WO2004110535A1 - Intradermal needle - Google Patents

Intradermal needle Download PDF

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Publication number
WO2004110535A1
WO2004110535A1 PCT/US2004/017488 US2004017488W WO2004110535A1 WO 2004110535 A1 WO2004110535 A1 WO 2004110535A1 US 2004017488 W US2004017488 W US 2004017488W WO 2004110535 A1 WO2004110535 A1 WO 2004110535A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle cannula
needle
cap
intradermal
set forth
Prior art date
Application number
PCT/US2004/017488
Other languages
French (fr)
Inventor
Paul G. Alchas
Marina S. Korisch
Peter W. Heyman
John Laiosa
Original Assignee
Becton, Dickinson And Company
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Becton, Dickinson And Company filed Critical Becton, Dickinson And Company
Priority to CN2004800198981A priority Critical patent/CN1893993B/en
Priority to AT04754156T priority patent/ATE488260T1/en
Priority to CA2527987A priority patent/CA2527987C/en
Priority to AU2004247085A priority patent/AU2004247085B2/en
Priority to MXPA05013021A priority patent/MXPA05013021A/en
Priority to BRPI0411018A priority patent/BRPI0411018B8/en
Priority to JP2006515125A priority patent/JP4676431B2/en
Priority to EP04754156A priority patent/EP1631338B1/en
Priority to DE602004030113T priority patent/DE602004030113D1/en
Publication of WO2004110535A1 publication Critical patent/WO2004110535A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/46Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for controlling depth of insertion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202Devices for protection of the needle before use, e.g. caps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61DVETERINARY INSTRUMENTS, IMPLEMENTS, TOOLS, OR METHODS
    • A61D7/00Devices or methods for introducing solid, liquid, or gaseous remedies or other materials into or onto the bodies of animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3247Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/002Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/28Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/281Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule
    • A61M5/282Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule by compression of deformable ampoule or carpule wall
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3213Caps placed axially onto the needle, e.g. equipped with finger protection guards
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/3278Apparatus for destroying used needles or syringes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/50Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5086Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile for indicating if defective, used, tampered with or unsterile

Definitions

  • the present invention is directed to an intradermal needle that protects a user of an
  • Intradermal injections are used for delivering a variety of medicinal substances into a
  • hepatitis B vaccines administered intradermally are more imunogenic than if administered intramuscularly.
  • substances have been injected intradermally for diagnostic purposes.
  • a prefilled container such as, by way of non-limiting example, a syringe, filled with a
  • An intradermal inj ection is made by delivering the substance into the epidermis and
  • subcutaneous tissue also sometimes called subcutaneous tissue
  • hypodermis layer referred to as the hypodermis layer
  • muscle tissue in that order.
  • the outer skin layer, or the epidermis has a thickness
  • a needle cannula that penetrates the skin deeper than about 3.0 mm has a potential of passing through the dermis layer of the skin and
  • the needle cannula may penetrate the skin
  • the preferred technique (using a standard needle) requires
  • the healthcare professional to stretch the skin, orient the needle bevel to face upwardly, and
  • the needle cannula is inserted into the skin at an
  • a further cause of error is derived from pinching rather than stretching the skin in
  • the needle cannula is inserted into the skin. By inserting the needle cannula at that angle,
  • the device disclosed by Mitchell includes a needle cannula guard which is
  • Hauck discloses a syringe having a cylindrical sheath sleeve which can be
  • distal end via a hinged member can be constructed to flip using one finger, from a fully
  • the device may not activate if the needle does
  • Such devices may also require excessive penetration into some patients to cause the
  • triggering means to activate the device, which can cause a healthcare professional to
  • needle cannula product can be immediately discarded in a safe, rigid container.
  • cap to a needle cannula assembly after use of the needle cannula using a one handed technique.
  • syringe or similar injection device includes a needle cannula assembly attachable to the
  • assembly may be lockably inserted after use to prevent exposure of a tip of a needle
  • the cap includes a forward cap removably matable to a rearward cap, wherein the
  • the rearward cap includes an internal clip to secure the needle cannula assembly in
  • the forward cap and rearward cap can be separated from each other; with the forward cap
  • a user may affix the hub portion of the needle cannula to the syringe.
  • the forward cap When ready to use, the forward cap may be removed,
  • cannula may be inserted into the open distal end of the rearward cap, thereby engaging the
  • the present invention thus provides a novel and simple device that significantly
  • Figure IA is a partially exploded perspective view of an intradermal needle constructed in accordance with an embodiment of the present invention, the forward and
  • Figure IB is perspective view of the intradermal needle of the present invention.
  • Figure 2 is a perspective view of the needle cannula assembly and forward cap of
  • Figure 3 is a side sectional view of the intradermal needle of the present invention
  • Figure 4 is a partial cross-sectional perspective view of the intradermal needle of
  • Figure 5 is a partial cross-sectional perspective view of the rearward cap with the
  • needle cannula assembly lockingly secured therein so as to shield the tip of the needle
  • Figure 6 is an enlarged perspective view of the locking clip of the present
  • an intradermal needle is
  • a needle cannula assembly having a hub, a needle cannula, and a
  • the cap has a forward cap and a rearward cap to protect and shield a needle cannula prior to and after use. Prior to use, the needle cannula
  • the needle cannula assembly is easily inserted into the rearward cap, which includes a clip for securely and permanently engaging ⁇ •
  • cannula assembly is lockingly engaged therein.
  • the forward cap When ready to use, the forward cap is
  • the rearward cap which includes a clip, is engaged with a clip engaging
  • the coupling of the clip and clip engaging feature may be accomplished using a one-handed technique.
  • the rearward cap then securely covers the
  • proximal refers to a location nearest the person using the
  • distal refers to a location farthest from the person using the device and closest to the
  • the inventive intradermal needle 100 includes a forward cap 16 removably
  • a needle cannula assembly 10 having a limiter portion 12
  • the hub portion 14 includes a throat 18 adapted to receive a syringe
  • the throat 18 may
  • the syringe 20 defines a reservoir 21 adapted to store a medicinal substance
  • the syringe 20 can be any of a variety of designs such
  • hypodermic syringe as, for example, a hypodermic syringe, cartridge, pen, and any other delivery device usable
  • the hub portion 14 might include threads (not shown) for attachment to a pen-type delivery
  • the syringe 20 depicted in the figures is intended for illustration purposes only, and is not intended to limit the scope or spirit of the present invention.
  • the limiter portion 12 defines a tubular chamber 22 wherein
  • a plurality of snaps 24 are disposed on a wall 23 of the hub portion 14 .
  • chamber 22 includes a ridge 30 that abuts a forward edge 32 of the hub portion 14.
  • the hub portion 14 defines a
  • a needle cannula 36 is received by and fixedly attached to the sheath 34.
  • an adhesive 38 fixedly
  • an epoxy adhesive that is
  • curable with ultraviolet light is used to fixedly attach the needle cannula 36 to the sheath 34.
  • other methods of affixing the needle cannula 36 to the sheath 34 may be
  • an interference fit such as, by way of non-limiting example, an interference fit.
  • the needle cannula 36 includes a rearward needle end 40 that extends through the
  • the syringe 20 is coupled to the needle cannula assembly 10 just prior to administering the
  • the throat 18 includes a tapered bottom 21 adapted to securely
  • a complementarity shaped feature on the syringe 20 preferably utilizing a Luer- type connection as is well known in the art.
  • a Luer Lok connection (not shown) may be utilized to retain the syringe 20 within the throat 18.
  • connection bayonet connection, and other art-recognized means.
  • the needle cannula 36 includes a forward tip 42 that is adapted to administer an
  • the forward tip 42 includes a beveled edge 44 having a
  • intradermal injections ranges from approximately 1.3 mm to 1.6 mm.
  • the reduced length of the beveled edge 44 of the present invention reduces the potential of the needle," cannula
  • the reduced length of the beveled edge 44 also reduces the potential for leakage of the medicinal substance from the site of the injection..
  • the limiter portion 12 surrounds the needle cannula 36 and extends away from the
  • limiter portion 12 also includes a generally flat skin engaging surface 46 extending in a
  • the skin engaging surface 46 is adapted to be received against the skin of
  • the needle cannula 36 passes through the aperture 48.
  • the length of the needle cannula 36 extending through the aperture 48 is available to be inserted into the skin of the patient.
  • the skin engaging surface 46 preferably has a diameter of
  • rib 50 may be continuous about the limiter portion 12, or it may be segmented.
  • Other rib 50 may be continuous about the limiter portion 12, or it may be segmented.
  • the rib 50 engages a complementarily shaped feature in the
  • rearward cap 17 to lockingly secure the needle cannula assembly 10 and rearward cap 17
  • portion 12 limits penetration of the needle cannula 36 so that the medicine or drug
  • cannula assembly 10 prior to use and also provide a sterile container for the needle cannula
  • the rearward cap 17 mates to the forward cap 16 and is removably secured
  • the forward cap 16 includes an
  • annular protuberance 45 positioned opposite the annular ribs 43 providing a snapping
  • a tamper indicator strip 47 is
  • the strip 47 is
  • the healthcare professional will normally dispose of the injection device, including a needle
  • cannula in a sharps collector, following U.S. Centers For Disease Control and Prevention ⁇
  • the forward and rearward cap 16 and 17 are identical to each other.
  • the rearward cap 17 allows the coupling of a syringe 20 to the hub portion 14, while the
  • forward cap 16 removably shields the needle cannula 36 during coupling of the syringe 20
  • the forward cap 16 is mated with the rearward cap 17, and is removably
  • the hub portion 14 is
  • the user inserts the forward tip 42 of the needle cannula 36 into the open end of the rearward cap 17, previously placed on a surface proximal to the
  • the clip 52 is secured within the rearward cap 17, as can
  • the clip 52 includes a plurality of raised profiles 56a, which engage a recess 19 or other complementary
  • the clip 52 includes a generally cylindrical body 54 having
  • a series of radially disposed flanges 58a-58d extend from the clip body 54 and
  • the flanges 58a-58d extend without interference with the proximal end of the needle cannula assembly 10 when the needle cannula assembly 10 and rearward
  • cap 17 are in the first orientation, shown in Figure 4.
  • the flanges 58a-58d receive and
  • each flange 58a-58d includes a lip 62, located at a free end of each flange 58a-58d, and which defines an
  • the lip 62 has a tapered surface 64 (see, e.g., Figure 3) over
  • flanges 58a-58d deflect slightly outward allowing the lip 62 to travel over the
  • flanges 58a-58d return to a non-deflected position and secure the lip 62 of each flange behind the rib 50, locking the clip 52 and rearward cap 17 in place at the distal end of the needle cannula assembly 10.
  • the clip 52
  • the clip 52 is configured to
  • cannula assembly 10 are firmly pressed together.
  • the healthcare professional Before the needle cannula assembly 10 is used, the healthcare professional first removes
  • the distal end of the needle cannula assembly 10 is inserted into the open distal end of the rearward cap 17, until the rib 50 engages the clip 52, thereby locking the used needle
  • present invention together form a hard packaging unit that contains the needle and acts as
  • the forward cap forms a removable
  • the rearward cap forms a hard packaging unit that contains the needle and acts as an irremovable protection barrier subsequent to use.
  • the health care professional will normally dispose of the syringes in a sharps

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Environmental & Geological Engineering (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Plasma Technology (AREA)
  • Eye Examination Apparatus (AREA)
  • Electron Sources, Ion Sources (AREA)

Abstract

An intradermal needle (100) comprising a needle cannula assembly (10) having a limiter portion (12), a hub portion (14) and a needle cannula (36), a protective cap having a forward (16) and rearward (17) cap to protect and shield a needle cannula prior to and after use, and means for engaging (52+50) the needle cannula assembly,and the rearward cap after use. The mated forward and rearward cap provide a sterile enclosure for the needle cannula assembly prior to use. Removing the rearward cap permits the needle cannula assembly to be coupled to a drug delivery device, while the forward cap removably shields the needle cannula. Removing the forward cap then exposes the needle cannula for use. After use, the distal end of the needle cannula assembly is placed into the rearward cap and lockingly engaged therewith.

Description

INTRADERMAL NEEDLE
FIELD OF THE INVENTION
[0001] The present invention is directed to an intradermal needle that protects a user of an
injection device against accidental needle stick injury.
BACKGROUND
[0002] Intradermal injections are used for delivering a variety of medicinal substances into a
patient. Many of these substances have proven to be more effectively absorbed into, or react
with, the immune response system of the body when injected into the intradermal region of
the skin (i.e., when injected intradermally). For example, recent clinical trials have shown
hepatitis B vaccines administered intradermally are more imunogenic than if administered intramuscularly. In addition, substances have been injected intradermally for diagnostic
testing, such as, for example, using what is known in the art as the "Mantoux test" to
determine the immunity status of the clinical subject against tuberculosis and the immediate
hypersensitivity status of Type I allergic diseases. It is desirable in some instances to provide
a prefilled container such as, by way of non-limiting example, a syringe, filled with a
medicinal substance and to also provide a needle cannula that may be coupled to the
container just prior to administering the injection.
[0003] An intradermal inj ection is made by delivering the substance into the epidermis and
upper layer of the dermis. Below the dermis layer is subcutaneous tissue (also sometimes
referred to as the hypodermis layer) and muscle tissue, in that order. 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, or the epidermis, has a thickness
between 500-200 microns, and the dermis, the inner and thicker layer of the skin, has a thickness between 1.5-3.5 mm. Therefore, a needle cannula that penetrates the skin deeper than about 3.0 mm has a potential of passing through the dermis layer of the skin and
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 inj ection. 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 "wet injection" because of reflux of the substance from the injection site.
[0004] Using a standard needle (i.e., one typically used for subcutaneous or intramuscular
injections) to deliver an intradermal injection requires the healthcare professional to
perform a complicated and sometime difficult technique; with the success of the injection being dependent upon the experience of the healthcare professional and his/her, ability to
properly execute the technique. The preferred technique (using a standard needle) requires
the healthcare professional to 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
substance into the skin of the patient. The needle cannula is inserted into the skin at an
angle varying from around 10 - 15 degrees so as to form a blister or wheal in which the
substance is deposited or otherwise contained. Accordingly, the technique utilized to
perform the standard intradermal injection is difficult and requires the attention of a trained
nurse or medical doctor. Inserting the needle to a depth greater than about 3.0 mm
typically results in a failed intradermal injection because the substance being expelled
through the cannula will be injected into the subcutaneous tissue of the patient.
[0005] The most frequent cause of a failed intradermal injection results from inserting the
needle into the skin at an angle greater than 15 degrees relative to the flattened skin
surface. A further cause of error is derived from pinching rather than stretching the skin in
the area of the injection, which is normally done when giving a subcutaneous rather than an intradermal injection (pinching increases the likelihood of giving a subcutaneous
injection). Procedural errors as described above result in delivering a medicinal substance
into the subcutaneous layer, which can reduce the effectiveness of the injection, as well as
possibly delivering the substance in a way not approved for delivery.
5. [0006] Intradermal injections performed by using the technique described above also are
known to cause a significant amount of pain to the patient because of the angle at which
the needle cannula is inserted into the skin. By inserting the needle cannula at that angle,
about 5 mm to about 6 mm of the needle is actually inserted into the skin. This results in a significant disruption of the pain receptors dispersed throughout the upper layers of the
0 skin. Also, self-administered intradermal injections are not possible using that technique.
[0007] Upon completion of an intradermal injection, shielding and disposal ,of the
contaminated needle cannula becomes a primary concern. Because of the great concern that healthcare professionals and other users may become contaminated by accidental
sticks from the needle cannula, it is preferable to cover the contaminated needle as soon as
5 the intradermal injection is completed. As discussed in U.S. Patent No. 5,893,845 to
Newby et al., for example, the entire content of which is incorporated herein by reference,
developments have been made to provide means for covering the contaminated needle
cannula upon completion. These devices usually involve some form of shield arrangement
that moves in place over the contaminated needle once it has been removed from the
0 patient. However, these shield arrangements often require the use of two hands to perform
the operation of moving the shield over the contaminated needle.
[0008] Alternatively, needle cannulas with internal or external blunting cannulas have been
used that extend from the needle to blunt the distal end. However, these devices require an
operation to drive the blunting cannula into position upon completion of the intradermal
5 injection to protect the user from the sharp end of the needle, yet also must allow use without triggering the safety device. In doing so, such devices can require the internal diameter of the needle to be decreased, which may affect flow of the medicinal substance
therethrough, or may require the external diameter of the needle to be enlarged, resulting in
unnecessary discomfort to the patient.
[0009] Numerous other shielding devices also exist, such as those discussed in U.S. Patent
No. 4,631 ,057 to Mitchell, for example, the entire content of which is incorporated herein
by reference. The device disclosed by Mitchell includes a needle cannula guard which is
releasably retained in a retracted position, allowing the syringe to be used for injection, and
thereafter, lockably retained in the extended position. A similar device is disclosed in U.S. Patent No. 4,747,837 to Hauck, the entire content of which is also incorporated herein by
reference. Hauck discloses a syringe having a cylindrical sheath sleeve which can be
advanced to a locked, irreversible position, which prevents further access to the needle
cannula tip. Still other shielded designs, such as the device disclosed in U.S. Patent No. 4,998,920 to Johnson, U.S. Patent No. 4,801,295 to Spencer, and U.S. Patent No.
5,053,018 to Talonn et al., the entire content of each being incorporated herein by .
reference, allows the needle cannula guard to be moved to an extended position through
axial movement without locking the guard. However, in this position, the guard can still
be moved to expose the sharp needle cannula tip. These devices also require an additional
rotation of the needle guard while the guard is fully extended to place it in a locked
position.
[0010] Other methods of covering the needle cannula include the use of caps located at the
distal end of the syringe. As discussed in U.S. Patent No. 5,496,288 to Mall Sweeney, the
entire content of which is incorporated herein by reference, a protective cap attached at a
distal end via a hinged member can be constructed to flip using one finger, from a fully
closed position covering the needle, to a fully opened position exposing the needle. This allows a healthcare professional who may be holding a patient or medical instrument with one hand to use the other hand to remove the protective cap, administer a partial dose of
medicine, and then conveniently place the cap into a protective position.
[0011] Other needle cannula devices have shields that are activated during the procedure
when the shield comes in contact with the skin. Using the skin to activate the device is not
desirable in all applications however, since the device may not activate if the needle does
not penetrate sufficiently, or may cause the shield to inadvertently lock when probing.
Such devices may also require excessive penetration into some patients to cause the
triggering means to activate the device, which can cause a healthcare professional to
unnecessarily change their standard method or procedure.
[0012] Of still further concern upon completion of such intradermal injections, and as
discussed in U.S. Patent No. 5,674,203 to Lewandoski, the entire content of which is
incorporated herein by reference, is the fact that in many areas in a hospital where such needle cannula devices are used, disposal bins are provided so that a syringe or other
needle cannula product can be immediately discarded in a safe, rigid container. However,
there are areas of medical practice where disposal containers are not readily available or
practical. In these areas, products having some form of permanent shielding device are
even more desirable. In these areas, permanent shielding after use allows the device to be
safely transported to a disposal system.
BRIEF DESCRIPTION OF THE INVENTION
[0013] In contrast to the two handed shielding devices and conventional caps discussed
above, it has been found by the applicants that safe and secure needle cannula shielding can
be performed in connection with the present invention to effectively and reliably secure a
cap to a needle cannula assembly after use of the needle cannula using a one handed technique.
[0014] In an embodiment of the present invention, an intradermal needle usable with a
syringe or similar injection device includes a needle cannula assembly attachable to the
syringe, and a cap that provides a secure and sterile enclosure for the needle cannula
assembly prior to use, and that also provides a shield within which the needle cannula
assembly may be lockably inserted after use to prevent exposure of a tip of a needle
cannula thereby significantly reducing the possibility of accidental needle stick injury after
use.
[0015] The cap includes a forward cap removably matable to a rearward cap, wherein the
mated forward and rearward cap enclose the needle cannula assembly therebetween and
form a sterile enclosure for storing the needle cannula assembly prior to use. .
[0016] The rearward cap includes an internal clip to secure the needle cannula assembly in
the rearward cap after use of the intradermal needle. Prior to use of the intradermal needle,
the forward cap and rearward cap can be separated from each other; with the forward cap
and needle cannula still being coupled together. Holding the forward cap, which
protectively covers the forward tip of the needle cannula, a user may affix the hub portion of the needle cannula to the syringe. When ready to use, the forward cap may be removed,
thereby exposing the forward tip of the needle cannula and rendering the syringe ready to
use.
[0017] Upon separation of the forward and rearward cap, the rearward cap may be placed
on a surface with its open end facing upward, i.e., the distal or open end of the rearward
cap being accessible. Upon completion of an injection, the forward tip of the needle
cannula may be inserted into the open distal end of the rearward cap, thereby engaging the
clip within the rearward cap with a complementary feature defined on the needle cannula
assembly to permanently lock the needle cannula assembly and rearward cap together, thus covering the needle cannula.
[0018] The present invention thus provides a novel and simple device that significantly
reduces the risk of accidental needle stick injury to a patient or healthcare professional,
without changing the manner in which an intradermal injection is administered.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] Other advantages of the present invention will be readily appreciated as the same
becomes better understood by reference to the following detailed description when
considered in connection with the accompanying drawings wherein:
[0020] Figure IA is a partially exploded perspective view of an intradermal needle constructed in accordance with an embodiment of the present invention, the forward and
rearward caps being separated from each other and a needle cannula assembly being held
within the forward cap;
[0021] Figure IB is perspective view of the intradermal needle of the present invention
with the forward and rearward caps mated together;
[0022] Figure 2 is a perspective view of the needle cannula assembly and forward cap of
the present invention coupled to a syringe;
[0023] Figure 3 is a side sectional view of the intradermal needle of the present invention
including the assembled forward and rearward cap and needle cannula assembly;
[0024] Figure 4 is a partial cross-sectional perspective view of the intradermal needle of
the present invention;
[0025] Figure 5 is a partial cross-sectional perspective view of the rearward cap with the
needle cannula assembly lockingly secured therein so as to shield the tip of the needle
cannula; and [0026] Figure 6 is an enlarged perspective view of the locking clip of the present
invention.
[0027] In the drawing figures, it will be understood that like numerals refer to like
structures.
DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION
[0028] In accordance with embodiments of the present invention, an intradermal needle is
provided that includes a needle cannula assembly having a hub, a needle cannula, and a
limiter, a cap for housing the needle cannula assembly, and means for locking the needle
cannula assembly in a portion of the cap. The cap has a forward cap and a rearward cap to protect and shield a needle cannula prior to and after use. Prior to use, the needle cannula
assembly is contained, in a sterile condition, within the forward cap and rearward cap,
which are removably mated together. After use, the needle cannula assembly is easily inserted into the rearward cap, which includes a clip for securely and permanently engaging
a clip engaging feature defined on the hub of the needle cannula assembly. A forward tip
of the needle cannula is thus safely contained within the rearward cap, and the needle
cannula assembly is lockingly engaged therein.
[0029] Before the needle cannula assembly is used, the healthcare professional removes
the rearward cap, which exposes an open end of the hub into which a tip of a syringe may
be inserted for locking engagement therebetween. When ready to use, the forward cap is
removed, exposing the forward tip of the needle cannula. The rearward cap can be placed
on a nearby surface, with the open or distal end of the rearward cap facing upwards.
[0030] After use, the rearward cap, which includes a clip, is engaged with a clip engaging
feature defined on the hub thereby securely coupling the rearward cap over the forward tip
of the needle cannula. The coupling of the clip and clip engaging feature may be accomplished using a one-handed technique. The rearward cap then securely covers the
pointed and contaminated (after use) forward tip of the needle cannula, preventing
accidental needle sticks and inadvertent cap removal.
[0031] As used herein, the term "proximal" refers to a location nearest the person using the
intradermal needle or drug delivery device, and farthest from the patient. Conversely, the
term "distal" refers to a location farthest from the person using the device and closest to the
patient. In addition, the terms "medicinal substance" and "drug" are used in an illustrative
and non-limiting manner to generally describe any substance that may be injected into a
patient for any purpose. The term "syringe" is also used herein in an illustrative and non-
limiting manner to describe a device suitable for delivering a medicinal substance into a
patient via injection.
[0032] Referring to Figures IA and IB, an intradermal needle in accordance with an
embodiment of the present invention is there depicted and generally identified by reference
numeral 100. The inventive intradermal needle 100 includes a forward cap 16 removably
mated with a rearward cap 17, a needle cannula assembly 10 having a limiter portion 12
and a hub portion 14 disposed inside the limiter portion 12, and a needle cannula 36, and means for locking the needle cannula assembly 36 in the rearward cap 17, as described in
more detail below. The hub portion 14 includes a throat 18 adapted to receive a syringe
20, as shown in Figure 2, and as is generally known in the art. The throat 18 may
alternatively be adapted to receive other types of drug delivery devices, in accordance with
embodiments of the present invention.
[0033] The syringe 20 defines a reservoir 21 adapted to store a medicinal substance
intended for intradermal delivery. The syringe 20 can be any of a variety of designs such
as, for example, a hypodermic syringe, cartridge, pen, and any other delivery device usable
to contain and deliver a medicinal substance via injection into a patient. For example, the hub portion 14 might include threads (not shown) for attachment to a pen-type delivery
device, or other means for securing the needle cannula assembly 10 to a variety of different
drug delivery devices. The syringe 20 depicted in the figures is intended for illustration purposes only, and is not intended to limit the scope or spirit of the present invention.
[0034] Referring to Figure 3 , the limiter portion 12 defines a tubular chamber 22 wherein
the hub portion 14 is received. A plurality of snaps 24 are disposed on a wall 23 of the
tubular chamber 22 and clasp a flange 26 circumscribing a rearward end 28 of the hub
portion 14 thereby securing the hub portion 14 inside the tubular chamber 22. The tubular
chamber 22 includes a ridge 30 that abuts a forward edge 32 of the hub portion 14. The
forward edge 32 defines the periphery of hub portion 14. The hub portion 14 defines a
sheath 34 that is centrally disposed to the forward edge 32. A needle cannula 36 is received by and fixedly attached to the sheath 34. Preferably, an adhesive 38 fixedly
attaches the needle cannula 36 to the sheath 34. More preferably, an epoxy adhesive that is
curable with ultraviolet light is used to fixedly attach the needle cannula 36 to the sheath 34. However, other methods of affixing the needle cannula 36 to the sheath 34 may be
used such as, by way of non-limiting example, an interference fit.
[0035] The needle cannula 36 includes a rearward needle end 40 that extends through the
sheath 34 into the throat 18 of the hub portion 14. When the syringe 20 is inserted into the
throat 18, the rearward needle end 40 pierces a pierceable member of the syringe (not
shown) that seals a distal end of the syringe 20. The rearward needle end 40 is then in fluid
communication with the reservoir 21 thereby allowing the substance contained within the
reservoir 21 to be expelled through the needle cannula 36 and into the patient. Preferably,
the syringe 20 is coupled to the needle cannula assembly 10 just prior to administering the
intradermal injection. The throat 18 includes a tapered bottom 21 adapted to securely
engage a complementarity shaped feature on the syringe 20, preferably utilizing a Luer- type connection as is well known in the art. Alternatively, a Luer Lok connection (not shown) may be utilized to retain the syringe 20 within the throat 18. As noted above, other
means for connecting the needle cannula assembly 10 to the drug delivery device are also
contemplated by the present invention, such as, by way of non-limiting example, threaded
connection, bayonet connection, and other art-recognized means.
[0036] The needle cannula 36 includes a forward tip 42 that is adapted to administer an
intradermal injection. Preferably, the forward tip 42 includes a beveled edge 44 having a
length ranging from approximately 0.8 mm to 1.0 mm. More preferably, the beveled edge
44 is approximately 0.9 mm in length. A standard bevel tip length (i.e., for non-
intradermal injections) ranges from approximately 1.3 mm to 1.6 mm. The reduced length of the beveled edge 44 of the present invention reduces the potential of the needle," cannula
36 passing through the dermis layer of the skin of the patient and resulting in undesirable
injection into the subcutaneous region. The reduced length of the beveled edge 44. also reduces the potential for leakage of the medicinal substance from the site of the injection..
[0037] The limiter portion 12 surrounds the needle cannula 36 and extends away from the
hub portion 14 toward the forward tip 42 of the needle cannula 36. The limiter portion 12
preferably includes an aperture 48 through which the needle cannula 36 passes, with or
without contacting interference between the limiter portion 12 and needle cannula 36. The
limiter portion 12 also includes a generally flat skin engaging surface 46 extending in a
, plane that is generally perpendicular to a longitudinal axis of the needle cannula 36 within
about fifteen degrees of perpendicular, or more preferably, within about five degrees of
perpendicular. The skin engaging surface 46 is adapted to be received against the skin of
the patient during administration of an intradermal injection and provides for a stable
placement of the needle cannula 36 against the patient's skin. When the hub portion 14 is
inserted into the limiter portion 12, the needle cannula 36 passes through the aperture 48. Thus, only the length of the needle cannula 36 extending through the aperture 48 is available to be inserted into the skin of the patient.
[0038] As shown in Figures 3, 4 and 5, the limiter portion 12 surrounds the needle cannula
36 and extends away from the hub portion 14 toward the forward tip 42 of the needle
cannula 36, as described above. The skin engaging surface 46 preferably has a diameter of
5 mm to 20 mm, most preferably, a diameter of 5.5 mm. The limiter portion 12 also
includes an annular rib 50 extending about an outside circumference of the limiter portion
12 and spaced apart in a proximal direction from the skin engaging surface 46. The rib 50
may be continuous about the limiter portion 12, or it may be segmented. Other rib 50
configurations and constructions are also contemplated by and within the scope and spirit of the present invention. The rib 50 engages a complementarily shaped feature in the
rearward cap 17 to lockingly secure the needle cannula assembly 10 and rearward cap 17
after use of the needle cannula assembly 10, as described in greater detail below.
[0039] The forward tip 42 of the needle cannula 36 extends beyond the skin engaging
surface 46 a distance of approximately 0.5 mm to 3.0 mm and preferably about 1.0 to 2.0
mm, and more preferably 1.5 mm ± 0.2 to 0.3 mm. The length the needle cannula 36
extends beyond the skin engaging surface 46 is determined by the position of the ridge 30
relative to the skin engaging surface 46 as shown in Figure 3. Therefore, the limiter
portion 12 limits penetration of the needle cannula 36 so that the medicine or drug
substance is injected only into the dermis layer of the patient.
[0040] Referring once again to Figures 1 A, 1 B and 3 , the forward and rearward cap 16 and
17, together contain and conceal the forward tip 42 of the needle cannula 36 of the needle
cannula assembly 10 prior to use and also provide a sterile container for the needle cannula
assembly 10. The rearward cap 17 mates to the forward cap 16 and is removably secured
with an interference fit provided by a plurality of annular ribs 43 disposed upon a surface of the rearward cap 17 and abutting the forward cap 16. The forward cap 16 includes an
annular protuberance 45 positioned opposite the annular ribs 43 providing a snapping
action when the forward cap 16 and the rearward cap 17 are mated, thereafter providing a
sanitary and sterile enclosure for the needle cannula assembly 10. To ensure the needle
cannula assembly 10 has not been accessed prior to use, a tamper indicator strip 47 is
positioned over a seam formed between the mated caps 16 and 17. The strip 47 is
perforated along the seam, and a ripped or torn perforation indicates that the forward and
rearward cap 16 and 17 have been opened and that the needle cannula assembly 10 may no
longer be sanitary. Additionally, as described in greater detail below, the rearward cap 17
provides a locking enclosure for the contaminated needle cannula assembly 10 after use.
[0041] As discussed above, after use of an injection device of the type described herein, the healthcare professional will normally dispose of the injection device, including a needle
cannula, in a sharps collector, following U.S. Centers For Disease Control and Prevention
(CDC) guidelines. If this is not possible, for example, due to the absence or. lack of lf proximity to a sharps collector, then the risk of needle stick injury is significantly
increased. In such cases, it is necessary to shield the needle cannula after use of the
injection device.
[0042] In an embodiment of the present invention, the forward and rearward cap 16 and 17
first provide a sterile enclosure for the needle cannula assembly 10 prior to use. Removing
the rearward cap 17 allows the coupling of a syringe 20 to the hub portion 14, while the
forward cap 16 removably shields the needle cannula 36 during coupling of the syringe 20
and hub portion 14. Once the hub portion 14 is coupled to the syringe 20, the forward cap
16 is removed thereby exposing the needle cannula 36 for use. After use, the forward tip
42 of the needle cannula 36 is placed into the rearward cap 17, with the rib 50 and clip 52 (discussed in more detail below) locking the rearward cap 17 and needle cannula assembly
10, permanently shielding the forward tip 42 of the needle cannula 36.
[0043] In Figures 3 and 4, the rearward cap 17 and needle cannula assembly 10 are shown
in a first orientation, or an orientation prior to administering the intradermal injection. In
Figures 3 and 4, the forward cap 16 is mated with the rearward cap 17, and is removably
secured to the limiter portion 12 of the needle cannula assembly 10 with an interference fit.
Prior to use, the rearward cap 17 is separated from the forward cap 16, with the needle
cannula assembly 10 being removably held by the forward cap 16. The hub portion 14 is
then coupled to the syringe 20, and the forward cap 16 removed exposing the forward tip
42 of the needle cannula 36 and rendering the injection device ready for use. Subsequent
to use of the injection device, the user inserts the forward tip 42 of the needle cannula 36 into the open end of the rearward cap 17, previously placed on a surface proximal to the
user during administration of the injection. As the forward tip 42 of the needle cannula 36
is inserted into the rearward cap 17, the rib 50 defined about the limiter 12 engages the clip
52, placing the needle cannula assembly 10 and rearward cap 17 in a second orientation, as
shown in Figure 5. The rearward cap 17 and clip 52 are thus securely engaged with the rib
50 of the limiter portion 12 and fully cover the forward tip 42 of the needle cannula 36 for
safe handling and disposal after use. As described in greater detail below, the rearward cap
17 and needle cannula assembly 10 are locked together, and cannot be easily separated.
[0044] The rearward cap 17 and needle cannula assembly 10 are lockingly engaged with
each other by the complementarily structured clip 52 and rib 50. While an embodiment of
the clip 52 and rib 50 is disclosed herein, the present invention also contemplates other
embodiments that function in a similar manner to lockingly engage the rearward cap 17
and needle cannula assembly 10. The clip 52 is secured within the rearward cap 17, as can
be seen in Figures 3 and 4. In an embodiment of the present invention, the clip 52 includes a plurality of raised profiles 56a, which engage a recess 19 or other complementary
structure defined within the rearward cap 17. Threaded, snap-fit, or other manners of engagement between the raised profiles 56a and recess 19, for example, are contemplated
by, and within the scope and spirit of the present invention, as are other means for securing
the clip 52 within the rearward cap 17. The clip 52, once secured within the rearward cap
17, is used to grasp the rib 50 when the rearward cap 17 is engaged with the needle cannula
assembly 10. The clip 52 and rib 50 thus secure the rearward cap 17 to the needle cannula
assembly 10 and, thereafter, prevent separation of those parts.
[0045] As shown in Figure 6, the clip 52 includes a generally cylindrical body 54 having
an outside diameter sufficient to securely fit within the rearward cap 17, and to allow
engagement between a number of raised thread profiles, such as 56a (shown) and an engagement mechanism (e.g., recess 19 depicted in Figure 4) located within the rearward
cap 17. A series of radially disposed flanges 58a-58d extend from the clip body 54 and
define an opening 60. The flanges 58a-58d extend without interference with the proximal end of the needle cannula assembly 10 when the needle cannula assembly 10 and rearward
cap 17 are in the first orientation, shown in Figure 4. The flanges 58a-58d receive and
engage the distal end of the needle cannula assembly 10 when the needle cannula assembly
10 and rearward cap 17 are in the second orientation, shown in Figure 5. Each flange 58a-
58d includes a lip 62, located at a free end of each flange 58a-58d, and which defines an
inner diameter of opening 60. The lip 62 has a tapered surface 64 (see, e.g., Figure 3) over
which the rib 50 can easily pass during engagement of the needle cannula assembly 10 and
rearward cap 17. During engagement between the rearward cap 17 and the needle cannula
assembly 10, flanges 58a-58d deflect slightly outward allowing the lip 62 to travel over the
rib 50. Upon complete engagement between the rearward cap 17 and the needle cannula
assembly 10, flanges 58a-58d return to a non-deflected position and secure the lip 62 of each flange behind the rib 50, locking the clip 52 and rearward cap 17 in place at the distal end of the needle cannula assembly 10. In the embodiment described above, the clip 52
can be constructed of any suitable material, such as plastic or metal, and can be constructed
to screw into the rearward cap 17 as described above, or snap into a series of under cuts in
the cap.
[0046] As described above, once within the rearward cap 17, the clip 52 is configured to
engage the limiter portion 12 when the rearward cap 17 and the distal end of the needle
cannula assembly 10 are firmly pressed together. One method to achieve this in accordance
with an embodiment of the present invention is with a one-handed capping technique. Before the needle cannula assembly 10 is used, the healthcare professional first removes
and separates the forward and rearward cap 16 and 17, and places the rearward cap 17 on a
nearby surface with the open distal end of the rearward cap 17 facing upwards. After use,
the distal end of the needle cannula assembly 10 is inserted into the open distal end of the rearward cap 17, until the rib 50 engages the clip 52, thereby locking the used needle
cannula assembly 10 in the rearward cap 17. Once secured, the rearward cap 17 is
permanently locked to the needle cannula assembly 10, protecting the healthcare
professional against needlestick inj ury from the contaminated forward tip 42 of the needle
cannula 36.
[0047] Such a technique as described above and defined by the U.S. Occupational Safety
and Health Administration (OSHA) as recapping a contaminated needle, is discussed in
OSHA Regulation 29 CFR 1910.1030(d)(2)(vii)(B), the entire content of which is
incorporated herein by reference. Specifically, the requirement states, such bending,
recapping or needle removal must be accomplished through the use of a mechanical device
or a one-handed technique, such as described above, by placing an open cap on a surface, and directing the contaminated needle cannula into the cap using one hand. Such one
handed methods are intended for protecting the second hand from needle contact.
[0048] The embodiments of the present invention described herein effectively and safely
cover a needle prior to, and subsequent to, use. The forward and rearward cap of the
present invention together form a hard packaging unit that contains the needle and acts as
an effective sterility barrier prior to use of the needle cannula assembly as part of a drug
delivery device for administering the intradermal injection. One the needle cannula
assembly is secured to a syringe, for example, the forward cap forms a removable
protective barrier prior to use, and the rearward cap forms a hard packaging unit that contains the needle and acts as an irremovable protection barrier subsequent to use. As
noted above, the health care professional will normally dispose of the syringes in a sharps
collector, however if this is not possible, the embodiment of the present invention
described above can be used as an alternate, or backup system. ,i
[0049] The invention has been described in an illustrative manner, and it is to be
understood that the terminology which has been used is intended to be in the nature of
words of illustration rather than of limitation. Obviously, many modifications and
variations of the present invention are possible in light of the above teachings. It is,
therefore, to be understood that within the scope of the appended claims, wherein reference
numerals are merely for convenience and are not to be in any way limiting, the invention
may be practiced otherwise than as specifically described.

Claims

Atty. Docket No. P-4498P2P1.70CLAIMS What is claimed is:
1. An intradermal needle comprising:
a needle cannula assembly comprising:
a hub portion;
a needle cannula held by said hub portion and having a forward tip
extending away from said hub portion;
a limiter portion surrounding said needle cannula and extending away from
said hub portion toward said forward tip of said needle cannula, said limiter including a generally
flat skin engaging surface extending in a plane generally perpendicular to a longitudinal axis of
said needle cannula, said needle cannula forward tip extending beyond said skin engaging
surface;
a cap having a forward cap and a rearward cap removably matable together and
within which said needle cannula assembly may be held; and
means for locking said needle cannula assembly in said rearward cap to contain
said forward tip of said needle cannula within said rearward cap.
2. An intradermal needle as set forth in claim 1, wherein said means for locking
comprises a first part defined on said limiter and a second part defined in said rearward cap, said
first and said second parts being complementary so as to lockingly engage said needle cannula assembly in said rearward cap after use of said intradermal needle.
3. An intradermal needle as set forth in claim 2, wherein said first part comprises a rib Atty. Docket No. P-4498P2P1.70 defined about said liniiter and wherein said second part comprises a clip to engage said rib.
4. An intradermal needle as set forth in claim 3, wherein said rib comprises a
continuous annular rib defined about said limiter.
5. An intradermal needle as set forth in claim 3, wherein said clip has a plurality of
radially disposed flanges to engage said rib.
6. An intradermal needle as set forth in claim 1 , wherein said forward cap has a closed
distal end and an open proximal end, said open proximal end being sized and shaped to mate with
said rearward cap, said needle cannula being located in proximity to said closed distal end prior to
use of said intradermal needle.
7. An intradermal needle as set forth in claim 6, wherein said rearward cap has a closed
proximal end and an open distal end, said means for locking being contained in proximity to said
closed proximal end, said open distal end being sized and shaped to mate with said forward cap,
said needle cannula being located in proximity to said closed proximal end after use of said
intradermal needle.
8. An intradermal needle as set forth in claim 3 , wherein one of said plurality of flanges
has a lip to engage said rib and lock said needle cannula assembly in said rearward cap. Atty. Docket No. P-4498P2P1.70
9. An intradermal needle as set forth in claim 1, wherein said forward cap and said rearward cap form a sterile enclosure for said needle cannula assembly.
10. An intradermal needle as set forth in claim 1 , wherein said forward tip of said needle
cannula extends away from said hub portion a distance of not greater than 3 mm.
11. An intradermal needle as set forth in claim 10, wherein said forward tip of said
needle cannula extends away from said hub portion a distance ranging from 0.5 mm to 3 mm.
12. An intradermal needle as set forth in claim 10, wherein said forward tip of said
needle cannula extends away from said hub portion a distance of 1.5 mm, ± 0.2 to 0.3 mm.
13. An intradermal needle as set forth in claim 1 , wherein said skin engaging surface
has a diameter ranging from 5 mm to 20 mm.
14. An intradermal needle as set forth in claim 13 , wherein said skin engaging surface
has a diameter of 5.5 mm.
15. An intradermal drug delivery device comprising:
a needle cannula assembly comprising: a hub portion;
a needle cannula held by said hub portion and having a forward tip
extending away from said hub portion; Atty. Docket No. P-4498P2P1.70 a limiter portion surrounding said needle cannula and extending away ftom
said hub portion toward said forward tip of said needle cannula, said limiter including a generally
flat skin engaging surface extending in a plane generally perpendicular to a longitudinal axis of
said needle cannula, said needle cannula forward tip extending beyond said skin engaging surface;
a cap having a forward cap and a rearward cap removably matable together and
within which said needle cannula assembly may be held; and
means for locking said needle cannula assembly in said rearward cap to contain
said forward tip of said needle cannula within said rearward cap; and
a syringe having a distal end sized and shaped to receive said hub portion of said needle cannula assembly.
16. An intradermal drug delivery device as set forth in claim 15, wherein said means for
locking comprises a first part defined on said limiter and a second part defined in said rearward cap, said first and said second parts being complementary so as to lockingly engage said needle cannula
assembly in said rearward cap after use of said intradermal drug delivery device.
17. An intradermal drug delivery device as set forth in claim 16, wherein said first part
comprises a rib defined about said limiter and wherein said second part comprises a clip to engage said rib.
18. An intradermal drug delivery device as set forth in claim 17, wherein said rib
comprises a continuous annular rib defined about said limiter. Atty. Docket No. P-4498P2P1.70
19. An intradermal drug delivery device as set forth in claim 17, wherein said clip has a
plurality of radially disposed flanges to engage said rib.
20. An intradermal drug delivery device as set forth in claim 15, wherein said forward
cap has a closed distal end and an open proximal end, said open proximal end being sized and
shaped to mate with said rearward cap, said needle cannula being located in proximity to said
closed distal end prior to use of said intradermal drug delivery device.
21. An intradermal drug delivery device as set forth in claim 20, wherein said rearward
cap has a closed proximal end and an open distal end, said means for locking being contained in
proximity to said closed proximal end, said open distal end being sized and shaped to mate with
said forward cap, said needle cannula being located in proximity to said closed proximal end after
use of said intradermal drug delivery device.
22. An intradermal drug delivery device as set forth in claim 17, wherein one of said
plurality of flanges has a lip to engage said rib and lock said needle cannula assembly in said
rearward cap.
23. An intradermal drug delivery device as set forth in claim 15 , wherein said forward
cap and said rearward cap form a sterile enclosure for said needle cannula assembly.
24. An intradermal drug delivery device as set forth in claim 15, wherein said forward Atty. Docket No. P-4498P2P1.70 tip of said needle cannula extends away from said hub portion a distance of not greater than 3 mm.
25. An intradermal drug delivery device as set forth in claim 24, wherein said forward
tip of said needle cannula extends away from said hub portion a distance ranging from 0.5 mm to
3 mm.
26. An intradermal drug delivery device as set forth in claim 24, wherein said forward
tip of said needle cannula extends away from said hub portion a distance of 1.5 mm, ± 0.2 to 0.3
mm.
27. An intradermal drug delivery device as set forth in claim 15, wherein said skin
engaging surface has a diameter ranging from 5 mm to 20 mm.
28. An intradermal drug delivery device as set forth in claim 27, wherein said skin
engaging surface has a diameter of 5.5 mm.
PCT/US2004/017488 2003-06-06 2004-06-03 Intradermal needle WO2004110535A1 (en)

Priority Applications (9)

Application Number Priority Date Filing Date Title
CN2004800198981A CN1893993B (en) 2003-06-06 2004-06-03 Intradermal needle
AT04754156T ATE488260T1 (en) 2003-06-06 2004-06-03 INTRADERMAL NEEDLE
CA2527987A CA2527987C (en) 2003-06-06 2004-06-03 Intradermal needle
AU2004247085A AU2004247085B2 (en) 2003-06-06 2004-06-03 Intradermal needle
MXPA05013021A MXPA05013021A (en) 2003-06-06 2004-06-03 Intradermal needle.
BRPI0411018A BRPI0411018B8 (en) 2003-06-06 2004-06-03 intradermal needle
JP2006515125A JP4676431B2 (en) 2003-06-06 2004-06-03 Intradermal needle and intradermal drug transfer device
EP04754156A EP1631338B1 (en) 2003-06-06 2004-06-03 Intradermal needle
DE602004030113T DE602004030113D1 (en) 2003-06-06 2004-06-03 INTRADERMAL NEEDLE

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US20030199822A1 (en) 2003-10-23
US7674242B2 (en) 2010-03-09
CA2527987C (en) 2012-07-31
ATE488260T1 (en) 2010-12-15
MXPA05013021A (en) 2006-03-09
CN1893993B (en) 2010-09-01
DE602004030113D1 (en) 2010-12-30
BRPI0411018B1 (en) 2016-05-10
AU2004247085B2 (en) 2010-04-08
BRPI0411018A (en) 2006-07-04
BRPI0411018B8 (en) 2021-06-22
AU2004247085A1 (en) 2004-12-23
ES2356245T3 (en) 2011-04-06
EP1631338A1 (en) 2006-03-08
ZA200600127B (en) 2007-04-25
CA2527987A1 (en) 2004-12-23
US7241275B2 (en) 2007-07-10
US20070255225A1 (en) 2007-11-01
JP4676431B2 (en) 2011-04-27
EP1631338B1 (en) 2010-11-17
CN1893993A (en) 2007-01-10
JP2007526002A (en) 2007-09-13

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