CA2484817A1 - Safety injectors - Google Patents
Safety injectors Download PDFInfo
- Publication number
- CA2484817A1 CA2484817A1 CA002484817A CA2484817A CA2484817A1 CA 2484817 A1 CA2484817 A1 CA 2484817A1 CA 002484817 A CA002484817 A CA 002484817A CA 2484817 A CA2484817 A CA 2484817A CA 2484817 A1 CA2484817 A1 CA 2484817A1
- Authority
- CA
- Canada
- Prior art keywords
- needle
- barrel
- syringe
- single use
- cap
- Prior art date
- Legal status (The legal status 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 status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
- A61M5/281—Syringe 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
- A61M5/282—Syringe 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31501—Means for blocking or restricting the movement of the rod or piston
- A61M5/31505—Integral with the syringe barrel, i.e. connected to the barrel so as to make up a single complete piece or unit
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; 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
- A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
- A61M5/321—Means for protection against accidental injuries by used needles
- A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
- A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; 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
- A61M5/3287—Accessories for bringing the needle into the body; Automatic needle insertion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/50—Devices 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
- A61M5/5066—Means for preventing re-use by disconnection of piston and piston-rod
Abstract
A simple mechanism that provides the manipulations required to deliver a correct injection and also incorporates the saftey modifications that are needed to prevent needlestick injury and ensure self destruct capability. A
surprisingly simple and cheap modification to a sterile package for the standard syringe and needle can successfully be used to automate the medical skills needed to deliver a safe injection and dispose of the hazardous needle afterwards. The sterile package consists of a housing for the syringe barrel (15), which can telescope into a larger diameter hollow cap (4) covering the syringe plunger (19). The syringe (1) and needle (3) are located fully inside this two-part packaging sheath, which completely encloses and protects them.
surprisingly simple and cheap modification to a sterile package for the standard syringe and needle can successfully be used to automate the medical skills needed to deliver a safe injection and dispose of the hazardous needle afterwards. The sterile package consists of a housing for the syringe barrel (15), which can telescope into a larger diameter hollow cap (4) covering the syringe plunger (19). The syringe (1) and needle (3) are located fully inside this two-part packaging sheath, which completely encloses and protects them.
Description
SAFETY INJECTORS
Field of the Invention The present invention relates to the field of injecting predetermined doses of medication without a patient seeing a needle before, during or after an injection.
Baclc,~ound of the Invention The conventional syringe and needle that are used to give injections are dangerous. Over 8,000 cases of hepatitis B are caused every year by needlestick injuries in the United States. The HIV virus and hepatitis C are also often transmitted by this route.
The situation has become so severe that the United..States Congress passed the Needlestick Safety and Prevention Act, which became law in November, X000, prohibiting injections except by means of safety syringes which prevent contact with the needle after use.
However injections using a safety syringe are still cumbersome and painful and the needle is exposed and dangerous before the injection is given.
AIDS, Hepatitis B and Hepatitis C are much more prevalent as result of unsafe injection practices in the developing world. It is estimated that 8-16 million cases of Hepatitis B, 2.3-4.7 million cases ofHepatitis C and 80,000-160,000 HIV infections occur each year as a direct result of unsafe injections (A. Kane, J. Lloyd, M. Zaffran, L. Simonsen, and M. Kane, Transmission of hepatitis B, hepatitis C and human immunodeficiency viruses through unsafe injections in the developing world: model-based regional estimates. Bull. World Health Org. 77, 801-807 (1999).
Field of the Invention The present invention relates to the field of injecting predetermined doses of medication without a patient seeing a needle before, during or after an injection.
Baclc,~ound of the Invention The conventional syringe and needle that are used to give injections are dangerous. Over 8,000 cases of hepatitis B are caused every year by needlestick injuries in the United States. The HIV virus and hepatitis C are also often transmitted by this route.
The situation has become so severe that the United..States Congress passed the Needlestick Safety and Prevention Act, which became law in November, X000, prohibiting injections except by means of safety syringes which prevent contact with the needle after use.
However injections using a safety syringe are still cumbersome and painful and the needle is exposed and dangerous before the injection is given.
AIDS, Hepatitis B and Hepatitis C are much more prevalent as result of unsafe injection practices in the developing world. It is estimated that 8-16 million cases of Hepatitis B, 2.3-4.7 million cases ofHepatitis C and 80,000-160,000 HIV infections occur each year as a direct result of unsafe injections (A. Kane, J. Lloyd, M. Zaffran, L. Simonsen, and M. Kane, Transmission of hepatitis B, hepatitis C and human immunodeficiency viruses through unsafe injections in the developing world: model-based regional estimates. Bull. World Health Org. 77, 801-807 (1999).
2 0 This is a problem that urgently requires a safe and cost-effective solution.
With most drug formulations, the approved process of giving a subcutaneous or intramuscular injection with a needle and syringe involves performing the following steps, all of 3 ~ ;;;. t~ ~~I E ~E F~~ ";::PCT/US03/12762;:lr.
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which require sterile technique:
1. Take the freeze-dried drug, in its rubber-capped glass vial, from the refrigerator and open the a sterile cap.
2. Take a vial of sterile water for injection (WFI) from its box.
3. Remove a wide-bore needle from its sterile packaging.
With most drug formulations, the approved process of giving a subcutaneous or intramuscular injection with a needle and syringe involves performing the following steps, all of 3 ~ ;;;. t~ ~~I E ~E F~~ ";::PCT/US03/12762;:lr.
1I ~-1~".',_ ..2i..ri: f,,"~ H:,;t~ E~r,l~ ::"... , ,...,: t:",.._ .~ ~,.";t :~.4..
which require sterile technique:
1. Take the freeze-dried drug, in its rubber-capped glass vial, from the refrigerator and open the a sterile cap.
2. Take a vial of sterile water for injection (WFI) from its box.
3. Remove a wide-bore needle from its sterile packaging.
4. Remove a sterile disposable syringe from its sterile packaging.
5. Attach the needle to the syringe.
6. Use the syringe to aspirate the correct volume of sterile WFI.
7. Deliver this WFI into the vial containing the freeze-dried drug.
8. Swirl or gently shake the vial, without foaming, until the drug is completely dissolved.
9. Aspirate the required dose back into the syringe.
10. Remove a narrow bore needle:from its sterile packaging.
11. Replace the used wide bore needle with the fresh narrow bore needle for injection.
12. Expel all the air from the syringe and needle.
13. Carefully swab the skin over the injection site with disinfectant.
I4. Insert the needle'to the correct depth and location with minimal pain.
15. Inj ect the drug and withdraw the needle.
16. Permanently dispose of the needles and syringe to prevent needlestick injury to the operator or third parties.
2 o These techniques must be taught to health care professionals. This is not a suitable process WO 03/095003 ~ . (~.EE 4~~,~~-"E~"Y.,I ~~y~,~=~e iE.~~ zPCT/US03/12762;:;.r, r ~ n u, tts,. _ ~ ,~.w:;r :;",~
for the untrained layman. .
The World Health Organization has estimated that it will need to deliver 3 .6 billion inj ections per year by 2005 and that it will not be able to access the medically trained staff to achieve this goal.
This old fashioned technology has therefore been deemed by the World Health Organization (WHO) to be incompatible with their requirements for planned Global Program of Vaccination and Immunization (GPV) initiatives. The WHO has formally called for a program of research and development to develop radical new technology for vaccine delivery. (L. Jodar, T. Aguado, J. Lloyd, and P-H Lambent (1998), Revolutionizing Immunizations, Geh. Ehg. News 18 (p.
6).
The functional criteria required by the WHO are;
~ Injection device and vaccine dose packaged together;
~ Safe disposal of contaminated needles and other material;
~ Zero risk of cross infection;
~ No waste;
~ No pain; and ~ Affordable.
Another hazard of syringes is their re-use; often after inadequate washing and sterilizing, especially in the developing world. These re-used syringes have also caused serious outbreaks of infection. This problem requires "self destruct" or "single-use" syringes that automatically disable themselves after their first use.
WO 03/095003 ~ E~~E~ E . ' :'~ EEsy~ ~;,~c,~z'k~ "PCT/US03/12762 ::ar i~" Jf".er .. ~k~.~ur° ~ ~~ .u.. ! ~.ut,. x u'ttx.. tteu.. .<e- rri..tt tL.:., The industryhas addressed these challenges by a complete redesign of the needle and syringe to incorporate, automatic or semi-automatic covering of the needle after use (U.S. Patent No.
5,980,488) or retraction of the needle by rubber bands, springs or vacuum into the body of the syringe (U.S. Patent Nos. 5,782,804; 6,015,438; 6,050,977) or modifications that destroy the functionality of the syringe mechanism after one use (Becton Dickinson "SoloshotTM" syringes).
These so-called safety syringes are inevitablymuch more expensive than the standard syringe which retails at around $0.03 - 0.07 per unit. Many of the new safety syringes cost $0.50 to $1.00 each.
These devices are not yet universally used in mass vaccination campaigns because the increase in expense cannot be supported by the agencies involved.
l0 An inexpensive, single-use, self destruct, pxe-filled device recently introduced is the "Unij ectTM" made by Becton Dickinson and Company. This plastic blister with attached needle is certainly cheap but it still requires training and skill to use and has a dangerous exposed needle, which can cause needlestick injury both before and after the injection.
A series of novel solutions to.these problems in the form of a family of disposable injector devices that operate on principles different from the standard syringe and needle is described in U. S.
Patent No. 6,102,896. Essentially these devices, along with most others that have been described, involve redesigns of the technology of injection to eliminate the hazards and simplify the skills needed so that training is no longer required.
Some ofthe devices described in the '896 patent actuallyincorporate similarprinciples to the 2 o conventional syringe and hollow metal needle as well as features to simplify and automate the steps of injection. This approach will only be successful if the new devices can demonstrate the remarkable durability and robustness of design that.has enabled the syringe and needle to totally WO 03/095003 , ~ ~ i,"!t ~!~'wn°y~"' : ~ ~jr~~ s~~~~ ~~°~
~~PCT/US03/12762tE~°is tttt.ns: ' u'- , ek Ef t.., n: v c~ :n. ..~ . _ ...
dominate the field for over 150 yeaxs without any fundamental changes.
Additionally, some of the elements of design in the devices described in '896 patent require very precise manufacturing and quality control to ensure that a sequence of steps required for their operation proceed in the required order. These considerations make these devices less than ideal.
A more attractive solution would be a robust and easily manufactured device that has the elegant simplicity of the syringe and needle plus the benefits of automation and safety now required by law.
Summary of the Invention A novel approach is to actually retain the existing well-proven devices such as the syringe and needle or the Unij ectT~'t as the core drug delivery device but to add to them a simple mechanism that provides the manipulations required to deliver a correct inj ection and also incorporates the safety modifications that are needed to prevent needlestick injury and ensure self destruct capability. A
surprisingly simple and cheap modification to a sterile package for the standard syringe and needle can successfullybe used to automate the medical skills needed to deliver a safe injection and dispose of the hazardous needle afterwards. The sterile package consists of a housing for the syringe barrel, which can telescope into a larger diameter hollow cap covering the syringe plunger. The syringe and needle are located fully inside this two-part paclcaging sheath, which completely encloses and protects them.
Accordingly, it is an object of the present invention to provide an injection of a predetermined dose of medication without a patient seeing a needle before, during or after an 2 0 inj ection.
It is another object of the present invention to provide a sterile package consisting of a CA 02484817 2004-11-02 r, f WO 03/095003 ~~;;~E ~~~_~, m~E'°:: ~T il"~~;e:;~r ~~j(~
~'%~PCT/US03/12762;E
housing :for a syringe barrel, which can telescope into a larger diameter hollow cap covering a syringe plunger with a syringe and needle located fully inside the syringe barrel and hollow cap to completely enclose the syringe after use.
It is yet another obj ect of the present invention to provide two plastic inj ection molding parts and a spring which are used in combination with a pre-filled syringe to inject an individual and completely conceal a used syringe.
It is still yet another object of the present invention to use a pre-filled blister-type injection device for injection of a predetermined amount of medication and have the injection needle sealed between a barrel and a cap for safe disposal.
These and other obj ects of the invention, as well as many of the intended advantages thereof, will become more readily apparent when reference is made to the following description taken in conjunction with the accompanying drawings.
Brief Description of the Drawings Figure lA illustrates a conventional pre-filled syringe.
Figure 1B is an exploded view of the safety injector according to the present invention illustrating a cylindrical cap, a cylindrical barrel housing and spring.
Figure 1 C is a sectional view of a syringe of Figure lA mounted in the assembled parts of Figure 1B.
Figure 2A illustrates the safety inj ector of the present invention positioned against a pat'ient's 2 0 skin.
Figure 2B illustrates a partial compression of the cylindrical cap towards the cylindrical WO 03/095003 ~ 1~;;~.E ~;~'~s ,°!,°,~2 j 'P ~~."',,~ ;t'";t ~pCT/US03/12762 ~~::y ~. .~ ., i". .1.. ,m~ r s , tt:.x,. ~ ' .s: i' barrel housing for inj ection of a patient with a syringe.
Figure 2C illustrates the continued movement of the cap towards the barrel housing for dispensing of medication through the syringe into the subcutaneous tissues of a patient.
Figure '?D shows the final positioning of the cap interlocked with the barrel housing to form a disposal container for a used syringe.
Figure 3A is a side view of a pre-filled UnijectTM syringe including a plastic blister containing a dose of medication.
Figure 3B is a plan view of a shaped plastic moulding.
Figure 3C is an elevational view of the plastic moulding shown in Figure 3B.
Figure 3D is a partially folded view of the plastic moulding shown in Figures 3B and 3C.
Figure 3E is a sectional view of the plastic moulding mounted onto the blister injector contained within a cap and a barrel with a spring surrounding the syringe of the blister injector.
Figure 3F is a sectional view taken along-the longitudinal axis ofthe blisterinjectormounted in an injection capsule.
Figure 4A(1) is a sectional view showing the mounting of the distal free end of the safety injection device pressed against the skin of the patient.
Figure 4A(2) is a longitudinal sectional view shifted 90 degrees with respect to Figure 4A(1).
Figure 4B(1) shows the initial downward movement of the cap to compress the spring and move the needle into the skin of the patient.
2 Q Figure 4B(2) is a longitudinal sectional view shifted 90 degrees with respect to Figure 4B(1).
Figure ~.C(1) illustrates the continued downward movement of the cap and the compression of the collar of the syringe inside the hollow hub of the syringe.
CA 02484817 2004-11-02 i WO 03/095003 ~ ~ E~~!y Nr ~ ~~ t' .~' h ~c ; ~~ m( ~~~t~PCT/US03/12762 ~ ~f. '~ .G.r~ '~ ~~ .~' vs, tt .;<..f: ~E..,~~, ,.,roar ,~ x.,tb, cz..~. e~-.~: is"",..
Figure 4C(2) is a longitudinal sectional view shifted 90 degrees with respect to Figure 4C(1).
Figure,4D(1 ) illustrates continued downward movement ofthe cap to force medication from the blister into the subcutaneous tissues of the patient and the surrounding of the blister by the shaped plastic molding.
Figure 4D(~) is a longitudinal sectional view shifted 90 degrees with respect to Figure 4D(1).
Figure 4E(1) illustrates the release of downward pressure on the blister injector so that the bias of. the return spring causes the blister injector to move upward into the cap as the final downward movement ofthe cap causes a cap lock ring to engage a barrel lock ring to house the used syringe.
Figure 4E(2) is a longitudinal sectional view shifted 90 degrees with respect to Figure 4E(1).
Detailed Description of the Preferred Embodiments In describing a preferred embodiment of the invention illustrated in the drawings, specific terminology will be resorted to for the sake of clarity. However, the invention is not intended to be limited to the specific terms so selected, and it is to be understood that each specific term includes 1.5 all technical equivalents which operate in a similar manner to accomplish a similar purpose.
Figure 1 B shows the device ofthe present invention in an exploded view and in an assembled view (Figure 1 C) incorporating apre-filled syringe as shown in Figure 1A. A
conventional pre-filled syringe (1) such as the HypakTM (Becton Dickinson and Company) or a similar syringe, contains the dose of drug or vaccine (2) and has an attached needle (3). The syringe is to be housed in a 2 o cylindrical cap (4) and is located on a spring (5) which Iies in the lumen of a cylindrical barrel housing (6), the free end of which is protected by an adhesive foil (7) having a pull tab at one end.
WO 03/095003 i'r;~'~;t, )'r1'~ ~"c~°'a ,~,''~ ~~ ~r tE.".,"~~ fy"~,f~
w;pCT/US03/12762~,=~.
ft . "amR ~ s L~~ ra,pV aw~~ vna a xfutYau ttnfa _u sCa-f f The cap (4) has, on its inside surface, three sets of different sized break-tabs (8, 9 and 10) and a ramp shaped locking ring (11) which, during assembly, locks over the distal end of the wider part of the barrel housing ( 12) and, after use, locks over a matching ramp shaped locking ring (13) on the barrel housing (6) to lock and disable the used device. Aftermanufacture, assembly and sterilization, sterility is maintained in the device by sealing the needle orifice (14) in the barrel housing (6) with the adhesive foil (7) made of an adhesive transfer tape such as the Adhesives Research Ltd., type ARcare 7396 CO# H2923 or similar adhesive tape.
The barrel (15) of the syringe (1) has a hub end (16) into which the blunt end of a stainless steel hollow needle (3) is fused. The opposite end of the needle is sharpened in the conventional way to a needle point (17).
The other end of the barrel (15) carnes an expanded flange (18). The plunger (I9), which is located inside the barrel (15), has an elastomeric stopper (20) at one end, which is in a sliding seal in the barrel.(15) and, at the other end, a flange (21) which is smaller in diameter than the barrel flange (18).
For assembly, the free end (22) of the barrel housing (6) is first closed off by applying the adhesive transfer foil (7). The spring (5) is inserted into the lumen (23) of the barrel housing (6) in which it is in a loose sliding fit. Because the barrel (15) of the syringe (1) is in a sliding fit in the barrel housing (6), the syringe is held in a coaxial orientation with respect to the barrel housing thus facilitating the attachment of the cap (4) in the correct position.
2 0 The cap (4) is slid over the barrel housing until the locking ring (11) seats into the recess (24) of the barrel housing (6) and simultaneously, the first snap tabs (8) come to rest on the wide top (25) of the barrel housing (6). This locks the cap (4) in place on the barrel housing (6) producing a closed WO 03/095003 ~ ~t", t.~: »,te'~u~.,~ lefty " ",E~ ""PCT/US03/12762~,ro 't;~
to '~ .~.,.;, a = ,~~ :: i~ ~.~as N",~ .. ,::f;,~ E~...... .~~ ~":~ E~,.::
and protective environment for the syringe, needle and contents. In this storage position, the second set of break tabs (9) is in register with and just above (26) the barrel flange (18) and the third set of break tabs (10) is in register with and just above (27) the plunger flange (21). Above the third set of break tabs (10) there is a free space (28), which will eventually house the flange (21) end of the syringe (1) when the device has been used.
In use, the adhesive transfer foil (7) is removed which transfers a layer of skin adhesive from the adhesive transfer foil (7) to the free end (22) of the barrel housing (6).
This adhesive coated end (22) of the device is held against the patient's slcin (30) (Fig. 2A) at the inj ection site by the operator pressing on the free end (29) of the cap (4). The adhesive prevents accidental slippage of the device as increasing pressure is applied to the free end (29) of the cap (4) until the first set ofbreak tabs (8) suddenly give way causing the cap (4) to telescope over and around the barrel housing (6).
This causes the second set of break tabs (9) to engage with the barrel flange (18) and drive the syringe barrel towards the free end (22) of the housing (6) thus compressing the spring (5) between the hub end (16) of the barrel (15) and the orifice (14) end of the lumen (23) of the barrel housing (6). This action causes the needle (3) to emerge through the orifice (14) and penetrate to the subcutaneous tissues (31) of the patient (Fig. 2B) until the spring (5) is fully compressed and the syringe (1) bottoms out in the barrel housing (6). Since both the length of the needle (3) and the thickness of the free end (22) of the barrel housing (6) are variable, the depth of needle penetration is factory pre-set.
2 0 When the syringe bottoms out by the complete compression of the spring 5, the sudden increase in pressure of the barrel flange (18) on the second set ofbreak tabs (9) causes the break tabs (9) to give way thus allowing the third set of break tabs (10) to engage the flange (21) on the plunger io WO 03/095003 ~i;a.~G~~==~°~~~°~ f,<~ <<«i;r";4 ~~,~~6pCT/US03/12762' ;;°.' x;"~« .:..,~~ . ;'., (19). The continuation of the downward telescopic movement of the cap (4) over the barrel housing (6) then causes the plunger (19) to push the elastomeric stopper (20) towards the hub end (16) ofthe baz~el (15). The friction between the-elastomeric stopper (20) and the barrel (15) ensuxes that downward pressure continues on the barrel and maintains pressure on the spring (5).keeping it fully compressed. The downward movement of the stopper (20) in the barrel (15) causes the discharge ofthe dose ofrnedicament (2) through the needle (3) and into the subcutaneous tissues (31) until the plunger (19) also bottoms out in the barrel (15) discharging the drug (2) at location (3?) (Fig. 2C).
This causes an increase in the pressure of the plunger flange (21) on the third set of break tabs (10) causing them to yield. When this happens all downward force on the syringe (1) ceases and the compressed spring (5) causes the syringe (1) to be forced into the free end~(29) ofthe cap (4) thus withdrawing the needle from the tissues (Fig. 2D).
In practice, the high speed of the retraction of the syringe causes the plunger flange to strike the underside of the free end (29) of the cap giving the operator a tactile and audible signal that the syringe has safely withdrawn the needle from the tissues. The final small additional telescopic - movement of the cap (4) over the barrel housing (6) engages the lock ring (11) of the cap (4) with the lock ring (13) of the barrel housing (6) thus sealing the used syringe and needle in the device in a safe manner. If the cap (4) is made of transparent or translucent material the safe withdrawal of the needle can be confirmed visually before the adhesive-coated free end (22) of the device is peeled from the patient's skin (30).
2 o Because of this design and method of action, the patient does not see a needle before, during or after the injection. Indeed, if the barrel housing (6) is made,from an opaque plastic the patient need not even know that a needle is involved. From the patient's point of view the device would lI
WO 03/095003 ~ ~ 'p';~_. ~~:~R [E sE ~~ .,r", p' jPCT/US03/12762 ~;;;I!
~~n k. 'v'St'n'e[' ~~_u.G ~,...E"..~.~. ,.~,:r: :~ ,. .. . r ._ :.nci :eu:,e appear identical to a liquid jet injector such as described in U.S. Patent No.
6,102,896 and in U.S.
Patent No. 6,224,567. As well as protecting the needle from damage or contamination and the operator from needlestick injury, its concealment reduces anxiety, and therefore perceived pain, in nervous patients. Of equal importance from the patient's point of view, the snap-tab mechanism ensures that the needle is thrust through the skin very rapidly thus further reducing pain. Because this design ensures precise axial forces on the needle, which is supported by the surrounding sheath, it also .enables the use of needles of smaller outside diameter and wall thickness, thus fizrther reducing trauma and the consequent pain of injection. For these reasons the device is virtually painless in operation.
In its simplest form the device consists only of three parts, two of which can be inexpensive plastic injection-mouldings and the third a simple spring, which can be coiled metal, elastomer or a gas spring. The plastics used have only minor structural requirements and do not need to be expensive "engineering" plastics. The total additional cost of the vaccinator will probably not exceed the original cost of the syringe and needle itself. Thus this device can achieve all of the requirements of safety in injection technology for a modest doubling of the total device cost to around six to ten cents. This should be compared with the $0.20 to $1.50 costs of competitive safety injectors. Unlike other "safety syringes" which require expert handling, the action of the present invention is automatic and the inj ection depth and the dose are pre-determined in the factory making it suitable for use by minimally trained or even untrained personnel.
2 0 It is of course possible to use the same principles of automating the function of a syringe and needle described above, to convert other injection devices such as the plastic blister UnijectT'~ into a safe, comfortable auto inj ector for subcutaneous or intramuscular delivery.
Again, the advantages WO 03/095003 ~ ,~.,E ~I"~~ "'~"'i,,< (~,u~~ ~k;.a~ ''rc' '°PCT/US03/12762::.°.!t S. ~ ~ ~r.al~ :u. S. :..~ s- e..vm of this approach are that the needle is enclosed before, during and after the injection; the whole process of injection is fully automated and the cost of the final device is very modest. The design of such a device is illustrated in Figures 3A through 3F and its mode of action in Figures 4A through 4E. The additional element in the design is a folded, shaped plastic moulding which holds the pre-filled UnijectTM in place in the sheath and which transfers pressure to empty the plastic blister containing the dose at the correct point in the inj ection cycle.
The UnijectTM device shown in Figure 3A is made from two layers of plastic film (1') in which dome shaped depressions are vacuum-formed and which are fused together with the depressions in register so as to form a lenticular cavity; the blister (2'), which is filled with the dose 1 o of medicament. Additionally sealed to the film is a hollow hub (3'), which is separated offinternally from the dose of medicament in the blister by a thin wall of plastic. A needle (4'), which is sharpened at both ends, is accommodated in the hub by means of a plastic collar (5') firmly attached to it near one end; the hub end. The collar (5') is a snug, sliding fit in the hollow hub (3') and can be moved therein to drive the needle towards the blister thus causing the sharp hub-end of the needle to perforate the thin wall of plastic. This penetrates the seal of the blister so that the dose of medicament is able to flow through the needle when it is expelled by pressure on the blister.
Figures 3B and 3C illustrate a plan view and an elevation view, respectively, of a shaped plastic moulding which is used to enclose the UnijectTM device. The shaped plastic moulding is symmetrical about its central axis; the line A-A in Figure 3C. During assembly of the injector, the 2 0 shaped plastic moulding is folded about this axis A-A. An intermediate shape during the folding process is shown in Figure 3 D.
The final folded configuration is shown inside the injection capsule in Figure 3E in which WO 03/095003 ~ ~;,~~ ° ° '°~#~' r~' ~ i~ ~~°
''vt PCT/US03/12762 'f:.°~h a v ~~..': _, .. ' ~:.,a ~,;au ~~,rt~ ,:,:,_ : " ",.w,. ." :"". -t.H~, the shaped plastic moulding (I 1') is illustrated enclosing the Unij ectTM
device (12'). The moulded features of the shaped plastic moulding consist of a curved extension (6'), which is shaped to surround the blister (2') on two sides and to rest on the top of the hub (3') as shown in Fig. 3F.. The curved extension (f) is attached to a dome shaped area (T), which is similar in size but opposite in convexity to the blister. In the storage position in the device (Figures 3E
and 3F) this dome shaped area (T) sits just above the blister in the injector device. The part of the shaped plastic moulding between the curved extension (6') and the dome (7') contains a grooved defect (8'), which weakens the structure so that it will snap at this point and not elsewhere when under a sufficient compressive force. When the shaped plastic moulding is fully folded the area of the moulding adj acent to the 1 o point of folding (10') is fused together, either with heat or adhesive to hold the moulding permanently in the fully folded position.
Figures 3E and 3F illustrate the final inj ector device assembled in the storage configuration.
The whole device is oval in cross section. Figure 3 E is an elevation of the mid point section of the short axis of the oval and Figure 3 F is a mid point section of the long axis of the oval. This convention also applies to Figures 4 A through 4E in which the device is also shown as pairs of views.
Assembly in the factory requires first that the shaped plastic moulding ( 11') is slid sideways over the filled UnijectTM device (12') so that the end of the curved extension (6') is located resting on the top of the hub (3') and enclosing the blister (2'). The enclosed UnijectTM is then inserted into 2 o the barrel (13') of the injector supported by a return spring (14'). The cap (15') which contains two sets of snap tabs (16') and (1 T) is then pushed over the barrel ( 13') until the first set of snap tabs (16') locates at the top of the barrel and the lock ring (18') of the cap engages with the underside of the WO 03/095003 ~ °~;t ~f=Y °~[t," ~:'~ ~x~E''~.~E ~',~'..1~
"pCT/US03/12762 ~,e";' .,z,., . ,.."
widened part of the upper end of the barrel. At this point, the second set of snap tabs (1T) also rests upon the free end of the folding (10') of the shaped plastic moulding (11') thus holding the enclosed UnijectTM snugly in place. The barrel also carries a lock ring (19') at its distal end, which will lock the cap in the closed position after use. The device is sealed against contamination and the interior maintained sterile by an adhesive transfer foil (20') having a pull tab at one end. The transfer foil (20') is applied to the distal free end of the device.
In use, the adhesive transfer foil (20') is removed from the distal free end of the device thereby transferring a Iayer of adhesive to the free end of the device. The distal free end of the device is pressed against the skin (22') of the patient (Figure 4A(1) and 4A(2)) by modest hand l0 pressure applied to the free end (21') of the cap. The layer of adhesive serves to fix the device in position even on wet skin thus preventing slippage and damage to the patient's skin as the pressure on the cap is increase by the operator until the first set ofbreak tabs (16') yield (Figure 4A(2)). This suddenly frees the cap (15') to slide telescopically over the barrel (13').
This causes the second set of break tabs (1 T) to press on the free end of the folding (10') of the shaped plastic moulding which transmits this pressure via the shaped extension (6') to the top of the hub (3'). Downward movement of the hub compresses the spring ( 14') and pushes the needle into the subcutaneous tissues (23') until the plastic collar (5') on the needle bottoms out in the barrel (Figures 4 B(1) and 4B(2)). Continued downward movement forces the collar inside the hollow hub (3') towards the blister causing the sharp hub-end of the needle to penetrate the thin plastic wall sealing the blister and giving the dose 2 0 of medicament (2') access to the needle (4'). The movement of the collar inside the hollow hub stops when the collar is flush with the bottom of the hollow hub as the hub (3') in turn bottoms out in the bairel (13') (Figures 4C(1) and 4C(2,)). The bottoming out of the hub (3') causes a sudden increase WO 03/095003 ~ ;~:.E ~;~.,( ...~.a[ :. ~~ ,,},~t:a }t ...t#
t.;"',pCT/US03/12762t~
?n.t vxt aaaa'tss.t a-.ss?~ s- 0..ttu tCU,sn S~' ~fntr t4 in compressive force on the curved extension (6') causing the weakened area (24') of grooved defect (8') to break (Figure 4 D(1)). This causes the shaped plastic moulding (11') to slide over the UnijectTM (12') until the dome (T) comes into register with, and presses on, the blister (2') discharging its contents ofmedicament through the needle (4') into the subcutaneous tissue ormuscle S Iayer (25') (Figures 4 D(1) and 4D(2)). When the dome (T) is fully in register with the blister (2') the UnijectTM is entirely engulfed by the shaped plastic moulding and no further downward movement of the enclosed UnijectTM is possible causing an increase in pressure on the second set of break tabs (1 T).
The top of the barrel then also presses on the underside of the second set of break tabs (1 T) greatlyincreasing the force on them and causing them to, give way (Figures 4 D(1) and 4D(2)). This thereby releases all downward pressuxe on the enclosed UnijectTM. The return spring (14') then causes the enclosed UnijectTM to move suddenly into the cap as the final downward movement of the cap (I5') over the barrel housing (13') causes the cap lock ring (18') to engage the barrel lock ring (19') thus securely locking the device shut and preventing any possibility of contact with the used needle (Figures 4 E(1) and 4E(2)). Appropriate design of the device can ensure that the free end (10') of the shaped plastic moulding (11') strikes the underside of the cap giving a tactile and audible signal to the operator that the needle is fully retracted in a safe manner. If the cap (15') is made from transparent or translucent plastic, the safe retraction of the needle can be cor~f'umed visually before the device is peeled from the patient's skin for disposal.
2 0 It is important to emphasize that the full sequence of a safe and effective injection with both devices described herein is achieved with a simple, single downward thrust. No separate operator manipulations are required to insert the needle, deliver the injection or withdraw the needle; all of WO 03/095003 ~ ;;;=fE ~ ~ °°2°° ..~ r. ;q ,°~°~_ ~°~~ ~ °pCT/US03/12762' ::~~
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which happen automatically during the single downward movement of the cap from the open to the locked position. After use the devices are locked in a safe configuration with no possibility of needlestick injury. This absence of any requirement for operator training or skill makes the present invention ideal for use by untrained personnel and even possibly for over the counter (OTC) sales to the general public.
The foregoing description should be considered as illustrative only of the principles of the invention. Since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and, accordingly, all suitable modifications and equivalents may be resorted to, falling within the 1 o scope of the invention.
I4. Insert the needle'to the correct depth and location with minimal pain.
15. Inj ect the drug and withdraw the needle.
16. Permanently dispose of the needles and syringe to prevent needlestick injury to the operator or third parties.
2 o These techniques must be taught to health care professionals. This is not a suitable process WO 03/095003 ~ . (~.EE 4~~,~~-"E~"Y.,I ~~y~,~=~e iE.~~ zPCT/US03/12762;:;.r, r ~ n u, tts,. _ ~ ,~.w:;r :;",~
for the untrained layman. .
The World Health Organization has estimated that it will need to deliver 3 .6 billion inj ections per year by 2005 and that it will not be able to access the medically trained staff to achieve this goal.
This old fashioned technology has therefore been deemed by the World Health Organization (WHO) to be incompatible with their requirements for planned Global Program of Vaccination and Immunization (GPV) initiatives. The WHO has formally called for a program of research and development to develop radical new technology for vaccine delivery. (L. Jodar, T. Aguado, J. Lloyd, and P-H Lambent (1998), Revolutionizing Immunizations, Geh. Ehg. News 18 (p.
6).
The functional criteria required by the WHO are;
~ Injection device and vaccine dose packaged together;
~ Safe disposal of contaminated needles and other material;
~ Zero risk of cross infection;
~ No waste;
~ No pain; and ~ Affordable.
Another hazard of syringes is their re-use; often after inadequate washing and sterilizing, especially in the developing world. These re-used syringes have also caused serious outbreaks of infection. This problem requires "self destruct" or "single-use" syringes that automatically disable themselves after their first use.
WO 03/095003 ~ E~~E~ E . ' :'~ EEsy~ ~;,~c,~z'k~ "PCT/US03/12762 ::ar i~" Jf".er .. ~k~.~ur° ~ ~~ .u.. ! ~.ut,. x u'ttx.. tteu.. .<e- rri..tt tL.:., The industryhas addressed these challenges by a complete redesign of the needle and syringe to incorporate, automatic or semi-automatic covering of the needle after use (U.S. Patent No.
5,980,488) or retraction of the needle by rubber bands, springs or vacuum into the body of the syringe (U.S. Patent Nos. 5,782,804; 6,015,438; 6,050,977) or modifications that destroy the functionality of the syringe mechanism after one use (Becton Dickinson "SoloshotTM" syringes).
These so-called safety syringes are inevitablymuch more expensive than the standard syringe which retails at around $0.03 - 0.07 per unit. Many of the new safety syringes cost $0.50 to $1.00 each.
These devices are not yet universally used in mass vaccination campaigns because the increase in expense cannot be supported by the agencies involved.
l0 An inexpensive, single-use, self destruct, pxe-filled device recently introduced is the "Unij ectTM" made by Becton Dickinson and Company. This plastic blister with attached needle is certainly cheap but it still requires training and skill to use and has a dangerous exposed needle, which can cause needlestick injury both before and after the injection.
A series of novel solutions to.these problems in the form of a family of disposable injector devices that operate on principles different from the standard syringe and needle is described in U. S.
Patent No. 6,102,896. Essentially these devices, along with most others that have been described, involve redesigns of the technology of injection to eliminate the hazards and simplify the skills needed so that training is no longer required.
Some ofthe devices described in the '896 patent actuallyincorporate similarprinciples to the 2 o conventional syringe and hollow metal needle as well as features to simplify and automate the steps of injection. This approach will only be successful if the new devices can demonstrate the remarkable durability and robustness of design that.has enabled the syringe and needle to totally WO 03/095003 , ~ ~ i,"!t ~!~'wn°y~"' : ~ ~jr~~ s~~~~ ~~°~
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dominate the field for over 150 yeaxs without any fundamental changes.
Additionally, some of the elements of design in the devices described in '896 patent require very precise manufacturing and quality control to ensure that a sequence of steps required for their operation proceed in the required order. These considerations make these devices less than ideal.
A more attractive solution would be a robust and easily manufactured device that has the elegant simplicity of the syringe and needle plus the benefits of automation and safety now required by law.
Summary of the Invention A novel approach is to actually retain the existing well-proven devices such as the syringe and needle or the Unij ectT~'t as the core drug delivery device but to add to them a simple mechanism that provides the manipulations required to deliver a correct inj ection and also incorporates the safety modifications that are needed to prevent needlestick injury and ensure self destruct capability. A
surprisingly simple and cheap modification to a sterile package for the standard syringe and needle can successfullybe used to automate the medical skills needed to deliver a safe injection and dispose of the hazardous needle afterwards. The sterile package consists of a housing for the syringe barrel, which can telescope into a larger diameter hollow cap covering the syringe plunger. The syringe and needle are located fully inside this two-part paclcaging sheath, which completely encloses and protects them.
Accordingly, it is an object of the present invention to provide an injection of a predetermined dose of medication without a patient seeing a needle before, during or after an 2 0 inj ection.
It is another object of the present invention to provide a sterile package consisting of a CA 02484817 2004-11-02 r, f WO 03/095003 ~~;;~E ~~~_~, m~E'°:: ~T il"~~;e:;~r ~~j(~
~'%~PCT/US03/12762;E
housing :for a syringe barrel, which can telescope into a larger diameter hollow cap covering a syringe plunger with a syringe and needle located fully inside the syringe barrel and hollow cap to completely enclose the syringe after use.
It is yet another obj ect of the present invention to provide two plastic inj ection molding parts and a spring which are used in combination with a pre-filled syringe to inject an individual and completely conceal a used syringe.
It is still yet another object of the present invention to use a pre-filled blister-type injection device for injection of a predetermined amount of medication and have the injection needle sealed between a barrel and a cap for safe disposal.
These and other obj ects of the invention, as well as many of the intended advantages thereof, will become more readily apparent when reference is made to the following description taken in conjunction with the accompanying drawings.
Brief Description of the Drawings Figure lA illustrates a conventional pre-filled syringe.
Figure 1B is an exploded view of the safety injector according to the present invention illustrating a cylindrical cap, a cylindrical barrel housing and spring.
Figure 1 C is a sectional view of a syringe of Figure lA mounted in the assembled parts of Figure 1B.
Figure 2A illustrates the safety inj ector of the present invention positioned against a pat'ient's 2 0 skin.
Figure 2B illustrates a partial compression of the cylindrical cap towards the cylindrical WO 03/095003 ~ 1~;;~.E ~;~'~s ,°!,°,~2 j 'P ~~."',,~ ;t'";t ~pCT/US03/12762 ~~::y ~. .~ ., i". .1.. ,m~ r s , tt:.x,. ~ ' .s: i' barrel housing for inj ection of a patient with a syringe.
Figure 2C illustrates the continued movement of the cap towards the barrel housing for dispensing of medication through the syringe into the subcutaneous tissues of a patient.
Figure '?D shows the final positioning of the cap interlocked with the barrel housing to form a disposal container for a used syringe.
Figure 3A is a side view of a pre-filled UnijectTM syringe including a plastic blister containing a dose of medication.
Figure 3B is a plan view of a shaped plastic moulding.
Figure 3C is an elevational view of the plastic moulding shown in Figure 3B.
Figure 3D is a partially folded view of the plastic moulding shown in Figures 3B and 3C.
Figure 3E is a sectional view of the plastic moulding mounted onto the blister injector contained within a cap and a barrel with a spring surrounding the syringe of the blister injector.
Figure 3F is a sectional view taken along-the longitudinal axis ofthe blisterinjectormounted in an injection capsule.
Figure 4A(1) is a sectional view showing the mounting of the distal free end of the safety injection device pressed against the skin of the patient.
Figure 4A(2) is a longitudinal sectional view shifted 90 degrees with respect to Figure 4A(1).
Figure 4B(1) shows the initial downward movement of the cap to compress the spring and move the needle into the skin of the patient.
2 Q Figure 4B(2) is a longitudinal sectional view shifted 90 degrees with respect to Figure 4B(1).
Figure ~.C(1) illustrates the continued downward movement of the cap and the compression of the collar of the syringe inside the hollow hub of the syringe.
CA 02484817 2004-11-02 i WO 03/095003 ~ ~ E~~!y Nr ~ ~~ t' .~' h ~c ; ~~ m( ~~~t~PCT/US03/12762 ~ ~f. '~ .G.r~ '~ ~~ .~' vs, tt .;<..f: ~E..,~~, ,.,roar ,~ x.,tb, cz..~. e~-.~: is"",..
Figure 4C(2) is a longitudinal sectional view shifted 90 degrees with respect to Figure 4C(1).
Figure,4D(1 ) illustrates continued downward movement ofthe cap to force medication from the blister into the subcutaneous tissues of the patient and the surrounding of the blister by the shaped plastic molding.
Figure 4D(~) is a longitudinal sectional view shifted 90 degrees with respect to Figure 4D(1).
Figure 4E(1) illustrates the release of downward pressure on the blister injector so that the bias of. the return spring causes the blister injector to move upward into the cap as the final downward movement ofthe cap causes a cap lock ring to engage a barrel lock ring to house the used syringe.
Figure 4E(2) is a longitudinal sectional view shifted 90 degrees with respect to Figure 4E(1).
Detailed Description of the Preferred Embodiments In describing a preferred embodiment of the invention illustrated in the drawings, specific terminology will be resorted to for the sake of clarity. However, the invention is not intended to be limited to the specific terms so selected, and it is to be understood that each specific term includes 1.5 all technical equivalents which operate in a similar manner to accomplish a similar purpose.
Figure 1 B shows the device ofthe present invention in an exploded view and in an assembled view (Figure 1 C) incorporating apre-filled syringe as shown in Figure 1A. A
conventional pre-filled syringe (1) such as the HypakTM (Becton Dickinson and Company) or a similar syringe, contains the dose of drug or vaccine (2) and has an attached needle (3). The syringe is to be housed in a 2 o cylindrical cap (4) and is located on a spring (5) which Iies in the lumen of a cylindrical barrel housing (6), the free end of which is protected by an adhesive foil (7) having a pull tab at one end.
WO 03/095003 i'r;~'~;t, )'r1'~ ~"c~°'a ,~,''~ ~~ ~r tE.".,"~~ fy"~,f~
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ft . "amR ~ s L~~ ra,pV aw~~ vna a xfutYau ttnfa _u sCa-f f The cap (4) has, on its inside surface, three sets of different sized break-tabs (8, 9 and 10) and a ramp shaped locking ring (11) which, during assembly, locks over the distal end of the wider part of the barrel housing ( 12) and, after use, locks over a matching ramp shaped locking ring (13) on the barrel housing (6) to lock and disable the used device. Aftermanufacture, assembly and sterilization, sterility is maintained in the device by sealing the needle orifice (14) in the barrel housing (6) with the adhesive foil (7) made of an adhesive transfer tape such as the Adhesives Research Ltd., type ARcare 7396 CO# H2923 or similar adhesive tape.
The barrel (15) of the syringe (1) has a hub end (16) into which the blunt end of a stainless steel hollow needle (3) is fused. The opposite end of the needle is sharpened in the conventional way to a needle point (17).
The other end of the barrel (15) carnes an expanded flange (18). The plunger (I9), which is located inside the barrel (15), has an elastomeric stopper (20) at one end, which is in a sliding seal in the barrel.(15) and, at the other end, a flange (21) which is smaller in diameter than the barrel flange (18).
For assembly, the free end (22) of the barrel housing (6) is first closed off by applying the adhesive transfer foil (7). The spring (5) is inserted into the lumen (23) of the barrel housing (6) in which it is in a loose sliding fit. Because the barrel (15) of the syringe (1) is in a sliding fit in the barrel housing (6), the syringe is held in a coaxial orientation with respect to the barrel housing thus facilitating the attachment of the cap (4) in the correct position.
2 0 The cap (4) is slid over the barrel housing until the locking ring (11) seats into the recess (24) of the barrel housing (6) and simultaneously, the first snap tabs (8) come to rest on the wide top (25) of the barrel housing (6). This locks the cap (4) in place on the barrel housing (6) producing a closed WO 03/095003 ~ ~t", t.~: »,te'~u~.,~ lefty " ",E~ ""PCT/US03/12762~,ro 't;~
to '~ .~.,.;, a = ,~~ :: i~ ~.~as N",~ .. ,::f;,~ E~...... .~~ ~":~ E~,.::
and protective environment for the syringe, needle and contents. In this storage position, the second set of break tabs (9) is in register with and just above (26) the barrel flange (18) and the third set of break tabs (10) is in register with and just above (27) the plunger flange (21). Above the third set of break tabs (10) there is a free space (28), which will eventually house the flange (21) end of the syringe (1) when the device has been used.
In use, the adhesive transfer foil (7) is removed which transfers a layer of skin adhesive from the adhesive transfer foil (7) to the free end (22) of the barrel housing (6).
This adhesive coated end (22) of the device is held against the patient's slcin (30) (Fig. 2A) at the inj ection site by the operator pressing on the free end (29) of the cap (4). The adhesive prevents accidental slippage of the device as increasing pressure is applied to the free end (29) of the cap (4) until the first set ofbreak tabs (8) suddenly give way causing the cap (4) to telescope over and around the barrel housing (6).
This causes the second set of break tabs (9) to engage with the barrel flange (18) and drive the syringe barrel towards the free end (22) of the housing (6) thus compressing the spring (5) between the hub end (16) of the barrel (15) and the orifice (14) end of the lumen (23) of the barrel housing (6). This action causes the needle (3) to emerge through the orifice (14) and penetrate to the subcutaneous tissues (31) of the patient (Fig. 2B) until the spring (5) is fully compressed and the syringe (1) bottoms out in the barrel housing (6). Since both the length of the needle (3) and the thickness of the free end (22) of the barrel housing (6) are variable, the depth of needle penetration is factory pre-set.
2 0 When the syringe bottoms out by the complete compression of the spring 5, the sudden increase in pressure of the barrel flange (18) on the second set ofbreak tabs (9) causes the break tabs (9) to give way thus allowing the third set of break tabs (10) to engage the flange (21) on the plunger io WO 03/095003 ~i;a.~G~~==~°~~~°~ f,<~ <<«i;r";4 ~~,~~6pCT/US03/12762' ;;°.' x;"~« .:..,~~ . ;'., (19). The continuation of the downward telescopic movement of the cap (4) over the barrel housing (6) then causes the plunger (19) to push the elastomeric stopper (20) towards the hub end (16) ofthe baz~el (15). The friction between the-elastomeric stopper (20) and the barrel (15) ensuxes that downward pressure continues on the barrel and maintains pressure on the spring (5).keeping it fully compressed. The downward movement of the stopper (20) in the barrel (15) causes the discharge ofthe dose ofrnedicament (2) through the needle (3) and into the subcutaneous tissues (31) until the plunger (19) also bottoms out in the barrel (15) discharging the drug (2) at location (3?) (Fig. 2C).
This causes an increase in the pressure of the plunger flange (21) on the third set of break tabs (10) causing them to yield. When this happens all downward force on the syringe (1) ceases and the compressed spring (5) causes the syringe (1) to be forced into the free end~(29) ofthe cap (4) thus withdrawing the needle from the tissues (Fig. 2D).
In practice, the high speed of the retraction of the syringe causes the plunger flange to strike the underside of the free end (29) of the cap giving the operator a tactile and audible signal that the syringe has safely withdrawn the needle from the tissues. The final small additional telescopic - movement of the cap (4) over the barrel housing (6) engages the lock ring (11) of the cap (4) with the lock ring (13) of the barrel housing (6) thus sealing the used syringe and needle in the device in a safe manner. If the cap (4) is made of transparent or translucent material the safe withdrawal of the needle can be confirmed visually before the adhesive-coated free end (22) of the device is peeled from the patient's skin (30).
2 o Because of this design and method of action, the patient does not see a needle before, during or after the injection. Indeed, if the barrel housing (6) is made,from an opaque plastic the patient need not even know that a needle is involved. From the patient's point of view the device would lI
WO 03/095003 ~ ~ 'p';~_. ~~:~R [E sE ~~ .,r", p' jPCT/US03/12762 ~;;;I!
~~n k. 'v'St'n'e[' ~~_u.G ~,...E"..~.~. ,.~,:r: :~ ,. .. . r ._ :.nci :eu:,e appear identical to a liquid jet injector such as described in U.S. Patent No.
6,102,896 and in U.S.
Patent No. 6,224,567. As well as protecting the needle from damage or contamination and the operator from needlestick injury, its concealment reduces anxiety, and therefore perceived pain, in nervous patients. Of equal importance from the patient's point of view, the snap-tab mechanism ensures that the needle is thrust through the skin very rapidly thus further reducing pain. Because this design ensures precise axial forces on the needle, which is supported by the surrounding sheath, it also .enables the use of needles of smaller outside diameter and wall thickness, thus fizrther reducing trauma and the consequent pain of injection. For these reasons the device is virtually painless in operation.
In its simplest form the device consists only of three parts, two of which can be inexpensive plastic injection-mouldings and the third a simple spring, which can be coiled metal, elastomer or a gas spring. The plastics used have only minor structural requirements and do not need to be expensive "engineering" plastics. The total additional cost of the vaccinator will probably not exceed the original cost of the syringe and needle itself. Thus this device can achieve all of the requirements of safety in injection technology for a modest doubling of the total device cost to around six to ten cents. This should be compared with the $0.20 to $1.50 costs of competitive safety injectors. Unlike other "safety syringes" which require expert handling, the action of the present invention is automatic and the inj ection depth and the dose are pre-determined in the factory making it suitable for use by minimally trained or even untrained personnel.
2 0 It is of course possible to use the same principles of automating the function of a syringe and needle described above, to convert other injection devices such as the plastic blister UnijectT'~ into a safe, comfortable auto inj ector for subcutaneous or intramuscular delivery.
Again, the advantages WO 03/095003 ~ ,~.,E ~I"~~ "'~"'i,,< (~,u~~ ~k;.a~ ''rc' '°PCT/US03/12762::.°.!t S. ~ ~ ~r.al~ :u. S. :..~ s- e..vm of this approach are that the needle is enclosed before, during and after the injection; the whole process of injection is fully automated and the cost of the final device is very modest. The design of such a device is illustrated in Figures 3A through 3F and its mode of action in Figures 4A through 4E. The additional element in the design is a folded, shaped plastic moulding which holds the pre-filled UnijectTM in place in the sheath and which transfers pressure to empty the plastic blister containing the dose at the correct point in the inj ection cycle.
The UnijectTM device shown in Figure 3A is made from two layers of plastic film (1') in which dome shaped depressions are vacuum-formed and which are fused together with the depressions in register so as to form a lenticular cavity; the blister (2'), which is filled with the dose 1 o of medicament. Additionally sealed to the film is a hollow hub (3'), which is separated offinternally from the dose of medicament in the blister by a thin wall of plastic. A needle (4'), which is sharpened at both ends, is accommodated in the hub by means of a plastic collar (5') firmly attached to it near one end; the hub end. The collar (5') is a snug, sliding fit in the hollow hub (3') and can be moved therein to drive the needle towards the blister thus causing the sharp hub-end of the needle to perforate the thin wall of plastic. This penetrates the seal of the blister so that the dose of medicament is able to flow through the needle when it is expelled by pressure on the blister.
Figures 3B and 3C illustrate a plan view and an elevation view, respectively, of a shaped plastic moulding which is used to enclose the UnijectTM device. The shaped plastic moulding is symmetrical about its central axis; the line A-A in Figure 3C. During assembly of the injector, the 2 0 shaped plastic moulding is folded about this axis A-A. An intermediate shape during the folding process is shown in Figure 3 D.
The final folded configuration is shown inside the injection capsule in Figure 3E in which WO 03/095003 ~ ~;,~~ ° ° '°~#~' r~' ~ i~ ~~°
''vt PCT/US03/12762 'f:.°~h a v ~~..': _, .. ' ~:.,a ~,;au ~~,rt~ ,:,:,_ : " ",.w,. ." :"". -t.H~, the shaped plastic moulding (I 1') is illustrated enclosing the Unij ectTM
device (12'). The moulded features of the shaped plastic moulding consist of a curved extension (6'), which is shaped to surround the blister (2') on two sides and to rest on the top of the hub (3') as shown in Fig. 3F.. The curved extension (f) is attached to a dome shaped area (T), which is similar in size but opposite in convexity to the blister. In the storage position in the device (Figures 3E
and 3F) this dome shaped area (T) sits just above the blister in the injector device. The part of the shaped plastic moulding between the curved extension (6') and the dome (7') contains a grooved defect (8'), which weakens the structure so that it will snap at this point and not elsewhere when under a sufficient compressive force. When the shaped plastic moulding is fully folded the area of the moulding adj acent to the 1 o point of folding (10') is fused together, either with heat or adhesive to hold the moulding permanently in the fully folded position.
Figures 3E and 3F illustrate the final inj ector device assembled in the storage configuration.
The whole device is oval in cross section. Figure 3 E is an elevation of the mid point section of the short axis of the oval and Figure 3 F is a mid point section of the long axis of the oval. This convention also applies to Figures 4 A through 4E in which the device is also shown as pairs of views.
Assembly in the factory requires first that the shaped plastic moulding ( 11') is slid sideways over the filled UnijectTM device (12') so that the end of the curved extension (6') is located resting on the top of the hub (3') and enclosing the blister (2'). The enclosed UnijectTM is then inserted into 2 o the barrel (13') of the injector supported by a return spring (14'). The cap (15') which contains two sets of snap tabs (16') and (1 T) is then pushed over the barrel ( 13') until the first set of snap tabs (16') locates at the top of the barrel and the lock ring (18') of the cap engages with the underside of the WO 03/095003 ~ °~;t ~f=Y °~[t," ~:'~ ~x~E''~.~E ~',~'..1~
"pCT/US03/12762 ~,e";' .,z,., . ,.."
widened part of the upper end of the barrel. At this point, the second set of snap tabs (1T) also rests upon the free end of the folding (10') of the shaped plastic moulding (11') thus holding the enclosed UnijectTM snugly in place. The barrel also carries a lock ring (19') at its distal end, which will lock the cap in the closed position after use. The device is sealed against contamination and the interior maintained sterile by an adhesive transfer foil (20') having a pull tab at one end. The transfer foil (20') is applied to the distal free end of the device.
In use, the adhesive transfer foil (20') is removed from the distal free end of the device thereby transferring a Iayer of adhesive to the free end of the device. The distal free end of the device is pressed against the skin (22') of the patient (Figure 4A(1) and 4A(2)) by modest hand l0 pressure applied to the free end (21') of the cap. The layer of adhesive serves to fix the device in position even on wet skin thus preventing slippage and damage to the patient's skin as the pressure on the cap is increase by the operator until the first set ofbreak tabs (16') yield (Figure 4A(2)). This suddenly frees the cap (15') to slide telescopically over the barrel (13').
This causes the second set of break tabs (1 T) to press on the free end of the folding (10') of the shaped plastic moulding which transmits this pressure via the shaped extension (6') to the top of the hub (3'). Downward movement of the hub compresses the spring ( 14') and pushes the needle into the subcutaneous tissues (23') until the plastic collar (5') on the needle bottoms out in the barrel (Figures 4 B(1) and 4B(2)). Continued downward movement forces the collar inside the hollow hub (3') towards the blister causing the sharp hub-end of the needle to penetrate the thin plastic wall sealing the blister and giving the dose 2 0 of medicament (2') access to the needle (4'). The movement of the collar inside the hollow hub stops when the collar is flush with the bottom of the hollow hub as the hub (3') in turn bottoms out in the bairel (13') (Figures 4C(1) and 4C(2,)). The bottoming out of the hub (3') causes a sudden increase WO 03/095003 ~ ;~:.E ~;~.,( ...~.a[ :. ~~ ,,},~t:a }t ...t#
t.;"',pCT/US03/12762t~
?n.t vxt aaaa'tss.t a-.ss?~ s- 0..ttu tCU,sn S~' ~fntr t4 in compressive force on the curved extension (6') causing the weakened area (24') of grooved defect (8') to break (Figure 4 D(1)). This causes the shaped plastic moulding (11') to slide over the UnijectTM (12') until the dome (T) comes into register with, and presses on, the blister (2') discharging its contents ofmedicament through the needle (4') into the subcutaneous tissue ormuscle S Iayer (25') (Figures 4 D(1) and 4D(2)). When the dome (T) is fully in register with the blister (2') the UnijectTM is entirely engulfed by the shaped plastic moulding and no further downward movement of the enclosed UnijectTM is possible causing an increase in pressure on the second set of break tabs (1 T).
The top of the barrel then also presses on the underside of the second set of break tabs (1 T) greatlyincreasing the force on them and causing them to, give way (Figures 4 D(1) and 4D(2)). This thereby releases all downward pressuxe on the enclosed UnijectTM. The return spring (14') then causes the enclosed UnijectTM to move suddenly into the cap as the final downward movement of the cap (I5') over the barrel housing (13') causes the cap lock ring (18') to engage the barrel lock ring (19') thus securely locking the device shut and preventing any possibility of contact with the used needle (Figures 4 E(1) and 4E(2)). Appropriate design of the device can ensure that the free end (10') of the shaped plastic moulding (11') strikes the underside of the cap giving a tactile and audible signal to the operator that the needle is fully retracted in a safe manner. If the cap (15') is made from transparent or translucent plastic, the safe retraction of the needle can be cor~f'umed visually before the device is peeled from the patient's skin for disposal.
2 0 It is important to emphasize that the full sequence of a safe and effective injection with both devices described herein is achieved with a simple, single downward thrust. No separate operator manipulations are required to insert the needle, deliver the injection or withdraw the needle; all of WO 03/095003 ~ ;;;=fE ~ ~ °°2°° ..~ r. ;q ,°~°~_ ~°~~ ~ °pCT/US03/12762' ::~~
h.. ~~ ~~:u. tf ,:~ ~",~- .:::.e t~,:lE ,.".~. ,: .. .,_ ._"", .. ".~ ~f;.,:.
which happen automatically during the single downward movement of the cap from the open to the locked position. After use the devices are locked in a safe configuration with no possibility of needlestick injury. This absence of any requirement for operator training or skill makes the present invention ideal for use by untrained personnel and even possibly for over the counter (OTC) sales to the general public.
The foregoing description should be considered as illustrative only of the principles of the invention. Since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and, accordingly, all suitable modifications and equivalents may be resorted to, falling within the 1 o scope of the invention.
Claims (20)
1. A single use injector device for dispensing mediation from a pre-filled syringe and sealing the syringe in the device after use, the pre-filled syringe including a barrel open with a flange at one end and having a needle mounted in a hub at an opposite end, a plunger slidably mounted in the barrel having a stopper at one end engaging a predetermined dose of a drug and a flange at an opposite end, the single use injector device comprising:
a housing, a spring located in a lumen of the housing for engaging the hub of the barrel of the syringe, and a cap slidably mounted on the housing for progressively moving along a longitudinal axis of the housing while the needle of the syringe is moved from an interior of the housing to an exterior of the housing and delivery of the predetermined dose of the drug and retraction of the needle into the housing after use to prevent exposure to the used needle.
a housing, a spring located in a lumen of the housing for engaging the hub of the barrel of the syringe, and a cap slidably mounted on the housing for progressively moving along a longitudinal axis of the housing while the needle of the syringe is moved from an interior of the housing to an exterior of the housing and delivery of the predetermined dose of the drug and retraction of the needle into the housing after use to prevent exposure to the used needle.
2. The single use injector device as claimed in claim 1, wherein one end of said housing is sealed with an adherent foil having a pull-tab for removal of the foil and leaving an exposed adhesive surface at the one end of the housing.
3. The single use injector device as claimed in claim 1, wherein said cap includes three sets of break tabs.
4. The single use injector device as claimed in claim 3, wherein a first set of said three sets of break tabs engages one end of the housing prior to movement of the syringe in the housing.
5. The single use injector device as claimed in claim 4, wherein a second set of said three sets of break tabs engages the flange of the barrel of the syringe after the first set of break tabs is broken by movement of the cap.
6. The single use injector device as claimed in claim 5, wherein a third set of said three sets of break tabs engages the flange of the plunger of the syringe after the first set and the second set of break tabs are broken.
7. The single use injector device as claimed in claim 6, wherein the third set of said three sets of break tabs are broken upon movement of the cap along the barrel after breaking of the first and second sets of break tabs.
8. The single use injector device as claimed in claim 7, wherein the spring retracts the needle into the housing and moves the plunger and the barrel of the syringe up into the cap after the third set of break tabs is broken.
9. The single use injector device as claimed in claim 8, wherein a locking ring of the cap engages a locking ring of the housing to lock the cap and housing together after extension and retraction of the needle from the housing to prevent exposure to the used needle.
10. The single use injector device as claimed in claim 7, wherein the first set of break tabs project into the interior of the cap less than the second and third sets and the second set projects into the interior of the cap less than the third set of break tabs.
11. A single use injector device for dispensing medication from a pre-filled syringe and sealing the syringe in the device after use, the pre-filled syringe including a blister having a predetermined dose of a drug, a hollow hub, a collar and a needle mounted on the collar, the single use injector comprising:
a shaped moulding for engaging the blister, a barrel, a spring located in the barrel, and a cap slidably mounted on the barrel to progressively moving along a longitudinal axis of the barrel while the needle of the syringe is moved from an interior of the barrel to an exterior of the barrel and delivery of the predetermined dose of the drug and retraction of the needle into the barrel after use to prevent exposure to the used needle.
a shaped moulding for engaging the blister, a barrel, a spring located in the barrel, and a cap slidably mounted on the barrel to progressively moving along a longitudinal axis of the barrel while the needle of the syringe is moved from an interior of the barrel to an exterior of the barrel and delivery of the predetermined dose of the drug and retraction of the needle into the barrel after use to prevent exposure to the used needle.
12. A single use injector device as claimed in claim 11, wherein one end of said barrel is sealed with an adherent foil having a pull-tab for removal of the foil and leaving an exposed adhesive surface at the one end of the barrel.
13. A single use injector device as claimed in claim 11, wherein said cap includes two sets of break tabs.
14. A single use injector device,as claimed in claim 13, wherein a first set of said two sets of break tabs engages one end of said barrel prior to movement of the syringe in the barrel.
15. A single use injector device as claimed in claim 14, wherein a second set of said two sets of break tabs engages an end of said syringe opposite to the needle and moves a dome shaped area of the shaped moulding to squeeze said blister after breakage of the first set of break tabs.
16. A single use injector device as claimed in claim 15, wherein continued movement of the cap with respect to the barrel after breakage of the first set of tabs causes breakage of the second set of tabs and movement of the syringe into the cap and retraction of the needle by a bias force of the spring.
17. A single use injector device as claimed in claim 11, wherein the moulding includes two curved extensions.
18. A single use injector device as claimed in claim 17, wherein the curved extensions each include a grooved defect.
19. A single use injector device as claimed in claim 11, wherein the moulding is folded in half.
20. A single use injector device as claimed in claim 11, wherein movement of the cap with respect to the barrel causes one end of the needle to puncture a patient's skin and an opposite end of the needle punctures the blister containing the drug by extension of the needle through the hollow hub.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US10/141,968 US6808507B2 (en) | 2002-05-10 | 2002-05-10 | Safety injectors |
| US10/141,968 | 2002-05-10 | ||
| PCT/US2003/012762 WO2003095003A1 (en) | 2002-05-10 | 2003-04-24 | Safety injectors |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2484817A1 true CA2484817A1 (en) | 2003-11-20 |
Family
ID=29399777
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002484817A Abandoned CA2484817A1 (en) | 2002-05-10 | 2003-04-24 | Safety injectors |
Country Status (9)
| Country | Link |
|---|---|
| US (1) | US6808507B2 (en) |
| EP (1) | EP1506028A1 (en) |
| KR (1) | KR20050025179A (en) |
| CN (1) | CN100339137C (en) |
| AU (1) | AU2003223720B2 (en) |
| CA (1) | CA2484817A1 (en) |
| RU (1) | RU2300396C2 (en) |
| WO (1) | WO2003095003A1 (en) |
| ZA (1) | ZA200409474B (en) |
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-
2002
- 2002-05-10 US US10/141,968 patent/US6808507B2/en not_active Expired - Fee Related
-
2003
- 2003-04-24 KR KR1020047018131A patent/KR20050025179A/en not_active Application Discontinuation
- 2003-04-24 WO PCT/US2003/012762 patent/WO2003095003A1/en not_active Application Discontinuation
- 2003-04-24 CA CA002484817A patent/CA2484817A1/en not_active Abandoned
- 2003-04-24 RU RU2004136169/14A patent/RU2300396C2/en not_active IP Right Cessation
- 2003-04-24 EP EP03719921A patent/EP1506028A1/en not_active Withdrawn
- 2003-04-24 AU AU2003223720A patent/AU2003223720B2/en not_active Ceased
- 2003-04-24 CN CNB038105659A patent/CN100339137C/en not_active Expired - Fee Related
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2004
- 2004-11-24 ZA ZA200409474A patent/ZA200409474B/en unknown
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|---|---|
| AU2003223720B2 (en) | 2008-12-04 |
| RU2004136169A (en) | 2005-07-10 |
| CN100339137C (en) | 2007-09-26 |
| CN1652834A (en) | 2005-08-10 |
| ZA200409474B (en) | 2006-06-28 |
| US20030212362A1 (en) | 2003-11-13 |
| WO2003095003A1 (en) | 2003-11-20 |
| EP1506028A1 (en) | 2005-02-16 |
| KR20050025179A (en) | 2005-03-11 |
| AU2003223720A1 (en) | 2003-11-11 |
| US6808507B2 (en) | 2004-10-26 |
| RU2300396C2 (en) | 2007-06-10 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| FZDE | Discontinued |
Effective date: 20130715 |