Blood sampling device and method

• US 4,883,068 A
• Filed: 03/14/1988
• Issued: 11/28/1989
• Est. Priority Date: 03/14/1988
• Status: Expired due to Fees

• Current Assignee: DEC In Tech Incorporated
• Original Assignee: DEC In Tech Incorporated
• Inventors: Dechow, Frederick L.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Lacyk, J. P.
• Application Number:
  US07/167,778
• Time in Patent Office: 624 Days
• Field of Search: 128/760, 128/763, 128/764, 128/770, 604/413, 604/415, 604/171, 604/198, 604/148, 604/117, 604/192, 604/194, 604/197
• US Class Current: 600/573
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• 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 5/150633 Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing

Abstract

A disposable blood sampling device wherein inner and outer spaced apart pad members, separated by a compressible pad-bridging enclosure respectively carry an axially extending evacuated collecting container closed by a penetrable end cap and an axially aligned, double-ended cannula. In normal position the cannula is maintained in withdrawn position within the enclosure. The cannula is prevented from penetrating the cap of the collecting tube when the outer member is depressed toward the inner member until after penetration of the epidermis has occurred.

Claims

1. In a disposable blood sampling device particularly for removing a small volume of blood from the epidermis of the body for testing purposes:

a. a housing comprising inner and outer, spaced apart, walls separated by an axially compressible, axially extending bridging enclosure;

b. said outer wall carrying an axially extending, evacuated, collecting container housed within said axially compressible enclosure and having an open end closed by a penetrable end member;

c. a double-ended cannula device axially slidably carried by said inner wall in axial alignment with said end member, and having an end member-penetrating end and a skin-penetrating end;

d. said inner wall having a cannula device passing portion in axial alignment with said cannula device for passing the skin-penetrating end through the inner wall into the epidermis; and

e. means for preventing said cannula device from penetrating the end member of the collecting container when the inner and outer walls are relatively axially compressed, until after penetration of the epidermis by the cannula device.

2. The invention defined in claim 1 in which a dual function tubular guide is provided on said inner wall to project axially toward said outer wall for slidably accommodating said cannula device, and stop means is provided on said cannula device, for interaction with said guide to limit the protrusion of said cannula device from said inner wall.

3. The invention defined in claim 1 in which a means is provided to normally hold the skin penetrating end of he cannula device in retracted position within the inner wall and to limit the permissible protrusion of said cannula device through said inner wall.

4. The invention defined in claim 2 in which a coil spring is provided in engagement with said stop means and inner wall, which functions to normally hold the cannula device in retracted position inboard of the inner surface of the inner wall.

5. The invention defined in claim 1 wherein stop means is provided on said cannula device and said enclosure comprises upper and lower layers of crushable rigid foam in engagement with opposite sides of said stop means adjacent said outer and inner walls respectively, the upper layer adjacent said outer wall having a predetermined greater resistance to axial crush than the lower layer adjacent said inner wall.

6. The invention defined in claim 4 wherein said end member includes a rubber plug;

the plug being of a predetermined durometer guaged to offer greater resistance to axial penetration than the resistance required to overcome said spring.

7. The invention defined in claim 4 wherein a second stiffer coil spring is provided on said cannula device on the opposite side of said stop means from the first mentioned spring.

8. The invention defined in claim 1 in which said enclosure comprises an opaque, surrounding member.

9. The invention of claim 8 in which said enclosure is a bellows.

10. The invention defined in claim 1 wherein said outer wall is fixed to one end of said enclosure and to said container.

11. The invention defined in claim 10 wherein said inner wall is fixed to the opposite end of said enclosure.

12. A method of operating a disposable blood sampling device having inner and outer spaced apart wall surfaces separated by an axially compressible, axially extending wall surface-bridging enclosure to form a housing;

the outer wall surface carrying an axially extending evacuating collecting tube closed by a penetrable tube end member;

a double-ended cannula device axially slidably carried by the inner wall surface in axial alignment with the end member and having an end member-penetrating end and a skin-penetrating end;

the inner wall surface having a portion in axial alignment with the cannula device for passing the skin-penetrating end through the inner wall surface into the epidermis; and

means for causing the cannula device to penetrate the epidermis prior to penetrating the end member of the collecting tube when the inner and outer wall surfaces are relatively axially compressed comprising the steps of;

a. axially moving the outer wall surface toward the inner wall surface to a predetermined extent to cause the collecting tube to force the skin penetrating end of the cannula device to pass through the inner wall surface and penetrate the epidermis;

b. then engaging the cannula device to halt the movement of the cannula device into the epidermis despite further movement of the outer wall surface toward the inner wall surface and continuing the movement of the outer wall surface toward the inner wall surface to puncture the collecting tube end member; and

c. withdrawing the blood into the evacuated collecting tube via the suction forces in the tube.

13. The method defined in claim 12 wherein members provided on the cannula device and on the inner wall surface are engaged to halt the penetration of the cannula device into the epidermis.

14. The method defined in claim 12 wherein said enclosure is formed by a layer of crushable rigid plastic foam enclosing the tube and a second layer of crushable rigid plastic foam enclosing the cannula device;

the layer of foam surrounding the sample-collecting tube being more resistant to compressive crush than the second layer of plastic foam so that the layer of foam surrounding the tube is less compressed than the other layer of foam when the outer wall surface is moved toward the inner wall surface and the greater compressibility of the said other layer permits penetration of the epidermis before the compressibility of the layer of foam surrounding the tube permits penetration of the tube end member.