WO2017088153A1 - Leakage detection device for medical devices - Google Patents

Abstract

Disclosed is a leakage detection device (30) for medical devices, comprising a substrate (31) having a surrounding portion for surrounding and exposing a contact area (11) of the medical device with the skin; a leakage detection circuit (32) disposed on an upper surface of the substrate (31) and comprising a first electrode lead (321) and a second electrode lead (322) spaced apart from each other, which are conducted and short-circuited when they are crossed by liquid; and an alarm module (33) electrically connected to said first and second electrode leads, which is triggered when said first and second electrode leads are conducted and short-circuited. The leakage detection device (30) can easily and accurately realize the detection of leakage, with low cost, simple process, and high accuracy and safety.

Description

Liquid leakage detecting device for medical instruments Technical field

The invention relates to a detecting device, in particular to a medical device leak detecting device.

Background technique

There are many medical devices that need to be in contact with the human body for a long time, such as needles. In the case of drip or infusion, especially in dialysis, the needle needs to be inserted into the blood vessels under the skin for a long time, and once the needle is abnormally released, , it is likely to cause blood leakage or infection, and even life-threatening. In addition to blood leakage, other leaks can occur frequently, such as tissue fluids from the body, or nutrient solutions delivered by medical devices.

There are many situations in which the needle is abnormally released, such as the problem of the needle itself, or the involuntary or mental irritability caused by the patient's sleeping, but it is often not detected in time, thus posing a safety hazard.

Although some devices are currently available for detecting needle removal and blood leakage, for example, by analyzing the composition or color of blood flowing through the needle catheter. However, the equipment required for the existing detection method is too complicated, the manufacturing cost is high, and it is not comfortable and convenient to use.

Summary of the invention

The technical problem to be solved by the present invention is to provide a liquid leakage detecting device for a medical device to detect whether or not liquid leakage occurs in a region where the medical device is in contact with the skin.

In order to solve the above technical problem, the present invention provides a liquid leakage detecting device for a medical device, comprising:

a substrate having a surrounding portion for surrounding and exposing a contact area of the medical device with the skin;

The liquid leakage detecting circuit is disposed on the upper surface of the substrate, and includes at least a first electrode wire and a second electrode wire. The first and second electrode wires are spaced apart by a distance, and are short-circuited when being bridged by the liquid.

The alarm module may further be electrically connected to different electrode wires, and an alarm is triggered according to the short-circuit conduction between the different electrode wires.

Through the embodiment of the invention, the detection of liquid leakage can be realized very conveniently and accurately, the cost is low, the process is simple, and the sensitivity, the accuracy and the safety are high.

DRAWINGS

1 is a schematic diagram of an embodiment of a liquid leakage detecting device for a medical device according to an embodiment of the present invention.

2 is a schematic diagram showing details of a liquid leakage detecting circuit according to an embodiment of the present invention.

3 is a detailed diagram of a liquid leakage detecting circuit according to an embodiment of the present invention.

4 is a detailed diagram of a liquid leakage detecting circuit according to an embodiment of the present invention.

FIG. 5 is a detailed diagram of a liquid leakage detecting circuit according to an embodiment of the invention.

FIG. 6 is a detailed diagram of a liquid leakage detecting circuit according to an embodiment of the invention.

detailed description

The technical solutions of the present invention will be described in detail below with reference to the accompanying drawings. Between the various embodiments, the implementation, working principle, and beneficial effects of the same or similar components and method steps may be referred to and referenced by each other, and may not be performed in each embodiment for the sake of space. The detailed statement is hereby stated in advance.

The present invention first provides an embodiment of a liquid leakage detecting device for a medical device. Taking a medical needle as an example, as shown in Fig. 1, at the time of infusion or dialysis, the needle 20 is generally tied to the inside of the arm 10, thereby forming a contact area 11 of the needle with the skin. The range of the contact area is not limited to FIG. 1 , and may be expanded or reduced according to different technical needs and the contact manner of the medical device with the skin in actual use. Provided around the contact area 11 is a liquid leakage detecting device 30 according to an embodiment of the present invention.

As shown in FIG. 2, the detecting device 30 according to the embodiment of the present invention, located in the vicinity of the contact area, may include:

The substrate 31 has a surrounding portion for surrounding and exposing the contact area 11 of the medical device and the skin;

The liquid leakage detecting circuit 32 is disposed on the upper surface of the substrate 31 and includes at least a first electrode lead 321 and a second electrode lead 322. The first and second electrode leads are spaced apart by a distance and are connected by a liquid. Conduction short circuit

The alarm module 33 is electrically connected to different electrode wires, and triggers an alarm according to the short-circuit conduction between the different electrode wires.

2 is only one embodiment of the present invention, and the practical application is not limited thereto. For example, the alarm module 33 can supply power to the detecting circuit 32, and can be short-circuited or disconnected according to different electrode wires, and a short circuit or a short circuit occurs. The combination of the broken electrode wires and the like trigger different alarm levels, but the combination of the alarm module and the substrate 31 and the detecting circuit 32 may be an integral connection or a split connection. When the separate body is connected, the substrate 31 and the liquid leakage The detecting circuit 32 can separately constitute a liquid leakage detecting device, which can be separately sold, and then combined with the alarm module 33, can be applied to the clinic. In this way, the alarm module can be reused even after the substrate is stained, saving the overall cost.

In addition, the substrate 31 may be in a form of full or semi-enclosed to surround the contact area 11 as long as the medical device is prevented from contacting the electrode lead; the first and second electrode leads of the detecting circuit 32 may respectively form a The extension portion is electrically connected to the alarm module 33, or the alarm module is electrically connected to different electrode wires through a wire extension portion; the shape of the detection circuit 32 and the electrode wire may also be other patterns, preferably, The substrate 31 is disposed around the contact region 11, for example, the surrounding portion of the substrate 31 has an inner edge adjacent to the contact region and an outer edge of the opposite side; the first electrode wire is distributed along the inner edge The second electrode lead is distributed along the outer edge to monitor leakage as much as possible.

According to another embodiment of the present invention, in addition to the first and second electrode leads, at least one intermediate electrode lead may be further included, the different electrode leads being spaced apart by a distance, and guided by the liquid bridge Short circuit.

As shown in FIG. 3, the detecting circuit 32 may further include a third electrode lead (an intermediate electrode lead) 323 spaced apart from the first and second electrode leads, and when connected by a liquid And/or the second electrode wire is electrically shorted; and the alarm module 33 is electrically connected to the third electrode wire, when the third electrode wire is short-circuited with the first and/or second electrode wires, Touch Send an alarm. Since the distance and position between the different electrode wires are predicted, the amount of liquid leakage and the extended area can be perceived according to the short circuit condition between the different electrode wires, such as short circuit between the first electrode wire 321 and the third electrode wire 323. When the third electrode wire 323 and the second electrode wire 322 are short-circuited, a second-level alarm is triggered, and since the position of the second electrode wire is closer to the outer edge, the leakage degree is higher, and the extended area is Increase, therefore, the level of the secondary alarm is higher than the level of the primary alarm.

The distribution patterns of the first, second, and third electrode wires are not limited to FIG. 3, and may be other distribution modes, for example, as shown in FIG. 4, which is another distribution pattern of different electrode wires, second and third. The electrode wires 322 and 323 are the same distance as the first electrode wire 321 but are opposite in position, so that when the first electrode wire 321 is short-circuited with the second electrode wire 322 or the third electrode wire 323, a first-level alarm is triggered, and when When one electrode lead 321 and the second electrode lead 322 and the third electrode lead 323 are short-circuited, a secondary alarm is triggered. The more short-circuit points, the larger the leakage area, so the alarm level is higher.

When there are more different electrode wires distributed in the liquid leakage detecting circuit, the more detection regions that can be formed, the more accurate the detection of the liquid leakage, and the alarm level can be adjusted accordingly.

In order to further increase the sensitivity of the detection, on the one hand, the distance between the individual electrode wires can be reduced. On the other hand, the specific shape of the electrode wires can also be designed to increase the density of the electrode wire distribution, for example, in the leakage At least one interlaced sensing region is designed between the different electrode leads of the detecting circuit, and in the interleaved sensing region, the different electrode wires form a closely adjacent staggered shape.

As shown in FIG. 5, at least one interlaced sensing region 324 is disposed between the different electrode leads 321, 322. Preferably, a plurality of interleaved sensing regions are evenly distributed according to the surrounding shape, and in the interlaced sensing region 324, The different electrode wires form a closely interlaced shape. When the leaking liquid flows through the first electrode lead 321 but has not flown to the second electrode lead 322, if there is no interlaced sensing area 324, the short circuit alarm is not triggered, but if it just flows through the interlaced sensing area 324, A short circuit alarm can occur immediately. If the number of distributions of the interlaced sensing regions is further increased, the sensitivity can be further enhanced.

When the liquid leakage detecting circuit includes a plurality of intermediate electrode wires in addition to the first and second electrode wires, multi-point detection between different electrode wires can be formed by designing an interlaced sensing region between the two electrode wires. The alarm module can sense the number and/or position of the electrode leads that are short-circuited. Knowing the amount of liquid leakage and the area of the leak, it is possible to trigger different alarm levels.

For example, as shown in FIG. 6, at least one interlaced sensing region is respectively disposed between the first electrode lead 321 and the remaining electrode leads, and in the interleaved sensing region, the different electrode leads form a closely interlaced shape. . Thus, because of the distance and position correspondence between the remaining electrode wires and the first electrode wires, the alarm module triggers different alarm levels according to the position and/or number of electrode wires that are short-circuited.

In the embodiment of the invention, the substrate is a flexible substrate, so that the substrate is adapted to the shape of the body surface, so that the liquid leakage detecting device is more compliant and attached to the body surface region.

The lower surface of the substrate may have a layer of adhesive material, and the liquid leakage detecting device is directly attached to the body surface region in a patch shape. If the adhesive material is not used, the leakage detecting device can be fixed to the body surface region by using an auxiliary material such as gauze or a bandage, which is not limited in the present invention.

Furthermore, according to an embodiment of the present invention, the liquid leakage detecting device may further include a tape layer, the substrate and the liquid leakage detecting circuit being disposed on the upper surface of the tape layer, and having a paste on the lower surface of the tape layer Material layer.

At least one side end of the tape layer may have an easy-to-tear portion connected to the tape layer side end of another liquid leakage detecting device to form a continuous structure. This makes it easy to store and use.

In addition, according to an embodiment of the present invention, the liquid leakage detecting device may further include a cover layer covering the substrate and the liquid leakage detecting circuit; the covering layer may be a layer of a permeating material, such as gauze, bandage, etc. Medical aids.

In order to prevent the liquid leakage detecting device from falling off from the body surface, according to another embodiment of the present invention, the lower surface of the substrate has a separation detecting circuit including an A-electrode wire and a B-th electrode wire, and the A- and B-th electrode wires They are separated by a distance and short-circuited when in contact with the skin of the body surface.

The alarm module can be electrically connected to the A and B electrode wires respectively, and an alarm is triggered when the A and B electrode wires are short-circuited and then open.

In an embodiment of the invention, the alarm module can be electrically connected to different electrode wires by conductive clamps and/or pins.

In order to make the medical device more compliant, according to an embodiment of the present invention, the leakage detecting device may further include a fixing component for fixing the medical device to the contact area; The lower surface of the fixing member may be fixed to the body surface region by an adhesive material layer or a gauze or the like, and the lower surface of the fixing member has a first electrode lead and a bth electrode lead, and the a-th and b-th electrode leads are spaced apart by a distance, and Short-circuit conduction when in contact with the skin of the body surface.

The alarm module can be electrically connected to the first and fourth electrode wires, respectively, and when an open circuit occurs after the first and second electrode wires are short-circuited, an alarm is triggered.

According to another embodiment of the present invention, the fixing member may be combined with the substrate for fixing the medical device to the contact area, and the fixing element may include:

a ridge for receiving and holding the medical device through the ridge;

a side wing portion extending outwardly from both sides of the ridge portion, made of a flexible material for operating the medical device through the side wing portion; the lower surfaces of the two side wing portions respectively have a sensing electrode lead, when operating a side wing portion and short-circuiting when the two sensing electrode wires are in contact;

The alarm module can be electrically connected to the two sensing electrode wires respectively, and an alarm is triggered when the two sensing electrode wires are short-circuited and then open.

In addition, the liquid leakage detecting device according to the embodiment of the present invention may further include a body temperature sensor such as temperature, humidity, pH value, heart rate, etc., and is electrically connected to the alarm module, and is triggered according to a deviation from a preset physical threshold. Call the police.

Claims (10)

A liquid leakage detecting device for a medical device, comprising: a substrate having a surrounding portion for surrounding and exposing a contact area of the medical device with the skin; The liquid leakage detecting circuit is disposed on the upper surface of the substrate, and includes at least a first electrode wire and a second electrode wire. The first and second electrode wires are spaced apart by a distance, and are short-circuited when being bridged by the liquid. The device according to claim 1, further comprising: an alarm module electrically connected to the different electrode leads, and triggering an alarm according to the short-circuit conduction between the different electrode wires. The device according to claim 2, wherein said liquid leakage detecting circuit further comprises at least one intermediate electrode wire between said first and second electrode wires, said different electrode wires being spaced apart by a distance And conduct a short circuit when being bridged by a liquid. The device according to claim 2, wherein said liquid leakage detecting circuit has at least one interlaced sensing region between different electrode wires, and said different electrode wires are closely formed in said interlaced sensing region Interlaced shape. 3. Apparatus according to claim 3 or claim 4 wherein the alarm module triggers different alarm levels depending on the number and/or position of the electrode leads that are shorted to conduct. The device according to claim 2, wherein said substrate is a flexible substrate, said lower surface of said substrate has a layer of adhesive material; said device further comprising a cover layer overlying said substrate and said liquid leakage detecting circuit The cover layer is a layer of permeable material. The device according to claim 2, wherein said lower surface of said substrate has a detachment detecting circuit, and includes an A-electrode wire and a B-th electrode wire, said A- and B-th electrode wires being spaced apart by a distance, and Short-circuit conduction when the skin surface is in contact; The alarm module is electrically connected to the A and B electrode wires respectively, and when an open circuit occurs after the A and B electrode wires are short-circuited and turned on, an alarm is triggered. The device of claim 2 further comprising a securing member for The medical device is fixed to the contact area; the lower surface of the fixing element is fixed to the body surface area, and has a first electrode lead and a bth electrode lead, and the a and b electrodes are spaced apart by a distance And short-circuiting when in contact with the skin of the body surface; The alarm module is electrically connected to the first and fourth electrode wires, respectively, and when an open circuit occurs after the a-th and b-th electrode wires are short-circuited, an alarm is triggered. The device of claim 2, further comprising a securing member for engaging the substrate for securing the medical device to the contact area, the securing member comprising: a ridge for receiving and holding the medical device through the ridge; a side wing portion extending outwardly from both sides of the ridge portion, made of a flexible material for operating the medical device through the side wing portion; the lower surfaces of the two side wing portions respectively have a sensing electrode lead, when operating a side wing portion and short-circuiting when the two sensing electrode wires are in contact; The alarm module is electrically connected to the two sensing electrode wires respectively, and an alarm is triggered when the two sensing electrode wires are short-circuited and then open. The device of claim 2, further comprising a vital sign sensor electrically coupled to said alarm module to trigger an alarm based on a deviation from a preset threshold threshold.

Images