CA1337167C - Needle housing with retractable needle - Google Patents

Needle housing with retractable needle

Info

Publication number
CA1337167C
CA1337167C CA000610529A CA610529A CA1337167C CA 1337167 C CA1337167 C CA 1337167C CA 000610529 A CA000610529 A CA 000610529A CA 610529 A CA610529 A CA 610529A CA 1337167 C CA1337167 C CA 1337167C
Authority
CA
Canada
Prior art keywords
needle
housing
mounting means
container
mounting
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 - Fee Related
Application number
CA000610529A
Other languages
French (fr)
Inventor
Johannes Jacobus Porte
Richard Lewis Columbus
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Eastman Kodak Co
Original Assignee
Eastman Kodak Co
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Eastman Kodak Co filed Critical Eastman Kodak Co
Application granted granted Critical
Publication of CA1337167C publication Critical patent/CA1337167C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5021Test tubes specially adapted for centrifugation purposes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/15003Source of blood for venous or arterial blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150213Venting means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150221Valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150351Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150633Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
    • A61B5/150641Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves comprising means to impede repositioning of protection sleeve from covering to uncovering position
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150732Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150748Having means for aiding positioning of the piercing device at a location where the body is to be pierced
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150755Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150885Preventing re-use
    • A61B5/150893Preventing re-use by indicating if used, tampered with, unsterile or defective
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150885Preventing re-use
    • A61B5/150916Preventing re-use by blocking components, e.g. piston, driving device or fluid passageway
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/153Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A61B5/154Devices using pre-evacuated means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; 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
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3271Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150389Hollow piercing elements, e.g. canulas, needles, for piercing the skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150473Double-ended needles, e.g. used with pre-evacuated sampling tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150572Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/153Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; 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
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/322Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3221Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3228Constructional features thereof, e.g. to improve manipulation or functioning the needle being retracted by a member protruding laterally through a slot in the barrel, e.g. double-ended needles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; 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
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3271Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position
    • A61M5/3272Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position having projections following labyrinth paths
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/50Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5086Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile for indicating if defective, used, tampered with or unsterile

Abstract

A needle device and method of use are disclosed, wherein the needle moves out of and into a protective housing, between two operative positions, one of which causes the housing to shield the needle. Each operative position includes releasable locking detents to temporarily hold the needle in one of those positions, the holding force of one being less than the other. A third position beyond the one that shields the needle in the housing is used to permanently lock the needle in the housing against accidental reuse.
The needle device can be used with a blood collection container or a syringe drug delivery container, each one releasably mating with the device during use.

Description

NEEDLE HOUSING WITH RETRACTABLE NEEDLE
FIELD OF THE IN~1 10N
The invention is directed to a needle device used to collect blood from a mammal, or deliver drugs thereto.
BACKGROUND OF THE I~v~;NLlON
In needle devices, it is known to mount a needle on a frame that telescopes inside a sheath, the sheath extending around the needle to protect the needle except when in use. In such a device, the sheath and needle are moved from a needle-sheathed, nonuseful position, to a needle-unsheathed position in which the needle extends out through the aperture, as shown in, e.g., U.S. Patent 4,425,120. However, the disadvantage of such a device is that there is no provision to prevent the needle from being reused.
Even if it is moved back into said sheathed (protected) position, there is nothing that prevents it from being pushed out again where it can either intentionally or unintentionally inject a person.
That is, the detent mechanism for keeping the needle sheathed is not a permanent disabling feature. This is understandable, since the device has to be unsheathed to be used. However, it means that no permanent disabling of the needle can be done after its first use.
Current methods of drawing blood from or injecting drugs into a mammalian body run substantial risks of contamination if a needle can be reused or restuck into another mammal, after having been used once. For this reason, standard health practice is to destroy each needle after one use. However, there is always the possibility, for standard syringe-type devices that do not provide adequate sheathing, that the needle will be stuck accidentally into another body before or while it is being destroyed.
Furthermore, the snapping of a used needle, one method u~ed to break them, can produce an aerosol that can be contaminating.
Because of the above problems, packaging has been provided to ensure that the needle iB used only once and is not reuæable when closed into its container. Thus, devices of the type shown in U.S.
Patent 4,664,259, allow a needle to pivot relative to a package through a slot, and when the package is pivoted back over the needle, the needle is captured by a hook to permanently prevent its reuse. Such a design, however, has several drawbacks. Most important is the fact that the sheathed position of the needle within the housing is the same whether or not the disabling mechanism is in place - that is, an operator cannot tell the status simply by looking at the housing. What has been needed, therefore, prior to this invention is a needle housing and locking mechanism for permanent disabling, that is operable using visual positioning that is unique to the needle status.
Yet another difficulty with devices such as are shown in U.S. Patent No. 4,425,120 is that the relative movement of needle and housing, to expose or withdraw the needle, is a fairly complicated two-handed operation requiring both a twisting and a translation. There has been a need prior to this invention to provide needle housing devices that are not only protective, but can be operated with one hand.
SUMMARY OF THE INVENTION
I have constructed a needle device and method of use that meet the above-mentioned needs.
More specifically, in accord with one aspect of the invention, there is provided a needle device for safely collecting blood or injecting drugs, the device compri~ing a needle and a housing for the needle, the housing including an aperture at one end;
means slidably disposed within the housing for mounting the needle, the mounting means being shaped at one end to releasably mate with a container constructed to collect or deliver a liquid, the needle projecting into a mated container end sufficiently to penetrate the container when sufficient force is applied, means for holding the mounting means in the housing in at least two positions, one of the positions locating the needle so as to be surrounded by the housing and the other position locating the needle to project through the aperture, and means for locking the needle and the mounting means permanently against further movement in the housing when the mounting means is moved from the one position to and past the other position to a third position.
In accord with another aspect of the invention, there is provided a needle device for safely collecting blood or delivering a liquid, the device comprising a needle and a housing for the needle, the housing including an aperture at one end;
means slidably disposed within the housing for mounting the needle, the mounting means being shaped at one end to releasably mate with a container constructed to collect or deliver a liquid, the needle projecting into a mated container sufficiently to penetrate the container when sufficient force is applied, means for holding the mounting means in the housing in at least two positions, one of the positions locating the needle 80 as to be surrounded by the housing and the other position locating the needle to project through the aperture, the holding means being constructed to release the mounting means from the one position when a blood collection -- ~337167 container i8 pushed into contact with the mounting means and the needle, and from the other position only in response to an effective force created by manually engaging and pulling the mounting means and the needle towards the one housing position, the effective force being greater than the force created by disengaging the container from the needle.
In accord with still another aspect of the invention, there is provided a needle device for safely collecting blood or injecting drugs, the device comprising a needle and a housing for the needle, the housing including an aperture at one end;
means slidably disposed within the housing for mounting the needle, the mounting means being shaped at one end to releasably mate with a container constructed to collect or deliver a liquid, the needle projecting into a mated container end sufficiently to penetrate the container when sufficient force is applied, means for holding the mounting means in the housing in at least two positions, one of the positions locating the needle so as to be surrounded by the housing and the other position locating the needle to project through the aperture, and a button slidably mounted in a slot in the housing, the button including a portion inside the housing that engages the mounting means when the button is moved rearwardly from the other position to the one position.
In accord with yet another aspect of the invention, there is provided a method for safely injecting a needle into a mammalian body to collect blood or inject a drug, using a needle device comprising a needle, a protective housing with an aperture, and means for mounting the needle to slide within the housing and in and out of the aperture.
The method comprises the steps of: a) obtaining the - - 1337l67 needle device from a source of supply with the needle in a first position that is completely and protectively withdrawn into the housing, b) locating the needle device at an injection site on a mammalian body, c) pushing the needle out of the first position to a second position with the needle exposed, by pushing a container against the needle, the container being constructed to collect blood or deliver a drug, d) injecting the needle into the mammalian body, e) collecting blood or injecting a drug through the needle, f) withdrawing the needle from the mammalian body, g) withdrawing the needle from the second position to the first position, and h) moving and permanently locking the needle to a third position different from the first and second positions.
Accordingly, it is an advantageous feature of the invention that a needle device is provided for blood collection or drug injection that, once used, is permanently locked in its protected position against reuse in a manner that readily demonstrates its status.
It is another advantageous feature of the invention that such a needle device and method of use are provided that allow for one-handed operation of the needle within the housing, at least for the withdrawal step after use, and optionally for both withdrawal and projection of the needle out of the housing.
It is yet another advantageous feature of the invention that such a needle device, when used to collect blood, does not allow improper coaction between collection container and needle until the needle is projected for injection into the patient.
It is still another related advantageous feature of the invention that such a needle device, when used to collect blood, resists withdrawal of the needle into its housing until after all collection containers are removed.
It is a further advantageous feature of the invention that the engagement and disengagement of the needle with a blood collection container is coordinated with the desired movement of the needle in and out of the housing.
Other advantageous features will become apparent upon reference to the following Detailed Description of the Preferred Embodiments, when read in light of the attached drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is a plan view of a needle device constructed in accordance with the invention;
Figure 2 is an end elevation view of the device of Figure l;
Figure 3A and 3B are two section views taken generally along the line III-III of Figure 1, but illustrating two alternative embodiments;
Figure 4 is a section view taken generally along the line IV-IV of Figure 3;
Figure 5 is a section view similar to that of Figure 3, but illustrating the device with the needle in its extended position;
Figure 6 is a section view similar to that of Figure 3, but illustrating the device in its permanently locked position;
Figure 7 is an enlarged section view of the portion in Figure 6 circled as "VII", the manual button having been removed for clarity;
Figure 8 is a fragmentary section view similar to that of Figure 3, illustrating the device when used with a drug delivery container;
Figure 9 is a section view similar to that of Figure 5, but illustrating the device in one stage of its use with a blood collection container;

Figure 10 is a section view taken generally along the line X-X of Figure 9, illustrating, however, the container with the needle penetrating itg gtopper at one end and the skin at the other;
Figure 11 i8 a fragmentary section view similar to that of Figures 3 and 9, but illustrating an alternate embodiment;
Figure 12 is a section view similar to that of Figure 9, showing a blood collection container just prior to its removal; and Figure 13 is the same section view as Figure 12 but with the container fully disengaged.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
The invention is hereinafter described with respect to preferred embodiments, wherein the needle device cooperates and is mated with either a blood collection container or a syringe for delivering a drug to a human. In addition, it is useful regardless of what liguid is collected or the particular construction of the collection container, and in the case of a syringe, it is useful regardless of what liquid is being delivered or the construction of the syringe. It is further useful in treating non-human animals.
Turning to Figures 1-5, a needle device 8 constructed as per the invention comprises a housing 10 having a front, tapered end 12 and an open rear end 14. The entire housing is hollow, with end 12 being apertured at 16 on the axig 17 of the housing, Figures 3A and 3B. The taper at end 12 is at an angle alpha designed to allow the housing (and needle, when extended) to enter the skin at an angle that is reduced compared to the angle required if end 12 were blunt, as is more clearly shown in Figure 10. End 14 is open at 20, Figure 2, to receive either a mating drug-delivering syringe container or a blood collection container. A gripping flange 22 is provided at the terminal end surface.
Housing 10 has two pairs of opposing sides 24, 26, Figure 2. These are provided with flats 28, 30, respectively, the flats of an opposing pair being preferably parallel. Such flats prevent the housing from rolling when the device is on a horizontal surface.
As is clearly shown in Figure 3A or 3B, housing 10 is preferably entirely hollow, having slidably mounted therein mounting means 40 and its needle 42. Needle 42 has a skin-penetrating end 44 and a container-penetrating end 46. Means 40 comprise a front, cone-shaped member 48 shaped to mate with tapered end 12 of the housing, and a rear cylinder 50 shaped to matingly engage a blood collection container or a syringe container. End 46 of needle 42 fixedly projects through member 48 and part way into cylinder 50. Optionally, a boot 52 is mounted over end 46, provided from a self-sealing elastomer, to ensure that any body fluids that might 8pi 11 out of end 46 are contained within the boot.
Boot 52 is also effective in reducing the risk of accidental pricking of a finger that might get put into open end 20.
Cylinder 50 is preferably tapered at side surfaces 54 when seen in one elevational direction, Figure 4, to allow a conforming fit to a preferred taper to walls 26 of housing 10.
One of the other walls 56 of cylinder 50 joins front member 48 at an indicia edge 51, Figures 3A and 3B and Figure 4. Wall 56 includes means for releasably locking mounting means 40 into one of two positions within housing 10 - a first position with needle 42 completely withdrawn, Figure 3A or 3B, and a second position with the needle fully extended, Figure 5. Preferably, such releasable locking means comprise one and most preferably, two detents 60, 62, Figure 4, in wall 56 that cooperate with a matching slot 70 and 72 in one wall 24 of housing 10, Figure 3A and 3B. Detents 60 and 62 are preferably mounted on the end of cantilever arms 64 and 66, respectively, Figure 4, each constructed with a thickness and of a material to provide a predetermined resistance force before its detent can be elastically forced out of its slot, as is well-known. Two arms are preferred to allow the resistance force of one arm to be greater than the other. If no difference is needed, one lever arm suffices.
A manually operated button 80 is slidably mounted in a slot 82 in wall 24 of housing 10, as is best shown in Figure 3A or 3B. Button 80 either engages mounting means 40 when it is moved rearwardly by being integrally attached to mounting means 40, Figure 3A, or it is free-floating within slot 82 and engages means 40 during rearward movement only, Figure 3B, because of projection 90 on mounting means 40 at end 92 thereof, Figures 3B and 5. In the latter case, surface 84 of button 80, under wall 24, has an edge 86 that projects down far enough to catch projection 90, as is more clearly shown in Figure 6, when button 80 is moved rearwardly, discussed in greater detail hereinafter.
Figure 3B also illustrates the optional use of a cover member 93 that is disposed between aperture 16 and needle end 44. Member 93 acts as a wipe when the needle is withdrawn, and thus is an absorbent material such as paper or a foam. By such means, the risk of a drop of blood floating around inside the device is minimized.
As is more clearly shown in Figures 7 and 11, end 92 of mounting means 40 also includes locking -lo- 1337167 detent 94 for permanently engaging housing 10 when means 40 is moved into a third position rearwardly beyond that shown in Figures 3A and 3B. Cooperating with detent 94 is an aperture 96 built into wall 24 adjacent to flange 22, Figure 7. To render it easy-for locking detent 94 to "jump out of" slot 82, Figure 11, and into aperture 96, Figure 7, the end surface 100 of slot 82 is chamfered, Figure 8, as is the rear edge of projection 94. ~owever, the forward surface 102 of aperture 96 and the forward edge 104 of detent 94 are generally perpendicular to axis 17 of housing 10, to prevent unlocking of the two, once the third position of Figures 6 and 7 is reached.
To render the locking feature invisible to the user, and also inaccessible, rear portion 105 of button 80 preferably extends over aperture 96, Figure 6.
Thus, the first withdrawn position shown in Figures 3A and 3B is in between the extended position of Figure 5 and the locked position of Figure 6.
This permanently locked position is the final position of the needle device after it is used once.
To readily indicate such, indicia can be placed on wall surface 24, Figure 1, which show an arrow lined up with the front edge 51 of mounting means 40 when the device is unused, and a ~'used" arrow further back which will line up with edge 51 when means 40 is in the third, locked position of Figure 6.
Alternatively, other indicia formats can be used to help distinguish the device being in the third position rather than the first position.
Whether button 80 is integrally attached to mounting means 40, or is free to slide independent thereof, depends upon the usage desired of the device. A preferred usage of the integrally attached version, Figure 3A, is one in which there is no 33716~
reason to be concerned about premature injection of the needle into a mated collection container or syringe delivery container. That is, the presence of button 80 invites the user to place a thumb thereon while the mating container is being loaded into cylinder 50. Thus, if button 80 is integral with mounting means 40, it i8 most likely penetration of the container by needle end 46 will occur while needle end 44 is still sheathed within housing 10.
Accordingly, a highly preferred use of the integrally attached button 80, Figure 3A, is that illustrated in Figure 8. A syringe drug delivery container 110 is inserted into housing 50, 80 that needle end 46 preferably penetrates ~eptum 112 of container 110 before detent 62 moves out of slot 72.
Container 110 comprises a conventional syringe cylinder 114 that holds septum 112, and any suitable plunger or piston 116. Cylinder 114 can be provided with male threads 118 to cooperate with female threads 120 of cylinder 50, as shown, or simply be slid into place. The threaded connection is preferred, since the ~crewing motion while button 80 is held down, will aid in puncturing septum 112 without having to exert considerable force F on flange 122 of cylinder 114, and thus accidentally depress piston 116. When drug injection is ready, the operator simply applies to button 80, a force Fl that is sufficent to override the force holding detent 62 in ~lot 72, and mounting means 40 plus the syringe assembly slide forward to allow needle end 46 to penetrate the mammal that is to receive the drug.
Thus, the insertion of the needle device of Figure 8 into the mammal can be done with one hand - the fingers grip housing 10 and the thumb pushes forward button 80. Thereafter, piston 116 is depressed to inject the drug.

As with the embodiment shown in Figure 6, rear portion 105 of button 80 covers the locking portions 94 and 96. Alternatively, the aperture portion can be formed only as a depression 96' as shown, Figure 8, instead of a penetrating aperture.-~ owever, if the container to be used withthe needle device is a blood collection container, then preferably button 80 is free-floating as shown in Figure 3B. It is precisely because the user may hold button 80 down while inserting a collection container 130, that it should be free-floating.
Otherwise, premature needle penetration of the container 130, which preferably has a partial vacuum, may occur.
In this embodiment, detent 62 engages slot 72 with a force having an axial component F2, Figure 3B, that is a function of the dimensions of detent 62 and slot 72, and the materials of the detent lever arm. As container 130 is pushed against boot 52 and needle end 46, Figure 9, there i~ a force F3 (not shown) that will be needed to cause needle end 46 to penetrate septum 132 of container 130.
Conventionally, evacuated containers 130 are constructed 80 that such force F3 is for a 10 mm size of container 130, between about 1 (0.45 Kgm) and 3 lbs. (1.36 Kgm). See, e.g., Percarpio, Transaction of the ASME, Vol. 102, p. 242-246 (April 1980).
Since detent 62 and slot 72 (Figure 8) are to disengage before such a force i~ reached, to allow needle end 44 to protrude out of housing 10 and into the mammal skin S, Figure 9, the construction of detent 62 and slot 72 is such as to release at a force F2+ that is just greater than F2 and less than 0.45 ~gm (1 lb.), e.g., at a force of 0.225 Kgm (0.5 lb.). The selection of detent sizes and materials to accomplish such a value of F2 are known to the skilled engineer. The force of engagement F2 should be greater than negligible, to prevent accidental premature extension of the needle.
As a result, application of force F2+, Figure 9, to end 134 slides container 130 and mounting means 40 (and button 80) into the extended position of housing 10, but without penetrating needle 42 into container 130, thus penetrating the skin S. The taper of end 12 provides for the shallow angle of insertion alpha, as shown. The longer the taper, the shallower this angle can be.
When mounting means 40 is in the position shown in Figure 9, detent 60 engages slot 70 of housing 10.
Upon the application of force F3, noted above, to end 134 of container 130, container 130 slides further forward, Figure 10, to allow puncture of septum 132 and the immediate draw of blood from the mammal.
To aid in ensuring that mounting means 40 moves out of its first position, Figure 3B and into the second position, Figure 9, without needle penetration of septum 132, break-away tabs 140 can be optionally included, Figure 11, on the inside surface of cylinder 50. The tabs are located to resist penetration of the septum by the needle when force F2+ is applied. These can be molded in place, or caused to be formed by punching them inwardly.
However formed, when force F3 is applied, they break off to allow needle penetration.
It is conventional practice to remove container 130 when full, and insert yet another one, of the same or different size or volume, while still keeping needle 42 in the ~m~l. In this invention, such additional containers are constructed to mate with cylinder 50, regardless of their volumes. Boot 52 returns to the position shown in Figure 9 or 13, and reseals, when a container is withdrawn, thus preventing blood from spilling. ~owever, it is essential in such cases that the force F4 used to pull container 130 out, be insufficient to release detent 60 from its slot 70 of housing 10, Figure 12.
The materials and dimensions used to construct detent 60, its lever arm, and slot 70 are adjusted accordingly. Because such container withdrawal forces are conventionally less than 0.45 Kgm (1 lb.) for a 10 mm container (Percarpio, noted above), the axial force F5 (not shown) needed to disengage detent 60 from slot 70 is greater than 0.45 Kgm (1 lb.), for example, 0.9 Kgm to 1.36 Kgm (2 to 3 lbs.).
The result is the removal of container 130, Figure 13, with needle device 8 still inserted into the mammal.
When blood collection is complete, preferably the operator simply applies a thumb to button 80, while holding housing 10 stationary, and forcefully withdraws it and the mounting means 40 now engaged by the button, ~ith a force greater than the disengaging force F5 of detent 60 and slot 70, noted above. This simultaneously withdraws the needle from the mammal and pulls means 40 to its withdrawn position. Since that disengaging force is preferably 0.9 to 1.36 Kgm (2 to 3 lbs.), such can be readily done with a single hand. Most preferably, the rearward movement of thumb, button 80, and mounting means 40 is continued until means 40 locks into its third, most rearward position, Figures 6 and 7. At this position, the device is locked permanently against reu~e, apart from deliberate disassembly of the device, a task that is difficult at best.

-15- 13371~7 Alternatively, although it is not preferred, the needle 42 can be withdrawn from skin S prior to the movement of cylinder 50 and means 40 from the needle-extended position to the third, completely-withdrawn-and-locked, position.
The invention has been described in detail with particular reference to preferred embodiments thereof, but it will be understood that variations and modifications can be effected within the spirit and scope of the invention.

Claims (24)

1. A needle device for safely collecting blood or injecting drugs, said device comprising a needle and a housing for said needle, said housing including an aperture at one end;
means slidably disposed within said housing for mounting said needle, said mounting means being shaped at one end to releasably mate with a container constructed to collect or deliver a liquid, said needle projecting into a mated container end sufficiently to penetrate said container when sufficient force is applied, means for holding said mounting means in said housing in at least two positions, one of said positions locating said needle 80 as to be surrounded by said housing and the other position locating said needle to project through said aperture, and means for locking said needle and said mounting means permanently against further movement in said housing when said mounting means is moved from said one position to and past said other position to a third position.
2. A needle device as defined in claim 1, and further including a plurality of different blood collection containers, each constructed to matingly engage one of said needle ends within said mounting means and within said housing.
3. A needle device as defined in claim 1, and further including a slot in the side of said housing and a button mounted in said housing slot for manual engagement by an operator, and means on said button for engaging said mounting means when said button is moved rearwardly towards said third position, whereby said needle and said mounting means can be withdrawn into said housing by moving said button rearwardly.
4. A needle device as defined in claim 3, wherein said button is free of means for engaging said mounting means when said button is moved towards said other position.
5. A needle device as defined in claim 1, wherein said one housing end is tapered, whereby the injection angle said needle makes with the skin can be minimized.
6. A needle device as defined in claim 1, wherein said housing includes along its length, a flat on a side of said housing to prevent said housing from rolling when placed on a surface.
7. A needle device as defined in claim 1, wherein said holding means include means for releasably locking said mounting means and needle within said housing at said one position.
8. A needle device as defined in claim 7, wherein said releasable locking means is insufficient to prevent release of said locking means when a blood collection container is pushed into contact with said mounting means and said needle.
9. A needle housing as defined in claim 8, wherein said releasable locking means is constructed to release from said one position as a result of said contact with a force that is insufficient to cause said needle to penetrate said blood collection container.
10. A needle housing as defined in claim 7, wherein said releasable locking means comprises a lever arm and a projection on the free end of said arm, and a notch in said housing, said projection engaging said notch with a force less than 0.45 Kgm (1 lb.).
11. A needle device as defined in claim 1, and further including means for releasably locking said mounting means within said housing when said mounting means is at said other position with said needle extended.
12. A needle housing as defined in claim 11, wherein said releasable locking means engages with a force sufficient to resist unlocking forces created by withdrawing a blood collection container from said needle, and with a force insufficient to resist unlocking forces created by manually engaging and pulling said mounting means towards said one housing position.
13. A needle housing as defined in claim 12, wherein said releasable locking means comprises a lever arm and a projection on the free end of said arm, and a notch in said housing, said projection engaging said housing notch with an axial force greater than about 0.45 Kgm (1 lb.).
14. A needle housing as defined in claim 1, and further including means for releasably locking said mounting means to said housing at both said one and said other positions.
15. A needle housing as defined in claim 14, wherein said releasable locking means comprise two independent detents and two slots in the housing each constructed to receive one of said detents.
16. A needle housing as defined in claim 15, and further including two cantilever arms each with one of said detents mounted on the free end of one of said arms, said arms being positioned to engage said detents in said slots.
17. A needle housing as defined in claim 1, wherein said permanent locking means is inaccessible to the user.
18. A needle device for safely collecting blood or delivering a liquid, said device comprising a needle and a housing for said needle, said housing including an aperture at one end;
means slidably disposed within said housing for mounting said needle, said mounting means being shaped at one end to releasably mate with a container constructed to collect or deliver a liquid, said needle projecting into a mated container sufficiently to penetrate said container when sufficient force is applied, means for holding said mounting means in said housing in at least two positions, one of said positions locating said needle so as to be surrounded by said housing and the other position locating said needle to project through said aperture, said holding means being constructed to release said mounting means from said one position when a blood collection container is pushed into contact with said mounting means and said needle, and from said other position only in response to an effective force created by manually engaging and pulling said mounting means and said needle towards said one housing position, said effective force being greater than the force created by disengaging said container from said needle.
19. A needle device as defined in claim 18, wherein said holding means include releasable locking means constructed to release from said one position as a result of said contact with a force that is insufficient to cause said needle to penetrate said blood collection container.
20. A needle device for safely collecting blood or injecting drugs, said device comprising a needle and a housing for said needle, said housing including an aperture at one end;

means slidably disposed within said housing for mounting said needle, said mounting means being shaped at one end to releasably mate with a container constructed to collect or deliver a liquid, said needle projecting into a mated container end sufficiently to penetrate said container when sufficient force is applied, means for holding said mounting means in said housing in at least two positions, one of said positions locating said needle so as to be surrounded by said housing and the other position locating said needle to project through said aperture, and a button slidably mounted in a slot in said housing, said button including a portion inside said housing that engages said mounting means when said button is moved rearwardly from said other position to said one position.
21. A needle device as defined in claim 20, wherein said button portion engages said mounting means only when said button is moved rearwardly from said other position to said one position.
22. A needle device for use with a container, said device comprising, a needle having two opposite, pointed ends, mounting means supporting said needle, said needle being affixed to said means in between said two ends, said means being constructed to releasably mate with a container pierced by said needle, an enclosure housing surrounding said mounting means and having two opposite ends, the length of said housing between its ends being greater than the length of said needle plus said mounting means, said housing including means for sliding said mounting means within the housing means between at least two positions so that in one of said two housing positions both of said needle ends is totally enclosed by said housing, and in the other of said two positions said needle projects out of one of the housing ends, said mounting means being slidable to a third position beyond said one housing position, and locking means in said third position for locking said mounting means and said needle from movement to said other housing position, said locking means being constructed to permanently engage said mounting means when said third position is reached.
23. A needle device for use with a container, said device comprising, a needle having two opposite, pointed ends, one end being adapted to penetrate living tissue, mounting means supporting said needle, said needle being affixed to said means in between said two ends and closer to the other of said ends than said one end, said mounting means being shaped surrounding said closer end to create a compartment for matingly-receiving a blood collection container pierced by said closer end, a housing surrounding said mounting means and having two opposite ends, said housing including means allowing sliding of said mounting means within the housing between at least two positions adjacent said two housing ends, the length of said housing between said ends exceeding the length of said needle, one of said housing ends having an aperture slightly larger than the diameter of said needle, so that when said mounting means is in a) one of said positions, the needle is totally withdrawn in said housing and b) the other of said positions, the needle extends through said aperture, and locking means in said housing for locking said mounting means to said housing, said locking means being engagable with said mounting means by moving said mounting means to a third position beyond said one position so that said one position is between said third position and said other position, wherein said locking means permanently engages said mounting means when said mounting means is in said third position to prevent reextension of said needle out through said aperture.
24. The use of a needle device of any one of claims 1 to 8 or 18 to 23 for safely injecting a needle into a mammalian body to collect blood or to inject a drug.
CA000610529A 1989-03-14 1989-09-07 Needle housing with retractable needle Expired - Fee Related CA1337167C (en)

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US32345989A 1989-03-14 1989-03-14
US323,459 1994-10-14

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JPH0377A (en) 1991-01-07
EP0388169A3 (en) 1991-07-31
EP0388169A2 (en) 1990-09-19
US5193552A (en) 1993-03-16
FI901268A0 (en) 1990-03-14
US5070884A (en) 1991-12-10

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