APPARATUS AND METHOD FOR MANUALLY POWERED BODILY FLUID EXTRACTION

• US 20140073992A1
• Filed: 09/12/2012
• Published: 03/13/2014
• Est. Priority Date: 09/12/2012
• Status: Abandoned Application

• Current Assignee: Charles Stark Draper Laboratory Incorporated
• Original Assignee: Charles Stark Draper Laboratory Incorporated
• Inventors: Sun, Hoi-Cheong S., Hufford, Kevin A.
• Application Number:
  US13/612,207
• Publication Number:
  US 20140073992A1
• Time in Patent Office: Days
• 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 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150251 Collection chamber divided into at least two compartments, e.g. for division of samples injection syringes having more than one chamber A61M5/19; syringes for injection of two or more media A61M5/2448, A61M5/284; sample preparation for further analysis A61B5/150755
• CPC Class Codes: A61B 5/150297 for piercing devices, i.e. devices ready to be used for lancing or piercing for piercing elements A61B5/150282, for driving devices A61B5/15029
• 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 5/150427 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/15061 by material engagement, e.g. welding, bonding
• CPC Class Codes: A61B 5/150702 fully automatically removed, i.e. the removing does not require any action by the user
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• 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 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
• CPC Class Codes: A61B 5/154 Devices using pre-evacuated means
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

Apparatuses and methods are disclosed herein for extracting bodily fluids. The apparatus consists of a housing, a releasable lancet stored in the housing, an inlet flow channel formed in the housing, a mechanically powered vacuum generator, and a storage area formed in the housing. The releasable lancet is released to pierce the skin of the subject to allow fluid to be extracted from the subject. The vacuum generator generates a partial vacuum within the inlet flow channel. After the lancet has pierced the skin of the subject, the partial vacuum draws fluid from the subject and into the inlet flow channel. The storage area is in fluid connection with the inlet flow channel, and receives the fluid drawn from the subject from the inlet flow channel.

Claims

1. An apparatus for extracting bodily fluids, the apparatus comprising:

a housing;

a manually releasable lancet housed in the housing for piercing the skin of a subject when the lancet is released to allow fluid to be extracted from the subject;

an inlet flow channel formed in the housing;

a mechanically powered vacuum generator for generating a partial vacuum within the inlet flow channel, wherein the partial vacuum draws fluid from the subject and into the inlet flow channel after the lancet has pierced the skin of the subject; and

a storage area formed in the housing in fluid connection with the inlet flow channel for receiving the fluid drawn from the subject from the inlet flow channel.

2. The apparatus of claim 1, further comprising a septum that forms at least a part of a wall of the inlet flow channel, wherein the septum is pierced by the lancet during the release of the lancet.

3. The apparatus of claim 2, wherein the vacuum mechanism comprises a barb attachment on the lancet, and the barb stretches the septum after the release of the lancet to create the partial vacuum within the inlet flow channel.

4. The apparatus of claim 1, further comprising a spring for retracting the lancet after the lancet has been released.

5. The apparatus of claim 1, wherein the vacuum mechanism comprises a deflatable, resilient bladder in fluid connection with the inlet flow channel, wherein deflating and releasing the deflatable bladder creates a partial vacuum in the inlet flow channel for drawing the fluid into the storage area.

6. The apparatus of claim 5, wherein the deflatable bladder further comprises a flexible membrane that can be engaged by an operator to manually deflate the bladder.

7. The apparatus of claim 5, wherein the vacuum mechanism comprises a rotatable cam configured such that rotating the cam causes the deflatable bladder to deflate to create a partial vacuum within the storage area.

8. The apparatus of claim 7, wherein the cam is further configured such that rotating the cam further causes the release of the lancet.

9. The apparatus of claim 5, wherein the storage area is the deflatable bladder.

10. The apparatus of claim 1, further comprising a capillary flow channel in fluid connection with the inlet flow channel and the storage area, wherein the capillary flow channel causes fluid to flow from the inlet flow channel to the storage area via capillary action.

11. The apparatus of claim 1, further comprising at least one assay channel in fluid connection with at least one of the inlet flow channel and the storage area for running a test on extracted fluid.

12. The apparatus of claim 1, further comprising a fluid port in fluid connection with the storage area for extracting fluid from the storage area.

13. The apparatus of claim 1, wherein the storage area comprises a pierceable membrane which, when pierced, allows the extraction of fluid from the storage area.

14. The apparatus of claim 1, wherein the fluid is blood, the apparatus further comprising a separation area in fluid connection with the inlet flow channel and in fluid connection with the storage area for separating blood plasma from the blood, wherein, after the blood plasma separates from the blood, the blood plasma flows from the separation area to the storage area.

15. The apparatus of claim 1, wherein the vacuum generator is configured such that the partial vacuum is automatically released after a predetermined amount of fluid has been collected.

16. The apparatus of claim 1, wherein the lancet passes through the inlet flow channel during the release of the lancet.

17. A method of extracting bodily fluids by a fluid extraction apparatus, comprising:

in response to a manual manipulation of a mechanical trigger incorporated into the fluid extraction apparatus, releasing, by the fluid extraction apparatus, a spring-loaded lancet housed therein;

mechanically inducing a partial vacuum within an inlet flow channel of the fluid extraction apparatus, thereby drawing fluid from a subject through a surface of the subject pierced by the lancet as a result of its release;

storing the drawn fluid within the fluid extraction apparatus.

18. The method of claim 17, wherein the release of the lancet is after the partial vacuum is induced.

19. The method of claim 17, wherein the release of the lancet is before the partial vacuum is induced.

20. An apparatus for extracting bodily fluids, the apparatus comprising:

a housing;

a lancet housed in the housing for piercing the skin of a subject when the lancet is released to allow fluid to be extracted from the subject;

a manual triggering means for releasing the lancet;

an inlet flow channel formed in the housing;

a vacuum means for generating a partial vacuum within the inlet flow channel, wherein the partial vacuum draws fluid from the subject and into the inlet flow channel after the lancet has pierced the skin of the subject; and

a storage area formed in the housing in fluid connection with the inlet flow channel for receiving the fluid drawn from the subject from the inlet flow channel.