KR102557320B1 - Flexible Patch for Hypoallergenic Patient Monitoring - Google Patents

Abstract

The present invention is a porous silicone skin adhesive layer; a high absorbent polyurethane foam layer; flexible sensor; It relates to a flexible patch for patient monitoring based on a hypoallergenic adhesive in which highly moisture-permeable polyurethane film layers are sequentially laminated.

Description

Flexible patch for hypoallergenic patient monitoring based on hypoallergenic adhesive {Flexible Patch for Hypoallergenic Patient Monitoring}

The present invention relates to a hypoallergenic adhesive-based flexible patch for patient monitoring, and more particularly, to a hypoallergenic adhesive-based flexible patch for patient monitoring with excellent moisture permeability, moldability, high absorbency and adhesiveness.

There are four types of wearable devices based on the user's application field: fitness and wellness function, healthcare and medical function, infotainment function, and industrial and military function. are classified as

Among the wearable devices for healthcare and medical, the patch type is for bio-signal monitoring for general health and exercise management, bio-signal monitoring for elderly health care such as emergency monitoring for the elderly living alone, and inpatients Non-restraint bio-signal monitoring of patients in hospitals to ensure mobility, bio-signal monitoring for ubiquitous healthcare such as emergency monitoring of high-risk patients such as those with cardiovascular disease, chronic disease management, and high-risk occupational workers such as firefighters, soldiers, and police It can be used for bio-signal monitoring to monitor whether a dangerous situation occurs.

The healthcare/medical wearable device function is a fusion of wBAN (wireless Body Area Network) and U Healthcare (Ubiquitous Healthcare) technologies, and the electronic device being worn accurately measures the body situation and delivers it to patients and doctors.

Health-related biosignals such as electrocardiogram, exercise amount, and respiration rate can be monitored during daily life, and in particular, prompt action can be taken in case of an emergency. do.

In general, in the case of a patient in an emergency or in an unstable state, the patient himself is in most cases defenseless, and it is practically difficult to observe the patient while medical personnel are present. Therefore, such a system enables immediate response to emergency situations, enabling systematic management of patients.

Existing equipment having the above functions restricts the patient's basic actions, such as going to the bathroom or a treatment room or moving his or her hands and feet in bed, when various wired electronic devices are directly attached to the patient's body, causing inconvenience.

In addition, in conventional hospitals, the patient's real-time condition and condition change are recorded on a chart and stored in a PC to manage the patient, and the doctor in charge spends about 1 to 5 minutes to make rounds to check the patient's condition. Since it is common for patients to judge information about a patient's condition by listening to other doctors or nurses accompanying them, the system is not easy for the doctor in charge to accurately know the patient's condition information in real time and make a multifaceted judgment.

From this point of view, implementation of an electronic management system that not only allows the doctor or nurse in charge to check the patient's condition in real time anytime, anywhere, but also allows the patient's data to be updated in real time after the doctor's or nurse's rounds. this is requested

In addition, it is necessary to implement it in the form of a patch that can be adhered to the user's skin so that it can be used in daily life, and it is flexible for monitoring patients based on an adhesive that maintains adhesiveness when attached for a long time, and is accompanied by moisture absorption and moisture permeability such as sweat generated from the skin. Patch development is required.

In order to overcome the above problems, the present invention provides a flexible patch for patient monitoring that is low-irritating to the skin and has excellent adhesiveness.

In addition, the present invention provides a flexible patch for patient monitoring using a polyurethane foam and film having high absorbency and excellent moisture permeability in order to discharge moisture secreted from the skin to the outside.

In addition, the present invention provides a flexible patch for monitoring a patient having excellent moldability of a thin film and flexible physical properties so as to provide excellent comfort on the skin.

In order to solve the above problems, the present invention is a porous silicone skin adhesive layer; a high absorbent polyurethane foam layer; flexible sensor; Provided is a flexible patch for patient monitoring based on a hypoallergenic adhesive in which highly moisture-permeable polyurethane film layers are sequentially laminated.

In addition, the present invention provides a hypoallergenic adhesive-based flexible patch for patient monitoring characterized in that a second highly absorbent polyurethane foam layer is added on top of the flexible sensor.

In addition, in the present invention, the flexible sensor is a thin film type and is less than 70% of the area of the highly absorbent polyurethane foam layer, and is hypoallergenic, characterized in that a plurality of blocks are connected, an empty space is formed inside, a circle, a polygon, or an irregular shape. An adhesive-based flexible patch for patient monitoring is provided.

In addition, in the present invention, the porous silicone skin adhesive layer is an adhesive film having a thickness of 10 to 50 μm composed of any one of polyurethane, polyethylene, polypropylene, polyvinyl chloride or polyethylene terephthalate, and silicone to a height of 100 to 300 μm on the skin contact surface. Provided is a hypoallergenic adhesive-based flexible patch for patient monitoring characterized in that an adhesive is applied.

In addition, in the present invention, the porous silicone skin adhesive layer has a hole diameter of 1 to 3 mm, and the shortest distance of the circumferential surface of another hole adjacent to the hole circumferential surface is 1 to 5 mm. patch is provided.

In addition, the present invention provides a hypoallergenic adhesive-based flexible patch for patient monitoring, characterized in that the silicone adhesive is a one-component or two-component type.

In addition, in the present invention, the silicone adhesive is used by adding 2.0 to 10.0 parts by weight of a hydrophilic polymer to 100 parts by weight, and the hydrophilic polymer is alginate, hydroxyethyl cellulose, carboxymethyl cellulose, Pectin, xanthan gum, alginic acid, chitosan, SAP, poly acrylic acid, polyethylene oxide, poly vinyl siloxane, glyceryl polyacrylate, dimethicone ( Provides a hypoallergenic adhesive-based flexible patch for patient monitoring, which is characterized by the mixed use of at least two of Dimethicone and Cyclomethicone.

In addition, in the present invention, the high moisture permeability polyurethane film layer has a thickness of 10 to 50 μm, a moisture permeability of 500 g/m2·24h or more, a tensile stress of 100 kgf/cm2 or more, and a tensile strain of 200% or more. Provides a flexible patch.

According to the present invention, a flexible patch for patient monitoring using a silicone adhesive has low irritation to the skin and excellent adhesive strength.

In addition, the present invention is characterized by excellent wearing comfort even when attaching a flexible patch for patient monitoring for a long period of time by using a polyurethane foam and film having excellent absorbency and moisture permeability to quickly discharge moisture secreted from the skin to the outside.

In addition, the configuration of the present invention has excellent molding properties and flexible physical properties as a thin film, so it has excellent wearing comfort on the skin.

1 is a cross-sectional view of a flexible patch for patient monitoring based on a hypoallergenic adhesive according to the present invention.
2 is a cross-sectional view of a hypoallergenic adhesive-based flexible patch for patient monitoring to which a second highly absorbent polyurethane foam layer according to the present invention is added.
3 is a plan view of various types of the flexible sensor of the present invention.
4 is an example of a 4-channel platform type among the flexible sensors of the present invention.

Hereinafter, preferred embodiments of the present invention will be described in detail. First of all, in describing the present invention, detailed descriptions of related known functions or configurations are omitted in order not to obscure the gist of the present invention.

As used herein, the terms 'about', 'substantially', and the like are used in a sense at or approximating that number when manufacturing and material tolerances inherent in the stated meaning are given, and are intended to convey an understanding of the present invention. Accurate or absolute figures are used to help prevent exploitation by unscrupulous infringers of the disclosed disclosure.

1 is a cross-sectional view of a flexible patch for patient monitoring based on hypoallergenic adhesive of the present invention, comprising a porous silicone skin adhesive layer 40; Highly absorbent polyurethane foam layer 30; flexible sensor 20; It relates to a flexible patch for patient monitoring based on a hypoallergenic adhesive in which highly moisture-permeable polyurethane film layers 10 are sequentially laminated.

In addition, Figure 2 is a cross-sectional view of a hypoallergenic adhesive-based patient monitoring flexible patch to which a second highly absorbent polyurethane foam layer 31 is added as another example of the present invention. It is characterized in that a second high absorbent polyurethane foam layer identical to the absorbent polyurethane foam layer is laminated.

However, since the thickness of the flexible patch is thick with the additional second super absorbent polyurethane foam layer, the function and flexibility may be deteriorated, so it is preferable to configure it smaller than the thickness of each super absorbent polyurethane foam layer.

The flexible sensor 20 is a thin film type and is 70% or less of the area of the highly absorbent polyurethane foam layer, preferably 40% or less. The flexible sensor 20 is composed of a circuit board, electronic parts, and packing that seals them. The flexible sensor 20 has a thin film form to have a flexible property, and the circuit board is made of synthetic resin with elasticity rather than metal or hard plastic material. It consists of the main components.

In addition, it is preferable to have an empty space other than the space occupied by the circuit necessary for operation so that the flexible sensor 20 is not disturbed in order to move the moisture absorbed from the skin to the outside.

3 is a plan view of various types of the flexible sensor of the present invention. It may be configured in a form in which a plurality of blocks are connected to secure a passage for the movement of moisture secreted from the skin, a form in which an empty space is formed inside, or a circular, polygonal, or irregular shape having a minimum area without an empty space. The above shape shows an example, and an area of 70% or less of the area of the superabsorbent polyurethane foam layer needs to be satisfied.

The flexible sensor 20 may use a 1-channel sensor or a 4-channel sensor platform, and the 1-channel sensor platform has advantages in miniaturization and low cost.

In the case of the 4-channel sensor platform, it is a model that secures strength in mechanical precision by preventing measurement errors in the attachment process due to mechanical limitations common in wearable devices. Flexible pattern shape depending on application of flexible patch sensor design can be applied.

4 is an example of a 4-channel platform form of the flexible sensor 20 of the present invention. In addition, flexible sensors of various types of platforms can be used and are not limited to the above-mentioned flexible sensors.

The porous silicone skin adhesive layer 40 is a silicone adhesive at a height of 100 to 300 μm on the skin contact surface of a 10 to 50 μm thick adhesive film composed of polyurethane, polyethylene, polypropylene, polyvinyl chloride or polyethylene terephthalate. What is applied is characteristic.

In addition, the porous silicone skin adhesive layer 40 is characterized in that the diameter of the hole is 1 to 3 mm, and the shortest distance from the circumferential surface of the hole to the circumferential surface of another hole adjacent to it is 1 to 5 mm. As the hole size increases, the moisture permeability increases, but the contact surface with the skin decreases, so the adhesive strength decreases.

Therefore, the hole diameter and the hole spacing within the above range are the ranges in which moisture permeability and adhesive strength are simultaneously satisfied.

In addition, the silicone adhesive may be used in either a one-component type or a two-component type, and a two-component type is preferable if possible. The two-component type may be used by mixing a first solution composed of a silicone resin and a catalyst and a second solution composed of a silicone resin and a curing agent.

In the specific composition of the two-component type, the first solution may be composed of polymethylvinylsiloxanes, silica, and an additive (PLATINUM), and the second solution is polymethylvinyl, It may consist of polymethylhydrogenosiloxanes.

As the curing agent, dibenzoyl peroxide, tertbutylcumyl peroxide, ditertbutyl peroxide, di-2,4-dichlorobenzoyl peroxide peroxide series, and hydrosilane series may be used.

Silicone adhesive generally has a hydrophobic property, so when it is attached to the skin, its adhesive strength may be weakened by secreted moisture such as sweat, and the silicone adhesive itself has a weak water absorption capacity.

Therefore, adding a hydrophilic additive to the silicone adhesive can absorb moisture secreted from the skin and maintain the skin adhesive function for a long time.

The silicone adhesive may be used by adding 2.0 to 10.0 parts by weight of a hydrophilic polymer additive to 100 parts by weight.

The hydrophilic polymer is alginate, hydroxyethyl cellulose, carboxymethyl cellulose, pectin, xanthan gum, alginic acid, chitosan, SAP or polyacrylic acid, polyethylene oxide (Polyethylene oxide), poly vinyl siloxane, glyceryl polyacrylate, dimethicone, and cyclomethicone.

2.0 to 10 parts by weight of the additive may be added to 100 parts by weight of the mixed solution. When added in excess of 10.0 parts by weight, separation may occur in the adhesive film and the skin contact surface due to changes in the physical properties of the silicone adhesive.

Conversely, if the amount is less than 2.0 parts by weight, the hydrophilic property is insufficient and the water absorption ability is reduced.

Most of the moisture absorbed from the skin passes through the hole of the porous silicone skin adhesive layer 40, passes through the polyurethane foam, and passes through the highly absorbent polyurethane film layer to be released to the outside. Some are absorbed into the silicone adhesive as described above.

The super absorbent polyurethane film layer 10 has a thickness of 10 to 50 μm, a moisture permeability of 500 g/m2 24 h or more, preferably 500 to 4,000 g/m 2 24 h, and a tensile stress of 100 kgf/cm 2 or more, preferably 100 to 4,000 g/m 2 24 h. 800kgf/cm2, the tensile strain is 200% or more, preferably 200 to 800%. Flexibility can be secured within the above ranges of tensile stress and tensile strain, and moisture transferred to the lower high moisture permeability polyurethane film layer can be released to the outside with the ability of moisture permeability of 500 g/m2·24h or more.

Features and other advantages of the present description as described above will become more apparent from the following examples, which are described for illustrative purposes only and cannot be construed as limiting or limiting the scope of protection of the present invention. .

Example 1

A 220㎛ high two-component silicone adhesive is applied to one side of a 20㎛ thick polyurethane film, and a 2mm thick polyurethane foam on the back side, a 4-channel thin film flexible sensor of 40% of the polyurethane foam area, and a 20㎛ thick A polyurethane film layer was laminated, and 2.0 parts by weight of a mixture of dimethicone, cyclomethicone, and polyacrylate was added to the two-component silicone pressure-sensitive adhesive.

Example 2

It is the same as Example 1 except that polyurethane foam having a thickness of 1.5 mm is configured on the upper and lower portions of the thin film flexible sensor.

Example 3

It is the same as in Example 2 except that 5.0 parts by weight of a mixture of dimethicone, cyclomethicone, and polyacrylate was added as a two-component silicone adhesive.

Example 4

It is the same as in Example 2 except that 10.0 parts by weight of a mixture of dimethicone, cyclomethicone, and polyacrylate was added as a two-component silicone adhesive.

comparative example One

Conditions other than that the silicone additive was not included were the same as in Example 2.

Test Methods

1. Measurement of peel strength

The peel strength of the silicone skin adhesive layer prepared in the above Examples and Comparative Examples was measured according to ASTM D3330. Specifically, after cutting to a width of 25 mm and a length of 100 mm or more, samples were prepared by attaching to a stainless steel (SUS) plate. did

In order to measure the peel strength at room temperature, the sample was left for 24 hours at a temperature of 23 ± 1 ° C and a relative humidity of 50 ± 5%, and its 180 ° peel strength (gf12mm) was measured.

2. Adhesion time measurement

50 people were attached to the same location on the chest area, and the average adhesion retention time after daily life and 15 minutes of light running (5 to 7 km/h) was measured.

3. Absorption rate test method

(1) Fill distilled water in a 5ml disposable eyedropper and drop it from a height of 7cm to measure the time required for the water to completely permeate.

(2) Record the average value by dropping a total of 10 times

4. Absorbance (absorption amount) test method

(1) Application

This test method is applied to the adhesion test of wound dressing materials during the characteristic test.

1) Test the adhesion test method of ASTM D 3330 - Method A

2) Calculations that do not reach the standard width are converted into standard width.

(2) Devices and instruments

- Oven (OF-22)

- Test plate of 50mm×125mm

- Rubber roller weighing 2kg

- Adhesion tester (AR1000)

(3) Test method

[Specimen production and storage]

- The specimen is cut into 12mm wide and 100~130mm long.

- To minimize the interference of other forces caused by the stretching of the foam during the adhesion test, attach a PET adhesive film to the surface of the specimen and store it in a constant temperature and humidity chamber (23℃, 50%) for about a day to stabilize it.

1) Prior to the test, set the grip and the bottom of the tester to 90˚ or 180˚ according to the desired test item and then calibrate.

2) Attach the prepared specimen in the longitudinal direction to the center of the test plate left in an oven at 37℃ for more than 10 minutes.

3) After passing a rubber roller weighing 2,040 g back and forth twice over the sample at a speed of 10 mm/s, attach a piece of tape as long as the length of the sample to the end of the sample that is not attached to the test plate.

4) Fix the test plate on the bottom of the adhesive strength tester, tilt back the tape at the end of the specimen, bite it into the grip, and measure at a speed of 11.8 inches/min.

5) Find and set an appropriate range in the result graph that appears after measurement, and record the average value.

6) After measuring the remaining 4 specimens in the same way, find the average of the 5 result values.

division peel strength
(gf/12mm) Detachment time after attaching in daily life Detachment time after attaching during exercise absorption rate
(sec) absorbance
(g/g) Example 1 41.3 48h 45h 1.34 13.54 Example 2 47.5 50h 46h 1.26 16.25 Example 3 49.7 62h 51h 1.19 16.60 Example 4 51.6 55h 47h 1.13 16.55 Comparative Example 1 41.3 6h 2.5h 1.31 15.90

As shown in Table 1, the biggest difference between Examples 1 to 4 according to the present invention and Comparative Example 1 without a silicone additive is the attachment time, and there is a greater difference, especially when there is moisture discharge from the skin after exercise.

It can be seen that the presence or absence of silicone additives has a significant effect on the skin adhesion time. Peel strength, absorption rate, and absorption other than that are affected by two-component silicone, PU foam, and PU film, and there is no significant difference between Examples 1 to 4 and Comparative Example 1, which are commonly configured. 1 has a different difference because there is no second highly absorbent polyurethane foam layer on top of the flexible sensor.

The silicone skin adhesive layer should minimize skin irritation and at the same time have excellent skin adhesion and re-adhesion, so a range of 200 gf / 12 mm or less is appropriate. Examples 1 to 4 satisfy the above range.

The present invention described above is not limited by the foregoing embodiments and the accompanying drawings, and various substitutions, modifications, and changes are possible within a range that does not deviate from the technical spirit of the present invention. It will be clear to those who have knowledge of

10: polyurethane film layer 20: flexible sensor
30: polyurethane foam layer 31: second polyurethane foam layer
40: porous silicone skin adhesive layer

Claims (8)

a porous silicone skin adhesive layer; a high absorbent polyurethane foam layer; flexible sensor; Highly moisture-permeable polyurethane film layers are sequentially laminated,
The porous silicone skin adhesive layer is an adhesive film having a thickness of 10 to 50 μm composed of any one of polyurethane, polyethylene, polypropylene, polyvinyl chloride or polyethylene terephthalate, and a silicone adhesive is applied to the skin contact surface at a height of 100 to 300 μm. will,
The silicone adhesive is a two-component type,
The two-component type is used by mixing a first solution composed of a silicone resin and a catalyst and a second solution composed of a silicone resin and a curing agent,
The first solution is polymethylvinylsiloxanes, silica, and an additive (PLATINUM),
The second solution is polymethylvinyl and polymethylhydrogenosiloxanes,
The curing agent is any one of dibenzoyl peroxide, tert-butyl cumyl peroxide, di-tert-butyl peroxide, and di-2,4-dichlorobenzoyl peroxide, a hypoallergenic adhesive-based flexible patch for patient monitoring.
According to claim 1,
A hypoallergenic adhesive-based flexible patch for patient monitoring, characterized in that a second highly absorbent polyurethane foam layer is added on top of the flexible sensor.
According to claim 1 or 2,
The flexible sensor is a thin-film type, less than 70% of the area of the superabsorbent polyurethane foam layer, and hypoallergenic adhesive-based patient monitoring characterized in that a plurality of blocks are connected, an empty space is formed inside, a circle, a polygon, or an irregular shape. flexible patch for
delete According to claim 1 or 2,
The porous silicone skin adhesive layer has a hole diameter of 1 to 3 mm, and a shortest distance from the circumferential surface of the hole to the circumferential surface of another hole adjacent to the hole is 1 to 5 mm.
delete According to claim 1,
The silicone adhesive is used by adding 2.0 to 10.0 parts by weight of a hydrophilic polymer to 100 parts by weight,
The hydrophilic polymer is alginate, hydroxyethyl cellulose, carboxymetnhyl cellulose, pectin, xanthan gum, alginic acid, chitosan, SAP, polyacrylic acid, polyethylene oxide Hypoallergenic adhesive characterized by mixing at least two of Polyethylene oxide, Poly vinyl siloxane, Glyceryl Polyacrylate, Dimethicone, and Cyclomethicone Flexible patch for based patient monitoring.
According to claim 1 or 2,
The high moisture permeability polyurethane film layer has a thickness of 10 to 50 μm, a moisture permeability of 500 g / m 2 24 h or more, a tensile stress of 100 kgf / cm 2 or more, and a tensile strain of 200% or more.

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