SELECTIVE FLUID

BARRIER DEVICE
Derek Eller, 2017 | derek.r.eller@gmail.com | 614-562-0086

PROBLEM SUMMARY
Many interventional procedures involve the insertion of large diameter
sheaths into arteries. While in place, a hemostatic seal must be maintained at
the proximal end of the sheath to prevent catastrophic blood loss, while still
allowing the insertion and retraction of instruments of various sizes.

Cook manufactures a large volume of sheaths ever year, most of which

include hemostatic valves. The previous design, present on most sheaths in-
volved two different seals arranged in series; a first passive elastomeric seal,
with a second ‘active’ seal, involving an elastomeric sleeve which was manu- Complete device exterior:
Note the rotatable handle
ally twisted by the physician to close against crossing objects. The secondary
(12), which is rotated relative
seal design was vulnerable to leakage at some crossing sizes, and was prone
to the external stationary
to fail if it experienced over-tightening or excess longitudinal forces. base (14) to create a seal

Cook wanted a new design to replace the current ‘active’ seal with a more
robust and reliable mechanism.
PROCESS
I was responsible for designing a replacement mechanism, starting from an
early pre-concept stage. Much of the development was CAD based, with mul-
tiple generations of models, and a series of prototypes which combined rapid
prototyping, machining, and silicone molding.

My concept functions as follows: The device consists of four primary compo-

nents; a silicone sleeve which acts as a sealing surface through which devic-
es are passed, a movable handle, a stationary handle, and three cables inter-
locked around the exterior of the silicone sleeve, each with one end anchored
in the stationary handle and the other end anchored in the rotatable handle.

To create a seal, the physician rotates the movable handle, which in turn
pulls the cables which are anchored to the movable handle, creating tension
in the cables, and closing them around the elastomer sleeve, compressing it’s
surface against whatever object is passing through. The sleeve, compressed
against crossing objects provides the fluid seal.

To prevent over-tightening, a torque-breaking ratchet mechanism was imple-

mented on the rotatable handle, causing the handle to slip at a certain level
of torque.

I led mechanical and material development on this project simultaneously,

leading to a complete, functional device.

Exploded View: Note the

cables/cable anchor points
(62,64,66) and their trajectory
around the elastomer sleeve
(112)
RESULTS
I pushed the device through feasibility testing, demonstrating superior performance and reliability over current
devices, moving the device out of research phase and into marketing and development engineering.

Cook filed IP on the device in my name in both the US and EU, where it is currently pending. All figures were
taken from the published patent applications, and were taken from my CAD models for the project.

See US Patent application 20150305859 for further reference.

Side cutaway of elastomer

sleeve (20), stationary han-
dle (16), and cables (22, 24)
as the cables are tightened
around the sleeve.

Overhead view of the cables

(22, 24, 26) with sleeve
removed, as they are tight-
ened, closing the aperture
between them (136).

Overhead view of the cables

as they are tightened around
the silicone sleeve (20), clos-
ing the aperture through the
center (116)
ENDOGRAFT FOR
THORACIC AORTA
Derek Eller, 2017 | derek.r.eller@gmail.com | 614-562-0086

PROBLEM SUMMARY
An endograft is a section of prosthetic blood vessel, which is opened against
the walls of a native vessel in a diseased area, in order to prevent blood from
exerting pressure on the diseased vessel. The graft itself consists of a fabric
tube, supported by self-expanding stents, and is deployed from a contracted
state within a sheath. The sheath is tracked into place in the aorta through
peripheral vessels. To aid in accurate deployment, grafts are held in a par-
tially contracted state after deployment by means of ‘trigger wires’ which are
subsequently removed to complete the deployment. There are currently no
grafts on the market for the most proximal section of aorta.
Side cutaway diagram of
an aorta, depicting the 180
Cook Medical wanted to create a line of aortic endografts which could cover degree turn of the aortic
from the left ventricle to the iliac arteries. I executed critical research and arch. The left ventricle of
development on an endograft for the ascending aorta; an area of anatomy the heart sits just below the
with a number of unique challenges. Specifically, because the vessel takes “W” shaped section on the
a sharp 180 degree bend in the aortic arch, accurate implant deployment is left, and the vessel supplies
difficult. In addition, the location and importance of the coronary arteries add blood to the rest of the body.
procedural complexity. The side vessels (15) on the
left side of the figure are the
coronary arteries and re-
PROCESS quire constant blood supply
throughout the procedure.
I took over technical leadership of this project at an early, pre-concept This therapy is intended for
phase. Leveraging academic literature, competitive benchmarking, an aneurysm or dissection in
the ascending section, on the
process development, and Cook Medical’s endograft portfolio, I created left.
concepts and prototypes intended for benchtop and animal study.

The development required systems-level design, with many compo-

nents being developed simultaneously. The implant, delivery system,
and procedure were all new technology for the field.

My team developed and tested new device iterations every few weeks,
in a highly creative, hands-on design cycle. In so doing, I honed skills
in a wide range of prototyping and manufacturing processes, including
machining, textiles, coiling, tipping, and NiTiNOL heat treatment.

Risk management activities were tantamount to success, and the de-

A graft in a state of partial
sign process was informed by fault-tree analyses and FMEA activities deployment. The graft is
which were updated and referenced throughout. compressed into a sheath to
be tracked into place. When
the sheath is retracted, the
graft expands. “Trigger wires”
hold the graft in a partially
compressed state, to allow
greater control over the de-
ployment.
RESULTS
My team successfully deployed a device into a sheep aorta, proving that our procedure was feasible and that
our graft could successfully be manufactured, loaded, and deployed. In the process, we delivered several new
graft and delivery system technologies with patents pending, and several more which have passed out of re-
search and into marketing and development engineering, to be included in future generations of endografts.

See patent applications US14982539, US14977041, EP20160275022, EP20160275178, EP20150275264 for fur-
ther reference.

View of the graft from below, showing the long,

three dimensional curvature of the right coronary
branch, with the relatively straight path of the left.
The branches are nearly parallel at their proximal
ends, allowing easy cannulation and passage of
wires, catheters, and stents, followed by a branch
which points the distal end directly toward the
openings of the coronary arteries.

The graft, deployed within the ascending aorta.

The graft sits flush with the walls of the blood
vessel, with branches to accommodate the coro-
nary arteries. In order to make the placement of
the branch stents simpler, the delivery system was
pre-loaded with wires and catheters, which could
easily be tracked through the branches and into
the coronary arteries.