Re-armable single-user safety finger stick device having reset for multiple use by a single patient

• US 5,741,288 A
• Filed: 06/27/1996
• Issued: 04/21/1998
• Est. Priority Date: 06/27/1996
• Status: Expired due to Fees

• Current Assignee: Chemtrak
• Original Assignee: Chemtrak
• Inventors: Rife, Douglas Earl
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): MULCARE, NANCY C
• Application Number:
  US08/670,513
• Time in Patent Office: 663 Days
• Field of Search: 606/167, 606/181-182, 606/184-185, 606/189, 604/46-47, 604/136-137, 128/760, 128/763, 128/770
• US Class Current: 606/181
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• CPC Class Codes: A61B 5/150549 Protectors removed by rotational movement, e.g. torsion or screwing
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/150908 by disconnecting components, e.g. breaking or rupturing of connected parts, e.g. piston and rod
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit

Abstract

A lancet or finger-stick device operable to make a small incision into the vascular tissue of the skin to induce a controllable blood flow is particularly suited for incisions of the finger-tip of a patient. The device and method provide multiple use by a single-user in that the device provides an autologous re-use feature, such that an individual can reset and reuse the device on the same patient in case of an accidental misfire prior to actual use or if the first incision does not provide a sufficient blood sample. A disabling mechanism which the individual performs immediately prior to disposal of the used device is incorporated into the invention. These features permit the user of a consumer self-test or professional-use test to re-stick an individual'"'"'s fingertip in the event that the first try is unsuccessful or the blood flow is inadequate. It also insures sterility of the unused unit and provides enhanced safety since the device cannot be accidentally fired or reused by another individual after being disposed.

Claims

1. A finger stick device for producing a plunge incision into the skin of a patient;

said device comprising;

a housing having a first aperture;

a sharp lancet tip initially disposed within said housing;

a lancet support body disposed within said housing and connected to said lancet tip for supporting said lancet tip;

resettable force means coupled to said support body for storing energy and for releasing said stored energy to linearly move said lancet tip from a location inside said housing through said first aperture to a predetermined location outside of said housing;

resettable latch means for latching said force means in an energy storing state; and

resettable release means for releasing said latch means to allow said force means to release said stored energy to drive said lancet tip outwardly from said housing

wherein said resettable force means and resettable release means make up an autologous re-use feature, such that the finger stick device can be reset for use on the same patient in the event of an accidental release of stored energy producing linear movement of the lancet tip outwardly from the housing or in the event that a supplemental plunge incision is desired on the same patient,

and a disabling means adapted to permanently disable the finger stick device comprising a plunger connected to said support body by a frangible neck section, said frangible neck adapted to be broken by rotation of said plunger relative to said support body,

wherein said rotation of the plunger is not automatic or coincident with the movement of the lancet through the aperture the retraction of the lancet and can be voluntarily and manually performed.

2. The device in claim 1, wherein said device further comprises a protective cover disposed proximate said first aperture to prevent access to said sharp lancet tip from outside of said housing.

3. The device in claim 1, wherein said force means comprises an elastic member.

4. The device in claim 1, wherein said force means comprises a spring having a first end fixedly connected to said support body and a second end fixedly connected to said housing.

5. The device in claim 4, wherein said housing comprises a molded plastic elongated cylinder, said first aperture is defined at a first end of said cylinder and said housing defines a second aperture at an opposite end of said cylinder, said device further comprising:

a plunger removably coupled at a first end to said support body by a frangible coupling and extending through said second aperture to the outside of said housing;

whereby movement of said plunger in a first direction by an external agent stores energy in said spring.

6. The device in claim 5, wherein said resettable latch means for latching said force means in an energy storing state comprises an extensible probe and a receptacle for receiving said extensible probe, said extensible probe connected to said lancet support body and moving with said support body in response to movement of said plunger, said extensible probe freely extending into said receptacle when said probe is position coincident with said receptacle, movement of said plunger in said first direction resulting in position coincidence between said probe and said receptacle.

7. The device in claim 6, wherein said resettable release means for releasing said latch means to allow said force means to release said stored energy to drive said lancet tip outwardly from said housing, comprises a trigger button disposed external to said housing and extending into abutting contact with said probe and operative to dislodge said probe from said receptacle, thereby releasing said latch means.

8. A finger stick assembly comprising:

a hollow housing having a first aperture at one end and a second aperture at an opposite end;

a lancet unit having a sharp lancet tip slidably disposed near said first aperture and a lancet body enclosed and supported by said housing, and supporting said tip and extending from said tip toward said second aperture;

a spring coupled to said lancet body and disposed within said housing;

means for coupling energy into said spring to alter said spring from a relaxed condition to an activated condition;

latch means for latching said spring in said activated condition;

release means for releasing said spring from said activated condition; and

disabling means for permanently disabling said finger stick assembly from moving said lancet tip forward.

9. A re-armable automatically retractable penetrating finger stick assembly, comprising:

a hollow tubular housing having a first aperture at one end of said housing, a second aperture at an opposite end of said housing, and a third aperture along a wall of said housing;

a spring having a first end fixedly attached to the interior of said housing proximate said second aperture and having a spring second end;

a longitudinally slidable lancet support mounted within said housing, fixedly attached to said spring second end, and extending toward said first aperture, said lancet support including means for mounting a lancet unit to said support;

a lancet unit comprising a sterile lancet tip, and a lancet body;

a plunger coupled to said support and extending through said second aperture;

resettable latch means for releasably holding said spring in a compressed condition and said support in a rearward retracted position when said plunger is pulled rearward; and

resettable release means for releasing said latch means;

whereby when said latch means is released said compressed spring is allowed to extend to a relaxed position thereby accelerating the combination of said support, said lancet unit, and said spring, forwardly toward said first aperture;

the momentum possessed by said combination resulting in movement of said combination beyond an equilibrium position for said spring so that said lancet tip momentarily extends through said first aperture but is pulled back into said housing;

said plunger being coupled to said support by a frangible neck section, said frangible neck adapted to be broken by rotation of said plunger relative to said support

wherein said resettable force means and resettable release means make up an autologous re-use feature, such that the finger stick device can be reset for use on the same patient in the event of an accidental release of stored energy producing linear movement of the lancet tip outwardly from the housing or in the event that a supplemental plunge incision is desired on the same patient,

and wherein said rotation of the plunger is not automatic or coincident with the movement of the lancet through the aperture the retraction of the lancet and can be voluntarily and manually performed.

10. The device in claim 9, wherein said lancet unit further comprises a protective cover disposed over said lancet tip, and wherein said protective cover is connected to said lancet body proximate said lancet tip by a frangible neck section coaxial with said lancet tip.

11. The device in claim 9, wherein said lancet body is coextensive and integral to said lancet support.

12. The device in claim 9, wherein said lancet body is mounted to said lancet support means by mechanical coupling.

13. A re-armable retractable-lancet finger-stick device, comprising:

a housing having a lancet tip exit aperture at a first end, a second aperture at an opposite end, and a third aperture;

a spring disposed within said housing and having first and second ends, said first end fixedly attached to said housing, said spring being movable between an extended state, a relaxed state, and a compressed state;

a lancet tip supported by a lancet support body slidably disposed within said housing, said support body fixedly attached to said spring second end;

retracting means for moving said support body from a first location to a second location and for placing said spring in said activated state;

resettable latch-release means for engaging a latch-release probe into said third aperture to latch said spring in said activated state and for releasing said probe from said third aperture to allow said spring to transition from said activated state through said relaxed state and to an extended state before returning to said relaxed state; and

wherein said resettable latch-release means is an autologous re-use feature, such that the finger stick device can be reset for use on the same patient in the event of an accidental release of stored energy producing linear movement of the lancet tip outwardly from the housing or in the event that a supplemental plunge incision is desired on the same patient,

disabling means for permanently disabling said finger stick device and comprising a plunger connected to said support body by a frangible neck section, said frangible neck adapted to be broken by rotation of said plunger relative to said support body,

wherein said rotation of the plunger is not automatic or coincident with the movement of the lancet through the aperture the retraction of the lancet and can be voluntarily and manually performed.

14. The device in claim 13, wherein said disabling means comprises means for disabling said retracting means to prevent placing said spring in said activated condition.

15. The device in claim 14, wherein said disabling means further comprises a plunger connected to said support body by a frangible neck section, said frangible neck adapted to be broken by rotation of said plunger relative to said support body.

16. A method for providing a blood sample comprising the steps of:

providing an apparatus including a housing having a lancet tip exit aperture at a first end, a second aperture at an opposite end, and a third aperture;

a spring disposed within said housing and having first and second ends, said first end fixedly attached to said housing, said spring being movable between an extended state, a relaxed state, and a compressed state;

a lancet tip supported by a lancet support body slidably disposed within said housing, said support body fixedly attached to said spring second end;

retracting means for moving said support body from a first location to a second location and for placing said spring in said activated state;

latch-release means for engaging a latch-release probe into said third aperture to latch said spring in said activated state and for releasing said probe from said third aperture to allow said spring to transition from said activated state through said relaxed state and to an extended state before returning to said relaxed state; and

disabling means for permanently disabling said device;

arming said device using said retracting means to place said device in an activated condition a first time;

latching said device in said activated condition a first time;

releasing said device to propel said lancet tip forward through said exit aperture a first time;

rearming said device using said retracting means to again place said device in an activated condition a second time;

relatching said device in said activated condition a second time;

releasing said device to propel said lancet tip forward through said exit aperture a second time; and

manually rotating the plunger relative to the support enough to break the frangible neck section of the plunger and thus permanently deactivating said device so that one of said arming, latching, and releasing operations is prevented.

17. The method in claim 16, wherein said device further includes a activation plunger connected to said lancet support, and wherein step of permanently deactivating said device comprises the steps of:

breaking said activation plunger from said device to prevent further activation of said device.

18. The method in claim 17, wherein said activation plunger is connected to said lancet support by an frangible neck section, and wherein said step of breaking said activation plunger from said device comprises rotationally twisting said activation plunger about the axis of said frangible neck section to break said frangible neck section and sever said plunger from said lancet support.