Externally programmable magnetic valve assembly and controller

Abstract

To provide an externally programmable shunt valve assembly with a motor having a rotor that is operable in response to an externally applied magnetic field and configured to increase or decrease the working pressure of the shunt valve assembly.SOLUTION: The motor may further include a position sensing mechanism that allows a position of the rotor and associated pressure setting of the valve to be determined using an external magnetic sensor. In certain examples, the motor further includes a mechanical brake which is magnetically operable between a locked position and an unlocked position and which, in the locked position, prevents rotation of the rotor.SELECTED DRAWING: Figure 1A

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 PROGRAMMABLE MAGNETIC VALVE ASSEMBLY AND CONTROLLER", and claims the benefit under 35 U.S.C. § 119(e) and PCT Article 8 of U.S. Provisional Application No. 62 / 374,046, filed on August 12, 2016, entitled "EXTERNALLY PROGRAMMABLE MAGNETIC VALVE ASSEMBLY AND CONTROLLER", which is now expired, and the entire content of which is 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 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 hydrocephalus associated with an obstructive lesion within the subarachnoid space. Normal pressure hydrocephalus (NPH), a form of communicating hydrocephalus, mainly affects people over 60 years old and is characterized by nominally normal - pressure CSF. Typical symptoms of NPH include gait disorder, incontinence, and dementia. In summary, NPH presents as ventricular enlargement with substantially normal CSF pressure.

[0003] The goal in treating hydrocephalus is to reduce ventricular pressure so that the size of the ventricles returns to normal levels. Hydrocephalus is often treated by implanting a shunt in the brain to drain excess CSF from the ventricles or lumbar spinal meningeal space (in communicating hydrocephalus). Such shunts are called ventriculoatrial (VA) when the fluid is diverted from the ventricles to the atria, or ventriculoperitoneal (VP) when the fluid is diverted from the ventricles to the peritoneum, or lumbar-peritoneal (LP) when CSF is diverted from the lumbar region to the peritoneum. These shunts generally consist of a cerebral catheter (for ventricular shunts) inserted through the brain into the ventricles or a lumbar catheter (for lumbar shunts) inserted through a needle into the lumbar spinal space, and a one-way valve system that drains the fluid from the ventricles to a body reservoir such as the jugular vein (ventricular shunt) or the peritoneal space (ventriculoperitoneal or lumbar shunt).

[0004] U.S. Patent No. 4,595,390 describes a shunt having a spherical sapphire ball biased against a conical valve seat by a stainless steel spring. The pressure of the CSF pushes the sapphire ball and spring in a direction that lifts the ball away from the seat. When the pressure difference across the valve exceeds the so-called "popping" or opening pressure, the ball rises away from the seat, allowing the CSF to flow through the valve and thereby discharge the CSF. U.S. Patent No. 4,595,390 further describes an externally programmable shunt valve that allows the valve pressure setting to be changed by attaching a transmitter that emits a magnetic signal above the patient's head above the location of the implanted shunt. By using an external programmer with a magnetic transmitter, the valve pressure setting can be non-invasively adjusted according to ventricular size, CSF pressure, and treatment goals.

[0005] U.S. Patent No. 4,615,691 describes, for example, an example of a magnetic stepping motor that can be used with a shunt valve, U.S. Patent No. 4,595,390.

[0006] Magnetically adjustable shunts allow the pressure of an implanted shunt to be adjusted externally, but these existing shunts have several limitations. For example, the pressure setting of a magnetically adjustable shunt valve may change when a patient with an implanted magnetically adjustable shunt valve is near a strong magnet or strong magnetic field, such as a magnetic resonance imaging (MRI) device. In addition, verifying the pressure setting of existing magnetic valves may require the use of radiopaque markers on the valve, which are detected using X-rays taken at the location where the valve is implanted. Furthermore, some programmers used to adjust the pressure setting of implanted valves are relatively large and heavy and require 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 Initiative] [Problems that the invention aims to solve]

[0008] Therefore, it would be desirable to design improved ventricular and lumbar shunts, as well as improved programmers for adjusting the shunts. [Means for solving the problem]

[0009] The embodiments and aspects relate to an externally programmable valve assembly comprising a magnetic motor configured to increase or decrease the pressure setting of the valve in a continuous or finite increment. The valve assembly may be adapted for implantation in a patient to drain fluid from a patient's organ or body cavity. In these embodiments, the valve assembly includes an inlet port adapted for fluid connection (by a surgeon during fabrication or surgery) to one end of a catheter. The second end of the catheter is inserted into an organ or body cavity to drain 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 extracorporeal drainage reservoir such as a bag. Examples of organs and body cavities from which fluid can be drained using the valve assembly of the present invention include, but are not limited to, the eye, ventricle, peritoneal cavity, pericardial sac, (pregnant) uterus, and pleural cavity. In particular, the valve assembly may be adapted for implantation in a patient suffering from hydrocephalus. In such embodiments, the inlet port is adapted to a fluid connection to the first end of an inflow catheter (i.e., an intracerebral or intrathecal catheter), and the outlet port is adapted to a fluid connection to the first end of a drainage catheter. When implanted in the patient, the second end of the intracerebral catheter is inserted into the patient's ventricle or lumbar spinal cavity, and the second end of the drainage catheter is inserted into a suitable body reservoir in the patient, such as the jugular vein or peritoneal cavity. Thus, when implanted in the patient, the device enables fluid communication between the patient's ventricle or lumbar region and the subject's body reservoir, allowing cerebrospinal fluid to flow from the ventricle or lumbar region through the valve casing to the body reservoir when the pressure in the ventricle or CSF exceeds the opening pressure of the valve assembly. The patient may have hydrocephalus with increased intracranial pressure or normal pressure hydrocephalus. Removing CSF from the ventricle or lumbar cavity reduces intracerebral pressure.

[0010] Further aspects and embodiments relate to methods for determining the pressure setting of an implanted valve assembly and adjusting the pressure setting of the valve assembly after implantation in a patient. As will be described in more detail below, according to certain embodiments, adjustment of the valve pressure setting can be achieved by the displacement of a magnetically actuated rotor within the valve assembly, resulting in a change in the tension of a spring that provides a biasing force on the valve elements. The rotor rotates within the rotor casing in response to an applied external magnetic field.

[0011] As will be described in more detail below, certain aspects and embodiments relate to magnetically operable motors suitable for integration into implantable valve assemblies. A magnetic motor assembly includes a stator having a plurality of stator lobes and a rotor having a plurality of magnetic poles and configured to rotate around the stator. As will be further described below, an externally applied magnetic field (from outside the body in which the valve assembly is implanted) is used to magnetize the stator to cause rotation of the rotor. Magnetically operable motors have the advantage of allowing mechanical movement within an implantable valve assembly to change the pressure setting of the valve, avoiding the need for physical connection to the valve assembly from outside the body or the use of implantable batteries. Furthermore, as will be further described below, embodiments of magnetic motor assemblies are configured to have high resistance to any influence from strong external magnetic fields not particularly relevant to the desired control of the motor, such as magnetic fields generated by MRI or nuclear magnetic resonance (NMR) devices. In addition, certain embodiments of magnetic motors include a mechanism that allows an individual, such as a physician, to view the current pressure setting of the valve in which the magnetic motor is used without requiring the use of X-rays or other imaging techniques.

[0012] Certain embodiments also include a method for reducing the ventricular size of a patient requiring it, which includes surgically implanting a valve assembly in the patient and setting the valve's opening pressure to a pressure lower than the ventricular pressure prior to the valve's implantation. Alternatively, the opening pressure of an implantable valve assembly may be set to a pressure higher than the ventricular pressure so that the ventricular size can be increased in a patient requiring it.

[0013] According to one embodiment, a surgically implantable shunt valve assembly comprises a housing formed externally from a physiologically compatible material, and a magnetically operable motor disposed within the housing, the magnetically operable motor including a stator and a rotor configured to rotate relative to the stator in response to a change in the magnetic polarity of the stator induced by an external magnetic field, the rotor including a rotor casing and a plurality of rotor permanent magnet elements arranged in a circular arrangement within the rotor casing and having alternating magnetic polarities, the rotation of the rotor relative to the stator generating a selected pressure setting for the shunt valve assembly. The shunt valve assembly further comprises an inlet port located between the rotor casing and the outside of the housing, terminating at the end of the rotor casing within the valve seat; a spring and a valve element biased by the spring toward the valve seat, wherein the valve element and the valve seat together form an opening; and an outlet port located between the rotor casing and the outside of the housing, wherein the shunt valve assembly is configured such that the opening opens when the pressure of the fluid in the inlet port exceeds a selected pressure setting of the shunt valve assembly in order to discharge fluid through the opening to the outlet port.

[0014] Another embodiment relates to a system comprising an externally programmable, surgically implantable shunt valve assembly, a non-implantable transmitter head, and a control device coupled to the transmitter head. The surgically implantable shunt valve assembly comprises a housing having an exterior formed from a physiologically compatible material, and a magnetically operable motor disposed within the housing, wherein the magnetically operable motor includes a stator and a rotor configured to rotate relative to the stator in response to a change in the magnetic polarity of the stator induced by an external magnetic field, the rotor including a rotor casing and a plurality of rotor permanent magnet elements arranged in a circular arrangement within the rotor casing and having alternating magnetic polarities, the number of rotor permanent magnet elements such that radially opposing elements among the plurality of rotor permanent magnet elements have the same magnetic polarity, and the rotation of the rotor relative to the stator is transmitted to the shunt valve The assembly may include a motor that generates a selected pressure setting for the assembly; an inlet port located between the rotor casing and the outside of the housing, the inlet port terminating at the end of the rotor casing within a valve seat; a spring; a valve element biased by the spring toward the valve seat, the valve element and the valve seat together forming an opening; and an outlet port located between the rotor casing and the outside of the housing, the shunt valve assembly configured such that the opening opens when the pressure of the fluid in the inlet port exceeds a selected pressure setting for the shunt valve assembly, allowing fluid to be discharged through the opening to the outlet port. A non-embedd transmitter head may include a magnet assembly configured to generate an external magnetic field to induce rotation of the rotor relative to the stator. A control device may be configured to provide signals to the transmitter head to control the transmitter head to generate an external magnetic field in order to set the pressure setting of the shunt valve assembly to a selected pressure setting.

[0015] Another embodiment relates to a surgically implantable valve including a magnetic motor for adjusting the pressure setting of the valve, wherein the magnetic motor is physically isolated from a power source and powered by an external magnetic field applied from outside the valve. The magnetic motor may comprise a rotor including a circular rotor casing and a plurality of permanent rotor magnets arranged in a circular arrangement within the rotor casing and having alternating magnetic polarities, wherein the rotor casing is configured to rotate around a central axis of rotation, and a stator formed as a facing circular stator disk and positioned for each of four quadrants below the rotor magnets, wherein when magnetized under the influence of an external magnetic field, the stator strengthens and directs the local magnetic field in its vicinity such that it causes incremental movement of the rotor around the central axis of rotation. The number of permanent rotor magnets may be such that radially opposing permanent rotor magnets have the same or opposite magnetic polarity.

[0016] According to another embodiment, a surgically implantable shunt valve assembly comprises a spring, a valve element biased by the spring against a valve seat, the valve element and valve seat together forming an opening through which fluid is diverted by the valve, and a magnetic motor for adjusting the pressure setting of the valve, the magnetic motor being physically isolated from a power source and powered by an external magnetic field applied from outside the valve assembly. The magnetic motor may include a rotor casing, a rotor having a plurality of permanent rotor magnets arranged in a circle within the rotor casing and having alternating magnetic polarities, and a cam for engaging a spring, configured such that the rotor rotates around a central axis of rotation, and a stator made of a soft magnetic and permeable material, positioned below the rotor, which, when magnetized under the influence of an external magnetic field, strengthens and directs a local magnetic field in its vicinity so as to cause rotation of the rotor around the central axis of rotation, the rotation of the rotor causing rotation of a cam for adjusting the tension of the spring against the valve element, thereby adjusting the pressure setting of the shunt valve assembly.

[0017] According to another embodiment, a surgically implantable shunt valve assembly comprises a spring, a valve element biased by the spring against a valve seat, the valve element and valve seat together forming an opening through which a fluid is diverted by the valve, and a magnetic motor for adjusting the pressure setting of the valve, the magnetic motor being physically isolated from a power source and powered by an external magnetic field applied from outside the valve assembly. The magnetic motor may include a rotor having a rotor casing, a plurality of permanent rotor magnets arranged in a circle within the rotor casing and having alternating magnetic polarities, and a cam for engaging a spring, configured such that the rotor rotates around a central axis of rotation; a stator made of a soft magnetic and permeable material and positioned below the rotor, which, when magnetized under the influence of an external magnetic field, strengthens and directs a local magnetic field near itself so as to cause rotation of the rotor around the central axis of rotation, the rotation of the rotor causing rotation of a cam for adjusting the tension of a spring on a valve element, thereby adjusting the pressure setting of a shunt valve assembly; and a mechanical brake that is magnetically operable between a locked position and an unlocked position and configured to prevent rotation of the rotor in the locked position.

[0018] Another embodiment relates to a surgically implantable valve, comprising a magnetic motor for adjusting the pressure setting of a valve, the magnetic motor being physically isolated from a power source and powered by the influence of an external magnetic field applied from outside the valve, the magnetic motor comprising a rotor including a circular rotor casing and a plurality of permanent rotor magnets arranged in a circular manner within the rotor casing and having alternating magnetic polarities, the rotor casing being configured to rotate around a central axis of rotation, and an X-shaped stator made of a soft magnetic and permeable material formed and positioned relative to the rotor, the stator, when magnetized under the influence of an external magnetic field, strengthens and directs the local magnetic field in its vicinity to cause incremental movement of the rotor around the central axis of rotation. The number of permanent rotor magnets may be such that radially opposing permanent rotor magnets have the same or opposite magnetic polarities.

[0019] In another embodiment, a method for adjusting the operating pressure of a shunt valve assembly implanted in a patient requiring it includes applying an external magnetic field to the outside of the patient in close proximity to the implanted shunt valve assembly.

[0020] According to one embodiment, a method for reducing the ventricular size of a patient requiring such reduction includes implanting a shunt valve assembly in the patient and setting a selected pressure in the valve assembly to a pressure lower than the patient's ventricular pressure prior to valve implantation.

[0021] According to another embodiment, a method for treating a patient suffering from hydrocephalus includes implanting a shunt valve assembly in the patient and setting a selected pressure in the shunt valve assembly to a pressure lower than the patient's ventricular pressure.

[0022] In another embodiment, a method for increasing the ventricular size of a patient requiring it includes implanting a shunt valve assembly in the patient and setting a selected pressure in the shunt valve assembly to a pressure higher than the patient's ventricular pressure.

[0023] During the treatment process, it is expected that the clinician will need to increase or decrease the selected operating pressure of the valve in order to effectively manage the patient's disease. However, during use, the valve is exposed to an environmental magnetic field that can potentially change the operating pressure of the valve. Aspects and embodiments provide a valve mechanism design that facilitates adjusting the valve mechanism using a magnetic field generated by a programmer while resisting adjustment by an external environmental magnetic field.

[0024] Further aspects and embodiments relate to a kit for setting the pressure within a surgically implantable shunt valve. In some embodiments, the kit includes a surgically implantable shunt valve assembly having a magnetically operable motor configured to provide a selected pressure setting of the shunt valve assembly, a pressure reader configured to provide a pressure reading of the surgically implantable shunt valve assembly, and a programmer having at least one programmer magnet, the at least one programmer magnet being selectively movable and configured to activate the magnetically operable motor to allow a user to adjust the pressure setting of the surgically implantable shunt valve assembly to match the pressure setting value of the programmer.

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

[0026] In some embodiments, the pressure reader further includes a concave surface defined on the lower surface of the pressure reader.

[0027] In some embodiments, the programmer further includes a user interface.

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

[0029] In some embodiments, the program writer further comprises a wheel rotatable in a first direction to increase the pressure setpoint, and the wheel rotatable in a second direction to decrease the pressure setpoint.

[0030] In some embodiments, the program programmer further includes a cavity on the underside of the program programmer.

[0031] In some embodiments, the pressure reader includes one of a magnet and a Hall sensor.

[0032] In some embodiments, a surgically implantable shunt valve assembly comprises a housing, the exterior of which is formed from a physiologically compatible material; a magnetically operable motor disposed within the housing, the magnetically operable motor comprising a stator and a rotor configured to rotate relative to the stator in response to a change in the magnetic polarity of the stator induced by an external magnetic field, the rotor comprising a rotor casing and a plurality of rotor permanent magnet elements arranged in a circular arrangement within the rotor casing and having alternating magnetic polarities, the rotation of the rotor relative to the stator generating a selected pressure setting for the shunt valve assembly, The shunt valve assembly comprises a magnetically operable motor including a rotor casing, an inlet port located between the rotor casing and the outside of the housing, the inlet port terminating at the end of the rotor casing within a valve seat, a spring, a valve element biased by the spring toward the valve seat, the valve element and the valve seat together forming an opening, and an outlet port located between the rotor casing and the outside of the housing, the shunt valve assembly configured such that the opening opens when the pressure of the fluid in the inlet port exceeds a selected pressure setting of the shunt valve assembly in order to discharge fluid through the opening to the outlet port.

[0033] In some embodiments, a surgically implantable shunt valve assembly includes a rotor marker attached to a rotor, which rotates with the rotor, and a housing marker fixedly attached to the housing, the position of the rotor marker relative to the housing marker indicating the pressure setting of the surgically implantable shunt valve assembly.

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

[0035] In some embodiments, the magnetically operable motor is a stepper motor having a rotatable rotor, and the surgically implantable shunt valve assembly further comprises a mechanical brake mechanism that is magnetically operable between a locked position and an unlocked position and configured to prevent the rotor from rotating in the locked position, and an indicator magnet assembly configured to allow an external sensor to magnetically determine the position of the rotor and thereby determine the pressure setting.

[0036] Another embodiment relates to a surgically implantable shunt valve assembly comprising a housing. The exterior of the housing is formed from a physiologically compatible material. The valve assembly further comprises a magnetically operable motor located within the housing. The magnetically operable motor includes a stator and a rotor configured to rotate relative to the stator in response to a changing magnetic polarity of the stator induced by an external magnetic field. The rotor includes a rotor casing and a plurality of rotor permanent magnet elements arranged in a circular pattern within the rotor casing and having alternating magnetic polarities. The rotation of the rotor relative to the stator generates a selected pressure setting for the shunt valve assembly, and the rotor casing has a plurality of motor teeth. The valve assembly further comprises an inlet port located between the rotor casing and the exterior of the housing, the inlet port terminating at its end in the rotor casing within the valve seat. The valve assembly further comprises a spring and a valve element biased by the spring toward the valve seat, the valve element and valve seat together forming an opening, and an outlet port located between the rotor casing and the exterior of the housing. The valve assembly is configured such that the opening opens when the pressure of the fluid in the inlet port exceeds a selected pressure setting of the shunt valve assembly in order to discharge fluid through the opening to the outlet port. The valve assembly further includes a magnetically operated mechanical brake assembly, which includes an indicator having an indicator housing and a magnet disposed within the indicator housing, and a brake coupled to the indicator and movable in response to the movement of the indicator between a locked position in which the brake is positioned between the teeth of a plurality of motor teeth to prevent the rotation of the rotor and an unlocked position in which the brake disengages the teeth of a plurality of rotor teeth, and the brake is movable in response to the indicator being exposed to an external magnetic field.

[0037] Embodiments of the valve assembly may further include configuring a rotor casing that includes a cam that engages with a spring, such that the rotation of the rotor changes the biasing tension of the spring on the cam, thereby adjusting the tension of the spring on the valve element to produce a selected pressure setting of the shunt valve assembly. The cam may be formed to realize an Archimedean spiral shape or a combination of Archimedean spirals. The spring may be a cantilever spring. The cantilever spring may include a cantilever arm that abuts against the valve element and a second arm that abuts against the cam. The rotor casing may further include a rotor stopper that prevents 360-degree rotation of the rotor. The stator may be plus (+) shaped. The valve assembly may further include a cam that engages with the spring and is integrated with the rotor casing, so that the rotation of the rotor causes the rotation of the cam to adjust the tension of the spring on the valve element. The spring may be a cantilever spring comprising a pivot point, a first arm attached to the pivot point and configured to engage with a cam, and a cantilever arm extending from the pivot point and having a free end configured to abut against a valve element. The pivot point, the first arm, and the cantilever arm may be configured to provide a lever effect such that a first force applied to the first arm by the cam is converted into a second force applied to the valve element by the cantilever spring, the second force being less than the first force. The spring may be a cantilever spring. A magnetically operable motor may further include first and second positioning magnets that orient indicator magnets, enabling an external sensor to magnetically determine the position of the rotor. The valve assembly may further include a rotor marker attached to the rotor such that the rotor marker rotates with the rotor, and a housing marker fixedly attached to the housing. The position of the rotor marker relative to the housing marker can indicate the pressure setting of a surgically implantable shunt valve assembly. The rotor marker may include tantalum, and the housing marker may include tantalum.

[0038] Another embodiment relates to a kit for setting pressure in a surgically implantable shunt valve. In one embodiment, the kit comprises a surgically implantable shunt valve assembly having a magnetically actuated motor configured to provide a selected pressure setting for the shunt valve assembly; a monitoring device configured to detect the pressure setting of the surgically implantable shunt valve assembly; and a programmer device having at least one programmer magnet. The at least one programmer magnet is selectively movable and configured to actuate a magnetically actuated motor, allowing a user to adjust the pressure setting of the surgically implantable shunt valve assembly to match the pressure setting of the programmer. The surgically implantable shunt valve assembly includes a magnetically actuated mechanical brake assembly, which includes an indicator having an indicator housing and a magnet disposed within the indicator housing; and a brake coupled to the indicator and movable in response to the movement of the indicator between a locked position in which the brake is positioned between the teeth of a plurality of motor teeth to prevent rotation of the motor rotor, and an unlocked position in which the brake disengages the teeth of a plurality of rotor teeth, and the brake is movable in response to the indicator being exposed to an external magnetic field applied by the programmer device.

[0039] Embodiments of the kit may further include configuring a programmer device to have a user interface. The programmer device may further include at least one button for turning the programmer device on and off. The user interface of the programmer device may include a first button for increasing a pressure setpoint and a second button for decreasing a pressure setpoint. The programmer device may include at least one start button for starting a programming sequence. The user interface may further include a liquid crystal display (LCD) configured to display pressure readings. The programmer device may include a housing, a motor coupled to the housing, and a magnet assembly coupled to the motor and configured to rotate relative to the housing. The magnet assembly may include at least one permanent magnet for applying an external magnetic field to a surgically implantable shunt valve assembly. The motor may include a shaft having a drive gear. The magnet assembly may further include a magnet support having a bearing, a driven gear coupled to the drive gear, a magnetic bridging plate coupled to the magnet support, and at least one permanent magnet coupled to the magnetic bridging plate. The motor may be a DC motor. The programmer device may include software that controls the movement of at least one permanent magnet to achieve a proper programming sequence. The monitor device may include a user interface. The user interface may include buttons for turning the monitor device on and off. The user interface may further include a liquid crystal display (LCD) configured to display pressure setting readings. The monitor device may include a housing and a monitor assembly supported by the housing. The monitor assembly may include a monitor sensor that occupies the center of the monitor assembly and is configured to detect the position of a magnetically operable motor of a surgically implantable shunt valve assembly. At least one monitor sensor may include a first sensor that occupies the center of the monitor assembly and a second sensor that detects the position of a magnetically operable motor of a surgically implantable shunt valve assembly.The valve assembly may further include a housing. The exterior of the housing may be formed from a physiologically suitable material. A magnetically operable motor may be located within the housing. The magnetically operable motor may include a stator and a rotor configured to rotate relative to the stator in response to a changing magnetic polarity of the stator induced by an external magnetic field. The rotor may include a rotor casing and a plurality of rotor permanent magnet elements arranged in a circular pattern within the rotor casing and having alternating magnetic polarities. The rotation of the rotor relative to the stator can generate a selected pressure setting for the shunt valve assembly. The rotor casing may have a plurality of motor teeth. The valve assembly may include an inlet port located between the rotor casing and the exterior of the housing, the inlet port terminating at its rotor casing end in the valve seat. The valve assembly may further include a spring, a valve element biased by the spring relative to the valve seat, the valve element and valve seat together forming an opening, and an outlet port located between the rotor casing and the exterior of the housing. The valve assembly may be configured such that the opening opens when the pressure of the fluid in the inlet port exceeds a selected pressure setting of the shunt valve assembly, allowing fluid to be discharged through the opening to the outlet port. The valve assembly may include a rotor marker mounted on the rotor so as to rotate with the rotor, and a housing marker fixedly mounted to the housing. The position of the rotor marker relative to the housing marker can indicate the pressure setting of the surgically implantable shunt valve assembly. The rotor marker may contain tantalum, and the housing marker may also contain tantalum. The kit may further include a positioning disc used to position a monitoring device and optionally a programming device on the surgically implantable shunt valve assembly.

[0040] Another embodiment relates to a kit for setting pressure in a surgically implantable shunt valve. In one embodiment, the kit comprises a surgically implantable shunt valve assembly having a magnetically operable motor configured to provide a selected pressure setting for the shunt valve assembly; a monitoring device configured to detect a pressure setting reading for the surgically implantable shunt valve assembly; and a programmer device having at least one programmer magnet. The at least one programmer magnet is selectively movable and configured to actuate the magnetically operable motor, allowing a user to adjust the pressure setting of the surgically implantable shunt valve assembly to match the pressure setting of the programmer. The programmer device includes a housing; a motor coupled to the housing; and a magnet assembly coupled to the motor and configured to rotate relative to the housing, the magnet assembly including at least one permanent magnet for applying an external magnetic field to the surgically implantable shunt valve assembly.

[0041] Embodiments of the kit may further include configuring a programmer device to have a user interface. The programmer device may further include at least one button for turning the programmer device on and off. The user interface of the programmer device may include a first button for increasing the pressure setpoint and a second button for decreasing the pressure setpoint. The programmer device may include at least one start button for starting a programming sequence. The motor may include a shaft having a drive gear. The magnet assembly may further include a magnet support having a bearing, a driven gear coupled to the drive gear, a magnetic bridging plate coupled to the magnet support, and at least one permanent magnet coupled to the magnetic bridging plate. The motor may be a DC motor. The kit may further include a positioning disc used to position the monitor device and optionally the programmer device on a surgically implantable shunt valve assembly. The programmer device may be configured to rotate the rotor of the valve device in a first direction to a minimum pressure setting before starting to rotate the rotor in a second direction opposite to the selected pressure setting.

[0042] Another embodiment relates to a kit for setting pressure in a surgically implantable shunt valve. In one embodiment, the kit comprises a surgically implantable shunt valve assembly having a magnetically operable motor configured to provide a selected pressure setting for the shunt valve assembly; a monitor device configured to detect a pressure setting reading of the surgically implantable shunt valve assembly; and a programmer device having at least one programmer magnet. The at least one programmer magnet is selectively movable and configured to actuate the magnetically operable motor, allowing a user to adjust the pressure setting of the surgically implantable shunt valve assembly to match the pressure setting of the programmer. The monitor includes a housing and a monitor assembly supported by the housing. The monitor assembly includes at least one monitor sensor occupying the center of the monitor assembly and configured to detect the position of the magnetically operable motor of the surgically implantable shunt valve assembly.

[0043] Embodiments of the kit may further include configuring the monitor device to have a user interface. The user interface may include buttons for turning the programmer device on and off. The user interface may further include a liquid crystal display (LCD) configured to display pressure setting readings. The kit may further include a positioning disk used to position the monitor device and optionally the programmer device on a surgically implantable shunt valve assembly. The monitor may further include a pressure recall button configured to recall previous pressure readings. At least one monitor sensor may include a first sensor occupying the center of the monitor assembly and a second sensor for detecting the position of a magnetically operable motor on the surgically implantable shunt valve assembly.

[0044] Further embodiments, configurations, and advantages of these exemplary aspects and configurations are described in detail below. The embodiments disclosed herein can be combined with other embodiments in any manner consistent with at least one of the principles disclosed herein. References to “embodiments,” “several embodiments,” “alternative embodiments,” “various embodiments,” and “one embodiment” are not necessarily mutually exclusive, and indicate that certain features, structures, or characteristics described may be included in at least one embodiment. The appearance of such terms herein does not necessarily mean that all refer to the same embodiment.

[0045] Various aspects of at least one embodiment are described below with reference to the accompanying drawings, where similar reference letters refer to the same parts throughout the various drawings. For clarity, not all components may be labeled in all drawings. The drawings are not necessarily to scale, and instead, the emphasis is generally on illustrating the principles of the invention. The drawings are included to illustrate and further understand the various aspects and embodiments, and are incorporated into and constitute part of this specification, but are not intended to define limitations of the invention. [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 designs relate to valve assemblies incorporating a magnetic motor configured to increase or decrease the operating pressure of a valve in a continuous or finite increment. As will be described in more detail below, the opening pressure of a valve element may be adjusted by magnetically repositioning a rotor within the casing of the valve assembly, thereby increasing or decreasing the fluid flow through the valve assembly. Certain embodiments of the valve assembly may be adapted for implantation in patients suffering from hydrocephalus and used to drain CSF.

[0048] In detail, certain aspects and embodiments provide an externally magnetically programmable valve incorporating a magnetic motor and external controller having the following features: The valve is configured to allow an operator, such as a physician, to adjust the valve continuously or in small pressure increments (e.g., increments of about 10 mmH2O) up to a pressure of about 200 mmH2O, and the valve has a "closed" setting of about 300-400 mmH2O. The valve is highly resistant to unprogrammed external magnetic fields in environments such as the magnetic field of a 3 Tesla MRI, and as a result, the valve's pressure setting does not change significantly when a patient is near an MRI machine or other instrument (other than the valve controller) that generates the magnetic field. In certain embodiments, the valve is configured to allow an operator (e.g., a physician) to verify the valve's pressure setting by means other than X-rays. Furthermore, according to certain embodiments, the valve controller is small, highly portable, and battery-powered. These and other features and configurations of the valve according to various embodiments are described in more detail below.

[0049] Referring to Figures 1A and 1B, an example of an implantable shunt valve assembly 100 is shown, which includes two valves 200 and 300 separated by a pump chamber 110. In one example, a ventricular catheter 120 can be connected to the inlet 130 of the valve assembly 100, and a drainage catheter can be attached to the connector 140 and connected to the outlet 150 of the valve assembly. The recess of the pump chamber 110 pumps fluid through valve 300 toward the outlet 150 and the drainage catheter. When the pump chamber is released after being compressed, fluid is pumped through valve 200. Valve 200 is an externally programmable valve including a magnetic motor, as will be described in more detail below. The second valve 300 may be, for example, a check valve. In this case, after passing through the programmable valve 200, the fluid flows through the check valve 300 before exiting to the drainage catheter. In one example, the programmable valve 200 operates to keep the valve assembly 100 closed until the fluid pressure rises to a predetermined pressure setting of the valve. Generally, the check valve 300 may be set to a low pressure, allowing the pressure setting of the programmable valve 200, which includes a magnetic motor, to control the fluid flow through the valve assembly 100. In another example, the second valve 300 may be a gravity-actuated valve that allows the valve assembly 100 to automatically adjust in response to changes in CSF hydrostatic pressure that occur when the patient's posture changes (i.e., abruptly moving from a horizontal (lying down) position to a vertical (standing) position). Specifically, to avoid opening the valve in response to these pressure changes, which could cause excessive discharge of CSF, the valve assembly 100 may include a gravity-actuated valve connected in series with the programmable valve 200 on the outlet side, as shown in Figures 1A and 1B, and the gravity-actuated valve is configured to open at a higher pressure when the patient is substantially vertical.

[0050] Those skilled in the art will understand, in light of the advantages of this disclosure, that the length, size, and shape of various embodiments of the valve assembly 100 can be adjusted. Certain embodiments of the valve assembly 100 may further include a reservoir or pre-burning chamber or sub-chamber for sampling fluid and / or injecting pharmaceuticals or dyes, a power on / off device, a siphon prevention device or other flow compensation device, and / or additional catheters. If included, a pre-burning chamber (not shown in Figures 1A and 1B) should be connected between the inlet 130 and the programmable valve 200. According to certain embodiments, the valve assembly 100 may include a combination of a pump chamber 110, a pre-burning chamber, a second valve 300 (which may be, for example, a check valve or a gravity-operated valve), and optionally a siphon prevention device (not shown). In other embodiments, one or more of these components may be omitted. For example, the valve assembly 100 may include a pump chamber 110 and a second valve 300 without a pre-burning chamber, as shown in Figures 1A and 1B. The pump chamber 110 may be omitted, either or alternatively. In such embodiments, after the fluid passes through the programmable valve 200, the fluid flows through the second valve 300. Alternatively, the valve assembly 100 may include a pre-burning chamber with or without the pump chamber 110 or the second valve 300. The valve assembly 100 can be surgically implanted in a patient using well-known procedures.

[0051] Figure 2 shows a three-dimensional view of an example of an implantable, magnetically programmable valve 200 according to a particular embodiment. Figures 3A and 3B show external views of the implantable, magnetically programmable valve 200 of Figure 2 according to a particular embodiment. Figure 3A is a plan view and Figure 3B is an end view. The valve 200 includes a valve body 202 (also called a housing) that accommodates the components of the valve. The valve 200 includes an inlet port 204 and an outlet port 206. The inlet port 204 may be connected to a proximal (or inflow) catheter, and the outlet port 206 may be connected to a distal or outflow catheter. In the case of a valve assembly for diverting CSF fluid, the proximal catheter may be a ventricular catheter 120 or a lumbar catheter. In this case, the CSF fluid from the ventricle enters the ventricular catheter or lumbar catheter and enters the inlet port 204 of the valve assembly 100. The distal catheter functions as a drainage catheter connected to connector 140, guiding fluid to distant locations in the body for drainage, such as the right atrium of the heart (VA shunt) or the peritoneal cavity (VP or LP shunt).

[0052] The valve body 202 may include an upper cap 202a and a lower cap 202b that fits with the upper cap 202a to form a sealed enclosure suitable for implantation in the human body. The “upper” of the valve 200 is the side of the device oriented upward toward the patient’s scalp when implanted. The valve body 202 may be made from any physiologically compatible material. Non-limiting examples of physiologically compatible materials include polyethersulfone and silicon. As will be understood by those skilled in the art, the valve body 202 may have a variety of shapes and sizes, at least in part, depending on the size, shape, and arrangement of the components within the valve 200.

[0053] Various aspects and features of the valve 200, including the operation of the magnetic motor, as well as its operation, are described below with reference to Figures 2, 3A-3B, and 4A-4C. Figure 4A is a cross-sectional view of an example of the valve 200 showing specific components of the magnetic motor, taken along line AA in Figure 3A. Figure 4B is a three-dimensional cross-sectional view of the example of the valve 200 in Figures 2 and 3A-3B showing specific components of the magnetic motor, taken along line BB in Figure 3A. Figure 4C is another cross-sectional view of the example of the valve 200 in Figures 2 and 3A-3B showing specific components of the magnetic motor, taken along line CC in Figure 3B. Figure 5 is another cross-sectional view of the example of the valve 200 in Figures 2 and 3A-3B, taken along line AA in Figure 3A.

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

[0055] The fluid enters the valve 200, for example, via a ventricular catheter, flows through the inlet port 204, and terminates at its casing end on the valve seat 210. The pressure of the fluid (e.g., CSF) pushes the valve element 208 and spring 400 in a direction that raises the valve element 208 away 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 flowing through the valve 200. The valve element 208 preferably has a larger diameter than the valve seat 210 so that the opening is substantially closed when the valve element 208 contacts the valve seat 210. The valve element 208 is positioned 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 pre-selected popping pressure. The term “popping pressure” refers to the pressure at which the valve opens, which is generally slightly higher than the operating pressure and is required to overcome inertia when the ball settles on the seat. The term "operating pressure" can also be called "working pressure," and it is the pressure at the valve while the fluid is flowing through valve 200. The closing pressure is the pressure at 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 Figures 4C and 5, the valve element 208 is a spherical ball. The spherical ball and / or valve seat 210 can be made from any suitable material, including, for example, synthetic ruby ​​or sapphire. The valve seat 210 provides a complementary surface, such as a frustoconical surface for the spherical valve element, such that the seating of the valve element 208 within the valve seat 210 results in a liquid-tight seal when the valve 200 is in the closed position. The pressure setting of such a valve, for example, the opening pressure, is adjusted by changing the biasing force of the valve element 208 against the valve seat 210. In one example, the valve element 208 and valve seat 210 are press-fitted into the housing 202 and, once the initial pressure setting is reached, may be held in place by friction. In this example configuration, the valve element 208 includes a ruby ​​ball, and the valve seat 210 is also made from ruby.

[0057] According to one embodiment, the biasing of the spring 400 on the valve element 208 is achieved using a magnetic motor that continuously or in finite increments increases or decreases the operating pressure of the valve 200. According to a particular embodiment, the magnetic motor includes a stator 528 and a rotor 510 that rotates relative to the stator 528 in response to an external magnetic control magnetic field. In one example, the rotor 510 rotates around a rotational axis 214. The configuration and operation of the embodiment of the magnetic motor will be described in more detail below.

[0058] Referring to Figures 2, 4A-4C, and 5, according to a particular embodiment, the rotor 510 includes a plurality of rotor magnet elements 512 arranged within a rotor casing 514. Figures 4C and 5 show the plurality of rotor magnet elements 512 arranged in a circular pattern and placed within the rotor casing 514. Thus, the rotor casing 514 includes a substantially circular channel 522 in which the rotor magnet elements 512 are housed. In one example, the rotor magnet elements 512 are permanent magnets, each having a south pole and a north pole. The rotor magnet elements 512 are arranged in a substantially circular pattern with alternating polarities, as shown in Figure 4C, so that the south and north poles alternate among all rotor magnet elements, whether viewed from above or below (as in Figure 4C). Thus, at any one angular position, the pole exposed on the upper surface of an element is opposite to the pole exposed on the lower surface. The rotor magnet elements 512 can be fixedly mounted to the rotor casing 514, which can house the rotor magnet elements 512 and function as a magnetic guide for directing their rotation. In Figures 2, 4C, and 5, the rotor magnet elements 512 are shown as circular disks, but it should be understood that the rotor magnet elements 512 do not have to be disk-shaped, but can have any shape, including, but are not limited to, elliptical, square, rectangular, hexagonal, or freeform. It is preferable that all rotor magnet elements 512 are either substantially the same size or substantially the same magnetic strength, even if their sizes vary to ensure smooth rotation of the rotor 510. According to one embodiment, the rotor 510 includes 12 rotor magnet elements 512 arranged in a circle, as shown in Figure 4C. According to another embodiment, the rotor 510 includes 10 rotor magnet elements 512 arranged in a circle, as will be further described below. In other examples, the rotor 510 may include a different number of rotor magnet elements 512, and the embodiments of the programmable valve disclosed herein are not limited to including 10 or 12 rotor magnet elements.

[0059] According to certain embodiments, in addition to the rotor magnet element 512, the rotor 510 may further include one or more additional reference magnet elements 524 (also called positioning magnets), as shown in Figures 4A and 5. 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 magnets 552, which are described below with reference to Figure 32. The (one or more) reference magnet elements 524 can be positioned on one or more rotor magnet elements 512 and can be used to enable a physician to determine the pressure setting of the valve 200 using an external magnetic sensor, such as a Hall sensor, without requiring X-rays or other imaging techniques, for example, as described further below.

[0060] The rotor 510 is configured to rotate around the rotor shaft 214 in response to an applied external magnetic field acting on the stator 528. Thus, the rotor 510 may further include bearing rings 516 arranged adjacent to the inner circumference of the rotor casing 514 to allow rotation of the rotor casing 514, as shown in Figures 4A and 4B. The bearing rings 516 may be made from, for example, synthetic ruby. In certain examples, the magnetic motor includes two bearing rings 516, namely an upper bearing ring and a lower bearing ring, as shown in Figures 4A and 4B. However, in other examples, the upper bearing ring may be omitted. In this case, the rotor 510 may tilt on the lower bearing ring 516 as it rotates. In certain examples, this tilt may be advantageous in increasing the resistance of the magnetic motor to adjustment by an external environmental magnetic field. In other examples, the lower bearing ring 516 may be wide enough to avoid tilting as the rotor 510 rotates on the bearing ring.

[0061] According to one embodiment, magnetic pulses from an external magnetic field are used to selectively magnetize the stator 528, which then acts on the magnetic rotor, thereby controlling the movement of the rotor 510. The external magnetic field may be generated, for example, by a magnetic coil or permanent magnet positioned in close proximity to the valve assembly, as will be described in more detail below. The stator 528 can be fabricated from a soft magnetic material that can be selectively magnetized by the application of an external magnetic field, and its magnetic polarity can be selectively controlled. For example, the stator 528 can be fabricated from a nickel-iron alloy having, for example, about 72-83% nickel. By controlling the magnetization and magnetic polarity of the stator 528, the rotor 510 can be fabricated to rotate in a controlled manner such that the rotor magnetic elements 512 rotate in response to the changing magnetization and magnetic polarity of the stator 528, as will be described further below.

[0062] The valve 200 is configured such that the rotation of the rotor 510 controls a spring 400 to adjust the bias of the valve element 208 against the valve seat 210, thereby adjusting the size of the opening and controlling the flow of fluid through the valve 200. In one embodiment, the valve 200 includes a cam 212 that engages with the spring 400, as shown in Figures 2, 4C, and 5. In the illustrated example, the cam 212 is integrated with the rotor casing 514, thereby avoiding the need for a separate cam element. In other embodiments, however, the cam can be coupled to the rotor 510 and positioned in contact with the spring 400, so that the rotation of the rotor 510 causes the movement of the cam 212, which in turn adjusts the tension of the spring 400 against the valve element 208. For example, the cam 212 can be mounted to the rotor casing 514 via a central shaft 520 so that the rotor casing 514 and the cam 212 can rotate together around a central axis 214. As used herein, the term “cam” refers to a separate cam element that can be attached to the rotor, or to a rotor casing 514 that acts as a cam, as in the illustrated example where the cam is integrated with the rotor casing.

[0063] For example, in certain applications of valve assembly 100, such as the treatment of hydrocephalus, the valve pressure range may be a very low pressure range, for example, about 0 to 200 mmH2O or 0 to 400 mmH2O. Furthermore, it may be desirable to make small pressure changes within that range. However, it may not be practical (due to manufacturing constraints, etc.) to manufacture a valve assembly in which the cam 212 is capable of making very small movements, for example, on the order of a few micrometers. Therefore, a very soft spring may be required to adapt to the low pressure range and small incremental changes in pressure. Conventionally, to obtain a sufficiently soft spring, the spring 400 would have to be very long. However, housing a very long and soft spring inside a retractable housing can present challenges. Therefore, aspects and embodiments relate to spring configurations that generate a lever or “gear reduction” effect so that reasonable (i.e., within the range of standard manufacturing capabilities) movement of the cam 212 can be translated into very small adjustments in low-pressure settings. In detail, certain embodiments include a cantilever spring configuration, for example, as shown in Figure 6A.

[0064] Figures 6A, 6B, 6C, and 6D show a portion of the programmable valve 200, showing a cam 212 and spring 400 biased against the valve element 208. Figures 6A and 6B show the cam 212 in the position of minimum tension relative to the biasing spring 400, and Figure 6C shows the cam 212 in the position of maximum tension relative to the biasing spring 400. Figure 6D shows an enlarged view of an example of the spring 400. In Figure 6D, the spring 400 is shown with the valve element 208 seated on the valve seat 210. In this example, the spring 400 is a cantilever spring and includes a first spring arm 410 that is in direct or indirect contact with the cam 212, and a cantilever arm 420 biased against the valve element 208. Both the first spring arm 410 and the cantilever arm 420 extend in the same direction from the pivot point 430 (or the fixed mounting point of the spring 400). Therefore, the cantilever arm 420 has a fixed end at the pivot point 430 and a free end 422 that contacts the valve element 208, as shown in Figures 6A and 6C. Similarly, the first spring arm 410 has a fixed end at the pivot point 430 and a free end that engages with the cam 212. In certain examples, the cantilever arm 420 may be longer than the spring arm 410. In the illustrated example, the spring arm 410 is "curved" including an inflection point 412. This configuration allows for a reduction in the overall size of the spring 400 compared to an example where the first spring arm is straight. As the cam 212 rotates, pressure is applied to the spring arm 410 in contact with the cam, changing the tension of the spring 400. The pressure is distributed and reduced via a spring structure so that the resulting pressure applied to the valve element 208 by the cantilever arm 420 can be very low, without imposing any difficult or impractical constraints on the rotational motion of the cam 212, and more specifically, so that it can be within a desired range (e.g., 0 to 200 mmH2O as described above). By appropriately selecting the relative lengths of the two arms 410 and 420 and the width of each arm, an equivalent to a lever or gear reduction mechanism may be realized. Thus, a spring soft enough to provide the low pressure required for a particular application (e.g., 0 to 200 mmH2O) may be realized using a short two-arm spring 400 rather than a conventional long spring.

[0065] The spring 400 is not limited to the examples shown in Figures 6A to 6D and can have a variety of different shapes and configurations. For example, Figures 7A and 7B show a leaf spring 460. Figure 7A shows only the leaf spring, and Figure 7B shows a spring installed in a valve and biased against the valve element 208. The leaf spring 460 includes a first spring arm 462 that is in direct or indirect contact with the cam 212 and a cantilever arm 464 that is biased against the valve element 208. In this example, the cantilever arm 464 includes a circular end 464a that abuts against the valve element 208. Both the first spring arm 462 and the cantilever arm 464 are flat and extend from the pivot point 430. The cam 212 is not shown in Figure 7B.

[0066] Figures 8A and 8B show examples of a U-shaped cantilever spring 480. Figure 8A shows only the U-shaped spring 480. Figure 8B is a partial cross-sectional view of an example of a programmable valve 200 showing the U-shaped spring 480 installed within the valve 200. The U-shaped spring 480 includes a first spring arm 482 that directly or indirectly contacts the cam 212 and a cantilever arm 484 biased against the valve element 208. The cantilever arm 484 has a free end 486 that abuts against the valve element 208. The first spring arm 482 and the cantilever arm 484 are connected by a U-shaped portion 483 supported by a strut 488. In some embodiments, the U-shaped portion 483 is a spring biased around the strut 488 so that the U-shaped portion 483 frictionally engages with the strut 488.

[0067] Similar to Figures 6B and 6C described above, Figures 8C and 8D show examples of U-shaped springs 480 positioned to correspond to different pressure settings of the programmable valve 200. Figure 8C shows the U-shaped spring 480 when the cam 212 is oriented so that the programmable valve 200 is set to the lowest pressure setting. Figure 8D shows the U-shaped spring 480 when the cam 212 is oriented so that the programmable valve 200 is set to the highest pressure setting.

[0068] Figure 9A shows another example of a cantilever spring 490 having a first spring arm 492 configured to contact the cam 212 directly or indirectly, and a cantilever spring arm 494 biased against the valve element 208. The cantilever spring arm 494 has a free end 496 that abuts against the valve element 208. In this example, the first spring arm 492 and the cantilever spring arm 494 are fixed to the strut 498, for example, by welding. Figure 9B shows an example of the spring 490 of Figure 9A in a programmable valve 200. The strut 498 is configured to rotate relative to two ruby ​​bearings 491 and 493. One ruby ​​bearing 491 is located at the top of the strut 498, and the second ruby ​​bearing 493 is located at the bottom of the strut 498. The ruby ​​bearings 491 and 493 allow the strut 498 to pivot relative to the valve body 202.

[0069] As will be understood by those skilled in the art, considering the advantages of the present disclosure, the spring 400 may have other configurations in addition to the configuration described above and shown in the drawings.

[0070] In a particular example, as the cam 212 rotates, the force exerted on the spring 400 is adjusted in fine increments or continuously over a range from a minimum force to a maximum force. As shown in Figure 6C, when the cam 212 is in a position where it exerts maximum pressure on the spring 400, the cantilever arm 420 moves toward the valve element 208. Thus, the pressure setting of the valve 200 is highest relative to this position of the cam 212. In one example, the pressure exerted on the spring 400 by the cam 212, and therefore the tension of the spring 400, increases with the clockwise rotation of the cam 212, as indicated by arrow 216. However, those skilled in the art will understand, in consideration of the advantages of the present disclosure, that the rotor 510, cam 212, and spring 400 may, alternatively, be configured such that counterclockwise rotation of the rotor 510 increases the tension of the spring 400.

[0071] As described above, the valve element 208 and the valve seat 210 form an opening through which the fluid flows. The inlet port 204 can be oriented so that the fluid enters the opening (or, in other words, pushes the valve element) perpendicular to the central axis of the rotor 510. The inlet port 204 can also be oriented so that the fluid enters the opening (or pushes the valve element) perpendicular to the central axis 214 of the rotor 510. In certain embodiments, when the inlet port 204 is oriented so that the fluid enters the opening perpendicular to the central axis 214 of the rotor 510, the cam 212 directly or indirectly generates a horizontal displacement of the spring 400, for example, as shown in Figures 6A and 6B.

[0072] In embodiments of the valve assembly 100 disclosed herein, the cam 212 may, in any configuration, have a constant or linear gradient, a piecewise linear gradient, a nonlinear gradient, and a combination of such gradients within one or more surfaces that engage with the spring 400. If the cam 212 has a linear gradient, rotation of the cam 212 linearly increases or decreases the pressure setting. If the cam 212 has a nonlinear gradient, the pressure may increase more, for example, towards the end of rotation. This gives the possibility of initially having small increments of pressure between, for example, 0 and 200 mmH2O, followed by larger increments of pressure. For example, the cam 212 shown in Figures 6A and 6B includes a surface having a nonlinear gradient that engages with the first arm 410 of the spring 400. Specifically, the cam 212 includes a projection 218, which changes the rate of increase of the pressure exerted on the spring 400 by the cam 212 as the cam 212 rotates. Thus, in certain examples, the force exerted on the spring 400 by the cam 212 increases substantially linearly over most of the rotational cycle of the cam 212, but towards the end of the cycle, the force increases more dramatically due to the effect of the projection 218.

[0073] For example, in certain applications in the treatment of hydrocephalus in children, it may be desirable to be able to determine whether the patient still needs the valve after some time of use, or whether the hydrocephalus has stopped and the shunt is no longer needed. For example, depending on the cause of the hydrocephalus, after using the implanted shunt valve assembly 100 for several years, the patient may no longer need the valve. One test method to determine whether the patient still needs the valve is to significantly increase the pressure of the spring 400 on the valve element 208, thereby closing the valve 200 almost completely, and then observe the patient's condition. Thus, the above-described configuration, in which the step pressure increase is significantly large at or near the maximum pressure position of the spring 400 and cam 212, can be advantageously made possible to perform this test. If the patient's condition worsens after the pressure setting of the valve 200 has been significantly increased, the pressure setting may be simply reduced again by rotating the cam 212. In this way, this configuration provides a safe semi-off setting for the valve 200 without completely closing or removing the valve 200.

[0074] In certain examples, the magnetic motor may include a rotor stopper or cam stopper 220 that prevents 360-degree rotation of the cam 212, thereby preventing the valve from moving immediately from fully open to fully closed or vice versa in a single step. The cam 212 can rotate either clockwise or counterclockwise to a position set by the cam stopper 220, and then must rotate in the opposite direction. Thus, a full rotation of the cam 212 is required not only for small steps or incremental rotations, but also to move the valve from fully open to fully closed or vice versa.

[0075] In certain cases, a calibration device is typically required to adjust the pressure setting after the valve assembly 100 has been manufactured. For example, in certain embodiments, the spring 400 may be constructed to be linear with respect to each step, i.e., with each step of rotation of the cam 212, and the spring 400 is tensioned such that the pressure in the valve 200 increases by X, and this applies with each additional step of rotation. Therefore, it may be necessary to set the cam 212 in a given position and calibrate the device to pretension the spring 400 to the appropriate pressure in that position. Thus, after the valve 200 has been assembled, a flow of nitrogen (or some other fluid) through the valve assembly may be present during calibration.

[0076] Figures 10A and 10B schematically illustrate an example of a magnetic rotor 510, including 10 rotor magnet elements 512 arranged in a circle and configured such that clockwise rotation increases the pressure setting of the programmable valve 200, as described above. Figure 10A shows the rotor 510 and spring 400 at the position of minimum tension on the spring, corresponding to the lowest pressure setting of the valve 200. Figure 10B shows the rotor 510 and spring 400 after clockwise rotation from the position shown in Figure 10A to the position of maximum tension on the spring, corresponding to the highest pressure setting of the valve 200. As described above, the rotor 510 can rotate through a number of incremental steps shown in 518, each step corresponding to a change defined by the pressure setting of the valve 200. Also as described above, the rotor 510 may include a cam stopper 220 that can prevent 360-degree rotation of the cam 212, thereby preventing the valve from immediately transitioning from fully open to fully closed or vice versa in a single step. In one schematic example shown in Figures 10A and 10B, the cam stopper 220 is adjacent to the housing stopper 222 at the maximum and minimum pressure settings of the valve 200. The cam stopper 220 and housing stopper 222 are sized and arranged such that the cam stopper cannot pass through the housing stopper, thereby preventing the cam from rotating further in the same direction. Thus, when the rotor 510 is at the minimum pressure setting position of the valve 200 (Figure 10A), the rotor must rotate clockwise, thereby gradually increasing the pressure setting of the valve. Counterclockwise rotation that would move the valve 200 from the minimum pressure setting to the maximum pressure setting in one step is prevented by the cam stopper 220 and housing stopper 222. Similarly, when the rotor 510 reaches the position corresponding to the maximum pressure setting of the valve 200 (Figure 10B), further clockwise rotation of the cam is prevented by the cam stopper 220 and housing stopper 222, and as a result, the rotor must rotate counterclockwise, thereby gradually decreasing the pressure setting of the valve.

[0077] Furthermore, as schematically shown in Figures 10A and 10B, in certain examples, the valve 200 may include a pair of radiopaque markers, namely a rotor marker 224 and a housing marker 226, which are visible in X-rays and indicate the position of the rotor 510 and therefore the pressure setting of the valve 200. In one example, the pair of radiopaque markers 224 and 226 are specified so that, at the lowest pressure setting of the valve, the two markers are aligned with the center of the cam. The housing marker 226 is fixed within the housing of the valve 200 and does not rotate with the rotor 510, while the rotor marker 224 rotates with the cam / rotor.

[0078] In some embodiments, the radiopaque markers 224, 226 include tantalum. In some embodiments, the radiopaque markers 224, 226 include tantalum spheres and / or tantalum beads.

[0079] As described above, since the embodiment of the valve assembly 100 includes a magnetically actuated rotor 510, the pressure setting of the implanted programmable valve 200 can be adjusted by placing an external adjustment device (also referred to herein as a valve program writer) adjacent to but outside the implanted valve 200. The valve program writer includes a magnetic field generator along with various control and input / output (I / O) components to enable a user (e.g., a physician) to control the valve program writer to set and possibly read the pressure setting of the implanted programmable valve 200. In certain embodiments, the magnetic field generator may include an array of electromagnets, as described below with reference to Figures 11A, 13, 15, 16A–16H, 17, and 18A–18H. In other embodiments, as will be further described below with reference to Figures 11B, 11C, 19–22, 23A–23E, and 24, the magnetic field generator may include one or more permanent magnets, and the valve program writer may be battery-powered.

[0080] Figure 11A shows a valve programmer 600, which includes a transmitter head 610 that may be positioned above the patient's head in a location above an implanted magnetically programmable valve 200. The transmitter head 610 includes a magnetic field generator that applies magnetic pulses to selectively magnetize the stator 528, thereby rotating the rotor 510, as will be further described below. Fluid flows from the ventricle through a ventricular catheter 120 and through an implanted valve to a distal catheter connected to a connector 140, which then drains the fluid at a distant location in the body (such as the right atrium of the heart or the peritoneal cavity). The valve programmer 600 can transmit magnetic signals via the transmitter head 610 to rotate the rotor 510. A control device 620 may be used to control the transmitter head 610 to generate magnetic pulses, as will be further described below, and may be coupled to the transmitter head 610 via a communication link 630, such as a cable or a wireless link.

[0081] Referring to Figure 12, according to a particular embodiment, the control device 620 may include various components or modules that enable a user to control an adjustment device to change the pressure setting of the embeddable valve 200 and to determine the current pressure setting of the valve. The control device 620 may include a user interface 622 that enables a user to interact with the control device. The user interface may include one or more displays or input devices, such as input keys or a touchscreen, to enable a user to view and adjust the pressure setting of the valve 200. In a particular embodiment, the control device 620 may further include a drive circuit 624 that communicates with a transmitter head 610. A controller 632 may be used, for example, to provide commands to the drive circuit 624 to drive a magnetic field generator in the transmitter head 610 with a predetermined current, duration, cycle, etc., based on commands received via the user interface 622. The controller 632 may further receive input from a setting detector 626 and control the user interface 622 to display the valve pressure setting in response to the information received from the setting detector. The controller 632 may be pre-programmed with computer instructions stored in a computer-readable medium or device, such as a hard disk drive, an optical disk readable by an optical disk reader, or a flash memory device. The control device 620 can operate to allow a user to adjust the valve 200 via the programmable controller 632 and determine the settings of the valve 200. In some embodiments, the control device 620 may further include a communication interface 628 that can be used to connect the control device 620 to another device, such as an application server on a network computer, to similarly control or otherwise operate the valve 200.

[0082] Figure 11B shows another embodiment of the external tuning device 640, which includes a single integrated device rather than separate transmitter head 610 and control device 620 as in the example in Figure 11A. In one example, the external tuning device 640 includes permanent NS magnets that generate a magnetic field, which, when rotating, selectively magnetizes the stator 528, thereby causing the rotor 510 to rotate.

[0083] Figure 11C shows an example of an external valve reading device, including a valve reading device (pressure reader) 660 for detecting the positional configuration of the rotor 510 when determining the pressure setting of the valve 200. In the illustrated example, the pressure reader 660 includes a mechanical compass, but in other examples, the mechanism may be an electronic device including, for example, a magnetic position sensor. Embodiments of the pressure reader are described in more detail below. In a particular example, the pressure reader may be incorporated into an embodiment of the valve program writer 600 in Figure 11A and configured to determine the positional configuration of the rotor 510 or to read the pressure setting of the valve 200 in another way when the magnetic field generator in the transmitter head 610 is off.

[0084] According to certain embodiments, valve pressure can be adjusted by applying a pulsed magnetic field near the programmable shunt valve, as schematically shown in Figures 13, 14, 15, 16A–16H, 17, and 18A–18H. A transmitter head 610 is positioned in close proximity to the embedded valve 200. In one embodiment, the transmitter head 610 includes four electromagnets schematically shown in Figure 13 as coils 1, 2, 3, and 4, which are controlled separately by an external control device 620 (e.g., via a drive circuit 624 as described above). In the examples shown in Figures 13 and 14, as described above, the magnetically operable motor of the embedded valve 200 includes a rotor 510 having 12 rotor magnet elements 512 arranged in alternating polarity within a channel 522 of a rotor casing 514, as described above. The motor further includes a stator 528 located below the rotor 510. In the illustrated example, the stator 528 has an X-shape. Thus, in this example, the four electromagnets (also called coils) in the transmitter head 610 are arranged such that coils 1 and 3 and coils 2 and 4 are closer to each other than coils 1 and 4 and coils 2 and 3, as shown in Figure 13. The four electromagnets can further be positioned equidistant from the central axis 530. When the transmitter head 610 is properly positioned on the recessed valve 200, the central axis 530 of the electromagnets coincides with the rotation axis 214 of the rotor 510, and each electromagnet is aligned to the same angular position as one arm of the stator 528, as shown in Figure 13. However, this alignment does not need to be precise. Embodiments allow for alignment errors, which may be unavoidable due to the fact that the user cannot see the rotor 510 or stator 528 and the size of their elements is small compared to the size of the external electromagnets.

[0085] Each of the electromagnets 1, 2, 3, and 4 can be excited to have either a north or south pole facing the stator 528, or each can be left completely off. Movement of the rotor 510 in a desired direction and angle is achieved by exciting the electromagnets in the order shown in the table in Figure 15 (clockwise rotation) or Figure 17 (counterclockwise rotation), which then magnetizes the stator 528, which then attracts or repels the rotor magnet elements 512 (depending on their polarity), causing the rotor 510 to rotate.

[0086] For example, referring to Figures 15 and 16A-16H, clockwise motion is achieved by first exciting both electromagnets 1 and 2 to the south pole and leaving electromagnets 3 and 4 off (Step 1). In the next step (Step 2), electromagnets 1 and 2 remain off, and electromagnets 3 and 4 are both excited to the south pole. In Step 3, electromagnets 1 and 2 are both excited to the north pole, and electromagnets 3 and 4 remain off, and in Step 4, electromagnets 1 and 2 remain off, and electromagnets 3 and 4 are excited to the north pole. The sequence repeats itself after the fourth step.

[0087] The rotor 510 is shown in Figure 16B in the position reached after the first step (the polarity of the rotor magnet elements 512 is the polarity corresponding to the bottom surface). When electromagnets 1 and 2 are excited so that their south poles face towards the stator 528 and they face each other, as shown in Figures 16A and 16B, the stator 528 is magnetized to its north pole. Thus, the stator 528, now magnetized to its north pole, attracts its rotor magnet elements 512, which have their south poles, towards itself and repels its rotor magnet elements 512, which have their north poles. As a result, the rotor 510 rotates clockwise, as indicated by arrow 532. The rotation of the rotor 510 may be further observed through Figures 16A–16H by observing the changing position of the reference marker 526. Similarly, in step 2, when electromagnets 3 and 4 are excited so that their south poles face the stator 528 and they face each other, the stator 528 is again magnetized to its north pole, acting on the rotor magnet elements 512 to induce further clockwise rotation of the rotor 510, as shown in Figures 16C and 16D. Figures 16E–16H show the operation corresponding to steps 3 and 4 in Figure 15. In detail, when electromagnets 1 and 2 are excited so that their north poles face the stator 528 and they face each other (step 3), the stator 528 is magnetized to its south pole, as shown in Figure 16E. Thus, the stator 528, now magnetized to its south pole, attracts its rotor magnet elements 512, which have north poles, towards itself and repels them, which have south poles. As a result, the rotor 510 rotates further clockwise, as indicated by arrow 532 and shown in Figure 16F. Similarly, in step 4, when electromagnets 3 and 4 are excited so that their north poles face the stator 528 and they face each other, the stator 528 is again magnetized to its south pole, acting on the rotor magnet element 512 to induce further clockwise rotation of the rotor 510, as shown in Figures 16G and 16H.

[0088] The motion of the rotor 510 is primarily influenced by the stator 528, which is positioned beneath the rotor 510 and close to the rotor magnet elements 512 of the rotor 510. Thus, the external magnetic fields applied from electromagnets 1, 2, 3, and 4 do not directly cause the motion of the rotor 510, but instead control the magnetization and polarity of the stator 528, which then acts on the rotor magnet elements 512 to induce the rotation of the rotor 510. The number of rotor magnet elements 512 and the shape of the stator 528 are selected so as to satisfy two conditions. First, a pair of radially opposing stator arms are aligned with a pair of radially opposing rotor magnet elements 512 (for example, referring to Figure 16C, stator arms 534a and 534b are aligned with rotor magnet elements 512a and 512b, respectively), and the other two stator arms are each alternately arranged between two of the rotor magnet elements 512, for example, as shown in Figure 16C. Secondly, each pair of radially opposing rotor magnet elements (e.g., 512a and 512b in Figure 16C) has the same magnetic polarity. During operation, the control device 620 energizes the electromagnet closest to a pair of stator arms alternately arranged between two rotor magnet elements 512, thereby moving the rotor 510 by an angle corresponding to half the width of one rotor magnet element 512. As described above, in one example there are 12 magnetic rotor elements 512, and therefore 24 angular increments in one revolution of the rotor 510. Furthermore, this configuration, in which radially opposing rotor magnet elements 512 have the same magnetic polarity and radially opposing electromagnets are also energized to have the same magnetic polarity facing the stator 528 (e.g., S in Figure 16A), advantageously results in a magnetically programmable valve with high resistance to other (non-programmable) magnetic fields. A randomly applied magnetic field originating from a natural phenomenon or an external device unrelated to the control device 620 (e.g., an MRI machine) is highly unlikely to have two identical poles applied to both ends of the stator 528 (e.g., both poles being either north or south).Conversely, an external, unprogrammed magnetic field is far more likely to have adjacent north and south poles and cannot uniformly magnetize the stator 528 as required for controlled operation (shown in Figures 16A-16H), and therefore cannot cause undesirable or accidental rotation of the rotor 510. In contrast, conventional magnetic rotors, such as the magnetic rotor disclosed in U.S. Patent No. 4,615,691, unlike the stator 528 disclosed herein, which is uniformly magnetized with a single magnetic polarity in response to an external, programmed magnetic field as described above, include radially opposing permanent magnets with opposite magnetic polarities (as shown in Figure 9 of U.S. Patent No. 4,615,691), along with a cruciform stator magnetized with one half having one polarity and the other half having the opposite polarity. As a result, conventional devices are far more susceptible to undesirable rotation and therefore undesirable adjustments to the valve pressure setting due to an external, unprogrammed magnetic field.

[0089] As described above, in one example the rotor 510 includes 12 rotor magnetic elements 512, but in other examples the rotor 510 can be sized and designed to include a different number of rotor magnetic elements 512 (e.g., 8), provided that radially opposing elements have the same magnetic polarity. Furthermore, in other examples where the rotor 510 is configured to operate with valve program writers of different configurations the rotor can be sized and designed to accommodate several rotor magnetic elements 512 such that radially opposing rotor magnetic elements have opposite polarity (e.g., 10), as will be described in more detail below.

[0090] A similar operation can be initiated to rotate the rotor 510 counterclockwise. For example, Figure 17 is a table similar to the one shown in Figure 15 and shows an example of an electromagnet excitation sequence for the device in Figure 13 to rotate the rotor 510 counterclockwise. Figures 18A to 18H show the magnetic polarity of the electromagnet and stator 528, as well as the resulting motion of the rotor 510, corresponding to the sequence shown in Figure 17.

[0091] Thus, referring to Figures 17 and 18A-18H, counterclockwise motion is achieved by first exciting both electromagnets 1 and 2 to the north pole and leaving electromagnets 3 and 4 off (Step 1). In the next step (Step 2), electromagnets 1 and 2 are left off, and electromagnets 3 and 4 are both excited to the south pole. Figures 18A-18D correspond to Step 1 and Step 2, Figure 18B shows the rotor 510 in the position reached after Step 1, and Figure 18D shows the rotor 510 in the position reached after Step 2. As shown in Figures 18A-18B, exciting electromagnets 1 and 2 to the north pole magnetizes the stator 528 to the south pole, which acts on the rotor magnet element 512 as described above, thereby inducing 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, inducing further counterclockwise rotation of the rotor 510 indicated by arrow 536. In step 3, both electromagnets 1 and 2 are excited to the south pole, and electromagnets 3 and 4 remain off. In step 4, electromagnets 1 and 2 remain off, and electromagnets 3 and 4 are excited to the north pole. Figures 18E to 18H show the operation corresponding to steps 3 and 4 in Figure 17. In detail, when electromagnets 1 and 2 are excited so that their south poles face the stator 528 and they face each other (step 3), the stator 528 is magnetized to the north pole, as shown in Figure 18E. Thus, the stator 528, now magnetized to the south pole, attracts its rotor magnet elements 512, which have north poles, towards itself and repels its rotor magnet elements 512, which have south poles. As a result, the rotor 510 rotates further counterclockwise, as indicated by arrow 536 and shown in Figure 18F. Similarly, in step 4, when electromagnets 2 and 3 are excited so that their north poles face the stator 528 and they face each other, the stator 528 is magnetized to its south pole, acting on the rotor magnet element 512 to induce further counterclockwise rotation of the rotor 510, as shown in Figures 18G and 18H. The sequence repeats itself after the fourth step.Each step results in an increment of angular motion of the rotor 510 corresponding to half the width of one rotor magnet element 512, as described above.

[0092] While the operation of the magnetic motor and transmitter head 610 has been described above with reference to a rotor containing 12 rotor magnet elements 512, those skilled in the art will understand, in consideration of the advantages of the present disclosure, that the operation of the transmitter head 610 and its electromagnet can be adjusted for rotors having a different number of rotor magnet elements, such as 10 rotor magnet elements.

[0093] Thus, when the embedded valve 200 having the magnetic motor described above is used with an external controller including a control device 620 and a transmitter head 610 having four electromagnets 1, 2, 3, and 4, 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 designed and calibrated so that each angular increment of the rotor 510 produces a change (e.g., 10 mmH2O) that is clearly defined and selected for the valve's pressure setting. In one example, the control device 620 can be configured to allow the user to input a desired pressure setting for the valve, and then automatically actuate the transmitter head 610 using, for example, one of the sequences shown in Figure 15 or Figure 17 to achieve the selected pressure setting.

[0094] In one example, to ensure the precise pressure setting of valve 200, the control device 620 may be configured to first activate the counterclockwise rotation sequence shown in Figure 17 to set valve 200 to its fully open position, and then activate the clockwise rotation sequence shown in Figure 15 to set valve 200 to a user-selected pressure setting. According to a particular example, when the counterclockwise rotation sequence is activated, the valve programmer is configured to actuate the rotor 510 to rotate through a sufficient number of counterclockwise steps so that the rotor is positioned so that valve 200 has its minimum pressure setting. As described above, the presence of the cam stopper 220 and the housing stopper 222 prevents the rotor from continuing to rotate beyond the minimum pressure setting position. After stopping the counterclockwise rotation sequence, the programmer may start a clockwise sequence from a known position (corresponding to the minimum pressure setting, where the cam stopper 220 is adjacent to the housing stopper 222). The valve programmer 700 can actuate the rotor 510 to rotate through a selected number of clockwise steps in order to program the valve 200 to a pressure setting selected by the user.

[0095] The above example uses clockwise rotation of the rotor 510 to program the pressure setting of the valve 200 (and uses counterclockwise rotation to set the rotor to a known position to initiate the programming sequence); however, in consideration of the advantages of the present disclosure, those skilled in the art will understand that the system (valve and programmer) can instead be configured to program the pressure setting of the valve using the opposite arrangement, i.e., counterclockwise rotation of the rotor (and uses clockwise rotation to set the rotor to a known position to initiate the programming sequence).

[0096] In some cases, it may be preferable for the external valve program programmer to be battery-powered. Transmitter heads, such as the transmitter head 610 which includes an electromagnet, may require too much power (to excite the electromagnet) to be battery-powered. Therefore, further embodiments and designs relate to valve program programmers, such as the exemplary valve program programmer shown in Figure 11B, which can be used with a recessed valve 200 and may be battery-powered, by incorporating a permanent magnet together with a small DC motor, such as a stepper motor.

[0097] Referring to Figure 19, a block diagram of an example of a valve program programmer 700 incorporating permanent magnets instead of electromagnets is shown. The valve program programmer 700 includes a controller 702, a user interface 704, a battery 706, a stepper motor 708, and a permanent magnet assembly 710. These components can be packed together in a single housing that can be held near a recessed valve 200 to control and adjust the pressure setting of the valve 200, for example, as shown in Figure 11B. Alternatively, certain components such as the permanent magnet assembly 710, the stepper motor 708, and the battery 706 can be packaged together with a controller that may optionally perform all or part of the functions of the controller 702, and the user interface 704 (along with a controller that may optionally perform all or part of the functions of the controller 702) can be packaged separately to allow the user to more conveniently view the user interface 704 while operating the valve program programmer 700. For example, the user interface 704 can be implemented as an application running on a mobile computing device, such as a smartphone or tablet computer, which allows the user to view the pressure settings of the valve 200 and input commands (such as selecting a desired pressure setting for the valve 200). The user interface 704 can, for example, receive pressure setting information from the controller 702 and send user commands to other separately packaged components of the valve program writer 700, such as the controller 702 or the stepper motor 708, to actuate the permanent magnet assembly 710 to adjust the pressure setting of the valve 200.

[0098] Figure 20A shows an example of a permanent magnet assembly 710a that can be used in a valve program writer 700 according to a particular embodiment. The permanent magnet assembly 710a includes a housing 712 and a rotatable magnet guide 714 located within the housing 712 and configured to rotate around a rotational axis 716. In one example, a stepper motor 708 drives the rotation of the magnet guide 714 under the control of a controller 702. The rotation of the magnet guide 714 may be continuous or a series of individual steps. Multiple permanent magnets are mounted on or within the magnet guide 714 so that the permanent magnets rotate together with the magnet guide 714. In the example shown in Figure 20A, there are four permanent magnets 722, 724, 726, and 728. Two radially opposing permanent magnets have the same magnetic polarity. For example, as shown in Figure 20A, permanent magnets 722 and 724 have north poles, and permanent magnets 726 and 728 have south poles. This configuration is suitable, for example, for controlling a rotor 510 having 12 rotor magnet elements 512.

[0099] Those skilled in the art will understand that a wide variety of modifications can be made to the permanent magnet assembly 710. For example, in Figure 20A, four permanent magnets 722, 724, 726, and 728 are shown as circular, but they may have other shapes, such as rectangular, elliptical, rod-shaped, or caliper-shaped, but are not limited to these. Furthermore, there may be more or fewer than four permanent magnets. For example, Figure 20B shows a configuration in which the permanent magnet assembly 710b includes a pair of permanent magnets 732 and 734 with opposite magnetic polarities. This configuration may be suitable for controlling a rotor 510 having, for example, 10 rotor magnet elements 512 instead of 12. In another example, the permanent magnet assembly 710b may include a single diametrically magnetized permanent magnet instead of two separate magnets with opposite polarities. Furthermore, it should be understood that any of the permanent magnets 722, 724, 726, 728, 732, or 734 may consist not of a single permanent magnet, but of a cluster of multiple permanent magnets of the same magnetic polarity. When actuated by the stepper motor 708, the magnet guide 714, and thus the multiple permanent magnets 722, 724, 726, and 728, or 732 and 734, rotate around the rotation axis 716. When the valve program writer 700 is placed on the embedded valve 200, the permanent magnet assembly 710 magnetizes the stator 528. The rotation of the magnet guide 714 changes the magnetization of the stator 528, thereby inducing the movement of the rotor 510, as described above with respect to the transmitter head 610.

[0100] Figures 21A–21E schematically illustrate an example of a valve program programmer 700 including the permanent magnet assembly 710a of Figure 20A, illustrating an example of the change in magnetic polarity of the stator 528 and the resulting rotation of the rotor 510 in response to the rotation of the magnet guide 714. In Figures 21A–21E, the permanent magnet assembly 710a is schematically represented by a ring 718. For example, as shown in Figure 21A, the ring 718 has four magnetic quadrants corresponding to the four permanent magnets 722, 724, 726, and 728 shown in Figure 20A, two of each magnetic polarity (730a and 730c are N, and 730b and 730d are S), as well as radially opposing quadrants with the same magnetic polarity. The ring 718 includes a controller reference marker 736, which is intended to show the rotation of the magnet guide 714 throughout Figures 21A–21E and does not necessarily correspond to a physical structure. Similarly, to show the rotation of the rotor 510 through Figures 21A to 21E, a rotor reference marker 538 is shown on one of the rotor magnetic elements 512.

[0101] Referring to Figure 21A, in the first position, two opposing permanent magnets (permanent magnets 726 and 728 in Figure 20A) having south poles corresponding to quadrants 730b and 730d of ring 718 magnetize the nearest or aligned opposing stator arms 534c and 534d to the north pole. Similarly, two other opposing permanent magnets (permanent magnets 722 and 724 in Figure 20A) having north poles corresponding to quadrants 730a and 730c of ring 718 magnetize the nearest or aligned opposing stator arms 534a and 534b to the south pole. Here, the stator arms 534a and 534b, magnetized to the south pole, are arranged alternately between two rotor magnet elements of opposite magnetic polarity, and thus pull on the north pole rotor magnet elements 512a and 512b while repelling the south pole rotor magnet elements 512c and 512d, causing the rotor 510 to rotate to the position shown in Figure 21B. The rotor 510 rotates through an angle corresponding to half the width of one rotor magnet element 512, as shown by the relative displacement of the rotor reference marker 538 from Figure 21A to Figure 21B. The degree of rotation of the rotor 510 corresponds to a 45-degree rotation of the ring 718, as shown by the relative displacement of the controller reference marker 736 from Figure 21A to Figure 21B.

[0102] In Figure 21A, the four permanent magnets 722, 724, 726, and 728, represented by quadrants 730a–730d of ring 718, are each aligned with one of the stator arms 534a–534d. Referring to Figure 21B, in this second position, achieved by a 45-degree rotation of ring 718 from the first position (Figure 21A) (i.e., as indicated by the reference marker 736 of the permanent magnet assembly 710a), each of the four permanent magnets 722, 724, 726, and 728, represented by quadrants 730a–730d of ring 718, are now alternately arranged across two stator arms. As a result, each of the stator arms 534a–534d has a divided magnetic polarization, with a portion of each arm magnetized to the north pole and another portion to the south pole, as shown in Figure 21B.

[0103] Referring to Figure 21C, a further 45-degree rotation of the magnet guide 714, indicated by the reference marker 736, realigns the four permanent magnets 722, 724, 726, and 728 of the permanent magnet assembly 710a with the stator arms 534a-534d. As shown, the opposing stator arms 534a and 534b are now magnetized to the north pole, and the opposing stator arms 534c and 534d are now magnetized to the south pole. The stator arms 534a and 534b, now magnetized to the north pole, are again alternately aligned between the two rotor magnet elements 512 of opposite magnetic polarity, thus repelling the north-pole rotor magnet elements 512a and 512b and pulling the south-pole rotor magnet elements 512c and 512d, resulting in another angular increment of rotation of the rotor 510 (corresponding to half the width of one rotor magnet element 512) to the position shown in Figure 21D.

[0104] Referring to Figure 21D, a further 45-degree rotation of the magnet guide 714, represented by the ring 718 and indicated by the reference marker 736, again results in each arm of the stator 528 having divided magnetic polarity. Another 45-degree rotation of the magnet guide 714 returns the stator 528 to the magnetic polarity configuration of Figure 21A and rotates the rotor 510 by another angular increment, as shown in Figure 22. The cycle is repeated with further rotations of the magnet guide 714 for the external permanent magnets 722, 724, 726, and 728, as shown in Figure 21E.

[0105] Thus, in a valve controller implementation including, for example, the rotor 510 shown in Figure 4C (a circular arrangement of 12 rotor magnets 512) and the permanent magnet arrangement shown in Figure 20A, a 180-degree rotation of the magnet guide 714 (as can be seen by comparing the positions of the controller reference markers 736 in Figures 21A and 21E) results in four angular increments of rotation of the rotor 510 (corresponding to a movement equivalent to twice the width of one rotor magnet element 512), as can be seen by comparing the positions of the rotor reference markers 538 in Figures 21A and 21E. In this way, three full rotations of the magnet guide 714 result in one full rotation of the rotor 510. This "gear reduction" effect, achieved through the indirect operation of the valve programmer 700 relative to the rotor 510 (via the stator 528), is advantageous in that it allows for very small incremental movements of the rotor 510 without requiring corresponding small movements within the valve programmer 700. This means that the magnetic guide 714 does not need to be as small as the rotor 510 of the embedded valve 200, which can improve the ease of use of the valve programmer 700 by the user, or simplify the manufacturing of the valve programmer 700.

[0106] Adjustment of the gear ratio between the valve program writer 700 and the rotor 510 can be achieved by changing the configuration of the permanent magnet assembly or the rotor 510 (e.g., the number of magnets). For example, a permanent magnet assembly using a rotor arrangement similar to that shown in Figure 4C, but with 10 rotor magnets instead of 12, and with two permanent magnets 732 and 734 in Figure 20B instead of the permanent magnet in Figure 20A, results in five full rotations of the magnet guide 714 and one full rotation of the rotor 510. As will be understood by those skilled in the art, given the advantages of the present disclosure, various other combinations of external permanent magnets and rotor magnets can be implemented and are intended to be part of the present disclosure and within the scope of the invention.

[0107] Figure 22 is a flowchart showing the rotation of the valve program writer and the corresponding changes in stator magnetization and rotor rotation due to the operation described above with reference to Figures 21A to 21E. Arrow 119A indicates the rotation of the rotor at each step of the flowchart.

[0108] In certain examples, the valve programmer 700 can be packaged in a handheld housing 762 for user comfort and ease of use. Figures 23A–23D show an example 760 of the valve programmer 700. In this example, the valve programmer 760 has a shape similar to a computer mouse. As illustrated, in some embodiments, the valve programmer 760 may have rounded corners on its outer surface and an overall rounded shape, which may be easy and / or comfortable for the user to hold. In some embodiments, the valve programmer 760 can be easily held by the user with one hand.

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

[0110] As described above, the valve programmer 760 may be battery-powered. Therefore, in some embodiments, the housing 762, together with the magnet assembly 710 (not shown in Figures 23A-23D), can house one or more batteries. As described above, in some embodiments, the valve 200 includes a 10-magnet stepper motor, and the magnet assembly 710 of the valve programmer 760 includes two oppositely magnetized magnets for rotating the stepper motor of the valve 200. The two oppositely magnetized magnets have opposite magnetic fields oriented downward within the valve programmer 760. In some embodiments, the programmer magnets have a surface electric field strength of 6000 gauss.

[0111] As shown in Figures 23A and 23D, the valve program writer 760 may include a user interface 764 that displays information such as pressure settings, battery status 770, and possibly other information. For example, the center of the screen of the user interface 764 may show the selected pressure (in digital reading). The boundaries of the screen may include indications of what is shown by X-rays or the position of the valve rotor, which may be indicated by a pressure reader, as will be further described below.

[0112] The valve program programmer 760 includes an interface mechanism that allows the user to select a pressure setting value for the valve program programmer 760, thereby setting the pressure of the valve 200. In some embodiments, as shown in Figure 23A, the program programmer 760 includes a first button 761a for increasing the pressure setting value and a second button 761b for decreasing the pressure setting value. Alternatively, the valve program programmer 760 may include a wheel (such as the wheel shown in the embodiment of Figure 23E) that is rotatable in a first direction to increase the pressure setting value and rotatable in a second direction to decrease the pressure setting value. In some embodiments, the valve program programmer 760 may include the first button 761a, the second button 761b, and the wheel. In some embodiments, the valve program programmer 760 can set the valve 200 to one of 20 pressure settings, as described above. In some embodiments, the highest pressure setting does not completely close the valve 200. This may be useful in testing whether the patient still needs valve 200 without completely closing it, thereby avoiding potential injury to the patient.

[0113] The valve programmer 760 may further include a programming button 769 that, when pressed, causes the valve programmer 760 to activate a magnetic assembly 710 to program the valve 200. In some examples, the programming button 769 may be located on the leading edge of the housing 762, as shown in Figure 23A.

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

[0115] Referring to Figures 23B and 23C, the housing 762 of the valve program programmer 760 can be molded to facilitate the correct orientation of the valve program programmer 760 over the embedded valve 200 and the programming of the pressure settings of the valve 200. In a particular example, the housing 762 includes a molded cavity 763 defined by the lower side wall 765 of the valve program programmer 760. The cavity 763 is shaped and sized to at least substantially correspond to the shape and size of the embedded valve 200. The cavity 763 includes a pair of channels 767 defined within the side wall 765. As described above, the inlet port of the programmable valve 200 can be connected to an inflow catheter, and the outlet port of the programmable valve 200 can be connected to a drainage catheter. Channel 767 can be sized and arranged such that when the valve programmer 760 is positioned above the implanted valve 200 in the patient's head, channel 767 aligns with the inflow catheter and drainage catheter, thereby helping to correctly align the valve programmer 760 with the implanted valve 200.

[0116] After the user sets the desired pressure setting on the programmer 760, the user places the programmer 760 on top of the valve 200. Next, the user presses the programming button 769 on the front edge of the programmer 760 to start programming.

[0117] Figure 23E shows a top view of the valve program programmer 777. The valve program programmer 777 has a housing 762 that can be held by the user's hand. The valve program programmer 777 includes a user interface 764 that displays information such as pressure settings, battery status 770, and possibly other information. The valve program programmer 777 includes a wheel 787 that is rotatable in a first direction to increase the pressure setting value and rotatable in a second direction to decrease the pressure setting value. In Figure 23E, the wheel extends partially horizontally beyond the side of the housing 762 so that it can be rotated by the user's fingers.

[0118] Figure 24 is a flowchart showing an example of a method 1100 for operating a valve program programmer 700, such as the valve program programmer 760 in Figures 23A-23D or the valve program programmer 777 in Figure 23E. In step 1102, the user turns on the valve program programmer 760 by pressing the on / off button 772 of the programmer. In some embodiments, the valve program programmer 760 turns on if the user holds down the on / off button 772 for 2 seconds. After being turned on, the valve program programmer 760 proceeds to initial mode in step 1104. In initial mode, the valve program programmer 760 performs a self-test in which the motor rotates counterclockwise and counts the steps of one revolution, comparing the number of steps to the number of steps that should be required for one revolution. In some embodiments, the motor self-test is always active when the motor is rotating. In some embodiments, the valve program programmer display (user interface screen) 764 displays all icons for 3 seconds in step 1104. If the valve programmer battery charge is too low, the valve programmer 760 proceeds to step 1106, where the battery status indicator 770 or an indicator flashes on the user interface screen 764 and the valve programmer 760 turns off. In some examples, if the valve programmer 760 battery charge is low, the battery status indicator 770 flashes slowly on the programmer display 764, and if the battery charge is extremely low, the battery status indicator 770 flashes rapidly on the programmer display 764.

[0119] If the battery is sufficiently charged, the valve program programmer 760 proceeds to step 1108, which is edit mode. The battery status may be displayed on the user interface screen 764, as described above. In edit mode in step 1108, an icon indicating that edit mode is enabled appears on the program programmer display 764. In edit mode, the user can increase or decrease the pressure setting value of the valve program programmer for the embedded valve 200 by pressing the increase button 761a or the decrease button 761b. In other examples where the valve program programmer 760 includes a wheel 787 for adjusting the pressure setting value instead of buttons 761a, 761b, the user can rotate the wheel in step 1108 to select the desired pressure setting.

[0120] Once a pressure setting value is selected, the valve program programmer 760 is ready to be used to program the embedded valve 200. Thus, the user can position the valve program programmer 760 on the patient's head above the embedded valve 200, using the shape of the housing 762 to correctly align the valve program programmer 760 with the embedded valve 200, as described above. To begin programming the valve 200, the user presses the programming button 769 on the valve program programmer 760 and enters programming mode in step 1110. In programming mode, the program programmer display 764 may show the selected pressure setting value along with a lock symbol, for example, as shown in Figure 23A.

[0121] In one example, to ensure the precise pressure setting of valve 200, the valve programmer 700 may be configured to first operate the rotation of the magnetic guide 714 in one direction (e.g., counterclockwise) to set valve 200 to its fully closed position, and then initiate a sequence of rotations in the opposite direction (e.g., clockwise) to set valve 200 to a user-selected pressure setting. Thus, in a particular embodiment, after a predetermined time period, for example 1 second, the valve programmer 760 proceeds to step 1112, where the programmer magnet rotates counterclockwise to initialize valve 200. For example, the programmer magnet of permanent magnet assemblies 710a, 710b can first rotate approximately 6 turns counterclockwise so that the cam of programmable valve 200 is in its lowest position. After reaching the initial position, the valve programmer 760 proceeds to step 1114, where the programmer magnet begins to rotate clockwise. While the programmer magnet is rotating, the valve programmer 760 displays the current and final positions of valve 200. When the programmer magnet reaches its final position, the valve program writer 760 proceeds to step 1116, where an alarm, such as an audible alarm, indicates that the selected pressure setpoint has been reached. After a predetermined period of time, for example 3 seconds, the valve program writer 760 returns to editing mode in step 1108. At this stage, the user can turn off the valve program writer 760 by pressing the on / off button 772. In some embodiments, the valve program writer 760 automatically turns off after a certain period of time when the user does not interact with the valve program writer 760, for example 60 seconds.

[0122] Returning to Figures 14, 16A–16H, 18A–18H, 21A–21E, and 22, in the examples described above, the stator 528 has an X shape, as shown in Figure 14, for example, and is a “solid” or one-piece structure. The shape of the stator 528 may vary, for example, between a + shape with a 90° angle between the stator arms and a very narrow X shape. In addition, according to certain embodiments, the stator 528 can be implemented using multiple individual stator elements rather than a single solid or one-piece structure. Figures 25A–25C show three schematic examples of stators with different shapes combined with a 12-magnet rotor. Figure 25A shows an example of a one-piece stator 540 with a + shape. Figure 25B shows an example of a stator including four stator elements 542 positioned below the rotor magnet elements 512, which are located approximately corresponding to the tips of the four stator arms in the example shown in Figure 25A. In the example shown in Figure 25B, the four stator elements 542 are composed of four circular dots, but the stator elements may have any variety of other shapes. For example, Figure 25C shows another example of a stator that includes four stator elements 544 composed of "double circular dots" or expanded ellipses. In other examples, the stator elements 542 or 544 may be squares or rectangles, or 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 90°, but as described above, the angle 546 may vary. As will be understood by those skilled in the art, considering the advantages of the present disclosure, the angle 546 may have any value between 90° and the minimum non-zero value, which may depend, for example, on the size of the stator 528 and the configuration of the rotor 510 (if the angle value is 0 or very close to 0, it becomes a 2-arm stator instead of a 4-arm stator, and the operation of the magnetic motor changes). Figures 26A to 26C show further examples of stators in which the angle 546 is approximately 75°. In detail, Figure 26A shows an example of an X-shaped integrated stator 540a in which the angle between the two closer stator arms is 75°, and therefore the complementary angle between the further apart stator arms is 105°. Figures 26B and 26C show an exemplary stator including four separate stator elements 542 and 544, respectively, with angle 546 of 75°. In certain examples, the value of angle 546 may be selected at least in part on achieving resistance to external unprogrammed magnetic fields (e.g., from MRI or other magnetic field generators unrelated to the valve program writer) and desired movement of the rotor 510 (e.g., a specific incremental movement of the rotor corresponding to a particular incremental pressure setting of the valve). In certain examples, it may be desirable to configure the stator 528 so that the motor has a relatively high cogging torque. The cogging torque corresponds to the force required to hold the rotor 510 in a particular position. A high cogging torque can increase the motor's resistance to external unprogrammed magnetic fields and can also prevent the rotor 510 from moving due to the reaction force of the spring 400.

[0124] Using separate stator elements 542 or 544 instead of a solid stator reduces the amount of magnetic material compared to the example of stators 540, 540a illustrated in Figures 25A and 26A. The magnetization of stator elements 542 or 544 from an external magnetic field acts to rotate the rotor 510 in a manner similar to that described above with reference to Figures 16A–16H, 18A–18H, 21A–21E, and 22. The rotation of the rotor 510 can be achieved, for example, by an external electromagnet described above and shown in Figure 13, or by an external permanent magnet described above and shown in Figures 20A and 20B. In certain examples, the stator elements 542 may be slightly larger than each rotor magnet element 512 (for example, larger in diameter if circular). For example, if the rotor magnet element 512 has a diameter of 1.3 mm, the circular stator element 542 shown in Figure 25B or Figure 26B may have a diameter of 1.4 mm.

[0125] As described above, according to certain embodiments, the programmable valve 200 may include a magnetic indicator mechanism that allows a physician to determine the pressure setting of the valve 200 using an external magnetic sensor, such as a Hall sensor, without requiring, for example, X-rays or other imaging techniques. In particular, in certain examples, the magnetic motor may include one or more reference magnets or indicator magnets that indicate the position of the rotor 510. As described above, the rotor position directly correlates to the pressure setting of the programmable valve 200. Thus, in some examples, the external valve programmer 700 may include a magnetic sensor configured to read or detect the pressure setting of the embedded valve 200 based on (one or more) indicator magnets. In other examples, a separate pressure reader may be provided, as will be further described below.

[0126] According to certain embodiments, an indicator mechanism can be incorporated into the rotor 510. For example, as described above, the rotor 510 may include a reference or positioning magnet element 524 positioned above certain rotor magnet elements 512, as shown in Figures 4A, 5, 6A, and 14. Figure 27 shows a schematic example of a rotor 510 including three reference magnet elements 524a, 524b, and 524c positioned above certain rotor magnet elements 512. In the illustrated example, the reference magnet element 524a has a magnetic polarity of N, and the reference magnet elements 524b and 524c are positioned substantially radially across from the reference magnet element 524a (on either side of the rotor magnet element 512 directly radially opposite to the reference magnet element 524a), and both have a magnetic polarity of S. As described above, the rotor magnet elements 512 are arranged with alternating magnetic polarities, and each pair of rotor magnet elements 512 directly radially opposite to each other have the same magnetic polarity. Therefore, to provide a reference magnet having both north and south poles and spanning the rotor 510, an array of three reference magnet elements 524, such as that shown in Figure 27, can be used. As stated above, in other embodiments, the rotor 510 may include a number of rotor magnet elements 512 other than 12. For example, the rotor 510 may include 10 magnet elements. In such an example, since opposing rotor magnet elements in a 10-magnet rotor have opposite polarities, unlike in a 12-magnet rotor, only two reference magnet elements 524 may be used. In another example where the rotor 510 includes 10 magnet elements, four reference magnets (two pairs arranged opposite each other) can be used. Thus, as will be understood by those skilled in the art, considering the advantages of the present disclosure, various numbers and arrays of reference magnet elements 524 can be used, at least partially based on the configuration of the rotor 510. Furthermore, in certain embodiments, instead of including a separate reference magnet element 524, the rotor magnet element 512 corresponding to a desired position of the reference magnet element can simply be "higher" than the other rotor magnet elements, thereby acting as both a rotor magnet element that causes rotation of the rotor 510 and a position indicator magnet.

[0127] In other examples, as shown in Figures 4A, 5, 6A, 14, and 27, instead of positioning the reference magnet element 524 above the rotor magnet element 512, the reference or positioning magnet element can be positioned on one or more sides of the rotor 510. Figures 28A–28C show an example of a motor configuration in which a side positioning magnet element 553, oriented vertically (relative to the horizontally oriented rotor magnet element 512), is positioned radially outward from the rotor magnet element 512. As will be further described below with reference to Figure 32, the positioning magnets are oriented to indicate an indicator magnet (not shown in Figures 28A–28C) that can be read by a pressure reader 660 to indicate, for example, the position of the rotor 510 and thus the pressure setting of the valve 200. Referring to Figure 28A, an example is shown in which two side positioning magnet elements 553 are provided. In this example, the polarity of each inner surface 555 of each side positioning magnet element 553 (i.e., the surface closer to the rotor magnet element) is opposite to the polarity of the upper surface of the adjacent rotor magnet element 512. In some embodiments, each side positioning magnet 553 has, for example, a diameter of 1.0 mm and a height of 0.3 mm. Figure 28B shows another example with four side positioning magnet elements 557. In this example, the polarity of each inner surface 555 of each side positioning magnet element 557 is the same as the polarity of the upper surface of the adjacent rotor magnet element 512. In some embodiments, each side positioning magnet 557 has, for example, a diameter of 0.85 mm and a height of 0.25 mm. Figure 28C shows another example with two side positioning magnet elements 559. In contrast to the example shown in Figure 28A, where two lateral positioning magnet elements 553 are arranged diametrically opposite to each other across the rotor 510, in the example shown in Figure 28C, the two lateral positioning magnet elements are arranged within the same hemisphere of the rotor 510. The polarity of the inner surface 555 of each lateral positioning magnet 559 is the same as the polarity of the upper surface of the adjacent rotor magnet. In some embodiments, each lateral positioning magnet 559 has, for example, a diameter of 1.0 mm and a height of 0.3 mm.

[0128] Referring to Figure 29, a block diagram of an example of an external valve programming assembly 800 is shown, which incorporates a magnetic sensor 812 configured to detect a magnetic signal from a reference magnetic element 524 or indicator magnet (positioned, for example, by positioning magnetic elements 553, 557, or 559) and derive the position of the rotor 510 and the corresponding pressure setting of the valve 200 from there. As shown in Figure 29, the valve programming assembly 800 may include a magnetic assembly 814 (such as one of the sets of electromagnets described above with reference to the permanent magnet assembly 710 or the transmitter head 610) for adjusting the pressure setting of the valve 200, and a transmitter head 810 which includes a communication / control circuit 816 (such as an electronic communication port, motor, actuator, drive circuit) that may be required to control and operate the magnetic assembly 814. The valve programming assembly 800 further includes a control device 820, which includes a user interface 822 that allows a user to provide control commands, such as a desired pressure setting for valve 200, along with a communication / control circuit 824 that may be required to view information such as the current pressure setting of valve 200 and operate the control device 820 or communicate with the transmitter head 810. In certain examples, the transmitter head 810 and the control device 820 are separate and communicate via a wired or wireless communication link 804. In other examples, the transmitter head 810 and the control device 820 may be packaged together, as indicated by the dashed line 802, in a valve program writer 760, for example. The magnetic sensor 812 can communicate with either the communication / control circuit 816 in the transmitter head 810 or the control device 820. In certain examples, which include an electromagnet that the magnet assembly 814 can turn off, the magnetic sensor 812 may be packaged within the transmitter head 810. In other examples, the magnetic sensor 812 may be packaged as a separate unit.

[0129] In one embodiment, in which a magnetic sensor 812 is included in the transmitter head 810, the pressure setting of the embedded valve 200 can be detected and transmitted to the control device 820. In one example, the magnetic sensor 812 detects the position of the rotor 510 inside the valve 200 and converts the detected position into a pressure setting reading. Such a correlation between rotational position and pressure setting can be determined for each valve according to a calibration process. The correlation can provide a retrieval capability in which rotational position can be converted into a pressure setting and vice versa. Such a pressure adjustment solution can be achieved according to the techniques employed herein (for example, based on the known size of the rotor magnetic element 512). Alternatively or additionally, the selection of spring type and / or spring constant in combination with the shape of the cam can be used to control pressure fluctuations per rotation step. The magnetic sensor 812 may be, for example, a Hall sensor or a compass.

[0130] According to certain embodiments, a valve programming assembly, such as a valve programming assembly 800, may include a valve program writer, such as the valve program writer 760 described above, and a separate pressure reader. The pressure reader can be used to read the pressure setting of the embedded programmable valve 200, and the valve program writer 760 can be used to program the pressure setting of the embedded valve 200, as described above. The pressure reader may be a compass including a magnet configured to provide a pressure reading based on the orientation of the magnet. The compass may be a mechanical or electronic compass.

[0131] In some embodiments, the pressure reader may be handheld. In some embodiments, the pressure reader is electronic. In certain examples, the pressure reader may have a physical appearance very similar to that of, for example, the valve program writer 760.

[0132] Figures 30A and 30B show an example of a pressure reader 660 according to a particular embodiment. Figure 30A is a perspective view of the pressure reader 660, and Figure 30B is a top view. The magnet of the pressure reader 660 is oriented relative to the valve 200 by positioning the pressure reader 660 on top of the recessed valve 200 such that an arrow 662 on the top surface of the pressure reader 660 aligns with the direction of fluid flow through the valve 200. The pressure reader 660 can be shaped and sized to facilitate its alignment with the recessed valve 200. For example, the pressure reader 660 may include a recess or cavity on its underside that corresponds to the size and shape of the recessed valve 200, similar to those described above with respect to the valve programmer 760. As shown in Figures 30A and 30B, the pressure reader 660 may have a circular shape and may include a display having a range of pressure settings arranged around its circumference. The display may be mechanical or electronic. When the pressure reader 660 is positioned on and aligned with the recessed valve 200, the pressure indicator 664 points to the pressure setting on the pressure reader 660 (shown in Figure 30B) that corresponds to the pressure setting of the valve 200, based on the aforementioned reference magnetic element.

[0133] Figure 31 shows an example of a method 1000 for operating a pressure reader, such as the pressure reader 660 in Figures 30A-30B. In step 1002, the user turns on the pressure reader 660. In some embodiments, the pressure reader 660 turns on when the user presses and holds the on / off button of the pressure reader for a predetermined period of time, such as 2 seconds. After being turned on, the pressure reader 660 proceeds to its initial operating mode in step 1004. In the initial mode of step 1004, the pressure reader sensor is calibrated, for example, to eliminate or compensate for the effects of the Earth's magnetic field. During calibration, devices that can generate a magnetic field, such as the valve program writer 760, should be kept away from the pressure reader 660. In certain embodiments in which the pressure reader 660 includes an electronic display, the display may include a battery status indicator, as described above with reference to the valve program writer 760. According to a particular embodiment, if the battery charge of the pressure reader 660 is too low, the battery status indicator may flash, and the pressure reader then proceeds to step 1006, where the pressure reader turns itself off. During operation of the pressure reader 660, if the battery charge becomes too low, the battery status indicator may flash to indicate to the user that the battery of the pressure reader needs to be replaced. If the battery charge becomes extremely low, the battery status indicator may begin flashing more rapidly, and eventually the pressure reader 660 can turn itself off.

[0134] If the battery charge of the pressure reader 660 is sufficient, the pressure reader 660 performs magnetic sensor calibration in step 1004, and then the pressure reader 660 proceeds to step 1008, the exploration mode. During the exploration mode, the user can position the pressure reader 660 on the patient's head above the implanted valve 200. In the exploration mode of step 1008, a exploration icon, such as a magnifying glass icon, may be displayed on the electronic display of the pressure reader 660 to indicate to the user that the detected magnetic field strength is too low. This prompts the user to reposition the pressure reader 660 to increase the detected magnetic field strength. If the detected magnetic field strength cannot be improved, this may indicate to the user that the magnetic field indication of the pressure reader 660 is unreliable.

[0135] When the pressure reader 660 detects a magnetic field of sufficient strength, the display of the pressure reader 660 indicates the direction of the magnetic field for the valve corresponding to the valve's pressure setting in step 1010. For example, as shown in Figure 30A, the pressure indicator 664 may indicate the pressure setting for valve 200. In examples where the pressure reader 660 includes an electronic display, in step 1012, the valve's pressure setting may be displayed and updated at periodic intervals, for example, every 2 seconds. If the magnetic field strength is too low in either step 1010 or step 1012, the pressure reader 660 returns to step 1008, where the display may indicate that the pressure reader is searching for a sufficiently strong magnetic field.

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

[0137] In certain embodiments, a kit for setting the pressure within a surgically implantable shunt valve 200 may include a pressure reader 660 and a valve programmer 760. In other embodiments, a valve assembly 100 may include an integrated valve programmer 760 and a pressure reader 660. In certain embodiments, the pressure reader 660 and the valve programmer 760 may be provided to the user together as part of a kit or separately. In some embodiments, the kit may further include a surgically implantable programmable shunt valve or valve assembly, such as the surgically implantable shunt valve 200 or valve assembly 100, or another surgically implantable programmable shunt valve or valve assembly.

[0138] In certain situations where the indicator mechanism rotates with the rotor 510 (for example, the indicator mechanism includes a reference magnet element 524 or a specific rotor magnet element, as described above), an external, non-programmed magnetic field, such as a magnetic field from an MRI, may act on the indicator / reference magnet and induce an undesirable torque on the rotor 510. Therefore, referring to Figure 32, an example of a programmable valve is shown that demonstrates an alternative indicator mechanism that can avoid this occurrence. In the illustrated example, the indicator mechanism includes a positioning magnet 550 mounted on the rotor 510 very close to the center of the rotor. The positioning magnet 550 can be used to orient the indicator magnet 552. Thus, the indicator mechanism further includes an indicator magnet 552 that is not mounted on the rotor 510 and 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 are magnetized in the diametrical direction. As the rotor 510 moves, the positioning magnet 550 rotates with the rotor 510, magnetically attracting the indicator magnet 552 and causing it to rotate by the same amount. 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 is insufficient to overcome the motor's cogging torque and rotate the rotor 510. The magnetic force of the positioning magnet 550 is sufficient to attract the indicator magnet 552 and rotate it by the same amount, as described above. The side positioning magnets 553, 557, and 559 described above can operate in a similar manner. In a particular example, the indicator magnet 552 has a strong magnetic field, which can be read by a compass, Hall sensor, or other magnetic sensor 812 placed outside the patient's body (e.g., at a distance of 10 mm or more from the second indicator magnet). For example, the indicator magnet may be a magnet magnetized in a single diametrical direction (i.e., having one north pole and one opposing south pole).The indicator magnet 552 may be affected by non-programming magnetic fields, such as those from an MRI, but since the indicator magnet 552 can rotate freely on its own bearing, its movement does not rotate the rotor 510. When the non-programming magnetic field is removed (for example, after an MRI scan is completed), the positioning magnet 550 automatically reorients the indicator magnet 552. By dividing the magnetic indicator mechanism into two separate magnets 550, 552, the valve 200 can have a magnet strong enough to be read from the outside, and at the same time, strong non-programming magnetic fields, such as those generated by an MRI, do not change the pressure setting of the valve 200 because the strong indicator magnet (552) is disconnected from the rotor 510.

[0139] In another embodiment, the positioning magnet 550 may be configured not as a single ring magnet magnetized in the diametrical direction, but as two smaller disk magnets with N and S polarities magnetized in the axial direction. In this case, for one of the two smaller disk magnets, the N pole points upward toward the indicator magnet 552, and the S pole points away from the indicator magnet 552. For the other of the two smaller disk magnets, the S pole points upward toward the indicator magnet 552, and the N pole points away from the indicator magnet 552. The operating principle of such a configuration is the same as that described above with respect to creating a local magnetic field for identifying the position of the indicator magnet 552. Using two very small disk magnets to implement the positioning magnet 550 may be preferable to a ring magnet in certain applications because this configuration may result in fewer artifacts in images of the patient's body (which may be taken, for example, using an MRI or CT scan).

[0140] The positioning magnet 550 can also have various other configurations. For example, as described above with reference to Figures 28A to 28C, in other embodiments the positioning magnet 550 can be replaced with any of the arrangements of positioning magnets 553, 557, or 559, or similar arrangements.

[0141] As described above, one limitation of conventional magnetically adjustable valves is that confirming the pressure setting may inevitably involve the use of X-rays to detect radiopaque markers on the implantable device. According to a particular embodiment, the initial orientation of the rotor 510 can be determined relative to a reference such as the housing and / or casing using the indicator mechanism described above. The pressure setting of the implantable valve 200 may be confirmed by placing a compass over the patient's head near the implantable valve 200. The compass needle aligns itself with the direction of the indicator magnet 552 as shown in Figure 32, or with the direction of the reference magnet elements 524a-524c as shown in Figure 27, and thus indicates the position of the rotor 510. The physician can then determine the pressure setting of the valve 200 by considering the position of the rotor 510 relative to the housing 202.

[0142] Therefore, the position of the rotor 510 may be precisely determined, and thereby the precise setting of the valve threshold release pressure may also be determined. In at least some embodiments, the rotor 510 can rotate freely in at least one direction for more than one revolution, and the pressure setting is repeated with each revolution. In this way, the position of the rotor 510 can uniquely identify the popping pressure.

[0143] As described above, in certain embodiments, the magnetic motor has intrinsic immunity or a high degree of resistance to external unprogrammed magnetic fields, including even the strong magnetic fields associated with MRI. However, in certain cases, further immunity to very strong magnetic fields, such as those associated with MRI (e.g., a very high or complete guarantee that no movement of the rotor 510 occurs), may be desirable. Therefore, in certain embodiments, the programmable valve 200 may include a mechanical brake that prevents movement of the rotor 510 when the brake is applied.

[0144] Referring to Figure 33, a partial cross-sectional view is shown of an example of a magnetic motor including an example of a mechanical brake according to one embodiment. In this example, the mechanical brake includes a brake spring 554 and a brake cylinder 556 that can rotate around a central pivot 558. In one example, the brake cylinder is made of a thermoplastic material such as polyoxymethylene. The brake spring 554 may be made of a metal, such as stainless steel. In the example shown in Figure 33, the brake spring 544 is a disc with a molded notch, but the brake spring can have a variety of different shapes, some of which are described further below. The brake cylinder 556 includes a plurality of brake cylinder teeth 560 configured to engage with a plurality of corresponding motor teeth 562. When the brake is in the locked position, the brake cylinder teeth 560 engage with the motor teeth 562 to prevent the rotor from rotating. When the brake is unlocked, the brake cylinder teeth 560 disengage from the motor teeth 562, allowing the rotor to rotate freely in response to the applied programming magnetic field, as described above.

[0145] According to certain embodiments, locking and unlocking the brakes is achieved using a second indicator magnet 552. As stated above, in certain examples, the indicator magnet 552 is a single magnet magnetized in the diametrical direction. Thus, although small, the second indicator magnet can have a relatively strong magnetic field that can be used to release the brakes. As stated above, the second indicator magnet 552 is a freely rotating magnet that is not coupled to the rotation of the rotor 510. If an external magnet is placed near the second indicator magnet 552, the second indicator magnet rotates to position itself according to the magnetic field of the external magnet. In the example where the second indicator magnet 552 is a magnet magnetized in the diametrical direction, if the external magnet is magnetized in the axial direction, one pole of the second indicator magnet will be attracted to the external magnet and the other will be repelled, and the two opposing forces will balance each other so that the second indicator magnet will not be pulled toward itself. In contrast, if the external magnet is also magnetized in the diametrical direction, when the external magnet is positioned near the valve, the second indicator magnet 552 rotates to position itself according to the magnetic field of the external magnet and is then attracted to the external magnet. Thus, the second indicator magnet 552 is pulled upward toward the external magnet. This upward movement can be used to disengage the brake, allowing the rotation of the rotor 510 to program the pressure setting of the valve 200. When no external magnetic field is applied, the brake spring 554 pushes down the brake cylinder, keeping the brake cylinder teeth 560 engaged with the motor teeth 562. Referring to Figure 34, in one example where the central pivot 558 is circular, the brake cylinder 556 includes one or more flat portions 563 in its inner wall surrounding the central pivot so that the brake cylinder can only move up and down and not rotate. In other examples, other features or shapes may be employed to prevent rotation of the brake cylinder 556. Figure 34 shows a schematic example of the motor 510 with the brake released.

[0146] Therefore, in certain embodiments, the permanent magnet assembly 710 of the valve program programmer 700 includes a diametrically magnetized brake controller magnet used to disengage the brake when the valve program programmer is positioned close to the valve 200 and programming the valve pressure setting. Figure 35 shows an example of the permanent magnet assembly 710c of the valve program programmer 700, which includes a brake controller magnet 740. The example shown in Figure 35 is similar to the permanent magnet assembly shown in Figure 20A and can be used to program a valve including a 12-magnet rotor 510, as described above.

[0147] An example of motor and mechanical brake operation using an example of a valve programmer 700 including the magnet assembly 710c shown in Figure 35 is described below with reference to Figures 36, 37A, and 37B. Figure 36 is a flowchart of an example of how to program valve 200. Figure 37A shows a cross-sectional view of an example of valve 200 showing a magnetic motor and mechanical brake configuration with the brake in the locked position, and Figure 37B is a corresponding diagram showing the brake in the unlocked position.

[0148] Referring to Figure 36, in the first step 902 of programming the pressure setting for valve 200, the physician or other user directly selects a new pressure setting for valve 200 on the valve program programmer 700. In one example, this can be achieved using a circular display, such as the one shown in Figure 11B, and using, for example, capacitive touch. In step 904, the physician / user positions the valve program programmer 700 close to the embedded valve and near one of the patient's heads. As a start to the process, the brake is in the locked position, for example, as shown in Figure 37A. In some cases, it may be easier or more convenient for the physician / user to first select the desired pressure setting for the valve (step 902) and then position the valve program programmer 700 close to the patient's head (step 904), but those skilled in the art will understand that steps 902 and 904 may be performed in reverse order. In step 906, the brake on valve 200 is released so that the valve program programmer 700 can act on a magnetic motor to program the selected pressure setting. In one embodiment of the valve program programmer 700, which includes a permanent magnet assembly 710c, a central diametrically magnetized brake controller magnet 740 is positioned higher than the other four magnets 722, 724, 726, and 728. For example, the brake controller magnet 740 can be held in this position by pushing up a spring. A doctor / user can push down the brake controller magnet 740 until it makes contact with the skin on top of the embedded valve 200, for example. When the brake controller magnet 740 is in contact with the skin, the brake controller magnet unlocks the brake by attracting the second indicator magnet 552, for example, as described above and shown in Figure 37B. In step 908, the valve program programmer 700 is used to program the selected pressure setting of the valve 200 by magnetizing the stator 528 and rotating the rotor 510 to a position corresponding to the selected pressure setting, as described above.In one example, the valve program writer 700 may include a programming "on" switch that can be activated after the brake is released to initiate programming. The "on" switch may be built within the permanent magnet assembly 710, more specifically, within the brake release mechanism. For example, the doctor / user may trigger the switch to initiate programming by pressing down the brake controller magnet 740 slightly harder. In one example, the switch must remain pressed down while programming is being performed. After programming is complete, an indication of completion may be provided to the doctor / user, for example, by hearing acoustic feedback. In this indication, the brake controller magnet 740 is released by the doctor / user and pushed back to its inactive position by a spring. Once the magnetic field is removed from the brake controller magnet 740, the second indicator magnet 552 is no longer attracted upward and returns to its neutral position, and as a result, the brake cylinder 556 moves downward (pushed down by the brake spring 554), re-engaging the brake cylinder teeth 560 with the motor teeth 562 and locking the rotor 510 in the programmed position (step 910). Next, the valve program programmer 700 can be removed from the patient's head (step 912).

[0149] Figure 38 shows another example of a magnet assembly 710d that can be used in a valve program writer 700 to program a valve including, for example, a 10-magnet rotor 510. In this example, the two permanent magnets 732, 734 of the exemplary permanent magnet assembly 710b shown in Figure 20B are replaced with a single diametrically magnetized controller magnet 742 used to release the brake and program the pressure setting of the valve 200, as described above.

[0150] Figure 39 is a flowchart of an example of how to program a valve 200 having a 10-magnet rotor 510 using a valve program programmer 200, which includes an example of a magnet assembly 710d shown in Figure 38. As in the example described above, in the first step 902 of the programming sequence, the physician / user selects a new pressure setting for the valve 200 directly on the valve program programmer 700. The physician / user can then position the valve program programmer 700 near the embedded valve (step 914), which automatically releases the brake due to the presence of a diametrically magnetized controller magnet 742. In step 916, the physician / user activates the programming sequence, which can be achieved, for example, by pressing the “start” button on the valve program programmer 200. In step 918, the valve program programmer 700 is used to program the selected pressure setting for the valve 200 by magnetizing the stator 528 and rotating the rotor 510 to a position corresponding to the selected pressure setting, as described above. Once the programming sequence is complete and the selected pressure setting is reached, the program writer may signal the completion of the programming sequence using, for example, an audible or visual indicator (e.g., a beep, a light of a specific color, or a flashing light) (step 920). After programming is complete and the signal is heard / seen, the physician / user may remove the valve program writer from near the patient's head, thereby automatically engaging the brake (step 922).

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

[0152] As will be understood by those skilled in the art, considering the advantages of the present disclosure, the brake mechanism and its components can have a variety of different structural forms and can be implemented in combination with any of the various embodiments of the magnetic motor and its components. In the example shown in Figures 37A and 37B, the magnetic indicator mechanism includes one or more first indicator magnets 550 cooperating with a second indicator magnet 552. However, the brake mechanism can also be implemented in a valve configuration in which one or more slightly "taller" rotor magnet elements 512 are used in combination with a second indicator magnet 552 for position sensing instead of the one or more first indicator magnets 550, as described above. In the example shown in Figure 33, the brake cylinder teeth 560 and motor teeth 562 are shown "inside" and "below" the second indicator magnet 552, near the central pivot 558. However, a wide variety of other configurations can be implemented. For example, referring to Figure 40, another embodiment is shown in which the brake cylinder 556 straddles the second indicator magnet 552, and the brake cylinder teeth 560 and the corresponding motor teeth 562 are located "outside" of the second indicator magnet 552.

[0153] In the examples shown in Figures 33, 34, 37A-37B, and 40, the brake cylinder 556 includes brake cylinder teeth 560 that engage with the motor teeth 562 to lock the rotor 510 in place, as described above. According to another embodiment, the brake spring 554 may include a mechanism that engages with the motor teeth 562, thereby eliminating the need for the brake cylinder teeth 560. Referring to Figure 41, for example, is shown a partial cross-sectional perspective view of another embodiment of the programmable valve 200 in which the brake spring 554 includes a pair of arms 566, each having projections 566a configured to engage with the motor teeth 562 to lock the rotor 510. In this example, the motor teeth 562 are arranged around the rotor casing 514. Figure 42 is a plan view of an example of the embodiment shown in Figure 41 in which the rotor 510 includes 12 rotor magnet elements 512. Figure 43 is a plan view of another example of an embodiment similar to the embodiment shown in Figure 41, in which the rotor 510 includes 10 rotor magnet elements. Figure 44A is a cross-sectional view taken along line AA in Figure 42, and Figure 44B is another cross-sectional view taken along line BB in Figure 42. In one example in which the rotor includes 12 rotor magnet elements 512, the plurality of motor teeth 562 include 24 motor teeth, and as a result the rotor can be locked in each position corresponding to a rotation step of half the width of the rotor magnet elements. However, different configurations may include different numbers of motor teeth 562.

[0154] In the examples shown in Figures 41 and 42, the brake spring 554 includes two arms 566, each arm including a projection 566a at its end, the projection being thinner / narrower than the body of the arm 566 and configured to engage between a pair of adjacent motor teeth 562 when the brake is in the locked position. However, as will be understood by those skilled in the art, considering the advantages of the present disclosure, various different configurations can be implemented, provided that the brake spring 554 includes one or more mechanisms configured to engage with the motor teeth 562 to prevent the rotor 510 from rotating. For example, the brake spring 554 shown in Figure 43 includes arms 566 with a more uniform width and lacking the defined projection 566a. Referring to Figure 45, in another embodiment, the brake spring 554 includes four arms 566 instead of two, arranged around a central ring portion 568, and the arms are more uniform in width, similar to the example shown in Figure 43, rather than having the narrower end projections 566a shown in Figure 40. In the examples shown in Figures 43 and 45, the width of the arm 566 and the spacing between adjacent motor teeth 562 can be selected so that the arm can engage between adjacent motor teeth to lock the rotor 510 in place and prevent its rotation.

[0155] Referring to Figures 46A and 46B, an embodiment of a magnetic motor incorporating a braking mechanism using a brake spring 554 to engage with motor teeth 562 can operate in the same manner as described above using a brake controller magnet 740 or 742 to unlock or release the brake. In one example, the motor teeth 562 are positioned on the upper circumference of the rotor casing 514, as shown in Figure 46A, and in the locked position, the spring 554 rests so that the arm 566 is positioned between adjacent motor teeth, thereby preventing the rotor 510 from rotating. The brake spring 554 can be supported by the top cover 202a of the valve. As described above and as shown in Figure 46B, when a diametrically magnetized brake controller magnet 740 or 742 is positioned above the valve 200, it attracts a second indicator magnet 552, pushing up the brake spring 554, thereby unlocking the rotor 510, which in turn allows the rotor 510 to rotate freely. As shown in Figures 46A and 46B, in one example, the second indicator magnet 552 is located within a casing 570 that includes a casing projection 572. When the second indicator magnet 552 is pulled upward by the brake controller magnet 740 or 742, the casing projection 572 presses against a spring arm 566, lifting the arm above the motor teeth 562 so that the rotor 510 can rotate. When the brake controller magnet 740 or 742 is removed, the brake spring 554 descends so that the arm 566 comes to rest again between adjacent motor teeth 562, as shown in Figure 46A.

[0156] Figures 47A and 47B show another example of a programmable valve 200 including a 10-magnet rotor 510, which also illustrates an example of a braking mechanism. Figure 47A is a plan view of the programmable valve 200, and Figure 47B is a cross-sectional view taken along line AA in Figure 47A.

[0157] Figure 48 shows another example of a programmable valve 200a, including a stepper motor, a brake mechanism, and an indicator magnet assembly, according to a particular embodiment. In this example, the cam 212 has an inclined surface 213, and the spring 409 includes a central arm 409j with two parallel arms 409k positioned on its sides. The central arm 409j is a cantilever arm with its free end 409h in contact with the valve element 208, and the two parallel arms 409k are fixed below the pivot point 407. The relationship between the position of the cam 212 and the tension of the spring 409 depends on the position of the pivot point 407, the contact point between the spring 409 and the cam 212, and the contact point between the cantilever arm 409g and the valve element 208. Depending on these relationships, when the cam 212 is in its highest position, the cantilever arm 409g can be pushed toward the valve element 208 or pushed toward the valve element 208. In the configuration depicted in Figure 48, when the cam 212 is at its highest position (or its highest level of inclination) relative to the spring 409, the tension of the spring 409 is maximum, and it tends to push the cantilever arm 409g toward the valve element 208. The valve 200a in Figure 48 incorporates brake teeth 562 that engage with the brake spring 554 as described above to prevent undesirable changes to the pressure setting of the valve 200a when exposed to a magnetic field (other than the programming magnetic field).

[0158] Embodiments of the valve assembly 100 may be implanted in a patient using a well-described surgical procedure. The pressure setting of the valve 200 can be adjusted to a desired pressure setting prior to surgical implantation. In one embodiment, the operating pressure can be set to be approximately equal to the CSF pressure of the patient's ventricles so that no pressure changes occur after surgery. After the patient has recovered from surgery, the pressure setting can be adjusted as desired. For example, in a patient with NPH, the pressure setting can be reduced to initiate ventricular size reduction. Further adjustments to the pressure setting can be made. For example, once the ventricular size has sufficiently decreased, the valve pressure setting can be increased. As can be understood, the use of an implantable valve 200 allows for external adjustment of the valve 200's pressure setting as needed during the course of treating the patient.

[0159] In certain embodiments, a method for treating hydrocephalus involves implanting an embodiment of a valve assembly 100 having a ventricular catheter 120 in the ventricular cavity of the patient's brain and a distal catheter connected to a connector 140 located at a distant location within the patient's body from which the fluid is drained. Distant locations within the body from which the CSF is drained include, for example, the right atrium of the heart and the peritoneum.

[0160] In addition to hydrocephalus, there are several other conditions associated with the accumulation of excess fluid that can be treated by draining the fluid to another part of the body using a properly designed inflow catheter. Such conditions include, for example, chronic pericardial effusion, chronic pulmonary effusion, pulmonary edema, ascites, and ocular glaucoma. Embodiments of the programmable valve 200 may be used to treat these conditions.

[0161] The pressure settings of the valves described herein can be adjusted in many discrete steps or increments, or continuously over a given range, as described above. Embodiments of the valves described herein may have pressures that vary from low pressure, e.g., 10 mmH2O, to high pressure, e.g., 400 mmH2O. Most conventional valves only have a pressure height of 200 mmH2O and can only be adjusted in relatively large increments between each pressure setting.

[0162] Improved valve Referring to Figure 49, another example of an implantable shunt valve assembly is shown overall in 4900, which includes two valves 4902 and 4904 separated by a pump chamber 4906. In one example, a ventricular catheter can be connected to connector 4908 at inlet 4910 of valve assembly 4900, and a drainage catheter can be attached to connector 4912 and connected to outlet 4914 of valve assembly. The recess of pump chamber 4906 pumps fluid through valve 4904 toward outlet 4914 and the drainage catheter. When the pump chamber 4906 is released after being pressed down, fluid is pumped through valve 4902. Valve 4902 is an externally programmable valve including a magnetic motor, as will be described in more detail below. The second valve 4904 may be, for example, a check valve. In this case, after passing through the programmable valve 4902, the fluid flows through check valve 4904 before exiting to the drainage catheter. In one example, a programmable valve 4902 operates to keep the valve assembly 4900 closed until the fluid pressure rises to a predetermined pressure setting of the valve. Generally, a check valve 4904 may be set to a low pressure, allowing the pressure setting of the programmable valve 4902, which includes a magnetic motor, to control the fluid flow through the valve assembly 4900. In another example, the second valve 4904 may be a gravity-actuated valve that allows the valve assembly to automatically adjust in response to changes in CSF hydrostatic pressure that occur when the patient's position changes (i.e., moving from a horizontal (lying down) position to a vertical (standing) position).

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

[0164] Referring to Figures 50 and 51, an implantable, magnetically programmable valve device of one embodiment of the present disclosure is shown overall in 5000. The valve device 5000 includes a base 5002 (also called a body or housing) that houses the components of the valve device. The base 5002 of the valve device 5000 includes a lower wall 5004 and a circumferential wall 5006 that extends upward from the lower wall and defines a cavity 5008. The circumferential wall 5006 of the base 5002 includes an inlet port 5010 and an outlet port 5012. The inlet port 5010 may be connected to a proximal (or inflow) catheter 4908 of the valve assembly 4900, and the outlet port 5012 may be connected to a distal or outflow catheter. In the case of a valve assembly for diverting CSF fluid, the proximal catheter 4908 may be a ventricular catheter or a lumbar catheter. In this case, the CSF fluid from the ventricles enters a ventricular 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 a connector, guiding the fluid to a distant location in the body for drainage, such as the right atrium of the heart (VA shunt) or the peritoneal cavity (VP or LP shunt).

[0165] The valve device 5000 further includes an upper cap or lid 5014 that mates with the base 5002 of the valve device to form a sealed enclosure suitable for implantation in the human body. The upper cap 5014 of the valve device 5000 is a side of the device oriented to face upward toward the patient's scalp when implanted. The base 5002 and upper cap 5014 of the valve device 5000 may be made from any physiologically compatible material. Non-limiting examples of physiologically compatible materials include polyethersulfone, polysulfone, and silicon. As will be understood by those skilled in the art, the base 5002 and upper cap 5014 of the valve device 5000 may have a variety of shapes and sizes, at least in part depending on the size, shape, and arrangement of the components within the valve device.

[0166] According to a particular embodiment, the valve device 5000 includes a valve element 5016 biased against a valve seat 5018 by a spring, as shown 5020 in general. The spring 5020 may include, for example, a cantilever spring. A particular embodiment of the spring 5020 is described in more detail below. In one embodiment, the valve seat 5018 is press-fitted into the inlet port 5010 to fix the valve seat in place.

[0167] The fluid enters the valve device 5000, for example, via a ventricular catheter 4908, flows through the inlet port 5010, and terminates at its casing end on the valve seat 5018. The pressure of the fluid (e.g., CSF) pushes the valve element 5016 and spring 5020 in a direction that raises the valve element away from the valve seat. The surfaces of the valve element 5016 and the valve seat 5018 together define an opening, the size or diameter of which determines the velocity and amount of fluid flowing through the valve device 5000. The valve element 5016 preferably has a larger diameter than the valve seat 5018 such that the opening is substantially closed when the valve element abuts against the valve seat. The valve element 5016 is positioned on the inlet side of the opening and is biased against the circular periphery of the opening defined by the valve seat 5018, keeping it closed until the CSF pressure in the inlet chamber exceeds a pre-selected popping pressure.

[0168] The valve element 5016 may be spherical, conical, cylindrical, or other suitable shape; in the illustrated embodiment, the valve element is a spherical ball. The spherical ball and / or valve seat 5018 can be made from any suitable material, including, for example, synthetic ruby ​​or sapphire. The valve seat 5018 provides a complementary surface, such as a frustoconical surface for the spherical valve element, such that the seating of the valve element within the valve seat results in a liquid-tight seal when the valve device is in the closed position. The pressure setting of such a valve, for example, the opening pressure, is adjusted by changing the biasing force of the valve element 5016 relative to the valve seat 5018. In one example, as described above, the valve element 5016 and valve seat 5018 may be press-fitted into the inlet port 5010 of the base 5002 and, once the initial pressure setting is reached, held in place by friction. In one embodiment, the valve element 5016 includes a ruby ​​ball, and the valve seat 5018 is also made from ruby.

[0169] According to one embodiment, the biasing of the spring 5020 on the valve element 5016 is achieved using a magnetic motor, generally shown 5022, which increases or decreases the operating pressure of the valve device 5000 continuously or in finite increments. According to a particular embodiment, the magnetic motor 5022 includes a stator 5024 and a rotor, generally shown 5026, which rotates relative to the stator in response to an external magnetically controlled magnetic field. In one example, the rotor 5026 rotates around a central axis of rotation around a support column 5028 extending upward from the lower wall 5004 of the base 5002. The configuration and operation of embodiments of the magnetic motor 5022 are described in more detail below.

[0170] Referring further to Figures 52 to 54, according to a particular embodiment, the rotor 5026 includes a rotor casing 5030 and a plurality of rotor magnet elements, each indicated 5032, arranged within the rotor casing. In one embodiment, the rotor casing 5030 includes a cylindrical body 5034 having a peripheral wall with steps, each indicated 5036, formed on the upper surface of the peripheral wall. In the illustrated embodiment, there are 20 steps 5036, so that the rotor can be rotated 18 degrees between each step. The rotor casing 5030 further includes a lower part having a channel 5038 formed inside. The plurality of rotor magnet elements 5032 are arranged in a circle and placed within the channel 5038. As illustrated, there are 10 rotor magnet elements 5032. In one example, the rotor magnet elements 5032 are permanent magnets, each having a south pole and a north pole. The rotor magnet elements 5032 are arranged in a nearly circular pattern with alternating polarities, so that the south and north poles alternate among all rotor magnet elements, whether viewed from above or below. Thus, at any given angular position, the pole exposed on the top surface of the rotor magnet element 5032 is opposite to the pole exposed on the bottom surface. The rotor magnet elements 5032 can be fixedly mounted in the rotor casing 5030 within the channel 5038, and the rotor casing 5030 can house the rotor magnet elements and function as a magnetic guide for directing their rotation. Although the rotor magnet elements 5032 are shown as circular disks, it should be understood that the rotor magnet elements do not need to be disk-shaped and can have any shape, such as elliptical, square, rectangular, hexagonal, or freeform, but are not limited to this. It is preferable that all rotor magnet elements 5032 are either nearly the same size or nearly the same magnetic strength, even if their sizes vary to ensure smooth rotation of the rotor. According to one embodiment, ten rotor magnet elements 5032 are bonded to the rotor casing 5030 within a channel 5038.

[0171] According to a particular embodiment, in addition to the rotor magnet element 5032, the rotor 5026 may further include X-ray markers indicated 5040 and 5044, and positioning magnets, each indicated 5042. In one embodiment, the X-ray markers 5040 and 5044 are tantalum spheres, which are radiopaque and can be detected by an X-ray instrument. X-ray marker 5040 is fixed to a base by an adhesive, such as glue, and remains stationary during the operation of the rotor 5026. X-ray marker 5044 is fixed to the rotor 5026 by an adhesive, such as glue, and rotates with the rotor. The pressure setting of the valve device 5000 corresponds to the inherent angular rotation of the rotor 5026, and thus the current pressure setting of the valve can be read by taking an X-ray and comparing the angular deflection between the X-ray markers 5040 and 5044. Furthermore, since the X-ray marker 5040 points to the right side of the valve device 5000, the physician knows how to properly orient the X-ray to read the pressure setting of the valve device.

[0172] Referring further to Figure 55, the rotor 5026 is configured to rotate around the rotor axis of the strut 5028 in response to an applied external magnetic field acting on the stator 5024. Thus, the rotor 5026 may further include one or more bearing rings arranged adjacent to the inner circumference of the rotor casing 5030 to enable rotation of the rotor casing. For example, the rotor casing 5030 may include a single bearing ring 5046, which may be made from synthetic ruby, to enable relative rotation of the rotor casing around the strut 5028, for example.

[0173] According to one embodiment, magnetic pulses from an external magnetic field are used to selectively magnetize the stator 5024, which then acts on the magnetic rotor 5026, thereby controlling the rotor's movement. In one embodiment, the stator 5024 is fixed to the lower wall 5004 of the base 5002 in a recess contoured to accommodate a positive (+) shaped stator. The external magnetic field may be generated, for example, by a magnetic coil or permanent magnet positioned in close proximity to the valve device 5000, as will be described in more detail below. The stator 5024 can be fabricated from a soft magnetic material that can be selectively magnetized, and its magnetic polarity can be selectively controlled by the application of an external magnetic field. For example, the stator 5024 can be fabricated from a nickel-iron alloy having, for example, about 72-83% nickel. By controlling the magnetization and magnetic polarity of the stator 5024, the rotor 5026 can be fabricated, as will be described further below, so that the rotor magnetic element 5032 rotates in a controlled manner in response to the changing magnetization and magnetic polarity of the stator.

[0174] The valve device 5000 is configured such that the rotation of the rotor 5026 controls a spring 5020 to adjust the bias of the valve element 5016 against the valve seat 5018, thereby adjusting the size of the opening and controlling the flow of fluid through the valve device. In one embodiment, the valve device 5000 includes a cam 5048 that engages with the spring 5020. In the illustrated example, the cam 5048 is integrated with the rotor casing 5030 at the lower part of the rotor casing outside the cylindrical body 5034 and, in one embodiment, is formed to realize one or more Archimedean spiral shapes.

[0175] For example, in certain applications of valve device 5000, such as the treatment of hydrocephalus, the valve pressure range may be a very low pressure range, e.g., about 0 to 300 mmH2O. Furthermore, it may be desirable to make small pressure changes within that range. However, it may not be practical (due to manufacturing constraints, etc.) to manufacture a valve device in which the cam is capable of making very small movements, e.g., on the order of a few micrometers. Therefore, a very soft spring may be required to adapt to the low pressure range and small incremental changes in pressure. Conventionally, to obtain a sufficiently soft spring, the spring would have to be very long. However, housing a very long and soft spring inside an embeddable housing can present challenges. Therefore, aspects and embodiments relate to spring configurations that generate a lever or "gear reduction" effect so that reasonable (i.e., within the range of standard manufacturing capabilities) movement of the cam can be translated into very small adjustments in the low-pressure setting. In detail, certain embodiments include a cantilever spring 5020 illustrated and described herein.

[0176] As best shown in Figures 52 and 53, the cam 5048 and spring 5020 are biased against the valve element 5016, with the cam in a position of minimum tension relative to the biasing spring. In the illustrated embodiment, the spring 5020 is a cantilever spring and includes a first spring arm 5050 biased against the valve element 5016 and a second cantilever arm 5052 that directly or indirectly contacts the cam 5048. Both the first spring arm 5050 and the cantilever arm 5052 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 a free end that abuts against the valve element 5016. Similarly, the cantilever arm 5052 has a fixed end at the pivot point 5054 and a free end that engages with the cam 5048. In one embodiment, the pivot point 5054 of the spring 5020 is fixed to the base 5002 by a lower spring support 5056 and an upper spring support 5058, which are inserted into a dedicated cavity formed in the base 5002.

[0177] In certain examples, the first spring arm 5050 may be longer than the second cantilever spring arm 5052. In the illustrated example, the cantilever spring arm 5052 is "curved" including an inflection point. As the cam 5048 rotates, pressure is applied to the cantilever spring arm 5052 in contact with the cam, changing the tension of the spring 5020. This pressure is distributed and reduced through the spring structure so that the resulting pressure applied to the valve element 5016 by the first spring arm 5050 can be very low, in detail, so that it can be within a desired range (e.g., 0 to 200 mmH2O as described above), without imposing difficult or impractical constraints on the rotational motion of the cam 5048. By appropriately selecting the relative lengths of the two arms 5050, 5052 and the width of each arm, equivalents to lever or gear reduction mechanisms may be realized. Thus, a spring soft enough to provide the low pressure required for a specific application (e.g., 0-200 mmH2O) may be achieved using a short, two-arm spring rather than a conventional long spring.

[0178] In one embodiment, the pivot point 5054, the first spring arm 5050, and the cantilever arm 5052 are configured to provide a lever effect such that a first force applied to the first arm by the cam 5048 is converted into a second force applied to the valve element by the cantilever spring, the second force being smaller than the first force.

[0179] As illustrated, as the cam 5048 rotates, the force exerted on the spring 5020 is adjusted in fine increments or continuously over a range from a minimum force to a maximum force. When the cam 5048 is in a position where the cam exerts maximum pressure on the spring 5020, the first spring arm 5050 moves toward the valve element 5016. Thus, the pressure setting of the valve device 5000 is highest relative to this position of the cam 5048. In one example, the pressure exerted on the spring 5020 by the cam 5048, and therefore the tension of the spring, increases with the clockwise rotation of the cam. However, those skilled in the art will understand, in consideration of the advantages of the present disclosure, that the rotor 5026, cam 5048, and spring 5020 may, alternatively, be configured such that counterclockwise rotation of the rotor increases the tension of the spring.

[0180] As described above, the valve element 5016 and the valve seat 5018 form an opening through which the fluid flows. The inlet port 5010 can be oriented so that the fluid enters the opening perpendicular to the central axis of the rotor 5026 (or, in other words, pushes the valve element 5016). In certain embodiments, when the inlet port 5010 is oriented so that the fluid enters the opening perpendicular to the central axis of the rotor 5026, the cam 5048 directly or indirectly generates a horizontal displacement of the spring 5020.

[0181] In embodiments of the valve device 5000 disclosed herein, the cam 5048 is shaped to mimic an Archimedean spiral, but the cam may have a constant or linear gradient, a piecewise linear gradient, a nonlinear gradient, and a combination of such gradients within one or more surfaces that engage with the spring 5020.

[0182] In a particular example, the magnetic motor 5022 may include a rotor stopper or cam stopper 5060 that prevents 360-degree rotation of the cam 5048, thereby preventing the valve device 5000 from immediately transitioning from fully open to fully closed or vice versa in a single step. As shown, the rotor stopper 5060 is provided on the rotor casing 5030 of the rotor 5026 to prevent the rotor from rotating beyond the minimum rotor pressure position. As shown, the spring 5020 is configured to engage with the rotor stopper 5060 to prevent the rotor 5026 from rotating. A second stopper (not shown) may be formed on the upper cap 5014 of the valve device 5000 to prevent the rotor 5026 from rotating beyond the maximum rotor pressure position. The cam 5048 can rotate either clockwise or counterclockwise to a position set by the rotor stopper 5060, and then must rotate in the opposite direction. Therefore, a complete rotation of the cam 5048 is required not only for small steps or incremental rotations, but also to move the valve device 5000 from fully open to fully closed, or vice versa.

[0183] In certain cases, a calibration device is typically required to adjust the pressure setting after the valve device 5000 has been manufactured. For example, in certain embodiments, the spring 5020 may be constructed to be linear with respect to each step, i.e., with each step of rotation of the cam 5048, and the spring is tensioned such that the pressure in the valve device 5000 increases by X, and this applies with each additional step of rotation. Thus, it may be necessary to set the cam 5048 in a given position and calibrate the valve device 5000 to pretension the spring 5020 to the appropriate pressure in that position. Therefore, after the valve device 5000 has been assembled, a flow of nitrogen (or some other fluid) through the valve device may be present during calibration.

[0184] As described above, in one embodiment, the magnetic rotor 5022 includes 10 rotor magnetic elements 5032 arranged in a circle and configured such that clockwise rotation increases the pressure setting of the programmable valve device 5000. As described above, the rotor 5026 can rotate in a plurality of incremental steps, each step corresponding to a change defined by the pressure setting of the valve device 5000. Also as described above, the rotor 5026 may include a rotor stopper 5060 that can prevent 360-degree rotation of the cam 5048, thereby preventing the valve device 5000 from moving immediately from fully open to fully closed or vice versa in one step. Thus, when the rotor 5026 is in the position of the minimum pressure setting of the valve device 5000, the rotor must rotate clockwise, thereby gradually increasing the pressure setting of the valve device. Counterclockwise rotation that would move the valve device 5000 from the minimum pressure setting to the maximum pressure setting in one step is prevented by the rotor stopper 5060. Similarly, when the rotor 5026 reaches the position corresponding to the maximum pressure setting of the valve device 5000, further clockwise rotation of the cam 5048 is prevented by the rotor stopper 5060, so that the rotor must rotate counterclockwise, thereby gradually decreasing the pressure setting of the valve device.

[0185] As described above, the valve device 5000 is X-ray observable and includes X-ray markers 5040 and 5044 that indicate the position of the rotor 5026 and therefore the pressure setting of the valve device. In one example, the X-ray markers 5040 and 5044 are specified so that at the lowest pressure setting of the valve device 5000, the X-ray markers 5040 and 5044 are aligned with the center of the cam 5048. The X-ray marker 5040 is fixed to the base 5002 of the valve device 5000 and does not rotate with the rotor 5026, while the X-ray marker 5044 rotates with the rotor.

[0186] In some embodiments, the X-ray markers 5040, 5044 include tantalum. In some embodiments, the X-ray markers 5040, 5044 include tantalum spheres and / or tantalum beads.

[0187] The embedded programmable valve device 5000 further includes a brake assembly for locking the rotor 5026 in place and selectively releasing the rotor for programming. In one embodiment, the embedded programmable device 5000 further includes an indicator, collectively shown 5064, located within the rotor casing 5030 on a support column 5028. The indicator 5064 includes an indicator housing 5066 and a diametrically magnetized annular indicator magnet 5068 located within the indicator housing and fixed to the indicator housing, for example, by adhesive or glue. The arrangement is such that the indicator 5064 is able to rotate relative to the rotor 5026 when exposed to an external magnetic force. The embedded programmable valve device 5000 further includes a brake or stabilizer, collectively shown 5070, provided to lock the rotor 5026 in place once a desired pressure is achieved. Specifically, the brake 5070 includes a circular body 5072 and a pair of diametrically opposed arms 5074, 5076 that extend beyond the body and are received between steps 5036 of the rotor casing when positioned on the rotor casing 5030 of the rotor 5026. The body 5072 of the brake 5070 includes a molded opening 5078 designed to fit into a molded end of a strut 5028 to prevent the brake from rotating relative to the strut. The arrangement is such that the brake 5070 is prevented from rotating relative to the strut 5028, but the pair of arms 5074, 5076 are able to be displaced axially.

[0188] The positioning magnet 5042 orients or positions the indicator 5064, which includes a magnet 5068 magnetized in the diametrical direction. The indicator 5064 serves two purposes. One purpose is to release the brake 5074 from step 5036 when the programmer is positioned on top of the valve device and enables the rotor 5026 of the magnetic motor 5022. The other purpose is that the indicator 5064 is magnetically oriented by the two positioning magnets 5042 whenever the programmer is not in close proximity to the valve, i.e., always except when the valve is being programmed. The monitor reads the angular or circumferential direction of the indicator 5064 rather than the positioning magnets 5042. The magnetic field generated by the two relatively small positioning magnets 5042 is not strong enough for an external monitor to read. The indicator 5064 functions as a magnetic amplifier that mimics the orientation of two small positioning magnets 5042, which have a magnetic field strong enough to be read by an external monitor, but the indicator must be able to rotate freely when exposed to a strong external magnetic field, such as that generated by the MRI machine, and does not change the pressure setting of the valve device 5000. When the patient with the valve implanted is guided into the MRI machine, the indicator 5064 aligns itself according to the orientation of the MRI machine's magnetic field, but is not pulled up from the rotor 5026. This makes it possible to keep the rotor 5026 stationary with the brake engaged. When the patient leaves the MRI machine, the two positioning magnets 5042 reposition the indicator 5064, and the indicator 5064 can then be read by the monitor.

[0189] For example, when an external magnetic force is applied to the valve device by a programmer, the indicator 5064 is attracted to the external magnetic force, which lifts the brake arms 5074, 5076 away from the rotor 5026, thereby allowing the rotor to rotate and change the pressure in the valve device. Specifically, the indicator 5064 moves axially along the support 5028 toward the magnetic force, and therefore, in this particular configuration, the outer edge of the indicator 5064 displaces the brake arms 5074, 5076 axially. The arms 5074, 5076 of the brake 5070 are released from the space between the steps 5036 of the rotor casing 5030, allowing the rotor 5026 to rotate. At the same time, the stator 5024 is magnetized to attract the rotor magnetic element 5032, thereby preventing the rotor 5026 from moving axially.

[0190] Once the desired pressure is achieved, the external magnetic force is removed, allowing the brake arms 5074, 5076 to return to the position where they are positioned between the steps 5036 of the rotor casing 5030. Specifically, once the external magnetic force is removed, the indicator 5064 moves backward toward the rotor 5026, taking the brake arms 5074, 5076, which are positioned to lock the rotor in place.

[0191] Programmer device As described above, since the embodiment of the valve device 5000 includes a magnetic actuation rotor 5026, the pressure setting of the implanted programmable valve device can be adjusted by locating a programmer that is adjacent to the implanted valve device but located outside the body. The programmer includes a magnetic field generator along with various control and input / output (I / O) components to enable a user (e.g., a physician) to control the programmer to set and, if applicable, read the pressure setting of the implanted programmable valve device 5000. In certain embodiments, the magnetic field generator may include an array of electromagnets. In other embodiments, the magnetic field generator may include one or more permanent magnets, and the programmer may be battery-powered.

[0192] In one embodiment, the programmer is configured to be positioned above the patient's head at a location on an implantable magnetic programmable valve device. The programmer includes a magnetic field generator that applies magnetic pulses to selectively magnetize the stator 5024, thereby rotating the rotor 5026, as will be further described below. The fluid flows from the ventricles through the ventricular catheter to the inlet connector 4908, and through the implantable valve device 5000 to the distal catheter connected to connector 4912, which then drains the fluid at a distant location in the body (such as the right atrium of the heart or the peritoneal cavity). The programmer can transmit magnetic signals to rotate the rotor 5026. The programmer may be used to generate magnetic pulses, as will be further described below, and may be coupled to a communication link, such as a cable or a wireless link.

[0193] Referring to Figures 56A to 59, a programmer device of one embodiment of the present disclosure is shown overall as 5600. As illustrated, the programmer device 5600 includes a casing 5602 having an upper part 5604 (Figures 56A and 58), a lower part 5606 (Figure 57), and a continuous side wall 5608 connecting the upper and lower parts of the casing. The casing 5602 of the programmer device 5600 is sized to fit in the hand of a physician or professional using the programmer device. The upper part of the programmer device 5600 includes a user interface 5610, including a liquid crystal display (LCD) 5612, which is described in more detail below, to enable a physician to program the valve device 5000. The side wall 5608 of the programmer device 5600 includes two programming start buttons 5614, 5616 to initiate the programming sequence of the programmer and control the operation of the valve device 5000. The casing 5602 is configured to support the components of the programmer device 5000. In some cases, a USB port 5670 may be provided for charging a rechargeable battery and / or for modifying or updating the software of the programmer device 5600.

[0194] Referring particularly to Figure 59, the casing 5602 of the programmer device 5600 includes a lower casing 5618 and an upper casing 5620. The lower casing 5618 includes a battery housing 5622 configured to receive a battery, for example, four AAA batteries, and a battery cover 5624 configured to close the battery housing. The programmer device 5600 further includes a motor 5626 coupled to the battery housing 5622 and a gear 5628 mounted on the motor shaft. In one embodiment, the casing 5602 includes a support 5630 configured to support the motor 5626 when the programmer device 5600 is assembled. The battery provided in the battery housing 5622 supplies power to the motor 5626, which drives the rotation of the gear 5628.

[0195] The programmer device 5600 further includes a magnetic support 5632 having a central hub configured to support a magnetic gear 5634, a ball bearing 5636, a magnetic bridging plate 5638, and two permanent magnets, each indicated as 5640. The arrangement is such that a gear 5628 is configured to engage with the magnetic gear 5634 to drive the rotation of the two permanent magnets 5640 held by the magnetic support 5632. In the illustrated embodiment, the magnet 5640 is formed from two pieces, each having an N side and an S side, both mounted on the magnetic bridging plate 5638. The magnet 5640 is configured to drive the rotation of a rotor magnetic element 5032 to program the valve device 5000. The programmer device 5600 further includes a first programmer electronic board 5642 and a second programmer electronic board 5644, which together control the operation of the programmer device.

[0196] In one embodiment, for each rotation of the permanent magnet 5640 of the programmer device 5600, the rotor 5026 of the valve device 5000 rotates 1 / 5 of a single rotation. Thus, the programmer device 5600 is configured to provide incremental movement of the rotor 5026 of the valve device 5000 to finely position the rotor at a desired pressure. Furthermore, in one embodiment, for each rotation of the permanent magnet 5640 of the programmer device 5600, the indicator 5064 of the valve device 5000 rotates 1 rotation (1 / 1).

[0197] In certain examples, the casing 5602 of the programmer device 5600 is packaged to be comfortable and easy for the user to use. In this example, the programmer device 5600 has a shape similar to a computer mouse. As illustrated, in some embodiments, the programmer device 5600 may have rounded corners on its outer surface and have an overall rounded shape, which may be easy and / or comfortable for the user to hold. In some embodiments, the programmer device 5600 can be easily held by the user with one hand.

[0198] As described above, the programmer device 5600 may be battery-powered. Therefore, in some embodiments, the battery housing 5622 of the casing 5602 may house one or more batteries. As described above, in some embodiments, the motor 5626 of the programmer device 5600 is a DC motor, and the magnet 5640 of the programmer device includes two oppositely magnetized magnets to rotate the rotor 5026 of the valve device 5000. The two oppositely magnetized magnets 5640 have opposite magnetic fields oriented downward within the programmer device 5600. 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 further includes a user interface 5610 located on the upper part 5604 of the casing 5602 and a keyboard foil designed to create the aforementioned LCD 5612, which has a user interface that allows a physician to operate the programmer device and view relevant information, such as pressure setting information in mmH2O units. The programmer device 5600 further includes a wormhole housing 5646. The upper part 5604 of the casing 5602 of the programmer device 5600 is designed to allow a physician to view the positioning of the valve device 5000 relative to the programmer device 5600. Specifically, the user interface 5610 can be configured to display information such as pressure setting, battery status, and possibly other information. For example, the center of the user interface screen 5610 may indicate the selected pressure (in digital reading). The boundaries of the screen may include an indication of what the X-ray shows, or the position of the rotor 5026 of the valve device 5000, which may be indicated by the pressure device 5000, as will be further described below.

[0200] The user interface 5610 of the programmer device 5600 is configured to allow the user to select a pressure setting value for the programmer device, thereby setting the pressure of the valve device 5000. In some embodiments, a button 5652 on the programmer device 5600 can be configured to turn the programmer device on and off. The user interface 5610 can be configured to include a plus (+) button 5648 and a minus (-) button 5650 for increasing and decreasing the pressure setting value, respectively. The user interface 5610 can further be configured to include two programming start buttons 5614, 5616, and optionally a light button to provide illumination during use.

[0201] The casing 5602 of the programmer device 5600 can be molded to correctly orient the programmer device over the implanted valve device 5000 and facilitate programming the pressure setting of the valve device. In a particular example, the casing 5602 includes a molded cavity 5654 formed in the lower part 5606 of the programmer device 5600. The cavity 5654 is shaped and sized to at least substantially correspond to the shape and size of the implanted valve device 5000. The cavity 5654 includes a pair of channels defined in the lower part 5606 of the casing 5602. As described above, the inlet port 5010 of the programmable valve device 5000 can be connected to an inflow catheter, and the outlet port 5012 of the programmable valve device can be connected to a drainage catheter. The channels can be sized and arranged such that when the programmer device 5600 is placed on the implanted valve device 5000 in the patient's head, the channels align with the inflow catheter and drainage catheter, thereby helping to correctly align the programmer device with the implanted valve device. After the user sets the desired pressure setting value on the programmer device 5600, the user places the programmer device on top of the valve device 5000, which automatically releases the brake. The user then starts programming by pressing one of the two programming start buttons 5614, 5616 on the side wall 5608.

[0202] Referring again to Figures 56A to 56D, in one embodiment, the programmer device 5600 may include a magnetic shield 5660 to shield the very strong magnetic force generated by the permanent magnet 5640 of the programmer device when not in use. In one embodiment, the magnetic shield 5660 has a molded plastic outer body enclosing an internal steel plate. When attached to the bottom of the programmer device 5600, the magnetic field generated by the internal magnet 5640 closes a magnetic "circuit" through the steel shield, thereby isolating the environment outside the programmer device from the strong magnetic field. The magnetic shield 5660 is removed before operating the programmer device 5600 as described above. In one embodiment, the programmer device 5600 cannot operate as a safety mechanism until the magnetic shield 5660 is removed.

[0203] Monitor device Referring to Figures 60A and 60B, the monitoring device of an embodiment of the present disclosure is shown overall as 6000. The monitoring device 6000 can be used to monitor the pressure setting of the valve device 5000. The monitoring device 6000 can be used in conjunction with the programmer device 5600 to verify the pressure setting of the valve device 5000 before and / or after the programmer device 5600 programs the valve device 5000. As shown, the monitoring device 6000 includes a disc-shaped casing 6002 having an upper part 6004, a lower part 6006, and a side wall 6008 connecting the upper and lower parts of the casing.

[0204] Referring further to Figure 61, the upper part 6004 of the casing 6002 of the monitoring device 6000 includes an LCD 6010 and a central opening 6012 through which the user can view the position and operation of the monitoring device during use. The LCD 6010 of the monitoring device 6000 is used by a physician to measure the pressure setting of the valve device 5000. The upper part 6004 of the casing 6002 further includes a keyboard foil to provide a user interface 6014 for operating the monitoring device 6000. For example, the upper part 6004 of the casing 6002 of the monitoring device 6000 is provided with a dial 6016 that indicates the position of the rotor 5026 of the valve device 5000. An on / off button 6018 is provided for operating the monitoring device 6000, i.e., turning it on and off, as well as a pressure recall button 6020 for accessing previously read pressure settings. In some cases, a USB port 6070 may be provided for charging a rechargeable battery and / or for modifying or updating the software of the monitoring device 6000.

[0205] Referring to Figures 62 and 63, the casing 6002 of the monitor device 6000 includes a lower casing 6022 and an upper casing 6024. The lower casing 6022 of the monitor device 6000 includes a battery housing 6026 configured to house one or more batteries for powering the operation of the monitor device 6000. A battery cover, shown together with 6028, is provided to cover the battery housing 6026.

[0206] The monitoring device 6000 further includes a monitoring electronic board 6034 and a monitoring sensor board 6036, the monitoring sensor board 6036 being provided to determine the pressure setting of the valve device by identifying and detecting the angular or circumferential direction of the indicator 5064 of the valve device 5000. The monitoring device 6000 further includes a compass bridge 6038 provided on top of the monitoring assembly 6034. In one embodiment, the compass bridge 6038 is a plastic cover which is part of the casing 6002. One purpose of the compass bridge 6038 is to protect the sensor.

[0207] Referring to Figures 64 and 65, the monitor sensor board 6036 includes a first (upper) surface 6040 (Figure 64) and a second (lower) surface 6042 (Figure 65). The monitor sensor board 6036 includes a circular central body 6044 having a first arm 6046 terminating on a first tab and a second arm 6048 terminating on a second tab. Referring particularly to Figure 65, the central body 6044 includes four sensors, each shown in 6050, which detect magnets 5068 magnetized in the diametrical direction of indicators 5064 of the valve device 5000, and are configured so that the monitor device 6000 occupies the center of the valve device when the monitor device is placed on the valve device. Thus, the monitor device 6000 is configured to occupy the center on the valve device 5000 during the procedure in which the valve device is programmed by using the monitor device and programmer device 5600 in the manner described below. In one embodiment, the monitoring device 6000 includes a circular light array that indicates to the user which direction the monitor must be moved in order to achieve its precise centering on the valve device 5000.

[0208] The monitoring sensor further includes a fifth sensor, shown in 6052, which is centrally positioned relative to the four sensors 6050. This sensor 6052 is configured to measure the angular or circumferential direction of an indicator 5064 of the valve device 5000 to determine the pressure setting of the valve device. The angular or circumferential direction of the indicator 5064 is directly correlated with the angular or circumferential direction of the rotor 5026, and the angular or circumferential direction of the rotor 5026 is directly correlated with the pressure setting of the valve device 5000. In one embodiment, every 18-degree rotation corresponds to a specific pressure of the valve device 5000. A pair of light-emitting diodes (LEDs), each shown in 6054, are provided to illuminate the patient when using the monitoring device 6000. A first tab of the first arm 6046 includes a first magnetic sensor 6056 for measuring the Earth's magnetic field and / or any other magnetic fields present. Similarly, the second tab of the second arm 6048 includes a second magnetic sensor 6058 that similarly measures the Earth's magnetic field and / or any other magnetic fields present. Before positioning the monitor 6000 close to the valve device 5000, magnetic sensors 6048 and 6056 read the external magnetic fields and later subtract them from the readings of sensor 6052. This allows sensor 6052 to accurately read the angular or circumferential direction of indicator 5064, ignoring other external magnetic fields.

[0209] Similar to the programmer device 5600, the monitor device 6000 includes a molded cavity 6060 (Figure 60B) formed in the lower part 6006 of the monitor device. The cavity 6060 is shaped and sized to at least substantially correspond to the shape and size of the implanted valve device 5000. The cavity 6060 includes a pair of channels defined in the lower part 6006 of the casing 6002. The channels can be sized and arranged such that when the monitor device 6000 is placed on the implanted valve device 5000 in the patient's head, the channels align with the inflow catheter and drainage catheter, thereby helping to correctly align the monitor device with the implanted valve device.

[0210] Positioning Disk Referring to FIGS. 66 and 67, a positioning disk of an embodiment of the present disclosure is generally shown at 6600. In the illustrated embodiment, the positioning disk 6600 includes a thin body 6602 having a notch 6604 configured to receive a bulge generated by the embedded valve device 5000 to guide the positioning disk during use. The positioning disk is disposed on top of the valve device 5000 such that an arrow 6610 on the positioning disk indicates the direction of fluid flow within the valve device 5000. The body 6602 of the positioning disk 6600 further includes a recess 6606 having a positioning mechanism 6608 configured to mount a monitor device 6000 on the positioning disk. In use, the notch 6604 of the positioning disk 6600 is disposed on top of the valve device 5000 to roughly position the positioning disk over the patient. Once roughly positioned, the monitor device 6000 is disposed within the recess 6606 with the positioning mechanism 6608 received within a mating mechanism provided on the monitor device. At this time, the monitor device 6000 operates such that the monitor device occupies the center of the valve device 5000. As shown, the monitor device 6000 moves with the positioning disk 6600 in the direction indicated by the monitor, such that both the positioning disk and the monitor device can occupy the center with respect 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, and a programmer device 5600 can be disposed here on the positioning disk to program the valve device 5000. Similar to the monitor device 6000, the programmer device 5600 is disposed within the recess 6606 and the positioning mechanism 6608 is received within a mating mechanism provided on the programmer device.

[0212] Operation of Improved Valve, Programmer Device, and Monitor Device Figure 68 shows a programmer device 5600 having a magnetic shield 5660, a monitor device 6000 connected to a power cord 6620 via a USB port 6070, and a positioning disk 6600 disposed under the monitor device.

[0213] In certain embodiments, the valve device 5000 requires periodic monitoring to ensure that an appropriate pressure is achieved. In other embodiments, the valve device 5000 requires periodic reprogramming to increase or decrease the pressure. When monitoring the pressure, the positioning disk 6600 is disposed over the valve device 5000 as referred to above such that the opening of the positioning disk receives the contour of the embedded valve device therein, and the monitor device 6000 is disposed on the positioning disk. The monitor device 6000 operates such that the monitor device and the positioning disk 6600 occupy the center of the valve device 5000. When occupying the center, the monitor device 6000 detects the existing pressure of the valve device 5000 displayed on the LCD 6010. The position of the rotor 5026 of the valve device 5000 can also be detected on the user interface 6014 of the monitor device 6000 on the dial 6016. If the detected pressure is acceptable as determined by a physician, the monitor device 6000 is turned off by the on / off button 6018, and the monitor device and the positioning disk 6600 are removed from the patient.

[0214] If the detected pressure is deemed unacceptable by the physician, or if the valve device 5000 is scheduled to be reprogrammed, the monitor device 6000 is removed from the positioning disk 6600 and turned off by the on / off button 6018. Once the monitor is removed from the positioning disk 6600, the programmer device 5600 is turned on by the on / off button 5652. Once activated, the physician selects a pressure, for example 100 mmH2O, on the programmer device 5600 by operating the plus (+) button 5648 and minus (-) button 5650, as described above. In some embodiments, the programmer device 5600 can be programmed to a preset pressure, for example 70 mmH2O. Once a pressure is selected, the programmer device 5600 is placed on the positioning disk 6600, and either the start button 5614 or the start button 5616 is pressed to begin the programming sequence. The programmer device performs a reset operation as described above and then sets the pressure of the valve device 5000 to the selected or preset pressure. Specifically, the magnet 5640 of the programmer device 5600 is magnetized to lift the indicator 5064, and the brake arms 5074 and 5076, thereby releasing the rotor 5026 of the magnetic motor 5022. The rotor magnet element 5032 of the valve device 5000 is operated by the stator 5024, which is sequentially magnetized by the magnet 5640 of the programmer device 5600 in a similar manner to the valve device 200, to rotate the rotor 5026 to a selected position and pressure. Once the rotor 5026 is in the appropriate position, the programmer is lifted away from the embedded valve device 5000, allowing the indicator 5064 to return to its stationary position, where the brake 5070 is positioned between the steps 5036 of the rotor 5026 to lock the rotor in place. The programmer device 5600 is removed from the patient and turned off by the on / off button 5652. The physician can use a monitor to repeat the cycle and verify that the valve device 5000 is programmed correctly.Once pressure is confirmed, the physician can remove the monitoring device 6000 and positioning disk 6600 from the patient.

[0215] According to a particular embodiment, valve pressure can be adjusted by applying a pulsed magnetic field near the programmable embedded valve device 5000. When the positioning disk 5600 is centered by the monitoring device 6000, the programmer device 5600 is positioned in close proximity to the embedded valve device 5000 using the positioning disk 6600. In the illustrated embodiment, the magnet 5640 of the programmer device 5600 is configured to operate the rotor 5026 of the valve device 5000. The magnetically operable motor 5022 of the embedded valve device 5000 includes a rotor 5026 having 10 rotor magnet elements 5032 arranged in alternating polarity within a channel of a rotor casing 5030. The magnetic motor 5022 further includes a stator 5024 located below the rotor 5026 and magnetized by the programmer device 5600.

[0216] The operation of valve device 5000 is similar to that of valve device 200. For example, the magnet 5640 of programmer device 5600 may be a permanent magnet or may be excited to have either a north or south pole facing the stator 5024, or each may remain completely off. Movement of the rotor 5026 of valve device 5000 in a desired direction and angle is achieved either by the movement of the permanent magnet or by the excitation of the magnet 5640 in a specified sequence, thereby magnetizing the stator 5024, which then attracts or repels the rotor magnet element 5032 (depending on the polarity), causing the rotor 5026 to rotate.

[0217] Thus, by using the embedded valve 5000 having the magnetic motor 5022 described above, together with an external controller including a programmer device 5600 and a monitor device 6000, the pressure setting of the embedded valve device can be controlled and measured non-invasively in small increments. The configuration of the cam 5048 and the tension of the spring 5020 can be designed and calibrated so that each angular increment of the rotor 5026 produces a change (e.g., 10 mmH2O) that is clearly defined and selected for the pressure setting of the valve device 5000. In one example, the programmer device 5600 can be configured to allow a user to input a desired pressure setting for the valve device 5000. In one embodiment, the programmer device 5600 can be configured to set the pressure of the valve device from 0 to 300 mmH2O, from 0 to 180 mmH2O in 10 mm increments, and from 180 to 300 mmH2O in 40 mm increments. In one embodiment, the default or preset pressure is 70 H2O.

[0218] In one example, to ensure the precise pressure setting of valve 5000, the programmer device 5600 can be configured to first activate a counterclockwise rotation sequence to set the valve device to its fully open position, and then activate a clockwise rotation sequence to set the valve device to a user-selected pressure setting. According to a particular example, when the counterclockwise rotation sequence is activated, the programmer device 5600 is configured to actuate the rotor 5026 to rotate through a sufficient number of counterclockwise steps so that the rotor is positioned so that valve device 5000 has its minimum pressure setting. As described above, the presence of the rotor stopper 5060 prevents the rotor 5026 from continuing to rotate beyond the minimum pressure setting position. After stopping the counterclockwise rotation sequence, the programmer device 5600 can start a clockwise sequence from a known position (corresponding to the minimum pressure setting and having the rotor stopper 5060). The programmer device 5600 can actuate the rotor 5026 to rotate through a selected number of clockwise steps to program valve device 5000 to a user-selected pressure setting.

[0219] The above example uses clockwise rotation of rotor 5026 to program the pressure setting of valve device 5000 (and uses counterclockwise rotation to set rotor 5026 to a known position to initiate the program sequence); however, in consideration of the advantages of the present disclosure, a system (valve device 5000, programmer device 5600, monitor device 6000, and positioning disk 6600) can instead be configured to use the opposite arrangement, namely counterclockwise rotation of rotor 5026 to program the pressure setting of valve device 5000 (and uses clockwise rotation to set rotor to a known position to initiate the program sequence).

[0220] Embodiments of the valve assembly 4900 may be implanted in a patient using a well-described surgical procedure. The pressure setting of the valve device 5000 can be adjusted to a desired pressure setting prior to surgical implantation. In one embodiment, the operating pressure can be set to be approximately equal to the CSF pressure of the patient's ventricles so that no pressure changes occur after surgery. After the patient has recovered from surgery, the pressure setting can be adjusted as desired. For example, in a patient with NPH, the pressure setting can be reduced to initiate ventricular size reduction. Further adjustments to the pressure setting can be made. For example, once the ventricular size has sufficiently decreased, the valve pressure setting can be increased. As is understood, the use of an implantable valve device allows for external adjustment of the valve device's pressure setting as needed during the course of treating the patient.

[0221] In certain embodiments, a method for treating hydrocephalus involves implanting an embodiment of a valve assembly 4900 having a ventricular catheter in the ventricular cavity of the patient's brain and a distal catheter connected to a connector located at a distant location within the patient's body from which the fluid is drained. Distant locations within the body from which the CSF is drained include, for example, the right atrium of the heart and the peritoneum.

[0222] In addition to hydrocephalus, there are several other conditions associated with the accumulation of excess fluid that can be treated by draining the fluid to another part of the body using a properly designed inflow catheter. Such conditions include, for example, chronic pericardial effusion, chronic pulmonary effusion, pulmonary edema, ascites, and ocular glaucoma. Embodiments of programmable valve devices may be used to treat these conditions.

[0223] The pressure settings of the valves described herein, including valve device 5000, can be adjusted in many discrete steps or increments, or continuously over a given range, as described above. The embodiments of the valves described herein may have pressures ranging from low pressure, e.g., 0 mmH2O, to high pressure, e.g., 300 mmH2O. Most conventional valves only have a pressure height of 200 mmH2O and can only be adjusted in relatively large increments between each pressure setting.

[0224] While several aspects of at least one embodiment have been described above, it should be acknowledged that various changes, modifications, and improvements are readily conceivable to those skilled in the art. Such changes, modifications, and improvements are intended to be part of this disclosure and within the scope of the invention. Accordingly, the foregoing description and drawings are merely examples, and the scope of the invention should be determined by the appropriate structure of the appended claims and 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 Spring 407 Pivot point 409 Spring 409g Cantilever arm 409h Free end 409j Central arm 409k Arm 410 First spring arm 412 Inflection point 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[[ID=?]] 488 Support pillar 490 Cantilever spring 491 Ruby bearing 492 First spring arm 493 Ruby bearing 494 Cantilever spring arm 496 Free end 498 Support pillar 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 step 520 Central shaft 522 Channel 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, wherein the kit comprises, A surgically implantable shunt valve assembly having a magnetically operable motor configured to provide a selected pressure setting, A monitoring device configured to detect the pressure setting of the surgically implantable shunt valve assembly, A programmer device having at least one programmer magnet, wherein the at least one programmer magnet is selectively movable and configured to actuate a magnetically operable motor, enabling a user to adjust the pressure setting of the surgically implantable shunt valve assembly to match the pressure setting of the programmer device. Equipped with, The programmer device is separated from the monitor device, The programmer magnet includes at least one permanent magnet, The surgically implantable shunt valve assembly includes a magnetically operated mechanical brake assembly, The aforementioned magnetically operated mechanical brake assembly An indicator having an indicator housing and a magnet disposed within the indicator housing, A brake coupled to the indicator, which is movable in response to the movement of the indicator between a locked position in which the brake is positioned between the teeth of a plurality of motor teeth to prevent the rotation of the rotor of the motor, and an unlocked position in which the brake disengages the teeth of the plurality of motor teeth, wherein the brake is movable in response to the indicator being exposed to an external magnetic field applied by the programmer device, and including, kit.

2. The kit according to claim 1, wherein the programmer device further includes at least one of a user interface and at least one button for turning the programmer device on and off.

3. The kit according to claim 2, wherein the user interface of the programmer device includes a first button for increasing the pressure setting value and a second button for decreasing the pressure setting value.

4. The kit according to claim 2, wherein the programmer device includes at least one start button for initiating a programming sequence.

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, comprising the at least one permanent magnet for applying an external magnetic field to the surgically implantable shunt valve assembly, and The kit according to claim 1, comprising:

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

7. The kit according to claim 1, wherein the programmer device includes software that controls the movement of the at least one permanent magnet in order to realize a programming sequence.

8. The kit according to claim 1, wherein the programmer device is configured to rotate the rotor in the first direction to a minimum pressure setting before starting to rotate the rotor in a second direction opposite to the selected pressure setting.

9. The kit according to claim 1, wherein the monitoring device includes at least one user interface and a button for turning the monitoring device on and off.

10. The monitoring device includes a housing and a monitor assembly supported by the housing, The kit according to claim 1, wherein the monitoring device includes a monitoring sensor configured to occupy the center of the valve device and detect the position of the magnetically operable motor of the surgically implantable shunt valve assembly.

11. The kit according to claim 10, wherein the monitor sensor includes a first sensor that occupies the center of the monitor assembly and a second sensor that detects the position of the magnetically operable motor of the surgically implantable shunt valve assembly.

12. The kit according to claim 1, wherein the surgically implantable shunt valve assembly further includes a housing, the exterior of which is formed from a physiologically compatible material, and the magnetically operable motor is disposed within the housing, the magnetically operable motor including a stator and a rotor, the rotor being configured to rotate relative to the stator in response to a change in the magnetic poles of the stator induced by an external magnetic field.

13. The kit according to claim 12, wherein the rotor comprises a rotor casing and a plurality of rotor permanent magnet elements arranged in a circular manner within the rotor casing and having alternating magnetic polarities, the rotation of the rotor relative to the stator generates the selected pressure setting of the surgically implantable shunt valve assembly, and the rotor casing has the plurality of motor teeth.

14. The surgically implantable shunt valve assembly is An inlet port located between the rotor casing and the outside of the housing, the inlet port terminating at the end of the rotor casing within the valve seat, spring and, A valve element biased against the valve seat by the spring, wherein 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, wherein the surgically implantable shunt valve assembly is configured such that the opening opens when the pressure of the fluid in the inlet port exceeds the selected pressure setting of the surgically implantable shunt valve assembly, in order to discharge fluid to the outlet port through the opening. The kit according to claim 13, further comprising:

15. The kit according to claim 13, wherein the surgically implantable shunt valve assembly includes a rotor marker attached to the rotor, which as a result rotates with the rotor, and a housing marker fixedly attached to the housing, the position of the rotor marker relative to the housing marker indicates the pressure setting of the surgically implantable shunt valve assembly.

16. The kit according to claim 1, further comprising a positioning disk used for positioning the monitoring device and the programmer device on the surgically implantable shunt valve assembly.

Images