CA2636529A1 - Programmable shunt with electromechanical valve actuator - Google Patents
Programmable shunt with electromechanical valve actuator Download PDFInfo
- Publication number
- CA2636529A1 CA2636529A1 CA002636529A CA2636529A CA2636529A1 CA 2636529 A1 CA2636529 A1 CA 2636529A1 CA 002636529 A CA002636529 A CA 002636529A CA 2636529 A CA2636529 A CA 2636529A CA 2636529 A1 CA2636529 A1 CA 2636529A1
- Authority
- CA
- Canada
- Prior art keywords
- valve
- controller
- system controller
- resistance
- patient
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
- A61M27/002—Implant devices for drainage of body fluids from one part of the body to another
- A61M27/006—Cerebrospinal drainage; Accessories therefor, e.g. valves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3331—Pressure; Flow
- A61M2205/3337—Controlling, regulating pressure or flow by means of a valve by-passing a pump
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
- A61M27/002—Implant devices for drainage of body fluids from one part of the body to another
- A61M27/008—Implant devices for drainage of body fluids from one part of the body to another pre-shaped, for use in the urethral or ureteral tract
Abstract
Devices and methods for regulating and directing bodily fluids from one regi on of a patient to another region are disclosed. In general, an apparatus is provide d that can include an implantable shunt system and a system controller. The implantable shunt system can have an adjustable valve for regulating the flow of fluid, a sensor element for measuring a physiological characteristic of a patient, and an electromechanical valve actuator that can be adapted to adjust a resistance of the valve. The implantable shunt system ca n be in electrical communication with the system controller. The system controller can generall y be adapted to receive a physiological characteristic of the patient and operate the electromechanical valve actuator to adjust a resistance of the valve. The apparatus can also include an external programming device that is in communication with the system controller.</SDO AB>
Description
PROGRAMMABLE SHUNT WITH
ELECTROMECHANICAL VALVE ACTUATOR
FIELD OF THE INVENTTON
The present invention relates to methods and devices for regulating and directing bodily fluids from one region of a patient to another region_ BACKCROUND OF "fHE INVENTIpN
Hydrocephalus is a neurological condition oaused by the abnormal accumulation of cerebrospinal fluid (CSF) within the ventricles, or cavities, of the brain.
Hydrocephalus, which can affect infants, children and adults, arises when the normal drainage of CSF in the bra_in becomes blocked in somc way. Such blockage can be caused by a number of factors, inaluding, for example, genetic predisposition, intraventricular or intracranial hemorrhage, infections such as meningitis, or head trauma. Blockage of the flow of CSF
consequently creates an imbalance between the rate at which CSF is produced by the ventricular system and the rate at which CSF is absorbed into the bloodstream. This imbalance increases pressure on the brain and causes the brain's ventricles to enlarge. Left untreated, hydrocephalus can result in serious medical conditions, including subdural hematoma, compression of the brain tissue, and impaired blood flow.
Hydrocephalus is most often treated by surgically inserting a shunt system to divert the flow of CSF from the ventricle to anot.her area of the body, such as the right atrium, tiie pcritoneum, or other locations in the body where CSF can be absorbed as part of the circulatory system. Various shunt systems have been developed for the treatment of hydrocephalus. Typically, shunt systems include a ventricular catheter, a shunt valve, and a dxainage catheter. At one end of the shunt system, the ventricular catheter can have a first end that is inserted through a hole in the skull of a patient, such that the first end resides within the ventricle of a patient, and a second end of the ventricular catheter that is typically coupled to the inlet portion of the shunt valve. The first end of the ventricular catheter can contain multiple boles or pores to allow CSF to enter the shunt system. At the other end of the shunt system, the drainage catheter has a first end that is attached to the outlet portion of the sbunt valve and a second end that is configured to allow CSF to cxit the shunt system for reabsorption into the blood stream.
Generally, the shunt valve, which can have a variety of cozrfigurations, is effective to regulate the flow rate of fluid through the shunt system. In some shunt valve mechanisms, the fluid flow rate is proportional to the pressure diference at the valve mechanism. These shunt valve mechanisms permit fluid flow only after thc fluid pressure has reached a certain threshold level. Thus, when the fluid pressure is slightly greater than the threshold pressure laval, the fluid flow rate is relatively low, but as the pressure increases, the fluid flow rate simulta.neously increases. Typically, the shunt valve allows fluid to flow normally until the intracraDial pressure has been reduced to a level that is less than the threshold pressure of the shunt valve, subject to any h.ysteresig of the device.
Certain conventional shunt valves allow extemal adjustment of the threshold pressure level at whieh fluid flow will eozxmenee to avoid invasive surgical procedures_ In some shunt systems, the shunt valve contains a magnetized rotor to control the pressure threshold of the valve. Physicians can then use an external adjustment mechanism, such as a magnetic programrner, to adjust the pressure threshold of the shunt valve.
However, these magnetized rotors can be unintentionally adjusted in the presence of a strong external magnetic field, such as during an MRI procedure. 'C_Tnintentional adjustment of the pressure threshold could lead to either the overdrainage or underdrainage of CSF, which can result in dangerous conditions, such as subdural hematoma.
Attempts have been made to provide a locking mechanism that prevents unintentional valve adjustment, even in the presence of a strong extemal m.agnetic field, while simultaneously allowing intentional adjustment of the pressure threshold. One such approach has been detailed in U.S. Patent No. 5,643,194, in which Negre describes a locking means having two opposed micro-magnets mounted on the rotor. In the presence of a bi-directional magnetic field, thase micro-magnets move linearly in the rotor, in a substantially radial direction, to activate the locking means. However, the Negre locking means does not eliminate the risk of inadvertent valve adjustrnent in the presence of a strong external
ELECTROMECHANICAL VALVE ACTUATOR
FIELD OF THE INVENTTON
The present invention relates to methods and devices for regulating and directing bodily fluids from one region of a patient to another region_ BACKCROUND OF "fHE INVENTIpN
Hydrocephalus is a neurological condition oaused by the abnormal accumulation of cerebrospinal fluid (CSF) within the ventricles, or cavities, of the brain.
Hydrocephalus, which can affect infants, children and adults, arises when the normal drainage of CSF in the bra_in becomes blocked in somc way. Such blockage can be caused by a number of factors, inaluding, for example, genetic predisposition, intraventricular or intracranial hemorrhage, infections such as meningitis, or head trauma. Blockage of the flow of CSF
consequently creates an imbalance between the rate at which CSF is produced by the ventricular system and the rate at which CSF is absorbed into the bloodstream. This imbalance increases pressure on the brain and causes the brain's ventricles to enlarge. Left untreated, hydrocephalus can result in serious medical conditions, including subdural hematoma, compression of the brain tissue, and impaired blood flow.
Hydrocephalus is most often treated by surgically inserting a shunt system to divert the flow of CSF from the ventricle to anot.her area of the body, such as the right atrium, tiie pcritoneum, or other locations in the body where CSF can be absorbed as part of the circulatory system. Various shunt systems have been developed for the treatment of hydrocephalus. Typically, shunt systems include a ventricular catheter, a shunt valve, and a dxainage catheter. At one end of the shunt system, the ventricular catheter can have a first end that is inserted through a hole in the skull of a patient, such that the first end resides within the ventricle of a patient, and a second end of the ventricular catheter that is typically coupled to the inlet portion of the shunt valve. The first end of the ventricular catheter can contain multiple boles or pores to allow CSF to enter the shunt system. At the other end of the shunt system, the drainage catheter has a first end that is attached to the outlet portion of the sbunt valve and a second end that is configured to allow CSF to cxit the shunt system for reabsorption into the blood stream.
Generally, the shunt valve, which can have a variety of cozrfigurations, is effective to regulate the flow rate of fluid through the shunt system. In some shunt valve mechanisms, the fluid flow rate is proportional to the pressure diference at the valve mechanism. These shunt valve mechanisms permit fluid flow only after thc fluid pressure has reached a certain threshold level. Thus, when the fluid pressure is slightly greater than the threshold pressure laval, the fluid flow rate is relatively low, but as the pressure increases, the fluid flow rate simulta.neously increases. Typically, the shunt valve allows fluid to flow normally until the intracraDial pressure has been reduced to a level that is less than the threshold pressure of the shunt valve, subject to any h.ysteresig of the device.
Certain conventional shunt valves allow extemal adjustment of the threshold pressure level at whieh fluid flow will eozxmenee to avoid invasive surgical procedures_ In some shunt systems, the shunt valve contains a magnetized rotor to control the pressure threshold of the valve. Physicians can then use an external adjustment mechanism, such as a magnetic programrner, to adjust the pressure threshold of the shunt valve.
However, these magnetized rotors can be unintentionally adjusted in the presence of a strong external magnetic field, such as during an MRI procedure. 'C_Tnintentional adjustment of the pressure threshold could lead to either the overdrainage or underdrainage of CSF, which can result in dangerous conditions, such as subdural hematoma.
Attempts have been made to provide a locking mechanism that prevents unintentional valve adjustment, even in the presence of a strong extemal m.agnetic field, while simultaneously allowing intentional adjustment of the pressure threshold. One such approach has been detailed in U.S. Patent No. 5,643,194, in which Negre describes a locking means having two opposed micro-magnets mounted on the rotor. In the presence of a bi-directional magnetic field, thase micro-magnets move linearly in the rotor, in a substantially radial direction, to activate the locking means. However, the Negre locking means does not eliminate the risk of inadvertent valve adjustrnent in the presence of a strong external
2 rnagnetic field.
Another approach has been described in U.S. Patent No. 5,637,0$3, in which Bertrand et al. describe a valve that includes means for locking the rotor assembly in a desired position. This iocking means uses a pin having a first end adapted to engage a series of detents in an outer peripheral surface of the rotor assembly, thereby preventing the rotor assembly from rotating. The locldng means is disengaged by a pin-actuating means having two levers that move the pin from a first, extended position, i.e., within the detent(s) in the outer peripheral surface, to a second, retracted position. The first lever is a pivotable lever having a shaft adapted to engage a second end of the pin, while the second lever is a manually actuated lever that is biased to urge the pin into the first, exten.ded posidon. This mianually actuated lever, however, is located witbin the valve chamber that is used to pump, or flush, fluid from the shunt valve. Thus, by virtue of its location within the pumping ehamber, the manually actuated lever, and consequently the pin-actuating means, can impair or inhibit the function of the pumping chamber.
Accordingly, a need exists for improved methods and devices for regulating cerebrospinal fluid flow.
SUMMARY OF THE ]NV'ENTYON
Devices and methods for regulating and directing bodily fluids from one region of a patient to another region are disclosed. lu general, arn apparatus is provided that can include an implantable sbunt system and a system controller, While a variety of configurations are available for the implantable shunt system, in one excmplary embodiment, the system can have an adjustable valve for regulating the flow of fluid, a sensor element for measuring a physiological characteristic of a patient, and an electromechanical valve actuator that can be adapted to adjust a resistance of the valve. The implantable shunt system can be in electrical commurucation with the system controller. The system controller can generally be adapted to receive a physiological characteristic of the patient and operate the electromechanical valve actuator to adjust a resistance of the valve. In one exemplary embodiment, the ser.sor element can be a pressure sensor for detecti.no a cerebro-spinal fluid pressure. In another
Another approach has been described in U.S. Patent No. 5,637,0$3, in which Bertrand et al. describe a valve that includes means for locking the rotor assembly in a desired position. This iocking means uses a pin having a first end adapted to engage a series of detents in an outer peripheral surface of the rotor assembly, thereby preventing the rotor assembly from rotating. The locldng means is disengaged by a pin-actuating means having two levers that move the pin from a first, extended position, i.e., within the detent(s) in the outer peripheral surface, to a second, retracted position. The first lever is a pivotable lever having a shaft adapted to engage a second end of the pin, while the second lever is a manually actuated lever that is biased to urge the pin into the first, exten.ded posidon. This mianually actuated lever, however, is located witbin the valve chamber that is used to pump, or flush, fluid from the shunt valve. Thus, by virtue of its location within the pumping ehamber, the manually actuated lever, and consequently the pin-actuating means, can impair or inhibit the function of the pumping chamber.
Accordingly, a need exists for improved methods and devices for regulating cerebrospinal fluid flow.
SUMMARY OF THE ]NV'ENTYON
Devices and methods for regulating and directing bodily fluids from one region of a patient to another region are disclosed. lu general, arn apparatus is provided that can include an implantable sbunt system and a system controller, While a variety of configurations are available for the implantable shunt system, in one excmplary embodiment, the system can have an adjustable valve for regulating the flow of fluid, a sensor element for measuring a physiological characteristic of a patient, and an electromechanical valve actuator that can be adapted to adjust a resistance of the valve. The implantable shunt system can be in electrical commurucation with the system controller. The system controller can generally be adapted to receive a physiological characteristic of the patient and operate the electromechanical valve actuator to adjust a resistance of the valve. In one exemplary embodiment, the ser.sor element can be a pressure sensor for detecti.no a cerebro-spinal fluid pressure. In another
3 embodiment, the shunt system can include a second sensor element for measuring an addition,al p}aysiologieal eharacteristio. The apparatus can be battery powered (i.e., by a battery contained therein) or can be powered by an external component.
In one exemplary embodiment, the valve can take the form of a ball valve that is operatively associated with an electromechanical valve actuator. Wkzile several configurations are available for the electromechanical valve actuator, in general, the actuator can include a spring and a pressure setting mechanism. A variety ol'sprirags can be used with the valve actuator including, for example, leaf and helical springs. The pressure setting mechanism can also have a variety of configurations. For example, in one embodiment, the pressure setting mechanism can, inelude a motor driven rotor assembly that is adapted to adjust a resistance of tlie valve upon actuator of the motor. In another exemplary embodiment, the pressure setting mechanism includes a niotor driven stop member that is adapted to apply a force to the spring to adjust a resistance of the valve.
In general, the systern controtler can be adapted to receive a physiological characteristic of the patient and operate the eleetromechanieal valve actuator to adjust a resistance of the valve. In one exemplary embodiment, the system controller can include a microprocessor for comparing measured values to predetermined target values.
For example, where the sensor element is a pressure sensor, the-microprocessor can be adapted to compare the measured pressure detected by the sensor element to a predeterznined target pressure. To facilitate the comparison, the system controller can also be configured to receive an input signal representative of a target value. In addition to comparing values, the microprocessor can be programmed to calculate a desired resistance for the valve to achieve a target pressure. A variety of conf gurations are available for the system controller, including, for example, configurations in which the controller is contained within the implantabte shunt system and configurations in which the controller is disposed on an implant separate from the shunt system.
The apparatus for regulating fluid flow can further include an external programming device that is in communication with tho system controller.- In geaeral, the programzrung device can include a user input element that allows an oper-ator to input one or more
In one exemplary embodiment, the valve can take the form of a ball valve that is operatively associated with an electromechanical valve actuator. Wkzile several configurations are available for the electromechanical valve actuator, in general, the actuator can include a spring and a pressure setting mechanism. A variety ol'sprirags can be used with the valve actuator including, for example, leaf and helical springs. The pressure setting mechanism can also have a variety of configurations. For example, in one embodiment, the pressure setting mechanism can, inelude a motor driven rotor assembly that is adapted to adjust a resistance of tlie valve upon actuator of the motor. In another exemplary embodiment, the pressure setting mechanism includes a niotor driven stop member that is adapted to apply a force to the spring to adjust a resistance of the valve.
In general, the systern controtler can be adapted to receive a physiological characteristic of the patient and operate the eleetromechanieal valve actuator to adjust a resistance of the valve. In one exemplary embodiment, the system controller can include a microprocessor for comparing measured values to predetermined target values.
For example, where the sensor element is a pressure sensor, the-microprocessor can be adapted to compare the measured pressure detected by the sensor element to a predeterznined target pressure. To facilitate the comparison, the system controller can also be configured to receive an input signal representative of a target value. In addition to comparing values, the microprocessor can be programmed to calculate a desired resistance for the valve to achieve a target pressure. A variety of conf gurations are available for the system controller, including, for example, configurations in which the controller is contained within the implantabte shunt system and configurations in which the controller is disposed on an implant separate from the shunt system.
The apparatus for regulating fluid flow can further include an external programming device that is in communication with tho system controller.- In geaeral, the programzrung device can include a user input element that allows an oper-ator to input one or more
4 instmctions to be coznmunicated to the system controller. For example, the externai programuiing device can be adapted to transmit a sirgnal to the system contrpller that is representative of a predetermined target value for the CSF pressure of a patient. The externa] programming device can have a vasiety configurations and in bne exemplary embodiment can inelude a display clement for comrnunicating a physiological characteristic to a user. In addition to communicating instructions to the system controller, the programn-+ing device can also be adapted to power the implantable shunt system.
In one exemplary embodiment, the implantable shunt systeyn, system controller, and external programming device can be configured to communicate via radiofrequency (RF) communication. In an exemplary enibodiment, the shunt system, system controller, and programming device can include signal transmitters/reeeivers or antennas that can be confiigured to send and/vr reeeive signals from one another. Such communication can provide non-invasive control of the electromechanical valve actuator. The antennas can have a variety of configurations as well as be disposed at various locations in the system.
p'or example, in one exemplary c,-inbodiment, both the system cantroller and antenna associated therewith can be disposed on the implantable shunt system, In another embodiment, the controller caai be contained vvithin tlie implantable shunt system but the antenna ean be disposed on a separate implant. In yet another exempIary embodirnent, both the system controller and antenna associated therewith can be disposed on an implant that is separate from the shunt system.
In some aspects, there is a systezn for regnlating fluid flow, comprising;
a housing having an inlet port and an outlet port, the housing configured to carry a fluid betweeu the inlet port and the outlet port;
a valve coupled to the housing and in fluid communication with the inlet port and the outlet port, the valve having an electromechanical valve actuator adapted to open and close the valve;
an internal system controller in eleetrical communication with and adapted to operate the electromechanical valve actuator, a sensor elemerit in communioation with the system controller and adapted to rneasure a physiological characteristic of a patient; and
In one exemplary embodiment, the implantable shunt systeyn, system controller, and external programming device can be configured to communicate via radiofrequency (RF) communication. In an exemplary enibodiment, the shunt system, system controller, and programming device can include signal transmitters/reeeivers or antennas that can be confiigured to send and/vr reeeive signals from one another. Such communication can provide non-invasive control of the electromechanical valve actuator. The antennas can have a variety of configurations as well as be disposed at various locations in the system.
p'or example, in one exemplary c,-inbodiment, both the system cantroller and antenna associated therewith can be disposed on the implantable shunt system, In another embodiment, the controller caai be contained vvithin tlie implantable shunt system but the antenna ean be disposed on a separate implant. In yet another exempIary embodirnent, both the system controller and antenna associated therewith can be disposed on an implant that is separate from the shunt system.
In some aspects, there is a systezn for regnlating fluid flow, comprising;
a housing having an inlet port and an outlet port, the housing configured to carry a fluid betweeu the inlet port and the outlet port;
a valve coupled to the housing and in fluid communication with the inlet port and the outlet port, the valve having an electromechanical valve actuator adapted to open and close the valve;
an internal system controller in eleetrical communication with and adapted to operate the electromechanical valve actuator, a sensor elemerit in communioation with the system controller and adapted to rneasure a physiological characteristic of a patient; and
5 an external system controller adapted to comrnunicate with the internal system controller and modify the operating parameters thereof.
Methods of regr.ilating cerebrospinal fluid flow are also provided. In general, the method can include comparing a target value to a value detected by a sensor associated with an im.plantable shunt system, and activating an electromechanical valve aetuator oftha implantable shunt system to adjust a resistance of a valve of the shunt system if the detected value is not equal to the target value. The method can also include inputting one or more target values to an external programming device and transmitting those values to a system controller of the implantable shunt system. In one exemplary embodiment, any of the above steps can be repeated until the detected value is equal to the target value.
There is also provided a use of the apparatus or system described above for regulating cerebrospinal fluid itow in a hydrdcephalus patient.
BRIEF DESCRIPTION OF TTTE DRAWINGS
l 5 The invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:
FIG. I is a diagrammatic view of a system of the invent.ion;
FIG. 1A is a cross-sectional perspective view of one embodiment of an apparatus for regulating fluid flow;
FIG. 2 is a schematic view of one ernbodiment of an electromechanical valve actuator;
FIG. 3 is a schematic view of another embQdiment of an electromechanical valve actuator, FIG. 4 is a schematic view of one embodiment of a shwxt valve asserrzbly for regulating fluid flow;
FIG. 5 is a schenctatic view of another embodiment of a shunt valve assembly for
Methods of regr.ilating cerebrospinal fluid flow are also provided. In general, the method can include comparing a target value to a value detected by a sensor associated with an im.plantable shunt system, and activating an electromechanical valve aetuator oftha implantable shunt system to adjust a resistance of a valve of the shunt system if the detected value is not equal to the target value. The method can also include inputting one or more target values to an external programming device and transmitting those values to a system controller of the implantable shunt system. In one exemplary embodiment, any of the above steps can be repeated until the detected value is equal to the target value.
There is also provided a use of the apparatus or system described above for regulating cerebrospinal fluid itow in a hydrdcephalus patient.
BRIEF DESCRIPTION OF TTTE DRAWINGS
l 5 The invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:
FIG. I is a diagrammatic view of a system of the invent.ion;
FIG. 1A is a cross-sectional perspective view of one embodiment of an apparatus for regulating fluid flow;
FIG. 2 is a schematic view of one ernbodiment of an electromechanical valve actuator;
FIG. 3 is a schematic view of another embQdiment of an electromechanical valve actuator, FIG. 4 is a schematic view of one embodiment of a shwxt valve asserrzbly for regulating fluid flow;
FIG. 5 is a schenctatic view of another embodiment of a shunt valve assembly for
6 regulating fluid flow; and FIG. 6 is a schenaatic view of another embodiment of a shunt valve assembly for regulating fluid flow.
DETAILED DESCIRIF'TION OF THE INVFNTION
Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be cotabined with the features of other enibodiments.
Such modifications and vaziations are intcnded to be included within the scope of the presentinvention.
Methods and dcvices for regulating and directing bodily tluids from one region of a patient to another region are disclosed. In general, an apparatus 10 (illustrated in FXG. 1) is provided that can include an implantable shunt system 12 and a system controller 18. While a variety of confi ,-ations are available, in one exemplary embodiment, the apparatus 10 can have an adjustable valve 14 for regulating the flow of fluid, a sensor element 20 for measuring a physiological characteristic of a patient, and an electromechanical valve actuator 16 that can be adapted to adjust a resistance of the valve. As used herein, "electromechanical actuator" includes mecha-vical systems (or mechanisms) that are actuated or controlled electrically such as, but not limited to, electiic motors, solenoids, and linear actuators. The implaritable shunt system can be in electrical communication with the system controller 18 which may or may not be provided within the shunt system housing. -ae systern controller 18 can generally be adapted to receive a physiological characteristic of the patient from the sensor 20 and operate the electromechanicaI valve actuator 16 to adjust a resistance of the valve 14. The system contxoller 18 may also receive instructions from an
DETAILED DESCIRIF'TION OF THE INVFNTION
Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be cotabined with the features of other enibodiments.
Such modifications and vaziations are intcnded to be included within the scope of the presentinvention.
Methods and dcvices for regulating and directing bodily tluids from one region of a patient to another region are disclosed. In general, an apparatus 10 (illustrated in FXG. 1) is provided that can include an implantable shunt system 12 and a system controller 18. While a variety of confi ,-ations are available, in one exemplary embodiment, the apparatus 10 can have an adjustable valve 14 for regulating the flow of fluid, a sensor element 20 for measuring a physiological characteristic of a patient, and an electromechanical valve actuator 16 that can be adapted to adjust a resistance of the valve. As used herein, "electromechanical actuator" includes mecha-vical systems (or mechanisms) that are actuated or controlled electrically such as, but not limited to, electiic motors, solenoids, and linear actuators. The implaritable shunt system can be in electrical communication with the system controller 18 which may or may not be provided within the shunt system housing. -ae systern controller 18 can generally be adapted to receive a physiological characteristic of the patient from the sensor 20 and operate the electromechanicaI valve actuator 16 to adjust a resistance of the valve 14. The system contxoller 18 may also receive instructions from an
7 exteznat programming device 22. The apparatus can be battery powered (i.e., by a battery contained therein) or can, be powered by an external component. Although the device is shovvn and described as regulating the flow of cerebrospinal lluid (CSF), one skilled in the art will appreciate that the device can be used to rcgulato the flow of any bodily fluid.
FZG, 1A illustrates one exeniplary embodiment of an apparatus 100 for regulating fluid flow. As indicated above, the apparatus can gelierally include an implantable shunt system 102 and a system controller 104, The shunt system 102 can be adapted to drai.n excess fluid from one area of a patient's body and direct the fluid to another site in the body.
A variety of configurations are avaiIable for the shunt system 102. As used herein, a shunt refers to any device that diverts a flow of fluid. A person of ordinary skill in the art will rccognaize that a variety of configurations for shunt devices are possible. In one exem.plary ernbodimcnt, shown in FIG. 1A, the shunt system. 102 includes a housing 106 defining an inlet port 110, an outlet port 112, and a chamber 108 oriented between the inlet port 110 and the outlet port 112, The inlet and outlet ports 110, 112 can be coupled to inlet aud outlet or drainage catheters 450, respectively (FIGS. 4-6). For example, in one embodiment, the apparatus can be used to treat hydrocephalus and the inlet catheter is inserted within a ventricle of a patient's brain and the drainage catheter is inseti:ed within another area of the patient's body, such as the peritoneum. During operation, the shunt system 102 can carry CSF, originating from the ventricle, from the inlet cat'heter, through the chamber, and to the drainage catheter.
The irnplantable shunt system 102 can also include an adjustable valve 114 for regulating the flow of fluid. The resistance of the valve 114 can be adjusted within the housing 106 to set a pressure threshold at which excess CSF begins to flow from the ventricle of a brain through the valve 114 and to another area of a patient's body. While the valve 114 can have several conf'igurations, in an exemplary embodiment, shown in FIG. 1A, the valve 114 takes the form of a ball valve. As shown, the ball 116 is disposed in the chamber 108 of the housing 106 and is seated in a circular orifice 118.
Although the valve 114 is shown and desctibed as a ball valve, one skilled in the art will appreciate that a number of valve conf'zgurations are available for use with the implantable shunt system 102.
'X'l-ie ba11116 can act as a stop member and regulate the fluid flow through the shunt system S
102. For example, fluid can be prevented from flowing through the shunt system when the ba11116 is fally seated within the circular orifice 118. Altematively, fluid can be allowed to flow through the shunt system 102 when the pressure in, the ventricle exceeds the force being applied to the ball 116 to seat it in the circular orit'ice I X S. Thus, varying the force applied to the ba11116 can be effective to vary the resistance of the valve 114 (i.e., the pressure threshold at which fluid begins to flow through the valve 114).
A variety of techniques can be used to adjust the resistance of the valve 114.
For example, in one exemplary embodiment, an electromechanical valve actuator 120 can be operatively associated with the valve 114 and adapted to adjust a resistance of the valve 114.
The electromechanical valve actuator 120 can be configured to adjust and maintain the pressure threshold at which fluid begins to flow through the valve 114 thereby reducing the risk of either over- or under-drainage of CSF from a brain veDtricle. The electromechanical valve actuator 120 can generally include a spring 122 and a pressure setting mechanism 124.
The electrom.echanical valve actuator 120 caz- effectively prevent movement of the valve 114, such as when the shunt system is exposed to environmental magnetic forces. In cextain cases, for example, the shunt system 102 can be subjected to a strong external magnetic field, such as when a patient having an implanted shunt system 102 undergoes an magnetic resonance imaging (MRI) procedure. The magnetic field generates a force on the shunt system 102 that can induce motion of the pressure setting mechanism 124 and can cause the pressure setting mechanism 124 to adjust the position of the valve 114. The electromechanical valve actuator 120, however, can lock the valve 114 in place to maintain a set pressuze threshold within the shunt system 102 when exposed to the magnetic field.
FIGS. 1-3 illustrate a variety of exemplary embodiments of electromechanical valve actuators 120 for use with the shunt system 102 described herein. One sicilled in the an will appreciate that various springs and configurations of pressure setting mechanisms can fortn the electromechanical valve actuator, and tbe actuator should not be limited to the features and configurations described below.
As shown, the electromechauical valve actuatoz 120 includes a leaf spring 122 that is coupled to a pressure settiug mechanism 124 having a cantilever 126 and a rotor assembly 12$. As indicated above, the ball 116 of the ball valve can regulate the fluid flow through the shunt system. Thoball 116 can be operatively joined to a first end 122a of the cantilevered spring 122 which a second end 122b of the spring 122 can engage a stair array 130 of the rotor assembly 128. In this embodiment, the rotor assembly 128 can include the stair-step array 130 in the foz-m of a spiral staircase to provide pressure settings in discrete steps. The rotor assembly 128 can also include an actuation mechanism 132 that is configurcd to rotate the stair array 130 with respect to the cantilevered spring 122. In general, the mechanism 132 can include a motor 134 that is operatively associated with the stair array 130. For exazrrple, in one exemplary embodiment, shown in FIG. 1A, the mechanism 132 includes a micro-motor 134 that is coupled to the stair array 130 via gear teeth provided on each (not shown). A variety of motors can be used to rotate the stair array 130 including, but not limited to, micro-motors, stepper-motors, and pzezo-motors.
In use, the actuation mechanism 132 of electrornechanical valvc actuator 120 can rotate the spira] stair array 130 with respect to the cantilevered spring 122, and the second end 122b of the spring 122 can move up or down each stair of the array 130.
Moving the second end 122b of the spzing 122 up or down can be effective to change th.e angle of deflection othe spring 122 (e.g., relative to the cantilever 126). The chaDge in the angle of deflection of the spring 122, in tum, alters the force that is exerted by the spring 122 on the ba11116. As indicated above, changing the force applied to the ba11116 can result in a corresponding increase or decrease of the established pressure threshold at which fluid begins to flow through the shunt system 102.
An antenna 430 can also be provided to allow for non-invasive control of the electromechanical valve actuator 120. As is described below in detail, one or more antenrxas 430 can have a variety of configurations as well as be disposed at various locations througf,,out the system. Refeiring generally to FIG. 1, the shunt system 12, system controller 18, and programrning device 22 can include signal transmitters/receivers or antennas 430 that can be configured to send andlor receive signals from one auother to allow the individual coitnponents of the apparatus 10 to commtuucate with each other as well as facilitate non-invasive control of the apparatus 10.
FIG. 2 illustrates anotber exemplary embodimerst of an electromechanical valve actuator 200 for use with the imp]antable shunt system 102. As shown, the electromecbanical valve actuator 200 includes a leaf spring 202 that is operatively associated with a pressure setting mechanism 204 that takes the form of a gear assembly 206. Similar to the embodiment shown in FIG. 1 A, a first end 202a of the leaf spring 202 can, be operatively associated with the ball 116 of the ball valve and a second end 202b of the spring 202 can engage the gear assembly 206. The gear assembly 206 can include first and second gears 206a, 206b. The first gear 206a can have a series of helical steps (not shown) fr,nned UacrCUn arnd can be adapted to engage the spring 202. The second gear 206b can engage the first gear 206a as well as be operatively associated with an actuation mechanisnx 208 of the gear assembly 206. The actuation mechanism 208 can be configured to drive the gears 206a, 206b and rotate the helical steps with respect to the spring 202. '1'he mechanism 208 shown in FIG. 2 includes a micro-motor 21'0 that is coupled to the second gear 206b via a cylindrical motor shaft 212. As indicated above, a variety of motors can be used to rotate the stair array including, but not limited to, micro-rr,otors, stepper-motors, and piezo-motors. In use, the actuation mechanism 208 can drive the gear assembly 206 to rotate the helical steps with respect to the spring 202 and move the second end 202b of the spring 202 up or down the steps. As desscribed above, such_naovement can be effective to change in the angle of deflection of the spring 202 tl-iezeby altering the force that is exerted on the bal] 116 and increasing or decreasing the established pressure threshold at which fluid begins to flow through the shunt system.
Another exemplary embodiment of an electromechanical valve actuator 300 is sh,own in FIG_ 3. As sbown, the electromechanical valve actuator 300. includes a helical spring 302 that is coupled to a pressure setting mccharaism 304 having a stop member 306 and motor assembly 308. A first end 302a of the helical spring 302 can engage the ball 116 of the ball valve, and a second end 302b of the spring 302 can abut a distal facing surface 307 of the stop member 306. The stop member 306 can have virtually any conliguration, for example, as shown in 1~IG. 3, the stop member 306 is a generally cylindrical cap that has a closed distal end 306b and an open proximal end 306a with a bore 309 formed therein. The bore 309 can be threaded and adapted to receive and engage a threaded shaft 308a of the motor assembly 308. A motor 308b, such as one described above, can drive the threaded shaft 308a to move the stop member 306 in the proximal and/or distal directions. The closed distal end 306b of the stop member 306 can be cnz-frgured to apply a force to the spring 302 such that distal movement of the stop member 306 is effective to compress the spring 302 and alter the force that is exerted by the spring 302 on the ball 116. As indicated above, changing the force applied to the ball 116 can result in a corresponding increase or decrease of the established pressure threshold at which fluid beg',ns to flow through the shunt system..
The implantable shunt system can further include a sensor element for measuring a physiological characteristic of a patient. The sensor element can be coupled to the valve or it can be separate from the valve. For example, as shown in FIGS. 4-6, the sensor element 402 is in. electrical communication with the shunt system 401 and is coupled to the system via wires 402a. Additionally, w11i1e the sensor element 402 is shown as being positioned within the CSF flow pathway 406 of the shunt system 401, in another exemplary embodiment, the sensor element 402 can be located outside of the CSF flow pathway 406 though still residing within the ventricular cavity of the patient. The sensor element 402 can be configured to measurc a variety of physiological clraracteristics of a patient including, but not lirnited to, CSF pressure. Although the sb,unt system 401 is shown as having a single sensor element 402, one skilled in the art will apprediate that the system can include multiple sensor elements having several, differcnt configurations. For exannple, in one embodiment, the system 401 can include multiple pressure sensors to measure the CSF
pressure at various points in the ventricular cavity. In another exemplary embodiment, the system 401 can include multiple sensor elements each configured to measure a different physiological characteristic of a patient.
As indicated above, thc apparatus 400 for regulating fluid flow can also include a system controller 408. In general, the controller 408 can be in electrical communication with the implantable sb.unt system 401 and can be adapted to receive the physiological characteristic measured by the sensor eiement 402 and to operate the electromechanical valve actuator 410 to adjust a resistance of the valve 114. For example, the system controller 408 can be configured to receive an input signal that is generated by the sensor element 402 and is representative of the measured value of the physiological cbaracteristic (e_g., the CSF pressure). The system controller 408 can also be configured to generate and transmit to the electromechanieal valve actuator 410 an output control signal that commands the actuator 410 to adjust the resistance of the valve 114. Avariety of conf'igurations are available for the system controller 408. For example, as shown in FIGS. 4 ud 5, in one exenmplary embodiment, the controller 408 is cantained within the impla.ntable shunt system 401. Depending on the size and configuration of the electromechanical valve actuator 410, it may not be desirable to have the controIler 408 contained within the shunt system 401.
Accordingiy, in another exemplary embodiment, the controller 408 can be disposed on an implant 412 that is separate from the implantable sliunt system 401 (FIG. 6).
The system controller 408 can also include a processing unit such as, for example, a micropmcessor, which enables the controller 408 to oompare the measured physiological characteristic (e.g., the measured CSF pressure) detected by the sensor element 402 to a predctcrmined target value for the physiological characteristic. The predetermimed target value can be ascertained through clinical assessruent of the patent and is therefore customized for each particular patient, This target value can then be preset or programmed into the system coniroller 408. In use, the system controller 408 can operate according to an algorithm which determines whether the value measured by the sensor element 402 is higher than, iower than, or within an acceptable Fange of the target value. Based on this assessment, the algorithm can then determine whether the resistance of the valve 114 should be increased, decreased, or maintained in order to achieve the target CSF
pressure for the patient. For example, where the physiological characteristic being measured is CSF
pressure, the valve's resistance can be decreased if the measured pressure is higher than the target pressure_ Conversely, the resistance of the valve 114 can be incrcased if the measured pressure is lower th,att the target pressure. The microprocessor can then generate an output control signal to the electromechanical valve actuator 410 which commands the actuator 410 to adjust its current resistance to the desired resistance. If the measured value is essentially the sar,ne as, or within an acceptable range of the target value, then the current resistance is maintained and no changes are made.
The apparatus 400 for regulating fluid flow can t'iarther include an external programiming device 420 that is in communication with the_system controller 408. In general, the programming device 420 can include a user input element that allows an operator to input one or more instructions to be communicated to the system eontrolIer 408.
For exarnple, the external prograrnming device 420=can be adapted to transmit a signal to the system controller 408 that is representative of a predetemined target value for the CSF
pressure of a patient. The external progra.mxning device 420 can have a variety configurations and in one exemplary embodiment can take the form of a hand-held remote control. The programming device 420 can include a display for communicating input and/or output values (e.g., the predetermined target value for a physiological characteristic being measured and/or the measured value of a physiological characteristic) to a user. In addition to communicating instructions to the systern controller 408, the programming device 420 can also be adapted to power the implantable shunt system 401.
As indicated above, one or more antenr,as 430 can be provided to allow the individual components of the apparatus 400 to comzuiutucate with each other as well as facilitate non-invasive control of the apparatus 400. The implantable shunt system 401, system controller 408, and external programming device 420 can be equipped with electronic circuitry sinnilar to those for medical telemetry systems that communicate physiological data (e.g., temperature, pressure, etc.) between an implant and a receiver unit.
For example, the system controller 408 can be configured to generate an analog data signal that is then converted electronicafly to a digital pulse which is ttxen transmitted by radiofrequency (RF) to the extenlal programming device 420. As illustrated in FIGS. 4-6, the shunt system 401, system controller 408, and programming device 420 include signal transmitters/receivcrs or antennas 430 that can be coufigured to send and/or receive signals from one another. Such communication can provide non-invasive control of the electromechanieaI valve actuator 410. The antennas 430 can have a variety of configurations as well as be disposed at various locations in the system. For example, in ono -exemplary embodiment shown in FIG. 4, both the system controller 408 and antenna 430 associated therewith are disposed on the implantable shunt system 401. In another embodiment, shown in F1G. 5, the controller 408 is contained within the implantable shunt system 401 but the antenna 430 is disposed on a separate implant 430a. Such a configuration can allow for a larger, more powerful antenna to be placed in a more convenient location (e.g., a patient's arm rather than their h.ead). In yet another exemplary embodiment, illustrated in FIG. 6, both the system controller 408 and antenna associated therewith are disposed on an implant 412 separate from the implantable shunt system 401. Similar to the embodiment shown in FIG. 5, this embodiment cau provide Iess restriction on the size of the system controller 408 and antenna 430, as these contponents are not part of the shunt system 401. One skilled in the art will recognize that these are merely examples of the forms of remote communication suitable for use with the fluid regulating apparatus 400 disclosed herein and a variety of other farms of non-invasive communication can be utilized without departing from the scope of the present invention.
Methods of regulating cerebrospinal fluid flow are also provided. In general, the method can include comparing a target value to a value detected by a sensor 402 associated witta an implantable shunt system 401, and activating an electromechanical valve actuator 410 of the implantable shunt system 401 to adjust a resistance of a valve 114 of the shunt system 401 if the detected value is not equal to the target value.
In one exemplary embodiment, the method ca.n'include energi.zing the apparatus with the external progralnming device 420 and detecting a physiological characteristic of a ventricular cavity (e.g., CSF pressure). The measumd value can then be compared to a predetermined target value for that physiological charaeteristic. The predeterrnined target value can be preset in tha system controller 408 or can be prograznzned in the controller via the external prograzruning device 420. If the system, controller 408 determines that the measured value is not equal to the target value, the controller 408 than determines whether the resistance for the valve 114 should be increased or deceased accordingly to achieve the predetermined target value for that physiological characteristic. The system controller 408 can theii generate and transmit an activation signal to activate the electromechanical valve actuator 410 and adjust a resistance of the valve 114. Tf the measured vaIue is essentially the same as, or within an acceptable range of the target value, then no change is made to the resistance of the valve 114, Ditring the operation of the extem.al programming device 420 (i.e., when the device 420 is applicd to the paticnt and the apparat'txs 401 is energized), data can be communicated between the device 420 and the systerrz controller 408. For example, a user can input a target value to the programming device 420 and the device can communicate data representative of the target value to the systeYn controller 408. Data can also be communicated between the implantable sbunt system 401 and the system controller 408.
'Z'he sensor element 402 can communicate data representative of the measured value of a physiologioal characteristic to the system controller 408, and the controller 408 can communicate a command to the electromechanical valve actuator 410 to adjust a resistance of the valve 114. More specifically, the system controIIer 408 can detect a value of a physiological characteristic measured by the sensor element 402 by receiving an input signal generated from the sensor element 402 that contains data about the measured value of the physiological characteristic. Similarly, the system controller 408 can adjust a resistance of the valve 114 by generating and transmitting an output control signal to the electromechanical valve actuator 410 that commands the actuator 410 to adjust a resistance of the valve 114.
In an application of the methods described above, if a patient experiences discomfort and/or pain, the apparatus 401 can be energized and data can be communicated from the external progrannming device 420 to the system controller 408. The appazatus 401 can be energized by either the patient himself or his attendin.g physician. If the measured value is the same as, or falls within an acceptable range of the target value, then the system controller 408 is programzned to make no changes to the resistance. If, however, the system controller 408 detects that the measured value is higher or lower than the preset target value, the controller 408 sends a command to the electromechanical valve actuator 410 to adjust a resistance of the valve 114. Then, after some time has elapsed (e.g., a day, two days, a week, etc.) to allow the patient's physiology to respond to the valve's 114 new resistance setting, and the patient still experiences discomfort or pain, or siraply wants to determine the current value of a particular physiological characteristic, tha apparatus 401 can agaiu bc energized to measure the cunrent value. If the system controller 408 does not detect a change in the measured value from the previous reading, the controller 408 can send another command to the electromechanical valve actuato* 410 to adjust the resistance accordingly.
It is contemplated that the above steps can be repeated until an appropriate resistance is attained and the system controlle.r 408 detects that the measured value is approaching or has approached the target value for that patient. For exannple, the above steps can be repeated whenever the patient begins to experience pain or disconlfort.
However, to safeguard against repeated or excessive valve 114 adjustnnents within a short window of time, whidi could produce deleterious health consequences for the patient, the system controller 408 can include a timed shutoff mechanism which would limit the user's ability to adjust the valve in a given time period. For example, the system controller's 408 valve adjustment features can be configuzed to deactivate a#ler each use until a preset amount of time (e.g., a day, two days, a weelc, etc.) has passcd whereby the valve adjustment feature is automatically reactivated. Such a safeguard ensures that a suflicient amount oftirrme passcs between adjustments so that the patient's physiology does not incur rapid CSF
flow changes in. a short amount of time. Of course, it is contemplated that the system controller 408 can still be capable of detecting a physiological characteristic of the patient's ventricular cavity even when the device's valve adjustment features are not active. Hence, the patient can continue to monitor a physiological characteristic of his veutricular cavity using the apparatus 401 even between stages of adjusting the valve 114.
One skilled in the art will appreciate further features and advautages of the invention based on the above-described embodiments. Accordingly, the invention is not to be limited by what bas been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety.
FZG, 1A illustrates one exeniplary embodiment of an apparatus 100 for regulating fluid flow. As indicated above, the apparatus can gelierally include an implantable shunt system 102 and a system controller 104, The shunt system 102 can be adapted to drai.n excess fluid from one area of a patient's body and direct the fluid to another site in the body.
A variety of configurations are avaiIable for the shunt system 102. As used herein, a shunt refers to any device that diverts a flow of fluid. A person of ordinary skill in the art will rccognaize that a variety of configurations for shunt devices are possible. In one exem.plary ernbodimcnt, shown in FIG. 1A, the shunt system. 102 includes a housing 106 defining an inlet port 110, an outlet port 112, and a chamber 108 oriented between the inlet port 110 and the outlet port 112, The inlet and outlet ports 110, 112 can be coupled to inlet aud outlet or drainage catheters 450, respectively (FIGS. 4-6). For example, in one embodiment, the apparatus can be used to treat hydrocephalus and the inlet catheter is inserted within a ventricle of a patient's brain and the drainage catheter is inseti:ed within another area of the patient's body, such as the peritoneum. During operation, the shunt system 102 can carry CSF, originating from the ventricle, from the inlet cat'heter, through the chamber, and to the drainage catheter.
The irnplantable shunt system 102 can also include an adjustable valve 114 for regulating the flow of fluid. The resistance of the valve 114 can be adjusted within the housing 106 to set a pressure threshold at which excess CSF begins to flow from the ventricle of a brain through the valve 114 and to another area of a patient's body. While the valve 114 can have several conf'igurations, in an exemplary embodiment, shown in FIG. 1A, the valve 114 takes the form of a ball valve. As shown, the ball 116 is disposed in the chamber 108 of the housing 106 and is seated in a circular orifice 118.
Although the valve 114 is shown and desctibed as a ball valve, one skilled in the art will appreciate that a number of valve conf'zgurations are available for use with the implantable shunt system 102.
'X'l-ie ba11116 can act as a stop member and regulate the fluid flow through the shunt system S
102. For example, fluid can be prevented from flowing through the shunt system when the ba11116 is fally seated within the circular orifice 118. Altematively, fluid can be allowed to flow through the shunt system 102 when the pressure in, the ventricle exceeds the force being applied to the ball 116 to seat it in the circular orit'ice I X S. Thus, varying the force applied to the ba11116 can be effective to vary the resistance of the valve 114 (i.e., the pressure threshold at which fluid begins to flow through the valve 114).
A variety of techniques can be used to adjust the resistance of the valve 114.
For example, in one exemplary embodiment, an electromechanical valve actuator 120 can be operatively associated with the valve 114 and adapted to adjust a resistance of the valve 114.
The electromechanical valve actuator 120 can be configured to adjust and maintain the pressure threshold at which fluid begins to flow through the valve 114 thereby reducing the risk of either over- or under-drainage of CSF from a brain veDtricle. The electromechanical valve actuator 120 can generally include a spring 122 and a pressure setting mechanism 124.
The electrom.echanical valve actuator 120 caz- effectively prevent movement of the valve 114, such as when the shunt system is exposed to environmental magnetic forces. In cextain cases, for example, the shunt system 102 can be subjected to a strong external magnetic field, such as when a patient having an implanted shunt system 102 undergoes an magnetic resonance imaging (MRI) procedure. The magnetic field generates a force on the shunt system 102 that can induce motion of the pressure setting mechanism 124 and can cause the pressure setting mechanism 124 to adjust the position of the valve 114. The electromechanical valve actuator 120, however, can lock the valve 114 in place to maintain a set pressuze threshold within the shunt system 102 when exposed to the magnetic field.
FIGS. 1-3 illustrate a variety of exemplary embodiments of electromechanical valve actuators 120 for use with the shunt system 102 described herein. One sicilled in the an will appreciate that various springs and configurations of pressure setting mechanisms can fortn the electromechanical valve actuator, and tbe actuator should not be limited to the features and configurations described below.
As shown, the electromechauical valve actuatoz 120 includes a leaf spring 122 that is coupled to a pressure settiug mechanism 124 having a cantilever 126 and a rotor assembly 12$. As indicated above, the ball 116 of the ball valve can regulate the fluid flow through the shunt system. Thoball 116 can be operatively joined to a first end 122a of the cantilevered spring 122 which a second end 122b of the spring 122 can engage a stair array 130 of the rotor assembly 128. In this embodiment, the rotor assembly 128 can include the stair-step array 130 in the foz-m of a spiral staircase to provide pressure settings in discrete steps. The rotor assembly 128 can also include an actuation mechanism 132 that is configurcd to rotate the stair array 130 with respect to the cantilevered spring 122. In general, the mechanism 132 can include a motor 134 that is operatively associated with the stair array 130. For exazrrple, in one exemplary embodiment, shown in FIG. 1A, the mechanism 132 includes a micro-motor 134 that is coupled to the stair array 130 via gear teeth provided on each (not shown). A variety of motors can be used to rotate the stair array 130 including, but not limited to, micro-motors, stepper-motors, and pzezo-motors.
In use, the actuation mechanism 132 of electrornechanical valvc actuator 120 can rotate the spira] stair array 130 with respect to the cantilevered spring 122, and the second end 122b of the spring 122 can move up or down each stair of the array 130.
Moving the second end 122b of the spzing 122 up or down can be effective to change th.e angle of deflection othe spring 122 (e.g., relative to the cantilever 126). The chaDge in the angle of deflection of the spring 122, in tum, alters the force that is exerted by the spring 122 on the ba11116. As indicated above, changing the force applied to the ba11116 can result in a corresponding increase or decrease of the established pressure threshold at which fluid begins to flow through the shunt system 102.
An antenna 430 can also be provided to allow for non-invasive control of the electromechanical valve actuator 120. As is described below in detail, one or more antenrxas 430 can have a variety of configurations as well as be disposed at various locations througf,,out the system. Refeiring generally to FIG. 1, the shunt system 12, system controller 18, and programrning device 22 can include signal transmitters/receivers or antennas 430 that can be configured to send andlor receive signals from one auother to allow the individual coitnponents of the apparatus 10 to commtuucate with each other as well as facilitate non-invasive control of the apparatus 10.
FIG. 2 illustrates anotber exemplary embodimerst of an electromechanical valve actuator 200 for use with the imp]antable shunt system 102. As shown, the electromecbanical valve actuator 200 includes a leaf spring 202 that is operatively associated with a pressure setting mechanism 204 that takes the form of a gear assembly 206. Similar to the embodiment shown in FIG. 1 A, a first end 202a of the leaf spring 202 can, be operatively associated with the ball 116 of the ball valve and a second end 202b of the spring 202 can engage the gear assembly 206. The gear assembly 206 can include first and second gears 206a, 206b. The first gear 206a can have a series of helical steps (not shown) fr,nned UacrCUn arnd can be adapted to engage the spring 202. The second gear 206b can engage the first gear 206a as well as be operatively associated with an actuation mechanisnx 208 of the gear assembly 206. The actuation mechanism 208 can be configured to drive the gears 206a, 206b and rotate the helical steps with respect to the spring 202. '1'he mechanism 208 shown in FIG. 2 includes a micro-motor 21'0 that is coupled to the second gear 206b via a cylindrical motor shaft 212. As indicated above, a variety of motors can be used to rotate the stair array including, but not limited to, micro-rr,otors, stepper-motors, and piezo-motors. In use, the actuation mechanism 208 can drive the gear assembly 206 to rotate the helical steps with respect to the spring 202 and move the second end 202b of the spring 202 up or down the steps. As desscribed above, such_naovement can be effective to change in the angle of deflection of the spring 202 tl-iezeby altering the force that is exerted on the bal] 116 and increasing or decreasing the established pressure threshold at which fluid begins to flow through the shunt system.
Another exemplary embodiment of an electromechanical valve actuator 300 is sh,own in FIG_ 3. As sbown, the electromechanical valve actuator 300. includes a helical spring 302 that is coupled to a pressure setting mccharaism 304 having a stop member 306 and motor assembly 308. A first end 302a of the helical spring 302 can engage the ball 116 of the ball valve, and a second end 302b of the spring 302 can abut a distal facing surface 307 of the stop member 306. The stop member 306 can have virtually any conliguration, for example, as shown in 1~IG. 3, the stop member 306 is a generally cylindrical cap that has a closed distal end 306b and an open proximal end 306a with a bore 309 formed therein. The bore 309 can be threaded and adapted to receive and engage a threaded shaft 308a of the motor assembly 308. A motor 308b, such as one described above, can drive the threaded shaft 308a to move the stop member 306 in the proximal and/or distal directions. The closed distal end 306b of the stop member 306 can be cnz-frgured to apply a force to the spring 302 such that distal movement of the stop member 306 is effective to compress the spring 302 and alter the force that is exerted by the spring 302 on the ball 116. As indicated above, changing the force applied to the ball 116 can result in a corresponding increase or decrease of the established pressure threshold at which fluid beg',ns to flow through the shunt system..
The implantable shunt system can further include a sensor element for measuring a physiological characteristic of a patient. The sensor element can be coupled to the valve or it can be separate from the valve. For example, as shown in FIGS. 4-6, the sensor element 402 is in. electrical communication with the shunt system 401 and is coupled to the system via wires 402a. Additionally, w11i1e the sensor element 402 is shown as being positioned within the CSF flow pathway 406 of the shunt system 401, in another exemplary embodiment, the sensor element 402 can be located outside of the CSF flow pathway 406 though still residing within the ventricular cavity of the patient. The sensor element 402 can be configured to measurc a variety of physiological clraracteristics of a patient including, but not lirnited to, CSF pressure. Although the sb,unt system 401 is shown as having a single sensor element 402, one skilled in the art will apprediate that the system can include multiple sensor elements having several, differcnt configurations. For exannple, in one embodiment, the system 401 can include multiple pressure sensors to measure the CSF
pressure at various points in the ventricular cavity. In another exemplary embodiment, the system 401 can include multiple sensor elements each configured to measure a different physiological characteristic of a patient.
As indicated above, thc apparatus 400 for regulating fluid flow can also include a system controller 408. In general, the controller 408 can be in electrical communication with the implantable sb.unt system 401 and can be adapted to receive the physiological characteristic measured by the sensor eiement 402 and to operate the electromechanical valve actuator 410 to adjust a resistance of the valve 114. For example, the system controller 408 can be configured to receive an input signal that is generated by the sensor element 402 and is representative of the measured value of the physiological cbaracteristic (e_g., the CSF pressure). The system controller 408 can also be configured to generate and transmit to the electromechanieal valve actuator 410 an output control signal that commands the actuator 410 to adjust the resistance of the valve 114. Avariety of conf'igurations are available for the system controller 408. For example, as shown in FIGS. 4 ud 5, in one exenmplary embodiment, the controller 408 is cantained within the impla.ntable shunt system 401. Depending on the size and configuration of the electromechanical valve actuator 410, it may not be desirable to have the controIler 408 contained within the shunt system 401.
Accordingiy, in another exemplary embodiment, the controller 408 can be disposed on an implant 412 that is separate from the implantable sliunt system 401 (FIG. 6).
The system controller 408 can also include a processing unit such as, for example, a micropmcessor, which enables the controller 408 to oompare the measured physiological characteristic (e.g., the measured CSF pressure) detected by the sensor element 402 to a predctcrmined target value for the physiological characteristic. The predetermimed target value can be ascertained through clinical assessruent of the patent and is therefore customized for each particular patient, This target value can then be preset or programmed into the system coniroller 408. In use, the system controller 408 can operate according to an algorithm which determines whether the value measured by the sensor element 402 is higher than, iower than, or within an acceptable Fange of the target value. Based on this assessment, the algorithm can then determine whether the resistance of the valve 114 should be increased, decreased, or maintained in order to achieve the target CSF
pressure for the patient. For example, where the physiological characteristic being measured is CSF
pressure, the valve's resistance can be decreased if the measured pressure is higher than the target pressure_ Conversely, the resistance of the valve 114 can be incrcased if the measured pressure is lower th,att the target pressure. The microprocessor can then generate an output control signal to the electromechanical valve actuator 410 which commands the actuator 410 to adjust its current resistance to the desired resistance. If the measured value is essentially the sar,ne as, or within an acceptable range of the target value, then the current resistance is maintained and no changes are made.
The apparatus 400 for regulating fluid flow can t'iarther include an external programiming device 420 that is in communication with the_system controller 408. In general, the programming device 420 can include a user input element that allows an operator to input one or more instructions to be communicated to the system eontrolIer 408.
For exarnple, the external prograrnming device 420=can be adapted to transmit a signal to the system controller 408 that is representative of a predetemined target value for the CSF
pressure of a patient. The external progra.mxning device 420 can have a variety configurations and in one exemplary embodiment can take the form of a hand-held remote control. The programming device 420 can include a display for communicating input and/or output values (e.g., the predetermined target value for a physiological characteristic being measured and/or the measured value of a physiological characteristic) to a user. In addition to communicating instructions to the systern controller 408, the programming device 420 can also be adapted to power the implantable shunt system 401.
As indicated above, one or more antenr,as 430 can be provided to allow the individual components of the apparatus 400 to comzuiutucate with each other as well as facilitate non-invasive control of the apparatus 400. The implantable shunt system 401, system controller 408, and external programming device 420 can be equipped with electronic circuitry sinnilar to those for medical telemetry systems that communicate physiological data (e.g., temperature, pressure, etc.) between an implant and a receiver unit.
For example, the system controller 408 can be configured to generate an analog data signal that is then converted electronicafly to a digital pulse which is ttxen transmitted by radiofrequency (RF) to the extenlal programming device 420. As illustrated in FIGS. 4-6, the shunt system 401, system controller 408, and programming device 420 include signal transmitters/receivcrs or antennas 430 that can be coufigured to send and/or receive signals from one another. Such communication can provide non-invasive control of the electromechanieaI valve actuator 410. The antennas 430 can have a variety of configurations as well as be disposed at various locations in the system. For example, in ono -exemplary embodiment shown in FIG. 4, both the system controller 408 and antenna 430 associated therewith are disposed on the implantable shunt system 401. In another embodiment, shown in F1G. 5, the controller 408 is contained within the implantable shunt system 401 but the antenna 430 is disposed on a separate implant 430a. Such a configuration can allow for a larger, more powerful antenna to be placed in a more convenient location (e.g., a patient's arm rather than their h.ead). In yet another exemplary embodiment, illustrated in FIG. 6, both the system controller 408 and antenna associated therewith are disposed on an implant 412 separate from the implantable shunt system 401. Similar to the embodiment shown in FIG. 5, this embodiment cau provide Iess restriction on the size of the system controller 408 and antenna 430, as these contponents are not part of the shunt system 401. One skilled in the art will recognize that these are merely examples of the forms of remote communication suitable for use with the fluid regulating apparatus 400 disclosed herein and a variety of other farms of non-invasive communication can be utilized without departing from the scope of the present invention.
Methods of regulating cerebrospinal fluid flow are also provided. In general, the method can include comparing a target value to a value detected by a sensor 402 associated witta an implantable shunt system 401, and activating an electromechanical valve actuator 410 of the implantable shunt system 401 to adjust a resistance of a valve 114 of the shunt system 401 if the detected value is not equal to the target value.
In one exemplary embodiment, the method ca.n'include energi.zing the apparatus with the external progralnming device 420 and detecting a physiological characteristic of a ventricular cavity (e.g., CSF pressure). The measumd value can then be compared to a predetermined target value for that physiological charaeteristic. The predeterrnined target value can be preset in tha system controller 408 or can be prograznzned in the controller via the external prograzruning device 420. If the system, controller 408 determines that the measured value is not equal to the target value, the controller 408 than determines whether the resistance for the valve 114 should be increased or deceased accordingly to achieve the predetermined target value for that physiological characteristic. The system controller 408 can theii generate and transmit an activation signal to activate the electromechanical valve actuator 410 and adjust a resistance of the valve 114. Tf the measured vaIue is essentially the same as, or within an acceptable range of the target value, then no change is made to the resistance of the valve 114, Ditring the operation of the extem.al programming device 420 (i.e., when the device 420 is applicd to the paticnt and the apparat'txs 401 is energized), data can be communicated between the device 420 and the systerrz controller 408. For example, a user can input a target value to the programming device 420 and the device can communicate data representative of the target value to the systeYn controller 408. Data can also be communicated between the implantable sbunt system 401 and the system controller 408.
'Z'he sensor element 402 can communicate data representative of the measured value of a physiologioal characteristic to the system controller 408, and the controller 408 can communicate a command to the electromechanical valve actuator 410 to adjust a resistance of the valve 114. More specifically, the system controIIer 408 can detect a value of a physiological characteristic measured by the sensor element 402 by receiving an input signal generated from the sensor element 402 that contains data about the measured value of the physiological characteristic. Similarly, the system controller 408 can adjust a resistance of the valve 114 by generating and transmitting an output control signal to the electromechanical valve actuator 410 that commands the actuator 410 to adjust a resistance of the valve 114.
In an application of the methods described above, if a patient experiences discomfort and/or pain, the apparatus 401 can be energized and data can be communicated from the external progrannming device 420 to the system controller 408. The appazatus 401 can be energized by either the patient himself or his attendin.g physician. If the measured value is the same as, or falls within an acceptable range of the target value, then the system controller 408 is programzned to make no changes to the resistance. If, however, the system controller 408 detects that the measured value is higher or lower than the preset target value, the controller 408 sends a command to the electromechanical valve actuator 410 to adjust a resistance of the valve 114. Then, after some time has elapsed (e.g., a day, two days, a week, etc.) to allow the patient's physiology to respond to the valve's 114 new resistance setting, and the patient still experiences discomfort or pain, or siraply wants to determine the current value of a particular physiological characteristic, tha apparatus 401 can agaiu bc energized to measure the cunrent value. If the system controller 408 does not detect a change in the measured value from the previous reading, the controller 408 can send another command to the electromechanical valve actuato* 410 to adjust the resistance accordingly.
It is contemplated that the above steps can be repeated until an appropriate resistance is attained and the system controlle.r 408 detects that the measured value is approaching or has approached the target value for that patient. For exannple, the above steps can be repeated whenever the patient begins to experience pain or disconlfort.
However, to safeguard against repeated or excessive valve 114 adjustnnents within a short window of time, whidi could produce deleterious health consequences for the patient, the system controller 408 can include a timed shutoff mechanism which would limit the user's ability to adjust the valve in a given time period. For example, the system controller's 408 valve adjustment features can be configuzed to deactivate a#ler each use until a preset amount of time (e.g., a day, two days, a weelc, etc.) has passcd whereby the valve adjustment feature is automatically reactivated. Such a safeguard ensures that a suflicient amount oftirrme passcs between adjustments so that the patient's physiology does not incur rapid CSF
flow changes in. a short amount of time. Of course, it is contemplated that the system controller 408 can still be capable of detecting a physiological characteristic of the patient's ventricular cavity even when the device's valve adjustment features are not active. Hence, the patient can continue to monitor a physiological characteristic of his veutricular cavity using the apparatus 401 even between stages of adjusting the valve 114.
One skilled in the art will appreciate further features and advautages of the invention based on the above-described embodiments. Accordingly, the invention is not to be limited by what bas been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety.
Claims (40)
1. An apparatus for regulating fluid flow, comprising:
an implantable shant system having:
an adjustable valve for regulating the flow of fluid, a sensor element for measuring a physiological characteristic of a patient, and an electromechanical valve actuator adapted to adjust a resistance of the valve; and a system controller in electrical communication with the implantable shunt system and adapted to receive the physiological characteristic of the patient and operate the electromechanical valve actuator to adjust a resistance of the valve.
an implantable shant system having:
an adjustable valve for regulating the flow of fluid, a sensor element for measuring a physiological characteristic of a patient, and an electromechanical valve actuator adapted to adjust a resistance of the valve; and a system controller in electrical communication with the implantable shunt system and adapted to receive the physiological characteristic of the patient and operate the electromechanical valve actuator to adjust a resistance of the valve.
2. The apparatus of claim 1, further comprising an external programming device in communication with the system controller.
3. The apparatus of claim 2, wherein the external programming device includes a display for communicating the physiological characteristic of the patient to a user.
4. The apparatus of claim 3, wherein the external programming device includes a user input element, the external programming device being configured to communicate one or more instructions to the system controller based upon user input.
5. The apparatus of claim 1, wherein the valve is a ball valve.
6. The apparatus of claim 1, wherein the electromechanical valve actuator comprises a spring operatively associated with a pressure setting mechanism.
7. The apparatus of claim 6, wherein the spring is a leaf spring.
8. The apparatus of claim 6, wherein the spring is a helical spring.
9. The apparatus of claim 6, wherein the pressure setting mechanism includes a motor driven rotor assembly adapted to adjust a resistance of the valve upon actuation of the motor.
10. The apparatus of claim 6, wherein the pressure setting mechanism includes a motor driven stop member, the stop member being adapted to apply a force to the spring to adjust a resistance of the valve.
11. The apparatus of claim 2, wherein the sensor element is a pressure sensor for detecting a cerebro-spinal fluid pressure.
12. The apparatus of claim 11, wherein the system controller includes a microprocessor for comparing the measured pressure detected by the sensor to a target pressure.
13. The apparatus of claim 12, wherein the system controller is configured to receive an input signal generated from the external programming device, the signal being representative of the target pressure.
14. The apparatus of claim 12, wherein the microprocessor is programmed to calculate a desired resistance for the valve to achieve the target pressure.
15. The apparatus of claim 1, wherein the controller is contained within the implantable shunt system.
16. The apparatus of claim 2, further comprising an antenna in electrical communication with the system controller for communicating with the external programming device.
17. The apparatus of claim 16, wherein the antenna is configured to communicate with the external programming device via RF communication.
18. The apparatus of claim 16, wherein controller and antenna are disposed on an implant separate from the implantable shunt system.
19. The apparatus of claim 1, wherein the implantable shunt system further includes a second sensor element for measuring an additional physiological characteristic, the second sensor element being configured to transmit data representing the measured value of the additional physiological characteristic to the system controller.
20. The apparatus of claim 1, wherein the implantable shunt system further includes a battery for powering the system.
21. The apparatus of claim 2, wherein the external programming device is adapted to power the implantable shunt system.
22. A system for regulating fluid flow, comprising:
a housing having an inlet port and an outlet port, the housing configured to carry a fluid between the inlet port and the outlet port;
a valve coupled to the housing and in fluid communication with the inlet port and the outlet port, the valve having an electromechanical valve actuator adapted to open and close the valve;
an internal system controller in electrical communication with and adapted to operate the electromechanical valve actuator;
a sensor element in communication with the system controller and adapted to measure a physiological characteristic of a patient; and an external system controller adapted to communicate with the internal system controller and modify the operating parameters thereof.
a housing having an inlet port and an outlet port, the housing configured to carry a fluid between the inlet port and the outlet port;
a valve coupled to the housing and in fluid communication with the inlet port and the outlet port, the valve having an electromechanical valve actuator adapted to open and close the valve;
an internal system controller in electrical communication with and adapted to operate the electromechanical valve actuator;
a sensor element in communication with the system controller and adapted to measure a physiological characteristic of a patient; and an external system controller adapted to communicate with the internal system controller and modify the operating parameters thereof.
23. The system of claim 22, wherein the valve is a ball valve.
24. The system of claim 23, wherein the electromechanical valve actuator comprises a spring operatively associated with a pressure setting mechanism.
25. The system of claim 24, wherein the spring is a leaf spring.
26. The system of claim 24, wherein the spring is a helical spring.
27. The system of claim 22, wherein the sensor element is a pressure sensor for detecting pressure variations within a ventricular cavity.
28. The system of claim 22, further comprising an antenna in electrical communication with the internal system controller for communicating with the external system controller.
29. A method for regulating cerebrospinal fluid flow in a hydrocephalus patient, comprising:
comparing a target value to a value detected by a sensor associated with an implantable shunt system; and activating an electromechanical valve actuator of the implantable shunt system to adjust a resistance of a valve of the shunt system if the detected value is not equal to the target value.
comparing a target value to a value detected by a sensor associated with an implantable shunt system; and activating an electromechanical valve actuator of the implantable shunt system to adjust a resistance of a valve of the shunt system if the detected value is not equal to the target value.
30. The method of claim 29, further comprising detecting a value of a physiological characteristic of a ventricular cavity.
31. The method of claim 30, wherein detecting a value of a physiological characteristic comprises communicating data representative of the detected value of the physiological characteristic from the sensor element to a controller of the implantable shunt system.
32. The method of claim 31, further comprising generating an activation signal via the controller to activate the electromechanical valve actuator.
33. The method of claim 32, wherein generating an activation signal to activate the electromechanical valve actuator and adjust the resistance of the valve comprises determining a desired resistance to achieve the target value.
34. The method of claim 29, further comprising transmitting the target value to a controller of the implantable shunt system.
35, The method of claim 34, wherein the target value is transmitted via an external programming device.
36. The method of claim 35, further comprising inputting one or more target values to the external programming device.
37. The method of claim 35, further comprising energizing the implantable shunt system with the external programming device.
38. The method of claim 29, wherein activating the electromechanical valve actuator to adjust a resistance of the valve is repeated until the detected value is equal to the target value.
39. A use of the apparatus of any one of claims 1 to 21 for regulating cerebrospinal fluid flow in a hydrocephalus patient.
40. A use of the system of any one of claims 22 to 28 for regulating cerebrospinal fluid flow in a hydrocephalus patient.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US11/771,015 US8123714B2 (en) | 2007-06-29 | 2007-06-29 | Programmable shunt with electromechanical valve actuator |
| US11/771,015 | 2007-06-29 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2636529A1 true CA2636529A1 (en) | 2008-12-29 |
| CA2636529C CA2636529C (en) | 2015-11-24 |
Family
ID=39717816
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2636529A Active CA2636529C (en) | 2007-06-29 | 2008-06-27 | Programmable shunt with electromechanical valve actuator |
Country Status (7)
| Country | Link |
|---|---|
| US (2) | US8123714B2 (en) |
| EP (1) | EP2008683A1 (en) |
| JP (1) | JP5931313B2 (en) |
| CN (1) | CN101342402B (en) |
| AU (1) | AU2008202818B2 (en) |
| CA (1) | CA2636529C (en) |
| CO (1) | CO6000189A1 (en) |
Families Citing this family (40)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9694166B2 (en) * | 2002-03-26 | 2017-07-04 | Medtronics Ps Medical, Inc. | Method of draining cerebrospinal fluid |
| US8123714B2 (en) | 2007-06-29 | 2012-02-28 | Codman & Shurtleff, Inc. | Programmable shunt with electromechanical valve actuator |
| US8992456B1 (en) * | 2009-02-17 | 2015-03-31 | N. Garrett Powell | Implantable pump for removal of cerebrospinal fluid |
| US8679048B2 (en) * | 2009-03-31 | 2014-03-25 | Likvor Ab | Optimization of hydrocephalus shunt settings |
| US8109899B2 (en) | 2009-07-06 | 2012-02-07 | Likvor Ab | Fully automated method of measuring and regulating cerebrospinal fluid parameters using disposable tube-set |
| US20110071457A1 (en) * | 2009-09-15 | 2011-03-24 | Northwestern University | Method and apparatus for controlling intracranial pressure |
| US8241240B2 (en) * | 2009-11-09 | 2012-08-14 | Medtronic Xomed, Inc. | Adjustable valve setting with motor control |
| DE102009060533B4 (en) * | 2009-12-23 | 2019-07-11 | Christoph Miethke Gmbh & Co Kg | Implantable shunt system |
| US8231563B2 (en) * | 2009-12-30 | 2012-07-31 | Codman Neuro Sciences Sarl | Electrokinetic actuator to titrate fluid flow |
| AU2011227017B2 (en) * | 2010-03-19 | 2016-03-17 | University Of Washington | Drainage systems for excess body fluids |
| US20120302938A1 (en) * | 2010-03-19 | 2012-11-29 | University Of Washington | Drainage systems for excess body fluids and associated methods |
| US8322365B2 (en) | 2010-08-17 | 2012-12-04 | Codman & Shurtleff, Inc. | Implantable adjustable valve |
| US9149615B2 (en) | 2010-08-17 | 2015-10-06 | DePuy Synthes Products, Inc. | Method and tools for implanted device |
| DE102010051743B4 (en) | 2010-11-19 | 2022-09-01 | C. Miethke Gmbh & Co. Kg | Programmable hydrocephalus valve |
| US8298168B2 (en) | 2011-01-27 | 2012-10-30 | Medtronic Xomed, Inc. | Adjustment for hydrocephalus shunt valve |
| WO2012125449A1 (en) * | 2011-03-11 | 2012-09-20 | Seaver Chad | Systems and methods of controlling flow of bodily fluids |
| US20130201316A1 (en) | 2012-01-09 | 2013-08-08 | May Patents Ltd. | System and method for server based control |
| US20130226066A1 (en) * | 2012-02-23 | 2013-08-29 | Jung-Tung Liu | Apparatus for monitoring cerebrospinal fluid drainage |
| ES2881330T3 (en) | 2012-06-21 | 2021-11-29 | Medtronic Xomed Inc | Rotors and magnets with increased resistance to inadvertent configuration changes |
| CN103504025A (en) * | 2012-06-25 | 2014-01-15 | 浙江康恩贝健康产品有限公司 | Wet preparation process of infant formula milk powder |
| WO2014092866A1 (en) * | 2012-12-10 | 2014-06-19 | Alcon Research, Ltd. | Suprachoriodal drainage tube in a flow control system |
| US9126009B2 (en) * | 2013-03-12 | 2015-09-08 | DePuy Synthes Products, Inc. | System and method for determining position and pressure of an implantable shunt |
| US9649481B2 (en) | 2013-03-14 | 2017-05-16 | Siddharth Sadanand | Shunt flow monitor |
| US9126010B2 (en) | 2013-03-14 | 2015-09-08 | Medtronic Xomed, Inc. | Device and method for finding the center and reading the setting of an implantable medical device |
| JP6461906B2 (en) * | 2013-03-15 | 2019-01-30 | ハキム，カーロス・エー | Externally programmable valve assembly |
| FR3010636B1 (en) | 2013-09-16 | 2015-10-02 | Sophysa Sa | ADJUSTABLE DRAINAGE VALVE |
| US9656006B2 (en) * | 2013-10-18 | 2017-05-23 | InfinivationBiomedical, LLC | Wearable external ventricular drain system |
| US10413710B2 (en) | 2014-01-16 | 2019-09-17 | University Of Washington | Pressure reference assemblies for body fluid drainage systems and associated methods |
| KR102527465B1 (en) * | 2016-08-12 | 2023-05-03 | 카를로스 에이. 하킴 | Externally Programmable Magnetic Valve Assemblies and Controllers |
| CN107281562B (en) * | 2017-06-12 | 2023-07-21 | 郑春玲 | Adjusting device in cerebrospinal fluid drainage system and cerebrospinal fluid drainage system |
| CN108331793B (en) * | 2018-02-07 | 2020-06-26 | 安徽工程大学 | Hydraulic pressure reposition of redundant personnel system of circuit control pressure proportion |
| CN108331794B (en) * | 2018-02-09 | 2020-06-26 | 安徽工程大学 | Hydraulic pressure reposition of redundant personnel system of arbitrary distribution pressure proportion |
| CN113194824A (en) * | 2018-10-26 | 2021-07-30 | 卡洛斯.A.哈金 | Self-adjusting hydrocephalus valve |
| US11103683B1 (en) * | 2020-02-10 | 2021-08-31 | Frederick H. Sklar | Implantable intracranial pulse pressure modulator and system and method for use of same |
| US20220032018A1 (en) * | 2020-07-31 | 2022-02-03 | Medtronic Ps Medical, Inc. | System And Method For Valve Control |
| US11701503B2 (en) * | 2020-07-31 | 2023-07-18 | Medtronic Ps Medical, Inc. | System and method for valve control |
| CN113323928B (en) * | 2021-05-24 | 2022-08-12 | 安徽工程大学 | Hydraulic pressure reposition of redundant personnel system of controllable and improvement pressure of proportion |
| WO2023009133A1 (en) * | 2021-07-30 | 2023-02-02 | Medtronic Ps Medical, Inc. | System for valve control |
| WO2023039541A1 (en) * | 2021-09-09 | 2023-03-16 | Wayne State University | Solid state shunt valve with active outflow regulator, ventricular catheters, and other embodiments |
| WO2023101506A1 (en) * | 2021-12-03 | 2023-06-08 | 서울대학교병원 | Brain water monitoring method and apparatus based on near-infrared spectroscopy |
Family Cites Families (44)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3886948A (en) * | 1972-08-14 | 1975-06-03 | Hakim Co Ltd | Ventricular shunt having a variable pressure valve |
| US4332255A (en) | 1979-01-10 | 1982-06-01 | Hakim Company Limited | Shunt valve |
| US4387715A (en) | 1980-09-23 | 1983-06-14 | Hakim Company Limited | Shunt valve |
| FR2502012A1 (en) | 1981-03-18 | 1982-09-24 | Sophysa Sa | VALVE FOR THE TREATMENT OF HYDROCEPHALIA |
| US4447224A (en) | 1982-09-20 | 1984-05-08 | Infusaid Corporation | Variable flow implantable infusion apparatus |
| US4551128A (en) | 1983-05-11 | 1985-11-05 | Salomon Hakim | Cerebrospinal fluid shunt valve |
| US4595390A (en) | 1983-07-21 | 1986-06-17 | Salomon Hakim | Magnetically-adjustable cerebrospinal fluid shunt valve |
| US4615691A (en) | 1983-12-08 | 1986-10-07 | Salomon Hakim | Surgically-implantable stepping motor |
| US4772257A (en) | 1983-12-08 | 1988-09-20 | Salomon Hakim | External programmer for magnetically-adjustable cerebrospinal fluid shunt valve |
| JPH0417708A (en) | 1990-05-07 | 1992-01-22 | Nissan Motor Co Ltd | Lubricating oil pressure adjusting device of internal combustion engine |
| FR2721520B1 (en) | 1994-06-24 | 1996-08-30 | Sophysa Sa | Subcutaneous valve and its external adjustment device. |
| JP3489643B2 (en) | 1995-08-31 | 2004-01-26 | エイ．ビラファナ マニュエル | Telemetry device for information on operating characteristics of implanted prosthetic heart valves |
| US5704352A (en) | 1995-11-22 | 1998-01-06 | Tremblay; Gerald F. | Implantable passive bio-sensor |
| US5637083A (en) | 1996-01-19 | 1997-06-10 | Pudenz-Schulte Medical Research Corporation | Implantable adjustable fluid flow control valve |
| US5980480A (en) * | 1996-07-11 | 1999-11-09 | Cs Fluids, Inc. | Method and apparatus for treating adult-onset dementia of the alzheimer's type |
| US5928182A (en) | 1997-07-02 | 1999-07-27 | Johnson & Johnson Professional, Inc. | Pediatric programmable hydrocephalus valve |
| FR2772278B1 (en) * | 1997-12-17 | 2000-09-22 | Nmt Neurosciences Implants | DEVICE FOR EXTERNAL DRAINAGE OF BIOLOGICAL FLUID |
| US6638234B2 (en) | 1998-03-03 | 2003-10-28 | Senorx, Inc. | Sentinel node location and biopsy |
| EP0982048A1 (en) | 1998-03-12 | 2000-03-01 | Leonhardt, Steffen, Dr.-Ing. | Implant for controlled drainage of cerebrospinal fluid |
| US6533733B1 (en) * | 1999-09-24 | 2003-03-18 | Ut-Battelle, Llc | Implantable device for in-vivo intracranial and cerebrospinal fluid pressure monitoring |
| CA2393221A1 (en) * | 1999-12-03 | 2001-06-07 | Neuron Therapeutics, Inc. | Method and apparatus for closed recirculation of synthetic cerebrospinal fluid |
| US20020026139A1 (en) | 2000-02-02 | 2002-02-28 | Bertrand William Jeff | Valve seat and valve |
| JP2002022048A (en) | 2000-07-06 | 2002-01-23 | Seiko Instruments Inc | Pressure variable valve device |
| US6585677B2 (en) * | 2000-08-30 | 2003-07-01 | John A. Cowan, Jr. | Shunt |
| FR2816513B1 (en) | 2000-11-13 | 2003-03-07 | Bernard Marion | SUBCUTANEOUS VALVE FOR THE TREATMENT OF HYDROCEPHALIA AND ITS ADJUSTMENT DEVICES |
| ES2228969T3 (en) * | 2000-12-11 | 2005-04-16 | CHRISTOPH MIETHKE GMBH & CO. KG | HYDROCEPHALIC VALVE. |
| US6702249B2 (en) | 2001-03-19 | 2004-03-09 | Seiko Instruments Inc. | Pressure-variable valve device and set-pressure adjusting device for the valve device |
| WO2003057015A2 (en) | 2002-01-04 | 2003-07-17 | Kuchta, John | Csf physiologic controller |
| US6953444B2 (en) * | 2002-01-24 | 2005-10-11 | Codman & Shurtleff, Inc. | Inherent anti-siphon device |
| CN1186102C (en) * | 2002-06-20 | 2005-01-26 | 杨际芝 | Monitoring and therapeutic apparatus for draining and displacing cerebrospinal fluid and pressurizing |
| US7390310B2 (en) | 2002-07-10 | 2008-06-24 | Codman & Shurtleff, Inc. | Shunt valve locking mechanism |
| US6902544B2 (en) | 2003-01-22 | 2005-06-07 | Codman & Shurtleff, Inc. | Troubleshooting accelerator system for implantable drug delivery pumps |
| JP2004321296A (en) * | 2003-04-22 | 2004-11-18 | Japan Lifeline Co Ltd | Apparatus and method for body liquid discharge controlling |
| US8353857B2 (en) | 2003-06-23 | 2013-01-15 | Codman & Shurtleff, Inc. | Implantable medical device having pressure sensors for diagnosing the performance of an implanted medical device |
| US20050055009A1 (en) * | 2003-09-05 | 2005-03-10 | Codman & Shurtleff, Inc. | Method and apparatus for managing normal pressure hydrocephalus |
| US7334582B2 (en) | 2003-10-31 | 2008-02-26 | Medtronic, Inc. | Electronic valve reader |
| US7599743B2 (en) | 2004-06-24 | 2009-10-06 | Ethicon Endo-Surgery, Inc. | Low frequency transcutaneous energy transfer to implanted medical device |
| JP4328680B2 (en) | 2004-07-01 | 2009-09-09 | 株式会社カネカメディックス | Subcutaneous implantable valve device |
| US20060020239A1 (en) | 2004-07-20 | 2006-01-26 | Geiger Mark A | Cerebral spinal fluid flow sensing device |
| WO2006091581A1 (en) * | 2005-02-22 | 2006-08-31 | Richard Saunders | Controllable shunt |
| CN1895694A (en) * | 2005-04-05 | 2007-01-17 | 科德曼及舒特莱夫公司 | Subarachnoid epidural shunt |
| US7334594B2 (en) * | 2005-06-29 | 2008-02-26 | Codman & Shurtleff, Inc. | Apparatus and method for adjusting a locking mechanism of a shunt valve |
| JP4742723B2 (en) | 2005-07-27 | 2011-08-10 | 日本精工株式会社 | Toroidal continuously variable transmission and continuously variable transmission |
| US8123714B2 (en) | 2007-06-29 | 2012-02-28 | Codman & Shurtleff, Inc. | Programmable shunt with electromechanical valve actuator |
-
2007
- 2007-06-29 US US11/771,015 patent/US8123714B2/en active Active
-
2008
- 2008-06-25 AU AU2008202818A patent/AU2008202818B2/en active Active
- 2008-06-27 JP JP2008168241A patent/JP5931313B2/en active Active
- 2008-06-27 CN CN2008102103327A patent/CN101342402B/en active Active
- 2008-06-27 CA CA2636529A patent/CA2636529C/en active Active
- 2008-06-30 EP EP08252236A patent/EP2008683A1/en not_active Withdrawn
- 2008-07-01 CO CO08067110A patent/CO6000189A1/en active IP Right Grant
-
2011
- 2011-10-28 US US13/284,272 patent/US9925360B2/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| US8123714B2 (en) | 2012-02-28 |
| EP2008683A1 (en) | 2008-12-31 |
| US20090005720A1 (en) | 2009-01-01 |
| CN101342402A (en) | 2009-01-14 |
| AU2008202818A1 (en) | 2009-01-15 |
| JP5931313B2 (en) | 2016-06-08 |
| CA2636529C (en) | 2015-11-24 |
| CN101342402B (en) | 2013-03-27 |
| CO6000189A1 (en) | 2009-01-30 |
| JP2009028526A (en) | 2009-02-12 |
| US20120046596A1 (en) | 2012-02-23 |
| US9925360B2 (en) | 2018-03-27 |
| AU2008202818B2 (en) | 2013-10-24 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CA2636529A1 (en) | Programmable shunt with electromechanical valve actuator | |
| JP5052745B2 (en) | Apparatus for regulating cerebrospinal fluid flow in hydrocephalus patients | |
| US7771381B2 (en) | Shunt valve locking mechanism | |
| US6383160B1 (en) | Variable anti-siphon valve apparatus and method | |
| EP1781366B1 (en) | Implantable cerebral spinal fluid drainage device | |
| US7025739B2 (en) | System and method for treating elevated intracranial pressure | |
| EP1491137B1 (en) | An implantable medical device having pressure sensors control | |
| EP1738792B1 (en) | Apparatus and method for adjusting a locking mechanism of a shunt valve | |
| US7189221B2 (en) | Methods for the treatment of a normal pressure hydrocephalus | |
| US20120323161A1 (en) | Electrokinetic Actuator to Titrate Fluid Flow | |
| WO2006014764A9 (en) | Implantable cerebral spinal fluid drainage device and method of draining cerebral spinal fluid | |
| US8211051B2 (en) | Electroactive polymer actuated cerebrospinal fluid shunt | |
| AU2013242833B2 (en) | Programmable shunt with electromechanical valve actuator | |
| WO2006091581A1 (en) | Controllable shunt |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request |
Effective date: 20130626 |