CN114602060B - Intelligent electrode and manufacturing method thereof - Google Patents
Intelligent electrode and manufacturing method thereof Download PDFInfo
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- CN114602060B CN114602060B CN202210500116.6A CN202210500116A CN114602060B CN 114602060 B CN114602060 B CN 114602060B CN 202210500116 A CN202210500116 A CN 202210500116A CN 114602060 B CN114602060 B CN 114602060B
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- electrode
- spiral guide
- guide wire
- tube
- stimulation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0526—Head electrodes
- A61N1/0529—Electrodes for brain stimulation
- A61N1/0534—Electrodes for deep brain stimulation
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
- B29C45/14—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor incorporating preformed parts or layers, e.g. injection moulding around inserts or for coating articles
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
- B29C45/14—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor incorporating preformed parts or layers, e.g. injection moulding around inserts or for coating articles
- B29C45/1418—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor incorporating preformed parts or layers, e.g. injection moulding around inserts or for coating articles the inserts being deformed or preformed, e.g. by the injection pressure
Abstract
The invention discloses an intelligent electrode and a manufacturing method thereof. The intelligent electrode includes: the device comprises a catheter, wherein an interlayer is arranged in the catheter, one end of the catheter is provided with a stimulation unit, and the other end of the catheter is provided with a connecting unit; the spiral guide wires are arranged in the interlayer, one ends of the spiral guide wires are connected with the stimulation unit, and the other ends of the spiral guide wires are connected with the connecting unit. According to the invention, through mutual matching of the inner tube, the outer tube and the spiral guide wire, micro-deformation of the intelligent electrode can be realized, so that the intelligent electrode has the capabilities of posture change and length change and can adapt to skull growth; meanwhile, the two ends of the outer pipe form a necking part in contact with the inner pipe through a pipe shrinkage process, an interlayer can be sealed, the overall compactness and the sealing performance of the intelligent electrode are improved, and the influence of spiral guide wire shaking on signal acquisition is reduced.
Description
Technical Field
The invention relates to the technical field of intelligent electrodes, in particular to an intelligent electrode and a manufacturing method thereof.
Background
The deep brain electrical stimulation system belongs to a kind of implanted nerve stimulation system, taking the deep brain electrical stimulation system as an example, mainly comprises a pulse generator implanted in a body, an electrode and a control device in vitro. The electrode is connected with the pulse generator, and the pulse generated by the pulse generator is transmitted to a specific nerve part to generate electrical stimulation, so that the normal human body function of the corresponding part is recovered. Deep brain stimulation may be used to treat a variety of diseases, including, for example, parkinson's disease, dystonia, essential tremor, chronic pain, and the like.
Currently, the flexibility of the existing intelligent electrodes is poor, for example, when the skull of a patient grows and the brain develops, the intelligent electrodes can be pulled, bent or compressed. If the flexibility of the intelligent electrode is poor, the intelligent electrode can be damaged, and further signal acquisition or transmission failure is caused, and the patient needs to be operated.
Disclosure of Invention
The technical problem to be solved by the invention is as follows: in order to solve the technical problem of poor posture change capability of the intelligent electrode in the prior art, the invention provides the intelligent electrode and the manufacturing method thereof, which can improve the deformation capability of the intelligent electrode so as to meet the posture change and the length change of the intelligent electrode.
In a first aspect, the technical solution adopted to solve the technical problem of the present invention is: a smart electrode comprising: the device comprises a catheter, wherein an interlayer is arranged in the catheter, one end of the catheter is provided with a stimulation unit, and the other end of the catheter is provided with a connecting unit; the spiral guide wires are installed in the interlayer, one ends of the spiral guide wires are connected with the stimulation unit, and the other ends of the spiral guide wires are connected with the connection unit.
Further, the catheter comprises an inner tube and an outer tube, the outer tube having an inner diameter larger than an outer diameter of the inner tube such that the interlayer is formed between the outer tube and the inner tube; the length of the outer pipe is smaller than that of the inner pipe, and necking parts which are in contact with the inner pipe are arranged at two ends of the outer pipe so as to seal the interlayer.
Furthermore, two ends of the inner tube extend out of the necking part to form a stimulation section and a connecting section; the stimulation unit comprises a plurality of stimulation electrodes sleeved on the stimulation section, and the plurality of stimulation electrodes are all sleeved on the inner tube; the connecting unit comprises a fixing ring and a plurality of connecting electrodes, the fixing ring and the connecting electrodes are sleeved on the connecting section, and the connecting electrodes are sleeved on the inner tube; the outer tube is positioned between the stimulation unit and the connection unit; the fixed ring and the stimulating electrode closest to the end part of the outer tube are respectively sleeved at the joint of the corresponding necking part and the stimulating section; the outer side fixing ring is positioned at the joint of the other necking part and the connecting section.
Furthermore, an insulating layer is arranged on the outer side of the spiral guide wire and is wound on the inner tube in a multi-wire parallel winding mode; two ends of the spiral guide wire respectively extend out of the end part of the outer tube and are fixed through corresponding necking parts; and the two ends of the spiral guide wire are respectively connected with the stimulating electrodes and the connecting electrodes in a one-to-one correspondence manner.
Furthermore, the spiral guide wire is provided with a first circuitous part in the stimulating electrode and is welded on the stimulating electrode through an exposed core wire at the end part of the spiral guide wire; and a second circuitous part is arranged in the spiral guide wire and the connecting electrode and is welded on the connecting electrode through an exposed core wire at the end part of the spiral guide wire.
Furthermore, the plurality of stimulating electrodes are distributed at equal intervals, and silica gel is filled in the stimulating electrodes and at intervals.
Furthermore, the plurality of connecting electrodes are distributed at equal intervals, and the fixing ring and the connecting electrodes are filled with resin at the inner part and the intervals.
Further, the thread pitch of the spiral guide wire is 2mm-4 mm; and silica gel is filled in the interlayer.
In a second aspect, the present invention further provides a method for manufacturing an intelligent electrode, including the following steps:
step S1, winding the spiral guide wire on the outer side of the inner tube;
step S2, sleeving an outer tube outside the spiral guide wire;
step S3, the length of the inner tube is longer than that of the outer tube, so that the two ends of the inner tube extend out of the outer tube to form a stimulation section and a connecting section; sleeving a plurality of stimulating electrodes on the stimulating sections respectively, and sleeving a fixing ring and a plurality of connecting electrodes on the connecting sections respectively;
step S4, connecting one end of the spiral guide wire with a stimulating electrode, and connecting the other end of the spiral guide wire with a connecting electrode;
step S5, inserting a tube core needle for supporting from the end of the connecting section to the inner part of the inner tube, and ensuring that one end of the tube core needle does not protrude out of the stimulating section and the other end of the tube core needle protrudes out of the connecting section;
step S6, performing a tube shrinking process through the stimulating electrode and the fixing ring which are closest to the end part of the outer tube, and deforming and shrinking the end part of the outer tube and the inner tube at the position to form a necking part which is contacted with the outer side surface of the inner tube at the end part of the outer tube;
and step S7, performing segmented injection molding on the stimulating electrode and the connecting electrode.
Further, the step S4 includes:
penetrating one end of the spiral guide wire into the stimulating electrode and leading the end of the spiral guide wire back to the end part of the stimulating electrode through a first roundabout part, stripping an insulating layer at one end of the spiral guide wire, and welding the exposed core wire at one end of the spiral guide wire with the stimulating electrode;
and penetrating the other end of the spiral guide wire into the connecting electrode and leading the other end of the spiral guide wire back to the end part of the connecting electrode through a second roundabout part, stripping the insulating layer at the other end of the spiral guide wire, and welding the exposed core wire at the other end of the spiral guide wire with the connecting electrode.
The invention has the beneficial effects that the micro-deformation of the intelligent electrode can be realized through the mutual matching of the inner tube, the outer tube and the spiral guide wire, so that the intelligent electrode has the capabilities of posture change and length change and can adapt to the growth of the skull; meanwhile, the integral compactness and the sealing performance of the intelligent electrode can be improved, and the influence of the shaking of the spiral guide wire on signal acquisition is reduced; the first roundabout part and the second roundabout part can prevent the spiral guide wire from being broken due to excessive pulling, and signal acquisition or transmission interruption is prevented; the spiral guide wire can be welded with the end part of the electrode after being circuitous, and the welding spot is arranged at the end part of the electrode, so that the welding difficulty can be reduced.
Drawings
The invention is further illustrated with reference to the following figures and examples.
FIG. 1 is a flow chart of a method of making a smart electrode of the present invention.
Fig. 2 is a schematic diagram of the structure of the smart electrode of the present invention.
Fig. 3 is a cross-sectional view of a catheter of the present invention.
Fig. 4 is a cross-sectional view of a stimulation unit of the present invention.
Fig. 5 is a sectional view of the connection unit of the present invention.
Fig. 6 is a schematic structural view of the first detour portion of the present invention.
FIG. 7 is a schematic view of a second detour portion according to the present invention.
In the figure: 1. a conduit; 11. an interlayer; 12. an outer tube; 121. a necking part; 13. an inner tube; 131. a stimulation section; 132. a connecting section; 2. a stimulation unit; 21. a stimulation electrode; 3. a connection unit; 31. connecting the electrodes; 32. a fixing ring; 4. a helical guide wire; 41. a first roundabout part; 42. a second roundabout part; 5. silica gel; 6. and (3) resin.
Detailed Description
The present invention will now be described in further detail with reference to the accompanying drawings. These drawings are simplified schematic views illustrating only the basic structure of the present invention in a schematic manner, and thus show only the constitution related to the present invention.
In the description of the present invention, it is to be understood that the terms "central," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," "circumferential," and the like are used in the orientations and positional relationships indicated in the drawings for convenience in describing the invention and to simplify the description, and are not intended to indicate or imply that the referenced devices or elements must have a particular orientation, be constructed and operated in a particular orientation, and are therefore not to be considered limiting of the invention. Furthermore, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present invention, "a plurality" means two or more unless otherwise specified.
In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.
As shown in fig. 1 to 7, the smart electrode includes: the device comprises a catheter 1 and a plurality of spiral guide wires 4, wherein an interlayer 11 is arranged in the catheter 1, one end of the catheter 1 is provided with a stimulation unit 2, and the other end of the catheter 1 is provided with a connecting unit 3; the spiral guide wire 4 is arranged in the interlayer 11, one end of the spiral guide wire 4 is connected with the stimulating unit 2, and the other end of the spiral guide wire 4 is connected with the connecting unit 3. The several helical guide wires 4 are of the same size and may have any cross-section, such as circular, elliptical, flat, etc. An insulating layer is arranged on the outer side of the spiral guide wire 4.
According to the invention, a plurality of spiral guide wires 4 are arranged in the interlayer 11 of the catheter 1, two ends of each spiral guide wire 4 are respectively connected with the stimulation unit 2 and the connecting unit 3, the stimulation unit 2 can be arranged at the positions of anterior thalamic nucleus, substantia nigra, subthalamic nucleus, and right thalamic nucleus of the brain, the connecting unit 3 can be connected with external monitoring equipment, the spiral guide wires 4 have certain deformation allowance, the posture change and the length change of an intelligent electrode can be met, the influence on the electrode caused by factors such as skull growth can be adapted, meanwhile, the integral compactness and the sealing performance of the intelligent electrode can be improved, and the influence on brain tissue caused by the shaking of the spiral guide wires 4 can be reduced.
The catheter 1 comprises an inner tube 13 and an outer tube 12, wherein the inner diameter of the outer tube 12 is larger than the outer diameter of the inner tube 13 so as to form an interlayer 11 between the outer tube 12 and the inner tube 13, the length of the outer tube 12 is smaller than that of the inner tube 13, and two ends of the outer tube 12 are provided with necking parts 121 which are in contact with the inner tube 13 so as to seal the interlayer 11. In other words, the outer tube 12 is sleeved outside the inner tube 13, and since the inner diameter of the outer tube 12 is larger than the outer diameter of the inner tube 13, an accommodating space (i.e. the interlayer 11) can be formed between the outer tube 12 and the inner tube 13, the spiral guide wire 4 can be installed in the interlayer 11, and after the installation of the spiral guide wire 4 is completed, the two ends of the outer tube 12 can be compressed to form the necking portions 121, so that the spiral guide wire 4 can be fixed. The length of the inner tube 13 is greater than that of the outer tube 12, both ends of the inner tube 13 extend out of the necking part 121, and a stimulation section 131 and a connection section 132 are formed at both ends of the outer tube 12 to be respectively used for installing the stimulation unit 2 and the connection unit 3.
The stimulation unit 2 comprises a plurality of stimulation electrodes 21, the stimulation section 131 of the inner tube 13 is sleeved with the stimulation electrodes 21, the connecting unit 3 comprises a fixing ring 32 and a plurality of connecting electrodes 31, the fixing ring 32 and the connecting electrodes 31 are sleeved with the connecting section 132 of the inner tube 13, the outer tube 12 is positioned between the stimulation unit 2 and the connecting unit 3, and the fixing ring 32 and the stimulation electrodes 21 closest to the end part of the outer tube 12 are sleeved with the corresponding necking parts 121 respectively. In other words, the stimulating electrode 21 closest to the end of the outer tube 12 is located at the junction of one of the necking portions 121 and the stimulating section 131, and the fixing ring 32 is located at the junction of the other necking portion 121 and the connecting section 132. The stimulating electrodes 21 are distributed at equal intervals, and the inside and the interval of the stimulating electrodes 21 are filled with silica gel 5. A plurality of connecting electrodes 31 are distributed at equal intervals, and the fixing ring 32 and the connecting electrodes 31 are filled with resin 6 at the inner part and intervals. In other words, the silicone 5 can fix and seal the stimulating electrode 21 and the inner tube 13, and the resin 6 can fix and seal the connecting electrode 31 and the fixing ring 32, respectively, and the inner tube 13. The material of the silica gel 5 is soft (the Shore hardness is between 50A and 70A), and is suitable for being in contact with nerves in the brain, and the material of the resin 6 is hard (the Shore hardness is 75D), so that the connection requirement can be met, and the stability of signal transmission is improved. The two ends of the bottom of the stimulating electrode 21, the fixing ring 32 and the connecting electrode 31 are connected with the outer side surface through arc chamfers, and the tissue is not easy to be damaged.
The outer side of the spiral guide wire 4 is provided with an insulating layer and is wound on the inner tube 13 in a multi-wire parallel winding manner, two ends of the spiral guide wire 4 respectively extend outwards to the end part of the outer tube 12 and are fixed through the corresponding necking parts 121, and two ends of the spiral guide wire 4 are respectively connected with the stimulating electrodes 21 and the connecting electrodes 31 in a one-to-one correspondence manner. For example, the helical guide wire 4 has a pitch of 2mm to 4mm, with a 10% margin for length variation. Both the inner tube 13 and the outer tube 12 may be made of polyurethane (e.g., TPU, PU, PTFE polytetrafluoroethylene, etc.) to facilitate bending, stretching, and compressing of the smart electrode. The spiral guide wire 4 can be attached to the surface of the inner tube 13 or suspended in the interlayer 11. The outer diameter of the outer tube 12 is 1.2mm-1.4mm, the inner diameter of the outer tube 12 is 0.9mm-1.1mm, the inner diameter of the inner tube 13 is 0.4mm-0.5mm, the outer diameter of the inner tube 13 is 0.7mm-0.8mm, and the sizes of the outer tube 12 and the inner tube 13 can be selected according to the sizes of the stimulation electrode 21 and the connecting electrode 31 which are actually adopted. The two ends of the spiral guide wire 4 can be respectively welded with the stimulating electrode 21 and the connecting electrode 31, the stimulating electrode 21 and the connecting electrode 31 can be annular electrodes, the material of the electrodes can be platinum, platinum-iridium alloy or stainless steel, and the biocompatibility is good. The interlayer 11 may be filled with silica gel to improve the strength of the catheter 1.
The spiral guide wire 4 is provided with a first circuitous part 41 inside the stimulating electrode 21 and is welded on the stimulating electrode 21 through an exposed core wire at the end part of the spiral guide wire 4, and the spiral guide wire 4 and the connecting electrode 31 are provided with a second circuitous part 42 inside and are welded on the connecting electrode 31 through an exposed core wire at the end part of the spiral guide wire 4. The first detour portion 41 and the second detour portion 42 may be formed by bending the spiral wire 4, for example, in an S-shape or a U-shape. The first detour 41 and the second detour 42 can prevent the spiral wire 4 from being broken when the spiral wire 4 is excessively pulled. After the end of the spiral guide wire 4 is circuitous, welding spots can be led to the ends of the stimulating electrode 21 and the connecting electrode 31, so that the welding difficulty can be reduced, and the connection stability can be ensured.
As shown in fig. 1, based on the above, the present invention further provides a method for manufacturing the intelligent electrode, including the following steps:
step S1, the spiral guide wire 4 is wound around the outer side of the inner tube 13.
Step S2, the outer tube 12 is fitted over the spiral guide wire 4.
Step S3, the length of the inner tube 13 is greater than the length of the outer tube 12, so that the two ends of the inner tube 13 extend out of the outer tube 12 to form the stimulation section 131 and the connection section 132; the plurality of stimulating electrodes 21 are respectively sleeved on the stimulating sections 131, and the fixing rings 32 and the plurality of connecting electrodes 31 are respectively sleeved on the connecting sections 132.
In step S4, one end of the spiral wire 4 is connected to the stimulating electrode 21, and the other end of the spiral wire 4 is connected to the connecting electrode 31.
Step S5 is to insert a supporting stylet from the end of the connecting section 132 into the inner tube 13 and to ensure that one end of the stylet does not protrude beyond the stimulating section 131 and the other end of the stylet protrudes beyond the connecting section 132.
Step S6 is to perform a tube shrinking process on the stimulation electrode 21 and the fixing ring 32 closest to the end of the outer tube, so as to deform and shrink the end of the outer tube 12 and the inner tube 13 at that position, thereby forming the end of the outer tube 12 into the necking portion 121 contacting the outer side surface of the inner tube 13.
And step S7, performing segmented injection molding on the stimulating electrode 21 and the connecting electrode 31.
Specifically, a plurality of spiral guide wires 4 are wound on the outer side of the inner tube 13 at the same pitch, and the inner tube 13 is hollow. Then, the outer tube 12 is sleeved outside the spiral guide wire 4, that is, the spiral guide wire 4 is located between the inner tube 13 and the outer tube 12, and at this time, both ends of the spiral guide wire 4 extend out of the outer tube 12. One end of the spiral guide wire 4 is inserted into the stimulation electrode 21 and led back to the end of the stimulation electrode 21 (i.e. the end close to the outer tube 12) through the first roundabout part 41, the insulating layer at one end of the spiral guide wire 4 is stripped, and the exposed core wire at one end of the spiral guide wire 4 is welded with the stimulation electrode 21. For example, one end of the spiral guide wire 4 extends to a half length of the stimulating electrode 21, then the spiral guide wire 4 is wound to form a first winding part 41 and returns to the end face or the side part of the end face of the stimulating electrode 21, then the insulating layer of the spiral guide wire 4 is partially peeled off, and the exposed core wire and the end part of the stimulating electrode 21 are welded. Similarly, the other end of the spiral wire 4 is inserted into the connection electrode 31 and led back to the end of the connection electrode 31 through the second detour 42, the insulating layer on the other end of the spiral wire 4 is stripped, and the bare core wire on the other end of the spiral wire 4 is welded to the connection electrode 31. The other end of the spiral guide wire 4 extends to a half length of the connecting electrode 31, then the spiral guide wire 4 is detoured to form a second detour portion 42 which is led back to the end face or the side portion of the end face of the connecting electrode 31, then the insulating layer of the spiral guide wire 4 is partially stripped, and the exposed core wire and the end portion of the connecting electrode 31 are welded.
After the spiral guide wire 4 is connected with the stimulating electrodes 21 and the connecting electrodes 31, a plurality of stimulating electrodes 21 are sleeved at one end of the inner tube 13, and a part of one stimulating electrode 21 closest to the outer tube 12 is sleeved on the outer tube 12; sleeving a fixing ring 32 and a plurality of connecting electrodes 31 at the other end of the inner tube 13, and sleeving a part of the fixing ring 32 on the outer tube 12; for example, the stimulation electrode 21, the fixing ring 32 and the connection electrode 31 may be fixed and positioned by a tooling mold, so that the stimulation electrode 21, the fixing ring 32 and the connection electrode 31 are respectively located at corresponding positions, and a supporting stylet is inserted from the end of the connection section 132 into the inner tube 13 and it is ensured that one end of the stylet does not protrude out of the stimulation section 131 and the other end of the stylet protrudes out of the connection section 132; the tube core needle can adopt a tungsten rod and a coating, the outer diameter of the tube core needle is in clearance fit with the inner diameter of the inner tube, and then the two ends of the outer tube 12 are shrunk by using a shrinking process, so that the two ends of the outer tube 12 form necking parts 121 in contact with the outer side surface of the inner tube 13 respectively, and silica gel and resin can be prevented from entering the interlayer 11 during segmented injection molding. At this time, both ends of the spiral guide wire 4 may be pressed by the constricted portions 121. The shrinking process may include, for example: forging is carried out by using a press-holding machine, for example, the press-holding die of the press-holding machine rotates and forges 360 degrees around the peripheral side of the stimulating electrode 21 or the fixing ring 32, the stimulating electrode 21 or the fixing ring 32 is gradually sent into the press-holding die in a certain step, and finally the forging is carried out to obtain a required small diameter, so that the stimulating electrode 21 or the fixing ring 32 is fixed on the outer tube 12, after the injection molding, the stimulating electrodes 21 are connected together through the silica gel 5 at the side part and the inner part, and the fixed connection of the stimulating unit 2 and the catheter 1 is realized; the fixing ring 32 and each connecting electrode 31 are connected together by the resin 6 at the side and inside, thereby realizing the fixed connection of the connecting unit 3 and the catheter 1. Meanwhile, the length of one necking part 121 extending into the stimulating electrode 21 is 1/6-5/6 of the length of the stimulating electrode 21, and the length of the other necking part 121 extending into the fixing ring 32 is 1/6-5/6 of the length of the fixing ring 32, so that the necking part 121 can be hidden, and the attractiveness is improved; on the other hand, the gap between the outer tube 12 and the inner tube 13 can be sealed, and the convenience of glue injection is improved. In addition, since the inner tube 13 and the outer tube 12 can both generate a certain amount of deformation, and the inner tube 13 is supported by the stylet, the inner tube 13 can be basically kept from deforming inwards. In the pressing and holding process, the stimulation electrode 21 or the fixing ring 32 causes the local part of the outer tube 12 to deform inwards and contact the inner tube 13 to form a necking part 121, so that the interlayer can be sealed, the spiral guide wire 4 can be fixed, and the spiral guide wire 4 is prevented from being damaged by extrusion of the contraction process. In this case, the parameters of the contraction process are matched with those of the catheter, otherwise the catheter 1 or the spiral guide wire 4 is easily damaged. For example, when the inner diameter of the inner tube 13 is 0.4mm and the outer diameter is 0.65 mm, the inner diameter of the outer tube 12 is 1.1mm and the outer diameter is 1.3 mm, and the diameter of the spiral guide wire 4 is 0.2 mm, four wires are wound; the parameters of the shrinkage process by adopting the crimping machine comprise: the swaging frequency of the fixing ring 32 or the stimulating electrode 21 was 10mm/s, the feeding step of the fixing ring 32 or the stimulating electrode 21 was 60mm/s, and the swaging shrinkage of the fixing ring 32 or the stimulating electrode 21 was 0.2 mm.
Finally, the stimulating electrode 21, the catheter 1, the fixing ring 32, and the connecting electrode 31 are placed in a mold to fix the relative positional relationship, and then injection-molded separately. The plurality of stimulation electrodes 21 are arranged at equal intervals, the stimulation section 131 can be injected at first, so that silica gel is filled at the end part of the inner tube 13 and the end part of the outer tube 12, and because one end of the core needle does not protrude out of the stimulation section 131, the silica gel can slowly flow towards the middle, so that gaps between the stimulation electrodes 21 and the inner tube 13, intervals between the stimulation electrodes 21 and the end part of the stimulation section 131 are sealed, the outer surface of the stimulation electrodes 21 is ensured to be exposed, and the outer surface of the stimulation electrodes 21 is used for contacting with nervous tissues to collect electroencephalogram signals. Similarly, a plurality of connecting electrodes 31 are arranged at equal intervals, the fixing ring 32 and the connecting electrode 31 at the end part can be firstly injected, so that resin is filled at the end part of the inner tube 13 and the end part of the outer tube 12, the resin can slowly flow towards the middle because the other end of the core pin protrudes out of the end part of the connecting section 132, so that a gap between the fixing ring 32 and the inner tube 13, a gap between the connecting electrode 31 and the inner tube 13 and a gap between the connecting electrodes 31 are sealed, the outer surface of the connecting electrode 31 is ensured to be exposed, the other end of the core pin is also exposed, and the connecting electrode 31 is used for being connected with external monitoring equipment to transmit electroencephalogram signals. After the segmented injection molding is completed, the tube core needle can be pulled out, so that the stimulation section 131 of the inner tube 13 is blocked, and the connecting section 132 of the inner tube 13 is opened, namely, the intelligent electrode is convenient for improving the injection molding effect through the segmented injection molding, and the sealing property of the intelligent electrode is improved.
Preferably, after the segmented injection molding, silica gel can be injected into the interlayer 11 by penetrating the outer tube 12 through a pinhole, so that the inner tube 13 and the outer tube 12 can be connected, the strength of the catheter 1 is improved, the spiral guide wire 4 can be further fixed, the inner tube 13, the outer tube 12 and the spiral guide wire 4 are connected into a whole through the silica gel, and the stability of the catheter 1 is improved. The necking parts 121 at the two ends of the interlayer 11 can prevent the silica gel 5 and the resin 6 from entering the interlayer 11 during the sectional injection molding, and further influence the sectional injection molding effect and the silica gel injection molding effect into the interlayer 11 by the pinhole penetrating the outer tube 12.
In conclusion, the intelligent electrode and the manufacturing method thereof can realize micro-deformation of the intelligent electrode through mutual matching of the inner tube 13, the outer tube 12 and the spiral guide wire 4, so that the intelligent electrode has the capabilities of posture change and length change and can adapt to skull growth; meanwhile, the overall compactness and the sealing performance of the intelligent electrode can be improved, and the influence of the shaking of the spiral guide wire 4 on signal acquisition is reduced. The assembly mode between the inner pipe 13 and the outer pipe 12 can improve the stability of the structure, the assembly process is simple, the assembly line production is convenient to realize, and the consistency of products is improved. The first detour 41 and the second detour 42 can prevent the spiral guide wire 4 from being broken due to excessive pulling, and prevent signal acquisition or transmission from being interrupted. The spiral guide wire 4 can be welded with the end part of the electrode after being roundabout, and the welding point is arranged at the end part of the electrode, so that the welding difficulty can be reduced.
In light of the foregoing description of the preferred embodiment of the present invention, many modifications and variations will be apparent to those skilled in the art without departing from the spirit and scope of the invention. The technical scope of the present invention is not limited to the contents of the specification, and must be determined by the scope of the claims.
Claims (7)
1. A smart electrode, comprising:
the device comprises a catheter (1), wherein an interlayer (11) is arranged in the catheter (1), one end of the catheter (1) is provided with a stimulation unit (2), and the other end of the catheter (1) is provided with a connecting unit (3);
the spiral guide wires (4) are arranged in the interlayer (11), one end of each spiral guide wire (4) is connected with the stimulation unit (2), and the other end of each spiral guide wire (4) is connected with the connecting unit (3);
the catheter (1) comprises an inner tube (13) and an outer tube (12), the inner diameter of the outer tube (12) being larger than the outer diameter of the inner tube (13) such that the outer tube (12) and the inner tube (13) form the interlayer (11) therebetween;
the length of the outer pipe (12) is smaller than that of the inner pipe (13), and both ends of the outer pipe (12) form a necking part (121) which is in contact with the inner pipe (13) through a pipe shrinking process so as to seal the interlayer (11);
two ends of the inner tube (13) extend out of the necking parts (121) to form a stimulation section (131) and a connecting section (132); the stimulation unit (2) comprises a plurality of stimulation electrodes (21) sleeved on the stimulation section (131); the connecting unit (3) comprises a fixing ring (32) and a plurality of connecting electrodes (31) which are sleeved on the connecting section (132); the stimulating electrode (21) closest to the end of the outer tube (12) is positioned at the connection part of the necking part (121) and the stimulating section (131); the fixing ring (32) is positioned at the connection part of the other necking part (121) and the connecting section (132);
the stimulation electrodes (21) are distributed at equal intervals, and silica gel (5) is filled in the stimulation electrodes (21) and at intervals; the connecting electrodes (31) are distributed at equal intervals, and the fixing ring (32) and the connecting electrodes (31) are filled with resin (6) at the inner part and the interval; silica gel is injected into the interlayer (11) through the outer tube (12) by a needle.
2. The smart electrode of claim 1,
the necking part (121) is formed by deforming and shrinking the end part of the outer tube (12) and the inner tube (13) at the position through performing a tube shrinking process on the stimulating electrode (21) and the fixing ring (32) which are closest to the end part of the outer tube so that the end part of the outer tube (12) is in contact with the outer side surface of the inner tube (13).
3. The smart electrode of claim 2,
the tube shrinking process comprises the steps of rotating and forging the stimulation electrode (21) or the fixing ring (32) in 360 degrees around the circumferential side of the stimulation electrode through a pressing and holding die of a pressing and holding machine, gradually feeding the stimulation electrode (21) or the fixing ring (32) into the pressing and holding die in a certain step, reducing the diameter inwards through forging, enabling two ends of the outer tube (12) to deform and shrink with the inner tube (13) at the position under the pressing of the stimulation electrode (21) or the fixing ring (32) to form the necking part (121), and fixing the stimulation electrode (21) or the fixing ring (32) on the outer tube (12).
4. The intelligent electrode according to claim 1, wherein the outer side of the spiral guide wire (4) is provided with an insulating layer and wound on the inner tube (13) in a multi-wire parallel winding manner; two ends of the spiral guide wire (4) respectively extend outwards to the end part of the outer tube (12) and are fixed through corresponding necking parts (121); and two ends of the spiral guide wire (4) are respectively connected with the stimulating electrodes (21) and the connecting electrodes (31) in a one-to-one correspondence manner.
5. The smart electrode according to claim 4, wherein the helical wire (4) is provided with a first detour (41) inside the stimulating electrode (21) and is welded to the stimulating electrode (21) by means of an exposed core wire at the end of the helical wire (4); a second circuitous part (42) is arranged inside the spiral guide wire (4) and the connecting electrode (31) and is welded on the connecting electrode (31) through an exposed core wire at the end part of the spiral guide wire (4).
6. A method for making a smart electrode according to any one of claims 1 to 5, comprising the steps of:
step S1, winding the spiral guide wire (4) on the outer side of the inner tube (13);
step S2, sleeving an outer tube (12) on the outer side of the spiral guide wire (4);
step S3, the length of the inner tube (13) is larger than that of the outer tube (12), so that two ends of the inner tube (13) extend out of the outer tube (12) to form a stimulation section (131) and a connecting section (132); a plurality of stimulating electrodes (21) are respectively sleeved on the stimulating sections (131), and the fixing rings (32) and a plurality of connecting electrodes (31) are respectively sleeved on the connecting sections (132);
step S4, connecting one end of the spiral guide wire (4) with a stimulating electrode (21), and connecting the other end of the spiral guide wire (4) with a connecting electrode (31);
step S5, inserting a tube core needle for supporting from the end of the connecting section (132) to the inner tube (13), and ensuring that one end of the tube core needle does not protrude out of the stimulating section (131) and the other end of the tube core needle protrudes out of the connecting section (132);
step S6, performing a tube shrinking process on the stimulating electrode (21) and the fixing ring (32) which are closest to the end part of the outer tube, and deforming and shrinking the end part of the outer tube (12) and the inner tube (13) at the position to enable the end part of the outer tube (12) to form a necking part (121) which is contacted with the outer side surface of the inner tube (13);
and step S7, performing segmented injection molding on the stimulating electrode (21) and the connecting electrode (31).
7. The method for manufacturing an intelligent electrode according to claim 6, wherein the step S4 includes:
one end of the spiral guide wire (4) penetrates into the stimulating electrode (21) and returns to the end part of the stimulating electrode (21) through a first circuitous part (41), an insulating layer at one end of the spiral guide wire (4) is stripped, and an exposed core wire at one end of the spiral guide wire (4) is welded with the stimulating electrode (21);
and the other end of the spiral guide wire (4) penetrates into the connecting electrode (31) and returns to the end part of the connecting electrode (31) through a second roundabout part (42), the insulating layer at the other end of the spiral guide wire (4) is stripped, and the exposed core wire at the other end of the spiral guide wire (4) is welded with the connecting electrode (31).
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| US7877150B2 (en) * | 2004-03-30 | 2011-01-25 | Medtronic, Inc. | Lead electrode for use in an MRI-safe implantable medical device |
| US8280526B2 (en) * | 2005-02-01 | 2012-10-02 | Medtronic, Inc. | Extensible implantable medical lead |
| US8968331B1 (en) * | 2010-04-24 | 2015-03-03 | Jerzy Roman Sochor | Implantable lead and surgical accessories |
| CN111265771A (en) * | 2018-12-05 | 2020-06-12 | 上海神奕医疗科技有限公司 | Electric lead, preparation method thereof and implantable bioelectrode |
| CN113457007A (en) * | 2020-03-31 | 2021-10-01 | 上海神奕医疗科技有限公司 | Nerve stimulation electrode, manufacturing method thereof and nerve stimulation system |
| CN113230535A (en) * | 2021-05-31 | 2021-08-10 | 杭州承诺医疗科技有限公司 | Implantable directional stimulating electrode and manufacturing method thereof |
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Application publication date: 20220610 Assignee: Boruikang medical technology (Shanghai) Co.,Ltd. Assignor: NEURACLE TECHNOLOGY (CHANGZHOU) CO.,LTD. Contract record no.: X2022980013150 Denomination of invention: Smart electrode and method of making the same Granted publication date: 20220812 License type: Common License Record date: 20220826 |