U.S. patent number 3,688,764 [Application Number 05/065,424] was granted by the patent office on 1972-09-05 for intracutaneous injection system.
This patent grant is currently assigned to Bard-Hamilton Company. Invention is credited to Jack Owen Reed.
United States Patent |
3,688,764 |
|
September 5, 1972 |
INTRACUTANEOUS INJECTION SYSTEM
Abstract
The present invention is directed to an intradermal injection
system adapted for multiple mass use, particularly for mass
diagnostic testing such as the Heaf Multiple Puncture Tuberculic
Test. The structure includes an elongated finger grip skin puncture
applicator with a set of puncture points mounted in the base face
of the applicator. Associated with the applicator is a solution
holder having therein an antigen well of pre-determined capacity.
An escape channel leading to an overflow well removes any excess
antigen from the well. Upstanding from the center of the antigen
well is a centering and stop element which cooperates with a
correspondingly shaped depression inside the base of the applicator
so that the applicator may be centered in the antigen well with all
of the applicator puncture points wetted by the antigen solution
therein to a pre-determined level.
Inventors: |
Jack Owen Reed (Englewood,
NJ) |
Assignee: |
Bard-Hamilton Company (Inc.,
West Englewood)
|
Family
ID: |
22062623 |
Appl.
No.: |
05/065,424 |
Filed: |
August 20, 1970 |
Current U.S.
Class: |
600/556; 206/367;
606/167; 604/46 |
Current CPC
Class: |
A61B
17/205 (20130101) |
Current International
Class: |
A61B
17/20 (20060101); A61b 010/00 () |
Field of
Search: |
;128/2W,2G,2R,213,253,333 ;206/63.4 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
1309352 |
|
Oct 1, 1962 |
|
FR |
|
1461996 |
|
Nov 1, 1966 |
|
FR |
|
232454 |
|
Sep 1, 1969 |
|
Soviet Union |
|
Primary Examiner: Kyle L. Howell
Attorney, Agent or Firm: Fidelman, Wolffe & Leitner
Claims
What is claimed is:
1. An intracutaneous applicator system comprising an intradermal
applicator member removably received in a solution supply holder,
said member and holder cooperating to apply solution to said
applicator for intradermal injections, said applicator having a
base injection surface, a plurality of puncture or scarifying means
located on said surface and projecting therefrom, a centrally
located depression in said surface, a first well in said holder, an
upstanding projection in said first well of a predetermined shape
and extending into said depression to center the applicator member
in relation to said first well and limiting the depth of
penetration of said base surface and puncture means into said first
well, an overflow well located in said holder, an escape channel
means in the top of said holder and communicating with both said
wells whereby excess solution placed in said first well will pass
to said overflow well to limit the amount of solution in said first
well to a predetermined level, said level being related to the
limited depth of penetration of said applicator by said upstanding
projection so that only said puncture means are coated with said
solution and not said base surface thus facilitating that an
accurately determined amount of solution will be on said applicator
when used on a patient.
2. A system as in claim 1 wherein said upstanding projection has a
peripheral ridge thereon, the shape of said projection and
depression being such that said ridge is sized to contact the area
of said base surface to limit the depth of penetration of said
applicator into said first well, said ridge also acting as a visual
indicator for determining when said first well has a predetermined
amount of solution therein.
3. A system as in claim 1 wherein the top of said holder is
generally depressed, said first well and upstanding projection
being located in the center of said depressed top and said overflow
well being located adjacent said first well.
4. A system as in claim 1 wherein said upstanding projection and
said depression are both frustro-conical in shape and said puncture
or scarifying means are integral with an insert piece located on
said base surface, said insert piece having a central aperture
overlying the opening of said depression, said puncture or
scarifying means being equally spaced from said depression.
Description
The present invention relates to an intracutaneous injection system
comprising a skin puncture applicator and a solution holder and is
explicitly intended for mass testing or treatment of an
intracutaneous nature. In particular, the present system is adapted
to mass conduct of the multiple puncture tuberculin test known as
the Heaf Test, and will be described for exemplary purposes in
terms of this particular usage.
A principal problem in mass testing, e.g. for tuberculosis, resides
in the need for sterile equipment of an inexpensive nature.
Desirably, the equipment must be utilizable (safely) by technicians
or semi-skilled personnel. An important criterion, one which
applies to individual tests as well as mass tests, is that the
proper amount of medicament must be applied. In mass screening this
requirement is translated into the usual statement that uniform
dosages must be employed.
An obvious way to insure uniform dosages is to package the
medicament in dosage units. However, for mass testing, such an
expedient sharply raises the medicament cost of the test program.
The present invention allows for bulk packaging of the medicament
and relies on the structure of the skin puncture applicator and an
associated antigen solution holder to insure that each test is
conducted with the same medicament dosage.
For further understanding of the invention, reference is now made
to the attached drawing wherein:
FIG. 1 is a side view of the medicament applicator and a protective
cap therefor;
FIG. 2 is a section taken along line 2--2 of FIG. 1 showing the
applicator and cap assembled;
FIG. 3 is a perspective view of the applicator;
FIG. 4 is an elevational view of the skin puncture end of the
applicator;
FIG. 5 is a perspective view of the applicator and the solution
holder; and
FIG. 6 is a partially broken away section taken along line 6--6 of
FIG. 5.
The intracutaneous or intradermal injection system of the present
invention comprises a skin puncture applicator 10 and a solution
holder 12. For sterile storage and shipment of the applicator, a
protective cap 14 is provided.
The applicator itself comprises a finger grip handle 16, preferably
of the bi-concave shape shown in FIGS. 3 and 5. The bi-concave
shape permits a good finger grip. Near the base end of applicator
10 is an annular circular flange 18 which seats over the top edge
of cylindrical body 22 of the protective cap 14 so that for sterile
shipment and storage the puncture points 20 on the base face of
applicator 10 are suspended above the bottom wall 24 of the cap 14,
as is illustrated in FIG. 2. Flange 18 also serves as a shield
preventing contact between the holder's fingers and the
medicament.
Beneath flange 18 and forming part of the applicator 10 is a
cylindrical body portion 26 and the skin puncture points 20 are
mounted on the base face at the bottom thereof. The puncture points
20, six annularly positioned points being illustrated (the usual
number for the Heaf test), form part of a metallic insert piece 28
set into the base face of body portion 26. Suitably, insert piece
28 is formed from sheet stock, e.g. stainless steel, by stamping
out the desired peripheral point configuration, then upending the
puncture points perpendicular to the remainder of the insert piece
28. The central aperture 32 in insert piece 28 may be stamped out
when the points are formed. Insert piece 28 is retained at the base
end of applicator 10 by a friction grip or by an overhand
engagement with lip-like projections 30 formed on the base face of
applicator 10.
An important structural feature of application 10 is the central
cone or frustro-conic depression 34 centrally of the base face. As
is shown in FIG. 4, central opening 32 in insert piece 28 underlies
depression 34 and the individual puncture points 20 are
symmetrically disposed therearound, so that a projection
corresponding in shape to central depression 34 can be employed as
a centering expedient.
The skin puncture applicator 10 can be employed, as is, for single
tests according to the usual techniques for such tests. For
example, the antigen may be placed directly on a small (about 1
inch square) clean skin region and the puncture point applicator
pushed in at that region so that the six puncture points penetrate
the upper layers of the skin and force antigen from the surface
intracutaneously. The applicator, which is relatively inexpensive,
may be considered as a disposable unit and discarded. The same
applicator structure, however, is equally adapted for mass testing
wherein it is employed in combination with medicament or antigen
holder 12.
As is shown in FIGS. 5 and 6, solution holder 12 has the general
shape of an inverted cup wherein a cylindrical skirt 38 supports an
upper depressed surface area 40 which contains thereon an antigen
well 42, an overflow well 44, and a connecting escape channel 46.
Should excess antigen be placed in well 42, the excess will
overflow through escape channel 46 into overflow well 44, from
which, at some convenient time, it may be recovered (by a sterile
eyedropper), and recovered or returned to antigen well 42.
Upstanding from the center of antigen well 42 is a frustro-conic
projection 48 corresponding in shape and dimensions to central
depression 34 in the base face of applicator 10. Projection 48 and
aperture 34 cooperate so that when the applicator 10 is inserted
into antigen well 42 the applicator is centered and all the
puncture points 20 are wet with the antigen therein, without coming
into contact with the well walls.
The projection 48 on solution holder 12 and central depression 34
on the applicator 10 constitutes also a stop structure which
prevents the user from inserting applicator 10 too deeply into well
42. Desirably, a ridge 50 formed peripherally around projection 48
at an appropriate level thereon acts as a visual filling indicator
and can also form a portion of the stop structure. Thus, when the
applicator 10 is fully inserted into solution well 42, as is
illustrated in FIG. 6, the inside rim of the metallic insert 28
(surrounding its central aperture 32) comes into abutting contact
with ridge 50; the entire area of each puncture point 20 is then
wetted by the solution in well 42. Any excess solution, in well 42,
is forced into escape channel 46 and overflows into overflow well
44. At this time the puncture points 20 are spaced apart from the
well side and bottom walls as is shown in the drawing and are
neither bent nor blunted by contact with the well walls. This
maintains the desired degree of test uniformity in a mass testing
program. Alternatively, the flat top of projection 48 can serve as
the stop element by abutting the flat end of depression 34, ridge
50 then serving a visual indicator purpose only.
For mass testing with the system of the present invention the
tuberculin antigen may be procured in bulk solution and the test
program commenced by placing whatever number of drops, three, four,
five that are required to fill well 42 to the level indicated by
the ridge 50. Any accidental overfilling will drain through escape
channel 46 into overflow well 44 (from which the antigen may be
retrieved). After every five or six tests, an additional drop of
tuberculin antigen solution is added to well 42 to maintain the
desired level of solution in the well. Accordingly, each successive
test is carried out with the proper quantity of solution on the
puncture points 20 of applicator 10. Any solution which wets the
surface of insert piece 28 has no effect on the test and,
constitutes a small wastage. When the test series is completed, the
solution holder 12 may be discarded (along with the test antigen
remaining in well 42), the solution holder 12 is a relatively
inexpensive, one-time use, disposable article. However, it may be
noted that the same solution holder 12 is employed for a series of
tests, e.g. 1 day's use. However, disposition of applicator 10
after each individual test might be unreasonably wasteful.
Accordingly, for use of the present system for mass testing
purposes, applicator 10 may, if desired, be meticulously cleaned
and sterilized and reused, the applicator being, however,
ultimately discarded as a disposable item.
Regardless of whether the intent is to employ applicator 10 on a
strictly one-time basis or for a reasonable number of tests, many
standard materials are available from which applicator and holder
may be formed, notably, the thermoplastic resins such as
polyvinylchloride, polystyrene, polyethylene, polypropylene, etc.,
all of which can be readily molded into the desired shaped with
conventional techniques and equipment. The thermoplastic resins
exhibit sufficient structural stability so that the well 42 and
escape channel 46 may be formed with volumetric accuracy and
projection 48 and its ridge 50 can be accurate enough to mate with
central depression 34 and central aperture 32 of applicator 10. In
addition, the standard thermoplastic resin moldings can include a
lip 30 for the friction or overlap fit which retains the metallic
insert piece 28 on the base face of applicator 10.
Although the structure of the present invention has been described
in terms of the Heaf Multiple Puncture Tuberculin Test, it should
be appreciated that the same or essentially the same structure is
equally applicable to other intracutaneous injections of a mass
nature, including both diagnostics and immunizations such as
vaccinations. The only expressly contemplated change in the system
for other uses is substitution of the six pointed insert piece 28
by a like insert piece having whatever skin puncture or scarifying
points are preferred for the particular usage.
* * * * *