Body fluid sampling device

• US 5,964,718 A
• Filed: 11/21/1997
• Issued: 10/12/1999
• Est. Priority Date: 11/21/1997
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Mercury Diagnostics, Inc.
• Inventors: Roe, Jeffrey N., Radwanski, Ryszard, Duchon, Brent G., Douglas, Joel S.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US08/975,978
• Time in Patent Office: 690 Days
• Field of Search: 600/573, 600/576, 600/583, 606/181-183
• US Class Current: 600/583
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150503 Single-ended needles 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 5/150549 Protectors removed by rotational movement, e.g. torsion or screwing
• CPC Class Codes: A61B 5/150618 Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
• 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 5/150717 manually removed
• CPC Class Codes: A61B 5/15111 Semi-automatically triggered, e.g. at the end of the cocking procedure, for instance by biasing the main drive spring or when reaching sufficient contact pressure, the piercing device is automatically triggered without any deliberate action by the user
• 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
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin

Abstract

Body fluid is sampled from a skin incision by placing a ring against the skin and repeatedly applying an elastic pressing force to the ring, whereby a stimulator surface of the ring depresses a ring of skin and body tissue in surrounding relationship to the incision to force body fluid from the incision. The stimulator surface is inclined at an angle of 10 to 65 degrees; a width of the stimulator surface is from 5 mm to 20 mm, and an inner diameter of the stimulator surface is no less than 6.0 mm.

Claims

1. A sampling device for sampling blood or interstitial fluid, comprising:

a manually grippable sleeve defining a longitudinal axis;

a carrier adapted to support a skin-lancing medium for producing an incision in skin;

a ring projecting from a longitudinal forward end of the sleeve and mounted for longitudinal movement relative to the sleeve, the ring including a front stimulator surface adapted to contact a skin surface; and

an elastically deformable force-transmitting element operably disposed between the sleeve and ring for transmitting a force from the sleeve to the ring in response to forward movement of the sleeve relative to the ring, to press the stimulator surface against the skin surface, the stimulator surface configured to depress a ring-shaped portion of skin and body tissue disposed in surrounding relationship to a skin incision, causing the incision to bulge and the sides of the incision to open, whereby body fluid is forced from the incision.

2. The sampling device according to claim 1, wherein the ring constitutes an inner ring, the device further including an outer ring arranged in telescoping relationship around the inner ring, the outer ring projecting forwardly from the sleeve and being longitudinally movable relative to the sleeve;

and a spring elastically biasing the outer ring forwardly, the outer ring being movable longitudinally relative to both the sleeve and the inner ring.

3. The sampling device according to claim 2, further including a housing mounted in the sleeve for longitudinal movement relative thereto, a trigger mounted in the housing for longitudinal movement relative thereto, the housing and trigger together defining a latching structure for releasably latching the trigger in a spring-biased cocked state, the latching structure being releasible in response to rearward movement of the housing relative to the sleeve.

4. The sampling device according to claim 3, further including an adapter connected to the ring by a snap-coupling, and connected to the housing by a bayonet coupling.

5. The sampling device according to claim 1 wherein the stimulator surface is inclined relative to a plane oriented perpendicular to the axis, the inclination being radially inwardly and longitudinally rearwardly, the inclination relative to the plane being from 10 to 65 degrees.

6. The sampling device according to claim 5 wherein a width of the stimulator surface is from about 5 mm to about 20 mm.

7. The sampling device according to claim 6 wherein an inner diameter of the stimulator surface is no smaller than about 6.0 mm.

8. The sampling device according to claim 7 wherein the inner diameter is no larger than about 12.0 mm.

9. The sampling device according to claim 1 wherein a width of the stimulator surface is from about 5 mm to about 20 mm.

10. The sampling device according to claim 9 wherein an inner diameter of the stimulator surface is from about 6.0 mm to about 12.0 mm.

11. The sampling device according to claim 1 wherein an inner diameter of the stimulator surface is no smaller than about 6.0 mm.

12. The sampling device according to claim 11 wherein the inner diameter is no larger than about 12.0 mm.

13. The sampling device according to claim 1, further including a housing mounted in the sleeve and being longitudinally movable relative to the sleeve;

an adapter attached to the housing and carrying the ring and carrier;

a collar disposed in the housing;

a retainer disposed in the housing in rearwardly spaced relationship to the collar;

a cocking spring operably disposed between the retainer and collar;

a hammer having a rear end attached to the retainer;

a hammer spring arranged for biasing the hammer forwardly toward the carrier;

a manual hammer-cocking knob having a manually grippable rear end projecting from the housing and sleeve, and a front end attached to the collar;

the housing forming a stop for releasably latching the hammer in a cocked state.

14. The sampling device according to claim 13 wherein the ring and adapter form a first coupling independent of a separate fastener;

the adapter and housing forming a second coupling independent of a separate fastener;

the housing and sleeve forming a third coupling independent of a separate fastener;

the hammer and retainer forming a fourth coupling independent of a separate fastener; and

the cocking knob and collar forming a fifth coupling independent of a separate fastener.

15. The sampling device according to claim 14 wherein each of the first, third, fourth and fifth couplings is a snap-in coupling.

16. The sampling device according to claim 1, in combination with a lancet mounted in the carrier;

a keeper mounted in the sleeve behind the carrier for preventing rearward movement of the lancet.

17. A sampling device for sampling blood or interstitial fluid, comprising:

a manually grippable sleeve defining a longitudinal axis; and

a ring projecting from a longitudinal forward end of the sleeve and mounted for longitudinal movement relative to the sleeve, the ring including a front stimulator surface adapted to contact a skin surface, wherein the stimulator surface is inclined relative to a plane oriented perpendicular to the axis, the inclination being radially inwardly and longitudinally rearwardly, the inclination relative to the plane being from 10 to 65 degrees, a width of the stimulator surface being from about 5 mm to about 20 mm, an inner diameter of the stimulator surface being no smaller than about 6.0 mm.

18. The sampling device according to claim 17 further including a carrier adapted to support a skin-lancing medium for producing an incision in skin.

19. A sampling device for sampling blood or interstitial fluid, comprising:

a manually grippable sleeve defining a longitudinal axis;

a ring projecting from a longitudinal forward end of the sleeve and mounted for longitudinal movement relative to the sleeve, the ring including a front stimulator surface adapted to contact a skin surface; and

an elastically deformable force-transmitting element operably disposed between the sleeve and ring for transmitting a force from the sleeve to the ring in response to forward movement of the sleeve relative to the ring, to press the stimulator surface against the skin surface, the stimulator surface configured to depress a ring-shaped portion of skin and body tissue disposed in surrounding relationship to a skin incision, causing the incision to bulge and the sides of the incision to open, whereby body fluid is forced from the incision.

20. The sampling device according to claim 19 wherein the stimulator surface is inclined relative to a plane oriented perpendicular to the axis, the inclination being radially inwardly and longitudinally rearwardly, the inclination relative to the plane being from 10 to 65 degrees.

21. The sampling device according to claim 19 wherein a width of the stimulator surface is from about 5 mm to about 20 mm.

22. The sampling device according to claim 19 wherein an inner diameter of the stimulator surface is no smaller than about 6.0 mm.

23. The sampling device according to claim 19 wherein the stimulator surface is inclined relative to a plane oriented perpendicular to the axis, the inclination being radially inwardly and longitudinally rearwardly, the inclination relative to the plane being from 10 to 65 degrees, a width of the stimulator surface being from about 5 mm to about 20 mm, an inner diameter of the stimulator surface being no smaller than about 6.0 mm.