Automatic regulation hydrocephaly valve

Abstract

To provide a system and a method for correctly measuring a pressure (Pp) in a human brain, using completely implanted or partially external hardware.SOLUTION: A system comprises: a first pressure transducer configured to measure a cerebrospinal fluid pressure (Pcsf) within a ventricle of a brain; a second pressure transducer configured to indirectly measure a second pressure (Pp) within the ventricle of the brain; and an adjustable implanted valve controller configured to calculate an effective pressure difference (Pei=Pcsf-Pp) between the measured pressures Pcsf and Pp and determine whether an effective pressure difference measured value represents a true secondary pressure.SELECTED DRAWING: Figure 5

Description

[Background technology]

[0001] Hydrocephalus is associated with enlargement of the ventricles due to the net accumulation of cerebrospinal fluid (CSF) within the ventricles. Non-communicating hydrocephalus (obstructive) or high pressure hydrocephalus (HPH) is a condition in which the ventricular system or Hydrocephalus is associated with obstruction of the cerebrospinal fluid (CSF) flow pathway, and is generally caused by increased cerebrospinal fluid (CSF) pressure. HPH is also characterized by the absence of obstruction to the ventricular flow pathways, but the CSF is not circulating through the ventricular system. It can also occur when there is a blockage at the site where the cerebrospinal fluid is drained into the cerebrospinal fluid flow. - Traffic (or non-obstructive) forms that do not result from visible (i.e. identifiable) blockages Hydrocephalus can also occur. Normal pressure hydrocephalus (NPH) is a condition in which the ventricular volume is increased at virtually normal CSF pressure. This is a form of communicating hydrocephalus in which there is enlargement, and is a clinical condition that mainly affects elderly people. In this type of hydrocephalus, the CSF pathways are intact and drainage into the bloodstream is impaired. NPH is characterized by the Hakim triad, which is associated with enlarged ventricular volumes in the absence of elevated intracranial pressure: It is characterized by three symptoms known as The first symptoms are usually movement disorders (mainly gait disturbances), Incontinence (mainly urinary incontinence), and Dementia.

[0002] Depending on severity and progression, symptoms may include one, two, or three symptoms, typically with walking disturbance as the predominant symptom. All symptoms may be present. In summary, NPH is characterized by ventricular enlargement under conditions of normal CSF pressure. It appears as:

[0003] NPH has a known clinical basis that justifies its differential diagnosis between itself and other brain atrophies and dementias. Unlike most dementias, dementia associated with NPH is a complex clinical entity. This can be reversed by treatment with the implantation of a catheter.

[0004] The goal of treatment for all forms of hydrocephalus is to reduce ventricular pressure and thereby ventricular volume. The aim of this study is to standardize ventricular volumes in both HPH and NPH patients. Hydrocephalus of the cerebrospinal fluid is often caused by fluid in the ventricles or lumbar meningeal space (communicating hydrocephalus, which communicates with the fluid compartments of the brain). This condition is treated by implanting a shunt into the brain's fluid compartment that drains excess CSF from the Examples of such shunts include: A ventriculoatrial (VA) shunt, which diverts fluid from the ventricles to the right atrium of the heart; Ventriculoperitoneal (VP) shunts, which divert fluid from the ventricles to the peritoneum; and Lumboperitoneal (LP) shunts, which divert CSF from the lumbar region to the peritoneum; Examples include:

[0005] Ventricular shunts can be used in patients with communicating or non-communicating hydrocephalus, whereas lumbar shunts , it can only be implanted in patients with communicating hydrocephalus.

[0006] These shunts are A cerebral catheter (for ventricular shunt) or hollow needle inserted into the ventricles through the brain parenchyma and inflow catheters such as lumbar catheters (for lumbar shunts) that are inserted into the lumbar meningeal space. , One-way valve system that controls fluid pressure from either the ventricles or the lumbar region and, Absorbs CSF to bypass obstruction in non-communicating or obstructive hydrocephalus or to reduce N Jugular vein reduces CSF pressure below parenchymal pressure (and normalizes ventricular volume) in PH A catheter inserted into a body reservoir such as the right atrium of the heart (advancing the tip to the right atrium) or the peritoneal cavity. A catheter and Generally consists of:

[0007] Ventriculoatrial, ventriculoperitoneal, and lumboperitoneal shunts are fixed, as discussed further below. Available with either pressure or variable pressure (programmable or adjustable) valve mechanisms It is.

[0008] Other uses include, but are not limited to, for the management of intracranial pressure (ICP) or to treat infections, To manage conditions such as intraventricular hemorrhage, elevated CSF proteins, etc., or NP To determine whether an implantable shunt is a management option as a screening procedure for H As a temporary procedure before permanent implantation of the shunt, a drainage bag (external ventricular drain) is inserted from the ventricle. drainage bag (external lumbar drainage system or EVDS) or from the lumbar meningeal space An external drainage system (EDS) draining into an external drainage system (ELDS) was used for several weeks. It is possible. Summary of the Invention [Problem to be solved by the invention]

[0009] Current technology, at best, offers techniques that can only be adjusted during routine visits to a clinician. Therefore, hydrocephalus and cerebrospinal fluid therapy should be considered to optimize shunting for the specific condition being treated. The need for self-regulating hydrocephalus valves (implantable and external) for the treatment of cerebrospinal fluid (CSF) space-related disorders There exists a need in the art. Therefore, aspects and embodiments provide a method for providing a method for treating a patient's Automatically adjusting valves allow the valve to automatically adjust as requirements change. do. [Means for solving the problem]

[0010] According to one embodiment, secondary cerebral infarction in the human brain is induced using fully implanted or partially external hardware. The most accurate method for measuring pressure, for example intraparenchymal venous pressure (Pp), is to measure the intraventricular cerebrospinal fluid pressure (Pcs f) and indirectly measure the intraparenchymal pressure (Pp) in the parenchymal cavity of the brain. Calculate the effective pressure difference between Pcsf and Pp (Pei = Pcsf - Pp) and and determining whether the pressure measurement represents a true intraparenchymal pressure.

[0011] In one example, the cerebrospinal fluid pressure measurement in the ventricles (Pcsf) is compared to the intraparenchymal pressure in the brain's parenchymal cavities (Pp). If the pressure difference is within a certain threshold, the ventricular pressure is reduced by a predetermined pressure value. In one example, the specific pressure drop is 10 mmH2O. The method is The pressure in the ventricle is then successively reduced until it is below the measured Pp pressure by a specified differential pressure threshold. In one example, the specified differential pressure threshold is 20 mmH2O. Pp measurements represent true intraparenchymal venous pressure.

[0012] In certain examples of the method, high pressure hydrocephalus is treated by reducing cerebrospinal fluid pressure.

[0013] In certain examples of the method, normal pressure hydrocephalus is treated by reducing cerebrospinal fluid pressure.

[0014] In one particular embodiment of the method, the reduction in cerebrospinal fluid pressure leads to the formation of pseudotumor cerebri (idiopathic intracranial hypertension). ) condition is treated.

[0015] In one particular embodiment of the method, continuous measurements of Pcsf and Pp are used to determine ventricular volume and intraparenchymal venous volume. A steady state balance with the pressure is provided.

[0016] According to another embodiment, the surgically implantable shunt valve system is connected to an inlet port. The inflow catheter is connected to the inlet port and implanted in the CSF space in the ventricle or spine. The shunt valve closes when pressure exceeds the selected pressure setting of the shunt valve assembly. An aperture in the valve assembly opens and fluid vents through the aperture into the outlet port. and a shunt valve assembly configured to be inserted into a body cavity through which cerebrospinal fluid can be absorbed. An outflow catheter provides drainage of fluid from an outlet port into the cavity within the cerebrospinal fluid pressure A first pressure transducer attached to the inflow catheter for measurement, and a second pressure transducer for measuring intraparenchymal pressure. A second pressure transducer is attached to the inflow catheter for measuring the pressure of the inflow catheter. an adjuster configured to vary a valve pressure setting based on measurements from a transducer; and a stable implantable valve controller.

[0017] According to another embodiment, a partially internal and partially external implantable shunt valve system is provided. The system is an implantable catheter that is connected to an inlet port and surgically placed into the CSF space in the ventricle or spine. The inlet catheter and the fluid pressure at the inlet port are adjusted to the selected pressure of the shunt valve assembly. When the force setting is exceeded, an aperture in the shunt valve assembly opens and The external shunt valve assembly is configured to vent the fluid through the outlet port. and discharge into a bag outside the body where the cerebrospinal fluid can be collected for analysis and / or disposal. External outflow connected to an external drainage bag providing drainage of fluids from the oral port The tube and the first pressure transducer attached to the inflow catheter for measuring cerebrospinal fluid pressure. and a second pressure transducer attached to the inflow catheter for measuring parenchymal pressure. and varies the valve pressure setting based on measurements from a pressure transducer. and an adjustable valve controller configured to measure instantaneous and trend values ​​and Other secondary measurements that provide useful information to clinicians include clinically relevant measurements such as mmH2O and mmHg. External screen display showing direct CSF and intraparenchymal pressure measurements in useful values , including.

[0018] In one particular example, a first pressure transducer for measuring cerebrospinal fluid pressure (Pcsf) The pressure sensor provides a first electrical signal representative of the measured pressure to the valve controller.

[0019] In one particular example, a second pressure transducer for intraparenchymal pressure (Pp) measurement is A second electrical signal representative of the measured pressure is provided to a valve controller.

[0020] In one example, the valve controller calculates the pressure difference between the measured Pcsf pressure and the Pp pressure. The valve controller adjusts the pressure difference between Pcsf and Pp to a predetermined level. In one example, a predetermined pressure difference between Pcsf and Pp may be determined. If the valve controller determines that the The pressure regulator reduces the pressure setting of the shunt valve assembly by a predetermined amount. In one example, the predetermined pressure level is 10 mmH2O. When the pressure difference between Pcsf and Pp exceeds a predetermined level, the valve control If the roller is determined, the valve controller will use the measured Pp pressure as the true Pp pressure. and identify it.

[0021] According to another embodiment, the surgically implantable shunt valve system is connected to an inlet port. The inflow catheter is connected to the inlet port and implanted in the CSF space in the ventricle or spine. The shunt valve closes when pressure exceeds the selected pressure setting of the shunt valve assembly. An aperture in the valve assembly opens and fluid vents through the aperture into the outlet port. and an outlet port into a cavity within the body. An outflow catheter provides drainage of fluid from the pleural effusion, and an inflow catheter is used to measure intraparenchymal pressure (Pp). First pressure transducer attached to the catheter and measuring cerebrospinal fluid pressure (Pcsf) a second pressure transducer attached to the inflow catheter for measuring the pressure of the inflow catheter; High pressure hydrocephalus (HPH) based on Pcsf and / or Pp measurements compared to established thresholds; Configured to determine whether the pathology of normal pressure hydrocephalus (NPH) or pseudotumor in the brain is present. and an adjustable implantable valve controller.

[0022] In one example, a first pressure transducer for measuring intraparenchymal pressure (Pp) is An electrical signal representative of Pcsf is provided to the valve controller each time Pcsf is measured.

[0023] In one example, the valve controller controls the surgically implanted valve by a predetermined value. In another example, the valve controller reduces the pressure setting of the front valve assembly. The measured Pcsf pressure exceeds the measured Pp pressure by a predefined amount. In one example, the difference between Pp and Pcsf is greater than 20 mmH2O. In another example, the valve controller maintains the valve pressure until the ventricle volume reaches normal volume. In another example, the valve controller maintains the set point until Pcsf is equal to Pp. Increase the pressure setting on the valve assembly until

[0024] According to another embodiment, the surgically implantable shunt valve system is connected to an inlet port. The inflow catheter is connected to the inlet port and implanted in the CSF space in the ventricle or spine. The shunt valve closes when pressure exceeds the selected pressure setting of the shunt valve assembly. An aperture in the valve assembly opens and fluid vents through the aperture into the outlet port. and an outlet port into a cavity within the body. An outflow catheter provides drainage of these fluids, and an inflow catheter is used to measure cerebrospinal fluid pressure. The first pressure transducer is attached to the catheter and the second pressure transducer is attached to the inflow catheter for measuring intraparenchymal pressure. a second pressure transducer attached to the pressure transducer; and An adjustable pressure regulator configured to vary the valve pressure setting based on measurements from Implantable valve controller, implantable power source, and adjustable implantable valve controller and a wireless communication mechanism between the controller and an external programming device.

[0025] In one example, the shunt valve assembly includes an adjustable implantable valve controller. In another embodiment, the implantable adjustable valve is separate from the implantable adjustable valve. The valve is electrically interfaced to the valve controller via a valve communication cable. In another example, the programmer receives operational set points and data from the valve controller. In another example, the programmer wirelessly receives new values ​​for the operational settings. Wirelessly transmit to the remote controller.

[0026] In one example, the shunt valve assembly is integrated into a valve controller. In one example, the adjustable valve is an implantable valve that is a modular, The valve is located within a polymer header of an implantable valve controller. The inflow catheter from the ventricle is connected to the first and second pressure transducers and the implanted valve. The pressure sensor includes a wire for transmitting pressure values ​​to a sub-controller. The adjustable valve and valve controller are powered by an implantable power source and wireless In one example, the shunt valve system is an implantable device that is separate from the communication mechanism. Integrated adjustable valve and valve controller with implantable power The wireless communication mechanism may further include an electrical cable connected between the wireless communication mechanism and the power source. The implanted power source is a primary battery. In another embodiment, the implanted power source is a rechargeable battery. In one example, the implantable rechargeable battery is a In one example, the implantable valve controller and The adjustable valve is located adjacent to the skull of a human patient. The lube controller and adjustable valve provide continuous power from a portable external device. Receive wirelessly.

[0027] In another embodiment, the pressure is measured by a pressure sensor configured to be implanted in fluid communication with the ventricle. Providing force data to a valve controller for surgically implantable shunt valve assemblies In one embodiment, the method comprises the steps of: , and the intraparenchymal pressure (Pp) in the parenchymal cavity of the brain is measured. and calculating the differential pressure between Pp and the surgically implantable shunt valve based on the differential pressure. and determining whether to adjust the pressure setting of a shunt valve in the assembly.

[0028] In one example, a Pcsf above a pre-determined threshold is indicative of high-pressure hydrocephalus. So the predefined threshold is 220mmH2O.

[0029] This method uses a valve controller to predetermine the pressure setting of the shunt valve. In one example, the method further includes decreasing the predetermined decrement. Minutes are 10mmH2O.

[0030] The method determines whether the differential pressure between Pp and Pcsf is greater than a predetermined differential pressure threshold. In one example, the predetermined differential pressure threshold is 10 mmH 2O. The method further comprises: Continue to lower the shunt valve pressure setting using the valve controller until the threshold is exceeded. In one example, the second predetermined differential pressure threshold is 20 In one example, the method comprises administering the valve control until the ventricles return to their normal size or volume. In another example, the method further includes maintaining the pressure set point with a controller. Use the valve controller to adjust the pressure of the shunt valve until Pp and Pcsf are equal. In one example, the method further includes increasing the force set point. and recording the Pp and Pcsf values ​​in memory using the same. In one example, a patient with normal Pcsf measurement is diagnosed with normal pressure hydrocephalus. The value is 150 mmH2O. This method uses a valve controller to control the shunt valve. The method may further include decreasing the pressure set point by a predetermined decrement. The predetermined decrement is 10 mmH2O. Determine whether the differential pressure between Pp and Pcsf exceeds a predetermined threshold using the In one example, the predetermined differential pressure threshold is 10 mmH2O. The method further comprises detecting when the differential pressure between Pp and Pcsf exceeds a second predetermined threshold. Continue to decrease the shunt valve pressure setting using the valve controller until In one example, the second predetermined differential pressure threshold is 20 mmH2O. The method includes using a valve controller to inflate the ventricles until they return to their normal size or volume. The method may further include maintaining the pressure set point. Increase the pressure setting of the shunt valve using the valve controller until The method further includes using the valve controller to measure the Pp and Pc in the memory. It may further include recording the sf value.

[0031] According to another embodiment, the surgically implantable shunt valve system is connected to an inlet port. The device includes an inflow catheter that is connected to the CSF cavity in the ventricle or spine and a shunt valve. The pressure of the fluid at the inlet port rises to the selected pressure setting of the shunt valve assembly. When the value is exceeded, the aperture of the shunt valve opens and fluid escapes through the aperture. A shunt valve assembly configured to be vented into an oral port and a cavity within a human body. An outflow catheter provides drainage of fluid from an outlet port to the cerebrospinal fluid pressure measurement a first pressure transducer attached to the inflow catheter for measuring intraparenchymal pressure; a second pressure transducer attached to the inflow catheter for detecting the first and second pressures; configured to vary a valve pressure setpoint based on a measurement from the transducer; An adjustable implantable valve controller, an implantable power source, and external programming configured to provide wireless communication between the implantable valve controller and the a first wireless communication device connected to the implantable valve controller and an external patient receiver; a second wireless communication device configured to provide wireless communication between the , including.

[0032] In one example, the implanted valve controller transmits wireless data to an external patient receiver. In one example, the transferred data includes a first and a second pressure transducer. In another example, the transferred data includes alarm data. The alarm data includes abnormal pressure measurements obtained from the first and second pressure transducers. In one example, the alarm data may be an indication of a device system failure. In one example, the external patient receiver provides an audio alarm to the patient. In one particular example, the external patient receiver provides a visual alarm to the patient. After transmitting the alarm signal, the valve controller transmits all measurement data to the external Wirelessly transmit to the patient receiver.

[0033] According to another embodiment, the shunt valve system is connected to the inlet port and is configured to The inflow catheter is implanted in the CSF space of the spine, and the pressure of the fluid at the inlet port is used to create a shunt. The shunt valve assembly is shut off when the selected pressure setting of the valve assembly is exceeded. The aperture opens so that the fluid is vented through the aperture into the outlet port. The shunt valve assembly is configured with an outlet port for an external ventricular drainage system. An outflow catheter provides drainage of fluid to the cerebrospinal fluid (CSF) and an inflow catheter is used to measure cerebrospinal fluid pressure. The first pressure transducer is attached to the catheter and the second pressure transducer is attached to the inflow catheter for measuring intraparenchymal pressure. A second pressure transducer is attached to the pressure gauge and the readings from the pressure transducer are an adjustable valve controller configured to vary a valve pressure setpoint based on Includes a controller and a.

[0034] In one example, a first pressure transducer for measuring cerebrospinal fluid pressure (Pcsf) is A first electrical signal representative of the constant pressure is provided to the valve controller. The second pressure transducer for measuring the internal pressure (Pp) is connected to a second electrical signal that represents the measured pressure. In one example, the valve controller provides a measured P In another example, the valve controller calculates the pressure difference between the CSF pressure and the Pp pressure. Determine whether the pressure difference between Pcsf and Pp exceeds a predetermined level. In the example, the valve is closed when the pressure difference between Pcsf and Pp is less than a predetermined level. When the valve controller is determined, the valve controller is set to a pre-determined value. In one example, the pressure setting of the shunt valve assembly is reduced by a predetermined amount. The pressure level measured is 10 mmH2O. In another example, the pressure difference between Pcsf and Pp is If the valve controller determines that the The controller identifies the measured Pp pressure as the true Pp pressure.

[0035] According to another embodiment, the shunt valve system is connected to the inlet port and is configured to The inflow catheter is implanted in the CSF space of the spine, and the pressure of the fluid at the inlet port is used to create a shunt. The shunt valve assembly is shut off when the selected pressure setting of the valve assembly is exceeded. The aperture opens so that the fluid is vented through the aperture into the outlet port. A shunt valve assembly having an outlet into a cavity in the body through which cerebrospinal fluid may be absorbed. An outflow catheter provides drainage of fluid from the port, and an inflow catheter is attached to the outflow catheter. The differential pressure was configured to measure cerebrospinal fluid pressure (Pcsf) and intraparenchymal pressure (Pp). A pressure transducer is connected to the pressure transducer to calculate the pressure difference between the measured cerebrospinal fluid pressure and the intraparenchymal pressure. and to vary the valve pressure setting based on measurements from a differential pressure transducer. and an adjustable valve controller configured as follows:

[0036] In one example, the differential pressure transducer is a first pressure transducer for measuring cerebrospinal fluid pressure. and a second pressure transducer for measuring intraparenchymal pressure.

[0037] In one example, the valve controller may be configured to determine whether the pressure difference between Pcsf and Pp is predetermined. In one example, the Pcsf and Pp The valve controller determines that the pressure difference between When this occurs, the valve controller deactivates the shunt valve assembly by a predefined amount. Reduce the pressure setting of the bleeder. The predefined pressure level is, for example, 10m In another example, the pressure difference between Pcsf and Pp is predetermined. If the valve controller determines that the amount of the ionizing radiation is greater than the specified level, the valve controller: The measured Pp pressure is identified as the true Pp pressure.

[0038] In another embodiment, pressure data is collected by a pressure sensor configured to be in fluid communication with the ventricle. A method for providing data to a valve controller to operate a shunt valve assembly In one embodiment, the method includes measuring intraventricular cerebrospinal fluid pressure (Pcsf) and The intraparenchymal pressure (Pp) in the parenchymal cavity is measured, and the differential pressure between the measured pressure Pcsf and Pp is calculated. Calculate and set the pressure of the shunt valve in the shunt valve assembly based on the pressure difference. and determining whether to adjust the constant.

[0039] Further aspects, embodiments, and advantages of these exemplary aspects and embodiments are described below. The embodiments disclosed herein are based on at least some of the principles disclosed herein. The present invention may be combined with other embodiments in any manner that corresponds to at least one of the above. "embodiments," "some embodiments," "alternative embodiments," "various embodiments," "one embodiment" References to "configurations" and "features" are not necessarily mutually exclusive and may include any particular feature, It is not intended to imply that a structure or feature may be included in at least one embodiment. The appearances of such terms in this specification do not necessarily all refer to the same embodiment. This is not necessarily the case.

[0040] Various aspects of the embodiments are discussed below with reference to the accompanying drawings. Not all components may be shown on all drawings. Drawings are not necessarily to scale. It is not necessarily to be construed as limiting the present invention, but emphasis instead is placed upon illustrating the principles of the invention. The aspects are included to facilitate illustration and understanding of the various aspects and embodiments and are not intended to be limiting unless otherwise specified. This document is incorporated in and constitutes a part of the present invention, but is not intended as a definition of the limits of the invention. stomach. [Brief description of the drawings]

[0041] [Figure 1] FIG. 1 illustrates the anatomy of the human brain presented in a spherical model with reference to various structures and associated pressure measurements. [Figure 2A] 1 is a graphical representation of a physician's clinical evaluation algorithm for self-adjusting valves for various clinical conditions. [Figure 2B] 1 is a graphical representation of a self-adjusting valve measurement and treatment algorithm for a patient diagnosed with hydrocephalus. [Figure 2C] 1 is an illustration of example laboratory study data of pressure measurements and graphical representations of the pressure measurements described herein. [Figure 3A] FIG. 1 illustrates device components of an example self-adjusting hydrocephalus valve system based on a mechanical design approach. [Figure 3B] FIG. 1 illustrates device components of an example self-adjusting hydrocephalus valve system. [Figure 3C] FIG. 1 illustrates other example device components of an auto-adjusting hydrocephalus valve system that also includes a portable wireless receiving device. [Figure 4] FIG. 13 illustrates a device component configuration providing another example self-adjusting hydrocephalus valve system with an integrated controller and adjustable valve. [Diagram 5]FIG. 13 illustrates a device component configuration providing another example self-adjusting hydrocephalus valve system having an integrated controller and adjustable valve along with a rechargeable power source. [Figure 6] 1 is a flow chart of an example of measuring and monitoring CSF pressure (Pcsf) and intraparenchymal venous pressure (Pp) during determination of the presence of hydrocephalus pathology. [Figure 7] 1 is a flow chart of an example treatment algorithm during steady state operation. [Figure 8] FIG. 1 is an electronic block diagram of an example implanted valve controller and external device. [Figure 9A] 7 is a graph illustrating a time-based graphical representation of pressure measurements for the algorithm of the flowchart presented in FIG. 6. [Figure 9B] 1 is a graph illustrating the steps followed in an example of treating high pressure hydrocephalus. [Figure 9C] 1 is a graph illustrating the steps followed in an example of treating normal pressure hydrocephalus. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0042] Aspects and embodiments include a catheter that is implanted in a patient or connected to a catheter that is implanted in a patient. The device is configured to be used to regulate the flow (drainage) of cerebrospinal fluid (CSF). Dynamic Adjustment Valve.

[0043] Definition: Arachnoid villi: Microscopic projections of the arachnoid membrane into some of the venous sinuses through which CSF is transported. Discharge into the stream. Atrium: One of the two upper chambers where blood enters the heart. Catheter: A thin tube made from medical grade materials for diversion of fluids. Atrial Catheter: The distal outflow tube of the shunt that drains into the atrium. Drainage catheter: The distal outflow catheter (tube) of the shunt. The tube allows the fluid to exit the shunt valve system. Inflow Catheter: The proximal tube of the shunt that is placed into one of the cerebrospinal fluid compartments. This allows CSF to flow into the shunt valve system. Lumbar catheter: The proximal tube of the shunt through which CSF passes around the spine. is drained from the CSF space. Peritoneal Catheter: The distal outflow tube of a shunt that drains into the peritoneum. Ventricular catheter: The proximal inflow tube of a shunt that drains CSF from the ventricles. Cerebrospinal fluid: A clear, colorless fluid that bathes the brain and spinal cord and is produced primarily in the choroid plexus of the ventricles. It acts as a cushion or buffer for the brain and provides a foundation for the brain and spinal column within the skull. The present invention provides effective mechanical and immunological protection. Choroid plexus: The choroid plexus is a vascular plexus of cells that produces most of the cerebrospinal fluid in the ventricles of the brain. The plexus consists of modified ependymal cells. External Drainage System (EDS): External drainage and monitoring is performed by gravity and C By using a combination of SF pressure, the lateral ventricles of the brain or the lumbar cavity of the spine are collected into an external collection bag. Temporary CSF drainage to the esophagus. External Lumbar Drainage System (ELDS): External drainage and monitoring is important. Temporary transfer of blood from the lumbar space of the spine into an external collection bag using a combination of force and CSF pressure. CSF drainage. External Ventricular Drainage System (EVDS): External drainage and monitoring is important. Transient C from the lateral ventricles of the brain into an external collection bag using a combination of force and CSF pressure This is SF drainage. Fixed Pressure: A valve that operates with a single operating pressure. Hydrocephalus: A condition associated with enlargement of the ventricles due to the net accumulation of cerebrospinal fluid (CSF) within the ventricles. A pathological condition. Communicating hydrocephalus: a non-obstructive form of hydrocephalus that does not result from a visible blockage of CSF flow Hydrocephalus. High-pressure hydrocephalus: A neurological disorder characterized by the excessive accumulation of CSF in the ventricles of the brain. CSF accumulates, causing increased pressure within the brain (cranial cavity), leading to an expansion of the ventricular volume and This causes tissue stretching and compresses critical structures. Nonobstructive hydrocephalus: See communicating hydrocephalus. Normal Pressure Hydrocephalus: This condition, abbreviated as NPH, is sometimes characterized by an increase in ICP, but is rarely seen. CSF accumulation resulting in ventricular enlargement without any associated hypercalcaemia, whereas "normal" CSF In the presence of pressure, the neurological triad (three groups) of symptoms - gait disturbance (typically the first to appear) Depending on the severity, one or more of these symptoms may occur. appears. Obstructive hydrocephalus: See High-pressure hydrocephalus. Lumbar-peritoneal shunt: A shunt that diverts CSF from the lumbar subarachnoid (lumbar meningeal) space to the peritoneal cavity. To-valve system. Brain parenchyma: The brain tissue that is made up of two types of brain cells: neurons and glial cells. Functional organization of. Peritoneum: The serous membrane that lines the abdominal cavity and covers the abdominal organs. Subarachnoid pressure: CSF pressure measured in the subarachnoid CSF space. Subdural pressure: Pressure measured in the subdural space. Programmable Pressure: Non-invasive adjustment of operating pressure that can be changed by programmer Variable pressure valve mechanism having a range. Shunt: Typically consists of two catheters (inflow and outflow) and a catheter that determines the volume, flow direction, and and a one-way valve that regulates CSF pressure in the fluid compartment of the brain. Superior sagittal sinus: of the falx cerebri that allows blood to drain from the lateral surface of the anterior cerebral hemisphere to the sinus venosus intersection. The upper longitudinal sinus in the human skull, an unpaired region along the attachment edge. Lumbar meningeal space: The CS surrounded by the thecal sac or dural sac, which is a membranous sheath of dura that surrounds the spinal cord and cauda equina. F Fluid Compartment. The thecal sac contains cerebrospinal fluid in which the spinal cord "floats". Subarachnoid space: It is lined with delicate connective tissue trabeculae and reciprocal channels that contain CSF. The gap between the arachnoid and pia mater is occupied by Valve: A resistance adjusting mechanism in a shunt that allows fluid flow in only one direction. Traditionally The valves can be fixed pressure or non-invasively adjustable pressure. Jugular vein: Vein in the neck that carries blood from the head to the superior vena cava (the large vein in the upper body) and empties into the heart . Superficial cerebral veins: superior cerebral vein, superficial middle cerebral vein, inferior cerebral vein, inferior anastomotic vein, and superior anastomotic vein The cerebral veins of the head, including: Ventricle: A cavity in the brain lined with ependymal cells in which CSF is produced The blood is then circulated in the cranial cavity that communicates with the spinal cord subarachnoid space or is discharged into the arachnoid villi. The ventricles include a pair of lateral ventricles which drain into the third and then the fourth ventricle. Ventriculoatrial Shunt: A shunt that transfers (diverts) fluid from the ventricles to the right atrium of the heart. System. Ventriculoperitoneal Shunt: A shunt-valve system that transfers (diverts) fluid from the ventricles to the peritoneal cavity. Hmm.

[0044] Abbreviation: CSF: Cerebrospinal fluid EDS: External Drainage System ELDS: External Lumbar Drainage System EVDS: External Ventricular Drainage System HPH: High-pressure hydrocephalus NPH: Normal pressure hydrocephalus Pcsf: intraventricular CSF pressure Pei: Effective intraventricular CSF pressure difference, Pei=Pcsf-Pp Pp: parenchymal venous pressure Psa: Subarachnoid pressure Pv: Extraparenchymal venous pressure (measured at the superior sagittal sinus (SSS)) Pvalve: Valve operating pressure SSS: Superior sagittal sinus

[0045] HPH and NPH arise from the interaction between different fluid pressures within the central nervous system.

[0046] As shown in Figure 1, the superficial cerebral vein emerges from the brain surface and drains blood from the cerebral parenchyma cavernosa. 105 passes through the subarachnoid space 115, enters the cerebrospinal fluid (CSF), and enters the dural venous sinuses. It connects to the superior sagittal sinus (SSS) 130 and drains into the normal SSS 130 in the horizontal position. The pressure is approximately 70mmH. 2 O (Pv = extraparenchymal venous pressure measured in the SSS).

[0047] CSF also drains into the SSS 130, but via a different route: the arachnoid membrane of the SSS wall. CSF pressure is mediated by resistance through these arachnoid villi 135, which is the SSS 13 0 pressure. Therefore, when the patient is in the horizontal position, the subarachnoid space 15 Normal CSF pressure (Psa = subarachnoid CSF pressure) is typically 120 mmH 2 O Subarachnoid CSF pressure induces parallel fluctuations in intraparenchymal venous pressure. The S130 level or the subsequent venous pressure change is transmitted equally to both the intraparenchymal venous system and the CSF system. Because both are discharged into SSS130, these two The mechanism ensures constant hydrostatic loading of the brain tissue or cavernous parenchyma 125 .

[0048] The brain tissue or parenchyma 125 is subjected to two opposing pressures. One is generated by the CSF system (Pcsf), which tends to expand the ventricles 110 (and reduce the volume of the parenchyma 125, i.e., reduce the volume of the sponge). The other pressure is generated by the intraparenchymal venous system 120 (Pp) within the parenchyma, which tends to reduce the ventricular volume (and increase the volume of the parenchyma 125) in opposition to ventricular volume expansion. As long as these two pressures are equal regardless of their absolute values, the differential pressure between them is zero, and the tissue is not subjected to any significant stress or strain, and the ventricular volume and further the parenchymal volume remain unchanged and are in a steady-state condition .

[0049] The gradient that controls the degree to which fluid is squeezed out of or into the parenchymal sponge, thereby changing and controlling the ventricular volume and potentially causing a specific form of hydrocephalus, is the difference between the intracerebroventricular CSF pressure (Pcsf) and the intraparenchymal venous pressure (Pp). This gradient is referred to as the effective intracerebroventricular CSF differential pressure (Pei = Pcsf - Pp). When Pcsf > Pp, Pei > 0, and fluid is squeezed out of the parenchyma 125 (i.e., the sponge is "squeezed"), and the ventricular volume increases. Conversely, when Pcsf < Pp, Pei < 0, and fluid can fill the parenchyma 125 and expand the parenchymal volume, and the ventricular volume decreases. When the ventricular volume expansion is not counteracted by an equal Pp and the ventricles expand, the symptoms of NPH (even with normal Pcsf) occur.

[0050] In a normal brain 100, the pressure of the cerebrospinal fluid (Pcsf) within the ventricles 110 is typically equal to the pressure (Pp) of the intraparenchymal venous pathway 120. Therefore, when Pcsf = Pp, the expansion of the ventricles Since there is no gradient between these two pressure compartments that could cause The brain is normally functioning normally and hydrocephalus does not occur. Hydrocephalus or enlargement of the ventricular cavity volume of the brain is This is caused by a pressure imbalance (i.e., the gradient between Pcsf and Pp) in the sf110 exceeds Pp120 (in the case of high pressure hydrocephalus) or Pp120 exceeds Pcsf11 This occurs when the cerebrospinal fluid level is either below 0 (in normal pressure hydrocephalus) or below 0 (in normal pressure hydrocephalus). The aim is to manipulate CSF pressure (Pcsf) so that it is below parenchymal pressure (Pp).

[0051] Primary shunt for hydrocephalus treatment (consisting of an inflow catheter, a valve, and a drainage catheter) In the current model, a fixed pressure valve was incorporated to regulate the flow through the shunt. In many cases, after implantation of a fixed pressure valve, the cause is either underdrainage or overdrainage. The physician then tests various operating pressure ranges until the optimal operating pressure range (equilibrium condition) is determined. 1 (e.g., lower pressure range for underdrainage or The higher pressure ranges required multiple surgeries to replace the initial valve. Instead of using surgery to replace the valve, it would be possible to do it non-invasively (through the skin). Externally (non-invasively) adjustable "programmable" valves with adjustable valve operating pressure However, there are still many programs that are being developed to optimize shunt performance. It is typically necessary to adjust the pressure setting of the hand valve frequently. This is a major drawback to clinicians. This is accomplished over one or more visits. After programming, re-administration is based on the clinician's clinical judgment. Until programmed, the adjustable valve acts like a fixed pressure valve (i.e. (i.e., do not adjust to the changing needs of the patient), thus reducing the need for patient visits to the clinician. The timing of when such valves can be adjusted to accommodate the patient's changing clinical conditions throughout the day is limited. The valve cannot be adjusted based on the above needs to accommodate the patient's daily requirements.

[0052] Aspects and embodiments continuously determine the required valve resistance and provide clinician intervention accordingly. This invention relates to an automatically adjusting valve that can be adjusted without the need for a valve.

[0053] Conventional shunt valves currently in use are either fixed pressure or non-invasive adjustable valves. It is either a pulmonary bypass or a pulmonary bypass, and two parameters are measured: inlet pressure (CSF) and outlet drainage pressure (cardiac These devices function either at the right atrium of the liver (essentially zero pressure) or at peritoneal cavity pressure. The valve system allows CSF to flow through the valve until the CSF pressure falls below the operating pressure setpoint of the valve system. This allows the control of CSF pressure. The ventricular volume and CSF pressure are used as indices for setting the valve operating pressure. Even if some parameters such as pressure are available to the physician, the choice of valve (fixed There is some trial and error involved with either constant pressure valves) or regulation (variable pressure valves). In contrast, aspects and embodiments provide a filter that automatically controls the adjustment of the pressure setting of the valve. By providing feedback, patients can receive ballots whenever and wherever necessary without clinician intervention. An autotuning valve with a third parameter provides a closed loop system to adjust the valve. Regarding Lub.

[0054] Early understanding of the brain suggested that in healthy patients, brain tissue absorbs CSF pressure from the ventricles. Therefore, the subdural pressure had a value of zero. When the values ​​of ventricular and / or CSF pressure increase, much of the ventricular pressure is transferred to the brain surface through the brain tissue or parenchyma. Since the pressure will be transmitted to the subdural space, the subdural pressure will have a positive value. This theory is based on the idea that subdural pressure in a normal person is equal to zero. Only in this case will the subdural pressure have a value above 0, which is the pressure of the valve draining the CSF. Will be used to lower the set point.

[0055] According to certain embodiments, more recent understanding of the hydraulics of the cranial cavity, as well as experimental evidence From this it can be concluded that the subdural pressure in healthy subjects will not have a value of zero. Instead, the subdural sensor measures the higher of two pressures, Pcsf and Pp. Therefore, aspects and embodiments of the self-regulating valve are at least in part based on the actual pressure. The sensor measures the higher of intraparenchymal venous pressure (Pp) and intraventricular CSF pressure (Pcsf). Pcsf can be measured directly using a sensor placed in the CSF. Therefore, the pressure readings from the subdural sensor probe and the CSF pressure sensor By comparing the pressure readings of with the pressure readings of, the observer or system can extrapolate Pp. be.

[0056] More specifically, at the starting point, patients with high pressure hydrocephalus (HPH) have high Pcsf and normal Pp (i.e., Pcsf>Pp). At the starting point, Pcsf is greater than Pp, so The parenchymal sensor measures Pcsf. The CSF pressure sensor also measures Pcsf. The valve then gradually reduces the patient's Pcsf. When Pcsf starts to decrease, the parenchymal and CSF sensors The sensor will continue to provide the same reading. However, if the patient's Pcsf drops below P p, the virtual sensor will instead begin to measure Pp. At this point, since the virtual sensor and the CSF sensor are measuring different pressure readings, the system or observer can know that Pcsf < Pp. The valve can hold this set value long enough to normalize the ventricles (i.e., drain them to a physiologically normal volume). Then, the valve can be adjusted to equalize Pcsf and Pp to maintain a steady-state equilibrium. As further discussed below, the aspects and embodiments disclosed herein provide a system and method for treating patients with HPH or NPH by correcting the pressure imbalance that causes ventricular volume expansion by equalizing Pcsf and Pp. As further discussed below, the aspects and embodiments disclosed herein provide a system and method for treating patients with HPH or NPH by correcting the pressure imbalance that causes ventricular volume expansion by equalizing Pcsf and Pp. Aspects and embodiments disclosed herein correct the pressure imbalance that causes ventricular volume expansion by equalizing Pcsf and Pp to treat patients with HPH or NPH. Aspects and embodiments disclosed herein correct the pressure imbalance that causes ventricular volume expansion by equalizing Pcsf and Pp to treat patients with HPH or NPH. Aspects and embodiments disclosed herein correct the pressure imbalance that causes ventricular volume expansion by equalizing Pcsf and Pp to treat patients with HPH or NPH.

[0057] Certain aspects are also based, at least in part, on the recognition that normal pressure hydrocephalus (NPH) is characterized by a pressure imbalance in the brain having normal Pcs f and Pp below normal values (i.e., Pcsf > Pp). Aspects and embodiments disclosed herein provide a system and method for treating patients with NPH by correcting the pressure imbalance that causes ventricular volume expansion at normal Pcsf by equalizing Pcsf and Pp. The concepts of these pressure relationships for non-hydrocephalus conditions, HPH, and NPH are summarized in the following table. Aspects and embodiments disclosed herein provide a system and method for treating patients with NPH by correcting the pressure imbalance that causes ventricular volume expansion at normal Pcsf by equalizing Pcsf and Pp. The concepts of these pressure relationships for non-hydrocephalus conditions, HPH, and NPH are summarized in the following table. Aspects and embodiments disclosed herein provide a system and method for treating patients with NPH by correcting the pressure imbalance that causes ventricular volume expansion at normal Pcsf by equalizing Pcsf and Pp. The concepts of these pressure relationships for non-hydrocephalus conditions, HPH, and NPH are summarized in the following table. Aspects and embodiments disclosed herein provide a system and method for treating patients with NPH by correcting the pressure imbalance that causes ventricular volume expansion at normal Pcsf by equalizing Pcsf and Pp. The concepts of these pressure relationships for non-hydrocephalus conditions, HPH, and NPH are summarized in the following table. The concepts of these pressure relationships for non-hydrocephalus conditions, HPH, and NPH are summarized in the following table. are summarized in the following table.

[0058]

Table 1

[0059] Advantageously, some patients experienced a noticeable, if not significant, reduction in ventricular size. In some cases, the pressure gradient that created the enlarged ventricles was simply reduced to allow the patient to recover. In other words, it may be sufficient to lower the ventricles to normal volume for the patient to recover. It may not be necessary to completely reduce the product. Therefore, certain embodiments may be implemented primarily as follows: It concerns reducing the pressure gradient between Pcsf and Pp.

[0060] In patients with high pressure hydrocephalus (HPH), Pcsf110 is above normal (CSF circulatory system Due to partial obstruction) and Pp120 is normal, therefore Pcsf>Pp. In patients with normal pressure hydrocephalus (NPH), Pcsf110 is normal (obstruction of the CSF circulation) Pcsf>Pp.

[0061] FIG. 2A illustrates a patient's ability to assess ventricular volume through clinical means (e.g., imaging). Graph of the process of visually assessing a patient's condition to determine if pre-existing hydrocephalus condition is present. Visual imaging assessments may include, for example, MRI or CT scans. If clinical evaluation suggests enlarged ventricles associated with hydrocephalus, valve pressure The set point can be decreased to lower the ventricular volume. Hydrocephalus conditions include high pressure hydrocephalus (HP The patient may be evaluated as either cerebrovascular disease (CEH) or normal pressure hydrocephalus (NPH). If the ventricular volume is determined to be of normal size, the hydrocephalus control system The system can measure Pcsf and Pp pressures and determine whether the hydrocephalus will stop. The device was then programmed into a "standby" steady-state mode that monitored CSF pressure and intraparenchymal venous pressure. However, normal ventricular volumes with high Pcsf and Pp suggest a pseudotumor pathology. In this case, valve pressure is reduced to reduce Pcsf and Pp to normal values. It is possible. The ventricles may have a "slit" condition (also known as slit or subnormal ventricles). If the assessment suggests that the valve pressure setting should be adjusted to expand the ventricular volume (i.e., to “normalize”) Ventricular volume may be increased to assess whether the ventricles return to normal size. It can be visually monitored.

[0062] FIG. 2B provides a graphical representation of the algorithm for a self-adjusting valve. 1 is an electronic sensor ( This shows that there may be a pressure transducer (i.e., a pressure transducer) for measuring Pcsf and Pp pressures. The fixed value may be equal to or greater than Pp, or Pcsf may be greater than or equal to Pp. may be compared to determine whether Pcsf may be less than Pp. If Pcsf is not less than Pp (Step 2), the Pp measurement may not yet be the actual extraparenchymal venous pressure (Pv). The valve pressure setting is changed, the valve pressure setting is waited for the set time, and Pcsf is below Pp. The Pcsf can be reduced by a closed loop algorithm that measures the two pressures until the Pcsf is full. When it becomes less than p (step 3), it is assumed that Pp can reflect the actual extraparenchymal venous pressure (Pv). It is possible.

[0063] Figure 2C shows that the sensor implanted under the dura of the cranial cavity measures intraparenchymal venous pressure (Pp) and cerebrospinal fluid pressure (CSF). Provide evidence based on research data that measures higher cerebrospinal fluid pressure (Pcsf) In healthy subjects, these two pressures are typically equal. In contrast, in HPH, In NPH or pseudotumor (a condition in which intracranial pressure is elevated without ventricular enlargement), the subdural sensilla The venous pressure sensor does not necessarily measure intraparenchymal venous pressure. The sensors, transducers, or other devices used in As with all other variables that tend to be measured, the highest pressure will be measured among the different fluids. In the three conditions mentioned above (i.e., HPH, NPH, or pseudotumor), the subdural area is The reason that the venous pressure sensor is a direct measure of intraparenchymal venous pressure (Pp) is that it is the higher of Pp and Pcsf. Only if there is pressure.

[0064] [Table 2]

[0065] From this we can conclude that the pressure measured is always the higher of the two pressures. Therefore, certain embodiments relate to methods for independently measuring Pp and Pcsf. Based on the hypothesis that CSF pressure controls intraparenchymal venous pressure under normal conditions, the following experiments were performed. was designed and the results are illustrated in the graph of FIG. 2C.

[0066] the below described: Ventricular CSF pressure (plot represented by circle labels) Subdural pressure (plot represented by square labels) Superior sagittal sinus pressure (plot represented by triangle labels) Concurrent measurements were performed in normal dogs.

[0067] While recording the pressure, a bag filled with saline solution connected to the ventricle is lowered. By this, ventricular CSF pressure (plot labeled with a circle) was gradually decreased. This reduces the pressure in the subdural sensor (square labelled It was observed that the two results caused an equal decrease in the β- Both pressures continue until they reach the value of the superior sagittal sinus pressure (plot labeled with a triangle). At that point, Pcsf continues to decrease but subdural pressure does not decrease further ( i.e., SSS is less than Pv). At this point, the subdural sensor now measures the intraparenchymal venous pressure ( Pp) and superior sagittal sinus pressure (abbreviated as Pv; in the center of this graph, P v=Pp). In the center of the graph, Pcsf is less than Pp, and The subdural sensor measures Pp. Then, the saline-filled bag is raised. When the ventricular CSF pressure is increased by stimulating the blood vessels, the CSF pressure exceeds the superior sagittal sinus pressure (Pv). After the venous pressure measurement, only the intraparenchymal venous pressure measured by the subdural sensor started to increase (right side of the graph). (shown in the side section).

[0068] As illustrated in FIGS. 2A and 2B and described further below, a true measurement of intraparenchymal venous pressure is The basic principle is to use the system as a mechanical adjustment system or as a sensor-based electronic adjustment control system. FIG. 3A illustrates an example of a mechanically designed self-regulating valve. The adjustable valve 310 may include a ventricular catheter 340 that may be implanted in the ventricle. Together, this can provide a Pcsf measurement. The pressure may also be used as a back pressure, as exemplified by the subdural pressure bag 305. The contact pressure on the surface of the dural membrane may be the surface pressure of the dural membrane. The adjustable valve 310 can mechanically reduce the pressure. It may also be connected to a distal outflow drainage catheter 390 and is located outside the skull. Ugh.

[0069] FIG. 3B illustrates device components of an example self-adjusting hydrocephalus valve system 300. As discussed above, the hydrocephalus adjustable valve 310 is implanted in the ventricle. In one particular example, the ventricular catheter 340 may include a ventricular catheter 340. or an external ventricular dosing device used to control the drainage of CSF from the spinal subarachnoid space. The system may be connected to a power supply system or part thereof, which may include sensor outputs and physiological The device is equipped with a display and data processing system that provides time-relevant data. 0 may be attached on the outer surface of the ventricular catheter 340 and may be connected to the C The second electronic pressure sensor 320 may be capable of measuring the brain SF pressure (Pcsf). The catheter 340 may be attached to the outside of the ventricular catheter 340 in a location that contacts the parenchyma, and may be attached to the inside of the parenchyma. The adjustable valve 310 may be capable of indirectly measuring venous pressure (Pp). The second catheter 390 may be connected to the catheter 390 and may be located outside the skull. The catheter or valve communication cable 350 is connected to a CSF pressure (Pcsf) sensor 330, Electrical connections or wires for the internal venous pressure (Pp) sensor 320 and the adjustable valve 31 The valve communication cable 350 may include an electronic control signal that changes the pressure setting of the valve. Also included is a valve controller 360 (including an implantable electronic valve control device and a power source). ) and this can provide information on which to base valve adjustments.

[0070] According to one particular embodiment, the valve controller 360 includes a power source, a microcontroller, controller, and wireless communication circuitry (not shown in FIG. 3B). This is further described below with reference to the block diagram of FIG. 8. The power source is a primary battery Receives continuous wireless power transfer from a rechargeable battery or external power source The present invention may be a device capable of performing the above-mentioned steps (or may be a combination of two or more of these elements). The microcontroller inside the Valve Controller 360 uses two pressure sensors The obtained pressure measurements can be analyzed and the adjustable valve 3 can be adjusted based on each measurement. These example algorithms may determine the actions to be taken to change the settings of 10. , which will be discussed in further detail with reference to the flow chart presented in FIG. The implanted valve can be used to retrieve stored records of pressure measurements or to perform specific actions. It can be used to instruct the controller 360 or to set the currently programmed Retrieve the operating settings stored in the adjustable valve 310 and implantable valve controller. The present invention may provide the clinician with the ability to reprogram (adjust) the operating settings of the controller 360. The electronic components of the Valve Controller 360 are commonly found in active implantable medical devices. Hermetically sealed enclosure (constructed of titanium or similar material) to receive The external programmer 380 may be housed within the implanted valve controller 36. Provides a graphical user interface for reviewing information retrieved from scratch. In addition, the external programmer 380 can provide review and archiving by physicians. and for patient monitoring, the physician can adjust the operating setpoints within the Valve Controller 360 to adjust the A wire is used to transmit program data so that the adjustable valve 310 can be controlled. The valve controller can receive data transmitted by the programming wand 370. Transcutaneous wireless communication may be provided that may retrieve data from 360.

[0071] FIG. 3C provides variations of the system components. In the example shown in FIG. All components may be combined with additional external devices or 3B, except for the presence of the patient wireless receiver 375. The wireless receiver 375 receives wireless communication from the implantable valve controller 360. Wireless communication may be initiated by the valve controller 360, e.g. The patient wireless radio is turned on as a result of an alarm condition identified by the RadioController 360. The alarm condition may be transmitted to the transceiver 375. , pressure measurements from either the intraparenchymal pressure (Pp) sensor 320, and / or the intraventricular CSP The alarm can also be the result of the differential pressure (Pei = Pcsf-Pp). as a result of a condition identified during a self-diagnosis check of the implanted system by the Detector 360 may occur.

[0072] According to another embodiment, an example self-adjusting hydrocephalus valve system 400 is illustrated in FIG. The adjustable valve 410 is integrated into one implantable automatic adjustment valve / A valve controller 460 physically assembleable into a controller device 470. Similar to the device shown in FIG. 3B, the electronics of the valve controller 460 include The product may be housed in a hermetically sealed titanium enclosure. The lubricant 410 may be housed in a polymer header 415. The drainage catheter 480 may include , and may exit adjustable valve 410 via polymer header 415. The self-regulating valve / controller device 470 also allows for the use of a simpler ventricular catheter 44 0, an intraventricular CSF pressure sensor 430, an intraparenchymal venous pressure sensor 420, and an adjustable valve The wire connection between the catheter 410 and the single ventricular or lumbar catheter and the pressure sensor wire Between the valve controller 460 and the adjustable valve 410 The electrical connections may be contained within the self-regulating valve / controller device 470.

[0073] Another embodiment of a self-adjusting hydrocephalus valve system 500 is shown in Figure 5. In this example However, the automatic adjustment valve / controller device 560 can still be integrated. However, the power source and wireless communication may be configured as separate modules 540. offers the advantage of a smaller self-regulating valve / controller device 560, shorter Automatically adjust valve / controller device for drainage catheters and sensor wires The power source in this embodiment may also include a rechargeable battery. This may include longer implant duration and / or smaller battery options. The implantable wireless communication and rechargeable power source 540 allows for automatic adjustment. The valve / controller device 560 may be located remotely. The wireless communication between the sensor 520 and the rechargeable power source 540 is The power transfer is from the power coil 522 to the coil in wireless communication and the rechargeable power The wireless communication and rechargeable power source 540 may transfer power to the Power to charge the 40 comes from portable (e.g. patient wearable) batteries and and power control 524 may be provided by the device or from an AC adapter (not shown). can be provided.

[0074] Recurrence of hydrocephalus during steady-state monitoring over a predefined interval An example process for determining this is shown as a flow chart in Figure 6. In this example, The CSF pressure (Pcsf) sensor 330 and the parenchymal pressure (Pp) sensor 320 are used. Measure and continuously monitor CSF pressure (Pcsf) 110 and intraparenchymal venous pressure (Pp) 120 This monitoring process also identifies possible hydrocephalus pathogenesis. To determine when the patient can receive the treatment, the patient's circadian rhythm was used as a parametric factor. Furthermore, valve control can be adjusted throughout the day (or other period) to account for the changing posture of the patient. This may enable recording and identification of fluctuations in Pcsf by Lar 360.

[0075] Referring to FIG. 6, in step 600, a program coded within the valve controller 360 The process begins by obtaining a pressure measurement from the CSF pressure (Pcsf) sensor 330. The Pcsf measurement may be compared to a predetermined Pcsf value and The process begins with the measured Pcsf being stored in the memory of the Valve Controller 360. and determining whether the patient's blood sugar level is within a predetermined normal range for the selected patient. If the Pcsf is within the normal range of Pcsf, step 610 determines whether the Pcsf is within the normal range of The method may include determining whether the pressure Δ is within a tolerance (or Δ) pressure from the specified Pp. If Pp is within the normal range, Pcsf should be adjusted to account for fluctuations in Pcsf throughout the day. may be added as a factor to the moving average calculation in step 650. The process then proceeds to calculate the next Pc Before performing sf measurement 600, the programmed Pcsf measurement delay time (for example, 1 hour) 655. If it is determined in step 605 that the Pcsf value is not within the normal Pcsf range for the patient, If so, step 620 determines whether a sufficient time interval (e.g., 3 The process may also include determining whether a differential pressure increase relative to Pp exists. To verify that the increase is not due to abnormal measurements (e.g., noise), multiple This may include taking sequential measurements of Pp (not shown in the flow chart). If the interval is longer than the Pcsf measurement interval, step 620 will Validation of Pcsf over time provides the ability to identify when the Pcsf may be out of range. Similar to Pcsf measurement, confirmation by repeat measurements can be provided for Pp measurement. Any measurement noise artifacts may be filtered out before proceeding to measurement. Confirmation of valid pressure values ​​by measurement is also important because it is assumed that significant pressure deviations may potentially occur. When the Pp measurement interval is set to step 620, other conditions may be applied throughout the process. If not, the Pcsf measurement is added as a factor into the moving average calculation in step 625. and the process performs a specific Pcsf measurement before performing the next Pcsf measurement in step 600. A fixed delay time may be waited 630. If the Pp measurement interval is reached in step 620, In step 635, Pp can be measured. The measurements from the Pp sensor 330 are used to determine the actual intraparenchymal venous An example method for determining whether the pressure can be represented is discussed further below in connection with FIG. If Pp is within the acceptable delta limits of Pcsf when determined at 0, then normal non-hydrocephalic pathology is identified. The Pp measurement may then be added to the calculation of the Pp moving average 645. The process proceeds to step 655 to wait for the next Pcsf measurement delay. If f is not within the tolerance Δ 640, the valve controller 360 may record the Pp value. Together, the condition may be identified as hydrocephalus in step 615. The physician may also alert the patient to the presence of pressure measurement deviations before proceeding with the treatment process. Program the Valve Controller 360 to alert and prompt the patient to contact the doctor. The measurement data can be remotely transmitted to a physician for review. The physician can Further clinical evaluation as described above with reference to FIG. 2A was performed to determine whether the hydrocephalus condition had recurred. To do so, the Valve Controller 360 can be remotely reprogrammed or The hospital may either:

[0076] Once the patient has returned to a non-hydrocephalic state (i.e., the ventricles have normalized), the physician should begin monitoring. The ringing and recording are continued to obtain mean and minimum pressures, which are indicative of the patient's daily circadian rhythm. According to a particular embodiment, the main valve controller 360 The objective is to measure P despite variability throughout the day and associated with changes in patient position (posture). The aim is to keep the pressure gradient between csf and Pp the same.

[0077] According to one embodiment, the adjustable valve 310 is first installed on a patient with hydrocephalus. To program the device, the physician may use preprogrammed default values. or select a value based on the patient's medical history based on previous pressure measurements and associated trends. Either one can be done.

[0078] In certain embodiments, the method for obtaining a measurement of intraparenchymal venous pressure (Pp) comprises measuring intraparenchymal pressure (P p) The sensor 320 detects the higher of the intraparenchymal venous pressure (Pp) and the intraventricular CSF pressure (Pcsf). Assume that Pp is adjusted until Pcsf falls below the measured Pp. The Pcsf can be tracked as the pressure setting of the valve 310 is decreased. may result in the treatment of hydrocephalus by lowering Pcsf.

[0079] An example control process is shown in Figure 7. The control process is implemented by an implantable valve controller 36. The process is based on the differential pressure, and therefore the head, between the two compartments. The method may include measuring two pressures that may be used to determine the potential presence of a pathological condition. The measurements from the Pcsf sensor 330 and the parenchymal pressure (Pp) sensor 320 are It can provide an indirect measurement of intraparenchymal venous pressure (Pp) in determining hydrocephalus (HPH).

[0080] As discussed above, pressure measurements are taken using a ventricular catheter connected to an adjustable valve 310. This can be done using an electronic pressure sensor that can be mounted on catheter 340. Starting from this, Pcsf can be measured and P can be set as a baseline value in step 705. The algorithm resident in the valve controller 360 performs step 71 0 reduces the valve pressure setting by a predefined amount (e.g. 10mmH2O). The adjusted valve pressure setting can be set by the physician or can be preprogrammed. The valve controller 360 then adjusts the pressure A specific time interval (e.g., 1 hour) may be waited in step 715 to allow stabilization. The two pressure measurements can be repeated in step 7. 20 and if Pcsf is equal to Pp, the valve controller 36 0 is the pressure that can be adjusted by a predefined set pressure (for example, 10 mmH2O). The pressure setting of the valve 310 may then be lowered and the two pressures measured and evaluated again. The second step is to wait another specific time interval (e.g., 1 hour) to determine whether the two pressures are equal. If not, and Pcsf is less than Pp, the process continues by determining whether the measured Pp value is true in step 730. In steps 735 and 740, the blood pressure may be the intraparenchymal venous pressure Pp. In step 740, the process determines whether the difference between Pcsf and Pp is a second predetermined amount. Adjust the valve pressure setting of the adjustable valve 310 until it exceeds (for example, 20 mmH2O). This may include continuously measuring Pcsf and Pp by lowering the The valve controller 360 may record the Pp value in step 745. When sf and Pp are once again within the specified equivalence range that indicates a return to normal conditions in step 750, This may include transitioning to an increased pressure setting on the adjustable valve 310 so that and maintaining the valve pressure set point at step 760.

[0081] FIG. 8 illustrates an implantable valve controller 805 and a device that can provide a user interface. and an external device including a programmer 845 and an external wireless communication 855 module. 8 provides an electronic block diagram of an example self-regulating valve system 800. It is assumed that the implantable valve controller 805 may be desired to be small in size, Therefore, as shown in Figure 5, the implanted power source is a rechargeable battery. 5. The implantable rechargeable battery 835 is identified as a Rechargeable from an external power source recharger 840 by transcutaneous wireless power transfer The wiring between the external programmer 845 device and the implantable valve controller 805 can be Wireless communication (855 and 830) allows physicians to review recorded pressure data and administer implants. Allows you to review the programmed settings of the included valve controller 805 and providing the physician with the ability to adjust the operating settings of the implantable valve controller 805. Wireless communications (855 and 830) may be provided by short-range electromagnetic or long-range radio waves. Telemetry, for example, MICS (Medical Implant Commun and the "Commercialization Services" method, both of which are well known in the art. It is.

[0082] The implantable valve controller 805 records pressures such as Pcsf pressure and Pp pressure 860. The data acquisition module 825 may include a data acquisition module 825 for amplifying 826, a filter, an analog-to-digital (A / D) converter 828, and other circuits. The signal from the data acquisition module 825 may include the flow charts of FIGS. A microprocessor capable of executing firmware algorithms to implement the process described in the The implantable valve controller 805 can be interpreted by the clocontroller 810. Flash memory or other devices that may contain operational firmware (e.g. algorithms) The device may further include a data storage 820, which may store the measured data and / or the recorded data. The microcontroller 810 may also control an autoregulating valve. / Controller 560 The implantable automatic adjustment shown in Figure 5 is used to change the pressure setting of the device. A valve that can send a signal to the hydrocephalus valve in the 560 device. In addition, the device may interface with a block control circuit 815. Before intentionally exposing the valve to strong magnetic fields, such as patient imaging using -845 is the programmed operating pressure for the Autoregulating Valve / Controller 560 device. Retrieving data from the implantable valve controller 805 for physician review After imaging with MRI, the programmer 845 may The data may be retrieved from the pre-MRI controller 805. The implantable valve controller 805 may be automatically reprogrammed for operating pressure set points. In addition, the Programmer 845 also prevents accidental adjustments when exposed to strong magnetic fields. Restore the operating pressure of the implantable valve controller 805 to the set point suspected to have been rammed. The last programmed setting of the implantable valve controller 805 may be used to restore The settings can be saved.

[0083] As discussed above, in certain instances, an implantable self-regulating valve and optionally an implantable In other examples, self-regulating valves and valve controllers may be used. The controller may remain external to the patient. For example, as discussed above, an autoregulating valve may be The lube is delivered to an implanted ventricular or lumbar catheter that may be part of an external ventricular drainage system. The self-regulating valve can then direct CSF to a location inside the patient's body or to an external The external device may include, for example, a bag or other fluid reservoir connected to a ventricular drainage catheter. The sensor (Pcsf and / or intraparenchymal pressure (Pp) sensor) The output of the sensor can be output directly to a display screen or can be used to monitor the patient's clinical assessment. Algorithmically processed to display physiological parameters that facilitate measurement It can be done.

[0084] FIG. 9A shows a set of favorable pressure readings from a hydrocephalus patient treated with a self-regulating valve. 9 illustrates a time-based graph representation of the example process illustrated in FIG. The Pp measurement may track the Pcsf measurement such that Pcsf may be greater than or equal to Pp. In the second phase 905, the Pp measurements continue to decrease as the valve pressure setting is decreased. The sf measurement may be tracked. If the Pcsf measurement falls below the Pp measurement, as in step 910 It can then be assumed that the measured value of Pp can indicate the true intraparenchymal venous pressure (Pp). In phase 915, the valve pressure set point is adjusted so that Pcsf represents the desired pressure to reduce hydrocephalus pathology. Then, in step 920, the adjustable valve 310 is The pressure set point is then restored to a steady state, with Pcsf and Pp once again equal, and normal ventricular The volume may be maintained while increasing until equilibrium of intracranial pressure is reached.

[0085] 9B and 9C illustrate steps that may be followed in the treatment of HPH and NPH, respectively. As discussed above, the principle behind the self-regulating valve is the gradient between Pcsf and Pp. The distribution of these two parameters controls the ventricular volume. By adjusting Pcsf upward or downward with respect to Pp, the adjustable valve The pressure head 310 can control the gradient between these two pressures to control the ventricular volume.

[0086] In the first example shown in FIG. 9B, both sensors track at the highest measured pressure value 930 in step 1. The Pp measured at each time was followed up at the same value, and the Pcsf was initially measured at 220 mmH2O. Pcsf can be greater than Pp, but both sensors measure the higher of the two actual pressures. The desired normal Pcsf may be equal to Pp. By gradually decreasing the pressure setting of the lube 310 (which may decrease the Pcsf value), The Pp measurement may continue to track Pcsf. When true Pv in mmH2O is reached (representing pressure at the superior sagittal sinus (SSS)), the Pp measurement Although there is no further decrease in Pcsf, the further decrease in Pcsf prevents CSF from being drained from the ventricles. 935 and may reduce the ventricular volume produced in step 4a. After a certain interval (for example, 1 hour) that can be reached, then Pcsf and Pp are again The valve pressure set point is adjusted until it equals Pcsf and Pcsf slightly exceeds the target Pp (step 4b). The intracranial pressure can then be equilibrated to maintain normal ventricular volume, resulting in a constant Steady state conditions can be maintained 940 and Pcsf becomes equal to Pp and Pv (step 4c).

[0087] In the second example illustrated in FIG. 9C, Pcsf was initially measured at a normal value of 150 mmH2O. The actual Pp value is much lower at 80mmH2O. As with HPH in step 1, both sensors achieved the highest measured Since the pressure value 945 is tracked, the measured Pp can track the Pcsf at the same value. By gradually decreasing the valve pressure setting (which may decrease the Pcsf), the Pp measurement In step 3, the Pcsf pressure and Pp pressure are 80 mmH2 Once the true Pv of O is reached, Pp cannot be further reduced, but further reduction of Pcsf This allows CSF to drain from the ventricles and reduces the ventricular volume produced in step 4a. After a certain interval (for example, 1 hour), Pcsf and Pp are then Once equal, adjust the valve pressure setting until Pcsf slightly exceeds the target Pp (step 4b). The value can then be increased to achieve equilibrium with intracranial pressure and maintain normal ventricular volume. , the steady state condition can be maintained and Pcsf becomes equal to Pp and Pv ( Step 4c).

[0088] In both examples of FIG. 9B and FIG. 9C, the pressure difference between Pcsf and Pp is related to hydrocephalus. It is the main factor in reducing volumetric pathology.

[0089] Although at least one embodiment of several aspects has been described above, those skilled in the art will be able to It should be recognized that changes, modifications, and improvements may be readily made. and improvements thereon are intended to be part of this disclosure and are within the scope of the present invention. It is contemplated that the method and apparatus embodiments discussed herein may be implemented in any manner as set forth in the above description and are not intended to be limiting. This specification is limited to the details of construction and arrangement of components illustrated in the accompanying drawings. It should be appreciated that the present method and apparatus may be implemented in other embodiments. The specific implementation examples are provided for illustrative purposes only. These are provided herein as examples only and are not intended to be limiting. The phraseology and terminology used are for the purpose of description and should not be regarded as limiting. There is no such thing as "including" or "comprising." "having," "containing," "i The use of "involving" and variations thereof herein means that It is intended to encompass the subsequently listed items and their equivalents as well as additional items. References to "or" may be construed as inclusive, so "or" Any term described with the symbol "\" refers to one, more than one, or all of the described term. Therefore, the above description and drawings are by way of example only, and the scope of the present invention is not to be construed as being limited to the scope of the present invention. The exact scope of the present invention should be determined from the appended claims and their equivalents.

Claims

1. Accurately measuring pressure (Pp) in the human brain using fully implanted or partially external hardware 1. A method for producing a pharmaceutical composition comprising the steps of: Measuring intraventricular cerebrospinal fluid pressure (Pcsf); Indirectly measuring a second pressure (Pp) in the brain cavity; Calculate the effective differential pressure (Pei = Pcsf - Pp) between the measured pressure Pcsf and Pp. And, determining whether the effective differential pressure measurement represents a true secondary pressure; The method includes:

2. The cerebrospinal fluid pressure measurement (Pcsf) of the ventricle is within a specific differential pressure threshold and the secondary pressure (Pp If the pressure in the ventricle is equal to or within a predetermined pressure value, the pressure in the ventricle is decreased by a predetermined pressure value. The method of claim 1, wherein the

3. 3. The method of claim 2, wherein the specified pressure drop is 10 mmH2O.

4. Indirectly measuring the second pressure (Pp) indirectly measures intraparenchymal pressure within the brain parenchymal cavity. and wherein the Pcsf pressure measurement is greater than the Pp pressure measurement by the specified differential pressure.

20. The method of claim 19, further comprising: continuing to reduce the pressure in the ventricle until it is below a threshold value.

2. The method according to claim 2.

5. 5. The method of claim 4, wherein the specified differential pressure threshold is 20 mmH2O.

6. The method of claim 4 , wherein the Pp measurement represents true intraparenchymal venous pressure.

7. The method according to any one of claims 1 to 6, wherein the reduction in cerebrospinal fluid pressure treats high pressure hydrocephalus. method.

8. The method of claim 1, wherein the reduction in cerebrospinal fluid pressure treats normal pressure hydrocephalus or other types of dementia.

7. The method according to any one of claims 6 to 6.

9. The reduction in cerebrospinal fluid pressure is believed to treat conditions such as pseudotumor cerebri (idiopathic intracranial hypertension). The method according to any one of claims 1 to 6.

10. Continuous measurements of Pcsf and Pp provide a steady-state balance between ventricular volume and intraparenchymal venous pressure. The method according to any one of claims 1 to 6,

11. an inflow catheter connected to an inlet port and implanted into the CSF space of the ventricle or spine; The pressure of the fluid at the inlet port exceeds a selected pressure setting of the shunt valve assembly. When the shunt valve assembly is exceeded, the valve aperture of the shunt valve assembly opens and the valve A shunt valve configured to vent fluid through an aperture into an outlet port. and providing drainage of fluid from said outlet port to a cavity in the body where cerebrospinal fluid may be absorbed; an outflow catheter for providing a first pressure transducer attached to the inflow catheter for measuring cerebrospinal fluid pressure; And, a second pressure transducer attached to the inflow catheter for measuring a secondary pressure; 、 Varying the valve pressure setting based on measurements from the pressure transducer. An adjustable implantable valve controller configured to:

1. A surgically implantable shunt valve system comprising:

12. An implanted inflow catheter is connected to an inlet port and surgically placed into the CSF space in the ventricle or spine. With The pressure of the fluid at the inlet port exceeds a selected pressure setting of the shunt valve assembly. When the shunt valve assembly is exceeded, the valve aperture of the shunt valve assembly opens and the valve An external shunt configured to vent fluid through an aperture into an outlet port. A valve assembly; The outlet port is connected to a bag outside the body where cerebrospinal fluid can be collected for analysis and / or disposal. into an external drainage bag or similar collection vessel, which provides for drainage of fluid from the an external outflow tube to be connected; a first pressure transducer attached to the inflow catheter for measuring cerebrospinal fluid pressure; And, A second pressure transducer attached to the inflow catheter or a separate catheter for measuring a secondary pressure. With the lancer, Varying the valve pressure setting based on measurements from the pressure transducer. An adjustable valve controller configured as follows: Instantaneous and trend values, as well as other secondary measurements that provide useful information to the clinician, include: Directly measures CSF and intraparenchymal pressure in clinically useful values ​​such as mH2O and mmHg. External screen display, A partially implanted and partially external implantable shunt valve system comprising:

13. The first pressure transducer for measuring cerebrospinal fluid pressure (Pcsf) is providing a first electrical signal representative of the measured pressure to the pressure controller.

13. The shunt valve system according to claim 12.

14. The second pressure transducer for measuring parenchymal pressure (Pp) is connected to the valve conduit.

13. The method of claim 11 or 12, further comprising: providing a second electrical signal representative of the measured pressure to the trawler.

13. The shunt valve system as described above.

15. The valve controller calculates the pressure difference between the measured Pcsf pressure and the Pp pressure. Item 15. The shunt valve system described in item 14.

16. The valve controller is configured to adjust the pressure difference between Pcsf and Pp to a predetermined value. The shunt valve system of claim 15, further comprising: a valve activator for activating a first level of the shunt valve;

17. When the pressure difference between Pcsf and Pp is less than a predetermined level, the valve When the controller determines that the valve controller is 17. The system of claim 16, wherein the system reduces the pressure setting of the shunt valve assembly by Switch valve system.

18. 18. The system of claim 17, wherein the predetermined pressure level is 10 mmH2O. Switch valve system.

19. When the pressure difference between Pcsf and Pp exceeds a predetermined level, the valve If the controller determines that the measured Pp pressure is the true Pp pressure, the valve controller The shunt valve system of claim 16, further comprising:

20. an inflow catheter connected to an inlet port and implanted into the CSF space of the ventricle or spine; The pressure of the fluid at the inlet port exceeds a selected pressure setting of the shunt valve assembly. When the threshold voltage is exceeded, an aperture in the shunt valve assembly opens and the aperture a shunt valve assembly configured to vent fluid into an outlet port via the shunt valve assembly; And, an outflow catheter for providing drainage of fluid from said outlet port to a cavity within the body; A first pressure transducer attached to the inflow catheter for measuring parenchymal pressure (Pp) With A second pressure transducer attached to the inflow catheter for measuring cerebrospinal fluid pressure (Pcsf) With Deuser, and comparing the Pcsf and / or Pp measurements against a predetermined threshold value to determine whether the high pressure water is being discharged. Determine whether the pathology of hydrocephalus (HPH), normal pressure hydrocephalus (NPH), or pseudotumor in the brain is present an adjustable implantable valve controller configured to 1. A surgically implantable shunt valve system comprising:

21. The first pressure transducer for measuring intraparenchymal pressure (Pp) measures Pcsf. and providing an electrical signal to said valve controller each time said pressure is measured.

21. The shunt valve system according to claim 20.

22. The valve controller adjusts the surgically implantable valve by a predetermined value.

21. The shunt valve system of claim 20, wherein the shunt valve system reduces the pressure setting of the shunt valve assembly. Stem.

23. The valve controller detects that the measured Pcsf pressure exceeds a predetermined amount.

23. The shunt valve system of claim 22, further comprising: a first pressure determining unit for determining whether the first pressure is lower than a measured Pp pressure.

24. 24. The shunt of claim 23, wherein the difference between Pp and Pcsf is greater than 20 mmH2O. Lube system.

25. The valve controller maintains the valve pressure setpoint until the ventricle volume reaches normal volume. The shunt valve system of claim 23.

26. The valve controller controls the valve assembly until Pcsf is equal to Pp.

26. The shunt valve system of claim 25, wherein the pressure set point is increased.

27. an inflow catheter connected to an inlet port and implanted into the CSF space of the ventricle or spine; The pressure of the fluid at the inlet port exceeds a selected pressure setting of the shunt valve assembly. When the threshold voltage is exceeded, an aperture in the shunt valve assembly opens and the aperture a shunt valve assembly configured to vent fluid into an outlet port via the shunt valve assembly; And, an outflow catheter for providing drainage of fluid from said outlet port to a cavity within the body; a first pressure transducer attached to the inflow catheter for measuring cerebrospinal fluid pressure; And, a second pressure transducer attached to the inflow catheter for measuring a secondary pressure; determining a valve pressure setpoint based on measurements from the first and second pressure transducers; an adjustable implantable valve controller configured to vary an implantable power source; A wire between the adjustable implantable valve controller and an external programming device. A wireless communication mechanism; 1. A surgically implantable shunt valve system comprising:

28. The shunt valve assembly is connected to the adjustable implantable valve controller.

28. The shunt valve of claim 27, comprising an implantable adjustable valve separate from the system.

29. The implantable adjustable valve is connected to the valve controller via a valve communication cable.

30. The shunt valve system of claim 28, electrically interfaced to

30. A programmer wirelessly receives operational settings and data from the valve controller.

28. The shunt valve system of claim 27.

31. A programmer wirelessly transmits new values ​​for operational settings to the valve controller. The shunt valve system of claim 27.

32. The shunt valve assembly is integrated into the valve controller.

28. The shunt of claim 27, further comprising an implantable adjustable valve that is an integrated module. Valve system.

33. The adjustable valve is mounted within a polymer header of the implantable valve controller.

33. The shunt valve system of claim 32, located at

34. The implantable valve controller receives pressure from the first and second pressure transducers.

33. The method of claim 32, wherein the inflow catheter from the ventricle includes a wire to transmit the force value. Shunt valve system.

35. The integrated adjustable valve and valve controller 4. The implantable device according to claim 1, wherein the implantable device is separate from the internal power source and the wireless communication mechanism.

33. The shunt valve system according to claim 32.

36. The integrated adjustable valve and valve controller, and an electrical cable connected between the built-in power source and the wireless communication mechanism. The shunt valve system of claim 35.

37. 36. The shunt valve system of claim 35, wherein the implanted power source is a primary battery. Tem.

38. 36. The shunt of claim 35, wherein the implanted power source is a rechargeable battery. Valve system.

39. The implanted rechargeable battery can be recharged via wireless means from an external device.

40. The shunt valve system of claim 38,

40. The implantable valve controller and the adjustable valve are positioned adjacent to the skull of a human patient.

36. The shunt valve system of claim 35,

41. The implantable valve controller and the adjustable valve are connected to a portable external device.

36. The shunt valve system of claim 35, wherein the shunt valve system receives continuous power wirelessly from a

42. The pressure sensor is implanted in fluid communication with the ventricle and transmits pressure data to the valve controller. and a method for operating a surgically implantable shunt valve assembly. So, Measuring intraventricular cerebrospinal fluid pressure (Pcsf); Measuring the secondary pressure (Pp) in the brain cavity; Calculating a differential pressure between the measured pressure Pcsf and the Pp; a shunt valve of the surgically implantable shunt valve assembly based on the pressure difference; determining whether to adjust the pressure setpoint; The method includes:

43. 43. The method of claim 42, wherein a Pcsf above a predetermined differential pressure threshold is indicative of high pressure hydrocephalus. The method described.

44. 44. The method of claim 43, wherein the predetermined differential pressure threshold is 20 mmH2O. 。

45. The shunt valve is then decelerated by a predetermined differential pressure decrement using the valve controller.

44. The method of claim 43, further comprising decreasing the pressure setting of the lube.

46. 46. ​​The method of claim 45, wherein the predetermined differential pressure decrement is 10 mmH2O. 。

47. Determining whether the differential pressure between Pp and Pcsf is greater than a predetermined differential pressure threshold.

47. The method of claim 46, further comprising:

48. 48. The method of claim 47, wherein the predetermined differential pressure threshold is 10 mmH2O. 。

49. until the differential pressure between Pp and Pcsf exceeds a second predetermined differential pressure threshold. Continuing to decrease the pressure setting of the shunt valve using a valve controller.

48. The method of claim 47, further comprising:

50. 50. The method of claim 49, wherein the second predetermined differential pressure threshold is 20 mmH2O. How to.

51. The valve controller is used to adjust the pressure until the ventricle returns to its normal size or volume.

50. The method of claim 49, further comprising maintaining the set point.

52. The shunt valve is then adjusted using the valve controller until Pp and Pcsf are equal.

52. The method of claim 51, further comprising increasing the pressure setting of the lube.

53. recording said Pp and Pcsf values ​​in memory using said valve controller; 53. The method of claim 52, further comprising:

54. 52. The method of claim 51, wherein the patient is clinically diagnosed with normal pressure hydrocephalus with a normal Pcsf measurement. Method of posting.

55. 55. The method of claim 54, wherein the Pcsf measurement is 150 mmH2O.

56. The valve controller is used to predetermine the pressure set point of the shunt valve.

55. The method of claim 54, further comprising decreasing the predetermined decrement.

57. 57. The method of claim 56, wherein the predetermined decrement is 10 mmH2O.

58. The differential pressure between Pp and Pcsf is predetermined using the valve controller.

57. The method of claim 56, further comprising determining whether the threshold is exceeded.

59. 59. The method of claim 58, wherein the predetermined differential pressure threshold is 10 mmH2O. 。

60. The valve is closed until the pressure difference between Pp and Pcsf exceeds a second predetermined threshold. and continuously decreasing the shunt valve pressure setpoint using a sub-controller. The method of claim 58, further comprising:

61. 61. The method of claim 60, wherein the second predetermined differential pressure threshold is 20 mmH2O. How to.

62. The valve controller is used to adjust the pressure until the ventricle returns to its normal size or volume.

61. The method of claim 60, further comprising maintaining the set point.

63. Use the valve controller to adjust the shunt valve until Pp and Pcsf are equal.

63. The method of claim 62, further comprising increasing the pressure setting of a lube.

64. and recording the Pp and Pcsf values ​​in memory using said valve controller. The method of claim 63, further comprising:

65. an inflow catheter connected to an inlet port and implanted into the CSF space of the ventricle or spine; a shunt valve and a pressure of the fluid at the inlet port is applied to the shunt valve assembly; The aperture of the shunt valve opens when the selected pressure setpoint of the a shunt configured to vent fluid through said aperture into an outlet port; A valve assembly; an outflow catheter for providing drainage of fluid from said outlet port to a cavity within the body; a first pressure transducer attached to the inflow catheter for measuring cerebrospinal fluid pressure; And, a second pressure transducer attached to the inflow catheter for measuring a secondary pressure; determining the valve pressure setting based on measurements from the first and second pressure transducers; an adjustable implantable valve controller configured to vary a value; an implantable power source; and providing wireless communication between an external programming device and the implantable valve controller. a first wireless communication device configured to provide Providing wireless communication between the implanted valve controller and an external patient receiver. a second wireless communication device configured to 1. A surgically implantable shunt valve system comprising:

66. Wireless data transmission from the implanted valve controller to the external patient receiver.

66. The shunt valve system of claim 65,

67. The data transferred includes measured pressure signals from the first and second pressure transducers.

67. The shunt valve system of claim 66, comprising:

68. 67. The shunt valve system of claim 66, wherein the transferred data includes alarm data. Hmm.

69. The alarm data is obtained from the first and second pressure transducers.

69. The shunt valve system of claim 68, which provides an index of force measurement.

70. 69. The method of claim 68, wherein the alarm data is indicative of a device system fault. Valve system.

71. 66. The method of claim 65, wherein the external patient receiver provides an audio alarm to the patient. Shunt valve system.

72. 66. The method of claim 65, wherein the external patient receiver provides a visual alarm to the patient. Shunt valve system.

73. The valve controller transmits an alarm signal to an external patient receiver.

73. The method according to claim 71 or 72, wherein all measurement data is transferred wirelessly. Shunt valve system.

74. an inflow catheter connected to an inlet port and implanted into the CSF space of the ventricle or spine; The pressure of the fluid at the inlet port exceeds a selected pressure setting of the shunt valve assembly. When the threshold voltage is exceeded, an aperture in the shunt valve assembly opens and the aperture a shunt valve assembly configured to vent fluid into an outlet port via the shunt valve assembly; And, an outflow port that provides drainage of fluid from the outlet port to an external ventricular drainage system; A catheter; a first pressure transducer attached to the inflow catheter for measuring cerebrospinal fluid pressure; And, a second pressure transducer attached to the inflow catheter for measuring a secondary pressure; varying a valve pressure setting based on measurements from said pressure transducer; An adjustable valve controller comprising:

2. A shunt valve system comprising:

75. The first pressure transducer for measuring cerebrospinal fluid pressure (Pcsf) is 75. The shock absorber of claim 74, further comprising: a first electrical signal representative of the measured pressure being provided to a sub-controller. valve system.

76. The second pressure transducer for measuring the secondary pressure (Pp) is connected to the valve control.

76. The shunt of claim 75, further comprising: a roller that provides a second electrical signal representative of the measured pressure. Lube system.

77. The valve controller calculates the pressure difference between the measured Pcsf pressure and the Pp pressure. Item 77. A shunt valve system as described in item 76.

78. The valve controller is configured to have a predetermined pressure difference between Pcsf and Pp.

78. The shunt valve system of claim 77, further comprising: a step of determining whether a pre-determined level has been exceeded.

79. When the pressure difference between Pcsf and Pp is less than a predetermined level, the valve When the valve controller is determined, the valve controller is 78. The method of claim 77, further comprising: decreasing the pressure setpoint of the shunt valve assembly by a value determined by the 13. The shunt valve system as described above.

80. 80. The system of claim 79, wherein the predetermined pressure level is 10 mmH2O. Switch valve system.

81. When the pressure difference between Pcsf and Pp exceeds a predetermined level, the valve If the valve controller determines that the measured Pp pressure is the true Pp pressure, the valve controller 78. The shunt valve system of claim 77, which identifies p-pressure.

82. an inflow catheter connected to an inlet port and implanted into the CSF space of the ventricle or spine; The pressure of the fluid at the inlet port exceeds a selected pressure setting of the shunt valve assembly. When the threshold voltage is exceeded, an aperture in the shunt valve assembly opens and the aperture a shunt valve assembly configured to vent fluid into an outlet port via the shunt valve assembly; And, providing drainage of fluid from said outlet port to a cavity in the body where cerebrospinal fluid may be absorbed; an outflow catheter for providing The inflow catheter is attached to the cerebrospinal fluid pressure (Pcsf) and secondary pressure (Pp) a differential pressure transducer configured to measure a differential pressure transformer for calculating the pressure difference between the measured cerebrospinal fluid pressure and the intraparenchymal pressure; an adjuster configured to vary a valve pressure setting based on measurements from a transducer; A stable valve controller, 2. A shunt valve system comprising:

83. The differential pressure transducer is a first pressure transducer for measuring cerebrospinal fluid pressure. and a second pressure transducer for measuring a secondary pressure. Shunt valve system.

84. The valve controller is configured to have a predetermined pressure difference between Pcsf and Pp.

83. The shunt of claim 82, further configured to determine whether a pre-determined level is exceeded. Valve system.

85. When the pressure difference between Pcsf and Pp is less than a predetermined level, the valve When the valve controller is determined, the valve controller is 85. The method of claim 84, wherein the pressure setpoint of the shunt valve assembly is decreased by a value determined by the 13. The shunt valve system as described above.

86. 86. The system of claim 85, wherein the predetermined pressure level is 10 mmH2O. Switch valve system.

87. When the pressure difference between Pcsf and Pp exceeds a predetermined level, the valve If the valve controller determines that the measured Pp pressure is the true Pp pressure, the valve controller 86. The shunt valve system of claim 85, which identifies p-pressure.

88. A pressure sensor configured to fluidly communicate with the ventricle provides pressure data to a valve controller.

1. A method for providing a cooling system to a cooling fan to operate a shunt valve assembly, comprising: Measuring intraventricular cerebrospinal fluid pressure (Pcsf); Measuring the secondary pressure (Pp) in the brain cavity; Calculating a differential pressure between the measured pressures Pcsf and Pp; A pressure setting value of a shunt valve of the shunt valve assembly is set based on the pressure difference. determining whether to adjust The method includes:

89. The second pressure transducer is connected to the first pressure transducer and the a Drainage through the outflow catheter under the control of an adjustable implantable valve controller.

13. The method according to claim 11 or 12, wherein the device is configured to be turned off to enable a power-on reset. Shunt valve system.

90. The first pressure transducer monitors only the secondary pressure measured by the system.

13. The method of claim 11, further comprising the steps of:

2. A shunt valve system according to claim 1.

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