Needle device for safely collecting blood or injecting drugs

• US 5,193,552 A
• Filed: 04/15/1991
• Issued: 03/16/1993
• Est. Priority Date: 03/14/1989
• Status: Expired due to Term

• Current Assignee: Clinical Diagnostic Systems Inc.
• Original Assignee: Eastman Kodak Company
• Inventors: Columbus, Richard L., Palmer, Harvey J., Porte, Johannes J.
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): Rafa, Michael
• Application Number:
  US07/685,107
• Time in Patent Office: 701 Days
• Field of Search: 604/192, 604/197, 604/198, 604/263, 604/403, 604/411-413, 128/760-766
• US Class Current: 600/573
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150351 Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel caps for bottles or containers in general B65D41/00
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150473 Double-ended needles, e.g. used with pre-evacuated sampling tubes hollow piercing element tip design A61B5/150396; needle sets for catheters A61M25/06; needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150641 comprising means to impede repositioning of protection sleeve from covering to uncovering position
• CPC Class Codes: A61B 5/150732 Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube,
• CPC Class Codes: A61B 5/150748 Having means for aiding positioning of the piercing device at a location where the body is to be pierced means for aiding positioning of devices for bringing media into the body A61M5/427, locating blood vessels A61B5/489
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150893 by indicating if used, tampered with, unsterile or defective
• CPC Class Codes: A61B 5/150916 by blocking components, e.g. piston, driving device or fluid passageway
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/154 Devices using pre-evacuated means
• CPC Class Codes: A61M 2005/3228 the needle being retracted by a member protruding laterally through a slot in the barrel, e.g. double-ended needles
• CPC Class Codes: A61M 5/3271 with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position
• CPC Class Codes: A61M 5/3272 having projections following labyrinth paths
• CPC Class Codes: A61M 5/5086 for indicating if defective, used, tampered with or unsterile
• CPC Class Codes: B01L 3/5021 Test tubes specially adapted for centrifugation purposes centrifuges B04B5/04

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.

Claims

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 being capable of penetrating a mated container when sufficient force is applied,

means for releasably locking said mounting means in said housing in a least two positions, one of said positions being a withdrawn position locating said needle so as to be withdrawn into and surrounded by said housing prior to use, and the other position being an extended position in which said needle extends and projects through said aperture,

permanent locking means for locking said needle and said mounting means permanently against further movement in said housing when said mounting means is moved from said extended position to a third locked position beyond said withdrawn position,

means defining a slot in the side of said housing, and a button mounted in said housing slot for manual engagement by an operator,

means on said button for engaging said mounting means when said button is moved rearwardly towards said third locked position, said button being free of means for engaging said mounting means when said button is moved towards said extended position,

whereby said needle and said mounting means can be withdrawn into said housing by moving said button rearwardly,

and further including either a blood collection container or a drug-injecting container preloaded with a drug, said either container being releasably engagable with one of said needle ends within said mounting means and within said housing, said releasable locking means in said withdrawn position being effective to release said mounting means and said needle only as a result of a contact force between said needle and either of said containers that is insufficient to cause said needle to penetrate either of said containers.

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, wherein said one housing end is tapered, whereby the injection angle said needle makes with the skin can be minimized.

4. A needle device as defined in claim 1, wherein said housing includes along its length, a flat surface on a side of said housing to prevent said housing from rolling when placed on a surface.

5. A needle device as defined in claim 1, 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 Kg (1 lb.).

6. A needle device as defined in claim 1, wherein said releasable locking means for said extended position engages with a force sufficient to resist unlocking forces created by withdrawing a blood collection container from said needle, but insufficient to resist the forces created by manually engaging and pulling said mounting means towards said withdrawn position.

7. A needle device as defined in claim 6, 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 Kg (1 lb.).

8. A needle device as defined in claim 1, wherein said releasable locking means comprise two independent detents and two slots in the housing each constructed to receive one of said detents.

9. A needle device as defined in claim 8, 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.

10. A needle device as defined in claim 1, wherein said permanent locking means is inaccessible to the user.

11. In a needle device for safely collecting blood or injecting drugs, said device including a needle, an outer housing with a long axis, means for mounting said needle, said mounting means being slidably mounted for movement along said axis within said housing, said outer housing having a first open end and an opposite second end that is closed except for a needle aperture aligned with said needle, and control means for manually engaging said needle mounting means to slide it from an extended position where the needle is extended out through said aperture, to a withdrawn position in which said needle is withdrawn in said housing;

the improvement wherein said control means is independently slidable within said housing and disconnected from said needle mounting means so as to be free to slide towards said aperture without advancing said needle, and said control means includes a member that projects into contact with said needle mounting means as said control means is withdrawn away from said aperture,

so that said control means is effective to move said needle relative to said housing only in a withdrawal of said needle from said extended position to said withdrawn position, and inadvertent extensions of said needle out said aperture by accidental movement of said control means are not possible.

12. A needle device as defined in claim 11, and further including means for releasably locking said needle mounting means to said housing at two positions along said axis.

13. A needle device as defined in claim 11, wherein said housing includes along its length, a flat surface on a side of said housing to prevent said housing from rolling when placed on a surface.

14. A needle device as defined in claim 12 wherein said releasable locking means is located at said withdrawn position and is effective to unlock when a blood collection container is pushed into contact with said mounting means and said needle.

15. A needle device 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 notch with a force less than 0.45 Kg (1 lb.).

16. A needle device as defined in claim 12, wherein said releasable locking means is located at said extended position and engages with a force sufficient to resist unlocking forces created by withdrawing a blood collection container from said needle, but insufficient to resist the forces created by manually engaging and pulling said mounting means towards said withdrawn position.

17. A needle device as defined in claim 12, wherein said releasable locking means comprise two independent detents and two slots in the housing each constructed to receive one of said detents.

18. 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 being capable of penetrating a mated container when sufficient force is applied,

means for releasably locking said mounting means in said housing in at least two positions, one of said positions being a withdrawn position wherein said needle is withdrawn and surrounded by said housing and the other position being an extended position in which said needle extends and projects 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 only when said button is moved rearwardly from said extended position to said withdrawn position.

19. 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 being capable of penetrating a mated container when sufficient force is applied,

either a blood collection container or a drug-injecting container preloaded with a drug, said either container being releasably engagable with one of said needle ends within said housing,

means for releasably locking said mounting means in said housing in at least two positions, one of said positions being a withdrawn position locating said needle so as to be withdrawn into and surrounded by said housing prior to use and the other position being an extended position in which said needle extends and projects through said aperture,

means for locking said needle and said mounting means permanently against further movement in said housing when said mounting means is moved from said extended position to a third position beyond said withdrawn position,

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, said button being free of means for engaging said mounting means when said button is moved towards said extended position, and means on said button for engaging said mounting means when said button is moved rearwardly towards said third locked position,

whereby said needle and said mounting means can be withdrawn into said housing by moving said button rearwardly.

20. 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 said needle to slide within said housing and in and out of said aperture,

the method comprising the step of

a) obtaining said needle device from a source of supply with said needle in a releasably locked first position that is completely and protectively withdrawn into said housing,

b) locating said needle device at an injection site on a mammalian body,

c) pushing said needle axially without rotation, out of said first position to a releasably locked second position with the needle extended and exposed, by pushing a container against said needle without penetrating said container with said needle, said container being constructed to collect blood or deliver a drug,

d) injecting the needle into the mammalian body and releasably injecting said needle into said container,

e) collecting blood or injecting a drug through said needle,

f) withdrawing said needle from the mammalian body,

g) withdrawing said needle from said extended position to said withdrawn position, and

h) moving and permanently locking said needle to a third position different from said withdrawn and extended positions.

21. A method as defined in claim 20, wherein said steps f) and g) are achieved generally simultaneously.

22. A method as defined in claim 20, wherein said step c) comprises the steps of pushing said container against said needle without said needle penetrating said container, until said needle is fully extended into said extended position.

23. A method as defined in claim 20, wherein said housing includes a button mounted for sliding within said housing in the direction of travel of said mounting means, and means on said button for engaging said mounting means as the button is moved from said extended position to said withdrawn position,

and wherein said step f) comprises the step of withdrawing said needle from the mammalian body to said withdrawn position with only one hand, by manually pulling said button back to withdraw said needle and said mounting means.