US3167071A

US3167071A - Apparatus for administering intradermal injections

Info

Publication number: US3167071A
Application number: US124586A
Authority: US
Inventors: Venditty Anthony
Original assignee: Catalent Pharma Solutions Inc
Current assignee: Catalent Pharma Solutions Inc
Priority date: 1961-07-17
Filing date: 1961-07-17
Publication date: 1965-01-26
Anticipated expiration: 1982-01-26

Description

A. VENDITTY Jan. 26, 1965 APPARATUS FOR ADMINISTERING INTRADERMAL INJECTIONS Filed July 17, 1961 I N V EN TOR: $222072; ATTORNEYS.

United States Patent My present invention relates to an apparatus for administering jet type intradermal injections.

One object of the invention is to provide apparatus that 3,167,071 Patented Jan. 26., 1965 On the accompanying drawing I have used the refer ence character I to indicate in general a multidose jet injector such as shown in the copending application above referred to. Referring to FIG. 3 the barrel of the jet injector J is illustrated at and is provided with a medicament discharge bore 12. A nozzle or nose 14 is utilizes jet injectors for intraderrnal injections, as distinguished from hypodermic jet injections given by jet injectors of the general type shown in the following patents: Patent Nos. 2,322,244, 2,322,245, 2,380,534, 2,398,544, 2,704,543, 2,714,887, 2,754,818, 2,762,369, 2,762,370 and 2,816,543, and which operate in accordance with the jet injection methods in Patent Nos. 2,322,245 and 2,704,542.

Another object is to provide apparatus for administering intradermal injections which cooperates with the nozzle of a jet injector in such manner as to force an area of the skin of the patient into contact with the discharge end of the nozzle for initial penetration of the jet stream at substantially right angles thereto, while a second area of the skin is held substantially parallel to the jet stream axis and at such lateral distance therefrom that the jet, after penetrating at right angles through said first mentioned area, discharges parallel to the surface of the skin and through the stratum gerrninativum which defines the separation plane between the epidermis and the dermis. Still another object is to provide an intradermal adapter in the form of a skin clamp that may be attached to the discharge nozzle of a jet injector. The adapter has provision for gripping the skin surface and is then operable to move it toward the jet nozzle in such fashion as to crowd a portion of the skin into firm contact therewith.

Still another object is to provide a two-part apparatus, one part for attachment to the jet injector nozzle and the other part movable relative thereto and provided with a relatively rough surface that can so cooperate with the skin as to move it across the underlying fat cells, there by producing a wrinkle in the skin which is forced against the discharge end of the jet injector nozzle for penetration of the jet while another portion thereof is so confined that intradermal injection is assured.

With these and other objects in view, my invention consists in the construction, arrangement and combination of the various parts of my intradermal injection apparatus and the method for usethereof whereby the objects above contemplated are attained, as hereinafter more fully set forth, pointed out in my claims and illustrated in detail on the accompanying drawing, wherein:

FIG. 1 is a perspective View of a multidose jet injector such as shown in the copending application of Alfred W. Kath and myself, Serial No. 49,662, filed August 15, 1960, now Patent No. 3,130,723, with my intradennal adapter attached thereto, the view being such that the surfaceof the adapter that contacts the skin of the patient is toward the viewer;

FIG. 2 is another perspective view from the reverse side and shows the adapter per se;

FIG. 3 .is an enlarged vertical sectional view through the adapter and the adjacent end of the jet injector showing the adapter in proper initial position contacting the skin of the patient;

1 FIGS. 4 and 5 are vertical sectional views on the lines 4-4 and 55 of FIG. 3; and

FIG. 6 is an enlarged diagrammatic view showing the relationship of the adapter and jet nozzle to the skin during the injecting operation.

screwed onto the barrel 10 and sealed relative thereto by means of an G-ring 16. The nozzle 14 has a jet discharge bore 18, and is provided with a groove 20 around its periphery.

My apparatus for administering intradermal injections is in the form of an adapter having a body 22 provided with a bore 24 to snugly fit over the nozzle 14. A set screw 26 (see FIG. 3) is used to retain the adapter in position on the nozzle. A skin gripping plate 28 is slidably mounted on the lower surface 22a of the body 22 and is provided with a surface 30 which is suitably roughened so as to tend to grip the skin surface. A covering of grit performs this function quite well. The surface 22a is substantially parallel to the axis of the

bores

12 and 18, and spaced laterally therefrom for a purpose which will hereinafter appear. The plate also has a beveled edge 23. A portion of the body 22 that surrounds the nozzle 14 may also be advantageously grit-covered as indicated at 32.

A stud extends upwardly from the body 22 and a handle of neoprene, plastic or the like 42 is mounted thereon. Opposing the handle 42 is a handle 46 on a shouldered stud 44 which extends thru a spacer sleeve 48 and threads into the plate 28. The body 22 is provided with a slot 50 for the sleeve 48 and stud 44. A pair of shouldered screws likewise extend through spacer sleeves 49 and thread into the plate 28, the sleeves being slidable in slots. 51 of the body 22. The stud 44 and the screws 45 thus mount the plate 28 slidably relative to the body 22, and a return spring 52 is mounted in the body 22 as shown in FIG. 3 to bear against the sleeve 48 and normally bias the skin gripping plate 28 to the left as shown.

Practical operation In use, my intradermal injection attachment comprising the parts bearing the reference numerals 22 to '52 is mounted on the jet injector J asshown :in FIG. 1, and may swivel therearound due to the peripheral groove and set screw arrangement 20-26, to any'position for convenience of operation during use for administering intradermal injections. f

The attachment is placed on the skin S as shown'in FIG. 3 and held firmly thereag'ainst, which locates the axis ofthe jet dischargebore 18 substantially parallel to the skin surface as illustrated. The

handles

42 and 46 are then manually engaged and moved relatively toward each other to the position shown in FIG. 6, which results in one portion of the skin bulging up as at 54 and another portion 56 thereof being forced into engagement flat against the discharge end of nozzle 14. The sliding of the plate 28 effects forcing of the skin into tight engagement with the nozzle orifice after the adapter is positioned against the skin as in FIG. 3. This insures subsequent penetration of the jet through the skin without loss of medicament on the skin surface. The bevel 23 provides a crevice to receive the bulge 54 and the stratum germinativum 63 of the skin is aligned with respect to the axis of the jet discharge bore 18.

The actuating lever 58 of the jet injector J is then depressed for releasing the jet 60, as also shown in FIG. 6,

and the jet passes at substantially right angles through the portion 56 of the skin S and then enters the stratum germinativum 63 that forms the division line between the skin layers (epidermis 62 and dermis64) thereby producing the desired injection intradermally. During the 7 age being .020".

V in such position that the jet penetrates the stratum germinativum. I

At first direct intradermal injection normal to the surface of the skin was attempted as in my Patent No. 2,714,- 887. Intradermal jet injections differ from hypodermic jet injections which go subcutaneous (under the skin), intramuscular, or within the muscle tissue. Jet pressures can be reduced to deposit medicament within the skin, but more often than not too much material goes subcutaneously. 'While for some medication that is acceptable, it is most unacceptable for others. Vaccinations for smallpox, for example, must be given within the skin layers in order to be effective. With this in mind it is imperative that injection be made somewhat parallel to the plane of the injection site. By first wrinkling the skin and then discharging into the wrinkled portion it is possible to avoid to a great degree going into the subcutaneous tissue.

Another important area is the advantage of my method of giving intradermal injections as compared with needle and syringe: a

(1) Speed.-It is possible to give approximately one thousand intradermal injections an hour using the injector and my intradermal nozzle attachment herein disclosed. Needle and syringe technique for intradermal injections is quite involved and requires quite a bit of practice. A lot of poking around and jabbing is necessary and this of course is time-consuming and painful.

- (2) Lack of pain.lntradermal jet injections are completely painless. There is not even the pin-prick sensation that is felt with subcutaneous or intramuscular jet injections. Conversely, an intradermal injection with a needle is quite painful, much more so than most subcutaneous and intramuscular needle injections. This is true because of the jabbing which must be done in order to insure that the needle is within the skin layers. 7

(3) Patient fear is practically eliminated by my apparatus and metlid.--While tests have been mostly in institutions, it is obvious there is considerable build-up of fear on the part of the patient; In tests that have been run there has been a lot of screaming on the part of people getting the needle, which is not the case when jet injections are given intradermally.

(4) The economics of giving intradermal jet injections are stupend0us.'1n the case of intradermal jet injections the economies are even more attractive than with normal subcutaneous and intramusclar jet injections. This again is true because of the slowness with which the intradermal injections must be given with needle and syringe, not to mention the personnel required to keep a line of patients moving. In certain comparative tests I have run there have been six people giving needle and syringe injections, each with a person to swab the arm and assist the patient. One doctor has been able to keep up with this entire group of twelve people very easily using my apparatus, and in some cases doing his own swabbing prior to injecting.

(5) Accuracy.The percentage of accuracy with jet injection using my apparatus and method is much higher than using the needle and syringe technique. After considerably experimentation it was found that the distance A in FIG. 3 from the gritted surface Stl of the skin gripping plate 28 to the center of the axis of the jet 6%) could vary from approximately .010" to .025, a suitable aver- This evidently places the center line of the jet at thesomewhat indeterminate parting line 6 3 between the epidermis 62 and the dermis 64 so that the jet enters intradermally as illustrated in FIG. 6. Of course the thickness of the skin varies from person to person and on various arts of the body, but this can be taken into consideration and the distance A varied accordingly. For instance, one interdermal jet injector attachment may be provided for use on the the arm and another for use on the leg. After exhaustive tests with different ones it will probably be possible to tailor different attachments for different areas of the body in this manner andpredict in advance which one should 'be used.

Technically speaking, the reason for using a tangental (jet tangent instead of normal to the skin) method of injection for intradermal injections versus the normal-tothe-surface-of-the-skin method, is that more pressure is required to penetrate the skin than to traverse the same distance within subcutaneous tissue as disclosed in Patents Nos. 2,322,245 and 2,704,542. Therefore:

(1) If enough force to penetrate the skin is used it will not stop within the skin to prevent undesired injection within the subcutaneous tissue.

(2) When the tangent method is used without my herein disclosed apparatus, due to the fact that the skin is pliable and resists penetration, the jet force rolls the skin up before it to a point where the skin no longer can resist this penetrating force and the jet then goes through the skin, again subcutaneously.

To overcome both of these objections, the nozzle 14 is placed in a position with its jet discharge bore substantially parallel to the skin and the gritted surface 30 of the. skin gripping plate 28 pushes a wrinkle of the skin against the nozzle face with enough force to resist the penetrating force of the jet, and holds the portion of the skin that receives the intradermal injection substantially parallel to the jet stream. The resulting wrinkle of the skin is not a primary factor but happens to be a result f forcing the skin, with a force greater than the force of the jet stream, to the nozzle face and filling in the crevice formed by the bevel 23 (see FIG. 6) that the gritted-surface plate 22 creates at the nozzle face.

The position of the gritted surface plate 22 relative to the center line or axis of the nozzle jet is somewhat critical. If the gritted surface is too close to the plane of the jet axis, the jet skips over the skin. -If it is too far away from the plane of the jet axis, the jet will again go subcutaneously rather than intradermally. By trail and error I have determined that approximately .020 space be somewhat modified without departing from the real.

spirit and purpose of my invention, and it is my intention to cover by my claims any modified forms of structure, use of mechanical equivalents or comparable method steps which may reasonably be included Within their scope. i

I claim as my inventions 1. Apparatus of the character disclosed comprising a. body member afiixed to a jet injection nozzle which has a 'et bore and a discharge end, said body member having a surface substantially parallel to the axis of said jet bore and located beyond said discharge end, and skin engaging means slidable on said surface toward said nozzle, said skin engaging means having a forward end facing said nozzle for moving a portion of the skin of the patient cngaged by said skin engaging means into substantially fiat engagement against said discharge end and'having a skin engaging surface substantially parallel to theaxis of said bore, said skin engaging surface confining another portion of the skin to a substantially parallel relation to said axis.

2. Apparatus of the character disclosed comprising a body member affixed to a jet injection nozzle which has a jet bore and a discharge end, a skin engaging element movably supported by said 'body member beyond said discharge end and having a forward end facing said discharge end and a surface substantially parallel to the axis of said jet bore and spaced laterally therefrom, said surface being roughened to constitute a skin gripping face for moving the skin of a patient engaged by said skin gripping face laterally in a direction parallel to the surface of said face, and manually operable means for moving said skin engaging element relative to said body memher and toward said nozzle whereby said forward end produces a wrinkle in the skin of said patient, a portion of said body member adjacent said nozzle being roughened to prevent slippage of the skin wrinkle across said discharge end.

3. Apparatus for administering intradermal injections comprising a body member affixed to a jet injection nozzle which has a jet bore and a discharge end, said body member having a surface substantially parallel to the axis of said jet bore and located beyond said discharge end, and an element slidable on said surface and having a gritlike skin gripping face parallel to said jet axis for moving a first portion of the skin of a patient engaged by said skin gripping face relative to said body member and parallel to said jet axis While a second portion of the skin of said patient is held by pressure of the discharge end of said nozzle thereagainst, said element having a bevelled forward edge to form in conjunction with said body membet a crevice that forms a Wrinkle in a third portion of the skin of said patient adjacent said nozzle as said forward edge advances toward said nozzle.

4. An attachment affixed to a jet injection nozzle which has a jet discharge orifice and a discharge end, said attachment comprising a body member having means to mount the same on said nozzle, said body member having a portion extending away from said discharge end in the jet discharge direction and having a surface substantially parallel to said jet bore, an element slidable on said surface and having a grit-covered surface to grip the skin of a patient engaged by said element, and means to slide said element on said surface toward said nozzle to move one portion of the skin of said patient into contact with said discharge face while holding another portion thereof substantially parallel to said jet discharge orifice, a portion of said body adjacent said nozzle and opposite said element being roughened to resist slippage of a third portion of the skin of said patient.

5. An attachment affixed to a jet injection nozzle which has a jet bore and a discharge end, said attachment comprising a body member having means to mount the same on said nozzle, said body member having a portion extending away from said discharge end in the jet discharge direction and having a surface substantially parallel to said jet bore, an element slidable on said surface and having a grit-covered surface to grip the skin of a patient, said element having a forward edge, and means to slide said element on said surface toward said nozzle whereby said forward edge moves one portion of the skin of said patient into contact with said discharge end. while holding another portion thereof substantially parallel to said jet bore and while a third portion is confined between said discharge end and said forward edge.

6. An attachment aflixed to a jet injection nozzle which has a jet discharge bore and a discharge end, said attachment comprising a body member having means to mount the same on said nozzle, said body member having a substantially fiat portion extending away from said discharge end in the direction of jet discharge and parallel to said jet bore, an element slidable on said body member and having a roughened surface to grip the skin of a patient engaged by said element, means to move said element along said surface toward said nozzle to engage one portion of the skin of said patient fiatwise with said discharge end While holding another portion thereof substantially parallel to said jet bore and in position relative to the jet axis such that the jet stream is substantially aligned with the stratum germinativum of the patients skin.

References Cited in the file of this patent UNITED STATES PATENTS 2,754,818 Scherer July 17, 1956 2,816,543 Venditty et a1. Dec. 17, 1957 2,821,981 Ziherl et a1 Feb. 4, 1958

Claims

2. APPARATUS OF THE CHARACTER DISCLOSED COMPRISING A BODY MEMBER AFFIXED TO A JET INJECTION NOZZLE WHICH HAS A JET BORE AND A DISCHARGE END, A SKIN ENGAGING ELEMENT MOVABLY SUPPORTED BY SAID BODY MEMBER BEYOND SAID DISCHARGE END AND HAVING A FORWARD END FACING SAID DISCHARGE END AND A SURFACE SUBSTANTIALLY PARALLEL TO THE AXIS OF SAID JET BORE AND SPACED LATERALLY THEREFROM, SAID SURFACE BEING ROUGHENED TO CONSTITUTE A SKIN GRIPPING FACE FOR MOVING THE SKIN FOR A PATIENT ENGAGED BY SAID SKIN GRIPPING FACE LATERALLY IN A DIRECTION PARALLEL TO THE SURFACE OF SAID FACE, AND MANUALLY OPERABLE MEANS FOR MOVING SAID SKIN ENGAGING ELEMENT RELATIVE TO SAID BODY MEMBER AND TOWARD SAID NOZZLE WHEREBY SAID FORWARD END PRODUCES A WRINKLE IN THE SKIN OF SAID PATIENT, A PORTION OF SAID BODY MEMBER ADJACENT SAID NOZZLE BEING ROUGHENED TO PREVENT SLIPPAGE OF THE SKIN WRINKLE ACROSS SAID DISCHARGE END.