CN114209980B - Nerve stimulation electrode, method for manufacturing same, and nerve stimulation device - Google Patents
Nerve stimulation electrode, method for manufacturing same, and nerve stimulation device Download PDFInfo
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- CN114209980B CN114209980B CN202210164630.7A CN202210164630A CN114209980B CN 114209980 B CN114209980 B CN 114209980B CN 202210164630 A CN202210164630 A CN 202210164630A CN 114209980 B CN114209980 B CN 114209980B
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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
- A61N1/02—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
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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
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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
- A61N1/36067—Movement disorders, e.g. tremor or Parkinson disease
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Abstract
The invention discloses a nerve stimulation electrode, a manufacturing method thereof and a nerve stimulation device, wherein the nerve stimulation electrode comprises a sleeve and a plurality of guide wires arranged in the sleeve, the sleeve comprises a first catheter, a second catheter and an infection-preventing blocking tube connected with the first catheter and the second catheter, a plurality of stimulation contacts are embedded on the outer wall of the first catheter, a plurality of pulse sending contacts are embedded on the outer wall of the second catheter, the stimulation contacts are connected with the pulse sending contacts through the guide wires, and the stimulation contacts, the guide wires and the pulse sending contacts are in one-to-one correspondence. The anti-infection blocking tube in the sleeve can avoid infection at the implanted wound, and the anti-infection blocking tube is arranged in a spring shape to relieve the extension of the infection depth, so that the infection degree is effectively reduced; set up on amazing contact and the pulse transmission contact embedding sleeve pipe for the whole transverse diameter of nerve stimulation electrode is the same, and the user can not have unevenness's sense organ experience in the use, makes the electrode implantation in-process more smooth and easy.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a nerve stimulation electrode, a manufacturing method thereof and a nerve stimulation device.
Background
Neurostimulation devices have been widely used in the treatment of neurological disorders such as parkinson's disease. The nerve stimulation device comprises a nerve stimulation electrode, one end of the nerve stimulation electrode is implanted near the nerve tissue of the human body, the other end of the nerve stimulation electrode is connected with an external pulse emitter, and the external pulse generator outputs pulse signals which are transmitted near the nerve tissue of the human body through the nerve stimulation electrode so as to achieve the purpose of stimulating nerves. The human tissue part that the nerve stimulation electrode passed through is very easy because the infection appears in the nerve stimulation electrode that sets up, and in case the infection takes place, forms the degree of depth infection along the nerve stimulation electrode from the human tissue outside extremely easily, and then influences human health.
And current nerve stimulation electrode is often because the setting of contact for the extremely unevenness in nerve stimulation electrode surface, and then the sense organ that appears unevenness at nerve stimulation electrode in-process of putting into human body reduces user experience.
Disclosure of Invention
The technical problem to be solved by the invention is that the part of the existing nerve stimulation electrode penetrating through a human body is very easy to generate deep infection, and the surface of the existing nerve stimulation electrode is uneven, so that the use experience of a user is reduced.
In order to solve the technical problem, the invention provides a nerve stimulation electrode, which comprises a sleeve and a plurality of guide wires arranged in the sleeve, wherein the sleeve comprises a first catheter, a second catheter and an infection prevention blocking tube connected with the first catheter and the second catheter, a plurality of stimulation contacts are embedded on the outer wall of the first catheter, a plurality of pulse sending contacts are embedded on the outer wall of the second catheter, the stimulation contacts are connected with the pulse sending contacts through the guide wires, and the stimulation contacts, the guide wires and the pulse sending contacts are in one-to-one correspondence.
Preferably, the first catheter is embedded with a diameter at the stimulation contact that is the same as a diameter at the stimulation contact that the first catheter is not embedded with, and the second catheter is embedded with a diameter at the pulsing contact that is the same as a diameter at the pulsing contact that the second catheter is not embedded with.
Preferably, the sleeve is a single-channel pipeline or a multi-channel pipeline, the guide wire is arranged in the channel of the sleeve, one end of the guide wire extends out from the stimulation contact embedding point of the first catheter to be connected with the stimulation contact, and the other end of the guide wire extends out from the pulse sending contact embedding point of the second catheter to be connected with the pulse sending contact.
Preferably, the guide wire is externally coated with an insulating material, and the insulating material is PTFE, ETFE, PFA, PI or PA.
Preferably, the infection prevention barrier tube is in a spring shape, the material of the spring-shaped infection prevention barrier tube is platinum iridium, nickel titanium, MP35N or stainless steel, and the outer surface of the spring-shaped infection prevention barrier tube is coated with an insulating material; or
The infection-preventing blocking pipe is in a straight pipe shape with an uneven surface, and the infection-preventing blocking pipe material in the straight pipe shape with the uneven surface is TPU or PA.
Preferably, the nerve stimulation electrode further comprises an anti-tripping device, wherein the anti-tripping device is fixed on the first conduit so as to fix the first conduit when the first conduit is embedded in a human body and prevent the nerve stimulation electrode from generating relative displacement with human body tissues.
Preferably, the anti-tripping device is in a barb shape, an umbrella shape or a spring shape.
Preferably, the material of the anti-infection barrier tube, the stimulation contact, the pulse delivery contact, and the guidewire is platinum iridium, nickel titanium, MP35N, or stainless steel.
In order to solve the technical problem, the invention also provides a manufacturing method of the nerve stimulation electrode, which comprises the following steps of
Connecting the first catheter and the second catheter by an infection prevention blocking tube to form a sleeve;
a plurality of guide wires are inserted into the sleeve passage, two ends of each guide wire respectively extend out of a stimulating contact embedding point and a pulse transmitting contact embedding point, and the guide wires, the stimulating contact embedding points and the pulse transmitting contact embedding points are in one-to-one correspondence;
embedding all stimulation contact rings and all pulse transmission contact rings on the sleeve to form a plurality of stimulation contacts and a plurality of pulse transmission contacts;
fixing an anti-drop buckle on the first catheter to form a nerve stimulation electrode;
wherein embedding all stimulation contact rings and all pulsing contact rings on the cannula to form a plurality of stimulation contacts and a plurality of pulsing contacts comprises:
stretching the sleeve to cause the sleeve to elastically deform to be in a stretched state, wherein the diameter of the sleeve in the stretched state is smaller than that of the sleeve in a relaxed state;
respectively sleeving all stimulation contact rings at each stimulation contact embedding point of the sleeve, respectively welding each stimulation contact ring with a guide wire extending out of the corresponding stimulation contact embedding point, simultaneously respectively sleeving all pulse transmitting contact rings at each pulse transmitting contact embedding point of the sleeve, and respectively welding each pulse transmitting contact ring with the guide wire extending out of the corresponding pulse transmitting contact embedding point;
release the sleeve pipe is in the relaxed state in order to make it resume elastic deformation, all stimulation contact ring embedding each stimulation contact embedding point forms a plurality of stimulation contacts, all pulse transmission contact ring embedding each pulse transmission contact embedding point forms a plurality of pulse transmission contacts, just first pipe is embedded the diameter at stimulation contact point with first pipe has not been embedded the diameter at stimulation contact point is the same, the second pipe has been embedded the diameter at pulse transmission contact point with the second pipe has not been embedded the diameter at pulse transmission contact point is the same.
In order to solve the above technical problem, the present invention further provides a neurostimulation device, which includes a neurostimulation signal generator and a neurostimulation electrode, wherein the neurostimulation electrode is connected to the neurostimulation signal generator, and a neurostimulation signal generated by the neurostimulation signal generator is input into a body through the neurostimulation electrode to stimulate a nerve.
Compared with the prior art, one or more embodiments in the above scheme can have the following advantages or beneficial effects:
by applying the nerve stimulation electrode provided by the embodiment of the invention, the infection at the implanted wound can be avoided due to the arrangement of the infection-preventing blocking tube in the sleeve, and the extension of the infection depth can be relieved by arranging the infection-preventing blocking tube into a spring shape or a straight tube shape with an uneven surface, so that the infection degree is effectively reduced; the stimulation contact and the pulse sending contact are arranged to be embedded into the sleeve, so that the overall transverse diameters of the nerve stimulation electrodes are the same, and a user does not have uneven sensory experience in the use process, so that the electrode implantation process is smoother; the anti-tripping device can effectively prevent the nerve stimulation electrode and human tissue from displacement.
Additional features and advantages of the invention will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by the practice of the invention. The objectives and other advantages of the invention will be realized and attained by the structure particularly pointed out in the written description and claims hereof as well as the appended drawings.
Drawings
The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the principles of the invention and not to limit the invention. In the drawings:
FIG. 1 is a schematic diagram of a neurostimulation electrode according to an embodiment of the invention;
FIG. 2 is a schematic diagram of a spring-like infection prevention barrier tube in a nerve stimulation electrode according to an embodiment of the present invention;
FIG. 3 is a schematic structural diagram of a straight tubular infection-preventing barrier tube in a nerve stimulation electrode according to an embodiment of the present invention;
FIG. 4 is a schematic cross-sectional view of a nerve stimulation electrode with an anti-trip device in the shape of an umbrella according to an embodiment of the present invention;
FIG. 5 is a schematic cross-sectional view of a nerve stimulation electrode with a spring-like anti-trip, in accordance with an embodiment of the present invention;
FIG. 6 is a schematic diagram of a multichannel transverse cross-section of a neurostimulation electrode according to an embodiment of the invention;
FIG. 7 is a flow chart of a second method for manufacturing a neurostimulation electrode according to the embodiment of the invention;
wherein, 1 is the anti-tripping, 2 is the stimulation contact, 3 is the seal wire, 4 is the pulse transmission contact, 5 is the infection-preventing separation pipe, 6 is the first pipe, 7 is the second pipe, 8 is the anti-stretching pipe.
Detailed Description
The following detailed description will be given with reference to the accompanying drawings and examples to explain how to apply the technical means to solve the technical problems and to achieve the technical effects. It should be noted that, as long as there is no conflict, the embodiments and the features of the embodiments of the present invention may be combined with each other, and the technical solutions formed are within the scope of the present invention.
The nerve stimulation device comprises a nerve stimulation electrode, one end of the nerve stimulation electrode is implanted near the nerve tissue of the human body, the other end of the nerve stimulation electrode is connected with an external pulse emitter, and the external pulse generator outputs pulse signals which are transmitted near the nerve tissue of the human body through the nerve stimulation electrode so as to achieve the purpose of stimulating nerves. The human tissue part that the nerve stimulation electrode passed through is very easy because the infection appears in the nerve stimulation electrode that sets up, and in case the infection takes place, forms the degree of depth infection along the nerve stimulation electrode from the human tissue outside extremely easily, and then influences human health. And current nerve stimulation electrode is often because the setting of contact for the surface of nerve stimulation electrode is extremely uneven, and then appears unevenness's sense organ at the human in-process of putting into of nerve stimulation electrode, reduces user experience.
Example one
In order to solve the technical problems in the prior art, the embodiment of the invention provides a nerve stimulation electrode.
FIG. 1 is a schematic diagram of a neurostimulation electrode according to an embodiment of the invention; referring to fig. 1, a nerve stimulation electrode according to an embodiment of the present invention includes a sleeve and a plurality of guide wires 3 disposed in the sleeve.
Further, the cannula is provided to comprise a first catheter tube 6, a second catheter tube 7 and an infection prevention barrier tube 5, the infection prevention barrier tube 5 structurally connecting the first catheter tube 6 and the second catheter tube 7. The first conduit 6 and the second conduit 7 are identical in structure and are uniformly arranged, and are made of one of TPU, PA and the like. The first catheter 6 and the second catheter 7 are coated with biocompatible materials on the outer portion to reduce rejection reaction generated after the nerve stimulation electrode enters a human body. The infection-preventing blocking tube 5 can be arranged in a uniform spring shape (as shown in fig. 2) or a straight tube shape with an uneven surface (as shown in fig. 3), when the infection-preventing blocking tube 5 is in a spring shape, the material is platinum iridium, nickel titanium, MP35N or stainless steel, at this time, the outer surface of the spring-shaped infection-preventing blocking tube is coated with an insulating material, and the insulating material can be selected from PTFE, ETFE, PFA, PI or PA and the like; and when preventing infecting separation pipe 5 and can set up to the straight tube form of surface unevenness, the straight tube form unevenness's surface can be the rectangular wave form, and the material of preventing infecting separation pipe 5 at this moment is TPU or PA. Prevent infecting separation tube 5's setting can effectively reduce the electrode and implant the wound and take place the infection, and will prevent infecting separation tube 5 and set up to spring form or the straight tubulose of surface unevenness, in case the electrode is implanted the wound and takes place the infection, because prevent infecting separation tube 5 and be spiral or unevenness deepening in the electrode is implanted the wound, can effectively alleviate the extension of infection degree of depth to reduce the infection degree.
The material of the guide wire 3 is platinum iridium, nickel titanium, MP35N or stainless steel, and the like, and the exterior of the guide wire 3 is coated with insulating materials to realize physical isolation, avoid the conduction short circuit between the guide wires 3 and better transmit the stimulation signals to the nervous tissue. The insulating material coated on the outside of the guide wire 3 may be PTFE, ETFE, PFA, PI, PA, or other insulating material. A channel for the guide wire 3 to pass through is arranged in the sleeve, and the sleeve can be arranged as a single-channel pipeline or a multi-channel pipeline (refer to fig. 6). When the sleeve is a single-channel pipeline, all the guide wires 3 are arranged in the channel, but the guide wires 3 are insulated and isolated by insulating materials coated on the surfaces of the guide wires; and when the sleeve pipe is the multichannel pipeline, can set up the passageway quantity to be the same with seal wire 3 quantity, all run through a seal wire 3 in every passageway to further realize the physical isolation between the seal wire 3, avoid appearing switching on the short circuit between the seal wire 3, make the stimulus signal transmit to nerve better. In order to avoid the wire 3 from being pulled apart when the nerve stimulation electrode is in a stretched state such as bending, the wire 3 in the casing is set in a non-tensioned state, that is, a proper amount of space is left in the casing.
The outer wall of the first catheter 6 is embedded with a plurality of stimulation contacts 2, the outer wall of the second catheter 7 is embedded with a plurality of pulse sending contacts 4, the stimulation contacts 2 are connected with the pulse sending contacts 4 through guide wires 3, the stimulation contacts 2, the guide wires 3 and the pulse sending contacts 4 are in one-to-one correspondence, namely, each stimulation contact 2 is connected with the corresponding pulse sending contact 4 through one guide wire 3, and therefore stimulation signals can be better transmitted to corresponding nerve tissues. The material of the stimulation contact 2 and the pulse transmission contact 4 is also provided as platinum iridium, nickel titanium, MP35N or stainless steel. In order to prevent the durability of the nerve stimulation electrode from being reduced due to the tensile fracture of the first catheter 6 and the second catheter 7, the anti-stretching tube 8 is further bonded to part of the inner walls of the first catheter 6 and the second catheter 7, the anti-stretching tube 8 is made of PEEK, PSU or PI, and the bonding manner between the anti-stretching tube 8 and the first catheter 6 or the second catheter 7 is hot melting or glue pouring. Further, the stretch-proof tube 8 in the first catheter tube 6 is bonded to the inner wall of the tube section between the last stimulation contact 2 (i.e., the stimulation contact 2 closest to the infection prevention barrier tube 5) of the first catheter tube 6 and the infection prevention barrier tube 5, and the stretch-proof tube 8 in the second catheter tube 7 is bonded to the inner wall of the tube section between the first pulse transmission contact 4 (i.e., the pulse transmission contact 4 closest to the infection prevention barrier tube 5) of the second catheter tube 7 and the infection prevention barrier tube 5.
Furthermore, the connection mode of the single guide wire 3 with the stimulation contact 2 and the pulse transmission contact 4 respectively is as follows: one end of a guide wire 3 arranged in the channel extends out of the stimulation contact embedding point of the first catheter 6 to be connected with the stimulation contact 2, the other end of the guide wire extends out of the pulse sending contact embedding point of the second catheter 7 to be connected with the pulse sending contact 4, and the connection mode of the guide wire 3 and the stimulation contact 2 or the pulse sending contact 4 can be resistance welding, laser welding, argon arc welding and the like.
In addition, in order to improve the use experience of a user, the diameter of the position, embedded with the stimulation contact 2, of the first catheter 6 in the sleeve is the same as the diameter of the position, not embedded with the stimulation contact 2, of the first catheter 6 (except for the tightening part at the front end of the first catheter), the diameter of the position, embedded with the pulse sending contact 4, of the second catheter 7 is the same as the diameter of the position, not embedded with the pulse sending contact 4, of the second catheter 7, and therefore the sense organ experience of unevenness cannot exist in the process of placing the nerve stimulation electrode into a human body, and the electrode implantation process is smoother.
The nerve stimulation electrode of the embodiment of the invention also comprises an anti-tripping device 1, so that the nerve stimulation electrode is prevented from being displaced relative to human tissue due to the action of a user after being implanted into a human body, and further the stimulation contact is driven to be displaced, and the stimulation effect of the nerve stimulation electrode is influenced. Further, the anti-drop buckle 1 in this embodiment is disposed on the first conduit 6, and the anti-drop buckle 1 may be in a barb shape, an umbrella shape or a spring shape.
Further, when the trip preventing device 1 is in a barb shape (as shown in fig. 1), the barb-shaped trip preventing device 1 includes a first flexible rod and a second flexible rod, the first flexible rod and the second flexible rod are connected by an elastic component, and the first flexible rod and the second flexible rod form an acute angle. The first flexible rod is fixed to the first guide tube 6 by being inserted into the distal end of the first guide tube 6. When the nerve stimulation electrode provided by the embodiment is used, one end of the first catheter 6 is placed in the inner cavity of the puncture needle, a doctor punctures the puncture needle into the body of a patient, and the nerve stimulation electrode enters the body of the patient together with the puncture needle. When the puncture needle reaches the designated position, the puncture needle is withdrawn, the anti-tripping device 1, the first catheter 6, part of the guide wire 3 and the anti-infection blocking tube 5 are left in the body of the patient, and the other end of the nerve stimulation electrode is arranged outside the body of the patient and is connected with a signal generator of the nerve stimulation electrode. Because the puncture needle withdraws from, the second flexible rod recovers to form an acute angle with the first flexible rod under the action of the elastic component, and the second flexible rod generates corresponding deformation along with the muscle, the bone and the like of the patient in the body of the patient to form a barb structure.
When the anti-release device 1 is umbrella-shaped (as shown in fig. 4), the umbrella-shaped anti-release device 1 is fixed on the first conduit 6, and the bending surface of the umbrella-shaped anti-release device 1 is bent towards the second conduit 7. The mode that the umbrella-shaped anti-tripping device 1 is fixed on the first conduit 6 can be thermal melting or dispensing and the like, and the umbrella-shaped anti-tripping device 1 is made of flexible materials, so that the normal work of stimulating electric shock cannot be influenced by the fixation of the umbrella-shaped anti-tripping device 1. When the nerve stimulation electrode provided by the embodiment is used, one end of the first catheter 6 is placed in the inner cavity of the puncture needle, a doctor punctures the puncture needle into the body of a patient, and the nerve stimulation electrode enters the body of the patient together with the puncture needle. When the puncture needle reaches the designated position, the puncture needle is withdrawn, the anti-tripping device 1, the first catheter 6, part of the guide wire 3 and the anti-infection blocking tube 5 are left in the body of the patient, and the other end of the nerve stimulation electrode is arranged outside the body of the patient and is connected with a signal generator of the nerve stimulation electrode. As the puncture needle is withdrawn, the umbrella-shaped anti-tripping device 1 is restored to the original shape by elastic deformation, and the umbrella-shaped anti-tripping device 1 is correspondingly deformed along with the muscle, the skeleton and the like of a patient in the body of the patient to form an umbrella-shaped structure.
When the anti-trip unit 1 is in the form of a spring (as shown in fig. 5, the spring density is thinner than the spring-like anti-infection blocking tube), the spring-like anti-trip unit 1 is fixed to the first guide tube 6 by being inserted into the end of the first guide tube 6. When the nerve stimulation electrode provided by the embodiment is used, one end of the first catheter 6 is placed in the inner cavity of the puncture needle, a doctor punctures the puncture needle into the body of a patient, and the nerve stimulation electrode enters the body of the patient together with the puncture needle. When the puncture needle reaches the designated position, the puncture needle is withdrawn, the anti-tripping device 1, the first catheter 6, part of the guide wire 3 and the anti-infection blocking tube 5 are left in the body of the patient, and the other end of the nerve stimulation electrode is arranged outside the body of the patient and is connected with a signal generator of the nerve stimulation electrode. As the puncture needle is withdrawn, the spring-shaped anti-tripping device 1 is fixed in the body of the patient along with the muscle, the skeleton and the like of the patient due to the spring shape.
One end of the nerve stimulation electrode provided by the embodiment of the invention is implanted near the nerve tissue of a human body, the other end of the nerve stimulation electrode is electrically connected with the external pulse generator, and the external pulse generator outputs pulse signals which are transmitted near the nerve tissue of the human body through the electrode so as to achieve the function of stimulating nerves.
According to the nerve stimulation electrode provided by the embodiment of the invention, the infection at the implanted wound can be avoided due to the arrangement of the infection-preventing blocking tube in the sleeve, and the extension of the infection depth can be relieved due to the arrangement of the infection-preventing blocking tube in a spring shape or a straight tube shape with an uneven surface, so that the infection degree is effectively reduced; the stimulation contact and the pulse sending contact are arranged to be embedded into the sleeve, so that the overall transverse diameters of the nerve stimulation electrodes are the same, and a user does not have uneven sensory experience in the use process, so that the electrode implantation process is smoother; the anti-tripping device can effectively prevent the nerve stimulation electrode and human tissue from displacement.
Example two
In order to solve the technical problems in the prior art, the embodiment of the invention provides a method for manufacturing a nerve stimulation electrode.
FIG. 7 is a flow chart of a second method for manufacturing a neurostimulation electrode according to the embodiment of the invention; referring to fig. 7, the neurostimulation electrode manufactured by the method for manufacturing the neurostimulation electrode according to the embodiment of the invention is the neurostimulation electrode in the first embodiment, and the specific structure and material of each component thereof can refer to the first embodiment, which is not described herein again.
The manufacturing method of the nerve stimulation electrode further comprises the following steps: s1: connecting a first catheter 6 and a second catheter 7 through an infection prevention barrier tube 5 to form a sleeve; s2: a plurality of guide wires 3 are inserted into the sleeve passage, two ends of each guide wire 3 respectively extend out of the stimulating contact embedding point and the pulse transmitting contact embedding point, and the guide wires, the stimulating contact embedding points and the pulse transmitting contact embedding points are in one-to-one correspondence; s3: embedding all stimulation contact rings and all pulse transmitting contact rings on a sleeve to form a plurality of stimulation contacts 2 and a plurality of pulse transmitting contacts 4; s4: the anti-tripping device is fixed on the first catheter 6 to form the nerve stimulation electrode.
Wherein, embedding all stimulating contact rings and all pulse transmitting contact rings on the sleeve to form a plurality of stimulating contacts 2 and a plurality of pulse transmitting contacts 4 comprises the following steps: stretching the sleeve to enable the sleeve to be in a stretching state after elastic deformation, wherein the diameter of the sleeve in the stretching state is smaller than that of the sleeve in a loosening state, and the stretching degree is such that the stimulating contact ring and the pulse transmitting contact ring can be sleeved on the sleeve; and simultaneously, all the pulse transmitting contact rings are respectively sleeved at each pulse transmitting contact embedding point of the sleeve, and each pulse transmitting contact ring is respectively welded with the guide wire 3 extending out of the corresponding pulse transmitting contact embedding point. It should be noted that the stimulation contact rings and the stimulation contact insertion points are in a one-to-one correspondence relationship, and the pulse transmission contact rings and the pulse transmission contact insertion points are also in a one-to-one correspondence relationship. This design may result in the cannula having the same diameter where the first catheter 6 is embedded with the stimulation contact 2 as where the first catheter 6 is not embedded with the stimulation contact 2 and the same diameter where the second catheter 7 is embedded with the pulse transmission contact 4 as where the second catheter 7 is not embedded with the pulse transmission contact 4. After the stimulating contact 2 and the pulse sending contact 4 are fixed with the sleeve, the overall outer diameter of the electrode cannot be changed, uneven experience is not needed in the using process, and the electrode implantation process is smoother.
According to the manufacturing method of the nerve stimulation electrode, the infection prevention blocking tube in the sleeve can avoid infection at the implanted wound, and the infection prevention blocking tube is arranged to be in a spring shape or a straight tube shape with an uneven surface, so that the extension of the infection depth can be relieved, and the infection degree can be effectively reduced; the stimulation contact and the pulse sending contact are arranged to be embedded into the sleeve, so that the overall transverse diameters of the nerve stimulation electrodes are the same, and a user does not have uneven sensory experience in the use process, so that the electrode implantation process is smoother; the anti-tripping device can effectively prevent the nerve stimulation electrode and human tissues from displacing.
EXAMPLE III
In order to solve the technical problems in the prior art, the embodiment of the invention provides a nerve stimulation device.
The neural stimulation device of the embodiment of the invention comprises a neural stimulation signal generator and the neural stimulation electrode of the first embodiment. The nerve stimulation electrode is connected with a nerve stimulation signal generator, and a nerve stimulation signal generated by the nerve stimulation signal generator is input into the body of the patient through the nerve stimulation electrode in the first embodiment to stimulate the designated nerve.
Although the embodiments of the present invention have been described above, the above description is only for the convenience of understanding the present invention, and is not intended to limit the present invention. It will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention as defined by the appended claims.
Claims (9)
1. A nerve stimulation electrode is characterized by comprising a sleeve and a plurality of guide wires arranged in the sleeve, wherein the sleeve comprises a first catheter, a second catheter and an infection prevention blocking tube connected with the first catheter and the second catheter, a plurality of stimulation contacts are embedded on the outer wall of the first catheter, a plurality of pulse sending contacts are embedded on the outer wall of the second catheter, the stimulation contacts are connected with the pulse sending contacts through the guide wires, and the stimulation contacts, the guide wires and the pulse sending contacts are in one-to-one correspondence;
the anti-infection blocking tube is in a spring shape, the material of the spring-shaped anti-infection blocking tube is platinum iridium, nickel titanium, MP35N or stainless steel, and the outer surface of the spring-shaped anti-infection blocking tube is coated with an insulating material; or the anti-infection blocking pipe is in a straight pipe shape with an uneven surface, and the anti-infection blocking pipe material in the straight pipe shape with the uneven surface is TPU or PA.
2. The neurostimulation electrode of claim 1, wherein the first catheter has embedded therein a diameter at the stimulation contact that is the same as a diameter at the stimulation contact that the first catheter does not have embedded therein, and wherein the second catheter has embedded therein a diameter at the pulsing contact that is the same as a diameter at the pulsing contact that the second catheter does not have embedded therein.
3. The neurostimulation electrode according to claim 1, wherein the cannula is a single channel tube or a multi-channel tube, the guide wire is disposed in the cannula channel, and one end of the guide wire extends from the stimulation contact insertion point of the first catheter to be connected with the stimulation contact, and the other end of the guide wire extends from the pulse delivery contact insertion point of the second catheter to be connected with the pulse delivery contact.
4. The neurostimulation electrode of claim 1, wherein the exterior of the guidewire is coated with an insulating material, the insulating material being PTFE, ETFE, PFA, PI or PA.
5. The neurostimulation electrode of claim 1, further comprising an anti-detachment clip secured to the first catheter for securing the first catheter when implanted in a human body to prevent relative displacement of the neurostimulation electrode with respect to body tissue.
6. The neurostimulation electrode of claim 5, wherein the anti-release device is barb-shaped, umbrella-shaped or spring-shaped.
7. The neurostimulation electrode of claim 1, wherein the material of the stimulation contact, the pulsing contact and the guidewire is platinum iridium, nickel titanium, MP35N or stainless steel.
8. A method of making the neurostimulation electrode of any one of claims 1 to 7, comprising:
connecting the first catheter and the second catheter by an infection prevention blocking tube to form a sleeve;
a plurality of guide wires are inserted into the sleeve passage, two ends of each guide wire respectively extend out of a stimulating contact embedding point and a pulse transmitting contact embedding point, and the guide wires, the stimulating contact embedding points and the pulse transmitting contact embedding points are in one-to-one correspondence;
embedding all stimulation contact rings and all pulse transmission contact rings on the sleeve to form a plurality of stimulation contacts and a plurality of pulse transmission contacts;
fixing an anti-drop buckle on the first catheter to form a nerve stimulation electrode;
wherein embedding all stimulation contact rings and all pulsing contact rings on the cannula to form a plurality of stimulation contacts and a plurality of pulsing contacts comprises:
stretching the sleeve to cause the sleeve to elastically deform to be in a stretched state, wherein the diameter of the sleeve in the stretched state is smaller than that of the sleeve in a relaxed state;
respectively sleeving all stimulation contact rings at each stimulation contact embedding point of the sleeve, respectively welding each stimulation contact ring with a guide wire extending out of the corresponding stimulation contact embedding point, simultaneously respectively sleeving all pulse transmitting contact rings at each pulse transmitting contact embedding point of the sleeve, and respectively welding each pulse transmitting contact ring with the guide wire extending out of the corresponding pulse transmitting contact embedding point;
-releasing the cannula so that it recovers elastic deformation and is in a relaxed state, all the embedding of the stimulating contact ring is individual the stimulating contact embedding point forms a plurality of stimulating contacts, all the embedding of the pulsing contact ring is individual the embedding of the pulsing contact embedding point forms a plurality of pulsing contacts, and the first catheter is embedded with the diameter of the stimulating contact point with the first catheter is not embedded with the diameter of the stimulating contact point is the same, the second catheter is embedded with the diameter of the pulsing contact point with the second catheter is not embedded with the diameter of the pulsing contact point is the same.
9. A neurostimulation device, comprising a neurostimulation signal generator and a neurostimulation electrode as claimed in any one of claims 1 to 7, wherein the neurostimulation electrode is connected with the neurostimulation signal generator, and a neurostimulation signal generated by the neurostimulation signal generator is input into a body by the neurostimulation electrode to stimulate a nerve.
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| CN111741789A (en) * | 2018-02-22 | 2020-10-02 | 艾克索尼克斯调制技术股份有限公司 | Neural stimulation leads for testing neural stimulation and methods of use |
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| US9427595B2 (en) * | 2013-07-10 | 2016-08-30 | Pacesetter, Inc. | Neurostimulation patch |
| CA2957962C (en) * | 2014-08-15 | 2018-05-01 | Axonics Modulation Technologies, Inc. | Implantable lead affixation structure for nerve stimulation to alleviate bladder dysfunction and other indications |
| US11097122B2 (en) * | 2015-11-04 | 2021-08-24 | The Regents Of The University Of California | Magnetic stimulation of the spinal cord to restore control of bladder and/or bowel |
| CN112121299A (en) * | 2020-09-11 | 2020-12-25 | 中国计量大学 | Anti-withdrawal pre-bent electrode with multiple notches and implantation method thereof |
| CN113559409A (en) * | 2021-07-01 | 2021-10-29 | 北京品驰医疗设备有限公司 | Isolating ring, composite contact, direction electrode and manufacturing method of direction electrode |
| CN113368391B (en) * | 2021-07-08 | 2022-07-22 | 杭州神络医疗科技有限公司 | Nerve stimulation electrode and stimulation device |
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| CN111741789A (en) * | 2018-02-22 | 2020-10-02 | 艾克索尼克斯调制技术股份有限公司 | Neural stimulation leads for testing neural stimulation and methods of use |
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| Title |
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| Intracortical Neural Stimulation With Untethered,Ultrasmall Carbon Fiber Electrodes Mediated by the Photoelectric Effect;Kaylene C. Stocking等;《IEEE TRANSACTIONS ON BIOMEDICAL ENGINEERING》;20190831;第66卷(第8期);第2402-2412页 * |
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