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  Intradermal injection deviceUSPTO Application #: 20070185460Title: Intradermal injection device Abstract: An intradermal injection device comprising a unitary body having an open distal end and a proximal end having a skin engaging surface defined thereon, a reservoir defined between the proximal and distal ends for accommodating a drug substance, and a channel defined at the proximal end of the unitary body and extending through, and distally from, the skin engaging surface to the reservoir. A needle cannula having a sharpened proximal end and a distal end may be provided in the channel. The needle cannula is secured in the channel with the distal end being in communication with the reservoir and the proximal end of the needle cannula extending from the skin engaging surface a distance in the range of about 0.5 mm to 3.0 mm such that the skin engaging surface limits penetration of the proximal end of the needle cannula to the dermis layer of the skin of a patient. (end of abstract)
Agent: David W. Highet, Vice President And Chief Intellectual Property Counsel - Franklin Lakes, NJ, US Inventors: Lionel Vedrine, Paul G. Alchas, Peter W. Heyman, Laurent Barrelle, Marina Korisch USPTO Applicaton #: 20070185460 - Class: 604240000 (USPTO) Related Patent Categories: Surgery, Means For Introducing Or Removing Material From Body For Therapeutic Purposes (e.g., Medicating, Irrigating, Aspirating, Etc.), Treating Material Introduced Into Or Removed From Body Orifice, Or Inserted Or Removed Subcutaneously Other Than By Diffusing Through Skin, Material Introduced Or Removed Through Conduit, Holder, Or Implantable Reservoir Inserted In Body, Means Moved By Person To Inject Or Remove Fluent Material To Or From Body Inserted Conduit, Holder, Or Reservoir, Injector Or Aspirator Syringe Supported Only By Person During Use (e.g., Hand Held Hypodermic Syringe, Douche Tube With Forced Injection, Etc.), Specific Structure Of Means Connecting Body Entering Conduit To Syringe The Patent Description & Claims data below is from USPTO Patent Application 20070185460. Brief Patent Description - Full Patent Description - Patent Application Claims
[0001] This application claims priority to U.S. Provisional Application No. 60/498,508, filed Aug. 28, 2003. FIELD OF THE INVENTION [0002] The present invention relates to an intradermal injection device. BACKGROUND [0003] Drug substances may be delivered into a patient's body via injection into the muscle, subcutaneous tissue, or into the epidermis and dermis (also referred to as an intradermal injection). The efficacy of a particular drug substance may change when the drug is delivered intradermally. In some cases, intradermal delivery may be more beneficial to the patient. There is considerable variation in the skin thickness both between individuals and within the same individual at different sites of the body. Generally, the outer skin layer epidermis has a thickness of ranging from 50 to 200 microns, and the dermis, the inner and thicker layer of the skin, has a thickness ranging from 1.5 to 3.5 mm. Therefore, a needle cannula that penetrates the skin deeper than about 3 mm has a potential of passing through the dermis layer of the skin, thus making the injection into the subcutaneous region, which may result in an insufficient immune response, especially where the substance to be delivered intradermally has not been indicated for subcutaneous injection. Also, the needle cannula may penetrate the skin at too shallow a depth to deliver the substance and result in what is commonly known in the art as a "wet injection" due to reflux of the substance from the injection site. [0004] The standard procedure for making an intradermal injection, generally referred to as the Mantoux procedure, is difficult to perform, and successful administration of an intradermal injection using that procedure depends upon experience and technique of the person using the injection device. The Mantoux procedure requires that the user of the injection device stretch the skin, orient the needle bevel to face upwardly, and insert a 26 gauge short bevel needle cannula to deliver a volume of 0.5 ml or less of the drug substance into the skin of the patient. During this procedure, the needle cannula must be maintained at an angle varying from around 10.degree. to 15.degree. with respect to the patient's skin to form a blister or wheal in which the drug substance is deposited or otherwise contained. The above-described technique is difficult to perform and typically requires the attention of a trained nurse or medical doctor. Inserting the needle to a depth greater than about 3 mm typically results in a failed intradermal injection because the drug substance being expelled through the cannula will be injected into the subcutaneous tissue of the patient. [0005] As disclosed in United States Patent Application Publication No. 2002/0068909 A1, which published on Jun. 6, 2002, and U.S. Pat. No. 6,494,865 B1, which issued on Dec. 17, 2002, both to the assignee herein, an intradermal needle assembly has been developed for use with a prefillable container having a reservoir capable of storing a drug substance for injection into the skin of a patient. A needle cannula is supported by the prefillable container and has a forward tip extending away from the container. The intradermal needle assembly includes a limiter that is securable to the prefillable container and which surrounds the needle cannula and provides a generally flat skin engaging surface extending in a plane generally perpendicular to an axis of the needle cannula. The flat skin engaging surface is adapted to be received against the skin of the patient during administration of the intradermal injection. The needle forward tip extends beyond the skin engaging surface a distance of approximately 0.5 to 3 mm. Therefore, the limiter limits penetration of the needle into the dermis layer of the skin of the patient so that the drug substance is injected into the dermis layer of the patient. SUMMARY OF THE INVENTION [0006] The present invention is directed to an intradermal injection device comprising a unitary body having an open distal end and a proximal end having a skin engaging surface defined thereon; a reservoir defined between the proximal and distal ends for accommodating a drug substance; and a channel defined at the proximal end of the unitary body and extending through, and distally from, the skin engaging surface to the reservoir. Further, the device comprises a needle cannula having a sharpened proximal end and a distal end. The needle cannula is secured in the channel with the distal end being in communication with the reservoir and the proximal end of the needle cannula extending from the skin engaging surface a distance in the range of about 0.5 mm to 3.0 mm such that the skin engaging surface limits penetration of the proximal end of the needle cannula to the dermis layer of the skin of a patient. [0007] In a further aspect of the subject invention, a protrusion is provided on the proximal end of the body of the device which extends proximally from a first surface portion. Preferably, the protrusion is annular and circumscribes the channel. The protrusion aides in the injection process by providing a good interface between the device and the patient's skin, limiting leakage from the injection site during the injection process. [0008] In yet a further aspect of the subject invention, a holder for a medicament comprising the unitary body is provided to which a needle cannula may be affixed. [0009] Advantageously, with the subject invention, a needle cannula is "staked" or directly affixed to an injection body or holder for a medicament to form an intradermal injection device, without the use of a separate limiter. The subject invention is particularly well-suited to be used as a glass prefillable intradermal syringe, although other applications are possible. [0010] As used herein, distal shall refer to a part or direction located away or furthest from a patient, whole proximal shall refer to a part or direction towards or located nearest to a patient. Also, a drug substance is used herein in an illustrative, non-limiting manner to refer to any substance injectable into the body of a patient for any purpose. Reference to a patient may be to any being, human or animal. [0011] These and other features of the subject invention shall be better understood through a study of the following detailed description and accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0012] In the drawings, which are not to scale, and in which like reference characters denote similar elements throughout the several views: [0013] FIG. 1 is a side partial cross-sectional view of an intradermal injection device constructed in accordance with an embodiment of the present invention; [0014] FIG. 2 is an enlarged partial view of Section 2 in FIG. 1; [0015] FIG. 3 is a top view of the intradermal injection device depicted in FIG. 2, as viewed from line 3-3; [0016] FIG. 4 is an elevational side view of a body of an intradermal injection device, constructed in accordance with an embodiment of the present invention; [0017] FIG. 5 is an enlarged partial view of Section 5 in FIG. 4; [0018] FIG. 6 is a partial side view of a body of an intradermal injection device having a protrusion extending therefrom constructed in accordance with an embodiment of the present invention; [0019] FIG. 7 is a top view of the intradermal injection device depicted in FIG. 6, as viewed from line 7-7; [0020] FIG. 8 is a cross-sectional view taken from line 8-8 of FIG. 7 without the needle cannula or adhesive being shown; and, FIGS. 9a-9b depict various cross-sections which may be used alternatively to the cross-section shown in FIG. 8. 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