Pneumatically coupled direct drive fluid control system and process

• US 10,342,920 B2
• Filed: 04/18/2016
• Issued: 07/09/2019
• Est. Priority Date: 05/23/2013
• Status: Active Grant

• Current Assignee: Newiv Medical Corp.
• Original Assignee: Turnpoint Medical Devices, Inc.
• Inventors: Carlisle, Jeffrey A., Kuba, Lawrence M.
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Wilson, Larry R.
• Application Number:
  US15/131,708
• Publication Number:
  US 20160228637A1
• Time in Patent Office: 1,177 Days
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/14513 with secondary fluid driving or regulating the infusion
• CPC Class Codes: A61M 2039/242 designed to open when a predetermined pressure or flow rate has been reached, e.g. check valve actuated by fluid
• CPC Class Codes: A61M 2205/123 with incorporated reservoirs
• CPC Class Codes: A61M 2205/128 with incorporated valves
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3337 Controlling, regulating pressure or flow by means of a valve by-passing a pump
• CPC Class Codes: A61M 2205/3379 Masses, volumes, levels of fluids in reservoirs, flow rates
• CPC Class Codes: A61M 39/24 Check- or non-return valves
• CPC Class Codes: A61M 5/14224 Diaphragm type
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/14593 the diaphragm being actuated by fluid pressure
• CPC Class Codes: A61M 5/155 pressurised by gas introduced into the reservoir
• CPC Class Codes: A61M 5/16822 by controlling air intake into infusion reservoir needle sets with air inlet A61M5/162
• 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 5/16881 Regulating valves on-off valves, e.g. clamps A61M39/28
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/365 : Air detectors A61M5/1684 takes precedence; in extracorporeal blood circuits A61M1/3626
• CPC Class Codes: A61M 5/385 : using hydrophobic filters

Abstract

A fluid control system for delivery of a liquid includes a pneumatic drive that incorporates a linear actuator to effect known volume changes in a gas reservoir. The gas reservoir is in fluid communication with a gas-side reservoir that is separated from a fluid-side reservoir by a flexible membrane. Movement of the linear actuator effects positive or negative volume differences on the gas in the gas-side reservoir, resulting in a decrease or increase in pressure of the gas that is transmitted to the fluid-side reservoir to draw fluid, primarily liquid, in from a source or deliver liquid out to a sink. In another aspect, a mechanism is provided for the detection and elimination of air bubbles in the fluid path.

Claims

1. A process for controlling an infusion of fluid from a fluid source to a liquid sink, comprising:

a) exerting a negative pressure on a gas reservoir in fluid communication with a gas-side chamber separated from a fluid-side chamber by a flexible membrane to draw fluid from the fluid source into the fluid-side chamber through a one-way inlet valve until the fluid-side chamber fills with fluid;

b) exerting a positive pressure on the gas reservoir in fluid communication with the gas-side chamber by effecting a plurality of known, incremental changes in a volume of the gas reservoir as a series of discrete steps to deliver fluid in the fluid-side chamber to the liquid sink through a one-way outlet valve, wherein the one-way inlet valve and one way outlet valve each are passively operated and only open when a pressure differential between an upstream fluid and a downstream fluid reaches a predetermined cracking pressure;

c) monitoring pressure in the gas reservoir during the steps of exerting the negative pressure and exerting the positive pressure; and

d) determining volumes of fluid in the fluid-side chamber from the plurality of known, incremental changes in the volume of the gas reservoir and the gas-side chamber and any connecting dead space by an ideal gas law relationship, wherein P₁V₁=P₂V₂, wherein P₁ and P₂ are pressures measured before and after volume changes, respectively, and V₁ and V₂ are volumes before and after the volume changes, respectively.

2. The process of claim 1, further comprising repeating steps a through d, and wherein a total volume of fluid delivered to the liquid sink is determined after each successive repetition of steps a through d by adding a calculated volume change to a previously determined total volume.

3. The process of claim 1, wherein in step a, the negative pressure is exerted until the pressure differential across the one-way inlet valve reaches the predetermined cracking pressure of the one-way inlet valve such that the one way inlet valve opens and fluid flows into the fluid-side chamber, and the negative pressure is exerted additionally to continue drawing fluid into the fluid-side chamber until the fluid-side chamber fills with fluid as determined by a volume determined in step d.

4. The process of claim 1, wherein in step b, the positive pressure is exerted until the pressure differential across the one-way outlet valve reaches the predetermined cracking pressure of the one-way outlet valve such that the one-way outlet valve opens and fluid flows out of the fluid-side chamber, and the positive pressure is exerted additionally to continue delivering fluid out of the fluid-side chamber until the fluid-side chamber is emptied of fluid as determined by a volume determined in step d.

5. The process of claim 1, wherein a volume of the fluid-side chamber and the gas-side chamber together is fixed and the volume of the gas reservoir is variable by a known and controlled amount using a reciprocating element and a bidirectional linear actuator.

6. The process of claim 1, wherein a pressure trend is determined from the step of monitoring the pressure, and further wherein the pressure trend is indicative of one or more conditions upstream of the fluid-side chamber, downstream of the fluid-side chamber, or both, the one or more conditions selected from the group consisting of one or more of:

an indication of remaining fluid in the fluid source, air in the fluid-side chamber, an occlusion in an upstream line, an occlusion in a downstream line, and a disconnection in an output line.

7. The process of claim 1, wherein a pressure trend is determined from the step of monitoring the pressure, and further wherein the pressure trend is indicative of air in a fluid flow path.

8. The process of claim 1, wherein the negative pressure and positive pressure are exerted using a reciprocating element selected from the group consisting of:

a bellows end coupled at one end to a linear actuator, an interior of the bellows comprising at least part of the gas reservoir; and

a piston reciprocable within a cylinder, the cylinder comprising at least part of the gas reservoir.

9. The process of claim 1, wherein in step d, sensed pressure data is received before and after each known, incremental change in volume of the gas reservoir, the sensed pressure data is compared to a known change in gas volume resulting from said known, incremental change in volume of the gas reservoir, and a total volume of gas is calculated based on the sensed pressure data and the known, incremental change in volume of the gas reservoir based on said ideal gas law relationship between the sensed pressure data and the known, incremental change in volume of the gas reservoir.

10. The process of claim 1, further comprising:

periodically determining a total volume of fluid delivered to the liquid sink; and

repeating steps a through d and until the total volume of fluid delivered to the liquid sink is equal to a predetermined target volume.

11. The process of claim 1, further comprising:

periodically monitoring changes in a volume of fluid delivered to the liquid sink over time to calculate a flow rate of fluid delivered to the liquid sink; and

adjusting a rate of effecting the plurality of known, incremental changes in volume of the gas reservoir until the flow rate of fluid delivered to the liquid sink is equal to a predetermined target flow rate.