Download Project I ‐ Background Worksheet

Project I ‐ Background Worksheet
Team Members: __Robert Karas and Corina Malone__________________________
Clinical problem __Decubitus Ulcers_______________________________________
1) Strategic Focus
a. Team name: Senior Projects 1 (Under Pressure)
Mission: Improve the quality of life of patients, caretakers, and everyday people through the use
of medical devices and assistive care devices. The ultimate goal of our group is to be able to
make someone who has had some of their joy in life taken from them by a disease or injury, and
give them a reason to smile and enjoy the life that they still have.
Vision: Our team’s vision is to give our patient, Mr. Stewart, a part of his life back that he
thought he had lost due to his accident. Mr. Stewart was a competitive fisherman, and loved
being on the water. After the war, he has had both legs amputated and suffers from PTSD. One
of the main concerns Mr. Stewart has is the pain that is associated with his decubitus ulcer on
his back that formed from being paralyzed and in a wheelchair. This causes muscular pain and
can only be relieved by lying down or getting a massage.
b. Strengths: Multidisciplinary (nurses, mechanical engineers, and biomedical engineers),
diversity with mindsets, communication, meeting with client, motivated by client and deadlines,
passionate for our field, desire to achieve and succeed, circuit design, knowledge of motor and
its function, 3D printing, materials, and materials testing.
Weaknesses: Separation of teams at different universities, having different deadlines within
group members, patient is in and out of the hospital for unknown reasons, team members not
wanting to speak up, making sure everyone is caught up to date, most of us are new to this
design process, and client communication.
c. Acceptance Criteria: Interested in high volume assistive care devices that will give the user
multiple uses. These products do not need to have a clinical trial period and can be classified as
Class I or Class II so that there isn’t a complicated premarket approval that is needed for Class
III devices. The market for this device has to be around $100M. The device has to be something
that our patient can use directly and will have an impact on his life in a positive way. Overall our
product needs to make our patient happy.
Not interested in products that require human clinical testing or IRB approval.
2) Needs Exploration
a. All interactions with our client and groupmates are kept in a senior project notebook or team
notebook that has documented all the brainstorming of needs and possible ideas to address
these needs.
b.
● Reduce Pressure to the diseased area
● Reduce recovery time for decubitus ulcers
● Increase mobility of patients with decubitus ulcers
● Improve user ability to use device at home instead of in a hospital
● Improve caretaker ability to change dressings
● Improve training of patients on ways to avoid ulcer formation
● Improve mobility of the device to work in a variety of situations
● Improve Customization to allow proper ergodynamics
3) Disease State Fundamentals
a. Anatomy and Pathophysiology
i. Normally patients that are in a hospital bed or wheelchair bound have a tendency to stay in
the same position most of the time. This causes pressure on one part of the body for a
prolonged period of time. Patients are advised to shift their weight every twenty minutes to avoid
the formation of pressure ulcers. Paralyzed individuals will have a lack of feeling somewhere in
their body. This will result in not feeling pain of being in the same position for a long period of
time. If the patient can keep their weight shifting the skin will not be red or irritated which is the
first signs of a pressure ulcer from forming. If a pressure ulcer doesn’t form the patient will not
have any injuries to the skin and comfort will be easy to achieve. Skin when it is not injured will
lighten when there is pressure applied to it and return to its normal color soon after the pressure
is released, this is called blanching.
ii. After a long period of pressure on an area of the skin, usually bony areas like the heels,
ankles, hips, spine, shoulder blades, and tailbone. The pressure will cause an injury to that site
on the skin and cause an ulcer to form. The healing of these injuries is complicated and the
treatment will vary from what stage the ulcer is in. In stage one, the skin is not broken. The skin
will appear red on people with lighter skin complexion and the skin will not briefly lighten when
touched. On people with a dark complexion, the skin may show discoloration and will not lighten
briefly when touched either. The site of the stage 1 ulcer may be tender, painful, firm, soft, warm
or cool compared with the surrounding skin. If the pressure continues the ulcer can start to
begin stage 2 where the outer layer and some of the inner layer of skin will be damaged or lost.
The skin will have a shallow hole look to it, and the color of the skin will be a light pink or red.
The overall look of the skin in stage 2 is like a blister, or a ruptured blister. If this is untreated the
injury will advance to stage 3. At this point the skin is lost and some fat may be present in the
injury site. The bottom of the injury might have some yellowish dead tissue, and the rest of the
injury looks crater-like. If there has been multiple occurrences of the injury in the same location
or the injury isn’t noticed due to lack of feeling by paralyzed individuals, then the injury could
advance to stage 4. In stage four there is a loss of a large-scale amount of tissue. The wound
can expose muscle, tendons, ligaments, and bone. This stage is hard to heal and most likely will
result in surgery. If the injury remains untreated there is a possibility for the injury to fall into the
unstageable category. A pressure ulcer is considered unstageable if its surface is covered with
yellow, brown, black or dead tissue. It’s not possible to see how deep the wound is. This is the
worst case of a pressure ulcer and there is not a clinically approved way to heal the injury site
without surgery and skin grafting.
Spinal cord injury patients have a few extra factors that make developing pressure ulcers easier
for them. One factor is the inability to regulate heat. There have been studies and an increase of
one degree Celsius can increase the chance of getting a pressure ulcer by as much as 10%.
Another factor is that some spinal cord injury patients have a compromised nervous system. It
affects their fight or flight instincts and can lead to increased perspiration. This increased
perspiration will cause moisture around certain areas of the body and lead to increased chances
of pressure ulcer formation. Along with the previous two factors many people who have to be in
a wheelchair do not take the proper precautions to try and prevent the pressure ulcer formation
process. The pressure of sitting on a wheelchair all day can lead to formation of pressure ulcers
near the bony areas of the body.
b. Clinical Presentation, Outcomes and Epidemiology
i. A thorough physical examination is necessary to evaluate the patient’s overall state of health,
comorbidities, nutritional status, and mental status. The patient’s level of comprehension and
extent of cooperation dictate the intensity of nursing care that will be required. The presence of
contractures or spasticity is important to note and may help identify additional areas at risk for
pressure ulceration.
After the general physical examination, attention should be turned to the wound. Adequate
examination of the wound may necessitate the administration of IV or oral pain medications to
ensure patient comfort. Chronic pain may be present among these patients and may be
exacerbated by examination ulcer.
Many classification schemes have been developed to define the severity of pressure ulcers. The
most widely accepted approach has been with the National Pressure Ulcer Advisory Panel.
The NPUAP system consists of 4 main stages of ulceration but is not intended to imply that all
pressure ulcers follow a standard progression from stage I to stage IV or that healing pressure
ulcers follow a standard regression from stage IV to stage I to a healed wound.[63] Rather, the
system is designed to describe the degree of tissue damage observed at a specific time of
examination and is meant to facilitate communication among the various disciplines involved in
the study and care of patients with these lesions.
Suspected deep tissue injury (precursor stage)- A “purple or maroon localized area of
discolored intact skin or blood-filled blister due to damage of underlying soft tissue from
pressure and/or shear”; this may be difficult to detect in individuals with dark skin
Stage I - Intact skin with signs of impending ulceration; initially, this presents as blanchable
erythema indicating reactive hyperemia, which should resolve within 24 hours after relief of
pressure; warmth and induration may be present; continued pressure creates erythema that
does not blanch with pressure and may represent the first outward sign of tissue destruction; the
skin may appear white from ischemia
Stage II - A partial-thickness loss of skin involving epidermis and dermis that appears as an
open shallow ulcer with a pink wound bed
Stage III - A full-thickness loss of skin with extension into subcutaneous tissue but not through
the underlying fascia; this presents as an ulcer that may include undermining and tunneling of
adjacent tissue; bone, tendon, and fascia are not exposed
Stage IV - A full-thickness tissue loss with extension into muscle, bone, tendon, or joint capsule;
slough or eschar may be present in the wound; osteomyelitis with bone destruction and
dislocations or pathologic fractures may be present; sinus tracts and severe undermining are
common
Unstageable - A full-thickness tissue loss in which the base of the ulcer is covered by slough or
eschar to such an extent that the full depth of the wound cannot be appreciated; only when the
slough or eschar is removed can the depth of the ulcer be evaluated and correctly staged
Such staging is only a small part of the initial assessment. The ulcer location, the size of the
skin opening, and the presence of any surrounding maceration or induration must be accurately
recorded. The presence of multiple ulcers prompts a search for interconnecting tracts with
overlying skin bridging that may not be readily apparent. The presence or absence of foul odors,
wound drainage, and soiling from urinary or fecal incontinence provides information about
bacterial contamination and the need for debridement or diversionary procedures.
ii. The patient will only experience discomfort and pain with this disease. The treatment is
difficult and can be quite costly. The patient might have to be hospitalized if the ulcer has
progressed past stage one, or there is worry about an infection. The patient will then have to
have a wound vac if the ulcer has progressed to the later stages, or will be sent home and the
bandages will have to be changed by a caretaker to avoid infection.
iii. To diagnose the stage of the ulcer there are multiple approaches including blood work,
imaging, biopsy, and culturing of the bacteria around the injury site. A complete blood count
should be done to check for WBC count to ensure that an inflammatory response is not
occurring, elevated ESR could indicate further signs of infection, Albumin levels, Prealbumin
levels, Transferrin levels, and serum protein levels can help indicate whether a patient is
experiencing a pressure ulcer or not. A urinalysis and a stool sample will also help see if the
injury has caused the patient to be anemic or low on any nutritions needed.
iv. There are about 2.5 million people that are treated or diagnosed with a pressure ulcer every
year. Some of these patients are due to getting an ulcer due to being in a wheelchair or on bed
rest due to an illness or pre-existing condition. There are about 17,000 lawsuits a year due to
getting pressure ulcers in the hospital resulting in a huge monetary loss to the hospitals each
year. Pressure ulcers will cause the individual to suffer extreme pain and discomfort and can
even advance to death if the injury is bad or advanced enough. Every year about 60,000
patients die a year due to the direct complications that are associated with a pressure ulcer. The
complications that can occur due to a pressure ulcer are malignant transformation, autonomic
dysreflexia, osteomyelitis, pyarthrosis, sepsis, urethral fistula, amyloidosis, and anemia Pain,
Depression, Local infection, Osteomyelitis, Gas, Gangrene, Necrotizing fasciitis (rare), Death.
c. Evaluate the Economic Impact
i. Pressure ulcers cost $9.1-$11.6 billion per year in the US. Cost of individual patient care
ranges from $20,900 to 151,700 per pressure ulcer. Medicare estimated in 2007 that each
pressure ulcer added $43,180 in costs to a hospital stay. These numbers only show how much
the hospital is charged with treatment and utilities needed to keep these patients. However,
there are lawsuits that are made from people who get ulcers in the hospital resulting in a lot of
more money lost by the hospital. On average there are 17,000 lawsuits a year associated with
pressure ulcers a year. There is no active way to prevent pressure ulcers being used in
paralyzed or hospitalized individuals. The cost is strictly due to treatment of ulcers once the
symptoms are being shown in a patient.
4) Existing Solutions
a. There are some already existing solutions. Many are dealing with manipulating the bed that
patients lie on in hospitals. There are low deflate air beds that circulate air throughout the
mattress in hopes of applying an even pressure throughout the body. There are also water or
gel filled mattresses that try to alleviate pressure in order to maintain a more balanced pressure.
Even though pressure is a main concern for decubitus ulcers, another concern is the shear
forces that are applied to the skin. There are many pads and coverings for mattresses and
chairs that are no slip covers that try to keep the body still. And lastly there are microclimate
controlled covers for chairs and beds that will try to keep the body cool and dry in order to
prevent excess sweat from developing and leading to increased tissue damage. For
wheelchairs, the main existing solution would be Geri Chair Alternating Pressure pad that has
air interwoven channels that will inflate a set of alternating channels to relieve pressure and will
also rotate the channels that are blown up in order to relieve pressure. However, these chair
pads still show a chance of pressure ulcers due to the ergonomics and the sweat and moisture
retention of the pads. Other treatment solutions would be a Band-Aid, pillows to reduce
pressure, ointments, and wound vacuums. The emerging technology is predictive pressure ulcer
medical devices that monitor where pressure is applied in a mattress and will alert staff if the
patient is at risk for a pressure ulcer to eliminate time taken to assess patients.
b.
c. From the analysis above, there is an opportunity to innovate in a device that is both effective
in both ability to solve the problem of helping alleviate pressure ulcers and cost effective.
5) Stakeholder Analysis
a. Influential stakeholders are hospitals, staff in the hospitals, paralyzed individuals, wheelchair
bound people, people who have been injured where bed rest is necessary, overweight
individuals, as well as the caretakers that take care of anyone mentioned previously.
b. In the stakeholders listed in part a of this problem, there are no conflicts of interest because
the product will benefit all of the previously mentioned stakeholders.
c. The decision makers would be the people who are in the wheelchairs or beds that have been
injured or paralyzed to the point where they can’t shift their weight on demand. These
individuals would be the decision makers because they are our target audience due to our
patient being permanently in a wheelchair. The device that we make could potentially be
modified for a hospital, but in general the disabled that are wheelchair bound will ultimately
responsible for if our product will be a success in the market or not.
d. Map of the Stakeholders
Hospital Staff: Nurses, Dermatologists, and Surgical Staff
Continuum of Care: Pressure reducing pad, changing of bandages, application of
ointment, constant position changes, and monitoring sore to make sure the ulcer doesn’t get
infected or advance to the next stage of the disease state.
6) Market Analysis
a. In a study done in 2015, there was 2.5 million pressure ulcers in the United States alone.
Along with the 2015 study it showed that 50% of all admissions and 8% of all deaths at
specialized spinal cord injury hospitals are due to pressure ulcers. It is estimated that 25% of all
people with a spinal cord injury develop pressure ulcers every year. The average cost to treat a
pressure ulcer according to the center for medicare services is $43,180. According to a report
by the medicare services there is an estimated 65,000 individuals who are both wheelchair
bound and develop a pressure ulcer every year inside the United States. If you take that 65,000
people and multiply that by the $43,000 there is a $2.8 billion dollar market available in this
product.
b. Pre Hospital Market Segment- Civilian treated, and therapeutic devices that are purchased in
hopes of healing/preventing pressure ulcer formation.
Hospital- Treatment of pressure ulcers as well as preventing patients from getting pressure
ulcers once they were admitted.
Post Hospital- Wound care and treatment options. Preventing ulcer from progressing to further
stages or preventing infection.
c. Market size is already large with all wheelchair individuals who suffer from a spinal cord injury
summing up to 65,000 individuals who suffer from a spinal cord injury and develop pressure
ulcers each year. The device that we are anticipating on creating will not only help the prehospital market as well as the hospital market. The device should be able to prevent the ulcer
from worsening and will also slow the development of pressure ulcers and hopefully eliminate
the main factors associated with pressure ulcers.
d. Pre-Hospital- The prevention of pressure ulcer factors to significantly reduce the cost of care
for these individuals. Also, the cost of preventative treatments are expensive and not mobile so
they can’t constantly be in use. Hospital- There will be less pressure ulcer cases if the device is
used in individuals who are at risk for pressure ulcer development. Post-Hospital- The device
should be able to stop progression of the pressure ulcers and provide a therapeutic aid in the
healing of the pressure ulcers.
e. Our target market is spinal cord injury patients who have to be in a wheelchair due to their
injury. Also, since spinal cord injury patients can’t regulate their heat and have sensitive nervous
systems they perspire more than if they weren’t injured. These patients already have a rough
condition and being able to keep them from developing a further injury is the overall goal of this
project.
We have neither given nor received unauthorized aid in completing this work nor have we
presented someone else’s work as our own.
Robert Karas
Corina Malone