The present invention relates to an intradermal injection device.
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.
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° to 15° 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.
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.
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.
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.
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.
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.
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.
These and other features of the subject invention shall be better understood through a study of the following detailed description and accompanying drawings.
In the drawings, which are not to scale, and in which like reference characters denote similar elements throughout the several views:
The body 10 narrows near the proximal end 30 to form a neck 28 that supports a limiter 50 defined at the proximal end 30 of the body 10. The neck 28 is preferably tapered, particularly to converge in a distal to proximal direction. A first transition 32 may be provided to accommodate a gradual change in the outer diameter between the barrel 20 and the neck 28, and a second transition 34 may be provided to accommodate a gradual change in outer diameter between the neck 28 and limiter 50. The transitions 32, 34 may be chamfered, radiused, or otherwise softened to avoid forming sharp, e.g., right angle, transitions between the various elements.
The limiter 50 defines a skin engaging surface 52 at its proximal end that contacts the skin of a patient during use of the injection device 100. The limiter 50 and skin engaging surface 52 are unitarily formed with the body 10. The skin engaging surface 52 may be formed flat or with any known configuration, including, but not limited to, those surface configurations disclosed in U.S. application Ser. No. 10/543,714, the entire disclosure of which is incorporated herein by reference.
With reference to
A channel 26 extends through the skin engaging surface 52 and in a distal direction into communication with the reservoir 24. The channel 26 preferably has a central longitudinal axis which is generally perpendicular to a plane defined by the skin engaging surface 52. The channel 26 may have a constant diameter, or it may have a diameter varying in size from one approximately matched to the outer diameter of a needle cannula, and increasing to a size greater than the outer diameter of the needle cannula. In either case, a portion of the channel 26 preferably has a diameter sized and shaped to accommodate a needle cannula, as described in more detail below. For a varying diameter channel 26, it is preferred that the end of the channel 26 nearest the skin engaging surface 52 have a larger diameter than other portions of the channel 26 to receive an adhesive for securing the needle cannula in the channel 26. Also, for a varying diameter configuration, the cross-sectional profile of the channel 26 may be tapered, stepped, or any other configuration that permits variation in the diameter of the channel 26. In a preferred embodiment, such as is depicted in
As shown in
With reference to
The distal end 74 is in fluid communication with the reservoir 24, and the needle cannula 70 provides a fluid path from the reservoir 24 through which the drug substance may be expelled from the injection device 100 and injected into the intradermal region in a patient's skin. A central axis of the needle cannula 70, indicated as reference character 76 in
The needle cannula 70 is secured to the body 10 and within the channel 26 using a suitable adhesive 60 (see, e.g.,
The plunger rod 90 is connected at one end to the plunger 80 and having, at its other end, a thumb pad 92 that may be depressed by a user to cause movement of the plunger 80 within the reservoir 24 to expel the drug substance therefrom. When the plunger 80 is caused to move within the reservoir 24, the drug substance housed in the reservoir 24 is caused to be expelled therefrom. The plunger 80 may come into contact with the bottom surface 124 of the reservoir 24. Optionally, the plunger 80 may be forced onto the distal end 74 of the needle cannula 70 to sealingly engage the needle cannula 70. With this arrangement, the plunger 80 may thus seal the needle cannula 70 and prevent additional drug substance or other material from exiting the needle cannula 70 (either into the patient's skin or elsewhere).
It is preferred that the body 10 of the inventive intradermal delivery device 100 be at least partially made from glass, preferably wholly, although other suitable materials that may be now known or hereafter developed may be used, including plastic. Although the inventive intradermal delivery device 100 may be used in various applications, it is particularly well-suited as a glass prefillable intradermal syringe.
In use, a drug substance is provided into the reservoir 24 and the plunger 80 is placed in the open distal end 40 of the barrel 20. As will be recognized by those skilled in the art, with the device being a prefilled device, the device 100 will be provided to a point-of-use with the drug substance and the plunger 80 being in the barrel 20 ready for use. With the device 100 not being prefilled, the plunger 80 is prepared and the drug substance is charged into the barrel by aspiration or other known methods at the point of use. Once ready, the inventive injection device 100 is preferably oriented in a generally perpendicular relationship with respect to the injection site. Thus, the central axis 76 of the needle cannula 70 is generally perpendicular to a plane defined by the patient's skin at the injection site. Deviations from generally perpendicular typically will not adversely impact the use and efficiency of the inventive injection device 100. The forward tip 72 of the needle cannula 70 is caused to pierce the patient's skin until the skin engaging surface 52 contacts the patient's skin. The length of the needle cannula 70 extending beyond the skin engaging surface 52 and the skin engaging surface 52 itself serve to limit the depth of penetration of the forward tip 72 of the needle cannula to the intradermal space of the patient's skin. Upon full insertion, the health care provider administering the injection depresses the thumb pad 92 to cause the plunger 80 to move in a distal to proximal direction in the reservoir 24 thus causing expulsion of the drug substance therefrom. Typically, the entire contents of the reservoir 24 are administered in a single dose. That is, each injection device 100 may be filled with a predetermined dose of a particular drug substance intended for administration in a single dose. Once the drug substance has been effectively expelled and administration of the injection is complete, the plunger 80 may be forced to sealingly engage the distal end 74 of the needle cannula 70 and prevent further expulsion of drug substance or other material through and from the needle cannula 70.
Although not shown in the figures, the inventive injection device 100 may also include a safety component that shields the forward tip 72 of the needle cannula 70 to reduce the possibility of accidental needle-stick injury from occurring after use of the device 100. The safety component may cover the forward tip 72 before use and/or after use, and preferably locks in place after use to prevent inadvertent exposure to the forward tip 72 after use of the device 100. The safety component may comprise a holder for the body 10, a shield to cover the forward tip 72 of the needle cannula 70, other components that facilitate manual or assisted activation, or variations and combinations thereof.
With reference to
The protrusion 300 may be formed with various cross-sectional shapes. In a most preferred embodiment, and with reference to
Other cross-sectional shapes are possible for the protrusion 300. With reference to
As indicated above, it is preferred to bound the channel 26 with the protrusion 300. With the body 10 being formed of glass, and as will be appreciated by those skilled in the art, the transition between the skin engaging surface 52 and the channel 26 shown in the embodiment of
While the invention has been described in relation to the preferred embodiments with several examples, it will be understood by those skilled in the art that various changes may be made without deviating from the spirit and scope of the invention as defined in the appended claims.
This application is a continuation of U.S. patent application Ser. No. 10/569,618, now abandoned, which was a National Stage Entry of PCT/US04/02783 filed Sep. 30, 2004 which claims priority from Provisional Application No. 60/498,508, filed Aug. 28, 2003.
Number | Name | Date | Kind |
---|---|---|---|
1934046 | Demarchi | Nov 1933 | A |
2588623 | Eliscu et al. | Mar 1952 | A |
2876770 | White | Mar 1959 | A |
3073306 | Linder | Jan 1963 | A |
3390678 | Lewis | Jul 1968 | A |
3400715 | Pederson | Sep 1968 | A |
3688764 | Reed | Sep 1972 | A |
3797490 | Hurschman et al. | Mar 1974 | A |
4014797 | Raines | Mar 1977 | A |
4040421 | Young | Aug 1977 | A |
4270537 | Romaine | Jun 1981 | A |
4304241 | Brennan | Dec 1981 | A |
4373526 | Kling | Feb 1983 | A |
4468223 | Minagawa et al. | Aug 1984 | A |
4512767 | Denance | Apr 1985 | A |
4769003 | Stamler | Sep 1988 | A |
4774948 | Markham | Oct 1988 | A |
4795445 | Jensen | Jan 1989 | A |
4834704 | Reinicke | May 1989 | A |
4883573 | Voss et al. | Nov 1989 | A |
4886499 | Cirelli et al. | Dec 1989 | A |
4898588 | Roberts | Feb 1990 | A |
4955871 | Thomas | Sep 1990 | A |
4978344 | Dombrowski et al. | Dec 1990 | A |
5137516 | Rand et al. | Aug 1992 | A |
5141496 | Dalto et al. | Aug 1992 | A |
5147328 | Dragosits et al. | Sep 1992 | A |
5190521 | Hubbard et al. | Mar 1993 | A |
5195526 | Michelson | Mar 1993 | A |
5222949 | Kaldany | Jun 1993 | A |
5267963 | Bachynsky | Dec 1993 | A |
5328483 | Jacoby | Jul 1994 | A |
5417662 | Hjertman et al. | May 1995 | A |
5505694 | Hubbard et al. | Apr 1996 | A |
5527288 | Gross et al. | Jun 1996 | A |
5578014 | Erez et al. | Nov 1996 | A |
5672883 | Reich | Sep 1997 | A |
5679355 | Alexander et al. | Oct 1997 | A |
5766124 | Polson | Jun 1998 | A |
5848991 | Gross et al. | Dec 1998 | A |
5858001 | Tsals et al. | Jan 1999 | A |
5873856 | Hjertman et al. | Feb 1999 | A |
5883668 | Kazama et al. | Mar 1999 | A |
5902278 | Aguilar | May 1999 | A |
5997501 | Gross et al. | Dec 1999 | A |
6004299 | Arai et al. | Dec 1999 | A |
6033387 | Brunel | Mar 2000 | A |
6099504 | Gross et al. | Aug 2000 | A |
6146361 | DiBiasi et al. | Nov 2000 | A |
6200291 | Di Pietro | Mar 2001 | B1 |
6203529 | Gabriel et al. | Mar 2001 | B1 |
6210361 | Kamen et al. | Apr 2001 | B1 |
6319224 | Stout et al. | Nov 2001 | B1 |
6428528 | Sadowski et al. | Aug 2002 | B2 |
6494865 | Alchas | Dec 2002 | B1 |
6565553 | Sadowski et al. | May 2003 | B2 |
6569143 | Alchas et al. | May 2003 | B2 |
6595960 | West | Jul 2003 | B2 |
6689100 | Connelly et al. | Feb 2004 | B2 |
6808506 | Lastovich | Oct 2004 | B2 |
6843781 | Alchas et al. | Jan 2005 | B2 |
6971999 | Py | Dec 2005 | B2 |
7077830 | Higaki et al. | Jul 2006 | B2 |
7556615 | Pettis | Jul 2009 | B2 |
7981081 | Marsh | Jul 2011 | B2 |
8021511 | Erskine | Sep 2011 | B2 |
8267890 | Alchas | Sep 2012 | B2 |
8496862 | Zelkovich et al. | Jul 2013 | B2 |
8721603 | Lundquist | May 2014 | B2 |
20010011171 | Alchas | Aug 2001 | A1 |
20010012925 | Alchas | Aug 2001 | A1 |
20020007811 | Kinoshita et al. | Jan 2002 | A1 |
20020045866 | Sadowski et al. | Apr 2002 | A1 |
20020052580 | Ooyauchi | May 2002 | A1 |
20020068909 | Alchas | Jun 2002 | A1 |
20020072709 | Sadowski et al. | Jun 2002 | A1 |
20020156426 | Gagnieux | Oct 2002 | A1 |
20020193740 | Alchas et al. | Dec 2002 | A1 |
20020193778 | Alchas et al. | Dec 2002 | A1 |
20030014018 | Giambattista et al. | Jan 2003 | A1 |
20030050602 | Pettis | Mar 2003 | A1 |
20030093032 | Py et al. | May 2003 | A1 |
20030100885 | Pettis et al. | May 2003 | A1 |
20030187395 | Gabel et al. | Oct 2003 | A1 |
20030199822 | Alchas et al. | Oct 2003 | A1 |
20030212379 | Bylund et al. | Nov 2003 | A1 |
20050033234 | Sadowski | Feb 2005 | A1 |
20050113753 | Alchas et al. | May 2005 | A1 |
20050256499 | Pettis et al. | Nov 2005 | A1 |
20070005017 | Alchas | Jan 2007 | A1 |
20080045900 | Alchas et al. | Feb 2008 | A1 |
20100270702 | Zelkovich et al. | Oct 2010 | A1 |
20120010573 | Lundquist | Jan 2012 | A1 |
20130138047 | Takemoto et al. | May 2013 | A1 |
Number | Date | Country |
---|---|---|
46325 | Feb 1889 | DE |
958766 | Feb 1957 | DE |
29918794 | Feb 2000 | DE |
2612401 | Sep 1988 | FR |
2321014 | Jul 1998 | GB |
113862 | Mar 1989 | JP |
200037456 | Feb 2000 | JP |
9302726 | Feb 1993 | WO |
9309826 | May 1993 | WO |
9413342 | Jun 1994 | WO |
9423777 | Oct 1994 | WO |
9501198 | Jan 1995 | WO |
9927986 | Jun 1999 | WO |
0128613 | Apr 2001 | WO |
0147586 | Jul 2001 | WO |
0193931 | Dec 2001 | WO |
02083215 | Oct 2002 | WO |
03022330 | Mar 2003 | WO |
03066126 | Aug 2003 | WO |
Number | Date | Country | |
---|---|---|---|
20150100022 A1 | Apr 2015 | US |
Number | Date | Country | |
---|---|---|---|
60498508 | Aug 2003 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 10569618 | US | |
Child | 14568526 | US |