Pulse generators and neurostimulators

Abstract

The present application relates to a pulse generator and a neural stimulator, the pulse generator comprising: a PCBA, comprising a PCB and electronic components, the PCB being provided with an installation area, the electronic components being fixedly arranged in the installation area; a magnetic isolation member, being a hollow cylindrical structure, the various parts of which are manufactured by injection molding or sintering molding; the electronic components and the installation area being located inside the magnetic isolation member; a receiving coil, comprising a coil body and pins connected to both ends of the coil body, the pins being electrically connected to the PCBA, and the coil body being tightly wound around the outer wall surface of the magnetic isolation member. Regardless of the shape of the receiving coil, as long as the outer wall surface of the magnetic isolation member is made into a shape that matches the coil body by injection molding or sintering molding, and then the receiving coil is wound around the outer wall surface of the magnetic isolation member, each turn of the receiving coil can be tightly fitted to the outer wall surface of the magnetic isolation member, thereby eliminating the gap between the magnetic isolation member and each turn of the receiving coil, and improving the energy conversion efficiency of the pulse generator.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a pulse generator and a nerve stimulator. Background Art

[0002] Some neurostimulators need to remain in the body for a long time to exert their therapeutic effects. In order to ensure that the neurostimulator can apply electrical stimulation to the body for many years, these neurostimulators need to be wirelessly charged through the skin and other tissues of the body. Specifically, a pulse generator is set in the neurostimulator. The pulse generator includes a PCBA and a receiving coil. A transmitting coil is set in the transmitter that matches the pulse generator. The transmitting coil generates magnetic field energy when energized. The receiving coil receives the magnetic field energy and converts it into electrical energy. The PCBA (Printed Circuit Board Assembly) converts the electrical energy into the electrical stimulation signal required for the neurostimulator to apply electrical stimulation.

[0003] For the convenience of the following description, the following definition is made: the efficiency of the pulse generator in converting the magnetic field energy generated by the transmitting coil into electrical energy is called the energy conversion efficiency of the pulse generator.

[0004] Small neurostimulators have the following advantages: easy implantation, minimal trauma during the implantation process, high safety, and the ability to significantly reduce patient discomfort. These advantages have made the miniaturization of neurostimulators a hot topic in the development of neurostimulators. As neurostimulators become smaller and smaller, the receiving coils inside them are also getting smaller and smaller, which results in a decrease in the ability of the receiving coils to receive magnetic field energy, and the energy conversion efficiency of the pulse generator is therefore reduced. When the energy conversion efficiency of the pulse generator drops to a certain level, the pulse generator cannot provide enough electrical energy, causing the neurostimulator to fail to work properly. Therefore, the energy conversion efficiency of the pulse generator has become an important factor restricting the miniaturization of neurostimulators. In order to make the neurostimulator smaller, it is necessary to increase the energy conversion efficiency of the pulse generator as much as possible.

[0005] In a pulse generator, a magnetic barrier is typically placed between the PCBA and the receiving coil, separating the electronic components on the PCBA from the receiving coil. On the one hand, the magnetic barrier concentrates and guides the magnetic field, acting as a magnetizing agent. This allows the receiving coil to more effectively capture and utilize the magnetic field energy transmitted from the transmitting coil, thereby improving the pulse generator's energy conversion efficiency. On the other hand, electromagnetic interference from the PCBA on the receiving coil can cause fluctuations and noise in the electrical stimulation signal output by the neurostimulator, making the stimulation signal unstable. An unstable stimulation signal may not accurately regulate the patient's neural activity, resulting in reduced therapeutic effectiveness. The magnetic barrier blocks the electromagnetic interference from the PCBA on the receiving coil, acting as a magnetic barrier, and facilitates the stable output of the stimulation signal from the neurostimulator, thereby ensuring therapeutic effectiveness.

[0006] Through experiments, the inventors of this application discovered that, assuming other conditions remain unchanged (such as the weight of the magnetic isolation layer and the relative position between the receiving coil and the transmitting coil), the smaller the gap between the magnetic isolation layer and the receiving coil, the higher the energy conversion efficiency of the pulse generator. However, in the prior art, the magnetic isolation layer is typically assembled from multiple die-cast magnetic isolation sheets, and the outer surface of such a magnetic isolation layer is flat. The receiving coil is wound around the outer surface of the magnetic isolation layer. When the receiving coil has curved surface features (for example, when the receiving coil is wound along a cylindrical helical line to form a cylindrical helical structure), a large gap exists between the magnetic isolation layer and the receiving coil, resulting in lower energy conversion efficiency of the pulse generator and hindering the reduction of the size of the neurostimulator. Summary of the Invention

[0007] Therefore, it is necessary to provide a pulse generator and a neurostimulator to address the above-mentioned problems. In this pulse generator, regardless of the shape of the receiving coil, as long as the outer wall surface of the magnetic shield is manufactured to a shape that is compatible with the receiving coil and the receiving coil is then wound against the outer wall surface of the magnetic shield, the desired receiving coil shape can be obtained. Furthermore, each turn of the receiving coil is closely attached to the outer wall surface of the magnetic shield, eliminating the gap between the magnetic shield and the receiving coil, thereby improving the energy conversion efficiency of the pulse generator.

[0008] In order to solve the above problems, this application provides the following technical solutions:

[0009] A pulse generator, comprising:

[0010] A PCBA, used to control and adjust the electrical signal, the PCBA comprising a PCB and electronic components, the PCB being provided with a mounting area, the electronic components being fixedly mounted in the mounting area;

[0011] The magnetic isolation member is a hollow cylindrical structure, and each part of the magnetic isolation member is manufactured by a process of injection molding or sintering molding; the electronic components and the installation area are located in the magnetic isolation member; and

[0012] The receiving coil includes a coil body and pins connected to both ends of the coil body, the pins are electrically connected to the PCBA, and the coil body is tightly wound around the outer wall of the magnetic isolation component.

[0013] The pulse generator has at least the following beneficial effects:

[0014] The various parts of the magnetic isolation member are manufactured through a process called infusion molding or sintering. Therefore, the various parts of the magnetic isolation member can be manufactured into complex shapes, and the outer wall surface of the magnetic isolation member can be manufactured into a shape that is compatible with the receiving coil. Regardless of the shape of the receiving coil, as long as the outer wall surface of the magnetic isolation member is manufactured into a shape that is compatible with the coil body, and then the receiving coil is wound against the outer wall surface of the magnetic isolation member, the turns of the receiving coil can be made to fit the outer wall surface of the magnetic isolation member, thereby eliminating the gap between the magnetic isolation member and the turns of the receiving coil and improving the energy conversion efficiency of the pulse generator. Moreover, the receiving coil of the desired shape can be wound against the outer wall surface of the magnetic isolation member. In other words, the magnetic isolation member acts as a coil mold. In this way, there is no need to manufacture an additional coil mold as a basis for winding the receiving coil before manufacturing the receiving coil.

[0015] In one embodiment, the magnetic isolation member is formed by injection molding a mixture, wherein the mixture includes magnetic isolation powder and a binder uniformly mixed together; in the mixture, the mass percentage of the magnetic isolation powder is greater than or equal to 30%.

[0016] With such an arrangement, the magnetic isolation member can be manufactured by injection molding.

[0017] In one embodiment, the magnetic isolation member is formed by sintering a mixture, wherein the mixture includes magnetic isolation powder and a binder uniformly mixed together; in the mixture, the mass percentage of the magnetic isolation powder is greater than or equal to 90%.

[0018] With such an arrangement, the magnetic isolation member can be manufactured by injection molding.

[0019] In one embodiment, the magnetic isolation member is composed of a plurality of shell-shaped bodies, and the shell-shaped bodies are fixedly connected together and together enclose a receiving cavity, and the electronic components and the installation area are located in the receiving cavity.

[0020] With this arrangement, the magnetic isolation component and the PCBA can be manufactured separately. In other words, the manufacturing processes of the two are independent of each other. After the two are manufactured, they can be assembled together, which can improve the production efficiency of the pulse generator.

[0021] In one embodiment, the magnetic isolation component is composed of two shell-like bodies, and the two shell-like bodies are arranged opposite to each other; the opposite sides of the two shell-like bodies are connecting sides, and a protrusion is provided on the connecting side of one of the shell-like bodies, and the protrusion is arranged around the accommodating cavity and connected end to end, and the other shell-like body is provided with a groove adapted to the protrusion, and the protrusion is located in the groove.

[0022] With such arrangement, the protrusion can prevent electromagnetic radiation generated by the electronic components from reaching the receiving coil through the gap at the connection between the two shell-shaped bodies and causing electromagnetic interference to the receiving coil.

[0023] In one embodiment, the coil body is wound into a cylindrical spiral structure, and the outer side surface of the magnetic isolation member is a cylindrical surface.

[0024] Such an arrangement enables the receiving coil to receive more magnetic field energy.

[0025] In one embodiment, the guide wire used to wind the coil body is a coil guide wire, the cross section of the coil guide wire is rectangular, and one side surface of the coil guide wire forms the inner side surface of the coil body.

[0026] With this arrangement, all inner sides of the coil body are in contact with the outer sides of the magnetic isolation member, so that there is no gap between the inner sides of the coil body and the outer sides of the magnetic isolation member, thereby improving the energy conversion efficiency of the pulse generator.

[0027] In one embodiment, the coil body is wound into a cylindrical spiral structure, and the guide wire used to wind the coil body is a coil guide wire, and the cross-section of the coil guide wire is circular; the outer side of the magnetic isolation member is provided with a spiral groove that is conformed to the coil body, and the part of the coil body facing the magnetic isolation member is located in the spiral groove.

[0028] With this arrangement, all inner sides of the coil body are in contact with the outer sides of the magnetic isolation member, so that there is no gap between the inner sides of the coil body and the outer sides of the magnetic isolation member, thereby improving the energy conversion efficiency of the pulse generator.

[0029] In one embodiment, a connection area is further provided on the PCB. The connection area is fixedly connected to one end of the installation area and is located outside the magnetic isolation component. The pin is electrically connected to the connection area.

[0030] With this arrangement, after the receiving coil is wound, the receiving coil can be conveniently connected to the connection area, so that the pins are electrically connected to the PCBA.

[0031] In one embodiment, the pulse generator further includes a protective member, which is injection molded or coated on the surface of the PCBA to separate the electronic components from the magnetic isolation member.

[0032] Such an arrangement can prevent the electronic components from being damaged during the process of manufacturing the magnetic isolation member through the processing technology of injection molding or sintering molding.

[0033] In one embodiment, the inner wall surface of the magnetic isolation component is in contact with the outer wall surface of the protective component.

[0034] This arrangement, on the one hand, fully utilizes the space within the pulse generator, eliminating any unused space and facilitating a smaller pulse generator. On the other hand, the various parts of the pulse generator fit together sequentially, enhancing the strength of the pulse generator.

[0035] The present application also provides a neurostimulator, which includes a housing, a stimulation contact, and the above-mentioned pulse generator. The stimulation contact is fixed to the housing and at least partially exposed to the outer peripheral surface of the housing, and is electrically connected to the PCBA.

[0036] The neurostimulator has at least the following beneficial effects:

[0037] The various parts of the magnetic isolation member are manufactured through a process of injection molding or sintering molding. Therefore, the various parts of the magnetic isolation member can be manufactured into complex shapes, and the outer wall surface of the magnetic isolation member can be manufactured into a shape that is compatible with the receiving coil. Regardless of the shape of the receiving coil, as long as the outer wall surface of the magnetic isolation member is manufactured into a shape that is compatible with the receiving coil, and then the receiving coil is wound against the outer wall surface of the magnetic isolation member, the turns of the receiving coil can be made to fit against the outer wall surface of the magnetic isolation member, thereby eliminating the gap between the magnetic isolation member and the receiving coil, improving the energy conversion efficiency of the pulse generator, and facilitating the reduction of the neurostimulator. Moreover, the receiving coil of the desired shape can be wound against the outer wall surface of the magnetic isolation member. In other words, the magnetic isolation member acts as a coil mold. In this way, there is no need to manufacture an additional coil mold as a basis for winding the receiving coil before manufacturing the receiving coil.

[0038] In one embodiment, the PCBA, the magnetic shielding member, and the receiving coil form an internal unit, and the housing is injection molded on a surface of the internal unit.

[0039] With such an arrangement, on the one hand, the outer shell plays a role in fixing the receiving coil to the magnetic isolation member; on the other hand, the outer shell plays a role in protecting the internal unit. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Figure 1 This is a three-dimensional schematic diagram of a pulse generator according to an embodiment of the present application;

[0041] Figure 2 for Figure 1 The schematic diagram of the structure of the PCBA in the pulse generator shown;

[0042] Figure 3 for Figure 2 Schematic diagram of the structure formed after the protective component is poured on the PCBA surface;

[0043] Figure 4 for Figure 3 Schematic diagram of the structure formed after the magnetic isolation member is poured into the surface of the structure shown;

[0044] Figure 5 A schematic diagram of the positional relationship between the PCBA, protective components, and mold in a perfusion method;

[0045] Figure 6 A schematic diagram of the positional relationship between the PCBA, protective component, and mold in another infusion method;

[0046] Figure 7 This is a three-dimensional schematic diagram of a pulse generator according to another embodiment of the present application;

[0047] Figure 8 for Figure 7 A perspective schematic diagram of the pulse generator excluding the receiving coil;

[0048] Figure 9 for Figure 8 An exploded schematic diagram of the structure shown;

[0049] Figure 10 for Figure 8 A schematic diagram of the structure shown from another perspective.

[0050] Reference numerals:

[0051] 1. PCBA; 11. PCB; 111. Installation area; 112. Connection area; 12. Electronic components; 2. Magnetic isolation member; 21. Shell; 211. Protrusion; 212. Groove; 3. Receiving coil; 31. Coil body; 4. Protective member; 5. Mold; 51. Cavity; 52. Glue channel; 6. Glue spray head. DETAILED DESCRIPTION

[0052] To make the above-mentioned objects, features, and advantages of the present application more clearly understood, the specific embodiments of the present application are described in detail below with reference to the accompanying drawings. The following description sets forth many specific details to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways than those described herein, and those skilled in the art can make similar improvements without violating the scope of the present application. Therefore, the present application is not limited to the specific embodiments disclosed below.

[0053] In the description of the present application, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present application.

[0054] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of the technical features being referred to. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of such features. Throughout the description of this application, "plurality" means at least two, for example, two, three, etc., unless otherwise specifically defined.

[0055] In this application, unless otherwise specified or limited, the terms "installed," "connected," "connect," "fixed," etc. should be understood in a broad sense. For example, they can refer to fixed connection, detachable connection, or integration; mechanical connection or electrical connection; direct connection or indirect connection through an intermediate medium; internal communication between two elements or interaction between two elements, unless otherwise specified. Those skilled in the art will understand the specific meanings of the above terms in this application based on specific circumstances.

[0056] In this application, unless otherwise expressly specified or limited, a first feature being "above" or "below" a second feature may mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium. Furthermore, a first feature being "above," "above," and "above" a second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is at a higher level than the second feature. A first feature being "below," "below," and "below" a second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is at a lower level than the second feature.

[0057] It should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be an intermediate element. When an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be an intermediate element. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only implementation methods.

[0058] See Figure 1 The present application first provides a pulse generator for generating an electrical signal. The pulse generator includes a PCBA 1, a magnetic isolation member 2, and a receiving coil 3.

[0059] PCBA1 is used to control and regulate electrical signals, see Figure 2 , PCBA1 includes PCB11 (Printed Circuit Board) and electronic components 12. PCB11 is provided with a mounting area 111, and electronic components 12 are fixedly mounted in the mounting area 111. Figure 2 , there are usually multiple electronic components 12. In some embodiments, only one electronic component 12 can also be provided.

[0060] See Figure 4 The magnetic isolation member 2 is a hollow cylindrical structure, and each part of the magnetic isolation member 2 is manufactured by a process of injection molding or sintering molding. In order to block the electromagnetic interference of the PCBA1 to the receiving coil 3, the electronic components 12 are located in the magnetic isolation member 2.

[0061] See Figure 1 The receiving coil 3 includes a coil body 31 and pins connected to both ends of the coil body 31 , the pins are electrically connected to the PCBA 1 , and the coil body 31 is tightly wound around the outer wall of the magnetic isolation member 2 .

[0062] In this pulse generator, the various components of the magnetic shield 2 are manufactured using a process called infusion molding or sintering. Therefore, the various components of the magnetic shield 2 can be manufactured into complex shapes, and the outer wall surface of the magnetic shield 2 can be manufactured into a shape that is compatible with the receiving coil 3. Regardless of the shape of the receiving coil 3, as long as the outer wall surface of the magnetic shield 2 is manufactured into a shape that is compatible with the coil body 31, and the receiving coil 3 is then wound against the outer wall surface of the magnetic shield 2, the turns of the receiving coil 3 can be made to fit the outer wall surface of the magnetic shield 2, thereby eliminating the gap between the magnetic shield 2 and the turns of the receiving coil 3 and improving the energy conversion efficiency of the pulse generator. Moreover, the receiving coil 3 of the desired shape can be wound against the outer wall surface of the magnetic shield 2. In other words, the magnetic shield 2 acts as a coil mold 5. As a result, there is no need to manufacture a separate coil mold 5 as a basis for winding the receiving coil 3 before manufacturing the receiving coil 3.

[0063] The pulse generator is used in conjunction with the transmitter. A transmitting coil is provided in the transmitter. When the transmitting coil is energized, it generates magnetic field energy. The receiving coil 3 receives the magnetic field energy and converts it into electrical energy. The PCBA1 converts the electrical energy into an electrical signal.

[0064] In some embodiments, the magnetic shielding member 2 is formed by injection molding using a mixture A comprising a uniformly mixed magnetic shielding powder and a binder. The magnetic shielding powder comprises greater than or equal to 30% by mass of the mixture A. Thus, the magnetic shielding member 2 can be manufactured by injection molding.

[0065] The pulse generator can be manufactured by the following perfusion method 1 and perfusion method 2:

[0066] The first perfusion method includes the following steps:

[0067] S110, manufacturing a mold 5, processing the side wall of the cavity 51 of the mold 5 into a shape that is compatible with the receiving coil 3 to be manufactured;

[0068] S120, see Figure 3 , a protective member 4 is fixedly arranged on the surface of the installation area 111 and the electronic components 12, so that the protective member 4 completely covers the installation area 111 and the electronic components 12; PCBA1 and the protective member 4 constitute a PCBA1 unit;

[0069] S130, see Figure 5 , placing the PCBA1 unit portion in the cavity 51 , wherein the protective member 4 is located in the cavity 51 and the connection area 112 is located outside the cavity 51 ;

[0070] S140, filling the mold cavity 51 with the mixture A. In the mixture A, the viscosity of the binder satisfies the following conditions: when the temperature is T, the position of the magnetic isolation powder remains unchanged during the natural curing process of the binder. In other words, the magnetic isolation powder always remains evenly distributed in the binder and does not settle. Waiting for the binder to naturally cure at the temperature T, after the binder cures, the mixture A forms the magnetic isolation member 2; and

[0071] S150, see Figure 4 , separate the mixture A from the mold 5, see Figure 1 The receiving coil 3 is wound along the outer wall of the magnetic isolation member 2 , and both ends of the receiving coil 3 (ie, the two pins of the receiving coil 3 ) are fixedly connected to the connection area 112 .

[0072] In mixture A, the mass percentage of the magnetic isolation powder is k. In the first pouring method, preferably, k satisfies: 30% ≤ k ≤ 90%. In this way, the magnetic isolation member 2 manufactured by the first pouring method has good magnetic attraction and isolation functions.

[0073] In the first pouring method, the magnetic isolation powder is preferably ferrite powder, and the binder is epoxy resin, with a temperature range of 20°C ≤ T ≤ 40°C. The viscosity of the binder is η, and when the temperature is T, η is ≥ 1000 cps. Because the binder has a high viscosity, the magnetic isolation powder remains evenly distributed within the binder during its natural curing process, preventing sedimentation.

[0074] The second perfusion method includes the following steps:

[0075] S210, manufacturing a mold 5, processing the lower portion of the side wall of the cavity 51 of the mold 5 into a shape that is compatible with the receiving coil 3 to be manufactured;

[0076] S220, see Figure 3 , a protective member 4 is fixedly arranged on the surface of the installation area 111 and the electronic components 12, so that the protective member 4 completely covers the installation area 111 and the electronic components 12; PCBA1 and the protective member 4 constitute a PCBA1 unit;

[0077] S230, see Figure 6 , place the PCBA1 unit in the cavity 51 so that the protective member 4 is located at the lower part of the cavity 51;

[0078] S240, pouring mixture A into the mold cavity 51, wherein the viscosity of the binder in the mixture A satisfies: when the temperature is T, during the natural curing process of the binder, the magnetic isolation powder settles to the lower part of the mold cavity 51; the amount of mixture A poured into the mold cavity 51 satisfies: the magnetic isolation powder settled to the lower part of the mold cavity 51 completely wraps the protective member 4 and is located below the connection area 112; waiting for the binder to naturally cure in an environment at a temperature of T, after the binder cures, the portion of the mixture A located in the lower part of the mold cavity 51 forms the magnetic isolation member 2; and

[0079] S250, see Figure 4 , separating the mixture A from the mold 5, and removing the portion of the mixture A except the magnetic isolation member 2 to expose the connection area 112; Figure 1 The receiving coil 3 is wound along the outer wall of the magnetic isolation member 2 , and both ends of the receiving coil 3 (ie, the two pins of the receiving coil 3 ) are fixedly connected to the connection area 112 .

[0080] exist Figure 6 In the embodiment, the glue channel 52 is connected to the mold cavity 51 , and the mixture A is poured into the glue channel 52 through the glue spray head 6 and flows into the mold cavity 51 through the glue channel 52 .

[0081] It is worth mentioning that in the second pouring method, the magnetic isolation powder settles and accumulates together. Therefore, in the magnetic isolation component 2 manufactured by the second pouring method, the mass percentage of the magnetic isolation powder can be greater than or equal to 90%, which makes the magnetic isolation component 2 have excellent magnetic attraction and magnetic isolation functions, and can improve the energy conversion efficiency of the pulse generator.

[0082] In pouring method 2, preferably, the magnetic barrier powder is ferrite powder, the binder is epoxy resin, and the temperature range is 5°C ≤ T ≤ 40°C. The binder has a viscosity, η, of 50 cps ≤ η ≤ 500 cps at temperature T. This allows the magnetic barrier powder in mixture A to settle and accumulate in the lower portion of cavity 51 due to the low viscosity of the binder.

[0083] In the first and second pouring methods, the magnetic isolation powder may be neodymium iron boron powder or samarium cobalt powder, and the binder may be polyurethane.

[0084] It is worth mentioning that, through the perfusion method 1 and the perfusion method 2, the magnetic isolation member 2 and the protective member 4 are tightly combined, which is beneficial to improving the rigidity of the pulse generator.

[0085] In some embodiments, the magnetic barrier 2 is formed by sintering a mixture B comprising a uniformly mixed magnetic barrier powder and a binder. The mass percentage of the magnetic barrier powder in the mixture B is greater than or equal to 90%. This allows the magnetic barrier 2 to be manufactured by injection molding. In these embodiments, the magnetic barrier powder may be ferrite powder, neodymium iron boron powder, or samarium cobalt powder, and the binder may be polyvinyl alcohol, acrylic resin, or a water-soluble polymer.

[0086] See Figures 7 to 10 In some embodiments, the magnetic shield 2 is composed of multiple shells 21, which are fixedly connected together and collectively enclose a housing cavity. The electronic components 12 and the mounting area 111 are located within the housing cavity. This allows the magnetic shield 2 and the PCBA 1 to be manufactured separately. In other words, their manufacturing processes are independent of each other. After both are manufactured, they can be assembled together, which improves the production efficiency of the pulse generator.

[0087] Exemplarily, the shell-shaped bodies 21 are bonded / clamped together in pairs.

[0088] Preferably, see Figures 7 to 10 , the magnetic isolation member 2 is composed of two shell-shaped bodies 21, and the two shell-shaped bodies 21 are arranged oppositely; the opposite sides of the two shell-shaped bodies 21 are the connection sides, see Figure 9 , a protrusion 211 is provided on the connection side of one shell 21, and the protrusion 211 is arranged around the accommodating cavity and connected end to end, see Figure 10 The other shell 21 is provided with a groove 212 adapted to the protrusion 211, and the protrusion 211 is located in the groove 212. In this way, the protrusion 211 can prevent the electromagnetic radiation generated by the electronic component 12 from reaching the receiving coil 3 through the gap at the connection of the two shells 21 and causing electromagnetic interference to the receiving coil 3.

[0089] Preferably, the protrusion 211 is snapped into the groove 212 to securely connect the two shells 21. In other embodiments, the protrusion 211 may simply be located in the groove 212 and abut against the bottom wall of the groove 212, but not be snapped into place with the groove wall of the groove 212.

[0090] In other embodiments, the magnetic isolation member 2 may also be composed of three or four shell-like bodies 21. In these embodiments, the above-mentioned protrusions 211 and grooves 212 are also respectively provided on the two shell-like bodies 21 connected together to prevent the electromagnetic waves generated by the electronic components 12 from reaching the receiving coil 3 through the gap at the connection between the two shell-like bodies 21 and causing electromagnetic interference to the receiving coil 3.

[0091] In the embodiment where the magnetic isolation member 2 is composed of two shell-shaped bodies 21, the pulse generator can be manufactured by the following perfusion method 3 and perfusion method 4:

[0092] Perfusion method three includes the following steps:

[0093] S310, manufacturing two molds 5, and processing the cavities 51 of the two molds 5 into shapes that are compatible with the two shell-shaped bodies 21 to be manufactured;

[0094] S320. Fill the mold cavity 51 with a mixture A comprising a uniformly mixed magnetic isolation powder and a binder. The viscosity of the binder satisfies the following conditions: when the temperature is T, the magnetic isolation powder remains in a fixed position during the natural curing process of the binder. In other words, the magnetic isolation powder remains uniformly distributed in the binder without settling. Wait for the binder to naturally cure at the temperature T. After the binder cures, the mixture A forms a shell 21.

[0095] S330, placing the PCBA 1 between the two shells 21, and then fixing the two shells 21 together to assemble the magnetic isolation member 2;

[0096] S340 , winding the receiving coil 3 close to the outer wall of the magnetic isolation member 2 , and fixing the two ends of the receiving coil 3 (ie, the two pins of the receiving coil 3 ) to the connection area 112 .

[0097] In mixture A, the mass percentage of the magnetic isolation powder is k. In the pouring method three, preferably, k satisfies: 30%≤k≤90%. In this way, the magnetic isolation member 2 manufactured by the pouring method three has good magnetic attraction and magnetic isolation functions.

[0098] In the third pouring method, the magnetic isolation powder is preferably ferrite powder, the binder is epoxy resin, and the temperature is 20°C ≤ T ≤ 40°C. The viscosity of the binder is η, and when the temperature is T, η ≥ 1000 cps. In this way, due to the high viscosity of the binder, the magnetic isolation powder remains evenly distributed in the binder during the natural curing process of the binder, and does not settle.

[0099] Perfusion method 4 includes the following steps:

[0100] S410, manufacturing two molds 5, and processing the lower parts of the cavities 51 of the two molds 5 into shapes that are compatible with the two shell-shaped bodies 21 to be manufactured;

[0101] S420, pouring a mixture A into the mold cavity 51, the mixture A comprising a mixed magnetic isolation powder and a binder; the viscosity of the binder satisfies the following conditions: when the temperature is T, the magnetic isolation powder settles to the lower part of the mold cavity 51 during the natural curing process of the binder; the amount of mixture A poured into the mold cavity 51 satisfies the following conditions: the magnetic isolation powder that settles to the lower part of the mold cavity 51 fills the lower part of the mold cavity 51; waiting for the binder to naturally cure at the temperature T, after which the portion of the mixture A located in the lower part of the mold cavity 51 forms the magnetic isolation member 2;

[0102] S430, placing the PCBA 1 between the two shells 21, and then fixing the two shells 21 together to assemble the magnetic isolation member 2;

[0103] S440 , winding the receiving coil 3 close to the outer wall of the magnetic isolation member 2 , and fixing the two ends of the receiving coil 3 (ie, the two pins of the receiving coil 3 ) to the connection area 112 .

[0104] It is worth mentioning that in the pouring method four, the magnetic isolation powder settles and accumulates together. Therefore, in the magnetic isolation component 2 manufactured by the pouring method four, the mass percentage of the magnetic isolation powder can be greater than or equal to 90%, which makes the magnetic isolation component 2 have excellent magnetic attraction and magnetic isolation functions, and can improve the energy conversion efficiency of the pulse generator.

[0105] In pouring method 4, the magnetic barrier powder is preferably ferrite powder, the binder is epoxy resin, and the temperature range is 5°C ≤ T ≤ 40°C. The binder has a viscosity η, which is 50 cps ≤ η ≤ 500 cps at temperature T. This allows the magnetic barrier powder in mixture A to settle and accumulate in the lower portion of cavity 51 due to the low viscosity of the binder.

[0106] In the third and fourth pouring methods, the magnetic isolation powder may be neodymium iron boron powder or samarium cobalt powder, and the binder may be polyurethane.

[0107] Under the condition of the same circumference, the area of ​​the circle is the largest. In order to enable the receiving coil 3 to receive more magnetic field energy, the coil body 31 is wound into a cylindrical spiral structure, and the outer side surface of the magnetic isolation member 2 is a cylindrical surface. In these embodiments, preferably, the guide wire used to wind the coil body 31 is a coil guide wire, the cross-section of the coil guide wire is rectangular, and one side surface of the coil guide wire forms the inner side surface of the coil body 31. In this way, all parts on the inner side surface of the coil body 31 are in contact with the outer side surface of the magnetic isolation member 2, so that there is no gap between all parts on the inner side surface of the coil body 31 and the outer side surface of the magnetic isolation member 2, which can improve the energy conversion efficiency of the pulse generator.

[0108] Preferably, the coil body 31 is wound into a cylindrical helical structure, and the guide wire used to wind the coil body 31 is a coil guide wire with a circular cross-section. The outer side of the magnetic shielding member 2 is provided with a spiral groove that conforms to the shape of the coil body 31, and the portion of the coil body 31 facing the magnetic shielding member 2 is located within the spiral groove. In this way, every point on the inner side of the coil body 31 contacts the outer side of the magnetic shielding member 2, ensuring that there is no gap between the inner side of the coil body 31 and the outer side of the magnetic shielding member 2, thereby improving the energy conversion efficiency of the pulse generator.

[0109] Preferably, see Figure 1PCB 11 is further provided with a connection area 112, which is fixedly connected to one end of the mounting area 111. Figure 4 The connection area 112 is located outside the magnetic isolation member 2, and the pins are electrically connected to the connection area 112. In other words, the receiving coil 3 bypasses the magnetic isolation member 2 and is fixedly connected to the connection area 112. In this way, after the receiving coil 3 is wound, it can be easily connected to the connection area 112, so that the pins are electrically connected to the PCBA 1.

[0110] Exemplarily, two pins (ie, two ends of the receiving coil 3 ) are bonded / welded to the connection area 112 .

[0111] In other embodiments, the receiving coil 3 may also pass through the magnetic isolation member 2 and be fixedly connected to the connection area 112. Figures 7 to 10 In the illustrated embodiment, a through hole may be reserved or opened on the portion of the magnetic isolation member 2 corresponding to the connection area 112 , and the two pins of the receiving coil 3 are fixedly connected to the connection area 112 after passing through the through hole.

[0112] See Figure 3 The pulse generator further includes a protective member 4, which is formed by injection molding or coated on the surface of the PCBA 1 to separate the electronic components 12 from the magnetic isolation member 2. In this way, the electronic components 12 can be prevented from being damaged during the process of manufacturing the magnetic isolation member 2 by injection molding or sintering molding.

[0113] It is worth mentioning that, in some embodiments, the protective member 4 is injection molded or coated on the surface of PCBA1, and the magnetic isolation member 2 is injection molded on the surface of the protective member 4 by the above-mentioned injection method 1 or injection method 2. In this way, PCBA1, the protective member 4 and the magnetic isolation member 2 are tightly combined, which is beneficial to improve the rigidity of the pulse generator.

[0114] Preferably, in order to ensure that the smaller magnetic isolation member 2 has sufficient magnetic attraction and isolation functions, in the above-mentioned pouring method 1 and pouring method 3, k satisfies: 70%≤k≤90%.

[0115] Preferably, the connection area 112 is located outside the insulating member. In this way, after the receiving coil 3 is wound, the receiving coil 3 can be conveniently connected to the connection area 112 so that the pins are electrically connected to the PCBA 1.

[0116] In some embodiments, a moisture-proof material is poured onto the surface of the PCBA 1, and the moisture-proof material is cured to form the protective member 4. For example, the moisture-proof material is epoxy resin or polyurethane.

[0117] In some embodiments, a moisture-proof material is coated on the surface of the PCBA 1, and the moisture-proof material is cured to form the protective member 4. For example, the moisture-proof material is conformal coating or parylene.

[0118] Preferably, the inner wall of the magnetic shield 2 is aligned with the outer wall of the protective member 4. This fully utilizes the space within the pulse generator, eliminating any unused space and facilitating a smaller pulse generator. Furthermore, the sequential alignment of the various parts of the pulse generator enhances its strength.

[0119] In other embodiments, the protective member 4 may not be provided, and the inner wall surface of the magnetic isolation member 2 may be directly attached to the outer side surface of the PCBA 1 .

[0120] The present application secondly provides a neurostimulator, which includes a housing, a stimulation contact and the above-mentioned pulse generator. The stimulation contact is fixed to the housing and electrically connected to PCBA1. The stimulation contact is at least partially exposed from the outer peripheral surface of the housing so that the stimulation contact can contact the part of the patient's body where electrical stimulation needs to be applied.

[0121] In this neurostimulator, the various components of the magnetic shield 2 are manufactured using a process called injection molding or sintering. Therefore, the various components of the magnetic shield 2 can be manufactured into complex shapes, and the outer wall surface of the magnetic shield 2 can be manufactured to match the receiving coil 3. Regardless of the shape of the receiving coil 3, as long as the outer wall surface of the magnetic shield 2 is manufactured to match the receiving coil 3 and the receiving coil 3 is then wound against the outer wall surface of the magnetic shield 2, the turns of the receiving coil 3 can be made to fit the outer wall surface of the magnetic shield 2, thereby eliminating the gap between the magnetic shield 2 and the receiving coil 3, improving the energy conversion efficiency of the pulse generator and facilitating the reduction of the neurostimulator. Moreover, the receiving coil 3 of the desired shape can be wound against the outer wall surface of the magnetic shield 2. In other words, the magnetic shield 2 acts as a coil mold 5, eliminating the need to manufacture a separate coil mold 5 as a foundation for winding the receiving coil 3 before manufacturing the receiving coil 3.

[0122] The PCBA 1, magnetic shield 2, and receiving coil 3 form an internal unit. In some embodiments, a housing is injection-molded onto the surface of the internal unit. This housing secures the receiving coil 3 to the magnetic shield 2 and protects the internal unit.

[0123] Exemplarily, the material used to cast the housing is epoxy resin or plastic.

[0124] It is worth mentioning that, in some embodiments, the protective member 4 is injection molded or coated on the surface of PCBA1, the magnetic isolation member 2 is injection molded on the surface of the protective member 4 by the above-mentioned injection method 1 or injection method 2, and the outer shell is injection molded on the surface of the internal unit. In this way, PCBA1, the protective member 4, the magnetic isolation member 2 and the outer shell are tightly combined, which is beneficial to improve the rigidity of the neurostimulator and prevent the neurostimulator from brittle fracture.

[0125] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0126] The above-described embodiments merely represent several implementation methods of the present application. While the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of protection of the present application. It should be noted that a person of ordinary skill in the art may make various modifications and improvements without departing from the spirit of the present application, and such modifications and improvements fall within the scope of protection of the present application. Therefore, the scope of protection of the present application shall be determined by the appended claims.

Claims

1. A pulse generator for generating an electrical signal, characterized in that: include: A PCBA (1) for controlling and adjusting the electrical signal, the PCBA (1) comprising a PCB (11) and an electronic component (12), the PCB (11) being provided with a mounting area (111), and the electronic component (12) being fixedly mounted in the mounting area (111); The magnetic isolation member (2) is a hollow columnar structure, the magnetic isolation member (2) is formed by injection molding of a mixture A, the mixture A comprising magnetic isolation powder and a binder uniformly mixed together; the electronic component (12) and the installation area (111) are located inside the magnetic isolation member (2); and A receiving coil (3), comprising a coil body (31) and pins connected to two ends of the coil body (31), the pins being electrically connected to the PCBA (1), and the coil body (31) being tightly wound around the outer wall surface of the magnetic isolation component (2); The PCB (11) is further provided with a connection area (112), the connection area (112) being fixedly connected to one end of the installation area (111) and located outside the magnetic isolation component (2), and the pin being electrically connected to the connection area (112); The pulse generator further comprises a protective member (4), the protective member (4) being disposed on the surface of the PCBA (1) by injection molding or coating, so as to separate the electronic component (12) from the magnetic isolation member (2); The pulse generator is manufactured by the following steps: a. manufacturing a mold (5), processing the lower portion of the side wall of the cavity (51) of the mold (5) into a shape that matches the receiving coil (3) to be manufactured; b. A protective member (4) is fixedly arranged on the surface of the installation area (111) and the electronic component (12), so that the protective member (4) completely covers the installation area (111) and the electronic component (12); the PCBA (1) and the protective member (4) constitute a PCBA1 unit; c. Place the PCBA1 unit in the cavity (51) so that the protective member (4) is located at the lower portion of the cavity (51); d. Pour the mixture A into the cavity (51), wherein the viscosity of the binder in the mixture A satisfies that: when the temperature is T, during the natural curing process of the binder, the magnetic isolation powder settles to the lower part of the cavity (51); the amount of the mixture A poured into the cavity (51) satisfies that: the magnetic isolation powder settled to the lower part of the cavity (51) completely wraps the protective member (4) and is located below the connection area (112); wait for the binder to cure naturally in an environment at a temperature of T, and after the binder cures, the portion of the mixture A located at the lower part of the cavity (51) forms the magnetic isolation member (2); wherein 5°C ≤ T ≤ 40°C; e. separating the mixture A from the mold (5), removing the portion of the mixture A except for the magnetic isolation member (2) to expose the connection area (112); winding the receiving coil (3) along the outer wall surface of the magnetic isolation member (2), and fixing the two ends of the receiving coil (3) to the connection area (112); In the magnetic isolation component (2), the mass percentage of magnetic isolation powder is greater than or equal to 90%.

2. The pulse generator according to claim 1, characterized in that The coil body (31) is wound into a cylindrical spiral structure, and the outer side surface of the magnetic isolation component (2) is a cylindrical surface.

3. The pulse generator according to claim 2, characterized in that The guide wire used for winding the coil body (31) is a coil guide wire, the cross section of the coil guide wire is rectangular, and one side surface of the coil guide wire forms the inner side surface of the coil body (31).

4. The pulse generator according to claim 1, characterized in that The coil body (31) is wound into a cylindrical spiral structure, the guide wire used for winding the coil body (31) is a coil guide wire, and the cross-section of the coil guide wire is circular; the outer side of the magnetic isolation member (2) is provided with a spiral groove that is conformally matched to the coil body (31), and the part of the coil body (31) facing the magnetic isolation member (2) is located in the spiral groove.

5. A neural stimulator, characterized in that: include: A housing, a stimulation contact, and a pulse generator according to any one of claims 1 to 4, wherein the stimulation contact is fixed to the housing and at least partially exposed from the outer peripheral surface of the housing, and is electrically connected to the PCBA (1).

6. The neurostimulator according to claim 5, characterized in that The PCBA (1), the magnetic shielding component (2) and the receiving coil (3) form an internal unit, and the outer shell is injection-molded on the surface of the internal unit.

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