US20140074064A1 - Intradermal delivery device including a needle assembly - Google Patents

Abstract

A drug delivery device including a needle assembly facilitates making intradermal injections using a variety of drug container types such as a syringe. A hub supports the needle while a limiter surrounds the needle. The limiter includes a skin engaging surface that is adapted to be received against the skin of an animal to be intradermally injected. A forward end of the needle extends beyond the skin engaging surface a selected distance to limit a depth that the needle penetrates into the animal's skin.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application is a continuation of Ser. No. 11/871,012, filed Oct. 11, 2007 which is a continuation of Ser. No. 09/825,017, filed Apr. 3, 2001, which is a divisional application of Ser. No. 09/417,671 filed Oct. 14, 1999, now Patented as U.S. Pat. No. 6,494,865.
FIELD OF THE INVENTION
• The present invention generally relates to delivery devices for delivering substances such as drugs, vaccines and the like, and more specifically relates to a drug delivery device for injecting such substances intradermally, i.e., into the skin. In addition, the present invention relates to a needle assembly that is adaptable for use with a variety of drug containers such as syringes for making intradermal injections.
BACKGROUND OF THE INVENTION
• A wide variety of hypodermic injection devices are commercially available. Most hypodermic injections are intended to be intramuscular so that the hypodermic needle penetrates through an individual's skin layer and subcutaneous tissue and into the muscle tissue. Under some circumstances, however, limited needle penetration is desired. Under some circumstances, for example, an intradermal injection is desired where the needle does not penetrate beyond the dermis layer.
• One technique for administering intradermal injections is known as the Mantoux procedure. A Mantoux procedure is relatively complicated and requires technical skill from the medical professional or individual administering the injection. Additionally, the Mantoux procedure can prove painful for the individual receiving the injection, especially when somebody without experience is administering the injection.
• Devices have been proposed for providing intradermal injections, which include shortened needles compared to conventional needle sizes. The smaller needles are not intended to penetrate beyond the dermis layer of the individual. Such devices are shown in U.S. Pat. No. 5,527,288, which issued on Jun. 18, 1996; U.S. Pat. No. 4,886,499, which issued on Dec. 12, 1989; and U.S. Pat. No. 5,328,483, which issued on Jul. 12, 1994. The proposed devices, however are not without shortcomings and drawbacks.
• For example, the devices shown in U.S. Pat. Nos. 5,527,288 and 4,886,499 are highly specialized injectors. The designs for these injectors include relatively complex arrangements of components that cannot be economically manufactured on a mass production scale. Therefore, such devices have limited applicability and use.
• Similarly, the device shown in U.S. Pat. No. 5,328,483 requires a specially designed injector and, therefore, it is not readily adapted to be used with a variety of syringe types. Additionally, the assembly of that patent is not conducive to economical mass production.
• There is need for an intradermal injection device that is suitable for use with a variety of syringe bodies. Additionally, there is a need for an intradermal injection device that can be economically manufactured on a mass production scale. This invention addresses those needs and avoids the shortcomings and drawbacks discussed above.
SUMMARY OF THE INVENTION
• In contrast to the prior devices discussed above, it has been found that a drug delivery device particularly suited for use in intradermally injecting substances such as drugs, vaccines and the like can be constructed in accordance with the present invention. Specifically, the present invention is directed to a drug delivery device including a needle assembly for use in making intradermal injections. The needle assembly has an adapter that is attachable to prefillable containers such as syringes and the like. The needle assembly is supported by the adapter and has a hollow body with a forward end extending away from the adapter. A limiter surrounds the needle and extends away from the adapter toward the forward end of the needle. The limiter has a skin engaging surface that is adapted to be received against the skin of an animal such as a human. The needle forward end extends away from the skin engaging surface a selected distance such that the limiter limits the amount or depth that the needle is able to penetrate through the skin of an animal.
• In addition, the present invention is directed to a method of intradermally injecting at least one substance into the skin including the steps of pressing the needle perpendicularly to the skin of the person to receive an injection, injecting the substance into skin of the person with the depth of penetration of the needle being mechanically limited to the intradermal space by the limiter that surrounds the needle. Also, in the preferred embodiment, the step of pressing the needle perpendicularly to the skin of the person includes orienting the needle perpendicularly to the skin, and the step of injecting the substance either includes moving a plunger that is received within the reservoir or deflecting two sheets of thermoplastic material forming the reservoir toward each other to expel the substance from the reservoir during an injection.
• The various features and advantages of this invention will become apparent to those skilled in the art from the following detailed description of the currently preferred embodiments. The drawings that accompany the detailed description can be briefly described as follows.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is an exploded, perspective illustration of a needle assembly designed according to this invention.
• FIG. 2 is a partial cross-sectional illustration of the embodiment ofFIG. 1.
• FIG. 3 shows the embodiment ofFIG. 2 attached to a syringe body to form an injection device.
• FIG. 4 is an exploded, side view of another embodiment of an injection device designed according to this invention.
• FIG. 5 is a cross-sectional illustration taken along the lines A-A inFIG. 4 but showing the components in an assembled condition.
• FIG. 6 is an exploded, cross-sectional view similar to that shown inFIG. 5 showing an alternative embodiment.
• FIG. 7 shows the embodiment ofFIG. 6 in an assembled condition.
• FIG. 8 is a flow chart diagram that schematically illustrates a method of filling a device designed according to this invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• FIGS. 1 and 2 diagrammatically illustrate theneedle assembly20 of the present invention that is designed to be used for making intradermal injections,FIG. 3 illustrates the drug container such assyringe60 for use with theneedle assembly20, andFIGS. 4-7 illustrated theintradermal delivery device80 of the present invention for making intradermal injections. Intradermal injections include administering substances such as drugs, vaccines and the like into the skin of an animal such as a human.
• Theneedle assembly20 includes ahub22 that supports aneedle24. Thelimiter26 receives at least a portion of thehub22 so that thelimiter26 generally surrounds theneedle24 as best seen inFIG. 2.
• Oneend30 of thehub22 is able to be secured to areceiver32 of a syringe. A variety of syringe types can be used with a needle assembly designed according to this invention, with several examples being given below. The opposite end of thehub22 preferably includesextensions34 that are nestingly received againstabutment surfaces36 within thelimiter26. A plurality ofribs38 preferably are provided on thelimiter26 to provide structural integrity and to facilitate handling theneedle assembly20.
• By appropriately designing the size of the components, a distance d between a forward end ortip40 of theneedle24 and askin engaging surface42 on thelimiter26 can be tightly controlled. The distance d preferably is in a range from approximately 0.5 millimeters to approximately 3 millimeters. When theforward end40 of theneedle24 extends beyond the skin engaging surface42 a distance within that range, an intradermal injection is ensured because the needle is unable to penetrate any further than the typical dermis layer of an animal. Typical tissue layers include an epidermis between 50 and 100 micrometers, a dermis layer between 2 and 3 mm then subcutaneous tissue followed by muscle tissue.
• As can be best seen inFIG. 2, thelimiter26 includes anopening44 through which theforward end40 of theneedle24 protrudes. The dimensional relationship between theopening44 and theneedle40 can be controlled depending on the needs of a particular situation. For example, theskin engaging surface42 surrounding theneedle24 has a thickness defined between an inner diameter and an outer diameter and the inner diameter is at least five times greater than an outside diameter of theneedle24. In the illustrated embodiment, theskin engaging surface42 is generally planar and continuous and provides a stable placement of theneedle assembly20 against an animal's skin. Although not specifically illustrated, it may be advantageous to have the skin engaging surface be slightly concave or convex in order to facilitate stretching or gathering the animal's skin in the vicinity of theneedle tip40 to facilitate making an injection. Additionally, theribs38 may be extended beyond theskin engaging surface42 to further facilitate manipulating the skin in the vicinity where the injection is to be given.
• Regardless of the shape or contour of theskin engaging surface42, the preferred embodiment includes enough of a surface area that contacts the skin to facilitate stabilizing the injector relative to the animal's skin. In the most preferred arrangement, theskin engaging surface42 facilitates maintaining the injector in a generally perpendicular orientation relative to the skin surface.
• It is important to note that althoughFIGS. 1 and 2 illustrate a two-piece assembly where thehub22 is made separate from thelimiter26, this invention is not limited to such an arrangement. Forming thehub22 andlimiter26 integrally from a single piece of plastic material is an alternative to the example shown inFIGS. 1 and 2. Additionally, it is possible to adhesively or otherwise secure thehub22 to thelimiter26 in the position illustrated inFIG. 2 so that theneedle assembly20 becomes a single piece unit upon assembly.
• Having ahub22 andlimiter26 provides the advantage of making an intradermal needle practical to manufacture. The preferred needle size is a small gauge hypodermic needle, commonly known as a 30 gauge or 31 gauge needle. Having such a small diameter needle presents a challenge to make a needle short enough to prevent undue penetration beyond the dermis layer of an animal Thelimiter26 and thehub22 facilitate utilizing aneedle24 that has an overall length that is much greater than the effective length of the needle, which penetrates the individual's tissue during an injection. With a needle assembly designed according to this invention, manufacturing is enhanced because larger length needles can be handled during the manufacturing and assembly processes while still obtaining the advantages of having a short needle for purposes of completing an intradermal injection.
• FIG. 3 illustrates aneedle assembly20 secured to a drug container such as asyringe60. A generallycylindrical syringe body62 can be made of plastic or glass as is known in the art. Thesyringe body62 provides areservoir64 for containing a substance to be administered during an injection. Aplunger66 has amanual activation flange68 at one end with astopper70 at an opposite end as known in the art. Manual movement of theplunger66 through thereservoir64 forces the substance within thereservoir64 out of theend40 of the needle as desired.
• Thehub22 can be secured to thesyringe body62 in a variety of known manners. In one example, an interference fit is provided between the interior of thehub22 and the exterior of theoutlet port portion72 of thesyringe body62. In another example, a conventional luer fit arrangement is provided to secure thehub22 on the end of thesyringe60. As can be appreciated fromFIG. 3, a needle assembly designed according to this invention is readily adaptable to a wide variety of conventional syringe styles.
• FIGS. 4 and 5 illustrate an alternative embodiment of anintradermal delivery device80 that includes a syringe made from two sheets of thermoplastic material. The syringe includes abody portion82 that is generally flat and surrounds areservoir84. Anoutlet port86 allows fluid substance within thereservoir84 to be communicated out of the reservoir to administer an injection. The syringe body preferably is formed using a thermoforming process as is known in the art.
• Areceiver90 includes a generallycylindrical neck portion92 that preferably is secured to theoutlet port86 using a heating or welding process as known in the art. Aflange94 preferably rests against thebody portion82 of the syringe to provide structural integrity. Anextension96 extends away from theflange94 in a direction opposite from thecylindrical portion92. Theneedle assembly20 preferably is received within theextension96 as shown inFIG. 5.
• Thereceiver90 preferably supports a sealingmembrane100 that closes off theoutlet port86 so that the syringe can be prefilled. Theneedle assembly20 preferably includes aback end102 of the needle that penetrates the sealingmembrane100 when thehub22 is received within theextension96.
• The side walls of thereservoir84 preferably are squeezed between a thumb and index finger so that the side walls collapse towards each other and the substance within thereservoir84 is expelled through the opening in theforward end40 of theneedle24. In the embodiment ofFIGS. 4 and 5, thehub22 andlimiter26 preferably are integrally molded as a single piece of plastic material. A snap fit arrangement secures thehub22 within theextension96 of thereceiver90. Another alternative is illustrated inFIGS. 6 and 7. In this embodiment, thehub22 is molded separately from thelimiter26′, which is integrated with theextension96. A difference between the embodiments ofFIGS. 6 and 7 compared to that ofFIGS. 4 and 5 includes anelongated extension96 so that the side wall of theextension96 provides theskin engaging surface42′ of thelimiter26′. In this embodiment, the limiter is supported by the syringe body. By appropriately choosing the dimensions of theneedle24 and the length of theextension96, the desired distant d between theskin engaging surface42 and theneedle tip40 can be achieved.
• FIG. 7 also illustrates aneedle shield110, which preferably is provided on thehub22 andneedle24. Theneedle shield110 facilitates inserting thehub22 within thereceiver90 until thehub22 is appropriately received within theextension96 so that theintradermal delivery device80 is ready for use. Theneedle shield110 can be discarded after thehub22 is in position. Alternatively, theneedle shield110 can be replaced over theneedle24 after an injection is complete to avoid the possibility for a needle stick while handling theintradermal delivery device80 after it has been used. Although theshield110 is only shown inFIG. 7, it preferably is utilized with the embodiments ofFIGS. 4-7.
• This invention provides an intradermal needle injector that is adaptable to be used with a variety of syringe types. Therefore, this invention provides the significant advantage of facilitating manufacture and assembly of intradermal needles on a mass production scale in an economical fashion.
• Operation and Use
• Having described the preferred embodiments of theintradermal delivery device80 of the present, including theneedle assembly20 anddrug container60, its operation and use is described below.
• Use of the delivery device to administer substances such as drugs, vaccines and the like into the intradermal layer is significantly easier than with a traditional syringe and needle. Using a traditional syringe and needle is technique-dependent and requires considerable skill to develop an acceptable skin wheal. In particular, the needle must be carefully guided at a shallow angle under the skin while maintaining correct orientation of the needle bevel. In contrast, with a prefilled intradermal delivery device of the present invention, the user simply presses the device perpendicularly on to the skin and injects the substance. The depth of penetration of the needle is mechanically limited to the intradermal space. In this way, there is no need o orient the needle bevel during injection. Orienting the device, particularly the needle, perpendicularly to the skin, as well as stability while injecting the substance, is facilitated by the design of the device.
• Referring now toFIG. 8, an example method of filling devices designed according to this invention is schematically illustrated in flow chart format. When the device includes a syringe of the style illustrated inFIG. 3, the following basic procedure is useful for prefilling the syringes with a desired substance.
• A supply of syringe barrels200 includes the desired form of syringe, such as those illustrated and discussed above. A locally controlledenvironment202 preferably is maintained in a known manner. The locally controlledenvironment202 preferably is situated to immediately accept the syringes without requiring any intermediate cleaning or sterilizing steps between thesupply200 and theenvironment202.
• In one example, the syringe barrels are washed with air at204 to remove any particulates from the syringes. The syringes preferably are then coated at206 with a lubricant such as a lubricating silicone oil on the inner surface. The lubricant facilitates moving thestopper70 andplunger rod66 through the syringe during actual use of the device.
• The end of syringes that eventually willneedle assembly20 may be capped with a tip cap within theenvironment202. In one example, tip caps are supplied at208. The tip caps are air washed at210. The cleaned tip caps and syringe barrels are conveyed to anassembly device212 where the tip caps are secured onto the syringes. The syringe barrel assemblies are then conveyed to afilling station214 to be filled with the desired substance.
• Once filled as desired, thestoppers70 are inserted into the open end of the syringes at220. Prior to inserting thestoppers70, they preferably are assembled with theplunger rods66 at222 and lubricated at224 with a conventional lubricant in a known manner. The assembled, filled syringes preferably are inspected at226 for defects and discharged from the locally controlled environment.
• The syringes typically will be sterilized at230 and packaged at232 into individual packages or into bulk packaging depending on the needs of a particular situation. Suitable sterilization techniques are known and will be chosen by those skilled in the art depending on the needs of a particular situation or to accommodate the properties of a given substance. Sterilizing a device designed according to this invention can be completed before or after packaging.
• Variations of the filling steps are within the scope of this invention. For example, the stopper can be inserted first, then fill the syringe, followed by applying a tip cap. Additionally, when the device includes a syringe body of the type shown inFIGS. 4 and 5, for example, the filling operation obviously does not include insertion of a stopper nor the lubrication steps described above. Instead, appropriate filling techniques that are known are utilized.
• The actual insertion of the desired substance into the syringe body can be accomplished in any of several known manners. Example filling techniques are disclosed in U.S. Pat. No. 5,620,425 to Hefferman et al.; U.S. Pat. No. 5,597,530 to Smith et al.; U.S. Pat. No. 5,537,042 to DeHaen; U.S. Pat. No. 5,531,255 to Vacca; U.S. Pat. No. 5,519,984 to Veussink et al.; U.S. Pat. No. 5,373,684 to Veussink et al.; U.S. Pat. No. 5,265,154 to Liebert et al.; U.S. Pat. No. 5,287,983 to Liebert et al.; and U.S. Pat. No. 4,718,463 to Jurgens, Jr. et al., each of which is incorporated by reference into this specification.
• The description given above provides example implementations of this invention. Variations and modifications may become apparent to those skilled in the art that do not necessarily depart from the basis of this invention. The scope of legal protection given to this invention can only be determined by studying the following claims.

Claims (16)

What is claimed is:

1. A method of intradermally injecting at least one substance such as a drug, vaccine or the like into the skin, comprising the steps of:

pressing a needle perpendicularly to the skin, said needle in fluid communication with an outlet port of a drug container having a reservoir adapted to contain a selected substance and the outlet port providing an exit path for the substance from the reservoir during an intradermal injection;

injecting the substance into the skin with the depth of penetration of the needle being limited to the intradermal space of the skin by a non-movable limiter that surrounds the needle and has a skin engaging surface that is adapted to be placed against the skin and a forward end of the needle extending away from the skin engaging surface a selected distance such that the limiter limits penetration of the needle forward end to the dermis layer of the skin so that the substance is injected into the dermis layer of the skin, said step of injecting the substance comprising deflecting at least two sheets of thermoplastic material forming a generally flat body portion that at least partially surrounds the reservoir toward each other to expel the substance from the reservoir during an injection.

2. The method ofclaim 1, wherein the step of pressing the needle perpendicularly to the skin of the animal includes orienting the needle perpendicularly to the skin.

3. The method ofclaim 1, wherein the step of injecting the substance includes moving a plunger that is received within the reservoir, with the plunger being selectively movable within the reservoir to cause the substance to be forced out of the outlet port during the injection.

4. The method ofclaim 1, wherein the step of injecting the substance into the skin of the animal includes deflecting at least two sheets of thermoplastic material forming a generally flat body portion that at least partially surrounds the reservoir toward each other to expel the substance from the reservoir during an injection.

5. The method ofclaim 1, further comprising the step of filling the drug container with the substance to be intradermally injected.

6. The method ofclaim 1, wherein said drug container is a syringe and said animal is human.

7. An intradermal delivery device for use in making intradermal injections, comprising:

a drug container formed of glass having a reservoir adapted to contain a selected substance and an affixed needle that allows the substance to exit the reservoir during an injection wherein the needle has a forward end that is adapted to penetrate an the skin of an animal; and

an limiter integrally formed on said drug container that is substantially located at a distal end of the needle and said limiter surrounds the needle and is fixed with respect to said limiter and said limiter has a skin engaging surface that is adapted to be placed against the skin of the animal to receive an intradermal injection, the needle forward end extending away from the skin engaging surface a preselected distance from 0.5 mm to 3.0 mm which is set during manufacture of the intradermal delivery device such that the limiter limits an amount that the needle forward end penetrates the skin which is equivalent to the preselected distance.

8. The device ofclaim 7, wherein the drug container is a syringe including a generally hollow, cylindrical body portion and a plunger that is received within the reservoir, the plunger being selectively movable within the reservoir to cause the substance to be forced out of the outlet port during an injection.

9. The device ofclaim 7, including an integrally formed hub portion that supports the needle and the hub portion contains said limiter.

10. The device ofclaim 7, wherein the needle has a fixed length and wherein the preselected distance is much less than the needle fixed length.

11. The device of claim41, wherein the selected distance is fixed and is in the range from approximately 0.5 mm to approximately 3 mm.

12. The device ofclaim 7, wherein the skin engaging surface is generally flat and extends through a plane that is generally perpendicular to an axis of the needle.

13. The device ofclaim 7, wherein the skin engaging surface includes a central opening that is slightly larger than an outside dimension of the needle and the skin engaging surface is continuous.

14. The device ofclaim 7, wherein the skin engaging surface includes a contact surface area that is large enough to stabilize the assembly in a desired orientation relative to the skin.

15. The device ofclaim 7, wherein the desired orientation is generally perpendicular to the skin.

16. The device ofclaim 7, wherein the drug container is prefilled with a substance.

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