Newell: The Mk2 Hypo-Hyperbaric Diabetic Therapy System 1

The Mk2 Hypo-Hyperbaric Diabetic Therapy System

Mark M. Newell PhD

Mark M. Newell PhD

826 Georgia Avenue,
North Augusta
SC 29841
803 442-7842 Res
706 399-6813 Cell
Newell: The Mk2 Hypo-Hyperbaric Diabetic Therapy System 2

Introduction
The HWTS-Mk2 Hypo-Hyperbaric Wound Therapy System (HWTS-Mk2) is
designed to prevent or treat peripheral wounds resulting from diabetic infection,
decubitus ulercation, trauma, (including accidents, injury, infected bites and
burns), amputations (diabetic, accident, combatant injury) by employing both
HIGH and LOW pressure technology (HypObaric and HypErbaric pressure). The
Mk2 device consists of a 48” long, 14” diameter acrylic cylinder with a filtered
extractor pump at one end and a latex pressure ‘collar’ at the other. The
technology is designed to provide a significantly less expensive and more readily
available wound treatment modality than is currently available with different
technology (high pressure hyperbaric chambers) – the only treatment of its kind
currently available for serious/difficult to treat wounds of these etiologies.

Specific medical protocols are designed for various applications of the device. In
the case of its primary use for Diabetic patients, very specific conditions
(including a specific range of blood glucose levels) must be met to ensure best
results. Typical uses would include a low-pressure protocol to promote health of
peripheral tissues via oxygenation and nerve regeneration (see medical section
below) thereby providing a prophylactic regimen against ulceration. A high-
pressure protocol is used in the case of existing ulceration or new wounds. In
such cases a high-pressure environment using atmospheric oxygen or supplied
oxygen of higher concentration levels is used to promote healing of the damaged
tissue. In addition, atomized or gaseous medications can be used in conjunction
with the high-pressure protocol by injecting them into the chamber during the
treatment process.

Fabrication Process:
The HWTS-Mk2 device is manufactured via assembly of components consisting of
1) mold formed acrylic low/high pressure chamber, 2) Latex pressure collar, 3)
Pressure strap, 4) Detachable filter container, 5) Detachable low/high pressure
pump.

Utilization Process:
The device is used by inserting the patient’s limbs (leg, foot to lower thigh or arm,
hand to upper arm) into the pressure chamber through the folded back latex
pressure collar. The limb rests upon disposable foam pads or towels (disinfected
through standard hospital process). The latex pressure collar is folded forward,
its end contacting the patient limb with light pressure. A thin layer of sealant gel
is applied to the inner surface of the end of the collar in contact with the patient
limb. The air filtration system and low/high pump are attached to each other, and
then are attached to the closed end of the chamber via a porthole into which a
disposable rubber grommet has been inserted. The pump mechanism is adjusted
for high or low pressure, depending upon the type of therapy protocol to be used.
In the case of a low pressure protocol, for example, the pump is activated,
reducing the internal pressure of the hypobaric chamber to approx 7-5psi,
causing the latex pressure collar to seal against the patient limb. The low
Newell: The Mk2 Hypo-Hyperbaric Diabetic Therapy System 3

pressure condition inside the hypobaric chamber is maintained, or released and

re-applied according to a written medical protocol for the specific condition being
treated (treatment protocols are developed by, and are the intellectual property
of, the medical specialists using the HWTS-Mk2 in their various areas of medical
practice). Upon completion of treatment, a reverse valve on the pump is
activated, allowing the internal pressure of the hypobaric chamber to return to
14psi or atmospheric pressure. The latex pressure collar is then peeled back, and
the HWTS-Mk2 is removed from the patient limb.

The pump is then removed from the air filtration system. The air filtration
system is removed from the closed end of the hypobaric chamber, its filter is
removed and discarded, as is the rubber grommet inserted into the air port of the
closed end of the chamber. The air filtration box is disinfected by washing,
dipping or wiping with a standard medical grade disinfectant. The pressure collar
is then removed from the chamber, and both the chamber and collar are
disinfected by washing, dipping or wiping with a standard medical grade
disinfectant.

Medical Premise:
Current medical treatment for serious peripheral wounds, including decubitus
ulcers, burn wounds, diabetic sores, and wounds resulting from trauma and other
etiologies, include administration of high pressure oxygen by immersion of the
patient in a high pressure oxygen atmosphere within a hyperbaric chamber.
While this treatment modality is efficacious, there are numerous drawbacks to
the treatment including limited availability of chambers, patient resistance to
chamber entry (sometimes requiring sedation), the inherent dangers of a high
pressure oxygen environment and high patient time demands for chambers
which limit length of treatment available to all patients. The physiological
process is based upon pressure driven increase of oxygen levels in the tissues
surrounding the wound, resulting in regeneration of the micro-vascular system
and neurological system in the damaged tissue and promotion of growth of new
tissue.

The physiological principles on which the HWTS-Mk2 device is based are drawn
from anecdotal experience, clinical experience and published clinical papers,
which all document growth of micro vasculature and nerve tissue in peripheral
tissue in response to increase blood flow to areas of the body submitted to
reduced atmospheric pressures. The evidence indicates that the body’s natural
vascular ‘delivery system’ responds to the reduction in pressure by increasing
blood flow, thereby delivering freshly oxygenated blood and nutrients (and
systemic medications) to the area subjected to the reduced pressure.

This premise will be the subject of medical clinical trials following completion of a
provisional patent application.
Newell: The Mk2 Hypo-Hyperbaric Diabetic Therapy System 4

Proposed Product Development:

Should the HWTS-Mk2 device receive an award from the Diabetes Mine 2010
Design Challenge, the funds and exposure will be used to pursue full patent
applications and to fund development of prototype devices suitable for use in
Institutional Review Board controlled clinical trials. The inventor is fully familiar
with the product design, development and manufacturing process, FDA and CE
approval process for medical devices and the medical marketing needed to take
advantage of the civilian and military uses of the HWTS-Mk2 device.

Prototype Product Illustrations:

Example shows low pressure application.

Figure 1: Preliminary design concept.

Newell: The Mk2 Hypo-Hyperbaric Diabetic Therapy System 5

Figure 2. Components of system.