Method for testing venous valves

• US 5,327,774 A
• Filed: 10/08/1993
• Issued: 07/12/1994
• Est. Priority Date: 04/25/1991
• Status: Expired due to Term

• Current Assignee: 3F Therapeutics Incorporated (Medtronic Plc)
• Original Assignee: Baxter International Inc.
• Inventors: Wieting, David W., Lee, Denis, Abolfathi, Amir H., Nguyen, Than, Nashef, Aws
• Primary Examiner(s): NOLAND, THOMAS
• Application Number:
  US08/133,701
• Time in Patent Office: 277 Days
• Field of Search: 73/865.9, 73/37, 73/168, 73/4 R, 73/866.4, 128/668
• US Class Current: 73/37
• CPC Class Codes: A61B 2017/00707 Dummies, phantoms; Devices simulating patient or parts of patient
• CPC Class Codes: A61F 2/2472 Devices for testing

Abstract

A method and device for testing artificial or natural venous valves. The device comprises chamber (10) a sample for mounting a test valve (V) on a liquid flow path and a muscle pump component (16) and/or respiratory pump component (50) and/or capacitance reservoir (58) and/or vertical hydrostatic column component (102) fluidly connected to the flow path to mimic the muscle pump, respiratory pump, capacitance and hydrostatic impedance effects on venous circulation in the mammalian body. Included in the invention are methods of testing venous valves by mimicking known hemodynamic flow conditions within a mammalian body.

Claims

1. A method for testing the function of venous valves, said method comprising:

(a) holding a venous valve sample in a substantially fixed position;

(b) fluidly connecting an inflow conduit in relation to said venous valve to pass a flow of liquid through said venous valve;

(c) fluidly connecting an outflow conduit in relation to said venous valve such that liquid passing through said venous valve will then flow through said outflow conduit;

(d) pumping a pulsatile flow of liquid through said inflow conduit to mimic the effect of a physiological muscle pump on venous return in a human being;

(e) creating cyclic variations in pressure on liquid exiting said venous valve through said outflow conduit to mimic the effect of intrathoracic variations in pressure which occur in a human being during respiration.

2. The method of claim 1 further comprising:

(f) attaching a variable capacitance reservoir to said outflow conduit and varying the capacitance within said reservoir to mimic changes in venous capacitance within a human being.

3. The method of claim 2 further comprising the steps of:

selecting a target venous pressure waveform; and

adjusting the pulsatile flow of liquid created in step (d), the cyclic variations in pressure created in step (e) and the capacitance within the variable capacitance reservoir of step (f) to cause the liquid flowing through said venous valve to mimic the pre-selected target waveform.

4. The method of claim 1 further comprising:

(f) attaching a vertically inclined tubular conduit to said outflow conduit such that liquid passing through said outflow conduit must flow against hydrostatic impedance created by said column.

5. The method of claim 4 further comprising the step of:

(g) varying the height of said vertically inclined column to mimic variations in hydrostatic impedance venous flow resulting from various postural positions of a human being.

6. The method of claim 5 further comprising the steps of:

selecting a target waveform; and

adjusting the pulsatile flow of liquid created in step (d) and the amount of hydrostatic impedance created in step (g) to cause the liquid flowing through said venous valve to mimic the pre-selected waveform.

7. The method of claim 1 wherein the venous valve sample to be tested is positioned within a harvested segment of vein and wherein:

step (a) further comprises holding the segment of vein wherein said venous valve sample is located in a substantially fixed position;

step (b) further comprises fluidly connecting an inflow conduit to the first end of said segment of vein to pass a flow of liquid through said segment of vein and through said venous valve; and

step (c) further comprises fluidly connecting an outflow conduit to an opposite end of said segment of vein such that liquid passing through said segment of vein and through said venous valve will then flow through said outflow conduit.

8. The method of claim 1 further comprising the step of:

controlling the temperature of liquid passing through said venous valve.

9. The method of claim 1 further comprising the step of:

monitoring the pressure of liquid passing through said venous valve.

10. The method of claim 1 further comprising the steps of:

selecting a target venous pressure waveform; and

adjusting the pulsatile flow of liquid created in step (d) and the cyclic variations in pressure created in step (e) so as to cause the liquid flowing through said venous valve to mimic the selected target waveform.