Packaging device and packaging method for neural stimulator coil assembly

Abstract

The present invention discloses a packaging device for a neural stimulator coil assembly, comprising: a coil assembly, a stimulator body, a lower mold, and a positioning tool: comprising a tool body and a positioning contact concave surface connected to the tool body, the positioning contact concave surface is in contact with a winding seat in the coil assembly and the contact surfaces of the two complement each other; the tool body is provided with a tool positioning hole and a tool locking hole, and the tool positioning hole is matched with a positioning pin; to match this, the lower mold is provided with a mold positioning hole and a mold locking hole whose size and position match the tool positioning hole and the tool locking hole.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical appliances, and in particular relates to a packaging device and method for a nerve stimulator coil assembly. Background Art

[0002] At present, in clinical neurosurgery, active implanted medical devices generally include neurostimulators, which are divided into rechargeable neurostimulators and non-rechargeable neurostimulators. The packaging device and packaging method for a neurostimulator coil assembly described in the present invention are tailored for rechargeable neurostimulators, and can assist stimulator installers to effectively and quickly install charging coils and communication coils. Summary of the invention

[0003] The object of the present invention is to provide a packaging device and method for a neural stimulator coil assembly to solve the problems raised in the above background technology.

[0004] To achieve the above object, the present invention provides the following technical solution: a packaging device for a neural stimulator coil assembly, characterized in that it comprises:

[0005] Coil assembly: comprising a winding seat and a charging coil and a communication coil wound on the winding seat;

[0006] The charging coil and the communication coil form three external pin-type interfaces;

[0007] Stimulator body: including a housing and three 3-pin feedthrough assemblies connected to the pin-type interface of the coil assembly;

[0008] Lower mold: the upper surface of the lower mold is provided with an injection molding cavity for placing the coil assembly and the stimulator body;

[0009] Positioning tooling: comprising a tooling body and a positioning contact concave surface connected to the tooling body, the positioning contact concave surface is in contact with the winding seat in the coil assembly and the contact surfaces of the two complement each other; the tooling body is provided with a tooling positioning hole and a tooling locking hole, and the tooling positioning hole is matched with a positioning pin; to match this, the lower mold is provided with a mold positioning hole and a mold locking hole that match the size and position of the tooling positioning hole and the tooling locking hole.

[0010] The above scheme includes four parts: a lower mold, a coil assembly, a stimulator body, and a positioning assembly. In actual operation, there are many difficulties and problems in electrically connecting and encapsulating the coil assembly with the stimulator body. The specific implementation process of the scheme of the present invention to solve the above problems is as follows: first, the stimulator body is fixedly connected to the lower mold, and the lower mold is provided with an injection molding cavity for accommodating the stimulator body and the coil assembly; the coil assembly is a whole, including a winding seat and a communication coil and a charging coil wound on the winding seat, and the output ports of the communication coil and the charging coil are three pin-type interfaces; the positioning tool is used to locate the relative position of the coil assembly and the lower mold, and the positioning tool is provided with a tool positioning hole and a tool locking hole, and the corresponding lower mold is provided with a lower mold positioning hole and a lower mold locking hole. The positioning tool is also provided with a positioning pin inserted into the tool positioning hole and the lower mold positioning hole, and a positioning contact concave surface, and the positioning contact concave surface is the contact surface with the coil assembly, and the two fit each other to achieve the purpose of positioning the coil assembly. When the relative positions of the coil assembly, the stimulator body and the lower mold remain fixed and the needle-type interface of the coil assembly and the 3-pin feedthrough assembly of the stimulator body are in contact with each other, the needle-type interface and the 3-pin feedthrough assembly are welded, and the injection cavity is injection molded. After the colloid solidifies, the packaging of the coil assembly and the stimulator body is completed.

[0011] Preferably, an upper mold is further included: the upper mold and the lower mold cooperate with each other, each is provided with a fixed hole of matching position, and the center of the upper mold is provided with an injection hole running through. The upper mold and the lower mold are arranged to cooperate, so that the injection cavity can be subjected to high-pressure injection molding, and the injection molding effect is better.

[0012] Preferably, the sides of the upper mold and the lower mold are provided with a clamping cover to prevent the stimulator body from being displaced during the injection molding process. After the upper mold, the lower mold and the stimulator body are assembled, the end of the stimulator body that is not connected to the coil assembly is exposed outside the injection molding cavity formed by the upper mold and the lower mold, and displacement is likely to occur during the high-pressure injection molding process, thereby affecting the relative positional relationship between the stimulator body and the coil assembly. Therefore, a clamping cover is provided at one end of the stimulator body to prevent the stimulator body from being displaced during the injection molding process.

[0013] Preferably, it also includes an adjustment tool, which includes a pin fixed to the lower surface of the lower mold and three adjustment screws provided on the pin, the adjustment screws are located directly below the vertical projection of the needle-type interface of the coil assembly, and correspondingly, the lower mold is provided with a through adjustment hole matching the size and position of the adjustment screw.

[0014] The adjusting fixture is fixed to the lower surface of the lower mold by countersunk screws. The three ejector pins on the adjusting fixture pass through the through adjustment holes on the lower mold and penetrate into the direction of the needle interface until they touch the needle interface and push the needle interface toward the 3-pin feed-through assembly, thereby achieving contact between the two. When the welding process is completed, the adjusting fixture can be removed.

[0015] A packaging method for a neural stimulator coil assembly, comprising the following components: a lower mold, a stimulator body, and a coil assembly, comprising the following steps:

[0016] A. Fixing the stimulator body: The lower mold is provided with an injection molding cavity for accommodating the stimulator body and the coil assembly. The stimulator body is placed in the injection molding cavity and fixedly connected to the lower mold;

[0017] B. Fix the positioning fixture and the coil assembly: There are complementary surfaces between the positioning fixture and the coil assembly. Assemble the coil assembly and the positioning fixture, and fix the positioning fixture on the lower mold. The coil assembly is also fixed between the positioning fixture and the lower mold, ensuring that the pin-type interface on the coil assembly contacts the 3-pin feedthrough assembly on the stimulator body.

[0018] C. Welding and fixing: After fixing the relative positions of the positioning fixture, coil assembly, stimulator body and lower mold, move the whole to the welding equipment, and weld the pin-type interface and the 3-pin feedthrough assembly;

[0019] D. Injection molding: Remove the positioning tooling and inject the plastic into the injection molding cavity. After the colloid solidifies, the coil assembly and the stimulator body are connected together to complete the packaging.

[0020] In the above scheme, the purpose is to package the coil assembly and the stimulator body together and realize electrical connection at the same time, wherein the auxiliary components used include: lower mold and positioning tool. The first step is to fix the stimulator body to the lower mold; the second step is to fix the coil assembly to the lower mold through the positioning tool; the third step is to realize the electrical connection between the pin interface of the coil assembly and the 3-pin feedthrough assembly of the stimulator body through the welding step; the fourth step is to package the coil assembly and the stimulator body as a whole through the injection molding step.

[0021] Preferably, in step B, when fixing the coil assembly and the positioning fixture on the lower mold, the needle-type interface of the coil assembly is pressed onto the 3-pin collapse assembly of the stimulator body to ensure that the needle-type interface and the 3-pin collapse assembly are in contact with each other.

[0022] The needle-type interface is made of metal and has a certain degree of elasticity. When the coil assembly and the stimulator body are fixedly connected to the lower mold, the height of the needle-type interface is lower than the 3-pin feedthrough assembly in the absence of external force. When the coil assembly is fixedly connected to the lower mold, ensure that the needle-type interface is located above the 3-pin feedthrough assembly. The needle-type interface will have a spatial conflict with the 3-pin feedthrough assembly, thereby achieving elastic contact between the needle-type interface and the 3-pin feedthrough assembly.

[0023] Preferably, when the coil assembly and the positioning tool are fixed on the lower mold in step B, the needle-type interface of the coil assembly is arranged below the 3-pin feedthrough assembly of the stimulator body. To ensure that the needle-type interface and the 3-pin feedthrough assembly are in contact with each other, a contact adjustment step is also included. An adjustment tool is arranged on the lower surface of the lower mold and directly below the needle-type interface. The adjustment tool has three ejector pins leading to the direction of the needle-type interface. There is an adjusting bolt under the ejector pin to adjust the depth of the ejector pin. The ejector pin presses against the needle-type interface and pushes the needle-type interface toward the 3-pin feedthrough assembly, thereby finally achieving contact between the needle-type interface and the 3-pin feedthrough assembly.

[0024] In the above scheme, the needle-type interface of the coil assembly is placed below the 3-pin feedthrough assembly, and there is no spatial conflict between the two. In the absence of external force, the two remain separated from each other, so an adjustment tool is set below the lower mold. The adjustment tool includes a pin in contact with the needle-type interface and an adjusting screw under the pin. The pin is pushed toward the needle-type interface by adjusting the adjusting screw on the tool, and the needle-type interface is pushed toward the 3-pin feedthrough assembly until the two are in contact.

[0025] Preferably, in step D, before injecting into the injection cavity, an upper mold is arranged and fixed on the lower mold, and a pressing cover is fixed on the sides of the upper mold and the lower mold to ensure that the stimulator is fixed in position during injection.

[0026] Compared with the prior art, the beneficial effect of the present invention is that the packaging device and method for the coil assembly of a neural stimulator of the present invention can effectively assist and guide assemblers in installing the stimulator. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 A schematic diagram of the coil assembly and the stimulator main body structure of an embodiment of a packaging device for a neural stimulator coil assembly of the present invention;

[0028] Figure 2 A schematic diagram of a coil assembly, a positioning tool and a lower mold structure of an embodiment of a packaging device for a neural stimulator coil assembly of the present invention;

[0029] Figure 3 for Figure 2 A schematic diagram of the enlarged structure of the middle part A;

[0030] Figure 4It is a schematic diagram of the structure of a positioning assembly of an embodiment of a packaging device for a neural stimulator coil assembly of the present invention;

[0031] Figure 5 It is a schematic diagram of the structure of an adjustment component and a lower mold of an embodiment of a packaging device for a neural stimulator coil assembly of the present invention;

[0032] Figure 6 for Figure 5 Schematic diagram of the enlarged structure of local B;

[0033] Figure 7 for Figure 5 Schematic diagram of the AA section structure;

[0034] Figure 8 It is a schematic diagram of the relative positions of the coil assembly, the stimulator body and the lower mold of an embodiment of a packaging device for a neural stimulator coil assembly of the present invention;

[0035] Fig. 9 It is a schematic diagram of the relative positions of an upper mold, a lower mold and a pressing cover of an embodiment of a packaging device for a neural stimulator coil assembly of the present invention;

[0036] Fig.10 It is a schematic flow chart of a packaging method for a neural stimulator coil assembly according to Embodiment 1 of the present invention;

[0037] Fig.11 The figure is a flow chart of a packaging method for a neural stimulator coil assembly according to a second embodiment of the present invention. DETAILED DESCRIPTION

[0038] The present invention will be further described below in conjunction with the embodiments.

[0039] The following examples are used to illustrate the present invention, but they cannot be used to limit the scope of protection of the present invention. The conditions in the examples can be further adjusted according to specific conditions. Simple improvements to the method of the present invention under the premise of the concept of the present invention belong to the scope of protection claimed in the present invention.

[0040] The present invention provides a packaging device for a neural stimulator coil assembly, comprising a coil assembly 1 and a stimulator body 2, the relative positions of which are as follows: Figure 1 As shown, the coil assembly 1 includes a winding base 101 , and a charging coil 102 and a communication coil 103 wound on the winding base 101 ; the coil assembly 1 is connected to a stimulator body 2 .

[0041] In order to achieve the relative position fixation of the coil assembly 1 and the stimulator body 2, the packaging device of the present invention is also provided with a lower mold 3 and a positioning tool 4. Figure 2The figure shows the relative position relationship between the positioning tool 4, the lower mold 3 and the coil assembly 1; Figure 3 Shown Figure 2 A partial enlarged view of Figure 4 The figure shows a schematic diagram of the structure of the positioning tool 4; the upper surface of the lower mold 3 is provided with an injection molding cavity 5 for placing the coil assembly 1 and the stimulator body 2; the positioning tool 4 includes a tool body 401 and a positioning contact concave surface 402 connected to the tool body 401, the positioning contact concave surface 402 is in contact with the winding seat 101 in the coil assembly 1, and the contact surfaces of the two are mutually complemented; the tool body 401 is provided with a penetrating tool positioning hole 403 and a tool locking hole 404, and the tool positioning hole 403 is matched with a positioning pin 405; to match this, the lower mold 3 is provided with a mold positioning hole 301 and a mold locking hole 302 whose size and position match the tool positioning hole 403 and the tool locking hole 404.

[0042] In order to achieve electrical connection between the coil assembly 1 and the stimulator body 2, the packaging device of the present invention is further provided with an adjustment tool 6. Figure 5 The figure shows the relative position relationship between the adjusting tool 6 and the lower mold 3; Figure 6 Shown Figure 5 A partial enlarged view of Figure 7 The structure and relative position diagram of the three adjusting screws 601 of the adjusting fixture 6 are shown. The electrical connection parts of the coil assembly 1 and the stimulator body 2 are respectively the needle interface 104 and the 3-pin feedthrough assembly 201. When the coil assembly 1 and the stimulator body 2 are fixedly connected to the lower mold 3, the needle interface 104 is located below the 3-pin feedthrough assembly 201. The adjusting fixture 6 includes an adjusting block 602 fixed to the lower surface of the lower mold 3 and three adjusting screws 601 arranged on the adjusting block 602. A ejector pin 603 is arranged above the adjusting screw 601. The position of the adjusting screw 601 is located directly below the projection of the needle interface 104 of the coil assembly 1 in the vertical direction. Correspondingly, the lower mold 3 is provided with a through adjustment hole 303 matching the size and position of the ejector pin 603. The adjusting fixture 6 is fixed to the lower surface of the lower mold 3 by countersunk screws. The three adjusting screws 601 on the adjusting fixture 6 are pressed against the ejector pin 603. The ejector pin 603 passes through the through adjustment hole 303 on the lower mold 3 and goes deep into the direction of the needle-type interface 104 until it contacts the needle-type interface 104 and pushes the needle-type interface 104 toward the 3-pin feed-through assembly 201, thereby realizing the electrical connection between the two.

[0043] Figure 8 It is a schematic diagram of the structure after the relative positions of the coil assembly 1, the stimulator body 2 and the lower mold 3 are fixed; Fig. 9The figure shows a schematic diagram of the structure after the upper mold 7 and the lower mold 3 are covered and reinforced by the clamping cover 8; the upper mold 7 is covered on the lower mold 3 and fixedly connected to each other; an injection hole 701 is provided in the center of the upper mold 701; a clamping cover 8 is provided on the side after the upper mold 7 and the lower mold 3 are fixed to each other, and the function of the clamping cover 8 is to prevent the stimulator body 2 from being displaced during high-pressure injection molding.

[0044] A specific embodiment of a packaging method for a neural stimulator coil assembly of the present invention is as follows:

[0045] Embodiment 1:

[0046] like Fig.10 The above is a flow chart of Example 1;

[0047] A packaging method for a neural stimulator coil assembly, comprising the following steps:

[0048] 1. Fix the stimulator body: put the stimulator body into the injection molding cavity of the lower mold, and fix the two together;

[0049] 2. Fix the coil assembly: After assembling the coil assembly and the positioning assembly, the whole is fixedly connected to the lower mold; the positioning fixture determines the relative position with the lower mold through the positioning pin; the coil assembly determines the relative position of the coil assembly and the positioning fixture through the positioning contact concave surface of the positioning assembly, thereby determining the relative position of the coil assembly and the lower mold; after the relative position of the coil assembly and the lower mold is determined, the pin-type interface of the coil assembly is located below the 3-pin feedthrough assembly of the stimulator body;

[0050] 3. Fix the adjustment tooling: Fix the adjustment tooling to the bottom of the lower mold. The exact position is that the pin interface of the coil assembly corresponds to the adjustment screw of the adjustment tooling. After the adjustment tooling is fixedly connected to the lower mold, adjust the adjustment screw on the adjustment tooling to push the ejector upward. The ejector pushes the pin interface to the 3-pin feed-through assembly to make the two contact.

[0051] 4. Welding: Place the entire device with the above-mentioned pin interface and the 3-pin feedthrough assembly in contact on the welding table, and perform laser welding on the connection between the pin interface and the 3-pin feedthrough assembly;

[0052] 5. Injection molding and packaging: After welding is completed, remove the positioning tooling and adjustment tooling, place the upper mold on the lower mold and fix it, and set a clamping cover on the side where the upper and lower molds are connected; perform injection molding through the injection port of the upper mold, and remove the upper and lower molds after the colloid has dried and solidified. At this point, the coil assembly and the stimulator body are packaged.

[0053] Embodiment 2:

[0054] like Fig.11 The flowchart of Example 2 is described;

[0055] A packaging method for a neural stimulator coil assembly, comprising the following steps:

[0056] 1. Fix the coil assembly: After assembling the coil assembly and the positioning assembly, the whole is fixedly connected to the lower mold; the positioning fixture determines the relative position with the lower mold through the positioning pin; the coil assembly determines the relative position of the coil assembly and the positioning fixture through the positioning contact concave surface of the positioning assembly, thereby determining the relative position of the coil assembly and the lower mold;

[0057] 2. Fix the stimulator body: put the stimulator body into the injection molding cavity of the lower mold, and fix the two together;

[0058] 3. Fix the adjustment tooling: Fix the adjustment tooling to the bottom of the lower mold. The exact position is that the pin interface of the coil assembly corresponds to the adjustment screw of the adjustment tooling. After the adjustment tooling is fixedly connected to the lower mold, adjust the adjustment screw on the adjustment tooling to push the ejector upward. The ejector pushes the pin interface to the 3-pin feed-through assembly to make the two contact.

[0059] 4. Welding: Place the entire device with the above-mentioned pin-type interface and the 3-pin feedthrough assembly in contact on the welding table, and perform laser welding on the connection between the pin-type interface and the 3-pin feedthrough assembly;

[0060] 5. Injection molding and packaging: After welding is completed, remove the positioning tooling and adjustment tooling, place the upper mold on the lower mold and fix it, and set a clamping cover on the side where the upper and lower molds are connected; perform injection molding through the injection port of the upper mold, and remove the upper and lower molds after the colloid has dried and solidified. At this point, the coil assembly and the stimulator body are packaged.

[0061] In the above scheme, the lower mold is used to determine the relative position of the coil assembly and the stimulator body and for injection molding; the upper mold is used for injection molding; the positioning assembly is used to determine the relative position of the coil assembly and the lower mold; the adjustment assembly is used to achieve electrical connection between the coil assembly and the stimulator body; the entire packaging process is simple and easy to operate, with high precision and high success rate, thereby helping assemblers to install the neurostimulator more quickly, effectively and correctly, and reducing assembly errors and unqualified assembly phenomena.

[0062] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A packaging device for a neural stimulator coil assembly, characterized in that: Include: Coil assembly: comprising a winding seat and a charging coil and a communication coil wound on the winding seat; The charging coil and the communication coil form three external pin-type interfaces; Stimulator body: including a housing and three 3-pin feedthrough assemblies connected to the pin-type interface of the coil assembly; Upper mold: The center of the upper mold is provided with an injection hole running through it; Lower mold: It is stacked with the upper mold in the vertical direction. The upper mold and the lower mold cooperate with each other and are each provided with a fixing hole with matching position. The upper surface of the lower mold is provided with an injection molding cavity for placing the coil assembly and the stimulator body; An adjusting tool, which is fixedly connected to the bottom of the lower mold, and the adjusting tool also includes an ejector pin fixed to the lower surface of the lower mold and three adjusting screws arranged on the ejector pin, and the ejector pin is arranged directly below the projection of the needle interface in the vertical direction, and the needle interface is located below the 3-pin feed-through assembly, and the lower mold is provided with a through adjustment hole matching the size and position of the ejector pin, and the three adjusting screws are pressed against the ejector pin; Positioning tooling: comprising a tooling body and a positioning contact concave surface connected to the tooling body, wherein the positioning contact concave surface contacts the winding seat in the coil assembly and the contact surfaces of the two mutually complement each other; the tooling body is provided with a tooling positioning hole and a tooling locking hole, and the tooling positioning hole is matched with a positioning pin; correspondingly, the lower mold is provided with a mold positioning hole and a mold locking hole whose size and position match the tooling positioning hole and the tooling locking hole; The upper mold, the lower mold, the adjusting tool and the positioning tool are used to be removed after the injection molding packaging is completed.

2. A packaging device for a neural stimulator coil assembly according to claim 1, characterized in that: The sides of the upper mold and the lower mold are provided with a clamping cover to prevent the stimulator body from being displaced during the injection molding process.

3. A packaging method for a neural stimulator coil assembly, characterized in that: The method comprises the following components: a lower mold, a stimulator body and a coil assembly, and comprises the following steps: A. Fixing the stimulator body: the lower mold is provided with an injection molding cavity for accommodating the stimulator body and the coil assembly, and the stimulator body is placed in the injection molding cavity and fixedly connected to the lower mold; B. Fix the positioning fixture and the coil assembly: There are complementary surfaces between the positioning fixture and the coil assembly. Assemble the coil assembly and the positioning fixture, and fix the positioning fixture on the lower mold. The coil assembly is also fixed between the positioning fixture and the lower mold, ensuring that the pin-type interface on the coil assembly contacts the 3-pin feedthrough assembly on the stimulator body. C. Welding and fixing: After fixing the relative positions of the positioning fixture, coil assembly, stimulator body and lower mold, move the whole to the welding equipment, and weld the pin-type interface and the 3-pin feedthrough assembly; D. Injection molding: Remove the positioning tooling, inject the plastic into the injection molding cavity, and after the colloid solidifies, the coil assembly and the stimulator body are connected together to complete the packaging; When the coil assembly and the positioning tool are fixed on the lower mold in step B, the needle-type interface of the coil assembly is arranged below the 3-pin feedthrough assembly of the stimulator body. To ensure that the needle-type interface and the 3-pin feedthrough assembly are in contact with each other, a contact adjustment step is also included. An adjustment tool is arranged on the lower surface of the lower mold and directly below the needle-type interface. The adjustment tool has three ejector pins leading to the direction of the needle-type interface. There is an adjusting bolt under the ejector pin to adjust the depth of the ejector pin. The ejector pin presses against the needle-type interface and pushes the needle-type interface toward the 3-pin feedthrough assembly, thereby finally achieving contact between the needle-type interface and the 3-pin feedthrough assembly.

4. A packaging method for a neural stimulator coil assembly according to claim 3, characterized in that: In step B, when fixing the coil assembly and the positioning fixture on the lower mold, the needle-type interface of the coil assembly is pressed onto the 3-pin collapse assembly of the stimulator body to ensure that the needle-type interface and the 3-pin collapse assembly are in contact with each other.

5. The packaging method for a neural stimulator coil assembly according to claim 3, characterized in that: In step D, before injection molding into the injection molding cavity, an upper mold is set and fixed on the lower mold, and a compression cover is fixed on the sides of the upper mold and the lower mold to ensure that the stimulator is fixed in position during injection molding.

Images