Medical device durability test apparatus having an integrated particle counter and method of use
AssigneeDynatek Laboratories, Inc.
InventorsJames C. Conti, Elaine R. Strope
Life of this patent
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Abstract
Apparatuses and methods for determining particle shed rates of implantable or inter-dwelling devices are disclosed. Durability test apparatuses with integrated particle counters produce time-dependent particle shed rate profiles. The apparatuses are designed to accommodate pulsatile flow, resembling a heartbeat at the implantable device. In an embodiment, the pulsatile flow is converted to a steady flow before fluid enters the integrated particle counter.
Claims4
An apparatus for determining a particle shed rate of an implantable medical device comprising:
- a pump that moves fluid in contact with the implantable medical device;
- and
- a particle counter, the particle counter collects data representative of a time-dependent particle shed profile of the implantable medical device;
- wherein the pump, the implantable medical device, and the particle counter are in fluidic communication;
- and
- wherein the pump applies pulsatile fluid pressure and there is a pulsatile to steady flow transition.
A method of determining a particle shed rate of an implantable medical device comprising:
- deploying the implantable medical device in a durability test apparatus;
- contacting fluid with the implantable medical device;
- and
- analyzing the fluid using an in-line particle counter by performing the steps of transitioning the fluid from a pulsatile flow to a steady flow and utilizing the particle counter to acquire data representative of a time-dependent particle shed profile of the implantable medical device.
A method of determining a time-dependent particle shed profile of an implantable medical device comprising:
- deploying the implantable medical device in a durability test apparatus;
- continuously cycling fluid through a medical device durability test apparatus,
- wherein the durability test apparatus has an in-line particle counter and an in-line filter;
- and
- analyzing the fluid with the particle counter over a period of time ranging from about 1 hour to 1 year;
- wherein the step of analyzing the fluid comprises the steps of transitioning the fluid from a pulsatile flow to a steady flow;
- and utilizing the particle counter to acquire data representative of a time-dependent particle shed profile of the implantable medical device over a period of time ranging from about 1 hour to 1 year.
Dependencies are inferred from the claim text.