BLOOD PARAMETER SENSOR AND FLOW CONTROL SYSTEM, METHOD AND COMPUTER PROGRAM PRODUCT

• US 20110319728A1
• Filed: 06/29/2010
• Published: 12/29/2011
• Est. Priority Date: 06/29/2010
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Petisce, James, Jackson, Emily, Carlin, Gregory J.
• Application Number:
  US12/826,542
• Publication Number:
  US 20110319728A1
• Time in Patent Office: Days
• US Class Current: 600/309
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 5/1407 Infusion of two or more substances
• CPC Class Codes: A61M 5/16804 Flow controllers
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

A system is provided for sensing a blood parameter, such as an analyte, in a patient'"'"'s vasculature. The system includes a vascular access device, a parameter sensor, a pressure sensor and a flow control device. The vascular access device supports the parameter sensor within the vasculature of the patient and includes an internal passageway for drawing samples onto and calibrating the parameter sensor. The pressure sensor is within the internal passageway. The flow control device modulates sample draw, calibration and flushing fluid flows to prevent or remove clots based on communication with the pressure sensor. Advantageously, the dynamic, adaptive modulation of flow reduces flushing and other cycle times while at the same time improving clot flushing. As another advantage, this enables reduction or elimination of the use of heparin and other anticoagulant components in the solution supplied for flushing and/or calibration.

Claims

1. A system for sensing a parameter of blood in a patient'"'"'s vasculature, the system comprising:

a vascular access device configured for connection to the patient'"'"'s vasculature and defining an internal fluid passageway configured for fluid communication with the blood;

at least one parameter sensor supported by the vascular access device and configured to sense the blood parameter;

at least one pressure sensor supported in the internal fluid passageway of the vascular access device; and

a flow control device connected in fluid communication with the internal fluid passageway and connected in communication with the at least one pressure sensor,

wherein the flow control device is configured to adapt fluid flow within the internal fluid passageway based on communication with the at least one pressure sensor.

2. A system of claim 1, wherein the flow control device is further configured to draw blood into the internal fluid passageway of the vascular access device and over the parameter sensor.

3. A system of claim 2, wherein the flow control device is further configured to flush a solution over the parameter sensor.

4. A system of claim 3, wherein the flow control device is configured to adapt a draw time for the blood based on communication with the at least one pressure sensor.

5. A system of claim 4, wherein the flow control device is configured to adapt a flush time for the solution based on communication with the at least one pressure sensor.

6. A system of claim 4, wherein the flow control device is configured to temporarily reduce a draw time in response to an increased pressure communicated by the at least one pressure sensor.

7. A system of claim 3, wherein the flow control device is configured to adapt a flow rate for the blood based on communication with the at least one pressure sensor,

8. A system of claim 7, wherein the flow control device is configured to adapt a flush rate for the solution based on communication with the at least one pressure sensor.

9. A system of claim 7, wherein the flow control device is configured to increase the flush rate of the solution in response to detection of a pressure increase by the pressure sensor.

10. A system of claim 9, wherein the flow control device is configured to stop drawing blood and start flushing solution in response to detection of the pressure increase.

11. A system of claim 1, wherein the flow control device is connected in communication with the at least one parameter sensor and is further configured to adapt fluid flow within the internal fluid passageway based on communication with the at least one parameter sensor.

12. A system of claim 1, wherein the vascular access device comprises a catheter defining at least a portion of the internal fluid passageway.

13. A system of claim 12, wherein at least a portion of the parameter sensor is positioned within the lumen of the catheter.

14. A system of claim 1, wherein the vascular access device comprises a hub defining at least a portion of the internal fluid passageway.

15. A system of claim 14, wherein at least a portion of the parameter sensor is positioned within the portion of the internal fluid passageway defined by the hub.

16. A system of claim 3, wherein the flow control device includes a pump and a controller.

17. A system of claim 16, further comprising a reservoir of the solution connected in fluid communication with the internal fluid passageway.

18. A system of claim 17, wherein the reservoir of solution without an anticoagulant component.

19. A system of claim 18, wherein the internal fluid passageway extends from the patient'"'"'s vasculature and through to a pump of the flow control device and further comprising at least two pressure sensors arrayed along the internal fluid passageway.

20. A system of claim 19, wherein the flow control device is configured to reverse drawing blood into flushing the solution in response to an increased pressure communicated by the at least one pressure sensor.

21. A system of claim 1, wherein the flow control device is further configured to adapt the fluid flow based on a pressure gradient communicated by the at least one pressure sensor.

22. A system of claim 1, wherein the flow control device includes a memory and is capable of storing pressures communicated by the pressure sensor over time and to adapt fluid flow based on a contour of the stored pressures.

23. A method of sensing a parameter of blood in a patient'"'"'s vasculature, the method comprising:

drawing blood over a parameter sensor and into an internal fluid passageway defined in a vascular access device;

sensing a pressure in the internal fluid passageway;

determining, based on the pressure sensed, that at least a partial occlusion has formed; and

flushing the internal fluid passageway with a solution so as to clear the occlusion.

24. A method of claim 23, wherein the solution without an anticoagulant component.

25. A method of claim 24, wherein flushing with the solution is with a sufficient duration and flow rate to clear the occlusion without an anticoagulant component.

26. A method of claim 23, wherein the occlusion is within the internal fluid passageway.

27. A method of claim 23, wherein the occlusion is on the parameter sensor.

28. A method of claim 23, further comprising sensing a blood parameter after drawing blood over the parameter sensor.

29. A method of claim 28, further comprising flushing the parameter sensor with a calibrant solution and calibrating the parameter sensor before drawing blood over the parameter sensor.

30. A method of claim 29, further comprising repeatedly flushing the parameter sensor with the calibrant, calibrating the parameter sensor, drawing the blood over the parameter sensor and sensing the blood parameter.

31. A method of claim 30, wherein flushing the parameter sensor, calibrating, drawing and sensing are done continuously in repeating series until determining, based on the pressure sensed, that the occlusion has formed.

32. A method of claim 31, further comprising reversing flow within the internal fluid passageway by stopping drawing and starting flushing in response determining that the occlusion has formed.

33. A method of claim 32, further comprising restarting:

flushing the parameter sensor, calibrating, drawing and sensing in repeating series after flushing the internal fluid passageway.

34. A method of claim 23, further comprising adapting a draw time for the blood based on sensing the pressure.

35. A method of claim 34, wherein adapting the draw time includes temporarily reducing the draw time in response to sensing an increase in the pressure.

36. A method of claim 23, further comprising adapting a flush rate based on sensing the pressure.

37. A method of claim 36, further comprising increasing a flush rate based on sensing an increase in the pressure.

38. A method of claim 23, wherein sensing the pressure includes sensing a pressure gradient and further comprising adapting the flushing the internal fluid passageway based on the pressure gradient.

39. A method of claim 23, further comprising storing pressures sensed in the internal fluid passageway and adapting the flushing based on a contour of the stored pressures.

40. A fluid-flow optimization system for connecting to a vascular access device connected to a patient'"'"'s vasculature and supporting at least one parameter sensor and at least one pressure sensor, the system comprising:

a flow control device connected in fluid communication with the internal fluid passageway and connected in communication with the at least one pressure sensor;

wherein the flow control device is configured to adapt fluid flow within the internal fluid passageway based on communication with the at least one pressure sensor.

41. A system of claim 40, wherein the flow control device is further configured to draw blood into the internal fluid passageway of the vascular access device and over the parameter sensor.

42. A system of claim 41, wherein the flow control device is further configured to flush a solution over the parameter sensor.

43. A system of claim 42, wherein the flow control device is configured to adapt a draw time for the blood based on communication with the at least one pressure sensor.

44. A system of claim 43, wherein the flow control device is configured to adapt a flush time for the solution based on communication with the at least one pressure sensor.

45. A system of claim 43, wherein the flow control device is configured to temporarily reduce a draw time in response to an increased pressure communicated by the at least one pressure sensor.

46. A system of claim 42, wherein the flow control device is configured to adapt a flow rate for the blood based on communication with the at least one pressure sensor.

47. A system of claim 46, wherein the flow control device is configured to adapt a flush rate for the solution based on communication with the at least one pressure sensor.

48. A system of claim 46, wherein the flow control device is configured to increase the flush rate of the solution in response to detection of a pressure increase by the pressure sensor.

49. A system of claim 48, wherein the flow control device is configured to stop drawing blood and start flushing solution in response to detection of the pressure increase.

50. A system of claim 40, wherein the flow control device is connected in communication with the at least one parameter sensor and is further configured to adapt fluid flow within the internal fluid passageway based on communication with the at least one parameter sensor.

51. A system of claim 40, wherein the flow control device is configured to reverse drawing blood into flushing the solution in response to an increased pressure communicated by the at least one pressure sensor.

52. A system of claim 40, wherein the flow control device is further configured to adapt the fluid flow based on a pressure gradient communicated by the at least one pressure sensor.

53. A system of claim 40, wherein the flow control device includes a memory and is capable of storing pressures communicated by the pressure sensor over time and to adapt fluid flow based on a contour of the stored pressures.

54. A system of claim 40, wherein the flow control device is further configured to communicate with multiple pressure sensors arrayed along the internal fluid passageway and to adapt the fluid flow based on differences in pressure measured between the sensors.