WO2023140584A1

WO2023140584A1 - Apparatus for collecting oral epithelial cells

Info

Publication number: WO2023140584A1
Application number: PCT/KR2023/000768
Authority: WO
Inventors: 김경
Original assignee: (주)휴먼스케이프
Priority date: 2022-01-21
Filing date: 2023-01-17
Publication date: 2023-07-27
Also published as: KR102518074B1

Abstract

The apparatus for collecting oral epithelial cells according to the present invention comprises: a cover having an opening formed at one end thereof to allow a finger to be inserted therein; and a collection part formed on the surface at the other end of the cover, wherein the collection part is a medical cotton cloth.

Description

Oral epithelial cell collection device

The present invention relates to an oral epithelial cell harvesting device. More specifically, the present invention relates to a collection device capable of easily harvesting oral epithelial cells of infants or toddlers.

DNA (deoxyribonucleic acid) has unique genetic information possessed by an individual, and it is possible to diagnose various diseases as well as to identify an individual by gene collection.

These gene collection methods include blood, saliva, and oral epithelial cells. In the case of double oral epithelial cells, it is widely used because it can increase accuracy compared to using saliva and can be easily collected by non-specialists at home without accompanying pain compared to blood sampling. Existing oral epithelial cell collection methods have been used to collect by strongly rubbing the inside of the left and right cheeks more than 20 times using a cotton swab or rod-type sampler.

However, these cotton swab or rod-type collectors may not collect cells evenly on the collection part and may not collect the required amount for examination due to the limited surface area. In addition, in order to collect a sufficient amount of cells, it is inconvenient to rub hard 20 to 30 times.

Therefore, there is a need to develop an instrument that can safely and conveniently collect oral epithelial cells effectively.

As related prior art, there is Korean Patent No. 1317296.

An object of the present invention is to provide a collection tool capable of easily harvesting oral epithelial cells without objection to infants and young children.

Another object of the present invention is to provide a sampling tool with excellent accuracy by not only increasing the amount of oral epithelial cells collected, but also uniformly harvesting the cells to the collection unit.

Another object of the present invention is to provide a collecting tool that can be manufactured easily and can reduce production cost.

The above and other objects of the present invention can all be achieved by the present invention described below.

One aspect of the present invention relates to an oral epithelial cell harvesting device. The oral epithelial cell harvesting device includes a cover having an opening formed at one end and into which a finger is inserted; and a collecting part formed on the surface of the other end of the cover, wherein the collecting part is a medical cotton cloth.

In one embodiment, the cover has a Shore A durometer hardness of 30-50, a tensile strength of 7 to 12 MPa (ISO 37 TYP 1), an elongation of 300 to 700% (ISO 37 TYP 1), and a tear strength of 30-45 N / mm (ASTM D624B).

In another embodiment, the cover may have a Shore A durometer hardness of 10-30, a tensile strength of 5 to 30 MPa (ISO 37 TYP 1), an elongation of 500 to 800% (ISO 37 TYP 1), and a tear strength of 10 to 30 N/mm (ASTM D624B).

In another embodiment, the cover may have protrusions formed around the collecting part.

The present invention can easily collect oral epithelial cells without objection to infants and young children, can increase the amount of oral epithelial cells collected, and can evenly sample the collection part, which has excellent accuracy and is easy to manufacture.

1 schematically illustrates an oral epithelial cell harvesting device according to the present invention.

Figure 2 (A) is a schematic diagram of an oral epithelial cell harvesting instrument according to one embodiment of the present invention, Figure 2 (B) is a schematic diagram of an oral epithelial cell harvesting instrument according to another embodiment of the present invention.

3 is a schematic diagram of an oral epithelial cell harvesting device according to another embodiment of the present invention.

4 is a longitudinal cross-sectional view of the oral epithelial cell harvesting device according to the present invention, centered on a protrusion.

FIG. 5 shows the state of the protrusion after inserting a finger into the oral epithelial cell harvesting device according to FIG. 4 .

6 is a state diagram showing the use of the oral epithelial cell harvesting instrument according to the present invention.

Hereinafter, the present invention will be described in more detail with reference to the accompanying drawings. However, the following drawings are only provided to aid understanding of the present invention, and the present invention is not limited by the drawings. In addition, since the shape, size, ratio, angle, number, etc. disclosed in the drawings are exemplary, the present invention is not limited to the illustrated details.

Like reference numbers designate like elements throughout the specification. In addition, in describing the present invention, if it is determined that a detailed description of related known technologies may unnecessarily obscure the subject matter of the present invention, the detailed description will be omitted.

When 'includes', 'has', 'consists of', etc. mentioned in this specification is used, other parts may be added unless 'only' is used. In the case where a component is expressed in the singular, the case including the plural is included unless otherwise explicitly stated.

In interpreting the components, even if there is no separate explicit description, it is interpreted as including the error range.

When the positional relationship of two parts is described with 'over', 'over', 'under', 'beside', etc., one or more other parts may be located between the two parts unless 'direct' or 'direct' is used.

Positional relationships such as 'top', 'top', 'bottom', and 'bottom' are described based on the drawings, and do not represent absolute positional relationships. That is, the positions of 'upper' and 'lower' or 'upper surface' and 'lower surface' may be changed depending on the observation position.

The oral epithelial cell harvesting instrument includes a cover 20 having an opening formed at one end and into which a finger is inserted; and a collecting part 10 formed on the surface of the other end of the cover.

The collecting unit 10 may be a medical cotton cloth such as gauze or swab. The collecting part 10 may be fixed to the cover 20 by an adhesive (not shown) positioned between the collecting part 10 and the cover 20 . In a specific example, the adhesive portion may be positioned only around the collecting part 10 or may be positioned over the entire area of the collecting part 10 to be firmly fixed to the cover.

The size of the collecting part 10 may have a size that can wrap the entire finger circumference or only a part of the finger circumference. For example, when the size of the collecting part 10 is h in the finger length direction and w in the finger circumferential direction, h may be 0.7 to 2 cm and w may be 0.7 to 2.5 cm. In a specific example, h may be 0.7 cm and w may be 2.5 cm. Preferably, the area of the collecting part 10 may be 1.4 to 5 cm ² . As described above, since the collecting device of the present invention can secure a wide area of the collecting part 10, the amount of sampling can be increased to the maximum, and a flexible material can be used to evenly collect the three-dimensional parts of the oral cavity.

In the case of a conventional cotton swab, there is a problem in that the collecting part is narrow and requires several times of rubbing. In the case of the rod type, it is not only difficult to collect uniformly because the collection part is flat, but also requires rubbing more than 20 times, and there is a great sense of rejection due to the tingling feeling of a hard object. On the other hand, the collection tool of the present invention is curved and can be collected gently as if stroking, so it can be collected without feeling of resistance, and the collection area is relatively large, so it can be collected easily, quickly and uniformly without rubbing several times.

An opening 21 is formed in the cover 20 so that a finger can be inserted, and the circumference may become narrower toward the end from the opening 21 . That is, the circumference of the opening may be larger than the circumference of the portion where the collecting part 10 is formed at the other end.

The cover 20 may be made of a rubber material, and may be formed of a hard type that can be erected or a soft type that cannot be erected.

Figure 2 (A) is a schematic diagram of an epithelial cell harvesting instrument according to one embodiment of the present invention, and Figure 2 (B) is a schematic diagram of an epithelial cell harvesting instrument according to another embodiment of the present invention.

As shown in FIG. 2(A), the cover 20 according to one embodiment is of a hard type and has elasticity, but can maintain a shape that can be erected. In this case, a silicone rubber having a Shore A durometer hardness of 30-50, a tensile strength of 7 to 12 MPa (ISO 37 TYP 1), an elongation of 300 to 700% (ISO 37 TYP 1), and a tear strength of 30-45 N/mm (ASTM D624B) may be used. The silicone rubber may be prepared from a polyorganosiloxane and a hydrosilylation catalyst.

As shown in FIG. 2(B), the cover 20 according to another embodiment of the present invention is a soft type that cannot be erected, and a vinyl glove or rubber glove material may be used. In specific examples, natural latex, polyisoprene, nitrile rubber, polyorganosiloxane, and the like may be used. In embodiments, a medical glove material may be preferably applied. The material of the cover 20 according to the embodiment of FIG. 2 (B) has a Shore A durometer hardness of 10-30, a tensile strength of 5 to 30 MPa (ISO 37 TYP 1), an elongation of 500 to 800% (ISO 37 TYP 1), and a tear strength of 10 to 30 N / mm (ASTM D624B) silicone rubber may be used. In the case of soft silicone rubber as shown in FIG. 2 (B), there is an advantage in that it can be stored rolled or turned upside down and the volume can be minimized.

3 is a schematic diagram of an epithelial cell harvesting device according to another embodiment of the present invention. As shown, protrusions 22 are formed around the collecting part 10 . The protrusion 22 is made of the same material as the cover 20 and may be integrally formed with the cover 20 .

The protrusion 22 can stimulate the oral mucosa to increase the collection amount of epithelial cells. In addition, the protrusion 22 allows the sample to be confined within the collecting unit 10, minimizes the amount of the sample escaping out of the collecting unit 10, and allows the sample to be sufficiently wetted in the collecting unit 10. The protrusion 22 may have a diameter of 0.1 to 1 mm and a height of 0.5 to 1.2 mm.

More specifically, the size of the protrusion 22 may be determined according to Equation 1 below.

[Equation 1]

r2 ≥ r1

In Equation 1, r2 is the height of the protrusion 22, and r1 is the diameter of the protrusion 22.

According to Equation 1, when the height of the protrusion 22 is at least equal to or greater than the diameter of the protrusion 22, stimulation points for the oral mucosa can be increased and more epithelial cells can be collected. When the protrusion 22 is arranged along the circumference of the collecting part 10, since the circumferential length of the collecting part 10 is limited, more protrusions can be arranged within the limited length range, so that the number of stimulation points on the oral mucosa is increased and the epithelial cell collecting effect is improved. can

4 is a longitudinal cross-sectional view of the oral epithelial cell harvesting device according to the present invention, cut around the protrusion 22, and FIG. 5 is a state of the protrusion 22 of the oral epithelial cell harvesting device according to FIG. 4 after a finger is inserted.

Referring to FIG. 4 , the protrusion 22 of the oral epithelial cell harvesting instrument may be provided with a protrusion pressing portion 22a at a symmetrical portion around the cover 20 . The protrusion pressing portion 22a may be provided in a conical shape with an area increasing toward the bottom, and when the lower surface is pressed, the protruding height of the protrusion 22 may be increased.

5, when a finger is inserted into the cover 20 and pressure is transmitted to the protrusion pressing portion 22a, the protruding height of the protrusion 22 is increased, so that oral epithelial cells are easily stimulated, and oral epithelial cells can be more easily separated.

Since the protrusion pressure portion 22a protrudes from the cover 20, when the user wears the device for collecting oral epithelial cells, the position of the protrusion 22 and the location of the collection portion 10 in which the oral epithelial cells are collected can be predicted by the touch of the user's finger, thereby improving the accuracy of collection and preventing the cover 20 from moving or being separated from the finger by increasing friction with the skin of the finger.

In another embodiment of the present invention, the protrusion 22 and the cover 20 may have different physical properties. For example, the protrusion 22 may be made of hard type silicone rubber, and the cover 20 may be made of soft type silicone rubber so that the protrusion 22 is formed more rigidly, thereby increasing stimulation to globular epithelial cells.

More specifically, the hardness of the protrusion may be determined according to Equation 2 below.

[Equation 2]

H ₁ ≥ H ₂

In Equation 2, H ₁ is the Shore hardness of the protrusion, and H ₂ is the Shore hardness of the cover.

The Shore hardness of the protrusion 22 is provided at least equal to or greater than the Shore hardness of the cover, so that the protrusion 22 maintains hardness even when the shape of the cover 20 changes according to the shape and movement of the finger. It can effectively stimulate oral epithelial cells.

6 is a state diagram showing the use of the oral epithelial cell harvesting instrument according to the present invention. Hereinafter, a method of using the oral epithelial cell harvesting instrument will be described. The user can easily collect the epithelial cells by inserting the epithelial cell collecting device into the user's index finger and then gently rubbing the inside of the testee's cheek so that the collecting part 10 touches the oral epithelial cells. If there is a need to increase the collection amount of globular epithelial cells, use an oral epithelial cell harvesting instrument equipped with protrusions 22, put it on the user's index finger, confirm that the protrusions 22 protrude to a sufficient height, and then insert the oral epithelial cell collection instrument into the mouth of the subject and gently rub it to collect globular epithelial cells. At this time, stimulation points for oral epithelial cells are increased by protruding protrusions, and since epithelial cell detachment is increased in the oral cavity, a large amount of globular epithelial cells can be collected in one collection.

Simple modifications or changes of the present invention can be easily performed by those skilled in the art, and all such modifications or changes can be considered to be included in the scope of the present invention.

Claims

A cover having an opening at one end to insert a finger into; and

a collecting part formed on the surface of the other end of the cover;

Including, wherein the collection unit is a medical cotton cloth, oral epithelial cell collection device.
The method of claim 1, wherein the cover is a silicone rubber having a Shore A durometer hardness of 30-50, a tensile strength of 7 to 12 MPa (ISO 37 TYP 1), an elongation of 300 to 700% (ISO 37 TYP 1), and a tear strength of 30-45 N/mm (ASTM D624B), or

Shore A durometer hardness is 10-30, tensile strength is 5 to 30 MPa (ISO 37 TYP 1), elongation is 500 to 800% (ISO 37 TYP 1), and tear strength is 10 to 30 N / mm (ASTM D624B).
The oral epithelial cell collecting device according to claim 1, wherein the cover has protrusions formed around the collecting part.