Blood and interstitial fluid sampling device

• US 8,696,596 B2
• Filed: 12/22/2009
• Issued: 04/15/2014
• Est. Priority Date: 05/17/1996
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Douglas, Joel S., Roe, Jeffrey N., Radwanski, Ryszard, Grage, Henry M., Sanchez, Michael S.
• Primary Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US12/644,528
• Publication Number:
  US 20100106058A1
• Time in Patent Office: 1,575 Days
• Field of Search: 600/583, 600/584, 600/573, 606181-183
• US Class Current: 600/583
• 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 5/150076 by heating
• CPC Class Codes: A61B 5/150083 by vibration, e.g. ultrasound
• CPC Class Codes: A61B 5/150183 Depth adjustment mechanism using end caps mounted at the distal end of the sampling device, i.e. the end-caps are adjustably positioned relative to the piercing device housing for example by rotating or screwing
• 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 5/150213 Venting means
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150236 Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150244 Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
• 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 5/150503 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 5/150946 Means for varying, regulating, indicating or limiting the speed or time of blood collection
• CPC Class Codes: A61B 5/150977 Arrays of piercing elements for simultaneous piercing
• 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 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15136 by use of radiation, e.g. laser
• CPC Class Codes: A61B 5/1519 : comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15196 : semi-automatically retracted, i.e. in which the retraction of the piercing unit requires a deliberate action by the user such as manual release of spring-biased retraction means
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood

Abstract

A device and method for lancing a patient, virtually simultaneously producing and collecting a small fluid sample from a body. The device comprises a blood collection system including a lancing needle (16), drive mechanism (11), kneading or vibration mechanism (25), optional suction system (7), and sample ejection mechanism. The device is preferably sized to be hand-held in one hand and operable with one hand. The device can optionally contain integral testing or analysis component (83) for receiving the sample and providing testing or analysis indication or readout for the user. A method involves piercing the skin at a rapid rate, kneading the surrounding area by ultrasonic action, piezoelectric or mechanical oscillation to stimulate the blood flow from the wound, drawing the fluid using a pumping system.

Claims

1. A device for sampling body fluid, comprising:

a body portion;

a needle comprising a sharpened distal tip and shaft portion which is slidably disposed within the body portion;

a spring mechanism in the body portion wherein the spring mechanism is configured to move the needle in a first direction relative to the body portion to form an incision in tissue;

a sample container communicating with the needle for receiving the sample from the needle; and

a retraction mechanism configured to retract the needle into the body portion after forming the incision.

2. The device of claim 1 wherein the sharpened distal tip of the needle is covered by the body portion when the needle is in a retracted position and the sharpened distal tip extending beyond a distal end of the body portion when the needle is in an extended position.

3. The device of claim 1, further comprising:

a stop member attached to the body portion configured to limit the depth of penetration of the needle into tissue.

4. A device for sampling body fluid, comprising:

a body portion configured to contain a needle for piercing skin, wherein the needle is slidably disposed within the body portion;

a means for driving the needle to form an incision in skin;

a sample container in fluid communication with the needle for receiving the body fluid sample; and

a means for retracting the needle from the skin.

5. The device of claim 4 wherein a sharpened distal tip of the needle exits a distal end of the body portion at an exit port.

6. The device of claim 4 wherein a sharpened distal tip of the needle is covered by the body portion when the needle is in a retracted position and the sharpened distal tip extending beyond a distal end of the body portion when the needle is in an extended position.

7. The device of claim 4, wherein the means for driving the needle to form the incision in skin includes a spring.

8. The device of claim 4, wherein the means for retracting the needle from the skin includes a spring.

9. The device of claim 4, further comprising:

a stop member configured to limit the depth of penetration of the needle into the skin.

10. A tissue penetrating device, comprising:

a housing;

at least one penetrating member configured to form an incision in tissue, the at least one penetrating member slidably received in the housing;

a penetrating member driver coupled to the at least one penetrating member;

a stop member configured to limit the depth of penetration of the at least one penetrating member into the tissue; and

a retraction mechanism configured to retract the at least one penetrating member after forming the incision.

11. The device of claim 10, further comprising:

wherein the penetrating member driver includes a spring mechanism in the housing that is configured to move the at least one penetrating member in the forward direction.

12. The device of claim 10, wherein the retraction mechanism includes a spring disposed in the housing.

13. The device of claim 10, wherein the at least one penetrating member is a needle.

14. The device of claim 10, further comprising:

a guard positioned over the at least one tissue penetrating member prior to forming the incision with the at least one tissue penetrating member, wherein the guard is attached to an end of the housing.