An SMA-driven hydrocephalus shunt valve and pressure reading tool

Abstract

An SMA-driven hydrocephalus shunt valve and pressure reading tool. Relating to the field of medical devices. Utilizing wireless functions to drive SMA wires to achieve step-by-step adjustment, thereby avoiding differences in manual operation and improving adjustment accuracy. The present invention comprises an upper end cover, a valve body, and a lower end cover. A ratchet and pawl mechanism driven by an SMA wire is provided in the upper valve chamber, and a cam groove is provided on the ratchet rotor in the ratchet and pawl mechanism; the SMA wire is connected to a circuit board; a bow spring mechanism is also provided in the upper valve chamber, the tail end of the bow spring is fixedly connected to the outer wall of the pivot sleeve, the head abuts against a hollow titanium ball, and the bow spring and the support rod have an angle α. The present invention breaks the traditional technology of relying on manual pressure adjustment in this field. SMA shape memory alloy wire is boldly introduced as an adjustment actuator. The present invention reduces the requirements for manual operation, overcomes the current situation of relying on operator experience, and can achieve high-precision pressure adjustment.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a hydrocephalus shunt valve with adjustable working pressure, a pressure regulating method thereof, and a pressure reading tool. Background Art

[0002] Hydrocephalus is characterized by excessive secretion of cerebrospinal fluid (CSF), insufficient reabsorption, or mechanical obstruction of its pathways. Most often, hydrocephalus is caused by a blockage at a CSF absorption site, resulting in excessive accumulation within the ventricular system, leading to neurological or motor impairments. If untreated, this blockage can lead to head enlargement in infants whose skull sutures have not yet fused, subsequently causing brain damage. In adults, due to the rigidity of the skull, the brain is subjected to increased pressure from the CSF, and symptoms such as headaches, gait disturbances, and dementia have been reported.

[0003] Treatment for hydrocephalus involves diverting the cerebrospinal fluid within the ventricles of the skull to any other absorption area, such as the heart or peritoneum. Typically, a hole drilled in the skull allows a catheter to be introduced into the ventricles. This catheter is connected to a hydrocephalus shunt valve inserted under the scalp, which is connected to another catheter inserted under the skin, which leads to the heart or peritoneum. Once implanted, the hydrocephalus shunt valve regulates the pressure within the patient's ventricles, and the opening pressure of the shunt valve can be adjusted non-invasively after surgery to accommodate normal pressure changes in the ventricles.

[0004] To address this issue, existing technologies primarily incorporate a rotor with a magnetic element within the hydrocephalus shunt valve. Rotating the rotor adjusts the valve pressure. Using an adjustment device equipped with a magnetic element, magnetic coupling between the rotor's magnetic element and the device's magnetic element allows for non-invasive adjustment of the shunt valve's opening pressure through the patient's skin. However, this adjustment method requires high alignment and relies on the precision of manual operation.

[0005] Therefore, how to avoid the differences in manual operation and design a technical solution that can accurately adjust the opening pressure of the diverter valve has become a technical problem that needs to be solved urgently in this field. Summary of the Invention

[0006] In response to the above technical problems, the present invention proposes an SMA-driven hydrocephalus shunt valve, pressure adjustment method, and pressure reading tool that completely breaks away from manual adjustment experience, utilizes wireless function to drive SMA wire to achieve step-by-step adjustment, thereby avoiding the differences in manual operation and improving the adjustment accuracy.

[0007] An SMA-driven hydrocephalus shunt valve of the present invention comprises an upper end cover, a valve body, and a lower end cover. A liquid inlet and a liquid outlet are respectively provided at both ends of the valve body. A middle diaphragm is also provided on the upper portion of the valve body. A receiving coil and a circuit board electrically connected to each other are provided between the middle diaphragm and the upper end cover.

[0008] A valve cavity partition structure is provided in the cavity of the valve body located below the middle partition plate. The valve cavity partition structure divides the cavity of the valve body into an upper valve cavity communicating with the liquid outlet and a lower valve cavity communicating with the liquid inlet. The lower valve cavity communicates with the upper valve cavity through a valve port. A hollow titanium ball containing a solid titanium ball is provided in the valve port.

[0009] A ratchet and pawl mechanism driven by an SMA wire is provided in the upper valve chamber, and a cam groove is provided on the ratchet rotor in the ratchet and pawl mechanism; the SMA wire is connected to the circuit board;

[0010] The valve cavity separation structure includes a hollow boss and a separation plate, a gap is left between the separation plate and the lower end cover to form the lower valve cavity, and the upper valve cavity is formed between the separation plate and the middle partition plate;

[0011] The boss has a side plate, the valve port is opened on the side plate, and the bottom edge of the valve port is higher than the top surface of the partition plate, so that the lower valve cavity is connected to the upper valve cavity through the valve port;

[0012] Also provided on the top surface of the partition plate are: a ratchet shaft in the middle position, and a bow spring mechanism rotating pin, a rotating pin, a bias spring hanging column, an SMA wire support column 1 and an SMA wire support column 2 arranged on the periphery;

[0013] A bow spring mechanism is also provided in the upper valve chamber, and the bow spring mechanism includes: a bow spring, a pivot sleeve and a support rod, the pivot sleeve is pivotally connected to the bow spring mechanism rotation pin on the upper surface of the valve chamber partition structure, the tail end of the support rod is fixedly connected to the outer wall of the pivot sleeve, the head end of the support rod is connected to the cam groove via a sliding pin, the tail end of the bow spring is fixedly connected to the outer wall of the pivot sleeve, the head end of the bow spring abuts the hollow titanium ball, and the bow spring and the support rod have an angle α;

[0014] The tail end of the SMA wire is fixedly connected to the second SMA wire support column, and after the SMA wire passes around the first SMA wire support column, the head end of the SMA wire is connected to the ratchet pawl mechanism;

[0015] The ratchet and pawl mechanism further includes a pawl A, a pawl B and a connecting rod;

[0016] The ratchet rotor is connected to the ratchet shaft,

[0017] The connecting rod is movably connected to the rotating pin, and the ratchet teeth of the pawl A and the pawl B are relatively movably hinged at the front end of the connecting rod. The tail end of the connecting rod is connected to a bias spring in the direction of the ratchet rotor, and the head end of the SMA wire is connected to the tail end of the connecting rod in the opposite direction to the bias spring.

[0018] Furthermore, a pair of magnets are symmetrically embedded on the top surface of the ratchet rotor for detecting the circumferential position of the ratchet rotor.

[0019] Furthermore, the SMA wire is connected to the circuit board via a pair of wires passing through the middle partition, and the outer surface of the SMA wire is covered with an insulating layer.

[0020] Furthermore, the circuit board includes a full-wave rectifier circuit for rectifying the alternating current of the receiving coil and outputting it to the SMA wire.

[0021] Furthermore, the solid titanium ball is sealed and wrapped inside the hollow titanium ball. The outer diameter of the solid titanium ball is smaller than the inner diameter of the hollow titanium ball, so that the solid titanium ball can move freely inside the hollow titanium ball. In the horizontal state, the solid titanium ball's own gravity does not act on the valve port. In the upright state, its own gravity acts on the valve port to compensate for the siphon effect caused by changes in body position.

[0022] Furthermore, the bow spring and the cam groove on the ratchet rotor are configured to allow the opening pressure of the cerebrospinal fluid shunt valve to be adjusted in stages within the range of 20 to 220 mmH2O.

[0023] The present invention provides a pressure regulation method for an SMA-driven hydrocephalus shunt valve, comprising the following steps:

[0024] S1. Hydrocephalus shunt valve positioning: The hydrocephalus shunt valve is implanted and the position of the hydrocephalus shunt valve is determined using a positioning tool;

[0025] S2. Hydrocephalus shunt valve opening pressure detection: A pressure detection device with a magnetic needle is used to detect the position of the ratchet rotor 106 to confirm the current opening pressure of the hydrocephalus shunt valve;

[0026] S3. Adjusting the opening pressure of the hydrocephalus shunt valve: Place the external transmitting coil close to the hydrocephalus shunt valve. The receiving coil inside the hydrocephalus shunt valve couples with the external transmitting coil to receive electrical energy. The received electrical energy is rectified by the circuit board and then output to the SMA wire. The SMA wire heats up and contracts, generating a driving force that drives the ratchet rotor to rotate counterclockwise. A single action can adjust the angle of the ratchet rotor's rotation through one ratchet tooth. This adjustment can be repeated until the opening pressure of the hydrocephalus shunt valve reaches the target opening pressure.

[0027] S4. Confirmation of the opening pressure of the hydrocephalus shunt valve: After completing steps S1-S3, use a pressure detection device with a magnetic needle to detect the opening pressure of the adjusted hydrocephalus shunt valve again.

[0028] A pressure reading tool for an SMA-driven hydrocephalus shunt valve applicable to the present invention comprises: a positioning seat and a pressure reading box,

[0029] The positioning seat comprises an annular seat body having an outer contour similar to the outer contour of the hydrocephalus shunt valve, the bottom surface of the seat body is provided with an inner flange, and windows are respectively provided at the two ends of the maximum distance of the inner flange;

[0030] The pressure reading box includes a box body, a central axis, a magnetic pointer and a transparent end cover. The box body can be embedded in the base body. The central axis is fixed at the center position of the bottom surface of the box body. The rotatable magnetic pointer is set on the central axis. The transparent end cover is set at the upper end of the box body.

[0031] This invention breaks with the traditional reliance on manual pressure adjustment in this field. It boldly introduces SMA (shape memory alloy) wire as the actuator for adjustment. To achieve this innovative concept, first, the invention utilizes wireless power transmission technology for transcutaneous energy transfer. Because a certain offset between the transmitting and receiving coils of a wireless power transmission system is permitted, alignment requirements are reduced. Second, the SMA offset actuator (the core technology of this invention) utilizes SMA wire as the driving element and is compatible with the wireless power transmission system. Each energy supply causes the SMA wire to actuate (contract) once. This contraction of the SMA wire actuates pawl A once via a connecting rod, which in turn rotates the ratchet rotor by one tooth. This, in turn, adjusts the angle of the support rod via a cam slot, further varying the elastic force of the bow spring, and thus the pressure against the hollow titanium ball, thereby regulating the working pressure. If the adjustment is insufficient, the above steps are repeated.

[0032] The present invention reduces the requirement for manual operation, overcomes the current situation of relying on operator experience, and realizes "gradual" pressure adjustment through wireless function, thereby achieving high-precision, non-human experience pressure adjustment. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0034] Figure 1It is a three-dimensional exploded view of the present invention,

[0035] Figure 2 It is a structural schematic diagram of the present invention,

[0036] Figure 3 yes Figure 2 Middle AA section view,

[0037] Figure 4 This is a three-dimensional diagram of the valve body in the present invention Figure 1 ,

[0038] Figure 5 This is a three-dimensional diagram of the valve body in the present invention Figure 2 ,

[0039] Figure 6 It is a structural schematic diagram of the valve body in the present invention;

[0040] Figure 7 This is a three-dimensional diagram of the internal structure of the valve cavity in the present invention. Figure 1 ,

[0041] Figure 8 This is a three-dimensional diagram of the internal structure of the valve cavity in the present invention. Figure 2 ,

[0042] Figure 9 This is a three-dimensional diagram of the internal structure of the valve cavity in the present invention. Figure 3 ,

[0043] Figure 10 This is a schematic diagram of the structure of the hollow titanium ball and the solid titanium ball in the present invention. Figure 1 ,

[0044] Figure 11 This is a schematic diagram of the structure of the hollow titanium ball and the solid titanium ball in the present invention. Figure 2 ,

[0045] Figure 12 This is a schematic diagram of the fluid flow direction when the present invention is working.

[0046] Figure 13 yes Figure 12 A top view of

[0047] Figure 14 This is the working state of the present invention Figure 1 ,

[0048] Figure 15 This is the working state of the present invention Figure 2 ,

[0049] Figure 16 This is a working principle diagram of the present invention in the first working state,

[0050] Figure 17This is a working principle diagram of the present invention in the second working state,

[0051] Figure 18 It is a structural diagram of the positioning seat in the present invention,

[0052] Figure 19 This is a three-dimensional exploded view of the pressure reading box of the present invention.

[0053] Figure 20 It is a structural diagram of the pressure reading box in the present invention.

[0054] In the picture:

[0055] 1 is the hydrocephalus shunt valve,

[0056] Among them, 101-liquid outlet, 102-middle partition, 103-receiving coil, 104-hollow titanium ball, 1041-hollow hemisphere A, 1042-hollow hemisphere B, 105-solid titanium ball, 106-ratchet rotor, 1061-cam groove, 107-valve body, 1071-base, 1072-ratchet shaft, 1073-bias spring hanging column, 1074-SMA wire support column 1, 1075-SMA wire support column 2, 1076-bow spring mechanism rotation pin, 108-circuit board, 109-upper end cover, 110 - Rotating pin, 111 - Valve chamber partition structure, 1110 - Boss, 1111 - Lower valve chamber, 1112 - Valve port, 1113 - Upper valve chamber, 11131 - Side channel, 112 - Lower end cover, 113 - Bow spring, 1131 - Pivot sleeve, 1132 - Support rod, 11321 - Sliding pin, 114 - Pawl A, 115 - Tension spring, 116 - Magnet, 117 - Pawl B, 118 - Bias spring, 119 - Connecting rod, 1191 is a hinge pin, 120 - SMA wire, 1201 - Wire, 121 - Liquid inlet;

[0057] 2 is the ventricle, 3 is the abdominal cavity;

[0058] 4 is a pressure reading box, 401 is the box body, 402 is the center axis, 403 is the magnetic pointer, and 404 is the transparent end cap;

[0059] 5 is a positioning seat, 501 is a seat body, and 502 is a window.

[0060] Figure 3 The arrow lines appearing in the diagram indicate the direction of movement of the relevant components.

[0061] Figure 10 The pair of hollow arrows in the figure indicate the direction in which the two hemispherical shells are combined.

[0062] Figure 12 、 13 The arrow line in the diagram indicates the direction of liquid flow.

[0063] Figure 14 、 15 Middle: IVP-intraventricular pressure, Pvalve-hydrocephalus shunt valve opening pressure, IPP-intraperitoneal pressure, HP-hydrostatic pressure caused by gravity,

[0064] Figure 16 、 17 Middle: mg-weight of solid titanium sphere; F P -The force exerted by the fluid on the composite ball; F 弹 -The force of the bow spring on the valve port combination ball. DETAILED DESCRIPTION

[0065] The technical solution of the present invention is further described below with reference to the accompanying drawings and through specific implementation methods.

[0066] Among them, the drawings are only used for illustrative purposes and represent only schematic diagrams rather than actual pictures, and should not be understood as limiting this patent; in order to better illustrate the embodiments of the present invention, some parts of the drawings may be omitted, enlarged or reduced, and do not represent the size of the actual product; for those skilled in the art, it is understandable that some well-known structures and their descriptions in the drawings may be omitted.

[0067] The same or similar numbers in the drawings of the embodiments of the present invention correspond to the same or similar parts; in the description of the present invention, it should be understood that if the terms "upper", "lower", "left", "right", "inside", "outside" and the like indicate an orientation or position relationship based on the orientation or position relationship shown in the drawings, it is only for the convenience of describing the present invention and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation. Therefore, the terms describing the position relationship in the drawings are only used for illustrative purposes and cannot be understood as limiting this patent. For ordinary technicians in this field, the specific meanings of the above terms can be understood according to specific circumstances.

[0068] In the description of the present invention, unless otherwise expressly specified or limited, when the term "connection" or the like appears to indicate a connection relationship between components, such term should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium; it can be internal communication between two components or an interaction between two components. For those skilled in the art, the specific meanings of the above terms in the present invention can be understood in specific circumstances.

[0069] The technical solution adopted by the SMA driven hydrocephalus shunt valve of the present invention is as follows: Figure 1-3As shown, it includes an upper end cover 109, a valve body 107 and a lower end cover 112. The two ends of the valve body 107 are respectively provided with a liquid inlet 121 (connected to the cerebral ventricle) and a liquid outlet 101 (connected to the abdominal cavity). A middle partition 102 is also provided on the upper part of the valve body 107. A receiving coil 103 and a circuit board 108 that are electrically connected to each other are provided between the middle partition 102 and the upper end cover 109.

[0070] Regarding the structure of the valve body 107, Figure 4-6 As shown, a valve cavity partition structure 111 is provided in the cavity of the valve body 107 located at the lower part of the middle partition 102. The valve cavity partition structure 111 divides the cavity of the valve body 107 into an upper valve cavity 1113 connected to the liquid outlet 101 and a lower valve cavity 1111 connected to the liquid inlet 121. The lower valve cavity 1111 and the upper valve cavity 1113 are connected through the valve port 1112; a hollow titanium ball 104 containing a solid titanium ball 105 is provided at the valve port 1112.

[0071] The specific valve cavity separation structure 111 includes a hollow boss 1110 and a separation plate. A gap is left between the separation plate and the lower end cover 112 to form a lower valve cavity 1111. An upper valve cavity 1113 is formed between the separation plate and the middle partition plate 102.

[0072] Boss 1110 has a side plate, and valve port 1112 is provided on the side plate. The bottom edge of valve port 1112 is higher than the top surface of the partition plate, so that lower valve chamber 1111 communicates with upper valve chamber 1113 through valve port 1112. The above arrangement of boss 1110 and partition plate establishes the separation of the internal chambers of valve body 107, that is, forms the working flow path structure within valve body 107.

[0073] On the top surface of the partition plate (it should be noted that Figure 4 、 6 The following structure appears to be located on the "bottom surface," but since this "bottom surface" is the top surface of the partition plate, it is defined herein as the top surface of the partition plate. Also provided are: a centrally located ratchet shaft 1072, and a peripherally arranged bow spring mechanism pivot pin 1076, pivot pin 110, bias spring hanger 1073, SMA wire support column 1074, and SMA wire support column 2 1075. The tail end of the SMA wire 120 is fixedly connected to SMA wire support column 2 1075. After the SMA wire passes around SMA wire support column 1074, the head end of the SMA wire 120 is connected to the ratchet pawl mechanism. The columns, shafts, and pins located on the top surface of the partition plate constitute the mounting structure.

[0074] like Figure 7-9 As shown, a ratchet and pawl mechanism driven by an SMA wire 120 is provided in the upper valve chamber 1113 , and a cam groove 1061 is provided on the ratchet rotor 106 in the ratchet and pawl mechanism; the SMA wire 120 is connected to the circuit board 108 through a wire 1201 .

[0075] A bow spring mechanism is also provided in the upper valve chamber 1113, and the bow spring mechanism includes: a bow spring 113, a pivot sleeve 1131 and a support rod 1132. The pivot sleeve 1131 is pivoted to the bow spring mechanism pivot pin 1076 on the upper surface of the valve chamber partition structure 111, and the tail end of the support rod 1132 is fixedly connected to the outer wall of the pivot sleeve 1131. The head end of the support rod 1132 is connected to the cam groove 1061 through the sliding pin 11321. The tail end of the bow spring 113 is fixedly connected to the outer wall of the pivot sleeve 1131, and the head of the bow spring 113 abuts the hollow titanium ball 104. The bow spring 113 and the support rod 1132 have an angle α.

[0076] It should be noted here that the cam groove 1061 opened on the top surface of the ratchet rotor 106 has different radii. When the ratchet rotor 106 rotates, the support rod 1132 in the bow spring mechanism, especially the sliding pin 11321 at its head end, is connected to the cam groove 1061, which can drive the support rod 1132 to change the angle α between it and the bow spring 113, thereby changing the elastic output force of the bow spring 113, and finally achieving a change in the low pressure on the outer surface of the hollow titanium ball 104; this is also the final "output" of the SMA wire of the present invention after "starting", that is, the working pressure adjustment.

[0077] The ratchet and pawl mechanism further includes a pawl A 114 , a pawl B 117 and a connecting rod 119 ; the ratchet rotor 106 is connected to the ratchet shaft 1072 , so that the ratchet rotor 106 can rotate around the ratchet shaft 1072 .

[0078] The connecting rod 119 is movably connected to the rotating pin 110. Specifically, a rotating hole is opened in the middle of the connecting rod 119, and the connecting rod 119 is movably connected to the rotating pin 110 through the rotating hole.

[0079] The ratchet teeth of pawl A114 and pawl B117 are hinged relative to each other at the front end of connecting rod 119. A tension spring (not shown) is provided between pawl A114 and pawl B117. This spring ensures that both pawls can reliably press against and engage the ratchet teeth on ratchet rotor 106. Pawl A114 and pawl B117 are hinged to the front end of connecting rod 119 via hinge pin 1191.

[0080] The tail end of connecting rod 119 is connected to a bias spring 118, oriented toward ratchet rotor 106. One end of bias spring 118 is connected to a bias spring hanger 1073, in the opposite direction of bias spring 118. The tip of SMA wire 120 is also connected to the tail end of connecting rod 119. This allows SMA wire 120 to oscillate after changing size (contracting) due to temperature fluctuations. Pawl A 114 at the front end of connecting rod 119 then drives ratchet rotor 106 counterclockwise, causing ratchet rotor 106 to rotate. Another pawl B 117, after opening relative to pawl A 114, engages with the ratchet teeth of ratchet rotor 106 at the rear. Bias spring 118 pulls connecting rod 119 back to its initial position when SMA wire 120 contracts when powered on and returns to its original length when powered off.

[0081] Furthermore, a pair of magnets 116 are evenly distributed and embedded on the top surface of the ratchet rotor 106 for detecting the circumferential position of the ratchet rotor 106 .

[0082] Furthermore, the SMA wire 120 is connected to the circuit board 108 via a pair of wires passing through the middle septum 102 , and the outer surface of the SMA wire 120 is covered with an insulating layer, so that it is suitable for in vivo application.

[0083] Furthermore, the circuit board 108 includes a full-wave rectifier circuit for rectifying the alternating current of the receiving coil and outputting the resultant current to the SMA wire 120 .

[0084] Further, if Figure 10 、 11 As shown, the solid titanium ball 105 is sealed and wrapped inside the hollow titanium ball 104. The outer diameter of the solid titanium ball 105 is smaller than the inner diameter of the hollow titanium ball 104, so that the solid titanium ball 105 can move freely inside the hollow titanium ball 104. The solid titanium ball 105 has no effect on the valve port 1112 due to its own gravity in the horizontal state. In the upright state, its own gravity acts on the valve port 1112 to compensate for the siphon effect caused by the change in body position. Figure 12 、 13 shown.

[0085] Furthermore, the bow spring 113 and the cam groove 1061 on the ratchet rotor 106 are configured to allow for graduated adjustment of the opening pressure of the cerebrospinal fluid diversion valve within a range of 20 to 220 mmH2O. Within the pressure adjustment range set forth in the present invention, i.e., a lower limit of 20 mmH2O and an upper limit of 220 mmH2O, those skilled in the art, in light of the inventive concept and the technical problem to be solved herein, can achieve graduated adjustment within the range of 20 to 220 mmH2O by selecting the size and material of the bow spring 113, and designing the support rod 1132 with different angle radii relative to the initial angle α of the bow spring 113 and the cam groove 1061.

[0086] like Figure 14 As shown, when the patient is horizontal, the ventricles and abdominal cavity are at the same level, and there is no hydrostatic pressure difference between the ventricles and abdominal cavity. The pressure difference at both ends of the hydrocephalus shunt valve 1 is:

[0087] ΔP 仰卧 = IVP - IPP

[0088] like Figure 15 As shown, when the patient is upright, there is a height difference between the ventricles and the abdominal cavity, and there is a hydrostatic pressure difference between the ventricles and the abdominal cavity. HP , the pressure difference between the two ends of hydrocephalus shunt valve 1:

[0089] ΔP 直立 = IVP + HP - IPP

[0090] Due to hydrostatic pressure difference HP The existence of will cause the problem of excessive drainage. Analysis of the structure designed to avoid the problem of excessive drainage:

[0091] The opening pressure of the SMA-driven hydrocephalus shunt valve 1 is P valve In the horizontal state, the valve port 1112 is subjected to the force as follows Figure 16 As shown, when the patient is in a horizontal state, the gravity of the solid titanium ball 105 has no effect on the valve port 1112, and the opening pressure of the SMA-driven hydrocephalus shunt valve 1 is only determined by the elastic force. F 弹 Determine that at this time, as long as the pressure of the fluid on the valve port 1112 meets the following requirements:

[0092] F p > P valve = F 弹

[0093] At this time, the valve port 1112 opens, and the SMA-driven hydrocephalus shunt valve 1 begins to divert;

[0094] In the upright state, the valve port 1112 is subjected to the force Figure 17 As shown in Figure 1, when the patient is in a horizontal position, the opening pressure of the SMA-driven hydrocephalus shunt valve 1 is:

[0095] P valve = F 弹 + mg

[0096] At this time, the pressure of the fluid on the valve port 1112 is required to be:

[0097] F p > P valve = F 弹 + mg ,

[0098] At this time, the valve port 1112 is opened, and the SMA-driven hydrocephalus shunt valve 1 begins to divert flow.

[0099] The solid titanium ball 105 compensates the hydrostatic pressure difference HP caused by the patient's body position difference between the horizontal state and the upright state through its own gravity mg.

[0100] A method for regulating the pressure of a hydrocephalus shunt valve comprises the following steps:

[0101] S1, Positioning of hydrocephalus shunt valve 1: The hydrocephalus shunt valve 1 is implanted, and the position of the hydrocephalus shunt valve is determined using a mechanical positioning tool;

[0102] S2. Detection of the opening pressure of the hydrocephalus shunt valve 1: A pressure detection device with a pair of magnetic needles is used to detect the position of the ratchet rotor 106, thereby confirming the current opening pressure of the hydrocephalus shunt valve 1;

[0103] S3. Adjusting the opening pressure of the hydrocephalus shunt valve 1: The external transmitting coil is placed close to the hydrocephalus shunt valve 1. The receiving coil inside the hydrocephalus shunt valve 1 couples with the external transmitting coil to receive electrical energy. The received electrical energy is rectified by the circuit board and then output to the SMA wire. The SMA wire heats up and contracts, generating a driving force that drives the ratchet rotor 106 to rotate counterclockwise. A single action can adjust the ratchet rotor 106 to rotate through one ratchet tooth. This adjustment can be repeated until the opening pressure of the hydrocephalus shunt valve 1 reaches the target opening pressure.

[0104] S4. Confirmation of the opening pressure of the hydrocephalus shunt valve 1: After completing steps S1-S3, the opening pressure of the adjusted hydrocephalus shunt valve 1 is again detected using a pressure detection device with a pair of magnetic needles.

[0105] A window with the same outline as the hydrocephalus shunt valve 1 is provided at the bottom of the mechanical positioning tool. When positioning, the approximate position of the subcutaneous hydrocephalus shunt valve 1 is determined by touch, and then the position is determined by matching the window of the mechanical positioning tool with the outline of the hydrocephalus shunt valve 1.

[0106] The pressure detection tool with a pair of magnetic needles determines the opening pressure of the hydrocephalus shunt valve by relying on the mutual attraction between the NS poles of the magnetic needles and the symmetrically distributed magnets on the ratchet rotor 106 inside the hydrocephalus shunt valve.

[0107] The in vitro transmitting coil and the supporting circuit board are encapsulated in the adjustment tool. The adjustment tool is provided with a power switch button. When the power switch is pressed, the SMA contracts once with power on. The single power-on time is about 4-6 seconds. After the power is turned off, the SMA naturally cools down to room temperature, completing one adjustment.

[0108] A pressure reading tool suitable for an SMA-driven hydrocephalus shunt valve of the present invention, such as Figure 18-20 , including: positioning seat 5 and pressure reading box 4,

[0109] The positioning seat 5 includes an annular seat body 501 whose outer contour is similar to the outer contour of the hydrocephalus shunt valve 1. The bottom surface of the seat body 501 is provided with a circle of inner flange, and windows 502 are respectively opened at the two ends of the maximum distance of the inner flange; the inner contour size of the inner flange is adapted to the outer contour size of the hydrocephalus shunt valve 1, which makes it convenient for the doctor to determine the subcutaneous position of the hydrocephalus shunt valve by touch and use the window to achieve positioning.

[0110] The pressure reading box 4 includes a box body 401, a central shaft 402, a magnetic pointer 403 and a transparent end cover 404. The box body 401 can be embedded in the base 501. The central shaft 402 is fixed at the center position of the bottom surface of the box body 401. The central shaft 402 is rotatably provided on the magnetic pointer 403. The transparent end cover 404 is provided at the upper end of the box body 401.

[0111] The pressure reading box 4 can display the real-time angle of the ratchet rotor 106, and then the current working pressure of the valve can be converted through the real-time angle to realize pressure reading.

[0112] During specific use, since the hydrocephalus shunt valve 1 is implanted under the patient's skin and the skin around the skull is relatively thin, the doctor can obtain the position and direction of the hydrocephalus shunt valve 1 by touch. The positioning seat 5 is placed according to the position and direction. When reading, the magnetic pointer 403 interacts with the magnet 116 on the ratchet rotor 106 in the shunt valve, and the N pole of the magnetic pointer 403 points to a certain value on the positioning tool scale, which represents the pressure level of the shunt valve at this time. When implementing the present invention, those skilled in the art can obtain the radius of the specific cam groove 1061 at different angles by calculation according to the technical task of this case, and design and convert it in combination with the elastic force data of the specific bow spring 113, and then obtain the pressure of the bow spring 113 acting on the surface of the hollow titanium ball 104 when the ratchet rotor 106 is at different deflection angles, and then obtain the real-time working pressure.

[0113] It should be noted that the above-described specific embodiments are merely preferred embodiments of the present invention and the technical principles employed. Those skilled in the art will appreciate that, based on the technical content disclosed in this application, various modifications, equivalent substitutions, and variations may be made to the present invention. However, as long as these modifications do not depart from the spirit of the present invention, they are intended to be within the scope of protection of the present invention. Furthermore, certain terms used in the specification and claims of this application are not intended to be limiting and are provided solely for ease of description.

Claims

1. An SMA-driven hydrocephalus shunt valve, comprising an upper end cover (109), a valve body (107) and a lower end cover (112), wherein the valve body (107) is provided with a liquid inlet (121) and a liquid outlet (101) at both ends thereof, and characterized in that: A middle diaphragm (102) is further provided on the upper portion of the valve body (107), and a receiving coil (103) and a circuit board (108) electrically connected to each other are provided between the middle diaphragm (102) and the upper end cover (109); A valve cavity partition structure (111) is provided in the cavity of the valve body (107) located below the middle partition plate (102). The valve cavity partition structure (111) divides the cavity of the valve body (107) into an upper valve cavity (1113) communicating with the liquid outlet (101) and a lower valve cavity (1111) communicating with the liquid inlet (121). The lower valve cavity (1111) communicates with the upper valve cavity (1113) through a valve port (1112). A hollow titanium ball (104) containing a solid titanium ball (105) is provided at the valve port (1112). A ratchet and pawl mechanism driven by an SMA wire (120) is provided in the upper valve chamber (1113), and a cam groove (1061) is provided on the ratchet rotor (106) in the ratchet and pawl mechanism; the SMA wire (120) is connected to the circuit board (108); The valve cavity partition structure (111) comprises a hollow boss (1110) and a partition plate, a gap is left between the partition plate and the lower end cover (112), forming the lower valve cavity (1111), and the upper valve cavity (1113) is formed between the partition plate and the middle partition plate (102); The boss (1110) has a side plate, the valve port (1112) is opened on the side plate, and the bottom edge of the valve port (1112) is higher than the top surface of the partition plate, so that the lower valve cavity (1111) is connected to the upper valve cavity (1113) through the valve port (1112); Also provided on the top surface of the partition plate are: a ratchet shaft (1072) in the middle position, and a bow spring mechanism rotating pin (1076), a rotating pin (110), a bias spring hanging column (1073), an SMA wire support column 1 (1074), and an SMA wire support column 2 (1075) arranged on the periphery; A bow spring mechanism is also provided in the upper valve chamber (1113), and the bow spring mechanism comprises: a bow spring (113), a pivot sleeve (1131) and a support rod (1132), wherein the pivot sleeve (1131) is pivotally connected to the bow spring mechanism pivot pin (1076) on the upper surface of the valve chamber partition structure (111), the tail end of the support rod (1132) is fixedly connected to the outer wall of the pivot sleeve (1131), the head end of the support rod (1132) is connected to the cam groove (1061) via a sliding pin (11321), the tail end of the bow spring (113) is fixedly connected to the outer wall of the pivot sleeve (1131), the head end of the bow spring (113) abuts against the hollow titanium ball (104), and the bow spring (113) and the support rod (1132) have an angle α; The tail end of the SMA wire (120) is fixedly connected to the second SMA wire support column (1075), and after the SMA wire (120) passes around the first SMA wire support column (1074), the head end of the SMA wire (120) is connected to the ratchet pawl mechanism; The ratchet and pawl mechanism further includes a pawl A (114), a pawl B (117) and a connecting rod (119); The ratchet rotor (106) is connected to the ratchet shaft (1072). The connecting rod (119) is movably connected to the rotating pin (110), and the ratchet teeth of the pawl A (114) and the pawl B (117) are relatively movably hinged at the front end of the connecting rod (119). The tail end of the connecting rod (119) is connected to a bias spring (118) in a direction opposite to the bias spring (118). The head end of the SMA wire (120) is further connected to the tail end of the connecting rod (119).

2. The SMA-driven hydrocephalus shunt valve according to claim 1, characterized in that: A pair of magnets (116) are symmetrically embedded on the top surface of the ratchet rotor (106) for detecting the circumferential position of the ratchet rotor (106).

3. The SMA-driven hydrocephalus shunt valve according to claim 1, characterized in that: The SMA wire (120) is connected to the circuit board (108) via a pair of wires passing through the middle partition (102), and the outer surface of the SMA wire (120) is covered with an insulating layer.

4. The SMA-driven hydrocephalus shunt valve according to claim 3, characterized in that: The circuit board includes a full-wave rectifier circuit for rectifying the alternating current of the receiving coil and outputting the alternating current to the SMA wire (120).

5. The SMA-driven hydrocephalus shunt valve according to claim 1, characterized in that: The solid titanium ball (105) is sealed and wrapped inside the hollow titanium ball (104). The outer diameter of the solid titanium ball (105) is smaller than the inner diameter of the hollow titanium ball (104), so that the solid titanium ball (105) can move freely inside the hollow titanium ball (104). In the horizontal state, the weight of the solid titanium ball (105) does not act on the valve port (1112). In the upright state, the weight of the solid titanium ball (105) acts on the valve port (1112) to compensate for the siphon effect caused by changes in body position.

6. The SMA-driven hydrocephalus shunt valve according to claim 1, characterized in that: The bow spring (113) and the cam groove (1061) on the ratchet rotor (106) are configured to allow the opening pressure of the cerebrospinal fluid shunt valve to be adjusted in stages within the range of 20 to 220 mmH2O.

7. A pressure reading tool suitable for the SMA-driven hydrocephalus shunt valve of claim 1, characterized in that: The pressure reading tool comprises: a positioning seat (5) and a pressure reading box (4), The positioning seat (5) comprises an annular seat body (501) whose outer contour is similar to the outer contour of the hydrocephalus shunt valve (1); the bottom surface of the seat body (501) is provided with an inner flange, and windows (502) are respectively provided at the two ends of the maximum distance of the inner flange; The pressure reading box (4) comprises a box body (401), a central shaft (402), a magnetic pointer (403) and a transparent end cover (404). The box body (401) can be embedded in the base (501). The central shaft (402) is fixedly provided at the center position of the bottom surface of the box body (401). The central shaft (402) is provided with a rotatable magnetic pointer (403). The transparent end cover (404) is provided at the upper end of the box body (401).

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