Models and methods of using same for testing medical devices
First Claim
1. A method of testing a device designed for invasive transmission through a luminal structure comprising:
- obtaining an artificial anatomic model configured to geometrically mimic a lumen possessing human or nonhuman animal anatomic structure, said model comprising a luminal structure having an inner luminal wall surface region comprising hydrogel, and an analog material employed by said artificial anatomic model designed to simulate at least one predetermined physical characteristic of a target tissue;
wherein said artificial anatomical structure is configured to geometrically mimic vasculature, further comprisingartificial support tissue;
a luminal structure supported by said artificial support tissue, and comprising a first analog material disposed along an inner luminal wall surface of said luminal structure, said first material analog having a structural integrity simulating at least one predetermined characteristic of an inner surface of said vasculature;
a liquid reservoir adapted to hold a liquid; and
a pump in fluid communication with said luminal structure, said pump causing a pulsed or continuous liquid circulation, said pump circulating said liquid from said reservoir through said luminal structure;
transmitting said device through said luminal structure such that said device bears on said region; and
evaluating how said region is affected by transmission of said device through said luminal structure.
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Abstract
Disclosed herein are synthetic anatomical models that are designed to enable simulated use testing by medical device compam'"'"'es, medical device designers, individual inventors, or any other entity interested in the performance of medical devices. These models are unique in possessing a level of complexity that allows them to be substituted for either a live animal, an animal cadaver, or a human cadaver in the testing of these devices. These models are further characterized by a similarity of geometry, individual component physical properties, and component-to-component interfacial properties with the appropriate target tissue and anatomy.
291 Citations
6 Claims
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1. A method of testing a device designed for invasive transmission through a luminal structure comprising:
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obtaining an artificial anatomic model configured to geometrically mimic a lumen possessing human or nonhuman animal anatomic structure, said model comprising a luminal structure having an inner luminal wall surface region comprising hydrogel, and an analog material employed by said artificial anatomic model designed to simulate at least one predetermined physical characteristic of a target tissue;
wherein said artificial anatomical structure is configured to geometrically mimic vasculature, further comprisingartificial support tissue;
a luminal structure supported by said artificial support tissue, and comprising a first analog material disposed along an inner luminal wall surface of said luminal structure, said first material analog having a structural integrity simulating at least one predetermined characteristic of an inner surface of said vasculature;a liquid reservoir adapted to hold a liquid; and a pump in fluid communication with said luminal structure, said pump causing a pulsed or continuous liquid circulation, said pump circulating said liquid from said reservoir through said luminal structure; transmitting said device through said luminal structure such that said device bears on said region; and evaluating how said region is affected by transmission of said device through said luminal structure. - View Dependent Claims (2, 3, 4, 5, 6)
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Specification