CA2051806A1 - Safety syringe cap minimizing needle-stick probability - Google Patents
Safety syringe cap minimizing needle-stick probabilityInfo
- Publication number
- CA2051806A1 CA2051806A1 CA002051806A CA2051806A CA2051806A1 CA 2051806 A1 CA2051806 A1 CA 2051806A1 CA 002051806 A CA002051806 A CA 002051806A CA 2051806 A CA2051806 A CA 2051806A CA 2051806 A1 CA2051806 A1 CA 2051806A1
- Authority
- CA
- Canada
- Prior art keywords
- slats
- needle
- hub portion
- sliding
- safety
- 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
- A61M5/3205—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
- A61M5/3275—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel being connected to the needle hub or syringe by radially deflectable members, e.g. longitudinal slats, cords or bands
-
- 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
- A61M5/3257—Semi-automatic sleeve extension, i.e. in which triggering of the sleeve extension requires a deliberate action by the user, e.g. manual release of spring-biased extension means
Abstract
This invention is a lockable and retractable safety cap for covering the needle of a hypodermic syringe to prevent accidental needle-stick. There is a unitary cap assembly (30) of a resiliently flexible plastic material including a hub portion (32) disposed concentrically about a base portion of the needle and attached to the barrel, a sliding safety hub portion (36) having a bore (38) therethrough slidably disposed with the needle passing through the bore and extending over a point end of the needle, and a plurality of slats (40) extending between the hub portion and the sliding safety hub portion. The slats are parallel to the needle whereby a longitudinal compressive force against the sliding safety hub portion is resisted by a longitudinal compressive resistance of the slats which must be overcome before the slats will deform and flex outward from the needle to expose the needle for use. A
releasable safety latch assembly (52) can be disposed over the slats for preventing deforming and outward flexing thereof. The preferred assembly comprises a coil spring (60) disposed over the slats, a sliding collar (58) carried by an outer end of the coil spring, a retaining button (56) located on one of the slats adjacent the inner end for holding the sliding collar to retain the coil spring in a compressed state, and a release for releasing a hold on the sliding collar when the slats bend outward whereby following use of the syringe the coil spring is released and returns to an extended state.
releasable safety latch assembly (52) can be disposed over the slats for preventing deforming and outward flexing thereof. The preferred assembly comprises a coil spring (60) disposed over the slats, a sliding collar (58) carried by an outer end of the coil spring, a retaining button (56) located on one of the slats adjacent the inner end for holding the sliding collar to retain the coil spring in a compressed state, and a release for releasing a hold on the sliding collar when the slats bend outward whereby following use of the syringe the coil spring is released and returns to an extended state.
Description
2 3 ~ PCl/US9t/00979 Safety Syringe Cap Minimizing Needle-Stick Probability TECHNICAL FIELD
5 This invention relates to safety covers for the needle of a hypodermic syringe and, more particularly, in a hypodermic syringe having a barrel with a needle extending outward therefrom, to a retractable safety cap for covering the needle to prevent accidental needle-stick therefrom comprising a unitary cap assembly of a resiliently flexible plastic material including a 10 hub portion disposed concentrically about a base portion of the needle and attached to the barrel, a sliding safety hub portion having a bore therethrough slidably disposed with the needle passing through the bore and extending over a point end of the needle, and a plurality of slats extending between the hub portion and the sliding safety hub portion, the 15 slats being spaced from one another along adjacent edges thereof at radially equal intervals about the periphery of the needle and being parallel to the needle whereby a longitudinal compressive force against the sliding safety hub portion is resisted by a longitudinal compressive resistance of the slats which must be overcome before the slats will deform 20 and flex outward from the needle to allow the sliding safety hub portion to slide along and expose the needle for use.
BACKGROUND ART
So called "needle-stick" is a major problem among health workers such as doctors, nurses, and the like. Needle-stick is the accidental puncturing of the skin of a health worker while working with hypodermic syringes. Needle-stick, per se, i9 not a new phenomenon for health care workers. In the past, however, it was more of an inconvenience than 30 anything else. The present level of activity of serum-transmitted diseases such as hepatitis and AIDS, however, has transformed needle-stick from a mere inconvenience to a major consideration for health care workers. When a health care worker is stuck, he of ~he must be tested for exposure to the various serum-transmitted diseases such as hepatitis and AIDS. Even if 35 such diseases were never actually contracted from the invasion of the needle through the skin, the C09tS of such testing would be (and are) WO 91/1284~ PCI/US91/00979 205~806 considerable. Unfortunately, the diseases are contracted by such accidental needle-stick. Thus, the health care worker who is stuck must suf~er the mental anguish of possi~ly having contracted hepatitis or AIDS by virtue of the accident.
6The typical syringe in use today is as depicted in Figure 1 where it i~
generally indicated as 10. The syringe 10 has a cylindrical barrel 12 into which a cylindrical plunger 14 is slidably inserted at one end. A needle 16 is attached to the opposite end of the barrel 12. For ease of puncturing the skin of a patient, the end of the needle 16 terminates in an extremely sharp 10 chisel point 18. The needle 16 is covered with a removable cylindrical cap 20 which typically lockingly attaches to the barrel 12. To remove the needle cap 20 for use of the syringe 10, the cap 20 is rotated to unlock it from the barrel 12 and then removed from over the needle 16. Once the protective cap 20 is removed, the point 18 is exposed and available for unintended 15 needle-stick. For example, the syringe 10 could be dropped and stick into the user or anyone in the area at any point of the body in the path of descent. The cap 20 is also replaced on the syringe 10 after use for safety purposes. That process itself is a major contributor to needle-stick as it is easy for the user to miss the opening to the cap 20 with the needle 16 and 20 stick a finger which i9 holding the cap 20.
Needle-stick is not a problem which has gone unnoticed in the art.
Unfort mately, with one e~cception which will be addressed shortly, those persons inventing with an eye to preventing needle-sick have not done ~o in a realistic manner. Typically, what is offered as a solution i~ a complicated 25 hypodermic syringe construction which (while it may work to prevent needle-stick) is so complex as to drive the co~t of a syringe beyond that which the health care industry is willing to pay. For e2~ample, one popular prior art approach is to have the needle 16 be mounted for automatic retraction into the barrel 12 after use. As can be appreciated, not only is 30 such construction complex and, therefore, extremely e~pensive; but, it does not take into consideration how such parts can be produced. As can be appreciated, the cylindrical barrel 12 and plunger 14 of the prior art syringe 10 of Figure 1 are easily and inexpensively produced employing injection molding techniques with plastic. The syringes come pre-sterilized 35 in a plastic wrap and are discarded after a single use thereby miDimizirlg the costs associated with each single injection.
wo 9l/12843 2 ~ ~ ~ 8 ~ ~ PC~/US91/009~9 The ~ingle known exception to the general and complete impracticality of prior art approaches to preventing needle-stick i~ that suggested by Dr. Marcial Alvarez in his 1979 U.S. patent number 4,139,009. This is not to say that Dr. Alvarez'~ retractable needle cap is a S complete solution to-the problem. There are, in fact, problems with Dr.
Alvarez's approach which account for the fact that despite the extreme nature of the problem and the fact that Dr. Alvarez's design has been available to the art for over eleven years, the Alvarez solution has not been adopted by the supplier~ of ~yringes. What the Alvarez cap suggests, 10 however, is that there can be a simple and ine~pensive approach to solving the needle-stick problem employing standard disposable syringes. The Alvarez approach is depicted in greatly simplified form in Figures 2 and 3 wherein his retractable cap i8 generally indicated as 22. The cap 22 comprises a cylindrical hub 24 which attaches to the barrel 12 of the 15 syringe 10 in the same manner as the prior art cap 20. An annular slider member 26 fits over the needle 16 adjacent the point 18. A plurality (four being suggested) of bowed members 28 extend from the hub 24 to the slider member 26 and extend out over the point 18 of the needle 16 80 as to completely encase the needle 16. In use, the slider member 26 can be 20 pressed against the rubber cover of a bottle (to fill the syringe 10) or against the skin of a patient (to inject from the syringe 10). By pushing the syringe forward, the slider member 26 is urged backward along the needle 16 as the bowed member~ ?8 bow outward to a retracted po~ition as in Figure 3. Alternately, the slider member 26 can be gripped and retracted 25 as, for e~ample, when doing an intravenous injection in which the positioning of the needle 16 must be observed.
On paper and as a fir~t impression, the Alvarez apparatus appears to be an ideal ~olution to the needle-stick problem. When one contemplates the totality of its operation and investigates the practicalities ~f producing 30 it on a commercial level, however, certain shortcomings become apparent.
For one thing, it is virtually impos~ible to mold the retractable cap 22 of Alvarez. Moreover, if one counts the parts in the retractable cap 22 of Alvarez as depicted in the patent drawing~, there are five part8 to each cap.
A~ those skilled in the art are readily aware, each part of a device adds to 3~ the co~t of manufacture and a~sembly. When manually retractiIlg the cap 22 of Alvarez by gripping the slider member 26, it can be ~een and wo 91/t2843 2 0 5 1 ~ O ~j PCr/US91/00979 appreciated that it would be an easy matter to have a finger in the line of movement of the needle point 18 and be stuck by it. Moreover, with the cap 22 in its "~,afety " position of Figure 2, if one were to longitudinally bump the slider member 26, it is highly likely that the slider member 26 vould ~, retract suf~lciently to allow the point 18 of the needle 16 to æ,tick someonesufficiently to puncture the F,kin. Thi~, can be seen with reference to the graph of Figure 4. AB soon as some longitudinal force i~, applied to the slider member ~6 of the Alvarez cap 22, the ælider member 26 begins to move back and expose the point 18 of the needle 16. What would be 10 desirable would be a retractable cap which would perform a~, depicted in Figure 5; that i8, have a step force which mu~,t be overcome before the cap begins to retract. The step force should be sufficient to prevent retraction from normal bumping force. Even more ideal wo~d be a way of locking the cap frc,m retraction until actual retraction wa~, desired.
15 Two approaches somewhat similar to Alvarez are contained in the 19~8 U.S. patents to Hagen (4,735,618) and Dombrowski et al. (4,790,828).
Wherefore, it iæ, an object of the present invention to provide a retractable safety cap for covering the needle of a hypodermic F'yringe to miI~imize the opportunity of needle-stick which iæ, simple and ine~penF'ive 20 to manufacture.
It i~ another object of the pre~,ent invention to provide a retractable safety cap for covering the needle of a hypodermic syringe to minirnize the opportunity of needle-stick which is reliable in operation.
It is yet another object of the present invention to provide a 25 retractable safety cap for covering the needle of a hypodermic 3yringe to minimize the opportunit~ of needle-stick which can be employed vith prior art syringe~ without any necessity of modifying the 3yringe.
It is still another object of the present invention to provide a retractable safety cap for covering the needle of a hypodermic syringe to 30 minimize the opportunity of needle-stick which has a safety threshold of force necessary to retract the cap which will avoid retraction from normal longitudinal bumping forces.
It iB still another object of the present invention to provide a retractable safety cap for covering the needle of a hypodermic syringe to 35 minimize the opportunity of nee~le-stick svhich has a safety lock a~sociated therewith which will avoid retraction until desired.
wo gl/12843 2 0 51 8 0 6 Pcr/uss1/oo979 Other objects and benefits of the invention will become apparent from the detailed description which follows hereinafter when taken in con,Junction with the drawing figures which accompany it.
1~
~5 wo 91/12843 2 0 5 1 8 ~ ~ Pcr/usg1/oo979 DISCLOSURE OF INVENTION
The foregoing objects have been achieved in a hypodermic syringe having a barrel with a needle extending outward therefrom by the lockable 5 and retractable safety cap for covering the needle to prevent accidental needle-stick therefrom of the present invention comprising a unitarv cap assembly of a resiliently flexible plastic material including a hub portion disposed concentrically about a base portion of the needle and attached to the barrel, a sliding safety hub portion having a bore therethrough ~lidably 10 disposed with the needle passing through the bore and extending over a point end of the needle, and a pluralit~r of slats e~tending between the hub portion and the sliding safety hub portion, the slats being spaced from one another along adjacent edges thereof at radially equal intervals about the periphery of the needle and being parallel to the needle whereby a 15 longitudinal compressive force against the sliding safety hub portion is resixted by a longitudinal compre~sive resistance of the slats which must be overcome before the slats will deform and fle~ outward from the needle to allow the sliding safety hub portion to slide along and expose the needle for use; and, a releasable safety latch disposed o~er the slata for preventing 20 deforming and outward flexing thereof whereby the cap as~embly is locked and resistance to accidental needle-sticl~ is increa~ed when the syringe i8 not in use.
In the preferred embodiment, the releasable safetv latch compri~es a coil spring disposed over the slats so as to be compressible adjacent an 2~ inner end of the slats at the hub portion to allow the slat~ to deform and flex outward. Additionally, there i8 a sliding collar carried by an outer end of the coil spring opposite the inner end of the slats.
The preferred embodiment also includes retaining button means located on one of the slats a~acent the inner end for holding the sliding 30 collar to retain the coil spring in a compressed state adjacent the inner endof the slats. The preferred retaining button means includes release means for releasing a hold on the sliding collar when the one of the slats bends outward whereby when the one of the slats returns to an unbent state following use of the syringe the coil spring is released and returns to an 35 extended state from a self-bias force thereof.
Preferably, the retaining button means includes a button for wo 91/1284~ 2 ~ ~ L 8 0 ~ Pcr/US91/00979 preventing the sliding collar from sliding along the ~lats; and, the release means comprises, a tab on the one of the slats facing the hub portion and carrying the retaining button, and a strongback formed along an inner surface of the one of the slats disposed between a midpoint of the one of the 5 slats and a point adjacent a rear edge of the tab whereby as the one of the slats bends outward the strongback pivots the tab downward about the rear edge thereby lowering the button an amount ~ufficient for the sliding collar to slide thereover.
wo 91/12843 2 ~ 5 1 8 ~ 6 PCr/US91/00979 BRrEF DESCR~PTION OF DRAW~GS
Figure 1 is a simplified partially cutaway drawing of a hypodermic syringe showing a prior art removable needle cap;
Figure 2 iB a simplified partially cutaway drawing of the needle portion of a hypodermic syringe showing a prior art needle protective sheath which retracts to expose the needle with the sheath in its e~ended position;
Figure 3 ia a simplified partially cutaway drawing of the needle 10 portion of a hypodermic ~vringe of Figure 2 showing the prior art needle protective sheath with the sheath in its retracted position;
Figure 4 i8 a graph depicting the force required to retract the prior art needle protective sheath of Figures 2 and 3;
Figure 5 is a graph depicting the force required to retract the needle 1~ protective sheath of the present invention in its simplest embodiment;
Figure 6 is a ~implified side view drawing of the needle portion of a hypodermic syringe showing the needle protective sheath of the present invention in its simplest embodiment;
Figu;re 7 i~ a cutaway end view drawing of the protective sheath of the 20 present invention at plane VII - VII of Figure 6 depicting the preferred ~quare cros~ section;
Figure 8 i~ a simplified partially cutaway side view drawing of the needle portion of a hypodermic syringe showing the needle protective 3heath of the present invention of Figure 6;
Figure 9 is a cutaway end view drawing of the protective sheath of the present invention depicting an alternate embodiment which has a circular cross section, Figure 10 is a cutaway end view drawing of the protective sheath of the present invention depicting another alternate embodiment which has a t~iangular cross ~ection;
Figure 11 is a simplified ~ide Yiew drawing of the needle portion of a hypodermic syringe showing the needle protective sheath of the present invention in its prefe~Ted embodiment incorporating a loc~ing spring over the ~heath;
Figure 12 i~ a cutaway side view drawing of the protective sheath and loc~ing spring of Figure 11;
WO 91/12843 2 9 5 ~ ~ O ~ PCI/US91/00979 Figure 13 i9 a simplified side view drawing of the needle protective sheath of the present invention in its preferred embodiment of Figure 11 with the locking spring withdrawn to a latched position which allows the ~heath to be retracted;
Figure 14 is a simplified side view drawing of the needle protective sheath of the present invention in its preferred embodiment of Figures 11 and 13 with the locking spring withdrawn to its latched position and the sheath in the process of being retracted;
Figure 15 is a simplified enlarged drawing of the latching button at 10 the base of the sheath depicting the way in which the button releases the spring during retraction of the sheath; and Figure 16 is a simplified side view drawing of the needle protective ~heath of the present invention with the locking spring relea~ed from its latched position ~o as to automatically return to its locked position when 15 the sheath is relea~ed from its retracted position.
WO 91~12843 2 ~ 0 6 PCT/US91/00979 _ 10--MODES FOR CARRYING OUT THE ~IVENTION
The retractable safety cap of the present invention is ~hown in it~
most basic preferred form in Figures 6 through 8 where it is generally 5 indicated-as 30. The cap 30 i9 of a molded plastic such as polypropylene and, a~ indicated in Figure 8, is of unitary construction. As those skilled in the molding art will appreciate, the design is such as to be easily and inexpen~ively molded. Since there is only one part, there i9 no cost of assembly as~ociated with the cap 30. The cap 30 comprises a cylindrical 10 hub portion 32 which is adapted to lockingly engage the barrel 12 of a standard syringe 10. The hub portion 32 has grooves 34 formed into the exterior surface 80 as to enhance the gripping thereof when mounting the cap 30 onto the barrel 12 of the syringe 10. Ridges could, of course, be substituted for the grooves 34 if desired and both could be eliminsted 15 without affecting the novel aspect~ of the cap 30. The oppo~ite end of the cap 30 is formed as a sliding ~afety hub 36. The hub 36 has a longitudinal bore 38 therethrough which slides on the needle 16. The hub 36 also extends out over the point 18 of the needle 16. In the preferred embodiment, the hub portion 32 and sliding safety hub 36 are 20 interconnected by four flat slats 40 disposed at 90 intervals around the needle 16 so as to form a square box around the needle 16 as shown in Figure 7. Note that the slat~ 40 abut one another along their longitudinal edges in slits 42 so as to be free to move independently. Note also that the slats 40 are not bowed with respect to the needle 16; that is, they are 25 parallel thereto along the entire length from the hu~ portion 32 to the sliding ~afety hub 36. The sliding ~afety hub 36 has a circumferential groove 44 disposed ba~k from the outer end 46. The bottom edge 48 of the groove 44 iB angled as depicted. This provides two functions. For one, the groove 44 call be gripped to manually retract the cap 30 without danger of 30 the user's fingers being in the line of movement of the needle point 18. For another, the angle of the edge 48 provides a slight outward force on the slats 40 to assure that they move outward for full retractability rather th~n moving inward against the needle, which would prevent full retractability.
One may also wish to make the material of the cap 3û where the slats 40 3~ join the sliding safety hub 36 slightly thinner so that bending will take place at that point. The angle of the edge 48 make~ that an easy task. In wo 9t/t2843 2 0 ~ ~ 8 ~ ~ Pcr/usgt/oo979 passing, it should be noted that the sliding safety hub 36 could be square if desired; but, a cylindrical shape is more aesthetically pleasing and, therefore, in the preferred embodiment the sliding safety hub 36 is generally cylindrical and smoothly curves to a square cross section where it 5 joins the-slats 40. If desired, the slats could be formed a8 cylindrical segments 40' as depicted in Figure 9 or, in the alternative, more or fewer flat slats 40 could be employed a~ in the triangular cross s~tion of Figure 10. Moreover, it is also preferred that the surface of the outer end 46 have 8 roughened texture fonned therein 80 as to grip the ~kin of a patient and 10 thereby minimize any pos~ibility of slipping.
It is the foregoing construction which causes the aafety cap 30 of this invention to perform in the manner shown in the graph of Figure 5. Since the slat~ 40 are parallel to the needle 16, an initial longitudinal force against the outer end 46 is wholly a compressive force along the length of 15 the slats 40. Thus, as depicted in the graph of Figure 5, the force must increase to a level where the slat~ suddenly begin to deform outward. Once this threshold level i3 overcome, a lower bending resistive force i~ all that i8imparted by the ~lats 40. It is contemplated that u~i~g polypropylene for the slats 40 a thickness of 10 mils will afford the proper initial re~istance 20 and subsequent restorative force; that is, once the cap 30 has been retracted, it should reliably, quickly, and positively return to its protectiYe position covering the needle 16 a~ the needle 16 i~ withdrawn from the patient. Initial prototype testing was done using a cylindrical arrangement as depicted in Figure 9. Since a cylindrical segment is more re~istive to 25 longitudinal compre~sive forces than a flst slat, ~atisfactory performance was achieved with a 4 mil wall thickness. It is on this ba~is that 10 mils is projected as being optimum for the flat slats of the preferred embodiment.
Turning now to Figures 11 through 16 where it iB generally indicated as 50, the safety cap of the preaent invention in its preferred embodiment 30 incorporating a safety latch will now be de~cribed in detail. A~ those skilled in the art will readily note and appreciate, the preferred safety cap 50 is comprised of only two components -- the basic safety cap 30' l~lightly modified) and a ~pring latch 62. The basic safety cap 30' is substantially as de~cribed above with the addition of an outer retention button 54 and an 3~ inner retention button 56 on the ~lats 40. The buttons 54, 56 will be addressed in greater detail shortly. The ~pring latch 52 iB of unitary WOgl/12843 205~ 80~ PCr/US91/00979 construction and comprises a sliding collar 58 formed on one end of a coil spring 60. The collar 58 and spring 60 are sized and shaped to fit close to the surface of the slats 40 yet slide surely and easily therealong between an e~tended (i.e. locked) position as depicted in Figures 11 and 12 and a 5 retracted (i.e. unlocked) position as depicted in Figures 13 and 14.
The spring latch 52 i8 slid over the slats 40 of the basic cap ~0' and held in place by the outer retention button 54. For as~embly purposes of this embodiment, it may be preferable to make the siding safety hub portion 36 of square cross section. In pa~sing it should also be noted that 10 one button 54 could be employed; but, that two buttons 54 disposed on opposite sides 180 from one another are preferred. A~ will be appreciated, with the spring latch 52 in it~ e~tended and locked po~ition of Figures 11 and 12, it is virtually impossible to cause the slats 40 to bow outward.
Thus, longitudinal compressive resistance continues to meet and resist any 15 longitudinal force attempting to expo~e the point 18 of the needle 16 and needle-stick i8 virtually eliminated. Of course, if the syringe were to be projected in the manner of a dart under extremely high force, something might give resulting in expo~ure of the point 18. Under normally encountered forces, however, needle-stick should not occur.
To use the syringe 10, the spring latch 52 is retracted to the po~ition of Figure 13 by gripping the sliding collar 58 and sliding it towards the hub portion 32 where it is held by the inner retention button 56. As with the outer retention button 54 as discussed abo~e, one button 56 could be used but two spaced on oppo~ite sides &t 180 intervals i~ preferred. With the 25 coil ~pring 60 withdrawn from its extende~ po~ition surrounding the slats 40, the sliding safety hub 36 can be slid along the needle 16 to e~pose it for use in the manner described above with respect to the basic cap 30 and a~
depicted in Figure 14.
The inner retention button ~6 is included in the preferred 30 embodiment to make use of a ~yringe 10 including the safet31 cap ~0 as easy as possible. The imler retention button ~6 could, of course, be eliminated if desired without making use of the syringe 10 e~ce~sively difficult. It should be noted at this point that ju~t as the material and thickness of the slats 40 i8 cho9en so that the slats 40 will fle~ when the sliding ~afety hub 36 i~
35 retracted but retain their plastic "memory" and therefore urge the ~liding safety hub 36 back to it~ extended position, the coil spring 60 portion of the W0 91/12843 2 ~ 5 1 ~ 9 ~ Pcr/uss1/oo979 spring latch 52 is also of a material and thickness 80 as to have a ~lcient spring constant which will return the spring latch 52 to its extended position of Figure 11 when it i8 relea~ed. If the inner retention button 56 is employed to hold the spring latch 52 in it~ retracted po~ition, those skilled 5 in the art will recognize and appreciate that provision must be made to repeatedly and positively relea~e the sliding collar 58 80 as to allow the spring latch 52 to automatically return to its locked safety position and maximize the protection afforded by the cap 50 again~t accidental needle-stick following use of the ~yringe 10. Such proviBion i8 included in 10 the cap 50 and will now be de~cribed.
The inner retention button 56 is mounted on a tab 62 formed into the slat 40. The tab 62 faces toward~ the syringe 10. Additionally, as shown ghosted in Fig-are 14 and in side view in Figure 15, a strong~ack 64 is forrned into the slat 40 containing the inner retention button 56 between a 15 point adjacent the midpoint of the slat 40 and the back edge 66 of the tab 62. As will beP~ be understood with reference to Figure 15, when the sliding collar 58 has c- n slid over the inner retention button 56 and is being held thereby and the sliding safety hub portion 36 is slid towards the ~yringe 10 to expose the ~eedle 16, the ~lats 40 begin to deform outward in the 20 manner depicted in figure 14. In 80 doing, the ~trongback 64 is raised and pivot~ about the back edge 66 o~ the tab 62 since it is the weal~est point adjacent the rear of the slat 40 containing the tab 62. The portions of the slat 40 on opposite side~ of the tab 62 bend; however, the tab 62 being free to move moves downward pivoting about its back edge 66 a~ depicted in 25 Figure 15. As the tab 62 pivots about its back edge 66, the inner retention button 56 moves downward sufficiently to release the ~liding collar 58. The sliding collar 58 then moves forward under its self-bia~ing force over the button 56 to the position of Figure 16 where it is held from extending by the outwardly bent slats 40. As will be recogDized and appreciated by those 30 skilled in the art by this point, when the inward compressive force on the sliding safety hub portion 36 i~ released and the slat~ 40 return to their flatted and extended position, the sliding collar 58 i8 no longer held and prevented from allowing the ~pring latch 52 to e~tend and, therefore, it immediately and automatically e~tends to lock the cap 50.
Thus it will be appreciated by those skilled in the ar~ from the foregoing description and the accompanying drawings that the present WO 91/12843 PCr/US91/00979 0 ~ ' _ 14--invention ha~ truly met its stated objectives by providing a retractable safety cap for attachment to a standard syringe as a replacement for the rigid needle cap of the standard ~yringe to thereby provide an inexpensive and po~itive mean~ of protecting health care worker~ and others again~t 5 accidental needle-~tick to the ma~imum degree pos~ible.
1~
5 This invention relates to safety covers for the needle of a hypodermic syringe and, more particularly, in a hypodermic syringe having a barrel with a needle extending outward therefrom, to a retractable safety cap for covering the needle to prevent accidental needle-stick therefrom comprising a unitary cap assembly of a resiliently flexible plastic material including a 10 hub portion disposed concentrically about a base portion of the needle and attached to the barrel, a sliding safety hub portion having a bore therethrough slidably disposed with the needle passing through the bore and extending over a point end of the needle, and a plurality of slats extending between the hub portion and the sliding safety hub portion, the 15 slats being spaced from one another along adjacent edges thereof at radially equal intervals about the periphery of the needle and being parallel to the needle whereby a longitudinal compressive force against the sliding safety hub portion is resisted by a longitudinal compressive resistance of the slats which must be overcome before the slats will deform 20 and flex outward from the needle to allow the sliding safety hub portion to slide along and expose the needle for use.
BACKGROUND ART
So called "needle-stick" is a major problem among health workers such as doctors, nurses, and the like. Needle-stick is the accidental puncturing of the skin of a health worker while working with hypodermic syringes. Needle-stick, per se, i9 not a new phenomenon for health care workers. In the past, however, it was more of an inconvenience than 30 anything else. The present level of activity of serum-transmitted diseases such as hepatitis and AIDS, however, has transformed needle-stick from a mere inconvenience to a major consideration for health care workers. When a health care worker is stuck, he of ~he must be tested for exposure to the various serum-transmitted diseases such as hepatitis and AIDS. Even if 35 such diseases were never actually contracted from the invasion of the needle through the skin, the C09tS of such testing would be (and are) WO 91/1284~ PCI/US91/00979 205~806 considerable. Unfortunately, the diseases are contracted by such accidental needle-stick. Thus, the health care worker who is stuck must suf~er the mental anguish of possi~ly having contracted hepatitis or AIDS by virtue of the accident.
6The typical syringe in use today is as depicted in Figure 1 where it i~
generally indicated as 10. The syringe 10 has a cylindrical barrel 12 into which a cylindrical plunger 14 is slidably inserted at one end. A needle 16 is attached to the opposite end of the barrel 12. For ease of puncturing the skin of a patient, the end of the needle 16 terminates in an extremely sharp 10 chisel point 18. The needle 16 is covered with a removable cylindrical cap 20 which typically lockingly attaches to the barrel 12. To remove the needle cap 20 for use of the syringe 10, the cap 20 is rotated to unlock it from the barrel 12 and then removed from over the needle 16. Once the protective cap 20 is removed, the point 18 is exposed and available for unintended 15 needle-stick. For example, the syringe 10 could be dropped and stick into the user or anyone in the area at any point of the body in the path of descent. The cap 20 is also replaced on the syringe 10 after use for safety purposes. That process itself is a major contributor to needle-stick as it is easy for the user to miss the opening to the cap 20 with the needle 16 and 20 stick a finger which i9 holding the cap 20.
Needle-stick is not a problem which has gone unnoticed in the art.
Unfort mately, with one e~cception which will be addressed shortly, those persons inventing with an eye to preventing needle-sick have not done ~o in a realistic manner. Typically, what is offered as a solution i~ a complicated 25 hypodermic syringe construction which (while it may work to prevent needle-stick) is so complex as to drive the co~t of a syringe beyond that which the health care industry is willing to pay. For e2~ample, one popular prior art approach is to have the needle 16 be mounted for automatic retraction into the barrel 12 after use. As can be appreciated, not only is 30 such construction complex and, therefore, extremely e~pensive; but, it does not take into consideration how such parts can be produced. As can be appreciated, the cylindrical barrel 12 and plunger 14 of the prior art syringe 10 of Figure 1 are easily and inexpensively produced employing injection molding techniques with plastic. The syringes come pre-sterilized 35 in a plastic wrap and are discarded after a single use thereby miDimizirlg the costs associated with each single injection.
wo 9l/12843 2 ~ ~ ~ 8 ~ ~ PC~/US91/009~9 The ~ingle known exception to the general and complete impracticality of prior art approaches to preventing needle-stick i~ that suggested by Dr. Marcial Alvarez in his 1979 U.S. patent number 4,139,009. This is not to say that Dr. Alvarez'~ retractable needle cap is a S complete solution to-the problem. There are, in fact, problems with Dr.
Alvarez's approach which account for the fact that despite the extreme nature of the problem and the fact that Dr. Alvarez's design has been available to the art for over eleven years, the Alvarez solution has not been adopted by the supplier~ of ~yringes. What the Alvarez cap suggests, 10 however, is that there can be a simple and ine~pensive approach to solving the needle-stick problem employing standard disposable syringes. The Alvarez approach is depicted in greatly simplified form in Figures 2 and 3 wherein his retractable cap i8 generally indicated as 22. The cap 22 comprises a cylindrical hub 24 which attaches to the barrel 12 of the 15 syringe 10 in the same manner as the prior art cap 20. An annular slider member 26 fits over the needle 16 adjacent the point 18. A plurality (four being suggested) of bowed members 28 extend from the hub 24 to the slider member 26 and extend out over the point 18 of the needle 16 80 as to completely encase the needle 16. In use, the slider member 26 can be 20 pressed against the rubber cover of a bottle (to fill the syringe 10) or against the skin of a patient (to inject from the syringe 10). By pushing the syringe forward, the slider member 26 is urged backward along the needle 16 as the bowed member~ ?8 bow outward to a retracted po~ition as in Figure 3. Alternately, the slider member 26 can be gripped and retracted 25 as, for e~ample, when doing an intravenous injection in which the positioning of the needle 16 must be observed.
On paper and as a fir~t impression, the Alvarez apparatus appears to be an ideal ~olution to the needle-stick problem. When one contemplates the totality of its operation and investigates the practicalities ~f producing 30 it on a commercial level, however, certain shortcomings become apparent.
For one thing, it is virtually impos~ible to mold the retractable cap 22 of Alvarez. Moreover, if one counts the parts in the retractable cap 22 of Alvarez as depicted in the patent drawing~, there are five part8 to each cap.
A~ those skilled in the art are readily aware, each part of a device adds to 3~ the co~t of manufacture and a~sembly. When manually retractiIlg the cap 22 of Alvarez by gripping the slider member 26, it can be ~een and wo 91/t2843 2 0 5 1 ~ O ~j PCr/US91/00979 appreciated that it would be an easy matter to have a finger in the line of movement of the needle point 18 and be stuck by it. Moreover, with the cap 22 in its "~,afety " position of Figure 2, if one were to longitudinally bump the slider member 26, it is highly likely that the slider member 26 vould ~, retract suf~lciently to allow the point 18 of the needle 16 to æ,tick someonesufficiently to puncture the F,kin. Thi~, can be seen with reference to the graph of Figure 4. AB soon as some longitudinal force i~, applied to the slider member ~6 of the Alvarez cap 22, the ælider member 26 begins to move back and expose the point 18 of the needle 16. What would be 10 desirable would be a retractable cap which would perform a~, depicted in Figure 5; that i8, have a step force which mu~,t be overcome before the cap begins to retract. The step force should be sufficient to prevent retraction from normal bumping force. Even more ideal wo~d be a way of locking the cap frc,m retraction until actual retraction wa~, desired.
15 Two approaches somewhat similar to Alvarez are contained in the 19~8 U.S. patents to Hagen (4,735,618) and Dombrowski et al. (4,790,828).
Wherefore, it iæ, an object of the present invention to provide a retractable safety cap for covering the needle of a hypodermic F'yringe to miI~imize the opportunity of needle-stick which iæ, simple and ine~penF'ive 20 to manufacture.
It i~ another object of the pre~,ent invention to provide a retractable safety cap for covering the needle of a hypodermic syringe to minirnize the opportunity of needle-stick which is reliable in operation.
It is yet another object of the present invention to provide a 25 retractable safety cap for covering the needle of a hypodermic 3yringe to minimize the opportunit~ of needle-stick which can be employed vith prior art syringe~ without any necessity of modifying the 3yringe.
It is still another object of the present invention to provide a retractable safety cap for covering the needle of a hypodermic syringe to 30 minimize the opportunity of needle-stick which has a safety threshold of force necessary to retract the cap which will avoid retraction from normal longitudinal bumping forces.
It iB still another object of the present invention to provide a retractable safety cap for covering the needle of a hypodermic syringe to 35 minimize the opportunity of nee~le-stick svhich has a safety lock a~sociated therewith which will avoid retraction until desired.
wo gl/12843 2 0 51 8 0 6 Pcr/uss1/oo979 Other objects and benefits of the invention will become apparent from the detailed description which follows hereinafter when taken in con,Junction with the drawing figures which accompany it.
1~
~5 wo 91/12843 2 0 5 1 8 ~ ~ Pcr/usg1/oo979 DISCLOSURE OF INVENTION
The foregoing objects have been achieved in a hypodermic syringe having a barrel with a needle extending outward therefrom by the lockable 5 and retractable safety cap for covering the needle to prevent accidental needle-stick therefrom of the present invention comprising a unitarv cap assembly of a resiliently flexible plastic material including a hub portion disposed concentrically about a base portion of the needle and attached to the barrel, a sliding safety hub portion having a bore therethrough ~lidably 10 disposed with the needle passing through the bore and extending over a point end of the needle, and a pluralit~r of slats e~tending between the hub portion and the sliding safety hub portion, the slats being spaced from one another along adjacent edges thereof at radially equal intervals about the periphery of the needle and being parallel to the needle whereby a 15 longitudinal compressive force against the sliding safety hub portion is resixted by a longitudinal compre~sive resistance of the slats which must be overcome before the slats will deform and fle~ outward from the needle to allow the sliding safety hub portion to slide along and expose the needle for use; and, a releasable safety latch disposed o~er the slata for preventing 20 deforming and outward flexing thereof whereby the cap as~embly is locked and resistance to accidental needle-sticl~ is increa~ed when the syringe i8 not in use.
In the preferred embodiment, the releasable safetv latch compri~es a coil spring disposed over the slats so as to be compressible adjacent an 2~ inner end of the slats at the hub portion to allow the slat~ to deform and flex outward. Additionally, there i8 a sliding collar carried by an outer end of the coil spring opposite the inner end of the slats.
The preferred embodiment also includes retaining button means located on one of the slats a~acent the inner end for holding the sliding 30 collar to retain the coil spring in a compressed state adjacent the inner endof the slats. The preferred retaining button means includes release means for releasing a hold on the sliding collar when the one of the slats bends outward whereby when the one of the slats returns to an unbent state following use of the syringe the coil spring is released and returns to an 35 extended state from a self-bias force thereof.
Preferably, the retaining button means includes a button for wo 91/1284~ 2 ~ ~ L 8 0 ~ Pcr/US91/00979 preventing the sliding collar from sliding along the ~lats; and, the release means comprises, a tab on the one of the slats facing the hub portion and carrying the retaining button, and a strongback formed along an inner surface of the one of the slats disposed between a midpoint of the one of the 5 slats and a point adjacent a rear edge of the tab whereby as the one of the slats bends outward the strongback pivots the tab downward about the rear edge thereby lowering the button an amount ~ufficient for the sliding collar to slide thereover.
wo 91/12843 2 ~ 5 1 8 ~ 6 PCr/US91/00979 BRrEF DESCR~PTION OF DRAW~GS
Figure 1 is a simplified partially cutaway drawing of a hypodermic syringe showing a prior art removable needle cap;
Figure 2 iB a simplified partially cutaway drawing of the needle portion of a hypodermic syringe showing a prior art needle protective sheath which retracts to expose the needle with the sheath in its e~ended position;
Figure 3 ia a simplified partially cutaway drawing of the needle 10 portion of a hypodermic ~vringe of Figure 2 showing the prior art needle protective sheath with the sheath in its retracted position;
Figure 4 i8 a graph depicting the force required to retract the prior art needle protective sheath of Figures 2 and 3;
Figure 5 is a graph depicting the force required to retract the needle 1~ protective sheath of the present invention in its simplest embodiment;
Figure 6 is a ~implified side view drawing of the needle portion of a hypodermic syringe showing the needle protective sheath of the present invention in its simplest embodiment;
Figu;re 7 i~ a cutaway end view drawing of the protective sheath of the 20 present invention at plane VII - VII of Figure 6 depicting the preferred ~quare cros~ section;
Figure 8 i~ a simplified partially cutaway side view drawing of the needle portion of a hypodermic syringe showing the needle protective 3heath of the present invention of Figure 6;
Figure 9 is a cutaway end view drawing of the protective sheath of the present invention depicting an alternate embodiment which has a circular cross section, Figure 10 is a cutaway end view drawing of the protective sheath of the present invention depicting another alternate embodiment which has a t~iangular cross ~ection;
Figure 11 is a simplified ~ide Yiew drawing of the needle portion of a hypodermic syringe showing the needle protective sheath of the present invention in its prefe~Ted embodiment incorporating a loc~ing spring over the ~heath;
Figure 12 i~ a cutaway side view drawing of the protective sheath and loc~ing spring of Figure 11;
WO 91/12843 2 9 5 ~ ~ O ~ PCI/US91/00979 Figure 13 i9 a simplified side view drawing of the needle protective sheath of the present invention in its preferred embodiment of Figure 11 with the locking spring withdrawn to a latched position which allows the ~heath to be retracted;
Figure 14 is a simplified side view drawing of the needle protective sheath of the present invention in its preferred embodiment of Figures 11 and 13 with the locking spring withdrawn to its latched position and the sheath in the process of being retracted;
Figure 15 is a simplified enlarged drawing of the latching button at 10 the base of the sheath depicting the way in which the button releases the spring during retraction of the sheath; and Figure 16 is a simplified side view drawing of the needle protective ~heath of the present invention with the locking spring relea~ed from its latched position ~o as to automatically return to its locked position when 15 the sheath is relea~ed from its retracted position.
WO 91~12843 2 ~ 0 6 PCT/US91/00979 _ 10--MODES FOR CARRYING OUT THE ~IVENTION
The retractable safety cap of the present invention is ~hown in it~
most basic preferred form in Figures 6 through 8 where it is generally 5 indicated-as 30. The cap 30 i9 of a molded plastic such as polypropylene and, a~ indicated in Figure 8, is of unitary construction. As those skilled in the molding art will appreciate, the design is such as to be easily and inexpen~ively molded. Since there is only one part, there i9 no cost of assembly as~ociated with the cap 30. The cap 30 comprises a cylindrical 10 hub portion 32 which is adapted to lockingly engage the barrel 12 of a standard syringe 10. The hub portion 32 has grooves 34 formed into the exterior surface 80 as to enhance the gripping thereof when mounting the cap 30 onto the barrel 12 of the syringe 10. Ridges could, of course, be substituted for the grooves 34 if desired and both could be eliminsted 15 without affecting the novel aspect~ of the cap 30. The oppo~ite end of the cap 30 is formed as a sliding ~afety hub 36. The hub 36 has a longitudinal bore 38 therethrough which slides on the needle 16. The hub 36 also extends out over the point 18 of the needle 16. In the preferred embodiment, the hub portion 32 and sliding safety hub 36 are 20 interconnected by four flat slats 40 disposed at 90 intervals around the needle 16 so as to form a square box around the needle 16 as shown in Figure 7. Note that the slat~ 40 abut one another along their longitudinal edges in slits 42 so as to be free to move independently. Note also that the slats 40 are not bowed with respect to the needle 16; that is, they are 25 parallel thereto along the entire length from the hu~ portion 32 to the sliding ~afety hub 36. The sliding ~afety hub 36 has a circumferential groove 44 disposed ba~k from the outer end 46. The bottom edge 48 of the groove 44 iB angled as depicted. This provides two functions. For one, the groove 44 call be gripped to manually retract the cap 30 without danger of 30 the user's fingers being in the line of movement of the needle point 18. For another, the angle of the edge 48 provides a slight outward force on the slats 40 to assure that they move outward for full retractability rather th~n moving inward against the needle, which would prevent full retractability.
One may also wish to make the material of the cap 3û where the slats 40 3~ join the sliding safety hub 36 slightly thinner so that bending will take place at that point. The angle of the edge 48 make~ that an easy task. In wo 9t/t2843 2 0 ~ ~ 8 ~ ~ Pcr/usgt/oo979 passing, it should be noted that the sliding safety hub 36 could be square if desired; but, a cylindrical shape is more aesthetically pleasing and, therefore, in the preferred embodiment the sliding safety hub 36 is generally cylindrical and smoothly curves to a square cross section where it 5 joins the-slats 40. If desired, the slats could be formed a8 cylindrical segments 40' as depicted in Figure 9 or, in the alternative, more or fewer flat slats 40 could be employed a~ in the triangular cross s~tion of Figure 10. Moreover, it is also preferred that the surface of the outer end 46 have 8 roughened texture fonned therein 80 as to grip the ~kin of a patient and 10 thereby minimize any pos~ibility of slipping.
It is the foregoing construction which causes the aafety cap 30 of this invention to perform in the manner shown in the graph of Figure 5. Since the slat~ 40 are parallel to the needle 16, an initial longitudinal force against the outer end 46 is wholly a compressive force along the length of 15 the slats 40. Thus, as depicted in the graph of Figure 5, the force must increase to a level where the slat~ suddenly begin to deform outward. Once this threshold level i3 overcome, a lower bending resistive force i~ all that i8imparted by the ~lats 40. It is contemplated that u~i~g polypropylene for the slats 40 a thickness of 10 mils will afford the proper initial re~istance 20 and subsequent restorative force; that is, once the cap 30 has been retracted, it should reliably, quickly, and positively return to its protectiYe position covering the needle 16 a~ the needle 16 i~ withdrawn from the patient. Initial prototype testing was done using a cylindrical arrangement as depicted in Figure 9. Since a cylindrical segment is more re~istive to 25 longitudinal compre~sive forces than a flst slat, ~atisfactory performance was achieved with a 4 mil wall thickness. It is on this ba~is that 10 mils is projected as being optimum for the flat slats of the preferred embodiment.
Turning now to Figures 11 through 16 where it iB generally indicated as 50, the safety cap of the preaent invention in its preferred embodiment 30 incorporating a safety latch will now be de~cribed in detail. A~ those skilled in the art will readily note and appreciate, the preferred safety cap 50 is comprised of only two components -- the basic safety cap 30' l~lightly modified) and a ~pring latch 62. The basic safety cap 30' is substantially as de~cribed above with the addition of an outer retention button 54 and an 3~ inner retention button 56 on the ~lats 40. The buttons 54, 56 will be addressed in greater detail shortly. The ~pring latch 52 iB of unitary WOgl/12843 205~ 80~ PCr/US91/00979 construction and comprises a sliding collar 58 formed on one end of a coil spring 60. The collar 58 and spring 60 are sized and shaped to fit close to the surface of the slats 40 yet slide surely and easily therealong between an e~tended (i.e. locked) position as depicted in Figures 11 and 12 and a 5 retracted (i.e. unlocked) position as depicted in Figures 13 and 14.
The spring latch 52 i8 slid over the slats 40 of the basic cap ~0' and held in place by the outer retention button 54. For as~embly purposes of this embodiment, it may be preferable to make the siding safety hub portion 36 of square cross section. In pa~sing it should also be noted that 10 one button 54 could be employed; but, that two buttons 54 disposed on opposite sides 180 from one another are preferred. A~ will be appreciated, with the spring latch 52 in it~ e~tended and locked po~ition of Figures 11 and 12, it is virtually impossible to cause the slats 40 to bow outward.
Thus, longitudinal compressive resistance continues to meet and resist any 15 longitudinal force attempting to expo~e the point 18 of the needle 16 and needle-stick i8 virtually eliminated. Of course, if the syringe were to be projected in the manner of a dart under extremely high force, something might give resulting in expo~ure of the point 18. Under normally encountered forces, however, needle-stick should not occur.
To use the syringe 10, the spring latch 52 is retracted to the po~ition of Figure 13 by gripping the sliding collar 58 and sliding it towards the hub portion 32 where it is held by the inner retention button 56. As with the outer retention button 54 as discussed abo~e, one button 56 could be used but two spaced on oppo~ite sides &t 180 intervals i~ preferred. With the 25 coil ~pring 60 withdrawn from its extende~ po~ition surrounding the slats 40, the sliding safety hub 36 can be slid along the needle 16 to e~pose it for use in the manner described above with respect to the basic cap 30 and a~
depicted in Figure 14.
The inner retention button ~6 is included in the preferred 30 embodiment to make use of a ~yringe 10 including the safet31 cap ~0 as easy as possible. The imler retention button ~6 could, of course, be eliminated if desired without making use of the syringe 10 e~ce~sively difficult. It should be noted at this point that ju~t as the material and thickness of the slats 40 i8 cho9en so that the slats 40 will fle~ when the sliding ~afety hub 36 i~
35 retracted but retain their plastic "memory" and therefore urge the ~liding safety hub 36 back to it~ extended position, the coil spring 60 portion of the W0 91/12843 2 ~ 5 1 ~ 9 ~ Pcr/uss1/oo979 spring latch 52 is also of a material and thickness 80 as to have a ~lcient spring constant which will return the spring latch 52 to its extended position of Figure 11 when it i8 relea~ed. If the inner retention button 56 is employed to hold the spring latch 52 in it~ retracted po~ition, those skilled 5 in the art will recognize and appreciate that provision must be made to repeatedly and positively relea~e the sliding collar 58 80 as to allow the spring latch 52 to automatically return to its locked safety position and maximize the protection afforded by the cap 50 again~t accidental needle-stick following use of the ~yringe 10. Such proviBion i8 included in 10 the cap 50 and will now be de~cribed.
The inner retention button 56 is mounted on a tab 62 formed into the slat 40. The tab 62 faces toward~ the syringe 10. Additionally, as shown ghosted in Fig-are 14 and in side view in Figure 15, a strong~ack 64 is forrned into the slat 40 containing the inner retention button 56 between a 15 point adjacent the midpoint of the slat 40 and the back edge 66 of the tab 62. As will beP~ be understood with reference to Figure 15, when the sliding collar 58 has c- n slid over the inner retention button 56 and is being held thereby and the sliding safety hub portion 36 is slid towards the ~yringe 10 to expose the ~eedle 16, the ~lats 40 begin to deform outward in the 20 manner depicted in figure 14. In 80 doing, the ~trongback 64 is raised and pivot~ about the back edge 66 o~ the tab 62 since it is the weal~est point adjacent the rear of the slat 40 containing the tab 62. The portions of the slat 40 on opposite side~ of the tab 62 bend; however, the tab 62 being free to move moves downward pivoting about its back edge 66 a~ depicted in 25 Figure 15. As the tab 62 pivots about its back edge 66, the inner retention button 56 moves downward sufficiently to release the ~liding collar 58. The sliding collar 58 then moves forward under its self-bia~ing force over the button 56 to the position of Figure 16 where it is held from extending by the outwardly bent slats 40. As will be recogDized and appreciated by those 30 skilled in the art by this point, when the inward compressive force on the sliding safety hub portion 36 i~ released and the slat~ 40 return to their flatted and extended position, the sliding collar 58 i8 no longer held and prevented from allowing the ~pring latch 52 to e~tend and, therefore, it immediately and automatically e~tends to lock the cap 50.
Thus it will be appreciated by those skilled in the ar~ from the foregoing description and the accompanying drawings that the present WO 91/12843 PCr/US91/00979 0 ~ ' _ 14--invention ha~ truly met its stated objectives by providing a retractable safety cap for attachment to a standard syringe as a replacement for the rigid needle cap of the standard ~yringe to thereby provide an inexpensive and po~itive mean~ of protecting health care worker~ and others again~t 5 accidental needle-~tick to the ma~imum degree pos~ible.
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Claims (17)
1. In a hypodermic syringe having a barrel with a needle extending outward therefrom, a retractable safety cap for covering the needle to prevent accidental needle-stick therefrom comprising a unitary cap assembly of a resiliently flexible plastic material including:
a) a hub portion disposed concentrically about a base portion of the needle and attached to the barrel;
b) a sliding safety hub portion having a bore therethrough slidably disposed with the needle passing through said bore and extending over a point end of the needle; and, c) a plurality of slats extending between said hub portion and said sliding safety hub portion, said slats being spaced from one another along adjacent edges thereof at radially equal intervals about the periphery of the needle and being parallel to the needle whereby a longitudinal compressive force against said sliding safety hub portion is resisted by a longitudinal compressive resistance of said slats which must be overcome before said slats will deform and flex outward from the needle to allow said sliding safety hub portion to slide along and expose the needle for use.
a) a hub portion disposed concentrically about a base portion of the needle and attached to the barrel;
b) a sliding safety hub portion having a bore therethrough slidably disposed with the needle passing through said bore and extending over a point end of the needle; and, c) a plurality of slats extending between said hub portion and said sliding safety hub portion, said slats being spaced from one another along adjacent edges thereof at radially equal intervals about the periphery of the needle and being parallel to the needle whereby a longitudinal compressive force against said sliding safety hub portion is resisted by a longitudinal compressive resistance of said slats which must be overcome before said slats will deform and flex outward from the needle to allow said sliding safety hub portion to slide along and expose the needle for use.
2. The retractable safety cap for a hypodermic syringe of claim 1 wherein:
there are four said slats wherein said slats are flat so that the safety cap is square in cross section along the length of said slats.
there are four said slats wherein said slats are flat so that the safety cap is square in cross section along the length of said slats.
3. The retractable safety cap for a hypodermic syringe of claim 1 wherein:
there are four said slats wherein said slats are semi-cylindrical so that the safety cap is cylindrical in cross section along the length of said slats.
there are four said slats wherein said slats are semi-cylindrical so that the safety cap is cylindrical in cross section along the length of said slats.
4. The retractable safety cap for a hypodermic syringe of claim 1 and additionally comprising releasable safety latch means disposed over said slats for preventing deforming and outward flexing thereof whereby resistance to accidental needle-stick is increased when the syringe is not in use.
5. The retractable safety cap for a hypodermic syringe of claim 4 wherein said releasable safety latch means comprises:
a coil spring disposed over said slats so as to be compressible adjacent an inner end of said slats at said hub portion to allow said slats to deform and flex outward.
a coil spring disposed over said slats so as to be compressible adjacent an inner end of said slats at said hub portion to allow said slats to deform and flex outward.
6. The retractable safety cap for a hypodermic syringe of claim 5 and additionally comprising:
a siding collar carried by an outer end of said coil spring opposite said inner end of said slats.
a siding collar carried by an outer end of said coil spring opposite said inner end of said slats.
7. The retractable safety cap for a hypodermic syringe of claim 6 and additionally comprising:
retaining button means located on one of said slats adjacent said inner end for holding said sliding collar to retain said coil spring in a compressed state adjacent said inner end of said slats.
retaining button means located on one of said slats adjacent said inner end for holding said sliding collar to retain said coil spring in a compressed state adjacent said inner end of said slats.
8. The retractable safety cap for a hypodermic syringe of claim 7 wherein:
said retaining button means includes release means for releasing a hold on said sliding collar when said one of said slats bends outward whereby when said one of said slats returns to an unbent state following use of the syringe said coil spring is released and returns to an extended state from a self-bias force thereof.
said retaining button means includes release means for releasing a hold on said sliding collar when said one of said slats bends outward whereby when said one of said slats returns to an unbent state following use of the syringe said coil spring is released and returns to an extended state from a self-bias force thereof.
9. The retractable safety cap for a hypodermic syringe of claim 8 wherein:
a) said retaining button means includes a button for preventing said sliding collar from sliding along said slats; and, b) said release means comprises, b1) a tab on said one of said slats facing said hub portion and carrying said retaining button, and b2) a strongback along an inner surface of said one of said slats disposed between a midpoint of said one of said slats and a point adjacent a rear edge of said tab whereby as said one of said slats bends outward said strongback pivots said tab downward about said rear edge thereby lowering said button an amount sufficient for said sliding collar to slide thereover.
a) said retaining button means includes a button for preventing said sliding collar from sliding along said slats; and, b) said release means comprises, b1) a tab on said one of said slats facing said hub portion and carrying said retaining button, and b2) a strongback along an inner surface of said one of said slats disposed between a midpoint of said one of said slats and a point adjacent a rear edge of said tab whereby as said one of said slats bends outward said strongback pivots said tab downward about said rear edge thereby lowering said button an amount sufficient for said sliding collar to slide thereover.
10. In a hypodermic syringe having a barrel with a needle extending outward therefrom, a lockable and retractable safety cap for covering the needle to prevent accidental needle-stick therefrom comprising:
a) a unitary cap assembly of a resiliently flexible plastic material including, a1) a hub portion disposed concentrically about a base portion of the needle and attached to the barrel, a2) a sliding safety hub portion having a bore therethrough slidably disposed with the needle passing through said bore and extending over a point end of the needle, a3) a plurality of slats extending between said hub portion and said sliding safety hub portion, said slats being spaced from one another along adjacent edges thereof at radially equal intervals about the periphery of the needle and being parallel to the needle whereby a longitudinal compressive force against said sliding safety hub portion is resisted by a longitudinal compressive resistance of said slats which must be overcome before said slats will deform and flex outward from the needle to allow said sliding safety hub portion to slide along and expose the needle for use;
and, b) releasable safety latch means disposed over said slats for sliding movement between a retracted position where said slats can deform and flex outward and an extended safety position where deforming and outward flexing of said slats is prevented, said releasable safety latch means including bias means for biasing said releasable safety latch means towards said extended safety position whereby said cap assembly is automatically locked and resistance to accidental needle-stick is increased when the syringe is not in use.
a) a unitary cap assembly of a resiliently flexible plastic material including, a1) a hub portion disposed concentrically about a base portion of the needle and attached to the barrel, a2) a sliding safety hub portion having a bore therethrough slidably disposed with the needle passing through said bore and extending over a point end of the needle, a3) a plurality of slats extending between said hub portion and said sliding safety hub portion, said slats being spaced from one another along adjacent edges thereof at radially equal intervals about the periphery of the needle and being parallel to the needle whereby a longitudinal compressive force against said sliding safety hub portion is resisted by a longitudinal compressive resistance of said slats which must be overcome before said slats will deform and flex outward from the needle to allow said sliding safety hub portion to slide along and expose the needle for use;
and, b) releasable safety latch means disposed over said slats for sliding movement between a retracted position where said slats can deform and flex outward and an extended safety position where deforming and outward flexing of said slats is prevented, said releasable safety latch means including bias means for biasing said releasable safety latch means towards said extended safety position whereby said cap assembly is automatically locked and resistance to accidental needle-stick is increased when the syringe is not in use.
11. The lockable and retractable safety cap for a hypodermic syringe of claim 10 wherein said releasable safety latch means comprises:
a coil spring disposed over said slats 50 as to be compressible adjacent an inner end of said slats at said hub portion to allow said slats to deform and flex outward.
a coil spring disposed over said slats 50 as to be compressible adjacent an inner end of said slats at said hub portion to allow said slats to deform and flex outward.
12. The lockable and retractable safety cap for a hypodermic syringe of claim 11 and additionally comprising:
a sliding collar carried by an outer end of said coil spring opposite said inner end of said slats.
a sliding collar carried by an outer end of said coil spring opposite said inner end of said slats.
13. The lockable and retractable safety cap for a hypodermic syringe of claim 12 and additionally comprising:
retaining button means located on one of said slats adjacent said inner end for holding said sliding collar to retain said coil spring in a compressed state adjacent said inner end of said slats.
retaining button means located on one of said slats adjacent said inner end for holding said sliding collar to retain said coil spring in a compressed state adjacent said inner end of said slats.
14. The lockable and retractable safety cap for a hypodermic syringe of claim 13 wherein:
said retaining button means includes release means for releasing a hold on said sliding collar when said one of said slats bends outward whereby when said one of said slats returns to an unbent state following use of the syringe said coil spring is released and returns to an extended state from a self-bias force thereof.
said retaining button means includes release means for releasing a hold on said sliding collar when said one of said slats bends outward whereby when said one of said slats returns to an unbent state following use of the syringe said coil spring is released and returns to an extended state from a self-bias force thereof.
15. The lockable and retractable safety cap for a hypodermic syringe of claim 14 wherein:
a) said retaining button means includes a button for preventing said sliding collar from sliding along said slats; and, b) said release means comprises, b1) a tab on said one of said slats facing said hub portion and carrying said retaining button, and b2) a strongback along an inner surface of said one of said slats disposed between a midpoint of said one of said slats and a point adjacent a rear edge of said tab whereby as said one of said slats bends outward said strongback pivots said tab downward about said rear edge thereby lowering said button an amount sufficient for said sliding collar to slide thereover.
a) said retaining button means includes a button for preventing said sliding collar from sliding along said slats; and, b) said release means comprises, b1) a tab on said one of said slats facing said hub portion and carrying said retaining button, and b2) a strongback along an inner surface of said one of said slats disposed between a midpoint of said one of said slats and a point adjacent a rear edge of said tab whereby as said one of said slats bends outward said strongback pivots said tab downward about said rear edge thereby lowering said button an amount sufficient for said sliding collar to slide thereover.
16. A lockable and retractable safety cap for covering a needle of a hypodermic syringe having a barrel with the needle extending outward therefrom to prevent accidental needle-stick comprising:
a) a unitary cap assembly of a resiliently flexible plastic material including a hub portion disposed concentrically about a base portion of the needle and attached to the barrel, a sliding safety hub portion having a bore therethrough slidably disposed with the needle passing through said bore and extending over a point end of the needle, and a plurality of slats extending between said hub portion and said sliding safety hub portion, said slats being spaced from one another along adjacent edges thereof at radially equal intervals about the periphery of the needle and being parallel to the needle whereby a longitudinal compressive force against said sliding safety hub portion is resisted by a longitudinal compressive resistance of said slats which must be overcome before said slats will deform and flex outward from the needle to allow said sliding safety hub portion to slide along and expose the needle for use;
b) releasable safety latch means disposed over said slats for preventing deforming and outward flexing thereof, said releasable safety latch means comprising, b1) a coil spring disposed over said slats so as to be compressible adjacent an inner end of said slats at said hub portion to allow said slats to deform and flex outward, b2) a sliding collar carried by an outer end of said coil spring opposite said inner end of said slats, b3) retaining button means located on one of said slats adjacent said inner end for holding said sliding collar to retain said coil spring in a compressed state adjacent said inner end of said slats, and b4) release means for releasing a hold on said sliding collar when said one of said slats bends outward whereby when said one of said slats returns to an unbent state following use of the syringe said coil spring is released and returns to an extended state from a self-bias force thereof.
a) a unitary cap assembly of a resiliently flexible plastic material including a hub portion disposed concentrically about a base portion of the needle and attached to the barrel, a sliding safety hub portion having a bore therethrough slidably disposed with the needle passing through said bore and extending over a point end of the needle, and a plurality of slats extending between said hub portion and said sliding safety hub portion, said slats being spaced from one another along adjacent edges thereof at radially equal intervals about the periphery of the needle and being parallel to the needle whereby a longitudinal compressive force against said sliding safety hub portion is resisted by a longitudinal compressive resistance of said slats which must be overcome before said slats will deform and flex outward from the needle to allow said sliding safety hub portion to slide along and expose the needle for use;
b) releasable safety latch means disposed over said slats for preventing deforming and outward flexing thereof, said releasable safety latch means comprising, b1) a coil spring disposed over said slats so as to be compressible adjacent an inner end of said slats at said hub portion to allow said slats to deform and flex outward, b2) a sliding collar carried by an outer end of said coil spring opposite said inner end of said slats, b3) retaining button means located on one of said slats adjacent said inner end for holding said sliding collar to retain said coil spring in a compressed state adjacent said inner end of said slats, and b4) release means for releasing a hold on said sliding collar when said one of said slats bends outward whereby when said one of said slats returns to an unbent state following use of the syringe said coil spring is released and returns to an extended state from a self-bias force thereof.
17. The lockable and retractable safety cap for a hypodermic syringe of claim 16 wherein:
a) said retaining button means includes a button for preventing said sliding collar from sliding along said slats; and, b) said release means comprises, b1) a tab on said one of said slats facing said hub portion and carrying said retaining button, and b2) a strongback along an inner surface of said one of said slats disposed between a midpoint of said one of said slats and a point adjacent a rear edge of said tab whereby as said one of said slats bends outward said strongback pivots said tab downward about said rear edge thereby lowering said button an amount sufficient for said sliding collar to slide thereover.
a) said retaining button means includes a button for preventing said sliding collar from sliding along said slats; and, b) said release means comprises, b1) a tab on said one of said slats facing said hub portion and carrying said retaining button, and b2) a strongback along an inner surface of said one of said slats disposed between a midpoint of said one of said slats and a point adjacent a rear edge of said tab whereby as said one of said slats bends outward said strongback pivots said tab downward about said rear edge thereby lowering said button an amount sufficient for said sliding collar to slide thereover.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US484,915 | 1990-02-23 | ||
| US07/484,915 US4998922A (en) | 1990-02-23 | 1990-02-23 | Safety syringe cap minimizing needle-stick probability |
| PCT/US1991/000979 WO1991012843A1 (en) | 1990-02-23 | 1991-02-13 | Safety syringe cap minimizing needle-stick probability |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2051806A1 true CA2051806A1 (en) | 1991-08-24 |
Family
ID=23926172
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002051806A Abandoned CA2051806A1 (en) | 1990-02-23 | 1991-02-13 | Safety syringe cap minimizing needle-stick probability |
Country Status (11)
| Country | Link |
|---|---|
| US (1) | US4998922A (en) |
| EP (1) | EP0470228B1 (en) |
| JP (1) | JPH04505414A (en) |
| KR (1) | KR920700711A (en) |
| AT (1) | ATE129641T1 (en) |
| AU (1) | AU642477B2 (en) |
| BR (1) | BR9104648A (en) |
| CA (1) | CA2051806A1 (en) |
| DE (1) | DE69114207D1 (en) |
| MX (1) | MX167265B (en) |
| WO (1) | WO1991012843A1 (en) |
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| US9408746B2 (en) | 2010-03-31 | 2016-08-09 | Ocuject, Llc | Device and method for intraocular drug delivery |
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| WO1989004681A1 (en) * | 1987-11-18 | 1989-06-01 | Catch 522 Pty. Limited | Single use syringe |
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| AU623139B2 (en) * | 1988-05-06 | 1992-05-07 | David John Deeks | Needle assembly |
-
1990
- 1990-02-23 US US07/484,915 patent/US4998922A/en not_active Expired - Fee Related
-
1991
- 1991-02-13 WO PCT/US1991/000979 patent/WO1991012843A1/en active IP Right Grant
- 1991-02-13 EP EP91904766A patent/EP0470228B1/en not_active Expired - Lifetime
- 1991-02-13 AU AU73321/91A patent/AU642477B2/en not_active Ceased
- 1991-02-13 DE DE69114207T patent/DE69114207D1/en not_active Expired - Lifetime
- 1991-02-13 CA CA002051806A patent/CA2051806A1/en not_active Abandoned
- 1991-02-13 BR BR919104648A patent/BR9104648A/en unknown
- 1991-02-13 JP JP3505566A patent/JPH04505414A/en active Granted
- 1991-02-13 AT AT91904766T patent/ATE129641T1/en not_active IP Right Cessation
- 1991-02-22 MX MX024660A patent/MX167265B/en unknown
- 1991-10-23 KR KR1019910701420A patent/KR920700711A/en not_active Application Discontinuation
Also Published As
| Publication number | Publication date |
|---|---|
| AU7332191A (en) | 1991-09-18 |
| EP0470228B1 (en) | 1995-11-02 |
| JPH04505414A (en) | 1992-09-24 |
| EP0470228A1 (en) | 1992-02-12 |
| MX167265B (en) | 1993-03-12 |
| ATE129641T1 (en) | 1995-11-15 |
| JPH0567309B2 (en) | 1993-09-24 |
| KR920700711A (en) | 1992-08-10 |
| WO1991012843A1 (en) | 1991-09-05 |
| BR9104648A (en) | 1992-05-19 |
| DE69114207D1 (en) | 1995-12-07 |
| AU642477B2 (en) | 1993-10-21 |
| US4998922A (en) | 1991-03-12 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued |