TWI573571B - Sensor patch, system, and method for detecting fluid leakage - Google Patents

Description

Inductive patch, system and method for detecting leakage

The present invention relates to liquid leakage detection of a target portion of a body target site. In particular, the present invention relates to inductive patches, systems and methods for detecting leakage.

Stitching or other means are typically used to close the wound caused by surgery or trauma. However, the closed wound may open again, causing the wound to bleed. When the wound is covered with a dressing, the patient is unconscious, or is unable to detect bleeding for other reasons, the caregiver or patient may be aware of the bleeding after a period of time. This can cause a lot of blood loss, which in turn affects the patient's recovery.

In addition, in the medical process, procedures such as injecting a liquid into a human body or extracting a body fluid from a human body are often involved. For example, drugs or other substances are usually delivered to the body through intravenous infusion (drip infusion); in addition, various body fluids such as blood and cerebrospinal fluid are also taken from the human body. Liquid, ascites and pleural effusion. In some cases (for example, dialysis), bodily fluids taken from the body are treated and returned to the body. These applications usually involve puncture the needle into the body; during the time the needle stays in the body, The fluid used to infuse the body or the body fluid being drawn may leak from the patient's blood vessels or improperly placed needles, or the tissue adjacent to the needle may bleed. These leaking liquids, if not properly disposed of, may damage the tissue near the injection site. This phenomenon is called extravasation. Extravasation can lead to severe or even permanent damage, such as tissue necrosis, depending on the type of drug, exposure, and location. Extravasation may also cause some minor effects, such as irritations such as pain and/or inflammation, and clinical symptoms such as fever, rash or pain may occur.

Injections containing vesicants and/or irritating substances often make the extravasation problem worse. Drugs with high blistering include chemotherapy drugs (such as adriamycin and vincristine), vasopressors (such as dopamine), developers, hypertonic glucose solutions, electrolyte solutions (such as potassium chloride). , calcium chloride and sodium bicarbonate solution), phenytoin and total parenteral nutrition solution. An infusion pump with a warning device is usually used for administration. However, a survey conducted by the Pennsylvania Patient Safety Advisory in 2007 showed that in about half of the cases, the warning device did give a warning signal.

It can be seen that in the field of medical care, leakage is still an urgent problem to be solved.

SUMMARY OF THE INVENTION The Summary of the Disclosure is intended to provide a basic understanding of the present disclosure. This summary is not an extensive overview of the disclosure, and is not intended to The important/critical elements of the embodiments are intended to define the scope of the invention.

One aspect of the present invention is directed to an inductive patch that can be placed over a target portion of a body and that can be used to detect liquid leaking from a target portion.

According to an embodiment of the invention, the sensing patch comprises a first detecting unit, a second detecting unit and a patch body. The first detecting unit includes a first pair of sensors, each having a first end, the first end of the first detecting unit can be placed at a first position adjacent to the target portion, and the second detecting unit The second pair of sensors respectively have a first end, and the first end of the second detecting unit can be placed at a second position away from the target portion. Each inductor includes a wire and an insulating sheath that encloses the wire such that a portion of the first end of the wire is exposed but does not directly contact the skin of the individual. The patch body has a viscous surface for securing the first and second detecting units to the individual.

According to some embodiments of the invention, the first ends of the two inductors in each detection unit are spaced apart from each other by about 2.5 to 7.5 mm; preferably 5 mm.

According to some embodiments of the invention, the exposed portion of the wire has a length of from 2.5 to 7.5 mm; preferably 5 mm.

In some embodiments, the first position and the second position are between 1 and 5 centimeters apart from each other.

In some embodiments, the thickness of the insulating sheath is from 0.1 to 0.5 mm; preferably 0.3 mm.

According to an optional embodiment of the present invention, the first detecting unit further includes a first connector, and the first pair of the first pair of sensors The second detecting unit further includes a second connector electrically coupled to the second end of the second pair of inductors.

Also optionally, the inductive patch proposed herein may further comprise a release paper attached to the viscous surface of the patch body.

In various embodiments of the invention, the liquid is blood or an infusion. According to an optional embodiment of the invention, a medical preparation may be included in the infusion solution.

According to an optional embodiment of the present invention, the inductive patch may further include a frame attached to the other surface of the patch body and disposed along at least a portion of the periphery of the patch body. In some embodiments, the bezel is disposed along a perimeter of the patch body.

According to some embodiments of the invention, the patch body is made of a waterproof transparent film. Alternatively or additionally, the patch body proposed herein is made of a gas and vapor permeable material.

Another aspect of the present invention is directed to a detection system that can be used to detect liquid leaking from a target portion of a body.

According to an embodiment of the invention, the system comprises the inductive patch, the wearable detecting device and the warning device according to the above aspect/embodiment of the invention. When the first or second detecting unit of the inductive patch is turned on, it can be used to generate a first electrical signal or a second electrical signal, respectively. The wearable detection device includes a power source, a processing unit, and a wireless communication unit. The processing unit is electrically coupled to the power source and the first and second detecting units, and is configured to receive the first electrical signal and/or the second electrical signal. The processing unit can also be used to determine the individual impedance of the first and/or second electrical signals, and when (1) the impedance of the first electrical signal is greater than or equal to a threshold, and (2) When the impedance of the two electrical signals is less than the threshold or the second electrical signal is not generated, a leakage signal is generated. The wireless communication unit is electrically coupled to the power supply and the processing unit; and when receiving the leakage signal from the processing unit, the wireless communication unit can be used to transmit the leakage signal. The warning device is in communication with the wireless communication unit; and is used to generate a warning when receiving a leakage signal transmitted by the wireless communication unit.

According to some embodiments of the present invention, the first detecting unit further includes a first connector electrically coupled to the second second end of the first pair of sensors; and the second detecting unit further includes a first The second connector is electrically coupled to the second second end of the second pair of sensors; and the wearable detecting device further includes two sockets for respectively receiving the first and second connectors.

In some embodiments, the wearable detection device proposed herein further includes a substrate, and the power source, the processing unit, and the wireless communication unit are surface mounted on the base plate.

Optionally, the wearable detection device proposed herein may further include an analog/digital converter, an operational amplifier, and/or a pulse width modulator electrically coupled to the processing unit.

In some embodiments, the analog/digital converter can be used to convert the first electrical signal or the first and second electrical signals into a third signal, and the processing unit can be used to determine the output of the third electrical signal. The voltage, and the type of leakage liquid is determined according to the above output voltage.

According to various embodiments of the present invention, the processing unit may be a microprocessor, a microcontroller, a digital signal processor, an application specific integrated circuit (ASIC) or a field programmable gate array (field). Programmable gate Array, referred to as FPGA).

According to some embodiments of the present invention, the wireless communication unit is a Bluetooth module, a Bluetooth smart module, a near field communication (NFC) module, a microelectromechanical system (MEMS) module, and a WIFI. Module, radio frequency (RF) module or radio frequency identification (RFID) module.

In some embodiments, the alert device is a multimeter, a personal digital assistant (PDA), a personal computer, a notebook computer, a tablet computer, or a smart phone.

In some embodiments, the alerting device presented herein can further include a user interface that can be used to present the alert to a user and/or receive input from the user.

In some embodiments, the system presented herein can further include a carrier that can be used to house the wearable detection device and that can be worn on a body part of the individual.

In still another aspect of the invention, the invention provides a method for detecting liquid leaking from a target portion of a body using a detection system according to the above aspects/embodiments of the invention. In this case, the first first end of the first pair of sensors is placed in the first position, the first end of the second pair of sensors is placed in the second position, and the wearable detection The measuring device is worn on one of the body parts of the individual.

According to some embodiments of the invention, the method comprises the following step. The first and/or second electrical signals from the first and/or second detecting unit are received by the processing unit, and then the individual impedances of the first and/or second electrical signals are determined by the processing unit. When (1) the impedance of the first electrical signal is greater than or equal to a threshold, and (2) the impedance of the second electrical signal is less than the threshold or the second electrical signal is not generated, a leakage signal is generated by the processing unit. The leakage signal is transmitted to the warning device by the wireless communication unit. An alert is generated based on the leak signal described above using the alerting device.

In various embodiments of the invention, the liquid can be blood or an infusion. According to an optional embodiment, the infusion solution comprises a medical preparation.

The basic spirit and other objects of the present invention, as well as the technical means and implementations of the present invention, will be readily apparent to those skilled in the art of the invention.

100‧‧‧Inductive patch

102‧‧‧ Non-stick surface

104‧‧‧Adhesive surface

110‧‧‧SMD ontology

112‧‧‧Transparent observation window

120A, 120B‧‧‧ sensor

121A, 121B‧‧‧ first end

122A, 122B‧‧‧ second end

123‧‧‧ upper

124‧‧‧ lower

125‧‧‧Wire

126‧‧‧Insulation sheath

127‧‧‧First detection unit

128‧‧‧Second detection unit

130A‧‧‧First connector

130B‧‧‧Second connector

140‧‧‧ release paper

150‧‧‧Border

400‧‧‧Wearing detection device

405‧‧‧Power supply

410‧‧‧Processing unit

415‧‧‧Wireless communication unit

420‧‧ ‧ socket

425‧‧‧ Analog/Digital Converter

430‧‧‧Operational Amplifier

435‧‧‧ pulse width modulator

440‧‧‧ Warning device

500‧‧‧ wearable detection device

505‧‧‧Power supply

510‧‧‧Bridge Circuit

515‧‧‧Bluetooth Module

570A‧‧‧ Multimeter

570B‧‧‧ computer

570C‧‧‧Mobile Phone

The above and other objects, features, advantages and embodiments of the present invention will become more <RTIgt; <RTIgt; </ RTI> <RTIgt; </ RTI> <RTIgt; </ RTI> <RTIgt; 1 is a cross-sectional view of the inductive patch shown in FIG. 1 along line 2-2; FIG. 3 is a partial enlarged view of the first end of the inductor according to an embodiment of the present invention; and FIG. 4 is a block diagram. A wearable detection device and a warning device of a detection system according to an embodiment of the invention are illustrated; FIG. 5 is a schematic diagram showing a wearable detecting device and a warning device of a detecting system according to an embodiment of the invention.

The various features and elements in the figures are not drawn to scale, and are in the In addition, similar elements/components are referred to by the same or similar element symbols throughout the different drawings.

The description of the embodiments of the present invention is intended to be illustrative and not restrictive. The features of various specific embodiments, as well as the method steps and sequences thereof, are constructed and manipulated in the embodiments. However, other specific embodiments may be utilized to achieve the same or equivalent function and sequence of steps.

The scientific and technical terms used herein have the same meaning as commonly understood by those of ordinary skill in the art to which the invention pertains, unless otherwise defined herein. In addition, the singular noun used in this specification covers the plural of the noun in the case of no conflict with the context; the plural noun of the noun is also included in the plural noun used. In addition, the expressions "at least one" or "one or more" used in this case have the same meaning, and the representatives include one, two, three or more.

Although numerical ranges and parameter boundaries are used to define a broad range of values for the present invention, the relevant values in the specific embodiments are presented as precisely as possible. However, any value is intrinsically inevitable Contains standard deviation due to individual test methods. As used herein, "about" generally means that the actual value is within plus or minus 10%, 5%, 1%, or 0.5% of a particular value or range. Alternatively, the term "about" means that the actual value falls within the acceptable standard error of the average, depending on the considerations of those of ordinary skill in the art to which the invention pertains. Except for the experimental examples, or unless otherwise explicitly stated, all ranges, quantities, values, and percentages used herein are understood (eg, to describe the amount of material used, the length of time, the temperature, the operating conditions, the quantity ratio, and the like. Are all modified by "about". Therefore, unless otherwise indicated to the contrary, the numerical parameters disclosed in the specification and the appended claims are intended to be At a minimum, these numerical parameters should be understood as the number of significant digits indicated and the values obtained by applying the general carry method. In the present specification, the range of values is expressed as an end point from the end point to the other end or between the two ends; unless otherwise stated, all numerical ranges recited herein are intended to cover the endpoint.

In the present specification, the terms "liquid leakage" or "leakage" refer to liquid leakage and/or moisture generated at or around a target portion of a body. For example, the target site can be a body wound and the fluid can be blood or other bodily fluids that ooze from the wound. Alternatively, the target site may be a location where fluids (eg, blood or other body fluids, water, and solutions containing drugs, antibiotics, or other substances) are removed from the body, returned, and/or input into the body; in these cases, leakage Fluid usually occurs where the needle is inserted.

The word "subject" or "patient" refers to a sensor patch, detection system and method that can be used in the present disclosure. Animals, including humans. Unless otherwise specified, "individual" or "patient" covers both male and female animals.

Here, the detection results can be divided into four categories according to the actual situation and the detected data. Specifically, when the system claimed in this case correctly detects a leak, the result is true positive. On the other hand, the so-called false positive result means that the system erroneously determines that the leak is not positive. When the system does not detect liquid leakage, it is called a false negative result. The so-called true negative result means that the system correctly determines that there is no liquid leakage at the target site.

In this specification, the term "detection sensitivity" refers to the ability to correctly identify a leaking condition; therefore, the detection sensitivity is defined as the number of true positive cases divided by the total number of leaking conditions (ie, true). The sum of positive and false negative numbers). It is conceivable that when the number of false negatives increases or the number of true positives decreases, it will result in reduced sensitivity to detection. On the other hand, "detection specificity" refers to the ability to correctly exclude leaks, so it can be expressed as the number of true negative cases divided by the total number of un leaked conditions (ie, true negative and false positive cases) Sum). Therefore, when the true negative result is reduced or the false positive result is increased, the detection specificity is lowered.

In order to more accurately detect the leakage situation and reduce the occurrence of false positive results (such as those caused by sweating), the sensing patch proposed in the present disclosure has two detecting units, each of which includes a pair of sensors. . Thus, a first aspect of the present disclosure is an inductive patch that can be used to detect when it is applied to a body of a body. The liquid leakage of the target area covered by the patch.

Hereinafter, the structure of the inductive patch 100 according to an embodiment of the present invention will be described with reference to the schematic diagram of Fig. 1 and the cross-sectional view (Fig. 2) obtained along the tangent 2-2 of Fig. 1. As shown in FIG. 1 , the inductive patch 100 includes a patch body 110 , a first detecting unit 127 , and a second detecting unit 128 .

The patch body 100 has a non-adhesive surface 102 and a viscous surface 104. The viscous surface 104 can be used to fix the first detecting unit 127 and the second detecting unit 128 to the individual.

In some embodiments, the patch system is made of a transparent film (including a transparent film). The patch body may also be made of a non-transparent film such as conventional bandages and Band-Aids. In some optional embodiments, the patch body is made of a waterproof and/or gas and vapor permeable material.

The first detecting unit 127 includes two inductors 120A, and each of the inductors has a first end 121A and a second end 122A. Similarly, the second detecting unit 128 also includes two inductors 120B having a first end 121B and a second end 122B, respectively. The inductors 120A, 120B each include a wire 125 and an insulating sheath 126. The insulating sheath 126 encloses the wire 125 such that a portion of the first end of the wire is exposed but does not directly contact the skin of the individual. For the sake of brevity, the following description is only taken by the first detecting unit 127 as an example; however, the reader can understand that a similar description is also applicable to the second detecting unit 128. In addition, for convenience of explanation, each inductor is divided into an upper portion and a lower portion herein. As shown in FIG. 2, the upper portion 123 of the first end 121A of the inductor 120A is not insulated. The sheath 126 is covered, and the upper portion 123 is toward the adhesive surface 104 of the patch body 110; and the lower portion 124 of the first end 121A of the sensor 120A is still covered by the insulating sheath 126, and the inductive patch 100 is used. At time, the insulating sheath 126 at the lower portion 124 will be in direct contact with the skin of the individual.

Fig. 3 is a partially enlarged view of the inductor 120A of Fig. 1. At the first end 121A of the inductor 120A, the wire 125 at the upper portion 123 is not covered by the insulating sheath 126; thus, the exposed portion of the wire 125 can be utilized to detect leakage. On the other hand, the remaining portion of the lead 125 is covered by the insulating sheath 126; since the lead 125 does not come into direct contact with the individual's skin, it can interfere with the noise caused by the individual's skin condition (eg, sweat). Minimized.

Another advantage of the design of the exposed portion of the lead wire used in the present invention when using this inductive patch for any leak detection (e.g., during intravenous infusion) is that the proportion of false positive results can be reduced. For example, at the first first end 121A of the first pair of inductors 120A, the lower portion 123 of the wire 125 is still covered by the insulating sheath 126; therefore, the pair of two inductors 120A are not due to the target site or A small amount of sweat or moisture that is present around it is easily turned on, thus reducing the occurrence of false positive detection results. Conversely, the liquid present at the target site or its surroundings must reach a certain amount, for example, until the exposed portion of the wire 125 is covered by the accumulated liquid, the paired sensor 120A in the first detecting unit 127 is turned on. To achieve this goal, the exposed portion of the wire 125 and the size of the cladding portion must be properly designed to achieve higher sensitivity and specificity. According to various embodiments of the invention, the length of the exposed portion of the wire 125 The degree L is about 2.5 to 7.5 mm; for example, the length may be 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, or 7.5 mm. In accordance with certain embodiments of the present invention, the insulating sheath 126 may have a thickness of from about 0.1 to 0.5 mm; preferably 0.3 mm.

In order to ensure that the desired detection specificity is obtained, the distance D between the first ends 121A of the two sensors 120A in the first detecting unit 127 is preferably about 2.5 to 7.5 mm. According to various embodiments of the invention, the upper distance D may be 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7 or 7.5 mm. It can be seen from the experimental examples set forth below that if the distance between the paired inductors is larger than the above range, the paired inductors cannot be turned on under the test conditions, thereby causing a decrease in the true positive result and an increase in the false negative result. .

In use, the first end 121A of the pair of sensors 120A in the first detecting unit 127 is placed at a first position adjacent to the target portion, and the pair of sensors 120B in the second detecting unit 128 are One end 121B is placed at a second position away from the target site. It will be understood that the leaking liquid will usually leak from the target site before it will spread out from the target site. By properly configuring the positions of the first detecting unit 127 and the second detecting unit 128 relative to the target portion, when the liquid leakage occurs, the conduction of the first detecting unit 127 is earlier than the second detecting unit 128. . On the other hand, sweating usually does not occur only from a specific point; in fact, the situation of sweating occurs in a certain area of the body surface. Therefore, when sweating, the first and second detecting units 127, 128 are turned on at substantially the same time. In this way, the sensing patch 100 proposed herein can distinguish between leakage and sweating when performing liquid leakage detection. In both cases, the detection specificity is improved. In view of this, the relative position between the first detecting unit 127 and the second detecting unit 128 is very important for the inductive patch 100 described herein. According to various embodiments of the present invention, the distance between the first end 121A of the pair of sensors 120A of the first detecting unit 127 and the first end 121B of the pair of sensors 120B of the second detecting unit 128 is about 1 to 5 cm; such as 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5 or 5 cm. In other words, when the inductive patch 100 is actually used, the distance between the first position and the second position is about 1 to 5 cm.

In some embodiments, the inductive patch 100 further includes two connectors 130A and 130B. The second connector 122A of the pair of sensors 120A of the first connector 130A and the first detecting unit 127 are electrically coupled. Similarly, the second connector 122B of the second connector 130B and the second detecting unit 128 are electrically coupled to the second terminal 122B of the pair of sensors 120B.

Optionally, the inductive patch 100 can further include a release paper 140 attached to the adhesive surface 104 of the patch body 110. The release paper is used to protect the viscous surface 104 of the patch body 110 from dust. In use, the release paper 140 is removed to expose the viscous surface 104, which in turn can be applied to the skin of an individual.

In accordance with an optional embodiment of the present invention, the inductive patch 100 can further include a bezel 150. The frame 150 is attached to the non-adhesive surface 102 of the patch body 110 and disposed along at least a portion of the periphery of the patch body 100. The bezel 150 can be used to maintain the integrity of the shape of the inductive patch prior to applying the inductive patch 100 to the individual's skin. The frame 150 can also prevent the patch body during the application of the patch body 110. 110 itself overlaps or produces a fold. After the sensing patch 100 is applied to the target site of the individual, the frame 150 may be optionally removed; or, the frame 150 may be left in the patch body 110 without being removed. As shown in Fig. 1, the frame 150 is provided along the entire periphery of the patch body 110; however, the present invention is not limited thereto. In some embodiments, the perimeter of the patch body is only partially provided with the bezel.

In some optional embodiments, the patch body 110 is provided with a transparent viewing window 112, and the first ends 121A and 121B of each of the sensors 120A and 120B are disposed within the transparent viewing window 112. The transparent viewing window 112 enables medical care personnel to visually observe/monitor the condition of the target site. As shown in FIG. 1, the patch body 110 is transparent, and the perimeter of the transparent viewing window 112 is defined by the bezel 150. In an alternative example, the patch body 110 itself may be opaque, and a portion of the patch body 110 is hollowed out and replaced with a transparent film, thereby forming a transparent viewing window as described herein.

According to various embodiments of the present invention, the inductive patch 100 can be used in a liquid leakage detecting process, for example, to detect blood leaking from an individual's wound or intravenous injection site, or to detect a vein from an individual. Infusion solution for leakage at the injection site. In some cases, the infusion solution described above may comprise a therapeutic agent (eg, a chemotherapeutic agent).

Another aspect of the present disclosure is directed to a system for detecting liquid leakage from a target site of an individual.

According to an embodiment of the invention, the detection system includes the inductive patch shown in FIG. 1 and the wearable detecting device 400 and the warning device 440 shown in the block diagram of FIG. 4.

The wearable detection device 400 includes a power source 405, a processing unit 410, and a wireless communication unit 415.

The processing unit 410 is electrically coupled to the power source 405 and the first ends 121A and 121B of the sensors 120A and 120B of the inductive patch 100. According to some embodiments of the present invention, the processing unit 410 further includes two sockets 420, which can respectively accommodate the first and second connectors 130A and 130B to establish the processing unit 410 and the first and second detecting units 127 and Electrical connection between 128. As can be appreciated, the individual first ends 121A of the sensors 120A and 120B of the processing unit 410 and the inductive patch 100 can be implemented without the first and second connectors 130A and 130B and the socket 420 being used. Electrical connection between 121B. For example, the first ends 121A and 121B and the processing unit 410 can be in direct contact to achieve electrical coupling. Alternatively, the first ends 121A and 121B and the processing unit 410 are electrically coupled indirectly through other connection modes than the first and second connectors 130A and 130B and the socket 420 described above.

In use, the first pair of sensors 120A of the first detecting unit 127 are turned on to generate a first electrical signal, and the second pair of sensors 120B of the second detecting unit 128 is turned on to generate a second electric signal. The processing unit 410 is configured to receive the first and second electrical signals from the first detecting unit 127 and the second detecting unit 128, respectively. The processing unit 410 can also be used to determine individual impedances of the first and second electrical signals. In addition, the processing unit 410 can be further configured to determine whether there is a leakage condition based on the first and/or second electrical signals. Specifically, when (1) the impedance of the first electrical signal is greater than or equal to a predetermined threshold, and (2) the impedance of the second electrical signal is less than the The processing unit 410 can be used to generate a leak signal when the threshold is not predetermined or the second electrical signal is not generated.

It will be understood by those skilled in the art that the sensor may be turned on due to leakage, sweat or moisture present around the first end of the inductor to form a closed loop. Due to the different types of components that cause the paired inductors to conduct (eg, blood, drug-containing solution, sweat, moisture, etc.), the impedance of the closed loop formed by them is also different. Therefore, an impedance value of a liquid that can be used to identify sweat and other leaks can be experimentally determined as a threshold, and a Wheatstone bridge is designed based on the threshold. According to some embodiments of the present invention, the processing unit 410 may include the above-described Wheatstone bridge circuit or its equivalent for determining the impedance of the first and second electrical signals. For example, in one embodiment, a Wheatstone bridge circuit can be designed using a resistance value of 160 KΩ as a threshold value, which is approximately equal to the impedance value of 0.5 ml of sweat formed on the body surface. In this way, when the impedance of the closed loop formed by the paired inductors is greater than or equal to a predetermined threshold, the processing unit 410 can determine that the electrical signal on the loop is other than sweat (eg, blood or Triggered by the drug solution).

According to various embodiments of the present invention, the processing unit 410 may be a microprocessor, a microcontroller, a digital signal processor, or an application specific integrated circuit. Referred to as ASIC) or field programmable gate array (FPGA).

The wireless communication unit 415 is electrically coupled to the power source 405 and the processing unit 410. During operation, the wireless communication unit 415 is configured to receive a liquid leakage signal from the processing unit 410 and wirelessly transmit the leakage signal to the warning device 440.

According to some embodiments of the present invention, the wireless communication unit 415 may be a Bluetooth module, a Bluetooth smart module, a near field communication (NFC) module, or a microelectromechanical system. -based, referred to as MEMS) module, WIFI module, radio frequency (RF) module or radio frequency identification (RFID) module.

In some embodiments, the wearable detecting device 400 proposed herein may further include a substrate (not shown in FIG. 4), and the power source 405, the processing unit 410, the wireless communication unit 415, and the socket 420, And other optional components described below are mounted on the substrate by surface mount technology (SMT).

For example, the wearable detection device 400 proposed herein may further include an analog to digital converter 425. The analog/digital converter 425 can be used to convert the received analog signal or processed analog signal (e.g., via the processing unit 410 or any other component processor described herein) to a digital signal. In some embodiments, the analog/digital converter 425 can convert the first electrical signal or the first and second electrical signals to a third signal; and the processing unit 410 can determine the output voltage (Vo) of the third electrical signal. And according to this output voltage To determine the type of liquid leaking.

According to an optional implementation, the wearable detection device 400 proposed herein may further include an operational amplifier 430. The operational amplifier 430 can be used to amplify the received signal or the processed signal (eg, via the processing unit 410 or any other component processor described herein), thereby enhancing the detection of the wearable detection device 400. Sensitive.

Optionally, the wearable detection device 400 proposed herein may further include a pulse width modulator (PWM) 435. The pulse width modulator 435 can be used in conjunction with a timer to adjust the duty cycle of the wearable detection device 400, thereby greatly reducing the power consumption of the wearable detection device 400.

In some embodiments, the power supply 405 presented herein includes a battery.

Optionally, the wearable detecting device 400 can include a housing (not shown in FIG. 4), and all components constituting the wearable detecting device 400 can be disposed in the housing.

The alert device 440 and the wireless communication unit 415 are communicatively coupled. During use, the alerting device 440 is configured to receive a leak signal from the wireless communication unit 415 and thereby generate an alert to leak to a user, such as a medical care professional or the individual.

In some embodiments, the alerting device 440 can be a multimeter, a personal digital assistant (personal digital) Assistant (referred to as PDA), personal computer, notebook, tablet computer or smart phone.

According to various embodiments of the present invention, the alert device 470 may generate sound, voice, text, graphics, light, and/or vibration after receiving the leak signal to alert the user.

In some embodiments, the alerting device 440 proposed herein can further include a user interface (not shown in FIG. 4) that can be used to alert the user and/or receive input from the user. For example, the alerting device 440 can include a display screen (not shown in FIG. 4) to present the user interface to the user, and the alert can utilize a pop-up window with text or graphical prompts. (pop-up window) to render.

In some embodiments, the detection system proposed herein may further include a carrying member (not shown in FIG. 4) that can be used to accommodate the wearable detecting device 400 and can be worn on the body of the individual. The appropriate part. For example, the carrying member may optionally be provided with a pocket, a hole or a recess to accommodate the wearable detecting device 400. Alternatively, the carrier member is provided with a securing member, such as a latching member or hook-shaped fiber (e.g., VELCO® fastener), such that the wearable detecting device 400 with the corresponding securing member can be attached to the carrying member.

According to various embodiments of the invention, the carrier described above may be prepared in the form of a wristband or an armband. In this case, the wristband or armband can be wrapped around the individual's wrist or arm. When it is conceivable, the carrier can also be worn on any other suitable body part, such as an ankle, Foot, leg, hand, head, neck, chest, abdomen, buttocks, etc.

Alternatively, the wearable detecting device 400 can be attached to the skin of an individual using a medical tape or an elastic band.

In accordance with yet another aspect of the present disclosure, the present invention provides a method for detecting liquid leaking from a target portion of a body. This detection method employs the detection system described in the above aspect/embodiment of the present invention.

Prior to beginning the detection method described herein, the medical caregiver applies an inductive patch (e.g., the inductive patch 100 shown in Figure 1) to the individual's body. Specifically, the first first end 121A of the first pair of sensors 120A is placed at a first position adjacent to the target portion, and the first first end 121B of the second pair of sensors 120B is placed at a second position away from the target portion. Positioning; thereafter or at the same time, the first and second detecting units 127 and 128 are respectively fixed to the first and second positions by the adhesive surface 104 of the patch body 110. In addition, a wearable detecting device (for example, the wearable detecting device 400 shown in FIG. 4) is disposed at an appropriate part of the individual body, and the first connector 130A and the second connector 130B are respectively inserted into the second bearing. In the socket 420, an electrical connection between the sensing patch 100 and the wearable detecting device 400 is established.

According to various embodiments of the invention, the detecting method comprises the following steps. The processing unit 410 receives the first electrical signal transmitted by the first detecting unit 127 and/or the second electrical signal transmitted by the second detecting unit 128. Processing unit 410 processes the first and/or second electrical signals to determine an impedance of the first and/or second electrical signals. When (1) the first electrical signal The processing unit 410 generates a liquid leakage signal when the impedance is greater than or equal to a threshold and (2) the impedance of the second electrical signal is less than the threshold or the second electrical signal is not generated. The wireless communication unit 415 wirelessly transmits the leak signal to the alert device 470. The alert device 470 issues an alert (eg, sound, voice, text, graphics, light, and/or vibration) based on the leak signal described above. The user is notified of the leakage occurring at the target site.

According to various embodiments of the invention, the detection method can be used to detect blood leakage that occurs at the wound or injection site of the individual; or can be used to detect leakage of the infusion agent that occurs at the injection site of the individual. In some cases, the infusion solution can comprise a medical formulation.

In the following, a plurality of experimental examples are set forth to illustrate certain aspects of the present invention, and the present invention is not limited by the scope of the present invention. It is believed that the skilled artisan, after reading the description set forth herein, may fully utilize and practice the invention without undue interpretation. All publications cited herein are hereby incorporated by reference in their entirety.

Experimental example 1

In the experimental example below, the wearable detection device proposed herein was constructed using a CC2540 Bluetooth chip (available from Texas Instruments) equipped with a programmable 8051 microprocessor. In order to obtain a smaller size (18*11*4 mm), various components are surface-mounted on both sides of the wafer. The wearable detection device proposed herein has an average Bluetooth transmission distance of about 10-50 meters. Power is supplied to the wafer using a CR 2032 battery (220 mAh); the average life of the battery is approximately 3,241 when the wearable detection device operates at a transmission rate of 1 per second. bell.

In order to determine the distance between the first ends of the pair of sensors in the pair of sensors, so that the palm of the experiment individual faces upward, the sensing patch with only one pair of sensors is fixed to the forearm of the individual; The distance between them is 2.5, 5 or 10 mm (n=3). The second end of the two inductors is coupled to a connector, and the connector is coupled to the socket on the wearable detection device. Thereafter, 1 ml of blood was slowly injected into the target portion adjacent to the first end of the two sensors using a needle; the volume injected when the warning was triggered was recorded, and the experimental results are summarized in Table 1.

As can be seen from the data in Table 1, when the individual first ends of the paired sensors are separated by 10 mm, the sensor cannot detect the presence of blood even if 1 ml of blood is injected into the target portion. On the other hand, using a pitch of 2.5 or 5 mm allows the inductive patch to detect the presence of blood in a relatively small volume.

However, the test results also show that false positive detection results may occur when the distance between the first ends used for detection is too close (eg, 2.5 mm apart). However, the inductive patch of the present invention Two pairs of sensors are used, which reduces the incidence of false positive detection results; and thus, according to various embodiments of the present invention, proper detection sensitivity is maintained when the sensor spacing is 2.5 mm. / Specificity.

Experimental example 2

In this experimental example, the detection time of the sensing patch and the detectable liquid volume are determined. In the three experimental groups, the first ends of the paired sensors (5 mm apart) were placed as follows: placed over an additional high-permeability adhesive bandage (experimental group 1), without high permeability Adhesive bandages (experimental group 2) and placed under an additional high-permeability adhesive bandage (experimental group 3) (n=3). Thereafter, the blood is slowly injected by the needle to the target portion adjacent to the first end of the pair of sensors until the warning device issues a warning. Record the amount of blood injected at the time of the warning and the time taken from the start of the injection to the warning. The results are summarized in Table 2.

The data in Table 2 indicates that when the paired sensor is placed above the adhesive bandage (experimental group 1), the wearable detecting device described in the present case Leakage can only be detected in the case of large leaks (eg, about 3.3 to 3.5 ml of blood) and after a prolonged period of time (eg, about 33 to 35 seconds after the start of the injection). . On the other hand, if the paired sensor is directly in contact with the skin of the individual (experimental group 2), it can be detected in a small volume (0.14 to 0.17 ml) and a shorter time (1 after the start of the injection). To leak. In addition, the placement of an adhesive bandage (experimental group 3) above the first end of the paired sensor compared to experimental group 2 also delays the time of correct detection and increases the volume of detectable liquid.

Experimental example 3

In this experimental example, a set of sensors was first used to confirm the impedance values formed by different liquids (0.5 ml) on the body surface. The test results showed that the impedance of the blood was 520 KΩ, the impedance of the glucose solution of 200 mg/mL was 550 KΩ, the impedance of the sweat was 160 KΩ, and the impedance of the physiological saline was 360 KΩ. Next, using this result to design a bridge circuit, the bridge circuit described below uses an impedance threshold of 100 KΩ.

Then, the wearable detecting device 500 shown in FIG. 5 is used and combined with two sets of sensors to detect leakage of different liquids. FIG. 5 illustrates a power supply 505 (3V), a bridge circuit 510, and a Bluetooth module 515 of the wearable detection device 500. The wearable detection device 500 can be coupled to a plurality of alert devices; for example, it can be electrically coupled to a multimeter 570A (such as a Ketheley 2000 multimeter), or can be communicatively coupled through the Bluetooth module 515 and the computer 570B or the mobile phone 570C. . One end of the bridge circuit 510 connected to the second set of inductors is connected across a 1 MΩ resistor.

Configuring the wearable detection device in the manner described in Experimental Example 1. After the 500 and the inductive patch are placed, 0.3 ml of various liquids or sweat are separately injected into the adjacent first or second group of sensors to measure the closed loop formed by the sweat, the different liquids or a combination thereof on the body surface. Analog to digital conversion output value (ADC value) and output voltage (Vo); the results are summarized in Table 3.

As can be seen from the data in Table 3, when the output voltage is in the range of -0.11 V to -0.3 V, it is a case where there is no liquid leakage. On the other hand, in other groups, it is possible to judge whether the leaked liquid is blood, physiological saline or glucose solution based on the detected output voltage.

Experimental example 4

In this experimental example, the wearable detecting device 500 described in the above Experimental Example 3 is used and the two sets of sensors are combined with two sets of inductors, and the first end of each sensor is in direct contact with the skin of the individual, and the two pairs of sensors are in contact with each other. One end is 5 mm apart. Thereafter, a different test liquid (blood, 200 mg/mL glucose solution and physiological saline) or sweat is slowly injected into the target portion adjacent to the first end of the first pair and the second pair of sensors, respectively, by means of a needle until the warning device Just issue a warning. Record the amount of test fluid injected at the time of the warning and the time taken from the start of the injection to the warning. The results are summarized in Table 4.

It can be seen from the data in Table 4 that the liquid leakage detecting system described in the present case can detect about 0.2 ml of liquid leakage about one second after the liquid leakage occurs.

Although the embodiments of the present invention are disclosed in the above embodiments, the present invention is not intended to limit the invention, and the present invention may be practiced without departing from the spirit and scope of the invention. Various changes and modifications may be made thereto, and the scope of the invention is defined by the scope of the appended claims.

100‧‧‧Inductive patch

110‧‧‧SMD ontology

112‧‧‧Transparent observation window

120A, 120B‧‧‧ sensor

121A, 121B‧‧‧ first end

122A, 122B‧‧‧ second end

125‧‧‧Wire

126‧‧‧Insulation sheath

127‧‧‧First detection unit

128‧‧‧Second detection unit

130A‧‧‧First connector

130B‧‧‧Second connector

140‧‧‧ release paper

150‧‧‧Border

Claims (28)

An inductive patch, which can be used to detect a liquid leaking from a target portion of a body during a liquid leakage detecting process, comprising: a first detecting unit comprising a first pair of sensors each having a The first end of the first detecting unit is disposed at a first position adjacent to the target portion, and the second detecting unit includes a second pair of sensors respectively having a first end. a first end of the second detecting unit is disposed at a second position away from the target portion; and a patch body having a viscous surface for fixing the first and second detecting units In the individual; each of the inductors includes a wire and an insulating sheath, wherein the insulating sheath covers the wire such that a portion of the first end of the wire is exposed but does not directly contact the skin of the individual; The first ends of the two sensors in one and the second detecting unit are spaced apart from each other by 2.5 to 7.5 mm. The inductive patch of claim 1, wherein the portion of the lead exposed is 2.5 to 7.5 mm in length. The inductive patch of claim 2, wherein the length is 5 mm. The inductive patch of claim 1, wherein the first location and the The second position is 1 to 5 cm apart. The inductive patch of claim 1, wherein the insulating sheath has a thickness of 0.1 to 0.5 mm. The inductive patch of claim 1, wherein the first detecting unit further includes a first connector electrically coupled to the second end of the first pair of sensors; and the second detecting unit Further comprising a second connector electrically coupled to the respective second ends of the second pair of inductors. The inductive patch of claim 1 further comprising a release paper attached to the adhesive surface of the patch body. The inductive patch of claim 1, wherein the liquid is blood or an infusion. The inductive patch of claim 8, wherein the infusion solution comprises a medical preparation. The inductive patch of claim 1 further comprising a frame attached to the other surface of the patch body and disposed along at least a portion of the periphery of the patch body. The inductive patch of claim 10, wherein the bezel is disposed along a perimeter of the patch body. The inductive patch of claim 1, wherein the patch system is made of a waterproof transparent film. The inductive patch of claim 1 wherein the patch system is made of a gas and vapor permeable material. A detecting system for detecting a liquid leaking from a target portion of a body, comprising: the sensing patch of claim 1, wherein the first pair of sensors are turned on, the first The detecting unit is configured to generate a first electrical signal; and when the second pair of sensors is turned on, the second detecting unit is configured to generate a second electrical signal; and the wearable detecting device comprises: a power source a processing unit electrically coupled to the power source and the first and second detecting units, wherein the processing unit is configured to determine an individual impedance of the first and second electrical signals; and when (1) the first When the impedance of an electrical signal is greater than or equal to a threshold, and (2) the impedance of the second electrical signal is less than the threshold or the second electrical signal is not generated, a leakage signal is generated; a wireless communication unit, and the power supply and the The processing unit is electrically coupled and configured to transmit the leakage signal generated by the processing unit; And a warning device, being in communication with the wireless communication unit, and generating an alert when receiving the leakage signal transmitted by the wireless communication unit. The detection system of claim 14, wherein the first detecting unit further comprises a first connector electrically coupled to the second end of the first pair of sensors; the second detecting unit Further comprising a second connector electrically coupled to the respective second ends of the second pair of sensors; and the wearable detecting device further includes two sockets for respectively receiving the first and second connectors. The detection system of claim 14, wherein the wearable detection device further comprises a substrate, and the power source, the processing unit and the wireless communication unit are surface mounted thereon. The detection system of claim 14, wherein the wearable detection device further comprises an analog/digital converter electrically coupled to the processing unit. The detection system of claim 17, wherein the analog/digital converter is configured to convert the first electrical signal or the first electrical signal and the second electrical signal into a third signal; The processing unit is configured to determine an output voltage of the third electrical signal, and determine a type of the leaked liquid according to the output voltage. The detection system of claim 14, wherein the wearable detection device further comprises an operational amplifier electrically coupled to the processing unit. The detection system of claim 14, wherein the wearable detection device further comprises a pulse width modulator electrically coupled to the processing unit. The detection system of claim 14, wherein the processing unit is a microprocessor, a microcontroller, a digital signal processor, an application specific integrated circuit (ASIC) or a field programmable gate Field programmable gate array (FPGA). The detection system of claim 14, wherein the wireless communication unit is a Bluetooth module, a Bluetooth smart module, a near field communication (NFC) module, and a microelectromechanical system-based (microelectromechanical system-based, Referred to as MEMS) module, WIFI module, radio frequency (RF) module or radio frequency identification (RFID) module. The detection system of claim 14, wherein the alert device is A multimeter, personal digital assistant (PDA), personal computer, laptop, tablet or smart phone. The detection system of claim 14, wherein the alerting device further comprises a user interface for presenting the alert to a user and/or receiving input from the user. The detection system of claim 14, further comprising a carrying member for accommodating the wearable detecting device and being wearable to a body part of the individual. A method for detecting a liquid leaking from a target portion of a body, wherein the detecting system of claim 14 is used, wherein the first first end of the first pair of sensors is placed on the first Position, the first pair of the first pair of sensors is placed in the second position, and the wearable detecting device is worn on a body part of the individual, and the method includes: determining, by the processing unit, the first And/or an individual impedance of the second electrical signal; when (1) the impedance of the first electrical signal is greater than or equal to a threshold, and (2) the impedance of the second electrical signal is less than the threshold or the second electrical signal is not generated Using the processing unit to generate a liquid leakage signal; transmitting the liquid leakage signal to the warning device by using the wireless communication unit; An alert is generated based on the leak signal by the alerting device. The method of claim 26, wherein the liquid is blood or an infusion. The method of claim 27, wherein the infusion solution comprises a medical preparation.