Device And Method For Determining A Value Of A Physiological Parameter Of A Body Fluid

• US 20090312622A1
• Filed: 07/31/2007
• Published: 12/17/2009
• Est. Priority Date: 09/28/2006
• Status: Abandoned Application

• Current Assignee: Werner Regittnig
• Original Assignee: Werner Regittnig
• Inventors: Regittnig, Werner
• Application Number:
  US12/443,081
• Publication Number:
  US 20090312622A1
• Time in Patent Office: Days
• US Class Current: 600/366
• CPC Class Codes: A61B 5/14525 using microdialysis
• CPC Class Codes: A61B 5/14528 invasively
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• 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 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150511 Details of construction of shaft
• 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 5/150992 Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• 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
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

A device for determining a value of a physiological parameter of a body fluid of a body under investigation, the device comprising a fluid reservoir for containing a perfusate fluid, a body interface insertable into the body under investigation for a fluid communication between the fluid reservoir and the body fluid, a fluid conduit between the fluid reservoir and the body interface, a bidirectional fluid transport unit for transporting the perfusate fluid from the fluid reservoir through the fluid conduit a the body interface into the body under investigation and for subsequently transporting a mixture of the perfusate fluid and the body fluid from the body under investigation through the body interface into the fluid conduit, and a sensor for sensing the value of the physiological parameter based on an analysis of the mixture of the perfusate fluid and the body fluid.

Claims

1. A device for determining a value of a physiological parameter of a body fluid of a body under investigation, the device comprising

a fluid reservoir for containing a perfusate fluid;

a body interface insertable into the body under investigation for a fluid communication between the fluid reservoir and the body fluid;

a fluid conduit between the fluid reservoir and the body interface;

a bidirectional fluid transport unit for transporting the perfusate fluid from the fluid reservoir through the fluid conduit and the body interface into the body under investigation and for subsequently transporting a mixture of the perfusate fluid and the body fluid from the body under investigation into the body interface; and

a sensor for sensing the value of the physiological parameter based on an analysis of the body fluid, particularly based on an analysis of the mixture of the perfusate fluid and the body fluid;

wherein the device is adapted for supplying a physiologically active substance to the body under investigation;

wherein the fluid reservoir contains the perfusate fluid including the physiologically active substance.

4. The device of claim 1, comprising a control unit adapted for controlling the bidirectional fluid transport unit for transporting the perfusate fluid from the fluid reservoir through the fluid conduit and the body interface into the body under investigation and for subsequently transporting the mixture of the perfusate fluid and the body fluid from the body under investigation into the body interface.

5. The device of claim 4, wherein the control unit is adapted for controlling the bidirectional fluid transport unit for transporting the mixture of the perfusate fluid and the body fluid from the body under investigation into the body interface only upon detecting that the perfusate fluid and the body fluid have been mixed sufficiently so as to exceed a predetermined mixture degree.

6. The device of claim 4, wherein the control unit is adapted for controlling the bidirectional fluid transport unit to switch a plurality of times between an operation state in which the perfusate fluid is transported in a direction from the body interface into the body under investigation, and an operation state in which the mixture of the perfusate fluid and the body fluid is transported in an opposite direction from the body under investigation into the body interface.

7. The device of claim 1, wherein the device comprises exactly one fluid conduit between the fluid reservoir and the body interface.

8. The device of claim 1, wherein the device comprises a bifurcation-free fluid conduit between the fluid reservoir and the body interface.

9. The device of claim 1, wherein the sensor is positioned within the fluid conduit.

10. The device of claim 1, wherein the sensor is positioned at a wall of the body interface, particularly at an interior wall or at an exterior wall of the body interface.

11. The device of claim 1, wherein the body interface comprises a wall having a plurality of fluid-exchange perforations.

12. The device of claim 1, comprising a single bidirectional fluid transport unit.

13. The device of claim 1, wherein a fluid transport direction of the bidirectional fluid transport unit is invertible.

14. The device of claim 1, comprising a calibration unit adapted for determining a mixture degree of the perfusate and the body fluid.

15. The device of claim 14, wherein the calibration unit is positioned at a wall of the body interface, particularly at an interior wall or at an exterior wall of the body interface.

16. The device of claim 4, wherein the control unit is adapted to determine an amount of the physiologically active substance to be delivered to the body under investigation based on the value of the physiological parameter sensed by the sensor.

17. The device of claim 14, wherein the control unit is adapted to determine an amount of the physiologically active substance based on the mixture degree determined by the calibration unit.

18. The device of claim 14, wherein the control unit is adapted to accept or reject to determine the amount of the physiologically active substance based on the mixture degree determined in the calibration unit, particularly by measuring an exogenous and/or an endogenous marker.

19. The device of claim 1, wherein the body interface is adapted to extract the mixture of the perfusate fluid and the body fluid from the body under investigation.

2. (canceled)

3. (canceled)

20-33. -33. (canceled)

34. A method of determining a value of a physiological parameter of a body fluid of a body under investigation, the method comprising

inserting a body interface into the body under investigation for enabling a fluid communication between the body fluid and a fluid reservoir containing a perfusate fluid;

transporting, by a bidirectional fluid transport unit, the perfusate fluid from the fluid reservoir through a fluid conduit and the body interface into the body under investigation;

subsequently transporting a mixture of the perfusate fluid and the body fluid from the body under investigation into the body interface;

sensing the value of the physiological parameter based on an analysis of the body fluid, particularly based on an analysis of the mixture of the perfusate fluid and the body fluid; and

supplying a physiologically active substance to the body under investigation;

wherein the fluid reservoir contains the perfusate fluid including the physiologically active substance.

35. A device for determining a value of a physiological parameter of a body fluid of a body under investigation, the device comprising

a fluid reservoir for containing a perfusate fluid;

a body interface insertable into the body under investigation for a fluid communication between the fluid reservoir and the body fluid;

a fluid conduit between the fluid reservoir and the body interface;

a fluid transport unit for transporting the perfusate fluid from the fluid reservoir through the fluid conduit and the body interface into the body under investigation;

a sensor positioned at the body interface and adapted for sensing the value of the physiological parameter based on an analysis of the body fluid, particularly based on an analysis of the mixture of the perfusate fluid and the body fluid;

a calibration unit positioned at the body interface and adapted for determining a mixture degree of the perfusate and the body fluid.

36. The device of claim 35, wherein the sensor is adapted to accept or reject to sense the value of the physiological parameter based on the mixture degree determined in the calibration unit.