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WO2022071910A1 - A device for detection of vascular access dislodgements and notification of the authorized person - Google Patents

A device for detection of vascular access dislodgements and notification of the authorized person Download PDF

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Publication number
WO2022071910A1
WO2022071910A1 PCT/TR2021/050989 TR2021050989W WO2022071910A1 WO 2022071910 A1 WO2022071910 A1 WO 2022071910A1 TR 2021050989 W TR2021050989 W TR 2021050989W WO 2022071910 A1 WO2022071910 A1 WO 2022071910A1
Authority
WO
WIPO (PCT)
Prior art keywords
vascular access
dislodged
values
patient
control unit
Prior art date
Application number
PCT/TR2021/050989
Other languages
French (fr)
Inventor
Umut GUNAY
Berkay KULLUKCU
Berke ATASEVEN
Original Assignee
Gunay Umut
Kullukcu Berkay
Ataseven Berke
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Gunay Umut, Kullukcu Berkay, Ataseven Berke filed Critical Gunay Umut
Publication of WO2022071910A1 publication Critical patent/WO2022071910A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3656—Monitoring patency or flow at connection sites; Detecting disconnections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3368—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback

Definitions

  • the present invention relates to a device which enables to detect dislodgement of vascular access.
  • Vascular access is an application used to deliver materials such as drugs, serum or blood into the patient's vein from outside.
  • materials such as drugs, serum or blood
  • vascular access By means of establishing vascular access, the need to puncture the patient's body with a needle for each material which needs to be administered into the vein is eliminated.
  • Delirium may occur in patients, especially after major surgical operations. These patients may tend to remove the vascular access. In addition, children may try to remove the vascular access thinking that it is a toy.
  • intravascular pressure can be observed or a clamp can be attached around the vascular access needle to detect the dislodgement of the vascular access.
  • these methods are complicated to implement. Therefore, an easily applicable and reliable method is required in order to detect if the vascular access is dislodged.
  • United States patent document no US20060130591 an application known in the state of the art, discloses a system which senses the dislodgement of the vascular access.
  • a photosensor is placed on the skin of the patient. If the vascular access is dislodged, the said photosensor is withdrawn from the skin, and the value perceived by the said photosensor will be different. This way, the said system detects dislodgement of the vascular access.
  • operation of the system is based on the photosensor, it loses its functionality at night when delirium is more common.
  • the objective of the present invention is to develop an alternative device for detecting the dislodgement of the vascular access.
  • Another objective of the present invention is to develop a device which notifies the authorized personnel of the status of the vascular access and warns the personnel in case of dislodgement of the vascular access.
  • a further objective of the present invention is to develop a device which can be calibrated for detecting the dislodgement of the vascular access.
  • FIG. 1 is a schematic view of the device according to the present invention in one embodiment of the invention.
  • the components shown in the figures are each given reference numbers as follows:
  • Alternative device (1) for detecting dislodgement of the vascular access essentially comprises
  • At least one temperature sensor (2) suitable for being fixed on the patient's body so as to cause a change in the patient's body temperature output value
  • control unit (6) which is suitable for being electrically connected to the temperature sensor (2), the pressure sensor (3) and/or the capacitive sensor (4) and to receive output values from the said sensors (2, 3, 4), and which determines whether the vascular access is dislodged by using the output values obtained from the temperature sensor (2), the pressure sensor (3) and/or the capacitive sensor (4).
  • the device (1) of the present invention comprises at least one temperature sensor (2).
  • the temperature sensor (2) is preferably placed between a patch used to fix the vascular access to the patient's body and the patient's body.
  • the temperature sensor (2) may contact the patient s body directly, as well as a material such as a patch, etc. may also be provided between the temperature sensor (2) and the patient's body.
  • the important thing here is that the temperature sensor (2) is fixed in such a way that the temperature value it reads will change if it leaves its fixed position.
  • the device (1) of the present invention comprises at least one pressure sensor (3) and/or capacitive sensor (4) whose output value when fixed to the patient's body is different from its output value when it is not fixed to the patient's body.
  • the said pressure sensor (3) and/or capacitive sensor (4) is/are preferably placed between a patch used to fix the vascular access to the patient's body and the patient's body.
  • the temperature sensor (2) and the pressure sensor (3) and/or the capacitive sensor (4) are suitable for being electrically connected to the control unit (6).
  • the control unit (6) receives the output values from the said sensors (2, 3, 4).
  • the control unit (6) determines whether the vascular access is dislodged by using the output values it receives from the temperature sensor (2) and the pressure sensor (3) and/or the capacitive sensor (4).
  • the control unit (6) monitors the change in temperature and pressure and/or capacitance values it reads in order to determine whether the vascular access is dislodged. It assumes that the vascular access is dislodged if one or more of these values change more than a predetermined value and/or fall below a predetermined threshold and/or rise above a predetermined threshold value.
  • the device (1) of the present invention comprises at least one communication means (5) suitable for the control unit (6) to transmit to a server the data it receives from the sensors (2, 3, 4) and/or the result that it has reached about whether the vascular access is dislodged as a result of interpreting the said data.
  • the information provided by the device (1) of the present invention can be monitored via a central computer to which this information is transmitted. Said information can be the temperature, pressure, capacitance change and/or the result reached about whether the vascular access is dislodged as a result of interpretation of these.
  • the device (1) of the present invention has at least one button (7).
  • the user presses the button (7) before or after the sensors (2, 3, 4) are placed on the patient's body, and the values received from the sensors (2, 3, 4) at that moment are recorded by the control unit (6) as reference values.
  • the button (7) is pressed before the sensors (2, 3, 4) are placed on the body, the values expected to be read in case of dislodgement of the vascular access are recorded as reference values; when the button (7) is pressed after the sensors (2, 3, 4) are placed on the body, the values expected to be read as long as the vascular access remains in place are recorded as reference values.
  • the device (1) of the present invention is calibrated and the deviations that may be caused by the tolerance values of the sensors (2, 3, 4) due to production are prevented from being misinterpreted.
  • the button (7) is pressed after the sensors (2, 3, 4) are placed on the body, both the deviations caused by the tolerance values of the sensors (2, 3, 4) due to production and the deviations that may occur during their placement on the patient's body are prevented from being misinterpreted.
  • the device (1) of the present invention has at least one feedback means (8).
  • the feedback means (8) is electrically connected to the control unit (6).
  • the control unit (6) can inform the user about the operating status of the device by controlling the said feedback means (8).
  • the feedback means (8) can be, for example, an LED.
  • a green light can be emitted, and if the vascular access is dislodged, a red light can be emitted. While emission can be realized by the same LED (e.g. RGB LED), it can also be realized using a plurality of LEDs.
  • the feedback means (8) can also be a means which provides audio feedback.
  • the sensors (2, 3, 4) and preferably the cables connecting them electrically to the control unit (6) can be disposable. Thus, before the device (1) is connected to another patient, the said sensors (2, 3, 4) and cables are replaced, allowing the device (1) to be connected to the new patient in a clean manner.
  • the power required by the device (1) of the present invention can be supplied from the mains and/or by a power supply.
  • the device (1) of the present invention can operate by being connected to a socket directly or by means of an adapter.
  • the device (1) can also be operated by means of a rechargeable battery or disposable batteries. In the case of using a rechargeable battery, the device (1) may have a charging circuit for charging these batteries.

Landscapes

  • 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)
  • Management, Administration, Business Operations System, And Electronic Commerce (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)

Abstract

The present invention relates to an alternative device (1) for detecting the dislodgement of the vascular access. In an embodiment of the invention, the device (1) of the present invention informs the authorized personnel about the status of the vascular access and warns the personnel in case of dislodgement of the vascular access. In one embodiment of the invention, the said device can be calibrated.

Description

A DEVICE FOR DETECTION OF VASCULAR ACCESS DISLODGEMENTS AND NOTIFICATION OF THE AUTHORIZED PERSON
Field of the Invention
The present invention relates to a device which enables to detect dislodgement of vascular access.
Background of the Invention
Vascular access is an application used to deliver materials such as drugs, serum or blood into the patient's vein from outside. By means of establishing vascular access, the need to puncture the patient's body with a needle for each material which needs to be administered into the vein is eliminated.
Delirium may occur in patients, especially after major surgical operations. These patients may tend to remove the vascular access. In addition, children may try to remove the vascular access thinking that it is a toy.
It is important that the personnel keeping the patient under observation are aware of the dislodgement of the vascular access. For this reason, there is a need for a structure which notifies the authorized personnel of the status of the vascular access and warns the personnel in case of dislodgement of the vascular access.
In the state of the art, intravascular pressure can be observed or a clamp can be attached around the vascular access needle to detect the dislodgement of the vascular access. However, these methods are complicated to implement. Therefore, an easily applicable and reliable method is required in order to detect if the vascular access is dislodged.
United States patent document no US20060130591, an application known in the state of the art, discloses a system which senses the dislodgement of the vascular access. In the said system, a photosensor is placed on the skin of the patient. If the vascular access is dislodged, the said photosensor is withdrawn from the skin, and the value perceived by the said photosensor will be different. This way, the said system detects dislodgement of the vascular access. However, since operation of the system is based on the photosensor, it loses its functionality at night when delirium is more common.
Summary of the Invention
The objective of the present invention is to develop an alternative device for detecting the dislodgement of the vascular access.
Another objective of the present invention is to develop a device which notifies the authorized personnel of the status of the vascular access and warns the personnel in case of dislodgement of the vascular access.
A further objective of the present invention is to develop a device which can be calibrated for detecting the dislodgement of the vascular access.
Detailed Description of the Invention
The device developed in order to achieve the objectives of the present invention is illustrated in the accompanying drawing, in which:
Figure 1 is a schematic view of the device according to the present invention in one embodiment of the invention. The components shown in the figures are each given reference numbers as follows:
1. Device
2. Temperature sensor
3. Pressure sensor
4. Capacitive sensor
5. Communication means
6. Control unit
7. Button
8. Feedback means
Alternative device (1) for detecting dislodgement of the vascular access essentially comprises
- at least one temperature sensor (2) suitable for being fixed on the patient's body so as to cause a change in the patient's body temperature output value,
- at least one pressure sensor (3) and/or capacitive sensor (4) whose output value when fixed to the patient's body is different from its output value when it is not fixed to the patient's body,
- at least one control unit (6) which is suitable for being electrically connected to the temperature sensor (2), the pressure sensor (3) and/or the capacitive sensor (4) and to receive output values from the said sensors (2, 3, 4), and which determines whether the vascular access is dislodged by using the output values obtained from the temperature sensor (2), the pressure sensor (3) and/or the capacitive sensor (4).
The device (1) of the present invention comprises at least one temperature sensor (2). The temperature sensor (2) is preferably placed between a patch used to fix the vascular access to the patient's body and the patient's body. The temperature sensor (2) may contact the patient s body directly, as well as a material such as a patch, etc. may also be provided between the temperature sensor (2) and the patient's body. The important thing here is that the temperature sensor (2) is fixed in such a way that the temperature value it reads will change if it leaves its fixed position.
The device (1) of the present invention comprises at least one pressure sensor (3) and/or capacitive sensor (4) whose output value when fixed to the patient's body is different from its output value when it is not fixed to the patient's body. The said pressure sensor (3) and/or capacitive sensor (4) is/are preferably placed between a patch used to fix the vascular access to the patient's body and the patient's body.
The temperature sensor (2) and the pressure sensor (3) and/or the capacitive sensor (4) are suitable for being electrically connected to the control unit (6). The control unit (6) receives the output values from the said sensors (2, 3, 4). The control unit (6) determines whether the vascular access is dislodged by using the output values it receives from the temperature sensor (2) and the pressure sensor (3) and/or the capacitive sensor (4). The control unit (6) monitors the change in temperature and pressure and/or capacitance values it reads in order to determine whether the vascular access is dislodged. It assumes that the vascular access is dislodged if one or more of these values change more than a predetermined value and/or fall below a predetermined threshold and/or rise above a predetermined threshold value.
In an embodiment of the invention, the device (1) of the present invention comprises at least one communication means (5) suitable for the control unit (6) to transmit to a server the data it receives from the sensors (2, 3, 4) and/or the result that it has reached about whether the vascular access is dislodged as a result of interpreting the said data. In this way, the information provided by the device (1) of the present invention can be monitored via a central computer to which this information is transmitted. Said information can be the temperature, pressure, capacitance change and/or the result reached about whether the vascular access is dislodged as a result of interpretation of these.
In one embodiment of the invention, the device (1) of the present invention has at least one button (7). The user presses the button (7) before or after the sensors (2, 3, 4) are placed on the patient's body, and the values received from the sensors (2, 3, 4) at that moment are recorded by the control unit (6) as reference values. When the button (7) is pressed before the sensors (2, 3, 4) are placed on the body, the values expected to be read in case of dislodgement of the vascular access are recorded as reference values; when the button (7) is pressed after the sensors (2, 3, 4) are placed on the body, the values expected to be read as long as the vascular access remains in place are recorded as reference values. In this way, the device (1) of the present invention is calibrated and the deviations that may be caused by the tolerance values of the sensors (2, 3, 4) due to production are prevented from being misinterpreted. In addition, when the button (7) is pressed after the sensors (2, 3, 4) are placed on the body, both the deviations caused by the tolerance values of the sensors (2, 3, 4) due to production and the deviations that may occur during their placement on the patient's body are prevented from being misinterpreted.
In one embodiment of the invention, the device (1) of the present invention has at least one feedback means (8). The feedback means (8) is electrically connected to the control unit (6). The control unit (6) can inform the user about the operating status of the device by controlling the said feedback means (8). The feedback means (8) can be, for example, an LED. For example, if the vascular access is positioned as it should be, a green light can be emitted, and if the vascular access is dislodged, a red light can be emitted. While emission can be realized by the same LED (e.g. RGB LED), it can also be realized using a plurality of LEDs. Of course, this is only an example, and any feedback which enables the user to receive information about the operating status of the device (1) can be provided by means of the said feedback means (8). The feedback means (8) can also be a means which provides audio feedback. In the device (1) of the present invention, the sensors (2, 3, 4) and preferably the cables connecting them electrically to the control unit (6) can be disposable. Thus, before the device (1) is connected to another patient, the said sensors (2, 3, 4) and cables are replaced, allowing the device (1) to be connected to the new patient in a clean manner.
The electrical connections mentioned above can be made directly or through any type of connector.
The power required by the device (1) of the present invention can be supplied from the mains and/or by a power supply. The device (1) of the present invention can operate by being connected to a socket directly or by means of an adapter. The device (1) can also be operated by means of a rechargeable battery or disposable batteries. In the case of using a rechargeable battery, the device (1) may have a charging circuit for charging these batteries.

Claims

1. A device (1) for detecting dislodgement of the vascular access characterized by at least one temperature sensor (2) suitable for being fixed on the patient's body so as to cause a change in the patient's body temperature output value,
- at least one pressure sensor (3) and/or capacitive sensor (4) whose output value when fixed to the patient's body is different from its output value when it is not fixed to the patient's body,
- at least one control unit (6) which is suitable for being electrically connected to the temperature sensor (2), the pressure sensor (3) and/or the capacitive sensor (4) and to receive output values from the said sensors (2, 3, 4), and which determines whether the vascular access is dislodged by using the output values obtained from the temperature sensor (2), the pressure sensor (3) and/or the capacitive sensor (4).
2. A device (1) according to claim 1, characterized by the control unit (6) which is adapted to monitor the change in the temperature and pressure and/or capacitance values it reads in order to determine whether the vascular access is dislodged and to conclude that the vascular access is dislodged if one or more of these values change more than a predetermined value.
3. A device (1) according to claim 1, characterized by the control unit (6) which is adapted to monitor the change in the temperature and pressure and/or capacitance values it reads in order to determine whether the vascular access is dislodged, and to conclude that the vascular access is dislodged if one or more of these values fall below a predetermined threshold value and/or rise above a predetermined threshold value. A device (1) according to any one of the preceding claims, characterized by at least one communication means (5) suitable for the control unit (6) to transmit to a server the data it receives from the sensors (2, 3, 4) and/or the result that it has reached about whether the vascular access is dislodged as a result of interpreting the said data. A device (1) according to any one of the preceding claims, characterized by at least one button (7) which, when pressed, enables the control unit (6) to record the momentary values it receives from the sensors (2, 3, 4) as reference values. A device (1) according to any one of the preceding claims, characterized by at least one feedback means suitable for informing the user about the operating status. A device (1) according to any one of the preceding claims, characterized by at least one rechargeable battery which provides the power required by the device.
8
PCT/TR2021/050989 2020-09-29 2021-09-29 A device for detection of vascular access dislodgements and notification of the authorized person WO2022071910A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR2020/15476A TR202015476A1 (en) 2020-09-29 2020-09-29 A DEVICE FOR DETECTION OF VASCULAR DISLOCATIONS AND NOTIFICATION TO THE CONCERNED PERSON
TR2020/15476 2020-09-29

Publications (1)

Publication Number Publication Date
WO2022071910A1 true WO2022071910A1 (en) 2022-04-07

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PCT/TR2021/050989 WO2022071910A1 (en) 2020-09-29 2021-09-29 A device for detection of vascular access dislodgements and notification of the authorized person

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WO (1) WO2022071910A1 (en)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020198483A1 (en) * 2001-06-22 2002-12-26 Ramesh Wariar Needle dislodgement detection
US20150374896A1 (en) * 2014-06-25 2015-12-31 Yi-Chun Du Needle dislodgement and blood leakage detection device
WO2017179060A1 (en) * 2016-04-13 2017-10-19 Fund For Medical Research Development Of Infrastructure And Health Services Barzilai Medical Center (Registered Endowment) Intravascular access device displacement alerting apparatus and method

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020198483A1 (en) * 2001-06-22 2002-12-26 Ramesh Wariar Needle dislodgement detection
US20150374896A1 (en) * 2014-06-25 2015-12-31 Yi-Chun Du Needle dislodgement and blood leakage detection device
WO2017179060A1 (en) * 2016-04-13 2017-10-19 Fund For Medical Research Development Of Infrastructure And Health Services Barzilai Medical Center (Registered Endowment) Intravascular access device displacement alerting apparatus and method

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Publication number Publication date
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