CN116159244A

CN116159244A - Injection type miniature nerve stimulator and nerve stimulation system

Info

Publication number: CN116159244A
Application number: CN202310262232.3A
Authority: CN
Inventors: 陈熠
Original assignee: Shanghai Shanling Medical Technology Co ltd
Current assignee: Shanghai Shanling Medical Technology Co ltd
Priority date: 2023-03-17
Filing date: 2023-03-17
Publication date: 2023-05-26
Anticipated expiration: 2043-03-17
Also published as: CN116159244B

Abstract

The invention provides an injection type micro nerve stimulator and a nerve stimulation system. According to the injection type mini nerve stimulator, the control circuit module is packaged in the implantable packaging shell, the stimulating electrode is mounted on the implantable packaging shell, so that the injection type mini nerve stimulator can be pushed into a human body in an injection device, minimally invasive implantation is realized, and surgical wounds to a patient are reduced; after the injection type mini nerve stimulator is delivered to a designated position by an injection device, the anchoring mechanism acts on human tissues at the designated position to reliably fix the injection type mini nerve stimulator, prevent displacement and ensure the effectiveness of subsequent nerve stimulation.

Description

Injection type miniature nerve stimulator and nerve stimulation system

Technical Field

The invention relates to the technical field of nerve stimulation, in particular to an injection type miniature nerve stimulator and a nerve stimulation system comprising the injection type miniature nerve stimulator.

Background

Peripheral nerve is generally located outside the brain or spinal cord, and peripheral nerve stimulation, commonly known as PNS, is a common method of treating chronic pain. The peripheral nerve stimulation device includes a small electronic device (similar to an electrode of a wire) placed beside the peripheral nerve, which delivers a rapid electrical pulse, stimulating the peripheral nerve, and feeling like a slight tingling sensation. Generally, the peripheral nerve stimulation device further includes an external device connected to the electronic device placed beside the peripheral nerve, and the external device is used for transmitting the electric signal. Similar to a cardiac pacemaker, electrical energy is delivered from a generator to the nerve through one or several electrodes. The patient can control the stimulation by turning the device on and off and adjusting the stimulation parameters as needed.

The spinal nervous system was invented in the middle 60 s of the 20 th century, even earlier than the usual spinal stimulation. Since 2012, some stimulation therapy devices that stimulate peripheral nerves or provide peripheral nerve domains have been approved by regulatory authorities in various regions of the world for the treatment of neuropathic pain, and in certain regions for the treatment of migraine and overactive bladder.

A common technique for peripheral nerve stimulation, such as spinal cord electrical stimulators (SCS), is to implant a very thin electrode into the dorsal epidural space of the spinal cord of a person and stimulate spinal nerves with pulsed current to reduce or alleviate pain. However, this technique typically involves a large number of instruments, including electrodes, stimulators, extension leads, etc., which are typically bulky and result in a correspondingly large surgical incision, which can cause various adverse effects such as infection, pain, etc. in the patient.

The invention patent application publication number CN 107362447A discloses a wireless powered neurostimulator that provides a tibial neurostimulator implant that is smaller in size without the larger implants and long leads of the sacral neurostimulation system traditionally used for OAB patients. However, the system consists of a tibial nerve stimulator implanted near the tibial nerve of the human body, an external program-controlled emitter, an external program-controlled instrument and a silica gel fixing ring, so the following problems exist: 1. because of the existence of the fixing ring, surgical incision is still needed for implantation, and the wound on a patient is large; 2. the mounting mode is that the stimulator is fixed on the tibial nerve trunk through a silica gel button, but because the implantation time is as long as a plurality of years, the stimulator can cause neuritis and the like due to daily accumulation and the friction of nerves.

In order to solve the problems, the Chinese patent publication No. CN 105899029B discloses a packaging structure of an injectable nerve stimulator, which has small volume and can be implanted by an injection method, but still needs to be cut off by an operation to implant the stimulator, and cannot achieve a more minimally invasive operation mode.

Disclosure of Invention

In view of the above-described drawbacks of the prior art, an object of the present invention is to provide an injection type micro-nerve stimulator which can be minimally invasively implanted and can be reliably fixed at a specified position.

In order to achieve the above object, the present invention provides an injection type micro nerve stimulator, comprising an implantable packaging shell, a control circuit module packaged in the implantable packaging shell, a stimulating electrode mounted on the outer peripheral surface of the implantable packaging shell, and an anchoring mechanism fixed on the outer peripheral surface of the implantable packaging shell, wherein the control circuit module is connected with the stimulating electrode.

Optionally, the implantable packaging shell is cylindrical, the diameter of the implantable packaging shell is 1.0-6.0 mm, and the axial height of the implantable packaging shell is 4-15 mm.

Optionally, the diameter of the implantable packaging shell is 2mm, and the axial height of the implantable packaging shell is 5mm.

Optionally, the implantable packaging shell is cylindrical, the stimulating electrode is installed at the axial end part of the implantable packaging shell, and the outer surface of the stimulating electrode is an arc curved surface.

Optionally, the anchoring mechanism is a self-expanding member secured at an end of the implantable housing.

Optionally, the material of the self-expanding component is a polymer material.

Optionally, a friction increasing part is fixedly arranged on the outer surface of the self-expanding component.

Optionally, the anchoring mechanism is a shape memory component secured at an end of the implantable package housing.

Optionally, the anchoring mechanism has an antimicrobial coating applied to an outer surface thereof.

Optionally, the control circuit module comprises a resonance circuit module and a waveform control module, and the resonance circuit module, the waveform control module and the stimulating electrode are sequentially connected.

Optionally, the maximum voltage amplitude output by the stimulation electrode is 12V, the pulse width is 30 mu s-240 mu s, and the stimulation frequency is 0-50 Hz.

Optionally, the material of the implantable packaging shell is borosilicate glass or ceramic, and the material of the stimulating electrode is platinum iridium alloy.

The application also provides a nerve stimulation system, which comprises the external program-controlled emitter and the injection type micro nerve stimulator, wherein the control circuit module is in communication connection with the external program-controlled emitter.

As described above, the injection type mini nerve stimulator and the nerve stimulating system according to the present invention have the following advantages:

in the application, the control circuit module is packaged in the implantable packaging shell, and the stimulation electrode is arranged on the implantable packaging shell, so that the injection type micro nerve stimulator has a compact overall structure, can be pushed into a human body in an injection device, realizes minimally invasive implantation, and reduces operation wounds to patients; meanwhile, after the injection type mini nerve stimulator is delivered to a designated position by the injection device, the anchoring mechanism acts on human tissues at the designated position, so that the injection type mini nerve stimulator is reliably fixed, displacement is prevented, and the effectiveness of subsequent nerve stimulation is ensured.

Drawings

Fig. 1 is a block diagram showing the configuration of a nerve stimulating system in the present application.

Fig. 2 is a block diagram showing the structure of the injection type mini nerve stimulator in the present application.

Fig. 3a is a schematic structural view of a first embodiment of an injection type mini nerve stimulator of the present application, in which the anchoring mechanism is in an undeployed state.

Fig. 3b is a schematic view of the anchoring mechanism of fig. 3a in an expanded state.

Fig. 4a is a schematic structural view of a second embodiment of an injection type mini nerve stimulator of the present application, in which the anchoring mechanism is in an undeployed state.

Fig. 4b is a schematic view of the anchoring mechanism of fig. 4a in an expanded state.

Fig. 5 is a schematic diagram of an electrical pulse signal applied around nerve tissue by a stimulation electrode in the present application.

Fig. 6 is an enlarged view of the portion of the a frame in fig. 5.

Fig. 7 is a schematic view of the structure of the injection device in the present application.

Fig. 8 is a schematic view of the injection mini-neurostimulator of the present application as it is being pushed within an injection device.

Fig. 9 is a schematic view of the injection type mini nerve stimulator of the present application detached from the injection device and anchored to human tissue.

Description of element reference numerals

10. Implantable packaging shell

20. Control circuit module

21. Resonant circuit module

22. Waveform control module

30. Stimulating electrode

40. Anchoring mechanism

41. Self-expanding member

42. Shape memory component

50. Outer sheath tube

51. Metal detecting head end

60. Operating handle

61. Metal connecting end

Detailed Description

Further advantages and effects of the present invention will become apparent to those skilled in the art from the disclosure of the present invention, which is described by the following specific examples.

It should be understood that the structures, proportions, sizes, etc. shown in the drawings are for illustration purposes only and should not be construed as limiting the invention to the extent that it can be practiced, since modifications, changes in the proportions, or adjustments of the sizes, which are otherwise, used in the practice of the invention, are included in the spirit and scope of the invention which is otherwise, without departing from the spirit or scope thereof. Also, the terms such as "upper," "lower," "left," "right," "middle," and "a" and the like are used herein for descriptive purposes only and not for purposes of limitation, and are intended to limit the scope of the invention as defined by the claims and the relative terms thereof as construed as corresponding to the claims.

The application provides an injection type miniature nerve stimulator and a nerve stimulation system comprising the same, wherein the injection type miniature nerve stimulator and the nerve stimulation system are suitable for stimulating peripheral nerves, such as for stimulating hypoglossal nerves, and then the injection type miniature nerve stimulator is implanted to the hypoglossal nerves of a human body, and the purpose of treating sleep apnea is achieved by stimulating the hypoglossal nerves.

As shown in fig. 1, the nerve stimulation system related in the application comprises an external program-controlled transmitter and an injection type miniature nerve stimulator, wherein the external program-controlled transmitter is an external equipment part of the nerve stimulation system, and the injection type miniature nerve stimulator is an internal implantation equipment part of the nerve stimulation system, namely an internal implant. As shown in fig. 2 and 3a, or as shown in fig. 2 and 4a, the injection type mini nerve stimulator according to the present invention includes an implantable package housing 10, a control circuit module 20 encapsulated in the implantable package housing 10, a stimulating electrode 30 mounted on the outer circumferential surface of the implantable package housing 10, and an anchoring mechanism 40 fixed on the outer circumferential surface of the implantable package housing 10, the control circuit module 20 being connected to the stimulating electrode 30; the control circuit module 20 is also in communication with an external program controlled transmitter.

In the injection type mini nerve stimulator, the control circuit module 20 is packaged in the implantable packaging shell 10, and the stimulating electrode 30 is mounted on the implantable packaging shell 10, so that the injection type mini nerve stimulator has a compact overall structure, can be pushed into a human body in an injection device, is easy to inject and implant, and thus the minimally invasive implantation of the injection type mini nerve stimulator is realized, and the operation wound to a patient is reduced. After the injection type mini nerve stimulator is injected and implanted into the peripheral nerve of the target, the anchoring mechanism 40 of the injection type mini nerve stimulator is released and acts on the human tissue (muscle tissue in the embodiment) at the peripheral nerve, so that the injection type mini nerve stimulator is reliably fixed to prevent displacement, and the effectiveness of the subsequent nerve stimulation is ensured.

After the injection type micro-nerve stimulator completes injection implantation, the injection type micro-nerve stimulator wears an in-vitro program-controlled transmitter at the mandible of a patient on the accessory of peripheral nerves of the patient, such as the accessory of hypoglossal nerves, and the in-vitro program-controlled transmitter sends a stimulation signal to the control circuit module 20 of the injection type micro-nerve stimulator through setting related stimulation parameters, the stimulation signal comprises energy and stimulation pulse, the control circuit module 20 outputs the stimulation signal to the stimulation electrode 30, and the stimulation electrode 30 applies electric pulse to the peripheral nerves of the target, so that the treatment aims of nerve stimulation and nerve regulation are achieved.

Further, as shown in fig. 2, the control circuit module 20 includes a resonant circuit module 21 and a waveform control module 22, where the resonant circuit module 21, the waveform control module 22 and the stimulating electrode 30 are sequentially connected, and the resonant circuit module 21 is also in communication with an external program controlled transmitter. The external program-controlled transmitter transmits energy and stimulation pulse to the internal resonant circuit module 21 in a resonant mode, in this embodiment, an electric signal is transmitted, the resonant circuit module 21 transmits the coupled energy from the external source to the waveform control module 22, the waveform control module 22 converts the resonant signal into an electric pulse signal and outputs the electric pulse signal to the stimulation electrode 30, and finally the stimulation electrode 30 transmits the electric pulse to the peripheral nerve.

Further, as shown in fig. 3a or 4a, the implantable housing 10 has a cylindrical shape, so that the injection type mini-nerve stimulator has an overall elongated cylindrical shape. The diameter of the implantable packaging shell 10 is 1.0-6.0 mm, particularly preferably 2mm; the axial height of the implantable housing 10 is 4 to 15mm, particularly preferably 5mm.

Further, for convenience of description, the axial direction of the injection type mini nerve stimulator is defined as the up-down direction; stimulation electrode 30 is preferably mounted at the axial end of implantable package housing 10: the stimulation electrode 30 may be provided only at the upper end or the lower end of the implantable package housing 10, or the stimulation electrode 30 may be provided at both the upper and lower ends of the implantable package housing 10. In the embodiment shown in fig. 3a and 4a, the stimulating electrodes 30 are provided at both the upper and lower ends of the implantable package housing 10, so that there are two stimulating electrodes 30. Preferably, the outer surface of the stimulating electrode 30 is a circular arc curved surface without sharp components, avoiding damaging human tissue.

Preferably, the material of the implantable packaging shell 10 is borosilicate glass or ceramic, namely, a borosilicate glass or ceramic packaging structure is adopted; the stimulating electrode 30 is made of platinum iridium alloy, namely, both ends of the stimulating electrode 30 are made of platinum iridium alloy with partial sphere shapes.

Preferably, as shown in fig. 5 and 6, in the present application, the maximum voltage amplitude output by the stimulation electrode 30 is 12V, the pulse width is 30 μs to 240 μs, and the stimulation frequency is 0 to 50Hz.

Further, there are a variety of configurations of anchoring mechanisms 40, based on the different configurations of anchoring mechanisms 40, such that an injectable mini-neurostimulator has a variety of embodiments. The following provides a preferred embodiment of two anchoring mechanisms 40.

Embodiment one of the anchoring mechanism 40

As shown in fig. 3a and 3b, the anchoring mechanism 40 is a self-expanding member 41, the self-expanding member 41 being fixed at the axial end of the implantable housing 10 where the stimulation electrode 30 is fixed. Such as: when the stimulation electrode 30 is provided only at the upper end of the implantable package housing 10, the self-expanding member 41 is fixedly provided only at the upper end of the implantable package housing 10. And, for example: when the stimulation electrodes 30 are provided at both the upper and lower ends of the implantable package housing 10, the self-expanding members 41 are fixedly provided at both the upper and lower ends of the implantable package housing 10. The self-expanding member 41 may be fixed to the end face of the implantable package 10 or may be fixed to the outer peripheral surface of the implantable package 10.

When the injection type mini nerve stimulator is in a pushed state, the whole injection type mini nerve stimulator is folded in the injection device, as shown in fig. 3a, the self-expanding member 41 is in a compressed state, and the outer diameter of the self-expanding member 41 is smaller than or equal to the outer diameter of the implantable package housing 10. When the injection type mini nerve stimulator is pushed to a designated position and separated from the injection device, as shown in fig. 3b, the self-expansion part 41 is in a released state, the outer diameter of the self-expansion part 41 is larger than that of the implantable packaging shell 10, namely the injection type mini nerve stimulator has the maximum outer diameter at the self-expansion part 41, the self-expansion part 41 is abutted with muscle tissue at the position to play a role of anchoring, and the injection type mini nerve stimulator is fixed at the position through friction force to prevent the injection type mini nerve stimulator from generating axial displacement.

Preferably, the self-expanding member 41 is a ring, and the anchoring mechanism 40 is a self-expanding ring. The material of the self-expanding member 41 is a polymer material, and the polymer material is further preferably a hydrogel material, such as: acrylic acid and acrylamide copolymers or hyaluronic acid, etc.; when the injection type mini nerve stimulator is detached from the injection device, the self-expanding member 41 absorbs moisture therein and self-expands to anchor.

Preferably, the friction increasing portion is fixed on the outer surface of the self-expanding member 41, for example, a concave-convex structure may be added to the outer surface of the self-expanding member 41 to form the friction increasing portion, and for example, a rough surface may be added to the outer surface of the self-expanding member 41 to form the friction increasing portion, and the rough surface may be obtained by surface treatment. The friction increasing part can increase the friction between the self-expanding member 41 and human tissue, improve the anchoring performance of the anchoring mechanism 40, and further prevent the axial displacement of the injection type micro-nerve stimulator.

Second embodiment of anchoring mechanism 40

As shown in fig. 4a and 4b, the anchoring mechanism 40 is a shape memory member 42, the shape memory member 42 being fixed in the implantable package housing 10 at the axial end where the stimulation electrode 30 is fixed. Such as: when the stimulating electrode 30 is provided only at the upper end of the implantable package housing 10, the shape memory member 42 is fixedly provided only at the upper end of the implantable package housing 10. And, for example: when the stimulating electrodes 30 are provided at both the upper and lower ends of the implantable package housing 10, the shape memory members 42 are fixedly provided at both the upper and lower ends of the implantable package housing 10. The shape memory member 42 may be fixed to the end face of the implantable package 10 or may be fixed to the outer peripheral surface of the implantable package 10.

When the injection type mini nerve stimulator is in a pushed state, the whole injection type mini nerve stimulator is folded in the injection device, as shown in fig. 4a, the shape memory member 42 is pressed and held in the injection device, and the shape memory member 42 is tightly attached to the outer peripheral surface or end surface of the implantable package housing 10. When the injection type mini nerve stimulator is pushed to a designated position and is released from the injection device, as shown in fig. 4b, the shape memory member 42 is unfolded to a predetermined shape, for example, unfolded to a grapple shape or a barb shape, and the shape memory member 42 pierces surrounding muscle tissue to play a role of anchoring, fixing the injection type mini nerve stimulator thereto, and preventing the injection type mini nerve stimulator from being axially displaced.

Preferably, the material of the shape memory member 42 is a shape memory alloy, such as nickel titanium alloy. The shape memory member 42 can also be made of high polymer materials, such as PCL, PLGA, PDLLA, PLLA, PDO and other absorbable materials, and can be absorbed by human tissues in the healing process while having shape memory performance, so that the damage to the tissues is further reduced, and the healing of a patient is promoted.

Preferably, the outer surface of the anchoring mechanism 40 is coated with an antimicrobial coating to enhance the antimicrobial effect of the injectable micronerve stimulator.

Furthermore, the application also provides an injection device which is used for pushing the injection type micro nerve stimulator, implanting the injection type micro nerve stimulator at the peripheral nerve of the object in the body and can be used as a tool for detecting the electrical stimulation of the muscle in operation.

As shown in fig. 7, the injection device according to the present application includes an outer sheath 50 for establishing a passageway, an injection pushing rod movably assembled inside the outer sheath 50 in the extending direction of the outer sheath 50, and an operation handle 60 mounted at the proximal end of the outer sheath 50, the operation handle 60 being in driving connection with the proximal end of the injection pushing rod, driving the injection pushing rod to move, the distal end of the injection pushing rod being for detachable connection with the injection mini nerve stimulator. In addition, herein, "proximal" refers to the end proximal to the practitioner, and "distal" herein refers to the end distal to the practitioner. Preferably, the distal end of the outer sheath 50 is a metal probing tip 51, i.e. a metal structure, the metal probing tip 51 is used for releasing electrical stimulation and probing myoelectric signals, the proximal end of the operating handle 60 is a metal connecting end 61, the metal probing tip 51 is connected to the metal connecting end 61 by a wire, the metal connecting end 61 is connected to an external probing device, such as an oscilloscope, by a wire.

Preferably, the detachable connection mode between the injection pushing rod and the injection type mini nerve stimulator can be as follows: 1. threaded connection; 2. a plurality of wrapping parts made of shape memory alloy are fixedly arranged at the distal end of the injection pushing rod, and when the injection type mini nerve stimulator is folded in the outer sheath 50, one end of the injection type mini nerve stimulator is wrapped by the wrapping parts to realize the connection of the two; when the injection pushing rod pushes out the injection type mini nerve stimulator, the wrapping part is unfolded outwards, and the injection type mini nerve stimulator is loosened, so that the connection of the injection type mini nerve stimulator and the wrapping part is released.

When in use, the injection device is firstly extended into the position where the implantation is expected by means of puncture by means of ultrasonic imaging and the like; in this process, the distal end of the injection pushing rod is connected to an injection type mini nerve stimulator, which is folded in the outer sheath 50; meanwhile, the metal detection head end 51, the metal connection end 61 and the oscilloscope are sequentially connected and are used for nerve monitoring of a patient in the operation process, namely, by using Electromyography (EMG) signals and electric stimulation on nerves, a doctor is helped to find out the position of the motor nerve; the electromyographic signal is used for a positive confirmation fed back by the metal detection head 51, and the electrical stimulation of the nerve is a negative confirmation of the electrical stimulation applied by the metal detection head 51. When the injection device reaches a desired position, the injection pushing rod is driven to move in the outer sheath 50 by the operation handle 60, so that the injection type micro nerve stimulator is pushed along the inner cavity of the outer sheath 50 in the injection device, as shown in fig. 8; after the injection type mini nerve stimulator leaves the injection device, as shown in fig. 9, the anchoring mechanism 40 is deployed and anchoring is completed, i.e., implantation is completed. After the injection type mini nerve stimulator is anchored at the designated position, a doctor can still observe EMG signals of corresponding muscles when the implant works through the injection device, and perform postoperative detection so as to evaluate the operation effect.

In summary, the present invention effectively overcomes the disadvantages of the prior art and has high industrial utility value.

The above embodiments are merely illustrative of the principles of the present invention and its effectiveness, and are not intended to limit the invention. Modifications and variations may be made to the above-described embodiments by those skilled in the art without departing from the spirit and scope of the invention. Accordingly, it is intended that all equivalent modifications and variations of the invention be covered by the claims, which are within the ordinary skill of the art, be within the spirit and scope of the present disclosure.

Claims

1. An injection type micro nerve stimulator is characterized in that: the device comprises an implantable packaging shell (10), a control circuit module (20) packaged in the implantable packaging shell (10), a stimulation electrode (30) mounted on the outer peripheral surface of the implantable packaging shell (10), and an anchoring mechanism (40) fixed on the outer peripheral surface of the implantable packaging shell (10), wherein the control circuit module (20) is connected with the stimulation electrode (30).

2. The injectable mini-neurostimulator of claim 1, wherein: the implanted packaging shell (10) is cylindrical, the diameter of the implanted packaging shell (10) is 1.0-6.0 mm, and the axial height of the implanted packaging shell (10) is 4-15 mm.

3. The injectable mini-neurostimulator of claim 2, wherein: the diameter of the implanted encapsulation shell (10) is 2mm, and the axial height of the implanted encapsulation shell (10) is 5mm.

4. The injectable mini-neurostimulator of claim 1, wherein: the implantable packaging shell (10) is cylindrical, the stimulating electrode (30) is arranged at the axial end part of the implantable packaging shell (10), and the outer surface of the stimulating electrode (30) is an arc curved surface.

5. The injectable mini-neurostimulator of claim 1, wherein: the anchoring mechanism (40) is a self-expanding member (41), the self-expanding member (41) being fixed at the end of the implantable packaging housing (10).

6. The injectable mini-neurostimulator of claim 5, wherein: the self-expanding member (41) is made of a polymer material.

7. The injectable mini-neurostimulator of claim 5, wherein: the outer surface of the self-expansion member (41) is fixedly provided with a friction increasing part.

8. The injectable mini-neurostimulator of claim 1, wherein: the anchoring mechanism (40) is a shape memory member (42), the shape memory member (42) being fixed at an end of the implantable package housing (10).

9. The injectable mini-neurostimulator of claim 1, wherein: the anchoring mechanism (40) is coated with an antimicrobial coating on an outer surface thereof.

10. The injectable mini-neurostimulator of claim 1, wherein: the control circuit module (20) comprises a resonance circuit module (21) and a waveform control module (22), and the resonance circuit module (21), the waveform control module (22) and the stimulation electrode (30) are sequentially connected.

11. The injectable mini-neurostimulator of claim 1 or 10, characterized in that: the maximum voltage amplitude output by the stimulating electrode (30) is 12V, the pulse width is 30 mu s-240 mu s, and the stimulating frequency is 0-50 Hz.

12. The injectable mini-neurostimulator of claim 1, wherein: the implantable packaging shell (10) is made of high borosilicate glass or ceramic, and the stimulating electrode (30) is made of platinum iridium alloy.

13. A nerve stimulation system comprising an in vitro programmable transmitter, characterized by: further comprising the injectable mini-neurostimulator of any one of claims 1-12, the control circuit module (20) being communicatively connected to an external programmable transmitter.