A flexible electrode implantation device

Abstract

The present invention provides a flexible electrode implantation device, which includes a flexible electrode and a puncture tube. The puncture tube has an inner hole for the flexible electrode to pass through. The flexible electrode is divided into a stimulation section, an extension section and a connection section along its length direction. A fixing seat that can be adhesively fixed on the surface of the organism is provided on the connection section. A first through hole for the stimulation section and the extension section to pass through is provided on the fixing seat. After the puncture tube assists the flexible electrode to reach the target position, the puncture tube can be withdrawn from the flexible electrode without interference. The flexible electrode implantation device provided by the present invention is only composed of a flexible electrode, a puncture tube and a fixing seat fixed at the connection section of the flexible electrode, and has the characteristics of simple structure. Moreover, since the fixing seat of the present invention is directly connected to the connection section of the flexible electrode, and the extension section of the flexible electrode can be bent and folded. Therefore, when the flexible electrode is implanted in place and the puncture tube is withdrawn, the fixing seat can be pressed and adhered to the surface of the organism, and the whole implantation process is convenient and fast.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to a flexible electrode implantation device. Background Art

[0002] A nerve stimulation electrode is a medical device for treating nerve diseases. When treating nerve diseases, it is necessary to implant the nerve stimulation electrode into the body to apply electrical stimulation to the site to be stimulated on the nerve tissue. With the continuous progress of microelectronics technology and materials science, implantable nerve electrodes are developing towards the direction of flexibility, miniaturization, and high density (i.e., multi-electrode channels). While the flexible electrode obtains better biocompatible characteristics, it sacrifices the rigidity of the electrode, increasing the difficulty of implanting the flexible electrode. To implant the flexible electrode into the body, a rigid implantation tool needs to be used for assistance. After the flexible electrode is implanted in place, the implantation tool needs to be withdrawn, and the part of the flexible electrode exposed outside the organism needs to be fully fixed to the organism to ensure that the electrical stimulation can be stably applied to the site to be stimulated.

[0003] The traditional fixing method is to suture and fix the flexible electrode to the surface of the organism, which not only causes harm to the organism but also has the problem of cumbersome operation. To avoid the defects of electrode suture fixation, there is currently a fixing device dedicated to fixing nerve stimulation electrodes. The fixing assembly includes a fixing base that can be pasted on the surface of the organism, an introduction gap penetrating the fixing base, and an expanding portion that can be inserted into the introduction gap to expand and form a first through-hole. After the electrode passes through the first through-hole and penetrates the fixing base to be implanted into the organism, the expanding portion is withdrawn. At this time, the first through-hole can contract and clamp the inserted electrode. Although this fixing device can achieve the fixation of the organism and the implanted electrode, it only uses the contraction of the first through-hole of the fixing base to clamp the inserted electrode, and the fixing ability is weak (i.e., the inserted electrode is prone to axial movement). In addition, this fixing device needs to be equipped with an expanding portion to expand the introduction gap, and there are still problems of complex structure and cumbersome operation. Therefore, it is particularly important to provide a flexible electrode implantation device with a simple structure and convenient operation to achieve the rapid implantation and stable fixation of the flexible electrode. Summary of the Invention

[0004] In view of the above disadvantages of the prior art, the purpose of the present invention is to provide a flexible electrode implantation device to achieve the rapid implantation and stable fixation of the flexible electrode at low cost.

[0005] To achieve the above and other related objectives, the present invention provides a flexible electrode implantation device, which includes a flexible electrode and a puncture tube. The puncture tube has an inner hole for the flexible electrode to pass through. The flexible electrode is divided into a stimulation section, an extension section, and a connection section along its length direction. A fixing base that can be detachably fixed on the surface of the organism is provided on the connection section of the flexible electrode. A first through hole for the stimulation section and the extension section to pass through is provided on the fixing base. After the puncture tube assists the flexible electrode to reach the target position, the puncture tube can withdraw from the flexible electrode without interference. The flexible electrode implantation device provided by the present invention is only composed of a flexible electrode, a puncture tube, and a fixing base fixed at the connection section of the flexible electrode, and has the characteristics of simple structure. Moreover, since the fixing base of the present invention is directly connected to the connection section of the flexible electrode, when the flexible electrode reaches the target position with the assistance of the puncture tube and the puncture tube is withdrawn, the fixing base can be fixed on the surface of the organism by means of pasting or straps to complete the stable fixation of the flexible electrode. During this process, if there is an excess extension section between the fixing base and the organism, the excess extension section will be bent and folded, which will not affect the pasting and fixing of the fixing base. The entire implantation and fixation process is convenient, fast, and easy to implement.

[0006] Preferably, the puncture tube is a puncture needle, and an axial notch is formed on the outer wall of the puncture needle. A second through hole for the puncture needle to pass through is provided on the fixing base. The puncture needle passes through the second through hole and is sleeved outside the stimulation section of the flexible electrode, and the axial notch is used to avoid the transition part between the extension section and the connection section, so as to facilitate the puncture needle to pass through the fixing base smoothly and be sleeved outside the stimulation section of the flexible electrode.

[0007] Preferably, the second through hole is a C-shaped hole, and the inner side wall of the C-shaped hole close to the central axis of the stimulation section encloses a guiding member. The stimulation section of the flexible electrode is located below the guiding member, and the guiding member and the puncture needle are slidably matched in the axial direction of the stimulation section, ensuring that the puncture needle can be accurately sleeved outside the stimulation section of the flexible electrode and improving the installation efficiency of the puncture needle.

[0008] Preferably, the width of the axial notch gradually increases in the direction away from the puncturing end of the puncture needle, and the minimum width of the axial notch is adapted to the root size of the guiding member; during the production and manufacturing of the puncture needle and the flexible electrode, there will always be machining accuracy issues (such as differences between the actual shape and the designed shape of the product), resulting in the inability of the puncture needle and the flexible electrode to cooperate smoothly (i.e., when the puncture needle sleeves the flexible electrode, it is prone to being blocked or stuck, leading to an increase in the positive pressure); to ensure the smoothness of their cooperation, the axial notch adopts a gradually widening axial notch with the width gradually increasing in the direction away from the puncturing end of the puncture needle, so as to reduce the risk of the puncture needle being blocked, thereby reducing the difficulty of inserting and removing the puncture needle; in addition, since the minimum width of the axial notch is adapted to the root size of the guiding member, it is ensured that the puncture needle will not be blocked by the root of the guiding member during insertion and removal; and because the minimum width of the axial notch is close to the puncturing end of the puncture needle, when the puncturing end is inserted into the biological tissue, only a small amount of biological tissue enters the puncture needle, avoiding the puncture needle being blocked by biological tissue.

[0009] Preferably, the puncture tube is a tearable sheath tube, so that the puncture tube can be withdrawn from the implanted flexible electrode without interfering with the fixed seat.

[0010] Preferably, two axially extending pre-pressed tearing seams are provided on the tearable sheath tube, so that the tearable sheath tube can be withdrawn from the implanted flexible electrode in a way of tearing while retreating.

[0011] Preferably, the two pre-pressed tearing seams are symmetrically arranged to ensure that the notch after the tearable sheath tube is torn is flexible enough for the flexible electrode to withdraw.

[0012] Preferably, a row of tearing holes are provided at the pre-pressed tearing seams at intervals in the axial direction to reduce the tearing difficulty for the user.

[0013] Preferably, two guiding protrusions are oppositely arranged on the inner wall of the inner hole of the puncture tube, and the guiding protrusions are in sliding fit with the stimulating section of the flexible electrode; since the puncture tube only slides with the flexible electrode through the two guiding protrusions on its inner wall, it not only reduces the problem of difficult insertion and removal caused by insufficient machining accuracy of the puncture tube, but also reduces the risk of frictional damage to the electrode contacts.

[0014] Preferably, an elastic sealing pad for pressing the puncture wound is provided on the fixed seat, and an introduction gap is provided on the elastic sealing pad; by pressing the puncture wound with the elastic sealing pad, the risk of wound infection can be reduced.

[0015] As described above, a flexible electrode implantation device of the present invention has at least the following beneficial effects:

[0016] The flexible electrode implantation device provided by the present invention is only composed of a flexible electrode, a puncture tube, and a fixing seat fixed at the connection section of the flexible electrode, featuring a simple structure. Moreover, since the extension section of the flexible electrode can be bent and folded arbitrarily, when the flexible electrode reaches the target position with the assistance of the puncture tube and the puncture tube is withdrawn, the fixing seat can be directly pressed and pasted on the surface of the organism to complete the stable fixation of the flexible electrode, which is convenient and time-saving for the whole process. In addition, since the fixing seat of the present invention is directly fixed on the connection section of the flexible electrode, when the fixing seat is pasted on the surface of the organism, the flexible electrode is not easily pulled out axially, ensuring the reliability of the flexible electrode fixation. Description of the Drawings

[0017] Figure 1 It is a perspective view of the flexible electrode implantation device in an embodiment of the present invention.

[0018] Figure 2 It is a perspective view of the flexible electrode in an embodiment of the present invention.

[0019] Figure 3 It is a top view of the fixing seat in the present invention.

[0020] Figure 4 It is a top view when the fixing seat is installed on the flexible electrode.

[0021] Figure 5 It is a main sectional view when the fixing seat is installed on the flexible electrode.

[0022] Figure 6 It is a front view of the puncture needle.

[0023] Figure 7 It is a cross-sectional view of the puncture needle.

[0024] Figure 8 It is a perspective view of the flexible electrode implantation device in another embodiment of the present invention.

[0025] Figure 9 It is a front view of the tearable sheath tube.

[0026] Figure 10 It is a schematic diagram of the flexible circuit board.

[0027] Figure 11 It is a schematic diagram of the manufacturing process of the flexible electrode with a fixing seat in an embodiment of the present invention.

[0028] Description of the Reference Numerals

[0029] Flexible electrode 1, stimulation segment 1a, extension segment 1b, connection segment 1c, flexible circuit board 11, electrode contact segment 11a, transition segment 11b, connection contact segment 11c, electrode ring 12, flexible insulating sleeve 13, fixing base 2, first through hole 2a, second through hole 2b, placement groove 2c, guiding member 21, puncture needle 3, axial notch 31, tearable sheath 4, pre-pressed tear seam 41, tear hole 42, guiding protrusion 5, elastic gasket 6. Detailed implementation mode

[0030] The following specific embodiments illustrate the implementation modes of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification.

[0031] Please refer to Figures 1 to 11 It should be noted that the structures, ratios, sizes, etc. shown in the drawings of this specification are only used to cooperate with the content disclosed in the specification for those skilled in the art to understand and read, and are not used to limit the limiting conditions for the implementation of the present invention. Therefore, they do not have technical essential significance. Any modification of the structure, change of the proportional relationship, or adjustment of the size, without affecting the effects that the present invention can produce and the purposes that can be achieved, should still fall within the scope that can be covered by the technical content disclosed in the present invention. At the same time, the terms such as "upper", "lower", "left", "right", "middle", and "one" cited in this specification are only for the convenience of clear narration, and are not used to limit the scope for the implementation of the present invention. The change or adjustment of their relative relationships, without substantial change in the technical content, should also be regarded as the scope for the implementation of the present invention.

[0032] The flexible electrode 1 has poor rigidity and needs to be implanted into a living body with the help of an implantation tool (such as a puncture needle). Taking the puncture needle as an example, the implantation process of the flexible electrode 1 is as follows: insert the flexible electrode 1 into the hollow channel of the puncture needle to form a puncture assembly. After the puncture assembly is punctured near the target stimulation site, withdraw the puncture needle so that the flexible electrode remains in the living body. At this time, the flexible electrode 1 includes an in-vivo part and an ex-vivo part, and the ex-vivo part is connected to the pulse generator; the pulse generator generates an electrical stimulation signal and transmits the electrical stimulation signal to the target stimulation site through the flexible electrode 1 to play a role in treating neurological diseases.

[0033] In order to prevent the ex-vivo part of the flexible electrode 1 from moving and affecting the treatment effect, the ex-vivo part of the flexible electrode 1 needs to be firmly fixed on the surface of the living body; the traditional fixing method is to suture and fix the ex-vivo part of the flexible electrode 1 to the surface of the living body, which not only causes harm to the living body, but also has the problem of cumbersome operation.

[0034] In view of this, the present invention provides a flexible electrode implantation device, which can conveniently and quickly implant a flexible electrode into a living body and fix it, so as to ensure that when the flexible electrode is connected to a pulse generator, the electrical stimulation signal provided by the pulse generator can be continuously and stably applied to the part to be stimulated in the living body. For the convenience of description, in the following embodiments, the puncture direction of the puncture tool (such as a puncture needle, etc.) is defined as the up-down direction; based on this, Figure 6 The upper direction of the paper surface is the upper end, and the lower direction of the paper surface is the lower end.

[0035] Embodiment 1

[0036] Please refer to Figures 1 to 6 , the flexible electrode implantation device involved in this embodiment includes a flexible electrode 1, a puncture tube and a fixing seat 2. The fixing seat 2 can be detachably fixed on the surface of the living body by means of pasting or straps, etc. In this embodiment, it is preferably to use the pasting method to realize the detachable fixation of the fixing seat 2 and the surface of the living body; wherein, the puncture tube is a puncture needle 3, which has an inner hole for the flexible electrode 1 to pass through; the flexible electrode 1 is divided into a stimulation section 1a, an extension section 1b and a connection section 1c along its length direction; the extension section 1b and the stimulation section 1a are coaxial, and the maximum outer diameter dimension of the extension section 1b is not greater than the maximum outer diameter dimension of the stimulation section 1a (the outer diameter dimension of the stimulation section 1a generally does not exceed 500 microns); a first through hole 2a for the stimulation section 1a and the extension section 1b to pass through is provided on the fixing seat 2, and the connection section 1c of the flexible electrode 1 is fixedly arranged on the fixing seat 2 by means of glue, etc. to form a flexible electrode 1 with a fixing seat 2; an axial notch 31 is opened on the outer wall of the puncture needle 3, and a second through hole 2b for the puncture needle 3 to pass through is provided on the fixing seat 2; the puncture needle 3 is sleeved outside the stimulation section 1a of the flexible electrode 1 through the second through hole 2b to form a puncture assembly. In this process, the axial notch 31 can play an avoidance role to ensure the smooth formation of the puncture assembly; when the puncture assembly sends the flexible electrode 1 to the target position with the assistance of the puncture needle 3, the puncture needle 3 can be directly pulled out along the second through hole 2b, so as to complete the separation of the puncture needle 3 and the flexible electrode 1 without interfering with the fixing seat 2.

[0037] During use, it is necessary to first assemble the flexible electrode 1 with a fixing seat 2 and the puncture needle 3 together to form a puncture assembly; then, with the help of the puncture function of the puncture needle 3, the puncture assembly is inserted into the living body until the flexible electrode 1 reaches the target position; the puncture needle 3 is pulled out. Then, the fixing seat 2 is directly pressed and pasted on the living body to complete the fixation of the flexible electrode 1. In this process, the redundant extension section 1b between the fixing seat 2 and the living body will be bent and folded.

[0038] In order to reduce the foreign body sensation caused by the bending and folding of the extension section 1b after the flexible electrode 1 is fixed, the extension section 1b is preferably in a flat plate shape.

[0039] In order to ensure the connection strength between the flexible electrode 1 and the fixing base 2, the connecting section 1c is preferably in the shape of a plate, and the connection area between the connecting section 1c and the fixing base 2 is not less than 1 square centimeter.

[0040] It is understandable that the connecting section 1c of the flexible electrode 1 can be fixed on the fixing base 2 vertically, or can be bent into a horizontal state and then fixed on the fixing base 2, and there is no limitation on this; based on the convenience of operation, such as Figure 4 As shown, in this embodiment, a portion of the connecting section 1 c of the flexible electrode 1 is preferably bent into a horizontal state and then fixed on the fixing base 2 .

[0041] In order to reduce the difficulty of bending the connecting section 1c and ensure the concentration of the distribution of the conductive pins on the connecting section 1c, the connecting section 1c is L-shaped as a whole before bending, and includes a pin arrangement portion and a to-be-bent portion vertically arranged at one end of the pin arrangement portion; when the width of the to-be-bent portion is large, in order to avoid the problem that the puncture needle 3 cannot be assembled on the flexible electrode 1, the to-be-bent portion of the connecting section 1c needs to be staggered and connected to the extension section 12 (that is, the side of the to-be-bent portion close to the free end of the pin arrangement portion is connected to the top of the extension end 12); at this time, the stimulation section 1a is just below the area surrounded by the second through hole 2b; when the puncture needle 3 is inserted through the second through hole 2b outside the stimulation section 1a of the flexible electrode 1, the axial notch 31 can be just aligned with the transition part of the connecting section 1c and the extension section 1b to play a avoidance role; in this embodiment, Figure 3 and Figure 4 As shown, the fixing seat 2 is preferably provided with a placement groove 2c for accommodating the horizontal portion of the connecting section 1c.

[0042] It is understandable that the second through hole 2b and the first through hole 2a can be connected to each other or not connected to each other; there is no limitation on this. In order to ensure the accuracy of the puncture needle 3 when inserting the sleeve, this embodiment preferably adopts the solution that the second through hole 2b and the first through hole 2a are not connected to each other. Specifically, Figure 3 and Figure 4 As shown, the second through hole 2b is a C-shaped hole, and the inner side wall of the C-shaped hole close to the axis of the stimulation segment 1a encloses a guide 21; the stimulation segment 1a of the flexible electrode 1 is located below the guide 21; the guide 21 can enter the inner hole of the puncture needle 3, and slide with the puncture needle 3 in the axial direction of the stimulation segment 1a; with this arrangement, the puncture needle 3 can be quickly and stably inserted into the outside of the stimulation segment 1a of the flexible electrode 1 under the guidance of the guide 21, and in this process, the axial notch 31 avoids the root of the guide 21 to avoid interference with the puncture needle 3 when inserting the sleeve; in this embodiment, the root of the guide 21 refers to the connecting part between the guide 21 and the fixing seat 2.

[0043] Since there will always be machining accuracy in the production and manufacturing of the puncture needle 3 and the guide member 21 (such as differences between the actual shape and the designed shape of the product), the puncture needle 3 and the guide member 21 cannot be smoothly matched (that is, when the puncture needle 3 is sleeved on the guide member 21, it is prone to obstruction or jamming, resulting in an increase in the positive pressure). To ensure the smoothness of the cooperation between the two, the axial notch 31 adopts a gradually widened axial notch with the width increasing gradually in the direction away from the puncture end of the puncture needle 3, so as to reduce the risk of the puncture needle 3 being obstructed, thereby reducing the difficulty of inserting and removing the puncture needle 3. In addition, the minimum width of the axial notch 31 is adapted to the root size of the guide member 21 to ensure that the puncture needle 3 will not be obstructed by the root of the guide member 21 during insertion and removal.

[0044] Due to the existence of the axial notch 31, when the puncture end of the puncture needle 3 is inserted into a living body, some biological tissues will inevitably enter the puncture needle 3. To reduce the entry of biological tissues, the transition part between the connection section 1c and the extension section 1b needs to be as thin as possible to ensure the minimum root size of the guide member 21. Based on this, the flexible electrode 1 in this embodiment is preferably manufactured based on a flexible circuit board 11 (i.e., a thin film electrode). The manufacturing process of the flexible circuit board 11 is relatively mature and belongs to the prior art, so it will not be elaborated here.

[0045] As Figure 10 shown, the flexible circuit board 11 is divided into an electrode contact section 11a, a transition section 11b, and a connection contact section 11c along its length direction. Among them, the transition section 11b is the extension section 1b of the flexible electrode 1, and the connection contact section 11c is the connection section 1c of the flexible electrode 1. The flexible circuit board 11 includes a plurality of electrode contacts arranged at intervals along its own length direction and connection contacts in one-to-one correspondence and communication with the electrode contacts. The connection contacts are located at the distal end of the connection contact section 11c, and each electrode contact is located on the electrode contact section 11a.

[0046] It can be understood that, in order to improve the action range of the flexible electrode 1, the stimulation section 1a of the flexible electrode 1 is preferably columnar. The columnar stimulation section 1a can be formed by winding the electrode contact section 11a of the flexible circuit board 11, or as Figure 11 shown, first, electrode rings 12 communicated with each electrode contact are welded on the electrode contact section 11a of the flexible circuit board 11, and then, the electrode contact section 11a welded with the electrode rings 12 is placed in a potting mold for overall potting with various medical flexible potting adhesives such as polyurethane potting adhesive or silicone potting adhesive to form the stimulation section 1a of the flexible electrode 1.

[0047] Furthermore, as Figure 7As shown, two guiding protrusions 5 are oppositely arranged on the inner wall of the inner hole of the puncture needle 3, and guiding sliding grooves cooperating with the guiding protrusions 5 are arranged on the outer wall of the guiding member 21. The two cooperate with each other to ensure the insertion and extraction stability of the puncture needle 3. In addition, the arrangement of the guiding protrusions 5 reduces the contact area between the puncture needle 3 and the stimulating section 1a of the flexible electrode 1, reducing the risk of the stimulating contacts on the stimulating section 1a being damaged by friction.

[0048] To reduce the risk of the puncture wound being infected, an elastic sealing pad 6 pressing on the puncture wound is arranged on the fixing base 2, and an introduction gap for the flexible electrode 1 and the puncture needle 3 to pass through is arranged on the elastic sealing pad 6. After the puncture needle 3 is withdrawn, the elastic sealing pad 6 will shrink and hold the flexible electrode 1 tightly to prevent external impurities from contaminating the wound.

[0049] The following is the usage method of the above flexible electrode implantation device, which includes:

[0050] Sheath the puncture needle 3 outside the flexible electrode 1 with the fixing base 2 to form a puncture assembly. The hand-held end of the puncture needle 3 is located above the fixing base 2.

[0051] Implant the puncture assembly into the living body so that the flexible electrode 1 reaches the target position. Axially move the puncture needle 3 in the direction close to the fixing base 2 until the puncture needle 3 withdraws from the flexible electrode 1.

[0052] Paste and fix the fixing base 2 on the outer surface of the living body to complete the implantation and fixation of the flexible electrode 1.

[0053] During this process, if there is an extra extended section 1b between the fixing base 2 and the living body, the extra extended section 1b will be bent and folded to avoid affecting the paste and fixation of the fixing base 2.

[0054] Embodiment 2

[0055] Please refer to Figure 2 、 Figure 3 、 Figure 4 、 Figure 5 and Figure 8, the flexible electrode implantation device involved in this embodiment includes a flexible electrode 1, a puncture tube, and a fixing seat 2 that can be adhered and fixed to the surface of a living body; among them, the puncture tube is a tearable sheath tube 4 with a puncture end, which has an inner hole for the flexible electrode 1 to pass through; the flexible electrode 1 is divided into a stimulation section 1a, an extension section 1b, and a connection section 1c along its length direction; the extension section 1b is coaxial with the stimulation section 1a, and the maximum outer diameter dimension of the extension section 1b is not greater than the maximum outer diameter dimension of the stimulation section 1a (the outer diameter dimension of the stimulation section 1a generally does not exceed 500 microns); the fixing seat 2 is provided with a first through hole 2a for the stimulation section 1a and the extension section 1b to pass through, and the connection section 1c of the flexible electrode 1 is fixedly arranged on the fixing seat 2 by means of glue or the like to form a flexible electrode 1 with a fixing seat 2; the tearable sheath tube 4 is sleeved on the stimulation section 1a of the flexible electrode 1 from bottom to top to form a puncture assembly; the puncture assembly penetrates into the living body by means of the puncture function of the tearable sheath tube 4, so that the flexible electrode 1 reaches the target position; thereafter, the tearable sheath tube 4 can be withdrawn from the living body in a way of tearing and retreating under the fixing seat 2 to be separated from the flexible electrode 1; after the tearable sheath tube 4 is withdrawn, the fixing seat 2 can be directly pressed and adhered to the living body to complete the fixation of the flexible electrode 1. During this process, the redundant extension section 1b between the fixing seat 2 and the living body will be bent and folded.

[0056] In order to reduce the foreign body sensation caused by the bending and folding of the extension section 1b after the flexible electrode 1 is fixed, the extension section 1b is preferably in a flat plate shape.

[0057] In order to ensure the connection strength between the flexible electrode 1 and the fixing seat 2, the connection section 1c is preferably in a flat plate shape, and the connection area between the connection section 1c and the fixing seat 2 is not less than 1 square centimeter.

[0058] It can be understood that the connection section 1c of the flexible electrode 1 can be vertically fixed on the fixing seat 2, or can be bent into a horizontal state and then fixed on the fixing seat 2, which is not limited in this regard; considering the operation convenience, as Figure 4 shown, in this embodiment, the connection section 1c of the flexible electrode 1 is preferably bent into a horizontal state and then fixed on the fixing seat 2.

[0059] As Figure 9 shown, at least two axially extending pre-pressed tearing seams 41 are provided on the tearable sheath tube 4. Through the pre-pressed tearing seams 41, the tearable sheath tube 4 can be divided into multiple parts; in this embodiment, two pre-pressed tearing seams 41 are provided on the tearable sheath tube 4, and the two pre-pressed tearing seams 41 are symmetrically arranged.

[0060] It can be understood that the forming methods of the pre-pressed tearing seams 41 include but are not limited to the following two:

[0061] The first method: Two half-tubes are formed separately, and then the two half-tubes are butted, and easy-to-tear materials such as polyethylene (PE), polytetrafluoroethylene (PTFE), and fluorinated ethylene propylene copolymer (FEP) are bonded at the butting position to form a pre-pressed tear seam 41; among them, the half-tube is made of metal materials such as stainless steel to ensure the mechanical properties during the puncture of the tearable sheath tube 4.

[0062] The second method: The tearable sheath tube 4 is integrally injection-molded, and the pre-pressed tear seam 41 is a thin-wall feature arranged along the axial direction. Among them, the tearable sheath tube 4 is made of metal materials such as stainless steel, and the formed thin-wall feature is the thickness of the hand-tearable steel, and its thickness is not greater than 0.02 mm to facilitate manual tearing.

[0063] In an alternative embodiment, the maximum wall thickness of the tearable sheath tube 4 does not exceed 0.15 mm; the tearable sheath tube 4 is cylindrical as a whole before being torn, and the stress distribution is uniform when stressed and it is not easy to deform, ensuring the mechanical properties during the puncture of the tearable sheath tube 4; when the tearable sheath tube 4 is torn into two sheet-like structures, the mechanical properties of the sheet-like structures are significantly reduced to facilitate bending of the sheet-like structures; thus, when the tearable sheath tube 4 is withdrawn from the flexible electrode 1 in a way of tearing while retreating, the two torn sheet-like structures can bend and extend outwards to avoid interference with the fixed seat 2.

[0064] Furthermore, as Figure 9 shown, a row of tear holes 42 are arranged at intervals along the axial direction at the pre-pressed tear seam 41 to reduce the tearing difficulty of the tearable sheath tube 4.

[0065] In order to reduce the risk of the puncture wound being infected, an elastic sealing pad 6 for pressing the puncture wound is provided on the fixed seat 2, and an introduction gap for the flexible electrode 1 to pass through is provided on the elastic sealing pad 6; the elastic sealing pad 6 will contract and hold the flexible electrode 1 tightly to avoid external impurities from contaminating the wound.

[0066] In this embodiment, the flexible electrode 1 is preferably manufactured based on a flexible circuit board 11 (i.e., a thin-film electrode); the manufacturing process of the flexible circuit board 11 is relatively mature and belongs to the prior art, so it will not be elaborated here.

[0067] As Figure 10 shown, the flexible circuit board 11 is divided into an electrode contact segment 11a, a transition segment 11b, and a connection contact segment 11c along its length direction; among them, the transition segment 11b is the extension segment 1b of the flexible electrode 1, and the connection contact segment 11c is the connection segment 1c of the flexible electrode 1; the flexible circuit board 11 includes a plurality of electrode contacts arranged at intervals along its own length direction and connection contacts in one-to-one correspondence and communication with the electrode contacts; the connection contacts are located at the distal end of the connection contact segment 11c, and each electrode contact is located on the electrode contact segment 11a.

[0068] It can be understood that in order to increase the effective range of the flexible electrode 1, the stimulation section 1a of the flexible electrode 1 is preferably columnar; the columnar stimulation section 1a can be formed by winding the electrode contact section 11a of the flexible circuit board 11, or as Figure 11 shown, first weld electrode rings 12 communicating with each electrode contact on the electrode contact section 11a of the flexible circuit board 11, and then place the electrode contact section 11a welded with the electrode rings 12 into a potting mold for overall potting with various medical flexible potting adhesives such as polyurethane potting adhesive or silicone potting adhesive to form the stimulation section 1a of the flexible electrode 1.

[0069] The following is the usage method of the above flexible electrode implantation device, which includes:

[0070] Sheath the tearable sheath 4 outside the flexible electrode 1 with the fixed seat 2 to form a puncture assembly;

[0071] Implant the puncture assembly into the living body so that the flexible electrode 1 reaches the target position; withdraw the tearable sheath 4 from the living body in a way of tearing while retreating and completely separate it from the flexible electrode 1;

[0072] Paste and fix the fixed seat 2 on the outer surface of the living body to complete the implantation and fixation of the flexible electrode 1.

[0073] During this process, if there is an extra extension section 1b between the fixed seat 2 and the living body, the extra extension section 1b will be bent and folded to avoid affecting the paste and fixation of the fixed seat 2.

[0074] In summary, since the flexible electrode implantation device of the present invention is only composed of a flexible electrode, a puncture tube and a fixed seat fixed at the connection section of the flexible electrode, it has the characteristics of simple structure; moreover, since the extension section of the flexible electrode can be bent and folded at will; therefore, when the flexible electrode reaches the target position with the assistance of the puncture tube and the puncture tube is withdrawn, the fixed seat can be directly pressed and pasted on the surface of the living body to complete the stable fixation of the flexible electrode, and the whole process is convenient and time-saving; in addition, since the fixed seat of the present invention is directly fixed on the connection section of the flexible electrode, when the fixed seat is pasted on the surface of the living body, the flexible electrode is not easily pulled out axially, ensuring the reliability of the flexible electrode fixation.

[0075] In conclusion, the present invention effectively overcomes various disadvantages in the prior art and has high industrial utilization value.

[0076] The above embodiments are only illustrative of the principles and effects of the present invention and are not intended to limit the present invention. Any person familiar with this technology can modify or change the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or changes made by those with ordinary knowledge in the technical field without departing from the spirit and technical ideas disclosed by the present invention should still be covered by the claims of the present invention.

Claims

1. A flexible electrode implantation device, comprising a flexible electrode (1) and a puncture tube, the puncture tube having an inner hole for the flexible electrode (1) to pass through; characterized in that, The flexible electrode (1) is divided into a stimulation section (1a), an extension section (1b), and a connection section (1c) along its length direction; a fixing base (2) detachably fixed on the surface of the organism is provided on the connection section (1c) of the flexible electrode (1); a first through hole (2a) for the stimulation section (1a) and the extension section (1b) to pass through is provided on the fixing base (2); after the puncture tube assists the flexible electrode (1) to reach the target position, the puncture tube can be withdrawn from the flexible electrode (1) without interference; the puncture tube is a puncture needle (3), and an axial notch (31) is formed on the outer wall of the puncture needle (3); a second through hole (2b) for the puncture needle (3) to pass through is provided on the fixing base (2), the puncture needle (3) is sleeved outside the stimulation section (1a) of the flexible electrode (1) through the second through hole (2b), and the axial notch (31) is used to avoid the transition part between the extension section (1b) and the connection section (1c); the second through hole (2b) is a C-shaped hole, and an inner side wall of the C-shaped hole close to the central axis of the stimulation section (1a) encloses to form a guiding member (21); the stimulation section (1a) of the flexible electrode (1) is located below the guiding member (21); the first through hole (2a) and the second through hole (2b) are not communicated with each other; when the axial notch of the puncture needle (3) is aligned with the root of the guiding member (21), the puncture needle (3) can be smoothly sleeved outside the stimulation section (1a) of the flexible electrode (1).

2. The flexible electrode implantation device according to claim 1, wherein The guiding member (21) and the puncture needle (3) are in sliding fit in the axial direction of the stimulation section (1a).

3. The flexible electrode implantation device according to claim 1, characterized in that, The width of the axial notch (31) gradually increases in the direction away from the puncture end of the puncture needle, and the minimum width of the axial notch (31) is adapted to the root size of the guiding member (21).

4. The flexible electrode implantation device according to claim 1, wherein Two guiding protrusions (5) are oppositely arranged on the inner wall of the inner hole of the puncture tube, and the guiding protrusions (5) are in sliding fit with the stimulation section (1a) of the flexible electrode (1).

5. A flexible electrode implantation device according to any one of claims 1 to 4, characterized in that, An elastic sealing pad (6) for pressing the puncture wound is provided on the fixing base (2), and an introduction gap is provided on the elastic sealing pad (6).

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