System and method for the extraction and monitoring of a biological fluid

• US 7,335,166 B2
• Filed: 05/22/2003
• Issued: 02/26/2008
• Est. Priority Date: 05/22/2002
• Status: Expired due to Term

• Current Assignee: Spectro Incorporated (Spectro Scientific, Inc.)
• Original Assignee: Spectro Incorporated (Spectro Scientific, Inc.)
• Inventors: Faupel, Mark, Lincoln, Danny
• Primary Examiner(s): Hindenburg; Max F.
• Assistant Examiner(s): Szmal; Brian
• Application Number:
  US10/515,039
• Publication Number:
  US 20060178599A1
• Time in Patent Office: 1,741 Days
• Field of Search: 600/573, 600575-584, 137/199, 422/101, 435/810, 604/228, 604/263, 604/405, 604/414, 606/181, 606/182
• US Class Current: 600/578
• 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 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• 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 5/150213 Venting means
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• 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 5/150969 Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146

Abstract

The systems and methods involve creating an opening in the biological tissue of the patient and placing a sampling aperture of the extraction device over the opening. The sampling aperture is defined in a contact surface of the extraction device that is placed into contact with the tissue of the patient. A pump of the extraction device such as a depressible bulb sealed to the body is charged to create a vacuum between the pump through a sampling channel to the sampling aperture, and the vacuum draws the biological fluid from the tissue opening into the sampling channel. An access point is exposed to the sampling channel, and the sample of fluid may be accessed from the access point. The access point may be an extraction opening covered by an access door, and the access door is opened to access the sample.

Claims

1. A device for extracting biological fluid from tissue having a biological opening, comprising:

a body including a separate contact surface that defines a sampling aperture and a sensor surface affixable on tissue with said aperture alignable over said opening and defining an access point;

a pump; and

a sampling channel between the sampling aperture and the pump thereafter affixable to said contact surface, wherein the sampling channel is thereby aligned to be in fluid communication with the access point.

2. The device of claim 1, further comprising a wick disposed within the sampling channel between the access point and the pump.

3. The device of claim 2, wherein the body further includes a ventilation surface defining a ventilation opening, the device further comprising a ventilation channel interconnecting the ventilation opening to the sampling channel.

4. The device of claim 3, wherein the wick is disposed between the ventilation channel and the sampling aperture along a path of the sampling channel.

5. The device of claim 3, further comprising a ventilation seal covering the ventilation opening.

6. The device of claim 1, wherein the pump is a depressible self-restoring bulb sealed to the body.

7. The device of claim 1, wherein the access point comprises analysis electrodes extending into the sampling channel.

8. The device of claim 1, wherein the contact surface is planar.

9. A device for extracting biological fluid, comprising:

a body including a contact surface that defines a sampling aperture and a sensor surface defining an access point;

a pump; and

a sampling channel between the sampling aperture and the pump, wherein the sampling channel is in fluid communication with the access point, and, wherein the access point comprises an extraction opening and an extraction door attached to the body and covering the extraction opening.

10. A method of extracting biological fluid from tissue having an opening, comprising:

creating an artificial unobstructed opening in biological tissue;

placing a contact surface of an extraction device on the biological tissue, the contact surface defining an aperture located proximate to the opening in the biological tissue;

attaching an extraction pump to said contact surface after said surface is affixed to said tissue, charging a pump of the extraction device to develop a vacuum at the aperture and draw the biological fluid through the aperture into a sampling channel; and

accessing the biological fluid contained within the extraction device.

11. The method of claim 10, further comprising:

removing a ventilation seal covering a ventilation opening of the extraction device to allow ventilation through a ventilation chamber between the ventilation opening and the sampling channel; and

removing the sampling device from the biological tissue.

12. The method of claim 10, wherein accessing the biological fluid contained within the extraction device comprises accessing the biological fluid with electrodes passing into the sampling channel.

13. The method of claim 10, wherein charging the pump of the extraction device comprises depressing a depressible self-restoring bulb sealed to the extraction body.

14. The method of claim 10, further comprising blocking the biological fluid at a wick located within the sampling channel between the pump and the sampling aperture.

15. A method of extracting biological fluid, comprising:

creating an artificial unobstructed opening in biological tissue;

placing a contact surface of an extraction device on the biological tissue, the contact surface defining an aperture located proximate to the opening in the biological tissue;

charging a pump of the extraction device to develop a vacuum at the aperture and draw the biological fluid through the aperture into a sampling channel; and

accessing the biological fluid contained within the extraction device and, wherein accessing the biological fluid contained within the extraction device comprises accessing the biological fluid through an extraction opening of the extraction device covered by an access door by opening the access door to access the extraction opening and extracting the biological fluid from the extraction opening.

16. A device for extracting biological fluid from tissue having an opening, comprising:

a body including a planar contact surface that defines a sampling aperture said contact surface being independently affixable to said tissue, a separable pump unit comprising a sensor surface defining an access point, and a ventilation surface defining a ventilation opening;

a depressible self-restoring bulb sealed to the body;

a sampling channel between the sampling aperture and the bulb, said pump unit being affixable to said contact surface after said contact surface has been affixed to said tissue, wherein the sampling channel is in fluid communication with the access point;

a wick disposed within the sampling channel between the access point and the bulb; and

a ventilation channel interconnecting the ventilation opening to the sampling channel, wherein the wick is disposed between the ventilation channel and the sampling aperture along a path of the sampling channel.

17. The device of claim 16, further comprising a ventilation seal covering the ventilation opening.

18. The device of claim 16, wherein the access point comprises analysis electrodes extending into the sampling channel.

19. The device of claim 16, wherein the sampling aperture has a countersink shape.

20. A device for extracting biological fluid, comprising:

a body including a planar contact surface that defines a sampling aperture, a sensor surface defining an access point, and a ventilation surface defining a ventilation opening;

a depressible self-restoring bulb sealed to the body;

a sampling channel between the sampling aperture and the bulb, wherein the sampling channel is in fluid communication with the access point;

a wick disposed within the sampling channel between the access point and the bulb; and

a ventilation channel interconnecting the ventilation opening to the sampling channel, wherein the wick is disposed between the ventilation channel and the sampling aperture along a oath of the sampling channel and wherein the access point comprises an extraction opening and an extraction door attached to the body and covering the extraction opening.