Self-contained, safety blood collection system

• US 5,052,403 A
• Filed: 12/29/1989
• Issued: 10/01/1991
• Est. Priority Date: 12/29/1989
• Status: Expired due to Fees

• Current Assignee: Habley Medical Technology Corporation
• Original Assignee: Habley Medical Technology Corporation
• Inventors: Foster, Clark B., Smedley, William H., Haber, Terry M.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US07/458,887
• Time in Patent Office: 641 Days
• Field of Search: 128/760, 128/763, 128/765, 128/770, 604/192-199
• US Class Current: 600/578
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150244 Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150511 Details of construction of shaft
• CPC Class Codes: A61B 5/150641 comprising means to impede repositioning of protection sleeve from covering to uncovering position
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/150916 by blocking components, e.g. piston, driving device or fluid passageway
• CPC Class Codes: A61B 5/150992 Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61M 2005/3227 the needle being retracted laterally outside the syringe barrel, e.g. with separate guideway

Abstract

A self-contained, safety blood collection system comprising a shatter-resistent blood collection tube in which a vacuum may be manually established and in which a blood sample, or the like, may be collected by way of a retractable, single ended needle cannula. A piston is relocated from an as-packaged, distal position within the blood collection tube to a proximal position so as to evacuate the tube, whereby the tube is automatically infused with blood under the influence of suction. A controllable fluid valve is formed in an elastomeric stopper, and the stopper is located within the distal end of the blood collection tube, such that the volume and rate at which blood is collected within the tube can be selectively varied. An auxiliary fluid port is formed in the stopper through which successive blood samples may be collected in additional blood collection systems from the same veni puncture.

Claims

1. A fluid collection system for collecting a sample of a bodily fluid and comprising:

a fluid collection tube having distal and proximal ends and in which a vacuum is to be established so that the fluid sample is collected within said tube under the influence of suction;

stopper means located at the distal end of said fluid collection tube to seal said distal end;

a needle cannula to penetrate the tissue of a patient at a first end and to communicate fluidically with said fluid collection tube at the opposite end thereof;

rotatable knob means located at the proximal end of said fluid collection tube;

piston means located at a relatively distal position within said fluid collection tube between said stopper means and said rotatable knob means; and

linking means extending between said piston means and said rotatable knob means, such that a rotation of said knob means causes said linking means to be pulled axially through said fluid collection tube and said piston means to be relocated proximally through said tube for expulsing air therefrom and establishing a vacuum therein.

2. The fluid collection system recited in claim 1, wherein said rotatable knob means has an exhaust passage extending between the interior of said fluid collection tube and the atmosphere, such that air from said tube is expulsed through said exhaust passage when said piston means is relocated proximally through said tube.

3. The fluid collection system recited in claim 1, wherein said linking means comprises at least one relatively non-extensible tether that is connected from said piston means to said rotatable knob means, such that a rotation of said knob means causes said tether to wind up around said knob means for correspondingly pulling said piston means through and establishing the vacuum in said fluid collection tube.

4. The fluid collection system recited in claim 3, further comprising ratchet means located within said fluid collection tube, said ratchet means connected to and rotated with said rotatable knob means;

and

detent means projecting inwardly from said fluid collection tube and cooperating with said ratchet means to prevent the counter-rotation of said knob means and an unwinding of said tether therefrom.

5. The fluid collection system recited in claim 1, further comprising means by which said needle cannula is moved axially and reciprocally relative to said fluid collection tube between a retracted position, at which said cannula is shielded to prevent an accidental needle stick, and an extended position, at which said cannula is advanced so as to be able to penetrate the patient'"'"'s tissue.

6. The fluid collection system recited in claim 5, wherein the means by which said needle cannula is movable includes a track extending axially along said fluid collection tube and a needle hub connected to said cannula and slidable reciprocally through said track so that said cannula is relocated between the retracted and extended positions.

7. The fluid collection system recited in claim 6, further comprising means to engage said needle hub to prevent both the displacement of said hub through said track and the relocation of said needle cannula to the extended position after a fluid sample has been collected within said fluid collection tube and said cannula has been relocated to the retracted position.

8. The fluid collection system recited in claim 1, further comprising valve means located between and in fluid communication with said needle cannula and said fluid collection tube so that the fluid collected in said tube via said cannula can be selectively controlled.

9. The fluid collection system recited in claim 8, wherein said stopper means is formed from an elastomeric material having a spring-like resiliency and said valve means includes a normally closed slit formed in said stopper means, said slit being responsive to a compressive force that is applied to said stopper means in axial alignment with said slit, such that the shape of said stopper means is deformed and said slit is opened to permit the passage of fluid from said cannula to said fluid collection tube.

10. The fluid collection system recited in claim 9, further comprising a fluid inlet passage formed in said stopper means and located between said needle cannula and said slit, such that fluid is conveyed from said cannula to said slit by way of said fluid inlet passage.

11. The fluid collection system recited in claim 1, further comprising a fluid exit port formed in said stopper means;

and normally closed valve means located between and in fluid communication with said needle cannula and said fluid exit port, such that a fluid path is established from said cannula to said port when said valve means is opened.

12. The fluid collection system recited in claim 11, wherein said stopper means is formed from an elastomeric material having a spring-like resiliency and said valve means includes a normally closed slit, said slit being opened when a fluid conveying means is inserted into said exit port and through said slit, so as to complete a fluid path from said needle cannula to the fluid conveying means that has been inserted into said port and through said slit.

13. A fluid collection system for collection a sample of bodily fluid and comprising:

a fluid collection tube having distal and proximal ends and in which a vacuum is to be established so that the fluid sample is collected within said tube under the influence of suction;

stopper means located at the distal end of said fluid collection tube to seal said distal end;

closure means located at the proximal end of said fluid collection tube;

piston means located at a relatively distal position within said fluid collection tube between said stopper means and said closure means;

means by which to move said piston means axially and proximally through said fluid collection tube for expulsing air therefrom and establishing a vacuum therein;

a needle cannula to penetrate the tissue of a patient at a first end and to communicate fluidically with said fluid collection tube at the opposite end thereof; and

means by which said cannula is moved axially and reciprocally relative to said fluid collection tube between a retracted position, at which said cannula is shielded to prevent an accidental needle stick, and an extended position, at which said cannula is advanced so as to be able to penetrate the patient'"'"'s tissue.

14. The fluid collection system recited in claim 13, wherein the means by which said needle cannula is movable includes a track extending axially along said fluid collection tube and a needle hub connected to said cannula and slidable reciprocally through said track so that said cannula is relocated between the retracted and extended positions.

15. The fluid collection system recited in claim 14, further comprising means to engage said needle hub to prevent both the displacement of said hub through said track and the relocation of said needle cannula to the extended position after a fluid sample bas been collected within said fluid collection tube and said cannula has been relocated to the retracted position.

16. The blood collection system recited in claim 13, wherein said closure means at the proximal end of said fluid collection tube is a rotatable knob, said system further comprising linking means connected between said piston means and said rotatable knob, such that a rotation of said knob causes said linking means to wind up around said knob for correspondingly pulling said piston means axially and proximally through said tube for expulsing air therefrom and establishing a vacuum therein.

17. The fluid collection system recited in claim 16, wherein said rotatable knob has an exhaust passage extending between the interior of said fluid collection tube and the atmosphere, such that air from said tube is expulsed through said exhaust passage when said piston means is relocated proximally through said tube.

18. The fluid collection system recited in claim 16, further comprising means located at the interior of said fluid collection tube to engage said rotatable knob so as to prevent a counter-rotation of said knob and an unwinding of said linking means therefrom.

19. The fluid collection system recited in claim 16, further comprising ratchet means located within said fluid collection tube, said ratchet means connected to and rotated with said rotatable knob;

and

detent means projecting inwardly from said fluid collection tube and cooperating with said ratchet means to prevent the counter-rotation of said knob and an unwinding of said linking means therefrom.

20. The fluid collection system recited in claim 13, further comprising normally closed valve means formed in said stopper means and communicating with said fluid collection tube, said valve means also communicating with said needle cannula when said cannula is advanced to the extended position to thereby establish a fluid path between said cannula and said tube when said valve means is opened and control the fluid which is supplied to said tube by way of said cannula.

21. The fluid collection system recited in claim 20, wherein said stopper means is formed from an elastomeric material having a spring-like resiliency and said valve means includes a normally closed slit formed in said stopper means, said slit being responsive to a compressive force that is applied to said stopper means in axial alignment with said slit, such that the shape of said stopper means is deformed and said slit is opened to permit the passage of fluid from said cannula to said fluid collection tube.