WO2004062512A1

WO2004062512A1 - Skin penetration device to simultaneously introduce a plurality of substances

Info

Publication number: WO2004062512A1
Application number: PCT/SE2003/001954
Authority: WO
Inventors: Gert Kindgren; Trine Vikinge; Stig Hasselqvist; Billy Nilson
Original assignee: Accelerator I Linköping Ab
Priority date: 2003-01-09
Filing date: 2003-12-15
Publication date: 2004-07-29
Also published as: AU2003287134A1

Abstract

A skin penetration device (1) adapted to be positioned on the skin (4) of a patient to essentially simultaneously introduce a plurality of substances and comprising at least a first and at least a second component (2, 3), which are releasably connected to each other such that the first component (2) is positioned underlying the second component (3). The first component (2) comprises a sheet (5) having a top layer and at least two sealed chambers (15). Each sealed chamber (15) comprises a substance and a needle device (20) in connection to the top layer. The second component (3) comprises a main body (26) with a substantial weight, at least two sustaining means (29) for elevating the main body (26) from an underlying structure, releasing means (30) for releasing the sustaining means (29) for allowing the weight of the main body (26) to apply an essentially equally distributed pressure on the first component (2) and at least two arms (32) adapted to press the needle devices (20) in the sealed chambers (15).

Description

Skin penetration device to s-L-r-ult-uaeously intr©auee a plurality of substances.

TECHNICAL FIELD

The present invention relates to a skin penetration device adapted to be positioned on the skin of a patient to essentially simultaneously introduce a plurality of substances into the skin and a method for essentially simultaneously introducing a plurality of substances into the skin of a patient.

BACKGROUND OF THE INVENTION

In skin testing procedures, skin diagnostic methods and medical introductions through skin, such as for example allergy testing, multiple vaccination and immunological testing, it is often necessary to introduce a plurality of substances into the skin of a patient. Allergy testing e.g. involves subjecting a patient to a wide variety of different allergens to determine which allergens cause allergic reactions in the patient. A commonly used allergy skin testing procedure today is the so-called skin prick test, which usually involves ten allergens and two control substances. A drop of a medium containing an allergen or a control substance is applied to an area of the skin of the patient, after which the medium is transferred into the skin by means of a needle device or the like piercing the skin. Any reactions that may arise, such as red spots or swellings, are then visually determined and interpreted. The test is usually performed testing one allergen or one control substance at a time, implying that the patient is usually subjected to piercing by the needle device or the like at twelve different times. Thus, the above described test is a relatively time-consuming procedure and a patient feeling uncomfortable being subjected to piercing may experience the procedure as very stressing. It is not unusual that the patient retracts his arm or other part of the body where the test is being performed, resulting in that the different media applied on the skin are mixed or drop off. Furthermore, the administrator at the clinic has to transfer each of the allergens and control substances from their packages to the application sites on the skin of the patient. Since the allergens are transferred and applied in an unsealed form, the administrator is thus subjected to an allergen exposure risk.

In order to reduce the time under which the patient is subjected to piercing by needle devices or the like, devices for essentially simultaneous introduction of different substances into the skin of a patient have been developed. For example, one such device is known through SE508094. In SE508094, an injector device having a carrier adapted to be applied on the skin is disclosed, which carrier comprises a plurality of needle means intended for injection of media containing allergens into the skin. Said plurality of needle means are arranged to be moved essentially simultaneously from a first position externally of the skin to a second position in which said needle means have pierced or penetrated the skin. The media are pipetted into spaces connected to the needle means and arranged to receive allergens. Alternatively, the different media are provided in different areas of a sheet to be penetrated by needle points of the needle means. Furthermore the device disclosed in SE508094 comprises a pressure generating means connected to an actuator. For the purpose of diverting the attention from the introduction device, the actuator can be actuated at a distance from the carrier, i e out of sight of the patient.

Using the device according to SE508094 does not solve the allergen exposure risk for the administrator at the clinic. Furthermore, the device is designed with a plurality of integrated members and is therefore relatively complicated and expensive to produce. The sterility of the device is also defective and the durability is thus affected.

In order to reduce the problem of an allergen exposure risk, devices having allergens sealed in a chamber or the like have been developed. For example, in US5104620, a disposable allergy skin testing kit is disclosed. The kit comprises a cardlike unit having a bottom layer, a membrane layer and a top layer. The bottom layer has a plurality of recesses formed at predetermined locations to form chambers into which an antigen is deposited. These chambers are covered by the membrane layer forming a liquid tight seal. An aperture is formed in the top layer above each antigen chamber and a push-button needle assembly is mounted in each of these apertures. The push-button needle assembly has a needle extending downwardly from its bottom surface. Flexible support arms attached to the edge and the push-button allow the needle to be pressed a sufficient distance in order to penetrate the membrane sheet, the antigen chamber and to prick the skin of a patient. The needles are prevented from penetrating the membrane sheet before use by means of a removable protective sheet between the top layer and the membrane layer.

One disadvantage with the testing kit disclosed in US5104620 is that it does not comprise a means for pushing all the push-button needle assemblies essentially simultaneously into the skin of a patient. Manual actuation of needle assemblies may imply that the needle assemblies are not essentially simultaneously introduced into the skin due to uncertainty or lack of practice of the administrator. Furthermore, the layer adapted to be applied on the skin of a patient is not maintained sterile nor is the attention of the patient diverted from the needle devices. The sterility of the device is also defective and the durability is thus affected. SUMMARY OF THE INVENTION

One object of the present invention is to provide an improved skin penetration device to essentially simultaneously introduce a plurality of substances into the skin of a patient. This object is achieved by means of a skin penetration device adapted to be positioned on the skin of a patient to essentially simultaneously introduce a plurality of substances and comprising at least one first and at least one second component, which first component and second component are releasably connected to each other such that the first component is positioned underlying the second component,

said at least one first component comprising

a) a sheet comprising a top layer having a top surface and a bottom surface, and

b) at least two sealed chambers in connection to the top layer, each sealed chamber comprising a predetermined amount of substance and a needle device, said needle device having a point being positioned in a first position before use and being adapted to penetrate into the skin of a patient,

said at least one second component comprising

a) a main body with a substantial weight having a top and a bottom

b) protruding from the bottom of said main body in a direction essentially orthogonal to said bottom at least two sustaining means for elevating said main body from an underlying structure, such as skin and/or the at least one underlying first component,

c) releasing means for essentially simultaneously releasing the at least two sustaining means for allowing the weight of the main body to apply an essentially equally distributed pressure on the first component, and

d) protruding from the bottom of said main body in a direction essentially parallel with the sustaining means at least two arms, said at least two arms being adapted to be positioned closely over or in contact with the at least one first component to transfer the pressure caused by the weight of said main body to the underlying at least one first component after release of said sustaining means and thereby to press the needle device in each of the sealed chambers to move the point from said first position to a second position in the skin when the skin penetration device is positioned on the skin of a patient. Preferred embodiments are listed in the dependent claims.

DESCRIPTION OF THE CLAIMS

In the following, the invention will be described in greater detail with reference to attached drawings, in which like reference characters denote similar elements and

Fig.l is a perspective view of the skin penetration device positioned on the arm of a patient,

Fig. 2a is a side view of a first component of a first embodiment of the skin penetration device,

Fig. 2b is an enlarged side view of a part of the first component of the first embodiment of the skin penetration device,

Fig. 3 is a top view of the first component of the first embodiment of the skin penetration device,

Fig. 4a is a side view of a second component of the first embodiment of the skin penetration device,

Fig. 4b is a front view of the second component of the first embodiment of the skin penetration device,

Fig. 5 is a side view of the first embodiment of the skin penetration device positioned on the skin of a patient before introduction of substances into the skin,

Fig.6 is a side view of the first embodiment of the skin penetration device positioned on the skin of a patient after introduction of substances into the skin,

Fig. 7a is a side view of the first component of a second embodiment of the skin penetration device,

Fig. 7b is a side view of a semispheric entity with a needle device,

Fig. 7c is a side view of the first component of the second embodiment with semispheric entities.

Fig. 7d is a side view of the first component according to fig. 7a but with openings. Fig. 7e is a side view of the first component according to fig. 7d with semispheric entities.

Fig. 8a is an enlarged side view of a needle device of the first component of a third, a fourth, a fifth and a sixth embodiment.

Fig. 8b is an enlarged bottom view of the needle device of the first component of the third, fourth, fifth and sixth embodiment.

Fig. 8c is an enlarged side view of a needle device and an aperture of the first component of the third and fourth embodiment.

Fig. 8d is an enlarged side view of a needle device, a spring and an aperture of the first component of a fifth and a sixth embodiment.

Fig. 8e is an enlarged side view of a needle device of the first component of a seventh and eighth embodiment. DESCRIPTION OF EMBODIMENTS

Figure 1 shows a skin penetration device 1 according to the invention positioned on the skin 4 on an arm of a patient in a perspective view. The skin penetration device 1 comprises a first component 2 and a second component 3, which are releasably connected to each other and used to essentially simultaneously introduce a plurality of substances into the skin 4 on for example an arm, the back, a leg or the stomach of a patient. The substance is for example an allergen, an antigen, an antibody or an adequate substance such as a control substance. By penetration it is hereby meant penetration into the skin but not through the skin.

Below, different embodiments of the skin penetration device 1 for allergy skin prick testing are described. The skin penetration device 1 for allergy skin prick testing according to the invention can e.g. be used to study the allergic reaction to one allergen or essentially simultaneously study the allergic reactions to a plurality of allergens introduced into the skin of a patient. All materials necessary to perform an allergy skin prick test involving one or a plurality of allergens are comprised in the skin penetration device according to the invention for allergy skin prick testing, which hence constitutes an allergy skin testing kit. The below described embodiments of the skin penetration device 1 for allergy skin prick testing comprise materials necessary to perform the above mentioned commonly used allergy skin prick test involving twelve substances, i e ten allergens and two control substances, to be introduced into the skin of a patient, but the skin penetration device can of course also be designed to comprise materials necessary to introduce other numbers of substances, such as 2-100. Figure 2a illustrates the first component 2 of a first embodiment of the skin penetration device 1 for allergy skin prick testing in a side view and figure 2b is an enlarged view of a part of the first component 2. In the first embodiment, the first component 2 is a cardlike unit constituting a sealed package and is designed as a so-called blisterpack. The first component 2 comprises a sheet 5, which comprises a top layer 6, a middle layer 7 and a bottom layer 8. Each layer 6,7,8 has a top and a bottom surface, i e the top layer 6 has a top surface 9 and a bottom surface 10, the middle layer 7 has a top surface 11 and a bottom surface 12 and the bottom layer 8 has a top surface 13 and a bottom surface 14. The layers 6,7,8 of the sheet 5 are unified forming a continuous entity of the sheet 5. The top layer 6 and the middle layer 7 are connected to each other through the bottom surface 10 of the top layer 6 being at least partially in contact with the top surface 11 of the middle layer 7. The middle layer 7 and the bottom layer 8 are connected to each other through the bottom surface 12 of the middle layer 7 being at least partially in contact with the top surface 13 of the bottom layer 8. The contacts between the top layer 6 and the middle layer 7 and the middle layer 7 and the bottom layer 8 are preferably achieved through welding.

The first component 2 is adapted to be positioned on the skin 4 of a patient with the bottom surface 12 of the middle layer 7 being in contact with the skin. The bottom surface 12 of the middle layer 7 is in the first embodiment a slightly adhesive surface in order to at least partially adhere the first component 2 to the skin 4. The sterility of the bottom surface 12 is maintained with use of the bottom layer 8 covering the middle layer 7. The bottom layer 8 is in the first embodiment removable connected to the middle layer 7 and is thus adapted to be removed before the first component 2 is positioned on the skin 4.

Furthermore, the first component 2 comprises at least two sealed chambers 15 in connection to the top layer 6. In order to form space for the at least two sealed chambers 15, at least two semispheric segments 16 are formed in the top layer 6 of the first component 2. Each semispheric segment 16 forms a semispheric space 17 adapted for a sealed chamber 15, which semispheric space 17 has a top 18. The semispheric space 17 has also an opening 19 in a direction from the bottom surface 10. The semispheric segment 16 are formed at predetermined distributed positions and protrude outwards from the sheet 5.

In the first embodiment of the invention, the openings 19 of the semispheric spaces 17 are sealed by the middle layer 7, which as previously mentioned is at least partially connected to the top layer 6. A sealed chamber 15 is formed in each semispheric space 17 between the bottom surface 10 of the top layer 6 and the top surface 11 of the middle layer 7. An enlarged side view of the sealed chamber 15 is shown in figure 2b. The layers 6,7,8 of the sheet 5 are preferably made of a plastic material, which is yieldable by application of a pressing force and which essentially return to the original form following deformation. Thus, the semispheric segments 16 are deformable through application of a pressing force and are designed to backspring after deformation.

A needle device 20 is comprised in each sealed chamber 15, which needle device

20 is positioned in the sealed chamber 15 having a point 21 positioned in a first position before use. The needle device 20 can be forced to be moved such that the point 21 of the needle device 20 is moved from the first position to another position in for example the skin 4 of a patient. When the skin penetration device 1 is positioned on the skin 4 of a patient, the position of the point 21 in the skin 4 of a patient when further movement of the needle device 20 is restricted is designated as the second position.

The needle device 20 of the first component 2 of the first embodiment is a needle 22 having a top surface 23, which is molded to the bottom surface 10 of the top layer 6 at the middle of the top 18 of the semispheric space 17. The point 21 of the needle 22 is positioned in the first position protruding contactless towards the middle layer 7. Thus, the needle 22 is completely comprised and held in place in the sealed chamber 15. The risk that the point 21 of the needle 22 perforates the middle layer 7 and/or is damaged during storage or transport is minimized.

The needle 22 can be moved towards the middle layer 7 through application of a pressing force on the top surface 23 of the needle 22, i e on the semispheric segment 16. The point 21 is then moved from the first position through the middle layer 7 to another position outside the sealed chamber 15. The needle 22 can be moved until the bottom surface 10 of the top layer 6 in the semispheric space 17 hits the top surface 11 of the middle layer 7, i e until the needle 22 is restricted by the middle layer 7. Thus, when the bottom layer 8 is removed and the skin penetration device 1 is positioned on the skin 4 of a patient, the point

21 of the needle 22 is therefore allowed to penetrate into the skin 4 until the bottom surface 10 of the top layer 6 in the semispheric space 17 hits the middle layer 7. As previously mentioned, the point 21 of the needle 22 is positioned in the skin 4 in the second position when further penetration is restricted. The depth of penetration into the skin 4 is thus reflected by the second position, which is restricted by the length of the needle 22 and the thickness of the middle layer 7 of the sheet 5 of the first component 1. Since the top surface 23 of the needle 22 is molded to the top 18 of the semispheric space 17 it is possible to direct the point 21 of the needle 22 to penetrate into the skin 4 in a direction which is essentially perpendicular to the extension of the sheet 5 of the first component 1 by applying the pressure on the semispheric segment 16 in a direction which is essentially perpendicular to the extension of the sheet 5 of the first component 2.

A predetermined amount of a substance to be introduced into the skin 4 of a patient is also comprised in each sealed chamber 15. In the skin penetration device 1 for allergy skin prick testing the substance is either an allergen or a control substance. In order to be able to perform the above mentioned commonly used allergy skin prick test involving ten allergens and two control substances, there are in the first embodiment of the invention twelve semispheric segments 16 and thus twelve sealed chambers 15 formed, and the substance is an individual allergen in ten sealed chambers 15 and control substances in two sealed chambers 15. The cross-section of the point 21 of the needle device 20 is star-shaped in order to better hold the substance through the surface tension.

The substances, i e the allergens or the control substances, are preferably formulated in a liquid, gel or freeze-dried form, most preferably in a liquid, and are comprised in the sealed chambers in the vicinity of the point 21 of the needle device 20 or in contact with the point 21. The substance comprised in the sealed chamber 15 is moved into the skin 4 together with the point 21 when it is moved into the second position. Since the chambers 15 are sealed, the substances and the needle devices 20 are encapsulated implying that the allergen exposure risk for administrators and the contamination risk are minimized.

In order to be able to easily distinguish which substance is comprised in a sealed chamber 15, the sealed chambers 15 of the first component 2 of the skin penetration device 1 can have a label indicating the substance. The label can for instance be a colour, a bar code and/or a graphical symbol. As previously mentioned, the semispheric segments 16 are positioned at positions which are predetermined distributed and also spaced from each other to separate the sealed chambers 15 from each other. The positions of the sealed chambers 15 constitute the positions at which the substances are introduced into the skin 4 of a patient when the skin penetration device 1 is positioned on the skin 4.

Furthermore, the first component 2 comprises two attachment points 24, which are openings 25 in the first embodiment, for attachment of the first component 2 to the second component 3. The openings 25 are shown in figure 3, which is a top view of the first embodiment of the skin penetration device 1.

Figure 4a illustrates the second component 3 of the first embodiment of the skin penetration device 1 in a side view and figure 4b illustrates the second component 3 in a front view. The second component 3 is connectable to the first component 2 in such a way that the first component 2 is underlying the second component 3 and is adapted to be used for essentially simultaneous movement of the needle devices 20 in the sealed chambers 15 and introduction of the substances, i e allergens and control substances, comprised in the sealed chambers 15 into the skin 4 of a patient. Furthermore the second component 3 can have such a design that the attention is at least partially diverted from the needle devices 20 of the first component 2 and that fear in above all children for piercing by needle devices 20 is reduced. As shown in figure 4a and 4b, the second component 3 is in the first embodiment of the skin penetration device 1 designed looking like a caterpillar, but the second component 3 may of course have a completely different design. It can also for instance be a simple box, but if it is formed like a special object, for instance a caterpillar, it has the advantage that the attention of preferably children to the needle devices 20 may be at least partially diverted.

The second component 3 comprises a main body 26, which has a substantial weight, i e preferably at least 150 g, being essentially equally distributed, and a top 27 and a bottom 28. Furthermore the main body 26 of the second component 3 comprises at least two sustaining means 29 for elevating the main body 26 from an underlying structure, such as skin 4 and/or the first component 2. The sustaining means 29 are protruding from the bottom 28 in a direction essentially orthogonal to the bottom 28.

The second component 3 also comprises a releasing means 30 for essentially simultaneously releasing the at least two sustaining means 29 for allowing the weight of the main body 26 to apply a pressure on the first component 2.

In the first embodiment of the invention there are three sustaining means 29, which are resilient pins 31 having a stiffness. The resilient pins 31 are adapted to be attached to the openings 25 of the first component 2 to attach the second component 3 to the first component 2. Furthermore the resilient pins 31 are adapted to in a first state be in a non-depressed state and to be fixed in the non- depressed state to elevate the main body 26 from the first component 2 as well as the skin 4 when the skin penetration device 1 is positioned on the skin 4. Then the main body 26 is held in place in relation to the first component 2 and the main body 26 is prevented from affecting the sealed chambers 15 of the first component 2.

The resilient pins 31 are releasable by the releasing means 30 from the fixation in the first state in order to allow the weight of the main body 26 to depress the resilient pins 31 and to move closer to the first component 2 and affect the sealed chambers 15 of the first component 2. When the resilient pins 31 are released, the weight of the main body 26 counteracts the stiffness of the resilient pins 31 to such a degree that the resilient pins 31 are depressed. Furthermore the releasing means 30 enables the resilient pins 31 to be essentially simultaneously released to enable the main body 26 to essentially simultaneously apply an equally distributed pressure on the sealed chambers 15 of the first component 2.

Furthermore, the second component 3 comprises at least two arms 32, which are protruding from the bottom 28 of the main body 26 in a direction essentially parallel to the direction of the sustaining means 29. The at least two arms 32 are adapted to be positioned closely over or in contact with the underlying first component 2 to affect and transfer the pressure caused by the weight of said main body 26 to the underlying first component 2 after release of the sustaining means 29, i e the resilient pins 31 in the first embodiment, from their first state. More specifically, the at least two arms 32 are located at predetermined distributed positions which are adapted to fit to the predetermined distributed positions of the at least two semispheric segments 16 in the first component 2, whereby the at least two arms 32 are pressed against the at least two sealed chambers 15 after release of the sustaining means 29.

In a first embodiment the second component 3 of the skin penetration device 1 has twelve arms 32, which are positioned to fit to the twelve sealed chambers 15 of the first component 2 of the first embodiment. Releasing the resilient pins 31 enables the arms 32 to affect the needle devices 20 in the underlying sealed chambers 15 through the arms 32 transferring the pressure caused by the weight of the main body 26 to the semispheric segments 16 by being pressed against the semispheric segments 16 and thus also to move the points 21 of the needle devices 20 from the first position to the second position. Since the releasing means 30 enables the resilient pins 31 to be essentially simultaneously released and since an essentially equally distributed pressure then is applied on the first component 2, the arms 32 are subjected to essentially the same pressure concurrently. Thus, all the arms 32 affect the sealed chambers 15 with essentially the same pressure and concurrently, whereby an essentially simultaneous movement of the points 21 of all the needle devices 20 from the first position to the second position is achieved.

In use of the first embodiment of the skin penetration device 1 the first component 2 is connected to the second component 3, whereby the resilient pins 31 of the second component 3 are attached to the openings 25 of the first component 2. Then the removable bottom layer 8 is removed to uncover the adhesive bottom surface 12 of the middle layer 7, which as previously mentioned is an adhesive surface and adapted to at least partially adhere to the skin 4 of a patient. In order to minimize the contamination risk of the bottom surface 12 of the middle layer 7, it is immediately positioned on the skin 4 of a patient such that the positions of the sealed chambers 15 correspond to the positions on the skin 4 at which the introduction of substances is to be performed. The skin penetration device 1 is held in place through the adhesive bottom surface 12 at least partially adhering to the skin 4. A side view of the preferred embodiment of the skin penetration device 1 positioned on the skin 4 of a patient before introduction of substances into the skin 4 is shown in figure 5. The points 21 of the needles 22 are then positioned in the first position and the resilient pins 31 are fixed in the first state.

In order to introduce the substances into the skin 4, the resilient pins 31 are released by the releasing means 30 from the first state and as follows the weight of the main body 26 counteracts the stiffness of the pins 31 and implies that the arms 32 are pressed against the underlying semispheric segments 16. Then the needles 22 in the sealed chambers 15 are depressed and the points 21 of the needles 22 are depressed from the first position together with the respective substances through the underlying middle layer 7 into the skin. As previously mentioned, the needles 22 are depressed until penetration is restricted by the bottom surface 10 of top layer 6 in the semispheric space 17 hits the top surface 11 of the middle layer 7. The points 21 of the needles 20 are then positioned in the second position in the skin 4, which is shown in figure 6. Since the weight of the main body 26 is equally distributed and the releasing means 30 release the resilient pins 31 essentially simultaneously, the arms 32 affect the semispheric segments 16 with essentially the same pressure at the same time. Thus, the points 21 of the needles 22 are introduced into the skin 4 essentially simultaneously. By using the first embodiment of the skin penetration device 1, it is thus possible to introduce e.g. twelve substances essentially simultaneously through one application. The points 21 of the needles 22 are moved out of the second position and thus out of the skin 4 through the semispheric segments 16 being backspringing, as previously mentioned, and/or by lifting the skin penetration device 1 from the patient.

When using the first embodiment of the skin penetration device 1, there are only a few steps for the administrator to perform, i e connecting the first component 2 to the second component 3, removing the bottom layer 8 of the first component 2, position the skin penetration device 1 on the skin 4 of a patient by placing the adhesive bottom surface 12 of the middle layer 7 on the skin 4, releasing the resilient pins 31 by the releasing means 30 and after finished introduction remove the skin penetration device 1 from the skin 4. Thus, a minimal amount of experience is necessary to be able to administrate the first embodiment of the skin penetration device 1.

In a second embodiment of the invention, which is shown in fig 7a-7c, the first component 2 corresponds to the first component 2 of the first embodiment except for that the openings 19 of the semispheric spaces 17 in the first component 2 of the second embodiment are not covered or sealed by the middle layer 7 and/or the bottom layer 8 and that the sealed chambers 15 hence not are formed within the sheet 5 between the top layer 6 and the middle layer 7. Each sealed chamber 15 is in the first component 2 of a second embodiment formed as a separate semispheric entity 33, which is insertable into one of the semispheric spaces 17. The semispheric entity 33 is formed between a bottom surface 47 of a second top layer 34 and a top surface 48 of a second middle layer 49. The second middle layer 49 having a bottom surface 50 is adapted to fit into and cover one of the openings 19 in the second embodiment.

After insertion of the semispheric entity 33 into one of the semispheric spaces 17, double top layers are formed by the top layer 6 of the sheet 5 of the first component 2 and the second top layer 34 of the semispheric entity 33. In the second embodiment, the bottom surface 10 of the top layer 6 is adapted to be held against the skin 4 of a patient and the bottom surface 10 can except for in the semispheric spaces 17 be an adhesive surface. In order to maintain sterility after insertion of the semispheric entities 33, a second bottom layer 51 can be applied on the bottom surface 10 of the top layer 6 after insertion of the semispheric entities 33.

In use of the second embodiment of the skin penetration device 1 the second bottom layer 51 has to be removed whereby the top layer 6 is uncovered between the semispheric entities 33 and can be applied on the skin 4 of a patient.

The semispheric entities 33 can be inserted into the semispheric spaces 17 at clinics and therefore the second embodiment of the skin penetration device 1 allows the administrator to select which substances have to be introduced into the skin 4 of a patient. However, the semispheric entities 33 can as well be inserted before reaching the clinic. Using the second embodiment of the skin penetration device 1 is more time-consuming than using the first embodiment of the skin penetration device 1, if the sealed chambers 15 are inserted at the clinic, but allows for a higher degree of flexibility.

Furthermore, there can be an opening 52, as shown in fig 7d and 7e, in the top layer 6at the top 18 of the semispheric segment 16, whereby double top layers are not formed after insertion of the semispheric entity 33 into the opening 52. In use of the second embodiment with an opening 52 in the top layer 6, the pressure applied on the first component 2 when the releasing means 30 is released, is applied on the second top layer 34. Then only one top layer, i e the second top layer 34, has to be depressed to depress the needle devices 20. Figure 7d and 7e show side views of the second embodiment with the openings 52 and with and without the bottom layer 8 respectively.

In a third embodiment of the invention, the first component 2 corresponds to the first component 2 of the first embodiment except for that the first component 2 of the third embodiment comprises another needle device 20 instead of the needle 22 and that an aperture 35 is formed in the middle layer 7 of the sheet 5 of the first component 2 in connection to each sealed chamber 15. The needle device 20 in the first component 2 of the third embodiment comprises a dome- shaped body 36 having a top surface 37 and a bottom surface 38. In figure 8a the needle device 20 of the third embodiment is shown in a side view and in figure 8b the needle device 20 is shown in a bottom view. The top surface 37 of the dome-shaped body 36 fits into the top 18 of the semispheric space 17 and is molded to the top layer 6 in the semispheric space 17. From the bottom surface 38 of the dome-shaped body 36 a needle 39 having the point 21 is protruding. The point 21 is positioned in a first position in an aperture 35 formed through the middle layer 7 of the sheet 5 of the first component 2 at a position corresponding to the first position of the point 21 of the needle 39. The aperture 35 is a protecting member, whereby the point 21 is protected against damage by being positioned in the aperture 35 during storage and transport. Furthermore, the aperture 35 is also a guiding member for guidance of the needle 39 during penetration of the star-shaped point 21 of the needle 39 through the middle layer 7. The aperture 35 has a size and a shape, which allow the point 21 and the needle 39 to pass through the aperture 35 and allow the point 21 to only pass through pointing in a direction which is essentially perpendicular to the extension of the sheet 5 of the first component 2. Thus, penetration of the point 21 into the skin 4 is guided by means of the aperture 35 and the risk that the point 21 penetrates into the skin 4 in a wrong direction is reduced. The movement of the point 21 from the first position and the penetration into the skin 4 can be achieved through application of a pressing force. The needle device 20 can be pressed until the bottom surface 38 of the dome-shaped body 36 of the needle device 20 is hitting the top surface 11 or the aperture 35. Thus the point 21 of the needle 39 is therefore allowed to penetrate into the skin 4 until the dome-shaped body 36 restricts the penetration. When further penetration is restricted the point 21 of the needle 39 is as previously mentioned positioned in the second position. The needle 39 and the point 21 of the needle 39 in the third embodiment can except for by the apertures 35 be directed during movement of the point 21 from the first position through the middle layer 7 to the second position through applying the pressing force on the semispheric segment 16 in a direction which is essentially perpendicular to the extension of the first component 2.

In a fourth embodiment of the invention, the first component 2 corresponds to the first component 2 of the second embodiment except for that the first component of the fourth embodiment further comprises the needle device 20 and the aperture 35 according to the fourth embodiment.

The needle device 20 and the aperture 35 comprised in the middle layer of the first component 2 of the third and the fourth embodiments are shown in a side view in figure 8c. In a fifth embodiment of the invention, the first component 2 corresponds to the first component 2 of the third embodiment except for that the fifth embodiment further comprises a return spring 40 in the sealed chamber 15. The return spring 40 is attached between the bottom surface 38 of the dome-shaped body 36 of the needle device 20 and the top surface 11 of the middle layer 7 of the sheet 5 of the first component 2 in the sealed chamber 15. After depression of the needle device 20 in which the point 21 of the needle 39 is moved from the first position to the second position, the return spring 40 aids in moving the point 21 of the needle 39 out of the second position and out of the skin 4, when the skin penetration device 1 is positioned on the skin 4 of a patient. As previously mentioned, the movement of the point 21 of the needle 39 out of the second position is performed by the backspringing semispheric segment 16 and/or by lifting the skin penetration device 1, but is thus in the fifth embodiment supplemented by the return spring 40.

In a sixth embodiment of the invention, the first component 2 corresponds to the first component 2 of the fourth embodiment of the invention except for that the first component 2 of the sixth embodiment further comprises a return spring 40 in the sealed chamber 15 according to the return spring 40 of the fifth embodiment.

The needle device 20, the aperture 35 and the return spring 40 comprised in the fifth and sixth embodiment are shown in figure 8d.

In a seventh embodiment of the invention, the first component 2 corresponds to the first component 2 of the first embodiment except for that the first component 2 of the seventh embodiment comprises another needle device 20 than the needle 22 and that the substance is not comprised in the vicinity or in contact with the point 21. The needle device 20 comprised in the seventh embodiment is shown in figure 8e and comprises a dome-shaped body 41 having a top surface 42 and a bottom surface 43. The top surface 42 of the dome- shaped body 41 fits into the top 18 of the semispheric space 17 and is molded to the bottom surface 10 of the top layer 6 in the semispheric space 17. A cavity 44 is formed within the dome-shaped body 41, in which cavity 44 the substance is comprised. From the bottom surface 43 of the dome-shaped body 41 a needle 45 having the point 21 and a bore 46 is protruding. The bore 46 communicates the cavity 44 of the dome-shaped body 41 with the point 21 of the needle 45. In the first position the point 21 of the needle 45 is protruding contactless towards the middle layer 7. Thus, the needle 45 is completely comprised in the sealed chamber 15 and is thus protected against damage by the sealed chamber 15.

When applying a pressure onto the top surface 42 of the dome-shaped body 41, the needle 45 is moved through the middle layer 7 at the same time as the substance comprised in the cavity 44 is moved through the bore 46 to reach the point 21. In an eighth embodiment of the invention, the first component 2 corresponds to the first component 2 of the second embodiment except for that the first component of the eighth embodiment comprises the needle device 20 according to the needle device 20 in the first component 2 of the seventh embodiment and that the substance is not comprised in the vicinity or in contact with the point 21.

The second component 3 of all above described embodiments corresponds to the second component 3 of the first embodiment.

The invention is not to be limited to the above described embodiments, but may be varied within the scope of the invention as defined in the appended claims. For instance, the skin penetration device can be designed for introduction of any number of substances, i e the number of sealed chambers of the first component and arms of the second component can be varied and can be used for other skin introductions than introductions in allergy skin testing. The first component can also comprise more than three layers. Furthermore, the skin penetration device can comprise more than one first component, i e there can be a plurality of first components which sideways can be coupled together forming a unified entity, and/or more than one second component, i e there can be a plurality of second components which sideways can be coupled together forming a unified entity. The first component can for instance be connected to the second component through the arms of the second component further comprising means for connecting the first component to the second component. Further variations can include using another type of needle device, another type of sustaining means, another type of form of the point of the needle, another type of attachment of the first component to the second component and if the sealed chambers are formed as separate entities, more than one sealed chamber can be insertable into one semispheric segment. Furthermore, the top layer of the sheet of the first component and the needle can also be injection molded together with cylindrical ingates forming lower part of the needle. A chopped point is formed on each needle by mechanical cutting the ingate askew.

Claims

PATENT CLAIMS

1. A skin penetration device (1) adapted to be positioned on the skin (4) of a patient to essentially simultaneously introduce a plurality of substances and comprising at least one first and at least one second component (2, 3), which first component (2) and second component (3) are releasably connected to each other such that the first component (2) is positioned underlying the second component (3),

said at least one first component (2) comprising

a) a sheet (5) comprising a top layer (6) having a top surface (9) and a bottom surface (10), and

b) at least two sealed chambers (15) in connection to the top layer (6), each sealed chamber (15) comprising a predetermined amount of substance and a needle device (20), said needle device (20) having a point (21) being positioned in a first position before use and being adapted to penetrate into the skin (4) of a patient,

said at least one second component (3) comprising

a) a main body (26) with a substantial weight having a top (27) and a bottom (28),

b) protruding from the bottom (28) of said main body (26) in a direction essentially orthogonal to said bottom (28) at least two sustaining means (29) for elevating said main body (26) from an underlying structure, such as skin (4) and/or the at least one underlying first component (2),

c) releasing means (30) for essentially simultaneously releasing the at least two sustaining means (29) for allowing the weight of the main body (26) to apply an essentially equally distributed pressure on the first component (2), and

d) protruding from the bottom (28) of said main body (26) in a direction essentially parallel with the sustaining means (29) at least two arms (32), said at least two arms (32) being adapted to be positioned closely over or in contact with the at least one first component (2) to transfer the pressure caused by the weight of said main body (26) to the underlying at least one first component (2) after release of said sustaining means (29) and thereby to press the needle device (20) in each of the sealed chambers (15) to move the point (21) from said first position to a second position in the skin (4) when the skin penetration device (1) is positioned on the skin (4) of a patient.

2. A skin penetration device (1) according to claim 1, wherein at least two semispheric segments (16) are formed in the top layer (6) of the sheet (5) of the first component (2) at predetermined distributed positions and protruding outwards from the sheet (5), each semispheric segment (16) forming a semispheric space (17) adapted for the sealed chamber (15), said semispheric space (17) having an opening (19) in a direction from the bottom surface (10) and having a top (18) in the semispheric segment (16).

3. A skin penetration device (1) according to claim 1 or 2, wherein the sheet (5) further comprises a middle layer (7) having a top surface (11) and a bottom surface (12), the top surface (11) of the middle layer (7) being at least partially in contact with the bottom surface (10) of the top layer (6).

4. A skin penetration device (1) according to claim 3, wherein the sheet (5) further comprises a bottom layer (8) having a top surface (13) and a bottom surface (14), the top surface (13) of the bottom layer (8) being at least partially in contact with the bottom surface (12) of the middle layer (7), said bottom layer (8) being removable.

5. A skin penetration device (1) according to claim 3 or 4, wherein the bottom surface (12) of the middle layer (7) is adapted to be positioned on the skin (4) of a patient.

6. A skin penetration device (1) according to any of claims 3-5, wherein the bottom surface (12) of the middle layer (7) is an adhesive surface for at least partially adhering the first component (2) to the skin (4) of a patient.

7. A skin penetration device (1) according to claim 2 and any of claims 3-6, wherein said opening (19) is sealed by the middle layer (7) forming said sealed chamber (15) between the bottom surface (10) of the top layer (6) and the top surface (11) of the middle layer (7) in said semispheric space (17).

8. A skin penetration device (1) according to claim 2, wherein the sealed chamber (15) is a separate semispheric entity (33) insertable into the semispheric space (17), said semispheric entity (33) is formed between a bottom surface (47) of a second top layer (34) and a top surface (48) of a second middle layer (49), said second middle layer (49) being adapted to fit into and at least partially cover one of said openings (19).

9. A skin penetration device (1) according to claim 8, wherein the bottom surface (10) of the top layer (6) is except for in the semispheric spaces (17) at least partially adhesive.

10. A skin penetration device (1) according to claim 9, wherein the bottom surface (10) of the top layer (6) and the openings (19) are covered by a second bottom layer (51).

11. A skin penetration device (1) according to any of claims 8-10, wherein the top layer (6) has an opening (52) at the top (18) of the semispheric segment (16).

12. A skin penetration device (1) according to any of claims 2-11, wherein said semispheric segment (16) is deformable through application of a pressing force.

13. A skin penetration device (1) according to claim 12, wherein said semispheric segment (16) is arranged to backspring following deformation.

14. A skin penetration device (1) according to any of the preceding claims, wherein said first component (2) comprises 2-100 sealed chambers (15).

15. A skin penetration device (1) according to claim 14, wherein said first component (2) comprises 12 sealed chambers (15).

16. A skin penetration device (1) according to any of the preceding claims, wherein said first component (2) is a card.

17. A skin penetration device (1) according to any of the preceding claims, wherein each sealed chamber (15) has a label indicating the comprised substance.

18. A skin penetration device (1) according to claim 17, wherein the label is a colour, a bar code and/or a graphical symboi.

19. A skin penetration device (1) according to any of the preceding claims, wherein the second component (3) comprises at least 2-100 arms (32).

20. A skin penetration device (1) according to any of claims 2-19, wherein the arms (32) of the second component (3) are located at predetermined distributed positions adapted to the predetermined distributed positions of the semispheric segments (16) of the first component (2).

21. A skin penetration device (1) according to any of claims 3-20, wherein the needle device (20) comprises a needle (22) having a top surface (23) being at least partially in contact with the top (18) of the semispheric space (17) and a point (21) being positioned in the first position within the sealed chamber (15) and protruding towards the middle layer (7) or the second middle layer (49), said point (21) of the needle (22) being adapted to penetrate the middle layer (7) or the second middle layer (49).

22. A skin penetration device (1) according to any of claims 3-20, wherein the needle device (20) comprises a dome-shaped body (36) having a top surface (37) fitting into and being at least partially in contact with the top (18) of said semispheric space (17) and a bottom surface (38) having a needle (39) projecting therefrom, said needle (39) having a point (21) adapted to penetrate the middle layer (7) or the second middle layer (49).

23. A skin penetration device (1) according to claim 22, wherein an aperture (35) is formed in the middle layer (7) or in the second middle layer (49) in connection to each sealed chamber (15), said point (21) of the needle device (20) being positioned in the first position in the aperture (35).

24. A skin penetration device (1) according to claim 22 or 23, wherein a return spring (40) is attached between said bottom surface (38) of the dome- shaped body (36) of the needle device (20) and said top surface (11) of the middle layer (7).

25. A skin penetration device (1) according to any of the preceding claims, wherein the substance is comprised in said sealed chamber (15) in the vicinity of the point (21) of the needle device (20) and/or in contact with the point (21).

26. A skin penetration device (1) according to any of claims 3-20, wherein the needle device (20) comprises a dome-shaped body (41) having a top surface (42) fitting into and being at least partially in contact with the top (18) of the semispheric space (17), a bottom surface (43) having a needle (45) with a point (21) projecting therefrom, a cavity (44) within the dome- shaped body (41) and a bore (46) communicating with the cavity (44) and the point (21) of the needle (45), said point (21) being positioned in the first position within the sealed chamber (15) and protruding towards the middle layer (7) or the second middle layer (49).

27. A skin penetration device (1) according to claim 26, wherein the substance is comprised in said sealed chamber (15) in said cavity (44).

28. A skin penetration device (1) according to any of the preceding claims, wherein the cross-section of the point (21) of the needle (22, 39, 45) is star-shaped.

29. A skin penetration device (1) according to any of the preceding claims, wherein the substance is selected from the group consisting of an allergen, an antigen, an antibody or an adequate substance.

30. A skin penetration device (1) according to any of the preceding claims, wherein the substance is formulated as a liquid, gel and/or freeze-dried powder.

31. A skin penetration device (1) according to any of claims 3-7 and 12-30, wherein the bottom surface (10) of the top layer (6) is at least partially welded to the top surface (11) of the middle layer (7).

32. A skin penetration device (1) according to any of claims 4-7 and 12-31, wherein the bottom surface (12) of the middle layer (7) is at least partially welded to the top surface (13) of the bottom layer (8).

33. A skin penetration device (1) according to any of the preceding claims, wherein the first component (2) comprises at least two attachment points (24) for attaching the first component (2) to the second component (3).

34. A skin penetration device (1) according to claim 33, wherein the attachment point (24) is an opening (25).

35. A skin penetration device (1) according to claim 33 or 34, wherein said at least two sustaining means (29) are attachable to said attachment points (24).

36. A skin penetration device (1) according to any the preceding claims, wherein the at least two sustaining means (29) are resilient pins (31).

37. Method for conducting a skin introduction using the skin penetration device (1) according to claim 1.

38. Method for conducting a skin introduction using a skin penetration device (1) comprising at least one first and at least one second component (2, 3), comprising the steps of:

a) connecting the first component (2) to the second component (3) b) removing a bottom layer (8) of a sheet (5) of the first component (2) to uncover a bottom surface (12) of an adhesive middle layer (7), c) applying the skin penetration device (1) on the skin (4) of a patient through an at least partial adhesion of the bottom surface (12) of the middle layer (7) to the skin (4) of the patient, d) releasing sustaining means (29) by releasing means (30), e) removing the skin penetration device (1) from the skin (4).