MILESTONE PAPERS PROJECT

General Description

The Milestone Papers is an annotated bibliography of published papers and other documents which describe the important milestones in the history and use of artificial organs. The Milestone Papers will:

•   serve as a annotated bibliography on the history of artificial organs;
•   provide information for timelines, formal histories, other products of Project Bionics;
•   offer a resource for other scholars of artificial organ history;
•   provide the basis for a collection of the actual papers for archival purposes or possibly re-publication;
•   engage members of the artificial organs research and industrial community in their history and to encourage their participation in Project Bionics.

Work Group members will contribute to the identification of ASAIO pioneers and help identify priorities for the personal histories project by serving as the initial contacts. Work Group members will personally contact select individuals and inquire into the existence of historical documentation - that is, where are their personal papers, laboratory records or devices? Are they being preserved (and if not, certainly Project Bionics can assist.) Members will also inquire into existing interviews conducted on these pioneers. These interviews will be reviewed, and will contribute to oral and video history planning for the purposes of our project.

Format of Milestone Papers

Fifteen (15) artificial organ categories are identified. In each category a list of milestone papers and documents will be compiled for:

1. Research and Development on the Artificial Organ
2. Clinical Application of the Artificial Organ in the perspective of treatment of disease
3. Industrial Milestones for the Artificial Organ.

A project director will be designated for each milestone list, 45 project directors in all. Each project director is encouraged to solicit contributions and advice from many other experts.

Each entry on the list should include the full reference including all authors and beginning and last page. Each paper on the list should have a brief description, describing the importance of this specific paper in the history and development of the artificial organ. The description should also include specific grant or other sponsor support, industrial collaboration, and presentation of the work at scientific meetings if noted in the paper. The description should also include the primary source material for that paper where that information is available.

1. Research and Development of Artificial Organs Milestone Papers should be grouped under the following headings:

• Concepts
• Laboratory Development
• Laboratory to clinical transition
• Early clinical trials
• Major clinical application within in the first 5 years of clinical usage
• Important papers identified as memoirs or historical reviews

2. Clinical Application of Artificial Organs Papers in this category should be grouped under the following headings:

• First clinical use (will overlap with the research list)
• Most important clinical trials
• Most important descriptions of clinical practice
• Most important papers that define the use of the artificial organ in the perspective of other treatment, transplantation or pharmacologic treatment
• Important papers identified as memoirs or historical reviews

3. Industrial Milestones in Artificial Organs Documents in this category should be grouped under the following headings:

• Most important patents related to the artificial organ
• FDA applications and documents related to the artificial organ
• Publications related to the commercialization of the artificial organ and the medical device industry
• Important publications defined as memoirs or historical reviews related to industry

Examples:

Hill JD, O'Brien TG, Murray JJ, Dontigny L, Bramson ML, Osborn JJ, Gerbode F., "Extracorporeal oxygenation for acute post-traumatic respiratory failure (shock-lung syndrome): Use of the Bramson Membrane Lung," New England. J. Med 286(12):629-34, 1972.

This paper describes the first successful clinical use of prolonged extracorporeal circulation with a membrane oxygenator for respiratory failure (a technique later called ECMO). The patient was a young man with ARDS after a motorcycle accident treated by Dr. O'Bien in Santa Barbara, California. Drs. Hill and Bramson took their equipment to Santa Barbara Cottage Hospital and treated the patient for 3 days.

Primary sources: JD Hill MD, San Francisco, CA Santa Barbara Cottage Hospital

Research funding: Not mentioned

Industry: Not mentioned

Kolobow T, Bowman RL., "Construction and evaluation of an alveolar membrane artificial heart lung," ASAIO Transactions 9:238 - 245, 1983.

The first description of the Kolobow spiral coil membrane lung developed in the Devries Lab at National Heart Institute, NIH. This lung became the standard device for laboratory and clinical prolonged extracorporeal circulation (ECMO) for the next forty years. This paper was presented at ASAIO in 1983 and discussed by .

Primary source: T. Kolobow, NIH NIH, Heart Institute Archives

Research support: NIH Intramural

Program Industry: This device was later manufactured by Sci-Med, Minneapolis, MN