Externally programmable magnetic valve assembly and controller

Abstract

The present invention provides an externally programmable shunt valve assembly, which includes a motor having a rotor that is capable of operating in response to an externally applied magnetic field and configured to increase or decrease the operating pressure of the shunt valve assembly. [Solution] The motor may further include a position sensing mechanism that allows the rotor position and associated pressure settings of the valve to be determined using an external magnetic sensor. In a particular example, the motor may further include a mechanical brake that is magnetically operable between a locked position and an unlocked position and prevents the rotor from rotating in the locked position.

Description

Technical Field

[0001] Cross - reference to Related Applications This application is a continuation - in - part of U.S. Patent Application No. 15 / 675,497, filed on August 11, 2017, entitled "EXTERNALLY PROGRA MMABLE MAGNETIC VALVE ASSEMBLY AND CONTR OLLER", and claims the benefit under 35 U.S.C. § 119(e) and is also related to U.S. Provisional Application No. 62 / 374,046, filed on August 12, 2016, entitled "EXTE RNALLY PROGRAMMABLE MAGNETIC VALVE ASSEM BLY AND CONTROLLER", the entire contents of which are incorporated herein by reference. BLY AND CONTROLLER", the entire contents of which are incorporated herein by reference. [Expired] Claims the benefit under Article 8 of the PCT and the entire contents of which are incorporated herein by reference. are incorporated herein by reference.

Background Art

[0002] Hydrocephalus is a disease associated with ventricular enlargement caused by the net accumulation of fluid within the ventricles of the brain. Non - communicating hydrocephalus is a type of hydrocephalus associated with obstruction of the ventricular system and is generally characterized by an increase in cerebrospinal fluid ( CSF) pressure. In contrast, communicating hydrocephalus is a type of hydrocephalus associated with obstructive lesions within the subarachnoid space. One form of communicating hydrocephalus, normal pressure hydrocephalus (NPH), mainly affects people over 60 years old and is characterized by nominally normal CSF pressure. Typical symptoms of NPH include gait disturbances, incontinence, and dementia. In summary, NPH presents as ventricular enlargement with substantially normal CSF pressure.

[0003] The goal in the treatment of hydrocephalus is to reduce ventricular pressure so that the size of the ventricles returns to a normal level. Hydrocephalus is often treated, in the case of communicating hydrocephalus, by (ventricular or lumbar meninges) It is treated by implanting a shunt in the brain that drains excess CSF from the cavity. When a ventricular shunt is used to divert fluid from the ventricle to the atrium, it is called a ventriculoatrial (VA) shunt. Alternatively, when the fluid bypasses from the ventricles to the peritoneum, it is called the ventriculoperitoneal (VP) space, or when the CSF flows through the lumbar region. When the shunt bypasses from the peritoneum to the lumbar-peritoneal cavity (LP), it is called the lumbar-peritoneal shunt. These shunts are generally , a brain catheter or needle (for ventricular shunt) inserted through the brain into the ventricles and then into the lumbar region A lumbar catheter (for a lumbar shunt) inserted into the spinal canal, and a ventricle-to-jugular vein (ventricular shunt) The body drains fluid into a reservoir such as a shunt or peritoneal cavity (ventricle or lumbar shunt). It consists of a one-way valve system.

[0004] U.S. Patent No. 4,595,390 relates to a conical valve seat with a stainless steel spring. In contrast, a shunt having a biased spherical sapphire ball is described. CSF pressure This pushes the sapphire ball and spring in a direction that lifts the ball away from the seat. When the pressure difference across the ball exceeds what is known as "popping" or release pressure, the ball will fall out of the seat. It rises, allowing CSF to flow through the valve, thereby discharging the CSF. U.S. Patent No. 4,595,390 concerns the placement of an implanted shunt on the patient's head. By attaching a transmitter that emits a magnetic signal to the top, the pressure setting of the valve can be changed. Further details are provided regarding externally programmable shunt valves that enable magnetic transmission. By using an external programmer equipped with the necessary functions, ventricular size, CSF pressure, and The valve pressure setting can be non-invasively adjusted according to the treatment goals.

[0005] U.S. Patent No. 4,615,691 is, for example, a copy of U.S. Patent No. 4,595,390. This document describes examples of magnetic stepping motors that can be used with cant valves. .

[0006] A magnetically adjustable shunt allows the pressure of the implanted shunt to be adjusted externally. This makes it possible, but these existing shunts have some limitations. For example, magnetic Patients with an implanted adjustable shunt valve undergo magnetic resonance imaging (MRI) procedures. When near a strong magnet or strong magnetic field, such as a chair, the valve pressure setting may change. It has that characteristic. In addition, checking the pressure setting of existing magnetic valves is done at the location where the valve is embedded. This requires the use of radiopaque markers on the valve that are detected using the captured X-rays. It is possible. Also, some are used to adjust the pressure setting of embedded valves. The programmer is relatively large and heavy and requires connection to a wall outlet. [Prior art documents] [Patent Documents]

[0007] [Patent Document 1] U.S. Patent No. 4,595,390 [Patent Document 2] U.S. Patent No. 4,615,691 [Overview of the project] [Problems that the invention aims to solve]

[0008] Therefore, improved ventricular and lumbar shunts, as well as to adjust the shunts It would be desirable to design an improved program programmer. [Means for solving the problem]

[0009] Aspects and embodiments relate to an externally programmable valve assembly comprising a magnetic motor configured to increase or decrease the pressure setting of the valve in continuous or finite increments. The valve assembly may be adapted to be implanted in a patient for draining fluid from the patient's organ or body cavity. In these embodiments, the valve assembly includes an inlet port adapted for fluid connection to one end of a catheter (by a surgeon during manufacture or surgery). The second end of the catheter is inserted into an organ or body cavity for draining fluid. The valve assembly further includes an outlet port adapted for fluid connection to the end of a drainage catheter. The other end of the drainage catheter can be inserted into a suitable body cavity such as a vein or peritoneal cavity, or into an external drainage reservoir such as a bag. Examples of organs and body cavities that can be drained using the valve assembly of the present invention include, but are not limited to, the eye, ventricles, peritoneal cavity, pericardial sac, uterus (during pregnancy), and pleural cavity. Specifically, the valve assembly may be adapted to be implanted in a patient suffering from hydrocephalus. In such embodiments, the inlet port is adapted for fluid connection to the first end of an inflow catheter (i.e., an intracerebral or intrathecal catheter), and the outlet port is adapted for fluid connection to the first end of a drainage catheter. When implanted in a patient, the second end of the intracerebral catheter is inserted into the patient's ventricle or lumbar intrathecal space, and the second end of the drainage catheter is inserted into a suitable body reservoir of the patient such as the jugular vein or peritoneal cavity. Thus, when implanted in a patient, this device connects the patient's ventricle or lumbar region to the subject 含む。カテーテルの第2の端部は、流体を排出するために臓器または体腔に挿入される。 含む。カテーテルの第2の端部は、流体を排出するために臓器または体腔に挿入される。 バルブアセンブリは、ドレナージカテーテルの端部に流体接続するように適合された出口 ポートをさらに含む。ドレナージカテーテルの他端は、静脈もしくは腹膜腔などの適切な 体腔に、またはバッグなどの体外のドレナージリザーバに挿入することができる。本発明 のバルブアセンブリを使用して排出することができる器官および体腔の例には、眼、脳室 、腹膜腔、心膜嚢、(妊娠中の)子宮、および胸膜腔が含まれるが、それらに限定されな い。詳細には、バルブアセンブリは、水頭症に罹患している患者に埋め込むように適合さ れてよい。そのような実施形態では、入口ポートは、流入カテーテル(すなわち、脳内ま たは髄腔内カテーテル)の第1の端部への流体接続に適合され、出口ポートは、ドレナー ジカテーテルの第1の端部への流体接続に適合される。患者に埋め込まれると、脳内カテ ーテルの第2の端部は、患者の脳室または腰部髄腔内に挿入され、ドレナージカテーテル の第2の端部は、頸静脈または腹膜腔などの患者の適切な身体リザーバに挿入される。し たがって、患者に埋め込まれると、このデバイスは、患者の脳室または腰部領域と被験者 This enables fluid communication between the body reservoir and the pressure in the cerebral ventricles or CSF via a valve assembly. If the pressure of the valve is exceeded, cerebrospinal fluid will leak from the ventricles or lumbar region through the valve casing. It becomes possible for it to flow into the body's reservoir. The patient suffers from hydrocephalus accompanied by increased intracranial pressure. It is possible that you have normal pressure hydrocephalus. Ventricles or lumbar cavity Removing CSF from the brain lowers intraventricular pressure.

[0010] Further aspects and embodiments determine the pressure setting of the embedded valve assembly. This document describes how to adjust the pressure settings of the valve assembly after implantation in the patient. More details are provided below. As will be explained in detail, according to a particular embodiment, the adjustment of the valve pressure setting is performed by the valve This can be achieved by the displacement of a magnetically actuated rotor within the semblage, and in the valve element This results in a change in the tension of the spring that provides the biasing force. The rotor responds to the applied external magnetic field. It rotates within the rotor casing in response.

[0011] As will be described in more detail below, certain aspects and embodiments are embedded valves Regarding magnetically operated motors suitable for integration into assemblies. A buri includes a stator with multiple stator lobes and multiple magnetic poles around the stator. Includes a rotor configured to rotate, as will be further described below (valve A magnetic field applied from the outside (from outside the body in which the assembly is embedded) will cause the rotor to rotate. Used to magnetize the stator in order to cause it to act. A magnetically operable motor is, Mechanical movement within the retractable valve assembly allows for changes in the valve's pressure setting. This eliminates the need to physically connect to the valve assembly from outside the body or to use an embedded battery. It has the advantage of avoiding. Furthermore, as will be explained further below, magnetic motor assembly The Bri embodiment involves a magnetic field generated by an MRI or nuclear magnetic resonance (NMR) device. For any influence from strong external magnetic fields that are not particularly related to the desired control of the motor, such as It is configured to have high resistance even if it is subjected to personal For example, a doctor could use a magnetic motor without needing to use X-rays or other imaging techniques. It includes a mechanism that allows you to see the current pressure setting of the valve.

[0012] Certain embodiments also involve surgically implanting a valve assembly into a patient and implanting the valve. This includes setting the valve opening pressure to a pressure lower than the ventricular pressure beforehand. This includes methods for reducing the required ventricular size of a patient, or implantable valve assembly. Bri's opening pressure can be increased in patients whose ventricular size requires it. It may be set to a pressure higher than the room pressure.

[0013] According to one embodiment, a surgically implantable shunt valve assembly is provided with a housing The housing is formed from a material that is physiologically compatible with the outside, and the inside of the housing It comprises a magnetically operable motor positioned at the base, and the magnetically operable motor is a stay And, in response to the change in the magnetic polarity of the stator induced by an external magnetic field, the stator It includes a rotor configured to rotate, and the rotor includes a rotor casing and a rotor casing. Multiple rotors arranged in a circular pattern within the housing, with alternating magnetic polarities. Including a permanent magnet element, the rotation of the rotor relative to the stator is selected by the shunt valve assembly. Generates the selected pressure setting. The shunt valve assembly consists of a rotor casing and a housing. An inlet port located between the outside of the valve seat and the rotor casing within the valve seat An inlet port terminating at the end, a spring, and a valve seat biased by the spring. A valve element in which the valve element and valve seat together form an opening. And an outlet port located between the rotor casing and the outside of the housing, The inlet valve assembly discharges fluid through the opening to the outlet port. When the fluid pressure inside exceeds the selected pressure setting of the shunt valve assembly, the opening closes. It further includes an exit port that is configured to open.

[0014] Another embodiment is an externally programmable, surgically implantable shunt valve assembly. The unit consists of a hub, a non-embeddable transmitter head, and a control device coupled to the transmitter head. Regarding the system for providing: Surgically implantable shunt valve assemblies are physiologically... A housing having an exterior formed from a material suitable for and a magnetic field placed inside the housing A motor that can operate electrically and a motor that can operate magnetically, comprising a stator and an external magnetic field In response to the change in the stator's magnetic polarity induced by the stator, it rotates relative to the stator. The rotor is configured such that the rotor has a rotor casing and a circular rotor inside the rotor casing. Multiple rotor permanent magnet elements are arranged in a specific shape and configured to have alternating magnetic polarities. Including the number of rotor permanent magnet elements, among the multiple rotor permanent magnet elements, the number of radially opposing elements The elements appear to have the same magnetic polarity, and the rotation of the rotor relative to the stator is such that the shunt The motor, rotor casing, and housing generate the selected pressure setting for the valve assembly. An inlet port positioned between the outside of the valve seat and the outside of the valve seat, wherein the inlet port is located within the valve seat. The inlet port terminates at the end of the rotor casing, and a spring and a spring are connected to the valve seat. A valve element biased toward, wherein the valve element and valve seat together open A valve element that forms the valve, and an outlet located between the rotor casing and the outside of the housing. An opening port, where a shunt valve assembly discharges fluid through the opening to the outlet port. To release the fluid, the pressure of the fluid in the inlet port is set to the selected pressure of the shunt valve assembly. It may include an exit port configured to open when a certain threshold is exceeded. Not for embedding. A capable transmitter head generates an external magnetic field to induce the rotor to rotate relative to the stator. The control device may include a magnet assembly configured to do so. To set the pressure setting of the humb to the selected pressure setting, send an external magnetic field to generate it. It may be configured to provide signals to the transmitter head in order to control the QR head.

[0015] Another embodiment includes a surgically implanted magnetic motor for adjusting the pressure setting of the valve. Regarding possible valves, the magnetic motor is physically isolated from the power supply and applied from the outside of the valve. It is powered by an external magnetic field. The magnetic motor consists of a circular rotor casing and a rotary rotor. Multiple permanent elements are arranged in a circular pattern within the casing, with alternating magnetic polarities. A rotor including a rotor magnet, wherein the rotor casing rotates around a central axis of rotation. A rotor configured as such, and a rotor magnet formed as an opposing circular stator disc. A stator made of soft magnetic and transparent material is positioned for each of the four quadrants below. And as a result, when magnetized under the influence of an external magnetic field, the stator rotates around its central axis. The local magnetic field in its vicinity is strengthened and oriented to cause incremental movement of the rotor. It may be equipped with a datameter. The number of permanent rotor magnets is determined by the radial direction of the multiple permanent rotor magnets. The numbers may be such that the opposing elements have the same or opposite magnetic polarity.

[0016] According to another embodiment, a surgically implantable shunt valve assembly includes a spring and, A valve element biased against the valve seat by a spring, wherein the valve element and the valve The lubricating sheet together forms an opening through which the fluid is diverted by the valve element and a magnetic motor for adjusting the pressure setting of a valve, wherein the magnetic motor is powered by a physical It is completely insulated and powered by an external magnetic field applied from the outside of the valve assembly. It comprises a magnetic motor. The magnetic motor has a rotor casing and a circular Multiple permanent rotor magnets arranged in a specific shape and having alternating magnetic polarities, and a spring A rotor having a cam that engages with the rotor so that the rotor rotates around the central axis of rotation It consists of a rotor and a soft magnetic and transparent material, which is positioned below the rotor. The stator, and as a result, when magnetized under the influence of an external magnetic field, becomes the center of rotation. The local magnetic field in its vicinity is strengthened and oriented to cause the rotor to rotate around the shaft, The rotation of the rotor causes the rotation of a cam that adjusts the spring tension on the valve element, This may include a stator that adjusts the pressure setting of the shunt valve assembly.

[0017] According to another embodiment, a surgically implantable shunt valve assembly includes a spring and, A valve element biased against the valve seat by a spring, wherein the valve element and the valve The lubricating sheet together forms an opening through which the fluid is diverted by the valve element and a magnetic motor for adjusting the pressure setting of a valve, wherein the magnetic motor is powered by a physical It is completely insulated and powered by an external magnetic field applied from the outside of the valve assembly. It comprises a magnetic motor. The magnetic motor has a rotor casing and a circular Multiple permanent rotor magnets arranged in a specific shape and having alternating magnetic polarities, and a spring A rotor having a cam that engages with the rotor so that the rotor rotates around the central axis of rotation It consists of a rotor and a soft magnetic and transparent material, which is positioned below the rotor. The stator, and as a result, when magnetized under the influence of an external magnetic field, becomes the center of rotation. The local magnetic field in its vicinity is strengthened and oriented to cause the rotor to rotate around the shaft, The rotation of the rotor causes the rotation of a cam that adjusts the spring tension on the valve element, This adjusts the pressure setting of the shunt valve assembly, the stator, and the lock position. It is magnetically operable between the unlocked and unlocked positions, and prevents the rotor from rotating in the locked position. It may include a configured mechanical brake.

[0018] Another embodiment is a magnetic motor for adjusting the pressure setting of a valve, and the magnetic motor However, it is physically isolated from the power source and the power is affected by an external magnetic field applied from outside the valve. The magnetic motor is supplied with a circular rotor casing and is arranged in a circular pattern within the rotor casing. The rotor includes a plurality of permanent rotor magnets arranged to have alternating magnetic polarities. A magnetic motor and a rotor casing configured to rotate around a central axis of rotation. , an X-shaped stator made of soft magnetic and transparent material formed and positioned relative to the rotor Therefore, when magnetized under the influence of an external magnetic field, the stator rotates around the circumference of the central axis of rotation. The local magnetic field in its vicinity is strengthened and oriented to cause incremental movement of the rotor. The invention relates to a surgically implantable valve, including an X-shaped stator. The number of permanent rotor magnets If radially opposing permanent rotor magnets have the same or opposite magnetic polarity It can be any number that one possesses.

[0019] In another embodiment, a shunt valve assembly implanted in a patient who requires it The method for adjusting the operating pressure is to use a device located near the embedded shunt valve assembly. This includes applying an external magnetic field to the area outside the patient.

[0020] According to one embodiment, a method for reducing the ventricular size of a patient who requires it is to shan The valve assembly is implanted in the patient, and the selected pressure of the valve assembly is controlled by the valve. This includes setting the pressure lower than the patient's ventricular pressure prior to implantation of the device.

[0021] According to another embodiment, a method for treating a patient suffering from hydrocephalus involves a shunt valve Implanting the assembly into the patient and the selected pressure of the shunt valve assembly into the patient This includes setting the pressure lower than the ventricular pressure.

[0022] In another embodiment, a method for increasing the ventricular size of a patient who requires it is a shunt Implanting the valve assembly into the patient and the selected pressure of the shunt valve assembly This includes setting the pressure higher than the patient's ventricular pressure.

[0023] During the course of treatment, the selected operating pressure of the valve is used to effectively manage the patient's condition. It is expected that adjustments will need to be made by the clinician. However, during use, The valve is exposed to an environmental magnetic field that could potentially alter the valve's operating pressure. The embodiments also resist adjustment by an external magnetic field, and are programmed by a programmer. We propose a valve mechanism design that facilitates adjustment of the valve mechanism using the magnetic field generated. To provide.

[0024] Further aspects and embodiments involve setting the pressure within a surgically implantable shunt valve. This relates to a kit for doing so. In some embodiments, the kit includes a shunt valve assembly. It has a magnetically operable motor configured to provide a selected pressure setting for the buri. A surgically implantable shunt valve assembly and a surgically implantable shunt valve A pressure reader configured to provide pressure readings for a lubricant assembly, and at least A programmer having one programmer magnet, wherein at least one programmer The magnet is selectively movable and operates a magnetically operated motor, allowing the user to Program the surgically implantable shunt valve assembly by adjusting the pressure settings. A programmer configured to allow matching to the pressure setting of the instrument, It is equipped with.

[0025] In some embodiments, the pressure reader further comprises an arrow on the top surface of the pressure reader. .

[0026] In some embodiments, the pressure reader has a concave surface defined on the lower surface of the pressure reader. Prepare for it.

[0027] In some embodiments, the program writer further includes a user interface. El.

[0028] In some embodiments, the programmer provides a first pressure setpoint for increasing the pressure setpoint. It further includes a button for the first setting and a second button for decreasing the pressure setting.

[0029] In some embodiments, the programmer increases the pressure setpoint by first It further features a wheel that can rotate in one direction, and the wheel is designed to reduce the pressure setpoint. It is rotatable in 2 directions.

[0030] In some embodiments, the program programmer has a cabinet on the bottom surface of the program programmer. To further enhance the T.

[0031] In some embodiments, the pressure reader includes one of a magnet and a Hall sensor. nothing.

[0032] In some embodiments, a surgically implantable shunt valve assembly is provided in the housing. A housing in which the exterior of the housing is formed from a material that is physiologically compatible. and a magnetically operable motor located within a housing, which is magnetically operable The motor responds to the change in the magnetic polarity of the stator, which is induced by an external magnetic field. A rotor configured to rotate relative to a stator, wherein the rotor casing The ring and rotor casing are arranged in a circular pattern and have alternating magnetic polarities. It includes multiple rotor permanent magnet elements, and the rotation of the rotor relative to the stator is controlled by the shunt valve. A magnetically operated motor, including a rotor, generates the selected pressure setting for the valve assembly. A data port and an inlet port located between the rotor casing and the outside of the housing, The inlet port terminates at the end of its rotor casing within the valve seat, and A valve element biased against the valve seat by a spring, the valve element The valve element, along with the valve seat, together forms an opening, and the rotor casing and housing An outlet port located between the outside of the ring and the shunt valve assembly, the opening To discharge the fluid through the section to the outlet port, the pressure of the fluid in the inlet port is reduced by the shunt bar. The outlet port is configured to open when the selected pressure setting of the lubricant assembly is exceeded. It is equipped with a .

[0033] In some embodiments, a surgically implantable shunt valve assembly is provided by the rotor. A rotor marker attached to the rotor, the rotor marker which rotates together with the rotor, and a how Includes a housing marker fixedly attached to the jigging, and relative to the housing marker The position of the rotor marker indicates the pressure setting of the surgically implantable shunt valve assembly. vinegar.

[0034] In some embodiments, the rotor marker is made of tantalum, and the housing marker is made of tantalum. It is equipped with a

[0035] In some embodiments, a magnetically operable motor has a rotatable rotor. The Tepper motor, a surgically implantable shunt valve assembly, has a locked position and It is magnetically operable between the unlocked and unlocked positions, and in the locked position, the rotation of the rotor is A mechanical brake mechanism configured to prevent this, and an external sensor that magnetically determines the rotor position. An indicator configured to determine and thereby allow the pressure setting to be determined. It further includes a magnet assembly.

[0036] Another embodiment is a surgically implantable shunt valve assembly with a housing. Regarding the following: The exterior of the housing is formed from physiologically compatible materials. Valve assembly The Bri further features a magnetically operated motor located within the housing. An operational motor consists of a stator and a stator whose magnetic field is induced by an external magnetic field. It includes a rotor configured to rotate relative to the stator in response to polarity. The rotor is A rotor casing and a circular arrangement within the rotor casing, having alternating magnetic polarities. It includes multiple rotor permanent magnet elements arranged in a certain manner. The rotation of the rotor relative to the stator is The selected pressure setting for the shunt valve assembly is generated, and the rotor casing has multiple motors. It has teeth. The valve assembly is located between the rotor casing and the outside of the housing. Further equipped with an inlet port, the inlet port is located within the rotor casing of the valve seat It terminates at the end. The valve assembly is biased against the valve seat by a spring. A valve element in which the valve element and valve seat together form an opening. The valve element and the outlet port located between the rotor casing and the outside of the housing Further preparations are made. The valve assembly is designed to discharge fluid through the opening to the outlet port. The fluid pressure in the inlet port exceeds the selected pressure setting of the shunt valve assembly. The valve assembly is configured to open the indicator housing and An indicator having a magnet placed inside the indicator housing, and a connection to the indicator The rotor is joined together, and a brake is positioned between the teeth of multiple motor teeth to prevent the rotor from rotating. The interval between the locked position and the unlocked position where the brake disengages the teeth of multiple rotor teeth. A brake that is movable in response to the movement of a dicator, wherein the indicator is exposed to an external magnetic field. A magnetically operated mechanical brake, including a brake that is movable in response to movement. It is further equipped with a key assembly.

[0037] In the valve assembly embodiment, the rotation of the rotor changes the biasing tension of the spring relative to the cam. Therefore, in order to generate the selected pressure setting of the shunt valve assembly, A rotor casing including a cam that engages with the spring to adjust the spring tension on the buoyant element. It may further include forming a cam. The cam may have the shape of an Archimedes spiral or an Archi It may be formed to realize a combination of Medes' spirals. The spring may be a cantilever spring. A cantilever spring consists of a cantilever arm that contacts the valve element and a second arm that contacts the cam. It may include: The rotor casing is a rotor stopper that prevents the rotor from rotating 360 degrees. It may further include the following. The stator may be positive (+) shaped. The valve assembly is , which may further include a cam that engages with a spring and is integrated with the rotor casing, as a result, The rotation of the rotor causes the rotation of the cam, which adjusts the spring tension on the valve element. The structure includes a pivot point and a first arm attached to the pivot point and configured to engage with a cam. A cantilever arm having a free end that extends from the pivot point and is configured to contact the valve element, It may be a cantilever spring including the fulcrum, first arm, and cantilever arm, by a cam The first force applied to the first arm is then applied to the valve element by the cantilever spring. It may be configured to provide a lever effect such that it is converted into a force of 2, where the second force is the first It is less than the force. The spring may be a cantilever spring. A magnetically operated motor is external. The sensor orients an indicator magnet, which allows the rotor position to be determined magnetically. The valve assembly may further include first and second positioning magnets. A rotor marker is attached to the rotor so as to rotate with the rotor, and the housing It may further include a housing marker that is fixedly attached. The position of the rotor marker is used for pressure setting of surgically implantable shunt valve assemblies. This can be shown. The rotor marker may contain tantalum, and the housing marker may contain tantalum. It is equipped with a

[0038] Another embodiment involves a kit for setting the pressure within a surgically implantable shunt valve. Regarding the kit, in one embodiment, the kit provides a selected pressure setting for the shunt valve assembly. A surgically implantable device having a magnetically operable motor configured to provide stability. Shunt valve assembly and pressure setting of surgically implantable shunt valve assembly A monitoring device configured to detect a constant, and at least one programmer magnet It comprises a programmer device, and at least one programmer magnet selectively moves It is possible to operate a magnetically operated motor, allowing the user to surgically implant a sigil. Adjust the pressure setting of the cant valve assembly to match the pressure setting value of the programmer. It is configured to allow for surgical implantation. The indicator housing has an indicator housing and a magnet placed inside the indicator housing. An indicator, coupled to the indicator, prevents the motor rotor from rotating. The rake is positioned in a locked position between the teeth of multiple motor teeth, and the brake is positioned between the teeth of multiple rotor teeth A movable swivel in response to the movement of the indicator between the unlocked position and the position where the teeth are disengaged. - The indicator is exposed to an external magnetic field applied by a programmer device. A magnetically operated mechanical brake, including a brake that is movable in response to movement. Contains Swertia japonica.

[0039] The kit embodiment configures the programmer device to have a user interface. It may further include doing the following. The programmer device turns the programmer device on and It may also include at least one additional button for turning it off. Programmer device The user interface has a first button for increasing the pressure setting value, and a pressure setting It may include a second button for decreasing the value. The programmer device is programme It may include at least one start button to initiate the sequence. The surface has a liquid crystal display (LCD) configured to display pressure readings. It may also include: a programmer device, a housing, and a motor coupled to the housing. A magnet assembly configured to be coupled to the motor and rotate relative to the housing. The magnet assembly may include a surgically implantable shunt valve assembly. The motor may include at least one permanent magnet for applying an external magnetic field. The motor has a drive gear. The magnet assembly may include a shaft having a bearing and a drive gear. A driven gear coupled to A, a magnetic crosslinking plate coupled to a magnetic support, and a magnetic crosslinking plate coupled to A It may further include at least one permanent magnet. The motor may be a DC motor. The programmer device must at least The monitoring device may include software to control the movement of a single permanent magnet. It may include an interface. The user interface turns on and It may include a button to turn it off. The user interface displays the pressure setting reading. The monitor device may further include a liquid crystal display (LCD) configured to display [something]. The housing may include a housing and a monitor assembly supported by the housing. The monitor assembly is central to the monitor assembly and is a surgically implantable shunt. A monitor configured to detect the position of the magnetically operable motor of the lubricant assembly. It may include sensors. At least one monitor sensor occupies the center of the monitor assembly. The first sensor and the magnetically operable shunt valve assembly that can be surgically implanted It may include a second sensor for detecting the position of the motor. The valve assembly is housed in a housing It may also include the following: The exterior of the housing may be formed from a physiologically compatible material. A magnetically operated motor may be placed inside a housing. The stator responds to the changing magnetic polarity of the stator induced by an external magnetic field. It may include a rotor configured to rotate relative to a stator. The rotor is a rotor case. The rotor casing and the rotor casing are arranged in a circular pattern, with alternating magnetic polarities. It may include a plurality of rotor permanent magnet elements. The rotation of the rotor relative to the stator is The selected pressure setting for the cant valve assembly can be generated. The valve may have multiple motor teeth. The valve assembly consists of a rotor casing and a housing. It may include an inlet port located between the valve seat and the outside, and the inlet port is located within the valve seat. It terminates at the end of the rotor casing. The valve assembly is supported by a spring and the valve seat A valve element biased toward the valve seat, wherein the valve element and valve seat open together. A valve element that forms the opening, and positioned between the rotor casing and the outside of the housing. The valve assembly may further include an outlet port. To discharge the fluid, the fluid pressure in the inlet port is selected for the shunt valve assembly. The valve assembly may be configured to open when the pressure exceeds a set pressure. A rotor marker is attached to the rotor so as to rotate with the rotor, and is fixed to the housing. It may include a housing marker that is attached to the housing marker. The position of the -ka indicates the pressure setting of a surgically implantable shunt valve assembly. Yes, it is possible. The rotor marker may contain tantalum, and the housing marker may be made of tantalum. The kit includes a monitoring device and field on a surgically implantable shunt valve assembly. Depending on the situation, a positioning disk may be used to position the programming device. It may further include the following.

[0040] Another embodiment involves a kit for setting the pressure within a surgically implantable shunt valve. Regarding the kit, in one embodiment, the kit provides a selected pressure setting for the shunt valve assembly. A surgically implantable device having a magnetically operable motor configured to provide stability. Shunt valve assembly and pressure setting of surgically implantable shunt valve assembly A monitoring device configured to detect constant readings, and at least one programmer The device comprises a programmer with a magnet. At least one programmer magnet is selected It is movable and operates with a magnetically controlled motor, allowing the user to have it surgically implanted. Adjust the pressure setting of the possible shunt valve assembly to the pressure setting value of the programmer. It is configured to allow matching. The programmer device is housed in a housing and , a motor coupled to a housing, and a motor coupled to a motor that rotates relative to the housing Includes a magnet assembly configured such that the magnet assembly is surgically implantable. The valve assembly includes at least one permanent magnet for applying an external magnetic field.

[0041] The kit embodiment configures the programmer device to have a user interface. It may further include doing the following. The programmer device turns the programmer device on and It may also include at least one additional button for turning it off. Programmer device The user interface has a first button for increasing the pressure setting value, and a pressure setting It may include a second button for decreasing the value. The programmer device is programme It may include at least one start button to initiate the motor sequence. It may include a shaft having a drive gear. The magnet assembly includes a magnet support having a bearing. , a driven gear coupled to a drive gear, a magnetic crosslinking plate coupled to a magnetic support, and a magnetic crosslinking plate It may further include at least one permanent magnet coupled to it. The motor is a DC motor. That's fine. The kit includes a monitoring device on a surgically implantable shunt valve assembly. Positioning tools used to position the s and, in some cases, the programming device. It may further include a disk. The programmer device is opposite to the selected pressure setting. Before starting the rotor to rotate in the second direction, the valve device is set in the first direction until the minimum pressure setting is reached. It may be configured to rotate the rotor.

[0042] Another embodiment involves a kit for setting the pressure within a surgically implantable shunt valve. Regarding the kit, in one embodiment, the kit provides a selected pressure setting for the shunt valve assembly. A surgically implantable device having a magnetically operable motor configured to provide stability. Shunt valve assembly and pressure setting of surgically implantable shunt valve assembly A monitoring device configured to detect constant readings, and at least one programmer The device comprises a programmer with a magnet. At least one programmer magnet is selected It is movable and operates with a magnetically controlled motor, allowing the user to have it surgically implanted. Adjust the pressure setting of the possible shunt valve assembly to the pressure setting value of the programmer. It is configured to allow matching. The monitor is a housing and a housing Includes a monitor assembly supported by the monitor assembly. At its core lies a magnetically operated motor for surgically implantable shunt valve assemblies. Includes at least one monitor sensor configured to detect the position of a data point.

[0043] The kit embodiment configures the monitoring device to have a user interface. It may further include turning on the programmer device and It may include a button to turn it off. The user interface may include a pressure setting reading. The kit may further include a liquid crystal display (LCD) configured to display data. A monitoring device and, if applicable, a surgically implantable shunt valve assembly. It further includes a positioning disk used to position the programming device. That's fine. The monitor has a pressure recall button configured to recall the previous pressure reading. It may also include: at least one monitor sensor occupies the center of the monitor assembly. The first sensor and the magnetically operable shunt valve assembly that can be surgically implanted It may include a second sensor for detecting the position of the motor.

[0044] Further embodiments, configurations, and advantages of these exemplary aspects and embodiments are described below. This will be explained in detail. Embodiments disclosed herein are less than the principles disclosed herein. It may be combined with other embodiments in any manner that matches at least one of them, “Embodiment” "Several embodiments," "alternative embodiments," "various embodiments," "one embodiment" References to such things are not necessarily mutually exclusive, and the specific features, structures, or This indicates that the characteristics may be included in at least one embodiment. The appearance of such terminology in this context does not necessarily refer to the same embodiment in all cases.

[0045] Various aspects of at least one embodiment are described below with reference to the accompanying drawings. In a plane, similar reference letters refer to the same part throughout various figures. Therefore, not all components can be labeled in every drawing. Furthermore, the emphasis is not on illustrating the scale, but rather on illustrating the principle of the present invention. The following sections are included to provide examples and further understanding of various aspects and embodiments. Incorporated into the specification and constituting part thereof, but intended as a definition of the limitations of the present invention isn't it. [Brief explanation of the drawing]

[0046] [Figure 1A] This is a plan view of an example of an embeddable valve assembly, showing a top view according to an aspect of the present invention. [Figure 1B] Figure 1A is a cross-sectional view of the valve assembly. [Figure 2] This is a three-dimensional view of an example of an embeddable valve according to an aspect of the present invention. [Figure 3A] This figure shows a plan view of an example of an embeddable valve corresponding to the example shown in Figure 2, according to an aspect of the present invention. [Figure 3B] Figure 3A is a side view of an example of a removable valve. [Figure 4A] This is a cross-sectional view of an example of the valve shown in Figures 2 and 3A-3B, taken along line AA in Figure 3A. [Figure 4B] Figure 3A is a cross-sectional view of an example of the valve shown in Figures 2 and 3A-3B, taken along line BB. [Figure 4C]Figure 3A is a cross-sectional view of an example of the valve shown in Figures 2 and 3A-3B, taken along line CC. [Figure 5] This is a three-dimensional cross-sectional view of an example of the valve shown in Figures 2 and 3A to 3B, according to an embodiment of the present invention. [Figure 6A] This figure shows an enlarged view of a portion of the valve in Figure 5, according to an embodiment of the present invention, where the cam is positioned at the minimum tension relative to the biasing spring. [Figure 6B] This figure shows another view of a portion of the valve in Figure 5, according to an aspect of the present invention, where the cam is positioned to exert minimum tension relative to the biasing spring. [Figure 6C] This figure shows an enlarged view of a portion of the valve in Figure 5, according to an embodiment of the present invention, where the cam is positioned at the maximum tension relative to the biasing spring. [Figure 6D] This figure shows an enlarged view of a portion of the valve in Figure 5, illustrating an example of a spring biased to a valve element and cam according to an aspect of the present invention. [Figure 7A] This figure shows an example of a leaf spring according to an aspect of the present invention. [Figure 7B] This is a partial perspective view showing an example of a leaf spring attached to a valve according to an aspect of the present invention, as shown in Figure 7A. [Figure 8A] This figure shows an example of a U-shaped spring according to an aspect of the present invention. [Figure 8B] This figure shows a U-shaped spring attached to a programmable valve according to an aspect of the present invention. [Figure 8C] This figure shows a portion of the programmable valve in Figure 8B when the programmable valve is set to the minimum pressure setting. [Figure 8D] This figure shows a portion of the programmable valve in Figure 8B when the programmable valve is set to the maximum pressure setting. [Figure 9A] This figure shows another example of a spring according to an aspect of the present invention. [Figure 9B] This figure shows a spring (Figure 9A) that engages with a valve element according to an aspect of the present invention. [Figure 10A]This is a schematic diagram of an example of a rotor positioned for setting the minimum pressure of a valve, for use in an embodiment of a magnetically operated, embeddable valve according to an aspect of the present invention. [Figure 10B] Figure 10A is a schematic diagram of the rotor, showing the rotor positioned for setting the maximum pressure of the valve. [Figure 11A] This figure shows an example of an embedded valve and an external valve program writer having control and display according to an aspect of the present invention. [Figure 11B] This figure shows another example of an embedded device and an external program writer according to an aspect of the present invention. [Figure 11C] This figure shows an example of a built-in valve and a pressure reading device for reading the pressure setting of the valve, according to an aspect of the present invention. [Figure 12] This is a block diagram of an example of an external control device that can be used in combination with an embedded programmable valve according to an aspect of the present invention. [Figure 13] This figure shows the operation of an example of a magnetic motor according to an aspect of the present invention, which includes 12 rotor magnet elements and is controlled by a controller that includes multiple electromagnets. [Figure 14] This is a three-dimensional partial cross-sectional view of an example of a magnetic motor according to an aspect of the present invention. [Figure 15] This table shows an example of a sequence for exciting the electromagnet of the controller in Figure 13 to rotate the magnetic rotor clockwise, according to an aspect of the present invention. [Figure 16A] This figure shows the stator's magnetic polarity and rotor's motion in response to the excitation sequence shown in Figure 15. [Figure 16B] This figure shows the stator's magnetic polarity and rotor's motion in response to the excitation sequence shown in Figure 15. [Figure 16C] This figure shows the stator's magnetic polarity and rotor's motion in response to the excitation sequence shown in Figure 15. [Figure 16D] This figure shows the stator's magnetic polarity and rotor's motion in response to the excitation sequence shown in Figure 15. [Figure 16E] This figure shows the stator's magnetic polarity and rotor's motion in response to the excitation sequence shown in Figure 15. [Figure 16F] This figure shows the stator's magnetic polarity and rotor's motion in response to the excitation sequence shown in Figure 15. [Figure 16G] This figure shows the stator's magnetic polarity and rotor's motion in response to the excitation sequence shown in Figure 15. [Figure 16H] This figure shows the stator's magnetic polarity and rotor's motion in response to the excitation sequence shown in Figure 15. [Figure 17] This table shows an example of a sequence for exciting the electromagnet of the controller in Figure 13 to rotate the magnetic rotor counterclockwise, according to an aspect of the present invention. [Figure 18A] This figure shows the stator's magnetic polarity and rotor's motion in response to the excitation sequence shown in Figure 17. [Figure 18B] This figure shows the stator's magnetic polarity and rotor's motion in response to the excitation sequence shown in Figure 17. [Figure 18C] This figure shows the stator's magnetic polarity and rotor's motion in response to the excitation sequence shown in Figure 17. [Figure 18D] This figure shows the stator's magnetic polarity and rotor's motion in response to the excitation sequence shown in Figure 17. [Figure 18E] This figure shows the stator's magnetic polarity and rotor's motion in response to the excitation sequence shown in Figure 17. [Figure 18F] This figure shows the stator's magnetic polarity and rotor's motion in response to the excitation sequence shown in Figure 17. [Figure 18G] This figure shows the stator's magnetic polarity and rotor's motion in response to the excitation sequence shown in Figure 17. [Figure 18H] This figure shows the stator's magnetic polarity and rotor's motion in response to the excitation sequence shown in Figure 17. [Figure 19] This is a block diagram of another example of an external valve programmer that can be used with an embodiment of an embedded valve assembly according to an aspect of the present invention. [Figure 20A] Figure 19 shows an example of a permanent magnet assembly for an external valve program writer according to an aspect of the present invention. [Figure 20B] Figure 19 shows another example of a permanent magnet assembly for an external valve program writer according to an aspect of the present invention. [Figure 21A] This figure shows an example of the stator's magnetic polarity and rotor's movement changing under the control of an example of an external valve program programmer incorporating the permanent magnet assembly shown in Figure 20A, according to an aspect of the present invention. [Figure 21B] This figure shows an example of the stator's magnetic polarity and rotor's movement changing under the control of an example of an external valve program programmer incorporating the permanent magnet assembly shown in Figure 20A, according to an aspect of the present invention. [Figure 21C] This figure shows an example of the stator's magnetic polarity and rotor's movement changing under the control of an example of an external valve program programmer incorporating the permanent magnet assembly shown in Figure 20A, according to an aspect of the present invention. [Figure 21D] This figure shows an example of the stator's magnetic polarity and rotor's movement changing under the control of an example of an external valve program programmer incorporating the permanent magnet assembly shown in Figure 20A, according to an aspect of the present invention. [Figure 21E] This figure shows an example of the stator's magnetic polarity and rotor's movement changing under the control of an example of an external valve program programmer incorporating the permanent magnet assembly shown in Figure 20A, according to an aspect of the present invention. [Figure 22] Figures 21A to 21E illustrate an example of the changing stator polarity and rotor movement, representing one rotation of an external permanent magnet valve program writer according to an aspect of the present invention. [Figure 23A] This figure shows a top view of an example of a valve program writer according to an aspect of the present invention. [Figure 23B] This figure shows a bottom view of the valve program programmer shown in Figure 23A. [Figure 23C] Figures 23A and 23B show end views of the valve program writer. [Figure 23D] Figures 23A to 23C show perspective views of the valve program programmer. [Figure 23E] This figure shows a top view of another example of a valve program programmer according to an aspect of the present invention. [Figure 24] This flowchart illustrates an example of a method for operating the valve program writer shown in Figures 23A to 23D to program the pressure setting of an embedded valve according to an aspect of the present invention. [Figure 25A] This figure shows examples of various configurations of a stator combined with a 12-magnet rotor according to an aspect of the present invention. [Figure 25B] This figure shows examples of various configurations of a stator combined with a 12-magnet rotor according to an aspect of the present invention. [Figure 25C] This figure shows examples of various configurations of a stator combined with a 12-magnet rotor according to an aspect of the present invention. [Figure 26A] This figure shows a further example of a stator combined with a 12-magnet rotor according to an aspect of the present invention. [Figure 26B] This figure shows a further example of a stator combined with a 12-magnet rotor according to an aspect of the present invention. [Figure 26C] This figure shows a further example of a stator combined with a 12-magnet rotor according to an aspect of the present invention. [Figure 27] This is a diagram of an example of a rotor including a reference magnet element according to an aspect of the present invention. [Figure 28A] This figure shows a further example of a motor assembly including a reference magnet element according to an aspect of the present invention. [Figure 28B] This figure shows a further example of a motor assembly including a reference magnet element according to an aspect of the present invention. [Figure 28C] This figure shows a further example of a motor assembly including a reference magnet element according to an aspect of the present invention. [Figure 29] This is a block diagram of an example of an external valve program programmer including a magnetic sensor for detecting a reference magnetic element, according to an aspect of the present invention. [Figure 30A]This is a perspective view of an example of a pressure reader according to an aspect of the present invention. [Figure 30B] Figure 30A is a top view of the pressure reader. [Figure 31] This is a flowchart illustrating an example of a method for operating a pressure reader to read the pressure setting of a recessed valve, according to an aspect of the present invention. [Figure 32] This figure shows a cross-sectional view of another example of a motor including a reference magnet element or a position-indicating magnet element according to an aspect of the present invention. [Figure 33] This is a partial three-dimensional cross-sectional view of an example of a programmable valve including a brake mechanism according to an aspect of the present invention. [Figure 34] This is a schematic diagram showing a specific embodiment of an example of a brake mechanism according to an aspect of the present invention. [Figure 35] This figure shows another example of a permanent magnet assembly for an external valve program writer, Figure 19, incorporating a magnetic brake controller mechanism according to an aspect of the present invention. [Figure 36] This is a flowchart illustrating an example of a method for programming an embedded programmable valve according to an aspect of the present invention. [Figure 37A] This is a cross-sectional view of an example of a programmable valve according to an embodiment of the present invention, showing the brake in the locked position, as shown in Figure 33. [Figure 37B] This is a corresponding cross-sectional view showing the brake in the unlocked position. [Figure 38] This figure shows another example of a permanent magnet assembly for an external valve program writer according to an aspect of the present invention, as shown in Figure 19. [Figure 39] This is a flowchart of another example of a method for programming an embedded programmable valve according to an aspect of the present invention. [Figure 40] This figure shows another example of a programmable valve including a braking mechanism according to an aspect of the present invention. [Figure 41] This is a partial cross-sectional perspective view of another example of a programmable valve including a magnetic motor with a brake mechanism, according to an aspect of the present invention. [Figure 42]Figure 41 is a plan view of an example of a valve. [Figure 43] This is a plan view of another example of a motor assembly for a valve similar to the valve shown in Figure 41, according to an aspect of the present invention. [Figure 44A] This is a cross-sectional view of an example of the valve shown in Figure 42, taken along line AA in Figure 42. [Figure 44B] This is a cross-sectional view of an example of the valve shown in Figure 42, taken along line BB in Figure 42. [Figure 45] This figure shows another example of a brake spring according to an aspect of the present invention. [Figure 46A] This is a schematic cross-sectional view of an example valve shown in Figure 42, indicating the brake in the locked position. [Figure 46B] Figure 42 shows a corresponding schematic cross-sectional view of an example valve, indicating the brake in the unlocked position. [Figure 47A] This is a plan view of another example of a programmable valve according to an aspect of the present invention. [Figure 47B] This is a cross-sectional view of the programmable valve shown in Figure 47A, taken along line AA in Figure 47A. [Figure 48] This figure shows another example of a programmable valve incorporating a braking mechanism according to an aspect of the present invention. [Figure 49] This is a perspective view of an embeddable valve assembly of another embodiment of the present disclosure. [Figure 50] This is a perspective view of a programmable valve in an embedded valve assembly according to an aspect of the present disclosure. [Figure 51] This is an exploded perspective view of a programmable valve. [Figure 52] This is a perspective view of a programmable valve with its casing removed to reveal the components housed within the programmable valve. [Figure 53] Another perspective view of a programmable valve. [Figure 54] This is a perspective cross-sectional view of a programmable valve. [Figure 55]This is a cross-sectional view of a programmable valve. [Figure 56A] This is a top perspective view of a programmer device with a magnetic shield cover attached, for a valve device according to one embodiment of the present disclosure. [Figure 56B] Figure 56A is a side view of the programmer device shown. [Figure 56C] This is a perspective view of the magnetic shield separated from the programmer device. [Figure 56D] This is a bottom view of the magnetic shield attached to the programmer device. [Figure 57] This is a bottom perspective view of a programmer device without a magnetic shield cover. [Figure 58] This is a top view of the programmer device. [Figure 59] This is a disassembled perspective view of a programmer device. [Figure 60A] This is a top perspective view of a monitor device for a valve device according to one embodiment of the present disclosure. [Figure 60B] This is a bottom perspective view of the monitor device. [Figure 61] This is a top view of the monitor device. [Figure 62] This is a disassembled perspective view of the monitor device. [Figure 63] This is a cross-sectional view of the monitor device. [Figure 64] This is a top perspective view of the circuit board of the monitor device. [Figure 65] This is a bottom perspective view of the circuit board of the monitor device. [Figure 66] This is a perspective view of a positioning disk used to position a monitor device and a programmer device on a valve device. [Figure 67] This is a top view of the positioning disc. [Figure 68] This is a perspective view of a programmer device having a magnetic shield, a monitor device connected to a power cord, and a positioning disk, positioned below the monitor device of an embodiment of the present disclosure. [Modes for carrying out the invention]

[0047] The embodiments and models increase or decrease the operating pressure of the valve in a continuous or finite increment. This relates to a valve assembly incorporating a magnetic motor configured to perform the following actions. As explained in detail, the rotor is magnetically repositioned within the casing of the valve assembly. This allows the opening pressure of the valve element to be adjusted, thereby allowing the valve assembly to The flow of fluid through increases or decreases. Certain embodiments of the valve assembly are used for hydrocephalus. It may be adapted for implantation in affected patients and used to expel CSF.

[0048] In detail, specific aspects and embodiments include a magnetic motor and external control having the following features. The valve provides an externally magnetically programmable valve with an integrated controller. The operator, for example, a doctor, can continuously or at small pressures up to approximately 200 mmH2O. The valve is configured to be adjustable in force increments (for example, increments of about 10 mmH2O), The valve has a "closed" setting of approximately 300-400 mmH2O. The valve is, for example, 3 Tesla. It is highly resistant to unprogrammed external magnetic fields in environments such as MRI magnetic fields, and As a result, the patient is affected by the MRI machine that generates the magnetic field or other devices (other than the valve controller). The valve pressure setting does not change much when you are near the container. In certain embodiments, Lub allows operators (e.g., doctors) to verify valve pressure settings using methods other than X-rays. It is configured to be so. Furthermore, according to a particular embodiment, the valve controller is small and These and other valves in various embodiments The features and configuration are described in more detail below.

[0049] Referring to Figures 1A and 1B, two valves 2 separated by the pump chamber 110 An example of an embeddable shunt valve assembly 100 including parts 00 and 300 is shown. For example, a ventricular catheter 120 is connected to the inlet 130 of a valve assembly 100. The drainage catheter can be attached to connector 140 and the valve assembly can be used. It can be connected to outlet 150. The recess in the pump chamber 110 is through valve 300. This pumps fluid towards outlet 150 and the drainage catheter. The pump chamber presses. After this, when the pump chamber is opened, the fluid is sent through valve 200. 00 is externally programmable, including a magnetic motor, as will be described in more detail below. It is a valve. The second valve 300 could be, for example, a check valve. In this case, After passing through the ram-operated valve 200, the fluid exits through the check valve 3 before reaching the drainage catheter. It flows through 00. In one example, programmable valve 200 is where the fluid pressure is at the valve. The valve assembly 100 is designed to remain closed until the pressure rises to a set pressure level. Generally, the check valve 300 may be set to low pressure and include a programmable magnetic motor. The pressure setting of valve 200 can control the fluid flow through valve assembly 100. In other examples, the second valve 300 is activated when the patient's posture changes (i.e., horizontally). Changes in CSF hydrostatic pressure that occur when rapidly moving from a supine position to a vertical (standing) position. In response, a gravity-actuated valve allows the valve assembly 100 to automatically adjust. It could be lubricant. In detail, these pressure changes could cause excessive discharge of CSF. To avoid valve opening in response to the change, the valve assembly 100 is as shown in Figure 1A and As shown in Figure 1B, the programmable valve 200 is connected in series with the outlet side. It may include gravity-operated valves, which are used when the patient is substantially vertical. It is sometimes configured to open under higher pressure.

[0050] Those skilled in the art will understand the advantages of the present disclosure, and the advantages of various embodiments of the valve assembly 100. Please understand that the size and shape can be adjusted. Features of valve assembly 100 A specific embodiment involves sampling a fluid and / or injecting a pharmaceutical or dye. Reservoir or pre-burning chamber or sub-chamber, power on / off device, siphon prevention device A vice or other flow compensation device, and / or additional catheters may be used. Good. When included, the pre-combustion chamber (not shown in Figures 1A and 1B) is located at inlet 130. It should be connected between and the programmable valve 200. According to a particular embodiment The valve assembly 100 is located in the pump chamber 110, the pre-fuel chamber, (for example, a check valve or gravity valve) A second valve 300 (which may be an operating valve), and possibly a siphon prevention device. This may include a combination of chairs (not shown). In other embodiments, among these components One or more may be omitted. For example, valve assembly 100 is shown in Figure 1A and As shown in Figure 1B, the pump chamber 110 and the second valve 300 are included without a pre-burning chamber. This is acceptable. The pump room 110 may be omitted in a similar or alternative manner. Then, after the fluid passes through the programmable valve 200, the fluid passes through the second valve 300. And so it flows. Alternatively, the valve assembly 100 is connected to the pump chamber 110 or the second valve A pre-burning chamber may be included, with or without 300. The valve assembly 100 is a well-known method. It can be surgically implanted into the patient using the appropriate sequence.

[0051] Figure 2 shows one of the embeddable and magnetically programmable valves 200 in a specific configuration. An example of a three-dimensional diagram is shown. Figures 3A and 3B show the embeddable in Figure 2 according to a specific embodiment. Figure 3A shows an external view of the magnetically programmable valve 200. Figure 3A is a plan view, and Figure 3 B is an end view. Valve 200 houses the components of the valve (also called a housing). The valve body 202 is included. The valve 200 has an inlet port 204 and an outlet port 2 Includes 06. The inlet port 204 may be connected to the proximal (or inflow) catheter and outlet The oral port 206 may be connected to a distal or outflow catheter to divert the CSF fluid. For valve assemblies, the proximal catheter is either a ventricular catheter 120 or a lumbar catheter. This may be the case. In this case, the CSF fluid from the ventricles is routed through a ventricular catheter or lumbar catheter. It enters the valve assembly 100 and goes into the inlet port 204. The distal catheter connects It functions as a drainage catheter connected to the Kuta 140, for drainage to the heart. Disconnecting the body from the right atrium (VA shunt) or peritoneal cavity (VP or LP shunt) Guide the fluid to the desired position.

[0052] The valve body 202 is fitted with the upper cap 202a, and the upper cap 202a is fitted with the person It includes a lower cap 202b that forms a sealed enclosure suitable for implantation in the body. The "upper part" of the valve 200 is oriented upward toward the patient's scalp when implanted. This is a side view of the device. The valve body 202 is made from any physiologically suitable material. It may be prepared. Non-limiting examples of physiologically compatible materials include polyethersulfone. It also contains silicone. As will be understood by those skilled in the art, the valve body 202 is a valve Depending at least partially on the size, shape, and arrangement of the components within B200, various It may have any shape and size.

[0053] Various aspects and features of the valve 200, including the operation of the magnetic motor, as well as its operation, are shown in Figure 2. This will be explained below with reference to Figures 3A-3B and Figures 4A-4C. Figure 4A is a figure One of the valves 200, which shows a specific component of the magnetic motor, taken along line AA of 3A. This is a cross-sectional view of the example. Figure 4B shows a specific magnetic motor, taken along line BB in Figure 3A. Figures 2 and 3A-3B show three-dimensional cross-sectional views of an example of valve 200, illustrating its components. 4C is taken along line CC in Figure 3B, showing a specific component of the magnetic motor in Figure 2. Figure 5 shows another cross-sectional view of the valve 200 example in Figures 3A and 3B. Figure 5 shows line AA of Figure 3A. Another cross-sectional view of the example valve 200 in Figures 2 and 3A-3B, taken along the line.

[0054] Referring to Figures 2, 3A-3B, and 4A-4C, according to a particular embodiment The valve 200 is biased against the valve seat 210 by the spring 400. Includes element 208. Spring 400 is, for example, a tension spring, compression spring, helical or coil spring. It may be equipped with a torsion spring, a flat spring, a leaf spring, or a cantilever spring. Yes. Specific embodiments of spring 400 are described in more detail below.

[0055] The fluid enters the valve 200, for example, via a ventricular catheter and passes through the inlet port 204, which terminates at the casing end of the valve seat 210. The pressure of the fluid (e.g., CSF) pushes the valve element 208 and the spring 400 in a direction that raises the valve element 208 from the valve seat 210. The surfaces of the valve element 208 and the valve seat 210 together define an opening, and the size or diameter of the opening determines the velocity and amount of fluid passing through the valve 200. The valve element 208 preferably has a diameter larger than the valve seat 210 such that the opening is substantially closed when the valve element 208 abuts against the valve seat 210. The valve element 208 is disposed on the inlet side of the opening and is biased against the circular periphery of the opening, keeping it closed until the CSF pressure in the inlet chamber exceeds a preselected popping pressure. The term "popping pressure" refers to the opening pressure of the valve and is generally a pressure slightly higher than the operating pressure, which is required to overcome the inertia when the ball settles on the seat. The term "operating pressure" can also be called "operating pressure" and is the pressure of the valve while the fluid flows through the valve 200. The closing pressure is the pressure of the valve at which the flow of fluid through the valve stops. The valve element 208 and the valve seat 210 together define an opening, and the size or diameter of the opening determines the velocity and amount of fluid passing through the valve 200. The valve element 208 preferably has a diameter larger than the valve seat 210 such that the opening is substantially closed when the valve element 208 abuts against the valve seat 210. The valve element 208 is disposed on the inlet side of the opening and is biased against the circular periphery of the opening, keeping it closed until the CSF pressure in the inlet chamber exceeds a preselected popping pressure. The term "popping pressure" refers to the opening pressure of the valve and is generally a pressure slightly higher than the operating pressure, which is required to overcome the inertia when the ball settles on the seat. The term "operating pressure" can also be called "operating pressure" and is the pressure of the valve while the fluid flows through the valve 200. The closing pressure is the pressure of the valve at which the flow of fluid through the valve stops. The valve element 208 preferably has a diameter larger than the valve seat 210 such that the opening is substantially closed when the valve element 208 abuts against the valve seat 210. The valve element 208 is disposed on the inlet side of the opening and is biased against the circular periphery of the opening, keeping it closed until the CSF pressure in the inlet chamber exceeds a preselected popping pressure. The term "popping pressure" refers to the opening pressure of the valve and is generally a pressure slightly higher than the operating pressure, which is required to overcome the inertia when the ball settles on the seat. The term "operating pressure" can also be called "operating pressure" and is the pressure of the valve while the fluid flows through the valve 200. The closing pressure is the pressure of the valve at which the flow of fluid through the valve stops. The valve element 208 preferably has a diameter larger than the valve seat 210 such that the opening is substantially closed when the valve element 208 abuts against the valve seat 210. The valve element 208 is disposed on the inlet side of the opening and is biased against the circular periphery of the opening, keeping it closed until the CSF pressure in the inlet chamber exceeds a preselected popping pressure. The term "popping pressure" refers to the opening pressure of the valve and is generally a pressure slightly higher than the operating pressure, which is required to overcome the inertia when the ball settles on the seat. The term "operating pressure" can also be called "operating pressure" and is the pressure of the valve while the fluid flows through the valve 200. The closing pressure is the pressure of the valve at which the flow of fluid through the valve stops. The valve element 208 preferably has a diameter larger than the valve seat 210 such that the opening is substantially closed when the valve element 208 abuts against the valve seat 210. The valve element 208 is disposed on the inlet side of the opening and is biased against the circular periphery of the opening, keeping it closed until the CSF pressure in the inlet chamber exceeds a preselected popping pressure. The term "popping pressure" refers to the opening pressure of the valve and is generally a pressure slightly higher than the operating pressure, which is required to overcome the inertia when the ball settles on the seat. The term "operating pressure" can also be called "operating pressure" and is the pressure of the valve while the fluid flows through the valve 200. The closing pressure is the pressure of the valve at which the flow of fluid through the valve stops. The valve element 208 is disposed on the inlet side of the opening and is biased against the circular periphery of the opening, keeping it closed until the CSF pressure in the inlet chamber exceeds a preselected popping pressure. The term "popping pressure" refers to the opening pressure of the valve and is generally a pressure slightly higher than the operating pressure, which is required to overcome the inertia when the ball settles on the seat. The term "operating pressure" can also be called "operating pressure" and is the pressure of the valve while the fluid flows through the valve 200. The closing pressure is the pressure of the valve at which the flow of fluid through the valve stops. The valve element 208 is disposed on the inlet side of the opening and is biased against the circular periphery of the opening, keeping it closed until the CSF pressure in the inlet chamber exceeds a preselected popping pressure. The term "popping pressure" refers to the opening pressure of the valve and is generally a pressure slightly higher than the operating pressure, which is required to overcome the inertia when the ball settles on the seat. The term "operating pressure" can also be called "operating pressure" and is the pressure of the valve while the fluid flows through the valve 200. The closing pressure is the pressure of the valve at which the flow of fluid through the valve stops. The term "popping pressure" refers to the opening pressure of the valve and is generally a pressure slightly higher than the operating pressure, which is required to overcome the inertia when the ball settles on the seat. The term "operating pressure" can also be called "operating pressure" and is the pressure of the valve while the fluid flows through the valve 200. The closing pressure is the pressure of the valve at which the flow of fluid through the valve stops. The term "popping pressure" refers to the opening pressure of the valve and is generally a pressure slightly higher than the operating pressure, which is required to overcome the inertia when the ball settles on the seat. The term "operating pressure" can also be called "operating pressure" and is the pressure of the valve while the fluid flows through the valve 200. The closing pressure is the pressure of the valve at which the flow of fluid through the valve stops. The term "operating pressure" can also be called "operating pressure" and is the pressure of the valve while the fluid flows through the valve 200. The closing pressure is the pressure of the valve at which the flow of fluid through the valve stops. The term "operating pressure" can also be called "operating pressure" and is the pressure of the valve while the fluid flows through the valve 200. The closing pressure is the pressure of the valve at which the flow of fluid through the valve stops.

[0056] The valve element 208 can be a sphere, cone, cylinder, or other suitable shape. In the examples shown in FIGS. 4C and 5, the valve element 208 is a spherical ball. The spherical ball and / or the valve seat 210 can be made of any suitable material, including, for example, synthetic ruby or sapphire. In the examples shown in FIGS. 4C and 5, the valve element 208 is a spherical ball. The spherical ball and / or the valve seat 210 can be made of any suitable material, including, for example, synthetic ruby or sapphire. The spherical ball and / or the valve seat 210 can be made of any suitable material, including, for example, synthetic ruby or sapphire. ​It can be manufactured from material. The valve seat 210 is in the closed position of the valve 200. The seating of the valve element 208 within the valve seat 210 provides a liquid-tight seal, It provides complementary surfaces such as a frustoconical surface for the lubrication element. Pressure setting of such valves, For example, the opening pressure changes the biasing force of the valve element 208 relative to the valve seat 210. It is adjusted by the following. For example, the valve element 208 and the valve seat 210 are adjusted by It is pressed into wedge 202, and once the initial pressure setting is reached, it is held in place by friction. This is possible. In one example of this configuration, the valve element 208 includes a ruby ​​ball and the valve seat 2 It is also made from rubies.

[0057] According to one embodiment, the biasing force of the spring 400 on the valve element 208 is This is achieved using a magnetic motor that increases or decreases the operating pressure continuously or in finite increments. According to a particular embodiment, the magnetic motor includes a stator 528 and an external magnetic control magnetic field. Includes a rotor 510 that rotates relative to the stator 528 in response to the rotor 5 10 rotates around the rotational axis 214. The configuration and operation of the embodiment of the magnetic motor are as follows: This will be explained in more detail below.

[0058] Referring to Figures 2, 4A to 4C, and 5, according to a particular embodiment, the rotor 5 10 includes a plurality of rotor magnet elements 512 arranged within the rotor casing 514. Figures 4C and 5 show multiple rotors arranged in a circular pattern and positioned within the rotor casing 514. The rotor magnet element 512 is shown. Thus, the rotor casing 514 is connected to the rotor magnet element 51 It includes a nearly circular channel 522 in which 2 is housed. In one example, the rotor magnet element 512 is permanent These are permanent magnets, each having a south pole and a north pole. The rotor magnet element 512 is shown in Figure 4C. As shown above, they are arranged in an almost circular pattern with alternating polarities, and as a result, when viewed from above (as in Figure 4C) Even when viewed from below, the south and north poles alternate among all rotor magnet elements. In this way, At any given angular position, the pole exposed on the top surface of the element is opposite to the pole exposed on the bottom surface. The rotor magnet element 512 is fixedly attached to the rotor casing 514. The rotor casing 514 houses the rotor magnet element 512 and directs its rotation. It can function as a magnetic guide for the rotor. In Figures 2, 4C, and 5, the rotor Although the magnetic element 512 is shown as a circular disk, the rotor magnetic element 512 is a disk It does not need to be U-shaped, and is not limited to that shape, but can be elliptical, square, rectangular, hexagonal, or free form. Please understand that they can have any shape, such as the rotor magnet element 5. 12 is even if their sizes change to ensure the smooth rotation of rotor 510. Preferably, they are either of approximately the same size or of approximately the same magnetic strength. One embodiment According to the report, the rotor 510 consists of 12 rotors arranged in a circle, as shown in Figure 4C. Includes a magnetic element 512. According to another embodiment, the rotor 510 is further described below. Thus, it includes 10 rotor magnet elements 512 arranged in a circle. In other examples, the rotor 510 may include a number of other rotor magnet elements 512 as disclosed herein. Embodiments of the dynamo valve are not limited to including 10 or 12 rotor magnet elements. do not have.

[0059] According to a particular embodiment, in addition to the rotor magnet element 512, the rotor 510 is as shown in Figure 4A. As shown in FIGS. 4 and 5, one or more additional reference magnet elements 524 (also referred to as positioning magnets) can be further included. The reference magnet elements 524 can be read by a pressure reader described herein, or the reference magnet elements 524 can be used as positioning magnets to orient indicator magnets such as indicator magnet 552 described below with reference to FIG. 32. The (one or more) reference magnet elements 524 can be placed on one or more rotor magnet elements 512, allowing a physician to determine the pressure setting of valve 200 using an external magnetic sensor such as a Hall sensor without the need for X-rays or other imaging techniques, as further described below. For example, as further described below, using an external magnetic sensor such as a Hall sensor without the need for X-rays or other imaging techniques. The rotor 510 is configured to rotate about the rotor axis 214 in response to an applied external magnetic field that acts on the stator 528. Thus, the rotor 510 can further include a bearing ring 516 arranged adjacent to the inner circumference of the rotor casing 514 to allow rotation of the rotor casing 514, as shown in FIGS. 4A and 4B. The bearing ring 516 can be made of, for example, synthetic ruby. In a particular example, the magnetic motor includes two bearing rings 516, namely an upper bearing ring and a lower bearing ring, as shown in FIGS. 4A and 4B. However, in other examples, the upper bearing ring may be omitted. In this case, the rotor 510 can tilt on the lower bearing ring 516 as it rotates. In a particular example, this tilt is resistant to adjustment by an external ambient magnetic field. For example, as further described below, using an external magnetic sensor such as a Hall sensor without the need for X-rays or other imaging techniques. To make it possible.

[0060] The rotor 510 is configured to rotate about the rotor axis 214 in response to an applied external magnetic field that acts on the stator 528. Thus, the rotor 510 can further include a bearing ring 516 arranged adjacent to the inner circumference of the rotor casing 514 to allow rotation of the rotor casing 514, as shown in FIGS. 4A and 4B. Therefore, the rotor 510, as shown in FIGS. 4A and 4B, can further include a bearing ring 516 arranged adjacent to the inner circumference of the rotor casing 514 to allow rotation of the rotor casing 514. The bearing ring 516 can be further included. The bearing ring 516 may be made of, for example, synthetic ruby. In a particular example, the magnetic motor includes two bearing rings 516, namely an upper bearing ring and a lower bearing ring, as shown in FIGS. 4A and 4B. However, in other examples, the upper bearing ring may be omitted. In this case, the rotor 510 can tilt on the lower bearing ring 516 as it rotates. In a particular example, this tilt is resistant to adjustment by an external ambient magnetic field. This may be advantageous when increasing the resistance of a magnetic motor. Another example is the lower bearing ring 516. This is sufficient to prevent the rotor 510 from tilting as it rotates on the bearing ring. It can be made more widespread.

[0061] According to one embodiment, a magnetic pulse from an external magnetic field selectively magnetizes the stator 528. Used to act on the stator 528, which acts on the magnetic rotor, thereby the rotor 510 Controlling movement. An external magnetic field, as will be explained in more detail below, for example, a valve It may be generated by a magnetic coil or permanent magnet placed in close proximity to the gentian. The 528 is made from a soft magnetic material that can be selectively magnetized by the application of an external magnetic field. It can be manufactured, and its magnetic polarity can be selectively controlled. For example, stator 528 is, for example, made from a nickel-iron alloy containing approximately 72-83% nickel. This is possible. By controlling the magnetization and magnetic polarity of the stator 528, the rotor 510 As will be further explained below, the rotor magnet element 512 changes the stator 528 It can be manufactured to rotate in a controlled manner in response to magnetization and magnetic polarity. Cut.

[0062] The valve 200 is controlled by the rotation of the rotor 510, which controls the spring 400 to move against the valve seat 210. The biasing of the valve element 208 is adjusted, thereby adjusting the size of the opening, and valve 2 It is configured to control the flow of fluid through 00. In one embodiment, valve 200 is As shown in Figures 2, 4C, and 5, the system includes a cam 212 that engages with the spring 400. In the illustrated example, the cam 212 is integrated with the rotor casing 514, thereby separating them This avoids the need for individual cam elements. In other embodiments, however, the cam is located on the rotor 5 It can be coupled to 10 and positioned in contact with spring 400, and as a result the rotation of rotor 510 The rotation causes the movement of the cam 212, which then moves against the valve element 208 of the spring 400. Adjust the tension. For example, cam 212 is connected to rotor casing 514 and cam 21 The central shaft 520 is used to allow parts 2 to rotate together around the central axis 214. The "cam" used herein can be mounted to the rotor casing 514. The term refers to a separate cam element that can be attached to the rotor, or a cam that can be attached to the rotor. As shown in the illustrated example, the rotor casing acts as a cam, integrated with the casing. This refers to G514.

[0063] For example, in certain applications of the valve assembly 100, such as the treatment of hydrocephalus, the valve pressure The force range is a very low pressure range, for example, about 0-200 mmH2O or 0-4 It may be 00 mmH2O. Furthermore, it is desirable to make small pressure changes within that range. There are cases where this is not the case. However, if the cam 212 is, for example, very small, on the order of a few micrometers Manufacturing a valve assembly that can perform minute movements is (manufacturing constraints) (Depending on the circumstances) it may not be practical. Therefore, low pressure range and small pressure increments In order to adapt to the changes, very soft springs are sometimes required. Conventionally, sufficiently soft springs were used. To obtain a soft spring, the spring 400 must be very long. However, embedded Housedting a very long, soft spring inside a flexible housing presents a challenge. There are cases where this is the case. Therefore, the embodiments and models are reasonable (i.e., standard) for the cam 212. Movements (within the range of quasi-manufacturing capacity) can be translated into very small adjustments in low-pressure settings. This relates to a spring configuration that generates a lever or "gear reduction" effect. For details, see specific practical applications. The implementation configuration includes a cantilever spring configuration, as shown in Figure 6A, for example.

[0064] Figures 6A, 6B, 6C, and 6D show the cam biased relative to the valve element 208. Figure 6A shows a portion of the programmable valve 200, including parts 212 and spring 400. Figure 6B shows the cam 212 in the position of minimum tension relative to the biasing spring 400, and Figure 6 C indicates the cam 212 in the position of maximum tension relative to the biasing spring 400. Figure 6D shows the spring An enlarged view of an example of 400 is shown. In Figure 6D, the spring 400 is connected to the valve element 208. It is shown seated on seat 210. In this example, spring 400 is a cantilever spring. , a first spring arm 410 that is in direct or indirect contact with the cam 212, and valve element 2 Includes a cantilever arm 420 biased toward 08. First spring arm 410 and cantilever Both arms 420 are in the same direction from the pivot point 430 (or the fixed mounting point of the spring 400). It extends. Therefore, the cantilever arm 420 is as shown in Figures 6A and 6C. It has a fixed end at the pivot point 430 and a free end 422 that abuts against the valve element 208. The first spring arm 410 has a fixed end at the pivot point 430 and a free end that engages with the cam 212. It has an end. In a particular example, the cantilever arm 420 is longer than the spring arm 410. In the illustrated example, the spring arm 410 is "curved" including an inflection point 412. This configuration, compared to the example where the first spring arm is straight, provides an overall difference in the spring 400. This allows for a reduction in size. When the cam 212 rotates, the spring arm 41 that is in contact with the cam Pressure is applied to 0, and the tension of spring 400 changes. This pressure affects the rotational motion of cam 212. Without imposing difficult or impractical constraints, the cantilever arm 420 allows the valve element 2 The resulting pressure applied to 08 can be very low, In detail, it will fall within the desired range (for example, 0-200 mmH2O as mentioned above). To enable this, the force is distributed and reduced via a spring structure. Two arms 410 and 4 By appropriately selecting the relative lengths and widths of each arm, the lever or gear reduction can be controlled. A mechanism equivalent to a speed mechanism may be realized. In this way, low voltage required for a specific application (for example) A spring soft enough to provide 0-200 mmH2O is not a conventional long spring. This can be achieved using a short two-arm spring 400.

[0065] The spring 400 is not limited to the examples shown in Figures 6A to 6D, but can have various different shapes and structures. It can have a configuration. For example, Figures 7A and 7B show a leaf spring 460. Figure 7A Figure 7B shows only the leaf spring, and is installed inside the valve and biased relative to the valve element 208. The spring is shown. The leaf spring 460 is a first leaf spring that is in direct or indirect contact with the cam 212. It includes a cantilever arm 462 and a cantilever arm 464 biased toward the valve element 208. In this example, the cantilever arm 464 includes a circular end 464a that contacts the valve element 208. Both the first spring arm 462 and the cantilever arm 464 are flat, and from the pivot point 430 It extends. Cam 212 is not shown in Figure 7B.

[0066] Figures 8A and 8B show an example of a U-shaped cantilever spring 480. Figure 8A shows a U-shaped spring 4 Only 80 is shown. Figure 8B shows the U-shaped spring 480 installed inside the valve 200. This is a cross-sectional view of a portion of an example of a ram-operated valve 200. The U-shaped spring 480 is connected to the cam 212 The first spring arm 482 is in direct or indirect contact with the valve element 208. It includes a biased cantilever arm 484. The cantilever arm 484 is in contact with the valve element 208. It has a free end 486 that is in contact with it. The first spring arm 482 and the cantilever arm 484 support It is connected by a U-shaped section 483 supported by a column 488. Several implementations In terms of form, the U-shaped portion 483 is supported such that the U-shaped portion 483 frictionally engages with the support column 488. This is a spring biased around column 488.

[0067] Similar to Figures 6B and 6C described above, Figures 8C and 8D are programmable. An example of a U-shaped spring 480 positioned to accommodate different pressure settings of the valve 200 is shown. 8C is configured such that the programmable valve 200 is set to the lowest pressure setting by cam 212. Figure 8D shows the U-shaped spring 480 when it is oriented. This shows the U-shaped spring 480 when the cam 212 is oriented to set the pressure.

[0068] Figure 9A shows the first spring configured to contact the cam 212 directly or indirectly. It has a 492 arm and a cantilever spring arm 494 that is biased relative to the valve element 208. Another example of the cantilever spring 490 is shown. The cantilever spring arm 494 abuts against the valve element 208. It has a free end 496. In this example, the first spring arm 492 and the cantilever spring arm The 494 is fixed to the support column 498, for example, by welding. Figure 9B shows the program. An example of the spring 490 in the movable valve 200 is shown in Figure 9A. The support column 498 has two It is configured to rotate relative to the ruby ​​bearings 491 and 493. One ruby ​​bearing 49 The first is located at the top of the support column 498, and the second ruby ​​bearing 493 is located at the bottom of the support column 498. The ruby ​​bearings 491 and 493 allow the support column 498 to pivot relative to the valve body 202. This makes it possible.

[0069] As will be understood by those skilled in the art, considering the advantages of the present disclosure, the spring 400 is as described above. In addition to the configuration shown in the drawing, other configurations may be included.

[0070] In a particular example, as the cam 212 rotates, the force exerted on the spring 400 is the minimum The force is adjusted in small increments or continuously across a range from the initial force to the maximum force. (Figure 6C) As shown, the cam 212 exerts maximum pressure on the spring 400. When in the position where it is being pushed, the cantilever arm 420 moves toward the valve element 208. Thus, the pressure setting of valve 200 is highest for this position of cam 212. So, the pressure exerted on spring 400 by cam 212, and therefore on spring 400 The tension increases with the clockwise rotation of the cam 212, as indicated by arrow 216. However, a person skilled in the art will see that, considering the advantages of this disclosure, the rotor 510, cam 212 , and spring 400, as an alternative, the counterclockwise rotation of rotor 510 is the tension of spring 400 It should be understood that it may be configured to increase power.

[0071] As described above, the valve element 208 and the valve seat 210 are openings through which fluid flows. The inlet port 204 is an opening that allows the fluid to flow in a direction perpendicular to the central axis of the rotor 510. It can be oriented to enter (or, in other words, to push the valve element). Port 204 also allows fluid to enter the opening in a direction perpendicular to the central axis 214 of the rotor 510. It can be oriented to push the valve element. In certain embodiments, the fluid can be directed to the rotor. The inlet port 204 is oriented so as to enter the opening in a direction perpendicular to the central axis 214 of 510. The cam 212 is positioned horizontally relative to the spring 400, as shown in Figures 6A and 6B, for example. To directly or indirectly cause directional displacement.

[0072] In the embodiment of the valve assembly 100 disclosed herein, the cam 212 is optional. In this configuration, within the (one or more) surfaces that engage with the spring 400, a constant or linear It is possible to have a gradient, a piecewise linear gradient, a nonlinear gradient, and a combination of such gradients. Yes, it is possible. If cam 212 has a linear gradient, the rotation of cam 212 increases the pressure setting linearly. To increase or decrease. If cam 212 has a nonlinear gradient, the pressure will be, for example, due to rotation. It can increase more towards the end. This means that initially, for example, 0 and 2 Possible to have small pressure increments between 00 mmH2O and a larger pressure increment thereafter. A property is given. For example, the cam 212 shown in Figures 6A and 6B is a spring 400 It includes a surface having a nonlinear gradient that engages with the first arm 410. Specifically, the cam 212 It includes a projection 218, which, as the cam 212 rotates, causes the spring 400 to move towards the cam The rate of increase in pressure exerted by 212 is changed. Thus, in certain examples, the cam The force exerted on the spring 400 by 212 is present for most of the rotational cycle of the cam 212. It increases linearly in effect, but towards the end of the cycle, due to the influence of protrusion 218 The force increases more dramatically.

[0073] For example, in certain applications in the treatment of hydrocephalus in children, after a period of use... Whether a valve is still needed, or whether the hydrocephalus has stopped and a shunt is no longer needed. In some cases, it is desirable to be able to determine whether or not it is present. For example, depending on the cause of hydrocephalus After using the implanted shunt valve assembly 100 for several years, the patient no longer needed the valve. It may not be necessary. To determine whether the patient still needs the valve. One test method involves significantly increasing the pressure of spring 400 on valve element 208, and This will nearly completely close valve 200, after which the patient's condition will be observed. Therefore, the step pressure rise is at or near the maximum pressure position of the spring 400 and cam 212. The aforementioned configuration, which is significantly larger than average, is advantageous in that it allows this test to be performed. It is possible. The patient's condition worsened after the pressure setting of valve 200 was significantly increased. In some cases, rotating cam 212 may simply decrease the pressure setting again. Thus, this configuration allows the valve 200 to be closed or removed without completely closing it. Provides a safe semi-off setting for Lube 200.

[0074] In certain examples, the magnetic motor has a rotor stopper that prevents the cam 212 from rotating 360 degrees. Alternatively, it may include a cam stopper 220, which allows the valve to move from fully open to fully closed in one step. or the reverse, it prevents an immediate transition. Cam 212 is stopped by cam stopper 220 It can be rotated either clockwise or counterclockwise to the set position, and then Therefore, it must rotate in the opposite direction. Thus, the complete rotation of cam 212 is small In addition to turning the valve in steps or increments, it can also move from fully open to fully closed, or vice versa. It is necessary for the transition.

[0075] In a specific example, after the valve assembly 100 is manufactured, a comparison is made to adjust the pressure setting. Positive devices are usually required. For example, in a particular embodiment, the spring 400 is each station It is such that it is linear with respect to the top, that is, along with each step of rotation of the cam 212 Well constructed, the spring 400 is tensioned so that the pressure in valve 200 rises by X. And this applies with each additional step of rotation. Therefore, the cam 212 is in a given position Set the device to the appropriate position and pretension the spring 400 to that position with the correct pressure. Calibration may be necessary. Therefore, after valve 200 is assembled, during calibration, A flow of nitrogen (or some other fluid) through the lubrication assembly may exist.

[0076] Figures 10A and 10B, as described above, are arranged in a circle and rotate clockwise. Ten rotor magnets configured to increase the pressure setting of the programmable valve 200. A schematic example of a magnetic rotor 510 including element 512 is shown. Figure 10A shows the valve 200 Rotor 510 and spring 400 are positioned at the minimum tension on the spring, corresponding to the lowest pressure setting. Figure 10B shows the position shown in Figure 10A, corresponding to the maximum pressure setting of valve 200. The rotor 510 and spring 400 after clockwise rotation to the position of maximum tension on the spring are shown. As described above, the rotor 510 moves through the multiple incremental steps shown in 518. It can rotate, and each step corresponds to a change defined by the pressure setting of valve 200. Furthermore, as mentioned above, the rotor 510 prevents the cam 212 from rotating 360 degrees. It may include a cam stopper 220 that allows the valve to open from fully open in one step. This prevents the device from immediately switching to fully closed or vice versa. (See Figures 10A and 10B for details.) In one simplified example, the maximum and minimum pressure settings of valve 200 are as follows: The cam stopper 220 is adjacent to the housing stopper 222. Cam stopper 220 and housing stopper 222 is a size and arrangement such that the cam stopper cannot pass through the housing stopper. This prevents the cam from rotating further in the same direction. When the 510 is in the position for the minimum pressure setting of the valve 200 (Figure 10A), the rotor rotates clockwise. It must rotate, which gradually increases the valve pressure setting. The counterclockwise rotation of valve 200, which moves it from the minimum pressure setting to the maximum pressure setting, is This is prevented by the stopper 220 and the housing stopper 222. Similarly, the rotor 510 When the valve 200 reaches the position corresponding to the maximum pressure setting (Figure 10B), the cam moves further. The rotation of the meter is prevented by the cam stopper 220 and the housing stopper 222, and as a result The rotor must rotate counterclockwise, thereby gradually setting the valve pressure. It decreases.

[0077] Furthermore, as schematically shown in Figures 10A and 10B, in certain examples, valve 20 0 can be seen in X-ray, indicating the position of rotor 510, and therefore the pressure setting of valve 200. A pair of X-ray opaque markers, namely the rotor marker 224 and the housing marker, show 226 may be included. In one example, a pair of radiopaque markers 224 and 226 are shown in Figure 1. As shown in 0A, at the lowest pressure setting of the valve, the two markers are aligned with the center of the cam. It is specified that it be done. The housing marker 226 is located inside the housing of the valve 200. It is fixed and does not rotate with the rotor 510, but the rotor marker 224 is with the cam / rotor It also rotates.

[0078] In some embodiments, the X-ray opaque markers 224, 226 include tantalum. In one embodiment, the X-ray opaque markers 224, 226 are tantalum spheres and / or Includes tantalum beads.

[0079] As described above, the embodiment of the valve assembly 100 is a magnetically actuated rotor 5 Since it is equipped with 10, the pressure setting of the embedded programmable valve 200 is (in this specification) An external adjustment device (also called a valve program programmer) is attached to the embedded valve 200. It can be adjusted by positioning it in close proximity but outside the body. Valve program writing. The device allows the user (for example, a doctor) to control the valve program programmer, and the embedded program programmer... The pressure setting of the Gram-capable valve 200 can be set and, in some cases, read. Therefore, a specific magnetic field generator along with various control and input / output (I / O) components is included. In the embodiment, the magnetic field generator is shown in Figures 11A, 13, 15, 16A to 16H, and 17. And, as described below with reference to Figures 18A to 18H, including an array of electromagnets This can be done. In other embodiments, see Figures 11B, 11C, 19-22, and 23A-22. As further explained below with reference to 3E and Figure 24, the magnetic field generator is one or It may contain multiple permanent magnets, and the valve program writer may be battery-powered.

[0080] Figure 11A shows the patient in position above the implanted magnetically programmable valve 200. A valve program programmer 600, including a transmitter head 610 which may be positioned above the head The transmitter head 610 applies magnetic pulses as described below. Includes a magnetic field generator that selectively magnetizes theta 528, thereby rotating the rotor 510. The fluid flows from the ventricle through the ventricular catheter 120 and through the implanted valve to connector 1. The fluid flows into the distal catheter connected to 40, and the distal catheter then proceeds to the right atrium of the heart. It drains fluid from a location away from the body (such as the peritoneal cavity). Valve program writer 60 0 transmits a magnetic signal via the transmitter head 610 to rotate the rotor 510. This is possible. As will be further explained below, the control device 620 generates magnetic pulses. It may be used to control the transmitter head 610 in such a way as a cable, for example, Alternatively, it may be coupled to the transmitter head 610 via a communication link 630 such as a wireless link. .

[0081] Referring to Figure 12, according to a particular embodiment, the control device 620 is embedded by the user The adjustment device controls the pressure setting of the valve 200, and the current pressure setting of the valve It can include various components or modules that enable the determination of pressure settings. The control device 620 allows the user to interact with the control device. It can include interface 622. The user interface allows the user to control the valve Input keys and touchscreen allow you to view and adjust 200 pressure settings. This may include one or more displays or input devices, such as: In this embodiment, the control device 620 communicates with the transmitter head 610 via a drive circuit 624. It can also include, for example, the controller 632, user interface 6 Based on the command received via 22, the magnetic field generator in the transmitter head 610 is given a predetermined power Used to provide commands to the drive circuit 624 to operate by current, duration, cycles, etc. It may be used. Controller 632 further receives input from setting detector 626 and setting The user interface displays the valve pressure setting in response to information received from the detector. The face 622 can be controlled. The controller 632 can control, for example, the hard disk Optical drives, optical discs readable by optical disc readers, flash memory devices Computer instructions stored in computer-readable media or devices such as chairs It may be pre-programmed. The control device 620 is a user-programmable controller. This allows for adjustment of valve 200 via R632, enabling the determination of the valve 200's settings. It can operate in such a way. In some embodiments, the control device 620 is a Network computer A to control or operate the B200 in a similar manner Used to connect the control device 620 to another device, such as an application server. It may further include a communication interface 628 that can perform the following actions.

[0082] Figure 11B shows a separate transmitter head 610 and control device 62, as in the example in Figure 11A. This shows another embodiment of the external adjustment device 640, which includes a single integrated device instead of 0. For example, the external adjustment device 640 includes permanent NS magnets that generate a magnetic field. As the field rotates, it selectively magnetizes the stator 528, thereby causing the rotor 510 to rotate. To make someone do it.

[0083] Figure 11C shows the detection of the rotor 510's position when determining the pressure setting of valve 200. External valve reading device including valve reading device (pressure reader) 660 for use An example is shown. In the illustrated example, the pressure reader 660 includes a mechanical compass, but other In the example, the mechanism could be an electronic device including, for example, a magnetic position sensor. The implementation details are described in more detail below. In a specific example, the pressure reader is as shown in Figure 11A. Incorporated into an embodiment of the Lube program programmer 600, the magnetic field generator in the transmitter head 610 When the device is off, determine the positional configuration of the rotor 510, or by other means, the valve It can be configured to read the pressure setting of B200.

[0084] According to a particular embodiment, Figures 13, 14, 15, 16A to 16H, 17, As also shown schematically in Figures 18A to 18H, the programmable shunt valve Valve pressure can be adjusted by applying a pulsed magnetic field nearby. Transmitter head The do 610 is positioned in close proximity to the recessed valve 200. In one embodiment, the transmitter head The D610 consists of four coils schematically shown in Figure 13 as coils 1, 2, 3, and 4. It includes magnets, which are externally controlled (for example, via the drive circuit 624 as described above). They are controlled separately by device 620. In the example shown in Figures 13 and 14, the above As described above, the magnetically operated motor of the embedded valve 200 is as Twelve rotors arranged in alternating polarity within channels 522 of the rotor casing 514. The motor includes a rotor 510 having magnetic elements 512. The motor is located below the rotor 510. Further includes a stator 528. In the illustrated example, the stator 528 has an X-shape. As shown in this example, the four electromagnets (also called coils) in the transmitter head 610 are As shown in Figure 13, coils 1 and 3 and coils 2 and 4 are connected to coil 1. The four electromagnets are positioned so that they are closer to each other than coils 4 and 2 and 3. Furthermore, it can be positioned equidistant from the central axis 530. The transmitter head 610 is embedded. When properly positioned on the oval valve 200, the central axis 530 of the electromagnet rotates the rotor 510. Coinciding with the rotation axis 214, as shown in Figure 13, each electromagnet is one of the arcs of the stator 528 It is aligned to the same angle as M. However, this alignment does not need to be precise. There is no such embodiment. The user cannot see the rotor 510 or stator 528. This is due to the fact that the size of these elements is small compared to the size of the external electromagnet. Alignment errors, which are sometimes unavoidable, should be tolerated.

[0085] Each of the electromagnets 1, 2, 3, and 4 has either a north pole or a south pole facing the stator 528. It is possible to energize them to have either one, or to leave each one completely off. This is possible. The movement of the rotor 510 in the desired direction and angle is shown in Figure 15 (clockwise). The electromagnets are energized in the order shown in the table in Figure 17 (counterclockwise rotation). Thus it is realized, which then magnetizes the stator 528, and then the stator 528 is (pole (Depending on the nature) attracts or repels the rotor magnet element 512, causing the rotor 510 to rotate. cause.

[0086] For example, referring to Figures 15 and 16A to 16H, first both electromagnets 1 and By exciting 2 to the south pole and keeping electromagnets 3 and 4 off, clockwise motion occurs. This is achieved (Step 1). In the next step (Step 2), electromagnets 1 and 2 The switch is left off, and both electromagnets 3 and 4 are excited to the south pole. In step 3, Electromagnets 1 and 2 are both excited to the north pole, while electromagnets 3 and 4 remain off. In step 4, electromagnets 1 and 2 remain off, and electromagnets 3 and 4 are set to the north pole. It is energized. The sequence repeats itself after the fourth step.

[0087] Rotor 510 is shown in Figure 16B in the position reached after the first step (Rotor 510) The polarity of the magnetic element 512 corresponds to the polarity of the bottom surface. (As shown in Figures 16A and 16B) As shown, electromagnets 1 and 2 are positioned so that their south poles face towards the stator 528 and they face each other. When energized, the stator 528 is magnetized to the north pole. Therefore, currently magnetized to the north pole The stator 528 pulls its rotor magnet elements 512, which have a south pole, toward itself. They are attracted to and repelled by those rotor magnet elements 512 which have north poles. As a result, arrow 532 As shown, the rotor 510 rotates clockwise. The rotation of the rotor 510 is By observing the changing position of the reference marker 526, as shown in Figures 16A to 16H... It is fine to see them together. Similarly, in step 2, the south pole faces the stator 528, and they When electromagnets 3 and 4 are excited so that they face each other, the stator 528 is magnetized to the north pole again. Then, as shown in Figures 16C and 16D, it acts on the rotor magnet element 512 and the rotor This induces a further clockwise rotation of 510. Figures 16E to 16H show the steps in Figure 15. The operation corresponding to 3 and 4 is shown. In detail, the N pole faces the stator 528 and faces each other When electromagnets 1 and 2 are excited so that they come into contact with each other (step 3), as shown in Figure 16E Therefore, stator 528 is magnetized to the south pole. 528 attracts those rotor magnet elements 512 having a north pole toward itself, and the south pole Those rotor magnet elements 512 have repulsion. As a result, indicated by arrow 532 Then, as shown in Figure 16F, the rotor 510 rotates further clockwise. Similarly, In step 4, the N pole faces the stator 528, and the three electromagnets are positioned so that they face each other. When 4 is energized, the stator 528 is again magnetized to the south pole, as shown in Figures 16G and 16H. As shown, the rotor magnet element 512 acts to cause further clockwise rotation of the rotor 510 It induces a turn.

[0088] The movement of the rotor 510 is primarily due to the rotor magnet elements of the rotor 510 beneath the rotor 510. It is affected by stator 528, which is located near 512. Thus, electromagnet 1 External magnetic fields applied from 2, 3, and 4 do not directly cause the movement of rotor 510. However, instead, the magnetization and polarity of the stator 528 are controlled, and then the stator 528 is The rotor magnet element 512 acts to induce rotation of the rotor 510. The number and shape of stator 528 are selected such that two conditions are met. First, A pair of radially opposing stator arms form a pair of radially opposing rotor magnet elements 5 Aligned with 12 (for example, referring to Figure 16C, stator arm 534a (Each element 534b is aligned with rotor magnet elements 512a and 512b, respectively.) The other two stator arms each support the rotor magnet, as shown in Figure 16C, for example. They are arranged alternately in the middle of two of the elements 512. Secondly, radially opposite ro Each pair of magnetic elements (for example, 512a and 512b in Figure 16C) has the same magnetic polarity. During operation, the control device 620 alternately arranges between the two rotor magnet elements 512. The electromagnet closest to the pair of stator arms arranged in a row is excited, thereby controlling one rotor magnet The rotor 510 is moved at an angle corresponding to half the width of the stone element 512. As described above. For example, in one rotation of the rotor 510, there are 12 magnetic rotor elements 512. There are 24 angle increments. Furthermore, the rotor magnet elements 512 facing each other in the radial direction are the same Electromagnets that have magnetic polarity and are radially opposite each other also have the same magnetic polarity facing the stator 528. For example, this configuration, which is excited to have S) in Figure 16A, is advantageous because it allows for other (non (Programming) This provides a magnetically programmable valve with high resistance to magnetic fields. Natural phenomena or external devices unrelated to the control device 620 (for example, an MRI machine) The randomly applied magnetic field generated from ) is applied to both ends of the stator 528. The possibility of having two poles (for example, both poles being either north or south) is extremely low. Low. Conversely, an external, unprogrammed magnetic field has the potential to have adjacent north and south poles. Much higher, as required for controlled operation (shown in Figures 16A to 16H) Theta 528 could not be magnetized uniformly, and therefore the rotor 510 was undesirable. or it cannot cause accidental rotation. In contrast, for example, U.S. 4, Conventional magnetic rotors, such as those disclosed in Patent Nos. 615 and 691, are as described above. , uniformly magnetized with a single magnetic polarity in response to an externally programmed magnetic field, as described herein Unlike the stator 528 shown, the rotor has one half with one polarity and the other with the opposite polarity. With a cross-shaped stator magnetized on the other half having a pair of polarities, (U.S. 4, 6 As shown in Figure 9 of No. 15,691, radially opposing permanents with opposite magnetic polarities It includes a permanent magnet. As a result, conventional devices are not suitable for external, unprogrammed magnetic fields. Undesirable rotation, and therefore far more affected by undesirable adjustments to the valve pressure setting. It's cheap.

[0089] As mentioned above, in one example, the rotor 510 includes 12 rotor magnetic elements 512, In another example, the rotor 510 has radially opposing elements that have the same magnetic polarity. The conditions include a size and configuration that includes a different number of rotor magnet elements 512 (for example, 8). It can be calculated. Furthermore, the rotor 510 is a valve program programmer with different configurations. In other examples where the rotor is configured to operate, the rotor is described in more detail below. Thus, the rotor magnet elements facing each other in the radial direction have opposite polarities (for example, 1 0) To make the size and design such that several rotor magnet elements 512 can be accommodated. can.

[0090] By initiating a similar operation, the rotor 510 can be rotated counterclockwise. Figure 17 is a table similar to the one shown in Figure 15, and rotates the rotor 510 counterclockwise. Figure 13 shows an example of the excitation sequence for the electromagnet of the device used to achieve this. Figures 18A to 1 8H is the magnetic pole of the electromagnet and stator 528, corresponding to the sequence shown in Figure 17. This shows the characteristics and the resulting movement of the rotor 510.

[0091] Thus, referring to Figures 17 and 18A to 18H, first both electromagnets 1 By exciting magnet 2 to the north pole and keeping electromagnets 3 and 4 in the off position (Step 1), This achieves counterclockwise motion. In the next step (step 2), electromagnet 1 and Electromagnet 2 is left off, and both electromagnets 3 and 4 are excited to the south pole. Figure 18A~ Figure 18D corresponds to Step 1 and Step 2, and Figure 18B shows the position reached after Step 1. Figure 18D shows rotor 510 in the position reached after step 2. This indicates 10. As shown in Figures 18A and 18B, electromagnets 1 and 2 are excited to the north pole. Then, the stator 528 is magnetized to the south pole and acts on the rotor magnet element 512 as described above. This induces counterclockwise rotation of the rotor 510 indicated by arrow 536. Similarly, as shown in Figures 18C to 18D, when electromagnets 3 and 4 are excited to the south pole, The stator 528 is magnetized to the north pole, and the rotor 510, indicated by arrow 536, This induces a counterclockwise rotation. In step 3, both electromagnets 1 and 2 are the south poles. When energized, electromagnets 3 and 4 remain off, and in step 4, electromagnet 1 and B2 remains off, and electromagnets 3 and 4 are excited to their north poles. Figures 18E to 18H are This shows the operation corresponding to steps 3 and 4 in Figure 17. In detail, the S pole is stator 528 When electromagnets 1 and 2 are energized so that they face each other (Step 3), Figure 18 As shown in E, stator 528 is magnetized to the north pole. Therefore, it is currently magnetized to the south pole. The stator 528, which has its own rotor magnet element 512 having an N pole It is attracted in one direction and repelled by those rotor magnet elements 512 which have a south pole. As a result, the arrow As shown by 536 and as shown in Figure 18F, the rotor 510 rotates further counterclockwise. It rotates. Similarly, in step 4, the N pole faces the stator 528 and they face each other. When electromagnets 2 and 3 are energized in this manner, the stator 528 is magnetized to the south pole, as shown in Figure 18G. And as shown in Figure 18H, the rotor magnet element 512 acts to further the rotor 510 This induces a counterclockwise rotation. The sequence repeats itself after the fourth step. Repeat. Each step is performed as described above, with respect to half the width of one rotor magnet element 512. This results in an increase in the angular motion of the corresponding rotor 510.

[0092] Referencing the rotor containing 12 rotor magnetic elements 512, the magnetic motor and transmitter head Although the operation of the D610 has been described above, considering the advantages of this disclosure, the transmitter head 610 and The operation of the electromagnet depends on the number of rotor magnet elements, such as 10 rotor magnet elements. Those skilled in the art will understand that it can be adjusted for a rotor having a specific element.

[0093] Thus, the embedded valve 200 having the magnetic motor described above is controlled by the control device 6 External controller including 20 and transmitter head 610 having four electromagnets 1, 2, 3, and 4 When used with a controller, the pressure setting of the embedded valve can be controlled non-invasively and gradually. The configuration of the cam 212 and the tension of the spring 400 can be adjusted for each angle of the rotor 510. The increment is a clearly defined and selected change in the valve pressure setting (e.g., 10 mmH2O). It can be designed and calibrated to generate. In one example, the control device 620 is This allows the user to input the desired pressure setting for the valve, and then, for example, Figure 15 Alternatively, the transmitter head 610 can be automatically controlled using one of the sequences shown in Figure 17. It can be configured to operate in a way that achieves the selected pressure setting.

[0094] For example, to ensure the precise pressure setting of valve 200, control device 620 First, the counterclockwise rotation sequence shown in Figure 17 is activated to move the valve 200 to its fully open position. Set it to this, then activate the clockwise rotation sequence in Figure 15 to turn valve 200 to the user It can be configured to set to the selected pressure setting entered by a specific user. For example, when a counterclockwise rotation sequence is activated, the valve program programmer will: The rotor 510 is operated so that the valve 200 has its minimum pressure setting. It is configured to rotate via a sufficient number of counterclockwise steps so that it can be positioned. As mentioned above, the presence of the cam retainer 220 and housing retainer 222 ensures that the rotor is minimal This prevents the unit from continuing to rotate beyond the pressure setting position. The programmer rotates counterclockwise. After stopping the rotation sequence, the cam stopper 220 is at a known position (corresponding to the minimum pressure setting). A clockwise sequence can be started from the position adjacent to the housing stopper 222. The valve program programmer 700 programmes valve 2 to the pressure setting selected by the user. To program 00, rotate through a selected number of clockwise steps. The rotor 510 can be operated.

[0095] The example described above uses the clockwise rotation of rotor 510 to set the pressure of valve 200. Program (and start the programming sequence using counterclockwise rotation). Setting the rotor in a known position, considering the advantages of this disclosure, the system (valve and The programmer, instead, uses the opposite arrangement, namely the rotor's counterclockwise rotation. Use to program the valve pressure setting (and use clockwise rotation to program Our company can configure it to set the rotor to a known position where the starting sequence begins. The person will be understood.

[0096] In some cases, it is preferable that the external valve program programmer be battery-powered. There is a compatibility. Transmitter heads such as transmitter head 610, which include an electromagnet, (excite the electromagnet) The power required is too great for it to be battery-powered. Therefore, further The embodiments and examples include, for example, a small DC motor such as a stepper motor, along with a permanent magnet It can be used with embedded valve 200 by incorporating stone, and may be battery-operated. An exemplary valve program, shown in Figure 11B, provides a very low-power controller. This concerns valve program programmers, such as programmers.

[0097] Referring to Figure 19, this is a valve program programmer that incorporates permanent magnets instead of electromagnets. An example block diagram of the 700 is shown. The valve program programmer 700 is controlled by Roller 702, User interface 704, Battery 706, Stepper motor 708 , and a permanent magnet assembly 710. These components are shown, for example, in Figure 11B. As shown, a recessed valve is used to control and adjust the pressure setting of valve 200. They can be packed together into a single housing that can hold nearly 200 units. Alternatively, the permanent magnet assembly 710, the stepper motor 708, and the battery 706 Any particular component may, in some cases, perform all or part of the functions of controller 702. It can include a controller that can run, and can be packaged together, (if Depending on the controller, it may be possible to perform all or part of the functions of controller 702. (Along with the ra) User interface 704 is packaged separately so that the user can Making the user interface 704 more convenient while operating the Lube Programmer 700 It can be made possible to see. For example, the user interface 704 is The system looks at the pressure setting of valve 200 (such as selecting the desired pressure setting for valve 200). (to enable) entering commands, for example, on a smartphone or tablet Applications that run on mobile computing devices such as personal computers. It can be implemented as a control. User interface 704 is, for example, a control The pressure setting information is received from the roller 702 and separately from the valve program programmer 700. Components that may be packaged, for example, controller 702 or stepper motor A user command is sent to the 708 to activate the permanent magnet assembly 710 and the valve The pressure setting can be adjusted to 200.

[0098] Figure 20A shows a valve program programmer 700 used in a specific embodiment. This is a diagram of an example of a permanent magnet assembly 710a that can be used. 0a is a housing 712 and is located within the housing 712, around a rotational axis 716. Includes a rotatable magnetic guide 714 configured to rotate a stepper. Motor 708 drives the rotation of the magnetic guide 714 under the control of controller 702. The rotation of the stone guide 714 may be continuous or a series of individual steps. Multiple permanent magnets The permanent magnet rotates together with the magnet guide 714, or It is installed inside the magnet guide. In the example shown in Figure 20A, there are four permanent magnets 722, 7 There are 24, 726, and 728. Two permanent magnets facing each other in the radial direction have the same magnetic polarity. It has, for example, as shown in Figure 20A, permanent magnets 722 and 724 have a north pole. The permanent magnets 726 and 728 have south poles. This configuration is, for example, 12 rods It is suitable for controlling a rotor 510 having a magnetic element 512.

[0099] Those skilled in the art can make a wide variety of modifications to the permanent magnet assembly 710. Please understand this. For example, in Figure 20A, there are four permanent magnets 722, 724, 726, and Although 728 is shown as circular, they are not limited to rectangles, ovals, or bars. They may have other shapes such as rod-shaped or bar-shaped. Furthermore, there may be more or fewer than four permanent magnets. It may exist. For example, Figure 20B shows a permanent magnet assembly 710b with opposite magnetic polarity. The diagram shows a configuration including a pair of permanent magnets 732 and 734. This configuration includes, for example, 12 Instead, it is suitable for controlling a rotor 510 having 10 rotor magnet elements 512. That's fine. In another example, the permanent magnet assembly 710b consists of two separate magnets with opposite polarities. Instead, it can include a permanent magnet magnetized in a single diametrical direction. Furthermore, permanent magnet 722, 724, 726, 728, 732, or 734 are all single permanent magnets. It should be understood that it is not composed of a single magnet, but rather of a cluster of multiple permanent magnets with the same magnetic polarity. When operated by the stepper motor 708, the magnet guide 714, and thus multiple permanent magnets, are activated. Stones 722, 724, 726, and 728, or 732 and 734, are located on the rotating axis 716 It rotates around it. The valve program writer 700 is positioned on top of the recessed valve 200. Then, the permanent magnet assembly 710 magnetizes the stator 528. The rotation changes the magnetization of the stator 528, thereby affecting the transmitter head 610. As described above, this induces the movement of the rotor 510.

[0100] Figures 21A to 21E show the valve program including the permanent magnet assembly 710a in Figure 20A. In the example of the programmer 700, in response to the rotation of the magnetic guide 714, the stator 528 A schematic diagram illustrates an example of a change in magnetic polarity and the resulting rotation of the rotor 510. In Figures 21A to 21E, the permanent magnet assembly 710a is schematically represented by the ring 718. As shown in Figure 21A, ring 718 is shown in Figure 20A. The four magnetic quadrants correspond to the four permanent magnets 722, 724, 726, and 728. Two of each magnetic polarity (730a and 730c are N, and 730b and 730d) The ring has quadrants that are opposite each other in the radial direction and have the same magnetic polarity (where S is the case). Figure 718 is intended to show the rotation of the magnetic guide 714 through Figures 21A to 21E. Includes a controller reference marker 736 that does not necessarily correspond to a physical structure. Similarly, Figure 21 A to Figure 21E illustrate the rotation of the rotor 510, and one of the rotor magnet elements 512 is shown. Rotor reference marker 538 is indicated.

[0101] Referring to Figure 21A, in the first position, the quadrants 730b and 730d of ring 718 Two opposing permanent magnets having corresponding south poles (permanent magnet 726 in Figure 20A) (and 728) are the opposing stator arms that are closest to or aligned with each other. 534c and 534d are magnetized to the north pole. Similarly, quadrant 730a of ring 718 Two other opposing permanent magnets having north poles corresponding to 730c (Figure 20A) Permanent magnets 722 and 724) are the two closest or aligned ones to each other. The opposing stator arms 534a and 534b are magnetized to the south pole. The modified stator arms 534a and 534b have two rotor magnets with opposite magnetic polarity. The rotor magnet elements 512c and 512d are arranged alternately between the elements, and therefore form the south pole. While repelling, it pulls the N pole rotor magnet elements 512a and 512b, and rotor 510 Rotate it to the position shown in Figure 21B. Rotor 510 moves from Figure 21A to Figure 21B. As indicated by the relative displacement of the reference marker 538, one rotor magnet element 512 It rotates through an angle corresponding to half the width. The rotational degree of rotor 510 is shown in Figure 21A to Figure As indicated by the relative displacement of the controller reference marker 736 to 21B, ring 7 Supports 18 45-degree rotations.

[0102] Figure 21A shows four permanent magnets represented by quadrants 730a to 730d of ring 718. Stones 722, 724, 726, and 728 each correspond to stator arm 534. It is aligned with one of a~534d. Referring to Figure 21B, the first position (Figure (21A) from (i.e., indicated by reference marker 736 of permanent magnet assembly 710a) In this second position, achieved by a 45-degree rotation of ring 718, Four permanent magnets 722, 724, and 722 are represented by quadrants 730a to 730d of 718. Each of the 26 and 728 is arranged alternately here across the two stator arms. As a result, each of the stator arms 534a to 534d is divided into magnetic polarizations. It has such that, as shown in Figure 21B, a portion of each arm is magnetized to the north pole, and another portion is magnetized to the south pole. It becomes magnetized at the poles.

[0103] Referring to Figure 21C, the magnetic guide 714 indicated by the reference marker 736 is further The 45-degree rotation is performed on the four permanent magnets 722, 724, and 726 of the permanent magnet assembly 710a. And realign 728 with stator arms 534a~534d. As shown in the diagram. Therefore, opposing stator arms 534a and 534b are magnetized to the north pole here, and opposite Stator arms 534c and 534d are magnetized to the south pole here. The modified stator arms 534a and 534b have two rotor magnets with opposite magnetic polarity. The elements 512 are again arranged alternately, and thus the N pole rotor magnet elements 512a and 512b is repelled, and the S-pole rotor magnet elements 512c and 512d are pulled, as shown in Figure 21D The position shown corresponds to half the width of one rotor magnet element 512 for the rotation of the rotor 510. This results in another angle increment.

[0104] Referring to Figure 21D, it is represented by ring 718 and indicated by reference marker 736. A further 45-degree rotation of the magnet guide 714 causes each arm of the stator 528 to move again. Each will have a divided magnetic polarity. Another 45-degree rotation of the magnetic guide 714 will Return the theta 528 to the magnetic pole configuration shown in Figure 21A, and separate the rotor 510 as shown in Figure 22. Rotate by the angle increment. The cycle is as shown by the external permanent magnets 722, 724, and 72 in Figure 20A. Repeat with the further rotations shown in Figure 21E of the magnetic guide 714 for 6 and 728.

[0105] Thus, for example, the rotor 510 shown in Figure 4C (circle of 12 rotor magnets 512) In the configuration of the valve controller including the permanent magnet array shown in Figure 20A (shape array), (By comparing the position of the controller reference marker 736 in Figures 21A and 21E) As can be seen, the 180-degree rotation of the magnetic guide 714 is shown in Figures 21A and 21E. As can be seen by comparing the position of the reference marker 538, (one rotor magnet) Four angular increments of the rotation of rotor 510 (corresponding to movement equivalent to twice the width of element 512) This results in three full rotations of the magnetic guide 714, which in turn result in one rotation of the rotor 510. This brings about full rotation. Valve protrusions relative to rotor 510 (via stator 528) This "gear reduction" effect, achieved through the indirect operation of the Gram programmer 700, is advantageous. Moreover, without requiring a corresponding small movement within the valve program programmer 700, This allows for very small incremental movement of the -510. This allows the magnetic guide 714 to be embedded. Since it is not necessary to make the rotor as small as the 200mm valve rotor 510mm, the user can make the valve The ease of use of the 700 program programmer, or the manufacturing of the 700 valve program programmer. This can improve the simplification.

[0106] The gear ratio adjustment between the valve program writer 700 and the rotor 510 is done using a permanent magnet. This can be achieved by changing the configuration of the semblage or rotor 510 (for example, the number of magnets). This is possible. For example, using a rotor arrangement similar to that shown in Figure 4C, It has 10 rotor magnets instead of 12 rotor magnets, and replaces the permanent magnets in Figure 20A. The permanent magnet assembly having two permanent magnets 732 and 734 in Figure 20B is a magnet This results in five full rotations of rotor 714 and one full rotation of rotor 510. As will be understood by those skilled in the art, considering the advantages of this disclosure, an external permanent magnet and a rod Various other combinations of magnets can be implemented and are considered part of this disclosure and are within the scope of the present invention. It is intended to be within a box.

[0107] Figure 22 shows the valve program based on the operation described above, referring to Figures 21A to 21E. Flowchart showing the rotation of the inlet and the corresponding changes in stator magnetization and rotor rotation. Arrow 119A indicates the rotation of the rotor at each step in the flow chart.

[0108] In certain cases, the valve program writer 700 is comfortable and easy for the user to use. It can be packaged in a handheld housing 762. (Figures 23A-2) 3D shows example 760 of the valve program programmer 700. In this example, the valve programmer The RAM programmer 760 has a shape similar to a computer mouse, as shown in the illustration. In some embodiments, the valve program writer 760 has rounded corners on its outer surface. It can have an overall circular shape, which makes it easy for the user to hold and / or may be comfortable. In some embodiments, the valve program writer 760 It can be easily held by the user with one hand.

[0109] Figure 23A shows a top view of the valve program writer 760. Figure 23B shows the valve programmer Figure 23C shows a bottom view of the RAM programmer 760. Figure 23C shows an end view of the valve program programmer 760. Figure 23D shows a perspective view of the valve program writer 760.

[0110] As mentioned above, the valve program programmer 760 may be battery-powered. In some embodiments, the housing 762 is (as shown in Figures 23A to 23D) (Not included) Together with the magnet assembly 710, it can accommodate one or more batteries. As described above, in some embodiments, the valve 200 is a 10-magnetic stepper motor. The magnet assembly 710 of the valve program writer 760, including the valve 200 Includes two oppositely magnetized magnets for rotating the stepper motor. The modified magnet is oriented downwards in the valve program programmer 760 and has an opposite magnetic field. It has. In some embodiments, the programmer magnet has a surface electric field strength of 6000 gauss. do.

[0111] As shown in Figures 23A and 23D, the valve program programmer 760 controls the pressure This user displays information such as settings, battery status (770), and possibly other information. The interface 764 may be included. For example, the image of the user interface 764 The center of the surface can indicate the selected pressure (in digital readout). Screen boundary The field is indicated by what the X-rays show, or by a pressure reader, as will be explained further below. This may include the position of the valve rotor, which may be indicated as such.

[0112] The valve program programmer 760 allows the user to control the pressure of the valve program programmer 760. An interface that allows you to select a setting value and thereby set the pressure of valve 200. Includes a face mechanism. In some embodiments, as shown in Figure 23A, the program The programmer 760 has a first button 761a for increasing the pressure setting value, and the pressure setting value Includes a second button 761b for reducing, or valve program writing. The instrument 760 is rotatable in a first direction to increase the pressure setpoint, and the pressure setpoint Rotatable in a second direction to reduce (the wheel shown in the embodiment in Figure 23E) It may include wheels such as the following. In some embodiments, a valve program writer 7 60 may include a first button 761a, a second button 761b, and a wheel. In some embodiments, the valve program programmer 760 is, as described above, the valve The pressure can be set to one of 20 pressure settings. Therefore, the maximum pressure setting does not completely close valve 200. This means that valve 200 is not completely closed. Do not close it and test whether the patient still needs valve 200, thereby the patient This could be useful in avoiding potential injuries to the person.

[0113] The valve program programmer 760, when pressed, activates the magnetic assembly 710 to activate the valve Program the valve programmer 760 to program Lube 200. It may further include a programming button 769. In some examples, a programming button 76 9 can be positioned on the front edge of the housing 762, as shown in Figure 23A.

[0114] The valve program writer 760 also performs the following actions, as shown in Figures 23A and 23C: It may include an on / off button 772.

[0115] Referring to Figures 23B and 23C, the housing of the valve program writer 760. 762 correctly aligns the valve program writer 760 on the embedded valve 200. It can be molded to facilitate programming the pressure settings of valve 200. In a specific example, the housing 762 is located on the lower side wall of the valve program writer 760. Includes a molded cavity 763 defined by 765. Cavity 763 is recessed. The shape and size are at least approximately to correspond to the shape and size of valve 200. The cavity 763 includes a pair of channels 767 defined within the side wall 765. As described, the inlet port of the programmable valve 200 is connected to the inflow catheter. The programmable valve 200's outlet port connects to a drainage catheter. Channel 767 is where the valve program programmer 760 implants in the patient's head. When placed on top of the oval valve 200, channel 767 connects to the inflow catheter and drainer. Align the catheter with the valve program programmer 760, thereby implanting it. The size and arrangement should help to properly align with the valve 200. can.

[0116] After the user sets the desired pressure setting value in the programmer 760, the user can program Place the RAM programmer 760 on top of the valve 200. Next, the user uses the program programmer Press the programming button 769 on the leading edge of the 760 to begin programming.

[0117] Figure 23E shows a top view of the valve program programmer 777. The valve unit 777 has a housing 762 that can be held by the user's hand. The program programmer 777 checks the pressure setting, battery status 770, and, if applicable, This includes a user interface 764 that displays other information. (Valve Program Manual) The inlet 777 is rotatable in a first direction to increase the pressure setting value, and the pressure setting Includes a wheel 787 that is rotatable in a second direction to decrease the value. In Figure 23E, The wheel is located in the housing 762 so that it can be rotated by the user's finger. It extends partially horizontally beyond the side.

[0118] Figure 24 shows the valve program programmer 760 in Figures 23A to 23D or the valve program programmer in Figure 23E. How to operate valve program programmers such as the 777 and 700. This is a flowchart showing an example of step 1100. In step 1102, the user programme By pressing the on / off button 772 on the programmer, the valve program programmer 76 Turn 0 on. In some embodiments, the valve program programmer 760 is used by the user It turns on when you press and hold the on / off button 772 for 2 seconds. After it is turned on, the valve In step 1104, the program programmer 760 proceeds to the initial mode. The valve program writer 760 is programmed so that the motor rotates counterclockwise in one-revolution steps. Perform a self-test to count the steps and determine the number of steps required for one rotation. Compare the numbers. In some embodiments, the motor self-test is performed when the motor is rotating. Sometimes it is always active. In some embodiments, the valve program programmer The display (user interface screen) 764 lasts for 3 seconds in step 1104. Display all icons. If the valve program programmer battery charge is too low, The valve program programmer 760 proceeds to step 1106, where the battery stator The indicator 770 or the indicator flashes on the user interface screen 764. And the valve program programmer 760 is turned off. In some cases, the valve programmer If the battery charge of programmer 760 is low, the battery status indicator 770 will The programmer display 764 is slowly blinking, indicating an extremely low battery charge. In this case, the battery status indicator 770 is the programmer display 764 It flashes rapidly at the top.

[0119] If the battery is sufficiently charged, the valve program programmer 760 will be in editing mode. Proceed to step 1108. The battery status is as described above, user interface It may be displayed on the face screen 764. In the editing mode of step 1108, the editing mode An icon indicating that the code is enabled appears on the program programmer display 764. In edit mode, the user presses the increase button 761a or decrease button 761b. Increase or decrease the pressure setting value of the valve program programmer for the embedded valve 200. It can be done. The valve program programmer 760 can be controlled by buttons 761a and 761b. In other examples that do not include a wheel 787 for adjusting the pressure setting value, the user proceeds to step 1108. The wheel can be rotated to select the desired pressure setting.

[0120] When a pressure setting is selected, the valve program programmer 760 programmers the embedded valve 200. It is ready to be used for programming. Therefore, the user can use as described above. To correctly align the valve program writer 760 with the embedded valve 200, Using the shape of housing 762, the valve is placed on the patient's head above the implanted valve 200. A programmer 760 can be installed. Programming of valve 200 To begin, the user presses the programming button 76 on the valve program writer 760. Press 9 to enter programming mode in step 1110. In this case, the program writer display 764 is as shown in Figure 23A, for example. The selected pressure setting can be displayed along with a lock symbol.

[0121] For example, to ensure the correct pressure setting of valve 200, the valve program is written. The control unit 700 first operates the rotation of the magnetic guide 714 in one direction (for example, counterclockwise). Then set valve 200 to its fully closed position, and then turn it in the opposite direction (for example, clockwise) The rotation sequence is initiated, and valve 200 is opened to the selected pressure entered by the user. It can be configured to set a setting. Therefore, in a particular embodiment, a predetermined After a certain period of time, for example 1 second, the valve program programmer 760 proceeds to step 1112. Then, the programmer magnet rotates counterclockwise to initialize valve 200. For example, the programmer magnets of permanent magnet assemblies 710a and 710b are programmable valves. The 200 cam should first rotate approximately 6 times counterclockwise so that it is in its lowest position. Yes, it is possible. After reaching the initial position, the valve program writer 760 proceeds to step 1114. Then, the programmer magnet begins to rotate clockwise. The programmer magnet is rotating. During this time, the valve program writer 760 displays the current and final positions of the valve 200. When the programmer magnet reaches its final position, the valve programmer 760 steps Proceed to 1116, where an audible alarm or other warning will sound when the selected pressure setting value has been reached. As shown, after a predetermined period of time, for example 3 seconds, the valve program programmer 760 steps Return to editing mode 1108. At this stage, the user presses the on / off button 772. The valve program programmer 760 can be turned off by doing so. In this configuration, there is a specific period of time during which the user does not interact with the valve program programmer 760, for example. For example, after 60 seconds, the valve program programmer 760 will automatically turn off.

[0122] Figures 14, 16A-16H, 18A-18H, 21A-21E, and Figure 2 Returning to point 2, in the example described above, the stator 528 is X as shown in Figure 14, for example. It has a shape and is a "solid" or one-piece structure. The shape of the stator 528 is, even Then, it changes between a + shape with a 90° angle between the stator arms and a very narrow X shape. It may be. In addition, according to certain embodiments, the stator 528 is a single solid structure or It is not a single, integrated structure, but can be implemented using multiple individual stator elements (Figure 2). Figures 5A to 25C show three stators with different shapes, combined with a 12-magnet rotor. A schematic example is shown. Figure 25A shows an example of a +-shaped integrated stator 540. Figure 25B is , located approximately at the tips of the four stator arms in the example shown in Figure 25A. An example of a stator including four stator elements 542 positioned below the rotor magnet element 512. This is shown. In the example shown in Figure 25B, the four stator elements 542 have four circular dots and Although it is constructed as shown, the stator elements may have any various other shapes. For example, Figure 25C consists of four stator elements 54 configured as "double circular dots" or extended ellipses. Here is another example of a stator that includes 4. In other examples, stator elements 542 or 544 are positive. It may be square or rectangular, or it may have other geometric or non-geometric shapes. .

[0123] In each of the examples shown in Figures 25A to 25C, the angle 546 between the stator "arms" is approximately Although it is 90°, as stated above, the angle 546 may vary. This will be understood by those skilled in the art. Considering the advantages of this disclosure, angle 546 is, for example, the stator 528 Depending on the configuration of the rotor 510, the range between 90° and the minimum non-zero value may vary. It can have any value (if the angle value is 0 or very close to 0, the 4-arm stay (It becomes a 2-arm stator instead of a single arm, and the operation of the magnetic motor changes.) Figures 26A to 26 C shows a further example of a stator where the angle 546 is approximately 75°. For details, see Figure 26A. The angle between the two stator arms that are closer together is 75°, and therefore the angle between the two stator arms that are further apart An example of an X-shaped integrated stator 540a with a complementary angle of 105° between the stator arms is shown. Figures 26B and 26C show four individual stator elements 542 with an angle 546 of 75°. An exemplary status containing and 544 is shown. In a particular example, the angle value of 546 is (For example, from other magnetic field generators unrelated to the MRI or valve program programmer) ) Resistance to external non-programmed magnetic fields and desired movement of the rotor 510 (for example) This enables the rotor's inherent incremental movement (corresponding to a specific incremental pressure setting of the valve) to be less If not, selection may be based on partial factors. In certain cases, the motor has relatively high cogging. It may be desirable to configure the stator 528 to have torque. Luk corresponds to the force required to keep the rotor 510 in a specific position. Cogging torque is A higher value can increase the motor's resistance or its resistance to external, unprogrammed magnetic fields. Furthermore, it is possible to prevent the rotor 510 from moving due to the reaction force of the spring 400. .

[0124] If you use separate stator elements 542 or 544 instead of a solid stator, Figure Compared to the examples of stators 540 and 540a illustrated in 25A and Figure 26A, the magnetic material The amount decreases. The magnetization of stator element 542 or 544 from the external magnetic field is shown in Figure 16A~ As described above with reference to Figures 16H, 18A-18H, 21A-21E, and 22. It acts to rotate the rotor 510 in a similar manner. The rotation of the rotor 510 is For example, the external electromagnet shown in Figure 13 above, or for example, the one shown in Figure 20A above. This can be achieved with any of the external permanent magnets shown in Figure 20B. In certain examples, Each stator element 542 is slightly larger than each rotor magnet element 512 (for example, In the case of a circular shape, the diameter may be larger. For example, if the rotor magnet element 512 is 1.3 If it has a diameter of mm, the circular stator element 542 shown in Figure 25B or Figure 26B is They may have a diameter of 1.4 mm.

[0125] As described above, according to a particular embodiment, the programmable valve 200 allows a physician to For example, without requiring X-rays or other imaging techniques, external magnetic sensors such as Hall sensors can be used. A magnetic indicator mechanism that allows you to determine the pressure setting of valve 200 using the S. This may include, in detail, in a particular example, the magnetic motor indicates the position of the rotor 510. It may include one or more reference magnets or indicator magnets as described above. Therefore, the rotor position directly correlates to the pressure setting of the programmable valve 200. In some cases, the external valve program writer 700 is (one or more) Read or detect the pressure setting of the embedded valve 200 based on the indicator magnet. It may include a magnetic sensor configured to do so. Other examples are described further below. A separate pressure reader can be provided for this purpose.

[0126] According to certain embodiments, an indicator mechanism can be incorporated into the rotor 510. For example, as mentioned above, the rotor 510 is shown in Figures 4A, 5, 6A, and 14. As shown, a reference or It may include a positioning magnet element 524. Figure 27 shows one of the rotor magnet elements 512. Three reference magnet elements 524a, 524b, and 524 are positioned above a specific object. A schematic example of rotor 510 including c is shown. In the illustrated example, the reference magnet element 524a is N Having magnetic polarity, the reference magnet elements 524b and 524c are located away from the reference magnet element 524a. (The rotor magnet element directly facing the reference magnet element 524a in the radial direction) (On both sides of 512) are positioned and both have S magnetic polarity. As described above, rotor The magnetic elements 512 are arranged with alternating magnetic polarities and each faces directly radially opposite to the other. The two rotor magnet elements 512 are arranged so that they have the same magnetic polarity. Therefore, To provide a reference magnet that has both a north pole and a south pole and spans the rotor 510, Figure 27 shows An array of three reference magnet elements 524, such as those shown above, can be used. As described above, in other embodiments, the rotor 510 has a number of rotor magnet elements 512 other than 12. It may include. For example, the rotor 510 may include 10 magnetic elements. Such an example So, the opposing rotor magnet elements in the 10-magnet rotor are opposite to those in the 12-magnet rotor. Since it has polarity, only two reference magnet elements 524 may be used. Rotor 510 Another example involving 10 magnetic elements includes four reference magnets (two pairs arranged opposite each other). This can be used. Thus, the advantages of this disclosure will be understood by those skilled in the art. Considering this, various numbers and arrangements are based at least partially on the configuration of the rotor 510. The reference magnet element 524 can be used. Furthermore, in certain embodiments, a separate base Rather than including the quasi-magnet element 524, the rotor magnet element corresponds to the desired position of the reference magnet element. Element 512 can simply be "higher" than other rotor magnet elements, thereby lower It acts as both a rotor magnet element that generates rotation and a position indicator magnet for the TA510.

[0127] In other examples, as shown in Figures 4A, 5, 6A, 14, and 27, the reference magnetic Instead of placing the stone element 524 above the rotor magnet element 512, a reference or positioning magnet Stone elements can be placed on one or more sides of the rotor 510. Figure 28A~ Figure 28C shows the side that is oriented vertically (relative to the horizontally oriented rotor magnet element 512) The motor configuration in which the positioning magnet element 553 is positioned radially outward of the rotor magnet element 512 An example of this is shown. As will be further explained below with reference to Figure 32, the positioning magnet is, for example For example, to indicate the position of rotor 510, and therefore the pressure setting of valve 200, pressure reading The input that can be read by device 660 (not shown in Figures 28A to 28C) The dicate magnets are oriented. Referring to Figure 28A, the two side positioning magnet elements 553 An example of the configuration is shown. In this example, each of the side positioning magnet elements 553 The polarity of the inner surface 555 (i.e., the surface closer to the rotor magnet element) is determined by the polarity of the adjacent rotor magnet element The polarity is opposite to that of the upper surface of element 512. In some embodiments, each side positioning magnet 55 For example, 3 has a diameter of 1.0 mm and a height of 0.3 mm. Figure 28B shows another example in which four side-positioning magnet elements 557 are provided. The polarity of the inner surface 555 of each side positioning magnet element 557 is determined by the polarity of the adjacent rotor magnet The polarity is the same as that of the upper surface of element 512. In some embodiments, each side positioning magnet 5 57, for example, has a diameter of 0.85 millimeters and a height of 0.25 millimeters. Figure 28C shows another example in which two side positioning magnet elements 559 are provided. The side positioning magnet elements 553 are arranged across the rotor 510, facing each other in the diametrical direction. In contrast to the example shown in Figure 28A, the example shown in Figure 28C shows two lateral positions The positioning magnet elements are arranged within the same hemisphere of the rotor 510. The polarity of each inner 555 is the same as the polarity of the upper surface of the adjacent rotor magnet. In this embodiment, each side positioning magnet 559 has, for example, a diameter of 1.0 mm. It has a height of 0.3 millimeters.

[0128] Referring to Figure 29, (for example, to positioning magnet elements 553, 557, or 559) Therefore, a magnetic signal is detected from the (positioned) reference magnet element 524 or indicator magnet. Then, the position of the rotor 510 and the corresponding pressure setting of the valve 200 are derived from there. External valve programming assembly 800 incorporating a magnetic sensor 812 configured as follows An example block diagram is shown. As shown in Figure 29, valve programming The Sembri 800 is for adjusting the pressure setting of the valve 200 (permanent magnet assembly 71 0 or any of the electromagnet sets described above, with reference to the transmitter head 610 Which of the magnet assembly 814 and what is necessary to control and operate the magnet assembly 814 In some cases, communication may be required (such as electronic communication ports, motors, actuators, and drive circuits). It may include a transmitter head 810 that includes a signal / control circuit 816. The valve assembly 800 allows the user to input information such as the current pressure setting of valve 200. Upon receiving the report, the control device 820 is activated, or communication is initiated with the transmitter head 810. Along with the communication / control circuit 824 which may be required for, for example, valve 200 A user interface that allows you to provide control commands such as desired pressure settings. Further includes control device 820 including S822. In a particular example, transmitter head 810 The control device 820 is separate and communicates via a wired or wireless communication link 804. In other examples, such as in the valve program writer 760, the dashed line 802 indicates As shown, the transmitter head 810 and the control device 820 are packaged together. The magnetic sensor 812 can communicate with the communication / control circuit 816 in the transmitter head 810. It can communicate with either of the control devices 820. The magnet assembly 814 is In certain examples that include an electromagnet that can be used as a transmitter, the magnetic sensor 812 is connected to the transmitter head 81 It may be packaged within 0. In other examples, the magnetic sensor 812 is a separate unit. It can be packaged.

[0129] In one embodiment, the transmitter head 810 includes a magnetic sensor 812, and the embedded valve 2 The pressure setting of 00 can be detected and transmitted to the control device 820. The magnetic sensor 812 detects the position of the rotor 510 inside the valve 200, and detected Convert the position to the pressure setting reading. Such a correlation between rotational position and pressure setting is This can be determined for each valve according to the calibration process. The correlation is the rotational position. It can provide search capabilities that allow conversion to force settings and vice versa. A solution for pressure regulation like this is based on the known size of the rotor magnet element 512 (for example). (This can be achieved according to the techniques employed herein. Alternatively or in addition, The selection of spring type and / or spring constant in combination with the cam shape is determined by the rotation step. It can be used to control pressure fluctuations. The magnetic sensor 812 is, for example, It could be a Hall sensor or a compass.

[0130] According to a particular embodiment, a valve programmer such as a valve programming assembly 800 The ramming assembly is a valve programmer such as the valve programmer 760 mentioned above. It may include a RAM writer and a separate pressure reader. The pressure reader is recessed. It can be used to read the pressure setting of the programmable valve 200, valve p As described above, the program programmer 760 programmers the pressure setting of the embedded valve 200. It can be used to measure grams. The pressure reader reads pressure based on the orientation of the magnet. A compass may include a magnet configured to provide readings. The compass is mechanical. It could be a compass or an electronic compass.

[0131] In some embodiments, the pressure reader may be handheld. In this case, the pressure reader is electronic. In a specific example, the pressure reader is, for example, a valve It can have a physical appearance very similar to that of the program programmer 760.

[0132] Figures 30A and 30B show an example of a pressure reader 660 according to a specific embodiment. Figure 30A is a perspective view of the pressure reader 660, and Figure 30B is a top view. Pressure reader The magnet 660 is located at the top of the pressure reader 660, where arrow 662 indicates the flow of fluid through valve 200. The pressure reader 660 is placed on top of the recessed valve 200 so that it is aligned with the direction and position. By positioning it, it is oriented relative to the valve 200. The pressure reader 660 is embedded. The shape and size can be designed to facilitate alignment with the type valve 200. For example, the pressure reader 660 is used with respect to the valve program writer 760 as described above. Similarly, recesses or caps corresponding to the size and shape of the recessed valve 200. The biti can be included on its lower surface. As shown in Figures 30A and 30B, pressure The reader 660 may have a circular shape, and pressure settings arranged around its circumference The display may include a range of mechanical or electronic displays. Obtain. The pressure reader 660 is placed on top of the recessed valve 200 and aligned with it. When this happens, the pressure indicator 664, based on the aforementioned reference magnetic element, will determine the valve 200 This refers to the pressure setting on the pressure reader 660 (shown in Figure 30B) that corresponds to the pressure setting.

[0133] Figure 31 shows the operation of pressure readers such as the pressure reader 660 shown in Figures 30A and 30B. An example of method 1000 is shown. In step 1002, the user controls the pressure reader 660. Turn it on. In some embodiments, the user turns the on / off button of the pressure reader. For example, if you press and hold the button for a predetermined period of time, such as 2 seconds, the pressure reader 660 will turn on. After this, the pressure reader 660 proceeds to its initial operating mode in step 1004. Hmm. In the initial mode of step 1004, the pressure reader sensor detects, for example, the Earth's magnetic field. It is calibrated to eliminate or compensate for the effects of [the valve program programmer] during calibration. A device capable of generating a magnetic field of 0 or similar is located away from the pressure reader 660. In certain embodiments where the pressure reader 660 includes an electronic display, the display Ray, referring to the valve program programmer 760, as described above, battery A status indicator may be included. According to a particular embodiment, a pressure reader 66 If the battery charge is too low (0), the battery status indicator may blink. Next, the pressure reader proceeds to step 1006, where the pressure reader turns itself off To disable it. If the battery charge becomes too low while the pressure reader 660 is operating, the battery will shut down. The status indicator is flashing, indicating that the pressure reader's battery needs to be replaced. This can be shown to the user. If the battery charge becomes extremely low, the battery status will be displayed. The indicator may start flashing more rapidly, and eventually the pressure reader 660 will self You can turn off your body.

[0134] If the battery charge of the pressure reader 660 is sufficient, the pressure reader 660 steps In step 1004, magnetic sensor calibration is performed, and then the pressure reader 660 is in step 10 08. Proceed to exploration mode. During exploration mode, the user will access the patient above the implanted valve 200. A pressure reader 660 can be placed on the head. In the search mode of step 1008 Search icons, such as a magnifying glass icon, appear on the electronic display of the pressure reader 660. This can be shown to the user if the detected magnetic field strength is too low. The user is prompted to reposition the pressure reader 660 so that the detected magnetic field becomes stronger. If the detected magnetic field strength cannot be improved, this is the case for pressure reader 660. This allows you to show the user that the magnetic field indication is unreliable.

[0135] When the pressure reader 660 detects a magnetic field of sufficient strength, the pressure reader 660 The display is in the direction of the valve's magnetic field corresponding to the valve's pressure setting in step 1010. It indicates the direction. For example, as shown in Figure 30A, the pressure indicator 664 indicates valve 2 A pressure setting of 00 can be indicated. In an example where the pressure reader 660 includes an electronic display... In step 1012, the valve pressure setting is adjusted at periodic intervals, for example every 2 seconds. It can be displayed and updated in steps 1010 and 1012. If the magnetic field strength is too low in any of the cases, the pressure reader 660 returns to step 1008. Therefore, the display indicates that the pressure reader is searching for a sufficiently strong magnetic field. It is possible.

[0136] The user can turn on / off the pressure reader 660 by pressing the on / off button on the pressure reader 6 60 can be turned on / off. In certain cases, a predetermined time period, for example, 360 seconds. Afterward, the pressure reader 660 will automatically turn off.

[0137] According to a particular embodiment, the pressure within a surgically implantable shunt valve 200 is set. The kit includes a pressure reader 660 and a valve program writer 760. This is possible. In another example, the valve assembly 100 has an integrated valve programmer. It may include 760 and pressure reader 660. In a specific example, pressure reader 66 The 0 and valve program programmer 760 are provided to the user together as part of the kit. They can be provided separately. In some examples, The device includes a surgically implantable shunt valve 200 or valve assembly 100, etc. A surgically implantable programmable shunt valve or valve assembly, This involves a separate surgically implantable programmable shunt valve or valve assembly. It can also include more.

[0138] The indicator mechanism rotates together with the rotor 510 (for example, the indicator mechanism, As described above, it includes a reference magnet element 524 or a specific rotor magnet element. In certain situations, for example, external unprogrammed magnetic fields such as magnetic fields from an MRI can have an effect. It may act on the indicator / reference magnet and induce undesirable torque in the rotor 510. Therefore, referring to Figure 32, an indicator can be used to avoid this occurrence. An example of a programmable valve is shown as an alternative to the tactile mechanism. In the illustrated example, The indicator mechanism is a positioning device mounted on rotor 510, very close to the center of the rotor. Includes magnet 550. Positioning magnet 550 is used to orient indicator magnet 552. It can be used. In this way, the indicator mechanism is not attached to the rotor 510. This further includes an indicator magnet 552 that pivots freely on its own ruby ​​bearing. In this example, both the positioning magnet 550 and the indicator magnet 552 have a ring shape, and It is magnetized radially. As the rotor 510 moves, the positioning magnet 550 moves toward the rotor 51 It rotates with 0, magnetically attracting the indicator magnet 552 and rotating it by the same amount. To cause this. In one embodiment, the positioning magnet 550 has a very small magnetic force, and therefore, The influence of MRI or other non-programming magnetic fields on the positioning magnet 550 affects the motor. It is insufficient to overcome the cogging torque and rotate the rotor 510. Positioning magnet 5 As mentioned above, the magnetic force of 50 attracts the indicator magnet 552 by the same amount. This is sufficient to rotate the side positioning magnets 553, 557, and 55 described above. 9 can operate in a similar manner. In a particular example, the indicator magnet 552 is strong It has a magnetic field, and the magnetic field is outside the patient's body (for example, within 10 mm from the second indicator magnet). By a compass, Hall sensor, or other magnetic sensor 812 positioned at the above distance It can be read. For example, an indicator magnet is magnetized in a single diametrical direction. That is, it may be a magnet (having one north pole and one opposing south pole). Magnet 552 may be affected by unprogrammed magnetic fields such as magnetic fields from an MRI. However, the indicator magnet 552 can rotate freely on its own bearing. Therefore, the movement does not rotate the rotor 510. (For example, when the MRI scan is finished.) Later, when the non-programmed magnetic field is removed, the positioning magnet 550 automatically indicates The magnet 552 is reoriented. The magnetic indicator mechanism is connected to two separate magnets 550 and 552. By dividing it, the valve 200 has a magnet strong enough to be read from the outside. This is possible, and at the same time, strong unprogrammed magnetic fields, such as those generated by MRI, are strong. Since the indicator magnet (552) is disconnected from the rotor 510, the valve 200 Do not change the pressure settings.

[0139] In another embodiment, the positioning magnet 550 is a single ring magnet magnetized in the diametrical direction and Rather, as two small disk magnets with N and S polarities magnetized in the axial direction. It may be configured as follows. In this case, for one of the two small disk magnets, the north pole is The indicator magnet 552 is facing upwards, and the south pole is away from the indicator magnet 552. It points to the point where it was hit. For the other of the two small disk magnets, the south pole is indicated by the indicator. The magnet 552 is facing upwards, and the north pole is away from the indicator magnet 552. It refers to the position of the indicator magnet 552. The operating principle of such a configuration is to identify the position of the indicator magnet 552. The same applies to creating the local magnetic field as described above. Positioning magnet 550 Using two very small disk magnets to implement this is a good idea for certain applications. This configuration may be preferable to a magnetic field because it is suitable for applications such as MRI or C (Can be taken using a T-scan) Images of the patient's body with minimal artifacts. Because it is possible.

[0140] The positioning magnet 550 can also have various other configurations. For example, as shown in Figure 28A~ As described above with reference to Figure 28C, in other embodiments, the positioning magnet 550 is located Replace the arrangement of magnets 553, 557, or 559, or any similar arrangement. It is possible to obtain it.

[0141] As mentioned above, one limitation of conventional magnetically adjustable valves is that they do not allow for confirmation of the pressure setting. This necessitates the use of X-rays to detect radiopaque markers on implanted devices. It can be accompanied by the target. According to a particular embodiment, the initial orientation of the rotor 510 is Using the above-described indicator mechanism, the housing and / or casing are aligned with a reference point. The pressure setting of the embedded valve 200 can be determined by the embedded valve 200. This can be confirmed by placing a compass above the patient's head in the vicinity of the compass. The needle points in the direction of the indicator magnet 552 as shown in Figure 32, or as shown in Figure 27. The direction of the reference magnet elements 524a to 524c is aligned with itself, and therefore the The position of rotor 510 is shown. Next, the doctor indicates the position of rotor 510 relative to housing 202. By considering the placement, the pressure setting for valve 200 can be determined.

[0142] Therefore, the position of the rotor 510 can be precisely determined, thereby the valve configuration The precise setting of the release pressure may also be determined. In at least some embodiments, The TA510 can rotate freely in at least one direction more than one full rotation, and pressure setting The process is repeated with each rotation. In this way, the position of the rotor 510 is controlled by the popping pressure. It can be distinguished by intent.

[0143] As described above, in certain embodiments, the magnetic motor is used in the strong magnetic field associated with MRI. It possesses inherent immunity or a high degree of resistance to external, non-programming magnetic fields, including those associated with E. However, in certain cases, such as those related to MRI, the resistance to very strong magnetic fields Furthermore, immunity (for example, a very high or complete absence of rotor 510 movement) A full guarantee may be desirable. Therefore, in certain embodiments, a programmable battery Lube 200 is a mechanical brake that prevents the rotor 510 from moving when the brakes are applied. It may include "ki".

[0144] Referring to Figure 33, an example of a magnetic motor including an example of a mechanical brake according to one embodiment. A partial cross-sectional view is shown. In this example, the mechanical brake consists of a brake spring 554 and It includes a brake cylinder 556 that can rotate around a central pivot 558. For example, the brake cylinder is made from a thermoplastic material such as polyoxymethylene. The brake spring 554 may be made of metal, such as stainless steel. Figure 33 In the example shown, the brake spring 544 is a disc with a molded notch. However, brake springs can have a variety of different shapes, some of which are shown below. Further explanation is provided. The brake cylinder 556 engages with a corresponding number of motor teeth 562. Includes multiple brake cylinder teeth 560 configured as such. At this time, the brake cylinder teeth 560 engage with the motor teeth 562 to prevent the rotor from rotating. When the brake is released, the brake cylinder teeth 560 engage with the motor teeth 562. Once released, the rotor rotates freely in response to the applied programming magnetic field, as described above. To enable rotation.

[0145] According to a particular embodiment, locking and unlocking the brakes is indicated by a second indicator. This is achieved using magnet 552. As mentioned above, in certain examples, the indicator magnet 552 is a single magnet magnetized in the diametrical direction. Therefore, it is small, but the second in Dicater magnets have a relatively strong magnetic field that can be used to release brakes. It is possible. As described above, the second indicator magnet 552 of the rotor 510 It is a freely rotating magnet that is not linked to rotation. An external magnet is the second indicator. When placed near magnet 552, the second indicator magnet follows the magnetic field of the external magnet. It rotates to position itself. The second indicator magnet 552 moves in the diametrical direction. In the case of a magnetized magnet, if the external magnet is magnetized in the axial direction, the second indicator One pole of the magnet is attracted to the external magnet, and the other is repelled, and the two opposing forces are mutual. Because it is balanced, the second indicator magnet will not be pulled toward itself. In contrast, if the external magnet is also magnetized in the diametrical direction, the external magnet is positioned near the valve. When this happens, the second indicator magnet 552 positions itself according to the magnetic field of the external magnet. It rotates in that manner and is then attracted to the external magnet. In this way, the second indicator Magnet 552 is pulled upward toward the external magnet. This upward movement acts as a brake. It can be used to release the lock, and the rotation of rotor 510 controls the pressure setting of valve 200. It makes it possible to program. When no external magnetic field is applied, the brake spring 55 4 pushes down the brake cylinder, engaging the brake cylinder teeth 560 with the motor teeth 562. Leave it as is. Referring to Figure 34, in one example where the central pivot 558 is circular, the blur The brake cylinder 556 is designed so that the brake cylinder can only move up and down and not rotate. The inner wall surrounding the central pivot includes one or more flat portions 563. In other examples, To prevent the rotation of the brake cylinder 556, other features or shapes may be adopted. This is possible. Figure 34 shows a schematic example of motor 510 with the brake released.

[0146] Therefore, in a particular embodiment, the permanent magnet assembly of the valve program programmer 700 The Bri 710 has a valve program programmer positioned close to the valve 200. When programming the pressure setting, the diametrically controlled direction is used to disengage the brake. Includes a magnetized brake controller magnet. Figure 35 shows the brake controller magnet 74. An example of a permanent magnet assembly 710c for a valve program programmer 700 containing 0 is shown. The example shown in Figure 35 is similar to the permanent magnet assembly shown in Figure 20A, as described above. As shown above, it can be used to program a valve including a 12-magnet rotor 510. Cut.

[0147] One of the valve program programmers 700, including the magnet assembly 710c shown in Figure 35. An example of the operation of the motor and mechanical brake using the example is shown in Figures 36, 37A, and 37A. See 37B below for details. Figure 36 shows one method for programming valve 200. This is the flowchart for the example. Figure 37A shows the magnetic motor and mechanical brakes in the locked position. Figure 37B shows a cross-sectional view of an example of a valve 200 illustrating the brake mechanism, with Figure 37B showing the unlocked position. This is a corresponding diagram showing the brakes located there.

[0148] Referring to Figure 36, the first step 902 is to program the pressure setting for valve 200. In this case, a doctor or other user directly on the valve program programmer 700, valve 2 Select a new pressure setting for 00. In one example, this is a circular setting as shown in Figure 11B. This can be achieved using a display, for example, using capacitive touch. In Step 904, the physician / user installs the valve program programmer 700 into the embedded valve. Position the device close to one or near the patient's head. As the start of the process, even As shown in Figure 37A, the brake is in the locked position. In some cases, first, Select the desired pressure setting for the lubricant (step 902), and then use the valve program programmer 700. Positioning it close to the patient's head (step 904) makes it easier for the physician / user. Alternatively, or perhaps more conveniently, steps 902 and 904 may be performed in reverse order. Those skilled in the art will understand this. In step 906, the valve program writer 70 0 acts on the magnetic motor so that the selected pressure setting can be programmed. The brakes of Lube 200 are released. Valve program including permanent magnet assembly 710c In one embodiment of the programmer 700, a brake controller is magnetized in the central diametrical direction. Magnet 740 is positioned higher than the other four magnets 722, 724, 726, and 728. Yes, for example, the brake controller magnet 740 works by pushing up the spring. It can be held in this position. The doctor / user can, for example, hold the top of the implantable valve 200. The brake controller magnet 740 can be pressed down until it makes contact with the skin. When the brake controller magnet 740 is in contact with the skin, the brake controller magnet For example, as described above and shown in Figure 37B, the second indicator magnet The brakes are unlocked by attracting stone 552. In step 908... As described above, the valve program programmer 700 magnetizes the stator 528 and By rotating the 510 to the position corresponding to the selected pressure setting, the valve 200 Used to program the selected pressure setting. For example, valve program The programmer 700 activates after the brake is released, and programming begins. It can include a programmable "on" switch. The switch is built within the permanent magnet assembly 710, more specifically, within the brake release mechanism. It is possible. For example, the doctor / user can press the brake controller magnet 740 a little harder. You can press down the switch to trigger the start of programming. For example... Therefore, the switch must remain pressed while the programming is in progress. After programming is complete, a completion instruction can be provided to the doctor / user, even Then, you can hear the acoustic feedback. In this instruction, the brake controller Magnet 740 is released by the doctor / user and pushed back to its inactive position by a spring. It is returned. When the magnetic field is removed from the brake controller magnet 740, the second indicator The magnet 552 is no longer attracted upwards and returns to its neutral position, resulting in a shake. The brake cylinder 556 moves downward (pushed down by the brake spring 554), and the brake - Re-engage the cylinder teeth 560 with the motor teeth 562 and the rotor 510 is programmed Lock it in place (step 910). Then, the valve program programmer 700 is connected to the patient. It can be removed from the head (step 912).

[0149] Figure 38 shows, for example, a valve for programming a valve including a 10-magnet rotor 510. Here is another example of a magnet assembly 710d that can be used with the programmer 700. This example shows two permanent magnets in the exemplary permanent magnet assembly 710b shown in Figure 20B. As described above, the magnets 732 and 734 release the brake and set the pressure of valve 200. A single diametrically magnetized controller magnet 742 is used to program it. It has been replaced with this.

[0150] Figure 39 shows a programmed valve 200 having a 10-magnet rotor 510, as shown in Figure 38. For those using the valve program programmer 200, which includes an example of a magnet assembly 710d. This is a flowchart of an example of the law. As in the example above, the first of the programming sequence In step 902, the physician / user directly programmed the valve program on the valve program programmer 700. Select a new pressure setting for the Lube 200. Then, the doctor / user will select the embedded valve. The valve program writer 700 can be placed nearby (step 914), this The presence of the diametrically magnetized controller magnet 742 automatically releases the brakes. In step 916, the physician / user activates the programming sequence. This is done, for example, by pressing the "Start" button on the valve program writer 200. This can be achieved. In step 918, the valve program writer 700 As described above, the stator 528 is magnetized and the rotor 510 is subjected to the selected pressure setting. By rotating it to the corresponding position, the selected pressure setting of valve 200 is programmed. Used to complete the programming sequence and reach the selected pressure setting. The programmer then uses, for example, an audible or visual indicator (e.g., a beep). The completion of the programming sequence is indicated by the display of a specific color of light or flashing light. Notification can be sent (step 920). Programming is complete and the signal has been heard / After it is visible, the doctor / user removes the valve program programmer from near the patient's head. This allows the brakes to be applied automatically (step 922).

[0151] As shown in Figures 37A and 37B, in one embodiment, the motor is as described above. For the purpose of showing the position of the rotor 510 and the corresponding pressure setting of the valve 200, a second The indicator magnet 552 is made to rotate relative to the brake cylinder 556. Includes a pair of ruby ​​bearings 564. In one example, the second indicator magnet 552 is a ruby ​​bearing. It is housed in a casing that rotates on 564.

[0152] As will be understood by those skilled in the art, considering the advantages of this disclosure, the brake mechanism and so The components can have various different structural forms, and the magnetic motor and its components It can be implemented in combination with any of the various basic embodiments. Figures 37A and Figure In the example shown in 37B, the magnetic indicator mechanism cooperates with the second indicator magnet 552. Includes one or more working first indicator magnets 550. However, The mechanism, as described above, uses (one or more) first indicator magnets 550 Alternatively, one or more are used in combination with a second indicator magnet 552 for position detection. It is implemented in a valve configuration where a slightly larger number of "taller" rotor magnet elements 512 are used. It is also possible. In the example shown in Figure 33, the brake cylinder teeth 560 and the motor teeth 56 2 is near the central pivot 558, the "inside" and " As shown below. However, a wide variety of other configurations can be implemented. For example For example, referring to Figure 40, the brake cylinder 556 is connected to the second indicator magnet 552. The brake cylinder teeth 560 and the corresponding motor teeth 562 straddle the second indicator Another embodiment is shown in which the magnet 552 is positioned "outside".

[0153] In the examples shown in Figures 33, 34, 37A-37B, and 40, the brake cylinder As described above, the motor tooth 556 engages with the motor tooth 562 to set the rotor 510 in place. Includes brake cylinder teeth 560 that engage. According to another embodiment, brake spring 554 It may include a mechanism that engages with the motor teeth 562, thereby engaging with the brake cylinder teeth Eliminate the need for 560. For example, referring to Figure 41, the brake spring 554 is, Each projection 566a is configured to engage with the teeth 562 to lock the rotor 510. A part of another embodiment of the programmable valve 200, including a pair of arms 566. A cross-sectional perspective view is shown. In this example, the motor teeth 562 are located on the rotor casing 514. They are arranged around the periphery. Figure 42 shows that the rotor 510 includes 12 rotor magnet elements 512. Figure 43 is a plan view of an example of the embodiment shown in 41. Figure 43 shows a rotor 510 with 10 rotors This is a plan view of another example of an embodiment similar to the embodiment shown in Figure 41, including a magnetic element. Figure 44A is a cross-sectional view taken along line AA in Figure 42, and Figure 44B is a cross-sectional view taken along line AA in Figure 42. Another cross-sectional view taken along line BB. The rotor has 12 rotor magnet elements 512 In one example, the multiple motor teeth 562 include 24 motor teeth, and as a result the rotor is It can be locked in each position corresponding to a rotation step of half the width of the magnetic element. However, different configurations can include different numbers of motor teeth 562.

[0154] In the example shown in Figures 41 and 42, the brake spring 554 includes two arms 566. Each arm includes a projection 566a at its tip, and the projection is thinner than the body of the arm 566. / Narrow, fitting between a pair of adjacent motor teeth 562 when the brake is in the locked position. It is configured in such a way. However, as will be understood by those skilled in the art, the advantages of this disclosure are Considering this, the brake spring 554 engages with the motor teeth 562 to prevent the rotor 510 from rotating. A variety of different mechanisms, provided that they include one or more mechanisms configured to do so. The configuration can be implemented. For example, the brake spring 554 shown in Figure 43 is defined It includes an arm 566 that lacks the projection 566a and has a more uniform width. See Figure 45. In another embodiment, the brake spring 554 is positioned around the central ring portion 568. It includes four arms 566 instead of two, and the arms have narrower end projections as shown in Figure 40. Instead of having a starting point 566a, the width is more uniform, similar to the example shown in Figure 43. In the examples shown in 43 and Figure 45, the width of the arm 566 and the space between adjacent motor teeth 562 are shown. The spacing is such that the arms fit between adjacent motor teeth to lock the rotor 510 in place. It can be selected to prevent that rotation.

[0155] Referring to Figures 46A and 46B, the brake spring engages with the motor tooth 562. An embodiment of a magnetic motor incorporating a braking mechanism using 554 locks the brake Use the brake controller magnets 740 or 742 to release or disengage as described above. It can operate in the same manner as shown. For example, motor tooth 562 is shown in Figure 46A. As shown, it is located on the upper circumference of the rotor casing 514, and in the locked position, The spring 554 is stationary so that the motor 566 is positioned between adjacent motor teeth, and as a result, The rotation of the 510 is thus prevented. The brake spring 554 is the top of the valve. It can be supported by bar 202a, as described above and shown in Figure 46B. As described above, the brake controller magnets 740 or 742, which are magnetized in the diametrical direction, are connected to the valve When positioned above 200, it attracts the second indicator magnet 552, and the brake The spring 554 is pushed up, thereby unlocking the rotor 510, and as a result the rotor 5 10 rotates freely. As shown in Figures 46A and 46B, in one example, the second I The indicator magnet 552 is located within the casing 570, which includes the casing projection 572. The second indicator magnet 552 is connected by the brake controller magnet 740 or 742. When pulled upward, the casing projection 572 presses against the spring arm 566, and the rotor 51 The arm is raised above the motor teeth 562 so that 0 can rotate. Brake controller When magnets 740 or 742 are removed, brake spring 554 is as shown in Figure 46A. As described above, the arm 566 descends again so that it comes to rest between the adjacent motor teeth 562.

[0156] Figures 47A and 47B also show an example of a brake mechanism, a 10-magnet rotor 510 Another example of the programmable valve 200 is shown. Figure 47A shows the programmable valve Figure 47B is a plan view of 200, and Figure 47A is a cross-sectional view taken along line AA. .

[0157] Figure 48 shows a stepper motor, brake mechanism, and indicator according to a specific embodiment. Another example of a programmable valve 200a including a magnet assembly is shown. In this example, The arm 212 has an inclined surface 213, and the spring 409 has two parallel arms 409k on its sides It includes a central arm 409j located at the valve. The central arm 409j has a free end 409h at the valve. It is a cantilever arm that abuts element 208, and the two parallel arms 409k are at the pivot point It is fixed to the underside of 407. The relationship between the position of cam 212 and the tension of spring 409 is: The position of the pivot point 407, the contact point between the spring 409 and the cam 212, and the cantilever arm. It depends on the contact point between 409g and valve element 208. Depending on these relationships, cam 2 When 12 is in its highest position, it pushes the cantilever arm 409g toward the valve element 208. Is it possible to move the cantilever arm 409g away from the valve element 208? It can be pushed. In the configuration depicted in Figure 48, the cam 212 is relative to the spring 409. When at its highest position (or its highest level of inclination), the tension of spring 409 is at its maximum. The cantilever arm 409g tends to push toward the valve element 208. Figure 48 shows the valve When valve 200a is exposed to a magnetic field (other than the programming magnetic field), the pressure of valve 200a To prevent undesirable changes to the force setting, the brake spring 55 as described above It incorporates brake teeth 562 that engage with 4.

[0158] Embodiments of valve assembly 100 are used to provide a patient with a well-described surgical procedure. It may be implanted. The pressure setting of valve 200 should be set to the desired pressure before surgical implantation. The settings can be adjusted. In one embodiment, the operating pressure is such that no pressure change occurs after surgery. It can be set to be approximately equal to the CSF pressure in the patient's ventricles. After recovery, the pressure setting can be adjusted as desired. For example, if suffering from NPH In patients who are experiencing this, the pressure setting can be reduced to initiate a reduction in ventricular size. Further adjustments to the pressure settings can be made. For example, if the ventricular size is sufficient When reduced, the valve pressure setting can be increased. As understood, embedded When using the 200-type valve, the pressure of the valve 200 can be adjusted as needed during the treatment of the patient. The settings will be able to be adjusted externally.

[0159] In certain embodiments, a method for treating hydrocephalus involves a ventricular catheter in the ventricular cavity of the patient's brain. 120 is connected to a connector 140 located at a remote location inside the patient's body from which the fluid is discharged. This includes embedding an embodiment of a valve assembly 100 having a distal catheter. CSF can be expelled from distant parts of the body, including, for example, the right atrium of the heart and the peritoneum. Born.

[0160] In addition to hydrocephalus, the accumulation of excess fluid is associated with the use of a properly designed inflow catheter. There are several other conditions that can be treated by draining the fluid to another part of the body. There are diseases. Such diseases include, for example, chronic pericardial effusion, chronic pulmonary effusion, pulmonary edema, This includes ascites and ocular glaucoma. Embodiments of the programmable valve 200 include these It is considered suitable for use in the treatment of the following disease.

[0161] The valve pressure settings described herein are, as stated above, many discrete steps It can be adjusted in increments, incrementally, or continuously over a specified range. The valve embodiments described in this document range from low pressure, for example, 10 mmH2O, to high pressure, for example Pressure can vary up to 400 mmH2O. Most conventional valves are 200 m It only has a pressure of mH2O level, and can only be adjusted in relatively large increments between each pressure setting. It's not possible.

[0162] Improved valve Referring to Figure 49, two valves 4902 separated by the pump chamber 4906 and Another example of an embeddable shunt valve assembly, including the 4904, is the overall 4900. As shown in one example, the ventricular catheter is inserted into the valve assembly 4900 at the inlet 491 The drainage catheter can be connected to connector 4908 at 0, and to connector 491 It can be attached to 2 and connected to outlet 4914 of the valve assembly. Pump chamber The recess 4906 leads through valve 4904 to outlet 4914 and drainage catheter Fluid is pumped towards it. After pump chamber 4906 is pushed down, the pump chamber is released. Then, the fluid is supplied through valve 4902. Valve 4902 is described in more detail below. As described, it is an externally programmable valve including a magnetic motor. Lube 4904 could be, for example, a check valve. In this case, programmable valve 4902 After passing through, the fluid flows through check valve 4904 before exiting the drainage catheter. For example, the programmable valve 4902 will receive fluid pressure until it reaches a predetermined pressure setting of the valve. It operates to keep valve assembly 4900 closed until it rises. Generally, The check valve 4904 may be set to low pressure and is a programmable valve including a magnetic motor. The pressure setting of 4902 can control the fluid flow through valve assembly 4900. In other examples, the second valve 4904 is used when the patient's posture changes (i.e., horizontal). Responding to changes in CSF hydrostatic pressure that occur when moving from a supine position to a vertical (standing) position. Therefore, it could be a gravity-actuated valve that allows the valve assembly to adjust automatically. ru.

[0163] As with the valve assembly 100, those skilled in the art will see that, considering the advantages of the present disclosure, the valve assembly The length, size, and shape of the various embodiments of the Nburi 4900 can be adjusted. Please understand this.

[0164] Referring to Figures 50 and 51, one embodiment of the present disclosure is an embeddable and magnetically programmed Ram-capable valve devices are shown in total at 5000. Valve device 500 0 is the base (also called the body or housing) that houses the components of the valve device. Includes 5002. The base 5002 of the valve device 5000 is connected to the lower wall 5004 and from the lower wall It includes a peripheral wall 5006 that extends upward and defines the cavity 5008. Wall 5006 includes inlet port 5010 and outlet port 5012. Inlet port 501 0 connects to the proximal (or inflow) catheter 4908 of valve assembly 4900. The outlet port 5012 can be connected to a distal or outflow catheter. For valve assemblies that divert CSF fluid, the proximal catheter 4908 is a ventricular catheter. It may be a tel or lumbar catheter. In this case, CSF fluid from the ventricles is used in the ventricular catheter. It enters the lumbar or lumbar catheter and then into the inlet port 5010 of the valve device 5000. The distal catheter functions as a drainage catheter connected to the connector. For drainage, the right atrium of the heart (VA shunt) or the peritoneal cavity (VP or LP shunt) It directs fluid to a location away from the body, such as (T).

[0165] The valve device 5000 is fitted with the base 5002 of the valve device and implanted in the human body. Further includes a top cap or lid 5014 that forms a suitable sealed enclosure. The upper cap 5014 of the valve device 5000 is inserted into the patient's scalp when implanted. This is the side of the device oriented to face upwards. (Base of valve device 5000) Part 5002 and the upper cap 5014 are made from any physiologically suitable material. It is acceptable. Non-limiting examples of physiologically compatible materials include polyethersulfone, polysulfone. This includes horn and silicone. As will be understood by those skilled in the art, valve device 5 The base 5002 and upper cap 5014 of the valve device are components within the valve device. Having various shapes and sizes, at least partially depending on the size, shape, and arrangement That's fine.

[0166] According to a particular embodiment, the valve device 5000 is as shown in 5020 overall. Includes a valve element 5016 biased against the valve seat 5018 by a spring 5. 020 may, for example, be a cantilever spring. A specific embodiment of spring 5020 is described below. This will be explained in more detail. In one embodiment, the valve seat 5018 positions the valve seat. It is press-fitted into the inlet port 5010 to secure it in place.

[0167] The fluid enters the valve device 5000, for example, via the ventricular catheter 4908. The fluid flows through inlet port 5010, and inlet port 5010 is connected to valve seat 5018. It terminates at the valve end. The pressure of the fluid (e.g., CSF) pushes the valve element through the valve seal. The valve element 5016 and spring 5020 are pushed in an upward direction from the top. The surfaces of 016 and valve seat 5018 together define the opening, and the size of the opening also The diameter determines the velocity and volume of fluid passing through the valve device 5000. Valve element 5 Preferably, when the valve element contacts the valve seat, the opening is substantially closed. Valve element 5016 has a larger diameter than valve seat 5018. It is positioned on the inlet side of the opening and is circular in the opening defined by the valve seat 5018. The popping pressure is pre-selected when the CSF pressure in the inlet chamber is biased toward the periphery. Keep it closed until it exceeds a certain value.

[0168] The valve element 5016 may be spherical, conical, cylindrical, or other suitable shape as shown in the figure. In this embodiment, the valve element is a spherical ball. Spherical ball and / or valve seat 5018 can be made from any suitable material, including, for example, synthetic ruby ​​or sapphire. It is possible. The valve seat 5018, in the closed position of the valve device, The frustoconical surface for the spherical valve element ensures that the seating of the valve element within the valve provides a liquid-tight seal. It provides complementary aspects such as the pressure setting of such a valve, for example, the opening pressure, Adjusted by changing the biasing force of the valve element 5016 relative to the lubrication seat 5018. For example, as described above, the valve element 5016 and the valve seat 5018 are It is pressed into the inlet port 5010 of the base 5002, and when the initial pressure setting is reached, friction occurs It can be held in a predetermined position. In one embodiment, the valve element 5016 includes a ruby ​​ball Furthermore, the 5018 valve seat is also made from ruby.

[0169] According to one embodiment, the biasing force of the spring 5020 on the valve element 5016 is applied to the valve driver. The operating pressure of the 5000 chair is increased or decreased continuously or in finite increments, overall. This is realized using the magnetic motor shown in 5022. According to a particular embodiment, the magnetic motor The stator 5022 rotates relative to the stator in response to an external magnetic control magnetic field. Rotating, including the rotor shown in 5026 overall. In one example, rotor 5026 is based Around the column 5028 that extends upward from the lower wall 5004 of section 5002, around the rotational axis It rotates. The configuration and operation of the embodiment of the magnetic motor 5022 are described in more detail below. It can be done.

[0170] Referring further to Figures 52 to 54, according to a particular embodiment, the rotor 5026 is The rotor casing 5030 and the rotor casing, each shown in 5032, are located within the rotor casing. It includes a plurality of rotor magnet elements. In one embodiment, the rotor casing 5030 has a peripheral wall A cylindrical body formed on the upper surface, having peripheral walls, each having a step indicated by 5036. Includes 5034. In the illustrated embodiment, there are 20 steps 5036, however This makes it possible to rotate the rotor by 18 degrees between each step. Rotor casing 50 30 further includes a lower part having a channel 5038 formed inside. Multiple rotor magnets The stone elements 5032 are arranged in a circular pattern and placed within the channel 5038, as illustrated. There are 10 rotor magnet elements 5032. In one example, the rotor magnet elements 5032 are These are permanent magnets, each having a south pole and a north pole. The rotor magnet element 5032 has alternating poles. They are arranged in a nearly circular pattern, and as a result, whether viewed from above or below, the south and north poles are always visible. The rotor magnet elements alternate. In this way, at any one angular position, the rotor The poles exposed on the upper surface of the magnetic element 5032 are opposite to the poles exposed on the lower surface. Rotor magnet Element 5032 is fixedly mounted to the rotor casing 5030 within the channel 5038. The rotor casing 5030 can accommodate the rotor magnet elements, and the rotor magnet elements It can function as a magnetic guide to direct rotation. Rotor magnetic element 5032 Although it is shown as a circular disk, the rotor magnet element does not need to be disk-shaped. While not limited to these, it can have any shape, such as an ellipse, square, rectangle, hexagon, or freeform. Please understand that this is possible. All rotor magnet elements 5032 are their size Even if the size changes to ensure the smooth rotation of the rotor, it will remain roughly the same size or almost It is preferable that they have the same magnetic intensity. According to one embodiment, 10 rotor magnets The stone element 5032 is bonded to the rotor casing 5030 within the channel 5038.

[0171] According to a particular embodiment, in addition to the rotor magnet element 5032, the rotor 5026 is 50 The X-ray markers shown in 40 and 5044, and the positioning magnets shown in 5042, respectively It can also include. In one embodiment, the X-ray markers 5040 and 5044 are tantalum spheres. Yes, they exist, and they are radiopaque, yet can be detected by X-ray equipment. The line marker 5040 is fixed to the base by an adhesive, such as glue, and the rotor 5026 It remains stationary during operation. The X-ray marker 5044 is attached by an adhesive, such as glue. Fixed to the 5026 and rotates with the rotor. Pressure setting of valve device 5000 This corresponds to the inherent angular rotation of the rotor 5026, and therefore, when a doctor takes an X-ray, the X-ray By comparing the angular deflection between marker 5040 and X-ray marker 5044, the valve It becomes possible to read the current pressure setting. Furthermore, the X-ray marker 5040 is used to read the valve. The right side of device 5000 is shown so the doctor can read the pressure setting of the valve device. They know how to properly orient X-rays.

[0172] Furthermore, referring to Figure 55, the rotor 5026 is subjected to the applied force acting on the stator 5024. It is configured to rotate around the rotor shaft of the support column 5028 in response to an external magnetic field. Therefore, the rotor 5026 allows the rotor casing to rotate. The bearing may further include one or more bearing rings arranged adjacent to the inner circumference of the 5030. Yes, it is possible. For example, the rotor casing 5030 is, for example, the rotor around the support column 5028. A single ruby ​​may be made from synthetic ruby ​​to allow for relative rotation of the casing. Includes bearing ring 5046.

[0173] According to one embodiment, a magnetic pulse from an external magnetic field selectively magnetizes the stator 5024. Used to do so, the stator 5024 acts on the magnetic rotor 5026, thereby the rotor Controls the movement of the stator. In one embodiment, the stator 5024 has a plus (+) shaped stator. It is fixed to the lower wall 5004 of the base 5002 in a recess contoured to receive the data. The external magnetic field, as will be explained in more detail below, for example, in valve device 500 It may be generated by a magnetic coil or permanent magnet positioned close to 0. Stator 5 024 can be made from a soft magnetic material that can be selectively magnetized, and its magnetism The polarity can be selectively controlled by applying an external magnetic field. For example, stator 50 24 is made, for example, from a nickel-iron alloy containing approximately 72-83% nickel. This is possible. By controlling the magnetization and magnetic polarity of the stator 5024, the rotor 502 6. As will be further explained below, the rotor magnet element 5032 controls the changing magnet of the stator. It can be manufactured to rotate in a controlled manner in response to changes in magnetic polarity and other factors. ru.

[0174] The valve device 5000 controls the rotation of the rotor 5026, which controls the spring 5020 to operate the valve. Adjust the bias of valve element 5016 relative to part 5018, thereby adjusting the size of the opening. It is configured to adjust and control the flow of fluid through the valve device. In one embodiment, The valve device 5000 includes a cam 5048 that engages with a spring 5020. In this example, the cam 5048 is located at the bottom of the rotor casing on the outside of the cylindrical body 5034. Integrated with the casing 5030, in one embodiment, one or more Archimedes screws It is formed to achieve a spiral shape.

[0175] For example, in certain applications of the valve device 5000, such as the treatment of hydrocephalus, the valve pressure The force range may be a very low pressure range, for example, about 0 to 300 mmH2O. Furthermore, it may be desirable to make small pressure changes within that range. However, The cam is capable of making extremely small movements, for example, on the order of a few micrometers. Manufacturing lubrication devices may not be practical (due to manufacturing constraints, etc.). Therefore, to adapt to low pressure ranges and small incremental pressure changes, it is very soft. There are times when a spring is needed. Traditionally, in order to obtain a spring that is soft enough, the spring is It should be very long. However, inside the recessed housing, it is very long and flexible. Housing the springs can present challenges. Therefore, the modes and implementations The state is that the cam's reasonable movement (i.e., within the range of standard manufacturing capabilities) is at low pressure settings. If you generate a lever or "gear reduction" effect, it can be converted into a very small adjustment. Regarding the configuration. In detail, specific embodiments are cantilevered as illustrated and described herein. Includes ne5020.

[0176] As best shown in Figures 52 and 53, the cam 5048 and spring 5020 are, The cam is biased against the valve element 5016 and is in a position of minimum tension relative to the biasing spring. In the illustrated embodiment, the spring 5020 is a cantilever spring and is relative to the valve element 5016. The biased first spring arm 5050 and the cam 5048 are in direct or indirect contact. It includes a second cantilever arm 5052. The first spring arm 5050 and the cantilever arm 50 Both of the 52s extend in the same direction from the pivot point 5054 (or the fixed mounting point of the spring). Thus, the first spring arm 5050 has a fixed end at the pivot point 5054, and the valve element 5 It has a free end that abuts against 016. Similarly, the cantilever arm 5052 is fixed to the pivot point 5054. It has a fixed end and a free end that engages with the cam 5048. In one embodiment, the spring 5020 The pivot point 5054 is a lower spring support inserted into a dedicated cavity formed in the base 5002. It is fixed to the base 5002 by the body 5056 and the upper spring support 5058.

[0177] In a particular example, the first spring arm 5050 is greater than the second cantilever spring arm 5052. It can be long. In the illustrated example, the cantilever spring arm 5052 includes an inflection point and is a "bend". It is "bent". When the cam 5048 rotates, the cantilever spring arm 505 that is in contact with the cam Pressure is applied to point 2, and the tension of spring 5020 changes. This pressure affects the rotation of cam 5048. Without imposing any difficult or impossible constraints on the movement, the first spring arm 5050 is used to... The resulting pressure applied to the lubricating element 5016 can be very low. In detail, the desired range (for example, 0-200 mmH2O as described above) The two arms are distributed and reduced via a spring structure so that they can be contained within. By appropriately selecting the relative lengths of 5050 and 5052 and the width of each arm, the lever - Or an equivalent gear reduction mechanism may be implemented. In this way, the necessary for a specific application A spring soft enough to provide low pressure (e.g., 0-200 mmH2O) is a conventional spring. This can be achieved using a short, two-arm spring instead of a long spring.

[0178] In one embodiment, the fulcrum 5054, the first spring arm 5050, and the cantilever arm 50 52 is the first force applied to the first arm by the cam 5048 by the cantilever spring It is configured to provide a lever effect that is converted into a second force applied to the valve element. Therefore, the second force is smaller than the first force.

[0179] As illustrated, as cam 5048 rotates, the force exerted on spring 5020 is It is adjusted in fine increments or continuously over a range from the minimum force to the maximum force. The cam 5048 is positioned so that it exerts maximum pressure on the spring 5020. At that time, the first spring arm 5050 moves toward the valve element 5016. The pressure setting of valve device 5000 is highest for this position of cam 5048. In the example, the pressure exerted by the cam 5048 on the spring 5020, and therefore the spring The tension increases with the clockwise rotation of the cam. However, those skilled in the art will benefit from the present disclosure. Considering the points, rotor 5026, cam 5048, and spring 5020 can be used as alternatives. It is understood that the rotor may be configured such that its counterclockwise rotation increases the spring tension. Let's do it.

[0180] As described above, the valve element 5016 and the valve seat 5018 are through which the fluid flows. An opening is formed. The inlet port 5010 is in a direction perpendicular to the central axis of the rotor 5026. Orienting it to enter the opening (or, in other words, to push the valve element 5016) This is possible. In certain embodiments, the fluid enters the opening in a direction perpendicular to the central axis of the rotor 5026. When the inlet port 5010 is oriented in such a way, the cam 5048 moves horizontally relative to the spring 5020. To directly or indirectly cause displacement.

[0181] In the embodiment of the valve device 5000 disclosed herein, the cam 5048 is A Shaped to mimic a Lucimedean spiral, the cam engages with spring 5020 (one Within a surface (or multiple surfaces), a constant or linear gradient, a piecewise linear gradient, a nonlinear gradient, and It can have such a combination of gradients.

[0182] In a specific example, the magnetic motor 5022 prevents the cam 5048 from rotating 360 degrees. It may include a stopper or cam stopper 5060, thereby the valve device 5000 This prevents the device from immediately transitioning from fully open to fully closed, or vice versa, in a single step. (See diagram) As described above, the rotor stopper 5060 prevents the rotor from rotating beyond the minimum rotor pressure position. To prevent this, it is provided in the rotor casing 5030 of the rotor 5026. As shown, the spring 5020 engages with the rotor stopper 5060 to prevent the rotor 5026 from rotating. It is configured to prevent the rotor 5026 from rotating beyond the maximum rotor pressure position. To do this, a second fastener (not shown) is attached to the upper cap 5014 of the valve device 5000. ) can be formed. The cam 5048 is positioned by the rotor stopper 5060. It can be rotated either clockwise or counterclockwise up to a certain point, and then in the opposite direction. It must rotate. Therefore, the full rotation of cam 5048 is in small steps. Furthermore, it's not just about incremental rotation; it's also about moving the valve device 5000 from fully open to fully closed, or vice versa. It is necessary to transition to it.

[0183] In a specific example, after the valve device 5000 was manufactured, a comparison was made to adjust the pressure setting. Positive devices are usually required. For example, in a particular embodiment, the spring 5020 is each It is linear with respect to the step, that is, with each step of rotation of cam 5048 It can be constructed such that the spring is tensioned so that the pressure of the valve device 5000 rises by X amount. A force is applied, and this applies with each additional step of rotation. Therefore, cam 5048 Set it to a given position and pretension the spring 5020 to the appropriate pressure in that position. The valve device 5000 may need to be calibrated. Therefore, the valve device 50 After the 00 is assembled, during calibration, nitrogen (or some other flow) passes through the valve device. A flow of energy (in the body) may exist.

[0184] As described above, in one embodiment, the magnetic rotors 5022 are arranged in a circular pattern and rotate clockwise. The rotation is configured to increase the pressure setting of the programmable valve device 5000. It includes 10 rotor magnet elements 5032. As described above, the rotor 5026 is multi It can rotate through a number of incremental steps, each step being the valve device 5000 It responds to the changes defined by the pressure setting. Also, as mentioned above, the rotor 5026, It may include a rotor stopper 5060 that can prevent 360-degree rotation of the cam 5048. This allows the valve device 5000 to move from fully open to fully closed, or vice versa, in one step. To prevent immediate transition. Therefore, rotor 5026 is valve device 500 When at the minimum pressure setting position of 0, the rotor must rotate clockwise, and Therefore, the pressure setting of the valve device gradually increases. 500 in one step. The counterclockwise rotation that transitions from the minimum pressure setting to the maximum pressure setting is controlled by the rotor stopper 506. This is prevented by 0. Similarly, the rotor 5026 sets the maximum pressure of the valve device 5000. When it reaches the corresponding position, the cam 5048 rotates further clockwise, stopping the rotor 50 This is prevented by 60, and as a result the rotor must rotate counterclockwise, and to that Therefore, the pressure setting of the valve device gradually decreases.

[0185] As mentioned above, the valve device 5000 can be seen by X-ray, and the rotor 502 X-ray markers 5040 and 504 indicate the position of 6, and therefore the pressure setting of the valve device. Includes 4. For example, X-ray markers 5040 and 5044 are the minimum of valve device 5000. The pressure setting aligns the X-ray markers 5040 and 5044 with the center of cam 5048. It is identified as follows. The X-ray marker 5040 is fixed to the base 5002 of the valve device 5000. The rotor 5026 does not rotate, but the X-ray marker 5044 rotates with the rotor. do.

[0186] In some embodiments, the X-ray markers 5040, 5044 contain tantalum. In this embodiment, the X-ray markers 5040, 5044 are tantalum spheres and / or tantalum Includes beads.

[0187] The embedded programmable valve device 5000 locks the rotor 5026 into place. Furthermore, the brake assembly is designed to selectively release the rotor for programming purposes. Included in one embodiment, the embedded programmable device 5000 is located on the support column 5028. The indicator, located within the upper rotor casing 5030, is shown overall as 5064. It further includes the indicator 5064, the indicator housing 5066, and the indicator It is placed inside the indicator housing and, for example, by adhesive or glue. Includes a diametrically magnetized annular indicator magnet 5068 fixed to the ring. The indicator 5064 rotates relative to the rotor 5026 when exposed to an external magnetic force. It is such that it is possible. The embedded programmable valve device 5000 is And, once the desired pressure is achieved, a mechanism is provided to lock the rotor 5026 in place. Specifically, it further includes brakes or stabilizers as shown in 5070. The 5070 consists of a circular body 5072 and a rotor 5026 that extends beyond the body. When placed on the casing 5030, it is received between the steps 5036 of the rotor casing. Includes a pair of diametrically opposed arms 5074, 5076 that can be inserted. Brake 50 The main body 5072 of part 70 fits onto the molded end of the support column 5028, so that the brake is against the support column. The array includes a molded opening 5078 designed to prevent rotation. 5070 is prevented from rotating relative to the support column 5028, but the pair of arms 5074, This is such that part 5076 can be displaced in the axial direction.

[0188] The positioning magnet 5042 is a indicator 50 which includes a magnet 5068 magnetized in the diametrical direction. To orient or position 64. Indicator 5064 has two purposes. 1. Eye The target is the magnetic motor 5022 with the programmer located on top of the valve device. Releasing brake 5074 from step 5036 when enabling step 5026 Another purpose is that whenever the programmer is not in close proximity to the valve, In other words, indicator 5064 is always 2 except when the valve is programmed. The monitor is magnetically oriented by two positioning magnets 5042. Read the angular or circumferential direction of indicator 5064, not magnet 5042. The magnetic field generated by the relatively small positioning magnet 5042 is read by the external monitor. It's not strong enough. The indicator 5064 is not strong enough for an external monitor to read. As a magnetic amplifier that mimics the orientation of two small positioning magnets 5042 with a strong magnetic field It works, but the indicator is affected by strong external magnetic fields, such as those generated by MRI machines. It must be able to rotate freely when exposed to the field, valve device 5000 Do not change the pressure settings. When a patient with an implanted valve is guided to the MRI machine, The sensor 5064 aligns itself according to the direction of the magnetic field of the MRI machine. , it cannot be pulled up from rotor 5026. As a result, with the brake engaged, It becomes possible to keep the 5026 stationary. When the patient leaves the MRI machine, 2 The positioning magnets 5042 realign the indicator 5064, and then the indicator Data 5064 can be read by the monitor.

[0189] For example, when an external magnetic force is applied to the valve device by a program programmer, The radiator 5064 lifts the brake arms 5074 and 5076 from the rotor 5026. Attracted by an external magnetic force, the rotor rotates, thereby changing the pressure in the valve device. It becomes possible to make it so. Specifically, the indicator 5064 is supported toward the magnetic force. Move axially along 5028, and therefore, in this specific configuration, indicator 50 The outer edge of 64 displaces brake arms 5074 and 5076 in the axial direction. Brake 507 Arms 5074 and 5076 are located between step 5036 of rotor casing 5030. It is removed from space, allowing the rotor 5026 to rotate. At the same time, the stator 5024 is magnetized to attract rotor magnet element 5032, thereby the rotor This prevents 5026 from moving in the axial direction.

[0190] Once the desired pressure is achieved, the external magnetic force is removed, and the brake arms 5074, 50 76 is positioned between the steps 5036 of the rotor casing 5030, brake Arms 5074 and 5076 can be made to return. Specifically, external magnetic force Once removed, indicator 5064 is positioned to lock the rotor in place. The brake arms 5074 and 5076 move backward towards the rotor 5026.

[0191] Programmer device As described above, the embodiment of the valve device 5000 includes a magnetically actuated rotor 5026. Therefore, the pressure setting of the embedded programmable valve device is Adjustment is made by positioning a program writer that is close to the body but located outside the body. The programmer allows the user (for example, a doctor) to program the programmer. Control the device to set the pressure setting of the embedded programmable valve device 5000, and Depending on the situation, various control and input / output (I / O) configurations are used to enable reading. The system includes a magnetic field generator along with the elements. In certain embodiments, the magnetic field generator includes an array of electromagnets. In other embodiments, the magnetic field generator may include one or more permanent magnets. Yes, the programmer can be battery-powered.

[0192] In one embodiment, the program writer is an embedded magnetic programmable valve device. It is configured to be positioned above the patient's head in the upper position. The programmer is as follows: As further explained, a magnetic pulse is applied to selectively magnetize the stator 5024, This includes a magnetic field generator that rotates the rotor 5026. The fluid flows from the ventricles to the ventricular catheter. The cable goes through the terminal to the inlet connector 4908, and through the recessed valve device 5000 to the connector. The distal catheter connected to the Kuta 4912 flows, and the distal catheter then (of the heart It drains fluid from a distant location in the body (such as the right atrium or peritoneal cavity). The programmer is The rotor 5026 can be rotated by transmitting a magnetic signal. The programmer is As will be further explained below, it may be used to generate magnetic pulses, even It may be coupled to a communication link such as a cable or wireless link.

[0193] Referring to Figures 56A to 59, the programmer device of one embodiment of the present disclosure is as follows As shown in 5600, the programmer device 5600 has an upper 56 04 (Figures 56A and 58), lower part 5606 (Figure 57), and upper and lower parts of the casing. Includes a casing 5602 having continuous side walls 5608 connecting the parts. The casing 5602 of the 5600 is for doctors or professionals using programmer devices. It is small enough to fit in the palm of your hand. The top of the programmer device 5600 is designed for doctors to use in their ValveD To enable programming of the Vice 5000, see below for more details. Includes a user interface 5610, including a liquid crystal display (LCD) 5612. The side wall 5608 of the programmer device 5600 is the programming screen of the programmer. To start the program and control the operation of the valve device 5000, two programs are used. Includes programming start buttons 5614 and 5616. Casing 5602 contains the programmer device. It is configured to support 5000 components. In some cases, it charges a rechargeable battery. To power and / or modify the software of programmer device 5600 or To perform updates, a USB port 5670 can be provided.

[0194] Referring particularly to Figure 59, the casing 5602 of the programmer device 5600 is located at the bottom. Includes casing 5618 and upper casing 5620. Lower casing 5618 is Battery housing 5 configured to accept a battery, for example, four AAA batteries. Includes 622 and a battery cover 5624 configured to close the battery housing. The programmer device 5600 is connected to the motor 5 of the battery housing 5622. The invention further includes 626 and a gear 5628 attached to the motor shaft. So, when the programmer device 5600 is assembled, the casing 5602 is... Includes a support 5630 configured to support the battery housing 5626. The battery located at 22 supplies power to the motor 5626, which drives the rotation of the gear 5628. To move.

[0195] The programmer device 5600 has a central housing configured to support the magnetic gear 5634. A magnetic support 5632 having a bu, a ball bearing 5636, and a magnetic bridging plate 5638, each The array further includes two permanent magnets shown in 5640. The array is gear 5628, which supports the magnets. To drive the rotation of the two permanent magnets 5640 held by the holder 5632, It is configured to engage with gear 5634. In the illustrated embodiment, The magnet 5640 is formed from two pieces, each having an N side and a S side, and both are magnetic. It is attached to the air bridge plate 5638. The magnet 5640 rotates the rotor magnet element 5032. It is configured to drive and program the valve device 5000. The S5600 is a first programmer that controls the operation of programmer devices together. The system further includes a sub-board 5642 and a second program writer electronic board 5644.

[0196] In one embodiment, each time the permanent magnet 5640 of the programmer device 5600 rotates, The rotor 5026 of the device 5000 rotates 1 / 5 of a revolution. In this way, The Grammar device 5600 provides incremental movement of the rotor 5026 of the valve device 5000. The rotor is then configured to precisely position itself at the desired pressure. Furthermore, in one embodiment... So, for each rotation of the permanent magnet 5640 of the programmer device 5600, the valve device 5 The 000 indicator 5064 completes one rotation (1 / 1).

[0197] In a specific example, the casing 5602 of the programmer device 5600 is for the user It is packaged for comfort and ease of use. In this example, programmer device 5600 It has a shape similar to a computer mouse. As illustrated, several implementation forms In this configuration, the programmer device 5600 has circular corners on its outer surface and is generally circular in shape. It can have a shape that is easy and / or comfortable for the user to hold. In some embodiments, the programmer device 5600 is designed to be easily held by the user with one hand. It is possible.

[0198] As mentioned above, the programmer device 5600 may be battery-powered. Therefore, In some embodiments, the battery housing 5622 of the casing 5602 is one or It can accommodate multiple batteries. As described above, in some embodiments The motor 5626 of programmer device 5600 is a DC motor, and programmer device Two magnets, 5640, are used to rotate the rotor 5026 of the valve device 5000. Includes magnets magnetized in the opposite direction. Two magnetized magnets 5640 are programmed The vice 5600 has an opposite magnetic field oriented downward. In some embodiments, The magnet 5640 of the programmer device 5600 has a surface electric field strength of 6000 gauss. .

[0199] The programmer device 5600 allows a physician to operate the programmer device and access relevant information, for example. For example, it has a user interface that allows you to view pressure setting information in mmH2O units. The user interface 5610 is located on the upper part 5604 of the casing 5602. and further includes a keyboard foil designed to create the aforementioned LCD5612. Hmm. The programmer device 5600 further includes a wormhole housing 5646. Pro The upper part 5604 of the casing 5602 of the Grama device 5600 is programmed by the physician. This allows us to see the positioning of valve device 5000 relative to chair 5600. It is designed. Specifically, the user interface 5610 allows for pressure setting, battery It can be configured to display information such as status and, in some cases, other information. For example, the center of the user interface screen 5610 is (digital readout The selected pressure can be shown. The screen boundaries are as described below. , indication of what is shown by X-rays, or valve device which may be indicated by pressure device 5000 The position of rotor 5026 of S5000 may be included.

[0200] The user interface 5610 of the programmer device 5600 allows the user to program... This allows the selection of the pressure setting value for the device, thereby enabling the valve device 500 It is configured to set the pressure to 0. In some embodiments, the programmer device 5 Button 5652 of unit 600 is used to configure the programmer device to turn on and off. This is possible. The user interface 5610 allows you to increase the pressure setting value, To decrease the pressure setting, press the plus (+) button 5648 and the minus (-) button. It can be configured to include n5650. User interface 5610 is further There are two programming start buttons 5614, 5616, and possibly in use. It can be configured to include a light button that provides illumination.

[0201] The casing 5602 of the programmer device 5600 is for the embedded valve device 500. Align the programmer device correctly above 0 and program the pressure setting for the valve device. It can be molded to facilitate this. In a particular example, the casing 5602 is including a molded cavity 5654 formed in the lower part 5606 of the programmer device 5600. The cavity 5654 has less shape and size than the recessed valve device 5000. The shape and size are almost identical. Cavity 5654 is a casing Includes a pair of channels defined in the lower part 5606 of 5602. As described above, the prog The inlet port 5010 of the ram-operable valve device 5000 is to be connected to the inflow catheter. The programmable valve device's outlet port 5012 can be connected to a drainage catheter. It can be connected. The channel is where the programmer device 5600 is implanted in the patient's head. When placed on a valve device 5000, the channel connects to the inflow catheter and drain. Align the valve catheter with the programmer device, thereby enabling the implantable valve device. They can be sized and arranged in a way that helps to properly align them with the chair. After the user sets the desired pressure setting value on the programmer device 5600, the user can program The ram device is placed on top of the valve device 5000, which automatically releases the brakes. Next, the user presses the two programming start buttons 5614 and 561 on the side wall 5608. Press one of the six buttons to begin programming.

[0202] Referring again to Figures 56A to 56D, in one embodiment, the programmer device 5600 In some cases, the permanent magnet 5640 of the programmer device may be used when not in use. Therefore, in order to shield the extremely strong magnetic force that is generated, a magnetic shield 5660 is included. Yes, it is possible. In one embodiment, the magnetic shield 5660 is a molded plastic that encloses an internal steel plate. It has an outer body. When attached to the bottom of the programmer device 5600, the internal magnet The magnetic field generated by 5640 closes the magnetic "circuit" through the steel shield, This isolates the programmer device from the external environment and strong magnetic fields. Magnetic shield 56 As mentioned above, 60 is removed before operating the programmer device 5600. In one embodiment, the programmer device 5600 is configured such that the magnetic shield 5660 is removed. It cannot function as a safety mechanism until then.

[0203] Monitor device Referring to Figures 60A and 60B, the monitoring device of the embodiment of the present disclosure is overall As shown in 6000, the monitoring device 6000 controls the pressure setting of the valve device 5000. It can be used to monitor the status. The monitor device 6000 is a programmer device. Before and / or after the 5600 program the valve device 5000, To verify the pressure setting of the lubrication device 5000, use the programmer device 5600 together. It can be used for the above. As shown in the illustration, the monitoring device 6000 is located above 6004 Dis Includes a rectangular casing 6002.

[0204] Furthermore, referring to Figure 61, the upper part 60 of the casing 6002 of the monitor device 6000 04 is the LCD6010 and the placement of the device and the user monitors through it while using it. Includes a central opening 6012 on which the operation can be observed. LCD of monitor device 6000 6010 is used by doctors to measure the pressure setting of valve device 5000. The upper part 6004 of the casing 6002 provides a user interface 6014. The monitor device 6000 also includes a keyboard foil for operation. For example, The upper part 6004 of the casing 6002 of the monitoring device 6000 contains the valve device 50 A dial 6016 is provided to indicate the position of rotor 5026 of 00. (Monitoring device) The 6000 is operated by an on / off button 6 configured to turn it on and off. 018, and the pressure recall button to access previously read pressure settings. 6020 is provided. In some cases, to charge the rechargeable battery, and / Alternatively, to modify or update the software of the Monitor Device 6000, use a USB port A 6070 can be provided.

[0205] Referring to Figures 62 and 63, the casing 6002 of the monitor device 6000 is Includes lower casing 6022 and upper casing 6024. Monitor device 6000 The lower casing 6022 is for supplying power to the operation of the monitor device 6000. Includes a battery housing 6026 configured to house one or more batteries. The battery cover shown together with 6028 is designed to cover the battery housing 6026. It is located at [location].

[0206] The monitoring device 6000 includes a monitor electronic board 6034 and a monitor sensor board 6036. The monitor sensor board 6036 further includes indicator 5 of the valve device 5000. Identify and detect the angular or circumferential direction of 064 to determine the pressure setting of the valve device. It is provided for this purpose. The monitor device 6000 is provided on top of the monitor assembly 6034. Further includes a compass bridge 6038. In one embodiment, the compass bridge 6 038 is a plastic cover that is part of casing 6002. Compass brittle One of the purposes of the 6038 is to protect the sensor.

[0207] Referring to Figures 64 and 65, the monitor sensor substrate 6036 has a first (upper) surface 60 Includes 40 (Figure 64) and a second (lower) surface 6042 (Figure 65). Monitor sensor substrate 60 36 has a first arm 6046 terminating on the first tab and a second arm terminating on the second tab. It includes a circular central body 6044 having a frame 6048. Referring particularly to Figure 65, the central The main unit 6044 includes four sensors, each indicated in 6050, and these sensors are The magnet 5068, which is magnetized in the diametrical direction of the indicator 5064 of the lubrication device 5000. When placing the monitoring device on top of the valve device, the monitoring device 6000 It is configured to occupy the center of the valve device. Therefore, the monitoring device 600 0 uses the monitor device and programmer device 5600 in the manner described below. During the procedure in which the valve device is programmed, the valve device 5000 It is configured so that it occupies the center position above. In one embodiment, the monitor device 6000 To achieve its precise centering on the valve device 5000, the monitor is in any direction. Includes a circular array of lights that indicates to the user whether something needs to be moved.

[0208] The monitor sensor further includes a fifth sensor as shown in 6052, the fifth sensor being 4 It is centrally positioned for two sensors 6050. This sensor 6052 is a valve device Measure the angular or circumferential direction of the 5000 indicator 5064 to the valve device It is configured to determine the pressure setting of the indicator 5064 in the angular or circumferential direction. The direction is directly correlated with the angular or circumferential direction of the rotor 5026, and the rotor 5026 The angular or circumferential direction is directly correlated with the pressure setting of the valve device 5000. In this embodiment, every 18-degree rotation corresponds to a specific pressure in the valve device 5000. Each pair of light-emitting diodes (LEDs) shown in 6054 is a monitor device 6000. It is provided to shine light on the patient when using it. The first arm 6046 The first magnetic sensor 6 measures the Earth's magnetic field and / or any other magnetic fields present. Including 056. Similarly, the second tab of the second arm 6048 is similarly the Earth's magnetic field and Includes a second magnetic sensor 6058 for measuring / or any other magnetic field present. Monitor 6 Before positioning 000 in close proximity to the valve device 5000, the magnetic sensor 6048 and the magnetic sensor The air sensor 6056 reads the external magnetic field and later combines it with the readings from sensor 6052. Subtract. This allows the sensor 6052 to ignore other external magnetic fields and determine the indicator 50 It will be possible to accurately read 64 angular or circumferential directions.

[0209] Similar to the programmer device 5600, the monitor device 6000 is a monitor device Includes a molded cavity 6060 (Figure 60B) formed in the lower part 6006. Cavity 60 60 corresponds at least approximately to the shape and size of the embedded valve device 5000. It has a shape and size like this. Cavity 6060 is the lower part of casing 6002 60 Includes a pair of channels defined in 06. The channels are used by the monitoring device 6000 to monitor the patient. When placed on top of the implantable valve device 5000 in the head, the channel enters the catheter and align with the drainage catheter, thereby implanting the monitoring device. The size and arrangement should help to properly align the lubrication device. can.

[0210] Positioning disk Referring to Figures 66 and 67, the positioning disk of one embodiment of the present disclosure is overall As shown in 6600. In the illustrated embodiment, the positioning disk 6600 is used Produced by the embedded valve device 5000 to guide the positioning disc inside. Includes a thin body 6602 having a notch 6604 configured to receive a bulge. The positioning disc is positioned so that arrow 6610 on the positioning disc is inside the valve device 5000. Positioning is performed on the valve device 5000 to indicate the direction of fluid flow. The main unit 6602 of disk 6600 places the monitor device 6000 on the positioning disk. It further includes a recess 6606 having a positioning mechanism 6608 configured to attach to it. During use, the notch 6604 of the positioning disc 6600 is positioned on the patient. It is placed on top of the valve device 5000 for rough placement. The monitor device 6000 has a positioning mechanism 6608 that is fitted to the monitor device. In a state where it is received within the coupling mechanism, it is placed in the recess 6606. At this time, the monitor device The 6000 operates so that the monitoring device occupies the center of the 5000 valve device. As shown in the diagram, the monitor device 6000 faces in the direction indicated by the monitor. Then it moves together with the positioning disk 6600, and the positioning disk and the monitoring device Both can occupy a central position relative to the valve device 5000.

[0211] Once centered, the Monitor device 6000 is removed from the positioning disk 6600. Leaving the positioning disk in place, the programmer device 5600 then moves the positioning disk The valve device 5000 can be programmed by placing it on the disc. Similar to the 6000 programming device, the 5600 programmer device is located within the recess 6606. The positioning mechanism 6608 is received within a mating mechanism provided in the programmer device. .

[0212] Improved operation of valves, programmer devices, and monitor devices Figure 68 shows a programmer device 5600 with a magnetic shield 5660 and a USB port. Monitor device 6000 connected to power cord 6620 via 6070, and monitor This shows the positioning disk 6600 located beneath the device.

[0213] In a particular embodiment, the valve device 5000 ensures that the appropriate pressure is achieved. Regular monitoring is required to ensure this. In other embodiments, valve device 500 A value of 0 requires periodic reprogramming to increase or decrease the pressure. Monitor the pressure. At that time, the positioning disk 6600 is positioned so that the opening of the positioning disk is a recessed valve device The valve device 5000, referenced above, is designed to accommodate the contour of the valve within it. The monitor device 6000 is positioned and placed on the positioning disk. 6000 is a monitoring device and positioning disk 6600 is a valve device 5000 It operates to occupy the center. When it occupies the center, Monitor device 6000 will LCD6 The existing pressure of valve device 5000 displayed at 010 is detected. Valve device 5 The position of rotor 5026 at 000 is the monitor device 6000 on dial 6016. It can also be detected on the interface 6014. The detected pressure can be detected by a physician. If it is deemed acceptable to determine, the monitor device will be turned on / off by the on / off button 6018. The S6000 was turned off, and the monitoring device and positioning disk 6600 were removed from the patient. It will be removed.

[0214] If the detected pressure is deemed unacceptable by a physician, or if the valve is If Vice 5000 was scheduled to be reprogrammed, the monitoring device 6000 would be located It is removed from the designated disc 6600 and turned off by the on / off button 6018. When the monitor is removed from the positioning disk 6600, the programmer device 5600 It is turned on by the on / off button 5652. When activated, the doctor will see the above. Operate the plus (+) button 5648 and the minus (-) button 5650. This allows the programmer device 5600 to select a pressure, for example, 100 mmH2O. In some embodiments, the programmer device 5600 controls a preset pressure, even It can be programmed to 70 mmH2O. When the pressure is selected, the programmer device The chair 5600 is placed on the positioning disk 6600, and the start button 5614 or start When any of buttons 5616 is pressed, the programming sequence begins. The rama device performs a reset operation as described above, and then the valve device 50 Select or set the pressure to 00 or a preset pressure. Specifically, programmer device Magnet 5640 of S5600 lifts indicator 5064 and brake arm 507 4 and the brake arm 5076 lift up to release the rotor 5026 of the magnetic motor 5022 It is magnetized to release. The rotor magnet element 5032 of the valve device 5000 is a stay Operated by stator 5024, stator 5024 operates in a similar manner to valve device 200. The programmer device 5600 is then sequentially magnetized by the magnet 5640, and the rotor 5026 Rotate it to the selected position and pressure. Once the rotor 5026 has moved to the appropriate position, The programmer is lifted away from the embedded valve device 5000, and the brake Ki 5070 is positioned between the steps 5036 of the rotor 5026 to lock the rotor into place. The indicator 5064 can return to its stationary position. The S5600 is removed from the patient and turned off by the on / off button 5652. The instructor repeated the cycle using a monitor to ensure that the valve device 5000 was programmed correctly. It can be confirmed that it is being monitored. Once pressure is confirmed, the doctor will use a monitoring device. The S6000 and positioning disc 6600 can be removed from the patient.

[0215] According to a particular embodiment, near the programmable embedded valve device 5000 Valve pressure can be adjusted by applying a magnetic field. Positioning disk When 5600 is centered around the monitor device 6000, the programmer device 560 0 is positioned close to the embedded valve device 5000 using the positioning disk 6600. It is arranged. In the illustrated embodiment, the magnet 5640 of the programmer device 5600 is Configured to operate the rotor 5026 of the valve device 5000. Embedded valve The magnetically operated motor 5022 of the device 5000 is located in the rotor casing 5030. A rotor having 10 rotor magnet elements 5032 arranged in alternating polarity within its channel. Includes 5026. The magnetic motor 5022 is magnetized by the programmer device 5600. It further includes a stator 5024 located beneath the rotor 5026.

[0216] The operation of valve device 5000 is the same as that of valve device 200. For example, is the magnet 5640 of the programmer device 5600 a permanent magnet or a stator? It is excited to have either a north pole or a south pole facing 5024. It is possible that each remains completely off. Low valve device 5000 The movement of the 5026 in the desired direction and angle is the movement of the permanent magnet or magnet 564 This is achieved by excitation in one of the specified sequences of 0, thereby stator 502 4 is magnetized and then (depending on the polarity) attracts or repels the rotor magnet element 5032. This triggers the rotation of rotor 5026.

[0217] Thus, the embedded valve 5000 having the magnetic motor 5022 described above is a professional Along with external controllers including the Graph Device 5600 and Monitor Device 6000 By using this method, the pressure setting of the implantable valve device can be controlled and measured non-invasively and gradually. It is possible. The configuration of the cam 5048 and the tension of the spring 5020 are determined by the rotor 5026. Each angle increment is a clearly defined and selected change in the pressure setting of valve device 5000 (for example) For example, it can be designed and calibrated to produce 10 mmH2O. The programmer device 5600 allows the user to input the desired pressure setting for the valve device 5000. It can be configured to enable the programmable device. In one embodiment, the programmer device The 5600 valve device pressure ranges from 0 to 300 mmH2O and from 0 to 180 mH2O. Set the values ​​in 10mm increments up to mH2O, and in 40mm increments from 180 to 300mmH2O. It can be configured as follows. In one embodiment, the default or preset pressure is 7 It is 0H2O.

[0218] For example, to ensure the precise pressure setting of valve 5000, a programmer device The 5600 first activates a counterclockwise rotation sequence to fully open the valve device. Set the valve device to the position, then activate the clockwise rotation sequence to allow the user to access it. Therefore, it can be configured to set the pressure to the selected input pressure setting. Specific example According to the report, when the counterclockwise rotation sequence is activated, the programmer device 5600 will The rotor 5026 is activated so that the valve device 5000 has its minimum pressure setting. So that the rotor is positioned and rotates through a sufficient number of counterclockwise steps. It is constructed as follows. As mentioned above, the presence of the rotor stopper 5060 means that the rotor 5026 is at minimum pressure This prevents the rotation from continuing beyond the force setting position. The programmer device 5600 is counterclockwise After stopping the rotation sequence of the instrument, the rotor stops at a known position (corresponding to the minimum pressure setting). A clockwise sequence can be started from the position with 5060. Device 5600 pushes valve device 5000 to the pressure setting selected by the user. To program, the rotor rotates through a selected number of clockwise steps. 5026 can be activated.

[0219] The example described above uses the clockwise rotation of rotor 5026 to control valve device 5000 Program the pressure settings (and program the sequence using counterclockwise rotation) Setting the rotor 5026 to a known starting position, but considering the advantages of this disclosure, Tem (Valve device 5000, programmer device 5600, monitor device 6000) , and positioning disk 6600) are instead arranged in the opposite order, namely rotor 5026 Use the counterclockwise rotation to program the pressure setting of valve device 5000 (or Set the rotor to a known position using clockwise rotation to start the program sequence. Those skilled in the art will understand that it can be configured to do so.

[0220] Embodiments of valve assembly 4900 are used in patients using a well-described surgical procedure. It may be implanted. The pressure setting of the valve device 5000 is prior to surgical implantation. The pressure can be adjusted to the desired setting. In one embodiment, the operating pressure changes after surgery. To prevent this from happening, it can be set to be approximately equal to the CSF pressure in the patient's ventricles. After the patient recovers from surgery, the pressure setting can be adjusted as desired. For example, In patients with NPH, the pressure setting is reduced to initiate a reduction in ventricular size. It is possible to make further adjustments to the pressure settings. For example, the ventricles Once the size is sufficiently reduced, the valve pressure setting can be increased. Thus, using an implantable valve device allows for valve adjustment as needed during the treatment of a patient. The pressure setting of the device can be adjusted externally.

[0221] In certain embodiments, a method for treating hydrocephalus involves a ventricular catheter in the ventricular cavity of the patient's brain. Then, a distal cardiogram connected to a connector located at a distant location inside the patient's body from which the fluid is discharged. This includes embedding an embodiment of a valve assembly 4900 having a tether. Distant locations in the body from which it is expelled include, for example, the right atrium of the heart and the peritoneum.

[0222] In addition to hydrocephalus, the accumulation of excess fluid is associated with the use of a properly designed inflow catheter. There are several other conditions that can be treated by draining the fluid to another part of the body. There are diseases. Such diseases include, for example, chronic pericardial effusion, chronic pulmonary effusion, pulmonary edema, This includes ascites and ocular glaucoma. Embodiments of programmable valve devices are this It is considered suitable for use in the treatment of these diseases.

[0223] The pressure settings for the valves described herein, including valve device 5000, are as described above. Thus, in many discrete steps or increments, or continuously over a given range It can be adjusted. The valve embodiments described herein are for low pressure, for example, 0 m Pressure can change from mH2O to high pressure, for example, 300 mmH2O. Conventional valves only have a pressure height of 200 mmH2O, and the range between each pressure setting is relatively large. It can only be adjusted in small increments.

[0224] Although several aspects of at least one embodiment have been described above, various changes, modifications, and Please understand that improvements are easily conceived by those skilled in the art. Such changes, modifications, and improvements This is intended to be part of the present disclosure and within the scope of the present invention. Therefore, the above description and drawings are merely examples, and the scope of the present invention is limited to the appended patent. This should be determined by the scope of the claims and the appropriate structure of their equivalents. [Explanation of symbols]

[0225] 100 Shunt Valve Assembly 110 Pump Room 119A Arrow 120 Ventricular catheter 130 Entrance 140 connectors 150 Exit 200 valves 200a valve 202 Valve body, housing 202a Top cap, top cover 202b Lower cap 204 Entrance Port 206 Exit Port 208 Valve element 210 valve seat 212 Cam 213 Slope 214 axes 216 Arrow 218 Protrusion 220 Cam stopper 222 Housing stopper 224 Marker 226 Marker 300 Second valve, check valve 400 springs 407 Pivot points 409 spring 409g cantilever arm 409h free end 409j central arm 409k arm 410 First spring arm 412 Inflection points 420 Cantilever Arm 422 Free end 430 Fulcrum 460 leaf spring 462 First spring arm 464 Cantilever Arm 464a Circular end 480 U-shaped spring 482 First spring arm 483 U-shaped part 484 Cantilever Arm 486 Free end 488 Pillar 490 Cantilever spring 491 Ruby bearing 492 First spring arm 493 Ruby bearing 494 Cantilever spring arm 496 Free end 498 Post 510 Rotor 512 Rotor magnet element 512a Rotor magnet element 512b Rotor magnet element 512c Rotor Magnet Element 512d Rotor Magnet Element 514 Rotor Casing 516 Bearing Ring 518 Increment Steps 520 Center shaft 522 channels 524 Reference Magnet Element 524a Reference magnet element 524b Reference magnet element 524c Reference Magnet Element 526 Reference Marker 528 stata 530 Center axis 532 Arrow 534a Stator Arm 534b Stator Arm 534c Stator Arm 534d Stator Arm 536 Arrow 538 Rotor Reference Marker 540+ integrated stator 540a X-shaped integrated stator 542 stater elements 544 stater elements 546 angle 550 Positioning Magnets 552 Indicator Magnet 553 Side positioning magnet element 554 Brake spring 555 Inner self 556 Brake Cylinder 557 Side positioning magnet element 558 Central Pivot 559 Side positioning magnet element 560 Brake cylinder teeth 562 teeth 563 Flat area 564 Ruby bearing 566 Arm 566a protrusion 568 Central ring section 570 Casing 572 Casing protrusions 600 Valve Programmer 610 Transmitter Head 620 Control Devices 622 User Interface 624 Drive Circuit 626 Setting Detectors 628 Communication Interface 630 Communication Link 632 Controller 640 External adjustment device 660 Pressure Reader 662 Arrow 664 Pressure Indicator 700 Valve Programmer 702 Controller 704 User Interface 706 Battery 708 Stepper Motor 710 Permanent Magnet Assembly 710a Permanent Magnet Assembly 710b Permanent Magnet Assembly 710c permanent magnet assembly 710d Permanent Magnet Assembly 712 Housing 714 Magnetic Guide 716 Rotational center axis 718 Ring 722 Permanent Magnet 724 Permanent Magnets 726 Permanent Magnet 728 Permanent Magnet 730a Magnetic Quadrant 730b Magnetic Quadrant 730c magnetic quadrant 730d Magnetic Quadrant 732 Permanent Magnet 734 Permanent Magnet 736 Controller Reference Marker 740 Brake Controller Magnet 742 Controller Magnet 760 Valve Programmer 761a First button 761b Second button 762 Handheld Housing 763 Molded Cavity 764 User Interface 765 side wall 767 Channel 769 Programming Buttons 770 Battery Status 772 On / Off button 777 Valve Programmer 787 Wheel 800 External Valve Program Assembly 802 Dashed line 804 Communication Link 810 Transmitter Head 812 Magnetic Sensor 814 Magnet Assembly 816 Communication / Control Circuits 820 Control Devices 822 User Interface 824 Communication / Control Circuits 1000 ways 1100 methods 4900 Valve Assembly 4902 Valve 4904 Valve, check valve 4906 Pump Room 4908 Connectors, Catheters 4910 Entrance 4912 connector 4914 Exit 5000 valve device 5002 base 5004 Lower wall 5006 Peripheral wall 5008 Cavity 5010 Entrance Port 5012 Exit Port 5014 Top cap 5016 Valve element 5018 Valve Seat 5020 spring 5022 Magnetic Motor 5024 Status 5026 Rotor 5028 Post 5030 Rotor Casing 5032 Rotor Magnet Element 5034 Cylindrical body 5038 channels 5040 X-ray marker 5042 Positioning Magnet 5044 X-ray marker 5046 Bearing Ring 5048 Cam 5050 First spring arm 5052 Second cantilever spring arm 5054 Fulcrum 5056 Lower spring support 5058 Upper spring support 5060 Rotor stopper 5064 Indicator 5066 Indicator Housing 5068 Annular Indicator Magnet 5070 Brake 5072 Circular body 5074 Brake Arm 5076 Brake Arm 5078 Molded opening 5600 Programmer Devices 5602 Casing 5604 Top 5606 Lower 5608 Side wall 5610 User Interface 5612 Liquid Crystal Display (LCD) 5614 Programming Start Button 5616 Programming Start Button 5618 Lower casing 5620 Upper casing 5622 Battery Housing 5624 Battery Cover 5626 Motor 5628 Gear 5630 Support 5632 Magnetic support 5634 Magnetic Gear 5636 Ball bearing 5638 Magnetic Crosslinking Plate 5640 Permanent Magnet 5642 First Programmer Electronic Circuit Board 5644 Second Programmer Electronic Circuit Board 5646 Wormhole Housing 5648 Plus (+) button 5650 Minus (-) button 5652 button 5654 Cavity 5660 Magnetic Shield 5670 USB ports 6000 Monitor Devices 6002 Disc-shaped casing 6004 Top 6006 Lower 6008 Side wall 6010 LCD 6012 Central opening 6014 User Interface 6016 Dial 6018 On / Off button 6020 Pressure Recall Button 6022 Lower casing 6024 Upper casing 6026 Battery Housing 6028 Battery Cover 6034 Monitor Electronic Circuit Board 6036 Monitor Sensor Board 6038 Compass Bridge 6040 First (upper) surface 6042 Second (bottom) surface 6044 Central Unit 6046 First Arm 6048 Second Arm 6050 Sensor 6052 Fifth Sensor 6054 Light-Emitting Diode (LED) 6056 First magnetic sensor 6058 Second magnetic sensor 6060 Cavity 6070 USB port 6600 Positioning disk 6602 Main Unit 6604 Notch 6606 recess 6608 Positioning mechanism 6610 Arrow 6620 Power Cord

Claims

1. A kit for setting the pressure in a surgically implantable shunt valve, the The kit is Externally, it has a magnetically operable motor configured to provide a selected pressure setting. A scientifically implantable shunt valve assembly, A motor configured to detect the pressure setting of the surgically implantable valve assembly. Nita Devices and A programmer device having at least one programmer magnet, wherein the at least Another programmer magnet is selectively movable and the magnetically operable motor The user activates the device and sets the pressure setting of the valve assembly to the programmer's pressure. A programmer device configured to allow adjustment to match the force setting value. chair and Equipped with, The valve assembly, The system comprises an indicator housing and a magnet disposed within the indicator housing. The indicator, A brake is coupled to the indicator to prevent the rotation of the motor rotor. A lock position positioned between the teeth of multiple motor teeth, and the brake is positioned between the multiple rotor teeth Moveable in response to the movement of the indicator between the unlocked position and the unlocked position where the teeth are disengaged. The brake is capable of the indicator being applied by the programmer device A brake and a mechanism that allows movement in response to exposure to an external magnetic field. A magnetically operated mechanical brake assembly including including, kit.

2. The programmer device, in order to turn the programmer device on and off, The user interface and at least one of at least one button further The kit according to claim 1, including

3. The user interface of the programmer device increases the pressure setting value. The device includes a first button for pressing and a second button for decreasing the pressure setting value. The kit described in item 2.

4. The programmer device for initiating the programming sequence The kit according to claim 2, further including one start button.

5. The programmer device, Housing and The motor coupled to the housing, A magnet assembly coupled to the motor and configured to rotate relative to the housing A valve assembly having at least one for applying the external magnetic field Magnet assemblies including permanent magnets and The kit according to claim 1, comprising:

6. The motor includes a shaft having a drive gear, and the magnet assembly has a bearing. A magnetic support, a driven gear coupled to the drive gear, and a magnetic support coupled to the magnetic support The invention further includes a crosslinking plate and the at least one permanent magnet coupled to the magnetic crosslinking plate. The kit described in claim 5.

7. The programmer device, in order to realize the appropriate programming sequence, The following is a description of the device according to claim 1, including software to control the movement of at least one permanent magnet. .

8. The programmer device moves the R in a second direction opposite to the selected pressure setting. Before starting the rotation of the valve, the rotor of the valve device is moved to the first position to the minimum pressure setting. The kit according to claim 1, configured to rotate in the direction.

9. The monitoring device is used by the user to turn the monitoring device on and off. The kit according to claim 1, comprising at least one of a surface and a button.

10. The monitoring device comprises a housing and a monitoring assembly supported by the housing. The monitor assembly includes a unit, and the monitor assembly occupies the center of the monitor assembly, and the unit A monitor configured to detect the position of the magnetically operable motor in the lube assembly The kit according to claim 1, comprising a tasensor.

11. The monitor sensor comprises a first sensor that occupies the center of the monitor assembly and the surgical The position of the magnetically operated motor in the embeddable shunt valve assembly is detected. The kit according to claim 10, further comprising a second sensor that emits an output.

12. The valve assembly further includes a housing, and the outside of the housing is physiologically Formed from a suitable material, the magnetically operable motor is disposed within the housing. The magnetically operable motor includes a stator and a rotor, and the rotor is In response to the change in the stator's magnetic poles induced by the external magnetic field, the stator... The kit according to claim 1, configured to rotate.

13. The rotor comprises a rotor casing and is arranged in a circular pattern within the rotor casing, alternating The stator includes a plurality of rotor permanent magnet elements arranged to have the magnetic polarity of The rotation of the rotor generates the selected pressure setting of the valve assembly. The kit according to claim 12, wherein the rotor casing has the plurality of motor teeth.

14. The valve assembly, An inlet port located between the rotor casing and the outside of the housing, , an inlet port terminating at the end of the rotor casing within the valve seat, spring and, A valve element biased with respect to the valve seat by the spring, wherein the valve The valve element and the valve seat together form an opening, An outlet port located between the rotor casing and the outside of the housing. Therefore, the valve assembly discharges fluid through the opening to the outlet port. Therefore, the pressure of the fluid in the inlet port is the selected pressure of the valve assembly. An outlet port is configured such that the opening opens when a setting is exceeded. The kit according to claim 13, further comprising:

15. The valve assembly is a rotor marker attached to the rotor, and its A rotor marker that rotates together with the rotor, and a housing that is fixedly attached to the rotor. The housing marker is included, and the position of the rotor marker relative to the housing marker is The kit according to claim 13, which shows the pressure setting of the valve assembly.

16. On the valve assembly, the monitoring device and, optionally, the program The claim further comprises a positioning disk used for positioning a sizing device. The kit described in item 1.

17. A surgically implantable shunt valve assembly, A housing formed from a physiologically compatible material on the outside, A magnetically operable motor disposed within the housing, comprising a stator and an external In response to the change in the magnetic polarity of the stator induced by the magnetic field, the stator A rotor configured to rotate, the rotor comprising a rotor casing and the rotor Multiple rods arranged in a circular pattern within the casing, with alternating magnetic polarities. The system includes a permanent magnet element and the rotation of the rotor relative to the stator, and the shunt bar The selected pressure setting for the lubrication assembly is generated, and the rotor casing generates multiple motor teeth A magnetically operable motor having, An inlet port located between the rotor casing and the outside of the housing, , an inlet port terminating at the end of the rotor casing within the valve seat, spring and, A valve element biased with respect to the valve seat by the spring, wherein the valve The valve element and the valve seat together form an opening, An outlet port located between the rotor casing and the outside of the housing. The shunt valve assembly then discharges fluid through the opening to the outlet port. To release the fluid, the pressure of the fluid in the inlet port is in front of the shunt valve assembly. An outlet port is configured such that the opening opens when the pressure exceeds the selected pressure setting, A magnetically operated mechanical brake assembly, The aforementioned magnetically operated mechanical brake assembly The system comprises an indicator housing and a magnet disposed within the indicator housing. The indicator, The brakes are coupled to the indicator and prevent the rotor from rotating. The lock position is positioned between the teeth of the motor teeth, and the brake is the plurality of rotor teeth A movable indicator that moves in response to the movement of the indicator between the unlocked position and the unlocked position in which the teeth are disengaged. The brake wherein the indicator moves in response to exposure to the external magnetic field. It is possible, with brakes and including, A surgically implantable shunt valve assembly.

18. The rotor casing includes a cam that engages with the spring, and as a result, the rotation of the rotor This changes the biasing tension of the spring relative to the cam, thereby affecting the shunt valve. To generate the selected pressure setting of the semblage, the spring relative to the valve element A surgically implantable shunt valve assembly according to claim 17, for adjusting tension.

19. The cam realizes the shape of an Archimedes spiral or a combination of Archimedes spirals. A surgically implantable shunt valve assembly according to claim 18, formed in such a manner. 。

20. The spring is a cantilever spring, and the cantilever spring contacts the valve element. The surgically implantable device according to claim 18, comprising a cam and a second arm that contacts the cam Possible shunt valve assembly.

21. The rotor casing is such that the rotor is in both clockwise and counterclockwise directions. The surgical method according to claim 17, further comprising a rotor stopper to prevent 360-degree rotation of the rotation An implantable shunt valve assembly.

22. The system further comprises a cam that engages with the spring and is integrated with the rotor casing, and as a result The rotation of the rotor causes the rotation of the cam, and the spring relative to the valve element Adjust the tension, The aforementioned spring, The fulcrum and, A first arm is attached to the pivot point and configured to engage with the cam, A cantilever has a free end that extends from the aforementioned pivot point and is configured to abut against the valve element. Chi Arm and It is a cantilever spring that includes The pivot point, the first arm, and the cantilever arm are connected by the cam to the first The first force applied to the arm is applied to the valve element by the cantilever spring. It is configured to provide a lever effect such that the second force is converted into the second force Less than a force of 1, The surgically implantable shunt valve assembly according to claim 17.

23. The magnetically operable motor is configured such that an external sensor magnetically determines the position of the rotor. A first positioning magnet and a second positioning magnet that orient the indicator magnet to enable this A surgically implantable shunt valve assembly according to claim 17, further comprising a stone.

24. A rotor marker attached to the rotor, the rotor that rotates together with the rotor The system further comprises a ta-marker and a housing marker fixedly attached to the housing. The position of the rotor marker relative to the housing marker is such that the surgically implantable The surgically implantable shunt valve assembly according to claim 17, showing the pressure setting of the shunt valve assembly. A capable shunt valve assembly.

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