Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-10-14
2002-12-17
Mendez, Mannel (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
Reexamination Certificate
active
06494865
ABSTRACT:
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; 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.
REFERENCES:
patent: 1934046 (1933-11-01), Demarchi
patent: 2876770 (1959-03-01), White
patent: 3400715 (1968-09-01), Pederson
patent: 4060073 (1977-11-01), Collica et al.
patent: 4270537 (1981-06-01), Romaine
patent: 4373526 (1983-02-01), Kling
patent: 4481001 (1984-11-01), Graham et al.
patent: 4583978 (1986-04-01), Porat et al.
patent: 4596556 (1986-06-01), Morrow et al.
patent: 4718463 (1988-01-01), Jurgens, Jr. et al.
patent: 4769003 (1988-09-01), Stamler
patent: 4790824 (1988-12-01), Morrow et al.
patent: 4883473 (1989-11-01), Thomas
patent: 4883573 (1989-11-01), Thomas
patent: 4886499 (1989-12-01), Cirelli et al.
patent: 4898588 (1990-02-01), Roberts
patent: 4940460 (1990-07-01), Casey et al.
patent: 4941880 (1990-07-01), Burns
patent: 4955871 (1990-09-01), Thomas
patent: 4978344 (1990-12-01), Dombrowski et al.
patent: 5015235 (1991-05-01), Crossman
patent: 5064413 (1991-11-01), McKinnon et al.
patent: 5071353 (1991-12-01), van der Wal
patent: 5141496 (1992-08-01), Dalto et al.
patent: 5190521 (1993-03-01), Hubbard et al.
patent: 5207983 (1993-05-01), Liebert et al.
patent: 5222949 (1993-06-01), Kaldany
patent: 5256154 (1993-10-01), Liebert et al.
patent: 5312335 (1994-05-01), McKinnon et al.
patent: 5328483 (1994-07-01), Jacoby
patent: 5331954 (1994-07-01), Rex et al.
patent: 5334144 (1994-08-01), Alchas et al.
patent: 5339163 (1994-08-01), Homma et al.
patent: 5368578 (1994-11-01), Covington et al.
patent: 5373684 (1994-12-01), Vacca
patent: 5383851 (1995-01-01), McKinnon, Jr. et al.
patent: 5417662 (1995-05-01), Hjerman et al.
patent: 5431155 (1995-07-01), Marelli
patent: 5437647 (1995-08-01), Firth et al.
patent: 5466220 (1995-11-01), Brenneman
patent: 5480381 (1996-01-01), Weston
patent: 5496286 (1996-03-01), Stiehl et al.
patent: 5503627 (1996-04-01), McKinnon et al.
patent: 5505694 (1996-04-01), Hubbard et al.
patent: 5514107 (1996-05-01), Haber et al.
patent: 5519984 (1996-05-01), Beussink et al.
patent: 5520639 (1996-05-01), Peterson et al.
patent: 5527288 (1996-06-01), Gross et al.
patent: 5531255 (1996-07-01), Vacca
patent: 5569089 (1996-10-01), Parsons
patent: 5573042 (1996-11-01), De Haen
patent: 5578014 (1996-11-01), Erez et al.
patent: 5582598 (1996-12-01), Chanoch
patent: 5597530 (1997-01-01), Smith et al.
patent: 5599302 (1997-02-01), Lilley et al.
patent: 5620425 (1997-04-01), Heffernan et al.
patent: 5649912 (1997-07-01), Peterson
patent: 5665071 (1997-09-01), Wyrick
patent: 5702362 (1997-12-01), Herold et al.
patent: 5704911 (1998-01-01), Parsons
patent: 5779677 (1998-07-01), Frezza
patent: 5873856 (1999-02-01), Hjertman et al.
patent: 5879327 (1999-03-01), Moreau De Farges et al.
patent: 5891085 (1999-04-01), Lilley et al.
patent: 5893397 (1999-04-01), Peterson et al.
patent: 5921963 (1999-07-01), Erez et al.
patent: 5957897 (1999-09-01), Jeffrey
patent: 5961495 (1999-10-01), Walters et al.
patent: 5993412 (1999-11-01), Deily et al.
patent: 6001089 (1999-12-01), Burroughs et al.
patent: 6004299 (1999-12-01), Arai et al.
patent: 6036675 (2000-03-01), Thorne et al.
patent: 6053893 (2000-04-01), Bucher
patent: 6083197 (2000-07-01), Umbaugh
patent: 6090077 (
Becton Dickinson and Company
Howard & Howard
Mendez Mannel
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