AU615161B2 - Allergy testing method and apparatus - Google Patents

Description

i AU-Al-73569/87 OR'L INTELLECTUAL PROPERTY ORGANIZATION International Bureau

S

r INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (51) International Patent Classification 4 (11) International Publication Number: WO 87/ 06115 A61B 10/00, 17/20 Al (43) International Publication Date: 22 October 1987 (22.10.87) (21) International Application Number: PCT/US87/00921 (74) Agent: HOLTZ, Leonard; Frishauf, Holtz, Goodman Woodward, 261 Madison Avenue, New York, NY (22) International Filing Date: 16 April 1987 (16.04.87) 10016 (US).

(31) Priority Application Numbers: 853,710 (81) Designated States: AT (European patent), AU, BE (Eu- 853,748 ropean patent), BR, CH (European patent), DE (European patent), DK, FI, FR (European patent), GB (32) Priority Dates: 18 April 1986 (18.04.86) (European patent), HU, IT (European patent), JP, 18 April 1986 (18.04.86) KR, LU (European patent), MC, NL (European patent), NO, RO, SE (European patent), SU.

(33) Priority Country:

US

Published (71)(72) Applicant and Inventor: FISHMAN, Henry [US/ With international search report.

US]; 5173 Linnean Terrace, Washington, DC 20008 (US).

&E .JR 1 0 DEC 1987 (72) Inventor: OLSHAKER, Robert 3946 Caminito Del- EC 1 mar Cove, San Diego, CA 92130

AUSTRALIAN

-9 NOV 1987 PATENT

OFFICE

(54) Title: ALLERGY TESTING METHOD AND APPARATUS (57) Abstract An allergy testing method and apparatus for testing a patient for a plurality of allergies at substantially the same time, wherein a carrier plate (14) carries a plurality of allergen sources (18) and a plurality of movable pricking needles (38) which are movable from an inactive position out of contact with the skin of a patient to an inactive position for pricking the skin of a patient and applying an associated allergen to the pricked skin when moved fr6m the inactive position to the active position. The plurality of pricking needles (38) are arranged with a given spacing therebetween, and an actuator (39) is coupled to the carrier (35) plate for moving the pricking needles from their inactive positions to their active positions to prick the skin of a patient and to thereby apply a respective allergen to the skin of the patient via the pricking needles.

i i WOR'7/niai4 c' PCT/US87/00921 ALLERGY TESTING METHOD AND APPARATUS BACKGROUND OF THE INVENTION This invention relates to allergy testing methods and apparatuses, and more specifically to improved apparatuses and methods for testing a patient for a plurality of allergies at substantially the same time.

Allergy testing generally involves giving a patient a plurality of "prick tests." Each prick test is applied in order to determine whether or not a patient is allergic to a particular substance, such as pollen, animal dander, dust, foods, etc. A conventional prick test involves placing a drop of a test substance on the patient's skin and then using a needle to scratch the substance through the skin. If a reaction occurs, the patient is considered to be allergic to the particular substance. At present, allergy testing is carried out on an individual basis. Each test substance is dropped, one drop at a time, on the patient's arm or back. Each drop is then individually pricked through the skin with a separate needle. This is a very time consuming process (for both the patient and the practitioner) and very often involves multiple office visits for the patient. This leads also to a substantial amount of patient discomfort, expense, and inconvenience.

An object of the present invention is to provide improved apparatuses and methods for testing patients for allergic reactions to a plurality of substances, all at substantially SUSSTITUTE

SHEET

No 1" r -2the same time. The invention will reduce the time required for testing, minimizing patient discomfort, expense and inconvenience, and improving productivity.

A further object of the invention is to provide improved methods and apparatuses which will enable the plurality of allergy tests to be applied simultaneously without requiring a great deal of technical skill on the part of the operator.

Yet another object of the invention is to provide improved apparatuses which used pre-packaged allergen and needles, which are easily insertible in and removable from a carrier, thereby facilitating loading the carrier with predetermined allergens, and improving the sterility of the apparatus.

Still another object is to provide an allergy testing system where the pricking of the skin is always done to a given skin penetration depth which is predictable and which is replicable without requiring highly skilled operators.

SUMMARY OF THE INVENTION According to one aspect of the invention there is provided an allergy testing apparatus for testing a patient for a plurality of allergies at substantially the same time, comprising: a plurality of sources of an allergen; a common allergen carrying means for carrying said plurality of sources of an allergen with said allergen sources in spaced apart relationship; e a plurality of spaced apart movable pricking means mounted on a common movable member so as to be movable as a unit with said common movable member; carrier means including means for supporting said movable member such that S said movable member and said pricking means mounted thereon are substantially simultaneously movable relative to said carrier means along a substantially fixed S predetermined path from an inactive position out of contact with the skin of a patient to an active position for pricking the skin of a patient, each of said pricking means ooe.oi S being arranged for applying allergen from a respective allergen source to the pricked S skin when moved along said path from said inactive position to said active position; said carrier means including means for at least partially defining said substantially fixed predetermined path in cooperation with said movable member; and actuating means, coupled to said movable member and movable relative to at Cl1 "I -3least part of said carrier means, for moving said movable member and said pricking means substantially simultaneously relative to said carrier means for causing each of said pricking means to contact a respective allergen source and to retain a respective allergen thereon, and for (ii) moving said movable member and said pricking means substantially simultaneously relative to said carrier means along said path from said inactive position to said active position thereof, for thereby substantially simultaneously applying allergens retained on respective pricking means at spaced apart positions on the skin of the patient when said respective pricking means reaches said active position.

According to another aspect of the present invention there is provided an allergy testing apparatus for testing a patient for a plurality of allergies at substantially the same time, comprising: a plurality of sources of an allergen; a common allergen carrying means for carrying said plurality of sources of an allergen with said allergen sources in spaced apart relationship; a plurality of spaced apart movable pricking means mounted on a common movable member so as to be movable as a unit with said common movable member; carrier means including meuins for contacting the skin of a patient and supporting said movable member relative to the skin of a patient such that said S movable member and said pricking means mounted thereon are substantially simultaneously movable along a substantially fixed predetermined path from an inactive position out of contact with the skin of the patient to an active position for I25 pricking the skin of a patient, each of said pricking means being arranged for applying allergen from a respective allergen source to the pricked skin when moved along said path from said inactive position to said active position; said carrier means including means for at least partially defining said substantially fixed predetermined path in cooperation with said movable member; and actuating means, coupled at least to said movable member, for moving said movable member and said pricking means substantially simultaneously relative to said allergen carrying means for causing each of said i L1 -3Apricking means to contact a respective allergen source and to retain a respective allergen thereon, and for (ii) moving said movable member and said pricking means substantially simultaneously, relative to said skin of said patient which is contacted by said carrier means, along said path from said inactive position to said active position thereof, for thereby substantially simultaneously applying allergens retained on respective pricking means at spaced apart positions on the skin of the patient when said respective pricking means reaches said active position.

According to a further aspect of the invention, there is provided an allergy testing method for testing a patient for a plurality of allergies at substantially the same time, comprising: providing a plurality of allergens in a common allergen carrying means for carrying said plurality of allergens with said allergens in mutually spaced apart relationship; providing a plurality of spaced apart movable pricking means mounted on a common movable member so as to be movable as a unit with said common movable S member; supporting said movable member on a carrier such that said movable member and said pricking means mounted thereon are substantially simultaneously movable relative to said carrier along a substantially fixed predetermined path for an inactive S position out of contact with the skin of a patient to an active position for pricking the skin of a patient, each of said pricking means being arranged for applying a respective allergen from said common allergen carrying means to the pricked skin when moved :25 to said active position; i at least partially defining said substantially fixed predetermined path by said carrier in cooperation with said movable member; moving said movable member with said pricking rn'ans thereon substantially o:e,.

S simultaneously relative to said carrier for causing each of said pricking means to contact a respective allergen and to retain the respective allergen thereon; and moving said movable member with said pricking means thereon substantially simultaneously relative to said carrier along said path from said inactive position to 1 I r -3B said active position thereof, for thereby substantially simultaneously applying allergens retained on respective pricking means at spaced apart positions on the skin of the patient when said respective pricking means reach said active position.

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a side view, in a partially disassembled state, of an embodiment of the present invention; gong o o• ooo0 0..

I VV e ol

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i i i 9 *n

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WO 87/06115 PCT/US87/00921 4 Fig. 2 is a side view of the embodiment of Fig. 1 arranged ready for use; Fig. 3 is a side view showing the apparatus of Figs. 1 and 2 after the needles have pierced or pricked the skin of the patient; Fig. 4 is a top view of the embodiment of Figs. 1-3; Fig. 5 is a partial view of a modified intermediate plate member; Fig. 6 is a perspective view of a modified embodiment, including three units of Figs. 1-4; Fig. 7 is a top plan view of the embodiment of Fig. 6; and Fig. 8 is a fractional view of a modified interconnection for use in the embodiment of Figs. 6 and 7.

Figure 9 is a perspective view of another embodiment of the present invention; Fig. 10 is a top view thereof with the top cover member in its fully opened position ready to receive allergen containers; Fig.. 11 is a front elevational view thereof with the top cover member partially closed in its "ready for activation" S position; Fig. 12 is a side elevational view in the same condition as shown in Fig. 11; Fig. 13 is a top view of an allergen container for use with the device of Figs. 9 12; Fig. 14 is a sectional view of the allergen container of Fig. 13; SU3STITUTI SHEET i, k L ST WO87/06115 PCT/US87/00921 Fig. 15 is a sectional view of the embodiment of Figs. 9- 14 showing the top cover member in its fully opened position and in its fully closed position in solid lines, and in intermediate positions in dashed lines; Fig. 16 is a sectional view of the housing portion of the apparatus of Fig. 9, but showing a modification to the internal construction thereof; Fig..17 is a top view of another embodiment of the invention; Fig. 17A is a sectional view taken along the line 9A-9A in Fig. 17; Fig. 18 is a side view of the embodiment of Fig. 17; Fig. 18A is a sectional view taken along the line 10A-1OA in Fig. 18; Fig. 19 is a top view of a cassette for use-with the emhodi.ment of Figs. 18 and 18A; Fig. 19A is an end view of the cassette of Fig. 19; Fig. 20 is a side view of the cassette of Fig. 19 Fig. 21 is a perspective view of the cassette of Figs. 19 and 20, partially loaded; V Fig. 22 is a perspective view of the unit of Figs. 17and 18 Figs.23-25 are top, bottom and side views of an allergen Scarrying member for use with the embodiment of Figs. 17-22, Fig. 26 is-a schematic view showing the efmbodiment of Figs.

17-22 in use; Figs. 27 and 28 are top and side views, respectively, of a further modified embodiment of the invention; Fig. 29 is an end view of the operating member of the embodiment of Figs. 27 and 28; sa.sTTUTX SHEET WO 87/06115 PCT/US87/00921 6 Fig. 29 is an end view of the operating member of the embodiment of Figs. 27 and 28; Fig. 30. is a perspective view of the embodiment of Figs. 27 and 28; Fig. 31 is a perspective view of a cassette for use with the embodiment of Figs. 27-30; Fig. 32 is a sectional view of the cassette taken along line 24-24 of Fig. 31; Fig. 33 is a side view of a modified allergen carrying member for use with the embodiment of Figs. 17 22; Fig. 34 is a top view of the bottom member of the allergen carrying member of Fig. 33, the top member being removed for ease of illustration; Fig. 35 shows a sectional view of a further modified allergen carrying member for use with the embodiment of Figs. 17 22; DETAILED DESCRIPTION The term "allergen" is used throughout this specification and claims to denote the substance applied to a patient.

However, the invention is equally applicable to antigens in general and the term "allergen" as used in the specification and claims denotes antigens as well as allergens.

-Referring to Figs. 1, 2 and 3, an allergy testing unit 1 of the present invention comprises a pair of vertical support posts 10,11 at opposite ends thereof, the support posts 10,11 having respective stops 12,13 at the upper ands thereof. The posts 10, 11 may be made, for example, of plastic material and SU 33TITUTE SHEET I WO 87/06115 87/0615 PCT/US87/00921 7 the end stops 12,13 can be integrally moulded with the posts 10,11 respectively. An intermediate plate member 14 has apertures 15, 16 formed at the ends thereof through which ,I7e4tber the posts 10,11 respectively pass. The plate number 14 is fixedly connected to and supported by posts 10, 11, for example by an adhesive or the like, in the position shown in Fig. 1. Plate member 14 also comprises a plurality of apertures 17, through which are mounted capsules or vials 18 containing allergens. The capsules 18 have rubber stoppers 19 at the top portions thereof and puncturable rubber seals at the lower portions thereof.

The apparatus further comprises an upper plate m7mber which has apertures 26, 27 therein so as to be slidably mountable on posts 10, 11. If the stops 12, 13 are integrally formed on posts 10, 11, the upper plate is mounted on posts 11 from the bottom, before the intermediate plate 14 is fixed to the posts 10, 11. The upper plate member 25 comprises engaging projecting members 28 which respectively engage into recesses in the upper rubber stopper members 19 of the respective capsules 18', as shown in Figs. 2 and 3. Upper plate member 25 also comprises handle members 29 a the opposite ends thereof to facilitate handling and -g of the apparatus in use.

The apparatus further comprises a lower plate member having apertures 36, 37 by means of which the lower plate member 35 is slidably mounted on posts 10, 11. Lower plate member 35 has a plurality of hollow needles 38 fixedly StBSTTUTrL SKEE1 WO 87/06115 PCT/1iS87/00921

I

i ii mounted therein, the needles 38 preferably having sharp tips at both opposite ends thereof. The needles 38 are mounted in registration with the capsules 18 and projecting members 28.

Lower plate member 35 further comprises handles 39 projecting from the opposite ends thereof, similar to the handles 29 of the upper plate member 25 and in registration with handles 29 of upper plate member As seen in Fig. 1, removable pins 50,52 may be inserted in holas 51,53, respectively, in posts 10,11 to "lock" the upper plate member 25 in its uppermost position. When ready for use, the pins 50,52 may be merely removed by the operator by pulling them out of their respective holes in the posts.

Similar pins and holes can be provided in posts 10,11 above the lower plate member 35 in order to physically prevent the lower plate member 35 from moving upwardly, to inadvertently pierce the punctuable rubber seals 20. When ready for use, the pins can, of course, be removed. Other types of locking arrangements could be used in place of pins 50,52 and respective holes 51,53.

Fig. 1 shows the apparatus in its partially assembled state. In operation, the upper plate member 25 is pressed downwardly in the direction of arrow A in Fig. 1, and the lower plate member 35 is pressed upwardly in the direction of the arrow B in Fig. I by means of pressing with the fingers of the operator, as shown in Fig. 2, until the apparatus reaches the condition shown in Fig. 2. When the apparatus is in the condition shown in Fig. 2, the posts 10,11 are placed against the skin 40 of the patient to support the apparatus b~~IT! rr~ WO 87/06115 PCT/US87/00921 9 against the patient's skin, as shown in Fig. 2. In the Fig. 2 condition, the needles 38 are pierced through the respective puncturable seals 20 at the lower portions of the respective capsules 18 and extend into the respective capsules and in contact with the allergens contained with the respective capsules'18. Then, the operator presses the lower plate member 35 downwardly toward the skin 40 as shown in Fig. 3.

While pressing downwardly, the needles 38 leave the respective capsule and prick the skin of the patient at predetermined spaced intervals corresponding to the positions at which the needles 38 are fixedly mounted in the lower plate member The allergens which passed into the respective hollow needles 38 are now applied to the pierced or pricked portions of the patient by capillary action. At this point, the upper portion of the unit 1, comprising the posts 10, 11, the upper plate member 25 and the intermediate member 14, can be removed with the other elements of the device or it can remain against the skin of the user for the desired amount of time to permit penetration of the allergen through the needles 38 and into the skin of the patient. After use, the lower plate member along with its needles 38 can either be discarded or sterilized for re-use.

Preferably, the puncturable seals 20 at the lower portions of the respective capsules 18 are of the type that sealingly reclose upon removal of the needle 38 therefrom. 'Such seals are well known. Thus, the capsules 18 containing the allergens can be re-used with either a new (sterilized) lower plate member 35 and corresponding new needles 38, or a..sterilized SU9STITUT* SHZrKT ,uL~ur srr WO 87/06115 PCT/US87/00921 re-used lower plate member 35 with its associated sterilized needles 38.

The needles 38 have a given length such that as the lower plate is moved downwardly toward the skin 40, the upper parts of the needles 38 leave the capsules 18 before the lower parts of the needles 38 prick the patient's skin. Thus, the allergens in the capsules 18 do not become contaminated since the needles are free of the capsules 18 when the skin is pricked, and the capsules and the upper part of the assembly can be re-used without sterilization.

The capsules 18 are preferably removably mounted in the intermediate plate 14, for example via screw threads 41 at the intermediate portions of the capsule 18 as illustrated in the j Figs. 1-3. Alternatively, the capsules 18 may be press fit in a tight sliding manner into the apertures in the intermediate plate 14, -r may be held in place by means of an adhesive. Preferably, such an adhesive is the type which can be easily broken to permit removal of the capsules 18 from plate 14, and replacement, as desired. As another alternative, S respective set screws 42 can be provided on intermediate plate member 14 for each of the capsules 18, as shown in Fig. After insertion of a capsule 18 into an aperture 17, the set screw 42 is tightened against the side of the capsule 18 to hold it in place. A similar set screw arrangement can be used to fix the intermediate plate 14 to the posts 10,11.

Preferably, the upper closure member 19 of the capsules' SUSSTITUTE

ISHET

r, 1 I I WO 87/06115 PCT/TJS87/00921 11 18 is resilient rubber or other suitable resilient material so that when the projecting members 28 are received therein and pressure is downwardly applied, the upper closure 19 will yield downwardly and will create pressure inside the capsule 18 to enhance transfer of the allergen out of the capsule, through the hollow needle 38 pierced therein (see Fig. 2) and onto the skin of the user when the device is in the condition shown in Fig. 3.

A plurality of units 1 can be stacked side-by-side, as shown .in Fig. 6. In Fig. 6, the outer units 1 are substantially identical to the units 1 of Figs. 1-4. The middle unit 1' in Fig. 6 is also substantially identical to unit 1 of the embodiment of Figs. 1-4, except that posts 10,11 are not required in the middle unit. However, the middle unit 1 could be provided with posts lq,ll, as in the outer units 1.

In the embodiment of Fig. 6, each unit 1,1' comprises ten capsules 18, so that each unit enables ten allergy prick tests to be applied at the same time. The capsules of each unit may contain different allergens, thus enabling a prick test for up to thirty different substances to be applied at the same time, greatly enhancing efficiency. While each unit 1, 1' of the apparatus is described as having ten capsules each containing different allergens, a different number of capsules can be provided in each unit, as desired. The number of units which are connected together side-by-side, may be other than three. For example, the number of units connected together side-by-side is a function of the body area ^Js3TITUT:K: iM T 87/06115 PCT/US87/00921 12 of the patient on which the test is to be performed. For example, if the test is to be performed on the arm of a patient, perhaps only one or two units 1 arranged side-by-side can be used. However, when the test is to be performed on the back of patient, which is relatively flat surface, three units or more 1, l' connected together side-by-side can be advantageously used in some cases.

In Fig. 6, each side of the combined apparatus comprises a single upper handle 29' and a..single lower handle 39' which extend between the outermost units 1. The side-by-side units are interconnected by means of male and female sockets and projections which cooperate to form respective interconnections 301. For example, the outer units I can comprise recesses 302 in the side walls thereof, and the intermediate unit 1' can comprise projections 303 extending from the side walls thereof for mating with the recesses 302. By providing such an arrangement, the center unit can be a special center unit, and the two outer units can be identical. Alternatively, the projections 303 can be provided on the side walls of the outer units 1, and the intermediate unit 1' can have recesses 302 for receiving the projections 303. Similar interconnections 301 are provided for the intermediate and/or lower plate members of the apparatus, in substantially the same manner as shown for the upper plate member. Alternatively, the units 1, 1' can be adhered together in the side-by-side relation, for example, by means of an adhesive or a solvent (if the plates are made of a suitable plastic material), or they may be otherwise connected for example by screws.

SUST .TUT. SHErr WO 87/06115 PCT/US87/00921 13 Fig. 7 shows a top view of an embodiment similar to the embodiment of Fig. 6, but wherein each of the units 1 comprises respective posts 10, 11. In Fig. 7, the interconnections 301 are shown as respective male-female (projection-recess) interconnections wherein the projections project from the upper and intermediate units, and the recesses are in the lower and intermediate units 1, as seen in Fig. 7.

The interconnections 301 in Figs. 6 and 7 may be of the press-fit or interference-fit type to improve the integrity of the interconnection. Snap-type connections may also be provided, such as shown in enlarged scale in Fig. 8. In Fig. 8, the projections 303 have a projecting rib 304, and the recesses 302 have a groove 305 therein to snappingly receive the ribs 304. This construction is particularly advantageous when the plate members (including the interconnections 301) are made of plastic material having some resiliency to permit the rib 304 to pass through the recess 302 and "snap" into a respective groove 305.

An advantage of the apparatus of the present invention is that the prick test is conducted at fixed predetermined spaced apart locations on the patient's skin. The spacing between the capsules 18 (and their associated needles 38) is arranged such that a sufficient distance is provided between adjacent needles so that the adjacent prick tests will not interfere with each other. In a preferred embodiment, the spacing between adjacent needles (see Fig. 1) is WO 870 115 PCT/---9 I WO 87/06115 PCT/US870092 1 14 approximately 1/2-3/4 inch. A similar needle spacing is provided between adjacent needles of side-by-side connected units in the direction perpendicular to the direction in Fig. 1. This eliminates the problem that respective prick tests may be applied too close to each other.

Preferably, the plate members 14, 25, 35 and the posts 11 are fabricated of sterilizable plastic material, such as polyvinylchloride

(PVC).

The capsules 18 are preferably made of glass or plastic material, and the needles, of course, are preferably made of metal, such as stainless steel.

An important advantage of the present invention is that the pricking or piercing of the skin is always done to a given skin penetration depth. The penetration depth is a function of the distance the needles 38 project downwardly from'the lower plate member 35. See Fig. 3. Moreover, the skin penetration depth is replicable without requiring highly skilled operators, since the penetration depth is not a function of the skill of the operator, but is a function of the distance the needles 38 project downwardly from the lower plate member 35. Thus, repeatable results are obtainable when using the system of the present invention.

The upper plate-like member 25 is not absolutely required. The handles 29 can be coupled to the ends of the intermediate plate-like member 14. Handling and operation J'Vsi STITTUX SM EZZ7 WO 87/06115 S87/06115 PCT/US87/00921 of the apparatus will be essentially similar to that described hereinabove. Also, the support rods or posts 10, 11 need not be round. They may be rectangular, oval or any other convenient shape.

Referring to Figs. 9-12, an allergy testing apparatus comprises an elongated housing 30 having a cover member 31 hingedly connected thereto, preferably by means of a "living hinge" 38. Preferably, the living hinge 38 extends along the complete length of the elongated housing and cover member, but it may be provided in small sections as shown in Fig. The housing 30 defines a plurality of compartments 32 for receiving respective packages or capsules containing allergens and/or an allergen applying needle. Holes or openings 35 are provided at the bottom of each respective compartment 32.

SSprings 33 (preferably leaf springs) are provided on the upper surface of the housing 30 for resiliently biasing the cover member in a partially open position as shown in Fig. 12. The cover member 31 may be moved further downwardly relative to ths. housing 30 upon application of a closing force to the cover member 31 which operates against the biasing force of the springs 33. This will be described hereinbelow with respect to Fig. The housing is provided with projecting handle portions 34 at opposite ends thereof for use in handling, the device, before, after and during allergy testing. The cover member 31 comprises a plurality of projections 36 extending downwardly :c iiTtiTyr WO 87/06115 PCT/US87/00921 16 therefrom. Projections 36 are used in actuating the allergen applying package or capsule which is placed in the respective compartments 32 of the housing 30. This will be described further hereinbelow.

Figs. 13 and 14 illustrate an allergen containing capsule which comprises a rectangular tubular member preferably made of plastic, such as styrene which may be, for example, 1/32 inches thick. Hingedly or pivotally connected to one internal wall of the tubular member 45 in'a horizontal plastic member 41 having a needle 42 projecting downwardly therefrom. The needle is preferably sealed within the plastic rectangular tube by means of a plastic covering 43, 44, at the upper and lower ends thereof, respectively. The tip of the needle 42 is preferably coated with an allergen at the factory before the upper and lower seals 43, 44 are applied. However, allergens could be provided in the manner shown in Figs. 33-35. The upper and lower seals 43, 44 are preferably very thin and are easily puncturable.

The apparatus is used by placing capsules 40, each containing a different allergen, in the respective compartments 32 of housing 30. After the capsules 4Q are placed in the respective compartments 32 (see Fig. 15), the cover member 31 can be closed over the capsules so that the projections 36 of the cover member break the upper seal 43 and bear down on the horizontal member 41 to push it downwardly to the dashed line position shown in Fig. 15. When the horizontal member 41 u:T~i: cw"~ I SWO 87/06115 PCT/US87/00921 17 and the needle 42, of the respective capsules move downwardly to the dashed line position, the needle punctures the lower seal 44 and pierces or pricks the skin of the patient to apply the allergen to the pierced or pricked skin portion of the patient. In Fig. 15, the cover 31 is shown in position A at its open position (most counterclockwise position), at which time the compartments 32 of the housing 30 can be loaded with respective capsules 40 containing respective.different allergens. After loading the respective capsules in the compartments 32 the housing 30 is placed against the skin of the patient and is held in place by the operator via handles 34.

Then, the cover member 31 is moved through positions B and C (shown in dashed lines) to the closed position C (shown in solid lines). When the cover is moved tc the closed position D, against the biasing force of the springs 33, the projections 36 first puncture the upper seal 43of their respective capsule, then push the respective horizontal member 41 and needle 42 downwardly so that the needle 42 punctures the lower seal 44, and passes through the respective hole or opening since at this time the housing 30 is held against the skin of a patient, the needle 42 will pierce or prick the skin of the patient after puncturing the lower seal 44 and passing through the respective hole 35 in the lower portion of the housing 32. In this manner, the allergen at the' tip of the needle or on the base as shown in Figs. 33-35 (factory applied) is applied to the pricked or pierced skin portion of the patient. Upon releasing the cover member 31 (when it is S1uJST1iUTTE -SMqErr WO 87/06115 PCT/US87/00921 18 in the closed position the springs 33 will lift the cover 31 upwardly to, the position shown in Fig. 12, thereby withdrawing the needles from the skin of the patient and into the interior of the compartments 32 of the housing After use, the housing 30 can be sterilized and re-loaded with fresh allergen containing capsules, ready for the next use.

The projections 36 may be in the form of rods, and may have inclined lower surfaces 37 as shown in Fig. 15. The inclined lower surfaces 37 provide a better surface contact with the pivotal member 41 of the capsule, as shown in Fig. The housing 30 and cover 31 are preferably fabricated of plastic as a single unit by means of injection molding.

Suitable plastic materials are, for example, polyvinylchloride (PVC), nylon, polycarbonate or the like.

Fig. 16 shows a sectional view taken through the longitudinal center of the housing 30, but showing a modified embodiment.

In the housing of Fig. 9, the compartments 32 are separated by respective pairs of walls 50. The central wall 51 is solid for supporting a spring 33 thereon. It should be clear that the embodiment of Figs. 9-15 could be modified-by providing only a single wall 50 between adjacent compartments 32. In the description of Fig. 16, like reference numerals will be used for parts which are similar to those parts described earlier.

SUITrrruT SHEET 1 I I S WO 87/06115 PCT/US87/00921 19 The embodiment of Figure 16 comprises a housing which is substantially similar to the housing 30 of Figs.

9-12. The housing comprises a plurality of walls 61 defining a plurality of compartments 32 therebetween. Holes 35 are provided in the bottom of housing 60 for passage of a needle therethrough, in the same manner as shown in Fig. 15. The central wall 62 of the housing 60 is substantially the same height as the end walls 63 of the housing. Springs 33 are placed on top of the end walls 63 and central wall 62, in a manner similar to that shown in Fig. 9.

The embodiment of Fig. preferably has a cover member 31 integrally formed therewith and connected thereto via a living hinge, as in the embodiment of Figs. 9-12.

In the foregoing embodiments, the cover member 31 could be provided separately, and connected to the housing by means of hinges or other pivotal connecting means.

Figs. 17 and 18 are top and side views, respectively, of a modified unit 100 for carrying out a plurality of allergy tests. Figs. 17 and 18 illustrate the holding unit and operating members, and Figs. 19, 20 and 21 illustrate removable cassettes which are removably received in the holding unit of Figs. 17 and 18.

Referring to Figs. 17, 17A, 18 and 18A, the holding unit comprises a rectangular base member 101 having a trough 102 (see Fig. 17A) therein for receiving cassettes (of Figs. 19- 21) containing allergens. The base member 101 also comprises V 53T1 TU T SM XET L WO 87/06115 PCT/US87/00921 a pair of grooves 103 extending along the length thereof (see Fig. 17A) for receiving an operating member 104 therein. The operating member 104 has side rails 105 extending along the length thereof which are guided in the grooves 103 of the base member 101. See Fig. 18A. The operating member 104 is slidable along the length of the base portion 101, with its side rails 105 guided in the elongated grooves 103 of the base member 101.

The removable cassette, shown in Figs. 19-21, is configured to fit within the trough 102 of the base member 101. The cassette 110 has an elongted trough 112 formed therein for receiving capsules or packages 125 of allergens, as shown in Fig. 21. The capsules or packages 125 of allergen are described below with references to Figs. 23-25.

The cassette 110 has side edges forming grooves 113 (see Fig. 19 into which the rectangular packages 125 of allergen are slidable. A stop 114 is provided at one end of the cassette to prevent the allergen packages from sliding off the end thereof. After the cassette is loaded with allergen packages 125 as shown in Fig. 21 (preferably, the allergen packages 125 are loaded along the complete length of cassette 110), the loaded cassette is placed within the trough 102 of the base .7h member 101. When placing the cassette in the base member 101, the end with the stop 114 thereon is placed toward the right as seen in Figs. 17 and 18, remote from the operating member 104. When in this condition, the tops 121 of the allergen packages 125 (see Figs. 23-25) provide inclined planes along Zr f I T U T X SM WO 87/06115 PCT/US87/00921 21 which the operating unit 104 slides, so as to press the inclined tops 121 of the allergen packages 125 downward, thereby causing the needles 122 in the allergen packages to be extended through the opening 123 of the lower surface of the package 125 through the opening 115 of the cassette to thereby pierce or prick the skin of the patient, while simultaneously applying the allergen contained within the package 125 to the pierced or pricked skin of the patient. The allergen can be applied to the needle tip at the factory as will be described below.

Stop 114 can be movable to accommodate fewer than the maximum number of allergen packages which can be received in the device. Alternatively, dummy or blank packages containing no allergen or needle, or a flat appropriately sized plate can be inserted in trough 12 to serve as a space filling member when fewer than the maximum number of allergen packages are used.

Figs. 23-25 show top, bottom and side views of the allergen carrying rectangular packages or capsules 125 for use in the embodiment of Figs. 17-22. The rectangular packages 125 each comprise a substantially rigid plastic base member 120 with a substantially rigid preferably plastic top member 121 which is hingedly or pivotally connected to the base member 120, as shown in Fig. 25. Preferably, the connection between base 120 and top 121 is by means of a living hinge. The top member 121 has a needle 122 secured to the underside thereof PCT/US87/00921 22 as seen best in Fig. 25. The bottom member 120 has a hole 123 in the bottom surface thereof in registration with the needle 122. The bottom member 120 is larger than the top member 121 so as to provide a flange portion 126'on each side of the package 125 to slide in the grooves 113. The top member 121 has a width so that it can be pressed down between the side rails forming the grooves 113.

In operation, the base member is loaded with a cassette 110 and is placed against the skin of a patient. Then, as the operating unit 104 is passed over the rectangular package 125 in the cassette, the top members 121 are pressed downwardly (see Fig. 26) and the needle 122 of the respective packages 125 passes through the hole 123 and through the opening 115 in the trough of the cassette 110 (and therefore through opening 127) so as to pierce or prick the skin of the patient. Preferably, the rectangular packages or capsules 125 of Figs. 23are one-piece moulded plastic structures with a 30 gauge, 1/8 inch long needle 122 secured to the underside of the top member 121. An allergen is preferably placed on the needle tips in the factory during manufacture, and the entire wedgeshaped unit is sealed in cellophane or other suitable sealing materials which are puncturable by the needle 122. When the _device is operated, the needles 122 pierce the wrapping of the package to apply the allergen to the skin of the patient. The top of the upper member 121 is marked at the factory with the type of allergen which is on the needle tip. The marking can be accomplished by imprinting or applying a label to the top of SWW$T rUTK SIME W 87/6115r PCT/US87/00921 23 the rectangular member. The lower and upper- surfaces 120,121 are preferably made of a flexible polyvinylchloride (PVC) material for a natural spring-effect so that the members remain sprung outwardly as shown in Fig. 24 when not in use.

The angle between the lower member 120 and the top member 121 is preferably 300. but this angle could be varied, depending upon application.

Fig. 26 schematically shows the apparatus in use. As the wedge-type operating member 104 is moved in the direction, of the arrow A in Fig. 25, it forces the upper surfaces of the rectangular packages downwardly and thereby forces the needles 122 to extend through the bottom opening in the trough and pierce or prick the skin, thereby applying the allergen on the needle tip to the skin of the patient. After the wedge-like operating member 104 passes over a package 125 and clears the package 125, the top 121 of the package 125 springs upwardly due to the natural spring-effect of the plastic material from which it is made, to the condition shown by package 150 in Fig. 26.

I As mentioned above, the rectangular members can be fsctory sealed in cellophane or other similar materials. To use same, the cellophane or other sealing materials need not be removed from the rectangular members before use. The rectangular members, with their cellophane or the like seal, can be inserted in the cassette 110 as shown in Fig. 20. When the operating member 104 passes over the rectangular member to 37117LUUM- SHEET+ nkr WO 87/06115 PCT/US87/00921 24 force the needle 122 downwardly, the needle automatically punctures the cellophane plastic sealing material to apply the allergen on the tip thereof to the skin of the patient.

This facilitates use and maintains sterility since the cellophane sealing material need not be removed prior to use of the apparatus.

A plurality of the units 100 can be arranged side-byside, each unit 100 having its own operating member 104.

Alternatively, the operating members 1-4 for each of the units 100 can be ganged together (as shown in Fig. 27) so that one movement by the operator will move all of the operating members 104 for each of the units LO0.

As seen in Fig. 27, a embodiment having a plurality of cassettes uses a single widthwise movable operating member 204.

The base unit 200 comprises a pair of elongated guide rails 201 within which side projections of operating member 204 are slidably received, in the same manner as shown in Fig. 18A.

The operating member 204 has side projections 205 which fit within the guide grooves of the rails 201.

The base member 200 comprises a plurality of troughs 210- 212 (in this embodiment three throughs) which are shaped similarly to the troughs-in Figs. 19 and 20. The cassettes which are insertable in the troughs 210-212 are different from the cassettes shown in Figs. 19 and 20, and are shown in Fig. Referring to Fig. 30, a cassette for use with the 3 8MEE S WO 87/06115 PCT/US87/00921 embodiment of Figs. 27-29 comprises an elongated base member 220 having a resiliently connected inclined top or cover member 221. The elongated top member 221 has a plurality of needles mounted thereon as shown in Fig. 31, the needles preferably having allergens placed.on the needle tips or as shown in Figs. 33-35 at the factory during manufacture. The cassette of Fig. 31 is also preferably factory sealed with a puncturable material. The cassette also has an elongated groove-like opening 222 through which the needles 223 pass when the top member is pressed downwardly in the direction of the arrow C in Figs. 30 and 31. Preferably, a cassette has from 10-12 needles, each tipped with different allegerens,although any number is possible.

In use, the cassettes are placed within the troughs 210- 212 of the base unit 200 of Fig. 27. Then, the operating member 202 is moved in the direction of the arrow D in Fig. so as to press the cover or top members 221 downwardly in the direction of the arrow C in Fig. 31, thereby causing all of the needles 223 of a respective cassette to substantially simultaneously extend through the opening at the bottom of the cassette and pierce or prick the skin of the patient, thereby testing the patient with a plurality of different allergens (each on a respective needle) at substantially the same time. As the operating member 204 is moved further in the direction of the arrow D in Fig. 29-, the next cassette is placed in trough 211 is operated, thereby piercing the patient's a- WO 87/06115 PCT/US87/00921l 26 skin with another plurality of needles. The operating member 204 is pushed further in the direction of the' arrow D to operate the cassette located in trough 212 in the same manner.

The embodiment of Figs. 27-32 is advantageous in that a single factory-prepared sealed cassette contains a plurality of allergens on respective needles or as in Figs. 33-35.

This eliminates the necessity of the operator loading each cassette with respective allergen carrying member, as is required in the embodiment of Figs. 17-22. However, the embodiment of Figs. 17-22 is advantageous if the operator wishes to test the patient for only a few different allergens, or if it is desired to test the patient with specific allergens which are not included in the factory-prepared large cassette of Figs. 31 and 32. Moreover, there may be cases where the large cassettes of Figs. 31 and 32 contain allergens which are known to be harmful to a particular patient. In such a case, the embodiment of Figs. 17-22 is desirable since the operator can load the apparatus with only those allergens for which it is specifically desired to test the patient.

It should be clear that various modifications and alterations can be made to the embodiments of the invention Sdiscussed above. For example, the rectangular allergen Spackages 125 of Figs. 23-25 could be used in the embodiment of the invention shown in Figs. 9-12. In this case the height of the base number 30 can be reduced since the packages 125 are substantially smaller than the packages 40 of Figs. 13 and ^.^TmnX :$MK^ WO 87/06115 27 PCT/US87/00921 14. Moreover, the base 30 of Figs. 9-12 can be modified to delete the walls 50, 61 between the respective compartments, and one single elongated compartment could be provided. Such a single elongated compartment could receive a cassette such as shown in Fig. 31. The cover 31 of such a modified embodiment need not, in this case, be provided with the projections 36, since the cover could merely press down the upper member 221 of the cassette of Fig. 31 to cause the needles 223 to project from the bottom of the base 30 to prick or pierce the skin of the patient.

A modified allergen containing package according to the present invention is illustrated in Figs. 33 and 34. As.

seen in Fig. 33, the package comprises a base member 160 having a quantity of an allergen substance 163 on the upper surface thereof. A top member 161 is hingedly or pivotally connected to the base member 160, in the same manner as in Figs. 23-25. A needle 162 projects downwardly from top member 161. During operation, when the top member 161 is pressed downwardly, the needle 162 passes through the allergen material 163 and then punctures the lower surface 160 to then proceed to prick the. skin of the patient. The needle 162 picks up sufficient allergen 163 for the allergy test. The central portion of base member 160 in the vicinity of the allergen 163 can be made of a weaker material which may be more easily puncturable by the needle 162.

m m- g PCT/US87/00921 28 Fig. 35 shows a modified embodiment having a pouch or cup-shaped member 173 for containing an allergen. In use, the needle 162 passes through the cup-shaped member 173 to contact the allergen contained therein, and continues to puncture the bottom of container 173 to then proceed to prick the skin of the patient and apply the allergen to the pricked skin. The cup-shaped member 173 is formed of an easily puncturable material so that the needle 172 can relatively easily pass therethrough.

The allergen containing package of Figs. 13 and 14 can be similarly modified so that the allergen is contained at a lower surface portion thereof so that the needle contacts the allergen upon passing downwardly.

Also, the embodiments of Figs. 33-35 are preferably sealea in a cellophane-like material for sterility.

The embodiment of Figs. 31 and 32 can be modified similarly to Figs. 33-35, as should be apparent.

An important advantage of the present invention is that the pricking or piercing of the skin is always done to a given skin penetration depth. Another important advantage is that the skin penetrations always have a given fixed spacing there- 1 Ibetween which does not rely upon operator judgment. The skin penetrations are appropriately spaced to separate allergen P-'!%!rn1rNtrrr TX SM-1-7 WO 87/06115 PCT/US87/00921 29 reactions from each other without overlap. The penetration depth is a function of the distance the various needles project downwardly from the lower surface of the device when they are actuated. Also, the skin penetration depth is replicable in a very accurate manner, without requiring highly skilled operators since the penetration depth is not a function of the skill of the operator, but is a function of the length of the needles and the other dimensions of the apparatus. Thus, repeatable results are obtainable when using the system of the present invention, thereby providing a highly accurate allergy testing system.

The term "allergen" is used throughout this specification and claims to denote the substance applied to a patient. However, the invention is equally applicable to antigens in general and the term "allergen" as used in the specification and claims denotes antigens as well as allergens.

Various additional modifications and alterations can be made within the scope of the appended claims.

I__

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SU-JDS-TrT: SHFP7' JV 11 1

Claims (7)

1. An allergy testing apparatus for testing a patient for a plurality of allergies at substantially the same time, comprising: a plurality of sources of an allergen; a common allergen carrying means for carrying said plurality of sources of an allergen with said allergen sources in spaced apart relationship; a plurality of spaced apart movable pricking means mounted on a common movable member so as to be movable as a unit with said common movable member; carrier means including means for supporting said movable member such that said movable member and said pricking means mounted thereon are substantially simultaneously movable relative to said carrier means along a substantially fixed predetermined path from an inactive position out of contact with the skin of a patient to an active position for pricking the skin of a patient, each of said pricking means being arranged for applying allergen from a respective allergen source to the pricked skin when moved along said path from said inactive position to said active position; said carrier means including means for at least partially defining said substantially fixed predetermined path in cooperation with said movable member; and

3....actuating means, coupled to said movable member and movable relative to at S least part of said carrier means, for A 9 moving said movable member and said pricking means substantially simultaneously relative to said carrier means for causing each of said pricking means to contact a respective allergen source and to retain a respective allergen thereon, and for (ii) moving said movable member and said pricking means 2 substantially simultaneously relative to said carrier means along said path from •said inactive position to said active position thereof, for thereby substantially -simultaneously applying allergens retained on respective pricking means at "-•spaced apart positions on the skin of the patient when said respective pricking means reaches said active position. 2. An allergy testing apparatus for testing a patient for a plurality of allergies at substantially the same time, comprising: a plurality of sources of an allergen; 'ST 31 a common allergen carrying means for carrying said plurality of sources of an allergen with said allergen sources in spaced apart relationship; a plurality of spaced apart movable pricking means mounted on a common movable member so as to be movable as a unit with said common movable member; carrier means including means for contacting the skin of a patient and supporting said movable member relative to the skin of a patient such that said movable member and said pricking means mounted thereon are substantially simultaneously movable along a substantially fixed predetermined path from an inactive position out of contact with the skin of the patient to an active position for pricking the skin of a patient, each of said pricking means being arranged for applying allergen from a respective allergen source to the pricked skin when moved along said path from said inactive position to said active position; said carrier means including means for at least partially defining said substantially fixed predetermined path in cooperation with said movable member; and actuating means, coupled at least to said movable member, for moving said movable member and said pricking means substantially simultaneously relative to said allergen carrying means for causing each of said *pricking means to contact a respective allergen source and to retain a g* respective allergen thereon, and for (ii) moving said movable member and said pricking means substantially simultaneously, relative to said skin of said patient which is 6 ocontacted by said carrier means, along said path from said inactive position to said active position thereof, for thereby substantially simultaneously applying allergens retained on respective pricking means at spaced apart positions on the 2 skin of the patient when said respective pricking means reaches said active O8 position. 3. The allergy testing apparatus of claim 1 or claim 2, wherein said sources of an allergen each comprise a receptacle containing an allergen, and wherein said movable pricking means each comprise a movable needle which is movable relative to said receptacles so as to be in communication with the interior of an associated receptacle so as to contact the respective allergen.

4. The allergy testing apparatus of claim 3, wherein each of said needles is A'r r 32 holloN 7 and said respective allergen passes through the hollows of said needles by capillary action. The allergy testing apparatus of any one of the preceding claims, wherein said common carrying means comprises an elongated member for carrying and receiving a plurality of said sources of allergen.

6. The allergy testing apparatus of claim 1 or claim 2, wherein: said carrier means comprises at least first and second members which are movable relative to each other; one of said first and second members comprising an elongated member carrying said plurality of pricking means; the other of said first and second members including support means for supporting said elongated member, said support means being adapted to be placed on the skin of a patient and spacing said pricking means for said skin in said inactive position; and S said elongated member carrying said plurality of pricking means being movably coupled to said support means for moving said plurality of pricking means to said active position.

7. The allergy testing apparatus of any one of the preceding claims, wherein said movable pricking means, in said active position thereof, is out of communication with said sources of an allergen, thereby preventing contamination of said sources of allergen due to contact of said pricking means with the skin of a patient.

8. The allergy testing apparatus of any one of the preceding claims, wherein said i actuating means includes means for moving said plurality of pricking means to prick the skin of the patent in said active position to a predetermined controlled depth of penetration. S 9. The allergy testing apparatus of claim 6, wherein said sources of an allergen each comprise a receptacle containing an allergen, and wherein said movable pricking means each comprise a movable needle which is movable relative to said receptacles so as to be in communication with the interior of an associated receptacle so as to contact the respective allergen. The allergy testing apparatus of claim 9, wherein said needles extend from said elongated member by a predetermined distance, whereby said needles prick the skin A4VL *p~ -4

33- of the patient to a predetermined controlled depth of penetration at said second position of said elongated member. 11. A method of testing a patient for a plurality of allergies at substantially the same time, comprising: providing a plurality of allergens in a common allergen carrying means for carrying said plurality of allergens with said allergens in mutually spaced apart relationship; providing a plurality of spaced apart movable pticking means mounted on a common movable member so as to be movable as a unit with said common movable member; supporting said movable member on a carrier such that said movable member and said pricking means mounted thereon are substantially simultaneously movable relative to said carrier along a substantially fixed predetermined path for an inactive position out of contact with the skin of a patient to an active position for pricking the 15 skin of a patient, each of said pricking means being arranged for applying a respective allergen from said common allergen carrying means to the pricked skin when moved to said active position; o at least partially defining said substantially fixed predetermined path by said carrier in cooperation with said movable member; moving said movable member with said pricking means thereon substantially simultaneously relative to said carrier for causing each of said pricking means to contact a respective allergen and to retain the respective allergen thereon; and moving said movable member with said pricking means thereon substantially simultaneously relative to said carrier along said path from said inactive position to oeeoo said active position thereof, for thereby substantially simultaneously applying allergens retained on respective pricking means at spaced apart positions on the skin of the patient when said respective pricking means reach said active position. 12. The allergy testing method of claim 11, wherein said common allergen carrying means comprises a plurality of receptacles each containing an allergen, and wherein said movable pricking means each comprise a movable needle which is movable with said movable member so as to be in communication with the interior of an associated receptacle to contact said respective allergens. _j -34- 13. The allergy testing method of claim 13, wherein each of said needles is hollow and said respective allergen passes through the hollows of said needles by capillary action. 14. The allergy testing method of any one of claims 11 to 13, wherein said common carrying means comprises an elongated member for carying and receiving a plurality of said sources of allergen. The allergy testing method of claim 11, wherein: said carrier comprises at least first and second members which are movable relative to each other; one of said first and second members comprises an elongated member carrying said plurality of pricking means; the other of said first and second members includes support means for supporting said elongated member, said support means being adapted to be placed on the skin of a patient and maintaining said pricking means spaced from said skin in said inactive position; and said elongated member carrying said plurality of pricking means is movably means, relative to said support means, to said active position. 16. The allergy testing method of any one of claims 11 to 15, further comprising maintaining said movable pricking means, in said active position thereof, out of S communication with said allergens, thereby preventing contamination of said allergens due to contact of said pricking means with the skin of a patient. 17. The allergy testing method of any one of claims 11 to 16, wherein said step of moving said plurality of pricking means to prick the skin of the patient in said 2 active position comprises moving said pricking means to a predetermined coauolled ooeee depth of penetration. 18. The allergy testing method of claim 15, wherein said common allergen carrying means comprises a plurality of receptacles each containing an allergen, and wherein said movable pricking means each comprise a movable needle which is movable with said movable member so as to be in communication with the interior of an associated receptacle to contact said respective allergens. 19. The allergy testing method of claim 18, wherein said needles extend from said ,.A I 35 elongated member by a predetermined distance, and said needles prick the sk;' of the patient to a predetermined controlled depth of penetration at said second position of said elongated member. Apparatus for or a method of testing a patient for a plurality of allergies at substantially the same time substantially as hereinbefore described with reference to the accompanying drawings. DATED this 10th day of July, 1991. HENRY FISHMAN as |e o o ee END-