Needle preparation method and needle

Abstract

The present disclosure provides a method for preparing a needle and a needle. Among them, the method for preparing the needle includes: immersing a part of the conductive member in an electrolyte solution; immersing a first part of the needle substrate in the electrolyte solution; while applying a first preset voltage between the anode and the cathode, controlling the needle substrate to move according to a preset movement pattern so that the first part is corroded to have a first characteristic dimension on a cross-section perpendicular to the elongation direction of the first part, wherein the first characteristic dimension is uniform in the elongation direction; immersing a second part of the needle substrate in the electrolyte solution, wherein the second length of the second part is less than the first length of the first part; and applying a second preset voltage between the anode and the cathode to corrode the second part until it breaks, so as to form a needle tip at the break of the remaining part of the needle substrate.

Description

Technical Field

[0001] The present disclosure relates to the field of implantation technology, and more particularly, to a method for preparing a needle and a needle. Background Art

[0002] In the fields of biology, medicine, etc., it is often necessary to monitor various physiological parameters of an organism in order to understand its health and disease status, or to formulate appropriate health care and treatment plans for it. Currently, the monitoring of physiological parameters can be achieved by implanting sensors or electrodes electrically connected to the sensors into the organism. In addition, in the fields of biology, medicine, etc., the application of neural electrodes related to brain-computer interfaces may also be involved, especially the new type of invasive flexible deep brain electrodes, which can record the electrophysiological signals of different brain regions simultaneously and stimulate the neurons around the electrodes targeted, so as to be able to treat some brain diseases (such as epilepsy, Alzheimer's disease, depression, etc.), which is a function difficult to achieve by conventional non-invasive electrodes or earlier Utah electrodes. Correspondingly, a suitable needle 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 for parameters such as the shape and size of the needle. Especially for the new type of flexible sensors and flexible deep brain electrodes, they are very thin and soft compared to rigid Utah electrodes or other silicon-based electrodes, and it is difficult to implant them into the brain region alone, especially the deep brain region. Therefore, there is a need to improve the needle and its preparation method. Summary of the Invention

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

[0004] According to a first aspect of the present disclosure, there is provided a method for preparing a needle, including:

[0005] Immerse a part of a conductive member in an electrolyte solution, wherein the conductive member is configured to be used as a cathode;

[0006] Immerse a first part of a needle substrate in the electrolyte solution, wherein the needle substrate is configured to be used as an anode;

[0007] While applying a first preset voltage between the anode and the cathode, control the needle substrate to move according to a preset movement pattern, so that the first part is corroded to have a first characteristic dimension on a cross-section perpendicular to the elongation direction of the first part, wherein the first characteristic dimension is uniform in the elongation direction;

[0008] Immerse a second part of the needle substrate in the electrolyte solution, wherein the second length of the second part is less than the first length of the first part; and,

[0009] Apply a second preset voltage between the anode and the cathode so that the second part is corroded until it breaks, thereby forming a tip at the break of the remaining part of the needle substrate.

[0010] In some embodiments, before the operation of dipping the first part of the needle substrate into the electrolyte solution, the needle preparation method further includes:

[0011] Dip the third part of the needle substrate into the electrolyte solution, wherein the absolute value of the difference between the third length of the third part and the first length of the first part is less than or equal to a preset length threshold;

[0012] Apply a third preset voltage between the anode and the cathode so that the third part is corroded to have a second feature size on the cross-section, wherein the second feature size is greater than the first feature size and less than a preset size threshold.

[0013] In some embodiments, the third preset voltage is 2 - 4V or 4 - 6V or 6 - 8V or 8 - 9V.

[0014] In some embodiments, the needle substrate is in a filamentous shape, and the conductive member includes an annular portion;

[0015] Wherein, during the corrosion of the needle substrate:

[0016] The needle substrate is perpendicular to the plane where the annular portion is located, and the needle substrate is located on the straight line where the center of the annular portion is located, or,

[0017] The annular portion is deeper in the electrolyte solution relative to the immersion end of the needle substrate.

[0018] In some embodiments, the conductive member further includes a rod-shaped portion connected to the annular portion;

[0019] Wherein, the needle substrate is slidably attached to the rod-shaped portion, and the needle substrate is configured to move in the up and down direction with respect to the liquid level of the electrolyte solution.

[0020] In some embodiments, the needle substrate is configured to move according to a preset movement pattern under the action of a driving motor.

[0021] In some embodiments, controlling the needle substrate to move according to a preset movement pattern includes:

[0022] Controlling the needle substrate to move uniformly upward at a preset rate with respect to the liquid level of the electrolyte solution until the first part leaves the electrolyte solution; or,

[0023] Controlling the needle substrate to move reciprocally in the up and down direction with respect to the liquid level of the electrolyte solution.

[0024] In some embodiments, controlling the movement of the needle substrate according to a preset movement pattern further includes:

[0025] After the uniform movement of the needle substrate in the first direction ends, detecting whether the first characteristic dimension is uniform in the elongation direction;

[0026] If so, end the movement of the needle substrate according to the preset movement pattern;

[0027] If not, control the needle substrate to move uniformly in a second direction opposite to the first direction.

[0028] In some embodiments, the needle substrate is formed of tungsten; and / or,

[0029] The conductive member is formed of copper; and / or,

[0030] 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.

[0031] In some embodiments, the first preset voltage is less than or equal to the second preset voltage; and / or,

[0032] The first preset voltage is 2-4 V or 4-6 V or 6-8 V or 8-9 V; and / or,

[0033] The second preset voltage is 4-6 V or 6-8 V or 8-10 V.

[0034] According to a second aspect of the present disclosure, there is provided a needle, including:

[0035] An implantation part, the implantation part includes an implantation end and a non-implantation end opposite to the implantation end, and the implantation part has a third characteristic dimension in a cross-section perpendicular to its elongation direction; and,

[0036] A clamping part, the clamping part is integrally formed with the implantation part, the clamping part is connected to the non-implantation end of the implantation part, and the clamping part has a fourth characteristic dimension in a cross-section perpendicular to its elongation direction, wherein the fourth characteristic dimension is greater than the third characteristic dimension.

[0037] In some embodiments, the needle is prepared by the needle preparation method as described above.

[0038] In some embodiments, the implantation length of the implantation part in the elongation direction is determined by the first length and the second length; and / or,

[0039] The implantation length of the implantation part is 100-300 μm or 300-500 μm; and / or,

[0040] The third characteristic dimension of the implanting portion is 10-20 μm or 20-100 μm; and / or,

[0041] The fourth characteristic dimension of the clamping portion is 30-60 μm or 60-300 μm.

[0042] In some embodiments, the needle is used to implant a physiological monitoring device or an electrode into a living body.

[0043] Other features and advantages of the present disclosure will become clearer from the following detailed description of exemplary embodiments of the present disclosure with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] The drawings forming a part of the specification depict embodiments of the present disclosure and, together with the specification, are used to explain the principles of the present disclosure.

[0045] With reference to the accompanying drawings, the present disclosure can be more clearly understood from the following detailed description, where:

[0046] Figure 1 A schematic structural diagram of a needle according to an exemplary embodiment of the present disclosure is shown;

[0047] Figure 2 A micrograph of a needle according to a specific example of the present disclosure is shown;

[0048] Figure 3 A schematic flow diagram of a method for preparing a needle according to an exemplary embodiment of the present disclosure is shown;

[0049] Figure 4 An experimental schematic diagram for implementing the method for preparing a needle according to a specific embodiment of the present disclosure is shown;

[0050] Figures 5 to 7 Micrographs of needles prepared at different first preset voltages and preset rates are respectively shown;

[0051] Figure 8 A schematic flow diagram of a method for preparing a needle according to another exemplary embodiment of the present disclosure is shown.

[0052] Note that in the embodiments described below, sometimes the same reference numerals are used among different drawings to denote the same or parts having the same functions, and their repeated descriptions are omitted. In this specification, similar reference numerals and letters are used to denote similar items. Therefore, once an item is defined in one drawing, it does not need to be further discussed in subsequent drawings.

[0053] For ease of understanding, the positions, dimensions, ranges, etc. of the various structures shown in the drawings and the like sometimes do not represent the actual positions, dimensions, ranges, etc. Therefore, the disclosed invention is not limited to the positions, dimensions, ranges, etc. disclosed in the drawings and the like. In addition, the drawings do not have to be drawn to scale, and some features may be enlarged to show details of specific components. Detailed Description of Specific Embodiments

[0054] Various exemplary embodiments of the present disclosure will now be described in detail with reference to the drawings. It should be noted that unless otherwise specifically stated, the relative arrangements of components and steps, numerical expressions, and numerical values set forth in these embodiments do not limit the scope of the present disclosure.

[0055] The following description of at least one exemplary embodiment is merely illustrative in nature and in no way limits the present disclosure, its application, or its use. Those skilled in the art will understand that they merely illustrate exemplary ways in which the present disclosure can be implemented, rather than exhaustive ways.

[0056] Techniques, methods, and devices known to those of ordinary skill in the relevant art may not be discussed in detail, but where appropriate, such techniques, methods, and devices should be considered as part of the specification.

[0057] In order to monitor various physiological parameters of an organism, implement brain-computer interface applications, or treat some diseases of the organism, etc., corresponding sensors or physiological monitoring devices such as electrodes electrically connected to the sensors, or deep brain electrodes, etc. can be implanted into the organism. For example, nerve electrodes can be implanted into the brain of the organism. In one implantation method, implantation holes can be opened in the physiological monitoring device or electrode to be implanted, and a needle can be inserted through the implantation holes 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 holes 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, during the implantation process, undesired shrinkage and other situations may occur, making it difficult to achieve an ideal monitoring effect; on the other hand, mechanical interference and the like may occur during the process of the needle leaving the implantation hole, making it difficult to smoothly withdraw the needle.

[0058] To solve the above problems, the present disclosure proposes a needle and a method for preparing the needle.

[0059] In an exemplary embodiment of the present disclosure, as Figure 1 and Figure 2As shown, the needle device 100 may include an implantation portion 110 and a clamping portion 120. Among them, the implantation portion 110 can be used to penetrate into the implantation holes of the physiological monitoring device or the electrode (for example, a through hole with both ends open, or a hole with a certain length and only one end open) to guide the physiological monitoring device or the electrode to a desired position in the living body, while the clamping portion 120 can be connected to other components, or directly or indirectly clamped and operated by an operator or an operating device such as a manipulator, so as to control the movement of the needle device 100 in the desired manner during the implantation process.

[0060] 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. Among them, the implantation end 111 can be set to be needle tip-shaped, or rather, the characteristic dimension of the cross-section of the implantation end 111 can be very small so as to penetrate into the implantation hole. Alternatively, the implantation end 111 may also have the same cross-section characteristic dimension as the main body portion of the implantation portion 110, which is not limited herein. 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 in a cross-section perpendicular to its elongation direction, and this third characteristic dimension d3 can be determined according to the size of the implantation hole of the physiological monitoring device or the electrode to be implanted. For example, it can be slightly smaller than the corresponding size of the implantation hole so that the needle device 100 can be attached to the physiological monitoring device or the electrode to be implanted. The clamping portion 120 may have a fourth characteristic dimension d4 in a cross-section perpendicular to its elongation direction, and this fourth characteristic dimension d4 can be determined according to the requirements of operations such as clamping, so as to perform the desired operations on the needle. Among them, the fourth characteristic dimension d4 may be greater than the third characteristic dimension d3, that is to say, the clamping portion 120 may be thicker than the implantation portion 110, so that in the case where a smaller-sized implantation hole is provided in the physiological monitoring device or the electrode, it is still possible to conveniently perform the desired operations via the clamping portion 120 of the needle device 100.

[0061] In a specific example, the implantation portion 110 may be cylindrical, and at this time, the third characteristic dimension d3 may refer to the cross-section diameter of the implantation portion 110. In other specific examples, the implantation portion 110 may also be in other shapes, and at this time, the third characteristic dimension characterizing its thickness can be determined according to the specific shape. In addition, in order to facilitate withdrawing the needle device 100 from the implantation hole after the implantation is completed and avoid mechanical interference between the implantation portion 110 and components such as the edge of the implantation hole during the withdrawal process, the cross-section of the implantation portion 110 may have a substantially uniform or constant third characteristic dimension, that is, the implantation portion 110 may be substantially uniform in thickness. For example, the third characteristic dimension d3 may be 10 - 20 μm or 20 - 100 μm. In Figure 2In a specific example shown, the cross-sectional diameter of the implantation part 110 of the needle device 100 (i.e., the third characteristic dimension d3) can be 21.351 μm.

[0062] Similarly, in a specific example, the clamping part 120 can also be cylindrical. At this time, the fourth characteristic dimension d4 can refer to the cross-sectional diameter of the clamping part 120. In other specific examples, for the convenience of clamping, the clamping part 120 can also be in other shapes. At this time, the fourth characteristic dimension representing its thickness can be determined according to the specific shape. It can be understood that the clamping part 120 can have uneven thickness. For example, in the direction from near the implantation part 110 to far from the implantation part 110, the clamping part 120 can gradually become thicker, or a stepped part convenient for clamping can be formed therein, etc., which is not limited herein. For example, the fourth characteristic dimension d4 of the clamping part 120 (in the case where the clamping part 120 has uneven thickness, the fourth characteristic dimension can be the characteristic dimension of the cross-section at a certain position of the clamping part 120) can be 30 - 60 μm or 60 - 300 μm.

[0063] In some embodiments, the length of the needle device 100 in its elongation direction, especially the implantation length L of the implantation part 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 the electrode. For example, the implantation length can be 100 - 300 μm or 300 - 500 μm. For example, in Figure 2 a specific example shown, the implantation length L can be 411.658 μm.

[0064] To form the needle device as described above, the present disclosure also proposes a method for preparing a needle device. In an exemplary embodiment of the present disclosure, as Figure 3 and Figure 4 shown, the method for preparing the needle device can include:

[0065] Step S910, immersing a part of the conductive member 200 in the electrolyte solution 300.

[0066] Among them, the conductive member 200 can be configured to serve as a cathode, which can be formed of a conductive material that basically does not react with the electrolyte solution 300. For example, it can be formed of copper. Additionally, as will be elaborated below, the needle base material 100' for forming the needle 100 can be configured to serve as an anode, which can be formed of materials such as tungsten or stainless steel. It can be understood that during the preparation of the needle 100, the shape of the needle base material 100' will change as the corrosion progresses. The electrolyte solution 300 can be a potassium hydroxide (KOH) solution or a sodium hydroxide (NaOH) solution with a concentration of 1 - 2 mol / L or 2 - 3 mol / L. For example, 500 mL of a NaOH solution with a concentration of 2 mol / L can be provided as the electrolyte solution 300. By applying a certain voltage between the anode and the cathode, the anode material can undergo an electrochemical reaction with the electrolyte solution and be corroded, thereby forming a needle 100 with a desired shape. It can be understood that in some other embodiments, other suitable materials can also be selected to form the conductive member 200, the needle base material 100', or the electrolyte solution 300, which is not limited herein.

[0067] As needed, the provided needle base material 100' and the conductive member 200 can have suitable shapes to improve the final corrosion effect, which is not limited herein. In the following, the shape of the needle base material 100' and the conductive member 200 shown in the specific embodiment of Figure 4 will be used as an example to elaborate in detail the method for preparing the needle of the present disclosure, but this does not mean a limitation to the present disclosure. As Figure 4 shown, the needle base material 100' can be in a filamentous shape, and the conductive member 200 can include a circular ring portion 210. During the corrosion of the needle base material 100', the needle base material 100' can be perpendicular to the plane where the circular ring portion 210 is located, and the needle base material 100' can be located on the straight line where the center (or the center of the circle) of the circular ring portion 210 is located. In this way, the distance between a certain point on the needle base material 100' serving as the anode and any point on the circular ring portion 210 of the conductive member 200 serving as the cathode can be basically equal, so that the needle base material 100' can be evenly corroded in all directions on its side surface, avoiding the situation that the obtained needle after corrosion deflects in a certain direction (for example, to the left or right as shown in Figure 4 .

[0068] Furthermore, considering that the corrosion rate of the needle base material 100' is related to the distance between it and the circular ring portion 210, in order to better control the process of corroding the needle base material 100' and avoid the undesired corrosion effect caused by excessive corrosion, during the corrosion of the needle base material 100', the circular ring portion 210 can be relative to the immersion end of the needle base material 100' (i.e., Figure 4The lower end (shown in [reference]) is located deeper in the electrolyte solution 300 to avoid too small a minimum distance between the needle substrate 100' and the ring portion 210. However, it can be understood that if it is necessary to increase the corrosion rate of the needle substrate 100' (for example, during the process of forming the tip of the needle as described later), the ring portion 210 can also be raised to reduce the distance between the needle substrate 100' and the ring portion 210, and even the immersion end of the needle substrate 100' can pass through the ring portion 210, which is not limited herein.

[0069] As will be described in detail later, during the corrosion process, it may be necessary to control the movement of the needle substrate 100' according to a preset movement pattern. To better control the movement of the needle substrate 100', as Figure 4 shown, the conductive member 200 may further include a rod-shaped portion 220 connected to the ring portion 210. The needle substrate 100' can be slidably attached to the rod-shaped portion 220, and the needle substrate 100' can be configured to move in the vertical direction with respect to the liquid level of the electrolyte solution 300. In this way, under the guiding action of the rod-shaped portion 220, the needle substrate 100' can be prevented from skewing during the up and down movement, thereby ensuring the uniformity of the corrosion of the side surface of the needle substrate 100'. For example, the needle substrate 100' can be attached to the rod-shaped portion 220 of the conductive member 200 by pasting or by means of a slide rail connection, etc., which is not limited herein. Further, in some embodiments, the needle substrate 100' can be configured to move according to a preset movement pattern under the action of a driving motor. For example, the non-immersion end of the needle substrate 100' (i.e., Figure 4 the upper end shown in [reference]) can be mechanically connected to the driving motor, so as to accurately control the immersion depth of the needle substrate 100' in the electrolyte solution 300 by controlling the driving motor.

[0070] As Figure 3 shown, in some embodiments, especially when the characteristic dimension of the cross-section of the needle substrate 100' is already suitable for preparing the implanted portion 110 of the needle 100 (or rather, when at least the first part of the needle substrate 100' is already thin enough to obtain the desired thickness of the implanted portion 110 without too long a corrosion time), the needle preparation method may further include:

[0071] Step S920, immersing the first part of the needle substrate 100' in the electrolyte solution 300; and,

[0072] 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 pattern so that the first part is corroded to have a first characteristic dimension on a cross-section perpendicular to the elongation direction of the first part.

[0073] Here, the purpose of steps S920 and S930 is to form at least the main part of the implanting part 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. Thus, 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, the situation of uneven thickness occurs. To solve this problem, the needle substrate 100' can be controlled to move according to a preset movement pattern while applying the 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 implanting part 110 with substantially uniform thickness, a suitable preset movement pattern can be determined according to factors such as the applied first preset voltage, the concentration of the electrolyte solution 300, and the characteristic dimension of the cross-section of the first part of the needle substrate 100' immersed in the electrolyte solution 300. Usually, the preset movement pattern includes the movement of the needle substrate 100' in the Figure 4 vertical direction shown in, so as to change the distance between the needle substrate 100' and the circular ring part 210 of the conductive member 200 (the conductive member 200 can remain stationary), and then adjust 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 correspondingly. 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 experimentally found that the first part of the needle substrate 100' immersed in the electrolyte solution 300 may vibrate violently and break, resulting in the inability to form the implanting part 110 with the desired morphology.

[0074] In a specific embodiment, controlling the needle substrate 100' to move according to a preset movement pattern may include controlling the needle substrate 100' to move upward uniformly at a preset rate with respect to the liquid surface of the electrolyte solution 300 until the first part leaves the electrolyte solution 300. Among them, the preset rate can be determined according to factors such as the applied first preset voltage, the concentration of the electrolyte solution 300, and the characteristic dimension of the cross-section of the first part of the needle substrate 100' immersed in the electrolyte solution 300. At a suitable preset rate, an implanting part 110 with uniform thickness can be formed. Otherwise, the cross-sectional characteristic dimensions of the implanting part 110 of the needle 100 formed may change.

[0075] For example, Figures 5 to 7 shows the micrographs of the needles prepared under different first preset voltages and preset rates. Among them, in Figure 5In the specific example shown, the first length of the first part of the needle substrate 100' immersed in the electrolyte solution 300 is 0.65 mm. The first preset voltage applied is 8 V, and the needle substrate 100' is uniformly moved upward away from the electrolyte solution 300 within a time of 100 s. Then, the obtained needle after corrosion will have an implant part with substantially uniform thickness. However, in Figure 6 and Figure 7 In the specific example shown, if the first preset voltage applied and the preset rate do not match, the implant part may gradually taper. For example, in Figure 6 the third characteristic dimension of the implant part decreases from 80.643 μm indicated by the right arrow to 68.951 μm indicated by the left arrow; or the implant part may have alternating thick and thin sections. For example, in Figure 7 the third characteristic dimension of the implant part only thickens first and then thins. The third characteristic dimensions 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 according to experiments and are not limited herein.

[0076] In another specific embodiment, controlling the needle substrate 100' to move according to a preset movement pattern may include controlling the needle substrate 100' to reciprocally move in the up and down directions with respect to the liquid level of the electrolyte solution. For example, in the case where the implant part is uneven in thickness as shown in Figure 6 and Figure 7 , the first part of the needle substrate 100' can be re-immersed in the electrolyte solution 300 and reciprocally moved up and down one or more times until a needle with an implant part having uniform thickness is corroded. During each upward or downward movement, the needle substrate 100' can move at a uniform speed. Additionally, the speed during the upward movement and the speed during the downward movement can be equal or unequal to each other, which can be determined according to the corrosion condition of the needle substrate 100' and is not limited herein.

[0077] Further, 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 to timely adjust the preset movement pattern. For example, controlling the needle substrate 100' to move according to a preset movement pattern may further include: after the uniform movement of the needle substrate 100' in the first direction ends, 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 pattern; if not, controlling the needle substrate 100' to move uniformly in the second direction opposite to the first direction.

[0078] Return Figure 3 , the method for preparing a needle according to the present disclosure may further include:

[0079] Step S940, dipping the second part of the needle substrate 100' into the electrolyte solution 300; and,

[0080] Step S950, applying a second preset voltage between the anode and the cathode to corrode the second part until it breaks, so as to form a tip at the break of the remaining part of the needle substrate 100' (i.e., the part of the needle substrate 100' different from the second part).

[0081] Here, the purposes of Step S940 and Step S950 are to form the implantation end 111 in the shape of a tip of the implantation part 110 of the needle 100. It can be understood that, generally, the second length of the second part can be less than the first length of the first part to retain the implantation part 110 with a uniform third characteristic dimension. In some embodiments, after the second part is corroded until it breaks, 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 the tip-shaped implantation end 111 from becoming blunt due to over-corrosion. 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 facilitate the breakage of the second part. In a specific example, the second length of the second part of the needle substrate 100' re-dipped into the electrolyte solution 300 after Step S930 can be 0.1 mm.

[0082] As described above, in some embodiments, during the entire corrosion process of the needle, the position of the conductive member 200 can remain unchanged to facilitate operation. Or, in other embodiments, for example, in order to accelerate the corrosion process of the tip, the distance between the immersion end of the needle substrate 100' and the conductive member 200 can be appropriately reduced, and even the immersion end of the needle substrate 100' can pass through the circular ring portion 210 of the conductive member 200 to generate a sharp implantation end 111.

[0083] According to the above description, the implantation length L of the implantation part 110 of the finally formed needle 100 in the elongation 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.

[0084] 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 implantation part 110 with the desired size, the needle substrate 100' can also be pre-corroded. As Figure 8 shown, before the operation of dipping the first part of the needle substrate 100' into the electrolyte solution 300, the needle preparation method can further include:

[0085] Step S960, dipping the third part of the needle substrate 100' into the electrolyte solution 300; and,

[0086] Step S970, applying a third preset voltage between the anode and the cathode to corrode the third part until it has a second feature size in the cross-section.

[0087] Wherein, 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 a 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 0.6 mm and the first length can be 0.65 mm. That is, the part of the needle substrate 100' with a length of 0.6 mm can be pre-corroded (the position of the needle substrate 100' can remain unchanged at this time) to reduce the feature size of its cross-section; then, the part of the needle substrate 100' with a length of 0.65 mm can be subjected to the refined corrosion as described in step S930 above (the needle substrate 100' moves according to a preset movement pattern at this time) so as to form an implant part 110 with a desired size and morphology. Here, the second feature size can be greater than the first feature size and the second feature size can be less than a preset size threshold, where the preset size threshold can be set according to specific corrosion requirements. 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 requirements of the needle substrate. In some specific examples, the third preset voltage can be 2 - 4 V or 4 - 6 V or 6 - 8 V or 8 - 9 V.

[0088] In the technical solution of the present disclosure, by controlling the movement of the needle according to a preset movement pattern during the corrosion of the needle, a needle with an implant part of uniform thickness can be formed. During the implantation process, the implant part can be inserted into the implantation hole of the physiological monitoring device or the electrode, and by operating the clamping part of the needle connected to the implant part, the physiological monitoring device or the electrode can be guided to a desired position in the living body. Since the implant part has a certain length, the desired shape of the physiological monitoring device or the electrode can be well maintained, improving the monitoring effect; in addition, since the implant part is of uniform thickness, mechanical interference between the implant part and components such as the edge of the implantation hole can be effectively avoided during the process of withdrawing the needle, thus facilitating the withdrawal of the needle from the living body.

[0089] In the description and claims, terms such as "left", "right", "front", "back", "top", "bottom", "upper", "lower", "higher", "lower", etc., if present, are used for descriptive purposes and do not necessarily describe invariant relative positions. It should be understood that such terms are interchangeable under appropriate circumstances, such that the embodiments of the present disclosure described herein, for example, can operate in orientations different from those shown or otherwise described herein. For example, when the device in the figures is inverted, a feature originally described as "above" other features can then be described as "below" those other features. The device can also be oriented in other ways (rotated 90 degrees or in other orientations), and the relative spatial relationships will be correspondingly interpreted.

[0090] In the description and claims, when an element is referred to as being "above", "attached" to, "connected" to, "coupled" to, or "in contact" with another element, etc., the element can be directly above, directly attached to, directly connected to, directly coupled to, or directly in contact with the other element, or there can be one or more intervening elements. In contrast, when an element is referred to as being "directly" above, "directly attached" to, "directly connected" to, "directly coupled" to, or "directly in contact" with another element, there will be no intervening elements. In the description and claims, a feature being arranged "adjacent" to another feature can mean that the feature has an overlapping portion with the adjacent feature or a portion located above or below the adjacent feature.

[0091] As used herein, the term "exemplary" means "serving as an example, instance, or illustration", rather than as a "model" to be precisely replicated. Any implementation described herein exemplarily is not necessarily to be construed as preferred or advantageous over other implementations. Moreover, the present disclosure is not limited by any theory, whether expressed or implied, given in the technical field, background art, summary of the invention, or detailed description.

[0092] As used herein, the term "substantially" means including any minor variations caused by design or manufacturing defects, tolerances of devices or components, environmental effects, and / or other factors. The term "substantially" also allows for differences from a perfect or ideal situation due to parasitic effects, noise, and other practical considerations that may exist in an actual implementation.

[0093] Additionally, for reference purposes only, terms such as "first", "second", etc. may also be used in this document and are thus not intended to be limiting. For example, unless the context clearly indicates otherwise, the words "first", "second", and other such numerical words referring to structures or elements do not imply an order or sequence.

[0094] It should also be understood that when the term "comprising / including" is used in this document, it indicates the presence of the stated features, wholes, steps, operations, units, and / or components, but does not exclude the presence or addition of one or more other features, wholes, steps, operations, units, and / or components and / or their combinations.

[0095] In this disclosure, the term "provide" is used in a broad sense to cover all ways of obtaining an object. Thus, "providing an object" includes, but is not limited to, "purchasing", "preparing / manufacturing", "arranging / setting", "installing / assembling", and / or "ordering" the object, etc.

[0096] As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items. The terms used in this document are for the purpose of describing particular embodiments only and are not intended to limit this 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.

[0097] Those skilled in the art should be aware 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 among additional operations, and operations can be performed at least partially overlapping in time. Moreover, alternative embodiments can include multiple instances of a particular operation, and the order of operations can be changed in various other embodiments. However, other modifications, variations, and substitutions are also possible. The aspects and elements of all the embodiments disclosed above can 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 the drawings should be regarded as illustrative rather than restrictive.

[0098] Although some specific embodiments of this disclosure have been described in detail by way of examples, those skilled in the art should understand that the above examples are for illustrative purposes only and not for limiting the scope of this disclosure. The embodiments disclosed herein can be combined arbitrarily without departing from the spirit and scope of this disclosure. Those skilled in the art should also understand that various modifications can be made to the embodiments without departing from the scope and spirit of this disclosure. The scope of this 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 in a filamentary form and is configured to serve 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 on a cross section perpendicular to the elongation direction of the first portion, wherein the first characteristic size is uniform in the elongation direction, and a portion of the needle substrate that is not immersed in the electrolyte solution has a characteristic size on a cross section perpendicular to the elongation direction that is greater than the first characteristic size; immersing a second portion of the needle substrate in an electrolyte solution, wherein the second portion is a portion of the first portion, and 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 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.

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