X-Message-Number: 2796
Date: 03 Jun 94 03:43:43 EDT
From: Mike Darwin <>
Subject: SCI.CRYONICS BPI Capability Improves

BioPreservation: Suspension Technology Report
by Mike Darwin


That past few months have seen rapid growth not only in 
Biopreservation Inc.'s (BPI's) basic cryopreservation 
capability, but also in innovations to transport procedures.  
Some of these innovations are simple and straightforward 
such as the reorganization of our Remote Standby Kit (RSK),  
while others involve profound changes in the very fabric of 
the transport procedure.

We have made several of what we would call "breakthrough" 
advances in patient care.  Unfortunately, we will be 
somewhat delayed in communicating very much detail about 
these advances until our patent applications are filed (a 
process which will take months; preliminary steps are now 
underway).  Most of this article will thus focus on what we 
CAN tell you about, and frankly, that's plenty enough in itself.

ACS/BPI Training

On Memorial Day weekend Jim Yount of ACS and Naomi Reynolds 
of BPI drove down from the Bay Area for a weekend of 
INTENSIVE one on two training.  The facility was 
deliberately emptied of EVERYONE but Mike Darwin, Jim and 
Naomi.  The objectives were tough ones: Jim and Naomi would 
perform 4 jugular cutdowns on a dog and two femoral cut 
downs.  They would pass small and large bore cannula on the 
jugular cutdowns to simulate getting vascular access for 
administration of Transport medications during human 
cryopreservations.  They would then (using the femoral-
femoral approach) go on cardiopulmonary bypass, hemodilute 
the dog to a hematocrit of less than 20 (diluting its blood 
by about half) and then come off bypass.  They would do ALL 
of this WITHOUT any significant physical assistance from 
Mike Darwin. (I didn't even scrub in; I just stayed in my 
street clothes and put on a mask and cap.)

We started at noon on Saturday and by 4:30PM they had two 
jugular cutdowns done.  The long hours of performing the 
femoral cutdown and going on bypass lay ahead (I should add 
that they had also set up the heart-lung machine and primed 
it.)  At that point I proposed we abandon the jugular 
cutdowns and go on to working on the femoral cutdowns and 
getting on with bypass.  To their credit BOTH Naomi and Jim 
immediately said in effect "No, we've come all this way and 
we damn well intend to get all the practice we can!" 

So, they did two more jugular cutdowns, picking up 
considerable speed and then went to work on the groin.  
About 12 hours after starting the dog had been put on bypass 
and cooled to 13*C at which point hearbeat had ceased.  At 
about 15*C I left the facility to buy food for man, woman 
and beasts and when I came back over an hour later Naomi and 
Jim were rewarming the dog.  

Aside from a close call where Naomi almost pumped air while 
I was away (a valuable learning experience) and a blow-off 
on the arterial line where it joined the cannula (this 
SHOULD NOT have happened and thus was an even MORE valuable 
learning experience) bypass was uneventful.  The dog's heart 
started beating on its own and she (the dog) came off bypass 
with minimal bleeding and an activated clotting time of 130 
sec. (prebypass was 80 sec.).

By 7:00 AM she had kicked out her endotracheal tube and by 
noon she was standing up.  When I arrived at 5:00 PM she was 
waiting for me by the door of the facility (no kidding)!  
She has done very well, required minimal pain medication and 
has suffered NO complications from 3 hours of 
cardiopulmonary bypass surgergy/perfusion conducted by two 
"rank amateurs" who did pretty darn well.

In addition to serving as a training dog  she also served as 
something of a control on BPI/21sts basic bypass technique 
(pretty darn good too!).

The dog's name, by the way, is Gouda.  In case you are 
wondering, she got this name when the kind soul who brought 
her back from the airport let her out of the shipping crate 
and fed her some cheese.  She then (a short while later) 
vomited up this 1/2 pound of cheese all over the interior of 
our kindly volunteer's BRAND NEW Nissan Pathfinder.  He has 
of course learned his lesson: let air-shipped crated dogs 
lie -- and don't feed them Gouda Cheese en route.

Also by the way, Gouda is a very sweet collie mix dog who 
weighs about 40 pounds and would love to have a home.  Any 
takers out there?  BPI/21st Century tries to place all good 
tempered surviving research/training animals.

Upgraded Remote Standby Capability

The first major improvment in Remote Standby Capability 
(RSC) came when the American Cryonics Society decided to 
purchase an RSK from BPI.  This RSK is a full capability kit 
designed to allow for field surgery, total body washout and 
near 0 degrees C shipping of patients to BPI or other 
cryonics organization's facilities for cryoprotective 
perfusion.  The ACS kit will be available for use by BPI to 
service ACS clients and thus frees up the BPI kit.  Also, in 
a critical emergency it is possible the ACS kit might be 
dispatched to "fill the gap" (and the same is true for the 
BPI kit if ACS has TWO emergencies at the same time -- a 
situation which HAS happened in the past).

The BPI kit has been radically upgraded and restructured.  
The weight of all the critical modules has been kept below 
the airline minimum of 65 pounds and the boxes are are all 
equipped with handles to facilitate handling as baggage 
rather than as freight.  This is an important capability 
because often freight space is NOT available on the same 
flight the Transport Technicians are going on, and even if 
it is, it means that the RSK must be processed through the 
*airfreight offices* of the carrier and picked up at a 
location remote from the passenger terminal: a delay that
can mean hours lost in a critical situation where a patient 
is profoundly unstable or already down.

A major element in achieving this weight reduction (aside 
from modularization) was the procurement of "state-of-the-
art" industrial instrumentation transport containers made of 
PLASTIC!  These rugged new plastics can take baggage 
handling stresses and still hold up.  Some of the modules 
(for less sensitive equipment) are heavy-gauge aluminum.

In addition to reconfiguring and modularizing the kit we 
have also made it easier to use.  The medications box is no 
longer a gray Flambeau tool chest but rather a suitcase type 
affair with a large, lift-out panel on which ALL the 
medications are mounted, in the order to be given, in clear 
acrylic boxes secured to the panel with Velcro.  Meds 
needing refrigeration are in color-coded overpacks to key 
personnel to insert them onto the panel just prior to use.  
Incompatible meds are also color-coded.  Many other changes 
to the rest of the kit, of the same nature, designed to 
facilitate both user-friendliness and speed of use, have 
also been incorporated, but space prevents us from detailing 
them here.

Three major functional advances have been made in the BPI 
RSK.  The first is the addition of extra patient 
monitoring/telemetery equipment.  We now have a Dinamap 
automatic, osscilographic, nonivasive blood pressure monitor 
(boy that's a mouthful, isn't it?).  This device allows us 
to monitor the patient's blood pressure using a cuff, but 
far more accurately and reliably than by using a cuff with a 
microphone or by listening with a stethescope.  This unit 
thus allows us to continue to monitor blood pressure 
NONIVASIVELY (i.e., without cutting into or sticking the 
patient and placing a catheter or sensor in his/her body) 
and with far greater accuracy than with conventional blood 
pressure equipment.  The unit has several other features 
which are very important to us:

* It operates automatically and can be set to take blood 
pressures at any arbitrary interval desired.

*  It automatically displays pulse and calculates/displays 
mean arterial pressure.  The latter is a critical value in 
evaluating how long a patient will "last" while agonal 
(i.e., is in the last stages of the dying process before 
heartbeat ceases).

* It has adjustable "High" and "Low" alarm limits on both 
systolic and diastolic pressures so that family or personnel 
can be alerted to any significant changes in the patient's 
status.  This is VERY important since it is all too easy for 
exhausted standby personnel or family members to drift off 
to sleep.  Our first experience with pulse oximetery in the 
field has clearly indicated a need for another modality of 
measuring patient "instability".

The Dinamap is old, reliable technology which is used by 
hospitals everywhere to monitor critically ill patients.  In 
fact, the new units (we have a new one) are increasingly 
replacing invasive blood pressure monitoring in the ICU 
since they have been found to be just as reliable for most 
applications and carry less risk and COST.  The down side to 
this of course is that used Dinamaps, even older ones, are 
very costly because they are now very much in demand (the 
lowest used price we've seen is $1200).

We have also added EKG and stethephone capability allowing 
us to transmit EKGs and breath and heart sounds to 
consulting clinicians remote from where the patient is.  
This allows us to put experts "on site" via telemedicine.  
We are investigating the use of videophones which will 
transmit modest quality images (Such as the AT&T 
Picturephone), but which could be of critical importance in 
assisting the consulting physician(s) in evaluating the 
patient's condition.  As we are learning from hard 
experience, even a crummy picture is worth a lot of words.  
Inclusion of this equipment in the kit (if we decide it is 
cost effective) would also allow less skilled personnel to 
be guided through equipment set-up in an emergency in a 
situation where the kit is on-site with the patient but 
highly skilled BPI personnel are not (we increasingly send 
out the kit well in advance of anticipated need).

Perhaps the most dramatic upgrades to the kit are the 
additions of a complete mini-clinical lab (MCL) and the 
capability for on-site preparation of the new 21st Century 
Medicine/BPI perfusate which has been shown effective in 
inhibiting cold-rigor mortis after blood washout (this 
solution will probably soon replace Viaspan for most remote 
uses).

The MCL is actually pretty sophisticated and will allow us 
to do the following evaluations: hematocrit (% of blood as 
red cells), hemoglobin, serum total protein, osmolality 
(blood/urine/perfusate), chemical urinalysis (ketones, 
glucose, bilirubin, blood, etc.) urine specific gravity 
(along with urine osmolality a critical indicator of the 
patient's fluid balance status or degree of dehydration-- 
very important if the patient is dying secondary to  
dehydration (either as a direct result of the disease 
process or by consciously choosing to refuse all food and 
fluid).  Blood/perfusate pH is also on line in the kit.

Within the next 6 months (hopefully sooner) we plan to add 
capability for serum ammonia and total bilirubin (indicators 
of certain kinds of liver failure), BUN and creatinine 
(indicators of renal function), amylase (indicator of 
pancreatic disease), as well as serum phosphorus and 
cholesterol and triglycerides (these last three tests are of 
little clinical relevance in the standby setting, but will 
come as part of the package capability).

Several questions probably come to mind about the addition 
of this clinical laboratory capability:

* First, why?  The answer is simple; we often find ourselves 
in field situations where we are unable to tell what is 
happening to the patient and/or what the patient's likely 
time-course to cardiac arrest is because medical consultants 
(remote and/or on site) do not have access to needed 
laboratory information.  This has been intensely 
frustrating, and was especially a problem in the last (and 
first) cryopreservation BPI did.

* Second, why not just send the sample in to a local 
clinical lab for analysis?  Not only is this not only costly 
(up to $200 for each "stat" run) it is often logistically 
difficult.  The sample has to be drawn, containerized, run 
down to the lab and then you WAIT for results.  Monitoring 
rapid deterioration of a patient's condition is not cost 
effective or practical when using an outside lab.  Also, 
since the information is not for "theraputic" purposes 
physicians will not usually order it because insurance won't 
reimburse the cost and setting up with the local lab  ( 
i.e., one near the PATIENT as opposed to the one across town 
the doctor uses) on pay-per-use basis is very problematic.  
An on-site lab lets the treating or consulting physician 
order labs effortlessly and allows everyone to get near 
instantaneous feedback.  Most test results are available 
within 5 minutes or less!

* Tests can be repeated at frequent intervals without 
draining the patient of blood.  A normal clinical analyzer 
requires about 3-5 cc of serum which means they need about 
7-10 cc of blood.  The Ektachem and other equipment we use 
requires about 1 cc of blood to perform ALL the tests we 
need to do!

*  Why is it so critical to know what is going on medically 
with the patient when the end-point (legal death) is always 
the same?  Here the answer is simple: preparedness and cost 
containment.  Every day of remote standby is a minimum of 
1K!  If medications are prepared too early and have to be 
discarded another 1-2K goes down the drain and what's more 
the meds might not be there when the patient needs them!  We 
believe that better in-field diagnostic capability will 
prove effective in containing standby costs AND giving 
better care to the patient.  Also, as we start to monitor 
these parameters we'll learn which values signal real 
trouble and build a database of "crisis" values which will 
improve our predictive skill. For instance, we know for our 
in-lab work with dying dogs that serum lactate and ammonia 
levels show a predictable pattern of increase right before 
an animal becomes agonal.  We need to build a similar series 
of curves for humans dying slowly too!

The MCL is not a luggage-able item so it must be air-
shipped.  But then, it is likely to be needed only in longer 
cases of standby anyway so we don't see this as a problem.

New CPR Equipment

By the time you read this BPI should have taken delivery on 
a new system for delivering CPR which should DOUBLE our 
cardiac outputs over the previous high-impulse system now 
used by Alcor.  In others words, this unit should allow us 
to deliver nearly NORMAL baseline cardiac output (blood 
flow) in many patients.  This system has been months in the 
designing/engineering and has required a great deal of 
innovation and a lot of effort on both our part and on the 
parts of our British colleagues who have worked with us to 
make this system possible.  We cannot give you the details 
yet, but we can tell you that this is only the "first half" 
of a revolution in suspension patient care centering on 
transport.  

This new CPR unit is computer driven and preliminary in- 
house tests (using a prototype of this system) indicate that 
we may at long last be on the threshold of solving many of 
the problems associated with conventional closed-chest CPR 
(pulmonary edema, grossly inadequate cardiac output, and 
rapid loss of brain perfusion).  A major problem has been 
getting a workable (portable) power supply since this unit, 
unlike Michigan Instruments Thumpers and Brunswick HLRs uses 
solid state logic and computer driven solenoids to move the 
chest.  Incidentally, the price tag on this unit was a 
"mere" $10,074.63!

Upgraded Cryoprotective Perfusion Capability

One innovative upgrade to cryoprotective perfusion has been 
the acquisition of fiber-optic endoscopy equipment (along 
with the expertise to use it!).  Endoscopy means to look 
inside the body and this area of medicine has been 
undergoing explosive developments since the  late 1960's.  
The pace has quickened in recent years and it now possible 
to perform major abdominal surgery such as gall bladder 
removal via endoscopic means.  BPI has acquired a reasonably 
sophisticated endoscopic capability.  We have a Sony high 
resolution CRT (Tv monitor) with accompany videorecorder, a 
Storz endoscopic television camera, an ACMI halogen, and a 
Storz Xenon light sources, as well as related suction and 
irrigation equipment.  

We have also acquired a variety of endoscopes including a 
gastroscope, a colonoscope (both made by Olympus) a rigid 
hysteroscope (which allows visualization of blood vessels 
well under .5 mm in diameter on the brain surface and even 
slightly (1-2 mm) BELOW the brain surface using our Xenon 
light source), and two ultrathin (1.5 and 2.5 mm diameter x 
1 M length) flexible "vascular" scopes (the latter has an 
irrigating/working channel down which an instrment can be 
passed) which allows us to visualize almost the entire brain 
surface through burr holes opened over each cerebral 
hemisphere.  We can thus snake these scopes between the 
tough dura mater which covers the brain and the brain 
surface and look at the pial blood vessels to assess the 
degree of blood washout or continued perfusion (via 
injection of dyes).  These two scopes can also be passed 
through blood vessels (the largest is the size of a Swan-
Ganz catheter for those with a medical bacground) and used 
to look inside carotid arteries and other vessels for 
retained clots after washout has taken place in patients who 
did not receive good transport/blood washout in the field.  


Added capabilities are the ability to inflate the abdomen 
with carbon dioxide(CO2) (we have a Wolff CO2 insufflator) 
and examine the abdominal viscera with our rigid scopes.  
This is a very important capability to have if we see 
abdominal distension (indicating possible perfusate leakage) 
during perfusion. These instruments also have "working 
channels" and we have biopsy equipment which can be passed 
down the working channel allowing us to biopsy abdominal 
organs on whole-body patients for evaluation of their 
response to cryoprotectuive perfusion/freezing -- something 
that could be done in the past only by making a large 
abdominal incision (clearly unacceptable for data gathering 
purposes in whole body patients).

 We can also examine the gastric mucosa (inside of the 
stomach) for lesions that may cause loss of perfusate 
(ulcerated mucosa from shock during the agonal period or 
absent post arrest stabilization) as well "treat" these 
lesions to a limited extent  (and thus stop loss of 
perfusate) by cauterizing the lesion or distending the 
stomach and compressing the leaking area with a gastric 
baloon filled with CO2.

Yet another added capability is pulsatile perfusion of the 
patient's circulatory system which is especially useful in 
facilitating perfusion of patients with extended post-arrest 
ischemic injury.

ACS MiniKits Deployed

On Memorial Day Weekend 2 minikits were deployed in the Bay 
Area.  The Minikit concept has been rattling around for 
about 6 months and Jim Yount deserves the credit for really 
pushing them into being.  ACS bought two of them for 
Northern California (in addition to two simpler ones which 
Jim had put together himself).  The Minikits have basic 
drugs, basic IV-start equipment, a bag-valve resuscitator, a 
cut down tray, paramedic holster (superscissors, etc.) and 
Zip-Loc bags.  The temperature sensitive meds (i.e., those 
that can't be left in the car) are packed in a fanny pack so 
they can be carried around with the person on-call.

The need for more minikits was brought home during the last 
ACS suspension when an overturned tanker cut-off staff with 
equipment from reaching the patient's nursing home in Walnut 
Creek, CA.

Since ACS was nice enough to buy the minikits, BPI decided 
to meet them half-way and deployed another Thumper 
(cardiopulmonary resuscitator) with regulators, wall adapter 
and 2 aluminum E-cylinders, with BPI Transport Tech Naomi 
Reynolds.  Naomi also has one of the ACS minikits so she is 
now a walking 1-woman cryonics Transport capability.


BPI to Deploy Transport Kit on East Coast

Due to the rapid growth of CryoCare membership on the 
Eastern Seaboard BPI will be deploying a full ER kit, 
possibly including blood pump/washout capability towards the 
first to middle part of July of this year.  Stay tuned for 
more details.

Portable Ice Bath (PIB) Redesign Underway

BPI is also redesigning the PIB so that it will be:

a) very lightweight
b) collapsible into an automobile/airline luggage cartable size
c) easier to set-up (just unfold it!).  We should have a 
   couple of these on-line in about a month.

We feel confident that these upgrades will go a long way 
towards improving patient care and we look forward to 
reporting on even more exciting ones in the near future.  If 
you have any questions about BPI's services, feel free to 
give us a call (909)987-3883.

Copyright 1994 by BioPreservation, Inc.

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