System for detecting and removing a gas bubble from a vascular infusion line

• US 20110197652A1
• Filed: 09/21/2010
• Published: 08/18/2011
• Est. Priority Date: 05/21/2004
• Status: Active Grant

• Current Assignee: Clearline MD LLC
• Original Assignee: David T. Healey, Ihsan A. Haddad
• Inventors: Healey, David T., Haddad, Ihsan A.
• Granted Patent: US 8,419,709 B2
• Time in Patent Office: Days
• US Class Current: 73/19.03
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/3313 used specific wavelengths
• CPC Class Codes: A61M 2205/3375 Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• CPC Class Codes: A61M 5/365 Air detectors A61M5/1684 takes precedence; in extracorporeal blood circuits A61M1/3626

Abstract

System for detecting and removing gas bubbles from a vascular infusion line, including a cassette adapted for disposition intermediate the fluid line, the cassette including a flexible tube having an inlet port for connection to a supply side of the fluid line, an outlet port configured for connection to a patient side of the fluid line, and a purge port intermediate the inlet and outlet ports, and a base unit adapted to receive the cassette and monitor fluid flow through the tube, the base unit including a sensor to detect the presence of a gas bubble in the fluid flow, a pinch valve adapted to stop the flow of fluid, and a control unit adapted to operate the base unit so that (i) fluid is permitted to flow past the pinch valve when no gas bubble is detected; and (ii) fluid flow is arrested when a gas bubble is detected.

Claims

1. A system for detecting and removing a gas bubble from a vascular infusion line, the system comprising:

a disposable cassette adapted for disposition intermediate the fluid line, the disposable cassette comprising;

a body; and

a flexible hollow tube having an inlet port being configured for connection to the supply side of the fluid line, an outlet port being configured for connection to the patient side of the fluid line and a purge port located intermediate the inlet port and the outlet port;

a base unit adapted to receive the disposable cassette and monitor fluid flow through the flexible hollow tube, wherein the base unit comprises;

a sensor adapted to detect the presence of a gas bubble in the fluid flowing through the flexible hollow tube; and

a pinch valve adapted to stop the flow of fluid through the flexible hollow tube; and

an electronic control unit adapted to operate the base unit so that (i) fluid is permitted to flow past the pinch valve when no gas bubble is detected by the sensor; and

(ii) fluid flow is arrested when a gas bubble is detected by the sensor.

2. A system according to claim 1 wherein the body of the disposable cassette comprises a groove configured to receive the flexible hollow tube.

3. A system according to claim 2 wherein the disposable cassette additionally comprises a cover for securing the flexible hollow tube within the groove.

4. A system according to claim 1 wherein the body of the disposable cassette encompasses at least a portion of the flexible hollow tube.

5. A system according to claim 1 wherein the disposable cassette comprises a flexible hollow tube arranged in an inline configuration, and further wherein the body comprises the structure for stabilizing the flexible hollow tube in this configuration.

6. A system according to claim 5 wherein the flexible hollow tube is arranged in a stacked inline configuration.

7. A system according to claim 5 wherein the flexible hollow tube is arranged in a planar inline configuration.

8. A system according to claim 1 wherein the body has an L-shaped configuration.

9. A system according to claim 1 wherein the flexible hollow tubing is arranged in a switchback configuration so as to create a sensor loop.

10. A system according to claim 9 wherein the sensor loop is sized so as to have a volume of approximately 1 cc.

11. A system according to claim 1 wherein, when the disposable cassette is mounted to the base unit, the portion of the flexible hollow tube located adjacent the sensor is displaced from the purge port so as to create a delay loop.

12. A system according to claim 11 wherein the delay loop is configured to have a length of approximately 10 cm.

13. A system according to claim 1 wherein the body of the disposable cassette comprises an opening to facilitate positioning of the flexible hollow tube adjacent to the sensor.

14. A system according to claim 1 wherein the body of the disposable cassette comprises an opening to facilitate positioning of the flexible hollow tube adjacent to the pinch valve.

15. A system according to claim 1 wherein the sensor comprises an ultrasound sensor.

16. A system according to claim 1 wherein the sensor comprises two halves hinged together.

17. A system according to claim 1 wherein the sensor is an infra red sensor.

18. A system according to claim 1 wherein the sensor utilizes electrical resistance to detect the presence of a gas bubble.

19. A system according to claim 1 wherein the sensor utilizes Doppler technology to detect the presence of a gas bubble.

20. A system according to claim 1 wherein the sensor comprises (i) a floatable device disposed in the fluid which rises in the presence of liquid and sinks in the presence of a gas bubble;

and (ii) apparatus for detecting the position of the floatable device.

21. A system according to claim 1 wherein the sensor is adapted to simultaneously detect the presence of a gas bubble in the fluid flowing through at least two portions of the flexible hollow tube.

22. A system according to claim 21 wherein the flexible hollow tube is configured so that the two portions are adjacent to one another.

23. A system according to claim 1 wherein the pinch valve is manually cocked.

24. A system according to claim 1 wherein the pinch valve comprises a solenoid.

25. A system according to claim 1 wherein the pinch valve is configured so as to selectively collapse the wall of the flexible hollow tube whereby the arrest the flow of fluid.

26. A system according to claim 1 wherein the electronic control unit is hard-wired to the base unit.

27. A system according to claim 1 wherein the electronic control unit is in wireless communication with the base unit.

28. A system according to claim 1 wherein the electronic control unit internally powered by a rechargeable power supply.

29. A system according to claim 1 wherein the electronic control unit internally powered by an external power source.

30. A system for detecting a gas bubble from a vascular infusion line, the system comprising:

a cassette adapted for disposition intermediate the fluid line, the cassette comprising;

a body; and

a passageway having an inlet port being configured for connection to the supply side of the fluid line, and an outlet port being configured for connection to the patient side of the fluid line; and

a first portion of a valve for selectively arresting fluid flow through the passageway;

a base unit adapted to receive the cassette and monitor fluid flow through the passageway, wherein the base unit comprises;

a sensor adapted to detect the presence of a gas bubble in the fluid flowing through the passageway; and

a second portion of a valve for selectively arresting fluid flow through the passageway; and

an electronic control unit adapted to operate the second portion of the valve so that (i) fluid is permitted to flow past the first portion of the valve when no gas bubble is detected by the sensor; and

(ii) fluid flow is arrested when a gas bubble is detected by the sensor.

31. A system according to claim 30 wherein the first portion of the valve is formed by providing the passageway with a flexible wall capable of being deformed so as to close off the passageway to fluid flow.

32. A system according to claim 31 wherein the second portion of the valve comprises an actuator for deforming the flexible wall of the passageway.

33. A system according to claim 30 wherein the first portion of the valve comprises a valve housing, a valve seat and a valve member for selective engagement with the seat, and wherein the second portion of the valve comprises an actuator for moving the valve member.

34. A method for detecting and removing a gas bubble from a vascular infusion line, the method comprising:

providing a system comprising;

a disposable cassette adapted for disposition intermediate the fluid line, the disposable cassette comprising;

a body; and

a flexible hollow tube having an inlet port being configured for connection to the supply side of the fluid line, an outlet port being configured for connection to the patient side of the fluid line and a purge port located intermediate the inlet port and the outlet port;

a base unit adapted to receive the disposable cassette and monitor fluid flow through the flexible hollow tube, wherein the base unit comprises;

a sensor adapted to detect the presence of a gas bubble in the fluid flowing through the flexible hollow tube; and

a pinch valve adapted to stop the flow of fluid through the flexible hollow tube; and

an electronic control unit adapted to operate the base unit so that (i) fluid is permitted to flow past the pinch valve when no gas bubble is detected by the sensor; and

(ii) fluid flow is arrested when a gas bubble is detected by the sensor;

initiating fluid flow through the disposable cassette; and

monitoring the fluid flowing through the disposable cassette for the occurrence of a gas bubble and, if a gas bubble is detected, arresting the flow of fluid through the fluid line.

35. A method according to claim 34 including the further step of removing a detected gas bubble through the purge port.

36. A method for detecting a gas bubble from a vascular infusion line, the method comprising:

providing a system comprising;

a cassette adapted for disposition intermediate the fluid line, the cassette comprising;

a body; and

a passageway having an inlet port being configured for connection to the supply side of the fluid line, and an outlet port being configured for connection to the patient side of the fluid line; and

a first portion of a valve for selectively arresting fluid flow through the passageway;

a base unit adapted to receive the cassette and monitor fluid flow through the passageway, wherein the base unit comprises;

a sensor adapted to detect the presence of a gas bubble in the fluid flowing through the passageway; and

a second portion of a valve for selectively arresting fluid flow through the passageway;

an electronic control unit adapted to operate the second portion of the valve so that (i) fluid is permitted to flow past the first portion of the valve when no gas bubble is detected by the sensor; and

(ii) fluid flow is arrested when a gas bubble is detected by the sensor;

initiating fluid flow through the cassette; and

monitoring the fluid flowing through the cassette for the occurrence of a gas bubble and, if a gas bubble is detected, arresting the flow of fluid through the fluid line.

37. A method according to claim 36 including the further step of removing a detected gas bubble through the purge port.

38. A system for detecting and removing a gas bubble from a flexible vascular infusion line, the system comprising:

a cassette adapted for disposition intermediate the fluid line, the cassette comprising;

a body; and

a passageway having an inlet port being configured for connection to the supply side of the fluid line and an outlet port configured for connection to the patient side of the fluid line;

a base unit adapted to receive the cassette and monitor fluid flow through the passageway, wherein the base unit comprises;

a sensor adapted to detect the presence of a gas bubble in the fluid flowing through the passageway;

an electronic control unit disposed adjacent to the flexible fluid line, upstream of the cassette, wherein the electronic control unit comprises a valve for selectively arresting fluid flow through the flexible fluid line and circuitry for communicating with the sensor and operating the valve so that (i) fluid is permitted to flow through the flexible fluid line when no gas bubble is detected by the sensor; and

(ii) fluid flow through the flexible fluid line is arrested when a gas bubble is detected by the sensor; and

a purge port located upstream of the patient and downstream of the electronic control unit.

39. A method for detecting and removing a gas bubble from a flexible vascular infusion line, the method comprising:

providing a system comprising;

a cassette adapted for disposition intermediate the fluid line, the cassette comprising;

a body; and

a passageway having an inlet port being configured for connection to the supply side of the fluid line and an outlet port configured for connection to the patient side of the fluid line;

a base unit adapted to receive the cassette and monitor fluid flow through the passageway, wherein the base unit comprises;

a sensor adapted to detect the presence of a gas bubble in the fluid flowing through the passageway;

an electronic control unit disposed adjacent to the flexible fluid line, upstream of the cassette, wherein the electronic control unit comprises a valve for selectively arresting fluid flow through the flexible fluid line and circuitry for communicating with the sensor and operating the valve so that (i) fluid is permitted to flow through the flexible fluid line when no gas bubble is detected by the sensor; and

(ii) fluid flow through the flexible fluid line is arrested when a gas bubble is detected by the sensor; and

a purge port located upstream of the patient and downstream of the electronic control unit;

initiating fluid flow through the flexible fluid line and through the cassette; and

monitoring the fluid flowing through the cassette for the occurrence of a gas bubble and, if a gas bubble is detected, arresting the flow of fluid through the flexible fluid line.