CA1064355A - Multipenetrant vaccination apparatus - Google Patents

Abstract

ABSTRACT
Multipenetrant vaccination apparatus in which a variable number of skin-penetrating tines may be selected according to the patient be vaccinated. The base of the apparatus has a series of stepped projections which receive a corresponding series of hollow support cylinders in press-fit relationship.
Each support cylinder has tines extending from the free end and by selecting a certain number of support cylinders the appropriate vaccination area is obtained. The base may be formed with an axial bore to receive a flexible capsule of vaccine and a protective cap can be provided for the apparatus.

Description

~64355 The present inven-tion relates to vaccination apparatus and, in particular, to multipenetrant vaccination apparatus.
Such multipenetrant vaccination apparatus functions by having a number of tines or teeth dipped in vaccine ~hich are then pressed against the skin so as to penetrate it. It is known, however, that the innoculation must be gauged with respect to the age of the patient, the older subject requiring more vaccine.
Generally, this leads to the necessity of vaccinating several differ-ent areas. The effect is disagreeable if not unpleasant for thepatient who will show scars for a relatively extended time. The procedure is not easy for the operator and involves a loss of time.
According to the invention there is provided multi-penetrant vaccination apparatus for dispensing an amount of vaccine ` adapted to a particular patient in re~ponse to a single application of pressure through the s~in. The apparatus comprises a base having a gripping and pressure receiving portion at one side thereof and means including a central support receiving an assembly of concen-tric, hollow, support cylinders at the other side. The free ends of the support cylinders and the central support have skin-penetrat-ing tines thereon.
According to a specific embodiment the support ; cylinders can be engaged in concentric groove~ formed in the base with the central projection solidly mounted therein. A protective cap may be used having an enlarged portion with conical contact sur-faces so as to seal against the support cylinders and prevent the vaccine escaping from the base of the cap. This enlarged portion also makes the cap more riyid and facilitates removal.
According to another variation the tines may have - 30 a cross section with radial extending edges. These tines may also have a cruciform cross section and be provided at the penetrating - . ~, . . . . . . . .

end with sides or cavities to retain vaccine by surface tension.
According to another variation the base has a single central projection with several tines at the free end. A
support cylinder is adapted to be retained on this projection in a removable manner by press fit or by threaded means. Tines are also provided at the free end of the support cylinder. The central projection of the base defines an aperture adapted to receive a flexible container of vaccine which is to be deposited on the skin of the patient either before or when the tines are pressed through the skin.
These features will become clearer from consider-ation of the following description takin in conjunction with the drawings.
Brief Description of the Drawi.~gs Figure 1 is an exploded view, in perspective, of vaccination apparatus according to the invention.
Figure 2 is a view on a larger scale of the assembled apparatus.
Figure 3 is a sectional view of the assembled apparatus.
Figure 4 is a view taken along arrow F in Figure 3 showing only the positioning of the tines on their support cylinders.
Figures 5 and 6 are sectional side and end views showing the apparatus after removal of one support cylinder.
Figures 7 and 8 are side and end views showing the ; apparatus after removal of two support cylinders.
Figure 9 is a view in section of another embodiment of the invention.
Figure 10 is a view taken along the direction of arrow Fl in Figure 9 showing only the support cylinders.
Figure 11 is a partial section view showing the

- 2 -arrangement of tines in another embodiment.
Figure 12 is an exploded view showing a further embodiment of the invention.
Figure 13 is a view in section of the assembled apparatus of Figure 12.
Figures 14 through 24 show different forms of the tines useful in the vaccination apparatus.
Figure 25 is a view in section of a further embodi-ment of the invention.

Figure 26 is a plan view of the apparatus shown in Figure 25.
Figure 27 shows one form of vaccine container.
Figure 28 shows the vaccination apparatus placed in a protective cover.
Figure 29 is an exploded view of the elements making ; up the apparatus of Figure 25.
Figure 30 is a plan view showing a variation of the , apparatus with additional gripping members.
Figure 31 is a view in section of another form of - the apparatus.
Figure 32 is a plan view of the apparatus of Figure ; 31.
F~`gure 33 is a different form o vaccine container particularly adapted to be used with the apparatus of Figure 31.
,~ Figure 34 is a different form of vaccine container in the form of a syringe.
Figures 35 and 36 give two examples of operation of `.,,1 '~; the vaccination apparatus.

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Description of the Preferred Embodiments The apparatus shown in Figures 1 to 8 consists of a body section 1 having a flat gripping member la joined to a flat circular base lb. A series of staggered cylindrical projections lc, ld, le, lf ... project from the base at the opposite side to the gripping member.
The first projection, lc, is adapted to receive the open end of a protective cover 2 in press-fitted sealing relationship.
The lower part of the cover forms a reservoir for the vaccine to be innoculated. The conical shape of the cover facilitates its fastening on the projection. The cover may be omitted, in which case the vaccine is carried in a separate container.
The furthest extending projection lf has tines in the form of points, teeth or other projections lg on one end giving a "
; roughened surface. A suitable number, typically five, may be ~ provided as shown in Figure 4. The intermediate projections such - as ld and le receive hollow support cylinders 3 and 4 in press-fitted relationship abutting on the respective upper shoulders.

The free ends carry tines in alignment with each other. A suitable number, typically nine on cylinder 3 and eighteen on cylinder 4, .. . .
are provided as shown in Figure 4.
The support cylinders, being hollow, define a cylindrical bore therein and have a conical outer surface with the larger diameter at the tine-supporting end. With the particular spacing of the cylindrical projections, this creates a small space E
between the support cylinders and between cylinder 3 and projec-tion lf, which serves to retain a quantity of vaccine. The .~ .
~ conical shape of the hollow cylinders aids in positioning and : :
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-` 106435S
removing them irom the projections because the wall is thinner at the top end. As shown in Figures 5 - 8, it is straightforward to change the number of tines to suit the patient being vaccinated by removing one of the cylinders (as shown in Figures 5 and 6) or two cylinders as shown in Figures 7 and 8.
Thus when the apparatus is assembled with all the tines, the maximum possible vaccination is achieved with only one pene-tration of the skin. If it is desired to innoculate less vaccine, one or more of the cylinders can be removed. For the minimum vaccination, only the projection lf is used.
The support cylinders and the projections are circular in section for ease of manufacture and to provide a concentration of tines in order to obtain the maximum innoculation on minimum skin surface. It will be clear, however, that other configura-tions can be manufactured in which the projections and cylinders are in polygonai form, for example with a square or hexagonal section.
Figures 9 and 10 illustrate a further embodiment in which the base 5 has only one projection 5a to receive the protec-tive cover 6. On the flat face of this projection is formed anaxial bore 5b to receive a support cylinder 7 equipped with tines -~ 7a. Circular grooves 5c and 5d are formed concentric with this bore, to receive hollow support cylinders 8 and 9 fitted with tines 8a and 9a. It will be clear that this embodiment could, alternatively, be formed with a central projection instead of ; support cylinder 7.
It will also be noted that instead of the tines being `I all of the same length, they may be formed in different lengths as shown in Figure 11. In this figure, the shortest tines 10 are at , .

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` ~064355 the centre and the longest tines 11 at the outside, with inter-mediate tines shown at 12. The same effect can be obtained by providing tines of equal length with the supporting cylinders being of different lengths (in apparatus of the type of Figure 9) or extending to different levels (in apparatus of the type of Figure 3). This different penetration of tines permits the selection of a particular depth of innoculation for any particular patient. As an example of the invention, but not limited to it, a typical vaccination device has the following dimensions:
Length - (approximately) 39 millimeters Exterior diameter - (approximately) 12 millimeters Length of the - (approximately) 17 millimeters grippinc member Length of the tines - (approximately) 3 millimeters, or

3, 2.8 and 2.5 millimeters if they are of different lengths Conical angle of the - (approximately) 2 support cylinders Space between the - (approximately) .5 millimeters support cylinders The selection of such dimensions permits the patient to be innoculated with the correct quantity of vaccine by adjustment of the movable elements. Vaccination is thus achieved with a precise amount having regard to the age of the patient and with a single penetration of the skin. The concentration of innoculating tines provided by the particular arrangement tends to the maximum innoculation possible on a minlmum surface of skin which avoids scarring. The spacing between the support cylinders provides for the storage of some vaccine.
In Figures 12 and 13 a further embodiment of the vaccinating apparatus is shown in which the base supports an ' ' ~ - 6 -Ir - ~ - : : . . . . .

arrangement of movable hollow support cylinders. In the arrange-ment shown, the cylindrical support cylinders are arranged in staggered fashion on the base, but it will be clear that the support cylinders could be positioned and supported by concentric circular grooves, as previously described.
The base 13 has a gripping member 13a formed as a flat projection terminating in a circular disc 13b. Staggered cylin-drical projections 13c, 13d, 13e, 13f and 13g extend from the opposite sides. The first projection 13c receives the open end of a protective cover 14 in a press-fit relationship. The other end of the cover retains the vaccine to be used.
Projec-tion 13g has on its face a suitable number of tines or points 15 to provide the normal roughened penetrating surface. A suitable number of intermediate projections 13d and `1 13e are provided and have press-fitted thereto hollow support -~ cylinders 16 and 17 having at their free ends a suitable number of tines 18-19. Support cylinders 16 and 17 have enlarged por-tions adjacent their free ends forming shoulders 16a and 17a having conical contact surfaces. Similar conical surfaces are formed by a chamfer 13h between projections 13f and 13g and a chamfer 14a on the inner surface of cover 14. As a~ alternative arrangement, the shoulders can be formed with contact faces per-pendicular to the axis of the device.
;l The contact surfaces ensure efficacious sealing of the assembly to avoid escape of the vaccine along the gap between the ~ supporting cylinders during manipulation. That is, support ,~ cylinder 16 is fitted on projection 13e and abuts on surface 13h.
Support cylinder 17 is fitted on projection 13d and abuts on . surface 16a of cylinder 16. The cover i5 supported on projection , ~ _ 7 106~355 13c and abuts on the surface of shoulder 17a of supporting cylinders 17.
It will be noted that to aid the support and disengage-ment of the cylinders, the surface can be roughened as by grooves 16b-17b or other fluting or a checkerboard pattern. The conical arrangement of the supporting cylinders adds to the rigidity of the assembly and facilitates assembly and disassembly.
Thus, a particular feature of the device shown in Figures 12 and 13 is the sealing effect, both at the shoulders where the supporting cylinders fit and between the conical con-tact surfaces 13h - 16a - 17a - 14a, which prevents the vaccine from escaping along the length of the supporting cylinders. The shoulders provided on the supporting cylinders add to the rigidity of the device, particularly diametrically. When positioning each supporting cylinder in assembling of the device, it engages with the previous cylinder and consequently seals the unit. The arrangement of the shoulders or reinforcing portion provides in effect a lengthening of the portion of the supporting cylinder being gripped when it is being moved, and thus avoids having ~ingers in contact with the vaccine and the tines. The tines of different lengths ~preferably shorter towards the centre) assure a progressive penetration of the skin with a re~uced pressure, thus greatly diminishing or eliminating unpleasant sensations experienced by the patient.
Th~ roughened surface provided to penetrate the skin is preferably formed from tines such as sharp teeth or points. As shown in Figures 14 through 24, different forms of these tines can be provided having equal or unequal length. For example, Figures 14, 15 and 22 illustrate tines 20 having in section three : ., : ' , -. , . , . . _ ., . - : - - : . . -or four sharp edges which can be joined by plane, convex or con-cave sides. In Figures 16 and 17 the tines 21 have a cruciform section with thin edges. In Figures 18 and 19 the tines 22 have a cruciform section with thick edges, and in Figures 20 and 21 the tines 23 have a cruciform section with thick edges and either convex or concave curved faces therebetween. In Figure 22 the tines 25 are shown as having a polygonal section with concave surfaces. In these various forms the sides of the tines between the edges serve to retain vaccine. Finally, Figures 23 and 24 show a further variation in which the tine 24 is formed from a cylindrical needle with a bevelled end 24a forming one or more concave cavities 24b.
The side faces of the tines between the radial edges, being of cruciform, bevelled or faceted shape, or having cavities or reservoirs, permit the retention of vaccine in the faces.

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Alternatively, internal cavities can be formed on straight or curved faces. In each case the vaccine is retained by the effect of surface tension. The tines or roughened surface form a pene-tration surface equivalent to a much larger area which permits the reduction in the number of tines used without causing a `, capillary effect by extremely close spacing of the tines. Optimum penetration of the vaccine is achieved due to the radial edges of the tines opening the skin in a manner which avoids the edges of the skin closing or wiping off the vaccine contained in the side surfaces or cavities.
Figures 25, 26, 28, 29, 35 and 36 show another form of the vaccination apparatus, in which the device includes a base 26 having a central cylindrical projection 26a with a reducing stepped diameter carrying at one end at least one, but preferably several, tines. The base is also formed with a shoulder 26c and ., , _ g _ - , . . . . . , ~ . , ~ . :
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-extends outwardly by means of two diametrically opposed wings or projections 26d. A conical passage 26e in the base communicates with an orifice 26f in the lower portion. A support cylinder 27 is frictionally engaged by fitting its bore 27a to the step portion 26a of the base. Support cylinder 27 has a collar 27b abutting against shoulder 26c of the base and has tines 27c at the free end.
- Other support cylinders can be used,frictionally engaged with support cylinder 27. In the particular embodiment illus-trated, only one support cylinder is provided, the outer diameter 27d of this cylinder receiving a protective cover 28 in a press-fit relationship. The cover gives mechanical protection to the tines to avoid wear by rubbing or friction, and bacterial protec-tion by ensuring that they remain sterilized. To maintain the sterile condition, the opening 26e in the base is covered when the device is contained in a case E (Figure 28).
It will be noted that tines 26b and 27c are of different , lengths with the tines 26b closest to the axis of the base being the longest and the tines situated furthest from the axis being ':
` 20 the shortest, thus defining an imaginary surface P (Figure 5) ` convex with respect to the axis in the direction of penetration `~ of the tines.
Figure 27 shows a container for the vaccine to be innoculated. It consists of a flexible capsule 29 having a ; reservoir portion 29a terminating in a conical end 29b adapted to be received in the bore 26e of the base and having a frangible `~ sealed end 29c. The conical portion 29b and the bore 26e are formed to conventional standards and may, for example, conform to French standard S90011. -, _ 10 _ : :' x ~

Figures 31 and 32 illustrate another form of the inven-tion in which the vaccination device has, as before, support cylinders 27 and a protective cover 28, while the base 30 has a central opening 30a with tines 30b. Also, cylindrical shoulder 30c, wings or projections 30d, conical bore 30e with the outlet ` orifice 30f, are provided. The upper portion of the base opposite shoulder 30c is formed with a boss 30g from which two ribs 30h extend vertically, joining together at a head 30i. The ribs lie outside a cylinder of a diameter defined by the bore 30j of ~he head 30i and by opening 30k in boss 30g leading to the conical bore 3Oe.
This particular form of base is adapted to receive and guide a vaccine container such as is shown in Figure 33 in the ~ .~
` form of a flexible tube 31 having a reservoir portion 31a leading to a conical end 31b adapted to be received in the bore 30e of the base and with a frangible sealed end 31c.
i Figure 34 illustrates a syringe type of vaccine container :`! 32 having a body forming a reservoir 32a for the vaccine ending in a conical portion 32b corresponding to the conical bore formed in the base. The syringe type container also has a piston 32c.
This container permits a controlled distribution and dosage of ,.j the vaccine as required by the practitioner for any individual patient. It will be noted that the flexible tube 31 and the syringe 32 can be also used with the vaccination device previously described. It will be noted that the apparatus is easily handled, since the wings 26d and 30d on the base permit it to be easily separated from the support cylinder 27 when the upper collar 27b abuts on the cylindrical projections 26c or 30c of the base (Figures 26 or 32). It can be seen that the support cylinders . - :: .. , . . : ~
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also have wings 27e, 27f (Figure 30) positioned angularly with respect to the wings 26d of the base to aid in their removal.
Additionally, different colours can be provided for the base and the support cylinders in order to facilitate their assembly. This differentiation in colour can be provided ~or all the elements or only on the wings or collars of the pieces.
The operation of the vaccination device of this inven-tion will now be described with reference to Figures 31, 35 and 36.
In Figure 35 a complete vaccination de~ice is shown having the maxim~n n~nber of tines and with a capsule of vaccine 29 fric-tionally engaged therein. The practitioner holds the capsule between the th~,nb and first finger and presses the vaccination device on the skin of the patient, pressing in on the sides of the capsule (arrows Fl, F2), the ends of the thumb and finger used for pressing being in contact with the wings of the base. The vaccine thus flows out through orifice 26f into the space between the tines and a certain quantity penetrates into the epidermis.
Alternatively, the capsule may be frictionally engaged in the bore 26e and held by the practitioner between the index finger and middle finger to press in on the capsule and apply pressure on the wings of the base (Figure 36 which shows only the base in use), so that the thumb passes behind the arm so that the hand applies appropriate pressure to the device~
~! ' With the flexible tube 31, the action is similar in that the practitioner holds the tube frictionally engaged in the base (broken line in Figure 31) and presses the apparatus on the skin while pressing the tube. If the practitioner wishes to employ a graduated syringe such as 32, he holds the vaccination device-syringe assembly in one hand,and pressing against the skin, : - - . . ~ : . . - .: .: ; : :

operates ~he piston 32c of the syringe with the other hand in order to deliver a particular dosage of the vaccine.
The advantages of the device according to the invention will be clear. In particular, it can be noted that the assembled device can be easily manipulated as can the elements be removed by means of the wings, the collars, or the different colours. A
precise dosage of vaccine is available, being introduced into the device at the time of penetration, avoiding losses in areas between the tines, the cylinders and the base. The sterile con-dition of the apparatus and of the vaccine container will be noted.The initial penetration by the central tines, then the outer tines, gives the most ffective vaccination because the vaccine is first introduced in the central part.

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Claims (28)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. Multipenetrant vaccination apparatus for dispensing an amount of vaccine adapted to a particular patient in response to a single application of pressure through the skin comprising a base having a gripping and pressure receiving portion at one side thereof and means including a central support receiving an assembly of con-centric, hollow, support cylinders at the other side, the free ends of the support cylinders and the central support having skin-penetrat-ing tines thereon.

2. Vaccination apparatus according to claim 1 in which the outer ends of the support cylinders lie in a single plane.

3. Vaccination apparatus according to claim 1 in which the outer ends of the support cylinders extend to different levels in staggered relationship, with the central support being the short-est.

4. Vaccination apparatus according to claim 2 or claim 3 in which the tines are all of the same length.

5. Vaccination apparatus according to claim 2 wherein the tines are of differing length with the tines on the central support being the shortest, the tines on a support cylinder of greatest diameter being the longest and the tines on an inter-mediate support cylinder being of intermediate length.

6. Vaccination apparatus according to claim 1, wherein the means receiving the support cylinders includes a series of stepped projections, the central support being the projection of smallest diameter, the support cylinders being press-fitted at one end against intermediate projections in the series.

7. Vaccination apparatus according to claim 1,claim 2 or claim 3 wherein the central support is a projection received in cm/

a bore on the base and the support cylinders are received in con-centric grooves on the face of the base.

8. Vaccination apparatus according to claim 6 wherein the support cylinders have a conical exterior surface and a dimin-ished wall thickness at the side abutting the corresponding pro-jection, in order to facilitate removal.

9. Vaccination apparatus according to claim 8 wherein the means receiving the support cylinders is dimensioned to provide a narrow space between the central support and the smallest support cylinder and between adjacent support cylinders to retain vaccine therein.

10. Vaccination apparatus according to claim 6 wherein a projection on the base receives a protective cap in press-fitted sealing relationship covering the assembly and providing a reservoir for vaccine.

11. Vaccination apparatus according to claim 1, claim 2 or claim 3 wherein the arrangement of support cylinders gives maximum innoculation on minimum skin surface, the arrangement of the tines being circular or able to be inscribed in a circle.

12. Vaccination apparatus according to claim 1 wherein the support cylinders are provided with enlarged portions adjacent their free ends forming conical contact surfaces therebetween.

13. Vaccination apparatus according to claim 12 in which the conical surfaces, the support cylinders and related chamfers on the central support and protective cap constitute a sealed closure retaining vaccine in the base of the protective cap in contact with the tines.

14. Vaccination apparatus according to claim 12 in which the support cylinders are roughened by grooves or striations giving a gripping surface to aid in assembly and disassembly.

15. Vaccination apparatus according to claim 1 in which cm/

the tines have beveled extremities to facilitate penetration and provide a surface to retain vaccine.

16. Vaccination apparatus according to claim 15 in which the beveled tines are provided with cavities to retain a quantity of vaccine therein.

17. Vaccination apparatus according to claim 1 in which the tines are formed with edges extending radially in section.

18. Vaccination apparatus according to claim 17 in which the tines are of cruciform cross section.

19. Vaccination apparatus according to claim 17 or claim 18 in which vaccine is retained along the surfaces between the sharp edges by surface tension.

20. Vaccination apparatus according to claim 1, claim 2 or claim 3 in which the central support has an axial opening in order to receive a capsule of vaccine so that in a single operation the tines perforate the skin and introduce the vaccine.

21. Vaccination apparatus according to claim 20 wherein the ends of the tines define a surface convex with respect to the axis of the device in the direction of penetration of the tines, the longest tines on the central support being those first con-tacting the skin.

22. Vaccination apparatus according to claim 20 wherein the protective cap is removably retained on the support cylinder of greatest diameter by a press-fit or a screw threaded connection.

23. Vaccination apparatus according to claim 20 wherein the base is provided with projecting wing and the support cylinders with circular collars to aid in assembly and disassembly.

24. Vaccination apparatus according to claim 23 wherein the vaccine supply is a flexible capsule having a conical end with a frangible sealed portion adapted to be received in the axial opening of the central support.

25. Vaccination apparatus according to claim 20 wherein the vaccine is contained in a flexible capsule having a conical end with a frangible sealed position adapted to be received in the axial opening of the central support and further including an extension yoke with a head positioned above the axial opening to receive the capsule.

26. Vaccination apparatus according to claim 20 wherein the capsule is a syringe permitting innoculation of a controlled amount of vaccine.

27. Vaccination apparatus according to claim 20 wherein the base, the support cylinders and the cap are protected prior to use by a sealed box or a sealed thermoplastic container, the assembly being sterilized.

28. Vaccination apparatus according to claim 23 wherein at least the collars and wings of the support cylinders are formed of different colors in order to facilitate assembly and disassembly of the apparatus.