Biological body contact detection sensor and biological body contact detection apparatus using the same

Abstract

The present application provides a living body contact detection sensor and a living body contact detection device using the same, which can detect in advance that a patient himself / herself removes a medical catheter or detaches a bandage, a dressing, a skin-adhesive tape or the like, and which includes a sheet-like base material and a detection portion made of a conductive material provided on one or both surfaces of the base material, the detection portion being made of one or more pairs of wires or electrodes having different polarities, and at least any one of current, voltage and resistance of the wires or electrodes being changed by contact with a living body.

Description

Technical Field

[0001] This invention relates to a sensor for detecting contact with a living organism, and more particularly to a biological contact detection sensor for detecting contact made by a wearer in order to remove or peel off the device, and a biological contact detection device using the biological contact detection sensor. Background Technology

[0002] In hospitals and other medical facilities, medical catheters are left in the patient's body for treatment, such as during extracorporeal circulation for dialysis or when medication is administered via intravenous drip. Additionally, bandages and dressings (including "skin-jointing tape," hereinafter the same) are used to protect wounds after surgery. However, the patients receiving these treatments are diverse, and sometimes, patients with severe or mild impairment of consciousness, dementia, or insufficient understanding of the treatment devices or their use may remove the medical catheters or remove the bandages or dressings themselves.

[0003] Therefore, several techniques for detecting the removal of the aforementioned medical catheters have been proposed in the past. For example, in Patent Document 1 (Japanese Utility Model Application Publication No. 5-79468), a soft leakage detection device is proposed, in which two or more foil-shaped electrodes are sandwiched between a synthetic resin strip and a synthetic resin non-woven fabric strip, and a sensor with an adhesive layer on the surface of the non-woven fabric strip is attached near the indwelling needle. The leakage of drip fluid or blood is detected by the short circuit between the electrodes when the non-woven fabric strip comes into contact with the electrodes, thereby indirectly detecting the removal of the indwelling needle.

[0004] Furthermore, as a technique for detecting signs related to the removal of an IV drip needle before it is withdrawn, Patent Document 2 (Japanese Patent Application Publication No. 2015-66071) discloses a monitoring device comprising: a first detection unit that detects the state of the site where the IV drip needle is inserted into the monitored object based on an image of the monitored object; a second detection unit that detects the state of the tube connected to the IV drip needle based on the image; a determination unit that determines whether there is a possibility of the IV drip needle being removed based on a change in at least one of the detected state of the IV drip needle insertion site and the state of the tube; and an output unit that outputs an alarm indicating the possibility of the IV drip needle being removed if it is determined that there is a possibility of the IV drip needle being removed.

[0005] Existing technical documents

[0006] Patent documents

[0007] Patent Document 1: Japanese Utility Model Application Publication No. 5-79468

[0008] Patent Document 2: Japanese Patent Application Publication No. 2015-66071 Summary of the Invention

[0009] The problem that the invention aims to solve

[0010] While the flexible leakage detection device in document 1 can detect needle removal by detecting leaked fluid or blood, it is difficult to prevent needle removal altogether. Furthermore, in patent document 2, the likelihood of removal is predicted based on the state of the insertion site of the IV needle and the state of the tube. Although this can prevent needle removal itself, it is ultimately only a prediction, and there is room for improvement in accuracy.

[0011] Therefore, the first objective of this invention is to provide a biological contact detection sensor and a biological contact detection device using the biological contact detection sensor, which can detect in advance when a patient removes a medical catheter or removes bandages, dressings, skin-sealing tape, etc.

[0012] Furthermore, a second objective of the present invention, which differs from the first objective described above, is to provide a biological contact detection sensor and a biological contact detection device using the biological contact detection sensor. This biological contact detection sensor is used not only to monitor contact between a biological body and the surgical site on a patient, but also to monitor whether a biological body has made contact in various applications.

[0013] Technical solutions for solving the problem

[0014] In order to solve at least one of the above-mentioned problems, the present invention provides a biological contact detection sensor and a biological contact detection using the biological contact detection sensor, the biological contact detection sensor being configured to obtain the presence or absence of biological contact through an electrical signal (including current and resistance value).

[0015] That is, in this invention, a biological contact detection sensor for detecting contact with a living organism is provided, which includes a sheet-like substrate and a detection part made of conductive material disposed on one or both sides of the substrate. The detection part is composed of a pair or more wires or electrodes with different polarities, and the wires or electrodes are configured to cause at least one of current, voltage and resistance to change due to contact with the living organism.

[0016] Furthermore, in the biological contact detection sensor of the present invention described above, the detection unit is composed of a pair or more wires or electrodes that are not electrically connected to each other, the conductive material of the wires or electrodes is exposed, and they are formed at intervals that would cause an electrical short circuit due to contact with a biological organism.

[0017] Furthermore, in the biological contact detection sensor of the present invention described above, the detection unit is composed of a pair or more wires or electrodes that are electrically connected to each other, the conductive material of which is exposed, and can be formed at intervals in which at least one of the current, voltage and resistance changes due to contact with a biological body.

[0018] In the biological contact detection sensor according to the present invention described above, the detection unit is formed by arranging one or more pairs of wires or electrodes of different polarities adjacently or oppositely, the wires or electrodes being separated at intervals such that at least one of the current, voltage, and resistance changes due to contact with a biological body. That is, when the pair of wires or electrodes is arranged adjacently, energization occurs via the biological body due to contact, and at least one of the current, voltage, and resistance changes. Conversely, when the pair of wires or electrodes is arranged oppositely, energization occurs due to contact with the biological body, the wires or electrodes come into contact with each other, and at least one of the current, voltage, and resistance changes. Particularly when the wires or electrodes are arranged adjacently, it is preferable to configure the wires or electrodes such that their conductive material is exposed to the outside so that energization occurs due to contact with a biological body.

[0019] The detection unit can adjust its detection sensitivity according to the necessity or urgency of detecting contact with a living organism. This adjustment of sensitivity can be achieved by modifying the material or thickness of the wiring or electrodes constituting the detection unit, or by adjusting their spacing (distance). For example, when detecting contact with a living organism fitted with medical devices such as artificial respiration, feeding catheters, or arterial lines, the urgency of detecting the contact is high, so the spacing between the wiring or electrodes can be set to 1 to 5 mm to increase the sensitivity of the detection unit. Conversely, when detecting contact with a living organism such as a distal indwelling needle, wound, urethral catheter, or diaper, the urgency of detecting the contact may be low, so the spacing between the wiring or electrodes can be set to 1 to 10 mm to decrease the sensitivity of the detection unit.

[0020] Furthermore, the sensitivity of the detection unit can be adjusted according to the part of the body it contacts. For example, to detect contact with the entire hand, the spacing between the wiring or electrodes can be set to 5 to 30 mm to reduce the detection sensitivity; to detect contact with a finger or similar object, the spacing between the wiring or electrodes can be set to 1 to 7 mm to increase the detection sensitivity. That is, in the biological contact detection sensor according to the present invention, the sensitivity during biological contact can be adjusted by adjusting the width or spacing of the wiring or electrodes. Moreover, by setting or adjusting the threshold in the judgment module described later based on the detection sensitivity of the detection unit, a biological contact detection sensor with fewer false alarms and fewer false negatives can be realized.

[0021] The sheet-like substrate with the aforementioned detection section can be formed from various materials such as resin sheets or fabric. To prevent short circuits between the wiring or electrodes constituting the detection section, at least the surface where the detection section is located can be made of an electrically insulating material. Furthermore, when the aforementioned bio-contact detection sensor is worn on a patient, the substrate can also be formed from a flexible sheet. Additionally, if the wiring or electrodes are not stretchable, to prevent breakage, the substrate can be formed from a sheet with little or no stretchability. When the substrate is made of a stretchable and flexible sheet, it can follow the flexion and extension movements of the wearer and reduce discomfort during wear. On the other hand, considering the possibility of wire breakage, the substrate can use a non-stretchable sheet, or a flexible sheet with sufficient flexibility to prevent wire or electrode breakage. Particularly when the wiring or electrodes are made of carbon, the substrate is preferably a sheet with strength sufficient to prevent carbon breakage. Moreover, when the substrate is used directly attached to the patient's epidermis, it is preferably formed from a biocompatible material, such as a material that has passed a biocompatibility test based on ISO standards.

[0022] Considering ease of wearing on the patient, it is preferable to provide a wearing part on the substrate. This is to improve versatility by allowing it to be worn on various parts of the body. In addition to providing adhesive or Velcro on either side of the substrate, this wearing part can also be formed into a structure that allows the substrate to be wrapped around the affected area for fixation. For example, when wearing the bio-contact sensor on top of a bandage, the material selected for wearing on the bandage is preferably a paste or adhesive corresponding to the area of ​​application. Furthermore, this wearing part is preferably easy to wear while having a structure that the patient cannot easily remove themselves. Alternatively, without the aforementioned wearing part, the bio-contact sensor can be fixed using tape or magnets.

[0023] The bio-contact detection sensor of the present invention can be directly attached to the skin, or to medical devices such as cannulas, or worn after the treatment area of ​​medical devices such as indwelling IV needles is protected with bandages. Especially when worn after protecting the treatment area with bandages, when a patient touches the bio-contact detection sensor of the present invention, the contact needs to be detected and reported before the bandages are removed. Therefore, it takes time to reach the unwanted treatment area and remove (or remove) the IV needle or other medical device. In other words, a certain amount of time is required from detecting the patient's contact to removing the medical device, allowing caregivers such as nurses to respond and prevent the removal from happening.

[0024] Furthermore, a detection portion formed of a conductive material can be provided on one or both sides of the substrate. This detection portion can consist of a pair or more wires or electrodes with different polarities, which can be formed by coating or printing the material of the wires or electrodes onto the substrate, such as a conductive material like silver, copper, carbon, or tin oxide. This conductive material can be conductive paste or conductive paint, etc. However, the wires or electrodes can also be formed by embedding metal wires in the substrate. This detection portion can be used without particular restriction as long as at least one of the current, voltage, and resistance changes due to contact with a biological body between a pair or more wires or electrodes with different polarities. Additionally, the wires or electrodes can be formed in a strip shape, and wires or electrodes with different polarities can be arranged alternately adjacent to each other.

[0025] There may be instances where the current, voltage, and resistance of the wiring or electrodes disposed on the substrate change even when in contact with conductive parts other than a living organism (such as a metal bed frame). Therefore, when the wiring or electrodes are energized via a living organism, it is preferable to provide an insulating shielding member covering the wiring or electrodes so that at least one of the current, voltage, and resistance does not change when in contact with a conductive part. That is, the patient must come into contact with the bio-contact detection sensor to remove medical catheters, bandages, dressings, skin grafts, etc., and must remove the shielding member to make contact with the bio-contact detection sensor.

[0026] The aforementioned shielding component is made of insulating material covering the detection unit, primarily serving to prevent false alarms when the detection unit comes into contact with a metal part. Therefore, it is preferable that at least the surface in contact with the detection unit is formed of an insulating material. Furthermore, the shielding component can be rigid or flexible, preferably formed in the form of a sheet, film, or tube. Further, the shielding component can also be an elastic fabric (tubular bandage), protective gear, cuff, etc.

[0027] Furthermore, in order to solve at least one of the above-mentioned problems, the present invention provides a biological contact detection device, which includes: a biological contact detection sensor according to the present invention; and a determination module that determines whether there is biological contact based on the change of at least one of current, voltage and resistance obtained by the detection unit in the biological contact detection sensor.

[0028] The judgment module in this biological contact detection device can be configured to output a biological contact signal indicating that there has been contact with a biological body when the change in at least one of the current, voltage, and resistance measured by the detection unit exceeds a preset threshold. Therefore, this judgment module can maintain a threshold corresponding to the intended use or the structure or characteristics of the biological contact detection sensor used; by setting this threshold, false alarms or missed alarms can be reduced. This judgment module can be configured using a numerical calculation device.

[0029] Furthermore, in order to solve at least one of the aforementioned problems, this invention provides a biological contact detection method for detecting contact with a living organism. The method involves placing a medical retainer such as a bandage or tape (i.e., a device for holding a medical instrument or medical material onto a living organism) in the target area of ​​the wearer's body, and placing a biological contact detection sensor on top of the medical retainer. The bandage, tape, or other medical retainer can be placed in any position, but is preferably placed in a position where it takes at least 10 seconds, more preferably 20 seconds, for the wearer to remove it.

[0030] Furthermore, in order to solve at least one of the aforementioned problems, this invention provides a method for preventing self-removal of medical devices such as catheters and dressings (i.e., medical devices worn on a living organism, including medical catheters and said medical retaining devices). The method involves placing a medical retaining device such as a bandage or tape in the placement area of ​​the medical device, and placing a bio-contact detection sensor on the top of the retaining device to detect contact with a living organism. By detecting contact with a living organism through the bio-contact detection sensor, self-removal of the medical device is prevented. The placement of the medical retaining device such as the bandage or tape can be arbitrary, but as described above, it is preferably placed in a manner that requires at least 10 seconds, more preferably at least 20 seconds, for removal by the wearer.

[0031] Invention Effects

[0032] The bio-contact detection sensor for detecting contact with a living organism according to the present invention includes a sheet-like substrate and a detection part made of conductive material disposed on one or both sides of the substrate. The detection part is composed of a pair or more wires or electrodes with different polarities, the conductive material of which is exposed and formed at intervals in which at least one of current, voltage, and resistance changes due to contact with a living organism. The bio-contact detection device using the bio-contact detection sensor is formed by the bio-contact detection sensor and a determination module, which determines whether there is contact with a living organism based on the change in at least one of current, voltage, and resistance obtained by the detection part.

[0033] This bio-contact detection sensor of the present invention can determine whether bio-contact has occurred when a patient, as a wearer, comes into contact with a pair or more wires or electrodes of different polarities using a part of their own body (such as a hand or arm). This is based on changes in at least one of the current, voltage, and resistance through the wires or electrodes. Therefore, a bio-contact detection sensor and a bio-contact detection device using the same sensor can be provided, which can detect contact with the detection part before the patient removes medical catheters, bandages, dressings, skin-adhesive tape, etc., thus enabling the detection of these actions in advance.

[0034] Furthermore, the biological contact detection sensor and the biological contact detection device using the biological contact detection sensor can detect biological contact based on changes in at least one of current, voltage, and resistance. Therefore, it is possible to provide a biological contact detection sensor and a biological contact detection device using the biological contact detection sensor. The biological contact detection sensor can be used not only to monitor biological contact with a patient's surgical site, but also for various purposes of detecting or monitoring whether a biological contact has occurred. Attached Figure Description

[0035] Figure 1 This is a perspective view of the biological contact detection sensor according to the first embodiment.

[0036] Figure 2 It means in Figure 1 An exploded perspective view of the biological contact detection sensor with a shielding component installed.

[0037] Figure 3 This is an exploded perspective view of the biological contact detection sensor according to the second embodiment.

[0038] Figure 4 This is an exploded perspective view of the biological contact detection sensor according to the third embodiment.

[0039] Figure 5 This is an exploded perspective view of the biological contact detection sensor according to the fourth embodiment.

[0040] Figure 6 This is a diagram illustrating the usage status of a body contact detection device constructed using a biological body contact detection sensor.

[0041] Figure 7 This is a table showing the experimental results of the embodiments. Detailed Implementation

[0042] Hereinafter, with reference to the accompanying drawings, the biological contact detection sensor 10 and the biological contact detection device 60 using the biological contact detection sensor according to this embodiment will be specifically described. In particular, this embodiment specifically shows the biological contact detection sensor 10 and the biological contact detection device 60 using the biological contact detection sensor 10. The biological contact detection sensor 10 is worn on a patient in a medical facility or the like, and can detect in advance when the patient intentionally removes medical catheters or removes bandages, dressings, skin-jointing bandages, etc.

[0043] Figure 1 The bio-contact detection sensor 10 according to the first embodiment shown includes a sheet-like substrate 11 and a detection portion 15 made of conductive material disposed on one or both sides of the substrate 11. In this embodiment, the substrate 11 is formed using a PET sheet with a thickness of 0.075 mm, and is particularly formed into a quadrilateral shape. However, the substrate 11 can also be formed using other resin materials, or even fabric. In addition, the shape of the substrate 11 can be appropriately changed depending on the location where the substrate 11 is disposed, for example, in addition to being formed into a strip to be wrapped around the target area, it can also be formed into various shapes such as circular or elliptical. Furthermore, in addition to a planar shape, the substrate 11 can also be formed into a three-dimensional shape such as a frustum conical shape.

[0044] The substrate 11 can also be formed of a stretchable and flexible resin sheet within the area where the wiring or electrode 12 constituting the detection unit 15 is continuous. This is to be able to follow the movements of the user, such as the patient wearing it, and to alleviate discomfort during wear.

[0045] Furthermore, the detection portion 15 disposed on the aforementioned sheet-like substrate 11 can be formed of various conductive materials; in this embodiment, carbon is used. This detection portion 15 can be composed of a pair or more wires or electrodes 12 with different polarities. In this embodiment, the detection portion 15 is formed of a pair of electrodes 12 consisting of a positive electrode 12a and a negative electrode 12b. However, it can also be composed of multiple electrodes 12 consisting of positive electrodes 12a and negative electrodes 12b, or more electrodes 12 of one polarity than the other. Particularly in this embodiment, the positive electrode 12 is formed by alternately arranging the strip-shaped positive electrode 12a and negative electrode 12b adjacent to each other, with the positive electrode 12a and negative electrode 12b each formed in a comb-like shape. By setting the electrode 12 in such a comb-like shape, the sensitivity for detecting biological contact can be the same in any area.

[0046] Furthermore, the wiring or electrodes 12 constituting the detection unit 15 are configured with their conductive material exposed. By exposing the conductive material, at least one of the current, voltage, and resistance can change due to contact with a living organism, and the contact with the living organism can be detected based on the amount or duration of this change. Therefore, wiring or electrodes 12 of different polarities are preferably formed with a thickness and spacing that allows at least one of the current, voltage, and resistance to change due to contact with a living organism. In this embodiment, the detection unit 15 is configured to detect self-removal of a medical catheter, and is formed by alternately arranging positive electrodes 12a and negative electrodes 12b, which are formed in the shape of strips, adjacent to each other. The positive electrodes 12a and negative electrodes 12b are each formed with a width of 2 to 12 mm and are separated from each other by a spacing of 2 to 12 mm. Since the intentional self-removal of a medical catheter is performed by the fingers, it is preferable that the wiring or electrodes 12 of different polarities are formed with a width and spacing that can detect the contact of the fingers.

[0047] In particular, in the bio-contact detection sensor 10 according to this embodiment, the electrodes 12 (positive electrode 12a and negative electrode 12b) can be formed using conductive materials (such as carbon) in addition to metallic materials such as gold, silver, and copper. Especially when using a printable material, such as carbon, the electrodes 12 can be formed by printing onto the substrate 11, resulting in simplified manufacturing processes and equipment, and enabling inexpensive manufacturing. Furthermore, when the electrodes 12 are formed of metal, they can be stretched due to the ductility of the metal itself, so when using a flexible substrate 11, electrodes 12 that are not easily cut can be formed.

[0048] In this embodiment, the detection unit 15 is configured with a pair of electrodes 12 of different polarities that are not electrically connected. As a result, if each electrode 12 is supplied with its own power, the electrodes 12 can be short-circuited due to contact with a living organism, allowing current to flow. Therefore, by pre-measuring the current value, it is possible to monitor whether there is contact with a living organism.

[0049] The bio-contact detection sensor 10, as described above, has a detection part 15 made of conductive material provided on a sheet-like substrate 11. Therefore, it can be directly applied to a living organism or to medical retaining devices such as bandages or tapes applied to a living organism. In other words, it is a highly versatile bio-contact detection sensor 10 because it can be used anywhere. In particular, since the conductive material is formed so that its wiring or electrodes 12 are exposed, bio-contact is detected by changes in current, voltage, and / or resistance caused by contact. Therefore, compared to detection sensors that detect pressure during contact, it can more accurately detect and prevent self-removal (bio-contact).

[0050] Figure 2 In the above Figure 1 An exploded perspective view of the stacked shielding component 20 on the biological contact detection sensor 10, as shown above. Figure 1 As shown in the bio-contact detection sensor 10, when the wiring or electrodes 12 constituting the detection unit 15 are exposed, they can become energized even when in contact with conductive parts such as metal bed frames or when fluids such as water or bodily fluids are present, potentially leading to false detection of biological contact. Therefore, in the bio-contact detection sensor 10 of this embodiment, a shielding member 20 is provided to at least cover the exposed portions of the wiring or electrodes 12 in the detection unit 15.

[0051] This shielding component 20 can be formed from a sheet or the like, and is configured such that the bio-contact detection sensor 10 cannot be peeled off unless the shielding component 20 is removed. Specifically, after the bio-contact detection sensor 10 is placed on the user, a sheet or film, or a bandage or cloth can be placed over it, thereby covering at least the detection part 15. Alternatively, an elastic fabric, protective gear, cuff, or the like can be placed over the bio-contact detection sensor 10, or the user's clothing (e.g., sleeves) can be placed over the bio-contact detection sensor 10.

[0052] With the shielding member 20 provided as described above, contact with the detection unit 15 in the bio-contact detection sensor 10 is essential for removing medical catheters or bandages, dressings, or skin grafts. Contact with the shielding member 20 is also essential for contact with the detection unit 15. Furthermore, since the wiring or electrodes 12 in the detection unit 15 are covered by the shielding member 20, at least one of the current, voltage, and resistance in the detection unit 15 will not change unless the patient intentionally peels off the shielding member 20. Thus, a bio-contact detection sensor 10 that can avoid false alarms is realized.

[0053] Figure 3 These are (A) an exploded perspective view and (B) a cross-sectional view along the X-axis of the bio-contact detection sensor 10 according to the second embodiment. The bio-contact detection sensor 10 according to this second embodiment is configured such that a detection unit 15 is formed by arranging a pair or more wires or electrodes 12 of different polarities opposite to each other. When a bio-body contacts the detection unit 15, at least one of the current, voltage, and resistance of the wires or electrodes 12 changes. Specifically, a pair or more wires or electrodes 12 of different polarities are provided on opposite surfaces of a substrate 11 arranged opposite to each other, and a spacer is provided to keep the pair or more wires or electrodes 12 of different polarities always separated from each other. Furthermore, when a bio-body contacts the spacer, it elastically deforms, causing the opposing wires or electrodes 12 to contact each other, thereby allowing at least one of their current, voltage, and resistance to change.

[0054] As the substrate 11, an ITO (indium tin oxide) thin film 14 can be used, or a substrate on which a conductive material layer 13, such as carbon, is provided can be used. In the ITO (indium tin oxide) thin film 14, the conductive surface can be used as the detection part 15, and in the substrate 11 on which the conductive material is provided, the conductive material 13 can be used as the detection part 15. Furthermore, between the relatively arranged detection parts (i.e., the electrodes 12), point-shaped spacers 30 are provided that elastically deform upon human contact, thereby allowing the wiring or electrodes 12 to contact each other.

[0055] In the biological contact detection sensor 10 according to this embodiment, a conductive material layer 13 is formed by coating carbon onto any one of the substrates 11, and a plurality of dot-shaped spacers 30 made of elastic resin are provided thereon at predetermined intervals. Furthermore, an ITO film 14 is disposed opposite to the conductive material layer 13 in a state that is always separated from the conductive material layer 13 by the dot-shaped spacers 30.

[0056] In the biological contact detection sensor 10 thus formed, by applying a pressure exceeding a certain magnitude in its thickness direction, at least one of the current, voltage, and resistance of the detection section 15 (i.e., wiring or electrode 12) can be changed. Moreover, in the biological contact detection sensor 10 according to this second embodiment, the sensitivity during contact can be adjusted based on the elasticity, spacing, and area of ​​the dotted spacers 30.

[0057] Figure 4 These are (A) an exploded perspective view and (B) a cross-sectional view in the XX direction of the biological contact detection sensor 10 according to the third embodiment. The biological contact detection sensor 10 according to this embodiment is configured such that, as described in the second embodiment above, a pair or more wires or electrodes 12 with different polarities are provided on opposite surfaces of opposing substrates 11, and the dot-shaped spacer 30 is provided between the opposite surfaces of the two substrates 11. Specifically, in the biological contact detection sensor 10 according to this third embodiment, wires or electrodes 12 made of conductive material are formed on each opposing substrate 11 by printing or the like as detection units 15, and the wires or electrodes 12 provided on one substrate 11 and the wires or electrodes 12 provided on the other substrate are arranged in an intersecting orientation. In this embodiment, in the rectangular substrate 11, in... Figure 4 Wiring or electrodes 12a are provided on the lower substrate 11, extending in the short side direction, and wiring or electrodes 12b are provided on the upper substrate 11, extending in the long side direction. Furthermore, dot-shaped spacers 30, using elastic resin as spacers, are provided on opposite surfaces of the substrate 11, and the opposing wiring or electrodes 12 are always separated from each other by these dot-shaped spacers 30. Moreover, when a predetermined pressure is applied in the thickness direction of the bio-contact detection sensor 10, the previously separated wiring or electrodes 12 come into contact due to the elastic deformation of the dot-shaped spacers 30, and at least one of the current, voltage, and resistance changes. Thus, the bio-contact detection sensor 10 can detect the presence or absence of biological contact.

[0058] Figure 5These are (A) an exploded perspective view and (B) a cross-sectional view in the X direction of the bio-contact detection sensor 10 according to the fourth embodiment. As shown in the third embodiment described above, the bio-contact detection sensor 10 according to this embodiment uses a conductive gel 40 disposed between opposingly arranged wirings or electrodes 12 to separate a pair or more wirings or electrodes 12 with different polarities. As shown in the third embodiment described above, the opposingly arranged wirings or electrodes 12 can be implemented using an ITO (indium tin oxide) thin film 14 as a substrate 11, or using a conductive material layer 13 or wiring or electrode 12 made of a conductive material such as carbon disposed on the substrate 11. Alternatively, existing conductive gels such as acrylic gel or polyurethane gel can be used.

[0059] According to the biological contact detection sensor 10 configured as described above, when pressure is applied in the thickness direction due to contact, the opposing wires or electrodes 12 come into contact with each other or the distance between them changes, thereby changing at least one of current, voltage, and resistance, thus enabling the detection of whether contact exists. In particular, the sensitivity during contact can be adjusted by the thickness or conductivity of the conductive gel 40, and the degree of contact can also be detected by monitoring minute changes in current, voltage, and / or resistance. Especially in the biological contact detection sensor 10 of this embodiment, the electrical connection between the wires or electrodes 12 with different polarities can be maintained via the conductive gel 40, and the intensity and width of biological contact can also be detected based on changes in their current, voltage, and / or resistance.

[0060] Figure 6 This is a diagram illustrating the operational state of the body contact detection device 60 constructed using the aforementioned biological contact detection sensor 10. The body contact detection device 60 includes the biological contact detection sensor 10 and a determination module 50. The determination module 50 determines whether biological contact has occurred based on changes in at least one of current, voltage, and resistance obtained from the detection unit 15 of the biological contact detection sensor 10. In this embodiment, a connection terminal is provided for connecting the determination module 50, and the determination module 50 can be connected to this connection terminal.

[0061] This judgment module 50 can be configured together with a judgment circuit composed of an integrated circuit, etc., which is used to determine whether there is biological contact based on the change in at least one of current, voltage, and resistance and / or the duration of the change obtained by the detection unit 15. In particular, a certain threshold can be set for the change in at least one of current, voltage, and resistance and / or the duration of the change, thereby avoiding false alarms in simple contact situations not intended for the removal of medical catheters or the removal of bandages, dressings, skin grafts, etc.

[0062] That is, the threshold can be set taking into account the time it takes for the resistance value of the biological contact detection sensor 10 to change. In particular, when setting this threshold, the threshold related to the time it takes for the resistance value to change can be adjusted according to the purpose of use (e.g., prevention of self-removal of IV needles, endotracheal intubation, indwelling bladder catheter, drainage tube, arterial catheter, central venous catheter, nasoenteric tube, wound site, diaper, etc.).

[0063] Furthermore, in the judgment module 50, when it is determined that there has been contact with a living organism at the detection unit 15 (i.e., contact for removing medical catheters, bandages or dressings, or skin bonding tape), a biological contact signal indicating that there has been contact with a living organism is output. This biological contact signal can be output to a nurse call button or a linked terminal 51. In addition, an alarm or warning light can be set on the judgment module 50. Furthermore, the judgment module 50 may include a wireless output unit for wirelessly outputting the biological contact signal. By including this wireless output unit, the biological contact detection device 60 can also perform wireless communication, so that nurses or caregivers can report biological contact signals even when they are not at the bedside. In addition, the patient's movement can be unrestricted even when using the biological contact detection device 60.

[0064] By using the biological contact detection device 60 configured as described above, it is possible to detect in advance actions such as patients intentionally removing medical catheters or removing bandages, dressings, or skin grafts, so that medical institutions can take appropriate countermeasures.

[0065] Furthermore, since the bio-contact detection according to this embodiment is a simple system for detecting whether a body has been touched, it can be effectively used as information for inferring patient conditions, even by nurses or caregivers working in clinical settings who are not accustomed to using such biosensors. In addition, in this bio-contact detection device 60, the presence or absence of contact has a greater impact on detection than the intensity of contact, in order to detect self-removal or self-peeling. Therefore, by using current, voltage, or resistance values ​​to detect whether a body has been touched, bio-contact can be detected more accurately and quickly.

[0066] Furthermore, the bio-contact detection device 60 according to this embodiment can be retrofitted to the affected area, thus allowing for easy installation at any clinical site without special construction, thereby achieving a compact and lightweight design. Moreover, by providing each bio-contact detection device 60 with a paired receiving device (pager type or tablet type, etc.), the bio-contact detection device 60 can also be used in the home.

[0067] Furthermore, the biological contact detection sensor 10 and the biological contact detection device 60 using the biological contact detection sensor 10 described above can not only be used to detect the intentional removal of medical catheters or the removal of bandages, dressings, skin bonding tapes, etc. by the patient in medical applications, but can also be used to detect biological contact in various fields.

[0068] Example 1

[0069] In this experiment, three modes of action were implemented to peel off the biological contact detection sensor, and the difference in resistance (i.e., the difference in response) caused by the difference in spacing was confirmed. The biological contact detection sensor used in this experiment used a sheet with a thickness of 0.075 mm as the substrate. Furthermore, the electrodes were formed by printing carbon. Moreover, the spacing of these electrodes was set to 4 mm and 6 mm, and the changes in resistance were confirmed for each. The results are as follows: Figure 7 As shown.

[0070] In this experiment, the same results were obtained in biological contact detection sensors with electrode spacing of 4 mm and 6 mm. Therefore, it can be predicted that there will be no difference in the detection of self-removal actions when the electrode spacing is set to 4 mm and 6 mm.

[0071] Furthermore, in this embodiment, the time from when the bio-contact detection sensor detects contact to when the treatment site is touched was confirmed after the bio-contact detection sensor is placed on the subject's treatment site following bandaging. As a result, it was confirmed that by wearing the detection part of the bio-contact detection sensor after bandaging, it takes more than 30 seconds from when contact with the detection part is detected to when the treatment site is reached, for example, until the removal of the IV drip begins. Therefore, a nurse or caregiver can arrive and prevent the removal of the IV drip before the treatment site is touched or before the IV drip is removed by the patient.

[0072] Furthermore, in this experiment, a biological contact detection sensor with the lowest false negative rate was used, which consisted of 2.0 mm thick wires or electrodes spaced at 2.0 mm intervals. However, even when wires or electrodes were formed with other thicknesses or intervals, the false negative rate of the biological contact detection sensor could be reduced by adjusting the threshold value for determining biological contact. This threshold value can be set based on factors such as the number of detections per unit time, the detection duration, the resistance value, the current value, or the voltage waveform shift and changes.

[0073] Industrial applicability

[0074] The biological contact detection sensor of the present invention and the biological contact detection device using the biological contact detection sensor can be used in the medical field to detect in advance the actions of a patient intentionally removing medical catheters or removing bandages or dressings, or skin bonding tape. Moreover, it is not limited to the medical field and can be used as a sensor for detecting biological contact.

[0075] Symbol Explanation

[0076] 10: Bio-contact detection sensor; 11: Substrate; 12: Electrode; 13: Conductive material layer; 14: ITO film; 15: Detection unit; 20: Shielding component; 30: Dot-shaped spacer; 40: Conductive gel; 50: Judgment module; 60: Bio-contact detection device.

Claims

1. A biological contact detection sensor for detecting contact with a living organism, characterized in that, The biological contact detection sensor includes a sheet-like substrate and a detection part made of conductive material disposed on one or both sides of the substrate. The detection unit consists of one or more wires or electrodes with different polarities. The wiring or electrodes are energized upon contact with a living organism, causing a change in at least one of the current, voltage, and resistance. The portion of the detection unit where the wiring or electrodes are exposed is provided with a shielding component made of insulating material, and is configured such that the biological contact detection sensor cannot be peeled off unless the shielding component is removed.

2. The biological contact detection sensor according to claim 1, wherein, The detection unit is composed of one or more pairs of wires or electrodes with different polarities arranged adjacently or oppositely. The wiring or electrodes are separated by intervals that cause at least one of the current, voltage, and resistance to change due to contact with a living organism. The sensitivity upon contact with a living organism can be adjusted by changing the width or spacing of the wiring or electrodes.

3. The biological contact detection sensor according to claim 1, wherein, The detection unit is composed of wires or electrodes of different polarities arranged alternately at intervals that are energized when contacted by a living organism; The conductive material of the wiring or electrodes is exposed and can be directly contacted by living organisms.

4. The biological contact detection sensor according to any one of claims 1 to 3, wherein, The substrate is formed from a soft resin sheet or fabric. The detection section is formed by coating or printing a conductive material containing conductive paste.

5. A biological contact detection device, comprising: The biological contact detection sensor according to any one of claims 1 to 4; as well as The judgment module determines whether there is biological contact based on the change in at least one of the current, voltage, and resistance obtained by the detection unit in the biological contact detection sensor.

6. The biological contact detection device according to claim 5, wherein, If the change in at least one of the current, voltage, and resistance obtained by the detection unit and / or the change time exceeds a preset threshold, the judgment module outputs a biological contact signal indicating that there has been contact with a biological body.

7. A method for detecting contact with organisms, characterized in that, The method describes a medical retainer for holding medical devices or materials on the body in the target area of ​​the wearer's body, and a bio-contact detection sensor for detecting contact with the body is disposed on the medical retainer. The biological contact detection sensor is the biological contact detection sensor according to any one of claims 1 to 4.

8. The biological contact detection method according to claim 7, wherein, The medical retainer is a bandage or tape.

9. A method for preventing self-removal of medical wearable devices, characterized in that, The method describes a method for setting a medical retainer for holding medical devices or materials on a living organism in the designated area of ​​the medical wearable device, and for setting a biological contact detection sensor on the top of the medical retainer for detecting contact with the living organism. By detecting contact with a living organism through the bio-contact sensor, the self-removal of medical wearable devices can be prevented. The biological contact detection sensor is the biological contact detection sensor according to any one of claims 1 to 4.

10. The self-removal prevention method according to claim 9, wherein, The medical device is a medical catheter or dressing.

11. The self-removal prevention method according to claim 9 or 10, wherein, The medical retainer is a bandage or tape.

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