Acute medical particulate testing device

• US 9,453,788 B2
• Filed: 02/06/2014
• Issued: 09/27/2016
• Est. Priority Date: 02/07/2013
• Status: Active Grant

• Current Assignee: Dynatek Labs, Inc.
• Original Assignee: Dynatek Labs, Inc.
• Inventors: Conti, James C., Strope, Elaine R.
• Primary Examiner(s): West, Paul
• Application Number:
  US14/174,565
• Publication Number:
  US 20140216181A1
• Time in Patent Office: 964 Days
• US Class Current: 1/1
• CPC Class Codes: G01N 15/02 Investigating particle size or size distribution by measuring osmotic pressure G01N7/10; investigating sedimentation of particle suspensions G01N15/04; investigating individual particles G01N15/10
• CPC Class Codes: G01N 2015/0053 in liquids, e.g. trouble
• CPC Class Codes: G01N 2015/1026 Recognising analyser failures, e.g. bubbles; Quality control for particle analysers
• CPC Class Codes: G01N 3/567 by submitting the specimen to the action of a fluid or of a fluidised material, e.g. cavitation, jet abrasion G01N3/565 takes precedence

Abstract

An acute medical particulate testing device for determining particle shed from a medical device during implantation. The device includes a closed loop system through which a solution is forcibly passed. An inlet port allows a catheter-mounted medical device to be incorporated into the flow loop. At least one tortuous passage is provided to replicate the vascular pathway and tortuosity which simulates the turns and bends and rubbing that affect particulate release from an implantable medical device as it is passed through the vasculature. A debubbler is provided to remove air bubbles from the solution before it is passed into a particle counting device that counts particle shed from the medical device during the simulated implantation. A filter having desired porosity removes particles from the solution. A final filter system removes all particles and air bubbles from the solution before it is re-circulated through the loop.

Claims

1. A system for testing a medical device comprising:

a primary flow line in fluidic communication with a test pathway comprising a substantially closed pathway for a test solution;

a port in the test pathway for inserting a medical device into the test pathway;

at least one tortuous passage within the test pathway through which a medical device may be passed;

at least one particle counter in fluidic communication with the primary flow line for counting and sizing particles in the test solution shed from a medical device passed through the at least one tortuous passage and

a debubbler within the primary flow line between the test pathway and the at least one particle counter wherein the debubbler captures air bubbles in the test solution.

2. The system of claim 1 wherein the debubbler further comprises a column provided with at least one fine mesh filter disposed across the column.

3. The system of claim 2 further comprising a computer control system for receiving data from the at least one particle counter.

4. The system of claim 3 further comprising a capacitance tank comprising a container for holding test solution, a heater attached to the container for maintaining the test solution at a preferred temperature, and an air pump pneumatically connected to the container for adjusting the air pressure within the container.

5. The system of claim 4 further comprising a particle filtration system in fluidic communication with the primary flow line for capturing particles shed from a medical test device.

6. The system of claim 1 wherein each of the at least one particle counter may be selectively connected to the primary flow line to provide for a desired flow rate through the primary flow line.

7. A method for testing a medical device using the system of claim 1 comprising the steps of:

pumping the test solution through the substantially closed pathway;

inserting the medical device through the port into the test pathway;

forcing the medical device through the at least one tortuous passage; and

counting and sizing the particles shed by the medical device with the at least one particle counter.

8. The method of claim 7 wherein the test solution is pumped through the substantially closed pathway in a pulsatile manner.

9. The method of claim 8 further comprising the step of maintaining the test solution at a systemic pressure by pressurizing the air within a tank of test solution in fluidic communication with the primary flow line.

10. The method of claim 8 wherein the test solution is maintained at a temperature and pH similar to human blood.

11. The method of claim 8 wherein the size and shape of the tortuous passage simulates a portion of the vasculature or ducts in a human body.

12. The method of claim 11 further comprising the steps of filtering the test solution to capture the particles in the test solution.

13. A testing system for a medical device, comprising:

a test solution maintained at a preferred pressure and temperature;

a substantially closed pathway through which the solution is forcibly circulated;

an introducer port in fluidic communication with the closed pathway through which a medical device may be deployed into the pathway;

at least one tortuous passage within the pathway through which a medical device may be forcibly passed;

at least one particle counter in fluidic communication with the pathway to count and size any particles shed from the test device as it is passed through the tortuous passage;

a particle filter system having at least one filter with predetermined porosity for capturing particles shed from the medical device; and

a debubbler device disposed in the pathway between the tortuous pathway and the at least one particle counter to substantially remove air bubbles from the test solution, the debubbler device including at least one fine mesh filter for capturing bubbles in the solution.