CN110882479A - Bioelectrode and assembly method thereof - Google Patents
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- CN110882479A CN110882479A CN201911378159.6A CN201911378159A CN110882479A CN 110882479 A CN110882479 A CN 110882479A CN 201911378159 A CN201911378159 A CN 201911378159A CN 110882479 A CN110882479 A CN 110882479A
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- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
- A61N1/36067—Movement disorders, e.g. tremor or Parkinson disease
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- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/36125—Details of circuitry or electric components
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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
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- B29C45/14467—Joining articles or parts of a single article
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Abstract
The invention relates to a bioelectrode and an assembly method thereof, wherein the bioelectrode comprises at least one electrode plate prefabricated part, and the electrode plate prefabricated part comprises at least one electrode plate, a prefabricated part base body and a lead wire section; the electrode plate is arranged on the outer surface of the prefabricated part base body; the lead wire section is connected with the electrode plate and fixed by the prefabricated part base body. The assembly among the electrode plate prefabricated parts is simpler than the existing direct assembly of the electrode plates, the assembly precision is high, the time is short, a plurality of clamps are avoided in the assembly process, and the manufacturing cost is saved.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a bioelectrode and an assembly method thereof.
Background
An implantable electrical nerve stimulator is an implantable medical device commonly used for treating complex physiological and psychological diseases, and delivers pulse signals to nerve tissues through electrodes so as to restore or improve normal skill operation of a human body. Compared with the traditional treatment means, the implantable nerve electrical stimulator has more excellent curative effect and higher safety, such as: the implanted nerve electrical stimulator can electrically stimulate the deep part of the brain, so as to effectively relieve the symptoms of diseases such as Parkinson's disease, epilepsy and the like, and has wider and wider application in the process of treating the diseases such as the Parkinson's disease, the epilepsy and the like.
Parkinson's disease is a common nervous system degenerative disease, the most important treatment means of the disease is drug therapy, however, with the gradual increase of the dosage of the intervention drugs, the drug therapy not only increases the risk of side effects, but also causes psychological burden to patients, and thus the drug therapy is not an ideal treatment means. In practice, supplementation of parkinson's disease medication by surgical methods is often required. There are two main surgical methods, which are nerve nucleus destruction and deep brain stimulation. Among them, the deep brain stimulation has been the first choice for surgical treatment because of its small trauma, safety and effectiveness, and the Parkinson's disease patient treated by the deep brain stimulation can show significant symptom improvement and can significantly reduce the dosage of the drug.
However, in the existing deep brain electrical stimulation system, the difficulty of manufacturing the electrode is large, especially the distal part of the electrode. The traditional electrode is provided with an annular electrode plate (or called as an electrode ring) at the far end, and the annular area around the electrode ring is stimulated in all directions, but on one hand, most of the stimulation target area is not in an ideal round shape, and on the other hand, the electrode ring is difficult to ensure to be just inserted into the center of a target point in the process of operation, so that the traditional electrode ring is likely to stimulate the tissue area which is not stimulated at the same time, and certain side effects are generated. Based on this limitation, some researchers and physicians have proposed the concept of directional electrodes. The directional electrode divides an electrode ring into a plurality of independent and unconnected electrode plates in the circumferential direction, and the stimulation direction and the stimulation area of the electrode ring can be accurately adjusted by independently controlling each electrode plate. The directional electrode can limit the stimulated area around the effective target spot, increase the treatment window, improve the treatment effect and reduce the risk of complications. According to the currently common manufacturing method, when the directional electrode is assembled, a plurality of independent electrode plates are required to be installed at the far end of the electrode and then are integrally injection-molded or installed, so that the purpose of integrating the electrode plates with the far end is achieved, and the manufacturing difficulty is high. For example, a plurality of electrode plates are manually installed on a fixed support, and then the distal end of the electrode is formed by integral injection molding, but the requirements on the assembly precision are higher and the production difficulty is higher based on the requirements on the functions and the appearance of the electrode, and the electrode plates are often assembled by means of a plurality of special fixtures, so that the assembly process is more complicated; the precision requirement on the position of the electrode plate is improved, so that the yield is reduced, and the cost is increased; in addition, as the number of electrode plates increases, if a process of assembling the electrode plates one by one is still adopted, the number of process steps increases, the time of an assembling process is longer, the production efficiency is lower, and the production cost is increased linearly.
Disclosure of Invention
Aiming at the defects of the prior art, the invention aims to provide a bioelectrode and an assembly method thereof, so as to solve the technical problems of complex assembly process, long assembly time, low yield, high manufacturing cost and the like of the conventional electrode plate.
In order to achieve the above object, the present invention provides a bioelectrode, comprising at least one electrode sheet preform, wherein the electrode sheet preform comprises at least one electrode sheet, a preform base body and a lead wire segment; the electrode plate is arranged on the outer surface of the prefabricated part base body; the lead wire section is connected with the electrode plate and fixed by the prefabricated part base body.
Optionally, in the above-mentioned directional bioelectrode, the bioelectrode includes at least two electrode sheet preforms connected along an axial direction thereof, a positioning device is provided on a preform base, and two adjacent electrode sheet preforms are circumferentially and/or axially fixed by the positioning device.
Optionally, in the above directional bioelectrode, the preform base body is axially provided with a peripheral through hole for accommodating and fixing the lead segment, and two adjacent electrode plate preforms are circumferentially fixed by matching the lead segment with the peripheral through hole.
Optionally, in the above directional bioelectrode, the number and/or circumferential position of the outer peripheral through holes matches the number and/or circumferential position of the lead segments, and the lead segments and the outer peripheral through holes constitute the lead segments of the positioning device.
Optionally, in the above-mentioned directional bioelectrode, the number of the peripheral through holes on each of the preform bases is not less than the sum of the number of the lead segments on all the electrode sheet preforms.
Optionally, in the above-mentioned directional bioelectrode, at least one of the peripheral through holes in the electrode sheet preform accommodates the lead wire segment connected to the electrode sheet on the electrode sheet preform.
Optionally, in the above directional bioelectrode, a through central hole is axially formed in the center of the preform base body, and the central hole is used for accommodating a guide wire.
Optionally, in the above-mentioned directional bioelectrode, a core rod providing support rigidity for the bioelectrode is installed between the central hole and the peripheral through hole.
Optionally, in the above directional bioelectrode, one end of the preform base body is provided with at least one clamping jaw, the opposite end of the adjacent preform base body is provided with at least one clamping groove matched with the clamping jaw, the clamping jaw and the clamping groove form the positioning device, and the adjacent two electrode sheet preforms are circumferentially and axially fixed by the matching between the clamping jaw and the clamping groove.
Optionally, in the above directional bioelectrode, one end of the preform base is provided with an outer tube thread, an opposite end of the adjacent preform base is provided with an inner tube thread matched with the outer tube thread, the outer tube thread and the inner tube thread form the positioning device, and two adjacent electrode plate preforms are axially fixed by screwing the outer tube thread and the inner tube thread.
Optionally, in the above directional bioelectrode, the outer tube thread is provided with a process hole for injecting a molding material, the process hole penetrates through the inside and outside of the preform base, and the molding material is used for connecting the adjacent electrode sheet preforms.
Optionally, the directional bioelectrode further comprises at least one electrode substrate, and the electrode substrate is connected with two adjacent electrode sheet prefabricated members.
Optionally, in the above directional bioelectrode, the electrode base body is formed by casting a gap portion between two adjacent electrode sheet preforms with a casting material.
Optionally, in the above-mentioned directional bioelectrode, the electrode base is a spacer assembly, and the spacer assembly is disposed between two adjacent electrode sheet preforms and bonded to the electrode sheet preforms by a medical adhesive.
Optionally, in the above directional bioelectrode, the electrode base body is formed by melting an insulating material and then injecting the melted insulating material into a gap between two adjacent electrode sheet preforms for welding.
Optionally, in the above-mentioned directional bioelectrode, the electrode sheet is at least one of an annular electrode sheet, a hemispherical electrode sheet, and a segmented electrode sheet.
Optionally, in the above directional bioelectrode, the electrode sheet located at the farthest end of the bioelectrode is formed by axially connecting an annular electrode sheet and a hemispherical electrode sheet.
Optionally, in the above-mentioned directional bioelectrode, at least one of the electrode sheet preforms includes at least two segmented electrode sheets, and the at least two segmented electrode sheets are distributed at intervals along a circumferential direction of the electrode sheet preform.
The invention also provides an assembly method of the bioelectrode, which comprises the following steps of forming at least one electrode plate prefabricated part:
preparing at least one preform matrix;
fixing at least one electrode plate on the outer surface of the prefabricated member base body;
taking lead wire sections matched with the electrode plates in number and respectively connecting the lead wire sections with the electrode plates;
and fixing the wire segments in the preform matrix.
Optionally, in the assembly method of the bioelectrode, the bioelectrode includes at least two electrode sheet preforms, a positioning device is disposed on a preform substrate, and the assembly method of the bioelectrode further includes the following steps:
firstly, connecting at least two electrode plate prefabricated parts along the axial direction of the bioelectrode according to a set sequence; (ii) a
Secondly, circumferentially and/or axially fixing the adjacent electrode plate prefabricated parts through the positioning device;
and finally, filling the gap part between the adjacent electrode plate prefabricated parts by using an electrode substrate to finish the assembly of the bioelectrode.
Optionally, in the assembly method of the bioelectrode, the filling of the gap portion between the adjacent electrode sheet preforms with the electrode base body includes:
pouring injection molding materials into the gap part between the adjacent electrode plate prefabricated parts, and performing injection molding to form the electrode base body; or,
and melting an insulating material, injecting the melted insulating material into a gap in the prefabricated part base body and/or a gap part between the adjacent electrode plate prefabricated parts, and welding to form the electrode base body.
Compared with the prior art, the bioelectrode comprises at least one electrode plate prefabricated part, wherein the electrode plate prefabricated part comprises at least one electrode plate, a prefabricated part base body and a lead wire section; the electrode plate is arranged on the outer surface of the prefabricated part base body; the lead wire section is connected with the electrode plate and fixed by the prefabricated part base body. The assembly among the electrode plate prefabricated parts is simpler than the existing direct assembly of the electrode plates, the assembly precision is high, the time is short, a plurality of clamps are avoided in the assembly process, and the manufacturing cost is saved.
Drawings
In the drawings, like reference numerals designate similar components or acts. The dimensions and relative positioning of the elements in the figures are not necessarily to scale. For example, the shapes of various elements and angles are not necessarily drawn to scale, and some of these elements may be arbitrarily enlarged and positioned to improve drawing legibility. Further, the particular shapes of the elements as drawn, are not necessarily to convey any information regarding the actual shape of the particular elements, and have been solely selected for ease of recognition in the drawings.
FIG. 1 is a schematic diagram showing the structure of a bioelectrode according to an embodiment of the present invention;
FIG. 2 is a schematic view showing a structure of a bioelectrode formed by axially connecting an annular electrode plate and a hemispherical electrode plate as a distal-most electrode plate in an embodiment of the present invention;
FIG. 3 shows a schematic view of an electrode sheet preform with an electrode sheet of an embodiment of the invention in a plurality of segmented electrode sheets;
FIG. 4 shows a schematic view of an electrode sheet preform with an electrode sheet of one annular shape according to an embodiment of the invention;
FIG. 5 is a schematic diagram illustrating the mating of wire segments and peripheral through holes in accordance with an embodiment of the present invention;
fig. 6 shows a cross-sectional view of the first electrode sheet preform from the distal end to the proximal end of fig. 1 and 2;
fig. 7 shows a cross-sectional view of a second electrode sheet preform from the distal end to the proximal end of fig. 1 and 2;
fig. 8 shows a cross-sectional view of a third electrode sheet preform from the distal end to the proximal end of fig. 1 and 2;
fig. 9 shows a cross-sectional view of a fourth electrode sheet preform from the distal end to the proximal end in fig. 1 and 2;
FIG. 10 is a schematic view of a jaw mating with a slot in accordance with an embodiment of the present invention;
FIG. 11 is a schematic view of an embodiment of the present invention showing the threading of an outer pipe thread with an inner pipe thread;
FIG. 12 is a flow chart showing a method for assembling the bioelectrode in the embodiment of the present invention.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.
In the description of the present invention, it is to be understood that the terms "center", "lateral", "upper", "lower", "left", "right", "vertical", "horizontal", "top", "bottom", "inner" and "outer" etc. indicate orientations or positional relationships based on those shown in the drawings, and are only for convenience of description and simplicity of description, and do not indicate or imply that the referenced devices or elements must have a particular orientation, be constructed in a particular orientation, and be operated, and thus, are not to be construed as limiting the present invention. Further, when an element is referred to as being "formed on" another element, it can be directly connected to the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may be present, including but not limited to mechanical, electrical, or communicative connections. When an element is referred to as being "secured to" another element, it can be directly connected to the other element or intervening elements may also be present. In contrast, when an element is referred to as being "directly on" another element, there are no intervening elements present.
In this document, "proximal" and "distal" are relative orientations, relative positions, directions of elements or actions with respect to each other from the perspective of a physician using the medical device, although "proximal" and "distal" are not intended to be limiting, but "proximal" generally refers to the end of the medical device that is closer to the physician during normal operation, and "distal" generally refers to the end that is first introduced into the patient.
A bioelectrode and a method for assembling the same, which are claimed in the present invention, will be described in detail with reference to the accompanying drawings.
Embodiments of the present invention provide a bioelectrode 32 including at least one electrode sheet preform 34. Preferably, the bioelectrode of the present invention comprises at least two said electrode sheet preforms 34 connected along the axial direction thereof. As shown in fig. 1-2, the bioelectrode 32 of the present embodiment includes four electrode sheet preforms 34 connected in the axial direction of the bioelectrode.
As shown in fig. 3 to 4, the electrode sheet preform 34 according to the embodiment of the present invention includes at least one electrode sheet 320, a preform base 341, and a lead segment 342. Specifically, the overall shape of the preform base 341 is cylindrical, and the electrode sheet 320 is disposed on the outer surface of the preform base 341. The lead segments 342 are connected to the electrode sheet 320 and fixed to the preform base 341. In practice, the wire segments 342 serve to electrically connect each electrode pad 320 to a connecting wire and/or pulse generator proximal to the bioelectrode 32, such that the electrode pads 320 are capable of providing electrical charge for electrical stimulation to stimulate a predetermined therapeutic target in the brain tissue of a patient.
The preform base 341 of this embodiment is provided with a positioning device 810, and two adjacent electrode sheet preforms 34 are circumferentially and/or axially fixed by the positioning device 810. Compared with the existing electrode manufacturing process, the assembly between the electrode plate prefabricated parts 34 is simpler than the direct assembly of the electrode plates, the assembly time is shorter, and the reasonable arrangement of process steps is facilitated. And a plurality of clamps are avoided in the assembling process, so that the manufacturing cost is saved.
Preferably, the electrode pad 320 of the present embodiment is at least one of an annular electrode pad 321, a hemispherical electrode pad 326, and a segmented electrode pad 322. Specifically, when the stimulation target area is in a nearly ideal ring shape, the electrode pad 320 may adopt one ring-shaped electrode pad 321 to stimulate the ring-shaped area around the electrode pad in all directions, so that the treatment effect is obvious. When the stimulation target area is not in an ideal annular shape, or the area of the stimulation target area is small, or one stimulation target area contains a plurality of stimulation targets to be stimulated respectively, the electrode sheet 320 may be a segmented electrode sheet 322 extending along a part of the electrode sheet preform 34 in the circumferential direction, and a projection of the segmented electrode sheet 322 on a plane perpendicular to the axial direction of the electrode sheet preform 34 is in an arc shape. Preferably, at least two segmented electrode plates 322 are arranged on one electrode plate preform 34, and the at least two segmented electrode plates 322 are distributed at intervals along the circumferential direction of the electrode plate preform 34, so that the brain stimulation area is limited near an effective target point, a treatment window is enlarged, a treatment effect is improved, and the risk of complications can be reduced.
In other embodiments, the electrode sheet 320 on the electrode sheet preform 34 may be formed by splicing a plurality of electrode sheets of different types, or may be a plurality of arbitrary electrode sheets with irregular shapes, and the electrode sheets are all claimed in the present invention as long as they can stimulate the brain tissue of the patient to a predetermined therapeutic target.
In specific implementation, the electrode sheets 320 on two adjacent electrode sheet preforms 34 in this embodiment may be the same annular electrode sheet 321, or the same plurality of segmented electrode sheets 322, or the electrode sheet 320 on one of the electrode sheet preforms 34 is the annular electrode sheet 321, and the electrode sheet 320 on the other electrode sheet preform 34 is the plurality of segmented electrode sheets 322.
As shown in fig. 1, in one embodiment of the present invention, the electrode pads 320 on the four electrode pad preforms 34 included on the bioelectrode 32 are, from the distal end to the proximal end, a ring-shaped electrode pad 321, three segmented electrode pads 322, and a ring-shaped electrode pad 321, respectively.
Alternatively, as shown in fig. 2, in another embodiment of the present invention, the electrode pad 320 located at the most distal end of the bioelectrode 32 is formed by axially connecting an annular electrode pad 321 and a hemispherical electrode pad 326.
The specific implementation manner of circumferential and/or axial fixation between two adjacent electrode sheet preforms 34 by the positioning device 810 in the embodiment of the invention is as follows.
The first embodiment is as follows: as shown in fig. 5, the preform base 341 of this embodiment has a cylindrical shape. The preform base 341 is axially provided with a peripheral through hole 344 for accommodating the lead segment 342, the lead segment 342 is tightly matched with the peripheral through hole 344, and the circumferential positions of two adjacent electrode plate preforms 34 are fixed by matching the lead segment 342 with the peripheral through hole 344. By repeating this process, every two electrode sheet preforms 34 are mutually constrained in position, and finally, a plurality of electrode sheet preforms 34 are fixedly fitted together in the circumferential direction. The wire segments 342 and the peripheral through holes 344 form the positioning device 810 in this embodiment. The wire segment 342 of the present embodiment not only enables the electrode sheet 320 to provide electric charge for electrical stimulation, but also enables the electrode sheet preform 34 to be positioned in the circumferential direction by cooperating with the peripheral through hole 344 as a positioning device.
In this embodiment, the circumferential positions of the adjacent segment electrode rings are fixed by the circumferential positioning structures of the lead segments 342 and the peripheral through holes 344 on the electrode plate preform 34, so as to ensure that the corresponding electrode plates of the adjacent segment electrode rings are arranged along the same bus. As shown in fig. 5, the corresponding segmented electrode sheets on the two electrode sheet preforms 34 including the three segmented electrode sheets 322 are arranged along the same straight line, so that the circumferential position relationship of the electrode sheet preforms 34 is ensured, and the assembly position accuracy is improved.
The number and/or circumferential position of the peripheral through holes 344 in this embodiment matches the number and/or circumferential position of the wire segments 342. Specifically, the number of the peripheral through holes 344 on each of the preform bases 341 is not less than the sum of the number of the lead segments 342 on all the electrode sheet preforms 34, so that the lead end 342 in the electrode sheet preform 34 at the farthest end can pass through the peripheral through holes 344 in all the electrode sheet preforms 34 and be electrically connected with the connecting lead and/or pulse generator at the proximal end of the bioelectrode 32. At least one of the peripheral through holes 344 in the electrode sheet preform 34 receives the lead wire segment 342 connected to the electrode sheet 320 on the electrode sheet preform 34 at the present time. In practice, each electrode pad 320 is connected to one lead segment 342. As shown in fig. 6-9, which are cross-sectional views of the electrode sheet preforms 34 in the assembled state from the distal end to the proximal end outer peripheral through hole 344 of the four electrode sheet preforms 34 in fig. 1 and 2, respectively. The electrode sheet 320 on the electrode sheet preform 34 shown in fig. 6 is an annular electrode sheet 321, and correspondingly, the annular electrode sheet 321 is connected with one lead segment 342; the electrode sheet 320 on the electrode sheet preform 34 shown in fig. 7 is three segment electrode sheets 322, and correspondingly, the three segment electrode sheets 322 are connected with three lead wire segments 342; the electrode sheet 320 on the electrode sheet preform 34 shown in fig. 8 is also three segment electrode sheets 322, and correspondingly, the three segment electrode sheets 322 are connected with three lead wire segments 342; the electrode sheet 320 on the electrode sheet preform 34 shown in fig. 9 is a single annular electrode sheet 321, and correspondingly, the single annular electrode sheet 321 is connected with one lead wire segment 342.
In view of the above, the number of the peripheral through holes 344 in each of the preform bases 341 of the present embodiment is preferably equal to the sum of the number of the lead segments 342 in all electrode sheet preforms 34, i.e., each of the preform bases 341 of the present embodiment includes eight peripheral through holes 344. One or more lead wire segments 342 connected with the electrode plates 320 on the electrode plate prefabricated member 34 are accommodated in the peripheral through hole 344; the remaining peripheral through holes 344 can accommodate the lead wire segments 342 from the other electrode sheet preforms 34. As shown in fig. 6 to 9, the black dots in the drawings are outer peripheral through holes 344 in which the lead segments 342 are already accommodated, and the corresponding peripheral side white dots are outer peripheral through holes 344 through which the lead segments 342 on the other electrode sheet preforms 34 are to pass.
The center of the preform base 341 in this embodiment is provided with a through central hole 343 in the axial direction, the central hole 343 being adapted to receive a guide wire for providing good delivery performance for implanting the bioelectrode 32 into brain tissue or other predetermined tissue, and being adapted to be withdrawn from the bioelectrode 32 after the delivery is completed. As shown in fig. 6-9, the inner white dot is shown as a central hole 343 for receiving a guidewire.
In this embodiment, a core rod 325 for providing support rigidity to the bioelectrode 32 is installed between the central hole 343 and the peripheral through hole 344. In particular implementations, the mandrel 325 may be processed by extrusion, injection molding, or the like.
Example two: as shown in fig. 10, the preform base 341 according to this embodiment is a cylinder, the surface of which is provided with the electrode sheet 320 (i.e., three segmented electrode sheets 322), and the inside of which is a lead segment 342, and the lead segment 342 is connected to the electrode sheet 320. Preferably, one end of the preform base 341 in this embodiment is provided with at least one claw 345, the opposite end adjacent to the preform base 341 is provided with at least one clamping groove 346 matched with the claw 345, and the circumferential position and the axial distance between two adjacent electrode sheet preforms 34 can be restricted by the mutual matching between the claw 345 and the clamping groove 346, so that the circumferential and axial positions of a plurality of electrode sheet preforms 34 are fixed. At this time, the pawl 345 and the locking groove 346 constitute the positioning device 810.
It should be noted that the number of the claws 345 and the locking grooves 346 on the electrode sheet preform 34 in this embodiment may be set as required. The shape, size and number of the claws 345 and the slots 346 are not limited in this embodiment, as long as the claws 345 and the slots 346 on two adjacent electrode sheet preforms 34 can be locked in a mutually matching manner, so as to achieve the purpose of restricting the circumferential position and the axial distance between two electrode sheet preforms 34, which is the claimed content of the present invention.
Example three: as shown in fig. 11, in this embodiment, the preform base 341 also has a cylindrical shape, an outer pipe thread 820 is formed at one end of the preform base 341, an inner pipe thread 830 matching with the outer pipe thread 820 is formed adjacent to the opposite end of the preform base 341, for example, the proximal end of the preform base 341 is provided with the extended outer pipe thread 820, and the distal end is provided with the inner pipe thread 830. In implementation, the proximal end of the electrode plate preform 34 and the distal end of another adjacent electrode plate preform 34 can be screwed together by the inner and outer pipe threads to temporarily assemble the two electrode plate preforms 34, so as to axially fix the electrode plate preforms 34. In this embodiment, the outer pipe thread 820 and the inner pipe thread 830 are mutually screwed to form the positioning device 810.
Further, in this embodiment, the outer pipe thread 820 is provided with a process hole 840 for injecting a molding material, the process hole 840 penetrates through the inside and the outside of the preform base 341, the molding material is used for connecting the adjacent electrode sheet preforms 34, so as to further realize circumferential and axial positioning of the adjacent electrode sheet preforms 34, and ensure that the corresponding electrode sheets of the adjacent segmented electrode rings are arranged along the same bus, so as to improve the position accuracy of assembly.
It should be noted that, in the embodiment of the present invention, by using the specific implementation manner of the positioning device 810 to fix the electrode plate preforms 34 circumferentially and/or axially, in addition to restricting the positional relationship between adjacent electrode plate preforms 34 by using the shape characteristics on the preform base 341, that is, by using the lead segments 342 to cooperate with the peripheral through holes 344, by using the claws 345 on the preform base 341 to cooperate with the clamping grooves 346 for positioning, and by using the inner and outer pipe threads on the preform base 341 for positioning, protruding clamping blocks capable of restricting each other are further processed on two electrode plate preforms 34; or a positioning pin is additionally added to connect and position two adjacent electrode plate prefabricated parts 34; or by incorporating a closely designed spacer ring of fixed width between the two electrode sheet preforms 34 to determine the axial position and thus the circumferential positional relationship between the two electrode sheet preforms 34.
In the embodiment, the circumferential positioning and the axial positioning of two adjacent electrode sheet preforms 34 are correlated, and in practice, the positioning device 810 can determine the position relationship in one direction to correlatively determine the position relationship in the other direction.
The bioelectrode 32 of this embodiment further includes at least one electrode base 323, and the electrode base 323 connects two adjacent electrode sheet preforms 34. In a specific implementation, after the relative positions of the electrode sheet preforms 34 and the core rod 325 are fixed, a plurality of electrode sheet preforms 34 are connected by using the electrode base 323, so as to complete the machining assembly of the bioelectrode.
In an embodiment of the present invention, the electrode base 323 is formed by casting a mold material into a gap between two adjacent electrode sheet preforms 34. Specifically, the injection molding material may fill the entire injection mold through the peripheral through holes 344 of the electrode sheet preform 34.
In another embodiment provided by the present invention, the electrode base 323 is a spacer assembly, and the spacer assembly is disposed between two adjacent electrode sheet preforms 34 and bonded to the electrode sheet preforms 34 by a medical adhesive. In practice, the electrode base 323 is processed and then stuck between the two electrode sheet preforms 34, thereby connecting the respective components of the electrode sheet preforms 34. In another preferred embodiment, the electrode base 323 is formed by machining the spacer assembly between the electrode sheet preforms 34, and then the electrode sheet preforms 34 and the spacer assembly are sequentially bonded one by an implant-grade adhesive (e.g., epoxy glue) and the distal electrode 32 is completed after the adhesive is cured.
In another embodiment of the present invention, the electrode base 323 is formed by melting an insulating material and then injecting the melted insulating material into a gap between two adjacent electrode sheet preforms 34 for welding. In a preferred embodiment, the polyurethane thermoplastic elastomer is heated to 110-120 ℃ to ensure uniform vitrification of the polyurethane prepolymer; then slowly injecting the polyurethane prepolymer until the polyurethane prepolymer completely covers the gap part between the electrode plate prefabricated parts 34; then placing the glass fiber cloth in a vacuum environment for 1-5 minutes, keeping the temperature at 110 ℃ as much as possible during the period, and exhausting bubbles as much as possible; finally, the distal electrode 32 is allowed to stand at room temperature until the distal electrode 32 is completely cooled to room temperature, thereby completing the machining of the distal electrode 32.
The electrode base 323 of the embodiment of the invention is used for connecting the components of each part of the electrode, and the connection of the electrode plate prefabricated parts can be realized through processes such as injection molding, bonding and the like, and the electrode plate prefabricated parts are used as the last process of assembling the bioelectrode.
As shown in fig. 12, an embodiment of the present invention provides an assembly method of a bioelectrode, the assembly method including forming at least one electrode sheet preform 34, the forming of the electrode sheet preform 34 including the steps of:
s1201, preparing at least one prefabricated member base 341;
s1202, fixing at least one electrode sheet 320 on the outer surface of the preform base 341;
s1203, taking lead segments 342 with the number matched with that of the electrode plates 320 and respectively connecting the lead segments with the electrode plates 320;
s1204, fixing the wire segment 342 in the preform base 341.
It should be noted that the sequence of steps S1202 to S1204 is only one embodiment of the present invention, and in other embodiments, steps S1202 to S1203 may be arranged in any sequence, which is not limited in the present invention.
The bioelectrode comprises at least two electrode sheet prefabricated parts 34, a positioning device 810 is arranged on the prefabricated part base 341, and the assembly method of the bioelectrode further comprises the following steps:
s1205, connecting at least two electrode plate prefabricated parts 34 along the axial direction of the bioelectrode according to a set sequence;
s1206, circumferentially and/or axially fixing the electrode sheet preforms 34 adjacent to each other by the positioning device 810;
s1207, filling the gap between the electrode sheet preforms 34 adjacent to each other with the electrode base 323, and completing the assembly of the bioelectrode.
In the assembly process of the present embodiment, different types of electrode sheet preforms 34 are first processed according to the design, and the pre-processed electrode sheet preforms 34 are arranged in a certain order for standby. Then, fixing the circumferential positions of the adjacent segmented electrode rings through a circumferential positioning structure on the electrode plate prefabricated part 34 to ensure that the corresponding electrode plates are positioned on the same bus; and then the axial position of the electrode plate prefabricated member 34 is fixed through an external tool or an axial positioning structure on the electrode plate prefabricated member 34. Finally, after the relative positions of the electrode plate prefabricated members 34 are fixed, the electrode base 323 is used for filling the gap part between the adjacent electrode plate prefabricated members 34 so as to complete the final process of assembling the bioelectrode 32.
The present embodiment divides the electrode manufacturing process into two major parts: machining the electrode plate prefabricated part and assembling the electrode plate prefabricated part. Compared with the existing electrode manufacturing process, the assembly of the electrode plate prefabricated part is simpler than the direct assembly of the electrode plate, the assembly time is shorter, and the reasonable arrangement of the process steps is facilitated. Meanwhile, the design also improves the position precision of the assembly of the distal electrode.
According to the embodiment of the invention, the assembled bioelectrode 32 can be polished as necessary, so that the surface of the assembled bioelectrode 32 is smoother.
Preferably, the filling of the gap portion between the adjacent electrode sheet preforms 34 with the electrode base 323 in this embodiment includes:
pouring injection molding materials into the gap part between the adjacent electrode plate prefabricated parts 34, and performing injection molding to form the electrode base body 323; or,
after melting the insulating material, the melted insulating material is injected into the gap in the preform base 341 and/or the gap portion between the adjacent electrode sheet preforms 34, and is welded to form the electrode base 323.
In summary, compared with the existing electrode manufacturing and assembling process, the bioelectrode and the assembling method thereof provided by the embodiment of the invention ensure the position relation of the electrode plate prefabricated member and improve the assembling position precision through the arrangement of the positioning device. And the assembly of the electrode plate prefabricated part is simpler than the direct assembly of the electrode plate, the assembly time is shorter, a plurality of clamps are not needed, and the manufacturing cost is saved.
The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.
Claims (21)
1. A bioelectrode, characterized in that it comprises at least one electrode sheet preform (34),
the electrode plate prefabricated part (34) comprises at least one electrode plate (320), a prefabricated part base body (341) and a lead segment (342);
the electrode plate (320) is arranged on the outer surface of the prefabricated part base body (341);
the lead wire section (342) is connected with the electrode plate (320) and is fixed by the prefabricated member base body (341).
2. The bioelectrode according to claim 1, characterized in that the bioelectrode comprises at least two electrode sheet preforms (34) connected along the axial direction thereof, a positioning device (810) is arranged on the preform base body (341), and two adjacent electrode sheet preforms (34) are circumferentially and/or axially fixed by the positioning device (810).
3. The bioelectrode according to claim 2, characterized in that the preform base body (341) is axially provided with a peripheral through hole (344) for accommodating and fixing the lead wire section (342), and two adjacent electrode plate preforms (34) are circumferentially fixed by the lead wire section (342) and the peripheral through hole (344) in a matching manner.
4. The directional bioelectrode according to claim 3, characterized in that the number and/or the circumferential position of said peripheral through holes (344) match the number and/or the circumferential position of said lead segments (342), said lead segments (342) and said peripheral through holes (344) constituting said positioning means (810).
5. The bioelectrode according to claim 3, characterized in that the number of said peripheral through holes (344) on each said preform base (341) is not less than the sum of the number of said lead segments (342) on all said electrode sheet preforms (34).
6. The bioelectrode according to claim 3, characterized in that at least one of the peripheral through holes (344) in the electrode sheet preform (34) accommodates the wire section (342) connected to the electrode sheet (320) on the electrode sheet preform (34) at the present time.
7. The bioelectrode according to claim 3, characterized in that the center of the preform base body (341) is provided with a through central hole (343) in the axial direction, said central hole (343) being intended to receive a guide wire.
8. The bioelectrode according to claim 7, characterized in that a core rod (325) providing a supporting stiffness for the bioelectrode is mounted between the central hole (343) and the peripheral through hole (344).
9. The bioelectrode according to any of the claims 2 to 8, characterized in that one end of the preform base body (341) is provided with at least one claw (345), the opposite end adjacent to the preform base body (341) is provided with at least one clamping groove (346) matched with the claw (345), the claw (345) and the clamping groove (346) form the positioning device (810), and two adjacent electrode sheet preforms (34) are circumferentially and axially fixed by the matching of the claw (345) and the clamping groove (346).
10. The bioelectrode according to any of claims 2 to 8, characterized in that one end of the preform base body (341) is provided with an outer pipe thread (820), the opposite end adjacent to the preform base body (341) is provided with an inner pipe thread (830) matching with the outer pipe thread (820), the outer pipe thread (820) and the inner pipe thread (830) form the positioning device (810), and two adjacent electrode sheet preforms (34) are axially fixed by screwing the outer pipe thread (820) and the inner pipe thread (830).
11. The bioelectrode according to claim 10, characterized in that the outer tube thread (820) is provided with a process hole (840) for injecting a molding material, the process hole (840) penetrating the inside and outside of the preform base body (341), and the molding material connecting the adjacent electrode sheet preforms (34).
12. The bioelectrode according to any of claims 2 to 8, characterized by further comprising at least one electrode base body (323), said electrode base body (323) connecting two adjacent electrode sheet preforms (34).
13. The bioelectrode according to claim 12, characterized in that the electrode base body (323) is formed by injection molding of a space portion between two adjacent electrode sheet preforms (34) by injection molding material.
14. The bioelectrode according to claim 12, characterized in that the electrode base body (323) is a spacer assembly which is arranged between two adjacent electrode sheet preforms (34) and is bonded to the electrode sheet preforms (34) by a medical adhesive.
15. The bioelectrode according to claim 12, characterized in that the electrode base body (323) is formed by melting an insulating material and then injecting the melted insulating material into a gap portion between two adjacent electrode sheet preforms (34) to be welded.
16. The bioelectrode according to claim 1, characterized in that said electrode pad (320) is at least one of a ring-shaped electrode pad (321), a hemispherical electrode pad (326) and a segmented electrode pad (322).
17. The bioelectrode according to claim 1 or 16, characterized in that said electrode pad (320) located at the most distal end of said bioelectrode is formed by an axial connection of an annular electrode pad (321) with a hemispherical electrode pad (326).
18. The bioelectrode according to claim 1 or 16, characterized in that at least one of said electrode sheet preforms (34) comprises at least two segmented electrode sheets (322), and that at least two segmented electrode sheets (322) are spaced apart along the circumference of said electrode sheet preform (34).
19. A method of assembling a bioelectrode, characterized in that it comprises forming at least one electrode sheet preform (34), said forming of an electrode sheet preform (34) comprising the steps of:
preparing at least one preform matrix (341);
fixing at least one electrode sheet (320) on the outer surface of the preform base body (341);
taking lead wire segments (342) with the number matched with that of the electrode plates (320) and respectively connecting the lead wire segments with the electrode plates (320);
-fixing the wire segments (342) in the preform matrix (341).
20. The assembly method of the bioelectrode according to claim 19, characterized in that the bioelectrode comprises at least two electrode sheet preforms (34), and a positioning device (810) is arranged on the preform base body (341), and the assembly method of the bioelectrode further comprises the following steps:
firstly, connecting at least two electrode plate prefabricated parts (34) according to a set sequence and along the axial direction of the bioelectrode;
secondly, fixing the adjacent electrode plate prefabricated parts (34) in the circumferential direction and/or the axial direction through the positioning device (810);
finally, filling the gap part between the adjacent electrode plate prefabricated parts (34) by using an electrode base body (323) to finish the assembly of the bioelectrode.
21. The assembly method of the bioelectrode according to claim 20, wherein the filling of the gap portion between the adjacent electrode sheet preforms (34) with the electrode base body (323) comprises:
pouring injection molding materials into the gap part between the adjacent electrode plate prefabricated parts (34) to form the electrode base body (323) in an injection molding mode; or,
and after melting the insulating material, injecting the melted insulating material into the gap in the preform base body (341) and/or the gap part between the adjacent electrode plate preform (34), and welding to form the electrode base body (323).
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
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| CN201911378159.6A CN110882479A (en) | 2019-12-27 | 2019-12-27 | Bioelectrode and assembly method thereof |
| CN202210159859.1A CN114392477A (en) | 2019-12-27 | 2019-12-27 | Bioelectrode |
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| CN201911378159.6A CN110882479A (en) | 2019-12-27 | 2019-12-27 | Bioelectrode and assembly method thereof |
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| CN202210159859.1A Division CN114392477A (en) | 2019-12-27 | 2019-12-27 | Bioelectrode |
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| CN202210159859.1A Pending CN114392477A (en) | 2019-12-27 | 2019-12-27 | Bioelectrode |
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