CN116747435A - Nerve stimulator and method for manufacturing nerve stimulator - Google Patents

Abstract

The invention relates to a nerve stimulator and a manufacturing method thereof, wherein the nerve stimulator comprises: a circuit board; the bearing piece is axially sleeved with the circuit board; the receiving coil is electrically connected to the circuit board and is axially sleeved with the bearing piece; a housing axially sleeved with a receiving coil; and the first nerve stimulating electrode is electrically connected to the circuit board, embedded in the shell and at least partially exposed out of the outer peripheral surface of the shell. The invention has the advantages that: the circuit board, the bearing piece, the receiving coil and the shell are sequentially sleeved axially, so that the length of the nerve stimulator can be reduced. In addition, the first nerve stimulating electrode is embedded in the shell, and a connector is not required to be additionally arranged for connecting the first nerve stimulating electrode, so that the length of the nerve stimulator can be reduced. Therefore, the length of the nerve stimulator is shorter, the nerve stimulator is not easy to break, and the damage to organisms caused by breaking of the nerve stimulator in the long-term use process can be avoided.

Description

Nerve stimulator and method for manufacturing nerve stimulator

Technical Field

The invention relates to the technical field of medical equipment, in particular to a nerve stimulator and a manufacturing method of the nerve stimulator.

Background

Currently, electrical stimulation is typically applied to a target nerve at a target location using a nerve stimulator. Some neurostimulators, which are usually designed in a rod shape for ease of use and ease of positioning, require total implantation into the living body to apply electrical stimulation for a long period of time. However, in the conventional art, a plurality of structures of the neural stimulator, which are all implanted in the living body, are sequentially connected in the length direction, and the length of the neural stimulator is significantly increased. Moreover, the nerve stimulators are connected with the first nerve stimulating electrode by inserting and pulling the connector, and the length of the nerve stimulators is further increased by arranging the connector. These neurostimulators often require years of use after implantation into the organism, and too long neurostimulators present a risk of breaking during prolonged use, potentially causing injury to the organism.

Disclosure of Invention

Based on this, it is necessary to provide a neural stimulator in view of the above-mentioned problems. The nerve stimulator has short length and is not easy to break, and damage to organisms caused by breakage of the nerve stimulator in a long-term use process can be avoided.

In order to solve the problems, the invention provides the following technical scheme:

a neural stimulator, comprising: a circuit board; the bearing piece is axially sleeved with the circuit board; the receiving coil is electrically connected to the circuit board and axially sleeved with the bearing piece; the shell is axially sleeved with the receiving coil; and the first nerve stimulating electrode is electrically connected to the circuit board, embedded in the shell and at least partially exposed out of the outer peripheral surface of the shell.

In one embodiment, the circuit board, the carrier, the receiving coil, and the housing are laminated in this order.

In one embodiment, the circuit board is strip-shaped, the bearing piece and the shell are hollow cylindrical bodies, and the receiving coil is spirally wound to form a hollow cylindrical structure.

In one embodiment, the first nerve stimulation electrode includes a stimulation portion that exposes an outer peripheral surface of the housing, the stimulation portion being lower than or flush with the outer peripheral surface of the housing.

In one embodiment, the outer circumferential surface of the shell is a cylindrical surface, and the stimulating part is in a circular arc shape; the number of the first nerve stimulating electrodes is at least two, wherein at least two first nerve stimulating electrodes are oppositely arranged and are arranged at intervals along the circumferential direction of the outer circumferential surface of the shell.

In one embodiment, the circuit board, the carrier, the receiving coil, and the housing each have a central axis, and the central axes of the circuit board, the carrier, the receiving coil, and the housing are parallel.

In one embodiment, the nerve stimulator further comprises a first anti-drop member, the first anti-drop member comprises an anti-drop portion and a connecting portion, the connecting portion is connected to the circuit board or the carrier, and the anti-drop portion is connected to the connecting portion, is located outside the housing, and has a gap with the housing.

In one embodiment, the neural stimulator further comprises a second neural stimulation electrode, wherein the second neural stimulation electrode is fixedly arranged at the tail end of the first anti-drop piece in the length direction and is electrically connected with the circuit board.

In one embodiment, the nerve stimulator further comprises a buffer member made of an elastic material, and the buffer member is sleeved on the connecting portion and is clamped between the buffer member and the housing.

In one embodiment, along the axis direction of the circuit board, the circuit board part extends out of the carrier, the connection part is connected to the part of the circuit board extending out of the carrier, and the first nerve stimulating electrode and the receiving coil are electrically connected to the part of the circuit board extending out of the carrier.

In one embodiment, the first nerve stimulating electrode includes a stimulating portion and a clamping portion, the stimulating portion exposes out of the outer peripheral surface of the housing, and the clamping portion is connected to an end portion of the stimulating portion in a circumferential direction and is clamped between the carrier and the first anti-drop member.

In one embodiment, a first limiting portion is disposed on a side, close to the anti-falling portion, of the bearing member, the first anti-falling member includes a second limiting portion disposed on the connecting portion, and the clamping portion is clamped between the first limiting portion and the second limiting portion.

The invention also provides a method for manufacturing the nerve stimulator, which is used for manufacturing the nerve stimulator, and comprises the following steps:

a. assembling the circuit board, the bearing piece, the receiving coil and the first nerve stimulating electrode into a preassembly;

b. placing the pre-assembly body into a mold, and attaching the outer circumferential surface of the stimulation part of the first nerve stimulation electrode to the inner wall of the mold;

c. the mold is closed and filled with an injection molding material to form the housing.

In one embodiment, step a comprises:

a1, injection molding a bearing piece on the circuit board, wherein the circuit board is provided with an end part extending out of the bearing piece and a middle part supporting the bearing piece;

a2, winding the receiving coil along the peripheral surface of the bearing piece;

a3, electrically connecting the receiving coil to the end part of the circuit board;

a4, fixing the clamping part of the first nerve stimulation electrode on the first limiting part of the bearing piece;

a5, electrically connecting the first nerve stimulating electrode to the end part of the circuit board to form the preassembly.

In one embodiment, before step b, the method further comprises the steps of:

d. connecting the connecting part of the first anti-falling piece to the end part of the circuit board;

in step b, it includes: extending the connecting part out of the die, and enabling all the anti-falling parts of the first anti-falling part to be positioned outside the die;

in step a4, it includes: the clamping part is clamped between the first limiting part and the second limiting part of the first anti-falling piece.

In one embodiment, before step d, the method further comprises the steps of:

e. sleeving the buffer piece on the connecting part;

in step b, it includes: the cushioning member is positioned within the mold.

The invention has at least the following beneficial effects:

in the nerve stimulator provided by the invention, the circuit board, the bearing piece, the receiving coil and the shell are sequentially sleeved in the axial direction, so that the length of the nerve stimulator can be reduced. In addition, the first nerve stimulating electrode is embedded in the shell, and a connector is not required to be additionally arranged for connecting the first nerve stimulating electrode, so that the length of the nerve stimulator can be reduced. Therefore, the length of the nerve stimulator is shorter, the nerve stimulator is not easy to break, and the damage to organisms caused by breaking of the nerve stimulator in the long-term use process can be avoided.

Drawings

FIG. 1 is a schematic diagram of a neural stimulator according to one embodiment of the present invention;

FIG. 2 is an exploded view of the embodiment of FIG. 1;

FIG. 3 is an enlarged schematic view of FIG. 2 at A;

FIG. 4 is an exploded view of the further exploded view of FIG. 2;

FIG. 5 is a schematic diagram of the structure of the first nerve stimulating electrode in FIG. 4;

FIG. 6 is a schematic view of the first anti-disengaging member shown in FIG. 4;

FIG. 7 is a schematic view of the carrier of FIG. 4;

FIG. 8 is a schematic diagram of the circuit board in FIG. 4;

FIG. 9 is a schematic diagram of a neural stimulator according to another embodiment of the present invention;

FIG. 10 is an exploded schematic view of the neurostimulator of FIG. 9;

FIG. 11 is a top view of a neural stimulator according to yet another embodiment of the present invention;

FIG. 12 is a left side view of the neural stimulator shown in FIG. 11;

fig. 13 is a flow chart of a method of manufacturing a neural stimulator according to an embodiment of the present invention.

Reference numerals:

1. a circuit board; 11. a wiring hole; 2. a carrier; 21. a first limit part; 211. a first abutment surface; 3. a receiving coil; 4. a housing; 5. a first neural stimulation electrode; 51. a stimulation unit; 52. a clamping part; 6. a first anti-falling member; 61. an anti-falling part; 611. a rotation stopping groove; 62. a connection part; 621. a clamping groove; 63. a second limit part; 631. a second abutment surface; 7. a gap; 8. a buffer member; 9. a second anti-falling member; 10. a second nerve stimulating electrode.

Detailed Description

In order that the above objects, features and advantages of the invention will be readily understood, a more particular description of the invention will be rendered by reference to the appended drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. The present invention may be embodied in many other forms than described herein and similarly modified by those skilled in the art without departing from the spirit of the invention, whereby the invention is not limited to the specific embodiments disclosed below.

In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings are merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the device or element being referred to must have a specific orientation, be configured and operated in a specific orientation, and therefore should not be construed as limiting the present invention.

Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include at least one such feature. In the description of the present invention, the meaning of "plurality" means at least two, for example, two, three, etc., unless specifically defined otherwise.

In the present invention, unless explicitly specified and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; either directly or indirectly, through intermediaries, or both, may be in communication with each other or in interaction with each other, unless expressly defined otherwise. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.

In the present invention, unless expressly stated or limited otherwise, a first feature "up" or "down" a second feature may be the first and second features in direct contact, or the first and second features in indirect contact via an intervening medium. Moreover, a first feature being "above," "over" and "on" a second feature may be a first feature being directly above or obliquely above the second feature, or simply indicating that the first feature is level higher than the second feature. The first feature being "under", "below" and "beneath" the second feature may be the first feature being directly under or obliquely below the second feature, or simply indicating that the first feature is less level than the second feature.

It will be understood that when an element is referred to as being "fixed" or "disposed" on another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like are used herein for illustrative purposes only and are not meant to be the only embodiment.

The present invention provides a neurostimulator for implantation into a target location of an organism to apply electrical stimulation to a target nerve at the target location.

Referring to fig. 1 to 8, the neural stimulator provided by the present invention includes a circuit board 1, a carrier 2, a receiving coil 3, a housing 4, and the neural stimulator, wherein the circuit board 1, the carrier 2, and the receiving coil 3 are all located in the housing 4. The receiving coil 3 is used for powering a first nerve stimulating electrode 5, the first nerve stimulating electrode 5 being used for applying electrical stimulation to the target nerve. Specifically, the receiving coil 3 and the first nerve stimulating electrode 5 are electrically connected to the circuit board 1, the circuit board 1 processes the current transmitted from the receiving coil 3 and transmits the processed current to the first nerve stimulating electrode 5, and the first nerve stimulating electrode 5 contacts with the target nerve to apply the electrical stimulation. The carrier 2 is capable of carrying the circuit board 1 and the receiving coil 3, and the housing 4 serves to protect the structure located inside thereof to prevent tissue fluid of the living being from contacting the structure inside the housing 4.

It will be appreciated that the neurostimulator is used with an external machine that provides power to the neurostimulator in real time. Specifically, the in vitro machine is tied to the organism and is positioned outside the organism at a position close to the implantation site of the nerve stimulator. The transmitting coil in the external machine generates magnetic field energy, and the receiving coil 3 in the nerve stimulator receives the magnetic field energy and converts the magnetic field energy into electric energy to supply power to the first nerve stimulating electrode 5.

Currently, nerve stimulators are often designed in stick form for ease of use and ease of positioning. However, in the conventional art, the structures of the neural stimulator are sequentially connected in the length direction, and the length of the neural stimulator is significantly increased. Moreover, these neurostimulators are connected to the first neurostimulation electrode 5 by means of connectors which are provided so as to further increase the length of the neurostimulators, which are typically 30mm to 40mm. These neurostimulators often require years of use after implantation into the organism, and too long neurostimulators present a risk of breaking during prolonged use, potentially causing injury to the organism.

In order to solve the above-mentioned problems, referring to fig. 1 and 2, in the neural stimulator provided by the present invention, the carrier 2 is axially sleeved with the circuit board 1, the receiving coil 3 is axially sleeved with the carrier 2, and the housing 4 is axially sleeved with the receiving coil 3, in other words, the circuit board 1, the carrier 2, the receiving coil 3 and the housing 4 are sequentially axially sleeved. This can reduce the length of the neurostimulator so that the neurostimulator does not break off easily.

In order to solve the above-mentioned problems, referring to fig. 1 and 4, in the neural stimulator provided by the present invention, the first neural stimulation electrode 5 is embedded in the housing 4, so that no additional connector is needed to connect the first neural stimulation electrode 5, which can also reduce the length of the neural stimulator so that the neural stimulator is not easy to break, for example, the length of the neural stimulator in the embodiment shown in fig. 1 may be less than 25mm. In a state of being fitted in the case 4, the first nerve stimulating electrode 5 is at least partially exposed to the outer peripheral surface of the case 4 so as to be brought into contact with the target nerve to apply electrical stimulation.

In summary, the nerve stimulator provided by the invention has a short length, is not easy to break, and can avoid damage to organisms caused by breakage of the nerve stimulator in a long-term use process.

In some embodiments, taps are provided at both the beginning and the end of the receiving coil 3, and the receiving coil 3 is connected to the circuit board 1 through the taps. The first nerve stimulating electrode 5 is electrically connected with the circuit board 1 through a wire. Specifically, referring to fig. 8, in some embodiments, the circuit board 1 is provided with a plurality of wiring holes 11, the wiring holes 11 are matched with the taps and the wires, and the taps of the receiving coil 3 are respectively inserted into the different wiring holes 11 to be connected with the circuit board 1. In order to prevent the tap and the wire from being separated from the circuit board 1, the tap and the wire are soldered to the circuit board 1 after being inserted into the circuit board 1. To prevent the lead from coming off the first nerve stimulating electrode 5, the lead is soldered to the first nerve stimulating electrode 5.

In some embodiments, the circuit board 1, the carrier 2, the receiving coil 3, and the housing 4 are laminated in this order. Therefore, the strength of the whole nerve stimulator can be increased, and the nerve stimulator is prevented from being broken.

For example, referring to fig. 4 and 8, the circuit board 1 is in a strip shape, the carrier 2 is a hollow column, and the circuit board 1 is wholly or partially located in the carrier 2 and is attached to the inner wall of the carrier 2. The receiving coil 3 is spirally wound into a hollow columnar structure against the outer peripheral surface of the carrier 2. The housing 4 is also a hollow columnar body, and the receiving coil 3 is attached to the inner wall of the housing 4. To facilitate the embedding of the electrode in the housing 4, the portion of the electrode for exposing the outer peripheral surface of the housing 4 is arc-shaped.

Referring to fig. 2, 4 and 7, in some embodiments, the outer periphery of the carrier 2 has a ring-shaped groove, the groove surrounds the central axis of the carrier 2, the receiving coil 3 is accommodated in the groove, and the receiving coil 3 and the outer Zhou Jun of the carrier 2 are attached to the inner wall of the housing 4.

Referring to fig. 1, in some embodiments, the first nerve stimulating electrode 5 includes a stimulating portion 51, the stimulating portion 51 exposing the outer peripheral surface of the housing 4, and the stimulating portion 51 is lower than or flush with the outer peripheral surface of the housing 4, in other words, the first nerve stimulating electrode 5 does not protrude from the outer peripheral surface of the housing 4. Thus, the dimension of the nerve stimulator perpendicular to the axial direction can be reduced to reduce the foreign body sensation of the living body, and simultaneously, the wound formed on the living body by implantation of the nerve stimulator can be reduced. It will be appreciated that when the neurostimulator is cylindrical, the dimension of the neurostimulator perpendicular to the axial direction is the radial dimension of the neurostimulator.

When the nerve stimulator is implanted, the nerve stimulator enters the living body generally along its axis. Therefore, reducing the dimension of the neurostimulator perpendicular to the axial direction can reduce the wound formed on the living body by implantation of the neurostimulator.

Referring to fig. 1, 2 and 3, in some embodiments, the outer peripheral surface of the housing 4 is a cylindrical surface, and the stimulating portion 51 is circular arc-shaped. The number of the first nerve stimulating electrodes 5 is at least two, wherein at least two first nerve stimulating electrodes 5 are arranged in pairs. The positional relationship between the two first nerve stimulating electrodes 5 arranged in pairs is: the two first nerve stimulating electrodes 5 are disposed opposite to each other and are spaced apart from each other in the circumferential direction along the outer peripheral surface of the housing 4. For the first nerve stimulating electrodes 5 arranged in pairs: to achieve directional stimulation, only one of the first nerve stimulation electrodes 5 may be energized; to achieve omnidirectional stimulation, both first nerve stimulating electrodes 5 may be energized.

It will be appreciated that reducing the gap between the two paired first nerve stimulating electrodes 5 in the circumferential direction along the outer peripheral surface of the housing 4 can make the paired two first nerve stimulating electrodes 5 perform better omnidirectional stimulation.

Further, referring to fig. 1, 2 and 4, in some embodiments, all of the first nerve stimulating electrodes 5 are arranged in pairs, i.e.: every two first nerve stimulating electrodes 5 are disposed opposite to each other and are disposed at intervals along the circumferential direction of the outer peripheral surface of the housing 4.

In some embodiments, the circuit board 1, the carrier 2, the receiving coil 3, and the housing 4 each have a central axis, and the central axes of the circuit board 1, the carrier 2, the receiving coil 3, and the housing 4 are parallel. Thus, the dimension of the neural stimulator perpendicular to the axial direction can be reduced to reduce foreign body sensation of the living body and reduce a wound formed on the living body due to implantation of the neural stimulator. Further, in some of these embodiments, the central axes of the circuit board 1, the carrier 2, the receiving coil 3 and the housing 4 are collinear.

Referring to fig. 1, 2, 4 and 6, in some embodiments, the nerve stimulator further includes a first anti-drop member 6, the first anti-drop member 6 includes an anti-drop portion 61 and a connection portion 62, the connection portion 62 is connected to the circuit board 1 or the carrier 2, the anti-drop portion 61 is connected to the connection portion 62 and is located outside the housing 4, and a gap 7 is provided between the anti-drop portion 61 and the housing 4. After the nerve stimulator is implanted in the living body, the newly grown living body tissue fills the gap 7, in other words, the newly grown living body tissue is caught between the escape prevention part 61 and the housing 4, which can limit the position of the nerve stimulator, and is advantageous in preventing the first nerve stimulation electrode 5 from escaping from the target position.

Referring to fig. 6, in some embodiments, the anti-falling portion 61 is provided with a rotation stopping groove 611. After the newly grown living tissue fills the rotation stopping groove 611, the nerve stimulator is hard to rotate, which is advantageous in preventing the first nerve stimulating electrode 5 from being separated from the target position.

In some embodiments, the neurostimulator further includes a buffer 8, the buffer 8 being made of an elastic material. The buffer member 8 is sleeved on the connecting portion 62 and is sandwiched between the buffer member 8 and the housing 4. The cushioning member 8 thereby separates the connecting portion 62 from the housing 4 to prevent the two from directly contacting each other and wearing away from each other during prolonged use to damage.

Referring to fig. 2 and 3, in some embodiments, the circuit board 1 partially protrudes from the carrier 2 along the axial direction of the circuit board 1. Thereby, the first anti-drop member 6 is conveniently connected to the circuit board 1, and the first nerve stimulating electrode 5 is conveniently electrically connected to the circuit board 1. Specifically, the connection portion 62 of the first drop-preventing member 6 is connected to a portion of the circuit board 1 extending out of the carrier 2, and the first nerve stimulating electrode 5 and the receiving coil 3 are both electrically connected to a portion of the circuit board 1 extending out of the carrier 2. Further, referring to fig. 3, the wiring hole 11 is disposed at a portion of the circuit board 1 extending out of the carrier 2.

Further, referring to fig. 6, in some embodiments, the connection portion 62 is provided with a slot 621, the slot 621 is adapted to the circuit board 1, and the connection portion 62 may be clamped to a portion of the circuit board 1 extending out of the carrier 2 through the slot 621.

Referring to fig. 2, 3 and 5, in some embodiments, the first nerve stimulating electrode 5 includes a stimulating portion 51 and a clamping portion 52, the stimulating portion 51 exposes the outer peripheral surface of the housing 4, and the clamping portion 52 is connected to a circumferential end of the stimulating portion 51 and is sandwiched between the carrier 2 and the first anti-drop member 6. Thereby, positioning of the first nerve stimulating electrode 5 is facilitated, so that assembling of the first nerve stimulating electrode 5 is facilitated.

Further, referring to fig. 2, 3, 6 and 7, in some embodiments, a first limiting portion 21 is disposed on a side of the carrier 2 near the anti-falling portion 61, the first anti-falling member 6 includes a second limiting portion 63, the second limiting portion 63 is disposed on the connecting portion 62, and the clamping portion 52 is sandwiched between the first limiting portion 21 and the second limiting portion 63. Thereby, the position of the first nerve stimulating electrode 5 can be defined by the first stopper 21 and the second stopper 63.

Specifically, referring to fig. 3 and 6, in some embodiments, the first limiting portion 21 is provided with a first abutment surface 211, the second limiting portion 63 is provided with a second abutment surface 631, and the first abutment surface 211 and the second abutment surface 631 respectively abut against two ends of the clamping portion 52.

Referring to fig. 9 and 10, in other embodiments, the first nerve stimulating electrode 5 may have a ring-shaped structure so as to increase the stimulation area of the nerve stimulator. In these embodiments, the spacing between the two first nerve stimulating electrodes 5 may be adaptively determined according to actual needs. It will be appreciated that the number of first nerve stimulating electrodes 5 may be set to a plurality, such as 4, 5, 6, etc., in order to further increase the stimulation area of the nerve stimulator.

Referring to fig. 9 and 10, in some embodiments, in order to increase the stimulation area of the neural stimulator, the neural stimulator further includes a second neural stimulation electrode 10, where the second neural stimulation electrode 10 is fixedly disposed at a distal end of the first anti-drop member 6 in a length direction and is electrically connected to the circuit board 1. It will be appreciated that the second nerve stimulating electrode 10 may be electrically connected to the circuit board 1 by a wire that is threaded through the first anti-slip member 6.

Referring to fig. 1 and 4, in some embodiments, the number of the first anti-falling pieces 6 is two, and two first anti-falling pieces 6 are connected to two ends of the housing 4.

In some embodiments, the first escape prevention member 6 does not protrude from the housing 4 in a direction perpendicular to the axis of the housing 4 in order to reduce foreign body sensation of the living body and reduce a wound formed on the living body due to implantation of the nerve stimulator. In some of these embodiments, the first anti-slip member 6 also has an axis, the axis of the first anti-slip member 6 being parallel to the axis of the housing 4. Further, in some of these embodiments, the axis of the first anti-slip member 6 is collinear with the axis of the housing 4.

Referring to fig. 11 and 12, in some embodiments, the nerve stimulator further includes a second drop-preventing member 9, one end of the second drop-preventing member 9 is connected to the outer peripheral surface of the housing 4, and the other end is movable relative to the housing 4 and can partially protrude from the outer peripheral surface of the housing 4. When the nerve stimulator is implanted in a living body, the second anti-drop member 9 is folded and folded on the outer circumferential surface of the housing 4, so that the overall size of the nerve stimulator can be reduced, and the wound formed on the living body due to the implantation of the nerve stimulator can be reduced. After the nerve stimulator is implanted in the living body, the second drop-off preventing member 9 protrudes from the outer circumferential surface of the housing 4 to abut against the muscle tissue of the living body, thereby fixing the nerve stimulator and preventing the first nerve stimulating electrode 5 from being separated from the target position.

In particular, for the embodiment shown in fig. 11 and 12, the second anti-drop member 9 may be an elastomer, which may be implanted through a conventional puncture needle. Before the nerve stimulator is implanted in the living body, the second retaining member 9 may be biased in the circumferential direction of the housing 4, so that the second retaining member 9 is elastically deformed and folded around the outer circumferential surface of the housing 4, and then the nerve stimulator is mounted on the puncture needle. During the process of implanting the nerve stimulator into the living body by using the puncture needle, the second drop-preventing member 9 is always retracted to the outer circumferential surface of the housing 4 due to the restriction of the tube wall of the puncture needle. After the nerve stimulator is implanted in the living body, the nerve stimulator is separated from the puncture needle, and the second retaining member 9 is protruded from the outer circumferential surface of the housing 4 by restoring its original shape without restriction of the puncture needle.

In the above embodiments, in order to prevent accidental injury to body tissue after implantation of the neurostimulator into the living body, the edges of the outer surface of the neurostimulator are rounded. Such as: the edges of the shell 4, the edges of the first anti-falling piece 6 and the edges of the second anti-falling piece 9 are rounded.

Referring to fig. 13, the present invention also provides a method for manufacturing the neural stimulator, which is used for manufacturing the neural stimulator. The manufacturing method of the nerve stimulator comprises the following steps:

a. assembling the circuit board 1, the carrier 2, the receiving coil 3 and the first nerve stimulating electrode 5 into a pre-assembly body;

b. placing the pre-assembly body into a mold, and attaching the outer circumferential surface of the stimulation portion 51 of the first nerve stimulation electrode 5 to the inner wall of the mold;

c. the mold is closed and filled with injection molding material to form the housing 4.

Fig. 2 shows a preassembly in one embodiment, the part of fig. 2 other than the housing 4 being the preassembly. The injection molding material used to form the housing 4 may be polyurethane or polysulfone or epoxy. The above-described nerve stimulator can be obtained by removing the mold after the formation of the case 4.

Since the outer circumferential surface of the stimulation portion 51 is adhered to the inner wall of the mold, the injection molding material does not submerge the stimulation portion 51 in step c. Therefore, after the housing 4 is formed, the outer circumferential surface of the stimulation portion 51 is exposed to the outer circumferential surface of the housing 4.

In the above-described nerve stimulator manufacturing method, the housing 4 can be formed integrally with the preassembly body in a tight thread manner by means of injection molding, thereby bringing about at least the following advantageous effects: firstly, the overall strength of the nerve stimulator is enhanced, so that the nerve stimulator is not easy to break; secondly, tissue fluid of a living body can be prevented from entering the nerve stimulator, so that abnormal operation of the nerve stimulator caused by the contact of the tissue fluid with electronic components in the nerve stimulator is avoided; in addition, the dimension of the nerve stimulator perpendicular to the axial direction is advantageously reduced, thereby reducing the foreign body sensation of the living body.

Specifically, in some embodiments, step a comprises the steps of:

a1, injection molding the carrier 2 on the circuit board 1, and enabling the circuit board 1 to have an end part extending out of the carrier 2 and a middle part supporting the carrier 2;

a2, winding the receiving coil 3 along the outer peripheral surface of the carrier 2;

a3, electrically connecting the receiving coil 3 to the end part of the circuit board 1;

a4, fixing the clamping part 52 of the first nerve stimulating electrode 5 on the first limiting part 21 of the carrier 2;

a5, electrically connecting the first nerve stimulating electrode 5 to the end of the circuit board 1 to form a preassembly.

Wherein: the material of the receiving coil 3 can be gold or platinum gold or silver or copper; the fixing manner between the clamping part 52 and the first limiting part 21 can be bonding by glue, and the glue can be instant adhesive, UV adhesive or epoxy resin; the receiving coil 3 may be soldered to the circuit board 1 to electrically connect the receiving coil 3 to the circuit board 1; the first nerve stimulating electrode 5 can be electrically connected to the circuit board 1 through a guide wire, and two ends of the guide wire are welded to the first nerve stimulating electrode 5 and the circuit board 1 respectively.

In some embodiments, to install the first anti-slip member 6, before step b, the steps are further included: d. connecting the connecting portion 62 of the first coming-off preventing member 6 to the end portion of the circuit board 1; in step b, it includes: the connecting portion 62 is partially protruded out of the mold, and the retaining portion 61 of the first retaining member 6 is entirely located outside the mold.

The connection portion 62 may be clamped to an end of the circuit board 1 through a clamping slot 621.

After the first drop-out prevention member 6 is mounted, the position of the first nerve stimulating electrode 5 may be defined by the first stopper 21 and the second stopper 63 of the first drop-out prevention member 6 together. Specifically, in step a4, it includes: the engaging portion 52 is sandwiched between the first stopper portion 21 and the second stopper portion 63 of the first falling off preventing member 6. Before the first anti-drop member 6 is mounted, one end of the locking portion 52 may be abutted against the first limiting portion 21, and then the first anti-drop member 6 may be mounted, and the second limiting portion 63 may be abutted against the other end of the locking portion 52.

In some embodiments, to install the buffer 8, before step d, the steps are further included: e. sleeving the buffer piece 8 on the connecting part 62; in step b, it includes: the cushioning element 8 is positioned in the mould. It will be appreciated that since the cushioning member 8 is made of an elastic material, the cushioning member 8 may be stretched and then fit over the connecting portion 62. To fix the position of the cushioning member 8, the cushioning member 8 may be adhered to the connecting portion 62 by glue.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.

Claims (16)

1. A neural stimulator, comprising:

a circuit board (1);

the bearing piece (2) is axially sleeved with the circuit board (1);

a receiving coil (3) electrically connected to the circuit board (1) and axially sleeved with the bearing piece (2);

a shell (4) axially sleeved with the receiving coil (3); and

and the first nerve stimulation electrode (5) is electrically connected to the circuit board (1), embedded in the shell (4) and at least partially exposed out of the outer peripheral surface of the shell (4).

2. The neurostimulator according to claim 1, wherein the circuit board (1), the carrier (2), the receiving coil (3), and the housing (4) are laminated in this order.

3. The neurostimulator according to claim 2, characterized in that the circuit board (1) is strip-shaped, the carrier (2) and the housing (4) are hollow cylindrical bodies, and the receiving coil (3) is spirally wound into a hollow cylindrical structure.

4. The neurostimulator according to claim 1, wherein the first neurostimulation electrode (5) comprises a stimulation portion (51), the stimulation portion (51) exposing the outer peripheral surface of the housing (4), the stimulation portion (51) being lower than the outer peripheral surface of the housing (4) or flush with the outer peripheral surface of the housing (4).

5. The neurostimulator according to claim 4, wherein the outer peripheral surface of the housing (4) is a cylindrical surface, and the stimulation portion (51) is circular arc-shaped; the number of the first nerve stimulating electrodes (5) is at least two, wherein at least two first nerve stimulating electrodes (5) are oppositely arranged and are arranged at intervals along the circumferential direction of the outer peripheral surface of the shell (4).

6. The neurostimulator according to claim 1, characterized in that the circuit board (1), the carrier (2), the receiving coil (3), the housing (4) each have a central axis, the central axes of the circuit board (1), the carrier (2), the receiving coil (3), the housing (4) being parallel.

7. The neurostimulator according to claim 1, further comprising a first anti-drop member (6), the first anti-drop member (6) comprising an anti-drop portion (61) and a connecting portion (62), the connecting portion (62) being connected to the circuit board (1) or the carrier (2), the anti-drop portion (61) being connected to the connecting portion (62), being located outside the housing (4) and having a gap (7) with the housing (4).

8. The nerve stimulator of claim 7, further comprising a second nerve stimulating electrode (10), wherein the second nerve stimulating electrode (10) is fixedly arranged at the end of the first anti-drop member (6) in the length direction and is electrically connected to the circuit board (1).

9. The neurostimulator according to claim 7, further comprising a buffer member (8) made of an elastic material, wherein the buffer member (8) is sleeved on the connecting portion (62) and is sandwiched between the buffer member (8) and the housing (4).

10. The neurostimulator according to claim 7, characterized in that along the axial direction of the circuit board (1), the circuit board (1) partially protrudes out of the carrier (2), the connection portion (62) is connected to the portion of the circuit board (1) protruding out of the carrier (2), and the first neurostimulation electrode (5) and the receiving coil (3) are both electrically connected to the portion of the circuit board (1) protruding out of the carrier (2).

11. The nerve stimulator according to claim 10, characterized in that the first nerve stimulating electrode (5) includes a stimulating portion (51) and a clamping portion (52), the stimulating portion (51) is exposed out of the outer peripheral surface of the housing (4), and the clamping portion (52) is connected to a circumferential end of the stimulating portion (51) and is sandwiched between the carrier (2) and the first drop-preventing member (6).

12. The nerve stimulator according to claim 11, characterized in that a first limiting part (21) is arranged on one side of the bearing member (2) close to the anti-drop part (61), the first anti-drop member (6) comprises a second limiting part (63) arranged on the connecting part (62), and the clamping part (52) is clamped between the first limiting part (21) and the second limiting part (63).

13. A method of manufacturing a neurostimulator for a neurostimulator according to any one of claims 1-12, comprising the steps of:

a. assembling the circuit board (1), the bearing piece (2), the receiving coil (3) and the first nerve stimulating electrode (5) into a preassembly;

b. placing the pre-assembly body into a mold, and attaching the outer circumferential surface of the stimulation part (51) of the first nerve stimulation electrode (5) to the inner wall of the mold;

c. the mould is closed and filled with injection moulding material to form the housing (4).

14. The method of manufacturing a neurostimulator of claim 13, wherein step a comprises:

a1, injection molding a carrier (2) on the circuit board (1), and enabling the circuit board (1) to have an end part extending out of the carrier (2) and a middle part supporting the carrier (2);

a2, winding the receiving coil (3) along the outer peripheral surface of the bearing piece (2);

a3, electrically connecting the receiving coil (3) to the end part of the circuit board (1);

a4, fixing the clamping part (52) of the first nerve stimulation electrode (5) on the first limiting part (21) of the carrier (2);

a5, electrically connecting the first nerve stimulating electrode (5) to the end part of the circuit board (1) to form the preassembly.

15. The method of manufacturing a neurostimulator of claim 14, further comprising, prior to step b, the steps of:

d. connecting a connecting part (62) of the first anti-falling piece (6) to the end part of the circuit board (1);

in step b, it includes: extending the connecting part (62) out of the die, and positioning all the anti-falling parts (61) of the first anti-falling piece (6) outside the die;

in step a4, it includes: the clamping part (52) is clamped between the first limiting part (21) and the second limiting part (63) of the first anti-falling piece (6).

16. The method of manufacturing a neurostimulator of claim 15, further comprising, prior to step d), the steps of:

e. sleeving the buffer piece (8) on the connecting part (62);

in step b, it includes: the cushioning member (8) is positioned in the mold.