Documents tags: DBMineContest11

DIRECT BLOOD ACCESS FOR AN

ARTIFICIAL PANCREAS

Arnold J. Landé, MD

Direct access to flowing blood, 24/7/52, would permit

an artificial pancreas (closed loop blood glucose sensor
and insulin and glucagon pumps) to function in real
time, like a natural organ.

Concerted efforts are ongoing in the US and EU to

create an Artificial Pancreas. However, prevailing
wisdom is that direct blood access cannot be sustained
over a lifetime. Therefore, all of those efforts are based
on sensing from and injecting into interstitial tissues,
usually the belly wall, to avoid blood clotting and
clogging glucose sensors and insulin and other
medications infusion cannulae.

Also required for that interstitial approach is

coordinating, after the fact, the significant time
separated prior sensor readings and future medications
infusions, by means of an immensely complicated
computer algorhythm. This is because the Achilles heel
of those interstitial based efforts is the multiple minutes
long delay between actual blood --> reflected interstitial
glucose levels and the multiple minutes long delay
between interstitial infusions --> actual blood response.
Those delays are difficult to compensate and much
effort is being expended to program physiological
clairvoyant and thereby to accommodate.

We believe the In Situ Debranched Vein Fistula Graft

(VFG) that is illustrated, offers a real possibility of
sustaining direct access to flowing blood throughout a
Type I or severe Type II diabetic's lifetime.
Just as for kidney hemodialysis, a fistula (connection between an artery and a vein, usually at the wrist)
is created, by a local surgical procedure, through a very small incision. As usual, run off from the
artery should result in a network of engorged, maturing veins. The one best vein is selected and its
accessory vein branches are tied off, or “obliterated” from within by coils, so that the preponderance of
the arterial blood is directed through the single vein.

This is already done routinely today, in order to rescue a poorly maturing or failing dialysis fistula.
Severed vein twigs return to normal, or atrophy, and do not remain unsightly. The high flow VFG
functions as a natural tissue “graft”, in its natural location, with all its supporting fibrous and elastic
tissues and vasa vasorum (minor blood vessels that supply large blood vessels) intact. Minimally
visible, just under the skin and likely to heal promptly from multiple punctures with twice weekly
changed #20 or smaller plastic cannulae, the VFG is expected to grow along with the pediatric patient.

When occlusive compression is applied onto the skin overlying the middle of the VFG, arterial pressure
can be accessed through a small twice weekly replaced plastic cannula upstream (usually distal) while
venous runoff remains accessible through a small replaceable cannula downstream (usually proximal).
A small diversion of A/V arteriovenous blood flow (~3 ml/min for an artificial pancreas, which is 1/10
of the ~30 ml/min for a forearm wearable kidney and 1/10 again for a typical ~300 ml/min chairside
kidney dialysis machine) can be fully “therapeutically” anticoagulated while the patient remains no
more than safely, “prophylactically” anticoagulated. Sensors and infusion cannulae. as well as the
entire device, are thus fully protected from clotting and fouling while the ambulatory patient is not
threatened by bleeding.

Transcutaneous compressions are automatically applied over the middle of the VFG, against the
underlying long bones or the interosseous fascia stretched between the bones of the forearm.
Compressions are alternated between neighboring sites to further avoid unlikely clotting or pressure
necrosis. An only fleetingly interrupted arteriovenous A/V pressure differential is thus engendered.

Extracorporeal arteriovenous A-->V flow through the device, may be modulated down to an easily
fully anticoagulated ~3 ml/min, by a simple lever and bladders volumetric or other mechanism, without
the need for bulky and hazardous electrical pumps, by the small, forearm athletic sweat band like
fashion accessory appearing, artificial pancreas. The patient remains barely prophylactically
anticoagulated.

The unobtrusive single small scar VFG, is often located along the inner, easily “sleight of hand”
concealed surface of the forearm. The twice weekly replaced blood contacting disposable will already
include sterile sealed on cannulae and finger crushable glass ampules of insulin, glucagon and heparin,
radiofrequency sealed into pouches. The real time blood contacting mobile digital forearm artificial
pancreas, will be even far simpler and smaller than our forearm wearable artificial kidney (prototype)
that also has to accomplish membrane dialysis and dialysate recycling. A real time blood accessing
artificial pancreas might benefit an even much larger number of patients than the kidney.

We propose a very small, wrist watch to Walkman sized, fashionable athletic sweatband, forearm
encircling artificial pancreas. The anticoagulant contained, even if inadvertently injected as a bolus,
would not be sufficient to endanger the patient. Likewise, needle valving will lessen the likelyhood
that a dangerous injection of insulin might occur. Also, hypoglycemia triggered automatic glucagon
and glucose injections, would immediately counter the insulin, and vice versa. Designed in wisdom,
would prevent a see-saw effect.
Redundancy of all miniature sensing and injecting systems is desirable, to reduce any dangers of over
or under device reaction down to nearly non-existent. All elements would have to agree before
injection could occur. Override would be available in case of confirmed life-threatening danger, by the
patient, partner or hands-on or mobile digital healthcare supplier. A VFG direct blood based artificial
pancreas, would surely be much simpler, safer and more efficacious than the interstitial fluid based
approach.