BodyNotes: Low-cost telemedicine & prosthetic improvement kits for amputees

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Dec 10, 2013 (3 years and 4 months ago)

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BODYNOTES: LOW
-
COST TELEMEDICINE &
PROSTHETIC IM
PROVEMENT KITS FOR A
MPUTEES

ALEX OLWAL & DAVID S
ENGEH, MIT MEDIA LAB




WWW.BODYNOTES.ORG




1


BodyNotes:

Low
-
cost telemedicine & prosthetic
improvement kits for amputees

BACKGROUND

1.7 MILLION AMPUTEES IN THE US

In the United States, there are about 1
,
7 million amputees; the majority of whom are
lower

limb amputees. On average, 185,
000 new amputa
tions are performed each year in
the United States. The main reasons for amputations in the developed world are from
complications in the vascular system, diabetes, cancer and trauma. Across all
geographies, diabetes levels are on the rise and so are amput
ations.

AMPUTEES WORLDWIDE D
UE TO NATURAL DISAST
ERS AND WAR

Though the majority of such amputees are the elderly,
younger adults now also loose
their limbs at higher rates (e.g., due to the conflicts in Iraq and Afghanistan). Landmines
in Iraq caused nearl
y 1,100 amputations


85% of amputations of all servicemen
between 2001 and 2009.
In the developing world, rebels often use maiming and
amputation of the limbs of civilians
for
intimidat
ion
. Between 1991 and 2002, rebels
maimed over 20,000 civilians durin
g the 10
-
year civil war in Sierra Leone. The
earthquake in Haiti left a reported 8,000 people amputated and the number of
amputations in Japan are

yet unknown
.

THE SOCKET


THE MOST IMPORTANT P
ART OF THE
PROSTHESIS

Irrespective of location or socio
-
econom
ic
background, prosthetic socket comfort is the most
important feature in a prosthetic device. The prosthetic
socket is the device that interfaces the prosthetic limb
with the human limb. Over 90% of amputees indicate
that the socket is the most important
part of their
prosthetics. If painful and uncomfortable,
it may
prevent
an amputee
from using
their prosthetic leg.

THE DANGER OF PROBLE
MATIC SOCKETS & THE
DIFFICULTY OF PROVID
ING GOOD COMFORT

Changes in residual limb volume can have devastating effects o
n an amputee's health.
Comfort relies on the residual limb's fit in the prosthetic socket. Friction between the
socket and skin
may
result in sores, infection
s

and
,
serious secondary health conditions.
Today, no effective way exists for patients to communi
cate their problems,
and
to get
advice or help
, from their prosthetist
. In many cases, small modifications could improve
socket comfort, but amputees do not have the resources, tools, knowledge or capabilities

Figure 1. Prosthetic Socket Fitting.

BODYNOTES: LOW
-
COST TELEMEDICINE &
PROSTHETIC IM
PROVEMENT KITS FOR A
MPUTEES

ALEX OLWAL & DAVID S
ENGEH, MIT MEDIA LAB




WWW.BODYNOTES.ORG




2

to do those changes. Because amputees are youn
ger and more agile

today, the
re is an
even greater

need
for
effective
and comfortable
socket

design
.
T
he ability to
independently
modify their socket in collaboration with their health care practitioners
with
the right tools

is an important step in this di
rection
.

PATIENTS
-
PROSTHETIST COMMUNIC
ATION IS LIMITED, DE
SPITE ADVANCES IN MO
BILE TECHNOLOGY

Advances in cell phone technology allow for remote communication between patients
and their care providers. However, a prosthetist often
needs
to be able to
visu
ally assess

and understand the discomfort an amputee feels before they could offer possible
solutions. A video call falls short
since
the care practitioner
can not
actively indicat
e

specific points on the amputees socket or limb.


SELF
-
MODIFICATION IS RA
RE, DUE TO LACK OF R
EMOTE ASSISTANCE

Presently, two companies


Ossur and Otto Bock


make prosthetic inserts to allow
prosthetists to modify
patient

sockets. Both companies make disc
-
shaped inserts of
different sizes. Ossur develops “Pressure Pads
-

Discs

,

while Otto Bock manufactures
circular
“Sticky Spots”. Amputees do not use these inserts
on their own
to modify their
sockets,

as they could not get proper assistance from prosthetists today
. In
stead, inserts
are used by prosthetists during socket produc
tion. Prosthetists use these inserts to
improve socket fit and relieve undue pressure on the residual limb once the socket has
been completely made.

T
hey are
, however,

limited by the shape and sizes of the inserts
available



the thickness of the discs pro
duced by both companies is the same and only
the diameter of the discs is varied.

INNOVATION 1

PROSTHETIC IMPROVEMENT KITS

(PIKs)

PROSTHETIC IMPROVEME
NT KITS



ENABLING SELF
-
ADJUSTMENTS

When the residual limb of an amputee looses volume (usually over a d
ay or more) it sinks
into the prosthetic socket. This causes the different anatomical components of the limb to
experience pressure changes that can cause pain and friction sores for the amputee.

Our Prosthetic Improvement Kits (PIKs) will include optimal
ly designed inserts of
different sizes and shapes to prevent pressure pain and sores whether there is volume loss
or not. The PIKs empower the patient to be able to make the necessary socket changes
with advice from their prosthetist. Prosthetists can also

use the kit during the initial
socket design, for a more comfortably fitting socket.

3D model (SolidWorks)

3D
-
printed mold

Silicon insert

Insert + Socket


Figure 2. Prosthetic Improvement Kit process for first prototype
development

BODYNOTES: LOW
-
COST TELEMEDICINE &
PROSTHETIC IM
PROVEMENT KITS FOR A
MPUTEES

ALEX OLWAL & DAVID S
ENGEH, MIT MEDIA LAB




WWW.BODYNOTES.ORG




3

PIK: OPTIMAL DESIGN
AND ENGINEERING FOR
FLEXIBLE FORM FACTOR
S

The complexity of the human anatomy means that pressure pains
are not all solved by

disc shaped pads. Pains

at the distal ends of the
limb for example might require different shaped inserts to get full
comfort. Present inserts designed by Ossur and Otto Bock are made
from silicone rubber with adhesives
that
include only
circular
shapes or different sizes.
BodyN
otes takes a radically new approach
to adapting inserts for individuals, by using readily available force
-
sensors that can be temporarily worn in the socket to get high
-
precision mappings of the weight distribution. This will make it
possible to better add
ress problems of discomfort by combining the
inserts in our kit.

We are already exploring multiple shapes (circular, rectangular,
teardrop, oval) and sizes in our prototype kit. We will also vary the thickness of the
inserts for better options.


AFFORDABL
E AND AVAILABLE TO A
MPUTEES

Prosthetic inserts from Otto Bock and Ossur are expensive and not readily available for
purchase by amputees for personal use. Our PIKs will be made available for purchase at
different prosthetist offices. They
could also be bou
ght online at various outlets once they
are
mass
manufactured and packaged. We intend to make these PIKs affordable
especially as we expand our project into the developing world.

TABLE 1.
PROSTHETIC IMPROVEME
NT KIT

COMPONENTS


Figure 3. Pressure
map for a limb helps
identify problematic
areas.

Component
Shape
Size (inches)
Material
L x W x H
PIK 1a
Rectangle
3.5 x 2.10 x 0.25
Silicone
PIK 1b
Rectangle
2.63 x 1.58 x 0.25
Silicone
PIK 1c
Rectangle
1.75 x 1.05 x 0.25
Silicone
PIK 2a
Disc
3.5 x 3.5 x 0.3
Silicone
PIK 2b
Disc
2.65 x 2.65 x 0.3
Silicone
PIK 2c
Disc
1.75 x 1.75 x 0.3
Silicone
PIK 3a
Tear Drop
3.5 x 1.75 x 0.2
Silicone
PIK 3b
Tear Drop
2.65 x 1.32 x 0.2
Silicone
PIK 3c
Tear Drop
1.75 x 0.88 x 0.2
Silicone
PIK 4a
Ellipse
3.5 x 1.75 x 0.23
Silicone
PIK 4b
Ellipse
2.63 x 1.31 x 0.23
Silicone
PIK 4c
Ellipse
1.75 x 0.88 x 0.23
Silicone
Cotton Prosthetic Socks used to increase v olume
Silicone Adhesiv e
Measuring ring to measure limb diameter
Lip Stick to mark pain points in a socket
BODYNOTES: LOW
-
COST TELEMEDICINE &
PROSTHETIC IM
PROVEMENT KITS FOR A
MPUTEES

ALEX OLWAL & DAVID S
ENGEH, MIT MEDIA LAB




WWW.BODYNOTES.ORG




4

INNOVATION 2

MOBILE TELEMEDI
CINE APPLICATION

When a patient is fitted with a new socket, the
prosthetist and patient take images of the socket and
the residual limb
. These

files
are automatically
downloaded both into the health record and
accessible from

their phones and the prosth
etist

s
computer.

The BodyNotes mobile application
augments the
process
in t
hree

ways
:


1) DETAILED PAIN TRA
CKING & VISUALIZATIO
N

Firstly, the user can track pain on their residual limb
by
annotat
ing

image
s

of
the

residual limb
with data,
such as, the
exa
ct location
and extent
of the pain

region,
pain

intensity
,
when it started, how long it
lasted
,

and the
activity

that might have caused it
. The
amputee
can

also
enter
additional
notes which
are
uploaded

together with the other data to the health
record
dat
abase
, making them immediately
available
to their prosthetist. The
system allows
patient
and
prosthetist to visualize and analyze the data (since
they both have the same images)
such that they can
improve the comfort of the socket. Patients could see
how t
heir “activity” (walking, running, sitting, etc) correlates with pain intensity and how
time (how long after wearing a socket) affects the location and intensity of pain. Th
is rich

historical data was
not
previously
available to the prosthetist

and could n
ow
allow them
to design better
patient
-
specific
interventions.



Figure 6. The BodyNotes mobile application provides advanced pain tracking and logging in a multi
-
touch
mobile user interface.

2) REA
L
-
TIME REMOTE PATIENT
-
PROSTHETIST COLLABOR
ATION

Secondly,
current

technology make
s

it
difficult
for prosthetists to remotely interact with
amputees about their prosthetic devices to offer the best possible advice on how to
modify their sockets. The amount
of prosthetists available to amputees is few even in the
developed world. In the developing world, this proportion is worse with almost no
prosthetists available to the
many
thousands of amputees. Our technology enhances


Figure 4. Prosthetist photographing
Socket for use in BodyNotes.


Figure 5. BodyNotes visualization of
historical data.

BODYNOTES: LOW
-
COST TELEMEDICINE &
PROSTHETIC IM
PROVEMENT KITS FOR A
MPUTEES

ALEX OLWAL & DAVID S
ENGEH, MIT MEDIA LAB




WWW.BODYNOTES.ORG




5

remote, real
-
time synchronized cons
ultation between patients and health care providers
using telemedicine functionality on mainstream mobile phones.


During a phone conversation between an amputee and their prosthetist, a patient
could
connect
to
visually
show to the prosthetist exact locat
ions on images of their residual
limb where they feel pain. The prosthetist is also able to offer advice on specific
locations, which are synchronously visible to the patient. The prosthetist could then help
the patient decide on which components to use fr
om the prosthetic improvement kit to
enhance
their comfort. This level of detailed collaborative and remote interaction has the
potential to improve the quality of life of the amputee in ways not presently available.



Figure 7
. The BodyNotes system allows prosthetist (left) and patient (right) to connect and explore
options for improvement on a shared display, where both cursors are simultaneously visible.

3) BUILT
-
IN ADVICE FOR SELF
-
HELP

In the event that a prosthetist is not

readily available to advice a modification process, the
BodyNotes app will be enabled to offer smart diagnosis and suggest interventions for
patients. From the regularly updated pain report, the app will offer
limited
interventions
designed by
prosthetist
s
. For example, in the event that there is a constant sore and a
highly reported pain on the femoral head of an amputee, a prosthetist would measure the
residual limb circumference of the amputee. He would do this to see if there was a loss in
volume. Base
d on this information, the prosthetist would likely ask the patient to add the
number of socks he wears, recommend a different liner or use an insert in the prosthetic
socket. The BodyNotes app will be able to help the patient make
similar
decisions and
ba
sed on the feedback from the patient, they could be either asked to
schedule a
BodyNotes
call
with their
prosthetist or encouraged to

test the adjustments on their own
.

BODYNOTES: LOW
-
COST TELEMEDICINE &
PROSTHETIC IM
PROVEMENT KITS FOR A
MPUTEES

ALEX OLWAL & DAVID S
ENGEH, MIT MEDIA LAB




WWW.BODYNOTES.ORG




6

FEASIBILITY

IMPLEMENTED & TESTED HARDWARE & SOFTWARE PROTOTYPES

The first
BodyNotes
pro
totype
platform was
completed
in
early
2011 at the MIT Media
Lab

and is based on previous technology and experience developed by the team
.
It was
presented at the MIT Media Lab Health and Wellness Workshop in January.

WORKING MOBILE APP F
OR REMOTE COLLABO
RATION

Since our first working android based cell phone app
(
http://www.youtube.com/watch?v=WVqzoLue7LY
)
, we have been able to
integrate with
a
n open source personal health record system
using Ind
ivo
X
(
developed by
Children’s
Hospital in Boston) and
the
CollaboRhythm
visualization
platform (
developed by the
New Media Medicine
group at the MIT

Media Lab
)
. The database can be populated with
inputs from a mobile phone
or a
web browser. Those data can

then be dynamically
retrieved to

display visualizations
and render interactive
pain maps. The same
visualizations
are accessible from a
web browser and the CollaboRhythm network at a
prosthetists office. We have interacted with both amputees and prostheti
sts to identify
ways in which we can improve the app both as a diagnosing tool for prosthetists and a
remote collaborative tool with their patients.

MANUFACTURED PROTOTY
PE IMPROVEMENT KIT

Since early February, in collaboration with our partners
,
we have d
eveloped silicone
inserts of different shapes to be tested by amputees. After a series of prototypes, our latest
designs are in the shapes and dimensions advised by our collaborators who are certified
prosthetists. Presently, we have the mold and silicone
rubber inserts in four shapes;
rectangular, circular, tear drop and elliptical.
The first
prototype
is a single
size,
but
we
have
recently completed
the design for two other sizes for all the inserts. BodyNotes has
been in conversation with different manuf
acturing companies about the cost for
production of the inserts as we investigate the most cost efficient processes.

CHALLENGES

Though we have all the foundation for the success of the project in place (app framework
built and silicone inserts designed an
d produced), there is still a long way before the app
is ready to be effectively used along with the improvement kit. Below is a tentative plan
for how we intend to bring the completed system to the market over the next year.

As seen from the below timelin
e, feedback from amputees and prosthetists

will be the
most crucial in
designing and engineering

high
-
quality, low
-
cost
improvement kits for
patients in both the developed and developing world. It is very important to realize that
misuse of different items

in the kit can cause negative consequences to an amputee. Thus,
our guided feedback and development phases are steps to control and limit the risks the
improvement kits will have towards an amputee. We are also hoping that our timeline
will allow us to be

able to develop the technology in a way that means it can be
appropriately deployed (software and hardware)
worldwide.

US INITIAL TARGET GR
OUP, FOLLOWED BY SIE
RRA LEONE & INDIA

The
technology
is first developed, evaluated and validated
in
Cambridge and B
oston
(
before ca
rrying out projects in
Sierra Leone

and India) as we have unique access to
amputees, prosthetists and facilities in the region.
The cell phone application presently
relies on Android smart pho
nes, which
are readily available among amputees
in the USA
BODYNOTES: LOW
-
COST TELEMEDICINE &
PROSTHETIC IM
PROVEMENT KITS FOR A
MPUTEES

ALEX OLWAL & DAVID S
ENGEH, MIT MEDIA LAB




WWW.BODYNOTES.ORG




7

and this will provide
critical early
-
stage user
feedback.
The team has, however, extensive
experience from development on limited feature phones (using Java ME and Symbian)
that are more common in the developing world, and has already started to

look at a port
of the platform to those devices.

Nonetheless, smart phones
are expected to gain significant momentum
in the developing
world in the near future. Evidently, cell phones as a technology continue to close the
technology divide and its metamo
rphosis will follow its disruptive pattern. We all can
imagine a significant increase in Android based smart phones in the developing world as
these devices become cheaper and more pervasive in society.

TIMELINE

Action Point
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
Jan
Feb
Mar
Apr
‘11
‘12
Mobile App
Software development
x
x
x
x
x
x
x
x
x
x
x
x
Testing
x
x
x
x
x
x
User studies
x
x
x
x
x
x
Field tests
x
x
x
x
PIKs
Finalize insert designs
x
x
x
Test initial inserts with collaborator
x
x
x
Final designs for inserts
x
x
Complete prosthetic improvement kit
x
x
x
Test kits with other prosthetists
x
x
x
Test App and Kit in Sierra Leone
x
x
Modify Kit for the developing world
x
x
Finalize BodyNotes and roll out
x
x
x


The BodyNotes team includes graduate stu
dents
, researchers

and faculty
from three
groups
at the MIT Media Lab
,

in addition to a certified prosthetist. BodyNotes is a
collaboration between Biomechatronics (

uses technology to enhance human physical
capability through rehabilitation and augmentati
on

), Camera Culture (“focuses on
creating tools to better capture and share visual information”) and New Media Medicine
(“how radical new collaborations between doctors, patients, and communities will
catalyze a revolution in human health”). With access t
o the right prototyping skills,
faculty advisers and a network of resources at a prosthetic outfitting center through our
partner “Lifestyle Prosthetics & Orthotics”, BodyNotes is well situated to be able to
provide a functional system to amputees and thei
r prosthetists in one year.

COMMUNITY CONNECTION & IMPACT

Presently, prosthetist
s

use pads and inserts during the socket design produced by Ossur
and Otto Bock. These inserts are incorporated into the process from the very start and are
not made available

to patients. However, because the shapes of inserts available to them
limit prosthetists, they are forced to use other methods, which are not optimal. Having a
more generalized library of shapes that can fit into the crevices of the socket and around
BODYNOTES: LOW
-
COST TELEMEDICINE &
PROSTHETIC IM
PROVEMENT KITS FOR A
MPUTEES

ALEX OLWAL & DAVID S
ENGEH, MIT MEDIA LAB




WWW.BODYNOTES.ORG




8

huma
n anatomical shapes will significantly improve the socket production phase for
prosthetists.

Furthermore, creating the right environments that will enable patients to have the proper
training, remote access to a prosthetist, and the capability to modify th
eir own socket is a
unique untested idea. This disruptive idea
might have the implications that
millions of
amputees
could
benefit from the BodyNotes app and kit
,

independent of location in the
world. To ensure that the ideas are implemented at the right p
ace and
adapted

to the
user
s
, we are collaborating with certified prosthetists and amputees in both the developed
and developing world.

LIFESTYLE PROSTHETIC
S & ORTHOTICS
, BOSTON, USA

Lifestyle Prosthetics & Orthotics’ mission is to “to create partnerships

in selecting
appropriate and innovative solutions that improves the quality of life for prosthetic and
orthotic clients.” Our main collaborator, Bob Emerson is a transfemoral amputee himself
and a trained and certified prosthetist partner at Lifestyle. He

has collaborated with our
research group
, which is
led by
Hugh Herr,
a double transtibial amputee and professor at
MIT
,
for many years on products and processes, which continue to improve the lives of
amputees. Mr. Emerson will provide the platform to imp
lement our system with
amputees and prosthetists affiliated with Lifestyle. The Prosthetic Improvement Kits will
also be assembled and tested by certified prosthetists at all stages of development to
minimize any negative risks and to optimize the level of

comfort that can be given to the
users.

In India and Sierra Leone, we have relationships that are ready to support the
implementation of this project.

NATIONAL REHABILITAT
ION CENTER,
SIERRA LEONE


Formally run by Handicap International, the National Reha
bilitation Center (NRC) in
Sierra Leone is now completely run by the Ministry of Health. Though the NRC has two
other branches in the rural areas, these facilities fall very short of serving the people who
need it. A significant proportion of amputees live
s outside the major cities and do not
have access to any care.
W
e
will
begin our work
with
the NRC in Murray Town in
Freetown

and
aim to expand the service to centers and communities outside the cities.
More people will be given better quality care in
less

time.

MINISTRY OF HEALTH,
SIERRA LEONE


The Biomechatronics Group has a Memorandum of Understanding with the Ministry of
Health of Sierra Leone, which focus on collaboration and partnerships in research
between the two entities.

JAIPUR FOOT, INDIA


Memb
ers of our team are instructors of an MIT
-
wide DLab class called Developing
World Prosthetics (DWP). DWP is a “series of design innovations which are meant to
develop low cost, effective, and durable prosthetic parts for people in the developing
world” and

they have a long
-
standing relationship with Jaipur Foot. Jaipur Foot has the
experience of having fitted tens of millions of amputees (free of charge to the amputee).
Members of the Biomechatronics Group have traveled to Jaipur in India multiple times in
the past five years to collaborate with Jaipur Foot on numerous projects and they
maintain a good relationship with the institution. Jaipur Foot’s wide network and stream
BODYNOTES: LOW
-
COST TELEMEDICINE &
PROSTHETIC IM
PROVEMENT KITS FOR A
MPUTEES

ALEX OLWAL & DAVID S
ENGEH, MIT MEDIA LAB




WWW.BODYNOTES.ORG




9

of amputees will give BodyNotes a great opportunity for development and feedback. In
both India and Sierra Leone, the prosthetist
-
to
-
patient ratio is low and we expect the
impact to be even greater than anticipated in the developed world.


PRIMARY TEAM CONTACT

David Sengeh

Building E14 (Rm 274B),

75 Amh
erst Street,

Cambridge, MA 02142 USA

dsengeh@mit.edu

617
-
999
-
4319

PROJECT SUMMARY

BodyNotes is a mobile telemedicine application which enhances remote, real
-
time
synchronized consultation between amputees and health

care providers using advanced
logging and telemedicine functionality. BodyNotes is also enabled with prosthetic
improvement kits which allows patients to modify their sockets to improve their overall
comfort and health.

TEAM BIOGRAPHY

David Sengeh (
dsengeh@mit.edu
)

A native of Sierra Leone, David graduated from Harvard College in 2010 (Engineering
Sciences) before joining the MIT Biomechatronics Group for his Masters. His research
investigates ways by which we can i
ntimately connect man and machine comfortably.
David's interests include human anatomy, material science, medical devices, and
CAD/CAM processes. He has previously worked with the National Rehabilitation Center
of Sierra Leone. He is the founder of Global
Minimum Inc (www.gmin.org)
-

an
international NGO that has distributed over 10,500 mosquito nets in Sierra Leone over
the past 4 years. David will design and prototype the prosthetic improvement kits and
work with prosthetists to test the devices.


Alex Ol
wal (
olwal@mit.edu
)

Dr. Alex Olwal is a post
-
doctoral fellow at the MIT Media Lab. He has previously
worked with the development of new technologies for Human
-
Computer Interaction at
KTH (Stockholm, Sweden), Columbia U
niversity (NY), UC Santa Barbara (CA) and
Microsoft Research (WA). Alex's research (www.olwal.com) focuses on novel
interaction techniques and user interface technology. His interests include augmented
reality, telemedicine, ubiquitous computing, visualiza
tion, spatially aware mobile
devices, touch
-
screen interaction, and new input devices and displays. Alex will design
the cell phone platform, which will be used for the telemedicine.

BODYNOTES: LOW
-
COST TELEMEDICINE &
PROSTHETIC IM
PROVEMENT KITS FOR A
MPUTEES

ALEX OLWAL & DAVID S
ENGEH, MIT MEDIA LAB




WWW.BODYNOTES.ORG




10

BUDGET

Item
Unit Cost
Qty
Final Cost
Notes
(USD)
(USD)
Silicone molds
2,500
4
10,000
Injection molded tooling
Silicone parts
15
400
6,000
100 per shape
Adhesives and other materials
N/A
0
2,000
To be used with inserts
Android cell phones
300
10
3,000
For our initial tests
Product development and tests
1
5,000
Prototyping costs
Software development
40/h
600
0
(in-house)
Total cost (USD)
26,000