CN116473562A - Intelligent electrode and manufacturing method thereof - Google Patents
Intelligent electrode and manufacturing method thereof Download PDFInfo
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- CN116473562A CN116473562A CN202310735771.4A CN202310735771A CN116473562A CN 116473562 A CN116473562 A CN 116473562A CN 202310735771 A CN202310735771 A CN 202310735771A CN 116473562 A CN116473562 A CN 116473562A
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- 238000004519 manufacturing process Methods 0.000 title claims abstract description 16
- 238000005253 cladding Methods 0.000 claims abstract description 46
- 239000011248 coating agent Substances 0.000 claims description 40
- 238000000576 coating method Methods 0.000 claims description 40
- 238000001746 injection moulding Methods 0.000 claims description 31
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 28
- 239000000741 silica gel Substances 0.000 claims description 28
- 229910002027 silica gel Inorganic materials 0.000 claims description 28
- 238000000034 method Methods 0.000 claims description 16
- 238000002347 injection Methods 0.000 claims description 9
- 239000007924 injection Substances 0.000 claims description 9
- 238000003466 welding Methods 0.000 claims description 8
- 238000004804 winding Methods 0.000 claims description 8
- 229910052751 metal Inorganic materials 0.000 claims description 7
- 239000002184 metal Substances 0.000 claims description 7
- 239000000853 adhesive Substances 0.000 claims description 5
- 230000001070 adhesive effect Effects 0.000 claims description 5
- WABPQHHGFIMREM-UHFFFAOYSA-N lead(0) Chemical group [Pb] WABPQHHGFIMREM-UHFFFAOYSA-N 0.000 claims description 3
- 238000004026 adhesive bonding Methods 0.000 claims description 2
- 210000005036 nerve Anatomy 0.000 abstract description 28
- 230000000694 effects Effects 0.000 abstract description 4
- 230000007547 defect Effects 0.000 abstract description 2
- 210000002569 neuron Anatomy 0.000 description 13
- 238000010586 diagram Methods 0.000 description 5
- 239000000243 solution Substances 0.000 description 4
- 230000007423 decrease Effects 0.000 description 3
- 230000000149 penetrating effect Effects 0.000 description 3
- 229910000566 Platinum-iridium alloy Inorganic materials 0.000 description 2
- 239000004743 Polypropylene Substances 0.000 description 2
- 229920000297 Rayon Polymers 0.000 description 2
- 238000005452 bending Methods 0.000 description 2
- 238000002513 implantation Methods 0.000 description 2
- 238000009434 installation Methods 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 238000000465 moulding Methods 0.000 description 2
- HWLDNSXPUQTBOD-UHFFFAOYSA-N platinum-iridium alloy Chemical class [Ir].[Pt] HWLDNSXPUQTBOD-UHFFFAOYSA-N 0.000 description 2
- 229920001296 polysiloxane Polymers 0.000 description 2
- 210000001519 tissue Anatomy 0.000 description 2
- 230000007704 transition Effects 0.000 description 2
- 239000004809 Teflon Substances 0.000 description 1
- 229920006362 Teflon® Polymers 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 238000004590 computer program Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 210000000944 nerve tissue Anatomy 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- -1 polypropylene Polymers 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 230000004936 stimulating effect Effects 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/25—Bioelectric electrodes therefor
-
- 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
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02E—REDUCTION OF GREENHOUSE GAS [GHG] EMISSIONS, RELATED TO ENERGY GENERATION, TRANSMISSION OR DISTRIBUTION
- Y02E60/00—Enabling technologies; Technologies with a potential or indirect contribution to GHG emissions mitigation
- Y02E60/10—Energy storage using batteries
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- General Health & Medical Sciences (AREA)
- Pathology (AREA)
- Molecular Biology (AREA)
- Surgery (AREA)
- Medical Informatics (AREA)
- Heart & Thoracic Surgery (AREA)
- Physics & Mathematics (AREA)
- Biophysics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Radiology & Medical Imaging (AREA)
- Electrotherapy Devices (AREA)
Abstract
The invention relates to the technical field of electrodes, in particular to an intelligent electrode and a manufacturing method thereof. According to the intelligent electrode and the manufacturing method thereof, the proximal end and the distal end of the electrode are connected through the arranged electrode lead, the two encircling arms arranged in the distal end of the electrode and the cladding body encircle to form the cavity to accommodate nerves, and the encircling arms are arranged to oppositely bend and encircle, so that the formed cavity is only provided with a transverse slit, the cladding effect on the nerves is enhanced, and the defect of subsequent signal acquisition caused by the stretching of the slit after the growth of the nerves is avoided.
Description
Technical Field
The invention relates to the technical field of electrodes, in particular to an intelligent electrode and a manufacturing method thereof.
Background
The intelligent electrode is used as a nerve electrode for recording nerve signals and stimulating nerve tissues, the nerves are required to be wrapped for realizing the recording of the nerve signals, then the signals are collected through an electric contact, the existing intelligent electrode wraps the neurons through a set kafu, a seam is required to be arranged on the side wall of the kafu for introducing the nerves into the kafu, and the electrodes are easy to escape from the kafu due to the existence of the seam, so that the normal use of the electrodes is affected.
Disclosure of Invention
The invention provides an intelligent electrode and a manufacturing method thereof.
In a first aspect, the present invention provides an intelligent electrode comprising: an electrode lead; the sleeve is sleeved outside the electrode lead; the electrode distal end is arranged at one end of the electrode lead; wherein the distal end of the electrode is provided with a cavity with adjustable radial space; and the side wall of the cavity is provided with a transverse slit.
Further, the electrode distal end includes: a coating body for coating the electrode lead; the two encircling arms are respectively positioned at two sides of the cladding body; the electrode plates are respectively positioned on the coating body and communicated with the electrode leads from the inside of the coating body; the free ends of the two encircling arms are oppositely bent to be overlapped so as to form the cavity with the cladding body in a surrounding mode, and therefore the radial space of the cavity is adjustable; and the overlapping part of the two encircling arms forms the transverse seam.
Further, the transverse seam is a cambered surface joint parallel to the side wall, the two sides of the cambered surface joint are free ends of the two encircling arms, and the two ports of the cambered surface joint are respectively led out along the free ends of the two encircling arms.
Further, one port of the transverse slit is positioned on the inner side surface of the cavity, and the other port is positioned on the outer side surface of the cavity.
Further, both ports of the transverse slit are located at the outside surface of the cavity.
Further, the electrode lead includes: a spiral portion and a lead portion; the spiral part is wound by a plurality of single strand guide wires; the lead wire parts are formed by sequentially leading out corresponding single-strand guide wires at the tail ends of the spiral parts along the axial direction of the spiral parts, and are electrically connected with the electrode plates in a one-to-one correspondence manner.
Further, an insulating layer is arranged on the outer side of the single-strand guide wire.
Further, a positioning protrusion matched with the encircling arm for positioning is arranged on the cladding body; the positioning bulge is cylindrical protruding out of the cladding body.
Further, the cladding body and the encircling arm are fixedly installed in an injection molding integrated forming or gluing mode.
Further, the smart electrode also includes a suture line disposed transversely through the cover.
In a second aspect, the present invention provides a method for manufacturing an intelligent electrode, including: preparing an electrode lead; welding electrode plates; and (3) injection molding silica gel.
Further, the preparing an electrode lead includes: coating an insulating coating on the surface of the single strand guide wire; winding a plurality of single-strand guide wires into a spring guide wire, namely a multi-strand parallel-wound spiral part; and sequentially leading out single-strand guide wires at the tail end of the spiral part along the axial direction of the spiral part to form a lead part.
Further, a sleeve is provided outside the spiral portion of the electrode lead.
Further, the welding electrode sheet includes: making the metal sheet into an electrode sheet to form a contact part of a concave cambered surface and a connecting part which is arranged back to the concave cambered surface; a plurality of through holes are arranged on the connecting part; stripping the insulating coating at the tail end of the lead part to expose the guide wire; the guide wire at the end of the lead portion is inserted and soldered in any one of the through holes.
Further, the injection molding silica gel includes: two encircling arms are independently injection molded by using silica gel; the first core rod and the second core rod are respectively inserted into the spiral part of the electrode lead and the concave cambered surface of the electrode plate; forming an arch structure with a concave cambered surface on the inner wall by utilizing a silica gel injection molding coating body; two encircling arms are arranged on two sides of the cladding body.
Further, mounting two encircling arms on both sides of the cladding body includes: the top of the encircling arm is a fixed end; the fixed ends of the two encircling arms are respectively clamped and positioned with positioning bulges at two sides of the cladding body, and the free ends of the two encircling arms are adjusted to be oppositely bent to overlap, so that a cavity with adjustable radial space is formed by encircling the inner wall of the arch structure; and the contact surfaces of the two encircling arms and the cladding body are fixedly arranged in a viscose manner.
Further, the injection molding silica gel includes: the first encircling arm is independently injection molded by silica gel; the first core rod and the second core rod are respectively inserted into the spiral part of the electrode lead and the concave cambered surface of the electrode plate; the coating body is integrally molded by utilizing silica gel injection molding, and the second encircling arm is positioned at one side of the coating body; the first encircling arm is mounted on the opposite side of the cladding.
Further, mounting the first embracing arm on the opposite side of the cladding body includes: the top of the first encircling arm is a fixed end; the fixed end of the first encircling arm is clamped and positioned with a positioning protrusion on the other side opposite to the cladding body, and the free end of the first encircling arm and the free end of the second encircling arm are adjusted to be oppositely bent to overlap, so that a cavity with adjustable radial space is formed by encircling the inner wall of the arch structure; and fixedly mounting the first encircling arm and the contact surface of the cladding body in a viscose manner.
Further, the injection molding silica gel includes: the first core rod and the second core rod are respectively inserted into the spiral part of the electrode lead and the concave cambered surface of the electrode plate; a diaphragm is arranged on the surface of the second core rod, a first end of the diaphragm is in contact with the outer surface of the second core rod, and the second end of the diaphragm stretches at a certain angle around the outer surface of the second core rod; utilize silica gel injection molding's cladding body and be located two surrounding arms of cladding body both sides.
Further, several sutures were placed transversely over and perpendicular to the electrode leads before injection molding of the silicone to allow the sutures to penetrate the cover after injection molding.
The intelligent electrode and the manufacturing method thereof have the beneficial effects that the electrode lead wire is connected with the electrode far end, the two encircling arms arranged in the electrode far end and the cladding body encircle to form the cavity for accommodating the nerve, and the encircling arms are arranged to oppositely bend and encircle, so that the formed cavity only has a transverse seam, the cladding effect on the nerve is enhanced, and the defect of subsequent signal acquisition caused by the extension of the seam after the nerve grows is avoided.
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 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 drawings.
In order to make the above objects, features and advantages of the present invention more comprehensible, preferred embodiments accompanied with figures are described in detail below.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are needed in the description of the embodiments or the prior art will be briefly described, and it is obvious that the drawings in the description below are some embodiments of the present invention, and other drawings can be obtained according to the drawings without inventive effort for a person skilled in the art.
FIG. 1 is a perspective view of a smart electrode of the present invention;
FIG. 2 is a perspective view of a smart electrode of the present invention;
FIG. 3 is a schematic cross-sectional view of a smart electrode of the present invention;
FIG. 4 is a top perspective view of the smart electrode of the present invention;
fig. 5 is a schematic diagram of the connection of the electrode leads and electrode sheets of the present invention;
FIG. 6 is a schematic front view of the intelligent electrode of the present invention after two encircling arms are encircling;
FIG. 7 is a prior art schematic drawing referred to in the background of the invention;
FIG. 8 is a flow chart of a method of manufacturing a smart electrode of the present invention;
FIG. 9 is a perspective view of a smart electrode with suture according to the present invention;
FIG. 10 is a left side view of the smart electrode with suture of the present invention;
fig. 11 is a top perspective view of a smart electrode of the present invention with a positioning protrusion in the shape of a cylinder.
In the figure:
an electrode lead 1, a spiral portion 10, and a lead portion 11;
a cannula 2, an electrode proximal end 3;
the electrode distal end 4, the cladding body 41, the positioning protrusion 411, the encircling arm 42, the fixed end 421, the free end 422, the transverse slit 423, the port 424 of the transverse slit, the electrode sheet 43, the contact portion 431, the connecting portion 432, the hole structure 433;
a cavity 5;
a transition 6.
Detailed Description
For the purpose of making the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings, and it is apparent that the described embodiments are some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
As shown in fig. 1 to 11, the present embodiment provides an intelligent electrode, including: an electrode lead 1; the sleeve 2 is sleeved outside the electrode lead 1; an electrode distal end 4 provided at one end of the electrode lead 1; the electrode distal end 4 comprises: a cover 41 for covering one end of the electrode lead 1; two encircling arms 42 which are respectively positioned at two sides of the cladding body 41; a plurality of electrode tabs 43 respectively disposed on the covering body 41 and communicated with the electrode lead 1 from the inside of the covering body 41; the free ends 422 of the two encircling arms 42 are oppositely bent to overlap so as to enclose a cavity 5 (or a Carff) with the cladding body 41; and a transverse slit 423 is formed at the overlapping position of the two encircling arms 42 so that the radial space of the cavity is adjustable. The electrode leads 1 are multi-stranded cables or multi-core cables, and are respectively connected with the corresponding electrode plates 43 in a one-to-one correspondence manner, and the other ends of the electrode leads 1 can output signals collected by the electrode plates 43 through connectors at the proximal ends of the electrodes.
Because the nerve is located in the cavity 5, the nerve can prop open the seam of the carper in the growth process or grow along the seam in a penetrating way, the sealing treatment of the seam in the prior art is generally to plug the seam from the outside of the seam through an additional component, and the problem of the suture prop open is not fundamentally solved. For example, patent CN109310859a discloses an implantable cuff electrode, specifically shown in fig. 7, which covers a nerve B by a tubular flexible cuff D, and closes a longitudinal seam C of the flexible cuff by bending a first lip a extending on the cuff and a second lip a in the same direction. The entrance of the longitudinal seam is sealed by the first lip A and the second lip A, when the nerve grows naturally, the seam can be obviously swelled, the exit of the seam faces the nerve, and the angle of the exit can enable the nerve to easily enter the inside of the longitudinal seam C along the exit or grow along the exit of the nerve and even escape out of the Kafu electrode.
To fundamentally solve the problem of slit opening, the present solution places the slit direction of the kafu transversely, i.e. axially parallel, instead of longitudinally (radially) as in CN109310859 a. Referring to fig. 1 and 6, the electrode proximal end 3 and the electrode distal end 4 are connected through the electrode lead 1, and two encircling arms 42 arranged in the electrode distal end 4 encircle the cladding 41 to form a cavity to accommodate neurons, and the encircling arms 42 are arranged to bend and encircle the formed cavity in opposite directions, so that the formed cavity is only provided with a transverse seam 423, the transverse seam 423 is a cambered surface seam parallel to the side wall, the two sides of the cambered surface seam are free ends 422 of the two encircling arms 42, when the radial growth of the nerve is faced, the free ends 422 of the inner encircling arms 42 positioned at the overlapping position are close to the free ends 422 of the outer encircling arms 42, and the transverse seam 423 at the overlapping position of the two encircling arms is contracted instead of being opened, so that the cladding effect of the cavity on the nerve is ensured. Simultaneously, two ports 424 of the cambered surface joint extend and are led out along the inner sides of the free ends 422 of the two encircling arms 42 respectively, so that the direction of the transverse slits 423 is changed, the phenomenon that the slits are opposite to nerves in the radial direction is avoided, the neurons can be prevented from growing along the slits in a penetrating way, and even if the neurons encounter radial external force, the directions of the external force are not opposite to the slits, so that the neurons are clamped in the slits. The lateral or axial direction in this case refers to the direction along the length of a parallel neuron or the direction parallel to the length of a neuron, and the radial direction in this case refers to the direction perpendicular to the length of a neuron.
Preferably, as seen in fig. 6, the thickness of the two encircling arms 42 decreases gradually from one end (fixed end 421) adjacent to the cover 41 to the free end 422. The thickness of the two encircling arms 42 is gradually reduced, so that the fit degree between the two encircling arms 42 can be increased, and the edge of the port 424 of the transverse seam, especially the port 424 positioned at the inner side of the cavity 5, can be prevented from damaging nerves.
Preferably, in this embodiment, the overlap of the two embracing arms 42 is in contact so that the cavity is closed in the radial direction.
As an alternative embodiment of the cavity.
Referring to fig. 6, the free ends 422 of the two encircling arms 42 are stacked inside and outside, where one port 424 of the transverse slot 423 is located on the inside surface of the cavity 5 and the other port 424 is located on the outside surface of the cavity 5. By controlling the installation angle of the two encircling arms 42 or the bending radian of the encircling arms 42, the overlapped parts of the two encircling arms are close to and even contact with each other as much as possible, and the closing of the transverse slits 423 is ensured, so that the radially closed cavity 5 is formed. The radial space of the cavity 5 can follow the nerve variation, and the size of the transverse slit 423 remains unchanged or decreases; for example, after the nerve grows, the radial space of the cavity 5 becomes larger, and the space at the overlap of the two encircling arms 42 instead decreases or contacts more tightly. Since the structure of the two embracing arms 42 is symmetrical, any embracing arm 42 can be installed on the inner side.
As an alternative embodiment of the cavity.
The free ends 422 of the two encircling arms 42 are in a cross overlapping manner, for example, the free ends 422 of the two encircling arms 42 are arranged in a rake tooth shape, so that the two free ends can be in cross overlapping, at this time, the two ports 424 of the transverse slit 423 are both positioned on the outer side surface of the cavity 5, which in principle can completely close the transverse slit of the cavity 5, and the escape difficulty of the nerve from the interior of the cavity 5 can be increased. Meanwhile, the free ends 422 of the two encircling arms 42 can be prevented from contacting neurons, so that the problem that the neurons are damaged due to the fact that the free ends 422 of the two encircling arms 42 are not attached to the inner wall of the cavity 5 is fundamentally solved.
In this embodiment, see fig. 2 and 5, the electrode lead 1 includes: a spiral portion 10 and a lead portion 11; the spiral part 10 is wound by a plurality of single strand guide wires; the lead portions 11 are formed by sequentially drawing out respective corresponding single-strand guide wires at the ends of the spiral portion 10 in the axial direction of the spiral portion 10, and are electrically connected to the electrode pads 43 in one-to-one correspondence.
In this embodiment, the guide wire includes, but is not limited to, platinum iridium alloy, and an insulating layer, such as a teflon coating, is arranged on the outer side of the single-strand guide wire to perform an insulating function. Preferably, the number of the electrode sheets 43 is selected to be plural, and the number of the guide wires is plural. For example, the number of the electrode sheets 43 is 3, and at this time, the number of the guide wires is 3, the three guide wires are spirally wound to form the spiral portion 10, and the distal ends of the respective guide wires are led out to form the lead portions 11 so as to be connected to the electrode sheets 43 in a one-to-one correspondence.
In the present embodiment, see fig. 2 and 3, the electrode sheet 43 includes: a connection portion 432 located inside the cover 41 and a contact portion 431 located on the connection portion 432; the contact portion 431 is exposed on the inner wall of the cavity 5; the connection parts 432 are electrically connected to the lead parts 11 in one-to-one correspondence.
In this embodiment, the electrode plate 43 is made of platinum iridium alloy, and the contact portion 431 of the electrode plate 43 is exposed on the inner wall of the cavity, so that when the neuron is wrapped in the cavity, the contact portion 431 contacts with the neuron, thereby acquiring an electrical signal of the neuron, and transmitting the electrical signal to the electrode lead 1 through the connection portion 432.
In this embodiment, as shown in fig. 2, the connecting portion 432 is provided with a plurality of hole structures 433; the lead portion 11 is adapted to be inserted into any one of the hole structures 433 and electrically connected to the connection portion 432.
In this embodiment, as one way of the hole structures 433, the hole structures 433 are through holes, and the lead portion 11 is connected to the hole structures 433 by laser welding after penetrating any through hole. The electrode tab 43 is easily connected to the electrode lead 1 by the hole structures 433.
In this embodiment, as shown in fig. 3, a surface of the contact portion 431 exposed on the inner wall of the cavity is a concave arc surface; referring to fig. 4, the connection portion 432 is disposed opposite to the concave arc surface and is biased to one side to form the accommodating space of the screw portion 10.
Preferably, since the shape profile of the connecting portion 432 is smaller than that of the contact portion 431, the contact portion 431 is exposed on the surface of the covering body 41, the electrode plate 43 is made of metal, and the adhesion effect with the silica gel is poor, so that the electrode plate is easy to loosen or fall off, and thus the hole structures 433 on each electrode plate 43 are all through holes and have a plurality of holes, not only the distal end of the electrode lead 1 can be covered, but also the silica gel can be injected into the remaining through holes except the through holes for welding the electrode plate and be connected with the covering body 41 into a whole, so that the electrode plate 43 can be prevented from falling off from the covering body 41.
In this embodiment, the cover 41 and the encircling arm 42 are fixedly mounted by injection molding.
In this embodiment, when the wrapping body 41 and the encircling arm 42 are fixedly mounted in an adhesive manner, the side wall of the wrapping body 41 is provided with a positioning protrusion 411 and is clamped with a groove provided on the fixed end 421 of the encircling arm 42, so that connection is achieved. Generally, the positioning protrusion 411 is elongated and protrudes from the covering body 41. Preferably, as shown in fig. 11, the positioning protrusion 411 has a cylindrical shape protruding from the cover 41.
In this embodiment, referring to fig. 2, a sleeve 2 is sleeved outside the spiral portion 10 of the electrode lead 1. When the cover 41 is integrally formed by injection molding, a transition portion 6 integrally formed with the cover 41 is also formed between the cover 41 and the sleeve 2.
In this embodiment, see fig. 9 and 10, several sutures 7 are provided transversely (i.e. perpendicular to the axial direction of the lumen 5) through the envelope and above the electrode lead 1. When the cover 41 is injection molded, the suture 7 penetrates the cover 41. The suture 7 is made of flexible materials, such as PP wires and polypropylene materials, and the two ends of the suture 7 are exposed out of the coating 41, so that the matching relationship of other parts is not affected, and the suture 7 is embedded into the coating 41 by injection molding, so that the suture 7 can be prevented from moving. Both ends of the suture 7 are left with a margin for binding or winding on tissue during the implantation procedure to further limit the implantation position of the smart electrode.
As shown in fig. 8, in another aspect, the present invention further provides a method for manufacturing an intelligent electrode, including: preparing an electrode lead 1; welding the electrode sheet 43; and (3) injection molding silica gel.
In this embodiment, the preparing electrode lead 1 includes: coating an insulating coating on the surface of the single strand guide wire; winding a plurality of single strands of guide wires into a spring guide wire, namely a multi-strand parallel wound spiral part 10; a single-strand guide wire is sequentially drawn out at the end of the spiral part 10 in the axial direction of the spiral part 10 to form a lead part 11.
In this embodiment, the welding electrode sheet 43 includes: the metal sheet is made into an electrode sheet 43 to form a contact portion 431 of a concave cambered surface and a connecting portion 432 arranged opposite to the concave cambered surface; a plurality of through holes are provided on the connection portion 432; stripping the insulating coating at the tail end of the lead part 11 to expose the guide wire; a guide wire at the end of the lead portion 11 is inserted and soldered in any one of the through holes.
In this embodiment, there are various ways of molding the silicone, for example, the two encircling arms 42 and the cover 41 may be formed by injection molding; or one encircling arm 42 and the cladding body 41 are formed in an injection molding integrated mode, and the other encircling arm 42 and the cladding body 41 are installed in an installation mode; or the two encircling arms 42 and the cladding body 41 can be respectively and independently injection molded, and the two encircling arms 42 are both arranged on the cladding body 41. According to the different modes of injection molding silica gel, various manufacturing methods of the intelligent electrode can be obtained, specifically comprising the following steps:
as a first embodiment for making the smart electrode.
(1) Coating an insulating coating on the surface of the single strand guide wire; winding a plurality of single strands of guide wires into a spring guide wire, namely a multi-strand parallel wound spiral part 10; a single-strand guide wire is sequentially drawn out at the end of the spiral part 10 in the axial direction of the spiral part 10 to form a lead part 11.
(2) The metal sheet is made into an electrode sheet 43 to form a contact portion 431 of a concave cambered surface and a connecting portion 432 arranged opposite to the concave cambered surface; a plurality of through holes are provided on the connection portion 432; stripping the insulating coating at the tail end of the lead part 11 to expose the guide wire; a guide wire at the end of the lead portion 11 is inserted and soldered in any one of the through holes.
(3) A sleeve 2 is sleeved outside the spiral part 10 of the electrode lead 1.
(4) The encircling arms 42 of the two J-shaped structures are independently injection molded by using silica gel, and the top of the J-shaped structure is a fixed end 421.
(5) Inserting the first core rod and the second core rod into the spiral part 10 of the electrode lead 1 and the concave cambered surface of the electrode plate 43 respectively; the inner wall of the cover body 41 is formed into an arch structure with a concave cambered surface by using silica gel injection molding.
(6) The fixed ends 421 of the two encircling arms 42 are respectively clamped and positioned with the two sides of the cladding body 41, and the free ends 422 of the two encircling arms 42 are adjusted to be oppositely bent and overlapped so as to form a cavity with adjustable radial space with the inner wall of the arch structure.
(7) The contact surfaces of the fixed ends 421 of the two encircling arms 42 and the coating body 41 are fixedly arranged in an adhesive mode.
As a second embodiment for making intelligent electrodes.
(1) Coating an insulating coating on the surface of the single strand guide wire; winding a plurality of single strands of guide wires into a spring guide wire, namely a multi-strand parallel wound spiral part 10; a single-strand guide wire is sequentially drawn out at the end of the spiral part 10 in the axial direction of the spiral part 10 to form a lead part 11.
(2) The metal sheet is made into an electrode sheet 43 to form a contact portion 431 of a concave cambered surface and a connecting portion 432 arranged opposite to the concave cambered surface; a plurality of through holes are provided on the connection portion 432; stripping the insulating coating at the tail end of the lead part 11 to expose the guide wire; a guide wire at the end of the lead portion 11 is inserted and soldered in any one of the through holes.
(3) A sleeve 2 is sleeved outside the spiral part 10 of the electrode lead 1.
(4) Utilize the independent J-shaped structure's of moulding plastics of silica gel first embracing arm 42, the top of first embracing arm 42 is stiff end 421.
(5) Inserting the first core rod and the second core rod into the spiral part 10 of the electrode lead 1 and the concave cambered surface of the electrode plate 43 respectively; a cover 41 integrally formed by injection molding of silica gel and a second encircling arm 42 positioned on one side of the cover 41.
(6) The fixed end 421 of the first encircling arm 42 is clamped and positioned with the opposite side of the cladding body 41, and the free end 422 of the first encircling arm 42 and the free end 422 of the second encircling arm 42 are adjusted to be oppositely bent and overlapped, so that a cavity with adjustable radial space is formed by surrounding the inner wall of the arch structure.
(7) The contact surface between the fixed end 421 of the first encircling arm 42 and the cladding body 41 is fixedly mounted by an adhesive mode.
As a third embodiment for making the intelligent electrode.
(1) Coating an insulating coating on the surface of the single strand guide wire; winding a plurality of single strands of guide wires into a spring guide wire, namely a multi-strand parallel wound spiral part 10; a single-strand guide wire is sequentially drawn out at the end of the spiral part 10 in the axial direction of the spiral part 10 to form a lead part 11.
(2) The metal sheet is made into an electrode sheet 43 to form a contact portion 431 of a concave cambered surface and a connecting portion 432 arranged opposite to the concave cambered surface; a plurality of through holes are provided on the connection portion 432; stripping the insulating coating at the tail end of the lead part 11 to expose the guide wire; a guide wire at the end of the lead portion 11 is inserted and soldered in any one of the through holes.
(3) A sleeve 2 is sleeved outside the spiral part 10 of the electrode lead 1.
(4) Inserting the first core rod and the second core rod into the spiral part 10 of the electrode lead 1 and the concave cambered surface of the electrode plate 43 respectively; a diaphragm is arranged on the surface of the second core rod, a first end of the diaphragm is in contact with the outer surface of the second core rod, and the second end of the diaphragm stretches at a certain angle around the outer surface of the second core rod; the cover 41 is integrally formed by injection molding of silica gel, and two encircling arms 42 are positioned on two sides of the cover 41.
As a fourth embodiment for making the intelligent electrode.
The sleeve 2 is not sleeved outside the spiral part 10 of the electrode lead 1, the sleeve 2 is injection molded outside the spiral part 10 of the electrode lead 1 during injection molding, and the rest of the steps can refer to any one of the first, second and third embodiments for manufacturing the intelligent electrode.
As a fifth embodiment for making the intelligent electrode.
The electrode lead 1 is a multi-strand side-by-side cable or a multi-core cable and is solid, a first core rod is not needed, and only a second core rod is needed to be respectively inserted into the concave cambered surface of the electrode plate 43; the remaining steps may refer to any of the first, second, third, fourth embodiments of making the smart electrode.
As a sixth embodiment for fabricating the intelligent electrode.
A plurality of sutures 7 are transversely arranged above the electrode lead 1, after the coating body 41 is injection molded, two ends of the sutures are exposed out of the coating body 41 and leave a margin for binding or winding tissues, and the rest of the steps can refer to any one of the first, second, third, fourth and fifth embodiments for manufacturing the intelligent electrode.
In summary, according to the intelligent electrode and the manufacturing method thereof, the proximal end and the distal end of the electrode are connected through the arranged electrode lead 1, the two encircling arms 42 arranged in the distal end 4 of the electrode and the cladding 41 encircle to form a cavity for accommodating the nerve, and the encircling arms 42 are arranged to oppositely bend and encircle, so that the formed cavity is only provided with a transverse seam, and the problem that the nerve penetrates along the seam to be produced or the nerve enters the seam by radial external force is fundamentally avoided through changing the direction of the seam.
In the several embodiments provided in this application, it should be understood that the disclosed apparatus and method may be implemented in other manners as well. The apparatus embodiments described above are merely illustrative, for example, of the flowcharts and block diagrams in the figures that illustrate the architecture, functionality, and operation of possible implementations of apparatus, methods and computer program products according to various embodiments of the present invention. In this regard, each block in the flowchart or block diagrams may represent a module, segment, or portion of code, which comprises one or more executable instructions for implementing the specified logical function(s). It should also be noted that in some alternative implementations, the functions noted in the block may occur out of the order noted in the figures. For example, two blocks shown in succession may, in fact, be executed substantially concurrently, or the blocks may sometimes be executed in the reverse order, depending upon the functionality involved. It will also be noted that each block of the block diagrams and/or flowchart illustration, and combinations of blocks in the block diagrams and/or flowchart illustration, can be implemented by special purpose hardware-based systems which perform the specified functions or acts, or combinations of special purpose hardware and computer instructions.
In the description of the present invention, it should be noted that the directions or positional relationships indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. are based on the directions or positional relationships shown in the drawings, are merely for convenience of describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.
With the above-described preferred embodiments according to the present invention as an illustration, the above-described descriptions can be used by persons skilled in the relevant art to make various changes and modifications without departing from the scope of the technical idea of the present invention. The technical scope of the present invention is not limited to the description, but must be determined according to the scope of claims.
Claims (20)
1. An intelligent electrode, characterized by comprising:
an electrode lead;
the sleeve is sleeved outside the electrode lead;
the electrode distal end is arranged at one end of the electrode lead; wherein the method comprises the steps of
The distal end of the electrode is provided with a cavity with adjustable radial space; and
the side wall of the cavity is provided with a transverse slit.
2. The intelligent electrode of claim 1, wherein the electrode comprises a plurality of electrodes,
the electrode distal end includes:
a coating body for coating the electrode lead; and
the two encircling arms are respectively positioned at two sides of the cladding body;
the electrode plates are respectively positioned on the coating body and communicated with the electrode leads from the inside of the coating body; wherein the method comprises the steps of
The free ends of the two encircling arms are oppositely bent to overlap so as to form the cavity with the cladding body in a surrounding way, so that the radial space of the cavity is adjustable; and
the overlapping part of the two encircling arms forms the transverse seam.
3. The intelligent electrode according to claim 2, wherein,
the transverse seam is a cambered surface seam parallel to the side wall, two sides of the cambered surface seam are free ends of two encircling arms, and two ports of the cambered surface seam extend and are led out along the free ends of the two encircling arms respectively.
4. The intelligent electrode according to claim 3, wherein,
one port of the transverse slit is positioned on the inner side surface of the cavity, and the other port is positioned on the outer side surface of the cavity.
5. The intelligent electrode according to claim 3, wherein,
both ports of the transverse slit are located on the outside surface of the cavity.
6. The intelligent electrode of claim 1, wherein the electrode comprises a plurality of electrodes,
the electrode lead includes: a spiral portion and a lead portion;
the spiral part is wound by a plurality of single strand guide wires;
the lead wire parts are formed by sequentially leading out corresponding single-strand guide wires at the tail ends of the spiral parts along the axial direction of the spiral parts, and are electrically connected with the electrode plates in a one-to-one correspondence manner.
7. The intelligent electrode according to claim 6, wherein,
an insulating layer is arranged on the outer side of the single-strand guide wire.
8. The intelligent electrode according to claim 2, wherein,
the wrapping body is provided with a positioning protrusion matched with the encircling arm for positioning;
the positioning bulge is cylindrical protruding out of the cladding body.
9. The intelligent electrode according to claim 2, wherein,
the cladding body and the encircling arm are fixedly arranged in an injection molding integrated forming or gluing mode.
10. The intelligent electrode according to claim 2, wherein,
the intelligent electrode further comprises a plurality of sutures which transversely penetrate through the coating body.
11. The manufacturing method of the intelligent electrode is characterized by comprising the following steps of:
preparing an electrode lead;
welding electrode plates; and
and (5) injection molding of silica gel.
12. The method of claim 11, wherein,
the preparing of the electrode lead includes:
coating an insulating coating on the surface of the single strand guide wire;
winding a plurality of single-strand guide wires into a spring guide wire, namely a multi-strand parallel-wound spiral part;
and sequentially leading out single-strand guide wires at the tail end of the spiral part along the axial direction of the spiral part to form a lead part.
13. The method of claim 12, wherein,
a sleeve is sleeved outside the spiral part of the electrode lead.
14. The method of claim 11, wherein,
the welding electrode sheet includes:
making the metal sheet into an electrode sheet to form a contact part of a concave cambered surface and a connecting part which is arranged back to the concave cambered surface;
a plurality of through holes are arranged on the connecting part;
stripping the insulating coating at the tail end of the lead part to expose the guide wire;
the guide wire at the end of the lead portion is inserted and soldered in any one of the through holes.
15. The method of claim 12, wherein,
the injection molding silica gel comprises:
two encircling arms are independently injection molded by using silica gel;
the first core rod and the second core rod are respectively inserted into the spiral part of the electrode lead and the concave cambered surface of the electrode plate;
forming an arch structure with a concave cambered surface on the inner wall by utilizing a silica gel injection molding coating body;
two encircling arms are arranged on two sides of the cladding body.
16. The method of claim 15, wherein,
installing two encircling arms on both sides of the cladding body comprises:
the top of the encircling arm is a fixed end;
the fixed ends of the two encircling arms are respectively clamped and positioned with positioning bulges at two sides of the cladding body, and the free ends of the two encircling arms are adjusted to be oppositely bent to overlap, so that a cavity with adjustable radial space is formed by encircling the inner wall of the arch structure; and
the contact surface between the fixed end of the encircling arm and the cladding body is fixedly arranged in an adhesive mode.
17. The method of claim 11, wherein,
the injection molding silica gel comprises:
the first encircling arm is independently injection molded by silica gel;
the first core rod and the second core rod are respectively inserted into the spiral part of the electrode lead and the concave cambered surface of the electrode plate;
the coating body is integrally molded by utilizing silica gel injection molding, and the second encircling arm is positioned at one side of the coating body;
the first encircling arm is mounted on the opposite side of the cladding.
18. The method of claim 17, wherein,
mounting the first encircling arm on the other side of the cladding body includes:
the top of the first encircling arm is a fixed end;
the fixed end of the first encircling arm is clamped and positioned with a positioning protrusion on the other side opposite to the cladding body, and the free end of the first encircling arm and the free end of the second encircling arm are adjusted to be oppositely bent to overlap, so that a cavity with adjustable radial space is formed by encircling the inner wall of the arch structure; and
the contact surface of the first encircling arm and the cladding body is fixedly arranged in an adhesive mode.
19. The method of claim 11, wherein,
the injection molding silica gel comprises:
the first core rod and the second core rod are respectively inserted into the spiral part of the electrode lead and the concave cambered surface of the electrode plate;
a diaphragm is arranged on the surface of the second core rod, a first end of the diaphragm is in contact with the outer surface of the second core rod, and the second end of the diaphragm stretches at a certain angle around the outer surface of the second core rod;
utilize silica gel injection molding's cladding body and be located two surrounding arms of cladding body both sides.
20. The method of manufacturing of claim 11, further comprising:
before the injection molding of the silica gel, a plurality of sutures are transversely placed above the electrode leads and are vertically arranged with the electrode leads, so that the sutures penetrate through the coating body after the injection molding.
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| CN202310735771.4A CN116473562A (en) | 2023-06-21 | 2023-06-21 | Intelligent electrode and manufacturing method thereof |
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| CN202310735771.4A CN116473562A (en) | 2023-06-21 | 2023-06-21 | Intelligent electrode and manufacturing method thereof |
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