SMA-driven hydrocephalus diverter valve, pressure adjusting method and pressure reading tool

Abstract

The invention discloses an SMA-driven hydrocephalus diverter valve, a pressure adjusting method and a pressure reading tool. Relates to the field of medical instruments. The wireless function is used for driving the SMA wire to realize stage dynamic adjustment, so that the difference of manual operation is avoided, and the adjustment precision is improved. The valve comprises an upper end cover, a valve body and a lower end cover, a ratchet wheel and pawl mechanism driven by an SMA wire is arranged in an upper valve cavity, and a cam groove is formed in a ratchet wheel rotor in the ratchet wheel and pawl mechanism; the SMA wire is connected with the circuit board; a bow-shaped spring mechanism is further arranged in the upper valve cavity, the tail end of a bow-shaped spring is fixedly connected to the outer wall of the pivoting sleeve, the head of the bow-shaped spring abuts against the hollow titanium ball, and an included angle alpha is formed between the bow-shaped spring and the supporting rod. The technical tradition that pressure adjustment depends on manual work in the field all the time is broken through. An SMA wire is boldly introduced to serve as an adjusting execution part. According to the invention, the requirement on manual operation is reduced, the current situation of dependence on the experience of an operator is overcome, and high-precision pressure adjustment can be realized.

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 cerebro-spinal fluid (CSF), insufficient reabsorption, or mechanical obstruction of the pathway. Most of the time, hydrocephalus is caused by a blockage in the site of CSF absorption, resulting in a state of excessive accumulation within the ventricular system, leading to neurological or motor impairments in the patient. If untreated, this blockage can lead to enlargement of the head in infants whose skull sutures have not yet fused, followed by brain damage. In adults, due to the rigidity of the skull, the brain is put under increased pressure from the pressure of the CSF, and symptoms such as headaches, gait disturbances, and dementia have been reported.

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

[0004] In order to solve this problem, the existing technology mainly sets a rotor with a magnetic element in the hydrocephalus shunt valve, and adjusts the valve pressure by rotating the rotor equipped with the magnetic element. Using a regulating device equipped with a magnetic element, the magnetic coupling between the magnetic element of the rotor in the valve and the magnetic element of the regulating device can be used to non-invasively adjust the opening pressure of the shunt valve through the patient's skin. However, this adjustment method has high requirements for alignment and relies on the accuracy 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 view of the above technical problems, the present invention proposes an SMA-driven hydrocephalus shunt valve, pressure regulation method, and pressure reading tool that completely gets rid of the experience of manual adjustment, 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, wherein two ends of the valve body are respectively provided with a liquid inlet and a liquid outlet, a middle diaphragm is further provided on the upper part of the valve body, and a receiving coil and a circuit board electrically connected to each other are provided between the middle diaphragm and the upper end cover; A valve cavity partition structure is provided in the cavity of the valve body located at the lower part of the middle partition, and the valve cavity partition structure divides the cavity of the valve body into an upper valve cavity connected to the liquid outlet and a lower valve cavity connected to the liquid inlet, and the lower valve cavity is connected to the upper valve cavity through a valve port; a hollow titanium ball containing a solid titanium ball is provided in the valve port; A ratchet 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 pawl mechanism; the SMA wire is connected to the circuit board; The valve cavity partition structure includes a hollow boss and a partition plate, a gap is left between the partition plate and the lower cover plate to form the lower valve cavity, and the upper valve cavity is formed between the partition plate and the middle partition plate; 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; Also provided on the top surface of the partition plate are: a ratchet shaft in the middle, and a bow spring mechanism rotating pin, a rotating pin, a bias spring hanging column, an SMA wire supporting column 1 and an SMA wire supporting column 2 arranged on the periphery; A bow spring mechanism is also provided in the upper valve cavity, and the bow spring mechanism comprises: a bow spring, a pivot sleeve and a support rod, the pivot sleeve is pivoted to the bow spring mechanism pivot pin on the upper surface of the valve cavity 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 through a sliding pin, the tail end of the bow spring is fixedly connected to the outer wall of the pivot sleeve, the head of the bow spring abuts against the hollow titanium ball, and the bow spring and the support rod have an angle α; The tail end of the SMA wire is fixedly connected to the second SMA wire support column, and after the SMA wire goes around the first SMA wire support column, the head end of the SMA wire is connected to the ratchet pawl mechanism; The ratchet and pawl mechanism also includes a pawl A, a pawl B and a connecting rod; The ratchet rotor is connected to the ratchet shaft. 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.

[0008] 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.

[0009] Furthermore, the SMA wire is connected to the circuit board via a pair of conducting wires penetrating the middle partition, and the outer surface of the SMA wire is covered with an insulating layer.

[0010] 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.

[0011] Furthermore, the solid titanium ball is sealed and wrapped inside the hollow titanium ball, and 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 a horizontal state, the solid titanium ball's own gravity does not act on the valve port, and in an upright state, its own gravity acts on the valve port to compensate for the siphon effect caused by changes in body position.

[0012] 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.

[0013] The present invention provides a pressure regulation method for a hydrocephalus shunt valve driven by an SMA, comprising the following steps: 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; S2, hydrocephalus shunt valve opening pressure detection: using a pressure detection device with a magnetic needle to detect the position of the ratchet rotor 106, and then confirming the current opening pressure of the hydrocephalus shunt valve; S3. Adjustment of the opening pressure of the hydrocephalus shunt valve: the external transmitting coil is placed close to the hydrocephalus shunt valve, and the receiving coil inside the hydrocephalus shunt valve is coupled 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, and the driving force generated is used to drive the ratchet rotor to rotate counterclockwise. A single action can adjust the angle of the ratchet rotor to rotate through one ratchet tooth, and the adjustment can be repeated, so that the opening pressure of the hydrocephalus shunt valve reaches the target opening pressure. S4. Confirmation of the opening pressure of the hydrocephalus shunt valve: After completing steps S1-S3, use the pressure detection device with a magnetic needle to detect the opening pressure of the adjusted hydrocephalus shunt valve again.

[0014] A pressure reading tool for implementing a pressure regulation method of an SMA-driven hydrocephalus shunt valve of the present invention, the pressure reading tool comprises: a positioning seat and a pressure reading box, The positioning seat comprises an annular seat body whose outer contour is similar to the outer contour of the hydrocephalus shunt valve, the bottom surface of the seat body is provided with a circle of inner flange, and windows are respectively provided at the two ends of the maximum distance of the inner flange; 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 central axis is rotatably provided with the magnetic pointer. The transparent end cover is provided at the upper end of the shell.

[0015] The present invention breaks the technical tradition of relying on manual pressure adjustment in this field. SMA (shape memory alloy) wire is boldly introduced as an adjustment actuator. To achieve this innovative concept, firstly, the present invention adopts wireless power transmission technology for transcutaneous energy transmission. Since there can be a certain offset between the transmitting coil and the receiving coil of the wireless power transmission system, the alignment requirements are reduced; secondly, the SMA biased driver (i.e., the core technical solution of the present invention) adopted by the present invention uses SMA wire as the driving element, which is adapted to the wireless power transmission system. When the energy is supplied once, the SMA wire moves (contracts) once. When the SMA wire contracts, the ratchet A is driven once by the connecting rod, and then the ratchet rotor is driven to rotate one ratchet tooth, and then the angle of the support rod is adjusted by the cam groove, and the elastic force of the bow spring, i.e., the pressure against the hollow titanium ball, is further changed to achieve the adjustment of the working pressure. If the adjustment amount is not enough, repeat the above action.

[0016] The present invention reduces the requirement for manual operation, overcomes the current situation of relying on operator experience, and realizes "gradual" pressure regulation through wireless function, thereby achieving high-precision, non-manual experience pressure adjustment. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. 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.

[0018] Figure 1 is a three-dimensional exploded view of the present invention, Figure 2 It is a structural schematic diagram of the present invention, Figure 3 yes Figure 2 Middle AA section view, Figure 4 It is a three-dimensional schematic diagram of the valve body in the present invention Figure 1 , Figure 5It is a three-dimensional schematic diagram of the valve body in the present invention Figure 2 , Figure 6 It is a structural schematic diagram of the valve body in the present invention; Figure 7 It is a three-dimensional schematic diagram of the internal structure of the valve cavity in the present invention. Figure 1 , Figure 8 It is a three-dimensional schematic diagram of the internal structure of the valve cavity in the present invention. Figure 2 , Fig. 9 It is a three-dimensional schematic diagram of the internal structure of the valve cavity in the present invention. Figure 3 , Fig.10 The structure of the hollow titanium ball and the solid titanium ball in the present invention is shown in FIG. Figure 1 , Fig.11 The structure of the hollow titanium ball and the solid titanium ball in the present invention is shown in FIG. Figure 2 , Fig.12 It is a principle diagram of the fluid flow direction when the present invention is working. Fig.13 yes Fig.12 A top view of Fig.14 This is the working state of the present invention Figure 1 , Fig.15 This is the working state of the present invention Figure 2 , Fig.16 is a working principle diagram of the present invention in the first working state, Fig.17 is a working principle diagram of the present invention in the second working state, Fig.18 It is a schematic diagram of the structure of the positioning seat in the present invention, Fig.19 is a three-dimensional exploded view of the pressure reading box of the present invention, Fig. 20 It is a schematic diagram of the structure of the pressure reading box in the present invention.

[0019] In the figure: 1 is the hydrocephalus shunt valve, 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-card seat, 1072-ratchet shaft, 1073-bias spring hanging column, 1074-SMA wire support column 1, 1075-SMA wire support column 2, 1076-bow spring mechanism rotating 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 hinge pin, 120-SMA wire, 1201-conducting wire, 121-liquid inlet; 2 is the cerebral ventricle, 3 is the abdominal cavity; 4 is a pressure reading box, 401 is a box body, 402 is a central axis, 403 is a magnetic pointer, and 404 is a transparent end cap; 5 is a positioning seat, 501 is a seat body, and 502 is a window.

[0020] Figure 3 The arrow lines appearing in the diagram indicate the direction of movement of the relevant components. Fig.10 The pair of hollow arrows in the figure indicate the direction in which the two hemispherical shells are combined. Fig.12 , 13 The arrow line in the diagram indicates the direction of liquid flow. Fig.14 , 15 In: IVP-Intraventricular Pressure, Pvalve-Hydrocephalus Shunt Valve Opening Pressure, IPP-Intraperitoneal Pressure, HP-Hydrostatic Pressure due to Gravity, Fig.16 , 17 Middle: mg-weight of solid titanium ball; 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

[0021] The technical solution of the present invention is further described below with reference to the accompanying drawings and through specific implementation methods.

[0022] Among them, the drawings are only used for illustrative explanations, and they only represent schematic diagrams rather than actual pictures, and should not be understood as limitations on 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.

[0023] 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", "inner", "outer", etc. appear, the orientation or position relationship indicated is based on the orientation or position relationship shown in the drawings, which is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated 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 a limitation on this patent. For ordinary technicians in this field, the specific meanings of the above terms can be understood according to specific circumstances.

[0024] In the description of the present invention, unless otherwise clearly specified and limited, if the term "connection" or the like appears to indicate the connection relationship between components, the 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 the internal connection of two components or the interaction relationship between two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0025] The technical solution adopted by the SMA-driven hydrocephalus shunt valve of the present invention is as follows: Figure 1-3 As 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.

[0026] 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 plate 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 is connected to 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.

[0027] The specific valve cavity partition structure 111 includes a hollow boss 1110 and a partition plate. A gap is left between the partition plate and the lower cover plate 112 to form a lower valve cavity 1111. An upper valve cavity 1113 is formed between the partition plate and the middle partition plate 102. The boss 1110 has a side plate, and the valve port 1112 is provided 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. The above arrangement of the boss 1110 and the partition plate establishes the separation of the internal chamber of the valve body 107, that is, forms the working flow channel structure inside the valve body 107.

[0028] On the top surface of the partition plate (it should be noted here that Figure 4 , 6 The following structure seems to be arranged on the "bottom surface", but since the "bottom surface" is the top surface of the partition plate, it is defined as the top surface of the partition plate here) and also provided: 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 supporting column 1 1074 and an SMA wire supporting column 2 1075 arranged on the periphery; the tail end of the SMA wire 120 is fixedly connected to the SMA wire supporting column 2 1075, and after the SMA wire goes around the SMA wire supporting column 1 1074, the head end of the SMA wire 120 is connected to the ratchet pawl mechanism. The above columns, shafts, and pins arranged on the top surface of the partition plate are installation structures.

[0029] like Figure 7-9 As shown, a ratchet 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 pawl mechanism; the SMA wire 120 is connected to the circuit board 108 through a wire 1201 .

[0030] 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, 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 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 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.

[0031] 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 realizing the change of 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 regulation.

[0032] The ratchet 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 .

[0033] 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.

[0034] The ratchet teeth of the pawl A114 and the pawl B117 are relatively hinged at the front end of the connecting rod 119, and a tension spring (not marked in the figure) is provided between the pawl A114 and the pawl B117. After the tension spring is provided, it can ensure that both pawls can be reliably pressed and meshed with the ratchet teeth on the ratchet rotor 106. The pawl A114 and the pawl B117 are hinged at the front end of the connecting rod 119 through the hinge pin 1191.

[0035] The tail end of the connecting rod 119 is connected to a bias spring 118 in the direction of the ratchet rotor 106. One end of the bias spring 118 is connected to a bias spring hanging column 1073. The head end of the SMA wire 120 is also connected to the tail end of the connecting rod 119 in the opposite direction to the bias spring 118. The SMA wire 120 can pull the connecting rod 119 to swing after the size changes (shrinks in size) due to temperature changes, and then the ratchet rotor 106 is driven by the ratchet pawl A114 at the front end of the connecting rod 119 to rotate counterclockwise, driving the ratchet rotor 106 to rotate a ratchet tooth; the other ratchet pawl B117 is engaged with the ratchet tooth of the ratchet rotor 106 at the rear after the "opening" movement relative to the ratchet pawl A114. The function of the bias spring 118 is to pull the connecting rod 119 back to the initial position when the SMA wire 120 contracts when powered on and restores to its original length when powered off.

[0036] Furthermore, a pair of magnets 116 are evenly embedded on the top surface of the ratchet rotor 106 for detecting the circumferential position of the ratchet rotor 106 .

[0037] Furthermore, the SMA wire 120 is connected to the circuit board 108 through a pair of wires penetrating the middle partition 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.

[0038] Furthermore, the circuit board 108 includes a full-wave rectifier circuit for rectifying the alternating current of the receiving coil and outputting it to the SMA wire 120 .

[0039] Furthermore, if Fig.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, and its own gravity acts on the valve port 1112 in the upright state to compensate for the siphon effect caused by the change of body position. Fig.12 , 13 shown.

[0040] Furthermore, 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. For the pressure adjustment range set by the present invention, i.e., the range of a lower limit of 20 mmH2O and an upper limit of 220 mmH2O, those skilled in the art, in combination with the inventive concept of the present case and the technical problem to be solved, can select the size and material of the bow spring 113, and design the support rod 1132 at different angle radii to the initial angle α of the bow spring 113 and the cam groove 1061, thereby realizing staged adjustment within the range of 20 mm to 220 mmH2O.

[0041] like Fig.14 As shown, when the patient is horizontal, the ventricles and the abdominal cavity are at the same level, and there is no hydrostatic pressure difference between the ventricles and the abdominal cavity. The pressure difference at both ends of the hydrocephalus shunt valve 1 is: ΔP 仰卧 = IVP - IPP like Fig.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 across the hydrocephalus shunt valve 1: ΔP 直立 = IVP + HP - IPP Due to hydrostatic pressure difference HP The existence of will cause the problem of over-drainage. Analysis of the structure designed to avoid the problem of over-drainage: The opening pressure of SMA-driven hydrocephalus shunt valve 1 is Pvalve In the horizontal state, the force on the valve port 1112 is as follows Fig.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 controlled by the elastic force. F 弹 It is determined that at this time, as long as the pressure of the fluid on the valve port 1112 meets the following requirements: F p > P valve = F 弹 At this time, the valve port 1112 opens, and the SMA-driven hydrocephalus shunt valve 1 begins to shunt; In the upright state, the force on the valve port 1112 is as follows Fig.17 As shown in FIG. 1 , when the patient is in a horizontal state, the opening pressure of the hydrocephalus shunt valve 1 driven by the SMA is: P valve = F 弹 + mg At this time, the pressure of the fluid on the valve port 1112 is required to be: F p > P valve = F 弹 + mg , At this time, the valve port 1112 opens, and the SMA-driven hydrocephalus shunt valve 1 starts to shunt.

[0042] 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.

[0043] A method for regulating the pressure of a hydrocephalus shunt valve comprises the following steps: 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; S2, detection of the opening pressure of the hydrocephalus shunt valve 1: using a pressure detection device with a pair of magnetic needles to detect the position of the ratchet rotor 106, and then confirming the current opening pressure of the hydrocephalus shunt valve 1; S3. Adjustment of the opening pressure of the hydrocephalus shunt valve 1: the external transmitting coil is brought close to the hydrocephalus shunt valve 1, the receiving coil inside the hydrocephalus shunt valve 1 is coupled with the external transmitting coil to receive electric energy, the received electric energy is rectified by the circuit board and then output to the SMA wire, the SMA wire heats up and contracts, and the driving force generated is used to drive the ratchet rotor 106 to rotate counterclockwise; a single action can adjust the angle of the ratchet rotor 106 to rotate through one ratchet tooth, and the adjustment can be repeated, so that the opening pressure of the hydrocephalus shunt valve 1 reaches the target opening pressure; S4. Confirmation of the opening pressure of the hydrocephalus shunt valve 1: After completing steps S1-S3, use a pressure detection device with a pair of magnetic needles to detect the opening pressure of the adjusted hydrocephalus shunt valve 1 again.

[0044] A window having the same outer contour 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 outer contour of the hydrocephalus shunt valve 1.

[0045] 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 in the hydrocephalus shunt valve.

[0046] The in vitro transmitting coil and the matching circuit board are packaged 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. The single power-on time is about 4-6s. After the power is turned off, the SMA naturally cools down to room temperature, completing one adjustment.

[0047] A pressure reading tool for implementing a pressure regulation method of an SMA-driven hydrocephalus shunt valve of the present invention, such as Figure 18-20 , including: a positioning seat 5 and a pressure reading box 4, 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, so that the doctor can determine the subcutaneous position of the hydrocephalus shunt valve by touch and use the window to achieve positioning.

[0048] The pressure reading box 4 includes a box body 401, a central axis 402, a magnetic pointer 403 and a transparent end cover 404. The box body 401 can be embedded in the base 501. The central axis 402 is fixed at the center position of the bottom surface of the box body 401. The central axis 402 is rotatably provided on the magnetic pointer 403. The transparent end cover 404 is provided at the upper end of the shell 401.

[0049] 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 calculated through the real-time angle to realize pressure reading.

[0050] 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 scale of the positioning tool, 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 tasks 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.

[0051] It should be noted that the above specific implementations are only preferred embodiments of the present invention and the technical principles used. Those skilled in the art should understand that various modifications, equivalent substitutions, changes, etc. can be made to the present invention based on the technical content disclosed in this application document. However, as long as these changes do not deviate from the spirit of the present invention, they should be within the scope of protection of the present invention. In addition, some terms used in the specification and claims of this application are not restrictive, but are only for the convenience 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 also provided on the upper part 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 at the lower part of 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) connected to the liquid outlet (101) and a lower valve cavity (1111) connected to the liquid inlet (121); the lower valve cavity (1111) is in communication with the upper valve cavity (1113) via 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 a 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 cover plate (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, and a bow spring mechanism rotating pin (1076), a rotating pin (110), a bias spring hanging column (1073), a first SMA wire supporting column (1074), and a second SMA wire supporting column (1075) arranged on the periphery; A bow spring mechanism is also provided in the upper valve chamber (1113), the bow spring mechanism comprising: a bow spring (113), a pivot sleeve (1131) and a support rod (1132), the pivot sleeve (1131) being 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) being fixedly connected to the outer wall of the pivot sleeve (1131), the head end of the support rod (1132) being connected to the cam groove (1061) via a sliding pin (11321), the tail end of the bow spring (113) being fixedly connected to the outer wall of the pivot sleeve (1131), the head end of the bow spring (113) being in contact with the hollow titanium ball (104), and the bow spring (113) and the support rod (1132) having 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 comprises 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); 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 facing the ratchet rotor (106); and the head end of the SMA wire (120) is connected to the tail end of the connecting rod (119) in a direction opposite to the bias spring (118).

2. The SMA-driven hydrocephalus shunt valve according to claim 1, characterized in that: A pair of magnets (116) are also 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 conductive wires penetrating 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 comprises a full-wave rectifier circuit, which is used to rectify the alternating current of the receiving coil and output it 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); the solid titanium ball (105) has no gravity acting on the valve port (1112) in a horizontal state, and has gravity acting on the valve port (1112) in an upright state 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. The method for regulating the pressure of a SMA-driven hydrocephalus shunt valve according to any one of claims 1 to 6, characterized in that: The following steps are involved: 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; S2, hydrocephalus shunt valve opening pressure detection: using a pressure detection device with a magnetic needle to detect the position of the ratchet rotor (106), thereby confirming the current opening pressure of the hydrocephalus shunt valve; S3. Adjustment of the opening pressure of the hydrocephalus shunt valve: the external transmitting coil is placed close to the hydrocephalus shunt valve, and the receiving coil inside the hydrocephalus shunt valve is coupled 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, and the driving force generated is used to drive the ratchet rotor to rotate counterclockwise. A single action can adjust the angle of the ratchet rotor to rotate through one ratchet tooth, and the adjustment can be repeated, so that the opening pressure of the hydrocephalus shunt valve reaches the target opening pressure. S4. Confirmation of the opening pressure of the hydrocephalus shunt valve: After completing steps S1-S3, use the pressure detection device with a magnetic needle to detect the opening pressure of the adjusted hydrocephalus shunt valve again.

8. A pressure reading tool for implementing the pressure regulation method of a SMA-driven hydrocephalus shunt valve according to claim 7, 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 a circle of inner flanges, and windows (502) are respectively provided at the two ends of the maximum distance of the inner flanges; The pressure reading box (4) comprises a box body (401), a central axis (402), a magnetic pointer (403) and a transparent end cover (404); the box body (401) can be embedded in the base (501); the central axis (402) is fixedly arranged at the center position of the bottom surface of the box body (401); the central axis (402) is rotatably arranged on the magnetic pointer (403); and the transparent end cover (404) is arranged at the upper end of the shell (401).

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