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CN108939185B - Portable blood vessel access state monitoring device - Google Patents

Portable blood vessel access state monitoring device Download PDF

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Publication number
CN108939185B
CN108939185B CN201710360786.1A CN201710360786A CN108939185B CN 108939185 B CN108939185 B CN 108939185B CN 201710360786 A CN201710360786 A CN 201710360786A CN 108939185 B CN108939185 B CN 108939185B
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vibration
data
evaluation index
sound
module
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CN108939185A (en
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彭啟峰
陈奕仲
王政仁
李宗谚
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Huatong Biomedical Co ltd
Nexcom International Co Ltd
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Huatong Biomedical Co ltd
Nexcom International Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • A61M1/3653Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3656Monitoring patency or flow at connection sites; Detecting disconnections
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Cardiology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)

Abstract

The invention discloses a portable blood vessel access state monitoring device which comprises a measuring device and a monitoring module. The measuring device senses the vibration data induced by the blood flow at the position of the blood vessel passage of the testee through the vibration sensing module, and transmits the sensed data to the outside through the communication module. The monitoring module controls the electronic device to receive data and determines a vibration evaluation index corresponding to the state of the part according to the received sensing data. The portable blood vessel access state monitoring device has the advantages of small volume, portability, low cost and the like, and is suitable for home blood vessel access state monitoring.

Description

Portable blood vessel access state monitoring device
Technical Field
The present invention relates to monitoring of vascular access status, and more particularly to a portable vascular access status monitoring device.
Background
Patients with renal function loss or insufficiency need to send blood to an extracorporeal hemodialysis machine by a vascular access to perform blood purification so as to filter waste in the blood. The aforementioned vascular access may be surgically created and used to transport the patient's blood to a hemodialysis machine and return the dialyzed blood to the patient.
Generally, there are two main types of vascular access created by surgery: arteriovenous self-Fistula (AVF), Arteriovenous artificial blood vessel (AVG).
Please refer to fig. 1A, which is a schematic diagram of an arteriovenous artificial blood vessel. The arteriovenous artificial blood vessel 14 may be an artificial plastic tube with one end connected to the artery 12 and one end connected to the vein 10. Please refer to fig. 1B, which is a schematic view of an arteriovenous self-fistula. The arteriovenous self-fistula 16 directly connects the artery 12 and the vein 10.
Any of the above vascular accesses has the possibility of a narrow or even blocked line, and once the vascular access is blocked or narrowed, the hemodialysis effect is not good, and in severe cases, the life of a patient is even damaged. Therefore, monitoring of the vascular access status is an important issue.
In the conventional monitoring of the vascular access state, a large-sized and high-cost ultrasonic image capturing device is used to capture an ultrasonic image of the vascular access and calculate the blood flow volume of the vascular access, and professional medical staff diagnose the vascular access state according to the ultrasonic image.
The current blood vessel access state monitoring is not suitable for home self-monitoring and is not beneficial to early discovery of poor blood vessel access state because of the limitation of the need of a large-size and high-cost ultrasonic imaging device and the diagnosis of professional medical care personnel.
Disclosure of Invention
The main objective of the present invention is to provide a portable blood vessel access status monitoring device, which can use a vibration sensing module with small volume and low cost to replace an ultrasonic imaging module for blood vessel access status monitoring.
In order to achieve the above object, the present invention provides a portable vascular access state monitoring device, comprising:
a measurement apparatus, comprising:
a monitoring patch, which has a patch structure for detachably attaching to the part, and is provided with a vibration sensing module, a radio module and a blood flow rate sensing module, wherein the vibration sensing module senses vibration data induced by blood flow at a part of a blood vessel passage of a testee, the radio module senses sound data induced by the blood flow at the part, and the blood flow rate sensing module senses flow rate data induced by the blood flow at the part; and
the communication module is electrically connected with the vibration sensing module, the radio module and the blood flow rate sensing module and used for transmitting data to the outside; and
a monitoring module, controlling an electronic device of the communication module connected to the measuring device, for reading a vibration critical data corresponding to the portion from a memory, and determining a vibration evaluation index corresponding to the state of the portion according to the vibration data and the vibration critical data, the monitoring module reading a sound critical data corresponding to the portion from the memory, and determining a sound evaluation index corresponding to the state of the portion according to the sound data and the sound critical data, the monitoring module reading a flow rate critical data corresponding to the portion from the memory, and determining a flow rate evaluation index corresponding to the state of the portion according to the flow rate data and the flow rate critical data;
wherein, the vibration evaluation index, the sound evaluation index and the flow rate evaluation index all fall into a designated range formed by a plurality of continuous numerical values, one end of the designated range is a positive index, and the other end is a negative index;
when the vibration data is less than the vibration critical data, the monitoring module determines that the vibration evaluation index is a value biased to the negative direction index in the specified range, and sets the same value as a vibration normal value of the testee when the vibration evaluation indexes monitored by the same testee for multiple times are the same value;
the monitoring module determines the sound evaluation index to be a value biased to the negative index in the specified range when the sound data is smaller than the sound critical data, and sets the same value as a sound normal value of the testee when the sound evaluation indexes monitored by the same testee for multiple times are the same value;
when the flow rate data is less than the flow rate critical data, the monitoring module determines that the flow rate evaluation index is a value biased to the negative index in the specified range, and sets the same value as a normal flow rate value of the testee when the flow rate evaluation indexes monitored by the same testee for multiple times are the same value;
the monitoring module determines an overall evaluation index according to the vibration evaluation index, the sound evaluation index and the flow rate evaluation index;
wherein, when the vibration evaluation index, the sound evaluation index and the flow rate evaluation index all bias towards the negative direction index, the monitoring module determines that the overall evaluation index is abnormal;
wherein, when the vibration evaluation index, the sound evaluation index and the flow rate evaluation index all deviate from the forward direction index, the monitoring module determines that the overall evaluation index is normal;
when all or more than half of the vibration evaluation index, the sound evaluation index and the flow rate evaluation index are neutral indexes, the monitoring module determines that the overall evaluation index is unknown.
Preferably, the vibration threshold data is an amplitude value, and the monitoring module determines that the vibration data is smaller than the vibration threshold data when a maximum value or an average value of a plurality of vibration amplitudes of the vibration data is smaller than the vibration threshold data.
Preferably, the monitoring module performs a time-domain to frequency-domain conversion process on the vibration data to obtain a vibration spectrum data, performs a pulse analysis process on the vibration spectrum data to obtain a vibration pulse spectrum data, filters the vibration pulse spectrum data from the vibration spectrum data to obtain a vibration pulseless spectrum data, performs a frequency-domain to time-domain conversion process on the vibration pulseless spectrum data to obtain a vibration pulseless time-domain data, and determines the vibration evaluation index according to the vibration pulseless time-domain data and the vibration threshold data.
Preferably, the memory stores a plurality of sample vibration data, and the monitoring module selects one of the sample vibration data as the vibration threshold data according to a physiological parameter of the subject.
Preferably, the memory stores a historical vibration data of the subject, and the monitoring module reads the historical vibration data of the subject as the vibration threshold data.
Preferably, the vibration sensing module senses a first vibration data induced by blood flow at a first portion and a second vibration data induced by blood flow at a second portion of the vascular access of the subject; the monitoring module controls the electronic device to read first vibration critical data corresponding to the first portion and second vibration critical data corresponding to the second portion from the memory, determine a first vibration evaluation index corresponding to the state of the first portion according to the first vibration data and the first vibration critical data, determine a second vibration evaluation index corresponding to the state of the second portion according to the second vibration data and the second vibration critical data, and determine an overall evaluation index according to the first vibration evaluation index and the second vibration evaluation index.
Preferably, the sound reception module is a microphone, the vibration sensing module is an accelerometer, the blood flow rate sensing module is an optical flow rate meter, and the communication module is a bluetooth network module.
The portable blood vessel access state monitoring device has the advantages of small volume, portability, low cost and the like, and is suitable for home blood vessel access state monitoring.
Drawings
Fig. 1A is a schematic view of an arteriovenous artificial blood vessel.
Fig. 1B is a schematic view of an arteriovenous self-fistula.
Fig. 2 is an architectural view of a portable vascular access status monitoring device according to a first embodiment of the present invention.
Fig. 3A is a schematic diagram illustrating the use of the portable vascular access status monitoring device for an arteriovenous artificial blood vessel according to the second embodiment of the present invention.
Fig. 3B is a schematic use view of the portable vascular access condition monitoring device for an arteriovenous self-fistula according to the second embodiment of the present invention.
Fig. 4 is an architectural view of a portable vascular access status monitoring device according to a third embodiment of the present invention.
Fig. 5A is a schematic diagram illustrating the use of the portable vascular access status monitoring device according to the fourth embodiment of the present invention in an arteriovenous artificial blood vessel.
Fig. 5B is a schematic diagram illustrating the use of the portable vascular access status monitoring device according to the fifth embodiment of the present invention in an arteriovenous artificial blood vessel.
Fig. 6 is a flowchart of a blood vessel access state monitoring method according to a first embodiment of the present invention.
Fig. 7 is a flowchart of a vascular access status monitoring method according to a second embodiment of the present invention.
Fig. 8 is a flowchart of a vascular access status monitoring method according to a third embodiment of the present invention.
Wherein, the reference numbers:
10 … vein
12 … artery
14 … arteriovenous artificial blood vessel
16 … arteriovenous self-fistula
2. 4 … portable blood vessel access state monitoring device
20. 20', 40 … measuring device
200. 400 … vibration sensing module
202. 402 … communication module
22. 42 … electronic device
220. 420 … monitoring module
404 … sound receiving module
406 … blood flow rate sensing module
422 … processor
424 … transceiver
426 … memory
428 … human-machine interface
430 … criticality of vibration data
432 … sound threshold data
434 … flow Rate Critical data
436 … model vibration data
438 … template sound data
440 … model flow rate data
442 … historical vibration data
444 … historical sound data
446 … historical flow Rate data
50. 52 … position
60 … first measuring device
600 … first radio
602 … first vibration sensor
604 … first transmitter
606 … first blood flow rate sensor
62 … second measuring device
620 … second radio
622 … second vibration sensor
624 … second transmitter
626 … second blood flow rate sensor
64 … third measuring device
640 … third radio
642 … third vibration sensor
644 … third transmitter
646 … third blood flow rate sensor
S100-S104 … first monitoring step
S200-S212 … second monitoring step
S300-S318 … third monitoring step
Detailed Description
A preferred embodiment of the present invention will be described in detail with reference to the accompanying drawings.
Fig. 2 is a schematic diagram of a portable vascular access status monitoring device according to a first embodiment of the present invention.
The portable vascular access status monitoring device (hereinafter referred to as "monitoring device") 2 of the present embodiment mainly includes a measuring device 20 and a monitoring module 220. The measurement apparatus 20 includes a vibration sensing module 200 and a communication module 202.
A vibration sensing module 200 (e.g., one or more triaxial accelerometers (accelerometers), force sensors, or other types of vibration sensors). The vibration sensor is used for sensing the vibration induced by the blood flow of a specific part of a blood vessel access (such as an artery, a vein, an arteriovenous self-fistula or an arteriovenous artificial blood vessel) of a tested person and generating the vibration data corresponding to the part.
The communication module 202 (e.g., a wireless transmitter such as a bluetooth network module, a ZigBee network module, a Wi-Fi network module, an infrared network module, etc., or a wired transmitter such as a serial communication module, a sound source line, a USB module, etc.) is used to connect the electronic device 22, and send data (e.g., vibration data) to the electronic device 22.
In one embodiment, the communication module 202 may include a micro-controller unit (MCU) for controlling the measurement device 20 and performing data signal processing.
The monitoring module 220 (e.g., a microcontroller or a processor) is disposed in the electronic device 22 for controlling the electronic device 22. Specifically, the monitoring module 220 may control the electronic device 22 to receive the vibration data from the communication module 202, and accordingly determine an Evaluation Index (Evaluation Index) corresponding to the state of the specific portion of the vascular access.
It is worth mentioning that, because the blood flow rate and blood pressure of each subject are different, there may be an error in determining the state of the vascular access according to the vibration induced by the blood flow, which may cause an error in the generated diagnosis result and may delay the treatment of the patient. Thus. The present invention does not directly provide the diagnosis result according to the sensed data, but determines the evaluation index of the subject, and the subject (or the monitoring device 2) automatically judges the state of the blood vessel access according to the long-term change of the evaluation index.
It is worth mentioning that in normal vascular access (no stenosis, nor obstruction), blood flow at the vascular junction can produce sustained tremor (still). In the event of an occlusion or stenosis of the vascular access, the blood flow merely induces Pulsation or weakened tremor. The invention judges whether the tremor disappears or weakens by analyzing the vibration data induced by the blood flow so as to determine the evaluation index of the state of the blood vessel access.
It should be noted that, although it is generally recognized that the blood passage is in a blocked state or a non-blocked state, the present invention sets a set of a predetermined range (e.g., 1 to 10) consisting of a plurality of consecutive numerical values in consideration of the above-mentioned determination error, and sets a positive indicator (e.g., closer to 1 indicates higher possibility of non-blocking) and a negative indicator (e.g., closer to 10 indicates higher possibility of blocking) at both ends of the predetermined range, respectively. Therefore, when the evaluation index of the subject changes toward the negative index a plurality of times (e.g., from 6 to 9), it can be judged that the state of the blood passage may be poor; when the evaluation index of the subject maintains constant (such as maintaining 8), the evaluation index can be determined as the normal value of the subject.
Compared with the prior art that the ultrasonic image capturing equipment with large volume and high manufacturing cost is used for matching with the diagnosis of professional personnel to monitor the state of the blood vessel access, the portable blood vessel access state monitoring device only uses the vibration sensing module, has the advantages of small volume, convenience in carrying, low manufacturing cost and the like, can automatically determine the evaluation index of the blood vessel access, and is suitable for monitoring the state of the blood vessel access at home.
Referring to fig. 2, fig. 3A and fig. 3B, fig. 3A is a schematic view illustrating the use of the portable blood vessel access state monitoring device for an arteriovenous artificial blood vessel according to the second embodiment of the present invention, and fig. 3B is a schematic view illustrating the use of the portable blood vessel access state monitoring device for an arteriovenous self-fistula according to the second embodiment of the present invention.
In the present embodiment, the measuring device 20 can be used to measure the vibration data induced by the blood flow at any part of the vascular access of the subject. The electronic device 22 is a device dedicated to the measurement device 20 (i.e. the measurement device 20 and the electronic device 22 are used in a set), and is connected to the measurement device 20 by a wire. In the present embodiment, the measuring device 20 further includes a patch structure for detachably attaching to a portion.
As shown in fig. 3A and 3B, the subject may attach the measuring device 20 to a specific portion of the vascular access of the subject (e.g. the position of the measuring device 20, which is the position of the arteriovenous artificial blood vessel in fig. 3A, and the position of the arteriovenous self-fistula in fig. 3B) for a first measuring time (e.g. 30 seconds) during measurement, so that the measuring device 20 continuously senses the blood flow-induced vibration data of the specific portion. Alternatively, the subject may attach the measurement device 20 to another portion of the vascular access of the subject (i.e., the location of the measurement device 20', which is the location of the vein in fig. 3A and 3B) for a second measurement time (e.g., 50 seconds) so that the measurement device 20 continuously senses another vibration data induced by the blood flow at the other portion.
The measuring device 20 can transmit the sensed vibration data to the electronic device 22 for analysis in real time or after sensing.
Finally, the monitoring module 220 controls the electronic device 22 to receive the vibration data (i.e., the vibration data of each portion), obtain the vibration threshold data corresponding to each portion, and determine the vibration evaluation index corresponding to the current state of each portion of the vascular access of the subject according to each vibration data and the corresponding vibration threshold data.
Although the monitoring module is implemented in hardware in the foregoing embodiments, the invention is not limited thereto. In another embodiment, the monitoring module can also be implemented in software.
Fig. 4 is a schematic diagram of a portable vascular access status monitoring device according to a third embodiment of the present invention. The portable vascular access status monitoring device 4 (hereinafter referred to as the monitoring device 4), the measuring device 40, the vibration sensing module 400, the communication module 402 and the electronic device 42 in the embodiment shown in fig. 4 are respectively the same as or similar to the monitoring device 2, the measuring device 20, the vibration sensing module 200, the communication module 202 and the electronic device 22 in the embodiment shown in fig. 2, and are not repeated herein.
In one embodiment, the measurement device 40 further includes a sound receiving module 404 (e.g., one or more omni-directional microphones, or other types of microphones) electrically connected to the communication module 402. The sound receiving module 404 is configured to receive sound induced by blood flow at a specific portion of a blood vessel passage of a subject and generate corresponding sound data, wherein a frequency range of the sound sensed by the sound receiving module 404 is close to or falls within an audible frequency range of human ears.
In one embodiment, the sound reception module 404 includes an audio amplifier and/or an audio filter (not shown). The audio amplifier amplifies the volume of the sensed sound data, and the audio filter filters noise of the sensed sound data. Furthermore, since the sound induced by the blood flow is very weak and there may be a lot of interference sound sources in the measurement environment, the invention uses the audio amplifier and the audio filter to preprocess the sensed sound data, so as to effectively amplify the volume and filter the noise, thereby improving the accuracy of the subsequent judgment.
In one embodiment, the measurement device 40 further includes a blood flow rate sensing module 406 electrically connected to the communication module 402. The blood flow rate sensing module 406 is configured to sense a flow rate of blood flowing through a specific portion of a blood vessel of a subject and generate corresponding flow rate data. Preferably, the blood flow rate sensing module 406 is an optical flow rate meter (e.g., one or more laser Doppler velocimeters).
Moreover, the electronic device 42 of the present embodiment is a general-purpose device (such as a smart phone, a notebook computer, a wearable device, a cloud host, or other types of multifunctional electronic devices), and includes a transceiver 424, a memory 426, a man-machine interface 428, and a processor 422 electrically connected to the above components.
The transceiver 424 and the communication module 402 may communicate with each other using a compatible communication technology, such as bluetooth communication. The memory 426 is used for storing data. The human-machine interface 428 (e.g., a light, a speaker, a microphone, a button, a touch screen, or any combination thereof) is used for receiving operation or outputting data. The processor 422 is used for controlling the electronic device 42.
Also, the monitoring module 420 of the present embodiment is a computer program stored in the non-transitory memory 426 and includes computer executable program code. After the processor 422 executes the program codes of the monitoring module 420, the electronic device 42 may be controlled to perform the steps of the vascular access status monitoring method according to the embodiments of the present invention with the measurement device 40.
Referring to fig. 4 and fig. 6, fig. 6 is a flowchart illustrating a method for monitoring a vascular access status according to a first embodiment of the present invention.
In the embodiment of fig. 6, the subject firstly attaches the measuring device 40 to the measured portion of the vascular access, so that the measuring device 40 senses the vibration data of the portion through the vibration sensing module 400 and sends the vibration data to the outside through the communication module 402 (step S100).
Next, the electronic device 42 reads the pre-stored vibration threshold data 430 from the memory 426 (step S102). In one embodiment, the memory 426 stores a plurality of vibration threshold data 430, each vibration threshold data 430 corresponds to a different portion of the vascular access, and the subject can set the current portion to be measured through the human-machine interface 428, so that the electronic device 42 can read the vibration threshold data 430 corresponding to the portion to be measured by itself.
Finally, the electronic device 42 determines a vibration evaluation index corresponding to the state of the portion according to the received vibration data and the read vibration threshold data (step S104).
In one embodiment, the vibration threshold data is a reference vibration amplitude of the specific portion of the blood vessel access of the subject under a normal condition, and the electronic device 42 analyzes a plurality of amplitudes of the vibration data and calculates a set of representative amplitudes (e.g., a maximum value or an average value of the plurality of amplitudes), and then compares the calculated representative amplitudes with the vibration threshold data. If the representative amplitude is smaller than the vibration threshold data, the electronic device 42 sets the vibration evaluation index to be a negative-biased index. Otherwise, the electronic device 42 sets the vibration evaluation index as the biased positive index.
The vessel access state monitoring method can effectively measure the vibration of the vessel access and provide the vibration evaluation index of the vessel access, so that a testee can deduce the state of the vessel access.
Referring to fig. 4 and 7, fig. 7 is a flowchart illustrating a method for monitoring a vascular access status according to a second embodiment of the present invention.
In the embodiment of fig. 7, the monitoring device 4 may simultaneously measure the vibration data, the sound data and the flow rate data of the same portion of the vascular access of the subject, determine the vibration evaluation index, the sound evaluation index and the flow rate evaluation index, and further determine the overall evaluation index of the portion according to the determined vibration evaluation index, sound evaluation index and flow rate evaluation index.
It should be noted that, in the present embodiment, the monitoring device 4 simultaneously measures the vibration data, the sound data and the flow rate data of the same portion of the vascular access of the subject, but is not limited thereto.
In another embodiment, the monitoring device 4 may measure only one or two of the vibration data, the sound data and the flow rate data, and determine the corresponding evaluation index according to the measured data. For example, the monitoring device 4 may measure only the vibration data and the sound data, determine the vibration evaluation index and the sound evaluation index, and determine the overall evaluation index according to the determined vibration evaluation index and sound evaluation index.
In the embodiment of fig. 7, the subject may attach the measurement device 40 to the measured portion of the vascular access, so that the measurement device 40 can sense the sensed data induced by the blood flow at the measured portion (step S200).
In one embodiment, the measurement device 40 senses the vibration data of the portion through the vibration sensing module 400, senses the sound data of the portion through the sound receiving module 404, senses the flow rate data of the portion through the blood flow rate sensing module 406, and sends the sensed vibration data, sound data and flow rate data to the outside through the communication module 402.
Next, the electronic device 42 reads threshold data corresponding to the portion from the memory 426 (step S202), such as the vibration threshold data 430, the sound threshold data 432, and the flow rate threshold data 434.
In one embodiment, the memory 426 stores a plurality of vibration threshold data 430, a plurality of sound threshold data 432, and a plurality of flow threshold data 434. Each vibration threshold data 430, each sound threshold data 432, and each flow threshold data 434 corresponds to a different portion of the vascular access. The electronic device 42 reads the vibration threshold data 430, the sound threshold data 432, and the flow threshold data 434 corresponding to the current location being measured.
In one embodiment, before performing the measurement, the medical staff may operate a more precise instrument (e.g., a vibration sensing module with higher sensitivity) to measure each part of the vascular access of the same subject, so as to obtain the vibration data, the sound data and the flow rate data of each part in a normal state, and use the vibration data, the sound data 432 and the flow rate data 434 of each part.
In one embodiment, the memory 426 stores a plurality of sample data (e.g., a plurality of sample vibration data 436, a plurality of sample sound data 438, and a plurality of sample flow rate data 440), each sample data corresponding to a different portion of the vascular access and a different physiological parameter (e.g., height, weight, age, or any combination thereof). The electronic device 42 selects corresponding template data as threshold data (such as vibration threshold data 430, sound threshold data 432, and flow threshold data 434) according to the measured part of the subject and the physiological parameters.
In one embodiment, memory 426 stores historical data of the subject measured in the background (e.g., historical vibration data 441, historical sound data 444, and historical flow rate data 446). This historical data corresponds to a particular portion of the vascular access. The electronic device 42 selects the historical data corresponding to the same portion as the threshold data (e.g., vibration threshold data 430, sound threshold data 432, and flow threshold data 434).
Next, the electronic device 42 performs a time-domain to frequency-domain conversion process on the received sensing data to obtain corresponding spectrum data (step S204).
In one embodiment, the electronic device 42 may further perform a band-pass filtering process on the generated spectrum data to filter noise frequencies outside a specific frequency (e.g., a frequency corresponding to tremor).
In an embodiment, the electronic device 42 may perform a time-domain to frequency-domain conversion process (such as fast fourier transform, laplace transform or discrete wavelet transform) on the received vibration data, sound data and flow velocity data to obtain corresponding vibration spectrum data, sound spectrum data and flow velocity spectrum data, but is not limited thereto.
In another embodiment, the electronic device 42 only performs the time-domain-to-frequency-domain conversion on the received vibration data and sound data to obtain the corresponding vibration spectrum data and sound spectrum data, and does not perform the time-domain-to-frequency-domain conversion on the flow rate data.
Next, the electronic device 42 performs a pulse analysis process on the generated spectrum data to obtain pulse data (step S206).
Taking the example where the electronic device 42 performs the time-domain to frequency-domain conversion process on the vibration data, the sound data, and the flow velocity data, the electronic device 42 identifies the frequency (fundamental frequency) with the highest amplitude from the sound spectrum data, the vibration spectrum data, and the flow velocity spectrum data, and then sets the identified frequency and the frequency multiplication (harmonic) thereof as the vibration pulse spectrum data, the sound pulse spectrum data, and the flow velocity pulse spectrum data, respectively.
Next, the electronic device 42 filters the pulse data from the spectrum data to obtain pulse-free spectrum data (step S208). In one embodiment, the electronic device 42 respectively filters the vibration pulse spectrum data, the sound pulse spectrum data and the flow rate pulse spectrum data from the sound spectrum data, the vibration spectrum data and the flow rate spectrum data to respectively obtain the vibration pulseless spectrum data, the sound pulseless spectrum data and the flow rate pulseless spectrum data.
Next, the electronic device 42 performs a frequency-domain to time-domain conversion process on the pulseless spectral data to obtain pulseless time-domain data (step S210).
In one embodiment, the electronic device 42 performs frequency-domain to time-domain conversion on the vibration pulseless frequency spectrum data, the sound pulseless frequency spectrum data and the flow rate pulseless frequency spectrum data to obtain vibration pulseless time domain data, sound pulseless time domain data and flow rate pulseless time domain data, respectively.
Next, the electronic device 42 determines an evaluation index according to the pulse-free time domain data and the critical data obtained in step S202 (step S212).
In one embodiment, the electronic device 42 determines a vibration evaluation index according to the vibration pulseless time domain data and the vibration threshold data 430, determines a sound evaluation index according to the sound pulseless time domain data and the sound threshold data 432, and determines a flow rate evaluation index according to the flow rate pulseless time domain data and the flow rate threshold data 434.
For example, if the evaluation index ranges from 1 to 10(10 means the highest blocking probability and 1 is the lowest). The more similar the pulse-free time domain data is to the critical data, the more biased the evaluation index is to 1, the less similar the evaluation index is to 10, and vice versa.
Therefore, the invention can determine the accurate evaluation index.
In an embodiment, the electronic device 42 may further determine an overall evaluation index of the measured portion according to the determined vibration evaluation index, sound evaluation index and flow rate evaluation index.
Take the range of each evaluation index (i.e. vibration evaluation index, sound evaluation index and flow rate evaluation index) as 1 to 10(10 means the highest possibility of blockage, and 1 is the lowest) as an example. When all (or half) of the evaluation indicators are negative indicators (e.g., any of the values between 7-10), the electronic device 42 may determine that the overall evaluation indicator is "abnormal". When all (or half) of the evaluation indicators are positive indicators (e.g., any value between 1-4), the electronic device 42 may determine that the overall evaluation indicator is "normal". When all (or half) of the evaluation indexes are neutral indexes (e.g., any value between 5 and 6), the electronic device 42 may determine that the overall evaluation index is "unknown".
In one embodiment, the critical data obtained in step S202 is spectrum data. In addition, in the present embodiment, the electronic device 42 does not perform step S210, but directly performs step S212 to determine the evaluation index according to the generated pulseless spectrum data and the threshold data.
Referring to fig. 4 and 8, fig. 8 is a flowchart illustrating a method for monitoring a vascular access status according to a third embodiment of the present invention.
In the embodiment of fig. 8, the monitoring device 4 may measure vibration data of a plurality of portions of the vascular access of the subject, determine a vibration evaluation index for each portion, and further determine a whole vibration evaluation index of the vascular access according to the plurality of determined vibration evaluation indexes.
It should be noted that, although the overall vibration evaluation index is determined according to the vibration data of a plurality of portions in the embodiment, the invention is not limited thereto
In another embodiment, the monitoring device 4 may also measure the vibration data, the sound data and the flow rate data of each portion at the same time, determine the vibration evaluation index, the sound evaluation index and the flow rate evaluation index of each portion according to the measured data, and determine the whole vibration evaluation index, the whole sound evaluation index and the whole flow rate evaluation index of the vascular access according to the vibration evaluation index, the sound evaluation index and the flow rate evaluation index of each portion.
In the embodiment of fig. 8, the subject may first attach the measuring device 40 to the first portion of the vascular access, so that the measuring device 40 senses the first vibration data of the first portion through the vibration sensing module 400 (step S300).
Next, the electronic device 42 determines whether to end the sensing of the location (step S302), if the sensing has been continued for a predetermined measurement time (e.g., 10 seconds). If the electronic device 42 determines that the sensing of the portion is not finished, step S300 is executed again to continue the sensing.
If the electronic device 42 determines to end the sensing of the portion, it further determines whether all the portions have been measured (step S304). In one embodiment, the electronic device 42 determines that all the portions of the vascular access of the subject (e.g., the first portion, the second portion, and the third portion) are measured and obtains the sensing data (e.g., the first vibration data, the second vibration data, and the third vibration data) of each portion.
If the electronic device 42 determines that there is no measurement site, an alarm is issued via the man-machine interface 428 to instruct the subject to replace the measurement site (step S318) and perform sensing again after replacing the measurement site.
If the electronic device 42 determines that all the parts have been measured, time-domain to frequency-domain conversion processing is performed on the received sensing data to obtain corresponding spectrum data (step S306). In an embodiment, the electronic device 42 performs a time-domain to frequency-domain conversion process on the first vibration data, the second vibration data and the third vibration data to obtain first vibration spectrum data, second vibration spectrum data and third vibration spectrum data.
Next, the electronic device 42 performs a pulse analysis process on the generated spectrum data to obtain pulse data (step S308), and filters the pulse data from the spectrum data (step S310). In an embodiment, the electronic device 42 performs a pulse analysis process on the first vibration spectrum data, the second vibration spectrum data and the third vibration spectrum data to obtain a first vibration pulse spectrum data, a second vibration pulse spectrum data and a third vibration pulse spectrum data, and respectively filters the first vibration pulse spectrum data, the second vibration pulse spectrum data and the third vibration pulse spectrum data from the first vibration spectrum data, the second vibration spectrum data and the third vibration spectrum data to obtain a first vibration pulseless spectrum data, a second vibration pulseless spectrum data and a third vibration pulseless spectrum data.
Next, the electronic device 42 performs a frequency-domain-to-time-domain conversion process on the frequency-domain data with the pulse data filtered out to obtain time-domain data (step S312). In one embodiment, the electronic device 42 performs a frequency-domain to time-domain conversion process on the first vibro-pulseless frequency spectrum data, the second vibro-pulseless frequency spectrum data and the third vibro-pulseless frequency spectrum data to obtain first vibro-pulseless time domain data, the second vibro-pulseless time domain data and the third vibro-pulseless time domain data.
Next, the electronic device 42 determines an evaluation index according to the generated time domain data (step S314). In one embodiment, the electronic device 42 reads the first vibration threshold data, the second vibration threshold data and the third vibration threshold data from the memory 426, determines a first vibration evaluation index according to the first vibration pulseless time domain data and the first vibration threshold data, determines a second vibration evaluation index according to the second vibration pulseless time domain data and the second vibration threshold data, and determines a third vibration evaluation index according to the third vibration pulseless time domain data and the third vibration threshold data.
Furthermore, the electronic device 42 determines the overall evaluation index of the blood vessel channel according to the first vibration evaluation index, the second vibration evaluation index and the third vibration evaluation index.
Finally, the electronic device 42 updates the threshold data in the memory 426 according to the evaluation result (step S316).
In one embodiment, the electronic device 42 can update the threshold data, the template data or the historical data stored in the memory 426 according to the currently determined evaluation index (such as the first vibration evaluation index, the second vibration evaluation index, the third vibration evaluation index and the overall evaluation index) by using the generated data (such as the first vibration pulseless time domain data, the second vibration pulseless time domain data and the third vibration pulseless time domain data) so as to make the threshold data, the template data or the historical data closer to the recent physiological characteristics of the subject.
With reference to fig. 4 and 5A, fig. 5A is a schematic diagram of a portable blood vessel access state monitoring device for an artificial artery and vein blood vessel according to a fourth embodiment of the present invention.
In the present embodiment, the monitoring device 40 obtains and compares the vibration data, the sound data, and the flow rate data induced by the blood flow at different parts of the subject. The electronic device 42 is a smart phone with a monitoring module 420 (in the embodiment, an application program) installed therein, and wirelessly connects to the communication module 402 of the measurement apparatus 40 via the transceiver 424 by using bluetooth communication technology.
As shown in fig. 5A, the subject may attach the measuring device 40 to the first portion of the vascular access of the subject (i.e. the position of the measuring device 40) for a first measuring time (e.g. 20 seconds) by himself/herself while measuring, so that the measuring device 40 continuously senses the first vibration data, the first sound data and the first flow rate data induced by the blood flow at the first portion and transmits the first vibration data, the first sound data and the first flow rate data to the electronic device 42 for analysis processing.
Then, the subject detaches the measurement device 40 from the first portion, and attaches the detached measurement device 40 to a second portion (position 50 shown in fig. 5A) of the vascular access of the subject for a second measurement time (e.g., 20 seconds) so that the measurement device 40 continuously senses second vibration data, second sound data, and second flow rate data induced by the blood flow at the second portion and transmits the second vibration data, the second sound data, and the second flow rate data to the electronic device 42 for analysis processing.
Next, the subject detaches the measurement device 40 from the second portion, and attaches the detached measurement device 40 to a third portion (position 52 shown in fig. 5A) of the vascular access of the subject for a third measurement time (e.g., 20 seconds) so that the measurement device 40 continuously senses third vibration data, third sound data and third flow rate data induced by the blood flow of the third portion and transmits the third vibration data, the third sound data and the third flow rate data to the electronic device 42 for analysis processing.
Finally, the electronic device 42 processes the received first vibration data, second vibration data, third vibration data, first sound data, second sound data, third sound data, first flow rate data, second flow rate data, and third flow rate data to determine corresponding evaluation indexes.
Referring to fig. 4 and 5B, fig. 5B is a schematic diagram of a portable blood vessel access state monitoring device for an artificial artery and vein blood vessel according to a fifth embodiment of the present invention. In the embodiment, the sound receiving module 404 includes a first sound receiver 600, a second sound receiver 620 and a third sound receiver 640. Vibration sensing module 402 includes a first vibration sensor 602, a second vibration sensor 622, and a third vibration sensor 642. The communication module 402 includes a first transmitter 604, a second transmitter 624, and a third transmitter 644. Blood flow sensing module includes first blood flow sensor 606, second blood flow sensor 626 and third blood flow sensor 646.
Also, the monitoring device 40 includes monitoring patches 60-64. The monitoring patch 60 is provided with a first radio 600, a first vibration sensor 602, a first transmitter 604 and a first blood flow rate sensor 606. The monitoring patch 62 is provided with a second radio 620, a second vibration sensor 622, a second transmitter 624 and a second blood flow rate sensor 626. The monitoring patch 64 is provided with a third radio 640, a third vibration sensor 642, a third transmitter 644, and a third blood flow rate sensor 646.
As shown in fig. 5B, the subject may attach the monitoring patch 60 to a first portion of the vascular access of the subject, attach the monitoring patch 62 to a second portion outside the vascular access, and attach the monitoring patch 64 to a third portion away from the vascular access by himself/herself while performing the measurement. Then, the subject waits for a predetermined measurement time (e.g., 30 seconds).
During the waiting period, the monitoring patch 60 senses the first sound data via the first radio 600, senses the first vibration data via the first vibration sensor 602, senses the first flow rate data via the first blood flow rate sensor 606, and transmits the sensed data to the electronic device 42 via the first transmitter 604 for analysis. Similarly, the monitoring patch 62 senses second acoustic data via the second radio 620, second vibration data via the second vibration sensor 622, second flow rate data via the second blood flow rate sensor 626, and sensed data via the second transmitter 624 to the electronic device 42 for analysis. The monitoring patch 64 senses third acoustic data via a third radio 640, third vibrational data via a third vibration sensor 642, third flow rate data via a third blood flow rate sensor 646, and sensed data via a third transmitter 644 to the electronic device 42 for analysis.
Finally, the electronic device 42 processes the received data and determines an evaluation index.
The invention can effectively shorten the measurement time by simultaneously using a plurality of monitoring patches for measurement.
It is noted that although the device of fig. 5A and 5B is used for a vascular access including an arteriovenous artificial blood vessel, it may be used for a vascular access including an arteriovenous self-fistula, without being limited thereto.
The present invention is capable of other embodiments, and various changes and modifications may be made by one skilled in the art without departing from the spirit and scope of the invention as defined in the appended claims.

Claims (7)

1.一种便携式血管通路状态监测装置,其特征在于,该便携式血管通路状态监测装置包括:1. A portable vascular access state monitoring device, wherein the portable vascular access state monitoring device comprises: 一量测装置,包括:A measuring device, comprising: 一监测贴片,具有用以能够拆卸式贴附于一受测者的血管通路的一部位的一贴片结构,该监测贴片设置有一振动感测模块、一收音模块与一血液流速感测模块,其中该振动感测模块感测该部位的血液流动诱发的一振动数据,该收音模块感测该部位的血液流动诱发的一声音数据,该血液流速感测模块感测该部位的血液流动诱发的一流速数据;及A monitoring patch has a patch structure for detachably attaching to a part of a subject's vascular access, the monitoring patch is provided with a vibration sensing module, a sound-receiving module and a blood flow rate sensor module, wherein the vibration sensing module senses a vibration data induced by the blood flow of the part, the radio module senses a sound data induced by the blood flow of the part, and the blood flow rate sensing module senses the blood flow of the part induced flow rate data; and 一通信模块,电性连接该振动感测模块、该收音模块与该血液流速感测模块,用以对外传输数据;及a communication module electrically connected to the vibration sensing module, the radio module and the blood flow velocity sensing module for externally transmitting data; and 一监测模块,控制连接该量测装置的该通信模块的一电子装置,用以自一存储器中读取对应该部位的一振动临界数据,并依据该振动数据及该振动临界数据决定对应该部位的状态的一振动评估指标,该监测模块自该存储器中读取对应该部位的一声音临界数据,并依据该声音数据及该声音临界数据决定对应该部位的状态的一声音评估指标,该监测模块自该存储器中读取对应该部位的一流速临界数据,并依据该流速数据及该流速临界数据决定对应该部位的状态的一流速评估指标;a monitoring module for controlling an electronic device connected to the communication module of the measuring device for reading a vibration critical data of the corresponding part from a memory, and determining the corresponding part according to the vibration data and the vibration critical data A vibration evaluation index of a state of The module reads a flow velocity critical data corresponding to the part from the memory, and determines a flow velocity evaluation index corresponding to the state of the part according to the flow velocity data and the flow velocity critical data; 其中,该振动评估指标、该声音评估指标与该流速评估指标皆是落入由多个连续数值所构成的一指定范围,该指定范围的一端为正向指标,另一端为负向指标;Wherein, the vibration evaluation index, the sound evaluation index and the flow velocity evaluation index all fall within a specified range formed by a plurality of continuous values, and one end of the specified range is a positive index, and the other end is a negative index; 其中,该监测模块是于该振动数据小于该振动临界数据时,决定该振动评估指标为该指定范围中偏向该负向指标的值,并于同一该受测者的多次监测的该振动评估指标都是相同值时,将该相同值设定为该受测者的一振动正常值;Wherein, when the vibration data is less than the vibration critical data, the monitoring module determines that the vibration evaluation index is a value biased toward the negative index in the specified range, and performs the vibration evaluation of the same subject's multiple monitoring When the indicators are all the same value, set the same value as a normal vibration value of the subject; 其中,该监测模块是于该声音数据小于该声音临界数据时,决定该声音评估指标为该指定范围中偏向该负向指标的值,并于同一该受测者的多次监测的该声音评估指标都是相同值时,将该相同值设定为该受测者的一声音正常值;Wherein, when the sound data is less than the sound critical data, the monitoring module determines that the sound evaluation index is a value that is biased towards the negative index in the specified range, and evaluates the sound in multiple monitoring of the same subject. When the indicators are all the same value, set the same value as a normal sound value of the subject; 其中,该监测模块是于该流速数据小于该流速临界数据时,决定该流速评估指标为该指定范围中偏向该负向指标的值,并于同一该受测者的多次监测的该流速评估指标都是相同值时,将该相同值设定为该受测者的一流速正常值;Wherein, when the flow velocity data is less than the flow velocity critical data, the monitoring module determines that the flow velocity evaluation index is a value biased toward the negative index in the specified range, and evaluates the flow velocity in the multiple monitoring of the same subject When the indicators are all the same value, the same value is set as the normal value of a flow velocity of the subject; 其中,该监测模块依据该振动评估指标、该声音评估指标及该流速评估指标决定一整体评估指标;Wherein, the monitoring module determines an overall evaluation index according to the vibration evaluation index, the sound evaluation index and the flow velocity evaluation index; 其中,当该振动评估指标、该声音评估指标与该流速评估指标皆偏向该负向指标时,该监测模块决定该整体评估指标为异常;Wherein, when the vibration evaluation index, the sound evaluation index and the flow velocity evaluation index are all biased towards the negative index, the monitoring module determines that the overall evaluation index is abnormal; 其中,当该振动评估指标、该声音评估指标与该流速评估指标皆偏向该正向指标时,该监测模块决定该整体评估指标为正常;Wherein, when the vibration evaluation index, the sound evaluation index and the flow velocity evaluation index are all biased towards the positive index, the monitoring module determines that the overall evaluation index is normal; 其中,当该振动评估指标、该声音评估指标与该流速评估指标中的所有或过半为一中立指标时,该监测模块决定该整体评估指标为不明。Wherein, when all or more than half of the vibration evaluation index, the sound evaluation index, and the flow rate evaluation index are a neutral index, the monitoring module determines that the overall evaluation index is unknown. 2.如权利要求1所述的便携式血管通路状态监测装置,其特征在于,该振动临界数据是振幅值,该监测模块是于该振动数据的多个振动振幅的最大值或平均值小于该振动临界数据时,决定该振动数据小于该振动临界数据。2 . The portable vascular access state monitoring device of claim 1 , wherein the vibration critical data is an amplitude value, and the monitoring module is based on a maximum value or an average value of a plurality of vibration amplitudes of the vibration data that is smaller than the vibration. 3 . In the case of critical data, it is determined that the vibration data is smaller than the vibration critical data. 3.如权利要求1所述的便携式血管通路状态监测装置,其特征在于,该监测模块是对该振动数据执行一时域至频域转换处理以获得一振动频谱数据,对该振动频谱数据执行一脉搏分析处理以获得一振动脉搏频谱数据,自该振动频谱数据中滤除该振动脉搏频谱数据以获得一振动无脉搏频谱数据,对该振动无脉搏频谱数据执行一频域至时域转换处理以获得一振动无脉搏时域数据,再依据该振动无脉搏时域数据及该振动临界数据决定该振动评估指标。3 . The portable vascular access state monitoring device of claim 1 , wherein the monitoring module performs a time domain to frequency domain conversion process on the vibration data to obtain vibration spectrum data, and performs a vibration spectrum data on the vibration spectrum data. 4 . Pulse analysis processing to obtain a vibration pulse spectrum data, filtering out the vibration pulse spectrum data from the vibration spectrum data to obtain a vibration pulseless spectrum data, and performing a frequency domain to time domain conversion process on the vibration pulseless spectrum data to Obtain a vibration pulseless time domain data, and then determine the vibration evaluation index according to the vibration pulseless time domain data and the vibration critical data. 4.如权利要求1所述的便携式血管通路状态监测装置,其特征在于,该存储器储存多个范本振动数据,该监测模块是依据该受测者的一生理参数自该多个范本振动数据中选择其中之一作为该振动临界数据。4 . The portable vascular access state monitoring device of claim 1 , wherein the memory stores a plurality of sample vibration data, and the monitoring module selects the plurality of sample vibration data according to a physiological parameter of the subject. 5 . Select one of them as the vibration critical data. 5.如权利要求1所述的便携式血管通路状态监测装置,其特征在于,该存储器储存该受测者的一历史振动数据,该监测模块是读取该受测者的该历史振动数据作为该振动临界数据。5 . The portable vascular access state monitoring device of claim 1 , wherein the memory stores a historical vibration data of the subject, and the monitoring module reads the historical vibration data of the subject as the Vibration critical data. 6.如权利要求1所述的便携式血管通路状态监测装置,其特征在于,该振动感测模块是感测该受测者的该血管通路的一第一部位的血液流动诱发的一第一振动数据及一第二部位的血液流动诱发的一第二振动数据;该监测模块控制该电子装置自该存储器中读取对应该第一部位的一第一振动临界数据及对应该第二部位的一第二振动临界数据,依据第一振动数据及该第一振动临界数据决定对应该第一部位的状态的一第一振动评估指标,依据该第二振动数据及该第二振动临界数据决定对应该第二部位的状态的一第二振动评估指标,并依据该第一振动评估指标及该第二振动评估指标决定一整体振动评估指标。6 . The portable vascular access state monitoring device of claim 1 , wherein the vibration sensing module senses a first vibration induced by blood flow in a first part of the vascular access of the subject. 7 . data and a second vibration data induced by the blood flow of a second part; the monitoring module controls the electronic device to read a first vibration threshold data corresponding to the first part and a first vibration threshold corresponding to the second part from the memory The second vibration threshold data, according to the first vibration data and the first vibration threshold data, determine a first vibration evaluation index corresponding to the state of the first part, and determine the corresponding vibration value according to the second vibration data and the second vibration threshold data A second vibration evaluation index of the state of the second part, and an overall vibration evaluation index is determined according to the first vibration evaluation index and the second vibration evaluation index. 7.如权利要求1所述的便携式血管通路状态监测装置,其特征在于,该收音模块是麦克风,该振动感测模块是加速度计,该血液流速感测模块是光学流速计,该通信模块是蓝牙网络模块。7 . The portable vascular access state monitoring device of claim 1 , wherein the radio module is a microphone, the vibration sensing module is an accelerometer, the blood flow rate sensing module is an optical flow meter, and the communication module is an accelerometer. 8 . Bluetooth network module.
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