CN108348675B - Leakage detection device for medical instrument - Google Patents
Leakage detection device for medical instrument Download PDFInfo
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- CN108348675B CN108348675B CN201580083833.1A CN201580083833A CN108348675B CN 108348675 B CN108348675 B CN 108348675B CN 201580083833 A CN201580083833 A CN 201580083833A CN 108348675 B CN108348675 B CN 108348675B
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- electrode lead
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- short circuit
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
Abstract
A leakage detection device (30) for a medical instrument, comprising a base plate (31) having a surrounding portion for surrounding and exposing a contact area (11) of the medical instrument with skin; a liquid leakage detection circuit (32) disposed on the upper surface of the substrate (31), including a first electrode lead (321) and a second electrode lead (322), the first and second electrode leads being spaced apart by a distance and being short-circuited when crossed by liquid; and the alarm module (33) is electrically connected with the first electrode lead and the second electrode lead, and triggers an alarm when the first electrode lead and the second electrode lead are in short circuit conduction. The leakage detection device (30) can conveniently and accurately realize the detection of leakage, and has the advantages of low cost, simple process, high accuracy and high safety.
Description
Technical Field
The invention relates to a detection device, in particular to a leakage detection device for medical instruments.
Background
Many medical devices are in contact with human body for a long time, such as needles, and during infusion or transfusion, especially renal dialysis, the needle needs to be inserted into blood vessel under skin for a long time, and if the needle is abnormally withdrawn, blood leakage or infection is likely to occur, even life risk occurs. In addition to blood leakage, other leakage situations often occur, such as tissue fluid of the human body, or nutrient fluid delivered by medical instruments, and the like.
There are many cases where the needle is abnormally withdrawn, such as problems of the needle itself, or caused by unconsciousness during sleep or agitation during mental agitation of the patient, but many times it is not detected in time, thereby causing a safety hazard.
There are several devices that can be used to detect needle dislodgment and blood leakage, for example, by analyzing the composition or color of blood flowing through the needle catheter. However, the existing detection methods require complicated equipment, have high manufacturing cost, and are uncomfortable and inconvenient to use.
Disclosure of Invention
The invention aims to provide a liquid leakage detection device for a medical instrument, which is used for detecting whether liquid leakage occurs in an area where the medical instrument is contacted with the skin.
In order to solve the above technical problem, the present invention provides a leakage detection device for a medical instrument, including:
the base plate is provided with a surrounding part which is used for surrounding and exposing the contact area of the medical device and the skin;
the liquid leakage detection circuit is arranged on the upper surface of the substrate and at least comprises a first electrode lead and a second electrode lead, and the first electrode lead and the second electrode lead are separated by a certain distance and are conducted and short-circuited when being bridged by liquid.
The alarm module can be further electrically connected with different electrode leads respectively, and triggers an alarm according to the short circuit conduction condition among the different electrode leads.
The embodiment of the invention can conveniently and accurately realize the detection of the leakage, and has the advantages of low cost, simple process, high sensitivity, high accuracy and high safety.
Drawings
Fig. 1 is a schematic diagram of an embodiment of a leakage detection device for a medical instrument according to an embodiment of the invention.
Fig. 2 is a detailed schematic diagram of a leakage detection circuit according to an embodiment of the invention.
Fig. 3 is a detailed schematic diagram of a leakage detection circuit according to an embodiment of the invention.
Fig. 4 is a detailed schematic diagram of a leakage detection circuit according to an embodiment of the invention.
Fig. 5 is a detailed schematic diagram of a leakage detection circuit according to an embodiment of the invention.
Fig. 6 is a detailed schematic diagram of a leakage detection circuit according to an embodiment of the invention.
Detailed Description
To further illustrate the technical means and effects of the present invention adopted to achieve the predetermined objects, the technical solutions of the present invention will be described in detail through a plurality of embodiments with reference to the accompanying drawings. The implementation, operation, and advantages of like or similar components and method steps between various embodiments may be mutually referenced and incorporated, and for the sake of brevity, detailed descriptions may not be provided in every embodiment and are set forth in advance herein.
The present invention first provides an embodiment of a leakage detection device for a medical instrument. In the case of a medical needle, as shown in fig. 1, a needle 20 is generally stuck on the inside of an arm 10 during infusion or dialysis, thereby forming a needle-skin contact area 11. The range of the contact area is not limited to fig. 1, and the contact area can be enlarged or reduced in practical use according to different technical requirements and contact ways of the medical device and the skin. And around the contact area 11 is provided a 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, which is located near the contact region, may include:
a base plate 31 having a surrounding portion for surrounding and exposing a contact area 11 of the medical device with the skin;
a liquid leakage detection circuit 32, disposed on the upper surface of the substrate 31, and including at least a first electrode lead 321 and a second electrode lead 322, wherein the first and second electrode leads are spaced apart from each other by a certain distance and are electrically connected to each other when bridged by liquid;
and the alarm module 33 is electrically connected with different electrode leads respectively, and triggers an alarm according to the short circuit conduction condition among the different electrode leads.
Fig. 2 shows only one embodiment of the present invention, and the practical application is not limited thereto, for example, the alarm module 33 may supply power to the detection circuit 32, and may trigger different alarm levels according to the short circuit or open circuit between different electrode wires, and the combination of the electrode wires with short circuit or open circuit, but the combination of the alarm module with the substrate 31 and the detection circuit 32 may be an integral connection or a split connection, and when the alarm module is split connected, the substrate 31 and the leakage detection circuit 32 may form a leakage detection device separately, and the leakage detection device is sold separately, and then combined with the alarm module 33, so that the leakage detection device can be applied clinically. Therefore, even if the substrate is stained, the alarm module can be reused, and the overall cost is saved.
The substrate 31 may be in a full-surrounding or semi-surrounding form so as to surround the contact region 11, as long as the electrode lead is prevented from being electrically connected by a medical device; the first and second electrode leads of the detection circuit 32 may form an extension respectively to be electrically connected to the alarm module 33, or the alarm module may be electrically connected to different electrode leads through a lead extension; the shapes of the detection circuit 32 and the electrode lead may be other shapes, and preferably, the detection circuit and the electrode lead may be disposed to surround the contact region 11 according to the shape of the substrate 31, for example, a surrounding portion of the substrate 31 has an inner edge close to the contact region and an outer edge on the opposite side; the first electrode leads are distributed along the inner edge, and the second electrode leads are distributed along the outer edge, so that liquid leakage can be monitored as omnidirectionally 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, and the different electrode leads are spaced apart by a distance and are electrically short-circuited when crossed by a liquid.
As shown in fig. 3, the detection circuit 32 may further include a third electrode lead (an intermediate electrode lead) 323 spaced apart from the first and second electrode leads and electrically short-circuited with the first and/or second electrode leads when bridged by the liquid; and the alarm module 33 is electrically connected to the third electrode lead, and triggers an alarm when the third electrode lead is short-circuited with the first and/or second electrode lead. Because the distance and the position between different electrode leads are known in advance, the amount of leakage and the extended area can be sensed according to the short circuit condition between different electrode leads, for example, when the first electrode lead 321 and the third electrode lead 323 are short-circuited, a primary alarm is triggered, and when the third electrode lead 323 and the second electrode lead 322 are short-circuited, a secondary alarm is triggered.
The distribution of the first, second, and third electrode leads is not limited to fig. 3, but may be other distribution, for example, as shown in fig. 4, the distribution of the second, and third electrode leads is different from that of the first electrode lead 321, and the second and third electrode leads 322, 323 are the same in distance from the first electrode lead 321, but opposite in position, so that when the first electrode lead 321 is short-circuited with the second electrode lead 322 or the third electrode lead 323, a primary alarm is triggered, and when the first electrode lead 321 is short-circuited with both the second electrode lead 322 and the third electrode lead 323, a secondary alarm is triggered. The more short-circuit points, the larger the leakage spreading area is, and the higher the alarm level is.
When more different electrode leads are distributed in the leakage detection circuit, more detection areas can be formed, the more accurate the detection of the leakage is, and the alarm level can be correspondingly adjusted.
In order to further increase the detection sensitivity, on the one hand, the distance between the electrode wires can be reduced, and on the other hand, the specific shape of the electrode wires can be designed to increase the distribution density of the electrode wires, for example, at least one interlaced sensing region can be designed between different electrode wires of the leakage detection circuit, and in the interlaced sensing region, the different electrode wires form a closely adjacent interlaced shape.
As shown in fig. 5, i.e. to arrange at least one interlaced sensing region 324 between different electrode wires 321, 322, preferably a plurality of interlaced sensing regions are evenly distributed according to a surrounding pattern, at said interlaced sensing regions 324, said different electrode wires form a closely adjacent interlaced shape. When leakage flows through the first electrode lead 321 but not before the second electrode lead 322, a short circuit alarm is not triggered if there is no interleaved sensing region 324, but can occur immediately if it happens to flow through the interleaved sensing region 324. The sensitivity can be further enhanced if the number of distributions of interleaved sensing regions is further increased.
When the leakage detection circuit comprises a plurality of intermediate electrode leads besides the first and second electrode leads, multi-point detection between different electrode leads can be formed by designing an interweaving sensing area between every two electrode leads, and the alarm module can sense the amount of leakage and the area of the leakage according to the number and/or the position of the electrode leads which are in short circuit conduction, so that different alarm levels can be triggered.
For example, as shown in fig. 6, at least one interlaced sensing region is designed between the first electrode lead 321 and the rest of the electrode leads, and the different electrode leads form a closely adjacent interlaced shape in the interlaced sensing region. Therefore, the alarm module triggers different alarm levels according to the positions and/or the number of the electrode leads which are in short circuit conduction because the distance and the position between the other electrode leads and the first electrode lead correspond to each other.
The substrate is a flexible substrate, so that the substrate is adapted to the form of the body surface, and the liquid leakage detection device is attached to the body surface area more comfortably.
The lower surface of the substrate can be provided with a pasting material layer, so that the leakage detection device is directly attached to a body surface area in a patch shape. If the adhesive material is not used, the leakage detection device may be fixed to the body surface area using an auxiliary material such as gauze or bandage, but the present invention is not limited thereto.
In addition, according to an embodiment of the present invention, the liquid leakage detection device may further include an adhesive tape layer, the substrate and the liquid leakage detection circuit are disposed on an upper surface of the adhesive tape layer, and a material layer is disposed on a lower surface of the adhesive tape layer.
At least one side end of the adhesive tape layer can be provided with an easy-tearing part and is connected with one side end of the adhesive tape layer of the other leakage detection device to form a continuous structure. Thus, the storage and the use are convenient.
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 cover layer may be a layer of permeable material, such as medical aids like gauze, bandages and the like.
In order to prevent the leakage detection device from falling off the body surface, according to another embodiment of the present invention, the lower surface of the substrate is provided with a detachment detection circuit, which includes an A-th electrode lead and a B-th electrode lead, wherein the A-th and B-th electrode leads are spaced apart from each other by a distance and are short-circuited when contacting the skin of the body surface.
The alarm module can be electrically connected with the A-th electrode lead and the B-th electrode lead respectively, and triggers alarm when the A-th electrode lead and the B-th electrode lead are switched on after short circuit and then are switched off.
In the embodiment of the invention, the alarm module can be separately and electrically connected with different electrode leads through the conductive clamp and/or the contact pin.
In order to make the medical device more conformable, according to an embodiment of the present invention, the leakage detection device may further comprise a fixation element for snugly fixing the medical device to the contact area; the fixing element lower surface accessible auxiliary materials such as viscous material layer or gauze are fixed in the body surface region, the fixing element lower surface has the a electrode wire and the b electrode wire, a distance is separated to the a and b electrode wire to short circuit switches on when contacting with body surface skin.
The alarm module can be respectively electrically connected with the a-th electrode lead and the b-th electrode lead, and when the a-th electrode lead and the b-th electrode lead are switched on in a short circuit and then are switched off, an alarm is triggered.
According to another embodiment of the invention, the fixation element may be combined with the base plate for snugly securing the medical device to the contact region, the fixation element may comprise:
a bulge for receiving and holding the medical device therethrough;
a wing part formed to extend outward from both sides of the swelling part, made of a flexible material, for operating the medical instrument through the wing part; the lower surfaces of the two side wing parts are respectively provided with an induction electrode lead, and when the side wing parts are operated and the two induction electrode leads are contacted, the two induction electrode leads are conducted in a short circuit way;
and the alarm module can be respectively electrically connected with the two induction electrode leads, and triggers an alarm when the two induction electrode leads are switched on in a short circuit and then are switched off.
In addition, the leakage detection device in the embodiment of the invention may further include a temperature, humidity, PH value, heart rhythm and other physical sign sensors, which are electrically connected to the alarm module, and trigger an alarm according to the deviation condition from the preset physical sign threshold value.
Claims (8)
1. A leak detection device for a medical instrument, comprising:
the base plate is provided with a surrounding part which is used for surrounding and exposing the contact area of the medical device and the skin;
the liquid leakage detection circuit is arranged on the upper surface of the substrate and at least comprises a first electrode lead and a second electrode lead, and the first electrode lead and the second electrode lead are separated by a certain distance and are conducted and short-circuited when being bridged by liquid;
the apparatus further comprises: the alarm module is electrically connected with different electrode leads respectively and triggers an alarm according to the short circuit conduction condition among the different electrode leads;
wherein at least one interweaving sensing area is arranged between the first electrode lead and the second electrode lead of the leakage detection circuit, and different electrode leads form a closely adjacent staggered shape in the interweaving sensing area;
the alarm module triggers different alarm levels according to the number and/or positions of the electrode leads which are in short circuit conduction.
2. The apparatus of claim 1 wherein said leakage detection circuit further comprises at least one intermediate electrode lead positioned between said first and second electrode leads, said different electrode leads being spaced apart and adapted to conduct a short circuit when crossed by fluid.
3. The device according to claim 1, wherein the alarm module triggers different alarm levels according to the number and/or position of the electrode leads that are short-circuited, specifically comprising: when the leakage liquid flows through the first electrode lead but does not flow to the second electrode lead, the alarm module does not give an alarm, and when the leakage liquid flows through the interweaving sensing area, the alarm module gives an alarm.
4. The device of claim 1, wherein the substrate is a flexible substrate, and the lower surface of the substrate is provided with a layer of adhesive material; the device further comprises a covering layer which covers the substrate and the leakage detection circuit; the covering layer is a permeable material layer.
5. The device of claim 1, wherein the lower surface of the substrate is provided with a detachment detection circuit, which comprises an A electrode lead and a B electrode lead, wherein the A electrode lead and the B electrode lead are spaced apart from each other by a certain distance and are in short circuit conduction when in contact with the skin on the body surface;
the alarm module is respectively electrically connected with the A-th electrode lead and the B-th electrode lead, and triggers alarm when the A-th electrode lead and the B-th electrode lead are switched on in a short circuit and then are switched off.
6. The device of claim 1, further comprising a securing element for snugly securing the medical device to the contact region; the lower surface of the fixing element is used for being fixed on a body surface area and is provided with an a-th electrode lead and a b-th electrode lead, and the a-th electrode lead and the b-th electrode lead are spaced by a certain distance and are in short circuit conduction when being in contact with the skin of the body surface;
the alarm module is respectively electrically connected with the a-th electrode lead and the b-th electrode lead, and triggers alarm when the a-th electrode lead and the b-th electrode lead are switched on in a short circuit and then are switched off.
7. The apparatus of claim 1, further comprising a securing element associated with the base plate for snugly securing the medical device to the contact region, the securing element comprising:
a bulge for receiving and holding the medical device therethrough;
a wing part formed to extend outward from both sides of the swelling part, made of a flexible material, for operating the medical instrument through the wing part; the lower surfaces of the two side wing parts are respectively provided with an induction electrode lead, and when the side wing parts are operated and the two induction electrode leads are contacted, the two induction electrode leads are conducted in a short circuit way;
the alarm module is respectively electrically connected with the two induction electrode leads, and triggers an alarm when the two induction electrode leads are switched on in a short circuit and then are switched off.
8. The device of claim 1, further comprising a vital sign sensor electrically connected to the alarm module for triggering an alarm based on a deviation from a preset vital sign threshold.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/CN2015/095712 WO2017088153A1 (en) | 2015-11-26 | 2015-11-26 | Leakage detection device for medical devices |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN108348675A CN108348675A (en) | 2018-07-31 |
| CN108348675B true CN108348675B (en) | 2020-12-22 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201580083833.1A Active CN108348675B (en) | 2015-11-26 | 2015-11-26 | Leakage detection device for medical instrument |
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| CN (1) | CN108348675B (en) |
| WO (1) | WO2017088153A1 (en) |
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| Publication number | Publication date |
|---|---|
| WO2017088153A1 (en) | 2017-06-01 |
| CN108348675A (en) | 2018-07-31 |
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