Needling instrument preparation method and needling instrument

Abstract

The invention provides a needling instrument preparation method and a needling instrument. The preparation method of the needling instrument comprises the following steps: immersing a part of a conductive part into an electrolyte solution; immersing the first part of the needling instrument substrate in the electrolyte solution; when a first preset voltage is applied between the anode and the cathode, the needling instrument base material is controlled to move according to a preset moving mode, so that the first part is corroded to have a first characteristic size on a cross section perpendicular to the extension direction of the first part, and the first characteristic size is uniform in the extension direction; immersing a second portion of the needling instrument substrate in the electrolyte solution, the second length of the second portion being less than the first length of the first portion; and a second preset voltage is applied between the anode and the cathode, so that the second part is corroded to be broken, and a needle tip is formed at the broken position of the remaining part of the needling instrument base material.

Description

Technical Field

[0001] The present disclosure relates to the field of implant technology, and more specifically, to a needle preparation method and a needle. Background Art

[0002] In the fields of biology and medicine, it is often necessary to monitor various physiological parameters of organisms in order to understand their health and disease status, or to formulate appropriate health care and treatment plans for them. At present, the monitoring of physiological parameters can be achieved by implanting sensors or electrodes electrically connected to sensors into the organism. In addition, in the fields of biology and medicine, the application of neural electrodes related to brain-computer interfaces may also be involved, especially new invasive flexible deep brain electrodes, which can simultaneously record electrophysiological signals from different brain regions and stimulate neurons around the electrodes in a targeted manner, thereby being able to treat some brain diseases (such as epilepsy, Alzheimer's disease, depression, etc.), which is a function that is difficult to achieve with conventional non-invasive electrodes or earlier Utah electrodes. Accordingly, suitable needles can be used to help implant physiological monitoring devices such as sensors or electrodes, or to help implant neural electrodes, etc. However, this implantation method usually has high requirements on the shape, size and other parameters of the needle, especially for new flexible sensors and flexible deep brain electrodes, which are very thin and soft compared to hard Utah electrodes or other silicon-based electrodes, and are difficult to implant alone into the brain area, especially the deep brain area. Therefore, there is a need to improve the needles and their preparation methods. Summary of the invention

[0003] One of the purposes of the present disclosure is to provide a needle preparation method and a needle.

[0004] According to a first aspect of the present disclosure, there is provided a needle preparation method, comprising: immersing a portion of a conductive member in an electrolyte solution, wherein the conductive member is configured to function as a cathode; immersing a first portion of a needle substrate in an electrolyte solution, wherein the needle substrate is configured to function as an anode; While applying a first preset voltage between the anode and the cathode, controlling the needle substrate to move according to a preset movement mode, so that the first portion is corroded to have a first characteristic size in a cross section perpendicular to an elongation direction of the first portion, wherein the first characteristic size is uniform in the elongation direction; immersing a second portion of the needle substrate in an electrolyte solution, wherein a second length of the second portion is less than a first length of the first portion; and A second preset voltage is applied between the anode and the cathode to corrode the second portion until it breaks, so as to form a needle tip at the broken portion of the remaining portion of the needle substrate.

[0005] In some embodiments, before the operation of immersing the first portion of the needle substrate in the electrolyte solution, the needle preparation method further comprises: Immersing the third portion of the needle substrate in an electrolyte solution, wherein an absolute value of a difference between a third length of the third portion and a first length of the first portion is less than or equal to a preset length threshold; A third preset voltage is applied between the anode and the cathode to corrode the third portion to have a second characteristic size in the cross section, wherein the second characteristic size is greater than the first characteristic size and smaller than a preset size threshold.

[0006] In some embodiments, the third preset voltage is 2-4V or 4-6V or 6-8V or 8-9V.

[0007] In some embodiments, the needle substrate is in a filamentous shape, and the conductive member includes a circular ring portion; Wherein, during the process of corroding the needle substrate: The needle base is perpendicular to the plane where the annular portion is located, and the needle base is located on the straight line where the center of the annular portion is located, or, The annular portion is located deeper in the electrolyte solution than the immersed end of the needle substrate.

[0008] In some embodiments, the conductive member further comprises a rod-shaped portion connected to the annular portion; The needle base is slidably attached to the rod-shaped portion, and the needle base is configured to move in an up-and-down direction with respect to a liquid surface of an electrolyte solution.

[0009] In some embodiments, the needle substrate is configured to move according to a preset movement pattern under the action of a driving motor.

[0010] In some embodiments, controlling the needle substrate to move according to a preset movement mode comprises: Controlling the needle substrate to move upward at a preset rate at a uniform speed relative to the liquid surface of the electrolyte solution until the first part leaves the electrolyte solution; or, The needle substrate is controlled to reciprocate in the up and down directions relative to the liquid level of the electrolyte solution.

[0011] In some embodiments, controlling the needle substrate to move according to a preset movement mode further comprises: After the needle substrate has finished moving at a uniform speed in the first direction, detecting whether the first characteristic dimension is uniform in the extension direction; If yes, ending the movement of the needle substrate according to the preset movement mode; If not, the needle substrate is controlled to move at a uniform speed in a second direction opposite to the first direction.

[0012] In some embodiments, the needle substrate is formed of tungsten; and / or, The conductive member is formed of copper; and / or, The electrolyte solution is a potassium hydroxide solution or a sodium hydroxide solution with a concentration of 1~2 mol / L or 2~3 mol / L.

[0013] In some embodiments, the first preset voltage is less than or equal to the second preset voltage; and / or, The first preset voltage is 2-4V or 4-6V or 6-8V or 8-9V; and / or, The second preset voltage is 4-6V or 6-8V or 8-10V.

[0014] According to a second aspect of the present disclosure, there is provided a needle tool, comprising: an implant portion, the implant portion comprising an implant end and a non-implant end opposite to the implant end, and the implant portion having a third characteristic dimension in a cross section perpendicular to its elongation direction; and A clamping part, wherein the clamping part is integrally formed with the implant part, the clamping part is connected to the non-implantation end of the implant part, and the clamping part has a fourth characteristic dimension on a cross section perpendicular to its elongation direction, wherein the fourth characteristic dimension is greater than the third characteristic dimension.

[0015] In some embodiments, the needle is prepared by the needle preparation method described above.

[0016] In some embodiments, the implantation length of the implant portion in the extension direction is determined by the first length and the second length; and / or, The implantation length of the implanted portion is 100-300 μm or 300-500 μm; and / or, The third characteristic size of the implanted portion is 10-20 μm or 20-100 μm; and / or, A fourth characteristic dimension of the clamping portion is 30-60 μm or 60-300 μm.

[0017] In some embodiments, the needle is used to implant a physiological monitoring device or an electrode into a living being.

[0018] Other features and advantages of the present disclosure will become more apparent from the following detailed description of exemplary embodiments of the present disclosure with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The accompanying drawings, which constitute a part of the specification, illustrate embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure.

[0020] The present disclosure may be more clearly understood from the following detailed description with reference to the accompanying drawings, in which: Figure 1 A schematic structural diagram of a needle according to an exemplary embodiment of the present disclosure is shown; Figure 2 shows a micrograph of a needle according to a specific example of the present disclosure; Figure 3 A schematic diagram showing a process of a needle preparation method according to an exemplary embodiment of the present disclosure is shown; Figure 4 An experimental schematic diagram of a needle preparation method according to a specific embodiment of the present disclosure is shown; Figures 5 to 7 Microscopic photographs of needles prepared at different first preset voltages and preset rates are shown respectively; Figure 8 A schematic flow chart of a needle preparation method according to another exemplary embodiment of the present disclosure is shown.

[0021] Note that in the embodiments described below, the same reference numerals are sometimes used in common between different drawings to represent the same parts or parts with the same functions, and their repeated descriptions are omitted. In this specification, similar reference numerals and letters are used to represent similar items, so once an item is defined in one drawing, it does not need to be further discussed in subsequent drawings.

[0022] For ease of understanding, the positions, sizes, and ranges of various structures shown in the drawings and the like sometimes do not represent actual positions, sizes, and ranges, etc. Therefore, the disclosed invention is not limited to the positions, sizes, and ranges, etc. disclosed in the drawings and the like. In addition, the drawings are not necessarily drawn to scale, and some features may be exaggerated to show details of specific components. DETAILED DESCRIPTION

[0023] Various exemplary embodiments of the present disclosure will now be described in detail with reference to the accompanying drawings. It should be noted that the relative arrangement of components and steps, numerical expressions and numerical values ​​set forth in these embodiments do not limit the scope of the present disclosure unless otherwise specifically stated.

[0024] The following description of at least one exemplary embodiment is merely illustrative in nature and is not intended to limit the present disclosure and its application or use. It will be appreciated by those skilled in the art that they are merely exemplary, rather than exhaustive, ways in which the present disclosure may be implemented.

[0025] Technologies, methods, and equipment known to ordinary technicians in the relevant art may not be discussed in detail, but where appropriate, the technologies, methods, and equipment should be considered as part of the specification.

[0026] In order to monitor various physiological parameters of an organism, realize brain-computer interface applications, or treat some diseases of an organism, etc., physiological monitoring devices such as corresponding sensors or electrodes electrically connected to the sensors or deep brain electrodes can be implanted into the organism, for example, neural electrodes can be implanted into the brain of the organism. In one implantation method, an implantation hole can be opened on the physiological monitoring device or electrode to be implanted, and a needle can be inserted into the implantation hole to place the physiological monitoring device or electrode at a desired position in the organism under the guidance of the needle; then, the needle can be separated from the implantation hole in the physiological monitoring device or electrode so that the needle can be withdrawn from the organism, leaving only the physiological monitoring device or electrode to be implanted. However, on the one hand, since the physiological monitoring device or electrode to be implanted is generally flexible and has a certain size, unexpected shrinkage may occur during the implantation process, making it difficult to achieve an ideal monitoring effect; on the other hand, mechanical interference may occur during the process of the needle leaving the implantation hole, making it difficult to withdraw the needle smoothly.

[0027] In order to solve the above problems, the present disclosure proposes a needle and a needle preparation method.

[0028] In an exemplary embodiment of the present disclosure, Figure 1 and Figure 2 As shown, the needle 100 may include an implantation portion 110 and a clamping portion 120. The implantation portion 110 may be used to penetrate into an implantation hole (e.g., a through hole with both ends open, or a hole with a certain length and only one end open) of a physiological monitoring device or electrode to guide the physiological monitoring device or electrode to a desired position in a biological body, and the clamping portion 120 may be connected to other components, or may be clamped and operated directly or indirectly by an operator or an operating device such as a manipulator, so as to control the needle 100 to move in a desired manner during the implantation process.

[0029] In some embodiments, the implantation portion 110 may include an implantation end 111 and a non-implantation end 112 opposite to the implantation end 111. The implantation end 111 may be configured to be in the shape of a needle tip, or in other words, the characteristic dimension of the cross section of the implantation end 111 may be very small so as to be inserted into the implantation hole. Alternatively, the implantation end 111 may also have a cross-sectional characteristic dimension substantially the same as that of the main body of the implantation portion 110, which is not limited here. In addition, the clamping portion 120 may be integrally formed with the implantation portion 110 and connected to the non-implantation end 112 of the implantation portion 110. In some embodiments, the implantation portion 110 may have a third characteristic dimension d3 on a cross section perpendicular to its elongation direction, and the third characteristic dimension d3 may be determined according to the size of the implantation hole of the physiological monitoring device or electrode to be implanted, for example, it may be slightly smaller than the corresponding size of the implantation hole, so that the needle 100 can be attached to the physiological monitoring device or electrode to be implanted. The clamping portion 120 may have a fourth characteristic dimension d4 on a cross section perpendicular to its elongation direction, and the fourth characteristic dimension d4 may be determined according to the requirements of clamping and other operations, so as to perform desired operations on the needle. The fourth characteristic dimension d4 may be greater than the third characteristic dimension d3, that is, the clamping portion 120 may be thicker than the implanting portion 110, so that when a smaller implanting hole is provided in the physiological monitoring device or electrode, the desired operation can still be conveniently performed through the clamping portion 120 of the needle 100.

[0030] In a specific example, the implant part 110 may be cylindrical, in which case the third characteristic dimension d3 may refer to the cross-sectional diameter of the implant part 110. In other specific examples, the implant part 110 may also be in other shapes, in which case the third characteristic dimension characterizing its thickness may be determined based on the specific shape. In addition, in order to facilitate the withdrawal of the needle 100 from the implant hole after the implantation is completed and to avoid mechanical interference between the implant part 110 and parts such as the edge of the implant hole during the withdrawal process, the cross-section of the implant part 110 may have a substantially uniform or constant third characteristic dimension, that is, the implant part 110 may be substantially uniform in thickness. For example, the third characteristic dimension d3 may be 10-20 μm or 20-100 μm. Figure 2 In a specific example shown, the cross-sectional diameter of the implant portion 110 of the needle 100 (ie, the third characteristic dimension d3) may be 21.351 μm.

[0031] Similarly, in a specific example, the clamping portion 120 may also be cylindrical, in which case the fourth characteristic dimension d4 may refer to the cross-sectional diameter of the clamping portion 120. In other specific examples, in order to facilitate clamping, the clamping portion 120 may also be in other shapes, in which case the fourth characteristic dimension characterizing its thickness may be determined according to the specific shape. It is understood that the clamping portion 120 may be uneven in thickness, for example, in the direction from close to the implant portion 110 to away from the implant portion 110, the clamping portion 120 may gradually become thicker, or a step portion may be formed therein for easy clamping, etc., which is not limited here. For example, the fourth characteristic dimension d4 of the clamping portion 120 (in the case where the clamping portion 120 is uneven in thickness, the fourth characteristic dimension may be the characteristic dimension of the cross section at a certain position in the clamping portion 120) may be 30-60 μm or 60-300 μm.

[0032] In some embodiments, the length of the needle 100 in its extension direction, especially the implantation length L of the implantation portion 110, can be determined according to the implantation requirements. For example, the implantation length L can be determined according to parameters such as the depth of the implantation hole in the physiological monitoring device or electrode. For example, the implantation length can be 100-300 μm or 300-500 μm. Figure 2 In a specific example shown, the implantation length L may be 411.658 μm.

[0033] In order to form the needle as described above, the present disclosure also provides a needle preparation method. In an exemplary embodiment of the present disclosure, as Figure 3 and Figure 4 As shown, the needle preparation method may include: In step S910 , a portion of the conductive member 200 is immersed in the electrolyte solution 300 .

[0034] Among them, the conductive member 200 can be configured to be used as a cathode, which can be formed of a conductive material that does not substantially react with the electrolyte solution 300, for example, it can be formed of copper. In addition, as will be described below, the needle substrate 100' used to form the needle 100 can be configured to be used as an anode, which can be formed of materials such as tungsten or stainless steel. It is understood that in the process of preparing the needle 100, the shape of the needle substrate 100' will change as the corrosion proceeds. The electrolyte solution 300 can be a 1~2mol / L or 2~3mol / L potassium hydroxide (KOH) solution or a sodium hydroxide (NaOH) solution, for example, 500mL of a NaOH solution with a concentration of 2mol / L can be provided as the electrolyte solution 300. By applying a certain voltage between the anode and the cathode, the anode material can be electrochemically reacted with the electrolyte solution and corroded, thereby forming a needle 100 with a desired shape. It is understandable that in some other embodiments, other suitable materials may be selected to form the conductive member 200 , the needle substrate 100 ′ or the electrolyte solution 300 , which is not limited here.

[0035] As required, the needle substrate 100' and the conductive member 200 provided may have a suitable shape to improve the final corrosion effect, which is not limited here. Figure 4 The needle preparation method of the present disclosure is described in detail by taking the shapes of the needle substrate 100' and the conductive member 200 shown in the specific embodiment of the present disclosure as an example, but this does not mean that the present disclosure is limited. Figure 4 As shown, the needle substrate 100' may be in a filamentary shape, and the conductive member 200 may include a circular ring portion 210. In the process of corroding the needle substrate 100', the needle substrate 100' may be perpendicular to the plane where the circular ring portion 210 is located, and the needle substrate 100' may be located on a straight line where the center (or center of the circle) of the circular ring portion 210 is located. In this way, the distance between a certain point on the needle substrate 100' serving as the anode and any point on the circular ring portion 210 of the conductive member 200 serving as the cathode may be substantially equal, so that the needle substrate 100' may be corroded uniformly in all directions on its side, thereby preventing the needle obtained after corrosion from being oriented in a certain direction (for example, in the direction of the needle). Figure 4 left or right side, etc.) as shown in the figure.

[0036] Furthermore, considering that the corrosion rate of the needle substrate 100' is related to the distance between it and the annular portion 210, in order to better control the corrosion process of the needle substrate 100' and avoid the undesirable corrosion effect caused by excessive corrosion, during the corrosion process of the needle substrate 100', the annular portion 210 can be relatively close to the immersion end (i.e., Figure 4The lower end (shown in FIG. 1 ) is located deeper in the electrolyte solution 300 to prevent the minimum distance between the needle substrate 100' and the annular portion 210 from being too small. However, it can be understood that if it is necessary to increase the corrosion rate of the needle substrate 100' (for example, in the process of forming the needle tip as described later), the annular portion 210 can also be raised to reduce the distance between the needle substrate 100' and the annular portion 210, and even the immersed end of the needle substrate 100' can be passed through the annular portion 210, which is not limited here.

[0037] As will be described in detail later, during the corrosion process, it may be necessary to control the needle substrate 100' to move according to a preset movement mode. In order to better control the movement of the needle substrate 100', such as Figure 4 As shown, the conductive member 200 may further include a rod-shaped portion 220 connected to the annular portion 210, the needle substrate 100' may be slidably attached to the rod-shaped portion 220, and the needle substrate 100' may be configured to move in the up and down directions with respect to the liquid level of the electrolyte solution 300. In this way, under the guidance of the rod-shaped portion 220, the needle substrate 100' may be prevented from tilting during the up and down movement, thereby ensuring the uniformity of the corrosion of the side of the needle substrate 100'. For example, the needle substrate 100' may be attached to the rod-shaped portion 220 of the conductive member 200 by gluing or by connecting with a slide rail, which is not limited here. Further, in some embodiments, the needle substrate 100' may be configured to move according to a preset movement mode under the action of a drive motor. For example, the non-immersion end (i.e. Figure 4 The upper end (shown in FIG. 1 ) is mechanically connected to a driving motor, so that the immersion depth of the needle substrate 100 ′ in the electrolyte solution 300 is precisely controlled by controlling the driving motor.

[0038] like Figure 3 As shown, in some embodiments, especially when the characteristic size of the cross section of the needle substrate 100' is suitable for preparing the implant portion 110 of the needle 100 (or in other words, at least the first portion of the needle substrate 100' is already thin, and the implant portion 110 of the desired thickness can be obtained without etching for too long), the needle preparation method may further include: Step S920, immersing the first portion of the needle substrate 100' in the electrolyte solution 300; and, Step S930 , while applying a first preset voltage between the anode and the cathode, controlling the needle substrate 100 ′ to move according to a preset movement mode, so that the first portion is corroded to have a first characteristic size in a cross section perpendicular to the elongation direction of the first portion.

[0039] Here, the purpose of step S920 and step S930 is to at least form the main body of the implant portion 110 of the needle 100. As mentioned above, the corrosion rate of the needle substrate 100' is related to the distance between it and the conductive member 200. In this way, the parts of the needle substrate 100' at different depths in the electrolyte solution 300 may be corroded to have different cross-sectional characteristic dimensions, that is, uneven thickness. In order to solve this problem, the needle substrate 100' can be controlled to move according to a preset movement mode while applying a first preset voltage, so that the first characteristic dimension (the first characteristic dimension is equal to or slightly larger than the third characteristic dimension described above) is uniform in the elongation direction of the first part. It can be understood that in order to form an implant portion 110 with substantially uniform thickness, a suitable preset movement mode can be determined based on factors such as the applied first preset voltage, the concentration of the electrolyte solution 300, and the characteristic dimensions of the cross section of the first part of the needle substrate 100' immersed in the electrolyte solution 300. Generally, the preset movement mode includes the needle substrate 100' in Figure 4 The movement in the up and down directions shown in the figure changes the distance between the needle substrate 100' and the annular portion 210 of the conductive member 200 (the conductive member 200 can remain stationary), thereby adjusting the corrosion rate. In some specific embodiments, the first preset voltage can be 2~4V or 4~6V or 6~8V or 8~9V. As the first preset voltage increases, the corrosion rate generally increases accordingly. However, it should be noted that the first preset voltage cannot be too large. For example, when the first preset voltage is 10V, it is found experimentally that the first part of the needle substrate 100' immersed in the electrolyte solution 300 may shake violently and break, resulting in the inability to form the implant portion 110 of the desired morphology.

[0040] In a specific embodiment, controlling the needle substrate 100' to move according to the preset movement mode may include controlling the needle substrate 100' to move upward at a preset rate at a uniform speed about the liquid surface of the electrolyte solution 300 until the first portion leaves the electrolyte solution 300. The preset rate may be determined according to factors such as the applied first preset voltage, the concentration of the electrolyte solution 300, and the characteristic size of the cross section of the first portion of the needle substrate 100' immersed in the electrolyte solution 300. At a suitable preset rate, a uniformly thick implant portion 110 may be formed, otherwise, the characteristic size of the cross section of the implant portion 110 of the formed needle 100 may change.

[0041] For example, Figures 5 to 7 The micrographs of the needles prepared at different first preset voltages and preset rates are shown. Figure 5In the specific example shown, the first length of the first portion of the needle substrate 100' immersed in the electrolyte solution 300 is 0.65 mm. The first preset voltage applied is 8V, and the needle substrate 100' is moved upward at a uniform speed to leave the electrolyte solution 300 within 100 seconds, so the needle obtained by corrosion will have an implantation portion with substantially uniform thickness. Figure 6 and Figure 7 In the specific example shown, if there is a mismatch between the applied first preset voltage and the preset rate, the implant portion may taper, e.g. Figure 6 The third characteristic dimension of the implanted portion decreases from 80.643 μm indicated by the right arrow to 68.951 μm indicated by the left arrow; or the implanted portion may be thick and thin, for example, Figure 7 The third characteristic size of the middle implanted portion first becomes thicker and then thinner from the left, and the third characteristic sizes indicated by the two arrows are 48.868 μm and 32.129 μm respectively. The specific first preset voltage and preset rate that meet the requirements can be determined based on experiments and are not limited here.

[0042] In another specific embodiment, controlling the needle substrate 100' to move according to the preset movement mode may include controlling the needle substrate 100' to move back and forth in the upper and lower directions relative to the liquid level of the electrolyte solution. Figure 6 and Figure 7 In the case where the implanted portion shown in the figure is uneven in thickness, the first portion of the needle substrate 100' can be immersed in the electrolyte solution 300 again, and moved up and down one or more times until a needle with an implanted portion of uniform thickness is corroded. During each upward or downward movement, the needle substrate 100' can move at a uniform speed. In addition, the speed during the upward movement and the speed during the downward movement can be equal to or different from each other, which can be determined according to the corrosion of the needle substrate 100', and is not limited here.

[0043] Furthermore, in some embodiments, the thickness of the first part of the needle substrate can also be detected during the corrosion process, for example, the morphology of the first part can be observed through a microscope, so as to timely adjust the preset movement mode. For example, controlling the needle substrate 100' to move according to the preset movement mode can also include: after the needle substrate 100' ends the uniform movement in the first direction, detecting whether the first characteristic dimension is uniform in the elongation direction; if so, ending the movement of the needle substrate 100' according to the preset movement mode; if not, controlling the needle substrate 100' to move uniformly in a second direction opposite to the first direction.

[0044] return Figure 3 The needle preparation method of the present disclosure may further include: Step S940, immersing the second portion of the needle substrate 100' in the electrolyte solution 300; and, In step S950 , a second preset voltage is applied between the anode and the cathode to corrode the second portion until it breaks, so as to form a needle tip at the break of the remaining portion of the needle substrate 100 ′ (ie, the portion of the needle substrate 100 ′ other than the second portion).

[0045] Here, the purpose of step S940 and step S950 is to form the needle-shaped implant end 111 of the implant part 110 of the needle 100. It is understood that, generally, the second length of the second part can be less than the first length of the first part to retain the implant part 110 with a uniform third characteristic size. In some embodiments, after the second part is corroded to fracture, the second preset voltage applied between the anode and the cathode can be immediately cut off, and the needle substrate 100' can be lifted to leave the electrolyte solution 300, so as to avoid excessive corrosion causing the needle-shaped implant end 111 to become blunt. Among them, the second preset voltage can be greater than or equal to the first preset voltage. For example, the second preset voltage can be 4~6V or 6~8V or 8~10V to promote the fracture of the second part. In a specific example, the second length of the second part of the needle substrate 100' re-immersed in the electrolyte solution 300 after step S930 can be 0.1mm.

[0046] As described above, in some embodiments, the position of the conductive member 200 can remain unchanged during the entire corrosion process of the needle to facilitate operation. Alternatively, in other embodiments, for example, to accelerate the corrosion process of the needle tip, the distance between the immersion end of the needle substrate 100' and the conductive member 200 can be appropriately reduced, and the immersion end of the needle substrate 100' can even pass through the annular portion 210 of the conductive member 200 to produce a sharp implant end 111.

[0047] According to the above description, the implantation length L of the implantation part 110 of the needle 100 finally formed in the extension direction can be determined by the first length L1 of the first part and the second length L2 of the second part. Generally speaking, L can satisfy L=L1-L2 or L≈L1-L2.

[0048] In another exemplary embodiment of the present disclosure, especially when the needle substrate 100' is relatively thick and it is difficult to directly form the implant portion 110 of the desired size, the needle substrate 100' may be corroded in advance. Figure 8 As shown, before the operation of immersing the first portion of the needle substrate 100' in the electrolyte solution 300, the needle preparation method may further include: Step S960, immersing the third portion of the needle substrate 100' in the electrolyte solution 300; and, Step S970: applying a third preset voltage between the anode and the cathode to corrode the third portion to have a second characteristic size in the cross section.

[0049] Among them, the absolute value of the difference between the third length of the third part and the first length of the first part can be less than or equal to the preset length threshold, that is, the third length and the first length can be equal or substantially equal. In a specific example, the third length can be 0.6mm, and the first length can be 0.65mm, that is, the portion of the needle substrate 100' with a length of 0.6mm can be pre-etched (at this time, the position of the needle substrate 100' can remain unchanged) to reduce the characteristic size on its cross section; then, the portion of the needle substrate 100' with a length of 0.65mm can be subjected to fine etching as described in step S930 above (at this time, the needle substrate 100' moves according to the preset movement mode) to form an implant portion 110 with a desired size and morphology. Here, the second characteristic size can be greater than the first characteristic size, and the second characteristic size can be less than the preset size threshold, wherein the preset size threshold can be set according to specific corrosion needs. It can be understood that the applied third preset voltage and the application time of the third preset voltage can be determined according to the corrosion needs of the needle substrate. In some specific examples, the third preset voltage may be 2-4V or 4-6V or 6-8V or 8-9V.

[0050] In the technical solution disclosed in the present invention, a needle having an implant portion of uniform thickness can be formed by controlling the needle to move according to a preset movement mode during the process of corroding the needle. During the implantation process, the implant portion can be inserted into the implantation hole of the physiological monitoring device or electrode, and the physiological monitoring device or electrode can be guided to the desired position in the organism by operating the clamping portion of the needle connected to the implant portion. Since the implant portion has a certain length, the desired shape of the physiological monitoring device or electrode can be well maintained, thereby improving the monitoring effect; in addition, since the implant portion is of uniform thickness, during the process of withdrawing the needle, mechanical interference between the implant portion and parts such as the edge of the implantation hole can be effectively avoided, thereby facilitating the withdrawal of the needle from the organism.

[0051] The words "left", "right", "front", "back", "top", "bottom", "up", "down", "high", "low", etc., in the specification and claims, if present, are used for descriptive purposes and are not necessarily used to describe an unchanging relative position. It should be understood that the words so used are interchangeable under appropriate circumstances, so that the embodiments of the present disclosure described herein, for example, can operate in other orientations than those shown or otherwise described herein. For example, when the device in the drawings is turned over, features originally described as "above" other features may now be described as "below" the other features. The device may also be oriented in other ways (rotated 90 degrees or in other orientations), and the relative spatial relationships will be interpreted accordingly.

[0052] In the specification and claims, when an element is referred to as being "on", "attached", "connected", "coupled", or "contacting" another element, the element may be directly on, directly attached, directly connected, directly coupled, or directly contacting another element, or one or more intermediate elements may be present. In contrast, when an element is referred to as being "directly" "on", "directly attached", "directly connected", "directly coupled", or "directly contacting" another element, there will be no intermediate elements. In the specification and claims, a feature being arranged "adjacent" to another feature may refer to a feature having a portion that overlaps with an adjacent feature or a portion that is located above or below an adjacent feature.

[0053] As used herein, the word "exemplary" means "serving as an example, instance, or illustration" rather than as a "model" to be exactly copied. Any implementation described as an example herein is not necessarily to be construed as preferred or advantageous over other implementations. Furthermore, the present disclosure is not to be limited by any expressed or implied theory given in the technical field, background, summary, or detailed description.

[0054] As used herein, the term "substantially" is intended to include any minor variations due to design or manufacturing imperfections, device or component tolerances, environmental influences, and / or other factors. The term "substantially" also allows for deviations from a perfect or ideal situation due to parasitic effects, noise, and other practical considerations that may exist in actual implementations.

[0055] In addition, the terms "first", "second" and the like may also be used herein for reference purposes only and are not intended to be limiting. For example, the terms "first", "second" and other such numerical terms referring to structures or elements do not imply a sequence or order unless the context clearly indicates otherwise.

[0056] It should also be understood that when the term “include / comprises” is used in this document, it indicates the presence of the specified features, integers, steps, operations, units and / or components, but does not exclude the presence or addition of one or more other features, integers, steps, operations, units and / or components and / or their combinations.

[0057] In this disclosure, the term "provide" is used in a broad sense to cover all ways of obtaining an object, and thus "providing an object" includes but is not limited to "purchasing", "preparing / manufacturing", "arranging / setting up", "installing / assembling", and / or "ordering" an object, etc.

[0058] As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items. The terms used herein are for the purpose of describing specific embodiments only and are not intended to limit the present disclosure. As used herein, the singular forms "a", "an", and "the" are also intended to include the plural forms, unless the context clearly indicates otherwise.

[0059] Those skilled in the art will appreciate that the boundaries between the above operations are merely illustrative. Multiple operations can be combined into a single operation, a single operation can be distributed in additional operations, and operations can be performed at least partially overlapping in time. Moreover, alternative embodiments may include multiple instances of a specific operation, and the order of operations may be changed in various other embodiments. However, other modifications, variations, and replacements are equally possible. Aspects and elements of all embodiments disclosed above may be combined in any manner and / or in combination with aspects or elements of other embodiments to provide multiple additional embodiments. Therefore, this specification and accompanying drawings should be considered illustrative, not restrictive.

[0060] Although some specific embodiments of the present disclosure have been described in detail by way of example, it should be understood by those skilled in the art that the above examples are for illustration only and are not intended to limit the scope of the present disclosure. The various embodiments disclosed herein may be combined in any manner without departing from the spirit and scope of the present disclosure. It should also be understood by those skilled in the art that various modifications may be made to the embodiments without departing from the scope and spirit of the present disclosure. The scope of the present disclosure is defined by the appended claims.

Claims

1. A method for preparing a needle, characterized in that: The needle preparation method comprises: immersing a portion of a conductive member in an electrolyte solution, wherein the conductive member is configured to function as a cathode; immersing a first portion of a needle substrate in an electrolyte solution, wherein the needle substrate is configured to function as an anode; While applying a first preset voltage between the anode and the cathode, controlling the needle substrate to move according to a preset movement mode, so that the first portion is corroded to have a first characteristic size in a cross section perpendicular to an elongation direction of the first portion, wherein the first characteristic size is uniform in the elongation direction; immersing a second portion of the needle substrate in an electrolyte solution, wherein a second length of the second portion is less than a first length of the first portion; and A second preset voltage is applied between the anode and the cathode to corrode the second portion until it breaks, so as to form a needle tip at the broken portion of the remaining portion of the needle substrate.

2. The needle preparation method according to claim 1, characterized in that: Before the operation of immersing the first part of the needle substrate in the electrolyte solution, the needle preparation method further comprises: Immersing the third portion of the needle substrate in an electrolyte solution, wherein an absolute value of a difference between a third length of the third portion and a first length of the first portion is less than or equal to a preset length threshold; A third preset voltage is applied between the anode and the cathode to corrode the third portion to have a second characteristic size in the cross section, wherein the second characteristic size is greater than the first characteristic size and smaller than a preset size threshold.

3. The needle preparation method according to claim 2, characterized in that: The third preset voltage is 2~4V or 4~6V or 6~8V or 8~9V.

4. The needle preparation method according to any one of claims 1 to 3, characterized in that: The needle base material is in a filamentous shape, and the conductive member includes a circular ring portion; Wherein, during the process of corroding the needle substrate: The needle base is perpendicular to the plane where the annular portion is located, and the needle base is located on the straight line where the center of the annular portion is located, or The annular portion is located deeper in the electrolyte solution than the immersed end of the needle substrate.

5. The needle preparation method according to claim 4, characterized in that: The conductive member further comprises a rod-shaped portion connected to the annular portion; The needle base is slidably attached to the rod-shaped portion, and the needle base is configured to move in an up-and-down direction with respect to a liquid surface of an electrolyte solution.

6. The needle preparation method according to any one of claims 1 to 3, characterized in that: The needle substrate is configured to move according to a preset movement mode under the action of a driving motor.

7. The needle preparation method according to any one of claims 1 to 3, characterized in that: Controlling the needle substrate to move according to a preset movement mode includes: Controlling the needle substrate to move upward at a preset rate at a uniform speed relative to the liquid surface of the electrolyte solution until the first part leaves the electrolyte solution; or The needle substrate is controlled to reciprocate in the up and down directions relative to the liquid level of the electrolyte solution.

8. The needle preparation method according to claim 7, characterized in that: Controlling the needle substrate to move according to a preset movement mode also includes: After the needle substrate has finished moving at a uniform speed in the first direction, detecting whether the first characteristic dimension is uniform in the extension direction; If yes, ending the movement of the needle substrate according to the preset movement mode; If not, the needle substrate is controlled to move at a uniform speed in a second direction opposite to the first direction.

9. The needle preparation method according to any one of claims 1 to 3, characterized in that: The needle substrate is formed of tungsten; and / or The conductive member is formed of copper; and / or The electrolyte solution is a potassium hydroxide solution or a sodium hydroxide solution with a concentration of 1~2 mol / L or 2~3 mol / L.

10. The needle preparation method according to any one of claims 1 to 3, characterized in that: The first preset voltage is less than or equal to the second preset voltage; and / or The first preset voltage is 2-4V or 4-6V or 6-8V or 8-9V; and / or The second preset voltage is 4-6V or 6-8V or 8-10V.

11. A needle, characterized in that: The needle comprises: an implant portion, the implant portion comprising an implant end and a non-implant end opposite to the implant end, and the implant portion having a third characteristic dimension in a cross section perpendicular to an elongated direction thereof; and A clamping part, wherein the clamping part is integrally formed with the implant part, the clamping part is connected to the non-implantation end of the implant part, and the clamping part has a fourth characteristic dimension on a cross section perpendicular to its elongation direction, wherein the fourth characteristic dimension is greater than the third characteristic dimension.

12. The needle according to claim 11, characterized in that The needle is prepared by the needle preparation method according to any one of claims 1 to 10.

13. The needle according to claim 12, characterized in that: The implantation length of the implantation portion in the extension direction is determined by the first length and the second length; and / or The implantation length of the implanted portion is 100-300 μm or 300-500 μm; and / or The third characteristic size of the implanted portion is 10-20 μm or 20-100 μm; and / or A fourth characteristic dimension of the clamping portion is 30-60 μm or 60-300 μm.

14. The needle according to claim 11, characterized in that: The needle is used to implant a physiological monitoring device or an electrode into a living body.

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