FedDev Ontario`s ARC Initiatives OCAD University Project # 5 – Heal.X

Transcription

FedDev Ontario`s ARC Initiatives OCAD University Project # 5 – Heal.X
FedDev Ontario’s ARC Initiatives OCAD University
Project # 5 – Heal.X
How can we design a new casting design and methodology that can revolutionize the way fractures are treated that
reduces healing time, reduces muscle atrophy, prevents skin irritations and infections, is waterproof, can be easily
removed for medical check-ups, customized to the injury and size of the patient and is affordable?
Introduction
Casts and splints have been used as immobilizing
devices since 15 century BC. Even with the
advancement of science and technology, these
ancient methods are still used as the preferred
method of treatment to immobilize bone fractures.
The current treatment for fractures, after ensuring
that the bones are aligned, is immobilization of the
limb to let the body heal naturally, which can take
4-24 weeks. Current casting systems have negative
effects such as muscle atrophy, infection, nerve
damage, skin irritation, lack of hygiene, psychological
impact, and unpleasant experience for the patient.
As well, the patient is required to visit the hospital
every other week—a high cost for the hospital and
extremely inconvenient for the patient
There have been many advancements in the
technology of materials suitable for casting. Also,
there are no casting systems on the market that
can provide the proper support
without causing a number of negative effects to
the patient which may become long-term
disabilities for children and adults.
Many of the casting products available, which are
not affordable nor are they very effective. One
solution to this problem requires attending
numerous physiotherapy sessions, which can be
time consuming, uncomfortable for patients, and
expensive. Ultimately, the results of traditional
casts do not ensure full recovery of the injured
limb or account for the psychological impact on
children.
SME
HEAL.X wanted to test its research assumptions in
actual situations and on real subjects. To support
business development, Heal.X sought to acquire
skills in strategic planning, business strategy and
foresight, and specifically understand the mergence
of design thinking and systemic technology
solutions.
For OCAD University, project HEAL.X presented an
opportunity to explore an industrial design, health
& wellness product that develops systemic value.
Heal.X Innovations was accommodated on campus
in the Imagination Catalyst incubation space,
which enabled peer to peer networking with other
incubator occupants.
Heal.X Innovations wanted to access industry
collaborators and market intelligence, to support
proof of concept development for the project, and
protect the resulting intellectual property (IP).
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FedDev Ontario’s ARC Initiatives OCAD University
Project # 5 – Heal.X
PROJECT BACKGROUND
Play is a key aspect of human development. Play is
simultaneously calming, relaxing and stimulating for
the brain and body.
However, unintentional falls are the leading cause of
nonfatal injury in children younger than 14 years of
age in the United States and Canada. Each year, 2.8
million children are treated in emergency rooms for
fall-related injuries such as bone fractures.
Although children’s bones have an amazing
capacity to heal, broken bones in children must
receive appropriate treatment due to frequent
growth plate injury. The growth plate is a part of
the bone that is actively growing and injuries can
cause long-term problems if not appropriately
treated. Therefore, doctors watch children closely as
they heal.
CT
SCAN
The most common treatment of fractures in
children is a simple cast. The most common type
of broken bone treated in a cast is called a buckle
fracture. There are several side effects that casts
cause during the recovery process. Muscle atrophy,
infection, nerve damage, and psychological impact
can have long term effects on children.
CT
SCAN
RP
Image 1:
User Scenario
Flow Chart
Heal.X - June 2013
RP
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FedDev Ontario’s ARC Initiatives OCAD University
Project # 5 – Heal.X
Market Review
The current selection of products available range
from $20–$1200 for just the cost of immobilization.
Additional costs such as physiotherapy are $150–
$300 per session with a minimum of 3 sessions to
enhance recovery.
In Canada the cost of treatment is covered by
Health Canada. However, the patient or personal
insurance company pays the cost of the casts or
splints used. A patient with a fractured bone needs
to visit the orthopedic doctor several times to
ensure the proper progress of healing. This may
take anywhere from 2 to 20 visits, which would be
of additional cost to Health Canada.
Depending on the injury and the method used to
immobilize the injured limb, the patient’s daily
routine can suffer and cause a lack of productivity
that can cost money and negative psychological
impact. Project HEAL.X is the future of casting
that will revolutionize the way fractures are treated
- with 5 novel ideas that make the system unique.
75mm
200mm
75mm
Image 2: Preliminary Prototype Sketch Models75mm
200mm
40mm
200mm
40mm
Image 3: Technical Sketch Models
Image 4: 3D CAD Experiment Models
40mm
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FedDev Ontario’s ARC Initiatives OCAD University
Project # 5 – Heal.X
Prototype
This example is based on a radial distal fracture
(wrist) and HEAL.X first product.
he HEAL.X Cast is designed and made up of two
T
parts that are placed on the wrist based on
immobilizations points. The cast immobilization
rate is 85%, which is 35% higher than other devices.
The cast is formed in a way that immobilizes the
whole hand and gives support to ensure the hand
is stabilized.
Image 5: Process of finding immobilization points
Each part is attached to the hand with a silicon
based medical adhesive which is breathable,
waterproof and can be removable with medical
adhesive spray. The design of the splints is inspired
by bone structures, which are porous yet very strong.
The unique structure of the splint makes it
breathable and lighter.
The Heal.X cast is customized using a unique
system flow. CT-Scan machines are used at the
beginning of the diagnosis process, to acquire a 3D
Image 6: Final HEAL.X prototype; Final Kit: Attachments with
silicone base adhesive
model of the injured limb and also a complete series
of x-rays to determine the fracture type.
emplate software that has a 3D model of the cast
T
is used to customize the cast to the 3D arm model
created by the CT SCAN.
he manufacturing of parts is done at the hospital
T
where a rapid prototyping department would print the
cast in medical grade resin with antibacterial
properties.
Image 7: Final HEAL.X prototype
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FedDev Ontario’s ARC Initiatives OCAD University
Project # 5 – Heal.X
Benefits
OBJECTIVES OF Heal.X
The 5 methods used in HEAL.X casting system
have many benefits for the patients and the
health system.
Affordable
Affordable for the budgets available to fracture
clinics in the United States and Canada.
1. Reduce healing time by allowing the patient to
exercise while wearing the cast
Customizable
Allows the final product to be customized
individually ensuring quality treatment and
comfortable setting for a child with fractured wrist.
2. R
educe the cost for patient and insurance
companies by reducing the need for
physiotherapy sessions to regain full recovery
3. R
eduction in operational cost for hospitals and
healthcare systems
Image 8: 3D CAD Models of final designs
Radiolucent
Enables x-rays of the broken part to be taken while
wearing the cast. This process should not interrupt
the function of a cast.
Indication Of Healing Progress
A cast design that gives feedback to the user showing
the progress rate of healing and as an indicator of
time needed to fully recover from a buckle fracture
in the wrist.
4. Customized exactly to the body part for
maximum comfort and support
5. Waterproof
6. T
he structure of the cast is porous, making it
lightweight and breathable
Breathable
Allows air circulation throughout the cast to
eliminate problems such as infection and rashes.
7. Easy application and removal method
8. Prevents skin irritation and infection
9. Ease of use while wearing clothing
Image 9: Heal.X user benefits
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FedDev Ontario’s ARC Initiatives OCAD University
Project # 5 – Heal.X
RESEARCH Methods
A number of activities were undertaken to complete
this research such as, literature reviews, competitive
analysis and user hierarchy.
During this research, traditional methods of orthopedic
bracing were re-evaluated and advanced
technologies available in Canada were used to design
a new system to prevent side effects, promote
healing and reduce the cost for both patient and
health care system.
The research of bone fracture immobilization started
with Mandad Tabrizi’s background in Kinesiology and
secondary research. An in-depth review of medical
journals and several studies on bone fracture
treatments provided insights about the common
results for immobilization devices. Furthermore,
these insights were evaluated with the help of Dr.
Javad Sattarian, Orthopedic Surgeon at the
Scarborough Hospital. Out of more than ten
reviewed studies that compared the benefits of the
cast and splint as a method of immobilization, 85
percent of the studies showed a better recovery
rate with the splints.
prototypes were made to test the insights from
these brainstorming sessions. These findings were
then compared with the insights of Dr. Sattarian. Not
only did these prototypes allow for a better
understanding, they also helped tremendously in
the advancements of the Computer Aided Design
(CAD) models of the final designs. These designs
were then fabricated using Additive Fabrication
Technology (AFT) also known as 3D printing.
Further information was gained through
stakeholder analysis and user experience flow charts.
Based on the overall need of the patients and
brainstorming sessions with OCAD University
Industrial Design thesis advisors, more than 100
The CAD models and the 3D printed prototypes
would not have been possible if it were not for
OCAD University and FedDev Ontario grant supports.
Image 10: Heal.X product customization methods
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FedDev Ontario’s ARC Initiatives OCAD University
Project # 5 – Heal.X
PROJECT summary
injuries are treated from the moment a patient
walks into a hospital to the point that the patient
fully recovers.
The start of this project was based on a sport-related
injury. It was through the research process that
remarkable potential was found for the use of
technology advancements such as 3D scanning and
3D printing in a more elaborate way to treat
musculoskeletal injuries and bone fractures. This
research also led to a number of new discoveries
and data that will be used in the next steps of this
research.
Results
The result of this research project created a solid
foundation for future research projects around
injuries and the use of technology to design a
human friendly solution which, is also sustainable.
Heal.X Innovation’s final design is a complete system
that customizes a two part brace for immobilization
of the injured limb. Its first product is called MANU.X
and has been designed for a wrist buckle fracture.
Along with MANU.X, a patent pending system has
been designed which uses a 3D scanner to obtain
an image of the arm and using the Heal.X
proprietary software to customize the brace to
patient’s size. The customized brace is fabricated
by a 3D printer and is secured to a patient’s wrist
with a silicone-based medical adhesive, which is
waterproof and can last up to a month.
Due to the extensive research of this design and
the tremendous support from OCAD University
and FedDev Ontario, project Heal.X is moving to
the next level by strategically entering the
orthopedic rehabilitation market. Heal.X project is
in its final stages of prototyping and will start
clinical testing in early 2014.
Process and design of the cast and manufacturing
process of the casts have patent pending status in
US and Canada. The Patent filing number: 27871
The purpose of this project was not only to design
a new product for bracing fractures and sprains
but to also design a new platform and system that
can fundamentally change the way musculoskeletal
Image 11: Final Heal.X prototype
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FedDev Ontario’s ARC Initiatives OCAD University
Project # 5 – Heal.X
Research Team
SME
Dianne Croteau
Principal Investigator, Associate Professor, Faculty
of Design, OCAD University
Mandad Tabrizi
Heal.X Innovation, SME, Founder,
Design Strategist
Richard Bozzato
Ph.D., Life Sciences & Healthcare, MaRS
Thomas Gehring
Business Development Manager, OCE
Pranay Gupta
B.Tech (polymer) MBA, U of T Rotman
Heal.X Innovation
http://healxinnovation.net
OCAD University:
http://www.ocadu.ca
MaRS:
http://marsdd.com
OCAD University Research:
http://www.ocadu.ca/research
Toronto Rehabilitation Institute
http://uhn.ca/TorontoRehab
Dr. Javad Sattarian
Orthopaedic Surgeon
Babak Taati
Ph.D., P.Eng, 3D Visualization, Toronto Rehab
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