WO2006018626A1 - Injection apparatus - Google Patents
Injection apparatus Download PDFInfo
- Publication number
- WO2006018626A1 WO2006018626A1 PCT/GB2005/003201 GB2005003201W WO2006018626A1 WO 2006018626 A1 WO2006018626 A1 WO 2006018626A1 GB 2005003201 W GB2005003201 W GB 2005003201W WO 2006018626 A1 WO2006018626 A1 WO 2006018626A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- sleeve
- needle assembly
- safety needle
- cap
- injection apparatus
- Prior art date
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
- A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used 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
- A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
-
- 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
- A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
- A61M2005/3247—Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
-
- 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
-
- 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
-
- 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
- A61M5/5086—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 for indicating if defective, used, tampered with or unsterile
Definitions
- This invention relates to injection apparatus and in particular to injection apparatus comprising a pre-filled injector together with a packaging sleeve therefor.
- Medicaments in the form of a liquid may be administered to a human or animal body by means of an injector having a hollow needle, the injector including a source of the medicament.
- the injector may be in the form of a small volume syringe holding the liquid medicament, the needle projecting from the forward end of the syringe and used to penetrate the body at the site at which the medicament is to be received.
- Self administration has the advantage that a patient may perform the required injections wherever that patient happens to be, without the need to seek the services of a medically-qualified person. Also, self-injection reduces the work-load on the medical services.
- an important part of an injection procedure is the safe disposal of the used injector and needle. In the case of self-administration, this becomes even more important, as non-qualified people could come into contact with the used equipment.
- the present invention stems from research into ways in which an injection apparatus may be supplied to a patient ready to perform a self- administered injection, or to a person who will administer an injection to the patient, and then to dispose of the used apparatus, minimising the risk both to the patient and others from the used syringe and needle.
- injection apparatus comprising:
- an injector pre-filled with a medicament and including a cylindrical body provided with a safety needle assembly on its forward end and having a plunger projecting from its rearward end which plunger is provided with a piston for expelling medicament out of the safety needle assembly; - a sleeve open at one end and closed at the other end, the syringe initially being located in the sleeve with the plunger nearer the closed end of the sleeve and the safety needle assembly projecting from the open end of the sleeve;
- a cap adapted to be fitted to the open end of the sleeve, the cap being configured to receive the safety needle assembly when fitted to the sleeve accommodating the syringe;
- the syringe may be removed from the sleeve and the cap from the safety needle assembly so permitting the syringe to be used to perform an injection, whereafter the syringe may be reinserted into the sleeve with the safety needle assembly nearer the closed end thereof, the co-operable retaining means then serving to retain the safety needle assembly in the sleeve.
- the used syringe and needle may be disposed of in a safe manner, using the packaging in which the syringe and safety needle assembly were supplied, so minimising the risk of injury either to the patient or others.
- the injector used in this invention may be an essentially conventional pre-filled syringe.
- the injector may have a cylindrical body typically of glass together with a plunger having a piston disposed within the cylindrical body whereby depression of the plunger expels medicament contained within the body.
- a needle maybe pre-fitted to the forward end of the body during the manufacture of the syringe, before filling.
- the safety needle assembly may take any known suitable form, and typically will have a sleeve which normally is in a projecting position where the sleeve surrounds and projects beyond the needle. The sleeve may be withdrawn from this projecting position so as to expose the needle and so permit the making of an injection. Then, following performance of the injection, the sleeve may move forward once more so as again to surround the needle, the sleeve then automatically locking-out so that it may not be withdrawn for a second time.
- Such safety needle assemblies are known in the art and will not be described in further detail here.
- the needle may be a part of the safety needle assembly, which assembly is fitted to the injector body following filling of the body with the medicament. Either way, the combination of the injector and the safety needle assembly is essentially the same and performs the same function.
- the sleeve employed in this invention may be a simple tubular sleeve closed at one end and of a sufficient diameter to accommodate the injector body and the safety needle assembly fitted thereto.
- the length of the sleeve should be sufficient for the plunger to be accommodated in its initial projecting condition (i.e. before depression), but with at least a part if not all of the safety needle assembly projecting from the sleeve.
- a short portion of the safety needle assembly may be disposed within the sleeve, with the injection apparatus in its initial condition.
- the cap must have a sufficient diameter to accommodate the safety needle assembly and also must be connectible to the open end of the sleeve. - A -
- the cap may have a closed end and an open end, the open end being inter-engageable with the open end of the sleeve.
- the respective open ends may be provided with one of a simple plug-in connection, a screw-threaded connection, a bayonet connection and a snap-fitting connection.
- the sealing means may perform three distinct functions. Firstly, the sealing means may serve to hold the cap to the sleeve or to prevent release of the cap from the sleeve, prior to use of the injection apparatus. Secondly, the sealing means may serve as a tamper-evident seal, such that it will be entirely obvious to an intending user if the cap has been removed from the sleeve, so giving access to the injector, prior to the intended first use of the injector. Thirdly, the sealing means may provide an essentially hermetic seal, in order to ensure the environment within the sleeve and cap remains sterile, until the injector is to be used.
- a frangible or strippable seal wrapped wholly around and adhered to the junction between the sleeve and the cap.
- a seal advantageously is of a paper or plastics material and further carries relevant data such as the nature of the contained medicament and its volume, date of manufacture, and so on.
- the co-operable retaining means provided between the safety needle assembly and the sleeve conveniently is defined by the provision of an interference fit between the outer surface of the safety needle assembly and the inner surface of the sleeve, in the region of the closed end thereof.
- an annular rib may be formed internally within the sleeve, at such a location that the safety needle assembly may pass over that rib and a shoulder of that assembly then locates behind the rib so as thereafter to resist withdrawal of the assembly from the sleeve.
- the shoulder may be formed by a rear end plane of the safety needle assembly or by a groove formed therearound, within which the rib may locate.
- the safety needle assembly may have a barb-like formation on the outer surface thereof which formation is inter-engageable with a corresponding formation on the inner surface of the sleeve, in the region of the closed end thereof.
- Figure 1 is an isometric view of the apparatus in its initial condition but with the cap partly cut away to show certain internal details;
- Figure 2 shows the apparatus of Figure 1 , but with the injector and cap removed from the sleeve;
- Figure 3 shows the injector with the cap removed therefrom
- Figures 4, 5 and 6 show successive stages in the administering of an injection with the injector;
- Figure 7 shows the used injector being re-inserted into the sleeve, with the safety needle assembly leading;
- Figure 8 is a part-sectional view, showing the used injector fully accommodated within the sleeve.
- Figure 9 shows the cap re-fitted to the sleeve such that the entire assembly is now ready for disposal.
- FIG. 1 shows the initial assembly of the embodiment of injection apparatus of this invention, partly in section.
- This assembly comprises a tubular sleeve 10 having a closed end 11 and an open end 12.
- a cap 13 is fitted to the open end, that cap also having a closed end 14 and an open end 15.
- At the open end of the cap there is a projecting rim 16 of a reduced diameter, for accommodation within the open end 12 of the tubular sleeve 10.
- the rim 16 may be provided with an external screw-thread, engageable with an internal screw-thread formed within the open end of the sleeve.
- An adhesive plastic seal 17 extends around and bridges the junction between the sleeve 10 and the cap 13. That presence of that seal thus indicates that the cap has not previously been removed from the sleeve and further serves to provide a hermetic seal to ensure the content of the sleeve remains in a sterile condition.
- the injector comprises a tubular body 19 containing a medicament to be injected, a plunger 20 extending away from the rearward end of the body and having a piston provided within the body so that depression of the plunger will expel contained medicament out of the forward end of the body.
- the cap 13 is then removed from the forward end of the injector ( Figure
- a safety needle assembly 22 Such an assembly may take any known form and typically has a tubular guard 23 which projects forwardly from the injector body, so as to protect a needle 24 contained therewithin.
- the sleeve may move rearwardly from this initial position of Figure 3, as shown in Figure 4, so as to expose the needle and thus permit the performance of an injection, by depressing the plunger 20 into the injector body 19 ( Figure 6).
- the tubular guard 23 On completion of the injection and removal of the syringe from the injection site, the tubular guard 23 may move forwardly once more ( Figure 6) so as once more to surround and protect a needle contained therewithin, the guard 23 then locking out so as to be prevented from moving rearwardly for a second time.
- the injector assembly is then offered to the sleeve 10 but with the safety needle assembly 23 leading, so as to enter the open end 12 of the sleeve (Figure 7).
- the injector is pushed fully into that sleeve ( Figure 8), the safety needle assembly 22 riding over an annular rib, shoulder or similar abutment 25 provided within the sleeve at a distance from the closed end thereof slightly greater than the length of the safety needle assembly.
- the safety needle assembly will be disposed wholly beyond the rib 25 which should be profiled to trap the safety needle assembly within the sleeve.
- the entire injector assembly is disposed within the sleeve. Any attempt to remove the assembly for example by pulling on the head 26 of the plunger (being the most accessible component) will simply pull the plunger out of the syringe body 19.
- the cap 13 may be re-fitted to the sleeve as shown in Figure 9 so making a compact package wholly containing the used injector, ready for disposal.
- the assembly as shown in Figure 9 essentially corresponds to the initial condition as shown in Figure 1 , except that the seal 17 has been broken, in Figure 9.
- a tube 28 projects internally from the closed end 14 of the cap 13 and accommodates the needle 24, until the cap is removed from the safety needle assembly. That tube 28 may also serve to maintain the safety needle assembly in an initial condition and to prevent the assembly locking out for example during transit, which otherwise might render the injector unusable.
- the tube 28 contains a plug 29 of soft pliable material such as of silicone rubber, to effect a seal to the needle, thereby to prevent medicament leaking out of the needle and also to prevent the medicament being contaminated by the ingress of foreign matter through the needle.
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Diabetes (AREA)
- Environmental & Geological Engineering (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
Description
Claims
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP05775246A EP1796764A1 (en) | 2004-08-18 | 2005-08-17 | Injection apparatus |
US11/675,743 US7815610B2 (en) | 2004-08-18 | 2007-02-16 | Injection apparatus |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB0418389.3 | 2004-08-18 | ||
GBGB0418389.3A GB0418389D0 (en) | 2004-08-18 | 2004-08-18 | Injection apparatus |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2006018626A1 true WO2006018626A1 (en) | 2006-02-23 |
Family
ID=33042232
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/GB2005/003201 WO2006018626A1 (en) | 2004-08-18 | 2005-08-17 | Injection apparatus |
Country Status (4)
Country | Link |
---|---|
US (1) | US7815610B2 (en) |
EP (1) | EP1796764A1 (en) |
GB (1) | GB0418389D0 (en) |
WO (1) | WO2006018626A1 (en) |
Cited By (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2008004976A1 (en) * | 2006-07-07 | 2008-01-10 | Insulution Svenska Ab | Syringe, capsule device therefore, and syringe device |
WO2009092430A1 (en) * | 2008-01-24 | 2009-07-30 | Arzneimittel Gmbh Apotheker Vetter & Co. Ravensburg | Syringe system and method for the production thereof |
WO2010081838A3 (en) * | 2009-01-14 | 2010-09-23 | Novartis Ag | Encasing a sterile prefilled container |
US8632503B2 (en) | 2008-03-13 | 2014-01-21 | Becton, Dickinson And Company | Safety pen needle assembly having shielding for patient and non-patient ends |
US8801673B2 (en) | 2008-03-13 | 2014-08-12 | Becton Dickinson & Company | Safety pen needle assembly having shield for non-patient end |
WO2017009763A1 (en) * | 2015-07-10 | 2017-01-19 | Fresenius Kabi Deutschland Gmbh | Syringe packaging system |
US9623194B2 (en) | 2013-12-10 | 2017-04-18 | Becton, Dickinson And Company | Passive safety pen needle assembly |
US9642971B2 (en) | 2008-03-13 | 2017-05-09 | Becton, Dickinson And Company | Safety needle assembly |
US9649452B2 (en) | 2013-12-10 | 2017-05-16 | Becton, Dickinson And Company | Active safety pen needle assembly |
US10052437B2 (en) | 2015-07-10 | 2018-08-21 | Fresenius Kabi Deutschland Gmbh | Syringe packaging system and shell |
US10814059B2 (en) | 2015-07-10 | 2020-10-27 | Fresenius Kabi Deutschland Gmbh | Syringe packaging system |
US12005238B2 (en) | 2020-10-20 | 2024-06-11 | Fresenius Kabi Usa, Llc | Impact resistant and tamper evident system for prefilled syringe |
Families Citing this family (4)
Publication number | Priority date | Publication date | Assignee | Title |
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US9526846B2 (en) | 2009-08-19 | 2016-12-27 | Safety Syringes, Inc. | Patient-contact activated needle stick safety device |
US9597455B2 (en) * | 2011-09-30 | 2017-03-21 | Becton Dickinson France S.A.S. | Syringe having a spring action plunger rod |
US11052201B2 (en) * | 2018-12-17 | 2021-07-06 | Verena Solutions LLC | Protective cover for a dental syringe needle |
KR102449080B1 (en) | 2019-03-29 | 2022-10-04 | 일라이 릴리 앤드 캄파니 | Drug delivery systems and methods |
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-
2004
- 2004-08-18 GB GBGB0418389.3A patent/GB0418389D0/en not_active Ceased
-
2005
- 2005-08-17 WO PCT/GB2005/003201 patent/WO2006018626A1/en active Application Filing
- 2005-08-17 EP EP05775246A patent/EP1796764A1/en not_active Withdrawn
-
2007
- 2007-02-16 US US11/675,743 patent/US7815610B2/en not_active Expired - Fee Related
Patent Citations (7)
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Also Published As
Publication number | Publication date |
---|---|
US20070156101A1 (en) | 2007-07-05 |
GB0418389D0 (en) | 2004-09-22 |
US7815610B2 (en) | 2010-10-19 |
EP1796764A1 (en) | 2007-06-20 |
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