SELECTIVE FLUID

BARRIER DEVICE
Derek Eller, 2016 | derek.r.eller@gmail.com | 614-562-0086

PROBLEM SUMMARY
Many types of interventional procedures involve the insertion of large diam-
eter sheaths (essentially hollow tubes) into arteries. While in place, a hemo-
static 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
involved two seal methods in series; a first passive elastomeric seal, with
a second ‘active’ seal, involving an elastomeric sleeve which was manual-
Complete device exterior:
ly twisted by the physician in order to cinch against crossing objects. The
Note the rotatable handle
secondary seal design was vulnerable to leakage at some crossing sizes, (12), which is rotated relative
and was prone to fail if it experienced over-tightening or excess longitudinal to the external stationary
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 given responsibility to design the replacement mechanism, starting
from an early pre-concept stage. Much of the development was CAD based,
with multiple generations of models, and a series of prototypes which com-
bined rapid prototyping, machining, and silicone molding.

The concept that I conceived of and developed worked as follows: The
device consists of four primary components; a silicone sleeve which acts as
a sealing surface through which devices are passed, a rotatable handle, a
stationary handle, and three or more cables interlocked 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.

The device creates a seal when the rotatable handle is rotated, which in turn
pulls the cables which are anchored to the rotatable handle, causing the
cables to tension and ‘cinch’ around the elastomer sleeve, compressing it’s
surface against whatever object is passing through, and therefore preventing
fluid leakage.

To reduce the likelihood of over-tightening, a torque-breaking ratchet mecha-
nism was implemented on the rotatable handle, causing the handle to slip at
a certain level of torque.

I developed this concept through three generations of prototypes, while
simultaneously performing studies to optimize the material for the elastomer
sleeve by mixing different silicone materials in different proportions. Exploded View: Note the
cables/cable anchor points
(62,64,66) and their trajectory
around the elastomer sleeve
(112)
RESULTS
Feasibility trails were conducted to measure leakage rates at various crossing sizes. The performance of my
device was statistically equal or superior to the current device at every crossing size tested in the feasibility
trial. As such, I passed the device design from research to development engineering, where it remained a
project until Cook halted all R&D activities.

Cook filed IP on the device in my name in both the US and EU, where it is currently pending review. All figures
were taken from the published patent applications, and all figures came from CAD models which I created 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, 2016 | derek.r.eller@gmail.com | 614-562-0086
PROBLEM SUMMARY
I was partnered with another engineer and tasked with creating an endograft
for the ascending aorta; an area of anatomy with a number of unique chal-
lenges. Specifically, because the vessel takes a nearly 180 degree bend in
the aortic arch, accurate longitudinal and rotational deployment of implants
is particularly difficult. In addition, the coronary arteries branch off from this
section of aorta, and must remain patent at all times during and after an
implantation.

An endograft is a section of prosthetic blood vessel, which is expanded
against the walls of a native vessel in a diseased area, in order to prevent
blood from exerting excess pressure on the diseased vessel. The graft itself
Proximal tie style trigger wires
consists of a fabric tube, supported by self-expanding metal struts, and is before being pulled taut.
deployed to an expanded state from a contracted state within a sheath. The Note the path of the wires
sheath is tracked through vessels to the point of the pathology. To aid in as they pass out of the hole
accurate deployment, grafts are generally held in a partially contracted state in the sleeve (13a), over a
after removal from the sheath by means of ‘trigger wires’ which are subse- stent apex (17a), and back in
quently removed to fully deploy the device. Currently, aortic endografts are through a second hole in the
available for all sections of the aorta except for the ascending. Our goal was sleeve (13a). Because this
to develop and prove feasibility for a graft intended to land in the ascending graft is using the modified
trigger wire technique, all
aorta. Although much of the project is proprietary, some elements of the de-
three loops are made from
vice and delivery system have been disclosed and published; this explanation
the same wire.
will focus on those elements.

One specific area where my advancements in developing an ascending aortic
graft pushed forward the technology for all endografts was in the realm of
trigger wires. A complex endograft may have as many as 7 different trigger
wires to bind different portions of the graft. Each one adds complexity, and
volume to a loaded graft, and it is possible for multiple trigger wires to inter-
act and bind against one another during extraction, making removal difficult,
and creating risk for an inaccurate deployment. As such, fewer trigger wires
are preferable to more. With this in mind, I pursued measures to reduce the
number of trigger wires.
PROCESS
The majority of the development for this project involved leveraging currently
available materials and technologies, and forging a path forward. Therefore,
careful study of manufacturing processes, and a deep understanding of cur-
rent products at Cook and elsewhere were central to finding points where the
technology needed to be advanced. The same graft, after the
modified trigger wire has
By the third generation of graft, my team had experienced several failed been tightened. Note that
benchtop deployments due to trigger wires becoming bound up with one an- the stent apices (17) have
other during extraction, and were also looking for ways to decrease packing been pulled in to contact the
density of the loaded graft. sleeve.
One standard type of trigger wire is a ‘proximal tie’ wire. Grafts generally have 3 proximal ties, oriented 120
degrees apart around the cannula which runs through the center of the graft in the delivery system. They pull
the graft inward to create a kind of ‘fish mouth’ configuration, before they are removed to allow the graft to
anchor in place.

With some changes to dimensions on several delivery system components, and a new loading procedure, I
was able to develop a single trigger wire with the same functionality as three proximal ties. The trigger wire
works as follows: The cannula running through the center of the graft is covered by an outer urethane sleeve.
In order to pull the graft inwards to contact the cannula, a trigger wire runs longitudinally between the sleeve
and the cannula, then passes out through a hole in the sleeve, passes over a strut on the stent, and passes
back in through a second hole in the sleeve. However, in my modified trigger wire technique, when the wire is
passed back into the urethane sleeve, it is inserted tangentially, such that it emerges 120 degrees around the
circumference of the sleeve from its entry point. This is repeated a second time, and finally passed out and
back in a third; thus a single wire passes over three different points.
RESULTS
With the aid of the modified trigger wire technique, and a number of other modifications to the delivery sys-
tem and graft which has not been disclosed, the number of trigger wires on the device were reduced from six
to two, which contributed to both a smooth procedure, and a smaller loaded diameter for the device.

I lead the effort which successfully deployed the device in an animal, demonstrating acute feasibility.

Cook filed for IP in my name on three different advancements made during this project. Currently, the modi-
fied trigger wire is published as US patent application 20160184116.

The modified trigger wire technique was made into a Cook development project, but was placed on indefinite
hiatus in the wake of the cessation of R&D at Cook.

A demonstration of the workings of
the modified trigger wire technique,
The wire (11) is passed through the
sleeve (7), is passed out of an aper-
ture (13a), forms a loop (15a), and is
passed back in, tangentially through a
second aperture (13a), before being
passed out again at the second set of
apertures (13b) and forming a second
loop (15b).

A cannula (1), wire (11) and sleeve (7)
demonstrating the full path of a modified
trigger wire in three dimensions. Each of
the pictured loops (15a, 15b, and 15c)
pass over the apex of a stent, and pull
that apex into contact with the sleeve
when tensioned.