US 3221740 A
Description (OCR text may contain errors)
Dec. 7, 1965 s. R. ROSENTHAL 3,221,740
INJECTION DEVICE Filed Aug. 51, 1962 F/GI FIG. 2-
IN VEN TOR. 50/ Roy Rosenfha/ United States Patent 3,221,740 INJECTION DEVICE Sol Roy Rosenthal, 230 E. Delaware Place Chicago 11, Ill. Filed Aug. 31, 1962, Ser. No. 220,776 6 Claims. (Cl. 128-253) This invention relates to a new and improved injection device for skin testing, vaccination, inoculation, and the like. More particularly, the invention relates to a device for making successive injections.
As disclosed in my US. Patent No. 2,619,962, I have heretofore provided an injection device by which skin tests, vaccinations, or inoculations are made by employing a multiple puncture technique. A biological test substance, a vaccine, or the like is introduced into the skin transcutaneously by multiple punctures of identical character and depth distributed over an area of the skin. The device disclosed in the patent includes a thin metal plate or disc having needle-like projections punched therefrom and extending in parallel relationship from one side thereof, outwardly beyond the level of the adjacent surfaces of the plate. The plate, as shown in the patent, is provided with a pair of arms extending from opposite sides thereof which may serves as handles or finger pressure points during the use of the device. After cleansing the skin and applying a quantity of test substance or vaccine thereto, the device is placed against the skin and pressed inwardly, thereby forming a plurality of skin punctures with a resulting injection of the substance at the site of each puncture, without scarification of the skin.
In my copending patent application, Serial No. 787,086, filed January 15, 1959, I have disclosed and claimed an improved injection device which includes interalia a rigid backing member of moldable plastic material adapted to be held in the fingers, a thin metal plate secured to the backing member, and a plurality of needle-like projections punched from the metal plate and projecting from one side thereof. Very advantageously, a prepared package is provided, wherein a dried biological substance is present on the needle-like projections for transcutaneous introduction into the body, and a substantially rigid, imperforate protective cover is removably secured to the backing member and covers the metal plate for protecting the needle-like projections and the biological substance thereon from contamination prior to use.
In my copending patent application, Serial No. 166,582, filed January 16, 1962, I have disclosed and claimed further improvements on my aforesaid injection devices. In particular, a transcutaneous injection device is provided which includes a skin perforating member having a plurality of needle-like projections extending from one side thereof outwardly beyond the level of the outermost adjacent surface on the device. A knob is secured to the perforating member and extends from the opposite side thereof. The knob is adapted to be held with one hand to press the perforating member against the skin, whereupon the needle-like projections puncture the skin at a plurality of points for the purpose of introducing biological substances into the body. The injection device can be grasped .at any aspect of its perimeter, and then applied quickly and accurately and with improved visibilty during the injection. The ease and rapidity of injection which is afforded enables the physician to vaccinate or treat large groups of patients within relatively short periods of time.
The foregoing injection devices have proven to be admirably suited for the intended purposes. The latter injection device, which includes a knob or thimble secured to a skin perforating member, is becoming increasingly popular owing to the additional advantages thereof. However, despite its relative simplicity and economy, enabling disposal of the device after it has been used once, there are important applications or potential applications of the device where it is necessary or desirable to reduce the cost still further.
In my copending application, Serial No. 182,220, filed March 26, 1962, I have disclosed and claimed additional improvements. A new injection device includes a holder, a skin perforating member, and means for detachably securing the perforating member on the holder. An injection may be made by grasping the holder and pressing the perforating member against the skin, and thereafter the perforating member may be removed from the holder and replaced by another like perforating member. In this 'manner, the holder may be reused while the skin perforating members are discarded. There is also provided a package containing a number of skin perforating members, which may be removed one at a time by the holder for a series of injections.
An important object of the present invention is to provide another low cost injection device for use where cost is a factor, such as in mass testing of patients or in multiple tests conducted on individuals.
An accompanying important object is to provide an injection device which maintains the necessary sanitary conditions and which preserves the purity of biological substances being injected.
More particularly, an object of the invention is to provide a device which is safeguarded against the transfer of body fluids from one person to another, thereby preventing the transmission of, e.g., infectious hepatitis. Similarly, when successive tests are made with a series of different biologcal subtances, the subtances are not inter mixed and the purity thereof is preserved for each injection.
Another important object is to provide a complete selfcontained injection device for making successive injections, with the same or different biological substances, and on one or more individuals.
A specific object is to provide a device which includes a column of superposed skin perforating members, for makink an injection, removing the outermost member, and repeating the operations with each member in the column until the last member is used.
These and other objects, advantages and functions of the invention will be apparent on reference to the specification and to the attached drawings illustrating preferred embodiments of the invention, in which like parts are identified by like reference symbols in each of the views, and in which:
FIGURE 1 is a broken side elevational view of one embodiment of the new injection device, enlarged from actual size for the purposes of illustration;
FIG. 2 is a vertical cross-sectional View thereof; with skin perforating members shown in elevation;
FIG. 3 is an axial cross-sectional view of one of the injection units employed in the device of FIG. 1, taken on line 33 of FIG. 4;
FIG. 4 is a bottom plan view of one of the injection units in the device of FIG. 1;
FIG. 5 is a further enlarged bottom perspective view of a skin perforating member as employed in the injection unit shown in the preceding views;
FIG. 6 is a top plan view of a modification of the injection unit shown in FIGS. 1-4;
FIG. 7 is a broken side elevational view enlarged from actual size, of another embodiment of the injection device, with a cover for the device broken away and in section to illustrate its relationship to the outermost injection unit, and also illustrating the provision of a fluent composition in the cover;
FIG. 8 is a cross-sectional view like FIG. 3 of an injection unit as employed in the device of FIG. 7;
FIG. 9 is a cross-sectional view of a modification of the unit of FIG. 8, including a modified skin perforating memher; and
FIG. 10 is a further enlarged top perspective view of the skin perforating member employed in the modification of FIG. 9.
The new injection device for making successive injections comprises a column of superposed skin perforating members, each perforating member including injection needle means extending from one side thereof, and means for removably joining the perforating members together in the column with the needle means extending towards the base of the column. An injection may be made by grasping the column and pressing the needle means of the outermost perforating member against the skin, the outermost perforating member may be removed from the column following the injection, and thereafter successive injections may be made in like manner with succeeding perforating members.
Referring to the drawings, one embodiment of the new injection device for making successive injections is a transcutaneous injection device generally indicated by the number 10 in FIGS. 1 and 2. The device includes a column of superposed injection units 12 surmounted by a holder 14. The outermost =or lowermost injection unit 12a is protected by a cover 16. The components of the device are detachably joined together in frictional interengagement.
Referring also to FIGS. 3-5, each injection unit 12 includes a skin perforating member 18 and a backing member 20. The perforating member includes a base 34 which preferably is a very thin circular flat disc or plate, having a central rectangular opening 36. Four needlelike projections 22 are punched or struck out from the base and extend perpendicular from one side thereof, at the corners of the opening 36. Each projection is triangular in configuration with a relatively small base, and each terminates at its free end in a sharp point. The skin perforating member thus is a one-piece integral construction of the base 34 and the projections 22. The presently preferred material of construction for the member is metal sheet material or the like. However, it is contemplated that other suitable materials may be employed, such as a rigid plastic material, which may be reinforced.
The backing member comprises a cup body, including a substantially cylindrical tubular side wall 24 and an integral substantially cylindrical tubular base 26 of reduced diameter. A slightly flared rim 28 preferably is provided at the top of the wall 24 as shown in FIG. 3. The bottom of the side wall is joined to the base 26 by an inwardly directed annular flange 30 forming a shoulder with the top of the base. The base is closed by a bottom wall 32.
The backing member 20 is a substantially rigid imperforate body preferably constructed in one piece. A preferred material of construction is plastic, e.g., a moldable thermoplastic resinous material such as polyethylene or other polyolefine, polystyrene and the like. However, other suitable materials may be employed, such as metal. The backing member and the perforating member are united in the illustrative embodiment by a layer 33 of any suitable adhesive or cement, joining the bottom wall 32 of the backing member to the side of the skin perforating member base 34 opposite to that from which the projections 22 extend. The backing member and the skin perforating member may be united in various other appropriate ways, such as by heating the backing member to cause it to stick to the perforating member, or to cause the base 34 to become embedded in the surface of the bottom wall 32. Another mode of attachment is illustrated by way of example in FIGS. 9 and 10 and is described subsequently. It is also contemplated that the backing and perforating members may be provided in an integral one-piece unit.
The backing member 20 of each injection unit 12 receives another like unit therein in nesting relation, as illustrated in FIGS. 1 and 2. The base 26 of the backing member for one unit nests within the side Wall 24 of an adjoining unit on which it is superposed. The perforating member 18 on the upper unit is received within and completely enclosed and protected by the backing member of the lower unit, preferably maintaining the projections 22 in spaced relation to and out of contact with the latter backing member. The inside diameter of the backing member side wall 24 is substantially the same as the outside diameter of the backing member base 26, to provide a size-on-size fit of adjoining units. In this manner, a plurality of units are removably joined together in a column of superposed units in frictional interengagement, with the projections 22 extending towards the base of the column.
Similarly, the cover 16 comprises a substantially rigid imperforate cup body, including a substantially cylindrical tubular side wall 17 and an integral bottom wall 19 providing a closed end. The cover preferably is constructed of plastic, or it may be constructed of other materials, as described above for the backing member. The cover receives the outermost injection unit 12a within its open end in nesting relation, to cover and protect the outermost perforating member 18. The cover may be employed in like manner on any succeeding unit 12 or the holder 14. The cover preferably is provided with a slightly flared rim like the rim 28 on the side wall 24 seen in FIG. 3.
The holder 14 is a substantially cylindrical body preferably constructed of plastic material of the type described above, or it may be constructed of other material, such as metal. The holder may be solid or hollow. In either event, it preferably includes a concave outer end wall 40. It includes a base 42 of reduced diameter, which is received within the wall 24 of an injection unit and subsequently may be received within the wall 17 of the cover in nesting relation. The injection device 10 is grasped with one or more fingers on the holder, and the holder is designed especially to facilitate the last one or several injections.
A skin perforating member 18 may be secured to the base 42 of the holder, in the same manner as for an injection unit 12. In such case, the holder may constitute a tubular body as shown, which is disposable following the last injection therewith. The holder has a side wall 44 which is elongated or extended as compared to the wall 24 of each unit, to enable the holder to be grasped by the fingers especially when the last injections are made with the device. Alternatively, a reusable holder 14 may be employed, in which case no perforating member 18 is mounted on the base 42, and the holder preferably is solid to provide greater durability. In this case, an injection device constituting a column of injection units 12 is supplied to the user, who inserts the holder in the upper most injection unit prior to performing a series of injections.
FIG. 6 illustrates a modified injection unit 12', in top plan view. The unit is the same as that of the preceding views, with the addition of a pair of tabs 46 which are integral with the rim 28 of the backing member wall, the tabs being in diametrically opposed relation. The tabs project outwardly from the backing member, and are adapted to facilitate manual removal of the unit from a column of units. The tabs of the several units may be arranged in staggered relation along the column of units, so that each unit may be removed in turn by finger pressure on one or both tabs of the unit.
An injection device 50 is illustrated in FIG. 7 which is made up of frustro-conical components in nesting relation, and in frictional engagement with each other. The device includes a plurality of injection units 52, a holder 54, and a cover 56. As illustrated in FIG. 8, each unit 52 includes a skin perforating member 18 and a backing member 58. The backing member is constructed preferably of plastic, and includes a frustro-conical side wall 60 and an integral circular bottom wall 62 at the small end thereof. As in the preceding embodiment, the perforating member is joined to the outer surface of the bottom wall by a layer 38 of adhesive or cement, or the parts may be joined by heating the plastic backing member to cause it to adhere to or enclose the base of the perforating member. The cover 56 comprises a cup body which may be constructed similarly to the backing member 58. As in the prior embodiment, the holder 54 may be provided with a skin perforating member 18 attached to the base thereof, in which case the holder may be constructed as a hollow disposable item. Alternatively, a more durable solid construction may be provided, with the omission of the perforating member 18, to render the holder reusable.
FIGS. 9 and 10 illustrate a modified injection unit 52', which is constructed with a modified skin perforating member 18. The skin perforating member includes a base 34 and integral needle-like projections 22 as in the preceding embodiment 18, and in addition, a pair of diametrically opposed upstanding wings or flanges 64 v which are integral with the margin of the base. The perforating member 18 is mounted on the bottom wall 62 of the backing member 58 by inserting the Wings 64 through corresponding openings 66 and bending or clinching the wings, as illustrated in FIG. 9. If desired, the backing member 58 may be softened, in the case of a thermoplastic substance, or a cement may be employed in the openings 66, to close and seal the openings around the wings.
The injection device of my present invention, as illustrated by the embodiments numbered 10 and 50 in FIGS. 1 and 7, is employed for skin testing, vaccination, or innoculation in similar manner to my aforesaid prior devices. For such applications, the skin perforating member base 34 may be about 0.2 mm. in thickness, and the projections 22 have the same thickness. The projections lie substantially on the circumference of a circle of lesser diameter than the base. The diameter of the base preferably is a minimum of about 8 to 10 mm. when a fourneedle device is employed. The projections are spaced preferably from 4 to 10 mm. apart, and are preferably disposed about 1.5 to 3.5 mm. inwardly from the periphery of the base. For use in tuberculin testing, the diameter of the base preferably does not exceed 10 mm, and the width of the margin between the projections 22 and the periphery of the base is about 1.5 to 2.5 mm. The projections extend from the outer side of the base for a distance of about 2 to 2.5 mm.
In making injections with the new device, an antigen, allergen, or chemotherapeutic agent may be applied on the skin, or it may be applied on the perforating member projections 22 for injection. In the latter case, such biological substances may be provided in dried or semi-dried form on the projections. In a further advantageous embodiment, the device 10 or 50 may include a quantity of an adherent fluent biologically active composition 68 (FIG. 7) in any of the cup bodies provided by the respective backing members 20 and 58, and covers 16 and 56. The combination injection device and package thus provided is especially useful for supplying active substances which deteriorate or lose their potency on drying. It also assists in retaining a coating of the active substance on the surfaces of the projections 22 up to the time of use. The active substance may be provided in a liquid or semi-liquid composition, such as in glycerine, agar or pectin. The cavity of each backing member or cover preferably is filled substantially to the base 34 of the perforating member, so as to immerse the projections in the composition.
The injection device 10 or 50 is assembled and supplied to the user in the manner illustrated in FIGS. 1 and 7. The perforating member projections 22 are uncoated, coated, or immersed in the fluid composition 68 in an adjacent injection unit or cover, as desired. The respective injection units 12 and 52, holders 14 and 54, and covers 16 and 56 are secured together in frictional interengagement in a column of superposed components. Alternatively, the user may be supplied with a separate holder 14 or 54 having no perforating member 18 thereon, for repeated use with a succession of columns of multiple injection units.
With the injection device 10 or 50 assembled as illustrated, the cover 16 or 56 is removed, and the holder 14 or 54 is grasped by the user. Initially, one or more fingers may grasp the column at the location of the injection units 12 or 52. The projections 22 of the outermost injection unit, such as indicated at 12a in FIG. 1, are placed against the skin and pressed inwardly to form a plurality of skin punctures with a resulting injection of the biological substance at the site of each puncture. The outermost injection unit may be removed from the column and discarded following the injection, and thereafter successive injections may be made in like manner with succeeding units 12. Projections such as the tabs 46 illustrated in FIG. 6 may be provided on the backing member of each unit, and they are engaged by the fingers to facilitate removal of a unit following injection. Successive injections are made rapidly and reliably until the injection units in the column have been consumed, the last injection being made with the holder 14 or 54 where it is of the disposable type provided with a perforating member 18. In the case of a reusable holder, the holder is engaged with the uppermost injection unit of a new column of units, and injections are continued therewith. When injections are discontinued before an injection device is consumed, the cover 16 or 56 may be placed over the outermost remaining unused injection unit in the manner illustrated, to protect the unit during the interval between injections.
In this manner, a great variety of transcutaneous injections may be made with biologically active substances, including various antigens, allergens, and chemotherapeutic agents. Vaccines which may be injected with the device include, for example, the vaccines for whooping cough, polio, rabies, yellow fever, smallpox, B.C.G. for tuberculosis, and others. Exemplary testing materials include coccidiodin, blastomycin, histoplasmimlepromin, and tuberculin, as well as allergens for foods and pollens. Chemotherapeutic agents include, for example, the antibiotics penicillin and streptomycin, and other active compounds.
Where biologically active substances are provided on the projections 22 in the injection devices 10 and 50, each column of units may be provided with a series of perforatmg members 18 having the same active substances on the projections, for making the same injection on a number of persons. In another very useful application, perforating members each having a different biologically active substance on the projections thereof may be arranged in the column in a predetermined sequence. In this manner, the physician may be provided with perforating members bearing different allergens, .for example, so that a predetermined pattern of injections may be made on the skin of one individual as is commonly done in testing for allergic reactions.
The backing members 20 and 58 interposed between the successive skin perforating members 18 provide effective barriers or shields and spacers which prevent blood or other body fluids from reaching the succeeding units, thus preventing transfer of infectious hepatitis, for example. In like manner, testing substances on the perforating members are prevented from reaching succeeding units. When the perforating members are employed with different testing substances, the construction prevents the substances from reaching succeeding units and possibly interfering with subsequent tests.
The new injection device is simply, economically and reliably constructed and used. The skin perforating members may be fabricated in quantity by precise methods and assembled with the backing members. The injection device maintains the sterility of the perforating members while being well suited for rapid, accurate and highly effective use in performing a series of injections.
It will be apparent that various changes and modifications may be made in the construction and arrangement of the components of the new injection device within the spirit and scope of the invention, and it is intended that such changes and modifications be included within the scope of the appended claims.
1. An injection device for making successive injections comprising, a column of superposed injection units, each said injection unit including a skin perforating portion and a substantially rigid backing portion, each said skin perforating portion including a plurality of needle-like projections extending from one side thereof and said backing portions including means for joining said units together in said column with all of said projections extending toward a first end of the column, a holder in said column, and means for removably joining said holder to said units adjacent the second end of said column, said holder being of a size easily to be gripped by the fingers and having an axial length greater than the axial length of each of said injection units, whereby an injection may be made by grasping said column and pressing against the skin said projections of the unit at said first end of said column, whereupon said last mentioned unit may be removed from said column, and thereafter successive injections may be made in like manner with succeeding units.
2. An injection device as defined in claim 1 and including a skin perforating portion on the base of said holder.
3. An injection device for making successive injections comprising a column of superposed injection units, said column being surmounted at one of its ends by a holder of a size to be easily gripped by the fingers and having an axial length greater than the axial length of each of said injection units, each injection unit including a skin perforating member and a substantially rigid backing member, said perforating member including a plurality of needle-like projections extending from one side thereof, said backing member comprising a cup body receiving the succeeding unit therein in nesting relation for removably joining said units together in said column with said projections extending towards the second end of the column, said backing member of the uppermost unit receiving said holder therein in nesting relation for removably joining the holder thereto, whereby an injection may be made by grasping said holder and pressing against the skin said projections of the unit at said second end of said column, whereupon said last mentioned unit may be removed from said column following the injection, and thereafter successive injections may be made in like manner with succeeding units.
4. An injection device as defined in claim 3 and including a skin perforating member secured to the base of the holder.
5. An injection device as defined in claim 3 and including a cover comprising a cup body receiving therein in nesting relation that one of said units at said second end of said column, said cover also being adapted for receiving any succeeding unit therein in nesting relation.
6. An injection device for making successive injections comprising a column of superposed injection units, each injection unit including a skin perforating member and a backing member, said perforating member including a plurality of needle-like projections extending from one side thereof, said backing member comprising a cup body receiving the succeeding unit therein in nesting relation for removably joining said units together in said column with said projections extending toward a first end of the column, and a quantity of an adherent fluent biologically active composition in at least one of said cup bodies for coating said projections on the succeeding unit therewith, whereby an injection may be made by grasping said column and pressing against the skin said projections of the unit at said first end of said column, whereupon said last mentioned unit may be removed from said column following the injection, and thereafter successive injections may be made in like manner with succeeding units.
References Cited by the Examiner UNITED STATES PATENTS 1,010,320 11/1911 Ruehs 22097 2,117,469 5/1938 Woodyatt 20643 X 2,619,962 12/1952 Rosenthal 128253 2,801,633 9/1957 Ehrlich 1283l4 2,818,070 12/1957 Barry 128-253 XR 2,876,774 3/1959 Kravitz et al 128253 2,893,392 7/1959 Wagner et a1. 128253 2,953,142 9/ 1960 Clementson 20656 RICHARD A. GAUDET, Primary Examiner.
R. I. HOFFMAN, ROBERT E. MORGAN, Examiners.