Methods and apparatus for suctioning and pumping body fluid from an incision

• US 6,878,120 B2
• Filed: 04/08/2002
• Issued: 04/12/2005
• Est. Priority Date: 04/28/1998
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Roe, Jeffrey N., Douglas, Joel S.
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US10/118,048
• Publication Number:
  US 20020111565A1
• Time in Patent Office: 1,100 Days
• Field of Search: 600/573, 600/576, 600/583
• US Class Current: 600/583
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• 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 5/150229 Pumps for assisting the blood sampling
• 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 5/15109 Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
• 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 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• 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

A sampling device for sampling body fluid includes a casing which is pressed against a skin surface to produce a seal therewith. A cocking mechanism is pulled rearwardly to place a lancing device in a cocked state. By releasing a trigger, the lancing device is driven forward to produce an incision in the skin, and then is retracted out of the incision. A plunger mounted on the cocking mechanism is then retracted to generate a negative pressure at the front end of the casing to draw body fluid from the incision.

Claims

1. A sampling device for sampling body fluid, comprising:

a casing defining a longitudinal axis;

a skin-lancing mechanism for extending a lancet through a longitudinal front end of the casing and against a skin surface to form an incision therein, and then retracting the lancet back into the casing;

a plunger being longitudinally rearwardly movable relative to the skin lancing mechanism, the plunger being constructed and arranged with the sampling device such that a negative pressure is generated at the front end of the casing by movement of the plunger away from the front end of the casing, the negative pressure acting to draw body fluid from the incision;

means for driving the plunger rearwardly relative to the skin-lancing mechanism; and

a latch constructed and arranged to release the plunger such that the plunger is rearwardly driven relative to the skin-lancing mechanism.

2. The device of claim 1, wherein the means for driving the plunger includes a spring.

3. The device of claim 2, wherein the spring is coupled to the plunger.

4. The device of claim 1, wherein:

the plunger defines a notch; and

the latch releasably engages the notch in the plunger to retain the plunger in a longitudinally forward state.

5. The device of claim 1, further comprising:

a cocking mechanism coupled to the skin-lancing mechanism for positioning the skin-lancing mechanism in a cocked state; and

wherein the plunger is longitudinally rearwardly movable relative to the cocking mechanism.

6. The device of claim 5, wherein the cocking mechanism includes a handle to manually position the skin-lancing mechanism in the cocked state.

7. The device of claim 5, wherein the cocking mechanism includes the latch adapted to be releasably latched through insertion of the lancet into the casing.

8. The device of claim 1, further comprising a trigger to releasably hold the skin-lancing mechanism in a cocked state.

9. The device of claim 8, further comprising an actuator to release the skin-lancing mechanism from the trigger.

10. A bodily fluid sampling device, comprising:

a casing defining an opening;

a skin-lancing mechanism disposed in the casing to extend a lancet from the opening of the casing to form an incision in skin;

a plunger disposed in the casing, the plunger being independently moveable with respect to the skin-lancing mechanism to reduce pressure at the opening to draw bodily fluid from the incision; and

a hollow member mounted around the opening in the casing, the hollow member having a skin engaging surface to establish a seal with the skin; and

an inner member positioned inside the hollow member, the inner member being movable relative to the hollow member to break the seal with the skin.

11. The device of claim 10, further comprising means for moving the plunger relative to the skin-lancing mechanism.

12. The device of claim 11, wherein the means for moving the plunger includes a spring.

13. The device of claim 11, further comprising a latch constructed and arranged to release the plunger such that the plunger is moved relative to the skin-lancing mechanism by the means for moving the plunger.

14. The device of claim 10, further comprising a spring coupled to the plunger to move the plunger relative to the skin-lancing mechanism.

15. The device of claim 10, further comprising:

a cocking mechanism coupled to the skin-lancing mechanism for positioning the skin-lancing mechanism in a cocked state; and

wherein the plunger is independently moveable with respect to the cocking mechanism.

16. The device of claim 10, further comprising a trigger to releasably hold the skin-lancing mechanism in a cocked state.

17. The device of claim 16, further comprising:

an actuator to release the skin-lancing mechanism from the trigger; and

wherein the plunger is independently moveable with respect to the actuator.

18. A sampling device for sampling body fluid, comprising:

a casing defining a longitudinal axis;

a skin-lancing mechanism for extending a lancet through a longitudinal front end of the casing and against a skin surface to form an incision therein, and then retracting the lancet back into the casing;

a plunger being longitudinally rearwardly movable relative to the skin lancing mechanism, the plunger being constructed and arranged with the sampling device such that a negative pressure is generated at the front end of the casing by movement of the plunger away from the front end of the casing, the negative pressure acting to draw body fluid from the incision;

a cocking mechanism coupled to the skin-lancing mechanism for positioning the skin-lancing mechanism in a cocked state;

wherein the plunger is longitudinally rearwardly movable relative to the cocking mechanism; and

wherein the cocking mechanism includes a handle to manually position the skin-lancing mechanism in the cocked state.

19. A bodily fluid sampling device, comprising:

a casing defining an opening;

a skin-lancing mechanism disposed in the casing to extend a lancet from the opening of the casing to form an incision in skin;

a plunger disposed in the casing, the plunger being independently moveable with respect to the skin-lancing mechanism to reduce pressure at the opening to draw bodily fluid from the incision;

means for moving the plunger relative to the skin-lancing mechanism; and

a latch constructed and arranged to release the plunger such that the plunger is moved relative to the skin-lancing mechanism by the means for moving the plunger.

20. A bodily fluid sampling device, comprising:

a casing defining an opening;

means for forming an incision in skin through the opening;

means for reducing pressure at the opening to draw bodily fluid from the incision;

an outer member having an end surface proximal the opening to establish a seal with the skin; and

an inner member positioned inside the outer member, the inner member being movable relative to the outer member to break the seal with the skin.

21. The device of claim 20, wherein the means for forming the incision includes a lancet.

22. The device of claim 20, wherein the means for reducing pressure includes a plunger.

23. The device of claim 20, wherein the outer member is ring-shaped.

24. The device of claim 20, wherein the inner member is ring-shaped.

25. The device of claim 20, wherein the end surface has a generally frusto-conical shape.

26. The device of claim 25, wherein the inner member has an end surface that has a generally frusto-conical shape.