WO2025118270A1 - Système et procédé d'évaluation de vanne - Google Patents
Système et procédé d'évaluation de vanne Download PDFInfo
- Publication number
- WO2025118270A1 WO2025118270A1 PCT/CN2023/137447 CN2023137447W WO2025118270A1 WO 2025118270 A1 WO2025118270 A1 WO 2025118270A1 CN 2023137447 W CN2023137447 W CN 2023137447W WO 2025118270 A1 WO2025118270 A1 WO 2025118270A1
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- WO
- WIPO (PCT)
- Prior art keywords
- sensor
- valve assembly
- assembly
- valve
- subject
- 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.)
- Pending
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Classifications
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- 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
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/03—Measuring fluid pressure within the body other than blood pressure, e.g. cerebral pressure ; Measuring pressure in body tissues or organs
- A61B5/032—Spinal fluid pressure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/48—Other medical applications
- A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
- A61B5/6868—Brain
Definitions
- the subject disclosure relates to a valve assembly, and particularly to a valve assembly and methods relating thereto.
- a system may be used to treat a selected or various conditions of a subject.
- the subject for example a human subject, may be treated for hydrocephalous.
- Hydrocephalous may be caused due to an overproduction, under absorption, or blockage of outflow of cerebral spinal fluid (CSF) from a ventricle in a brain of a subject.
- CSF cerebral spinal fluid
- It may be desirable to treat the hydrocephalous with a shunt system to allow for drainage of the CSF from the ventricle to a different area of the subject to treat or alleviate the undesired conditions of the subject.
- a shunt system may be implanted into a subject as a therapy for hydrocephalous.
- the shunt system may include an inlet and an outlet to shunt or direct fluid away from a first area to a second area of the subject.
- an inlet catheter may be implanted into a ventricle of the subject and an outlet catheter may be positioned in a distal area, such as within an abdomen (e.g., lined by a peritoneum) and/or vasculature of the subject.
- the shunt system may further include a flow control system. The shunt may be fixed to the peritoneum or the vasculature.
- the flow control system may include a valve assembly.
- the valve assembly may have an opening or cracking pressure that will allow fluid to flow through the valve system at a selected pressure.
- the valve system may include a valve seat and selected mechanism to select or control a cracking pressure of the valve body.
- One or more sensors may be provided relative to the valve.
- a first sensor may be provided in the shunt upstream of the valve and one or more may be provided in the shunt downstream of the valve.
- One or more sensors may be provided in a reservoir of the valve.
- the valve assembly may include a valve cover or housing that includes one or more sensors upstream or downstream of the valve.
- the sensors may be used to determine pressure or flow at the sensor.
- the sensor may then emit a signal based on the sensed pressure or flow.
- the signal may be transmitted from the shunt assembly for further analysis.
- the analysis may be provided or used for various purposes, such as diagnostics of the valve, operational efficiency of the valve, etc.
- Fig. 1 is a schematic environmental view of a shunt and system positioned in a subject, according to various embodiments
- Fig. 2 is a perspective view of a valve assembly, according to various embodiments
- Fig. 3 is a top plan view of a modular valve assembly, according to various embodiments.
- Fig. 4 is a schematic view of a sensor reading and collection system, according to various embodiments.
- Fig. 5 is a schematic view of a sensor reading and collection system, according to various embodiments.
- Fig. 6 is a schematic view of a sensor reading and collection system, according to various embodiments.
- Fig. 7A and Fig. 7B illustrate a flowchart of a process for analyzing sensor data, according to various embodiments.
- Fig. 1 includes an illustration of a fluid directing or shunt system 10.
- the shunt system 10 may be positioned or implanted within a subject 14, such as a human subject.
- the shunt system 10 may shunt or direct a fluid to flow along the shunt system 10, such as in the direction of arrow 18.
- the shunt system 10 may include a catheter 20, which may be an inlet catheter, positioned within a ventricle 24 in the subject 14.
- the inlet catheter 20 may be positioned (e.g., implanted) in the ventricle 24 to allow the fluid to be drained away from the ventricle 24.
- the shunt system 10 may further include a selected flow control system 28 and an outlet catheter 32.
- the selected flow control system 28 may be positioned (e.g., implanted) in the subject 14 in an appropriate position.
- the selected flow control system 28 may be implanted generally near a skull 36 of the subject 14, a torso or abdomen 38 of the subject 14, or any other appropriate location. It is understood that the inlet catheter 20 may be connected to the selected flow control system 28 as is the outlet catheter 32.
- the outlet catheter 32 may extend from the selected flow control system 28 to a selected location, such as a peritoneal cavity in the abdomen 38 of the subject 14.
- the inlet catheter 20, the selected flow control system 28, and the outlet catheter 32 may generally be understood to be a shunt system 10.
- the shunt system 10 may be useful as a hydrocephalus shunt system.
- the shunt system 10 may be entirely implanted in the subject 14.
- the fluid may flow in the direction of arrow 18 into and through the inlet catheter 20, through the selected flow control system 28, and through the outlet catheter 32.
- the fluid may then drain or pass through the outlet catheter 32 into the abdomen or peritoneal cavity, or any other appropriate location, of the subject 14.
- the fluid may be cerebral spinal fluid (CSF) that is produced in the ventricle 24.
- CSF cerebral spinal fluid
- the shunt system 10 may be implanted to assist in treating hydrocephalus in the subject 14. It is understood that the outlet catheter 32 may be positioned within the subject 14 in an appropriate location to allow for draining of the CSF from the ventricle 24 to an appropriate location, such as one with high blood flow. Accordingly, as illustrated in Fig. 3, the inlet catheter 20, the selected flow control system 28, and the outlet catheter 32 may be implanted or positioned in the subject 14 as a CSF shunt system.
- the shunt assembly 10 may include the flow control assembly 28.
- the flow control assembly may include a valve assembly.
- the vale assembly may be provided in various embodiments, such as one or more valve assemblies 50a, 50b, according to various embodiments. With reference to Figs. 2 and 3, the one or more valve assemblies 50a, 50b, according to various embodiments are illustrated.
- the valve assembly may be incorporated into the flow control assembly 28, including with other portions therein, such as inlet and outlet coverings, filters, and the like, or may be included as the only portion of the flow control assembly 28. Accordingly, the valve assembly may be understood to be the flow control assembly or system 28, as discussed above, or at least a portion thereof.
- valve assembly may be provided as the flow control assembly 28 for controlling a flow through the shunt assembly 10 according to various embodiments.
- the valve assembly may include the portions discussed further herein, and may be operated, as also discussed herein, in various embodiments.
- valve assembly 50a may generally include various portions, such as a first valve body or enclosure 54, that may also be referred to as a cap.
- the valve body 54 may include the cap or other removable portion relative to additional portions, such as a base or lower enclosure or body portion 58.
- the inlet catheter 20 may connect with an inlet connector or port 64 of the valve assembly 50.
- the connector 64 may be any appropriate port or assembly configuration.
- the connector 64 may include a barb portion 66 to allow the inlet catheter 20 to be pushed over and engage the connector 64 and be at least liquid sealed to the connector 64.
- the connector 64 may be formed a substantially rigid material to allow for a flexible material of the inlet catheter 20 to be slid over the barb portion 66.
- a liquid sealed connection may be made with the valve assembly 50a.
- the valve assembly 50a may further include an outlet connector 70.
- the outlet connector 70 may also include a barb portion 72.
- the barb portion 72 may operate in a similar manner with the outlet catheter 32.
- the outlet catheter 32 may be formed of a compliant or flexible material that it slid over the connector 70 to engage, including forming a liquid seal, with the connector 70.
- the inlet catheter 20 and the outlet catheter 32 may be liquid sealed and connected with the valve assembly 50a.
- the catheters 24, 32 may be interconnected with the valve assembly 50a at any appropriate time, such as after positioning of the various catheters, during construction of the valve assembly 50a, or any other appropriate time.
- the valve assembly 50a further includes a valve mechanism 76.
- the valve mechanism may be modular or integrated with the cover 54 or base 58 of the valve assembly 50a.
- the valve mechanism 76 may be any appropriate valve mechanism such as one or more or combinations of those disclosed in US Patent No. 11,701,503 issued July 18, 2023; US Patent No. 10,369,335 issued August 6, 2019; all of which are incorporated herein by reference. Further it is understood by one skilled in the art that proper or appropriate combinations thereof may also be usable as the valve mechanism 76 in the valve assembly 50a.
- the valve mechanism 76 may be associated with a cartridge or holder portion 78 that may interconnect with the connector 70.
- the connector 70 may be formed as a separate member, according to various embodiments, and be interconnected with the valve mechanism 76 in any appropriate manner. Further, according to various embodiments, a fluid tight connection can be made between the connector 70 and the connector 78 or the valve mechanism 76.
- the cover 54 may cover the valve mechanism 76 and the various connectors, such as the cartridge connector 78. Further the cover 54 may be formed or connected to the base 58.
- a reservoir 82 Upstream of the valve mechanism 76, and covered by the housing or cover 54, may be a reservoir 82.
- the reservoir 82 may be provided to allow or provide a selected pressure or volume within the valve assembly 50a.
- the reservoir 82 may collect fluid from the inlet side such as at the inlet connection 64.
- the reservoir 82 may be formed between the cap or cover 54 and the base 58.
- the valve assembly 50a may include various portions to allow for a transfer or shunting of fluid from the ventricle 24 to the abdomen or other portion of the subject 14.
- the valve assembly 50a including the valve mechanism 76, may control or selectively control a flow of the fluid.
- a flow rate may be selected via an adjustment of the valve mechanism 76.
- the flow rate may be any appropriate flow rate and may be subject 14 specific. Nevertheless, maintaining the selected flow rate and/or confirming a lack of an occlusion of the shunt assembly 10 may be selected, as discussed herein.
- Various sensors such as pressure sensors may provide signals that may be analyzed, as discussed herein, to assist in determining at least a probability of an occlusion.
- the valve assembly 50a thus may also be monitored for various purposes. For example, monitoring or sensing conditions of various portions of the valve assembly 50a may allow for determining whether an alteration of the valve assembly should be made, confirmation of operation of the valve assembly (or portions thereof, such as the valve mechanism 76) , and other information may be determined.
- a first sensor assembly 100 may be provided at an inlet.
- the sensor assembly 100 may be any appropriate sensor assembly may be incorporated into the valve assembly 50a.
- the sensor assembly 100 may be integrated and positioned in an inlet region, such as in the connector 64 of the valve assembly 50a.
- a second sensor assembly 104 may be integrated into the valve assembly 50a.
- the second sensor assembly 104 may be similar to the first sensor assembly 100 save that it is positioned near the outlet, such as in the outlet connector 70 of the valve assembly 50a. Accordingly, a first or inlet sensor assembly 100 and a second or outlet sensor assembly 104 may be provided in the valve assembly 50a.
- Alternative or additional sensor assemblies may include a sensor assembly 110 that is included in the reservoir or able to sense a condition of the reservoir 82.
- the valve assembly 50a may include any appropriate number of sensor assembly and the inlet sensor assembly 100, the outlet sensor assembly 104, and the reservoir sensor assembly 100 are merely exemplary.
- the sensor assemblies 100, 104 may be or include a sensor of a selected type or configuration, as discussed herein.
- the sensors assemblies may include a sensor portion, a transmission portion, a receiving portion, and/or a power source.
- the receiver portion may receive a signal to activate sensing and to generate portion for the sensor.
- the transmitter portion may transmit a signal from the sensor.
- the sensor assembly may further include a memory or a processor.
- Each of the portions of the sensor assembly may be module, as discussed herein.
- Each of the modules may sense a physical parameter and/or execute selected instructions.
- the parameter measured may be an intracranial pressure (ICP) of the subject 14.
- An ICP may be selected for the subject 14 and one or more of the sensors may sense the current or real time pressure and transmit a signal regarding the measurement.
- ICP intracranial pressure
- valve assembly 50b may include portions substantially similar to those of the valve assembly 50a. Similar numerals will be used to identify similar portions as those discussed above augmented with an apostrophe.
- the valve assembly 50b may include a case or cover 54’ and a base 58’.
- the valve assembly 50b may include a reservoir 82’ and an inlet connector 64’ and an outlet connector 70’.
- the valve assembly 50b may include a valve mechanism 76’ similar to that discussed above to assist in connecting or checking flow or controlling flow through the valve assembly 50b.
- the valve assembly 50b may include any of the portions discussed above regarding the valve assembly 50a and vice versa.
- the valve assembly 50 may be provided according to various embodiments, and the portions discussed and illustrated in the valve assemblies 50a, 50b are exemplary and may be mixed and matches.
- the valve assembly 50b may be connected with one or more sensor assemblies that may be connected to various portions of the valve assembly 50b.
- an inlet sensor assembly 120 may be connected to the inlet connector 64.
- the inlet connect sensor assembly may include a valve connection 124 that may connect directly or through a tube portion 126 with the inlet connecting 64.
- the inlet sensor assembly 120 may include a sensor housing 130 that may house a sensor portion or assembly 134.
- the sensor assembly 134 may be similar or identical to the inlet sensor assembly 100, discussed above.
- the sensor assembly 120 may include a catheter connector 136 to connect to the inlet catheter 20. Therefore the inlet sensor assembly 120 may be inline with the inlet 64’of the valve assembly 50b.
- An outlet sensor assembly 140 may be associated with the outlet portion of the sensor valve assembly 50b, such as with the outlet 70’.
- the sensor assembly 140 may have an outlet connector 144 that may connect directly with the outlet connector 70’ or through a tube portion 148 similar to the tube portion 126, discussed above.
- the outlet sensor assembly 140 therefore, may be associated with an outlet of the valve assembly 50b.
- the outlet sensor assembly 140 may include a sensor assembly 152 similar to the outlet sensor assembly 104 discussed above.
- the outlet sensor assembly 140 may further include an outlet catheter connector 156 that may connect with the outlet catheter 32. Therefore, the outlet sensor assembly 140 may be associated with the outlet 70’ of the valve assembly 50b.
- the valve assembly 50b may include any appropriate valve assembly, such as the valve assembly that includes no internal or integral sensors.
- the inlet sensor assembly 120 and/or the outlet sensor assembly 140 may be connected to the valve assembly 50b at our appropriate time.
- the inlet and outlet sensor assemblies 120, 140 may provide inlet and outlet sensor information similar to the inlet and outlet sensors 100, 104. Therefore, the valve assembly 50b need not be manufactured or include integral sensors but sensor information may be provided or sensed with the modular sensor assemblies 120, 140. Further the modular sensor assemblies 120, 140 may be provided to augment and/will replace a sensor if an integral sensor is provided, such as in the sensor assembly 50a discussed above.
- the sensor may be provided to sense information regarding the valve assembly and/or provide measurements regarding information relative to and/or of the valve assembly.
- the sensors such as the sensor 100, 104, 110, 134, and 152 may be a pressure sensor.
- the pressure sensor may be any appropriate pressure sensor that is able to sense a pressure within a respective volume.
- the pressure sensors may include pressure sensors sold by Injectsense, Inc. having a place of business in Minneapolis, MN, a pressure sensor sold by Micro having place of business at Fort Lauderdale, FL, or a pressure sensor sold by Christoph Miethke GMBH and Co., having a place of business at Germany.
- the pressure sensor may be provided to fit within the valve assembly 50a and/or provided adjacent to the valve assembly 50b, as discussed above.
- the sensors therefore, may generally be selected based upon size and power requirements to achieve placement relative to the respective valve assemblies 50a, 50b and have dimensions of less than 1 millimeter (mm) thick and about 1 mm to about 10 mm in other dimensions.
- valve assembly may be provided relative to the subject 14 during an appropriate procedure.
- the valve assembly 50 may be implanted in the subject, such as near a head or brain of the subject 14. Following the procedure, monitoring of operation of the shunt, including the valve assembly or control assembly 28 may be selected.
- the discussion herein may relate to or describe specifically the valve assembly 50a, but is understood that to the valve assemblies may be provided in any appropriate manner and the discussion with valve assembly 50a is merely exemplary.
- the valve assembly 50a may be implanted relative to the subject 14. The subject 14 may then be monitored following implantation of the valve assembly 50a as a part of the shunt assembly 10.
- the shunt assembly may have an optimal operational range that may include a selected flow rate through the valve assembly 50a. However, an occlusion of a portion of the shunt assembly 10 may occur which may lessen the flow through the shunt assembly 10, such as through the valve assembly 50a.
- the sensors may be operable to measure pressure at various portions of the valve assembly 50a (or relative thereto as illustrated with the connectable and modular sensors for the valve assembly 50b) .
- the sensors may sense pressure at the various regions or volumes of the valve assembly 50a, as discussed and illustrated above. Signals related to the sensed parameter (e.g., pressure) may then be transmitted for evaluation and further planning or adjustment of the valve assembly 50a.
- the signal may be a raw signal that is processed to determine a measured pressure.
- Measurements of parameters and/or sensor readings may be acquired or collected as a selected time.
- the subject or patient 14 may enter or be placed in a medical facility or setting 198.
- the subject 14 may be positioned on a patient support, such as the patient bed 200.
- a reader or sensing module 210 Associated with the patient bed 200 and/or configured or operable to be portable relative to the subject, such as with a user 204 (e.g., a physician) may be a reader or sensing module 210.
- the sensing module 210 may have appropriate components, such as a receiver or transceiver module 214 a memory and/or processor module 216, and a power source such as a battery 218 or a constant power source, such as wall power.
- the sensing module 210 may receive data from the sensors associated with the valve assembly 50a. The sensors may then transmit when activated by the sensor assembly 210, such as when a signal is transmitted by the transceiver 214. In initiation or activation signal 230 may be received at the sensors of the valve assembly 50a. The sensors may then transmit a sensor signal 234 to be received by the measuring or sensor assembly 210.
- the portable or sensor module 210 may be provided to be positioned relative to the subject 14 in an appropriate manner.
- the portable unit 210 may be associated with the bed 200 in a fixed or movable manner. Therefore, the sensor module 210 may be associated with the support 200 when an appropriate or selected subject, such as the subject 14, is positioned thereon.
- the sensor module 210 may also be provided in a support, such as a pillow or other support of the patient 14. Nevertheless, the sensor module 210 is generally positioned in an appropriate position relative to the subject 14 to allow for transfer of data from the subject valve assembly 50a.
- the activation signal 230 may power or cause the sensor to transmit a sensor signal 234.
- the activation signal may cause the sensor (s) to resonate to provide power to transmit the signal, cause the sensors to wake and send a signal, or other appropriate application.
- the sensor signal 234, however, may be received at the portable unit 210.
- the sensor signal 234 may include various information, such as a pressure signal based upon the sensed pressure by the at the sensor, a temperature, or other appropriate information.
- the transceiver 214 may then transmit a sensor unit signal 240 that includes the sensor information based upon the sensor signal 234.
- At the portable module 210 may be other sensors, such as a temperature sensor, pressure sensor, humidity sensor or other appropriate sensors and a sensor module 244.
- the sensor module 244 may be an ambient sensor module that measures parameters of the medical facility room 198. Therefore, the sensed pressure at the valve assembly 50a may be compared to the ambient pressure to assist in determining an actual or absolute pressure. Accordingly, the sensor module 210 may also transmit ambient measurements measured at the sensor module 244 separate from the sensors associated with the valve assembly 50a within the subject 14 with the signal 240.
- a data collection or transmission system 250 may also be portable, such as movable with the user 204.
- the portable or handheld unit 250 may received the signal 240.
- the handheld unit 250 may also include a processor 254, a memory module 258, and a power unit or power source 262.
- the portable unit 250 may also include a view screen 266 and/or various inputs such as a touch screen or other input buttons or keys 268.
- the portable unit 250 may be moved by the user to collect the data from the portable units or sensor module 210. For example, the user 204 may move to a plurality of subject 14 and collect sensor data from a plurality of valve assemblies 50.
- the data collected by the portable unit 250 may thereafter be communicated to a server or cloud system 280.
- the cloud system 280 may include one or more processor modules 284 and one or more memory modules 288. Therefore, the cloud system 280 may receive data from the portable unit 250 that has been collected from the sensor module 210 that includes ambient measurements and measurements from the patient 14, such as from the sensors associated with the valve assembly 50a. Therefore, data may be collected by the user 204 at an appropriate interval, such as based upon the treatment of the subject 14, prescription or ordered by a physician, or other appropriate intervals.
- the data regarding the sensed pressures at the valve assembly 50a may be collected for various purposes, as discussed further herein.
- the subject 14 may again be positioned within a medical facility 198.
- the patient 14 may be supported by a selective support such as a supported 200.
- Physician dorm planted within the subject may be the valve assembly 50a.
- the valve assembly 50a may again include the sensors, as discussed above. The sensors may sense features relative to the valve assembly. 50a, is also discussed above.
- a patient wearable and/or patient implanted transceiver assembling 300 may be provided.
- the transceiver assembly 300 may include all of the portions of the sensor module 210 discussed above.
- the patient wearable receiver module may include a processor module, memory module, power module (e.g. battery) , and sensor module. Therefore, the patient wearable sensor module 200 may again transmit a signal that activates the sensors of the valve assembly 50a. The signal may power the sensors, provide a wake signal to the sensors, or other appropriate signal.
- the sensors at the valve assembly 50a may transmit a sensor signal 310 that may be received at the patient wearable sensor module 300.
- the sensor signal 310 may be similar to the sensor signal 234 discussed above.
- the patient wearable sensor module 300 may be provided with the subject 14 for more constant or more set intervals without requiring the subject 14 to be positioned at the patient support 200.
- the patient wearable sensor module 300 may be selectively worn or selectively operated, such as with a program, to collect the sensor signals from the valve assembly at a selected time interval. As the patient wearable sensor module 300 is with the subject 14 always or at a selected time, collection of the sensor signal or sensor data may happen at smaller or more regular intervals than the portable module 210 may collected the sensor data. Further, the patient wearable sensor module 300 may allow the subject 14 to be mobile while still allowing for collection of data regarding the sensor assembly, such as the sensors in the valve assembly 50a.
- the user 204 may still include or have a portable module 250 to receive a sensor module signal 314.
- the sensor module signal 314 may be similar to the sensor module signal 240, discussed above. Therefore, the sensor signal or measurement information from the valve assembly 50a may be transmitted to the unit 250.
- the unit 250 may then transmit the measurements with a transmission signal 318 to the cloud system 280, discussed above.
- the user 204 may collect information or measurements at or from the valve assembly 50a.
- the measurements, such as the pressure measurements may therefore be collected and analyzed, such as at the cloud system 280, regarding the subject 14.
- the user 204 may collect or have a signal transmitted from the subject wearable sensor module 300.
- the information regarding the measurements of the sensors at the valve assembly 50a may therefore be collected in an appropriate time.
- the user 200 may move the portable module 250 relative to the patient wearable sensor module 300 to collect the sensor measurements
- the patient wearable module 300 may collect sensor measurements at an appropriate interval and save them, such as on the memory module as discussed above.
- the patient wearable module 300 may allow for collection at a selected interval that may be greater than the interval which the user 204 collects the data with the portable module 250.
- valve assembly 50a may be similar to that discussed above and/or include alternative or additional features or portions, as discussed herein.
- the valve assembly 50a may include a memory and/or processor module 360.
- the valve assembly 50a may include the adjustable valve mechanism or any appropriate valve mechanism, such as that disclosed in US Patent No. 11,701,503 issued July 18, 2023, incorporated herein by reference.
- the valve mechanism may be adjustable within the valve assembly 50a.
- the sensor assemblies may transmit a signal directly and/or through a transceiver, such as one associated with the processor/memory module 360. Therefore, the valve assembly 50a including the processor/memory module 360 may collect sensor measurements at selected intervals and/or over a selected period of time. The sensor measurements may be stored for transmission in the valve assembly 50a, such as with the memory/processor, module 360.
- the valve assembly 50a may transmit a sensor signal 364 that may be a collection or data set regarding a plurality of sensor measurements taken over a selected period of time and at selected intervals. No additional mechanism may be required to obtain the sensor measurements.
- the portable assembly 250 may send an activation signal 368 that activates the transmission of the sensor signal 364.
- the valve assembly 50a may be compact and not require additional portions to ensure a collection of an appropriate number of datum regarding the sensor measurements.
- the portable system 250 may send the transmission signal or activation signal 368 and receive the sensor log or sensor data 364.
- the portable module 250 may then transmit with a transmission signal 372 to the cloud 280, as discussed above.
- the cloud assembly 280 may then evaluate the data, as discussed above and further herein.
- the valve assembly 50a may include the sensor assemblies as discussed above. It is understood that the valve assembly according to various embodiments may include the valve assembly 50b and may include positioning of a subject according to the various transmission schemes, as discussed above and illustrated in Figs. 4, 5, and 6. Further each of the various transmission schemes include various features or portions that allow for the acquisition of the sensor data from the valve assembly 50 that is implanted in the subject 14 and the collection and transmission of the data to a cloud of system 280. It is understood that the various exemplary embodiments discussed above may be integrated together and/or include various portions or not include various portions as discussed above. Therefore, the exemplary embodiments describe various features and modules, such as the patient wearable module 300 that may be included or not included with any of the appropriate embodiments, as is understood by one skilled in the art.
- the collection of the data from the sensors may allow for an analysis of an operation of the valve assembly 50 that is inserted in the subject 14.
- the data may be transferred to the cloud assembly or cloud system 280 for analysis by executing instructions that are saved in a memory system, such as the memory system discussed above.
- the processor module may execute the instructions as discussed further herein.
- the pressure signals may relate to an intracranial pressure at various portions or positions relative to the valve assembly 50 and may allow for analysis of a selected or flow through the valve assembly 50.
- the various systems for providing sensors relative to the subject 14 may allow for the collection and transmission of transmission of a sensor signal that relates to measurements of parameters may by the sensor, as discussed above.
- the sensor measurements may be transmitted to a selected system, such as a cloud system or server assembling or any other appropriate processing assembly for executing instructions based upon the sensor measurements.
- a process 400 is illustrated in Fig. 7A and Fig. 7B, may be used to analyze and provide various outputs based upon the sensor measurements.
- the process 400 may include determining a probability of an occlusion, illustrating or providing pressure measurements in real time and/or overtime, providing probability of location of an occlusion, and providing probability of an outcome based upon a determined probability of an occlusion and its location. It is understood that any one or more of the various outputs, as discussed herein, may be output from the system 400 and each is merely exemplary. Therefore, the system 400 may provide a single output and/or plurality of outputs, as discussed herein.
- the system 400 may begin at start block 410.
- Starting the system may include initializing the system such as initializing the sensors after implantation, after powering the sensors, or the like.
- sensor data to be acquired in block 414 may include data from a first sensor, such as the input sensor, a second sensor, such as the output sensor, a third sensor such as the reservoir sensor, or any other appropriate sensor.
- the shunt system 10 may include a one or a plurality of sensors and therefore the acquisition of the sensor data may include acquisition from any one or more of the sensors.
- ambient data may include ambient pressure, ambient temperature, or the like.
- Ambient data may include sensor measurements that are exterior to the subject 14.
- various portions of the system such as the data collection module 210 (e.g., sensors in the sensor module 244) may collect sensor measurements regarding an environment exterior to the subject 14.
- the environment exterior to the subject 14 may be the ambient environment, such as within the medical room 198.
- Ambient measurements may assist in determining or calculating a true pressure, assisting in calibrating the sensor measurements of the shunt system 10, or the like.
- the acquired data may be transferred to a selected processing module, such as a cloud system, an offsite server system, or the like in block 422.
- the transferring of the sensor data may include the data from both the block 414 and block 418.
- any appropriate sensor data may be transferred to the processor system for executing instructions and analyzing the data based thereon.
- the data collected from the various sensors, such as block 414 and 418, may be used for various analyses. Any appropriate analysis may occur in any appropriate manner, sequentially or in parallel.
- a flow analysis may occur in block 430.
- the flow analysis in block 430 may include a flow sub-process and include various calculations or sub-processes in the flow analysis 430.
- the flow analysis may be used to determine or provide various outputs as discussed herein.
- the flow analysis may be a sub-process of the process 400 that is used to analyze and provide outputs related to the sensor measurements of the shunt system 10.
- the acquired sensor data from the sensors may be calibrated to or with a calibration curve.
- the calibration curve may be unique for each sensor and may be per sensor. That is, the sensor in the valve assembly, such as the sensor 100 that is the input sensor in the valve assembly 50a, may have a specific calibration curve, such as a calibration curve generated during manufacturing and testing of the sensor 100.
- the calibration curve may be used to calibrate or pre-process the sensor data prior to further analysis.
- the sensor signal from the sensor may be a raw signal.
- the pre-processing to the calibration curve may relate to transforming the raw signal to a related measurement of the parameter (e.g., pressure) .
- the signal from the sensor such as the sensor 100
- the signal from the sensor may be a raw data signal based upon various conditions such as a pressure change that provides an electrical signal, for example a signal change.
- the signal change may, however, need to be pre-processed with the calibration curve to determine a related pressure measurement.
- the calibration of block 434 allows for the output of an actual measurement of a selected parameter (e.g. pressure, temperature, etc. ) in block 438. Therefore, the acquired sensor data may be calibrated in block 434 of the flow analysis sub-process 430.
- output of actual measurements based on the calibration may be made in block 438.
- the output of the actual measurements may be based upon the calibration information of the sensor. Therefore, the sensor measurement may be compared or pre-processed to output an actual measurement.
- a determination of flow differentials may be made in block 442 based upon actual pressure measurements.
- the input sensor 100 may be positioned near an input of the valve assembly 50a.
- the output sensor 104 may be positioned near an output of the valve assembly 58.
- a differential that is determined to block 442 may relate to a flow within or through the valve assembly 50a. It is understood that any differential may be determined for any of the appropriate valve assemblies, including those discussed above such as the valve assembly 50b. Nevertheless, the differential of the valve pressure is based upon the actual measurements may be made in block 442.
- a determination of a flow may be made in block 446.
- the determination of the flow may be an actual flow rate, such as in millimeters per hour, or may be a comparison flow rate.
- an initial data collection period may be made with the sensor assemblies of the valve assembly after an initial implantation.
- a comparison to later pressure differentials may be used to determine whether a flow has increased or decreased.
- Such pressure differential measurements may be used to determine whether flow is occurring, has increased, or has decreased through the valve assembly, such as the valve assembly 50a.
- the flow determination may be output in block 448.
- the flow determination may be output from the server system 280 to any appropriate system, such as a user system including the portable system 250.
- the output may be used for various purposes, as discussed herein.
- the signal from the pressure sensors may be used in the analysis 400, including the flow analysis sub-process 430, to measure or calculate a flow rate through the valve system 50, according to various embodiments.
- the flow rate or flow occurrence may be used for various analysis and subject treatment as discussed further herein.
- occlusion analysis 460 may be an optional analysis based upon the sensor measurements as discussed above. Therefore, the occlusion analysis is not required in the process 400 and the process 400 may simply be the flow analysis in the subprocess 430. Nevertheless, if selected, the occlusion subprocess 460 may be performed to assist in determining and/or locating an occlusion relative to the valve assembly 50.
- the occlusion analysis 460 may include recalling a pressure history in block 464.
- the pressure history may be of a specific subject, such as the current subject.
- the pressure history may be recalled based upon acquired sensor data in block 414 that is saved, as discussed above. Further, a pressure history may be based upon trends in a plurality of subjects. The trends may be quantified or qualified based upon characteristics similar to the current subject and/or simply made as a grouped data collection. Regardless, the pressure history may be recalled in block 464, such as for example of the subject for which sensor data is collected in block 414.
- Recalling of the actual measurements that are collected in real time may be made in block 468.
- the recall of the actual real time measurements may be the output of the actual measurements from block 438, discussed above. Therefore, the actual real time measurements may be based upon comparison with ambient measurements and/or calibration of the various sensors.
- a comparison of the actual real time pressures measurements to the recalled pressures may then be made in block 472.
- the comparison may be a comparison over a selected period of time (e.g., a number of minutes, a number of hours, a number of days, or the like) .
- the comparison may allow for comparison of a selected period of time of the acquired data and related actual measurements from a selected current real time (e.g., past 12 hours) to a selected pressure history, such as a collection of sensor data from a number of hours or number of days prior to a current or real time selected.
- the comparison of the actual real time measurements to the recalled pressure history or trends may be operable to allow for a determination of a probability of occlusion in block 476.
- the determination of a probability of an occlusion may be based upon the comparison from block 472. For example, if a pressure at any of the sensors is increased relative to a recalled pressure history, a determination that an occlusion may exist may be determined. Accordingly, a value of increase, percent of increase, or the like may be used to determine the probability of occlusion of block 476.
- a decision block may then follow the determination of a probability in block 476, including whether an occlusion exists in block 480. If an inclusion is determined not to exist based upon the determination of block in 476 a NO path 484 may be followed to an output (e.g., display UI) portion of the process 400, as discussed further herein. However, if an inclusion is determined to exist in block 476 a YES path 488 may be followed. Accordingly, a determination of a probability of an inclusion of block 476 may allow for a split in the process 400, including a split in the process of the occlusion analysis subprocess 460.
- a selected probability e.g. greater than a selected percentage, such as 20%, 30%, 40%, or any appropriate percentage
- a determination of a probable location may be made in block 494.
- the valve assembly may include at least to the inlet 64 and the outlet 70. Further, the valve assembly, according to various embodiments, include a valve mechanism within the valve body of the valve assembly 50. According to various embodiments, therefore, a determination of the location of the occlusion may be at the input or a proximal portion of the valve assembly, the output or a distal portion of the valve assembly, or within the valve assembly, such as intermediate the input and the output and/or at the valve mechanism.
- a determination of a probable location may be based upon various measurements at the specific sensor locations. For example, a determination that the probable location of the occlusion is at the input may be based upon that the sensed input pressure value and amplitude decreasing relative to the recalled pressure history. Therefore, the recalled pressure history of the input or proximal pressure sensor may be compared to the real time actual measurement in block 472. If the input pressure value and amplitude decreases in the real time data relative to the recalled history, a determination that the probable occlusion is probably at the input may be made.
- a determination that the occlusion is intermediate or within the valve mechanism may be determined when a difference between the input and output pressures increases relative to the recalled pressure history. This allows for a determination that the probable location of the occlusion is intermediate between the input and the output.
- a determination that the occlusion is at the output may be based upon an output pressure increase.
- the recalled actual real time measurements increasing relative to the recalled pressure history at the output pressure sensor may allow for a determination that the probable location of an occlusion is at the output.
- a determination of the probable occlusion in block 476 may be a determination of the probable location of the occlusion of block 494.
- the process 400 may allow for a determination of an occlusion and also its possible location relative to the valve assembly 50.
- the probable location may be output in block 500.
- the output of the probable location of block 500 may be a visual output, a transmission of a probable location to a selected user interface, as discussed herein, or other appropriate outputs. Regardless, the determination of the probability of an occlusion and the probable location of the occlusion may be output for various purposes.
- Prio analysis and/or trends based on determined probabilities may be included in the process 400.
- a recall of occlusion trends may be made in block 504.
- the recall of occlusion trends may be from a plurality subjects in a related treatment and a resultant outcome of a similarly situated subject.
- a plurality of patients may include a valve assembly similar to the valve assembly 50 implanted therein in a shunt assembly. If an occlusion is found to occur in the shunt assembly and a patient outcome is later determined, the location of the occlusion and the outcome may be collated and stored for recall, such as in trends block 504.
- the specific patient data may not be recalled or saved with the occlusion location and patient outcome, but the trends may be saved for comparison to a current subject.
- a comparison of the output to the determined probable location to the recalled trends may be made in block 510.
- the comparison in block 510 may allow for the output of a probable outcome of the comparison in block 514.
- an output of probable outcomes of a specific or the current subject may be made in block 514 based upon the comparison. For example, if an output occlusion is determined as the probable location in block 494, a comparison of outcomes of other subjects with a distal or output occlusion may be recalled in block 504, compared to the determine probable location of block 510, and then output in block 514.
- the output of block 514 may be any appropriate output such as the visual output, an auditory output, saving to a selected memory for recall, display to a user interface, or other appropriate outputs.
- the path to “A” may be made to save selected data in block of 520.
- the selected data may include the flow rates, pressures from the sensor measurements, and/or occlusion analysis.
- the occlusion analysis may include both the probability of a presence of an occlusion and the probability of a location of the occlusion.
- the data based upon the acquired sensor data and the related analysis in the flow analysis 430 and the occlusion analysis in block 460 may be saved in block 520.
- the saving of the data in analysis may be saved in any appropriate manner, such as in a memory system as discussed above and/or as a part of the cloud or processor assembly 280.
- the data may be optionally saved in block 520 for later recall and/or access in block 524. Alternatively, the data and/or analysis may be immediately accessed for further processing in the process 400, as discussed herein. Accordingly, the various sensor data and outputs, as discussed above, may be displayed at a user interface (UI) in block 530.
- the display for the user at the UI may be a display of any of the appropriate data and/or analysis, including those discussed above.
- the display may include the specific actual measurements from block 438, the output of the flow determination from block 448, the determine probability of the occlusion in block 480, the determined probable location of the occlusion from block 494, the output of the probable outcome of the comparison in block 514, or any other appropriate display.
- the user 204 may view the data and analysis outputs and interact therewith based upon or with the user interface.
- the user interface may be a part of the cloud system 280 and/or any other appropriate system such as the portable device 250.
- the user may view the pressure measurements and/or the probable determinations of an occlusion, flow rate, or the like with the UI.
- the user may make a determination for further follow up and/or manipulation of the valve assembly of the subject based upon the sensor measurements and/or analysis as discussed above.
- the user may also select data for a subject record in block 538.
- the selection of the user data for the subject record may include saving or selecting data to save in a subject record. For example, if no occlusion is determined to exist or an analysis provides a probability that is outside of a selected range, selected data may not be saved in a subject record. Nevertheless, the user may select the data for a subject record in block 538.
- Data may then be selected for display to the subject in block 542. That is the user, such as the physician, may select to allow the subject 14 to be notified of selected data. For example, if a probable occlusion is determined to exist the physician may select data for display to the subject in block 542, such as an indication that the subject 14 should contact the user for follow up. Thus, the selected subject data may be displayed in a subject user interface in block 548.
- Based upon the selected data, such as the displayed to the user and/or selection by the user instructions for manipulating the implant in block 554 may be made or provided.
- the user may select to adjust the valve assembly based upon the determined flow rate in block 446 that is output in block 448.
- the instructions for adjustment may be provided or determined in block 554 such as from the user based upon the selected measurements and/or analyzed measurements to determine the flow or occlusion.
- the process 400 therefore, may include an input of adjustment value or type and/or actual adjustment in block 560.
- valve assembly may include an adjustable valve that may be adjusted by a manual adjuster that is provided externally to the subject 14, such as by the user.
- An external adjuster may include the adjustment system operable with valves and or adjustment systems operable with other valve systems such as the valve, all sold by Medtronic, Inc. having a place of business in Minnesota, USA.
- the adjustment system may be a manual adjuster that adjusts the valve mechanism 76 of the valve assembly 50. Further the valve mechanism may be adjusted with an internal adjustment mechanism, such as that disclosed in US Patent No.
- the output in block 578 may include instructions to the user, instructions to an alternative user, instructions to be executed by an internal adjustment mechanisms, or the like to provide the adjustments or instructions to the internal adjustment mechanism to adjust the valve mechanism 76.
- the process may also end in block 570.
- the process 400 may be used for collection of sensor data, determination of measurements of selected parameters, assisting in determining selected parameters relative to the valve assembly (such as flow rate or a probability of an occlusion) , and for possible output for manipulation of the valve assembly.
- the above described system may allow for an implant of a shunt assembly 10 into the subject 14 and collection of parameter measurements based upon sensor measurements included with the valve assembly and/or adjacent to the valve assembly.
- the sensor measurements may be used according to the process 400 to assist in providing analysis of the collected sensor measurements for possible further follow up with the subject 14.
- Example embodiments are provided so that this disclosure will be thorough and will fully convey the scope to those who are skilled in the art. Numerous specific details are set forth such as examples of specific components, devices, and methods, to provide a thorough understanding of embodiments of the present disclosure. It will be apparent to those skilled in the art that specific details need not be employed, that example embodiments may be embodied in many different forms and that neither should be construed to limit the scope of the disclosure. In some example embodiments, well-known processes, well-known device structures, and well-known technologies are not described in detail.
- Instructions may be executed by a processor and may include software, firmware, and/or microcode, and may refer to programs, routines, functions, classes, data structures, and/or objects.
- the term shared processor circuit encompasses a single processor circuit that executes some or all code from multiple modules.
- the term group processor circuit encompasses a processor circuit that, in combination with additional processor circuits, executes some or all code from one or more modules. References to multiple processor circuits encompass multiple processor circuits on discrete dies, multiple processor circuits on a single die, multiple cores of a single processor circuit, multiple threads of a single processor circuit, or a combination of the above.
- the term shared memory circuit encompasses a single memory circuit that stores some or all code from multiple modules.
- the term group memory circuit encompasses a memory circuit that, in combination with additional memories, stores some or all code from one or more modules.
- a processor also referred to as a processor module
- a processor module may include a special purpose computer (i.e., created by configuring a processor) and/or a general purpose computer to execute one or more particular functions embodied in computer programs.
- the computer programs include processor-executable instructions that are stored on at least one non-transitory, tangible computer-readable medium.
- the computer programs may also include or rely on stored data.
- the computer programs may include a basic input/output system (BIOS) that interacts with hardware of the special purpose computer, device drivers that interact with particular devices of the special purpose computer, one or more operating systems, user applications, background services and applications, etc.
- BIOS basic input/output system
- the computer programs may include: (i) assembly code; (ii) object code generated from source code by a compiler; (iii) source code for execution by an interpreter; (iv) source code for compilation and execution by a just-in-time compiler, (v) descriptive text for parsing, such as HTML (hypertext markup language) or XML (extensible markup language) , etc.
- source code may be written in C, C++, C#, Objective-C, Haskell, Go, SQL, Lisp, ASP, Perl, HTML5, Ada, ASP (active server pages) , Perl, Scala, Erlang, Ruby, Visual Lua, or
- Communications may include wireless communications described in the present disclosure can be conducted in full or partial compliance with IEEE standard 802.11-2012, IEEE standard 802.16-2009, and/or IEEE standard 802.20-2008.
- IEEE 802.11-2012 may be supplemented by draft IEEE standard 802.11ac, draft IEEE standard 802.11ad, and/or draft IEEE standard 802.11ah.
- a processor, processor module, module or ‘controller’ may be used interchangeably herein (unless specifically noted otherwise) and each may be replaced with the term ‘circuit. ’A ny of these terms may refer to, be part of, or include: an Application Specific Integrated Circuit (ASIC) ; a digital, analog, or mixed analog/digital discrete circuit; a digital, analog, or mixed analog/digital integrated circuit; a combinational logic circuit; a field programmable gate array (FPGA) ; a processor circuit (shared, dedicated, or group) that executes code; a memory circuit (shared, dedicated, or group) that stores code executed by the processor circuit; other suitable hardware components that provide the described functionality; or a combination of some or all of the above, such as in a system-on-chip.
- ASIC Application Specific Integrated Circuit
- FPGA field programmable gate array
- processors or processor modules such as one or more digital signal processors (DSPs) , general purpose microprocessors, application specific integrated circuits (ASICs) , field programmable logic arrays (FPGAs) , or other equivalent integrated or discrete logic circuitry.
- DSPs digital signal processors
- ASICs application specific integrated circuits
- FPGAs field programmable logic arrays
- processors or processor modules may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques.
- the techniques could be fully implemented in one or more circuits or logic elements.
- the processor or processors may operate entirely automatically and/or substantially automatically. In automatic operation the processor may execute instructions based on received input and execute instructions in light thereof. Thus, various outputs may be made without further or any manual (e.g., user) input.
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Abstract
L'invention concerne un système comprenant un ensemble de régulation de débit. Le système peut comprendre un ensemble vanne de régulation de débit et des capteurs relatifs. Des signaux provenant des capteurs peuvent être utilisés pour fournir des informations à un système externe concernant l'ensemble de dérivation et son fonctionnement.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/CN2023/137447 WO2025118270A1 (fr) | 2023-12-08 | 2023-12-08 | Système et procédé d'évaluation de vanne |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/CN2023/137447 WO2025118270A1 (fr) | 2023-12-08 | 2023-12-08 | Système et procédé d'évaluation de vanne |
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| Publication Number | Publication Date |
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| WO2025118270A1 true WO2025118270A1 (fr) | 2025-06-12 |
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| Application Number | Title | Priority Date | Filing Date |
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| PCT/CN2023/137447 Pending WO2025118270A1 (fr) | 2023-12-08 | 2023-12-08 | Système et procédé d'évaluation de vanne |
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| WO (1) | WO2025118270A1 (fr) |
Citations (6)
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|---|---|---|---|---|
| CN103002940A (zh) * | 2010-03-19 | 2013-03-27 | 华盛顿大学 | 用于过量体液的引流系统 |
| CN103491862A (zh) * | 2011-02-16 | 2014-01-01 | 艾尔弗雷德·伊·曼科学研究基金会 | 可植入的分流系统和相关联的压力传感器 |
| US20170203083A1 (en) * | 2016-01-15 | 2017-07-20 | Debiotech S.A. | Method of Adjustment for Hydrocephalus Valve |
| CN107666854A (zh) * | 2015-03-31 | 2018-02-06 | 美敦力Ps医疗股份有限公司 | 用于分流器的无线压力测量和监测 |
| CN115414582A (zh) * | 2022-08-05 | 2022-12-02 | 浙江大学 | 一种脑积水分流装置 |
| CN116077806A (zh) * | 2023-01-19 | 2023-05-09 | 深圳湃诺瓦医疗科技有限公司 | 脑脊液分流系统及其控制方法、控制装置和存储介质 |
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2023
- 2023-12-08 WO PCT/CN2023/137447 patent/WO2025118270A1/fr active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103002940A (zh) * | 2010-03-19 | 2013-03-27 | 华盛顿大学 | 用于过量体液的引流系统 |
| CN103491862A (zh) * | 2011-02-16 | 2014-01-01 | 艾尔弗雷德·伊·曼科学研究基金会 | 可植入的分流系统和相关联的压力传感器 |
| CN107666854A (zh) * | 2015-03-31 | 2018-02-06 | 美敦力Ps医疗股份有限公司 | 用于分流器的无线压力测量和监测 |
| US20170203083A1 (en) * | 2016-01-15 | 2017-07-20 | Debiotech S.A. | Method of Adjustment for Hydrocephalus Valve |
| CN115414582A (zh) * | 2022-08-05 | 2022-12-02 | 浙江大学 | 一种脑积水分流装置 |
| CN116077806A (zh) * | 2023-01-19 | 2023-05-09 | 深圳湃诺瓦医疗科技有限公司 | 脑脊液分流系统及其控制方法、控制装置和存储介质 |
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