Apparatus and a method for monitoring a vascular access

• US 9,138,536 B2
• Filed: 04/01/2008
• Issued: 09/22/2015
• Est. Priority Date: 04/01/2008
• Status: Active Grant

• Current Assignee: Gambro Lundia AB (Baxter International Inc.)
• Original Assignee: Gambro Lundia AB (Baxter International Inc.)
• Inventors: Stefani, David, Lodi, Carlo Alberto, Sanna, Salvatore
• Primary Examiner(s): Ho, Tan-Uyen (Jackie) T
• Assistant Examiner(s): WARDAS, MARK A
• Application Number:
  US12/935,672
• Publication Number:
  US 20110046533A1
• Time in Patent Office: 2,730 Days
• Field of Search: 600/301, 600/407, 600/473, 600/476, 600/477, 600/547, 604/4.01, 604/4.02, 604 501- 505, 604/93.01, 604/6.05, 604/6.06, 604/6.09, 604/6.11, 210/645, 210/646, 210/739, 210/741, 210/745
• US Class Current: 1/1
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 1/3669 Electrical impedance measurement of body fluids; transducers specially adapted therefor
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3375 Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 5/16836 by sensing tissue properties at the infusion site, e.g. for detecting infiltration detecting tissue temperature for diagnostic purposes A61M39/0247
• CPC Class Codes: A61M 5/16859 Evaluation of pressure response, e.g. to an applied pulse

Abstract

An apparatus for monitoring a vascular access includes a dialysis circuit having a venous needle and a blood pump of a peristaltic type which generates oscillatory perturbations in the circuit. An optical sensor, arranged on a patient'"'"'s body by the venous needle, perceives the perturbations transmitted through the needle and sends a pulsating signal to an analysis device. The absence of a pulsating signal indicates a detachment of the needle.

Claims

1. An apparatus for monitoring a vascular access, comprising:

a fluid transport system for moving a fluid;

at least one needle connected to the fluid transport system and to a vascular access of an individual, the needle being configured to supply the fluid to the vascular access, to remove the fluid from the vascular access, or to both supply the fluid to the vascular access and to remove the fluid from the vascular access;

a perturbation generator configured to generate variations of at least one parameter in the fluid transport system, to generate variations of at least one parameter in the needle, or to generate variations of at least one parameter in both the fluid transport system and in the needle;

a sensor configured to be applied directly to the individuals body independent of the needle and the fluid transport system,

wherein the sensor comprises at least an emitter of light radiation and a receiver of light radiation configured to emit a signal indicating the variations of at least one parameter generated by the perturbation generator and transmitted through the needle, the emitter of light radiations and the receiver of light radiations configured to be operatively associated to at least a tissue of the individual'"'"'s body; and

an analysis device configured to recognize a detachment of the at least one needle, on a basis of said signal.

2. The apparatus of claim 1, wherein the perturbation generator is operatively directly associated to the fluid transport system.

3. The apparatus of claim 1, wherein the perturbation generator comprises at least an actuator arranged in the fluid transport system.

4. The apparatus of claim 1, wherein the fluid transport system comprises at least an actuator, the perturbation generator comprising the actuator.

5. The apparatus of claim 1, wherein the sensor comprises at least an active part configured to assume at least an operative configuration in which the sensor interacts with the individual'"'"'s body and is not constrained rigidly to the needle.

6. The apparatus of claim 1, wherein:

the at least one needle has a proximal end configured to penetrate a vascular access at a point of penetration and a distal end connected to the fluid transport system;

the sensor comprises at least an active part configured to assume at least an operative configuration in which the sensor interacts with the individual'"'"'s body such that, when the proximal end is in a normal operative configuration in which the proximal end penetrates into the vascular access, said point of penetration is arranged in an intermediate zone between the distal end and the active part.

7. The apparatus of claim 1, wherein the sensor comprises at least an active part configured to assume at least an operative configuration in which the active part interacts contactingy or nearly contactingly with a surface of the individual'"'"'s body.

8. The apparatus of claim 1, wherein the sensor comprises a physiological sensor for detecting at least a physiological parameter of the individual.

9. The apparatus of claim 1, wherein the emitter of light radiation and the receiver of light radiation are configured to be arranged on first and second opposite sides of the tissue.

10. The apparatus of claim 1 wherein the emitter of light radiation and the receiver of light radiation are configured to be arranged on a same side of the tissue.

11. The apparatus of claim 1, wherein the receiver of light radiation comprises at least a receiver of light radiation reflected by the tissue or at least a receiver of light radiations absorbed by the tissue.

12. The apparatus of claim 1, wherein the sensor comprises one or more sensors selected from the group of sensors including:

a pulsimeter, an intracorporeal blood pressure sensor, an acoustic sensor, and an optic sensor.

13. The apparatus of claim 12, wherein the pulsimeter comprises a finger pulsimeter.

14. The apparatus of claim 12 or 13, wherein the intracorporeal blood pressure sensor is configured to measure at least one of a systolic pressure of the individual, a diastolic pressure of the individual, or the mean arterial pressure of the individual.

15. The apparatus of claim 1, wherein the analysis device is configured to discriminate, in the signal provided by the sensor, the variation of at least one parameter transmitted through the vascular access, and to compare the variation with at least one threshold value.

16. The apparatus of claim 1, wherein the analysis device comprises at least a filter for processing the signal emitted by the sensor, said filter configured to identify the variations of at least one parameter transmitted through the vascular access.

17. The apparatus of claim 1, wherein the fluid transport system comprises an extracorporeal blood circuit configured to remove blood from and return blood to the individual'"'"'s body, the needle being a blood return needle.

18. The apparatus of claim 17, wherein the fluid transport system comprises a membrane exchanger having a blood chamber and a fluid chamber separated from one another by a semipermeable membrane, the extracorporeal blood circuit having a blood removal line connected to an inlet of the blood chamber and a blood return line connected to an exit of the blood chamber.

19. The apparatus of claim 1, wherein the perturbation generator is configured to generate pulsating-type variations of the at least one parameter.

20. The apparatus of claim 1, wherein the perturbation generator is operatively associated in contact with a flexible wall delimiting a fluid path of the fluid transport system.

21. The apparatus of claim 1, wherein the at least one parameter comprises at least one parameter of the fluid selected from a group comprising:

pressure, flow, temperature, viscosity, hematocrit, conductivity, concentration of a substance in the fluid, optical properties, optical absorption, optical reflection, acoustic properties, acoustic impedance, and velocity of sound propagation.

22. The apparatus of claim 1, wherein the perturbation generator comprises at least a generator of variations of pressure, flow, or both pressure and flow in the fluid transport system.

23. The apparatus of claim 22, wherein the generator of variations of pressure, flow, or both pressure and flow comprises a flexible-wall deformation pump configured for fluid transport.

24. The apparatus of claim 23, wherein the flexible-wall deformation pump comprises a peristaltic pump.

25. The apparatus of claim 23, wherein the flexible-wall deformation pump is a rotary pump.

26. A method for monitoring a vascular access, comprising:

providing a fluid transport system;

connecting at least one needle to the fluid transport system and to a vascular access of an individual;

supplying, removing, or supplying and removing a fluid to the vascular access, from the vascular access, or to and from the vascular access through the at least one needle;

generating variations of at least one parameter in the fluid transport system, generating variations of at least one parameter in the at least one needle, or generating variations of at least one parameter in both the fluid transport system and in the at least one needle;

applying a sensor directly to the individual'"'"'s body independent of the needle and the fluid transport system,

wherein the sensor comprises at least an emitter of light radiation and a receiver of light radiation configured to emit a signal indicating the variations of at least one parameter generated by the perturbation generator and transmitted through the needle, the emitter of light radiations and the receiver of light radiations configured to be operatively associated to at least a tissue of the individual'"'"'s body;

monitoring the individual'"'"'s body in order to identify the signal indicating the variations of at least one parameter transmitted through the at least one needle; and

recognising a detachment of the at least one needle on a basis of the monitoring.

27. The method of claim 26, wherein the variations of at least one parameter are generated directly in the fluid transport system.

28. The method of claim 26, further comprising connecting an actuator to the fluid transport system, the variation of at least one parameter being generated by the actuator.

29. The method of claim 26, wherein the variations of at least one parameter are generated by an actuator of the fluid transport system.

30. The method of claim 26, further comprising stages of positioning a sensor for the monitoring on the individual'"'"'s body, and positioning the at least one needle on the individual'"'"'s body, the positioning stages being performed independently from one another.

31. The method of claim 26, wherein:

the at least one needle has a proximal end configured to penetrate a vascular access and a distal end connected to the fluid transport system;

the method further comprising a stage of positioning a sensor for monitoring on the individual'"'"'s body such that when the proximal end is in a normal operating configuration in which the proximal end is penetrating the vascular access, the proximal end is arranged in an intermediate zone between the distal end and an active part of the sensor which interacts with the individual'"'"'s body.

32. The method of claim 26, further comprising a stage of positioning a sensor for monitoring such that the sensor has an active part which interacts in contact or nearly in contact with a surface of the individual'"'"'s body.

33. The method of claim 26, wherein the stage of monitoring comprises detecting at least a physiological parameter of the individual.

34. The method of claim 26, wherein the stage of monitoring comprises at least an emission of light radiation on at least a tissue of the individual'"'"'s body, and at least a receiving of the light radiation.

35. The method of claim 34, wherein the emission and reception of light radiation are performed on first and second opposite sides of the tissue.

36. The method of claim 34, wherein the emission and reception of light radiation are performed on a same side of the tissue.

37. The method of claim 34, wherein the light radiation received comprises reflected light radiation from the tissue, light radiation absorbed by the tissue, or light radiation reflected from and absorbed by the tissue.

38. The method of claim 26, wherein the monitoring comprises measuring at least one of pulse oximetry, intracorporeal blood pressure, an acoustic characteristic, or an optical characteristic.

39. The method of claim 38, wherein the pulse oximetry is measured at a finger of the individual.

40. The method of claim 38, wherein the intracorporeal blood pressure comprises at least one of a systolic pressure, a diastolic pressure, or a mean arterial pressure of the individual.

41. The method of claim 26, wherein the stage of recognising the detachment of the needle comprises:

detecting a signal indicating a characteristic of the individual'"'"'s body;

discriminating, in the signal, a part due to the variation of at least one parameter transmitted through the vascular access; and

comparing the variation with at least one threshold value.

42. The method of claim 26, comprising at least a filtering stage for processing a signal indicating a characteristic of the individual'"'"'s body such as to identify, in the signal, the part thereof which is due to the variation of at least one parameter transmitted through the vascular access.

43. The method of claim 26, wherein the fluid transport system comprises an extracorporeal blood circuit configured for removing and returning blood from and to the individual'"'"'s body, the needle being a blood return needle.

44. The method of claim 43, wherein the fluid transport system comprises a membrane exchanger having a blood chamber and a fluid chamber separated from one another by a semipermeable membrane, the extracorporeal blood circuit having a blood removal line connected to an inlet of the blood chamber and a blood return line connected to an outlet of the blood chamber.

45. The method of claim 26, wherein the variation of at least one parameter comprises a variation of the parameter of a pulsating type.

46. The method of claim 26, comprising a stage of connecting a perturbation generator contactingly with a flexible wall delimiting a fluid path in the fluid transport system, the variation of at least one parameter being generated by the perturbation generator.

47. The method of claim 26, wherein the at least one parameter comprises at least one parameter of the fluid selected from a group comprising:

pressure, flow, temperature, viscosity, hematocrit, conductivity, concentration of a substance in the fluid, optical properties, optical absorption, optical reflection, acoustic properties, acoustic impedance, and velocity of sound propagation.

48. The method of claim 26, wherein the stage of generating variations of at least one parameter comprises varying pressure, flow, or both pressure and flow in the fluid transport system.

49. The method of claim 48, wherein the stage of generating variations of at least one parameter comprises activating a flexible-wall deformation pump configured for fluid transport.

50. The method of claim 49, wherein the flexible-wall deformation pump comprises a peristaltic pump.

51. The method of claim 48 or 49, wherein the flexible-wall deformation pump is a rotary pump.