# US 11,109,973 B2 · System for evaluation of prosthetic heart valves under steady hydrodynamic conditions

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- Number: US 11,109,973 B2
- Document ID: US11109973B2
- Status: Granted
- Kind: B2
- Application number: 17/151,104
- Filed: 2021-01-15
- Published: 2021-07-15
- Granted: 2021-09-07
- Earliest claimed: 2020-01-15
- Assignees: Biomedical Device Consultants and Laboratories of Colorado, LLC
- Applicants: Biomedical Device Consultants and Laboratories of Colorado, Lcc
- Inventors: Benjamin McCloskey; Craig Weinberg
- Web page: https://patentgrep.com/patent/US11109973B2

## CPC

- A61F 2/2472: {Devices for testing}
- A61M 60/871: Energy supply devices; Converters therefor
- F04D 15/0066: {by changing the speed, e.g. of the driving engine}
- F05D 2260/83: Testing, e.g. methods, components or tools therefor
- F05D 2270/3015: differential pressure
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- F04D: NON-POSITIVE-DISPLACEMENT PUMPS (engine fuel-injection pumps F02M; ion pumps H01J41/12; electrodynamic pumps H02K44/02)
- F05D: INDEXING SCHEME FOR ASPECTS RELATING TO NON-POSITIVE-DISPLACEMENT MACHINES OR ENGINES, GAS-TURBINES OR JET-PROPULSION PLANTS

## Abstract

Steady flow hydrodynamic performance testing is performed on a valved prosthesis mounted in a test conduit. The system is configured with prescribed test condition inputs into control software. Upon test initiation, a steady flow pump is activated and automatically adjusts its flow based on the software logic to meet the prescribed first test condition. During forward flow pressure drop testing, the flow pump is automatically adjusted to achieve and hold a particular flow rate. During back flow leakage testing, the steady flow pump is automatically adjusted to achieve and hold a particular differential pressure across the test prosthesis while a flow rate of the leakage flow is measured. After a first test condition has been achieved, the system control software then automatically adjusts the pump flow rate to meet a second test condition. This process then continues until all conditions set by software inputs are evaluated.

## Claims

### Claim 1

A system for testing steady flow hydrodynamic performance of a valved prosthesis in both forward fluid flow and back fluid flow directions comprising
a reservoir storing a working fluid;
a fluid pump in fluid connection with the reservoir and configured to pump working fluid from the reservoir throughout the system;
a test conduit with a proximal end and a distal end and configured to hold a valved prosthesis within a lumen of the test conduit;
a pressure transducer configured to measure a pressure difference across the valved prosthesis held within the test conduit;
a first conduit extending between and in fluid connection with the distal end of the test conduit and the reservoir;
a variable first 2-way control valve positioned in line with the first conduit between the distal end of the test conduit and the reservoir;
a second conduit extending between and in fluid connection with the proximal end of the test conduit and the reservoir;
a first flow meter configured to measure a flow rate of the working fluid through the second conduit;
a second 2-way control valve positioned in line with the second conduit between the proximal end of the test conduit and the reservoir; and
a first 3-way control valve having an inlet in fluid connection with an outlet of the fluid pump, a first outlet in fluid connection with the proximal end of the test conduit, and a second outlet in fluid connection with the first conduit between the distal end of the test conduit and the variable first 2-way control valve, and configured to alternately direct the working fluid to either the test conduit or the first conduit exclusively;
wherein, without adjustment of the valved prosthesis within or removal of the valved prosthesis from the test conduit,
in a first system configuration, the first 3-way control valve exclusively directs fluid flow to the proximal end of the test conduit and through the test conduit to the distal end, the variable first 2-way control valve is configured in a fully open position, the second 2-way control valve is configured in a fully closed position, and fluid flow is directed in a forward flow direction through the test conduit to pass through the valved prosthesis in an open position such that a first pressure drop value across the open valved prosthesis is measurable by the pressure transducer; and
in a second system configuration, the first 3-way control valve exclusively directs fluid flow to the first conduit and through the test conduit from the distal end to the proximal end, the variable 2-way control valve is configured in a partially open position, the 2-way control valve is configured in a fully open position, and fluid flow is directed through the test conduit in a reverse flow direction to pass through the valved prosthesis in a closed position such that a fluid leakage flow rate through the closed valved prosthesis is measurable by the first flow meter.

### Claim 2 (depends on 1)

The system of claim 1 further comprising a compliance chamber positioned between the fluid pump and the first 3-way control valve.

### Claim 3 (depends on 1)

The system of claim 1, wherein the fluid pump is a steady flow pump.

### Claim 4 (depends on 1)

The system of claim 1, wherein the reservoir is open to atmosphere.

### Claim 5 (depends on 1)

The system of claim 1 further comprising a flow straightener positioned at the proximal end of the test conduit to reduce turbulent fluid flow from the first 3-way control valve through the test conduit.

### Claim 6 (depends on 1)

The system of claim 1, wherein the test conduit is comprised of at least two conduit parts and the valved prosthesis is positioned between the at least two conduit parts.

### Claim 7 (depends on 1)

The system of claim 1, wherein in the second system configuration, the variable first 2-way control valve is configured in a fully closed position.

### Claim 8 (depends on 1)

The system of claim 1 further comprising
a second 3-way control valve positioned between the fluid pump and the first 3-way control valve and having an inlet in fluid connection with an outlet of the fluid pump, a first outlet in fluid connection with the inlet of the first 3-way control valve, and a second outlet; and
a heat circulation conduit in fluid connection at a first end with the second outlet of the second 3-way control valve and at a second end with the reservoir first conduit between the distal end of the test conduit and the variable first 2-way control valve; wherein
the second 3-way control valve is configured to alternately direct the working fluid to either the first 3-way control valve or the heat circulation conduit exclusively.

### Claim 9 (depends on 6)

The system of claim 6 further comprising a compliance chamber positioned between the fluid pump and the second 3-way control valve.

### Claim 10 (depends on 1)

The system of claim 1 further comprising a second flow meter positioned along the first conduit between the test conduit and the variable first 2-way valve.

### Claim 11 (depends on 1)

The system of claim 1 further comprising
a controller in control communication with the fluid pump, the first 3-way control valve, the variable first 2-way control valve, and the second two way control valve, and in data communication with the pressure sensor and the first flow meter; and
a computer configured with a test implementation software program that directs functionality of the controller, wherein
when the controller is directed by the computer to automatically implement the first system configuration, a first test schedule is automatically implemented in the controller that adjusts the pump rate of the fluid pump to change the flow rate to each of a plurality of prescribed flow rates according to the test schedule, the pressure sensor measures a pressure drop across the valved prosthesis for each prescribed flow rate in the first test schedule, and the controller records each measured pressure drop for each prescribed flow rate in the first test schedule; and
when the controller is directed by the computer to automatically implement the second system configuration, a second test schedule is automatically implemented in the controller, that adjusts the pump rate of the fluid pump to change the pressure difference across the valved prosthesis to each of a plurality of prescribed differential pressures according to the second test schedule, the pressure transducer measures a pressure differential across the valved prosthesis for each prescribed differential pressure in the second test schedule, and the controller records the fluid leakage flow rate for each measured pressure differential for each prescribed differential pressure in the second test schedule.

### Claim 12

A process implemented by a computer system for automatically controlling a test system for measuring steady flow hydrodynamic performance of a valved prosthesis in both forward fluid flow and reverse fluid flow directions without adjustment of the valved prosthesis within or removal of the valved prosthesis from the test conduit, the process comprising the following operations performed by the computer system:
directing the controller in control communication with a first valve downstream of the fluid pump to configure the first valve to direct flow of the working fluid from the fluid pump through a test conduit holding the valved prosthesis in-line with fluid flow in a forward flow direction from a proximal end of the test conduit to a distal end of the test conduit;
directing a controller in control communication with a fluid pump to instantiate pumping of a working fluid from a reservoir in the test system by the fluid pump;
receiving from the controller measurement values of a flow rate of the working fluid in the test system sensed by a flow rate sensor in the test system in data communication with the controller;
directing the controller to adjust a pump rate of the fluid pump to achieve a stable target flow rate of the working fluid through the test system based upon the flow rate measurement values received by the controller;
receiving from the controller measurement values of pressure drop through the valved prosthesis within the test conduit while the working fluid flows in the forward flow direction as sensed by a pressure sensor in the test system in data communication with the controller;
directing the controller to stop the fluid pump and reconfigure the first valve to direct flow of the working fluid through the test conduit and the valved prosthesis in a reverse flow direction from a distal end of the test conduit to a proximal end of the test conduit;
directing the controller to reinstantiate pumping of the working fluid from the reservoir by the fluid pump;
receiving from the controller measurement values of a pressure differential across the valved prosthesis within the test conduit as sensed by the pressure sensor;
directing the controller to adjust a pump rate of the fluid pump to achieve a stable target differential pressure of the working fluid across the valved prosthesis based upon the measurement values of the pressure differential; and
receiving from the controller measurement values of leakage flow through the valved prosthesis sensed by a flow rate sensor in the test system in data communication with the controller while the working fluid flows in the reverse direction.

### Claim 13 (depends on 12)

The process of claim 12 further comprising directing the controller to iteratively adjust the pump rate of the fluid pump to create different test system conditions while working fluid flows in both the forward flow direction and the reverse flow direction.

### Claim 14 (depends on 12)

The process of claim 12, wherein the computer system further directs the controller in control communication with a second valve in the test system in fluid connection with the distal end of the test conduit and the reservoir to open the second valve while the first valve is configured to direct flow of the working fluid in the forward flow direction to allow working fluid to flow into the reservoir.

### Claim 15 (depends on 14)

The process of claim 14, wherein the computer system further directs the controller in control communication with a third valve in the test system in fluid connection with the proximal end of the test conduit and the reservoir to open the third valve while the first valve is configured to direct flow of the working fluid in the reverse flow direction to allow working fluid to flow into the reservoir.

### Claim 16 (depends on 15)

The process of claim 15, wherein the computer system further directs the controller to partially, but not entirely, close the second valve when the third valve is open and the first valve directs the working fluid in the reverse flow direction.

### Claim 17 (depends on 15)

The process of claim 15, wherein the computer system further directs the controller to entirely close the third valve when the second valve is open and the first valve directs the working fluid in the forward flow direction.

### Claim 18 (depends on 15)

The process of claim 15, wherein the computer system further directs the controller in control communication with a fourth valve in the test system in fluid connection with the fluid pump, the first valve, and the reservoir to configure the fourth valve to direct flow of the working fluid from the fluid pump to the reservoir.

### Claim 19 (depends on 12)

The process of claim 12, wherein the test system is configured in the reverse flow direction before the test system is configured in the forward flow direction.

### Claim 20

A method of operating a test system for measuring steady flow hydrodynamic performance of a valved prosthesis, the method comprising
pumping a working fluid from a reservoir in the test system with a fluid pump;
in a forward flow configuration,
configuring a first valve in the test system to direct flow of the working fluid from the fluid pump through a test conduit holding the valved prosthesis in-line with fluid flow in a forward flow direction from a proximal end of the test conduit to a distal end of the test conduit;
responsive to measurement values of a flow rate of the working fluid in the test system sensed by a flow rate sensor in the test system, adjusting a pump rate of the fluid pump automatically by a controller driving the fluid pump to achieve a stable target flow rate of the working fluid through the test system;
responsive to a first test schedule automatically implemented in the controller, adjusting the pump rate of the fluid pump to change the flow rate to each of a plurality of prescribed flow rates according to the first test schedule;
measuring with a pressure sensor in the test system a pressure drop across the valved prosthesis for each prescribed flow rate in the first test schedule; and
recording, via the controller in communication with the pressure sensor, each measured pressure drop for each prescribed flow rate in the first test schedule; or
in a reverse flow configuration,
configuring the first valve in the test system to direct flow of the working fluid from the fluid pump through the test conduit holding the valved prosthesis in-line with fluid flow in a reverse flow direction from a distal end of the test conduit to a proximal end of the test conduit;
responsive to measurement values of a differential pressure of the working fluid in the test system sensed by the pressure sensor, adjusting the pump rate of the fluid pump to achieve a stable differential pressure of the working fluid across the valved prosthesis in the test conduit;
responsive to a second test schedule automatically implemented in the controller, adjusting the pump rate of the fluid pump to change the differential pressure across the valved prosthesis to each of a plurality of prescribed differential pressures according to the second test schedule;
measuring with the pressure sensor a pressure differential across the valved prosthesis within the test conduit for each prescribed differential pressure in the second test schedule while the working fluid flows in the reverse flow direction;
recording, via the controller in communication with a flow meter, a leakage flow rate for each measured pressure differential for each prescribed differential pressure in the second test schedule.

### Claim 21 (depends on 20)

The method of claim 20, wherein operation of the test system is alternately configurable between measurement of the pressure drop in the forward flow direction and measurement of the leakage flow rate in the reverse flow direction without adjustment of the valved prosthesis within or removal of the valved prosthesis from the test conduit.

### Claim 22 (depends on 20)

The method of claim 20 further comprising opening a second valve in the test system under control of the controller, wherein the second valve is in fluid connection with the distal end of the test conduit and the reservoir, to direct flow of the working fluid in the forward flow direction into the reservoir.

### Claim 23 (depends on 20)

The method of claim 20 further comprising opening a third valve in the test system under control of the controller, wherein the third valve is in fluid connection with the proximal end of the test conduit and the reservoir, to direct flow of the working fluid in the reverse flow direction into the reservoir.

### Claim 24 (depends on 23)

The method of claim 23 further comprising, under control of the controller, partially, but not entirely, closing the second valve when the third valve is open and the first valve directs the working fluid in the reverse flow direction.

### Claim 25 (depends on 23)

The process of claim 23 further comprising, under control of the controller, entirely closing the third valve when the second valve is open and the first valve directs the working fluid in the forward flow direction.

### Claim 26 (depends on 23)

The process of claim 23 further comprising configuring a fourth valve under control of the controller to direct flow of the working fluid from the fluid pump to the reservoir, wherein the fourth valve is in fluid connection with the fluid pump, the first valve, and the reservoir.