Syringe Pump Having A Pressure Sensor Assembly

• US 20150157791A1
• Filed: 02/20/2015
• Published: 06/11/2015
• Est. Priority Date: 01/22/2010
• Status: Active Grant

• Current Assignee: Deka Products Limited Partnership
• Original Assignee: Deka Products Limited Partnership
• Inventors: Desch, Martin D., Gray, Larry B., Bodwell, Jesse T., van der Merwe, Dirk A.
• Granted Patent: US 10,391,241 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/16863 Occlusion detection
• CPC Class Codes: A61M 2005/16872 Upstream occlusion sensors
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/14 Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/332 Force measuring means
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/6063 Optical identification systems
• CPC Class Codes: A61M 2205/8206 : battery-operated
• CPC Class Codes: A61M 2209/02 : Equipment for testing the apparatus
• CPC Class Codes: A61M 2209/082 : Mounting brackets, arm supports for equipment
• CPC Class Codes: A61M 2209/086 : Docking stations
• CPC Class Codes: A61M 5/1408 : in parallel, e.g. manifolds, sequencing valves access sites A61M39/02; tube connectors A61M39/10
• CPC Class Codes: A61M 5/1413 : Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/1415 : Stands, brackets or the like for supporting infusion accessories
• CPC Class Codes: A61M 5/14232 : Roller pumps
• CPC Class Codes: A61M 5/1452 : pressurised by means of pistons
• CPC Class Codes: A61M 5/1456 : with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir
• CPC Class Codes: A61M 5/1458 : Means for capture of the plunger flange
• 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 5/16831 : 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 5/16854 : by monitoring line pressure
• CPC Class Codes: A61M 5/16859 : Evaluation of pressure response, e.g. to an applied pulse
• CPC Class Codes: A61M 5/172 : electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: G01L 7/16 : in the form of pistons
• CPC Class Codes: G01L 9/00 : Measuring steady of quasi-steady pressure of fluid or fluent solid material by electric or magnetic pressure-sensitive elements G01L11/004 takes precedence; Transmitting or indicating the displacement of mechanical pressure-sensitive elements, used to measure the steady or quasi-steady pressure of a fluid or fluent solid material, by electric or magnetic means measuring differences of two or more pressure values G01L13/00; measuring two or more pressure values simultaneously G01L15/00
• CPC Class Codes: G01L 9/0089 : Transmitting or indicating the displacement of pistons by electrical, electromechanical, magnetic or electromagnetic means G01L9/0008 takes precedence
• CPC Class Codes: G06F 3/0488 : using a touch-screen or digitiser, e.g. input of commands through traced gestures
• CPC Class Codes: G16H 10/65 : stored on portable record carriers, e.g. on smartcards, RFID tags or CD
• CPC Class Codes: G16H 20/10 : relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: G16H 40/67 : for remote operation
• CPC Class Codes: G16H 70/40 : relating to drugs, e.g. their side effects or intended usage

Abstract

A syringe pump is disclosed that includes a body, a syringe seat, a syringe actuator, a memory, and one or more processors. The syringe seat is coupled to the body. The syringe actuator is configured to actuate a syringe secured within the syringe seat. The memory is configured to store a plurality of instructions. The one or more processors, in accordance with the plurality of instructions, is/are configured to: prime the syringe pump in a prime phase; determine if an occlusion exists during the prime phase using a first test; stop the prime phase; initiate fluid delivery into a patient; enter into a start-up phase; determine if an occlusion exists using a second test during the start-up phase; transition from the start-up phase into a steady-state phase; and determine if an occlusion exists during the steady-state phase using a third test.

Claims

1. A syringe pump comprising:

a body;

a syringe seat coupled to the body;

a syringe actuator configured to actuate a syringe secured within the syringe seat;

a memory configured to store a plurality of instructions stored thereon; and

at least one processor, in accordance with the plurality of instructions, configured to;

prime the syringe pump in a prime phase;

determine if an occlusion exists during the prime phase using a first test;

stop the prime phase;

initiate fluid delivery into a patient;

enter into a start-up phase;

determine if an occlusion exists using a second test during the start-up phase;

transition from the start-up phase into a steady-state phase; and

determine if an occlusion exists during the steady-state phase using a third test.

2. The syringe pump according to claim 1, wherein the at least one processor is configured to start the prime phase in response to a user input.

3. The syringe pump according to claim 2, further comprising a touch screen configured such that the user input is entered into the touch screen, the touch screen is in operative communication with the at least one processor, wherein the at least one processor and the touch screen are configured such that the at least one processor receives confirmation of the user input.

4. The syringe pump according to claim 1, further comprising:

a force sensor configured to determine a force applied to the syringe by actuation of the syringe actuator; and

a motor sensor operatively coupled to a motor of the syringe pump.

5. The syringe pump according to claim 4, wherein the at least one processor is in operative communication with the force sensor and the motor sensor.

6. The syringe pump according to claim 5, wherein the at least one processor is configured to use the motor sensor to determine a motor position and a motor rotation speed.

7. The syringe pump according to claim 6, wherein the at least one processor is configured to use the motor position, the motor rotation speed, and the force applied to the syringe to perform at least one of the first, second, and third tests.

8. The syringe pump according to claim 1, wherein the at least one processor is configured to perform the first test such that the at least one processor determines if the pressure, P, exceeds a first threshold to trigger an occlusion alarm.

9. The syringe pump according to claim 8, wherein the pressure, P, is determined by the at least one processor in accordance with:

10. The syringe pump according to claim 1, wherein the at least one processor is configured to perform the second test such that the at least one processor determines if the pressure, P, exceeds a second threshold or an occlusion metric exceeds a third threshold multiplied by a motor speed to trigger an occlusion alarm.

11. The syringe pump according to claim 10, wherein the at least one processor is configured to determine the pressure, P, in accordance with:

12. The syringe pump according to claim 10, wherein the occlusion metric, OM, is the pressure, P, minus an average pressure, Pavg.

13. The syringe pump according to claim 12, wherein the at least one processor is configured to determine the pressure, P, in accordance with:

14. The syringe pump according to claim 1, wherein the at least one processor is configured to perform the third test such that the at least one processor determines if:

a pressure, P, exceeds a fourth threshold;

or an occlusion metric, OM, exceeds a fifth threshold to trigger an occlusion alarm.

15. The syringe pump according to claim 1, wherein the at least one processor is configured to perform the third test such that the at least one processor determines if:

a pressure, P, exceeds a fourth threshold;

an occlusion metric, OM, exceeds a fifth threshold;

or the pressure, P, minus a first, P₀, of a series of the pressure, P, exceeds a sixth threshold to trigger an occlusion alarm.

16. The syringe pump according to claim 15, wherein the first, P₀, of a series of the pressure, P, is a first measurement of the pressure when the syringe pump enters into the steady-state phase.

17. The syringe pump according to claim 14, wherein the at least one processor is configured to determine the pressure, P, in accordance with:

18. The syringe pump according to claim 1, wherein the at least one processor is configured to transition from the start-up phase into the steady-state phase when:

an occlusion metric, OM, exceeds a first value; and

the occlusion metric, OM, is less than a second value.

19. The syringe pump according to claim 18, wherein the at least one processor is configured to transition from the start-up phase into the stead-state phase when the occlusion metric, OM, exceeds the first value before the occlusion metric, OM, is less than the second value.

20. The syringe pump according to claim 19, wherein the occlusion metric, OM, is the pressure, P, minus an average pressure, Pavg.

21. The syringe pump according to claim 20, wherein the at least one processor is configured to determine, P, in accordance with:

22. A method for operating a syringe pump, at least partially implemented by at least one processor executing a plurality of instructions configured for execution by the at least one processor, the method comprising:

priming the syringe pump in a prime phase;

determining if an occlusion exists during the prime phase using a first test;

stopping the prime phase;

initiating fluid delivery into a patient;

entering into a start-up phase;

determining if an occlusion exists using a second test during the start-up phase;

transitioning from the start-up phase into a steady-state phase; and

determining if an occlusion exists during the steady-state phase using a third test.

23. The method according to claim 22, further comprising receiving user initiation of the prime phase.

24. The method according to claim 22, further comprising determining a force applied to a syringe by actuation of a syringe actuator.

25. The method according to claim 22, further comprising:

determining a motor position; and

determining a motor rotation speed.

26. The method according to claim 22, further comprising performing the first test by determining if a pressure, P, exceeds a first threshold to trigger an occlusion alarm.

27. The method according to claim 26, wherein the pressure, P, is determined in accordance with:

28. The method according to claim 22, further comprising performing the second test by determining if the pressure, P, exceeds a second threshold or an occlusion metric exceeds a third threshold multiplied by a motor speed to trigger an occlusion alarm.

29. The method according to claim 28, wherein the pressure, P, is determined in accordance with:

30. The method according to claim 28, wherein the occlusion metric, OM, is the pressure, P, minus an average pressure, Pavg.

31. The method according to claim 30, the pressure, P, is determined in accordance with:

32. The method according to claim 22, further comprising performing the third test by determining if:

a pressure, P, exceeds a fourth threshold;

an occlusion metric, OM, exceeds a fifth threshold;

or the pressure, P, minus a first, P₀, of a series of the pressure, P, exceeds a sixth threshold to trigger an occlusion alarm.

33. The method according to claim 22, further comprising performing the third test by determining if:

a pressure, P, exceeds a fourth threshold;

an occlusion metric, OM, exceeds a fifth threshold;

or the pressure, P, minus a first, P₀, of a series of the pressure, P, exceeds a sixth threshold to trigger an occlusion alarm.

34. The method according to claim 33, wherein the first, P₀, of a series of the pressure, P, is a first measurement of the pressure when the syringe pump enters into the steady-state phase.

35. The method according to claim 33, wherein the pressure, P, is determined in accordance with:

36. The method according to claim 22, wherein the act of transitioning from the start-up phase into the steady-state phase occurs when:

an occlusion metric, OM, exceeds a first value; and

the occlusion metric, OM, is less than a second value.

37. The method according to claim 36, wherein act of transitioning from the start-up phase into the stead-state phase occurs only if the occlusion metric, OM, exceeds the first value before the occlusion metric, OM, is less than the second value.

38. The method according to claim 37, wherein the occlusion metric, OM, is the pressure, P, minus an average pressure, Pavg.

39. The method according to claim 38, wherein the pressure, P, is determined in accordance with:

40. A method for recovering from an occlusion, the method comprising:

dispensing fluid into a patient using a syringe pump;

monitoring the syringe pump;

determining whether an occlusion associated with the syringe pump exists;

stopping delivery in response to the determined occlusion;

determining if a force drops below a predetermined threshold within a predetermined period of time, wherein the predetermined threshold is a predetermined percentage of the difference between a steady state force and the force at the time of the determined occlusion;

reversing the syringe pump to relieve a pressure within the syringe pump is the syringe pump does not drop below the predetermined threshold within the predetermined period of time; and

stopping the syringe pump when the slope drops below a predetermined value and then rises above a second predetermined value.

41. A pressure sensor assembly, comprising:

a plunger having a sensing surface;

a first pressure sensor operatively coupled to the plunger and configured to estimate a force applied to the sensing surface; and

a second pressure sensor operatively coupled to the plunger and configured to estimate the force applied to the sensing surface.

42. The assembly according to claim 41, wherein a processor is coupled to the first and second pressure sensors.

43. The assembly according to claim 42, wherein the processor is configured to estimate a magnitude of the force applied to the sensing surface using the first and second pressure sensors.

44. The assembly according to claim 42, wherein the processor is configured to estimate a position on the sensing surface where the force is applied thereto.

45. The assembly according to claim 41, further comprising a guide configured to guide the plunger such that the sensing surface moves one of away from and toward the first and second pressure sensors.

46. The assembly according to claim 45, further comprising a seal disposed over the sensing surface.

47. A syringe pump, comprising:

a plunger head assembly configured to receive an actuatable portion of a syringe;

the pressure sensor assembly according to claim 41, the pressure sensor assembly is coupled to the plunger head such that the sensing surface receives the actuatable portion of the syringe.

48. A peristaltic pump, comprising:

a body configured receive an infusion tube;

the pressure sensor assembly according to claim 41, the pressure sensor assembly is coupled to the infusion tube such that the sensing surface responds to pressure within the infusion tube.

49. A syringe pump, comprising:

a plunger head assembly configured to receive an actuatable portion of a syringe;

a pressure sensor assembly coupled to the plunger head assembly and configured to sense a force applied to the plunger head assembly, the pressure sensor assembly comprising;

a plunger having a sensing surface configured to receive the force;

a first pressure sensor operatively coupled to the plunger and configured to estimate the force applied to the sensing surface; and

a second pressure sensor operatively coupled to the plunger and configured to estimate the force applied to the sensing surface; and

a processor coupled to the first and second pressure sensors, wherein the processor is configured to estimate a magnitude of the force.

50. The syringe pump according to claim 49, wherein the magnitude of the force is correlated with a pressure within the syringe.

51. The syringe pump according to claim 49, wherein the pressure sensor assembly further includes a seal disposed over the sensing surface of the plunger, wherein the seal is configured to seal the plunger head assembly from fluid ingress.

52. The syringe pump according to claim 49, wherein the plunger head assembly is configured to actuate the syringe and the processor is configured to determine if an occlusion exists using the first and second pressure sensors.

53. The syringe pump according to claim 49, wherein the processor is configured to determine where on the sensing surface the force is applied.

54. The syringe pump according to claim 49, wherein the processor is configured to estimate a magnitude of the force applied to the sensing surface using the first and second pressure sensors.

55. The syringe pump according to claim 49, wherein the processor is configured to estimate a position on the sensing surface where the force is applied thereto.

56. The syringe pump according to claim 49, further comprising a guide configured to guide the plunger such that the sensing surface moves one of away from and toward the first and second pressure sensors.

57. The syringe pump according to claim 49, wherein the sensing surface is elongated along a first direction.

58. The syringe pump according to claim 57, wherein the elongated sensing surface is configured to receive a plurality of syringe sizes loaded into the syringe pump.

59. The syringe pump according to claim 49, wherein the sensing surface is configured to receive a plurality of syringe sizes loaded into the syringe pump

60. A pressure sensor assembly, comprising:

a plunger comprising;

a sensing surface, the sensing surface having an elongated portion along a first axis and a width along a second axis, the first and second axes are orthogonal relative to each other, wherein the width is about constant along a substantial portion of elongated portion, wherein the elongated portion of the sensing surface defines first and second ends, wherein the first and second ends are curved;

a first extension disposed adjacent to or on the first end of the sensing surface and extending along a third axis orthogonal to the first and second axes away from sensing surface; and

a second extension disposed adjacent to or on the second end of the sensing surface and extending along a fourth axis orthogonal to the first and second axes away from sensing surface, wherein the third and fourth axes are parallel to each other;

a guide configured to guide the movement of the plunger along the third and fourth axes;

a first pressure sensor disposed adjacent to an end of the first extension opposite to the sensing surface, the first pressure sensor is configured to sense movement of the plunger within the guide; and

a second pressure sensor disposed adjacent to an end of the second extension opposite to the sensing surface, the second pressure sensor is configured to sense movement of the plunger within the guide.

61. The pressure sensor assembly according to claim 60, further comprising a seal at least partially disposed over at least a portion of the sensing surface.

62. The pressure sensor assembly according to claim 60, further comprising a brace operatively coupled to the first and second extensions.