Methods and apparatus for sampling and analyzing body fluid

• US 6,099,484 A
• Filed: 04/23/1999
• Issued: 08/08/2000
• Est. Priority Date: 05/17/1996
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Amira Medical (Roche Holding AG)
• Inventors: Roe, Jeffrey N., Radwanski, Ryszard, Duchon, Brent G., Douglas, Joel S.
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): MARMOR II, CHARLES ALAN
• Application Number:
  US09/298,386
• Time in Patent Office: 473 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 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150083 by vibration, e.g. ultrasound
• 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 5/150137 by vibration enhancing collection by vibration A61B5/150175
• CPC Class Codes: A61B 5/15016 by accessories for bringing the piercing element into the body, e.g. through rotation of the piercing element
• CPC Class Codes: A61B 5/15019 Depth adjustment mechanism using movable stops located inside the piercing device housing and limiting the travel of the drive mechanism mechanisms using distal end caps A61B5/150183, mechanisms at the piercing element carrier proximal end A61B5/150198
• CPC Class Codes: A61B 5/150198 Depth adjustment mechanism at the proximal end of the carrier of the piercing element
• 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 5/150358 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 5/150396 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150427 Specific tip design, e.g. for improved penetration characteristics
• 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 5/150503 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 5/150519 : Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150824 : by visual feedback
• CPC Class Codes: A61B 5/150977 : Arrays of piercing elements for simultaneous piercing
• CPC Class Codes: A61B 5/150984 : Microneedles or microblades
• 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 5/15113 : 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 5/15136 : by use of radiation, e.g. laser
• 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 5/1519 : 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
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: B82Y 30/00 : Nanotechnology for materials or surface science, e.g. nanocomposites

Abstract

A sampling device for sampling body fluid includes a lancet for making an incision, a capillary tube for drawing-up body fluid from the incision, and a test strip affixed to an upper end of the capillary tube for receiving the fluid. An absorbent pad can be disposed between the test strip and capillary tube for spreading-out the fluid being transferred to the test strip. An on-site analyzer such as an optical analyzer and/or an electrochemical analyzer can be mounted in the device for analyzing the fluid. Alternatively, a test strip can be slid through a slot formed in the bottom end of the device so that by passing the device against the skin after an incision has been formed, the test strip will directly contact body fluid emanating from the incision.

Claims

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

a housing;

a lancet carrier mounted in the housing and supporting a disposable lancet;

a mechanism disposed in the housing for displacing the lancet carrier toward a lower end of the housing for forming an incision through the skin of a user; and

a body fluid sampling member mounted in the lancet carrier for conducting body fluid from the incision, comprising

a capillary member including an elongated stem having a capillary passage extending longitudinally therethrough for conducting body fluid upwardly by capillary action, and

a test strip affixed to the capillary member at an upper end thereof and in communication with the capillary passage for receiving a sample of body fluid therefrom.

2. The sampling device according to claim 1 wherein the sampling member further comprises an absorbent pad disposed between the test strip and the upper end of the capillary passage for wicking body fluid from the passage to the test strip.

3. The sampling device according to claim 2 wherein the pad is affixed directly to the capillary member, and the test strip is affixed directly to the pad.

4. The sampling device according to claim 2, further including an electrochemical analyzing mechanism mounted in the housing, the pusher carrying electrical leads arranged for making electrical connection with a body fluid sample on the test strip, the leads being electrically connected to the analyzing mechanism.

5. The sampling device according to claim 1, further including an electrochemical analyzing meter mounted in the housing, a manually movable element mounted in the housing and carrying electrical leads arranged to make electrical connection with the meter.

6. The sampling device according to claim 1 further including a drop detecting mechanism disposed adjacent a lower end of the device for detecting a drop of body fluid disposed on the user'"'"'s skin.

7. The sampling device according to claim 6 wherein the drop detecting mechanism includes a pair of spaced apart electrodes arranged to contact the drop and provide a signal to an indicator.

8. The sampling device according to claim 6 wherein the drop detecting mechanism comprises a light emitter and light receiver disposed adjacent a lower end of the device and provide a signal to an indicator.

9. A sampling device for body fluid by forming an incision on a skin surface, comprising:

a housing;

a lancet carrier mounted in the housing supporting a disposable lancet;

a longitudinally slidable stimulator sleeve disposed within the housing and surrounding the lancet carrier, the sleeve constructed such that by the application of downward force on the housing, the sleeve is pressed against the skin surface;

a mechanism for displacing the lancet carrier toward a lower end of the housing for forming an incision through the skin of a user; and

a strip-holding mechanism mounted at a lower end of the housing for supporting a test strip across the lower end of the housing to enable the test strip to pick-up body fluid from the incision.

10. The sampling device according to claim 9 wherein the strip-holding mechanism comprises slots for receiving the test strip.

11. The sampling device according to claim 10 wherein the sleeve constitutes a first sleeve, the strip-holding mechanism further including a second sleeve surrounding the first sleeve and including slots radially aligned with the slots of the first sleeve, the second sleeve being slidable longitudinally relative to both the housing and the first sleeve and being spring biased downwardly, the slots formed in the second sleeve being elongated in a direction parallel to a longitudinal axis of the housing to enable the second sleeve to move longitudinally relative to a test strip mounted in the first sleeve.

12. A method of sampling body fluid comprising the steps of:

A) positioning a lower end of a sampling device against a skin surface;

B) displacing a lancet toward the lower end of the sampling device to form an incision through the skin;

C) repeatedly depressing an area of the skin surrounding the incision by applying a downward force to the housing a sufficient number of times to express a drop of body fluid from the incision;

D) mounting a test strip in the sampling device to extend across the lower end thereof; and

E) moving the sampling device toward the incision to bring the test strip into contact with body fluid emerging from the incision.

13. The method according to claim 12, wherein step D is performed prior to step B whereby the lancet pierces the test strip when displaced to form the incision.