the two ends of the fourth wire segment 380 are respectively connected to the control module 12 and the adapter module 50. The control module 12 is connected to the adapter module 50 through a third wire 390, and the third wire 390 is connected to the adapter module 50 by plugging and unplugging.

[0060] The adapter module 50 is also provided with a plugging channel for plugging and unplugging with the stimulation electrode, and the stimulation electrode can be plugged and unplugged with the adapter module 50, so that the stimulation electrode is connected to the stimulation module 10 through the adapter module 50 and the third wire 390. This is equivalent to integrating the above connector into the adapter module 50.

[0061] The first line segment 350, the second line segment 360, the third line segment 370, the fourth line segment 380 and the third wire 390 are respectively provided with plugs for cooperating with the adapter module 50, and the plugs are provided with conductive contacts. Each module is detachably connected to the adapter module 50, and when a module has a problem, it can be repaired and replaced separately, with a small surgical scope and low cost, which can solve the problem of high maintenance cost and large surgical scope of deep brain stimulator.

[0062] Figure 4 Embodiment of the present invention Figure 3 Schematic diagram of the transfer module.

[0063] like Figure 4 , the adapter module 50 has a front side ( Figure 4 The side surface shown), the back surface and the side surface between the front surface and the back surface. In this embodiment, the side orientation of the adapter module 50 is defined as the lateral direction. The adapter module 50 is provided with a plurality of plug-in channels 510 extending laterally, and a metal connector 550 is provided in the plug-in channel 510. After the plug of the wire 30 enters the plug-in channel 510, the metal connector 550 is in contact with the conductive contact. The metal connectors 550 in each plug-in channel 510 are connected correspondingly through conductive lines, so as to realize the conductive connection between the battery module 11 and the communication / charging module 20 and the control module 12 respectively.

[0064] Figure 4 The dotted box shows part of the internal structure of the adapter module. Except that the number of metal connectors 550 in each plug-in channel may be different, the rest of the structures are the same.

[0065] A notch 520 is provided on the front edge of the adapter module 50. The notch 520 forms notches on the front and side of the adapter module 50, and a passage opening is opened in the notch 520 toward the lateral wall. The first line segment 350, the second line segment 360, the third line segment 370, the fourth line segment 380, the third wire 390 and the stimulation electrode are respectively connected to the corresponding plug-in channel 510 and extend outward from the notch 520. Fixed convex bumps 530 are provided on opposite sides of the notch 520. The fixed convex bumps 530 are used to guard the notch located on the front of the adapter module 50 to prevent the wire 30 and the electrode from falling out.

[0066] An annular sealing protrusion 540 is also provided near the channel opening in each plug-in channel 510 to ensure the sealing after connection, and a sealing protrusion 540 is also provided between two adjacent metal connectors 550 to avoid short circuit between the two adjacent metal connectors 550. Preferably, the adapter module 50 is a "cross" flat structure to ensure that the plug-in channel 510 has a sufficient length and avoid the adapter module 50 being too large.

[0067] Figure 5 It is a schematic diagram of the connection between the wire and the housing in an embodiment of the present invention.

[0068] Figure 6 Embodiment of the present invention Figure 5 A partial cross-sectional schematic diagram of .

[0069] Each module of the above-mentioned deep brain stimulator is provided with a housing 110, and the wire 30, the first line segment 350, the second line segment 360, the third line segment 370, the fourth line segment 380 and the third wire 390 are respectively connected to the housing 110 as shown in FIG. Figure 5-6 As shown, for the sake of clarity and simplicity, “wire 30 ” is used to describe the connection structure with the housing 110 .

[0070] The wire 30 has a connection end 310, and a sealing layer 320a and a supporting layer 330a are provided on the peripheral side of the connection end 310 or the peripheral side close to the connection end 310, and the sealing layer 320a and the supporting layer 330a serve as the wire sheath of the wire 30. The sealing layer 320a is provided on the outside of the supporting layer 330a, and the sealing layer 320a is softer than the supporting layer 330a. The shell 110 is a rectangular plate-like structure, and the shell 110 is used to be fixed in the groove opened in the skull. The thickness of the shell 110 is within 5mm to reduce the groove depth of the skull. Preferably, the thickness of the shell is 3mm. A mounting hole is provided on the side of the shell 110, and a flange pipe 120a is installed in the mounting hole. The flange pipe 120a has a pipe hole, and the pipe hole connects the inside and outside of the shell 110.

[0071] In some other embodiments, the housing 110 may also be in other shapes, such as a circular, pentagonal, or hexagonal plate-like structure.

[0072] The connection end 310 of the wire 30 passes through the tube hole and extends into the housing 110. The core wire in the wire can be welded to the contacts on the main board, battery or coil in the housing. The sealing layer 320a is connected to the inner wall of the tube hole by extrusion sealing. When the sealing layer 320a is squeezed by the flange pipe 120a, the extrusion force is transmitted to the supporting layer 330a. The supporting layer 330a provides a reverse force to the sealing layer 320a, ensuring the compression force between the sealing layer 320a and the flange pipe 120a, and improving the sealing of the connection between the wire 30 and the housing 110.

[0073] The outer circumference of the flange pipe 120a is provided with a radially protruding stopper 122, which is located outside the housing 110 and fits the housing 110. The stopper 122 is sealed and connected to the housing 110 by laser welding, thereby achieving a sealed connection between the flange pipe 120a and the mounting hole. The wire 30 is connected with a fixing cap 340a, which is provided with a threading hole, and the wire 30 passes through the threading hole. Figure 6 In the example, during the installation of the wire 30, the fixing cap 340a is moved toward the flange pipe 120a, so that the fixing cap 340a and the stopper 122 are pressed tightly, and the fixing cap 340a and the stopper 122 are sealed and connected by laser welding.

[0074] The support layer 330a gradually becomes thinner from the middle to both ends in the axial direction of the wire 30, and the outer surface of the middle part of the support layer 330a close to the connecting end 310 forms a first conical surface 332, and the outer surface away from the connecting end 310 forms a second conical surface 333. The tube hole is conical and has the same taper as the first conical surface 332, and the tube hole is pressed and matched with the first conical surface 332. The threading hole of the fixing cap 340a is also conical and has the same taper as the second conical surface 333, and the threading hole is pressed and matched with the second conical surface 333, so that the compression force of the flange pipe 120a and the fixing cap 340a on the wire is maintained at a high level.

[0075] When the diameter of the wire 30 remains unchanged, the sealing layer 320a gradually becomes thinner from both ends of the supporting layer 330a to the middle, and the inner surface of the sealing layer 320a is a conical surface and the outer surface is a cylindrical surface. The threading hole and the tube hole have the same aperture, and the outer diameter of the wire 30 is larger than the aperture of the threading hole and the tube hole. The difference between the outer diameter of the wire 30 and the threading hole and the difference between the outer diameter of the wire 30 and the tube hole are defined as t. Since the tube hole and the threading hole are both conical holes, t is a variable value. The thickness of the overlapping area of ​​the sealing layer 320a and the supporting layer 330a is defined as t1, which is also a variable value. At any point in the overlapping area of ​​the sealing layer 320a and the supporting layer 330a, the relationship between t and t1 satisfies 0.15t1≤0.5t≤0.3t1.

[0076] In this example, the sealing layer 320a is made of silicone rubber, and the wire sheaths of other parts of the wire 30 can be made of polyurethane or silicone rubber. 0.3t1 and 0.15t1 are the upper and lower limits of the compression of the sealing layer 320a. When the compression of the sealing layer 320a is less than 0.15 times of its own thickness, the pressing force between the wire and the flange pipe fitting 120a and the fixing cap 340a is small, the sealing effect is poor, and the sealing layer 320a will be permanently deformed to a certain extent in the long-term extrusion state, causing the fixing cap 340a and the flange pipe fitting 120a to further reduce the pressing force of the wire 30; when the compression of the sealing layer 320a is greater than 0.3 times of its own thickness, considering the compression limit of the sealing layer 320a, the service life of the sealing layer 320a is short due to long-term extrusion, and the assembly between the wire 30 and the flange pipe fitting 120a and the fixing cap 340a is difficult.

[0077] Figure 7 It is another connection schematic diagram between the wire and the housing according to an embodiment of the present invention.

[0078] Figure 8 Embodiment of the present invention Figure 7 A partial cross-sectional schematic diagram of .

[0079] refer to Figure 7-8 As shown, in this example, the shell 110 is provided with a mounting hole, and a flange pipe 120b is sealed and installed in the mounting hole. The flange pipe 120b is provided with a tube hole, and the outer side of the flange pipe 120b is provided with a stopper 122 protruding radially along the tube cavity. The stopper 122 is located outside the shell 110 and fits the shell 110. The stopper 122 and the shell 110 are sealed and connected by laser welding, thereby realizing the sealed connection between the flange pipe 120b and the mounting hole. The wire 30 is provided with a connecting end 310, and a supporting layer 330b and a sealing layer 320b are arranged around the peripheral side of the connecting end 310 or around the peripheral side close to the connecting end 310. The sealing layer 320b is located outside the supporting layer 330b, and the sealing layer 320b is softer than the supporting layer 330b. At least one annular protrusion 331 is arranged on the outer peripheral side of the supporting layer 330b. Figure 8 In the example, two annular protrusions are provided, the sealing layer 320 b reflects the annular protrusion 331 , and the inner wall of the tube hole is provided with an annular groove 123 which is pressed and matched with the annular protrusion 331 .

[0080] During assembly, the wire 30 is passed through the flange pipe 120b and squeezed into the housing 110 until the mapped annular protrusion 331 and the annular groove match accurately. Since the outer diameter of the sealing layer 320b is larger than the tube hole, the sealing layer 320b is squeezed on the inner wall of the tube hole. In addition, the squeezing and matching of the annular groove 123 and the annular protrusion 331 can make the seal and connection between the wire 30 and the housing 110 more secure. In order to facilitate the assembly of the wire and the flange pipe 120b, the end of the flange pipe 120b facing the outside of the housing 110 is provided with a flare 124. The diameter of the flare 124 is smaller than the outer diameter of the wire at the annular protrusion 331 and larger than the outer diameter of other parts of the wire 30. This can prevent the flare 124 from being too large and allow the wire 30 to pass through the tube hole. A gap is formed between the flange pipe 120b and the wire 30 at the flare 124. Silicone is applied in the gap as protection to increase the reliability of the connection between the wire 30 and the flange pipe 120b. In some other embodiments, a flared opening 124 may also be provided at one end of the flange pipe 120 b located in the housing 110 for coating with silicone for protection.

[0081] Furthermore, the tube hole of the flange pipe 120b is set as a tapered hole, and the port at the larger end of the tube hole faces the outside of the housing 110. The outer surface of the support layer 330b has a tapered surface for matching with the tube hole, and the taper of the tube hole is consistent with the taper of the tapered surface of the support layer 330b, ensuring that the compression force of the flange pipe 120b on the wire 30 is maintained at a high level, thereby improving the sealing performance.

[0082] Fig. 9 It is another connection schematic diagram between the wire and the housing according to an embodiment of the present invention.

[0083] Fig.10 Embodiment of the present invention Fig. 9 A partial cross-sectional schematic diagram of .

[0084] like Fig. 9 In this example, the shell 110 is provided with a mounting hole, and a flange pipe 120c is sealed and installed in the mounting hole. The flange pipe 120c is sealed and connected to the shell 110 by laser welding.

[0085] The wire 30 has a connection end 310, and a support layer 330c and a sealing layer 320c are arranged around the peripheral side of the connection end 310 or around the peripheral side close to the connection end 310. The sealing layer 320c is located outside the support layer 330c, and the sealing layer 320c is softer than the support layer 330c. The sealing layer 320c is connected to the flange pipe 120c by extrusion sealing. The wire 30 is provided with a flange ring 321. Preferably, the flange ring 321 is integrally connected with the sealing layer 320c of the wire. After the connection end 310 of the wire 30 penetrates the housing 110 through the tube hole, the flange ring 321 is attached to the outside of the housing 110. The wire 30 is also provided with a fixing cap 340b, and the fixing cap 340b is provided with a threading hole, and the wire 30 is passed through the threading hole. The fixing cap 340b is provided with a cap cavity 341 for covering the flange ring 321. The depth of the cap cavity 341 is less than the height of the flange ring 321 protruding relative to the surface of the shell 110. Therefore, the flange ring 321 can be pressed by the fixing cap 340b to play a waterproof role. In the pressed state, the edge of the fixing cap 340b is welded to the shell 110 to achieve a permanent sealing effect.

[0086] Fig.11 It is another connection schematic diagram between the wire and the housing according to an embodiment of the present invention.

[0087] like Fig.11 As shown, a buckle 121 is further provided at one end of the flange pipe 120 c located in the housing 110 . A plurality of buckles 121 are provided around the pipe hole, and the hole diameter surrounded by the plurality of buckles 121 is smaller than the diameter of the wire 30 .

[0088] A slot 334 is provided on the peripheral side of the support layer 330c near the connection end 310, and an opening is provided on the sealing layer 320c corresponding to the slot 334 so as to expose the slot 334 through the opening. A plurality of anti-slip grooves cooperating with the buckle 121 are formed on the outer peripheral side of the wire 30. When the wire 30 passes through the housing 110, the wire 30 passes through the hole surrounded by the plurality of buckles 121, and the buckle 121 squeezes the sealing layer 320c. After the wire 30 and the flange pipe 120c are assembled, the anti-slip groove just moves to the buckle 121, so that the buckle 121 slides into the anti-slip groove, and the connection between the wire 30 and the housing 110 is more firmly. When the mating surface between the wire 30 and the flange pipe 120c is a conical surface, the wire is restricted from moving out of the housing, and the pressing force between the wire 30 and the flange pipe 120c can be ensured for a long time.

[0089] The flange ring 321 is provided with ribs 322 on one side facing the housing 110 and the other side facing away from the housing 110 , respectively, to improve the sealing performance between the flange ring 321 and the housing 110 and the fixing cap 340 b .

[0090] In the present invention, the conductor 30 is provided with a metal tube, the support layer 330 is formed by the tube wall of the metal tube, and the sealing layers 320a, 320b, and 320c are preferably made of silicone rubber.

[0091] Fig.12 Schematic diagram of a fixed cover 60 according to an embodiment of the present invention. Fig.13 2 is a schematic diagram of the fixing cover 60 from another perspective according to an embodiment of the present invention.

[0092] like Figure 12-13 The stimulation system also includes a fixed cover 60, which is used to fix each module placed in the skull groove. The fixed cover 60 is an arc-shaped bending structure, so that the fixed cover 60 can match the shape of the skull groove, and the upper surface of the fixed cover 60 is an arc, which is used to be consistent with the shape of the skull curved surface at the implantation position or to be rounded with the surrounding skull transition. The fixed cover 60 is also provided with a receiving groove 62, which is used to accommodate the functional modules (stimulation module 10, battery module 11, control module 12, communication / charging module 20) of the above-mentioned deep brain stimulator. The fixed cover 60 is also provided with an outlet 61 for the wire 30 to pass through, and the outlet 61 extends from the side of the fixed cover 60 to the upper surface, and forms a port connected to the side and the upper surface.

[0093] Fig.14 This is a schematic diagram of fixing part of a stimulator on a skull in a deep brain stimulation system according to an embodiment of the present invention.

[0094] like Fig.14 As shown, after the fixed cover 60 covers the functional module located in the skull groove, the upper surface of the fixed cover 60 is fixed with a fixing plate 70 by screws, and the fixing plate 70 is fixedly connected to the skull by screws, so that the fixed cover 60 is fixed relative to the skull. The wire 30 can be connected to other functional modules or stimulation electrodes after being led out from the outlet 61.

[0095] In this embodiment, a preoperative CT scan can be performed first to establish a 3D skull model, plan the implantation position and extract the skull model of the implantation position, and process a customized skull cutting tool and a fixing cover 60 according to the skull model and the shape of the stimulation module, thereby processing a skull groove that matches the stimulation module, and according to the number of modules of the deep brain stimulator, corresponding skull grooves are processed at different positions of the skull, and the modular deep brain stimulator is implanted.

[0096] In summary, the present invention provides a deep brain stimulator and a stimulation system, the deep brain stimulator is split into four different modules of battery, mainboard, connector, and communication / charging module, each module is sealed by a housing design, and each module is connected by a wire; or, the deep brain stimulator is split into a stimulation module, a connector, and a communication / charging module, the stimulation module includes a battery, a control mainboard, etc., the stimulation module is connected with a connector by a wire, and the connector can be connected to the communication / charging module and the stimulation electrode, and each module can be dispersed to different positions of the skull through a modular design. Because the volume of each module is smaller than that of the overall stimulator, the implanted modules can be made not to protrude from the skull surface, reduce skin tension, and reduce the unsightly appearance after implantation. The housing of each module is sealed and connected to the wire using the above-mentioned connection structure to ensure the sealing of the connection between each module and the wire, and to ensure the service life of the stimulator.

[0097] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A deep brain stimulator, characterized in that: It includes a housing and a wire, wherein the housing is used to be fixed in a groove formed in the skull; The shell is installed with a flange pipe, and the flange pipe has a pipe hole communicating with the inside and outside of the shell; The wire is provided with a connection end and a sealing layer and a supporting layer surrounding the connection end, wherein the sealing layer is provided on the outer side of the supporting layer; The connecting end of the wire extends into the shell through the tube hole, the sealing layer is squeezed and sealed with the tube hole, and the supporting layer is used to provide support for the sealing layer.

2. The deep brain stimulator according to claim 1, characterized in that The tube hole is tapered, with the large end of the tube hole facing the outside of the shell, and the support layer is provided with a first tapered surface for matching with the tube hole.

3. The deep brain stimulator according to claim 1, characterized in that The support layer gradually becomes thinner from the middle to both ends in the axial direction of the wire, and the outer surface of the middle of the support layer away from the connecting end forms a second conical surface; The wire is connected with a fixing cap for sealing connection with the flange pipe fitting, and the fixing cap is provided with a threading hole for the wire to pass through, and the threading hole is conical and matches with the second conical surface.

4. The deep brain stimulator according to claim 3, characterized in that: The sealing layer gradually becomes thinner from both ends to the middle in the axial direction of the wire, and the inner surface of the sealing layer is a conical surface and the outer surface is a cylindrical surface; The outer diameter of the sealing layer is larger than the aperture of the tube hole, and the difference between the two is t. The thickness of the sealing layer is t1, and the relationship between t and t1 satisfies: 0.15t1≤0.5t≤0.3t1.

5. The deep brain stimulator according to claim 3, characterized in that: The wire is also provided with a flange ring for fitting on the outside of the housing; The fixing cap is provided with a cap cavity for accommodating the flange ring, the depth of the cap cavity is less than the height of the flange ring protruding relative to the shell surface, and the fixing cap presses the flange ring and is sealed and connected to the shell.

6. The deep brain stimulator according to claim 1, characterized in that: The support layer is provided with at least one annular protrusion along the circumferential direction, the sealing layer reflects the annular protrusion, the inner wall of the tube hole is provided with an annular groove, and the annular groove is sealingly matched with the annular protrusion reflected by the sealing layer.

7. The deep brain stimulator according to any one of claims 1 to 6, characterized in that: The conductor includes a metal tube, and the support layer includes a tube wall of the metal tube.

8. The deep brain stimulator according to claim 1, characterized in that It also includes a stimulation module, which has the shell and a battery and a control mainboard located in the shell. The shell is connected to the wire, and the communication / charging module and the stimulation electrode are connected through the wire.

9. The deep brain stimulator according to claim 1, characterized in that It also includes a battery module, a control module, a communication / charging module and at least one connector, wherein the battery module, the control module and the communication / charging module respectively have the housing; The battery module and the control module, the communication / charging module and the control module, and the connector and the control module are connected respectively through the wires.

10. A deep brain stimulation system, characterized in that: A deep brain stimulator comprising the device described in any one of claims 1 to 9.

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