CA1308322C - Medical device - Google Patents
Medical deviceInfo
- Publication number
- CA1308322C CA1308322C CA000563167A CA563167A CA1308322C CA 1308322 C CA1308322 C CA 1308322C CA 000563167 A CA000563167 A CA 000563167A CA 563167 A CA563167 A CA 563167A CA 1308322 C CA1308322 C CA 1308322C
- Authority
- CA
- Canada
- Prior art keywords
- needle
- guard member
- guard
- tip
- pointed tip
- 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.)
- Expired - Lifetime
Links
Abstract
ABSTRACT OF THE DISCLOSURE
Disclosed is a vacuum tube type collection device for collecting blood or other body fluids from a patient.
The device includes a conventional sealed vacuum tube received in a tube holder having a removable needle assembly connected to the tube holder. The characterizing feature of the device of this invention is that the needle assembly has a guard member which protects the exposed tip of the needle after withdrawal of the needle from the patient's body.
This member is movable between a first position where the tip of the needle is exposed and a second position where the guard member covers the tip of the needle and prevents needle sticks. A locking element is mounted along the needle shaft which permanently locks the guard member in the second position upon movement of the guard member into the second position.
Disclosed is a vacuum tube type collection device for collecting blood or other body fluids from a patient.
The device includes a conventional sealed vacuum tube received in a tube holder having a removable needle assembly connected to the tube holder. The characterizing feature of the device of this invention is that the needle assembly has a guard member which protects the exposed tip of the needle after withdrawal of the needle from the patient's body.
This member is movable between a first position where the tip of the needle is exposed and a second position where the guard member covers the tip of the needle and prevents needle sticks. A locking element is mounted along the needle shaft which permanently locks the guard member in the second position upon movement of the guard member into the second position.
Description
~3~33~
BACKGROUND_OF T:HE XNVENTION
Field of the Invention~
This invention relates to a device for withdrawing blood or other fluids from a patient employing a dual-tip needle element, and particularly relates to a device where one of the needle tips is provided with a guard that prevents accidental needle sticks.
Back~round Discussion:
It is a common practice in withdrawing from a patient blood samples or other body fluids to employ a device which includes a disposable dual-tip needle element. This needle elament is removably connected to a reusable tube holder which holds a sealed tube having a partial vacuum in the interior of the tube. Becton Dickinson Corporation makes such a sampling device under the-br~n~ n~ ~o~ Vacutainer.
The disposable needle element is initially housed within a container that allows the nurse to connect the needle element to the tube holder without directly touching the needle element. This container usually includes a removable cover which surrounds the end (the patient end~
of the needle element that will eventually be inserted into the patient's body. The nurse, however, does not remove the cover until he or she is ready to withdraw blood from the patient, whereupon the patient end of the needle is inserted into the patient's body. The other end (the tube end) of the needle element is covered by a cap member which is removed prior to connecting assembly to the tube holder.
With the needle inserted in the patient, the tube is pushed into the tube holder with the sealed end of the tube being directed toward the tube end of the needle element.
As the nurse advances the tube toward the t~be end of the needle ~lement, the side walls of the tube holder guide the tube. When the sealed end reaches the tube end of ~he needle, the needle pierces the sealed end with the tip of the needle extendiny into the interior of the tube. The ~k 3~
vacuum within the ~ube causes blood to flow immediately from the pa~ient through the needle element into the interior of the tube, ~illing it.
Although this d~vice is extremely use~ul, there is one serious problem associated with using it, namely accidental needle sticks. Upon removal o~ the needle ~rom the patient, and in the process o~ disconnecting the needle alement from the tube holder, the nurse recovers the exposed patient end of the needle. When this is done, there is the possibility that an accidental needle stick will occur. When this happens, khe nurse is required to undergo a blood test to determine if he or she is already carrying an infectious disease. I~ the nurse is not, and later becomes infected, the hospital employing the nurse will be legally liable.
Some devices comprisinq a needle shield are known. In U.S. Patent No. 4,631,057 to Mitchell, there is described a syringe comprising a needle guard. The needle guard can be releasably retained in the retracted position and lock~d in the extended position. It is in the form of an elongated plastic sleeve mounted around the body of the syringe. The syringe described in the aforementioned patent is however complex to manu~acture and somewhat cumbersome to use.
Furthermore, in the Mitchell patent, the whole syringe including the tube holder section, has to be disposed of, an undesirable feature, as such syringes are expensive to manufacture and should be preferably reusable.
There is, there~ore, a need for a needle assembly to be used in a syringe which is easy to employ, of simple construction and efficient to protect the user against accidental needle sticks.
SUMMARY OF THE INVENTION
The problem discussed above has been obviated by the present invention which provides a simple, safe and convenient way to protect the user against accidental ~3~33~
needle sticks after withdrawal ~ the needle element from the body of the patient.
According to the present invention in a ~irst aspect, there is disclosed a dispo~able needle assembly comprising an elongated needle element terminating in ~irst and second opposed pointed tips, a hub member mounted between the opposed tips of the needle element for removably connecting the needle assembly to a tube holder of a syring~, a guard member mounted around the needle element and manually movable axially along the needle element betwleen a first position where the guard member is displaced inwardly from the first pointed tip to expose the first pointed tip to enable it to penetrate ~he body of a patient and a s~ond position where the guard member covers the first pointed tip to prevent needle sticks, and locking means mounted along the needle element between the hub member and the first pointed tip, the locking means permanently locking the gu~rd member in the second position upon movement of the guard member from the first position to the second position.
The second pointed tip of the needle element is preferably covered by a cap made of resilient material, the cap being punctured by the second pointed tip upon penetration of a tube in the tube holder.
Typically, the cap is made of rubber and is self-sealing upon withdrawal of the tube ~rom the second pointed tip.
According to the invention in a first aspect, th~
needle element is a unitary continuous structure which comprises first and second needle segments carrying respectively first and second pointed tips, the needle segments being securely connected to each other by means of the hub member, the needle segments being align~d along a common axis and extending outwardly ~rom the hub member.
According to the invention in a second aspect, the needle element is a discontinuous struckure which comprises two separate needle seyments detachably connected to each other by means o~ the hub me~ber, one o~
the ~egments carrying the ~irst pointed tip and the ~ther of the seyments carrying the second pointed tip, the needle segments being aligned along a common axia upon connecting the two needle segments together.
In a preferred embodiment of the present invention, the guard member comprises a tubular element having a collar member at the rearward end of the guard member towards the second pointed tip and a restricted opening at the forward end of the guard member towards the first pointed tip, the first pointed tip extending throuyh the restricted opening in the forward end when the guard member is in the first position.
The hub member advantageously has a recessed guard holding section extending therefrom towards the first pointed tip and the collar member has an orifice therein with tha recessed guard holding section fitting through the orifice when th~ guard member is in the first position.
The guard member and the recessed guard holding section may each comprise interactive elements which hold the guard member in the recessed guard holding section until the guard member is moved to the second position.
It is advantageous that the locking means has a receptacle in which the collar member of the guard member snaps into upon movement of the guard member into the second position.
The collar member of the guard member may also have an expandable orifice and the locking means includes a ramp section forward of the receptacle which fits into and forces expansion o~ the orifice as the guard member approaches the receptacle to move into the second position, the receptacle having an elevated wall which acts as a stop for the collar member of the guard member to prevent axial movement of the guard member after the collar member snaps into the receptacle.
-3a-3~
Preferably, the collar membsr o~ the guard member comprises two lateral tear drop slits, substantially opposed to each other and dividing the collar member into two generally semicircular elements, the receptacle and the semicircular elements abutting each other when the oollar member is received in the receptacle.
The locking means typically has a central passageway wherethrough the shaft of the needle element carrying the first pointed tip pass~s, with the locking m~3ans and the needle shaft being bonded to each other~
The needle assembly of the presenl: invention preferably comprises a sheath member which fLts over the first pointed tip of the needle element whe~n the guard member is in the first position to prevent exposure of the first pointed tip, the sheath member having one end closed and an open end opposed t~ the closed end, the hub member fitting snugly into the open end of the sheath end, so that the sheath member encases the needle element and the guard member but may be manually removed by pulling it off the hub member, the sheath member comprising interior splines which coact with ~xterior rib elements on the hub member to ~acilitate connecting the needle assembly to the tube holder and disconnecting the needle assembly from the tube holder.
The guard member advantageously comprises a plurality of ribs molded in the ext~rior surface thereof to facilitate grasping the guard member.
According to the present invention in a second aspect, thare is also disclosed a syringe for withdrawing bodily fluids comprising a tube holder which removably receives a collection tube having a sealed end, a needle element having a first pointed tip extending outwardly from the tube holder and adapted to penetrate the body of a patient and a second pointed tip extending into the tube holder and adapted to penetrate the sealed end o~ the collection tube upon insertion o~ the collection tube into the tube -3b-~3~3~
holder, the first and ~econd pointed tips beiny on a common axis and opposed to each other, a hub member mounted b~tween the opposed tips of the needle element for removably connecting the needle element to the tub~
holder, a guard member mounted along the needle element and manually movable axially along the needle element between a first position where the guard member is displaced inwardly from the first pointed tip to expose the first pointed tip to enable it to penetrate the body of the patient and a second position where the guard member cover6 the ~irst pointed tip to prevent needle sticks, and locking means mounted along the needle element between the hub member and the first pointed tip, the locking means permanently locking the guard member in the second position upon movement of the guard member from the first position to the second position.
According to the present invention in a third a~pect, there is disclosed a medical device comprising a needle element having first and second opposed pointed tips and a hollow shaft therebetween, a guard member movabl~ axially along said needle element from a first position in which the first pointed tip of said needle element is exposed, to a second position in which said guard member shields said first pointed tip of said needle element to prevent needle sticks and locking means disposed between said first and second pointe~ tips of said needle element for interacting with said guard member to permanently lock ~aid guard member in said second position upon movement of said guard member from ~aid first position. Praferably, in this medical device, the second pointed tip of the needle element is covered by a cap made of resilient material, the cap being punctured by the second pointed tip upon penetration of a tube in the medical device.
~ccording to the present invention in a fourth aspect, there is disclosed a safety device for withdrawing bodily fluids ~rom the body of a patient, comprising a hub -3c-f~
adapted to be r0movably secured to a tube holder of a syringe and having a central passageway therthrough, an elongated needle extendin~ from said hub and in fluid communication wi~h said syringe, said needle hav1ng first and second opposed pointed tips, a tubular guard m~mber disposed coaxially about said needle and axially movable from a first position in which the ~irst pointed tip of said needle is exposed and a second position in which the first pointed end of said needle i5 shielded against needle sticks, said guard member comprising a radially inwardly extending collar and a locking element secured to said needle distally of the tube holder of the syringe, said locking means comprising an annular recess adapted to receive said collar of said guard member when the guard mamber is in the second position.
According to the present invention in a ~ifth aspect, there is disclosed a madical device, comprising a needle having first and second pointed tips and a hollow shaft therebetween, a guard member movable axially along said needle from a ~irst position in which the first pointed tip of said needle is exposed, to a second position in which said guard member shields said first pointed tip of said needle to prevent needle sticks and a locking element disposed between said first and said second pointed tips of said needle, wherein said locking element comprises a tapered portion which increases in cross-sectional area in the distal direction, said tapered portion terminating in a shoulder defining the proximal boundary of an annular recess therein.
According to the present invention in a sixth aspect, there is disclosed a safety needle assembly for use with a medical device for withdrawing bodily fluids, comprising a connector adapted to be removably attached to said medical device, a needle secured to said connector, said needle having first and second pointed tips, a tubular guard disposed concentrically about ~aid needle and adapted for ~3d~
~3C~
axial movement from a flrst position where the first pointed tip of said needle is exposed, to a second position where the guard covers the first pointed tip to prevent needle sticks and a tubular sheath having one open end, wherein said needle and said guard are enclosed within said sheath, said sheath being disposed concentrically about said needle and said guard and being remoYably secured at its open end in frictional engagemenk with said connector.
According to the present invention in a seventh aspect, there is disclosed a medical device, comprising a needle having first and second pointed tips, adapted to be placed in communication with the tube holder of a withdrawal davice by way of said second pointed tip, a guard axially movable between a first position in which the first pointed tip of said needle is exposed, and a second position in which said first pointed tip is shielded and locking means disposed intermediate said first and second pointed tips and distally of said tube holder of said withdrawal device for retaining said guard in said second position.
The preferred embodiments of this invention illustrating all of its ~eatures will now be discussed in detail.
BRIEF DESCRIPTION OF THE DRAWINGS
~he device of this invention is illustrated in the drawings, with like numerals indicating like parts, and in which:
Figure 1 is a perspective view of the device of this invention.
Figure 2 is a perspective view of the needle assembly o this invention.
Figure 3 is an exploded enlarged view of the needle assembly shown in Figure 2.
Figure 4 is a cross-sectional view taken along line 4-4 of Figure 1.
Figure 5 is a cross-s0ctional view taken along line 5-5 of Figure 4.
Figure 6 is a cross-sectional view taken along line 6-6 of Figure 4.
Figure 7 is a cross-sectional view taken along line 7-7 of Figure 4.
Figure 8 is a cross-sectional view taken along line 8-8 of Figure 4.
Figure 9 is a cross-sectional view taken along line 9-9 of Figure 4.
Figure lO is an enlarged cross-s2ctional view, with sections broken away, showing the needle assembly connected to the tube holder and the tube being moved toward the inwardly projecting tube end of the needle elementO
Figure 11 is a cross-sectional view, with sections broken away, similar to that shown in Figure 10, with the tube -4a-~3~
moved lnwardly ~o that the tube end ~ the needle p~netrates the sealed end of the tube~
Plg. 12 1~ a cro~s-~ectional view sho~ng the guard member being moved forward to cover the t$p of ~he needle.
Fig. 13 i~ a croas-~ectional vlew taken along llne 13-13 of Fig~ 12.
Fig. 14 i~ a cro~s-~ectlonal vlew ~imll~r to that ~hown in Fig. 12 with the guard member moved completely ~orward and locked permanently in pos~tion to cover the tip of the patient end of the needle element.
Pig. 15 is a cross-sectional view ~howing the ~heath for the needle a~sembly recovering the patlent ~nd of the needle element~ with the needle ~s~embly removecl from the tube holder.
Fig. 16 is an e%ploded per~pective vlew of ~n alternate embodiment of the device of this ~nvention.
Fig. 17 i~ an enlarged cross-sectional vlew sho~ing the needle a~sembly illustrated in Fig. 16 connected to the tube holder.
2p DBSCRIPTION OF T~E PREFERR~D EMBODIMENTS
As be~t ~ho~n in PigO 1, the devlce 10 of this lnvention lnclude~ three components: a vacuu~ collection tube 12, a tube holder 14, and a disp~Rable needle assembly 16 (Fig.2) contained wLthin a housing 18. The collection tube 12 and tube holder 14 ~re of conventional design. The ~ispo~able needle assembly 16 1~ the unique feature of the device 10.
The vacuum collection tube 12 may be a glas~ or plastic tube having a closed 20 end and an open end 22 sealed with a ~elf~6ealing rubber ~topper 24. There i~ a vacuum on the in~ide of the tube 12 which c~use~ fluld to be ~0~
drawn int~ the interior of th~ tube ~hen the rubber 0topper 24 1~ purlctured. ~rhe collectlon tube ;l2 1~ received in the tube holder 14 during u~e. Thi~ tube holder has a generally cylindrlcal body which guides the collection tube toward~ the needle end 26 of the needle element 28 (Plg. 3) o~ the needle assembly 16. The ~ube holder 14 ha~ an open entry end 30 u~rounded by a Elange 32 whi~h lz gripped by the u~er durlng use. Oppo~ite the open entry end i~ a partlally closed port end 34 which has an adapter 3Z molded into the parti~lly clo~ed port end. This adap~:er 36 i~
designed to removably ~ecure the needle aszembly 16 to the tube holder 14. Thus, upon re~oval of the neetlle assembly 16 and replacemen~, the tube holder 14 can bè
repeatedly used rather than bei~g disposed. Moreover, as frequently i~ the ca~e, several collection tube~ 14 are filled during ~es~ing of ~he same pa~ient prio~ to replacing the needle aR~embly 16~
The needle assembly 16 of this inventlon i8 best illustrated in Fig~. 2 and 3. This needle as~2mbly 16 is held with~n the housing 18 which has two portions: a patient needle sheath 38 which coverg the patient end 40 of the needle element 28 and a cover 42 which covers the needle end 26 of the needle element ~8. The end of the ~heath 38 ~it~ with~n the open ~outh of the cover 42, 11th the combined ~tructure of sheath and cover ~or~ing the hou~ing 18 ~hich encases the needle as3embly 16. Prios to connecting the needle asgembly to the tube holder, the cover 42 is removed to expo~e the tube end 26 of the needle element. The needle end 26 i~ covered by a subber cap 44 30 ~ which fits snugly over ~ é it. As wlll be ~plained in greater detail hereafter, this rubber cap 44 acts as a valve to close off the tip of the needle end 26 upon removal of ~3~3~
the tube 12 from the tube holder 14.
The needle ~3sembly 16 include~ the needle element 28 which i8 mounted to ~ hub 46. One segment 28a of the needle element 28 pro~ects from one side o~ the hub 45 and the other ~egment 28b pro~ects from the oppo~lt0 side of the hub, with ~he end~ 26 and 40 of the needle slement being oppo6ed to one another and the longitudinal a~ls of these segments disposed along the longitudinal a~is of the hab.
The hub 46 has a connector ~ec~ion 48 and a sheath carrier section 50. Thi~ hub 4~, including the section8 48 and 50, i8 molded from plastic to provide a unitary structure having a central pas~ageway 52 therein which ~ -receives the two needle segments 28a dnd 28b. The segment 28a has a ~lightly larger diameter than the segment 28b oP the needle elemen~ 28. A~ shown in Fig. 5, both of the~e segmen~s 28a and 28b are lodged within the passageway havlng tw~ sections 52a and 52b with different diameter~. The needle segment~ 28a and 28b may be molded in place or an adhe~ive may be u ed to bond the segments securely to the hub 46. In the lat~r case, there 1B X
provided a series of annular reces~es 54 about the ~ection 52b of the passage~ay 52 into which an adhe~ive i8 placed to secure the needle ~egment 28b in po~ition~
The connector section ~8 of the hub ~6 includes a di~k portlon 56 having a raised cylindrical platfonm 58 extending fro~ the ~ide o the di3k which faces the tube holder 14 upon connection of the needle assembly 16 to the holder. A threaded section 60 extends outwardly from this side of the platform 58 and terminates in a noz~ like element 62 which ~its into the open end of the rubber cap 44~ As ~hown in Fig. 11, to connect ~he needle assembly 15 to ~he tube holder 14, the u~er simply screws ~3~
the threaded ~ection 60 lnto the open e~terlor end vf the adapter 36 which has correspondlng internal thread~ 64 to allow the u9~ to simply rot~te th0 needle ~ embly to secure lt to the tube holde~.
A~ best ~hown in Fig. 10, the sheath 38 covering the patient end 40 of the needle element 28 i8 retained in position covering the patien~ end of the needle element until the needle a~embly 16 i8 connected to the tube holder 14. The ~hea~h 38 lncludes in~ernal ~pllnes 66 (Fig.
3) running lengthwise along the ins~de ~all of the ~heath.
As illustrated best in Fig. 7, these spline~ 66 coact with a rib 68 carried on the outside wall of the sheath carrier ~ection 50 o~ the hub 46. The splines 66 abut the sides of the ribs 68 upon applying a torque to the sheath 80 that the splineR will pu6h against the ribs to turn the needle as3embly 16, ~crewing it into the adapter 36. To di6connect the needle as~embly 16 fro~ the tube h~lder 14, ~he sheath 38 again i8 placed in position covering the patient end 40 of the needle element 28 and rota~ed in an oppo3ite direction to unscrew the connector ~ection 48 from the adapter ~6. In thi~ lnstance, the splines 66 will al80 coact with the ribs 68 to apply turning force to the needle assembly 16.
The characterizing feature of this invention i~ a guard 70 which i8 mounted to move ~xially along the shaft of the needle element 28 from a rearward position a8 shown in Fig. 4 to a for~ard position shown in ~ig. 14. In ~his forward position the quard 70 cover~ the tip of the patient end 40 of the needle element 28 and protect~ the user against accidental needle sticks.
The sheath carrier section 50 of the hub 46 is designed to hold the guard 70 ln ~he po~1tion illu~trated in 3~Z, Fig~ 4 until the u~er i~ ready ~o mo~e the guarcl forward to ~over the tlp of the patient end ~0 of the needle element 28. ~hl~ ~heath carrler sectlon 50 is be~t lllustrated in Fig~. 3, 4 and 5. It is lnteyral wlth the hub 46 and include~ an annular rece~sed portion 72 which has a circumferential groove 74 ~ the mouth o~ the carrier ~ection 50. E~tendlng inwardly into the reces~ed portion 72 i6 a neck 78 from which the needle element 28 project~
out~ardly. In accordance with this embodlment of the invention, ~he connector ~ectlon 48 and ~he shedth carxier 6ect$0n 50 are integral, being molded from the ~!3ame pla~tic material to provide a unltary structure.
The guard 70 ha~ a generally cylindrical configuration with the rear BectiOn of the guard having a collar 80 which interacts ~ith a locking element 82 secured to the shat of the needle element 28, and oppoaite the collar, an open end 70a whlch ha~ a re~tricted dlameter that prevents the tip of the user'~ little finger fro~ entering the open end. Thus, ~hen th0 guard i~ ln the forward position as sho~n in Fig. 1~, the u~er, even if he or ~he intentionally pushe~ hi~ or ber little finger into the open end 70a, would not contact the tip of the patient end 40 of the needle element 28. Spaced apart in a row are nipples 84 ~hich pro~ect outwardly from the collar 80 and are received in the groove 74 of the sheath carxier section 50 as ~hown ln Fig. ~0 Along the e~terior of the guard 70 are a series of raised annular gripping elements 86 which a~6i8t the user in moving the guard for~ard along the shaft of the needle element 28. Th~ collar 80 i8 ~eparated by a pair of oppo~ed lateral tear drop ~lit~ 81 in the sidewall of the guard to divide the collar into kwo generally Remi-circular elements 80a and 80b as shown in Fig. 13. Between the ends ~33~J
of the~e elements 80a and 80b 1~ an open 0ection ~a that lnteracts with the locking element B2 as llluat:rated ln Figs. 12, 13 and 14. The semi-circular elements 80a and 80b of the collar 80 each provide a wedge-like plece that grips ~he locking element 82 a~ ~hown ~n Fig. 1~ when the guard 70 is moved forward.
The locking element 82 has a ramp sectlon 90 in the ~orm o~ a conical member which terminates in a rear shoulder section 92. The forward end of the locklng element 82 i~ in the form of a rai~ed shoulder section 94 ~ith ~n annular receptacle portion 96 being be~ween the raised shoulders 92 and 94. When the user pushe~ the guard 70 for~ard, the elements 80a and 80b of the collar 80 ride up the ramp section 90, with the two collar elements expanding outward.
The collar, becau~e of the teardrop ~lits ~eparating the two section~, has an internal refiiliency which allows the element~ 80a and 80b of the collar to ~nap int~ and wedge them~elves ln the annular receptacle ~ection 96 a9 shown in ~ig. 14 when the guard 70 i8 moved to the forward, permanently locking the guard in the ~or~ard position.
Operation:
To use the device 10, firstt the cover 42 for the tube end 26 of the needle element 28 i removed and di~carded. Ne~t~ the user grips the ~heath 38 coverlng the 2S patlent end 40 of the needle element 28 and $nserts the ~onnector ~ection 48 of the needle a~sembly 16 into the adapter 36 of the tube holder 14 turning the needle assembly 16 to screw the threaded section 60 lnto the adapter. The internal spline~ 66 of the sheath coact with the rib~ 68 on the ~heath carrier ~ection 50 to turn the needle assembly as the sheath i8 rotated by the user.
With the needle assembly 16 connected to the tube ~3~
holder 14, the ~heath 38 i~ pulled from th~ embly to expo~e the patient end ~0 of the needle element 28. The user places the collection tube 12 lnto the open end 30 of the tube holder 14, grasping the flange 32 ~ith the index finger and middle inger while slmul~aneou~ly pres~ing again~t the end of the tube 20 with the thumb. Thi~ pushes the collection tube 20 inwardly towards the tube end 26 of the needle element 28 as illustrated in Fi9B. 10 and 11.
The tip of the tube end 26 penetrates the ~topper 24, and the stopper depresRes the rubber cap 44,as the ~ube 12 advanceg. ~8 indicated by the arrow A in Pig. 11, blood or other body fluid will flow through the pati~n~ end 40 of the needle element 28 into and through the tube end 26 of the needle element lnto the lnterlor of the collectlon tube 12.
When the tube 12 i~ filled, the u~er pu116 it from the tube holder, whereupon the rubber cap 44 will return to it~
normal positlon a8 illustrated $n ~ig. 10. The rubber caR 4~ elf-seallng ~o that the hole produced ~n lt by penetration of the needle element 28 i8 sealed oPf, preventing blood fro~ e w aping from the tube end 26 o~ the needle element. Thus, lf the user wi~hes to fill another collection tube, he or ~he nay do 80 by simply placing another tube in the holder and ~oving it to the posltion illugtrated in Pig. 11.
When it i8 tlme to withdraw the patient end 40 of the needle element 28 from the body o~ the patient, the user 8~mply gra8p8 the guard 70 by ~he gripping ele~ent~ 86 and holds it steady while pulling the tube holder 14 away from the body of the patient. Thi6 will cause the guard 70 to move relative to the needle element 28 so that the collar 80 will engage the locking element 82, ride over the ramp section 90 and then snap into position, with the ~IL3~2~
elements 80a and ~Ob wedglng them~0lve~ lnto the annular cecep~acle 96. Thia permanently lock~ ~he guard 70 ln the posltion ~hown in Flg. 14. The ~heath 3a i~ then replaced as shown in Pig. lS and now ~sed to unscrew the needle assembly 16 rom the tube holder 14. Th~ needle asaembly 16 ~lth the guard in the forward position and the sheath 38 covering the assembly is then di~carded.
ALTERNATE 13ME~ODIMENT
The alternate e~bodiment of this lnvention 1~
illustrated in Figs. lS ~nd 17. In thi~ embodlment the medlcal device 98 illustrated in the related parent application, U. S. Patent ~pplicatlon seri~l number 06/849,148, is ù~ed with a special connector 100. This connector 100 is designed to fit into the open end of the hub 46, thereby allowing the medical device 98 to be used with a vacuum collection tube 12. The connector lOO iR
designed to lnclude a nçedle 102 ~hich e~ends outwardly rom molded plastic piece 104 having a tapered section 106 which fits into the open end 108 of the medical device 98.
There i8 an internal pas~ageway lOl in the section 106 that allows fluid to flow from the device 98 through the needle 102~
A cover (not ~hown) ~or the connector 100 i~ used to cover the needle 102 during sh$pment. This cover ha~
internal splines carried on it~ side wall which interact with ribs 110 on the exterior wall of the $apered section 106 to permit the cover to be used to screw the connector int3 the adapter 36. When the connector lOO ha~
been connected to the tube holder 14, as illu~trated ln Fig.
17, the tapered section 106 i8 simply force fitted into the open mouth 108 of the medical device 98 allowing th i8 device ~ 12 -3~
to be u~ed to collect blood or other Pluld ~rom ~he body of a patient. After belng uaed, the guard 70 18 moved forward as dl~cu~ed previou~ly ~o cover the patlent end ~0 of the needle element 28.
SCOPE OF T~E INVENTION
Tbe ~bove desrription pre~ent~ the best mode contemplated in carrying out the present invention. This invention i8, however, ~usceptlble to ~odlfication~ and alternate constructlon6 fro~ the embodiment~ ~hown $n the drawing and de~cribed above~ Consequently, it: i8 not the lntention to limlt this invention to the partlcular e~bodi~ents disclosed. On the contrary, the lntentlsn i~ to cover all modi~ications and alternate constructions comihg within the ~pirit and ~cope of the invention a6 generally expressed by the following claims.
BACKGROUND_OF T:HE XNVENTION
Field of the Invention~
This invention relates to a device for withdrawing blood or other fluids from a patient employing a dual-tip needle element, and particularly relates to a device where one of the needle tips is provided with a guard that prevents accidental needle sticks.
Back~round Discussion:
It is a common practice in withdrawing from a patient blood samples or other body fluids to employ a device which includes a disposable dual-tip needle element. This needle elament is removably connected to a reusable tube holder which holds a sealed tube having a partial vacuum in the interior of the tube. Becton Dickinson Corporation makes such a sampling device under the-br~n~ n~ ~o~ Vacutainer.
The disposable needle element is initially housed within a container that allows the nurse to connect the needle element to the tube holder without directly touching the needle element. This container usually includes a removable cover which surrounds the end (the patient end~
of the needle element that will eventually be inserted into the patient's body. The nurse, however, does not remove the cover until he or she is ready to withdraw blood from the patient, whereupon the patient end of the needle is inserted into the patient's body. The other end (the tube end) of the needle element is covered by a cap member which is removed prior to connecting assembly to the tube holder.
With the needle inserted in the patient, the tube is pushed into the tube holder with the sealed end of the tube being directed toward the tube end of the needle element.
As the nurse advances the tube toward the t~be end of the needle ~lement, the side walls of the tube holder guide the tube. When the sealed end reaches the tube end of ~he needle, the needle pierces the sealed end with the tip of the needle extendiny into the interior of the tube. The ~k 3~
vacuum within the ~ube causes blood to flow immediately from the pa~ient through the needle element into the interior of the tube, ~illing it.
Although this d~vice is extremely use~ul, there is one serious problem associated with using it, namely accidental needle sticks. Upon removal o~ the needle ~rom the patient, and in the process o~ disconnecting the needle alement from the tube holder, the nurse recovers the exposed patient end of the needle. When this is done, there is the possibility that an accidental needle stick will occur. When this happens, khe nurse is required to undergo a blood test to determine if he or she is already carrying an infectious disease. I~ the nurse is not, and later becomes infected, the hospital employing the nurse will be legally liable.
Some devices comprisinq a needle shield are known. In U.S. Patent No. 4,631,057 to Mitchell, there is described a syringe comprising a needle guard. The needle guard can be releasably retained in the retracted position and lock~d in the extended position. It is in the form of an elongated plastic sleeve mounted around the body of the syringe. The syringe described in the aforementioned patent is however complex to manu~acture and somewhat cumbersome to use.
Furthermore, in the Mitchell patent, the whole syringe including the tube holder section, has to be disposed of, an undesirable feature, as such syringes are expensive to manufacture and should be preferably reusable.
There is, there~ore, a need for a needle assembly to be used in a syringe which is easy to employ, of simple construction and efficient to protect the user against accidental needle sticks.
SUMMARY OF THE INVENTION
The problem discussed above has been obviated by the present invention which provides a simple, safe and convenient way to protect the user against accidental ~3~33~
needle sticks after withdrawal ~ the needle element from the body of the patient.
According to the present invention in a ~irst aspect, there is disclosed a dispo~able needle assembly comprising an elongated needle element terminating in ~irst and second opposed pointed tips, a hub member mounted between the opposed tips of the needle element for removably connecting the needle assembly to a tube holder of a syring~, a guard member mounted around the needle element and manually movable axially along the needle element betwleen a first position where the guard member is displaced inwardly from the first pointed tip to expose the first pointed tip to enable it to penetrate ~he body of a patient and a s~ond position where the guard member covers the first pointed tip to prevent needle sticks, and locking means mounted along the needle element between the hub member and the first pointed tip, the locking means permanently locking the gu~rd member in the second position upon movement of the guard member from the first position to the second position.
The second pointed tip of the needle element is preferably covered by a cap made of resilient material, the cap being punctured by the second pointed tip upon penetration of a tube in the tube holder.
Typically, the cap is made of rubber and is self-sealing upon withdrawal of the tube ~rom the second pointed tip.
According to the invention in a first aspect, th~
needle element is a unitary continuous structure which comprises first and second needle segments carrying respectively first and second pointed tips, the needle segments being securely connected to each other by means of the hub member, the needle segments being align~d along a common axis and extending outwardly ~rom the hub member.
According to the invention in a second aspect, the needle element is a discontinuous struckure which comprises two separate needle seyments detachably connected to each other by means o~ the hub me~ber, one o~
the ~egments carrying the ~irst pointed tip and the ~ther of the seyments carrying the second pointed tip, the needle segments being aligned along a common axia upon connecting the two needle segments together.
In a preferred embodiment of the present invention, the guard member comprises a tubular element having a collar member at the rearward end of the guard member towards the second pointed tip and a restricted opening at the forward end of the guard member towards the first pointed tip, the first pointed tip extending throuyh the restricted opening in the forward end when the guard member is in the first position.
The hub member advantageously has a recessed guard holding section extending therefrom towards the first pointed tip and the collar member has an orifice therein with tha recessed guard holding section fitting through the orifice when th~ guard member is in the first position.
The guard member and the recessed guard holding section may each comprise interactive elements which hold the guard member in the recessed guard holding section until the guard member is moved to the second position.
It is advantageous that the locking means has a receptacle in which the collar member of the guard member snaps into upon movement of the guard member into the second position.
The collar member of the guard member may also have an expandable orifice and the locking means includes a ramp section forward of the receptacle which fits into and forces expansion o~ the orifice as the guard member approaches the receptacle to move into the second position, the receptacle having an elevated wall which acts as a stop for the collar member of the guard member to prevent axial movement of the guard member after the collar member snaps into the receptacle.
-3a-3~
Preferably, the collar membsr o~ the guard member comprises two lateral tear drop slits, substantially opposed to each other and dividing the collar member into two generally semicircular elements, the receptacle and the semicircular elements abutting each other when the oollar member is received in the receptacle.
The locking means typically has a central passageway wherethrough the shaft of the needle element carrying the first pointed tip pass~s, with the locking m~3ans and the needle shaft being bonded to each other~
The needle assembly of the presenl: invention preferably comprises a sheath member which fLts over the first pointed tip of the needle element whe~n the guard member is in the first position to prevent exposure of the first pointed tip, the sheath member having one end closed and an open end opposed t~ the closed end, the hub member fitting snugly into the open end of the sheath end, so that the sheath member encases the needle element and the guard member but may be manually removed by pulling it off the hub member, the sheath member comprising interior splines which coact with ~xterior rib elements on the hub member to ~acilitate connecting the needle assembly to the tube holder and disconnecting the needle assembly from the tube holder.
The guard member advantageously comprises a plurality of ribs molded in the ext~rior surface thereof to facilitate grasping the guard member.
According to the present invention in a second aspect, thare is also disclosed a syringe for withdrawing bodily fluids comprising a tube holder which removably receives a collection tube having a sealed end, a needle element having a first pointed tip extending outwardly from the tube holder and adapted to penetrate the body of a patient and a second pointed tip extending into the tube holder and adapted to penetrate the sealed end o~ the collection tube upon insertion o~ the collection tube into the tube -3b-~3~3~
holder, the first and ~econd pointed tips beiny on a common axis and opposed to each other, a hub member mounted b~tween the opposed tips of the needle element for removably connecting the needle element to the tub~
holder, a guard member mounted along the needle element and manually movable axially along the needle element between a first position where the guard member is displaced inwardly from the first pointed tip to expose the first pointed tip to enable it to penetrate the body of the patient and a second position where the guard member cover6 the ~irst pointed tip to prevent needle sticks, and locking means mounted along the needle element between the hub member and the first pointed tip, the locking means permanently locking the guard member in the second position upon movement of the guard member from the first position to the second position.
According to the present invention in a third a~pect, there is disclosed a medical device comprising a needle element having first and second opposed pointed tips and a hollow shaft therebetween, a guard member movabl~ axially along said needle element from a first position in which the first pointed tip of said needle element is exposed, to a second position in which said guard member shields said first pointed tip of said needle element to prevent needle sticks and locking means disposed between said first and second pointe~ tips of said needle element for interacting with said guard member to permanently lock ~aid guard member in said second position upon movement of said guard member from ~aid first position. Praferably, in this medical device, the second pointed tip of the needle element is covered by a cap made of resilient material, the cap being punctured by the second pointed tip upon penetration of a tube in the medical device.
~ccording to the present invention in a fourth aspect, there is disclosed a safety device for withdrawing bodily fluids ~rom the body of a patient, comprising a hub -3c-f~
adapted to be r0movably secured to a tube holder of a syringe and having a central passageway therthrough, an elongated needle extendin~ from said hub and in fluid communication wi~h said syringe, said needle hav1ng first and second opposed pointed tips, a tubular guard m~mber disposed coaxially about said needle and axially movable from a first position in which the ~irst pointed tip of said needle is exposed and a second position in which the first pointed end of said needle i5 shielded against needle sticks, said guard member comprising a radially inwardly extending collar and a locking element secured to said needle distally of the tube holder of the syringe, said locking means comprising an annular recess adapted to receive said collar of said guard member when the guard mamber is in the second position.
According to the present invention in a ~ifth aspect, there is disclosed a madical device, comprising a needle having first and second pointed tips and a hollow shaft therebetween, a guard member movable axially along said needle from a ~irst position in which the first pointed tip of said needle is exposed, to a second position in which said guard member shields said first pointed tip of said needle to prevent needle sticks and a locking element disposed between said first and said second pointed tips of said needle, wherein said locking element comprises a tapered portion which increases in cross-sectional area in the distal direction, said tapered portion terminating in a shoulder defining the proximal boundary of an annular recess therein.
According to the present invention in a sixth aspect, there is disclosed a safety needle assembly for use with a medical device for withdrawing bodily fluids, comprising a connector adapted to be removably attached to said medical device, a needle secured to said connector, said needle having first and second pointed tips, a tubular guard disposed concentrically about ~aid needle and adapted for ~3d~
~3C~
axial movement from a flrst position where the first pointed tip of said needle is exposed, to a second position where the guard covers the first pointed tip to prevent needle sticks and a tubular sheath having one open end, wherein said needle and said guard are enclosed within said sheath, said sheath being disposed concentrically about said needle and said guard and being remoYably secured at its open end in frictional engagemenk with said connector.
According to the present invention in a seventh aspect, there is disclosed a medical device, comprising a needle having first and second pointed tips, adapted to be placed in communication with the tube holder of a withdrawal davice by way of said second pointed tip, a guard axially movable between a first position in which the first pointed tip of said needle is exposed, and a second position in which said first pointed tip is shielded and locking means disposed intermediate said first and second pointed tips and distally of said tube holder of said withdrawal device for retaining said guard in said second position.
The preferred embodiments of this invention illustrating all of its ~eatures will now be discussed in detail.
BRIEF DESCRIPTION OF THE DRAWINGS
~he device of this invention is illustrated in the drawings, with like numerals indicating like parts, and in which:
Figure 1 is a perspective view of the device of this invention.
Figure 2 is a perspective view of the needle assembly o this invention.
Figure 3 is an exploded enlarged view of the needle assembly shown in Figure 2.
Figure 4 is a cross-sectional view taken along line 4-4 of Figure 1.
Figure 5 is a cross-s0ctional view taken along line 5-5 of Figure 4.
Figure 6 is a cross-sectional view taken along line 6-6 of Figure 4.
Figure 7 is a cross-sectional view taken along line 7-7 of Figure 4.
Figure 8 is a cross-sectional view taken along line 8-8 of Figure 4.
Figure 9 is a cross-sectional view taken along line 9-9 of Figure 4.
Figure lO is an enlarged cross-s2ctional view, with sections broken away, showing the needle assembly connected to the tube holder and the tube being moved toward the inwardly projecting tube end of the needle elementO
Figure 11 is a cross-sectional view, with sections broken away, similar to that shown in Figure 10, with the tube -4a-~3~
moved lnwardly ~o that the tube end ~ the needle p~netrates the sealed end of the tube~
Plg. 12 1~ a cro~s-~ectional view sho~ng the guard member being moved forward to cover the t$p of ~he needle.
Fig. 13 i~ a croas-~ectional vlew taken along llne 13-13 of Fig~ 12.
Fig. 14 i~ a cro~s-~ectlonal vlew ~imll~r to that ~hown in Fig. 12 with the guard member moved completely ~orward and locked permanently in pos~tion to cover the tip of the patient end of the needle element.
Pig. 15 is a cross-sectional view ~howing the ~heath for the needle a~sembly recovering the patlent ~nd of the needle element~ with the needle ~s~embly removecl from the tube holder.
Fig. 16 is an e%ploded per~pective vlew of ~n alternate embodiment of the device of this ~nvention.
Fig. 17 i~ an enlarged cross-sectional vlew sho~ing the needle a~sembly illustrated in Fig. 16 connected to the tube holder.
2p DBSCRIPTION OF T~E PREFERR~D EMBODIMENTS
As be~t ~ho~n in PigO 1, the devlce 10 of this lnvention lnclude~ three components: a vacuu~ collection tube 12, a tube holder 14, and a disp~Rable needle assembly 16 (Fig.2) contained wLthin a housing 18. The collection tube 12 and tube holder 14 ~re of conventional design. The ~ispo~able needle assembly 16 1~ the unique feature of the device 10.
The vacuum collection tube 12 may be a glas~ or plastic tube having a closed 20 end and an open end 22 sealed with a ~elf~6ealing rubber ~topper 24. There i~ a vacuum on the in~ide of the tube 12 which c~use~ fluld to be ~0~
drawn int~ the interior of th~ tube ~hen the rubber 0topper 24 1~ purlctured. ~rhe collectlon tube ;l2 1~ received in the tube holder 14 during u~e. Thi~ tube holder has a generally cylindrlcal body which guides the collection tube toward~ the needle end 26 of the needle element 28 (Plg. 3) o~ the needle assembly 16. The ~ube holder 14 ha~ an open entry end 30 u~rounded by a Elange 32 whi~h lz gripped by the u~er durlng use. Oppo~ite the open entry end i~ a partlally closed port end 34 which has an adapter 3Z molded into the parti~lly clo~ed port end. This adap~:er 36 i~
designed to removably ~ecure the needle aszembly 16 to the tube holder 14. Thus, upon re~oval of the neetlle assembly 16 and replacemen~, the tube holder 14 can bè
repeatedly used rather than bei~g disposed. Moreover, as frequently i~ the ca~e, several collection tube~ 14 are filled during ~es~ing of ~he same pa~ient prio~ to replacing the needle aR~embly 16~
The needle assembly 16 of this inventlon i8 best illustrated in Fig~. 2 and 3. This needle as~2mbly 16 is held with~n the housing 18 which has two portions: a patient needle sheath 38 which coverg the patient end 40 of the needle element 28 and a cover 42 which covers the needle end 26 of the needle element ~8. The end of the ~heath 38 ~it~ with~n the open ~outh of the cover 42, 11th the combined ~tructure of sheath and cover ~or~ing the hou~ing 18 ~hich encases the needle as3embly 16. Prios to connecting the needle asgembly to the tube holder, the cover 42 is removed to expo~e the tube end 26 of the needle element. The needle end 26 i~ covered by a subber cap 44 30 ~ which fits snugly over ~ é it. As wlll be ~plained in greater detail hereafter, this rubber cap 44 acts as a valve to close off the tip of the needle end 26 upon removal of ~3~3~
the tube 12 from the tube holder 14.
The needle ~3sembly 16 include~ the needle element 28 which i8 mounted to ~ hub 46. One segment 28a of the needle element 28 pro~ects from one side o~ the hub 45 and the other ~egment 28b pro~ects from the oppo~lt0 side of the hub, with ~he end~ 26 and 40 of the needle slement being oppo6ed to one another and the longitudinal a~ls of these segments disposed along the longitudinal a~is of the hab.
The hub 46 has a connector ~ec~ion 48 and a sheath carrier section 50. Thi~ hub 4~, including the section8 48 and 50, i8 molded from plastic to provide a unitary structure having a central pas~ageway 52 therein which ~ -receives the two needle segments 28a dnd 28b. The segment 28a has a ~lightly larger diameter than the segment 28b oP the needle elemen~ 28. A~ shown in Fig. 5, both of the~e segmen~s 28a and 28b are lodged within the passageway havlng tw~ sections 52a and 52b with different diameter~. The needle segment~ 28a and 28b may be molded in place or an adhe~ive may be u ed to bond the segments securely to the hub 46. In the lat~r case, there 1B X
provided a series of annular reces~es 54 about the ~ection 52b of the passage~ay 52 into which an adhe~ive i8 placed to secure the needle ~egment 28b in po~ition~
The connector section ~8 of the hub ~6 includes a di~k portlon 56 having a raised cylindrical platfonm 58 extending fro~ the ~ide o the di3k which faces the tube holder 14 upon connection of the needle assembly 16 to the holder. A threaded section 60 extends outwardly from this side of the platform 58 and terminates in a noz~ like element 62 which ~its into the open end of the rubber cap 44~ As ~hown in Fig. 11, to connect ~he needle assembly 15 to ~he tube holder 14, the u~er simply screws ~3~
the threaded ~ection 60 lnto the open e~terlor end vf the adapter 36 which has correspondlng internal thread~ 64 to allow the u9~ to simply rot~te th0 needle ~ embly to secure lt to the tube holde~.
A~ best ~hown in Fig. 10, the sheath 38 covering the patient end 40 of the needle element 28 i8 retained in position covering the patien~ end of the needle element until the needle a~embly 16 i8 connected to the tube holder 14. The ~hea~h 38 lncludes in~ernal ~pllnes 66 (Fig.
3) running lengthwise along the ins~de ~all of the ~heath.
As illustrated best in Fig. 7, these spline~ 66 coact with a rib 68 carried on the outside wall of the sheath carrier ~ection 50 o~ the hub 46. The splines 66 abut the sides of the ribs 68 upon applying a torque to the sheath 80 that the splineR will pu6h against the ribs to turn the needle as3embly 16, ~crewing it into the adapter 36. To di6connect the needle as~embly 16 fro~ the tube h~lder 14, ~he sheath 38 again i8 placed in position covering the patient end 40 of the needle element 28 and rota~ed in an oppo3ite direction to unscrew the connector ~ection 48 from the adapter ~6. In thi~ lnstance, the splines 66 will al80 coact with the ribs 68 to apply turning force to the needle assembly 16.
The characterizing feature of this invention i~ a guard 70 which i8 mounted to move ~xially along the shaft of the needle element 28 from a rearward position a8 shown in Fig. 4 to a for~ard position shown in ~ig. 14. In ~his forward position the quard 70 cover~ the tip of the patient end 40 of the needle element 28 and protect~ the user against accidental needle sticks.
The sheath carrier section 50 of the hub 46 is designed to hold the guard 70 ln ~he po~1tion illu~trated in 3~Z, Fig~ 4 until the u~er i~ ready ~o mo~e the guarcl forward to ~over the tlp of the patient end ~0 of the needle element 28. ~hl~ ~heath carrler sectlon 50 is be~t lllustrated in Fig~. 3, 4 and 5. It is lnteyral wlth the hub 46 and include~ an annular rece~sed portion 72 which has a circumferential groove 74 ~ the mouth o~ the carrier ~ection 50. E~tendlng inwardly into the reces~ed portion 72 i6 a neck 78 from which the needle element 28 project~
out~ardly. In accordance with this embodlment of the invention, ~he connector ~ectlon 48 and ~he shedth carxier 6ect$0n 50 are integral, being molded from the ~!3ame pla~tic material to provide a unltary structure.
The guard 70 ha~ a generally cylindrical configuration with the rear BectiOn of the guard having a collar 80 which interacts ~ith a locking element 82 secured to the shat of the needle element 28, and oppoaite the collar, an open end 70a whlch ha~ a re~tricted dlameter that prevents the tip of the user'~ little finger fro~ entering the open end. Thus, ~hen th0 guard i~ ln the forward position as sho~n in Fig. 1~, the u~er, even if he or ~he intentionally pushe~ hi~ or ber little finger into the open end 70a, would not contact the tip of the patient end 40 of the needle element 28. Spaced apart in a row are nipples 84 ~hich pro~ect outwardly from the collar 80 and are received in the groove 74 of the sheath carxier section 50 as ~hown ln Fig. ~0 Along the e~terior of the guard 70 are a series of raised annular gripping elements 86 which a~6i8t the user in moving the guard for~ard along the shaft of the needle element 28. Th~ collar 80 i8 ~eparated by a pair of oppo~ed lateral tear drop ~lit~ 81 in the sidewall of the guard to divide the collar into kwo generally Remi-circular elements 80a and 80b as shown in Fig. 13. Between the ends ~33~J
of the~e elements 80a and 80b 1~ an open 0ection ~a that lnteracts with the locking element B2 as llluat:rated ln Figs. 12, 13 and 14. The semi-circular elements 80a and 80b of the collar 80 each provide a wedge-like plece that grips ~he locking element 82 a~ ~hown ~n Fig. 1~ when the guard 70 is moved forward.
The locking element 82 has a ramp sectlon 90 in the ~orm o~ a conical member which terminates in a rear shoulder section 92. The forward end of the locklng element 82 i~ in the form of a rai~ed shoulder section 94 ~ith ~n annular receptacle portion 96 being be~ween the raised shoulders 92 and 94. When the user pushe~ the guard 70 for~ard, the elements 80a and 80b of the collar 80 ride up the ramp section 90, with the two collar elements expanding outward.
The collar, becau~e of the teardrop ~lits ~eparating the two section~, has an internal refiiliency which allows the element~ 80a and 80b of the collar to ~nap int~ and wedge them~elves ln the annular receptacle ~ection 96 a9 shown in ~ig. 14 when the guard 70 i8 moved to the forward, permanently locking the guard in the ~or~ard position.
Operation:
To use the device 10, firstt the cover 42 for the tube end 26 of the needle element 28 i removed and di~carded. Ne~t~ the user grips the ~heath 38 coverlng the 2S patlent end 40 of the needle element 28 and $nserts the ~onnector ~ection 48 of the needle a~sembly 16 into the adapter 36 of the tube holder 14 turning the needle assembly 16 to screw the threaded section 60 lnto the adapter. The internal spline~ 66 of the sheath coact with the rib~ 68 on the ~heath carrier ~ection 50 to turn the needle assembly as the sheath i8 rotated by the user.
With the needle assembly 16 connected to the tube ~3~
holder 14, the ~heath 38 i~ pulled from th~ embly to expo~e the patient end ~0 of the needle element 28. The user places the collection tube 12 lnto the open end 30 of the tube holder 14, grasping the flange 32 ~ith the index finger and middle inger while slmul~aneou~ly pres~ing again~t the end of the tube 20 with the thumb. Thi~ pushes the collection tube 20 inwardly towards the tube end 26 of the needle element 28 as illustrated in Fi9B. 10 and 11.
The tip of the tube end 26 penetrates the ~topper 24, and the stopper depresRes the rubber cap 44,as the ~ube 12 advanceg. ~8 indicated by the arrow A in Pig. 11, blood or other body fluid will flow through the pati~n~ end 40 of the needle element 28 into and through the tube end 26 of the needle element lnto the lnterlor of the collectlon tube 12.
When the tube 12 i~ filled, the u~er pu116 it from the tube holder, whereupon the rubber cap 44 will return to it~
normal positlon a8 illustrated $n ~ig. 10. The rubber caR 4~ elf-seallng ~o that the hole produced ~n lt by penetration of the needle element 28 i8 sealed oPf, preventing blood fro~ e w aping from the tube end 26 o~ the needle element. Thus, lf the user wi~hes to fill another collection tube, he or ~he nay do 80 by simply placing another tube in the holder and ~oving it to the posltion illugtrated in Pig. 11.
When it i8 tlme to withdraw the patient end 40 of the needle element 28 from the body o~ the patient, the user 8~mply gra8p8 the guard 70 by ~he gripping ele~ent~ 86 and holds it steady while pulling the tube holder 14 away from the body of the patient. Thi6 will cause the guard 70 to move relative to the needle element 28 so that the collar 80 will engage the locking element 82, ride over the ramp section 90 and then snap into position, with the ~IL3~2~
elements 80a and ~Ob wedglng them~0lve~ lnto the annular cecep~acle 96. Thia permanently lock~ ~he guard 70 ln the posltion ~hown in Flg. 14. The ~heath 3a i~ then replaced as shown in Pig. lS and now ~sed to unscrew the needle assembly 16 rom the tube holder 14. Th~ needle asaembly 16 ~lth the guard in the forward position and the sheath 38 covering the assembly is then di~carded.
ALTERNATE 13ME~ODIMENT
The alternate e~bodiment of this lnvention 1~
illustrated in Figs. lS ~nd 17. In thi~ embodlment the medlcal device 98 illustrated in the related parent application, U. S. Patent ~pplicatlon seri~l number 06/849,148, is ù~ed with a special connector 100. This connector 100 is designed to fit into the open end of the hub 46, thereby allowing the medical device 98 to be used with a vacuum collection tube 12. The connector lOO iR
designed to lnclude a nçedle 102 ~hich e~ends outwardly rom molded plastic piece 104 having a tapered section 106 which fits into the open end 108 of the medical device 98.
There i8 an internal pas~ageway lOl in the section 106 that allows fluid to flow from the device 98 through the needle 102~
A cover (not ~hown) ~or the connector 100 i~ used to cover the needle 102 during sh$pment. This cover ha~
internal splines carried on it~ side wall which interact with ribs 110 on the exterior wall of the $apered section 106 to permit the cover to be used to screw the connector int3 the adapter 36. When the connector lOO ha~
been connected to the tube holder 14, as illu~trated ln Fig.
17, the tapered section 106 i8 simply force fitted into the open mouth 108 of the medical device 98 allowing th i8 device ~ 12 -3~
to be u~ed to collect blood or other Pluld ~rom ~he body of a patient. After belng uaed, the guard 70 18 moved forward as dl~cu~ed previou~ly ~o cover the patlent end ~0 of the needle element 28.
SCOPE OF T~E INVENTION
Tbe ~bove desrription pre~ent~ the best mode contemplated in carrying out the present invention. This invention i8, however, ~usceptlble to ~odlfication~ and alternate constructlon6 fro~ the embodiment~ ~hown $n the drawing and de~cribed above~ Consequently, it: i8 not the lntention to limlt this invention to the partlcular e~bodi~ents disclosed. On the contrary, the lntentlsn i~ to cover all modi~ications and alternate constructions comihg within the ~pirit and ~cope of the invention a6 generally expressed by the following claims.
Claims (23)
1. In a device used to withdraw blood or other fluids from a patient, including (a) tube means having a seal in an open end adapted to be penetrated by a needle, with said seal then being self-sealing upon withdrawal of the needle penetrating said seal, (b) reusable tube holder means into which the tube means is received during use, said tube holder means having an open end which receives the sealed end of the tube means, (c) opposite the open end, a connector for a needle assembly, and (d) a disposable needle assembly adapted to be removably connected to the tube holder means, the improvement wherein the needle assembly includes needle means having a first needle segment extending into the tube holder means upon connection with the tube holder means and a second needle segment extending outwardly from the tube holder means upon connection of the needle assembly to the tube holder means with the tip of the second needle segment being exposed prior to insertion of this second segment into the patient, a guard member mounted on the shaft of the second needle segment and movable axially along the shaft of said second needle segment between a first position where the guard means is displaced inwardly from the tip to expose said tip to enable it to penetrate the body of a patient and a second position where the guard member covers said tip to prevent needle sticks, and locking means mounted along said needle shaft which permanently locks the guard member in the second position upon movement of said guard member from the first position to the second position.
2. The device of claim 1 wherein the needle assembly is a unitary structure having a body member with said first and second needle segments aligned along a common axis and extending outwardly from the body member.
3. The device of claim 1 wherein the needle assembly has two separate sections which are adapted to be detachably connected together, one of said sections carrying one needle segment and the other section carrying the other needle segment.
4. The device of claim 3 wherein said needle segments are aligned along a common axis upon connecting the two sections together.
5. A disposable needle assembly including an elongated needle element terminating at first and second opposed pointed tips, a connector member mounted between the opposed tips of the needle element for removably connecting the needle assembly to a tube holder of a blood withdrawal device, a guard member mounted on the needle element and movable axially along the needle element between a first position where the guard means is displaced inwardly from the first pointed tip to expose said first tip to enable it to penetrate the body of a patient and a second position where the guard member covers said first tip to prevent needle sticks, and locking means mounted along said needle element between the connector means and said first tip which permanently locks the guard member in the second position upon movement of said guard member from the first position to the second position.
6. The disposable needle assembly of claim 5 wherein the connector member has a threaded element extending therefrom towards the second tip to enable the needle assembly to be screwed into a threaded opening in the tube holder.
7. The disposable needle assembly of claim 6 wherein the connector member has on its exterior rib elements which coact with splines on a needle sheath to facilitate connecting and disconnecting the needle assembly to the tube holder.
8. The disposable needle assembly of claim 5 wherein a rubber cap is seated on the second tip of the needle.
9. A disposable needle assembly including an elongated needle element terminating in first and second opposed pointed tips.
a connector member mounted along the needle element between said opposed tips of the needle element for removably connecting the needle assembly to a tube holder of a blood withdrawal device, said connector member having a recessed guard holding section at one end and a threaded tube connection section at the other end, a guard member mounted on the needle element and movable axially along the needle element between a first position where the guard means is displaced inwardly from the first pointed tip to expose said first tip to enable it to penetrate the body of a patient and a second position where the guard member covers said first tip to prevent needle sticks, said guard member in the first position being seated in the recessed guard holding section, and locking means mounted along said needle element between the connector means and said first tip which permanently locks the guard member in the second position upon movement of said guard member from the first position to the second position.
a connector member mounted along the needle element between said opposed tips of the needle element for removably connecting the needle assembly to a tube holder of a blood withdrawal device, said connector member having a recessed guard holding section at one end and a threaded tube connection section at the other end, a guard member mounted on the needle element and movable axially along the needle element between a first position where the guard means is displaced inwardly from the first pointed tip to expose said first tip to enable it to penetrate the body of a patient and a second position where the guard member covers said first tip to prevent needle sticks, said guard member in the first position being seated in the recessed guard holding section, and locking means mounted along said needle element between the connector means and said first tip which permanently locks the guard member in the second position upon movement of said guard member from the first position to the second position.
10. The needle assembly of claim 9 wherein the guard member and recessed guard holding section each including interactive elements which hold the guard member in said recessed section until the guard member is manually moved to the second position.
11. A needle assembly including an an elongated needle element terminating at one end in a pointed tip, a connector member displaced inwardly from said pointed tip mounted on the needle element for removably connecting the needle assembly to a tube holder, a guard member mounted on the needle element and movable axially along the needle element between a first position where the guard member is displaced inwardly from the tip to expose said tip to enable it to penetrate the body of a patient and a second position where the guard member covers said tip to prevent needle sticks, and locking means mounted along said needle element between the connector means and said first tip which permanently locks the guard member in the second position upon movement of said guard member from the first position to the second position.
12. The needle assembly of claim 11 wherein the connector member has a tapered open end which receives a needle carried in a hollow tapered fitting.
13. A medical device comprising a tube holding member which removable receives a vacuum tube having a sealed end, a needle element having a first end extending into the tube holding member and adapted to penetrate the sealed end of the vacuum tube upon insertion of the tube into the tube holding member and a second end extending outwardly from the tube holding member and adapted to penetrate the body of a patient, a guard member mounted to be moved between a retracted position exposing the second end of the needle and an extended position covering the second end of the needle, and locking means for permanently locking the guard member in the extended position upon movement to said extended position.
14. A disposable needle assembly, comprising:
an elongated needle element terminating in first and second opposed pointed tips;
a hub member mounted between the opposed tips of the needle element for removably connecting the needle assembly to a tube holder of a syringe;
a guard member mounted around the needle element and manually movable axially along the needle element between a first position where the guard member is displaced inwardly from the first pointed tip to expose the first pointed tip to enable it penetrate the body of a patient and a second position where the guard member covers the first pointed tip to prevent needle sticks, said guard member comprising a tubular element having a collar member at the rearward end of the guard member towards the second pointed tip and a restricted opening at the forward end of the guard member toward the first pointed tip, the first pointed tip extending through the restricted opening in the forward end when the guard member is in the first position; and locking means mounted along the needle element between the hub member and a first pointed tip, the locking means permanently locking the guard member in the second position upon movement of the guard member from the first position to the second position.
an elongated needle element terminating in first and second opposed pointed tips;
a hub member mounted between the opposed tips of the needle element for removably connecting the needle assembly to a tube holder of a syringe;
a guard member mounted around the needle element and manually movable axially along the needle element between a first position where the guard member is displaced inwardly from the first pointed tip to expose the first pointed tip to enable it penetrate the body of a patient and a second position where the guard member covers the first pointed tip to prevent needle sticks, said guard member comprising a tubular element having a collar member at the rearward end of the guard member towards the second pointed tip and a restricted opening at the forward end of the guard member toward the first pointed tip, the first pointed tip extending through the restricted opening in the forward end when the guard member is in the first position; and locking means mounted along the needle element between the hub member and a first pointed tip, the locking means permanently locking the guard member in the second position upon movement of the guard member from the first position to the second position.
15. The needle assembly as set forth in Claim 14, wherein the guard member comprises a tubular element having a collar member at the rearward end of the guard member towards the second pointed tip and a restricted opening at the forward end of the guard member towards the first pointed tip, the first pointed tip extending through the restricted opening in the forward end when the guard member is in the first position.
16. The needle assembly as set forth in Claim 15, wherein the hub member has a recessed guard holding section extending therefrom towards the first pointed tip and wherein the collar member has an orifice therein with the recessed guard holding section fitting through the orifice when the guard member is in the first position.
17. The needle assembly as set forth in Claim 16, wherein the guard member and the recessed guard holding section each comprise interactive elements which hold the guard member in the recessed guard holding section until the guard member is moved to the second position.
18. The needle assembly as set forth in Claim 15, wherein the locking means has a receptacle in which the collar member of the guard member snaps into upon movement of the guard member into the second position.
19. The needle assembly as set forth in Claim 15, wherein the collar member of the guard member has an expandable orifice and wherein the locking means includes a ramp section forward of the receptacle which fits into and forces expansion of the orifice as the guard member approaches the receptacle to move into the second position, the receptacle having an elevated wall which acts as a stop for the collar member of the guard member to prevent axial movement of the guard member after the collar member snaps into the receptacle.
20. The needle assembly as set forth in Claim 18, wherein the collar member of the guard member comprises two lateral tear drop slits, substantially opposed to each other and dividing the collar member into two generally semicircular elements, the receptacle and the semicircular elements abutting each other when the collar member is received in the receptacle.
21. A disposable needle assembly comprising:
an elongated needle element terminating in first and second opposed pointed tips;
a hub member mounted between the opposed tips of the needle element for removably connecting the needle assembly to a tube holder of a syringe;
a guard member mounted around the needle element and manually movable axially along the needle element between a first position where the guard member is displaced inwardly from the first pointed tip to expose the first pointed tip to enable it to penetrate the body of a patient and a second position where the guard member covers the first pointed tip to prevent needle sticks; and locking means mounted along the needle element between the hub member and the first pointed tip, the locking means permanently locking the guard member in the second position upon movement of the guard member from the first position to the second position, said locking means having a central passageway wherethrough the shaft of the needle element carrying the first pointed tip passes, with the locking means and the needle shaft being bonded to each other.
an elongated needle element terminating in first and second opposed pointed tips;
a hub member mounted between the opposed tips of the needle element for removably connecting the needle assembly to a tube holder of a syringe;
a guard member mounted around the needle element and manually movable axially along the needle element between a first position where the guard member is displaced inwardly from the first pointed tip to expose the first pointed tip to enable it to penetrate the body of a patient and a second position where the guard member covers the first pointed tip to prevent needle sticks; and locking means mounted along the needle element between the hub member and the first pointed tip, the locking means permanently locking the guard member in the second position upon movement of the guard member from the first position to the second position, said locking means having a central passageway wherethrough the shaft of the needle element carrying the first pointed tip passes, with the locking means and the needle shaft being bonded to each other.
22. A disposable needle assembly comprising:
an elongated needle element terminating in first and second opposed pointed tips;
a hub member mounted between the opposed tips of the needle element for removably connecting the needle assembly to a tube holder of a syringe;
a guard member mounted around the needle element and manually movable axially along the needle element between a first position where the guard member is displaced inwardly from the first pointed tip to expose the first pointed tip to enable it to penetrate the body of a patient and a second position where the guard member covers the first pointed tip to prevent needle sticks;
locking means mounted along the needle element between the hub member and the first pointed tip, the locking means permanently locking the guard member in the second position upon movement of the guard member from the first position to the second position; and a sheath member which fits over the first pointed tip of the needle element when the guard member is in the first position to prevent exposure of the first pointed tip, the sheath member having one end closed and an open end opposed to the closed end, the hub member fitting snugly into the open end of the sheath end, so that the sheath member encases the needle element and the guard member but may be manually removed by pulling it off the hub member, the sheath member comprising of the sheath end, so that the sheath member encases the needle element and the guard member but may be manually removed by pulling it off the hub member, the sheath member comprising interior spines which coact with exterior grip elements on the hub member to facilitate connecting the needle assembly to tube holder and disconnecting the needle assembly from the tube holder.
an elongated needle element terminating in first and second opposed pointed tips;
a hub member mounted between the opposed tips of the needle element for removably connecting the needle assembly to a tube holder of a syringe;
a guard member mounted around the needle element and manually movable axially along the needle element between a first position where the guard member is displaced inwardly from the first pointed tip to expose the first pointed tip to enable it to penetrate the body of a patient and a second position where the guard member covers the first pointed tip to prevent needle sticks;
locking means mounted along the needle element between the hub member and the first pointed tip, the locking means permanently locking the guard member in the second position upon movement of the guard member from the first position to the second position; and a sheath member which fits over the first pointed tip of the needle element when the guard member is in the first position to prevent exposure of the first pointed tip, the sheath member having one end closed and an open end opposed to the closed end, the hub member fitting snugly into the open end of the sheath end, so that the sheath member encases the needle element and the guard member but may be manually removed by pulling it off the hub member, the sheath member comprising of the sheath end, so that the sheath member encases the needle element and the guard member but may be manually removed by pulling it off the hub member, the sheath member comprising interior spines which coact with exterior grip elements on the hub member to facilitate connecting the needle assembly to tube holder and disconnecting the needle assembly from the tube holder.
23. A disposable needle assembly comprising:
an elongated needle element terminating in first and second opposed pointed tips;
a hub member mounted between the opposed tips of the needle element for removably connecting the needle assembly to a tube holder of a syringe;
a guard member mounted around the needle element and manually movable axially along the needle element between a first position where the guard member is displaced inwardly from the first pointed tip to expose the first pointed tip to enable it to penetrate the body of a patient and a second position where the guard member covers the first pointed tip to prevent needle sticks, said guard member comprising a plurality of ribs molded in the exterior surface thereof, to facilitate grasping of the guard member; and locking means mounted along the needle element between the hub member and the first pointed tip, the locking means permanently locking the guard member in the second position upon movement of the guard member from the first position to the second position.
an elongated needle element terminating in first and second opposed pointed tips;
a hub member mounted between the opposed tips of the needle element for removably connecting the needle assembly to a tube holder of a syringe;
a guard member mounted around the needle element and manually movable axially along the needle element between a first position where the guard member is displaced inwardly from the first pointed tip to expose the first pointed tip to enable it to penetrate the body of a patient and a second position where the guard member covers the first pointed tip to prevent needle sticks, said guard member comprising a plurality of ribs molded in the exterior surface thereof, to facilitate grasping of the guard member; and locking means mounted along the needle element between the hub member and the first pointed tip, the locking means permanently locking the guard member in the second position upon movement of the guard member from the first position to the second position.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US3543487A | 1987-04-07 | 1987-04-07 | |
| US07/035,434 | 1987-04-07 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1308322C true CA1308322C (en) | 1992-10-06 |
Family
ID=21882657
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000563167A Expired - Lifetime CA1308322C (en) | 1987-04-07 | 1988-03-31 | Medical device |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA1308322C (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7713247B2 (en) | 1991-12-18 | 2010-05-11 | Icu Medical, Inc. | Medical valve and method of use |
| US8002765B2 (en) | 1995-12-15 | 2011-08-23 | Icu Medical, Inc. | Medical valve with fluid escape space |
-
1988
- 1988-03-31 CA CA000563167A patent/CA1308322C/en not_active Expired - Lifetime
Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7713247B2 (en) | 1991-12-18 | 2010-05-11 | Icu Medical, Inc. | Medical valve and method of use |
| US7713248B2 (en) | 1991-12-18 | 2010-05-11 | Icu Medical, Inc. | Medical valve and method of use |
| US7713249B2 (en) | 1991-12-18 | 2010-05-11 | Icu Medical, Inc. | Medical valve and method of use |
| US7717883B2 (en) | 1991-12-18 | 2010-05-18 | Icu Medical, Inc. | Medical valve and method of use |
| US7717885B2 (en) | 1991-12-18 | 2010-05-18 | Icu Medical, Inc. | Medical valve and method of use |
| US7717887B2 (en) | 1991-12-18 | 2010-05-18 | Icu Medical, Inc. | Medical valve and method of use |
| US7717886B2 (en) | 1991-12-18 | 2010-05-18 | Icu Medical, Inc. | Medical valve and method of use |
| US7717884B2 (en) | 1991-12-18 | 2010-05-18 | Icu Medical, Inc. | Medical valve and method of use |
| US7722575B2 (en) | 1991-12-18 | 2010-05-25 | Icu Medical, Inc. | Medical valve and method of use |
| US7722576B2 (en) | 1991-12-18 | 2010-05-25 | Icu Medical, Inc. | Medical valve and method of use |
| US8002765B2 (en) | 1995-12-15 | 2011-08-23 | Icu Medical, Inc. | Medical valve with fluid escape space |
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| Date | Code | Title | Description |
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| MKLA | Lapsed |