CA2131324A1 - Hard cover for protected injection apparatus - Google Patents
Hard cover for protected injection apparatusInfo
- Publication number
- CA2131324A1 CA2131324A1 CA002131324A CA2131324A CA2131324A1 CA 2131324 A1 CA2131324 A1 CA 2131324A1 CA 002131324 A CA002131324 A CA 002131324A CA 2131324 A CA2131324 A CA 2131324A CA 2131324 A1 CA2131324 A1 CA 2131324A1
- Authority
- CA
- Canada
- Prior art keywords
- needle
- cover
- protective sleeve
- base
- medical device
- 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
- A61M5/32—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
- A61M5/3202—Devices for protection of the needle before use, e.g. caps
-
- 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
- A61M5/3213—Caps placed axially onto the needle, e.g. equipped with finger protection guards
-
- 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
- A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
- A61M2005/3107—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle for needles
- A61M2005/3109—Caps sealing the needle bore by use of, e.g. air-hardening adhesive, elastomer or epoxy resin
-
- 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
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)
- Environmental & Geological Engineering (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
2131324 9317739 PCTABS00025 This invention is directed to covers for holding and protecting needles of medical devices prior to use. It includes covers for holding and protecting needles of medical devices in which the needles are, in turn, contained within a retractable protective sleeve. In such case, the needle (16) and its protective sleeve (46) are held within the cover by a wedging action of a base portion with the cover. The cover contains projections which grip the base so that the needle and its protective sleeve can be turned with the cover to twist them on and off of the medical device safely.
Longitudinal vanes (92) in the cover can be included to hold a spring (88) and locking collar (86) over the protective sleeve in a retracted state prior to use. A cap with a flat end and square shoulders is aligned with a flat side of the cover and the entirety closed with a frangible security strip to indicate any possible tampering prior to use.
Longitudinal vanes (92) in the cover can be included to hold a spring (88) and locking collar (86) over the protective sleeve in a retracted state prior to use. A cap with a flat end and square shoulders is aligned with a flat side of the cover and the entirety closed with a frangible security strip to indicate any possible tampering prior to use.
Description
r WO 93/17739 ~, ~ 3 1 ~ 2 ~ PCI/US93/02081 I~ARE) COVER FOR l'ROTECTED INJI~CTION APPAR~TUS
BACKGROUND OF THE INVENTION:
This invention relates to medical devices for injecting living bodies and, more particularly, to covers for holding and protec~ing needles of medical devices prior to use.
In United States Patent No. 4,998,922 by Thomas C.
~Kuracina entitled SAFETY SYRINGE CAP MINIMIZING
NEEDLE-STICK PROBABILITY which issued 12 March 1991, a safety device for hypodermic needJes and the like is shown.
The inventions shown hereinafter are improvements thereto by 15 inventors including and/or working with Mr. Kuracina. ln the interest of simplicity herein, the teachings of that patent are incorporated herein by reference and the discussion of the background art will be kept to a minimum.
A typical prior art hypodermic syringe 10 as shown in 20 Figure 1 includes a barrel 12 having a moving plunger 14 therein. A needle 16 having a sharp b~eled tip 18 extends ~rom the end opposite the end of the barrel 12 into which the plunger 14 is inserted. The needle 16 is covered by a removeable cap 20 for safe~y purposes. The problem to be solved and avoided is ~5 the accidental sticking of users of the syringe 10 by the tip 18 after use where the tip 18 may carry body fluids containing agen~s of hepatitis B, AIDS, and the like. Accidental needle s~ick is a very common problem in the heal~h care industry and besides the risk of serious illness or even death as a result 30 therec)f, the insurance industry spends over a billion dollars a year in the testing of individuals who have been subjected to post-use needle stick.
The ;1979 patent of Alvarez proposed a retractable plastic p~otective sleeve over the needle. The Alvarez sleeve has an 35 inner hub which fits around the base of the needle and an outer WO 93/17739 PCI`/US93/O~.Q81
BACKGROUND OF THE INVENTION:
This invention relates to medical devices for injecting living bodies and, more particularly, to covers for holding and protec~ing needles of medical devices prior to use.
In United States Patent No. 4,998,922 by Thomas C.
~Kuracina entitled SAFETY SYRINGE CAP MINIMIZING
NEEDLE-STICK PROBABILITY which issued 12 March 1991, a safety device for hypodermic needJes and the like is shown.
The inventions shown hereinafter are improvements thereto by 15 inventors including and/or working with Mr. Kuracina. ln the interest of simplicity herein, the teachings of that patent are incorporated herein by reference and the discussion of the background art will be kept to a minimum.
A typical prior art hypodermic syringe 10 as shown in 20 Figure 1 includes a barrel 12 having a moving plunger 14 therein. A needle 16 having a sharp b~eled tip 18 extends ~rom the end opposite the end of the barrel 12 into which the plunger 14 is inserted. The needle 16 is covered by a removeable cap 20 for safe~y purposes. The problem to be solved and avoided is ~5 the accidental sticking of users of the syringe 10 by the tip 18 after use where the tip 18 may carry body fluids containing agen~s of hepatitis B, AIDS, and the like. Accidental needle s~ick is a very common problem in the heal~h care industry and besides the risk of serious illness or even death as a result 30 therec)f, the insurance industry spends over a billion dollars a year in the testing of individuals who have been subjected to post-use needle stick.
The ;1979 patent of Alvarez proposed a retractable plastic p~otective sleeve over the needle. The Alvarez sleeve has an 35 inner hub which fits around the base of the needle and an outer WO 93/17739 PCI`/US93/O~.Q81
2 ~ 3132 l hub through which the tip of the needle passes. The inner and outer hubs are connected by cun~ed slats. When the needle is to be inserted into the body of a patient, the force required to move the sleeve from its extended position to its retracted 5 position can be depicted as a straight line beginning with ve~y liltle required ~orce to initiate movement. Thus, there is really no actualiy safety from a large variety of ways in which accidental needle stick takes place. Even if the sleeve fu]ly extends after use, a slight blow against a user or observer in the 10 area will cau.se the sleeve to retract and the tip to stick the - unfortunate person.
With respect to the action of the basic protective sleeve of the above-referenced Kuracina patent by comparison, a high degree of force is required to move the protective sleeve from 15 its extended position covering the tip. Moreover, a spring-biased locking collar is added over the protective sleeve which all but prevents the protective sleeve from moving from its ex~ended position covering the tip. The collar must be moved from its locked position to a retracted~, unlocked position before 20 the unique deformation qualities of the sleeve take ef~ect. After use, the locking collar springs back to its locked position. Thus, in virtual~y all "accidental" contact with the tip end of a hypodermic syringe, actual penetration by the tip should be prevented.
ln a co-pending application- entitled MEDlCAL
lNJECllON DEVlCES WITH SAFETY FEATURES filed on even date herewi~h, certain improvements to the Kuracina protec~ive sleeve are disclosed. The inventions described hereinafter are protective hard covers intended to make the 30 Kuracina protective sleeve even safer and more easy to use whi~e also adapting it to various mounting configurations.
Embodin~ents of the protective hard covers also have certain benefits when employed with conventional injection devices as well.
r WO 93/17739 2 1 3 1 3 ~ ~1 PCI`/US93/02081 O~her objects and benefits of tlle inventions disclosed herein will become apparent from the detailed description which ~ollows hereinafter when taken in conjunction with the drawing rlgures which accompany it.
Sl;JM~ARY:
The foregoing object has been achieved in a medical device having a needJe carried by a base twistedly attached to the rnedical device, by the improvement for pro~ectively capping 10 the needle and providing ease of attachment and disattachment - of the needle of the present invention comprising, the base having a plurality of radial longitudinal vanes; and, a hollow cover sized to fit over the needle and the plurality of radial longitudinal vanes, the cover having a closed end and an 15 inwardly tapering open end into which the plurality of radial longitudinal vanes wedgedly fit to hold the base and the needle in the cover, the cover further having at least one inward projection contacting a side surface of one o the plurality of radial longitudinal vanes whereby a user can twist the base to 20 attach and disattach the needle by twisting the cover.
Preferably, there is also a cap for closing the open end, the cap having a tapered inner portion shaped to wedgedly fit into the open end. Also, the preferred cap has a square shouldered outer portion abutting the tapered inner portion whereby the 25 tapered inner portion can be twisted to remove it from the open end and ~he cap and the cover in combination are prevented from rolling oif of ~lat surfaces.
For added security, the cap has a flat outer end surface opposite the tapered inner portion; the c~ver has a flat 30 longitudinal outer sidewall aligned with a flat side of the square shouldered outer portion; and, there is a safety strip of a ~rangi~le material adhesively attached to and over the flat outer end surface, the Dat side of the square shouldered outer portion, and the flat longitudinal outer sidewall when the cover WO 93/17739 PCI'/US93/17Q~l ~-'13132/1 -~
and cap contain a sterile needle whereby breaking of the safety str;p prior to use indicates possible lack of sterility of the needle.
ln any cover for a pre-filled medical device needle, an elastomeric material having the qualities of silicone rubber may 5 be disposed wi~hin the closed end of the cover and in contact with a tip portion of a needle contained within the cover to seal Ihe tip portion against leakage.
ln any cover for a medical device needle, there may be a pierceable capsule carried by an outer surface of a closed end of 10 the cover and containing a needle-sealing material therein whereby a needlé contained within the cover can be sealed agains~ further use by inserting a tip portion thereof through the capsule into the needle-sealing ma$erial. In one embodiment, the closed end of the cover has funnel-shaped sidewall means 15 surrounding the pierceable capsule for guiding the tip portion of the needle into the pierceable capsule and the needle-sealing material contained therein. In another embodiment where the tip portion of the needle is dispos~d within a ~ell-shaped end of a protective sleeve, the pierceable ~apsule has a surface shaped 20 ~O fit into the bell-shaped end whereby the tip portion of the needle can pierce the capsule without the protective sleeve being retracted.
Where the needle has a retractable protective sleeve disposed thereover with a bias spring and locking collar disposed 25 o~er the retractable protective sleeve, including at least one v~rtical shoulder disposed inside the cover adjacent the open end holds the locking collar and the spring in a retracted position prior to use.
30 DESCRIPTlON OF THE DRAWINGS:
Figure 1 is a simplified, partially cutaway drawing of a prior art hypodermic syringe with a removeable protective cap.
Figure 2 is an end view of the needle-carrying inner hub of protec~ive sleeve assembly.
. , ,, , , , , ~ . .
` WO 93/17739 2 1 ~ i 3 2 ~ PCI'/US93/02081 .
Figure 3 is a cutaway drawing through the cap-carrying collar of a protective sleeve assembly.
Figure 4 is an exploded view of the cap-carrying collar and the needle-carrying inner hub in an aligned configuration.
Figure 5 is a partially cutaway view of a protective sleeve assembly with the addition of a preferred protective hard cover.
Figure 6 is a partial}y cutaway view of the preferred pro~ective hard cover of Figure 5 with the associated end cap thereof.
Figure 7 is a side view of the protective hard cover of Figure 5 with the end cap of Figure 6 attached thereto.
Figure 8 is an inner plan view of the end cap of Figure 6.
Figure 9 is a cutaway drawing through the body of the hard cover of Figure 7 at IX.
Figure 10 is a partial side view of the assembled hard cover and cap of Figure 7 with the addition of a frangible safety strip. ;
Figure 11 is a partially cutaway drawing of a hypodermic syringe employing a Kuracina type protective sleeve with a hard 20 cover according to the present invention disposed thereover in an embodiment including a seal for sealing the end of the needle when the syringe is shipped pre-filled.
Figure 12 is a partially cutaway drawing of a standard, unprotected hypodermic syringe with a hard cover according to 25 the present invention disposed thereover in an embodiment including a seal for sealing the end of the needle when the syringe is shipped pre-filled.
Figure 13 is a drawing of a portion of the hard cover of Figure 11 depicting the addition of a compartnient containing a r 30 sealing compound for rendering the needle and thereby the syringesunusableaf~er use.
Figure 14 is a drawing ~ï a portion of the hard cover of Figure 12 depicting ~he addition of a compartment containing a WO93/17739 2~ 31324 Pcr/uss3/o(nxl sealing compound for rendering the needle and thereby the syringe unusable a~ter use.
Figure 15 is a partially cutaway drawing of a hypodermic syringe employing a Kuracina type protective sleeve with a hard 5 co~er according to the present invention disposed thereover in an embodiment including longitudinal vanes for retaining the locking collar in a retracted position prior to use.
Figure 16 is a cutaway view through the apparatus of Figure 15 at XVI.
DESCRIPTlON ~F THE PREFERRED EMBODIMENTS:
Typically, in a prior art hypodermic syringe, the needle base is mounted over a cylindrical projection extending from the bar~el. In an embodiment of co-pending application entitled MEDlCAL lNJECTlON DEVlCES WITH SAFETY
FEATURES and as depicted in Figures 2-5 hereof, there is a needle/sleeve assembly 22 having a cylindrical hub assembly 24 which is threaded into internal threads 26 of a cylindrical hub 28 extending from the barrel 12 of t~e syringe 10. The hub 20 ~ssembly 24 comprises a cylindrical outer hub 30 which has a cylindrical inner hub 32 disposed therein. For alignment purposes, where desired, the inner hub 32 is retained by the projections 34 fitting into the bores 36. The inner hub 32 has ears 38 projecting out~vard therefrom which engage the threads 26 as the inner hub 32 is threaded inlo the outer hub 30. The inner hub 32 also concentrically holds the needle 16 at its base end in a bore 40 provided there~or. The outer hub 30 has $he protective sleeve assembly 42 extending concentrically therefrom.
The protective sleeve assembly 42 comprises a cover~
retaining hub 44 at the base end with the retracting slats 46 extending therefrom. The outer ends of the slats 46 are connected by an end cap 48. The cover-retaining hub 44 comprises a disk portion 50 having a plurality of radial vanes 52 - . WO 93/17739 PCI~/US93/02081 2~ 3i 3~4 extending forward therefrom. The vanes 52 can be employed to screw and unscrew the inner hub 32 with respect to the ~-cylindrical hub 28 extending from the barrel 12 of the syringe 10. t The disk portion 50 and vanes 52 in combination can also s support a hard cover 54 as shown ghosted in Figure 3 and in a side, cutaway view in Figure 5. The hard cover 54 can include inner projections 56 which fit between and engage the vanes 52 so that the hard cover 54 can be used to screw and unscrew the inner hub 32 with respect to the cylindrical hub 28 in a fully lO` protected manner. The open end 58 of the hard cover 54 is also tapered inward to grip the disk portion 50 and vanes 52 as the hard cover 54 is pressed into place so as to prevent its inadvertent loss prior to intended removal for use. The complete needle/sleeve assembly 22 is shipped in the hard cover 15 54 and retained therein by the end cap 60. rhe end cap 60 has a tapered plug portion 62 sized and shaped to snuggly fit within the tapered open end 58 of the hard cover 54 and seal it and its contents from contamination. Preferably, the disk portion 50 and vanes 52 are tightly gripped by~he open end 58 o the hard 20 cover 54 as shipped so that the needle/sleeve assembly 22 can only be removed from the hard cover 54 by using the hard cover 54 to screw the needle/sleeve assembly 22 into a syringe 10 and then pulling the syringe 10 with the needle/sleeve assembly 22 attached and the hard cover 54 apart.
As best seen in Figure 8, the end cap 60 has a square shoulder 64 adjacent the tapered plug portion 62. The square shoulder 64 serves several purposes. First, it provides a way of gripping the end c~p 60 for removal by twisting and pulling without the necessity of breaking fingernails. Second, it - 30 prevents the hard cover 54 from inadvertently rolling off a surface upon which it has been placed. Third, and most important, it acts as part of a security sealing system. As shown in the cross-sectional drawing of Figure 9, it is preferred that the hard cover 54 llave a flattened outer surface 66 adjacent its WO 93/17739 PCI`/US93/020~1 21~,i3~ 9 open end 58. I he flat outer end 68 of the elld c~p 60 in combination with one of the ila~ edges 70 of the shoulder 64 and the flattened outer surface 66 provide a continuous flat path bridging the joint 72 between the end cap 60 and the hard cover s 54 over which a frangible security strip 74 can be placed at the time of original shipment. The securi~y strip 74 is of a material and adhesively attached to this flat path using an adhesive of types well known in the art which result in the end cap 60 only being removeable from the hard cover 54 by breaking the 10 ~ security strip 74. Thus, if the security strip 74 is not intact at the time of use, the user knows that the hard cover 54 has been tampered with and that the contents may no longer be safe to use.
As the cost of manufacture of syringes goes down and the 15 ten~lency towards one-use, disposable syringes goes up, there is a corresponding tendency to dispense injectable fluids in one-dose, disposable syringes. There are also additional advantages to such an approach which are not important to the next embodiment to be described. Suf~lce it to say that there is trend 20 towards increased use of pre-filled syrin~es. In such case, there is a need to prevent leakage caused by jarring during shipping, dropping, and the like. As solution to this problem in the case of a syringe protec~ed by a Kuracina type protective sleeve is depicted in Figure 11. In this case, the inside of the closed end 25 76 of the hard cover 54 has a soft, silicone rubber finger 78 extending therefrom. The finger 78 is si~ed and shaped to fit within the preferred bell shape of the end cap 48. The tip 18 of the needle I6 embeds itself into the finger 78 and seals the needle 16 irom leaking. Silicone rubber or a similar material is 30 pre~erred for the finger 78-as it will not crumble and leave particles within or on the tip 18. Figure 12 depicts a similar approach to sealing a conventional syringe 10 as in Figure 1 not having a protec~ive sleeve. In this case, the silicone rubber finger 78 is adhesively af~ixed to the inner end of the cap 20.
--W093/17739 PCII/US93/OZ081 ~ ~
. 3132~ ' g , i ~
Figures 13 and i4 show provisions for sealing used needles to prevent reuse thereof which can be incorporated into hard covers or caps. In Figure 13, the hard cover 54 has a pierceable capsule 80 attached to the outside of the closed end 76. As with 5 the finger 78 of Figure 11, the capsule 80 is sized and shaped to ~lt within the preferred bell shape of the end cap 48 and be pierced by the tip 18 of the needle 16. Thus, the protective sleeve does not have to be retracted to seal the needle 16. The capsule 80 contains a sealing material 82 which is forced into the 10` open end of the needJe 16 upon insertion and/or can be drawn into the needle 16 by withdrawing the plunger slightly. The sealing material 82 can be an adhesive material such as a silicone rubber sealant which is a fluid when kept from the air and then hardens to a rubber or harder consistency after 15 exposure to the air. Being adhesives, such rnaterials are virtually impossible to remove once they have set up. Within the small bore of a hypodermic needle, any attempt to remove the hardened sealing material 82 to render the needle usable once again would be more trouble ~an it was worth and almost 20 assuredly result in failure. Fi~ure 14 shows a similar approach for the unprotected needle 16. ln this case, the capsule 80 containing the sealing material 82 is contained within a guide cone 84 formed into the end of the cap 20 for safety purposes.
Such an approach would not be desirable ior use by health care 25 workers dealing with others where there is a chance of exchange o~ body fluids during the needle sealing process. Such an approach could be employed with needles and other devices employed by diabetics, hernophiliacs, and the like, where it is a self-use situation and any accidental needle stick which takes 30 place during the subsequent needle sealing process would be without consequence. At present, it is believed that most if not all of such equipment is merely discarded and is capable of being reused by others for other purposes, such as drug use, wi~h the attendant risk of inrection and contamination.
WO 93/17739 PCI/US93/O}Q81 ~1 3132~ ( As mentioned in the above-referenced, co-pending application, there are instances where it may be desirable to ship a sleeve-protected device with the spring-biased locking collar 86 in its retracted position. The locking collar 86 then moves to 5 its locked position after use. This is not a problem as it is only after use that the trans~er of bodily fluids by means of accidental needle-stick becomes a problem. A hard cap 54' for such instances is shown in Figures 15 and 16. The locking collar 86 is pulJed back against the force of the spring 88 compressing the 10` spring 88 and causing the locking collar 86 to be retained in its re~racted position by the rear projections 90. To maintain the locking collar 86 in this position, prevent undue pressure on the vari~us componenLs, and prevent its accidental movement to its extended position (where in some embodiments it might lock 15 against further use), the inside of the hard cover 54' is provided with longitudinal vanes 92 having bearing surfaces 94 which abut the end of the locking collar 86 and hold it in place. Note that it is the bearing surfaces 94 wh;ch are important and that the vanes 92 are included along the leng~ of the hard cover 54' only 20 because they are formed such during the injection molding process.
Wherefore, having thus described the present invention, what is claimed is:
~ ,, . 5. ,~ ,.. .... .... .. ... . . . . . ... .. . . . . .
With respect to the action of the basic protective sleeve of the above-referenced Kuracina patent by comparison, a high degree of force is required to move the protective sleeve from 15 its extended position covering the tip. Moreover, a spring-biased locking collar is added over the protective sleeve which all but prevents the protective sleeve from moving from its ex~ended position covering the tip. The collar must be moved from its locked position to a retracted~, unlocked position before 20 the unique deformation qualities of the sleeve take ef~ect. After use, the locking collar springs back to its locked position. Thus, in virtual~y all "accidental" contact with the tip end of a hypodermic syringe, actual penetration by the tip should be prevented.
ln a co-pending application- entitled MEDlCAL
lNJECllON DEVlCES WITH SAFETY FEATURES filed on even date herewi~h, certain improvements to the Kuracina protec~ive sleeve are disclosed. The inventions described hereinafter are protective hard covers intended to make the 30 Kuracina protective sleeve even safer and more easy to use whi~e also adapting it to various mounting configurations.
Embodin~ents of the protective hard covers also have certain benefits when employed with conventional injection devices as well.
r WO 93/17739 2 1 3 1 3 ~ ~1 PCI`/US93/02081 O~her objects and benefits of tlle inventions disclosed herein will become apparent from the detailed description which ~ollows hereinafter when taken in conjunction with the drawing rlgures which accompany it.
Sl;JM~ARY:
The foregoing object has been achieved in a medical device having a needJe carried by a base twistedly attached to the rnedical device, by the improvement for pro~ectively capping 10 the needle and providing ease of attachment and disattachment - of the needle of the present invention comprising, the base having a plurality of radial longitudinal vanes; and, a hollow cover sized to fit over the needle and the plurality of radial longitudinal vanes, the cover having a closed end and an 15 inwardly tapering open end into which the plurality of radial longitudinal vanes wedgedly fit to hold the base and the needle in the cover, the cover further having at least one inward projection contacting a side surface of one o the plurality of radial longitudinal vanes whereby a user can twist the base to 20 attach and disattach the needle by twisting the cover.
Preferably, there is also a cap for closing the open end, the cap having a tapered inner portion shaped to wedgedly fit into the open end. Also, the preferred cap has a square shouldered outer portion abutting the tapered inner portion whereby the 25 tapered inner portion can be twisted to remove it from the open end and ~he cap and the cover in combination are prevented from rolling oif of ~lat surfaces.
For added security, the cap has a flat outer end surface opposite the tapered inner portion; the c~ver has a flat 30 longitudinal outer sidewall aligned with a flat side of the square shouldered outer portion; and, there is a safety strip of a ~rangi~le material adhesively attached to and over the flat outer end surface, the Dat side of the square shouldered outer portion, and the flat longitudinal outer sidewall when the cover WO 93/17739 PCI'/US93/17Q~l ~-'13132/1 -~
and cap contain a sterile needle whereby breaking of the safety str;p prior to use indicates possible lack of sterility of the needle.
ln any cover for a pre-filled medical device needle, an elastomeric material having the qualities of silicone rubber may 5 be disposed wi~hin the closed end of the cover and in contact with a tip portion of a needle contained within the cover to seal Ihe tip portion against leakage.
ln any cover for a medical device needle, there may be a pierceable capsule carried by an outer surface of a closed end of 10 the cover and containing a needle-sealing material therein whereby a needlé contained within the cover can be sealed agains~ further use by inserting a tip portion thereof through the capsule into the needle-sealing ma$erial. In one embodiment, the closed end of the cover has funnel-shaped sidewall means 15 surrounding the pierceable capsule for guiding the tip portion of the needle into the pierceable capsule and the needle-sealing material contained therein. In another embodiment where the tip portion of the needle is dispos~d within a ~ell-shaped end of a protective sleeve, the pierceable ~apsule has a surface shaped 20 ~O fit into the bell-shaped end whereby the tip portion of the needle can pierce the capsule without the protective sleeve being retracted.
Where the needle has a retractable protective sleeve disposed thereover with a bias spring and locking collar disposed 25 o~er the retractable protective sleeve, including at least one v~rtical shoulder disposed inside the cover adjacent the open end holds the locking collar and the spring in a retracted position prior to use.
30 DESCRIPTlON OF THE DRAWINGS:
Figure 1 is a simplified, partially cutaway drawing of a prior art hypodermic syringe with a removeable protective cap.
Figure 2 is an end view of the needle-carrying inner hub of protec~ive sleeve assembly.
. , ,, , , , , ~ . .
` WO 93/17739 2 1 ~ i 3 2 ~ PCI'/US93/02081 .
Figure 3 is a cutaway drawing through the cap-carrying collar of a protective sleeve assembly.
Figure 4 is an exploded view of the cap-carrying collar and the needle-carrying inner hub in an aligned configuration.
Figure 5 is a partially cutaway view of a protective sleeve assembly with the addition of a preferred protective hard cover.
Figure 6 is a partial}y cutaway view of the preferred pro~ective hard cover of Figure 5 with the associated end cap thereof.
Figure 7 is a side view of the protective hard cover of Figure 5 with the end cap of Figure 6 attached thereto.
Figure 8 is an inner plan view of the end cap of Figure 6.
Figure 9 is a cutaway drawing through the body of the hard cover of Figure 7 at IX.
Figure 10 is a partial side view of the assembled hard cover and cap of Figure 7 with the addition of a frangible safety strip. ;
Figure 11 is a partially cutaway drawing of a hypodermic syringe employing a Kuracina type protective sleeve with a hard 20 cover according to the present invention disposed thereover in an embodiment including a seal for sealing the end of the needle when the syringe is shipped pre-filled.
Figure 12 is a partially cutaway drawing of a standard, unprotected hypodermic syringe with a hard cover according to 25 the present invention disposed thereover in an embodiment including a seal for sealing the end of the needle when the syringe is shipped pre-filled.
Figure 13 is a drawing of a portion of the hard cover of Figure 11 depicting the addition of a compartnient containing a r 30 sealing compound for rendering the needle and thereby the syringesunusableaf~er use.
Figure 14 is a drawing ~ï a portion of the hard cover of Figure 12 depicting ~he addition of a compartment containing a WO93/17739 2~ 31324 Pcr/uss3/o(nxl sealing compound for rendering the needle and thereby the syringe unusable a~ter use.
Figure 15 is a partially cutaway drawing of a hypodermic syringe employing a Kuracina type protective sleeve with a hard 5 co~er according to the present invention disposed thereover in an embodiment including longitudinal vanes for retaining the locking collar in a retracted position prior to use.
Figure 16 is a cutaway view through the apparatus of Figure 15 at XVI.
DESCRIPTlON ~F THE PREFERRED EMBODIMENTS:
Typically, in a prior art hypodermic syringe, the needle base is mounted over a cylindrical projection extending from the bar~el. In an embodiment of co-pending application entitled MEDlCAL lNJECTlON DEVlCES WITH SAFETY
FEATURES and as depicted in Figures 2-5 hereof, there is a needle/sleeve assembly 22 having a cylindrical hub assembly 24 which is threaded into internal threads 26 of a cylindrical hub 28 extending from the barrel 12 of t~e syringe 10. The hub 20 ~ssembly 24 comprises a cylindrical outer hub 30 which has a cylindrical inner hub 32 disposed therein. For alignment purposes, where desired, the inner hub 32 is retained by the projections 34 fitting into the bores 36. The inner hub 32 has ears 38 projecting out~vard therefrom which engage the threads 26 as the inner hub 32 is threaded inlo the outer hub 30. The inner hub 32 also concentrically holds the needle 16 at its base end in a bore 40 provided there~or. The outer hub 30 has $he protective sleeve assembly 42 extending concentrically therefrom.
The protective sleeve assembly 42 comprises a cover~
retaining hub 44 at the base end with the retracting slats 46 extending therefrom. The outer ends of the slats 46 are connected by an end cap 48. The cover-retaining hub 44 comprises a disk portion 50 having a plurality of radial vanes 52 - . WO 93/17739 PCI~/US93/02081 2~ 3i 3~4 extending forward therefrom. The vanes 52 can be employed to screw and unscrew the inner hub 32 with respect to the ~-cylindrical hub 28 extending from the barrel 12 of the syringe 10. t The disk portion 50 and vanes 52 in combination can also s support a hard cover 54 as shown ghosted in Figure 3 and in a side, cutaway view in Figure 5. The hard cover 54 can include inner projections 56 which fit between and engage the vanes 52 so that the hard cover 54 can be used to screw and unscrew the inner hub 32 with respect to the cylindrical hub 28 in a fully lO` protected manner. The open end 58 of the hard cover 54 is also tapered inward to grip the disk portion 50 and vanes 52 as the hard cover 54 is pressed into place so as to prevent its inadvertent loss prior to intended removal for use. The complete needle/sleeve assembly 22 is shipped in the hard cover 15 54 and retained therein by the end cap 60. rhe end cap 60 has a tapered plug portion 62 sized and shaped to snuggly fit within the tapered open end 58 of the hard cover 54 and seal it and its contents from contamination. Preferably, the disk portion 50 and vanes 52 are tightly gripped by~he open end 58 o the hard 20 cover 54 as shipped so that the needle/sleeve assembly 22 can only be removed from the hard cover 54 by using the hard cover 54 to screw the needle/sleeve assembly 22 into a syringe 10 and then pulling the syringe 10 with the needle/sleeve assembly 22 attached and the hard cover 54 apart.
As best seen in Figure 8, the end cap 60 has a square shoulder 64 adjacent the tapered plug portion 62. The square shoulder 64 serves several purposes. First, it provides a way of gripping the end c~p 60 for removal by twisting and pulling without the necessity of breaking fingernails. Second, it - 30 prevents the hard cover 54 from inadvertently rolling off a surface upon which it has been placed. Third, and most important, it acts as part of a security sealing system. As shown in the cross-sectional drawing of Figure 9, it is preferred that the hard cover 54 llave a flattened outer surface 66 adjacent its WO 93/17739 PCI`/US93/020~1 21~,i3~ 9 open end 58. I he flat outer end 68 of the elld c~p 60 in combination with one of the ila~ edges 70 of the shoulder 64 and the flattened outer surface 66 provide a continuous flat path bridging the joint 72 between the end cap 60 and the hard cover s 54 over which a frangible security strip 74 can be placed at the time of original shipment. The securi~y strip 74 is of a material and adhesively attached to this flat path using an adhesive of types well known in the art which result in the end cap 60 only being removeable from the hard cover 54 by breaking the 10 ~ security strip 74. Thus, if the security strip 74 is not intact at the time of use, the user knows that the hard cover 54 has been tampered with and that the contents may no longer be safe to use.
As the cost of manufacture of syringes goes down and the 15 ten~lency towards one-use, disposable syringes goes up, there is a corresponding tendency to dispense injectable fluids in one-dose, disposable syringes. There are also additional advantages to such an approach which are not important to the next embodiment to be described. Suf~lce it to say that there is trend 20 towards increased use of pre-filled syrin~es. In such case, there is a need to prevent leakage caused by jarring during shipping, dropping, and the like. As solution to this problem in the case of a syringe protec~ed by a Kuracina type protective sleeve is depicted in Figure 11. In this case, the inside of the closed end 25 76 of the hard cover 54 has a soft, silicone rubber finger 78 extending therefrom. The finger 78 is si~ed and shaped to fit within the preferred bell shape of the end cap 48. The tip 18 of the needle I6 embeds itself into the finger 78 and seals the needle 16 irom leaking. Silicone rubber or a similar material is 30 pre~erred for the finger 78-as it will not crumble and leave particles within or on the tip 18. Figure 12 depicts a similar approach to sealing a conventional syringe 10 as in Figure 1 not having a protec~ive sleeve. In this case, the silicone rubber finger 78 is adhesively af~ixed to the inner end of the cap 20.
--W093/17739 PCII/US93/OZ081 ~ ~
. 3132~ ' g , i ~
Figures 13 and i4 show provisions for sealing used needles to prevent reuse thereof which can be incorporated into hard covers or caps. In Figure 13, the hard cover 54 has a pierceable capsule 80 attached to the outside of the closed end 76. As with 5 the finger 78 of Figure 11, the capsule 80 is sized and shaped to ~lt within the preferred bell shape of the end cap 48 and be pierced by the tip 18 of the needle 16. Thus, the protective sleeve does not have to be retracted to seal the needle 16. The capsule 80 contains a sealing material 82 which is forced into the 10` open end of the needJe 16 upon insertion and/or can be drawn into the needle 16 by withdrawing the plunger slightly. The sealing material 82 can be an adhesive material such as a silicone rubber sealant which is a fluid when kept from the air and then hardens to a rubber or harder consistency after 15 exposure to the air. Being adhesives, such rnaterials are virtually impossible to remove once they have set up. Within the small bore of a hypodermic needle, any attempt to remove the hardened sealing material 82 to render the needle usable once again would be more trouble ~an it was worth and almost 20 assuredly result in failure. Fi~ure 14 shows a similar approach for the unprotected needle 16. ln this case, the capsule 80 containing the sealing material 82 is contained within a guide cone 84 formed into the end of the cap 20 for safety purposes.
Such an approach would not be desirable ior use by health care 25 workers dealing with others where there is a chance of exchange o~ body fluids during the needle sealing process. Such an approach could be employed with needles and other devices employed by diabetics, hernophiliacs, and the like, where it is a self-use situation and any accidental needle stick which takes 30 place during the subsequent needle sealing process would be without consequence. At present, it is believed that most if not all of such equipment is merely discarded and is capable of being reused by others for other purposes, such as drug use, wi~h the attendant risk of inrection and contamination.
WO 93/17739 PCI/US93/O}Q81 ~1 3132~ ( As mentioned in the above-referenced, co-pending application, there are instances where it may be desirable to ship a sleeve-protected device with the spring-biased locking collar 86 in its retracted position. The locking collar 86 then moves to 5 its locked position after use. This is not a problem as it is only after use that the trans~er of bodily fluids by means of accidental needle-stick becomes a problem. A hard cap 54' for such instances is shown in Figures 15 and 16. The locking collar 86 is pulJed back against the force of the spring 88 compressing the 10` spring 88 and causing the locking collar 86 to be retained in its re~racted position by the rear projections 90. To maintain the locking collar 86 in this position, prevent undue pressure on the vari~us componenLs, and prevent its accidental movement to its extended position (where in some embodiments it might lock 15 against further use), the inside of the hard cover 54' is provided with longitudinal vanes 92 having bearing surfaces 94 which abut the end of the locking collar 86 and hold it in place. Note that it is the bearing surfaces 94 wh;ch are important and that the vanes 92 are included along the leng~ of the hard cover 54' only 20 because they are formed such during the injection molding process.
Wherefore, having thus described the present invention, what is claimed is:
~ ,, . 5. ,~ ,.. .... .... .. ... . . . . . ... .. . . . . .
Claims (18)
1. A medical device having a needle carried by a base twistedly attached to the medical device, a needle capping arrangement characterized by: for protectively capping the needle and providing ease of attachment and disattachment of the needle comprising:
a) the base having a plurality of radial longitudinal vanes; and, b) a hollow cover sized to fit over the needle and said plurality of radial longitudinal vanes, said cover having a closed end and an inwardly tapering open end into which said plurality of radial longitudinal vanes wedgedly fit to hold the base and the needle in said cover, said cover further having at least one inward projection contacting a side surface of one of said plurality of radial longitudinal vanes whereby a user can twist the base to attach and disattach the needle by twisting said cover; wherein additionally, c) the needle has a retractable protective sleeve disposed thereover with a bias spring and locking collar disposed over said retractable protective sleeve, said bias spring biasing said locking collar from a retracted position which allows the protective sleeve to retract, to an extended position which prevents the protective sleeve retraction; and additionally comprising, d) at least one vertical shoulder disposed inside said cover adjacent said open end for holding said locking collar and said spring in a retracted position.
a) the base having a plurality of radial longitudinal vanes; and, b) a hollow cover sized to fit over the needle and said plurality of radial longitudinal vanes, said cover having a closed end and an inwardly tapering open end into which said plurality of radial longitudinal vanes wedgedly fit to hold the base and the needle in said cover, said cover further having at least one inward projection contacting a side surface of one of said plurality of radial longitudinal vanes whereby a user can twist the base to attach and disattach the needle by twisting said cover; wherein additionally, c) the needle has a retractable protective sleeve disposed thereover with a bias spring and locking collar disposed over said retractable protective sleeve, said bias spring biasing said locking collar from a retracted position which allows the protective sleeve to retract, to an extended position which prevents the protective sleeve retraction; and additionally comprising, d) at least one vertical shoulder disposed inside said cover adjacent said open end for holding said locking collar and said spring in a retracted position.
2. A medical device according to claim characterized by:
a cap for closing said open end, said cap having a tapered inner portion shaped to wedgedly fit into said open end.
a cap for closing said open end, said cap having a tapered inner portion shaped to wedgedly fit into said open end.
3. A medical device according to claim 2 characterized in that:
said cap has a square shouldered outer portion abutting said tapered inner portion whereby said tapered inner portion can be twisted to remove it from said open end and said cap and said cover in combination are prevented from rolling off of flat surfaces.
said cap has a square shouldered outer portion abutting said tapered inner portion whereby said tapered inner portion can be twisted to remove it from said open end and said cap and said cover in combination are prevented from rolling off of flat surfaces.
4. A medical device according to claim 2 characterized in that:
a) said cap has a flat outer end surface opposite said tapered inner portion; and, b) said cover has a flat longitudinal outer sidewall aligned with a flat side of said square shouldered outer portion; and additionally comprising, c) a safety strip of a frangible material adhesively attached to and over said flat outer end surface, said flat side of said square shouldered outer portion, and said flat longitudinal outer sidewall when said cover and cap contain a sterile needle whereby breaking of said safety strip prior to use indicates possible lack of sterility of the needle.
a) said cap has a flat outer end surface opposite said tapered inner portion; and, b) said cover has a flat longitudinal outer sidewall aligned with a flat side of said square shouldered outer portion; and additionally comprising, c) a safety strip of a frangible material adhesively attached to and over said flat outer end surface, said flat side of said square shouldered outer portion, and said flat longitudinal outer sidewall when said cover and cap contain a sterile needle whereby breaking of said safety strip prior to use indicates possible lack of sterility of the needle.
5. A medical device according to claim 1 characterized by:
an elastomeric material having the qualities of silicone rubber disposed within said closed end of said cover and in contact with a tip portion of a needle contained within said cover to seal said tip portion.
an elastomeric material having the qualities of silicone rubber disposed within said closed end of said cover and in contact with a tip portion of a needle contained within said cover to seal said tip portion.
6. A medical device according to claim 1 characterized by:
a pierceable capsule carried by an outer surface of said closed end of said cover and containing a needle-sealing material therein whereby a needle contained within said cover can be sealed against further use by inserting a tip portion thereof through said capsule into said needle-sealing material.
a pierceable capsule carried by an outer surface of said closed end of said cover and containing a needle-sealing material therein whereby a needle contained within said cover can be sealed against further use by inserting a tip portion thereof through said capsule into said needle-sealing material.
7. A medical device according to claim 6 characterized by:
said closed end of said cover having funnel-shaped sidewall means surrounding said pierceable capsule for guiding said tip portion of said needle into said pierceable capsule and said needle-sealing material contained therein.
said closed end of said cover having funnel-shaped sidewall means surrounding said pierceable capsule for guiding said tip portion of said needle into said pierceable capsule and said needle-sealing material contained therein.
8. A medical device according to claim 6 characterized in that:
a) said tip portion of said needle is disposed within a bell-shaped end of a protective sleeve; and, b) said pierceable capsule has a surface shaped to fit into said bell-shaped end whereby said tip portion of said needle can pierce said capsule without said protective sleeve being retracted.
a) said tip portion of said needle is disposed within a bell-shaped end of a protective sleeve; and, b) said pierceable capsule has a surface shaped to fit into said bell-shaped end whereby said tip portion of said needle can pierce said capsule without said protective sleeve being retracted.
9. A medical device claim 1 characterized in that:
a) the needle has a retractable protective sleeve disposed thereover with a bias spring and locking collar disposed over said retractable protective sleeve;
and additionally comprising, b) at least one vertical shoulder disposed inside said cover adjacent said open end for holding said locking collar and said spring in a retracted position.
a) the needle has a retractable protective sleeve disposed thereover with a bias spring and locking collar disposed over said retractable protective sleeve;
and additionally comprising, b) at least one vertical shoulder disposed inside said cover adjacent said open end for holding said locking collar and said spring in a retracted position.
10. A security package for a medical device needle carried by a base characterized by:
a) a hollow cover sized to fit over the needle and the base, said cover having a closed end and an inwardly tapering open end into which a mating portion of the base wedgedly fits to hold the base and the needle in said cover;
b) a cap for closing said open end, said cap having a tapered inner portion shaped to wedgedly fit into said open end, said cap having a square shouldered outer portion abutting said tapered inner portion whereby said tapered inner portion can be twisted to remove it from said open end and said cap and said cover in combination are prevented from rolling off of flat surfaces, said cap further having a flat outer end surface opposite said tapered inner portion, said cover having a flat longitudinal outer sidewall aligned with a flat side of said square shouldered outer portion; and, c) a safety strip of a frangible material adhesively attached to and over said flat outer end surface, said flat side of said square shouldered outer portion, and said flat longitudinal outer sidewall whereby breaking of said safety strip prior to use indicates possible lack of sterility of the needle.
a) a hollow cover sized to fit over the needle and the base, said cover having a closed end and an inwardly tapering open end into which a mating portion of the base wedgedly fits to hold the base and the needle in said cover;
b) a cap for closing said open end, said cap having a tapered inner portion shaped to wedgedly fit into said open end, said cap having a square shouldered outer portion abutting said tapered inner portion whereby said tapered inner portion can be twisted to remove it from said open end and said cap and said cover in combination are prevented from rolling off of flat surfaces, said cap further having a flat outer end surface opposite said tapered inner portion, said cover having a flat longitudinal outer sidewall aligned with a flat side of said square shouldered outer portion; and, c) a safety strip of a frangible material adhesively attached to and over said flat outer end surface, said flat side of said square shouldered outer portion, and said flat longitudinal outer sidewall whereby breaking of said safety strip prior to use indicates possible lack of sterility of the needle.
11. A medical device having a needle carried by a base attached to the medical device, a protective cover, characterized by:
a) a hollow cover sized to fit over the needle and the base, said cover having a closed end and an open end into which the base wedgedly fits to hold the base and the needle in said cover; wherein additionally, b) the needle has a retractable protective sleeve disposed thereover with a locking collar and a bias spring disposed over said retractable protective sleeve, said bias spring biasing said locking collar from a retracted position which allows the protective sleeve to retract, to an extended position which prevents the protective sleeve retraction; and, c) vertical shoulder means disposed inside said cover adjacent said open end for contacting and holding said locking collar and said spring in a pre-cocked retracted position prior to use.
a) a hollow cover sized to fit over the needle and the base, said cover having a closed end and an open end into which the base wedgedly fits to hold the base and the needle in said cover; wherein additionally, b) the needle has a retractable protective sleeve disposed thereover with a locking collar and a bias spring disposed over said retractable protective sleeve, said bias spring biasing said locking collar from a retracted position which allows the protective sleeve to retract, to an extended position which prevents the protective sleeve retraction; and, c) vertical shoulder means disposed inside said cover adjacent said open end for contacting and holding said locking collar and said spring in a pre-cocked retracted position prior to use.
12. A medical device according to claim 11 characterized in that:
said vertical shoulder means comprises vertical ends of a plurality of longitudinal vanes peripherally disposed about an inner surface of said hollow cover.
said vertical shoulder means comprises vertical ends of a plurality of longitudinal vanes peripherally disposed about an inner surface of said hollow cover.
13. A security package for disabling the needle of a medical device having needle carried by a base after use thereof characterized by:
a) a hollow cover sized to fit over the needle and the base, said cover having a closed end and an open end into which a mating portion of the base fits to hold the base and the needle in said cover; and, b) a pierceable capsule carried by an outer surface of said closed end of said cover and containing a needle-sealing material therein whereby after use the needle can be sealed against further use by inserting a tip portion thereof through said capsule into said needle-sealing material.
a) a hollow cover sized to fit over the needle and the base, said cover having a closed end and an open end into which a mating portion of the base fits to hold the base and the needle in said cover; and, b) a pierceable capsule carried by an outer surface of said closed end of said cover and containing a needle-sealing material therein whereby after use the needle can be sealed against further use by inserting a tip portion thereof through said capsule into said needle-sealing material.
14. A security package according to claim 13 characterized by:
said closed end of said cover having funnel-shaped sidewall means surrounding said pierceable capsule for guiding said tip portion of the needle into said pierceable capsule and said needle-sealing material contained therein.
said closed end of said cover having funnel-shaped sidewall means surrounding said pierceable capsule for guiding said tip portion of the needle into said pierceable capsule and said needle-sealing material contained therein.
15. A security package according to claim 13 characterized by:
a) said tip portion of the needle is disposed within a bell-shaped end of a protective sleeve; and, b) said pierceable capsule has a surface shaped to fit into said bell-shaped end whereby said tip portion of the needle can pierce said capsule without said protective sleeve being retracted.
a) said tip portion of the needle is disposed within a bell-shaped end of a protective sleeve; and, b) said pierceable capsule has a surface shaped to fit into said bell-shaped end whereby said tip portion of the needle can pierce said capsule without said protective sleeve being retracted.
16. A security package according to claim 13 characterized in that:
a) the tip of the needle is disposed within a bell-shaped end of a protective sleeve; and, b) said pierceable capsule has a surface shaped to fit into said bell-shaped end whereby the needle can pierce said capsule without said protective sleeve being retracted.
a) the tip of the needle is disposed within a bell-shaped end of a protective sleeve; and, b) said pierceable capsule has a surface shaped to fit into said bell-shaped end whereby the needle can pierce said capsule without said protective sleeve being retracted.
17. A medical device having a needle carried by a base twistedly attached to the medical device, a protective cover, characterized by:
a) a hollow cover sized to fit over the needle and the base, said cover having a closed end and an open end into which the base wedgedly fits to hold the base and the needle in said cover; wherein additionally, b) the needle has a retractable protective sleeve disposed thereover with a locking collar and a bias spring disposed over said retractable protective sleeve, said bias spring biasing said locking collar from a retracted position which allows the protective sleeve to retract, to an extended position which prevents the protective sleeve retraction; and, c) vertical shoulder means disposed inside said cover adjacent said open end for holding said locking collar and said spring in a retracted position prior to use.
a) a hollow cover sized to fit over the needle and the base, said cover having a closed end and an open end into which the base wedgedly fits to hold the base and the needle in said cover; wherein additionally, b) the needle has a retractable protective sleeve disposed thereover with a locking collar and a bias spring disposed over said retractable protective sleeve, said bias spring biasing said locking collar from a retracted position which allows the protective sleeve to retract, to an extended position which prevents the protective sleeve retraction; and, c) vertical shoulder means disposed inside said cover adjacent said open end for holding said locking collar and said spring in a retracted position prior to use.
18. A medical device according to claim 17 characterized in that:
said vertical shoulder means comprises vertical ends of a plurality of longitudinal vanes peripherally disposed about an inner surface of said hollow cover.
said vertical shoulder means comprises vertical ends of a plurality of longitudinal vanes peripherally disposed about an inner surface of said hollow cover.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US07/850,681 US5254099A (en) | 1992-03-10 | 1992-03-10 | Hard cover for pre-cocking protected injection apparatus |
| US07/850,681 | 1992-03-10 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2131324A1 true CA2131324A1 (en) | 1993-09-16 |
Family
ID=25308834
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002131324A Abandoned CA2131324A1 (en) | 1992-03-10 | 1993-03-08 | Hard cover for protected injection apparatus |
Country Status (7)
| Country | Link |
|---|---|
| US (2) | US5254099A (en) |
| EP (1) | EP0630269A4 (en) |
| JP (1) | JPH07504583A (en) |
| KR (1) | KR950700091A (en) |
| BR (1) | BR9306052A (en) |
| CA (1) | CA2131324A1 (en) |
| WO (1) | WO1993017739A1 (en) |
Families Citing this family (65)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5836921A (en) | 1993-08-23 | 1998-11-17 | Mahurkar; Sakharam D. | Hypodermic needle assembly |
| US5643222A (en) * | 1993-08-23 | 1997-07-01 | Mahurkar; Sakharam D. | Hypodermic needle assembly |
| US5836917A (en) * | 1995-01-10 | 1998-11-17 | Specialized Health Products, Inc. | Self retracting medical needle apparatus and methods |
| US5823997A (en) * | 1995-01-10 | 1998-10-20 | Specialized Health Products, Inc. | Medical needle safety apparatus and methods |
| US5656031A (en) * | 1995-01-10 | 1997-08-12 | Specialized Health Products, Inc. | Medical syringe and self retracting needle apparatus |
| US5480385A (en) * | 1995-01-10 | 1996-01-02 | Specialized Health Products, Inc. | Self retracting medical needle apparatus and methods |
| US5487734A (en) * | 1995-01-10 | 1996-01-30 | Specialized Health Products, Inc. | Self retracting catheter needle apparatus and methods |
| US5705024A (en) * | 1995-09-28 | 1998-01-06 | Becton, Dickinson And Company | System for application of labels |
| DK2319556T3 (en) | 1996-02-27 | 2013-06-17 | Braun Melsungen Ag | Needle tip protector for needles |
| US5879337A (en) * | 1997-02-27 | 1999-03-09 | Injectimed, Inc. | Needle tip guard for hypodermic needles |
| US6629959B2 (en) * | 1996-02-27 | 2003-10-07 | Injectimed, Inc. | Needle tip guard for percutaneous entry needles |
| US5976111A (en) * | 1996-03-04 | 1999-11-02 | Emily A. Hart | Automatically positioned hypodermic needle guard |
| US5718239A (en) * | 1996-06-21 | 1998-02-17 | Becton, Dickinson And Company | Method of activating a needle assembly having a telescoping shield |
| US5919168A (en) * | 1997-08-25 | 1999-07-06 | Wheeler; Alton D. | Injection needle protection |
| US6063040A (en) * | 1998-01-16 | 2000-05-16 | Specialized Health Products, Inc. | Self retracting needle apparatus and method for phlebotomy |
| US5957892A (en) * | 1998-03-12 | 1999-09-28 | Specialized Health Products, Inc. | Safety catheter insertion apparatus and methods |
| US6036675A (en) * | 1999-02-03 | 2000-03-14 | Specialized Health Products, Inc. | Safety sterile cartride unit apparatus and methods |
| US6592556B1 (en) | 2000-07-19 | 2003-07-15 | Tyco Healthcare Group Lp | Medical needle safety apparatus and methods |
| US7029461B2 (en) | 1999-11-04 | 2006-04-18 | Tyco Healthcare Group Lp | Safety shield for medical needles |
| US6224576B1 (en) | 1999-11-04 | 2001-05-01 | Specialized Health Products, Inc. | Safety device for a needle having two sharpened ends |
| US8226617B2 (en) | 1999-11-04 | 2012-07-24 | Tyco Healthcare Group Lp | Safety shield apparatus and mounting structure for use with medical needle devices |
| US6280420B1 (en) | 1999-11-04 | 2001-08-28 | Specialized Health Products | Reaccessible medical needle safety devices and methods |
| US6984223B2 (en) | 2001-11-13 | 2006-01-10 | Becton, Dickinson And Company | Needle safety device |
| US7001363B2 (en) | 2002-04-05 | 2006-02-21 | F. Mark Ferguson | Safety shield for medical needles |
| US6997913B2 (en) | 2002-06-07 | 2006-02-14 | Becton, Dickinson And Company | Needle safety device |
| EP1558311B1 (en) * | 2003-02-11 | 2006-12-06 | Salvus Technology Limited | A safety needle |
| US8827961B2 (en) * | 2005-02-03 | 2014-09-09 | West Pharmaceutical Services, Inc. | Safety needle |
| WO2006082350A1 (en) * | 2005-02-03 | 2006-08-10 | Salvus Technology Ltd | A safety needle |
| US8597255B2 (en) * | 2005-02-03 | 2013-12-03 | Salvus Technology Limited | Safety needle |
| WO2006090118A1 (en) * | 2005-02-25 | 2006-08-31 | Salvus Technology Limited | Safety needle accessory |
| FR2884723B1 (en) * | 2005-04-20 | 2008-03-14 | Becton Dickinson France Soc Pa | DEVICE FOR PROTECTING AN INJECTION DEVICE |
| CN101437561B (en) | 2006-03-21 | 2011-09-28 | 泰科保健集团有限合伙公司 | Passive latch ring safety shield for injection devices |
| WO2007124474A2 (en) * | 2006-04-21 | 2007-11-01 | West Pharmaceutical Services, Inc. | Needle shield |
| GB0615589D0 (en) * | 2006-08-04 | 2006-09-13 | Salvus Technology Ltd | Safety needle accessory |
| JP4994775B2 (en) | 2006-10-12 | 2012-08-08 | 日本コヴィディエン株式会社 | Needle point protector |
| EP2125572A2 (en) * | 2006-11-29 | 2009-12-02 | West Pharmaceutical Services, Inc. | Syringe cartridge system |
| BRPI0721219B8 (en) * | 2007-02-07 | 2021-06-22 | Becton Dickinson Co | safety protection system for a single use flexible type compression syringe, and injection device |
| GB0719876D0 (en) * | 2007-10-11 | 2007-11-21 | Weston Terence E | Safety needle |
| US8323251B2 (en) | 2008-01-14 | 2012-12-04 | Fenwal, Inc. | Phlebotomy needle assembly and frangible cover |
| CA2719209C (en) | 2008-03-13 | 2016-10-18 | Becton, Dickinson And Company | Safety pen needle assembly having shield for non-patient end |
| WO2009114777A1 (en) | 2008-03-13 | 2009-09-17 | Becton, Dickinson And Company | Safety needle assembly |
| US8632503B2 (en) | 2008-03-13 | 2014-01-21 | Becton, Dickinson And Company | Safety pen needle assembly having shielding for patient and non-patient ends |
| US20110071475A1 (en) | 2009-09-18 | 2011-03-24 | Becton, Dickinson And Company | Outer cover of a pen needle for a drug delivery pen |
| US8512295B2 (en) | 2010-08-19 | 2013-08-20 | West Pharmaceutical Services, Inc. | Rigid needle shield |
| US8764711B2 (en) | 2011-02-28 | 2014-07-01 | Injectimed, Inc. | Needle guard |
| US9238104B2 (en) | 2011-02-28 | 2016-01-19 | Injectimed, Inc. | Needle guard |
| US8486024B2 (en) | 2011-04-27 | 2013-07-16 | Covidien Lp | Safety IV catheter assemblies |
| EP2760520A1 (en) | 2011-09-26 | 2014-08-06 | Covidien LP | Safety catheter |
| WO2013048768A1 (en) | 2011-09-26 | 2013-04-04 | Covidien Lp | Safety iv catheter and needle assembly |
| WO2013056223A1 (en) | 2011-10-14 | 2013-04-18 | Covidien Lp | Safety iv catheter assembly |
| US8414539B1 (en) | 2011-12-27 | 2013-04-09 | B. Braun Melsungen Ag | Needle tip guard for percutaneous entry needles |
| EP2979716B1 (en) * | 2013-03-26 | 2019-08-21 | Terumo Kabushiki Kaisha | Elastic cap and syringe assembly provided therewith |
| EP2883562B1 (en) | 2013-12-10 | 2016-08-17 | Becton Dickinson and Company | Passive safety pen needle assembly |
| CA2873770A1 (en) | 2013-12-10 | 2015-06-10 | Becton, Dickinson And Company | Active safety pen needle assembly |
| KR20160106161A (en) * | 2014-02-11 | 2016-09-09 | 일라이 릴리 앤드 캄파니 | Injection needle covering system |
| US11058825B2 (en) | 2015-11-27 | 2021-07-13 | Sanofi-Aventis Deutschland Gmbh | Cap for an injection device |
| US11147910B2 (en) | 2016-12-12 | 2021-10-19 | Becton, Dickinson And Company | Packaging for safety needle |
| US11173253B2 (en) | 2016-12-12 | 2021-11-16 | Becton, Dickinson And Company | Packaging for safety needle |
| US10729843B2 (en) * | 2016-12-12 | 2020-08-04 | Becton, Dickinson And Company | Dual packaging for fill needle and safety needle |
| AU2018294324B2 (en) | 2017-06-30 | 2024-03-07 | Regeneron Pharmaceuticals, Inc. | Auto-injector with anti-roll features |
| JP1629333S (en) | 2017-10-25 | 2019-04-15 | ||
| USD903856S1 (en) | 2018-06-29 | 2020-12-01 | Regeneron Pharmaceuticals, Inc. | Auto-injector |
| USD932006S1 (en) | 2018-11-21 | 2021-09-28 | Regeneron Pharmaceuticals, Inc. | Auto-injector cap |
| US11224699B2 (en) | 2020-03-27 | 2022-01-18 | Medivena Sp. Z O.O. | Needle-based device with a safety mechanism implemented therein |
| US20230355889A1 (en) | 2020-03-27 | 2023-11-09 | Jaroslaw Moleda | Needle-based device based on direct wing-based coupling of a needle shield to a barrel thereof and safety mechanism implemented therein |
Family Cites Families (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US2953243A (en) * | 1957-07-25 | 1960-09-20 | Roehr Zbislaw Maciej | Disposable needle assembly |
| US3101841A (en) * | 1961-05-24 | 1963-08-27 | Mfg Process Lab Inc | Needle package |
| US3149717A (en) * | 1962-08-27 | 1964-09-22 | Johnson & Johnson | Container for hypodermic needle |
| US3329146A (en) * | 1963-10-02 | 1967-07-04 | Baxter Laboratories Inc | Needle container |
| US3333682A (en) * | 1965-08-18 | 1967-08-01 | Burron Medical Prod Inc | Disposable needle container |
| US4931048A (en) * | 1986-04-07 | 1990-06-05 | Icu Medical, Inc. | Medical device |
| US4816024A (en) * | 1987-04-13 | 1989-03-28 | Icu Medical, Inc. | Medical device |
| US4863436A (en) * | 1987-11-03 | 1989-09-05 | Iatroban, Ltd. | Hypodermic needle with protective cover |
| US4887998A (en) * | 1987-12-14 | 1989-12-19 | Martin Catherine L | Hypodermic needle guard |
| US4878902A (en) * | 1988-02-25 | 1989-11-07 | Wanderer Alan A | Needle guard for body substance isolation |
| JPH03504205A (en) * | 1988-05-06 | 1991-09-19 | ディークス，デビッド，ジョン | Needle |
| US4863435A (en) * | 1988-08-24 | 1989-09-05 | Sturman Martin F | Safety hypodermic syringe |
| US4950242A (en) * | 1989-09-15 | 1990-08-21 | Marcial Alvarez | Hypodermic needle cover and assembly therewith |
| US5163915A (en) * | 1992-01-07 | 1992-11-17 | Barry Holleron | Safety needle set |
-
1992
- 1992-03-10 US US07/850,681 patent/US5254099A/en not_active Expired - Fee Related
-
1993
- 1993-03-08 WO PCT/US1993/002081 patent/WO1993017739A1/en not_active Application Discontinuation
- 1993-03-08 KR KR1019940703143A patent/KR950700091A/en not_active Application Discontinuation
- 1993-03-08 CA CA002131324A patent/CA2131324A1/en not_active Abandoned
- 1993-03-08 JP JP5515957A patent/JPH07504583A/en active Pending
- 1993-03-08 BR BR9306052A patent/BR9306052A/en not_active Application Discontinuation
- 1993-03-08 EP EP93907314A patent/EP0630269A4/en not_active Withdrawn
- 1993-08-24 US US08/111,162 patent/US5336197A/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| US5336197A (en) | 1994-08-09 |
| BR9306052A (en) | 1997-11-18 |
| US5254099A (en) | 1993-10-19 |
| WO1993017739A1 (en) | 1993-09-16 |
| JPH07504583A (en) | 1995-05-25 |
| EP0630269A4 (en) | 1995-12-06 |
| EP0630269A1 (en) | 1994-12-28 |
| KR950700091A (en) | 1995-01-16 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued |