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The programmable implantable medication system (PIMS): design features and pre-clinical trials
C D Saudek1, R E Fischell, M M Swindle
1Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Hormone and Metabolic Research = Hormon- Und Stoffwechselforschung = Hormones Et Metabolisme
|April 1, 1990
Summary
The Programmable Implantable Medication System (PIMS) is a low-power insulin pump that demonstrated long-term reliability in pre-clinical trials. This implantable insulin pump showed sustained function for over 3 years, indicating its potential for diabetes management.
Area of Science:
- Biomedical Engineering
- Medical Devices
- Diabetes Technology
Background:
- Implantable insulin pumps offer continuous glucose control.
- Previous devices faced challenges with power consumption and longevity.
- The Programmable Implantable Medication System (PIMS) was developed to address these limitations.
Purpose of the Study:
- To describe the design features of the PIMS.
- To evaluate the performance and reliability of PIMS in pre-clinical trials.
- To identify and resolve design flaws before clinical application.
Main Methods:
- The PIMS features a solenoid, pulsatile pump design with low power requirements (<15 microwatts) and a unique reservoir.
- Radiotelemetry enables two-way communication for programming and data recording.
- Pre-clinical trials involved 3.1 dog-years for initial testing and 16 dog-years for final evaluation of a single system design.
Main Results:
- Initial trials identified and led to the correction of four problems: diaphragm microcracks, valve leaks, microchip failures, and insulin aggregation.
- Final pre-clinical trials showed 5 pumps functioning continuously for up to 3.75 years (mean 3.3 years) without mechanical or electronic failure.
- The longest refill interval was 5 months; potential issues included catheter blockage and air lock.
Conclusions:
- The PIMS demonstrates significant long-term mechanical and electronic reliability for implantable insulin delivery.
- Further refinement is needed to mitigate risks such as catheter blockage and air lock.
- The PIMS shows promise as a durable solution for advanced diabetes management.