The intrathoracic compliance chamber (ICC) is the most successful solution to the variable volume problem of a totally implantable pulsatile artificial heart. However, existing designs are handicapped by the rate at which the gas permeates through the chamber diaphragm given that all polymeric membranes are subject to some degree of gas permeation. Given this limitation, percutaneous gas refills would be required at frequent intervals, measured at best in weeks. It is Foster-Miller's hypothesis that this limitation can be remedied by the use of liquid crystal polymers (LCPs), a material of remarkable mechanical performance and extremely low permeability. In the Phase I program, Foster-Miller demonstrated that LCPs have the biocompatibility, low permeability, high fatigue resistance and sufficient manufacturability to be ideal candidates for ventricular assist devices (VAD) and total artificial heart (TAH) compliance chamber diaphragms. The proposed Phase II program will demonstrate the long-term performance and stability of an integrated compliance chamber system. Pilot manufacturing techniques will be developed and components manufactured with these techniques will be evaluated both in-vitro and in-vivo. The long-term objective of this project is to design, develop, and qualify a compliance chamber system that can be integrated with existing and future blood pumps to make truly implantable systems.

Proposed Commercial Applications

The primary market for the proposed product is represented by the 35,000 to 70,000 patients per year estimated by the Institutes of Medicine to require permanent ventricular assist devices or total artificial hearts. This market could be even larger when blood- pumping systems are proven to be safe enough to use in more than the very sickest, near-terminal patients.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44HL061122-02
Application #
6294563
Study Section
Special Emphasis Panel (ZRG1-SSS-W (33))
Program Officer
Altieri, Frank
Project Start
1998-09-15
Project End
2004-06-30
Budget Start
2001-07-10
Budget End
2002-06-30
Support Year
2
Fiscal Year
2001
Total Cost
$749,970
Indirect Cost
Name
Foster-Miller, Inc.
Department
Type
DUNS #
City
Waltham
State
MA
Country
United States
Zip Code
02451