X-Message-Number: 2544
Date: 11 Jan 94 23:01:15 EST
From: Mike Darwin <>
Subject: SCI.CRYONICS BPI TECH BRIEF #001
BPI TECH BRIEFS
Biopreservation, Inc. is a human cryopreservation services provider and
brain cryopreservation research and development company. While BPI's
structure is a for-profit one, it is our intention to foster the growth of
knowledge and scientific advancement as rapidly as possible. In order to
facilitate these objectives we have decided to begin publishing technical
and nontechnical material of relevance to the field of human
cryopreservation in a rapid fashion. While some of our research will
remain proprietary or will be undisclosed until patenting, much of what we
do and learn will be appropriate for immediate dissemination. Aside from
the previously stated objectives of advancing the state-of-the-art we
strongly believe that such disclosures will enhance our position and
profitability a goal which we also believe is a worthy one.
Below is an introduction to BPI, its facilities and its staff. Future BPI
TECH BRIEFS (BPITB) will concentrate on specific technical problems in
the field of human cryopreservation and related disciplines.
Individuals wishing to submit material to BPI for inclusion in BPITB
should fell free to do so. Anyone wishing more information about the
company should contact Michael Darwin with *specific* questions. Since
BPI does not provide services directly to the public we do not have
promotional literature.
Introducing BioPreservation
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The best equipment
The most highly qualified personnel
A serious commitment to suspended animation research
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Introduction
BioPreservation, Inc. (BPI) is a for-profit company
which specializes in medicating, perfusing, and cooling
people who are under the legal control of cryonics
organizations such as CryoCare Foundation and The American
Cryonics Society. We offer unmatched experience and expertise
in the clinical procedures that are essential for optimum,
controlled cryopreservation.
Preliminary Steps
Working closely with the patient's cryonics
organization, we take an active role to insure that long
before cryopreservation procedures actually begin, the
elements which are critical to a high-quality outcome are
firmly in-place.
Ideally, the first step is to insure that the patient
has exhausted all medical options to remain alive with an acceptable
quality of life at the present time. Our medical staff reviews the
patient's medical records, consults with other experts, and reviews
appropriate medical databases in an attempt to determine the patient's
likely prognosis and current therapeutic options. The patient is informed
of the results of this search and therapeutic options, if any are
available, are discussed.
Since cryopreservation of humans is not yet a recognized
medical procedure, we cannot begin cryopreservation while the
patient is still alive. However, there is much that we can
and will do to insure that when legal death is pronounced,
within the limits of current techniques, the patient will
receive the best possible care and minimal injury.
If the patient has in fact exhausted the resources of
contemporary medicine and is terminally ill, we begin working
with the patient's cryonics organization, family, and medical
personnel, to achieve the following objectives:
* We establish a rapport with the treating medical staff
and secure their informed cooperation, as much as possible,
to facilitate the patient's cryopreservation under optimum
conditions.
* In conjunction with the patient's treating physician,
the patient, and (where appropriate) the patient's family, we
begin a program of pre-cryopreservation medication to
minimize the effect of the ischemic interval (i.e. the period
where the person experiences deep shock/no blood flow) which
inevitably occurs between the time legal death is pronounced
and cryopreservation procedures begin.
* Working closely with the patient's cryonics
organization, we evaluate the patient's home, hospital,
hospice, or nursing home to insure that facilities are
adequate to begin the initial phases of cryopreservation. For
instance, we will try to insure that the patient is physically
accessible, in a room that is big enough, with no obstacles
such staircases or impossibly narrow hallways. Again, in
conjunction with the patient's cryonics organization, we also
work to establish a liason with a local mortuary so that the
patient can be moved promptly and legally to our facilities
in Southern California for cryoprotective treatment and
cooling to -79 degrees Centigrade.
* If the patient wishes to remain at home for pre-
suspension (i.e., terminal) care, we work with the patient
and the patient's family and cryonics organization to insure
that the patient is enrolled in a home-hospice program in
which the hospice personnel and local authorities (where
appropriate) are adequatedly informed regarding special needs
such as prompt pronouncement of legal death and avoidance of
medico-legal autopsy (postmortem dissection).
* When the patient's condition reaches the point where the
need for cryopreservation is imminent, we move our equipment,
medications, and personnel as near to the patient as possible
and stand by on a twenty-four hour basis, ready to perform
cardiopulmonary support after legal death is pronounced.
Mechanically augmented CPR is used initially. Subsequently, a
heart-lung machine supports circulation, oxygenation, and
cooling of the patient's blood. The blood is then replaced
with Viaspan R(1) organ preservation solution. The patient is
cooled to a degree or two above freezing and is then moved
via air or surface transporation (depending upon distance and
logistics) to our facility in Southern California for the
next phase of the treatment.
Our standby team includes a perfusionist, emergency
medical technicians, and other certified cryopreservation
transport technicians. Our Medical Director (a licensed
physician) is also available for standbys and has
considerable experience dealing with attending physicians,
hospital/hospice/nursing home administration, and other
medical staff.
Perfusion
In a spacious operating room at our facility,
the patient is perfused with a cryoprotective solution that
will minimize tissue damage when the temperature is
subsequently lowered and deep cooling to -79 degrees
Centigrade is begun. We are better equipped than any
comparable organization to control and monitor the lengthy,
complex procedure of cryoprotective perfusion.
Our duties end when the patient's temperature dips to
-79 degrees Centigrade (the temperature of solid carbon
dioxide, or "dry ice"). At this point, the patient's cryonics
organization supervises transfer of the patient to the
service provider responsible for long-term care at -196
degrees Centigrade (the temperature of boiling liquid
nitrogen).
Research
At BioPreservation, we recognize that the techniques of
cryoprotective perfusion are imperfect at present and must be
actively refined and improved as rapidly as possible. In
pursuit of this goal, we are conducting privately funded research
in conjunction with several other companies aimed at
perfecting a reversible method of cryopreservation for the
brain (suspened animation).
In canine Total Body Washouts (TBW), we have revived
dogs successfully after they have been perfused with a
preservative solution (perfusate) and held without vital
signs for up to 5 hours at 3 degrees Centigrade. This
research is unmatched by any other laboratory in the world,
and it has already yielded important results leading to
significant improvements in the techniques of cryoprotective
perfusion.
Perhaps most importantly, we have made a major
commitment to understanding and defining the limitis of
current human cryopreservation techniques, and we are working
to improve them further. Currently, we are undertaking an
aggressive research program with both dogs and rabbits,
hoping to improve the degree of fine structural preservation
of the brain and eliminate the gross mechanical injury from
cracks or fractures which develop in tissues that are cooled
to liquid nitrogen temperature. The first phases of this work
have already resulted in significant improvements in our
human cryopreservation protocol. The complete results of
these studies (including a variety of evaluations of brain
structure at the organ, tissue, and molecular level) should
be available by mid-1995.
Our Facility
BioPreservation is located in Southern California,
forty-five minutes from downtown Los Angeles and five minutes from the
international airport at Ontario, California. The modern, 7200 square
foot building is larger and better equipped than any comparable facility
specializing in human cryopreservation. It is divided as follows:
Function Square Feet
Operating room 1400
Laboratory 1000
Materials prep/Sterile processing 300
Rest area for staff 200
Operating room staging area 450
Ambulance bay, workshop, storage 3000
Library/Conference room 200
Operating Room Details
The 1,400 square foot operating room is equipped with
cardiovascular perfusion and monitoring equipment of the same
type found in state-of-the-art medical centers. Blood gases
and electrolytes (including glucose, sodium, potassium,
calcium, chloride, pH, pO2, pCO2 and hematocrit) can be
monitored continuously while the patient is perfused with
cryoprotectants. Precise knowledge of these parameters
provides important information for the long-term benefit of
the patient and short-term benefit of others who may follow.
Such feedback is critical to improving the quality of the
cryopreservation treatment.
Monitoring is carried out with an in-line CDI 300
extracorporeal monitor and a Nova Stat 5 blood
gas/electrolyte analyzer. The CDI 300 provides continuous
feedback, enabling minute-by-minute adjustment of critical
blood gas parameters without the usual lag time which occurs
with off-line blood gas equipment. The Nova Stat 5 provides a
double-check of blood gases and allows for electrolyte
measurements during perfusion. Additional back-up capability
is provided by an IL1302 blood gas system, an IL282 co-
oximeter, and a Nova 1 electrolyte system.
The composition of sweep gas being delivered to the
oxygenator during bypass is precisely controlled with the use
of a Cobe Laboratories air, oxygen, CO2 blender which is
monitored by a Critikon Oxycheck oxygen concentration
monitor.
The operating room is equipped with three compete sets
of cardiothoracic surgical instruments, numerous non-
cardiovascular procedure instruments sets, and linens,
drapes, and sterile disposable supplies to allow for the
conduct of TBW cerebral resuscitation research and human
cryopreservation at or beyond the level of any major
university.
Laboratory Equipment
A Kodak Ektachem DT system measures clinical blood
chemistry factors such as albumin, ALKP, AST, ALT, CK, CKMB,
Creatinine, GGT, LDH, lipase, ammonia, amylase, total
bilirubin, BUN/urea, lactate, magnesium, phosphorus, and
total protein. Using the Ektachem system, a researcher has
most of the analytical capabilities of a commercial clinical
laboratory, in-house, twenty-four hours a day.
Our facility is also equipped with a wide range of
supportive equipment including osmometers, oncometers,
refractometers, centrifuges, pH meters, microscopes,
balances, autoclaves, shaker baths, controlled temperature
baths, and so on, to facilitate biomedical research.
Ambulances/Mobile Advanced Life Support System
Two ambulances are available at all times. (No other
cryopreservation organization has a backup ambulance.) One is
a late-model vehicle manufactured by Leader Industries,
extensively modified to accomodate a custom-fabricated Mobile
Advanced Life Support System (MALSS). This unit provides
rapid, controlled cooldown externally and internally (by
perfusion). It also monitors blood gases and pH and contains
its own independent power supply.
The MALSS is equipped with a Michigan Instruments
Thumper closed-chest heart-lung resuscitator so that CPR can
be reliably delivered as a bridge to the initiation of
extracorporeal support. The MALSS is currently configured to
run the Sarns hollow-fiber membrane oxygenator/heat exchanger
for extracorporeal oxygenation and cooling.
The second ambulance, a van-type unit, serves as back-
up for the first and is equipped to respond to a local
emergency if the primary vehicle is out in the field on a
standby.
Staff Quarters
To enable true twenty-four-hour capabilities, our
facility includes comfortable sleeping quarters for up to six
support staff.
Cryopreservation
To facilitate cryopreservation studies, excellent
equipment and consumables are available for isolated
cryoprotective perfusion of brains, kidneys, and whole
animals. A range of cryogenic refrigerators and temperature
monitoring and control equipment is available, including a
wide array of large- and narrow-mouth cryogenic dewars for
liquid-nitrogen storage of specimens as well as a Revco Ultra
Low -115C freezer which allows for fracture-free storage of
organs and small animals.
Work in progress
We are currently constructing automated systems that
will give us precise control of the introduction and removal
of cryoprotective drugs and the cooling of humans to -79
degrees Celsius.
Personnel
Our personnel have extensive experience in either deep
hypothermic canine perfusion, cerebral resuscitation
research, or both.
Medical Director: Steven B. Harris, MD. Dr. Harris is
board certified internist and gerontologist with extensive
ICU and Emergency Room experience. In addition to being a
professional gerontological researcher, Dr. Harris has also
served as physician and participated extensively in canine
deep hypothermia experiments sponsored by 21st Century
Medicine, using various bloodless perfusion protocols.
Team Leader: Michael Darwin, CRT. Mr. Darwin is a
certified hemodialysis technician with over 20 years
experience in deep hypothermia research. Mr. Darwin served as
President of the Alcor Life Extension Foundation from July of
1982 to February of 1988. He was Alcor's director of Research
from 1988 to 1991, and is responsible for the development of
many of the transport and perfusion techniques currently used
in human cryopreservation today. Additionally, Mr. Darwin has
authored numerous technical papers and two textbook/procedure
manuals on human cryopreservation and asanguineous perfusion
procedures. Mr. Darwin is also director of research for 21st
Century Medicine's canine TBW and cerebral resuscitation
research projects.
Scribe: Sandra Russell, BS (Biochemistry/Cell Biology).
Ms. Russell is a professional educator and businesswoman who
serves as scribe/perfusion monitor and blood gas technician.
She has extensive experience performing data acquisition and
ICU care in 21st Century Medicine's canine TBW and cerebral
resuscitation programs. Ms. Russell has also had extensive
clinical experience as a cardiac technician in a large
hospital where her duties included ECG testing/analysis,
treadmill monitoring, and Holter monitor analysis.
Facilities Manager: Paul Wakfer, BASc (Engineering
Physics), MA (Applied Mathematics). Mr. Wakfer's duties are
logistical support for research personnel, in-house equipment
technician, and business manager. He has participated also in
21st Century Medicine's canine TBW and cerebral resuscitation
experiments.
Respiratory Therapist, Equipment Technician: Michael
Fletcher, RT. Mr. Fletcher is a respiratory therapist,
respiratory equipment technician, and an EEG technician. Mr.
Fletcher's duties are equipment maintenance during research
(he has worked as a mechanic and sheet metal worker and has
extensive shop/fabrication/mechanical skills), and
respiratory therapist during in 21st Century Medicine's
canine research programs.
Engineering Support: Mark Connaughton, MS (Professional
Engineer). Mr. Connaughton has participated in canine TBW
research performing blood/perfusate analyses, and is
currently involved in the design of computer controlled
perfusion software and hardware for BioPreservation.
Primary Perfusionist: Paiboon Plookvongpanit, CCP. Mr.
Plookvongpanit is a certified clinical perfusionist with
experience in canine TBW research and canine cerebral
resuscitation experiments. Mr. Plookvongpanit is director of
clinical perfusion at Riverside Community Hospital and has
extensive experience in both research and clinical perfusion.
Perfusionist: Shawn Shermer, BS. (Physiology). Ms.
Shermer has 6 years' experience as operations manager in the
largest contract biomedical research facility in the Western
United States. In this capacity, she functioned as
perfusionist, surgical assistant, animal care technician,
recovery room nurse, and ICU nurse. She has also participated
in deep hypothermia/TBW experiments employing dogs, primates,
and sheep. Ms. Shermer participated in (and was laboratory
manager for the facility during) the testing and development
of the Johnson and Johnson hemopump intra-aortic turbine
pump.
Perfusate Preparation: Larry Wood, BS (Biochemistry).
Mr. Wood's duties are perfusate preparation and surgical
assistant. Mr. Wood has long experience in drug and
parenteral preparation and has participated in most of 21st
Century Medicine's canine TBW and Cerebral Resuscitation
experiments.
Scrub Nurse: Faye Smith, RN. F.S. is a surgical scrub
nurse at a large community hospital. She has over 10 years'
experience and has served as a consultant in sterile
processing and sterile technique. Mrs. Smith has also served
as scrub nurse during most of 21st Century Medicine's canine
research operations.
Circulator: Candy Wood. Candy Wood has been trained as
circulator in-house during 21st Century Medicine canine
experiments.
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