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.