GB2317113A

GB2317113A - Skin allergy test assemblies

Info

Publication number: GB2317113A
Application number: GB9619144A
Authority: GB
Inventors: Ray-Ling Hsiao
Original assignee: HSIAO RAY LING
Current assignee: HSIAO RAY LING
Priority date: 1996-09-13
Filing date: 1996-09-13
Publication date: 1998-03-18
Anticipated expiration: 2016-09-13
Also published as: GB9619144D0; GB2317113B; DE29711006U1

Abstract

A skin allergy test assembly comprises skin allergy test-bar 2, and multiple-test-bar holder 19. Also described are trays and antigen containers. Skin allergy test-bar 2, comprises finger grip 4, pointed projections 12, and raised portion 10a to limit penetration of the pointed projections 12 into the skin. The multiple-test-bar holder 19, comprises main frame 18, first clamping plate 30, second clamping plate 36, and outer panel 28. Test-bars 2 project through holes in outer panel 28 and are held in place by clamping plates 30, 36 under pressure from spring 32.

Description

Skin Allergy Test Assembly The present invention relates to a skin allergy test assembly, and more particularly to an improved skin allergy test bar by which a limited penetration can be made, and a multiple-test-bar access device for holding multiple skin allergy test bars simultaneously for facating a skin allergy test.

For a skin allergy test, the allergic test conducted by a skin test device of puncture type is one of the most common ways at present.

One example of such a device, as shown in FIG. 1, comprises a finger grip (A), an elongated stem (B) extending therefrom, and a plurality of punctures (C) attached to the end of the elongated stem (B). In use, the test device, like other skin allergy test bars of prior type, is employed to press in contact with a skin portion of a patient, such as the forearm skin, and then has its punctures brought into the epidermis layer (G) of the skin of a patient. A properly performed skin allergy test will leave a visible scarification which corresponds to the punctures thereof. In the test process, a certain amount of antigen liquid loading onto punctures by the capillary phenomenon may be transferred to the test site of the epidermis layer of the skin of the patient. Finally, the test result may be properly interpreted about 20 minutes after the specific antigen liquid has been provided.

Although various conventional skin allergy test bars of puncture type have provided the practitioners or technicians in the art with a convenient way in performing a skin allergy test, yet none of the conventional test devices can be performed to obtain a correct and reproducible test result by a person with ordinary skill in the art, since the skin allergy test performed by any skin allergy test bars of puncture type are required to meet the following test conditions in order to obtain an accurate interpretation for the test result.

(1) the punctures of a skin allergic prick test device are not allowed to penetrate past the epidermis layer of the skin of a patient during the skin allergy test, as indicated in Allergic Principles And Practice, 3rd edition, P423-425, by Elliott et al.; and (2) the skin allergy test is required to be easily used by anyone with ordinary skill, therefore making the test data reproducible and assuring the test reliability.

However, the epidermis layer of a human being is extremely thin, it is therefore very likely for the epidermis layer of the skin to be penetrated by the punctures of the test devices in the test process. As a result, the device as shown in FIGs. 1-3, should be operated by a practitioner or technician very skillful in the art in order to guarantee its reliability.

A disclosed skin allergy test bar, U.S. Pat. No. 4,237,906 to Havstad et al., as shown in FIG. 3, describes an applicator or skin puncture test device having the flat end surface (E) which is provided at the end of the elongated stem (D), and a plurality of pointed projection (F) which are attached to the flat end surface (E), where the flat end surface (E) may act as a stop to limit further penetration of the punctures in the test process.

Although the flat end surface (E) can act as a stop to limit the depth of penetration, it is very difficult for such an applicator to be in punctures of between about 0.1 mm to provide 0.5 mm in depth, so as to avoid excessive penetration of the punctures. Even though such a manufacturing difficulty may be overcome, the punctures thereof will be incapable of carrying sufficient antigen liquid, by its capillarity, so as to conduct the test.

The primary objective of the present invention is to provide an improved skin allergy test bar, which comprises a finger grip, a cover, an elongated stem extending therefrom, and a plurality of punctures; wherein the end of the elongated stem is provided with at least a raised portion to act as a stop to limit excessive penetration ofthe punctures.

Another objective of the present invention is to provide a multipletest-bar access device for holding multiple skin test bars simultaneously, which comprises a main frame, a first clamping plate, a second clamping plate, and an outer panel. The first clamping plate and the second clamping plate are furnished respectively with a plurality of semicircular-shaped cuts while the outer panel is furnished with two parallel rows of holes, where each hole is provided with an arcuate ridge at its outer edge for cooperating with each semicircular-shaped correspondingly cut to form multiple gripping holes therebetween for taking multiple skin allergy test bars simultaneously. Therefore the skin allergy test may be completed immediately simply by forcing the multiple-test-bar access device onto the test site of a patient.

Still another objective of the present invention is to provide a skin allergy test assembly for facilitating a skin allergy test, which comprises a plurality of skin allergy test bars, a plurality of antigen containers, a tray, and a multiple-test-bar access device. Regarding a skin allergy test which requires various specific kinds of antigen solution, the assembly may be operated in an one-by-one manner in which each skin allergy test bar applied with a specific antigen solution can be brought to force against the skin of a patient sequentially or in a whole manner in which all the skin allergy test bars involved in the skin allergy test will be completed immediately by pressing the multiple-test-bar access device onto the skin of a patient.

An embodiment of this invention is described by way of example with reference to the drawings, in hitch: FIG.1 shows a conventional skin allergy test device of prior art.

FIG.2 is a schematic diagram showing how a skin allergy test bar of prior art is to be operated.

FIG.3 shows another skin allergy test bar of prior art in which the punctures are formed at a flat end surface which acts as a stop.

FIG.4 shows an antigen container where a skin allergy test bar is brought to mate therewith.

FIG.S is a perspective view of a multiple-test-bar access device of the first embodiment.

FIG.6 is an exploded view regarding the multiple-test-bar access device of the first embodiment.

FIG.7 is a sectional view taken along A-A line of FIG. 5 R which shows the combination aspect of the multiple-test-bar access device of the first embodiment.

FIG.8 is a sectional view similar to FIG. 7 in which multiple skin allergy test bars (at least two) being held by the multiple-test-bar access device of the first embodiment is shown.

FIG.9 is a perspective view of a multiple-test-bar access device of the second embodiment.

FIG. 10 is an exploded view regarding the s .stiple-test-bar access device of the second embodiment.

FIG. 11 is a sectional view taken along A-A line of FIG.9 i which shows the combination aspect of the multiple-test-bar access device of the second embodiment.

FIG. 12 is a sectional view similar to FIG. 11, in which multiple skin allergy test bars (at least two ) being held by the multiple-test-bar access device of the second embodiment is shown.

FIG. 1 3A shows a multiple-test-bar access device to be attached with projections of resilient material around the hole of the outer panel.

FIG. 1 3B shows the mutiple-test-bar access device having the projections of resilient material loaded with the skin allergy test bar of this invention.

FIG. 14 is a perspective view of a tray which is specially designed for cooperating with the multiple-test-bar access device of this invention.

FIG. 15 shows an improved aspect of an antigen container of the present invention, where the outer surface of which is furnished with a ring which is viewed as a mark for indicating the upper limit of the antigen container.

FIG. 16 is a perspective view of a skin allergy test bar of the present invention.

FIG. 17 is an enlarged fragmentary view of FIG. 16.

FIG. 18 is another embodiment of the skin allergy test bar according to the present invention.

FIG. 19 is another embodiment of the skin allergy test bar according to the present invention.

FIG.20 is a sectional view of FIG.16, showing the operating method of the present invention FIG.21 is another embodiment of skin allergy test device according to the present invention.

Please refer to FIG. 16, it is the perspective view of a skin allergy test bar (2) of the present invention. As shown in the figure, the quantitative skin allergy test bar (2) comprises a finger grip (4) to be held by fingers; a cover (8) provided at the bottom of the finger grip (4), which has a sealing plug portion (8a) adaptfiil to the mouth of an antigen container (9) (see FIG. 15); and an elongated stem (6) extending downwardly from the sealing plug portion (8a), where there is a raised portion (lOa) formed at the end ofthe elongated stem (6) whereas there is a plurality of punctures (12), which are capable of carrying a certain amount of antigen solution (11) by capillary phenomenon, provided around the raised portion (1 0a) (see FIG.20). As shown in FIG. 17 and FIG.20, the punctures (12) are provided at the end of the elongated stem (6), substantially parallel to the axis of the raised portion (1 ova) as well as the longitudinal axis of the elongated stem (6), and each of the punctures (12) has a length greater than the height of the raised portion (1 0a) by a predetermined value which is less than the thickness of the epidermis layer of the skin of human beings. Desirably, the length of each puncture (12) is designed to project beyond the raised portion (10a) by about 0.1 mm to about 0.5 mm, so that the epidermis layer of a patient will not be penetrated by the punctures (12) while conducting a skin allergy test since the raised portion (1 0a) will act as a stop to limit excessive penetration of the punctures (12), which is the most important guideline that a technician or practitioner is required to obey in order to obtain an accurate interpretation of the test result and to make the test data reproducible and assure the test reliability.

Referring next to FIG.4, the skin allergy St bar (2) of the present invention may be put into an antigen container (9) whenever a skin allergy test is not in demand. As shown in the figure, the punctures (12) of the skin allergy test bar (2) will be wetted by the antigen solution (11) in the antigen container (9), such an aspect regarding the skin allergy test bar (2) will therefore facilitate the next skin allergy test. Also, as shown in the figure, we note that the sealing plug portion (8a) of the cover (8) of the skin allergy test bar (2) is placed over the mouth of the antigen container (9), such feature regarding the cover (8) will prevent foreign materials from entering the antigen container (9).

FIG. 18 and FIG. 19 show alternative embodiments of the skin allergy test bars according to the present invention, where the raised portions (1 ova) are formed with different configurations and arrangements, and they are also to act as stops to limit over-penetration.

Although the raised portion (1 0a) are in the form of the configurations and arrangements as shown in these figures, it is understood that various changes can be made thereto without departing the spirit and the purpose of this invention.

Further, the present device is not only applied in a skin allergy test of sequential manner, as described in this disclosure, where each time only one skin test device, with a specific antigen liquid, is allowed to do the test; but also applied in a skin allergy test of simultaneous manner, as described in U.S. Pat. No.3,556,080, issued in 1971, to Hein et al., where the present device can be provided at each leg of the disclosed multileg skin-testing device to assure its test reliability (see FIG.2 1).

Further, in order to allow a skin allergy test to be conducted more conveniently, a multiple-test-bar access device (19) is disclosed herein for cooperating with the skin allergy test bar (2) of the present invention.

As shown in FIG. 5-6, the multiple-test-bar access device (19), which can access multiple skin allergy test bars of any commercial types simultaneously, generally comprises a main frame (18), a first clamping plate (24), a second clamping plate (26), and an outer panel (28). The main frame (18) has a handle (20) to be held by fingers, a slot (22), and a bottom opening (23). The first clamping plate (24) is formed with a plurality of semicircular-shaped cuts (34a) along a longitudinal edge thereof and is furnished with a box at the other longitudinal edge thereof for housing a spring means (32) therein. The height of the box is greater than the depth of the slot (22) of the main frame (18). The second clamping plate (26) is formed with a plurality of semicircularshaped cuts (34b) along a longitudinal edge thereof and is furnished with a mating box (36) at the other longitudinal edge thereof. The height of the mating box (36) is greater than the depth of the slot (22).

The mating box (36) attached at the second clamping plate (26) is somewhat greater than the box (30) attached at the first clamping plate (24) for mating with the box (30). The outer panel (28) is formed with two parallel rows of holes (38) thereon, where each of the holes is furnished with an arcuate ridge (40) respectively at its outer edge for cooperating said semicircular-circular shaped cuts (34a)(34b) of the first and second clamping plates (24)(26) correspondingly.

Referring to FIG.7, it is a sectional view taken along A-A line of FIG.5, which shows the combination aspect of all comprising elements involved in the multiple-test-bar access device (19). All abovementioned elements regarding the multiple-test-bar access device (19) are assembled together in such a manner that the box (30) at the first clamping plate (24) is assembled with the mating box (36) at the second clamping plate (26) to form an elastic and relatively-movable integral enclosure in which the spring means (32) is housed. The enclosure, the height of which is greater than the depth of the slot (22) of the main frame (18), is assembled into the slot (22) of the main frame (18) and extends out of the slot (22) to form a switch portion (42) thereabove. The spring means (32) can therefore exert an elastic force on each inner surface of the box (30) and the mating box (36) so as to have the first clamping plate (24) and the second clamping plate (26) capable of providing an outward force, and the box (30) and the mating box (36) of the enclosure can be moved toward each other when pressing the switch portion (42) so as to accommodate multiple skin allergy test bars simultaneously, the performs with regard to which will become apparent after a reading of the fol. v ing description.

Referring again to FIG 7 the outer panel (28) is placed to cover the bottom opening (23) and abut both the first clamping plate (24) and the second clamping plate (26), wherein each of the holes (38) of the outer panel (28) is located to correspond to the semicircular-shaped cuts (34a ) (34b) and will therefore correspondingly cooperate with the arcuate ridges (40) which are furnished at the outer edges of the holes (38) respectively to form multiple gripping holes therebetween, which are formed coaxial with their corresponding holes (38) of the outer panel (28). In normal state, the diameter of each gripping hole is somewhat smaller than that of a skin allergy test bar (2). In use, when applying a force onto the switch portion (42), the first clamping plate (24) and the second clamping plate (26) will be moved toward each other so that all the gripping holes will get larger simultaneously to accommodate the multiple skin allergy test bars (2) simultaneously; when releasing the applying force, the spring means (32) enables the first clamping plate (24) and second clamping plate (26) to clamp the multiple skin test bars (2) by means of semicircular-circular shaped cuts (34a) (34b) and their cooperating arcuate ridges (40). Accordingly, the simultaneous gripping of multiple skin allergy test bars (2) for a skin allergy test can be achieved (referring to FIG.8).

Further more, another embodiment regarding a multiple-test-bar access device (19a) is introduced herein for the same purpose as the above-described multiple-test-bar access device (19). As shown in FIGs. 9-12, this embodiment has a similar structure with the abovedescribed multiple-test-bar device (19), except that the main frame (18a) which has two longitudinal sides (80a)(80b) of a wave-like configuration and two parallel rows of frame holes (82) corresponding to the holes (38) of the outer panel (28a), and the outer panel (28a) which forms with two wave-like edges (100a)(100b) corresponding to the wave-like sides (80a)(80b) so as to be adaptable to the main frame (1 8a). As shown in the figures, the finger grip of the skin allergy test bar (2) may pass through the holes (38) of the outer panel (28a) into the frame holes (82) of the main frame (18a). Such a feature will allow the user to make sure whether the skin allergy test bar (2) is pressed on the test skin surface of a patient properly or not, by checking the contact condition of the multiple-test-bar access device (19a) through the adjacent space (102) between the individual waves.

Still further more, as shown in FIG. 13A and 13B, in any one of the above-mentioned multiple-test-bar access device, projections (104) of resilient material may be attached to the outer panel (28) around each hole (38) of the outer panel (28) for providing the multiple-test-bar access device with resilience required in a skin allergy test.

For making the multiple-test-bar access device (19) of the present invention more effective and useful, a specially-designed tray (50) is introduced herein in cooperation with the device. Please refer to FIG. 14, the tray (50) is formed with two parallel rows of tray holes (52) for holding a plurality of antigen containers (9). The two parallel rows of tray holes (52) are aligned to correspond to the gripping holes which is formed by the semicircular-circular shaped cuts (34a)(34b) and the cooperating arcuate ridges (40), as well as the holes (38) of the outer panel (28). Accordingly, all the multiple skin allergy test bars (2) can be directly taken from the antigen containers (9) immediately which are already held in the tray holes (52) of the tray (50) for conducting a skin allergy test in which various specific kinds of antigen solution are required. Besides, the side surfaces of the tray (50) are designed with an assembling means whereon one of the side surfaces has a concave (54) furnished with side grooves (55) while the opposite side surface has a convex (56) fumished with side ridges (57). By the mating of said grooves (55) and ridges (57), a plurality of trays (50) can be assembled adjacently and continuously so as to facilitate skin allergy tests to be performed while multiple test samples are required.

Referring to FIG. 15, the antigen container (9) as described above can be further furnished with a ring (13) on the outer surface thereof, which is viewed as a mark for indicating the upper limit of the antigen container (9) in order to avoid the overflowing of the antigen solution when bringing the skin allergy test bar into the container.

The improved skin allergy test bar (2), the multiple-test-bar access device (19), the tray (50) and the antigen container (9) of the present invention may be combined into a skin allergy test assembly, which will be a more powerful and effective tool for a skin allergy test. In operating such an assembly, if only one specific antigen solution is required, then the skin allergy test bar (2) of this invention will suffice, if a skin allergy test in which various kinds of specific antigen solution are required is under consideration, then the multiple-test-bar access device (19) will give much assistance to the skin allergy test. Regarding the skin allergy test assembly, when conducting a skin allergy test, each of the antigen containers (9) is filled with various specific kinds of antigen solution, then multiple unused sterile skin allergy test bars (2) of the present invention may be put into the antigen containers (9) on the tray (50), and finally the multiple-test-bar access device (19) may be employed to take all the multiple skin allergy test bars (2) at a clamp by the procedures as described above. Simply by forcing the multiple-testbar access device (19) directly onto the desired test site of a patient, the skin allergy test will be completed at a press. After finishing the skin allergy test, the user may press the switch portion (42) of the multipletest-bar access device (19) once again to throw the used test bars away.

Although the description above contains many references to specific versions and aspects of the invention, this circumstance should not be construed as limiting the scope of the invention but as merely providing illustrations of some of the presently preferred embodiments of this invention. For example, the concave surface of the skin allergy test bar may be a flat recessed surface; the semicircular-shaped cut can be furnished with an arcuate ridge to cooperate with the arcuate ridge of the outer panel for improving the gripping tightness. Therefore, the scope of this invention should be determined by the appended claims and their legal equivalents, rather than by the examples given in the descriptions above.

Claims

CLAIMS:

1. In a skin allergy test bar of the type which has a finger grip, an elongated stem extending therefrom, and a plurality of punctures provided at the end of said elongated stem, the improvement comprising: the end of said elongated stem having at least a raised portion to act as a stop, each said puncture extending from the end of said elongated stem, substantially parallel to the longitudinal axis of said elongated stem as well as the axis of said raised portion, and each said puncture having a length greater than the height of said raised portion by a predetermined value which is less than the thickness of the epidermis layer of the skin of human beings, such that each puncture will not penetrate the epidermis layer of the skin of a patient due to said raised portion acting as a stop during a skin allergy test, in order to obtain an accurate interpretation of the test result.

2. The skin allergy test bar of claim 1, wherein he improvement further comprises a cover which has a sealing plua adaptful to the mouth of an antigen container to prevent the antigen liquid in said antigen container from being contaminated.

3. In a multileg skin allergy test bar of the type which has a barlike handle, multiple legs longitudinally attached to the barlike handle to form an integral body, wherein each leg is fumished with a plurality of punctures at the end thereof, the improvement comprising: each said leg being provided with at least a raised portion to act as a stop when performing a skin allergy test to prevent the epidermis layer of the skin of a patient from being penetrated, so that the multileg skin allergy test bar can be easily performed by practitioners or technicians with ordinary skill to obtain an accurate and reproducible test result.

4. The improvement of claim 3, wherein each said leg further comprises a cover which has a sealing plug adaptful to the mouth of an antigen container to prevent the antigen liquid in said antigen container from being contaminated.

5. A multiple-test-bar access device for holding multiple skin allergy test bars simultaneously, said device comprising: a main frame having a handle to be held by a user's fingers, a slot, and a bottom opening; a first clamping plate formed with a plurality of semicircular-shaped cuts along a longitudinal edge thereof and furnished with a box at the other longitudinal edge thereof for housing a spring means therein, the height of said box being greater than the depth of said slot of said main frame; a second clamping plate formed with a plurality of semicircular shaped cuts along a longitudinal edge thereof and furnished with a mating box at the other longitudinal edge thereof for mating with said box, the height of said mating box being greater than the depth of said slot of said main frame, said box and said mating box being assembled together to fbnn an elastic and relatively-movable integral enclosure in which said spring is housed, said enclosure being assembled into said slot of said main frame and extending out of said slot to form a switch portion thereabove, so that said spring means can exert an exert force on each inner surface of said box and said mating box to have said first clamping plate and said second clamping plate capable of providing an outward force, and said box and said mating box can be moved toward each other as pressing said enclosure; and an outer panel formed with two parallel rows of holes thereon, each hole corresponding to each said semicircular-shaped cut of said first and second clamping plates and each hole furnished with an arcuate ridge at its outer edge for cooperating with each said semicircular shaped cut correspondingly, said outer panel placed to cover said bottom opening of said main frame and abut both of said first clamping plate and said second clamping plate where each said hole of said outer panel is located to correspond to each said semicircular-shaped cut of said first and second clamping plate so that each said arcuate ridge furnished at its hole will cooperate with each said semicircular-shaped cut correspondingly to form multiple gripping holes therebetween, each gripping hole being coaxial with its corresponding hole of said outer panel, the diameter of each said gripping hole being somewhat smaller than that of a skin allergy test bar in normal state; when pressing said switch portion, said first clamping plate and said second clamping plate will move toward each other, thereby making all the gripping holes get larger simultaneously so as to accommodate said multiple skin allergy test bars simultaneously; when releasing the pressing force, said spring means will cause said first clamping plate and said second clamping plate to enable said multiple skin allergy te bars by means of said arcuate ridges and said semicircular-circui shaped cuts so as to take said multiple skin allergy test bars simultaneously.

6. The multiple-test-bar access device of claim 5 wherein said main frame having two wave-like sides and two parallel rows of frame holes, said outer panel having two wave-like edges corresponding to said wave-like sides to be adaptable to said main frame.

7. A skin allergy test assembly for facilitating a skin allergy test, said assembly comprising: a plurality of skin allergy test bars, each of which has a finger grip, an elongated stem extending therefrom, and a plurality of punctures provided at the end of said elongated stem, wherein the end of said elongated stem having at least a raised portion to act as a stop, each said puncture extending from the end of said elongated stem, substantially parallel to the longitudinal axis of said elongated stein as well as the axis of said raised portion, and each said puncture having a length greater than the height of said raised portion by a predetermined value which is less than the thickness of the epidermis layer of the skin of human beings; a plurality of antigen containers; a tray having two parallel rows of tray holes formed thereon for holding said antigen containers, said tray formed with an assembling means whereon one of the side surfaces has a concave furnished with side grooves while the opposite side surface has a convex furnished with side ridges; a multiple-test-bar access device for holding multiple skin allergy test bars simultaneously, said device having a main frame, a first clamping plate, a second clamping plate, and an outer panel; said main frame having a handle to be held by a user's fingers, a slot, and a bottom opening; said first clamping plate formed with a plurality of semicircular-shaped cuts along a longitudinal edge thereof and furnished with a box at the other longitudinal edge thereof for housing a spring means therein; said second clamping plate formed with a plurality of semicircular-shaped cuts along a longitudinal edge thereof and furnished with a mating box at the other longitudinal edge thereof for mating with said box, said box and said mating box being assembled together to form an elastic and relatively-movable integral enclosure in which said spring is housed, said enclosure being assembled into said slot of said main frame and extending out of said slot to form a switch portion thereabove; said outer panel formed with two parallel rows of holes thereon, each hole corresponding to each said semicircular-shaped cut of said first and second clamping plates and each hole furnished with an arcuate ridge at its outer edge for cooperating with each said semicircularshaped cut correspondingly, said outer panel placed to cover said bottom opening of said main frame and abut both of said first clamping plate and said second clamping plate where each said hole of said outer panel is located to correspond to each said semicircular-shaped cut of said first and second clamping plate, each gripping hole being coaxial with its corresponding hole of said outer panel, the diameter of each said gripping hole being somewhat smaller than that of a skin allergy test bar in normal state.