CN111729191A - Animal vagus nerve stimulation system and manufacturing method thereof - Google Patents
Animal vagus nerve stimulation system and manufacturing method thereof Download PDFInfo
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- CN111729191A CN111729191A CN202010524069.XA CN202010524069A CN111729191A CN 111729191 A CN111729191 A CN 111729191A CN 202010524069 A CN202010524069 A CN 202010524069A CN 111729191 A CN111729191 A CN 111729191A
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- vagus nerve
- animal
- protection tube
- nerve stimulation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
- A61N1/36064—Epilepsy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61D—VETERINARY INSTRUMENTS, IMPLEMENTS, TOOLS, OR METHODS
- A61D1/00—Surgical instruments for veterinary use
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0551—Spinal or peripheral nerve electrodes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0551—Spinal or peripheral nerve electrodes
- A61N1/0558—Anchoring or fixation means therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/36125—Details of circuitry or electric components
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/375—Constructional arrangements, e.g. casings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/375—Constructional arrangements, e.g. casings
- A61N1/37518—Anchoring of the implants, e.g. fixation
Abstract
The invention provides an animal vagus nerve stimulation system and a manufacturing method thereof, wherein the system comprises a protective tube formed by a flexible cylindrical plastic tube with an axial opening, two sides of the axial opening are respectively provided with a surgical suture, the axial opening of the protective tube can be pulled open by pulling the surgical sutures to the two sides, and after the surgical sutures are loosened, the axial opening of the protective tube is restored to the original state; the inner ring of the stimulating contact of the two hollow semi-annular metal pieces is contacted with the vagus nerve, and the outer ring is attached and fixed on the inner wall of the protection tube; one end of each of the two coating wires penetrates into the hollow position of the stimulation contact and is connected with the stimulation contact, the other end of each of the two coating wires penetrates out of the inner wall of the axial middle position of the protection tube along the radial direction, and the penetrating end of each of the two coating wires is connected with the plug connector. The animal vagus nerve stimulation electrode has the advantages of simple structure and small volume, and can be used for vagus nerve stimulation of small animals. The invention has short manufacturing period, simple implantation operation and high reliability, and can be implanted into the animal body for a long time and provide stable electrical stimulation.
Description
Technical Field
The invention belongs to the technical field of medical instrument manufacturing, and particularly relates to an animal vagus nerve stimulation system and a manufacturing method thereof.
Background
Epilepsy is a neurological disorder in which there is a sudden abnormal firing of cerebral neurons, resulting in transient cerebral dysfunction. The disease has high disability rate, long course of disease and repeated attack, and seriously threatens the physical and psychological health of patients. Vagal Nerve Stimulation (Vagus Nerve Stimulation) is a method of fixing electrodes on the Vagus Nerve to continuously stimulate the Nerve electrically to cause brain electrical activity and neurotransmitter change, thereby achieving the purpose of treating epilepsy. The therapy has the characteristics of non-destructive, reversible and adjustable, and becomes one of the important surgical methods for treating epileptic diseases.
The vagal stimulation mechanism of action is a synergy or balance of factors including changes in cerebral blood flow within the brain, electroencephalographic functional connections, or depletion, blockade of neurotransmitters, etc. At present, the actual action mechanism of vagus nerve stimulation by domestic and foreign medical workers is not clear. Due to the reasons of involvement in the aspects of particularity and ethical morality of human brains and the like, medical researchers mostly take animals as research objects (rats, mice, rabbits, monkeys and the like), simulate a stimulation process by using animal experimental bodies, research the action mechanism of vagus nerve electrical stimulation treatment, further improve the effect of nerve stimulation, and can be expanded to new targets and new indications in the future.
CN103638596A and CN203647859U disclose electrodes for stimulating vagus nerve of animals, but the welding point structure of the electrodes needs to be protected and insulated in separate plastic tubes, which increases the size and weight of the electrodes, and makes the electrodes unsuitable for small animals such as mice, and the electrodes are difficult to operate during surgical implantation and have poor reliability after implantation.
Disclosure of Invention
In view of the above problems, the present invention provides an animal vagus nerve stimulation system and a method of making the same.
In one aspect, the present invention provides an animal vagus nerve stimulation system comprising a stimulator, a stimulation electrode, wherein: the stimulation electrode comprises a protection tube, at least two stimulation contacts and at least two coating leads;
the protection pipe is a flexible insulation pipe which is opened along the axial direction;
the stimulating contact is a hollow semi-annular metal piece, the inner ring is in contact with the vagus nerve, and the outer ring is fixed on the inner wall of the protection tube;
the coating wires correspond to one of the stimulation contacts, one end of each coating wire penetrates into the hollow position of the stimulation contact and is connected with the stimulation contact, and the other end of each coating wire penetrates out of the protection tube and is directly or indirectly connected with the stimulator. Furthermore, two sides of the axial opening of the protection tube are respectively provided with a surgical suture, the axial opening of the protection tube can be pulled open by pulling the surgical suture to the two sides, and the axial opening of the protection tube is restored to the original state after the surgical suture is loosened.
Further, the center normal direction of the inner ring circular arc of the stimulation contact points faces the axial opening position of the protection tube.
Furthermore, the coating lead is indirectly connected with an external stimulator through a plug connector or directly connected with an internal stimulator.
Further, the coating lead is connected with the plug connector or the internal stimulator in a welding or crimping mode.
Further, the stimulator includes a circuit board and a protective housing; the circuit board can output electric signals with different frequencies, pulse widths and amplitudes; the protective shell is arranged outside the circuit board, can isolate the circuit board from the outside and plays a role in electrical insulation.
Furthermore, a marking tape with color is arranged at a position, close to one of the stimulating contacts, outside the protective tube and used for distinguishing the anode and the cathode of the electrode.
Further, the outer diameter of the protection tube is 0.5mm-2mm, the inner diameter is 0.4mm-1.8mm, and the length is 3mm-8 mm; the diameter of the inner ring of each stimulating contact is 0.1mm-1mm, the diameter of the outer ring is consistent with the inner diameter of the protection tube, the length of the outer ring is 0.3mm-2mm, and the distance between two adjacent stimulating contacts is 1mm-5 mm.
Further, the protection tube is made of silica gel, polyurethane or polyurethane-silicone rubber copolymer; the stimulation contact is made of platinum or platinum-iridium alloy; the material of the lead in the coating lead is stainless steel, cobalt-chromium-molybdenum alloy, nickel-titanium alloy or platinum-iridium alloy.
In another aspect, the present invention provides a method for making an animal vagus nerve stimulation system, comprising the steps of:
s1, welding the coated lead wire to the hollow position of the stimulating contact;
s2, fixing the outer ring of the stimulating contact on the inner wall of the protection tube by using biological glue to ensure that the arc center direction of the inner ring of the stimulating contact faces the axial opening position of the protection tube;
and S3, the other end of the coated lead penetrates out of the inner wall of the protective tube in the radial direction and is directly or indirectly connected with the stimulator.
The animal vagus nerve stimulation system has simple structure and small volume, and can be used for vagus nerve stimulation of small animals, such as mice, rats and the like. The system of the invention has short manufacturing period, simple implantation operation and high reliability, and can be implanted into the animal body for a long time and provide stable electrical stimulation.
Drawings
Fig. 1 is a schematic diagram of an animal vagal nerve stimulation system provided by a first embodiment of the present invention;
fig. 2 is a schematic diagram of an animal vagal nerve stimulation system provided by a second embodiment of the present invention;
fig. 3(a) -3 (d) are schematic diagrams of the implantation process of the animal vagus nerve stimulation system of the present invention.
The reference numbers in the figures illustrate: 110-protective tube, 111-surgical suture, 112-marker band, 113-axial opening, 120-stimulation contact, 130-coated lead, 140-plug, 141-protective gel, 150-internal stimulator, 151-circuit board, 152-protective shell, 200-animal vagus nerve, 300-surgical non-absorbable suture
Detailed Description
The present invention will be described in detail below by way of examples with reference to the accompanying drawings.
Fig. 1 is a schematic diagram of an animal vagus nerve stimulation system according to a first embodiment of the present invention, which includes an animal vagus nerve stimulation electrode, a connector 140, a protective gel 141, and an external stimulator (not shown). The animal vagus nerve stimulation electrode includes a protective tube 110, two stimulation contacts 120, and two coated leads 130.
The protective tube 110 is a flexible cylindrical plastic tube having an opening 113 along an axial direction, and a surgical suture 111 is provided at both sides of the opening. Pulling the two surgical sutures 111 to both sides pulls the axial opening 113 of the protective tube open, and the axial opening of the protective tube 110 can be restored to the original shape after the surgical sutures 111 are released. The outer diameter of the protective tube 110 is 0.5 to 2mm, preferably 1.3 mm; the length is 3-8mm, preferably 5 mm. The protective tube 110 is made of silicone, polyurethane, or polyurethane-silicone rubber copolymer, and plays an insulating role.
The two stimulating contacts 120 are hollow semi-annular shaped metal pieces. The material is platinum or platinum-iridium alloy. The stimulating contact 120 has an inner ring diameter of 0.1 to 1mm, preferably 0.4mm, an outer ring diameter corresponding to the inner diameter of the protective tube 110, and the inner diameter of the protective tube 110 being 0.4mm to 1.8mm, preferably 0.9 mm. The distance between the two stimulating contacts 120 is 1-5mm, preferably 3 mm; the length of the two stimulation contacts 120 is 0.3mm to 2mm, preferably 0.5 mm. The inner ring of the stimulation contact 120 contacts the vagus nerve 200, and the outer ring is attached and secured to the inner wall of the protective tube 110. The axes of the two stimulating contacts 120 are coincident with the axis of the protective tube 110, and the center normal of the inner circular arc faces the axial opening position of the protective tube 110. The hollow structure of the stimulating contact 120 may accommodate the coated lead 130.
The electrode has two coated wires 130, one end of each of the two coated wires 130 penetrates into the hollow portion of the stimulation contact 120 and is welded thereto, and the other end of each of the two coated wires 130 penetrates radially from the inner wall of the protection tube 110 at an axially intermediate position thereof. The end portions are welded to the corresponding connectors 140. The lead is made of stainless steel wires, cobalt-chromium-molybdenum alloy wires, nickel-titanium alloy wires, platinum-iridium alloy wires and the like, and can exist in a stranded wire or spiral wire mode so as to improve the integral fatigue resistance of the electrode.
The plug 140 is used for connecting an external stimulator (not shown). The plug 140 may be a micro usb male and female head, a dupont head, a wiring terminal, an alligator clip, etc. The exposed pin and pad area of the connector 140 is covered by a protective adhesive 141, which acts as an electrical insulator. The material of the protective adhesive 141 may be silicon rubber, polyurethane, or epoxy resin.
The position of the outer side of the protective tube 110, which is adjacent to the contact point on one side, is provided with a colored marking band 112 for distinguishing the anode and the cathode of the electrode, so that the implantation direction of the electrode can be conveniently determined during the operation.
Fig. 2 is a schematic diagram of an animal vagus nerve stimulation system including an animal vagus nerve stimulation electrode, an in-body stimulator 150 according to a second embodiment of the present invention. The animal vagus nerve stimulation electrode includes a protective tube 110, two stimulation contacts 120, and two coated leads 130. The coated lead 130 in this embodiment is connected directly to the in vivo stimulator 150. In this embodiment, the features of the other parts of the electrode are the same as those of the first embodiment.
The external stimulator or the internal stimulator 150 includes two parts, i.e., a circuit board 151 and a protective housing 152, and the circuit board 151 can output an electrical signal with fixed frequency, pulse width and amplitude. In the first embodiment described above, the plug 140 is connected to an extracorporeal stimulator; in the second embodiment, the coated wire 130 is soldered to the circuit board 151 at the end thereof extending out of the protective tube. The protective case 152 is located outside the circuit board 151, and can insulate the circuit board 151 from the outside and thus serve as an electrical insulator. As in the second embodiment, isolates the body fluid from the circuit board 151. The material of the protective casing 152 is silicon rubber, polyurethane, epoxy resin, etc.
The invention also provides a manufacturing method of the animal vagus nerve system, which comprises the following steps: the coated wire 130 is laser welded to the hollow position of the contact 120, and then the outer ring of the contact 120 is fixedly attached to the inner wall of the protection tube 110 by using the bio-adhesive, so that the arc center direction of the inner ring of the contact 120 is ensured to face the axial opening position of the protection tube 110. The other end of the coated wire 130 is radially extended from the axial middle position of the protective tube 110 and welded or crimped with the plug 140. The exposed part of the plug connector pin and the welding point are coated by protective glue 141, so as to ensure the mutual insulation between the positive electrode and the negative electrode. The external stimulator may be detachably connected to the plug 140. In the absence of the plug 140, the other end of the coated wire 130 is connected to the in vivo stimulator 150, and the coated wire 130 is welded or crimped directly to the in vivo stimulator 150 in a manner that is not removable.
Fig. 3 is a schematic illustration of an implantation procedure for the animal vagus nerve stimulation system of the present invention. The implantation method of the stimulation system comprises the following steps: step 1, after the animals are anesthetized, the neck is cut in the middle, the left side carotid sheath is exposed, and the vagus nerve trunk is separated by about 1 cm; step 2, the surgical suture 111 of the electrode protection tube 110 is pulled in the direction indicated by the arrow in fig. 3(a), the axial opening 113 is pulled open, and the inner rings of the two stimulation contacts 120 are exposed as shown in fig. 3(b) after the axial opening 113 is pulled open. Step 3, the vagus nerve 200 is placed within the protective tube 110 and contacted with the inner ring of the stimulation contacts 120, as shown in fig. 3 (c). In step 4, the surgical suture 111 is released and the protective tube 110 is restored to its original shape, confirming that the protective tube 110 completely covers the vagus nerve 200. Two surgical non-absorbable sutures 300 are then tied tightly at the two contact points 120, respectively, outside the protective tube 110 to secure the position of the electrodes on the vagus nerve 200, as shown in fig. 3 (d). Finally, the plug 140 is subcutaneously tunneled to the neck of the rat and fixed to the skull of the animal with dental cement. The connector 140 is connected to an external stimulator to deliver an electrical signal to the vagus nerve of the animal. If the coated lead 130 is directly connected to the in vivo stimulator 150, the in vivo stimulator 150 may be placed and secured subcutaneously on the back or abdomen of the animal.
The present invention is not limited to the above embodiments, and any changes or substitutions that can be easily made by those skilled in the art within the technical scope of the present invention are also within the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.
Claims (10)
1. An animal vagus nerve stimulation system comprising a stimulator, a stimulation electrode, wherein: the stimulation electrode comprises a protection tube, at least two stimulation contacts and at least two coating leads;
the device is characterized in that the protection tube is a flexible insulation tube with an opening along the axial direction;
the stimulating contact is a hollow semi-annular metal piece, the inner ring is in contact with the vagus nerve, and the outer ring is fixed on the inner wall of the protection tube;
the coating wires correspond to one of the stimulation contacts, one end of each coating wire penetrates into the hollow position of the stimulation contact and is connected with the stimulation contact, and the other end of each coating wire penetrates out of the protection tube and is directly or indirectly connected with the stimulator.
2. The animal vagus nerve stimulation system according to claim 1, wherein: the two sides of the axial opening of the protection tube are respectively provided with a surgical suture, the axial opening of the protection tube can be pulled open by pulling the surgical suture to the two sides, and the axial opening of the protection tube is restored to the original shape after the surgical suture is loosened.
3. The animal vagus nerve stimulation system according to claim 1, wherein: the center normal direction of the inner ring circular arc of the stimulation contact points faces the axial opening position of the protection tube.
4. The animal vagus nerve stimulation system according to claim 1, wherein: the coating lead is indirectly connected with an external stimulator through a plug connector or directly connected with an internal stimulator.
5. The animal vagus nerve stimulation system according to claim 4, wherein: the coating lead is connected with the plug connector or the internal stimulator in a welding or crimping mode.
6. The animal vagus nerve stimulation system according to claim 5, wherein: the stimulator comprises a circuit board and a protective shell; the circuit board can output electric signals with different frequencies, pulse widths and amplitudes; the protective shell is arranged outside the circuit board, can isolate the circuit board from the outside and plays a role in electrical insulation.
7. The animal vagus nerve stimulation system according to claim 1, wherein: and a marking belt with color is arranged at the position, close to one of the stimulating contacts, outside the protective tube and used for distinguishing the anode and the cathode of the electrode.
8. The animal vagus nerve stimulation system according to claim 1, wherein: the outer diameter of the protection tube is 0.5mm-2mm, the inner diameter is 0.4mm-1.8mm, and the length is 3mm-8 mm; the diameter of the inner ring of each stimulating contact is 0.1mm-1mm, the diameter of the outer ring is consistent with the inner diameter of the protection tube, the length of the outer ring is 0.3mm-2mm, and the distance between two adjacent stimulating contacts is 1mm-5 mm.
9. The animal vagus nerve stimulation system according to claim 1, wherein:
the protection tube is made of silica gel, polyurethane or polyurethane-silicone rubber copolymer;
the stimulation contact is made of platinum or platinum-iridium alloy;
the material of the lead in the coating lead is stainless steel, cobalt-chromium-molybdenum alloy, nickel-titanium alloy or platinum-iridium alloy.
10. The method of making an animal vagus nerve stimulation system according to any of claims 1-9, wherein:
s1, welding the coated lead wire to the hollow position of the stimulating contact;
s2, fixing the outer ring of the stimulating contact on the inner wall of the protection tube by using biological glue to ensure that the arc center direction of the inner ring of the stimulating contact faces the axial opening position of the protection tube;
and S3, the other end of the coated lead penetrates out of the inner wall of the protective tube in the radial direction and is directly or indirectly connected with the stimulator.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010524069.XA CN111729191B (en) | 2020-06-10 | 2020-06-10 | Small animal vagus nerve stimulation system and manufacturing method thereof |
| PCT/CN2020/141951 WO2021248895A1 (en) | 2020-06-10 | 2020-12-31 | Animal vagus nerve stimulation system and manufacturing method therefor |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010524069.XA CN111729191B (en) | 2020-06-10 | 2020-06-10 | Small animal vagus nerve stimulation system and manufacturing method thereof |
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| CN111729191A true CN111729191A (en) | 2020-10-02 |
| CN111729191B CN111729191B (en) | 2023-09-26 |
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| WO (1) | WO2021248895A1 (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113769270A (en) * | 2021-09-07 | 2021-12-10 | 北京品驰医疗设备有限公司 | Implantable nerve stimulator suitable for human neck |
| WO2021248895A1 (en) * | 2020-06-10 | 2021-12-16 | 北京品驰医疗设备有限公司 | Animal vagus nerve stimulation system and manufacturing method therefor |
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| WO2019122817A1 (en) * | 2017-12-21 | 2019-06-27 | Galvani Bioelectronics Limited | Nerve stimulation device for current steering |
| US20190336770A1 (en) * | 2018-05-02 | 2019-11-07 | Duke University | Systems and methods for percutaneous nerve stimulation |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2021248895A1 (en) * | 2020-06-10 | 2021-12-16 | 北京品驰医疗设备有限公司 | Animal vagus nerve stimulation system and manufacturing method therefor |
| CN113769270A (en) * | 2021-09-07 | 2021-12-10 | 北京品驰医疗设备有限公司 | Implantable nerve stimulator suitable for human neck |
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| Publication number | Publication date |
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| CN111729191B (en) | 2023-09-26 |
| WO2021248895A1 (en) | 2021-12-16 |
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