Body fluid sampling device and methods of use

• US 7,235,056 B2
• Filed: 04/23/2002
• Issued: 06/26/2007
• Est. Priority Date: 05/17/1996
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Amira Medical (Roche Holding AG)
• Inventors: Roe, Jeffrey N., Radwanski, Ryszard, Douglas, Joel S., Drexler, Andrew M., Duchon, Brent G.
• Primary Examiner(s): MARMOR II, CHARLES ALAN
• Application Number:
  US10/128,780
• Publication Number:
  US 20020177787A1
• Time in Patent Office: 1,890 Days
• Field of Search: 600/573, 600/576, 600/583, 600/584, 606/181, 606/182
• US Class Current: 600/583
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61B 2017/00765 Decreasing the barrier function of skin tissue by radiated energy, e.g. using ultrasound, using laser for skin perforation
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150152 by an adequate mechanical impact on the puncturing location
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• 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 5/150717 manually removed
• CPC Class Codes: A61B 5/150824 by visual feedback
• 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 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• 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

A device for sampling body fluid includes a housing having a sleeve at a forward end thereof which is displaceable in response to being pressed against a user'"'"'s skin to trigger the firing of a lancet. After the lancet is removed from the incision, the sleeve is repeatedly pressed against the skin to depress a ring of body tissue in surrounding relationship to the incision to express body fluid outwardly through the incision. A pusher member is then actuated to push a capillary tube through a front end of the housing for drawing-in body fluid. The lancet is a disposable lancet which includes a body supporting a skin-lancing member and the capillary tube. The disposable lancet passes through an upper end of a lancet carrier when being installed or removed. The device cannot be armed until the disposable lancet is installed in the housing, because the capillary tube functions to push a safety device to a non-safety position.

Claims

1. A method of collecting a bodily fluid sample, comprising:

forming an incision in skin with an integrated bodily fluid sampling device that has a sampling tube;

projecting an end of the sampling tube from the integrated bodily fluid sampling device after said forming; and

a collecting the bodily fluid sample from the incision with the sampling tube.

2. The method of claim 1, further comprising:

providing the integrated bodily fluid sampling device including an incising device and the sampling tube, the sampling tube having an inlet opening, the sampling tube being separate from the incising device, the sampling tube having a retracted position and a sampling position relative to the integrated bodily fluid sampling device;

placing the sampling device against the skin in a use position with the sampling tube in the retracted position having the inlet opening in a first location displaced from the skin;

wherein said projecting the end of the sampling tube includes moving the sampling tube from the retracted position to the sampling position at which the inlet opening is positioned adjacent the incision in the skin; and

maintaining the sampling device in the use position during said forming the incision and said projecting the end of the sampling tube.

3. The method of claim 1, wherein:

the device includes a lancet member; and

said forming the incision includes cutting the skin with the lancet member.

4. The method of claim 3, wherein:

the sampling tube is slidably coupled to the lancet member; and

said projecting includes sliding the end of the tube outwardly from the lancet member.

5. The method of claim 3, further comprising retracting the lancet member away from the incision after said cutting.

6. The method of claim 1, further comprising drawing out the sample from the sampling tube onto a test strip.

7. The method of claim 1, wherein:

the device includes a pusher member positioned proximal the tube; and

said projecting includes pushing the tube with the pusher member.

8. The method of claim 1, further comprising pressing the device against the skin to draw up the bodily fluid sample from the incision.

9. The method of claim 8, wherein said pressing includes repeatedly reciprocating the device against the skin.

10. A lancet member, comprising:

a body;

an incision-forming member extending from said body, said incision-forming member being adapted to form an incision in skin; and

a tube coupled to said body, said tube having an end adapted to move outwardly from said body, said tube having an extended position at which said end of said tube extends past said incision-forming member to collect a bodily fluid sample from the incision.

11. The lancet member of claim 10, wherein said incision-forming member includes a needle.

12. The lancet member of claim 10, wherein:

said incision-forming member includes a needle;

said body includes at least one lower boss to align said body in a lancet carrier and at least a pair of upper bosses disposed at a same elevation above said lower boss to align said body in the lancet carrier, said lower boss and said upper bosses being circumferentially spaced apart from one another along said body;

said body defines a slot in which said tube is received; and

said body has a plurality of opposed holding fingers disposed in said slot to grip said tube.

13. A lancet member, comprising:

a body;

an incision-forming member extending from said body, said incision-forming member being adapted to form an incision in skin;

a tube coupled to said body, said tube having an end adapted to move outwardly from said body to collect a bodily fluid sample from the incision; and

wherein said body includes;

at least one lower boss to align said body in a lancet carrier; and

at least a pair of upper bosses disposed at a same elevation above said lower boss to align said body in the lancet carrier, said lower boss and said upper bosses being circumferentially spaced apart from one another along said body.

14. A lancet member, comprising:

a body;

an incision-forming member extending from said body, said incision-forming member being adapted to form an incision in skin;

a tube coupled to said body, said tube having an end adapted to move outwardly from said body to collect a bodily fluid sample from the incision; and

wherein said body defines a slot in which said tube is received.

15. The lancet member of claim 14, wherein said body has a plurality of opposed holding fingers disposed in said slot to grip said tube.

16. A bodily fluid sampling device, comprising:

a housing including a contact surface for placement against skin in a use position;

a member coupled to said housing and adapted to form an incision in the skin with said contact surface in said use position;

a sampling tube provided in said housing, said tube having an inlet opening, said tube having a retracted position with said inlet opening displaced from the skin with said contact surface in said use position, said tube having a sampling position with said inlet opening adjacent the skin with said contact surface in said use position; and

a mechanism positioned proximal said tube to move said tube independently with respect to said member, said mechanism being operable to move said tube from said retracted position to said sampling position while said contact surface is maintained in said use position.

17. The device of claim 16, wherein said member includes a lancet member having a needle to form the incision in the skin.

18. The device of claim 16, wherein said mechanism includes a pusher member received in said housing, said pusher member being adapted to push on said tube.

19. The device of claim 18, wherein said pusher member includes:

a semi-cylindrical portion with a knob projecting radially outward therefrom;

an actuating rib extending from said semi-cylindrical portion towards said tube, said rib being adapted to push said tube.