JP4764593B2 - Pre-fillable intradermal delivery device - Google Patents

Description

【Technical field】
[0001]
The present invention relates generally to delivery devices for delivering drugs, vaccines, and other materials, and more particularly to the engagement of a needle cannula and the surface of the skin to penetrate the tip of the needle cannula into the skin. The present invention relates to a drug delivery device having a limiter for restricting the amount. More particularly, the present invention can fix the orientation of the needle cannula in a plane generally perpendicular to the skin engaging surface of the limiter and permanently surround the needle cannula after performing an intradermal injection. It relates to a limiter that can
[Background]
[0002]
Intradermal injection is used to deliver a variety of substances. Many of these substances have been proven to be effectively absorbed by the body and act on the body's immune response system when injected intradermally. In recent years, clinical trials have shown that hepatitis B vaccines injected intradermally are more immune when injected intramuscularly. In addition, the substance uses methods such as those known in the art, such as the “tuberculin test”, for example to measure the immune status of animals against tuberculosis and the symptoms of immediate hypersensitivity of type I allergies. Have been injected intradermally to perform diagnostic tests.
[0003]
Intradermal injection is performed by delivering substances to the upper layers of the epidermis and dermis. Under the dermis layer, there are subcutaneous tissue (sometimes referred to as the inferior layer) and muscle tissue in this order. Skin thickness varies considerably between individuals and even in different parts of the body, even on each of the same skin. Generally, the outer skin or epidermis has a thickness between 50-200 microns and the thicker layer inside the dermis or skin has a thickness between 1.5-3.5 mm. Thus, a needle cannula that punctures the skin deeper than 3.0 mm can pass through the dermal layer of the skin and into the subcutaneous region. As a result, the immune response is particularly poor when the substance to be delivered intradermally is not clearly indicated as a subcutaneous injection. In addition, the needle cannula may puncture the skin at a point where the depth is too shallow and deliver the substance, so as a “wet injection” due to the back flow of the substance from the point of injection. The result is generally known in the art.
DISCLOSURE OF THE INVENTION
[Problems to be solved by the invention]
[0004]
Standard procedures for performing intradermal injections are considered difficult and therefore depend on the experience and skills of healthcare workers. This procedure involves pulling the skin, with the beveled face of a 26 gauge short bevel needle cannula facing up, and inserting a needle cannula to deliver 0.5 ml or less of material to the animal's skin. The needle cannula at various angles between about 10-15 degrees with respect to the plane of the skin forming a blister or wheal where material is deposited or otherwise contained It is recommended that it be performed by being inserted into the skin. Thus, the techniques used to perform standard intradermal injections are difficult and require the attention of a trained nurse or doctor. This treatment further makes self-administration of intradermal injections fundamentally impossible. Inserting the needle deeper than about 3.0 mm results in the intradermal injection failing because the material pushed through the cannula will be injected into the animal's subcutaneous tissue. Furthermore, standard methods are unsuitable for intradermal injection self-administration.
[0005]
Furthermore, with the advent of viral infection transmitted by contact with bodily fluids, it is desirable to permanently enclose or cover the needle cannula after injection. Preferably, the delivery device should include a mechanism that can permanently enclose the needle cannula immediately following injection. For example, biohazards are present if the needle is left uncoated for even a short time after injection, such as during reattachment of the needle cap. Thus, it would be desirable to provide an intradermal delivery device that has a means for permanently enclosing a needle cannula that is simple in design, easy to use and ready to use immediately after injection.
[0006]
Thus, there is a need for a delivery device that provides the ability to perform intradermal injection of a substance that overcomes the challenges and limitations associated with conventional devices that are capable of self-administration. Furthermore, there is a need to provide a delivery device that has the ability to permanently enclose the needle cannula immediately following an intradermal injection. The combination of these two features in the same delivery device is both the ability to reduce the potential for failure and pain caused by intradermal injection, and the ability to permanently cover the needle cannula after the injection is made. Will provide the ability.
[Means for Solving the Problems]
[0007]
Unlike the devices discussed above, the present invention provides an intradermal injection using a simplified method that can reduce the likelihood of failure, and further allows the user to enclose the needle immediately after the injection. Both are possible.
[0008]
An intradermal delivery device used for intradermal injection of a substance into the skin of an animal includes a pre-fillable container adapted to store the substance. The outlet port is in fluid communication with the container. The needle cannula includes an outlet port and a fluid communication history, a front end extending away from the delivery device. The front end is adapted to puncture the animal's skin. The limiter includes a generally flat skin engaging surface that surrounds the needle cannula and extends in a plane generally perpendicular to the axis of the needle cannula. The hub is secured around the needle cannula and defines a limiter locator for positioning the limiter on the device. The skin engaging surface is suitable for being placed on the skin of an animal for performing an intradermal injection of the substance. The front end of the cannula is approximately equal to 0.5 mm to 3 mm so that the limiter limits the needle cannula puncture into the dermis layer of the animal's skin, thereby allowing the injection of substance into the dermis layer of the animal Extends beyond the skin engaging surface by a distance. The enclosing means permanently encloses the needle cannula following the subcutaneous injection.
【The invention's effect】
[0009]
The present invention provides the desirable features described above that are not currently included in the same needle assembly at the same time. The limiter allows the intradermal injection to be made at an angle generally perpendicular to the angle relative to the animal's skin, allowing the needle to be enclosed after the injection.
[0010]
Other advantages of the present invention will be readily appreciated by reference to the following detailed description when considered in conjunction with the accompanying drawings, in which:
BEST MODE FOR CARRYING OUT THE INVENTION
[0011]
With reference to FIGS. 1 and 2, an intradermal delivery device for injecting material into the skin of an animal is indicated generally at 10. The device includes a prefillable container 12 having a reservoir 14 for holding a substance intended to be injected into the skin of an animal. These substances include vaccines and certain drugs and drugs. In addition, these substances can be used in diagnostic tests such as, for example, tuberculin reaction to measure the immune status against the hypersensitive state of tuberculosis and type I allergic diseases.
[0012]
In addition, substances delivered intradermally by the method of the present invention include alpha 1 antitrypsin, anti-antigiogenesis agent, antisense, butorphanol, calcitonin and similar substances, cerebrosidase (Ceredase), COX-II inhibitors, skin drugs, dihydroergotamine, dopamine agonists and antagonists, Enkephalins and other opiate-like peptides, epidermal growth factor, erythropoiesis and similar substances, follicle stimulating hormone, Hirudin analogs such as granulocyte colony stimulating factor, glucagon, granulocyte macrophage colony stimulating factor, granisetron, growth hormones and similar substances (including growth hormone releasing hormone), growth hormone antagonists, hirudin and hirulog Substance, immunity Roblin E suppressor gene, insulin, insulinotropin and similar substances, insulin-like growth factor, interferon, interleukin, luteinizing hormone, luteinizing hormone-releasing hormone and similar substances, small molecule heparin, macrophage colony stimulating factor, metoclopramide , Midazolam, monoclonal antibodies, narcotic analgesics, nicotine, nonsteroidal anti-inflammatory drugs, oligosaccharides, ondansetron, parathyroid hormone and similar substances, parathyroid hormone antagonists, prostaglandin antagonists, prostaglandins , Recombinant soluble receptor, scopolamine, serotonin agonists and antagonists, sildenafil, terbutaline, thrombolytics, human tissue plasminogen activator, tumor necrosis factor, and tumor necrosis factor antagonism Drugs including drugs, poisoning, arthritis, cholera, cocaine addiction, diphtheria, tetanus, hemophilus-influenza type b (HIB), Lyme disease, meningococcus, measles, mumps, rubella, chickenpox, yellow fever, respiratory organ Polynuclear syncytial virus, tick-borne Japanese encephalitis, pneumococcus, streptococcus, typhoid, influenza, hepatitis including hepatitis A, B, C and E, otitis media, rabies, polio, human immunodeficiency virus (HIV), parainfluenza virus (Epstein barr virus), including rotavirus, Epstein-Barr virus, cytomegalovirus (CMV), chlamydia, non-typeable haemophilus, moraxella catarrhalis, human papilloma virus, BCG Mycobacterium tuberculosis, gonorrhea, asthma, atherosclerosis, malaria, Escherichia coli, Alzheimer's disease, helicopter Other similar substances, including all major therapeutics such as Cacter pylori, Salmonella, diabetes, cancer, herpes simplex, human papillomas and common cold drugs, anti-addiction, anti-allergy, anti-emetics, anti-obesity, anti Osteoporosis, anti-infective, analgesic, anesthetic, anorexia, anti-arthritis, anti-asthma, anti-convulsant, anti-epileptic, anti-diabetic, anti-histamine, anti-inflammatory, anti-migraine preparation, Motion sickness preparations, antiemetics, anti-neoplastics, anti-parkinsonism, anti-itch, antipsychotics, antipyretics, anticholinergics, benzodiazepine antagonists, systemic, heart, peripheral and cerebral bone stimulants Including vasodilators, central nervous system stimulants, hormones, hypnotics, immunosuppressants, muscle relaxants, parasympathomimetics, parasympathomimetrics, prostaglandins, proteins, peptides, polypeptides And other macromolecules, psychostimulants, sedatives, sexual dysfunction and tranquilizers and tuberculin, and other hypersensitivity diagnostics (subunit proteins, peptides and polysaccharides, polysaccharide complexes, toxoids) Preventive drugs and therapeutic antigens, including but not limited to, generic-based vaccines, live attenuated, genetically hybridized, whole cells, viral and bacterial vectors Selected from the group consisting of drugs, vaccines and the like used in the prevention, diagnosis, alleviation, treatment or therapy of disease, used with or without a carrier and / or adjuvant.
[0013]
Needle cannula 16 is in fluid communication with outlet port 18 leading to reservoir 14. The outlet port 18 allows material to be pushed from the pre-fillable container 12 through a receiver 20 disposed at the end of the pre-fillable container 12. Needle cannula 16 is inserted through hub 22 which is secured to receiver 20 in a number of well-known ways. In one example, an interference fit is applied between the inside of the hub 22 and the outside of the receiver 20. In another example, a conventional luer fitting process is applied to secure the hub 22 to the end of the prefillable container 12. As can be appreciated, needle assemblies designed in accordance with the present invention are easily adapted to a wide variety of conventional syringe styles.
[0014]
Instead of attaching the needle cannula 16 to the receiver 20, the needle cannula 16 may be attached to the hub 22 before attaching the hub 22 to the receiver 20. Limiter 24 includes a generally flat skin engaging surface 26 that surrounds needle cannula 16 and extends in a plane generally perpendicular to the axis of needle cannula 16. The skin engaging surface 26 may have an angle of about 15 degrees or preferably about 5 degrees with a plane perpendicular to the axis of the needle cannula 16. This skin engaging surface 26 is best shown in FIGS. This flat skin engaging surface 26 stabilizes the intradermal delivery device during infusion. Therefore, it is preferable to have a cross-sectional dimension of at least 5 mm or between 5 and 20 mm. The limiter 24 includes a needle opening 28 that closely receives the front end 30 of the needle cannula 16 extending therefrom (FIG. 4). The dimensional relationship between the needle opening 28 and the front end 30 can be adjusted as needed for a particular condition. The front end 30 extends away from the skin engaging surface 26 by a distance of about 0.5 mm to about 3 mm. Thus, the skin engaging surface 26 limits the depth that the needle cannula 16 can penetrate into the animal's skin. In addition, an elastomer insert or diaphragm 31 may be inserted in the center of the skin engaging surface 26, in which case the needle cannula 16 penetrates the elastomeric surface when the limiter 24 is attached to the hub 22 (FIG. 3). The elastomeric insert functions as an assembly aid so that the needle cannula 16 does not need to be advanced through the needle opening 28.
[0015]
The front end 30 includes an angled end 32 that is angled such that the length of the front end 30 is less than the length of a standard hypodermic injection end. The inclined end 32 is preferably between about 0.8 mm and 1.0 mm in length. More preferably, the inclined end 32 includes a length of about 0.9 mm. The standard beveled end length ranges from about 1.3 mm to 1.6 mm. The shortened beveled end 32 according to the present invention allows the needle cannula 16 to penetrate the dermis layer of the animal's skin, so that the substance from the reservoir 14 can be injected into the subcutaneous region of the animal. Reduce.
[0016]
The cap 34 is positioned in the vicinity of the skin engaging surface 26 to protect the front end 30 of the needle cannula. The cap 34 is preferably formed of an elastomeric material or a thermoplastic elastomer so that the front end 30 can penetrate the cap surface and thereby be sealed by the cap 34. Thus, by sealing the needle cannula 16, the cap 34 seals the reservoir 14 to prevent material from leaking from the reservoir 14 through the needle cannula 16 prior to making a subcutaneous injection.
[0017]
Referring to FIG. 2, the adapter 36 is fixed to a flange 38 disposed at the end of the pre-fillable container 12 opposite to the receiver 20. A plurality of snaps 40 tighten the flange 38 and secure the adapter 36 to the prefillable container 12. The adapter 36 provides an engagement surface for the prefillable container 12 to be received in a tray 42 that is used to process and transport the intradermal delivery device 10. The plunger 44 has an activation flange 46 at one end, as is well known in the art. (See Figure 1) A stopper 48 is included at the other end. Stopper 48 is slidably disposed within reservoir 14 and is selectively moved to push material from reservoir 14 through needle cannula 16. Thus, to perform an intradermal injection, the skin engaging surface 26 of the limiter 24 is pressed against the animal's skin, penetrating the skin through the needle cannula 16, and the actuating flange or end 46 of the plunger 44 is The solution is pushed down to push it out of the reservoir 14.
[0018]
In a preferred embodiment, the limiter 24 functions as a housing for covering or enclosing the needle cannula 16 after an intradermal injection has been performed. Thus, as shown in FIG. 4, the limiter 24 has a first position that exposes the front end 30 so that intradermal injection can be performed. In place Be placed. FIG. 5 illustrates a second position in which the needle cannula 16 is fully retracted into the limiter 24 to prevent further access to the needle cannula 16 after an intradermal injection has been performed. In place The limiter 24 being positioned is shown.
[0019]
Now referring to FIG. 3A, the hub 22 includes at least one locking finger 54 and at least one stop 56. Limiter 24 preferably includes two each of locking fingers 54 and stops 56. Each locking finger 54 is supported in a cantilever shape in a direction opposite to the front end 30. Each stopper 56 is supported in a cantilever shape in the same direction as the front end 30. Each locking finger 54 includes a tab 58, the purpose of which will be described below. Each locking finger 54 is attached to the hub 22 closest to the helical rib 60 for positioning the hub 22 in the center of the limiter 24. However, the locking finger 54 need not be attached to the limiter 24 proximate to the helical rib 60, which is merely shown as an example. The limiter 24 defines at least one slot 62 that is oriented generally parallel to the needle cannula 16 in the wall 64 of the limiter 24. A protrusion 66 is disposed on one side of the slot 62, the purpose of which will be clear below.
[0020]
Each tab 58 is received in a slot 62 when the hub 22 is inserted into the limiter 24. The protruding portion 66 is formed by the limiter 24. As shown in FIG. First place In place When positioned, it is positioned between each locking finger 54 and stop 56. Tabs 58 extend into the protrusions 66 in each slot 62 that provide sufficient resistance for the limiter 24 to slide over the hub 22 and to insert the needle cannula 16 into the animal's skin and make an intradermal injection. Abut. Tab 58 is used to place limiter 24 in the first position following the intradermal injection procedure. Place Et As shown in FIG. Second place In place It can be moved and snapped over the protrusion 66.
[0021]
Limiter 24 is the first place Place The second place In place The prefillable container 12 is withdrawn from the limiter 24 as if it were to be separated from the limiter 24 for movement. Under sufficient separation force, the tab 58 snaps over the protrusion 66, allowing the stop 56 to move from the inside of the limiter 24 to the outside. The rib 68 defines the range of the inner surface 70 of the limiter 24 and functions as a hook (FIG. 4). tab 58 Prevents the hub 22 from being removed from the limiter 24 by engaging the rear end of the slot 62. After passing through the ribs 68, each stop 56 expands to an inner surface 70 disposed on the inside of the limiter 24 and engages the ribs 68 so that the limiter 24 is in the second position. Place The first place In place Prevent moving. In this way, the needle cannula 16 is fixed inside the limiter 24, and once the limiter 24 is in the second position. In place When moved, there is no risk of exposure.
[0022]
With reference to FIGS. 2 and 3, the cap includes an annular ring 74 disposed on a surface that abuts the skin engaging surface 26 of the limiter 24. The ring is coaxially aligned with the needle cannula 16 and is an annular groove disposed in the skin engaging surface 26. 76 To be accepted. In a preferred embodiment, the outer dimension or diameter of the cap is equal to or smaller than the receiver 20. Ring 74 has an annular groove 76 And the cap 34 is fixed to the limiter 24. Tip protuberance 77 (FIG. 2) is received by a needle opening 28 in the skin engaging surface 26. The front end 30 of the needle cannula 16 seals the needle cannula 16 and prevents tip leakage through the needle cannula 16 and out of the reservoir 14. 77 Pierce through. FIG. B A plurality of spokes projecting outwardly from an axis formed from the needle cannula 16 59 Another skin engaging surface 67 is shown.
[0023]
Another embodiment is shown at 81 in FIGS. In this embodiment, another hub 80 secures another limiter 82 in the same manner as described in the preferred embodiment. Another limiter 82 is fixed to another hub 80 and is not moved to the first or second position. The needle plunger 84 is inserted through the other limiter wall 86 at a substantially normal angle to the needle cannula 16. The needle plunger 84 is held on the wall 86 by either a friction fit or equivalent means that allows the needle plunger 84 to be pushed inside another limiter 82. As shown in FIG. 7, the needle plunger 84 functions as a needle cannula housing when it is difficult to push inside another limiter 82. In that case, the needle cannula 16 is folded, thereby being taken inside the limiter 82 to prevent exposure of the needle cannula 16 after an intradermal injection has been performed.
[0024]
Referring to FIG. 8A, another assembly 110 is shown that is adapted to surround the needle cannula 36 after an intradermal injection has been performed. A sleeve 112 defining a tube slidably encloses the limiter 114. The sleeve 112 includes a skin engaging surface 116 that is disposed on substantially the same plane as the skin engaging surface 118 when the assembly 110 is prepared for performing an intradermal injection. The rear end 120 of the sleeve 112 tapers inwardly toward the axis of the needle cannula 16. The rear end 120 of the sleeve 112 abuts the rear flange 122 of the limiter 114, thereby preventing the sleeve 112 from being removed from the limiter 114 in the direction of the prefillable container 12. In this embodiment, the elastomeric tip cap 123 is removably secured to the skin engaging surface 118 and receives the front end 42 of the needle cannula 36.
[0025]
After performing the intradermal injection, the sleeve 112 may be manually pulled toward the front end 42 of the needle cannula 36, as shown in FIG. 8B. The limiter 114 includes a sleeve stop 124 that engages a corresponding contour 126 disposed on the inner surface of the sleeve 112, thereby preventing the sleeve from being removed from the limiter 114. When at least one ramp 128 is disposed on the outer surface of the limiter 114 and the sleeve 120 is moved to cover the front end 42 of the needle cannula 36, the rear end 120 of the sleeve 112 slides over it. The ramp 128 causes the sleeve 112 to move toward the prefillable container 20 and re-expose the front end 42 once the rear end 120 of the sleeve 112 is slid past the ramp 128 and encloses the needle cannula 16. To prevent.
[0026]
As will now be understood, the intradermal delivery device of the present invention encloses the tip of the needle cannula after injection, preferably concealing and preferably retracting to avoid contact or reuse of the needle by an accident. Incapable needle enclosing means. One embodiment shown in FIGS. 4 and 5 State In the meantime, the limiter 24 may extend after the injection and be locked in place. In the second embodiment shown in FIGS. 6 and 7, the needle cannula 16 is folded, ie, deformed beyond the elastic limit by the plunger 82, so that the tip 30 is permanently enclosed within the limiter 82. . In a third embodiment shown in FIGS. 8A and B, the assembly includes an extensible shield 112 that locks in the extended position and prevents contact with the needle. Or, the needle assembly is, for example, the name of the invention is “prefillable intradermal syringe” No. 09 / 834,669 filed April 13, 2001 (US Pat. No. 6,569,123) However, it may be retractable and retractable as in the disclosure where the disclosure is incorporated by reference.
[0027]
When the hub 22 and limiter 24 are attached to the front end of the prefillable container 12 in the form of a syringe barrel, the assembled device 10 is sterilized, cleaned and packaged for quick procedure. It is preferably supplied to the pharmaceutical industry in a state prepared for filling. This procedure includes filling and stopping while the device 10 is held in a nest (not shown). However, the diameter of the limiter 24 is much larger than the diameter of the 0.4 ml or 0.5 ml syringe barrel and barrel flange, and the barrel is usually retained in the nest. Thus, the nest typically used for this small size barrel has a hole (chimney) that is too small for the limiter 24 to pass through, and the nest typically used for large barrels (1-3 ml) is employed. It should be.
[0028]
In order to prevent the device 10 from falling through the nest, the syringe barrel flange must be increased in diameter by the addition of an adapter 36. In addition, Nest Chimney provides the ability to center the device under a filling nozzle or stopper insertion tube on an automated filling machine. If the device 10 is not properly centered, the filling nozzle may strike the side of the syringe barrel as it moves into the barrel at the beginning of the filling process, resulting in damage to the nozzle, improper If the syringe barrel is made of glass, it can lead to glass breakage, i.e. particulate contamination, or wetting of the inner wall of the barrel above the area that will later be plugged. This weakens the sterilization seal created between the stopper rib and the barrel wall and jeopardizes sterility. If centering is more important during the plugging process, the sweetness of the centering will cause damage to the stainless steel insert tube, glass breakage, or the stopper will be distorted in the barrel (or placed correctly in the barrel). Not) and result in a defective seal.
[0029]
With a small diameter syringe barrel placed in a nest chimney that is larger than the normal diameter, the chimney loses centering function when the barrel moves freely in a large radius. Therefore, the diameter of the barrel must be made so that it is almost smaller than the inner diameter of the chimney. This is achieved by the addition of an adapter 36. The adapter is preferably made of plastic and is slid from the tip of the barrel or snapped to the side of the syringe barrel prior to attaching the hub 22 and limiter 24.
[0030]
In order to minimize the number of parts attached to the syringe barrel, the flange extension feature sought above is combined with a diameter increasing feature and is a single component referred to as adapter 36 or barrel spacer. Form.
[0031]
Several lengths may be used for the adapter 36. The short adapter 36 provides two functions as previously described. The longer adapter (not shown) can serve as a surface for labeling instead of directly labeling the outer diameter of the syringe barrel. Large diameter adapters allow the use of large labels, so that information Could not be used for small diameter syringe barrels Allow to be incorporated into the label. The upper limit of the length of the adapter 36 is determined by the amount of liquid material placed in the syringe barrel and the length of the stopper. Good manufacturing practice (GMP) requires that liquid material that can be injected be 100% inspected for particulate contamination, which inspection is performed either visually by an operator or by an automated inspection system. All inspections are performed with a 360 degree inspection of the liquid material that is not obstructed. In addition, the stopper must be checked for the presence of liquid remaining between the ribs, which can jeopardize sterility. Thus, the adapter 36 must end beyond the rear end of the stopper and allow a clean field of view of both the liquid material and the stopper.
[0032]
The present invention has been described by way of example, and the words used are intended to be in the scope of the disclosed language rather than to be used as a limitation. You should understand that.
[0033]
Obviously, many modifications and variations of the invention are possible in accordance with the above disclosure. Thus, within the scope of the appended claims, the reference numerals are for convenience only and do not limit the method in any way, and the invention may be practiced otherwise than as specifically described. Should be understood.
[Brief description of the drawings]
[0034]
FIG. 1 is a perspective view of an intradermal delivery device according to the present invention.
FIG. 2 is a side cross-sectional view of a subcutaneous delivery device according to the present invention showing a needle assembly injected subcutaneously.
FIG. 3A is an exploded view of a limiter and a hub according to the present invention.
FIG. 3B is a perspective view of another skin engaging surface.
FIG. 4 is a side cross-sectional view of the needle assembly showing the front end exposed for administering an intradermal injection.
FIG. 5 is a side cross-sectional view of the needle assembly showing the front end retracted into the limiter and concealing the needle cannula.
FIG. 6 is a side cross-sectional view of another embodiment of a needle assembly showing a needle plunger according to the present invention.
FIG. 7 is a side cross-sectional view of another embodiment of a needle assembly showing the front end retracted into the limiter and hiding the needle cannula.
8A is a side cross-sectional view of another embodiment of a needle assembly showing a sleeve of the present invention. FIG.
8B is a side cross-sectional view of a sleeve according to the present invention surrounding a needle cannula. FIG.

Claims (39)

An intradermal delivery device used for intradermal injection of a substance into the skin of an animal,
A pre-fillable container adapted to store a substance; an outlet port in fluid communication with said container;
A needle cannula in fluid communication with an outlet port, the needle cannula including a front end for piercing the animal's skin;
A limiter that includes a generally flat skin engaging surface that surrounds the needle cannula and extends on a plane substantially perpendicular to the axis of the needle cannula, the skin engaging surface for performing intradermal injection of a substance The front end of the needle cannula is adapted to be placed against the skin of the animal, and the limiter limits the needle cannula piercing to the dermis layer of the animal's skin, thereby A limiter extending beyond the skin engaging surface by a distance approximately equal to 0.5 mm to 3 mm so as to allow injection of the substance into the
Enclosing means for permanently covering the needle cannula after injection;
A cap attachable to the skin engaging surface for obscuring the front end;
With
The cap is made of an elastomer, and the front end is inserted into the elastomer, thereby sealing the needle cannula and preventing the substance from leaking through the cannula from the prefillable container. An intradermal delivery device characterized by.   The enclosing means is slidably disposed around the needle cannula and includes a limiter having at least a first position and a second position, the first position exposing a front end of the needle cannula. The apparatus of claim 1, wherein the second position obscures the front end of the needle cannula.   The apparatus of claim 2, wherein the limiter defines at least one slot that is oriented generally parallel to the needle cannula and has a protrusion disposed on one side.   A hub supporting the needle cannula, the hub including at least one locking finger and at least one stop, wherein the at least one locking finger is supported in a cantilevered manner away from the front end; The apparatus according to claim 3, wherein the at least one stopper is supported in a cantilever shape toward the front end.   5. The apparatus of claim 4, wherein the at least one locking finger includes a tab that is received by the slot disposed in the limiter.   6. The apparatus of claim 5, wherein the tab is snappable beyond the protrusion to move the limiter from the first position to the second position.   The apparatus of claim 6, wherein the protrusion is disposed between the tab and the at least one stop when the limiter is positioned in the first position.   The limiter includes a hook that engages at least one stop so that when the limiter is in the second position, the limiter is moved from the second position to the first position. 8. The device according to claim 7, wherein the device is prevented from moving.   The apparatus of claim 1, wherein the limiter comprises a non-elastomeric polymer.   The apparatus of claim 9, wherein the skin engaging surface comprises an elastomeric polymer delimited by the non-elastomeric polymer.   11. The device of claim 10, wherein the elastomeric polymer is pierced by the needle cannula when the limiter is interlocked with the hub.   The apparatus of claim 11, wherein the front end includes a beveled end having a length in a range between approximately 0.8 mm and 1.0 mm.   The apparatus of claim 12, wherein the front end includes an inclined end having a length of approximately 0.9 mm.   The said enclosure means comprises a needle plunger inserted through said limiter and pushed down to fold the needle cannula, thereby retracting the needle cannula into the limiter. The device described.   The apparatus of claim 14, wherein the needle plunger is oriented generally perpendicular to the needle cannula. The apparatus of claim 1, wherein the enclosing means comprises a tubular shield that is extendable from a retracted position to an extended position that encloses the needle cannula. A delivery device used to inject medicinal substances into the skin of an animal,
A prefillable container adapted to store medicinal substances;
A needle cannula attached to the delivery device and having a front end extending away from the delivery device;
A limiter that surrounds the needle cannula and extends from a hub toward the front end of the needle cannula, the limiter extending in a plane generally perpendicular to the axis of the needle cannula for performing subcutaneous injection of a substance Including a substantially flat skin engaging surface adapted to be received against the skin of an animal, the front end extending beyond a skin engaging surface having a length of approximately 0.5 mm to approximately 3.0 mm, A limiter wherein the needle cannula limits entry into the dermis layer of the animal's skin, thereby injecting the substance into the dermis layer of the animal;
A hub secured about a needle cannula and defining the limiter positioning member, thereby positioning the limiter on the device;
Enclosing means for permanently covering the needle cannula after performing the subcutaneous injection;
A cap positioned proximate to the skin engaging surface, thereby covering the front end of the needle cannula;
With
The enclosure means comprises the limiter, the limiter being disposed on the hub having at least a first position and a second position, the first position exposing a front end of the needle cannula; The second position obscures the front end of the needle cannula;
The cap has an outer dimension equal to or less than the limiter, and the cap is made of an elastomeric material;
A delivery device characterized in that the front end of the needle cannula pierces the cap and thereby seals the needle cannula. 18. The device of claim 17, wherein the limiter includes at least one slot that is oriented generally parallel to the needle cannula and has a protrusion disposed on one side. The hub includes at least one locking finger and at least one stop, and the at least one locking finger is supported in a cantilever shape away from the front end, and the at least one stop includes the The apparatus according to claim 18, wherein the apparatus is supported in a cantilever shape toward the front end. The apparatus of claim 19, wherein the at least one locking finger includes a tab received by the slot in the limiter. 21. The apparatus of claim 20, wherein the tab is snappable beyond the protrusion to move the limiter from the first position to the second position. The apparatus of claim 21, wherein the protrusion is disposed between the tab and the at least one stop when the limiter is in the first position. The limiter engages the at least one stop that prevents the limiter from being moved from the second position to the first position when the limiter is in the second position. 23. The apparatus of claim 22, including a hooking tool. The enclosure means comprises a needle plunger that is inserted through the limiter and bends the needle cannula beyond its own elastic limit, thereby retracting the needle cannula into the limiter. The apparatus of claim 17. 25. The apparatus of claim 24, wherein the needle plunger is oriented generally perpendicular to the needle cannula. The apparatus of claim 17, wherein the hub is attachable to an outlet port of the prefillable container. An intradermal delivery device for the injection of substances into the skin of an animal,
A pre-fillable container having a reservoir adapted to store a selected substance and an outlet port allowing the substance to be pushed out of the container during infusion;
A needle cannula having a front end in fluid communication with the outlet port and adapted to pierce the animal's skin;
A substantially flat skin engagement surrounding the needle cannula and adapted to be placed against the skin of an animal for performing intradermal injection of a substance and extending on a plane generally perpendicular to the axis of the needle cannula. A front end of the needle cannula such that the limiter limits piercing of the front end into the dermis layer of the animal's skin, thereby injecting a vaccine into the dermis layer of the animal A limiter extending about 0.5 mm to about 3 mm away from the skin engaging surface;
Enclosing means movable to permanently obscure the needle cannula;
A removable cap positioned proximate to the skin engaging surface, thereby obscuring the front end of a needle cannula having an outer dimension equal to or less than the limiter;
With
The cap is made of an elastomer material,
An intradermal delivery device wherein the front end of the needle cannula pierces the cap, thereby sealing the needle cannula and preventing material from leaking out of the container. The pre-fillable container comprises a syringe having a generally hollow, cylindrical body and a plunger received in the reservoir, the plunger being selectively movable within the reservoir, thereby 28. The device of claim 27, wherein a substance is forced out of the outlet port during an internal injection. 29. The apparatus of claim 28, comprising a hub that supports the needle cannula and is selectively secured to the pre-filled container near the outlet port. The enclosure means includes the limiter, the limiter being slidably disposed on the hub having at least a first position and a second position, the first position defining the front end of the needle cannula. 30. The device of claim 29, wherein the device is exposed and the second position obscures the front end of the needle cannula. 31. The apparatus of claim 30, wherein the limiter defines at least one slot having a protrusion oriented generally parallel to the needle cannula and disposed on one side. The hub includes at least one locking finger and at least one stop, the locking finger being cantilevered away from the front end, and the at least one stop toward the front end. 32. The apparatus of claim 31, wherein the apparatus is supported in a cantilever shape. The apparatus of claim 32, wherein the at least one locking finger includes a tab received by the slot of the limiter. 34. The apparatus of claim 33, wherein the tab is snappable beyond the protrusion to move the limiter from the first position to the second position. The apparatus of claim 34, wherein the protrusion is disposed between the tab and the at least one stop when the limiter is in the first position. The limiter engages with the at least one stop to prevent the limiter from moving from the second position to the first position when the limiter is in the second position. 36. The apparatus of claim 35, comprising a hooking tool. 28. The enclosure means comprises a needle plunger that is inserted through the limiter and is depressed to fold the needle cannula, thereby retracting the needle cannula into the limiter. The device described in 1. 38. The device of claim 37, wherein the needle plunger is oriented generally perpendicular to the needle cannula. 28. The apparatus of claim 27, wherein the hub defines a limiter positioning member, thereby positioning the limiter on the assembly.

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