Whole-In-One: Devices that Do More

MDEA 2008

It may not be easy, but caregivers like to have everything they need in one place. And patients like having everything they need done in one visit. Fulfilling those needs means either creating devices that perform multiple tasks or increasing a device's portability. Many of this year's Medical Design Excellence Awards (MDEA) winners embody these principles. The devices enable users to control a system, which can make treatments fast and intuitive. Manufacturers must limit the number of steps of a procedure in a user-friendly way that facilitates timely care. This is key to developing award-winning products.

Automation Sets You Free

Actually, automation sets patients free—from multiple appointments and from settling for a device that might not be quite right. But it also allows healthcare providers to cut down on work traditionally sent out to laboratories or done by hand. The result is more-immediate and more-personalized care. “The advantages of a single, inclusive device are several,” says MDEA juror Craig Jackson. “You only have one device to learn and to maintain. An integrated system minimizes the manpower required.”

E4D Dentist System. The E4D Dentist System from D4D Technologies LLC (Richardson, TX) is a chairside system that enables dentists to create digital impressions and fabricate inlays, onlays, and full contour crowns. Every step can be done in a single visit to the dentist's office, thereby eliminating the need for temporary crowns and second appointments. Patients receive custom-made dental restorations without having to make repeated visits.

The E4D combines several machines into one. First, a design server allows dentists to scan and design the restoration. It comes with an IntraOral Digitizer that scans the prepared tooth and its neighbors. It also scans the preoperative tooth and bite registration. A 3-D digital impression is created. The second machine is the job server that uses a personal computer to run the software. The job server sends the data from the design center to the third machine, the milling center, where a unique implant is created.

There are multiple challenges presented by each aspect of these machines. Although none of the technologies are new, presenting them in one set of machines required a blending of several engineering
disciplines.

For example, the milling machine must produce a restoration that has less than a 50-µm difference from the original tooth, for clinical acceptability. Millions of 3-D coordinates are captured and the software intuitively generates a restoration that accounts for neighboring teeth, opposing teeth, and aesthetic factors.

The designers spent considerable time creating intuitive software. “Users can follow tabs from left to right, see visually descriptive icons, and access all of the features with a two-button and scroll-bar mouse to proceed from start to finish rather easily,” says Gary Severance, vice president of marketing and clinical affairs at D4D.

Juror Molly Story says there are various aspects that the MDEA jury found the E4D improved compared with traditional approaches. “Dangers with the traditional approach include the fact that the temporary [crown] itself may break, it may damage other teeth, or the surrounding teeth may shift during the time that it is in place,” she says. “The E4D device improves tooth safety and patient health, and reduces total cost.”

The company estimates that if an office performs 20 or more restorations per month, it can achieve significant revenue enhancement. “The short-term cost is steep, especially for a small office,” says Story, “but it would be practical for a fairly large facility.”

QuickLink Loader. Fewer doctor visits often means that several treatment steps must be condensed. These steps may traditionally have been performed between patient visits. To compress such steps into a single visit, the procedures must be made safer and more efficient. The rewards, however, are often more important than just saving time.

The QuickLink Loader from the urological division of C.R. Bard Inc. (Covington, GA) is used in conjunction with a radiation treatment of prostate cancer called brachytherapy. Brachytherapy has typically been a three-step procedure that involves three specialists and two patient visits. During the first visit, a urologist creates an ultrasound map of the cancerous area and the prostate, defining a grid for the quantity, location, and composition of the radioactive strands used to treat the tumor. Between hospital visits, a physician constructs the strands by hand in a central radiation lab, selecting the appropriate radioactive seed or bioabsorbable connector and placing it on a grooved track with tweezers. During the third step, the patient returns and a radiation oncologist injects the strands into the patient.

The QuickLink loader compresses the steps in the procedure into a single visit by automating the strand creation. “This automation replaces what is a painstaking manual task that is highly dependent on the skills and availability of the trained user,” says Hyman.

For patients, it translates to better care in surprising ways. “Besides being efficient, single-visit treatment in the cancer arena addresses the often overlooked anxiety factor that challenges patients as they move through diagnosis and treatment,” Hyman explains. “The days between these events, while perhaps not being clinically harmful, are torturous in terms of worrying about the next encounter. [Getting] treatment under way in a single visit can be an important adjunct to the direct clinical effect.”

In terms of safety, the QuickLink loader makes several improvements over previous versions. Users do not have to handle seeds and connectors. The cartridge placement includes visual and physical clues to reduce the risk of poor placement. The design team considered how to organize those cartridges so that the radiation seeds are farthest away from the loading site to reduce accidental seed placement. In addition, each part of the loader can be separated and removed to ensure that no seeds are lost.

Mobile Diagnostics: Seeing Is Believing

Among this year's winners, portability is a clear focus, says Story. “The technology has been miniaturized and made portable to maximize the amount of treatment it can deliver.” This is especially true for imaging devices.

Imaging technology is one of the most important aspects of diagnostics. For many years, however, this technology has been hindered because the equipment takes up entire rooms and patients must move to the system. Designers have put more emphasis on creating imagers that go to the patients.

xCAT Computed Tomography Scanner. “Imaging in the operating room is highly desirable for many procedures because it allows immediate results without having to move the patient, disrupt the procedure, or rely on pre- or post-images separated by long periods of time,” Hyman says. Xoran Technologies (Ann Arbor, MI) created its xCAT to work in the OR. It is designed to provide intra­operative scanning for ENT surgeries. The entire 500-lb system stands about 5 ft tall and 4 ft wide.

The weight and mobility of the device were important to the company, which wanted nurses, technicians, and doctors to be able to move the system quickly, without needing to ask for help. “Its large handles give workers plenty of gripping choices, ensuring that the device does not get away from them on ramps,” says juror Michael Wiklund. The design team worked hard to get the weight down to 500 lb. “We used lightweight materials such as aluminum,” explains Tara Prasad of Insight Product Development, the company that designed the xCAT.

The designers used a C-arm to ease access to patients and to relieve patients who might experience claustrophobia. Another key aspect of the design was ensuring that visuals were comparable with traditional scanners. “While the quality of the imagery is not as high as that of its full-scale counterpart, this device's portability makes it sufficient for this purpose,” Story says.

The design team interviewed and consulted numerous ENT surgeons to ensure that the device could be used in an operating room and still maintain the sterile field. They developed high-contrast visuals so that a display could be up to eight feet away and still be readable.

With traditional systems, a diagnostic image is taken weeks before the surgery. Such scans may be quickly outdated with a progressive disease or infection. In contrast, the xCAT enables a surgeon to continuously monitor during surgery, thereby increasing the chance of success. Surgeons testing the xCAT found that 30% of the time, when the surgeon believed that the surgery was complete, an intraoperative scan on the xCAT indicated the surgery was not finished and the surgeon continued.

In emergency situations, patients must be stabilized and diagnosed in one location and then immediately proceed to treatment. With the xCAT, there is no need to unhook patient monitors and equipment. “The xCAT brings sophisticated scanning to the patient, rather than making the patient go to the scanner,” says Wiklund. “This approach promises to make life easier for nurses who normally spend hours a week preparing patients to go for scans.”

Acuson P10. Increasing portability is all about making choices. There is always a cost for miniaturization. Siemens Medical Solutions (Mountain View, CA) created the Acuson P10 diagnostic ultrasound imaging tool with visual limitations in mind. But even with trade-offs, the device stands to have a dramatic effect on how medicine is practiced.

Weighing only 1.6 lb and small enough to fit in a lab coat pocket, the Acuson P10 is intended for both routine and urgent care. It provides immediate visual data to improve exam accuracy and to detect potentially life-threatening conditions at an early stage. The portable system can be used in intensive care units (ICUs), ambulances, and medical helicopters.

MDEA jurors were impressed with the system. “Could anyone have envisioned a pocket-sized ultrasound scanner a decade ago?” asks Wiklund. “[This] is the stethoscope of ultrasound scanners, stepping ahead of laptop computer–sized devices in terms of portability.”

Unlike many portable ultrasound systems, the Acuson doesn't try to do everything that the larger machines do. Instead it is targeted to provide a quick-look capability, giving clinicians immediate answers to the questions that guide patient-
care decisions.

However, the company readily admits that image quality is key to customer acceptance of any imaging device. Therefore, the designers adapted signal processing intellectual property and ASICs used in other Siemens products. Imaging and display were optimized using newly patented algorithms.

Benefits at the Bedside

A bed can't be just a bed anymore. Inpatient care requires a variety of daily tasks that can be difficult for busy hospital staff to manage. The beds that garnered juror attention go beyond singular function. “These [beds] relieve caregivers of concern for simple but important tasks and enable them to focus on critical aspects of the care,” Jackson says.

InTouch Critical-Care Hospital Bed. The InTouch hospital bed from Stryker Medical (Portage, MI) combines connectivity, intuitive operation, and ergonomics. It can be used as a general medical and surgical bed, but its primary intent is for ICU settings.

InTouch incorporates protocol reminders that help ensure compliance with patient care. A touch screen provides access to multiple menus and reduces the number of buttons. The touch screen is used for bed control, scale, and protocol reminders, with alarms for scheduled processes. “Foremost among the features of this product was its integration of the collection of mundane tasks into a unified product,” says Jackson. “Reminders for tasks that are necessary to meet the requirements of the protocol are provided by a data station at the foot of the bed.” Events such as feeding, medication, and baths can be programmed.

In addition, the InTouch bed features a shearless pivot that ensures minimal displacement of the patient when the head section of the bed is raised. The design enables an upward and horizontal motion that keeps the patient from sliding down. Various buttons around the bed also help achieve clinical body positions.

The company also designed a one-button electric brake. Other models have a footpad that requires 60 lb of pressure to lock the bed in place. A mechanical backup ensures the brakes function in the event of a power outage.

Motorized wheels enhance the bed's movement for events such as scans or x-rays. Even when pushing a 500-lb patient, the user only exerts the energy of pushing 20 lb.

Another notable feature is the height of the bed. At its lowest position, the bed is only 16 in. from the floor, so that patients can stand or transfer to a wheelchair.

“Stryker's bed has an athletic appearance when placed in an upright position, owing to its arcing profile. As such, it creates a very different impression than the conventional metal-frame beds,” says Wiklund. “Patients may feel that they are receiving higher-quality care and caregivers may feel that they are enabled to do their best work.”

TotalCare Bariatric Plus Therapy System. Manufactured by Hill-Rom Company, Inc. (Charleston, SC), the TotalCare Bariatric Plus is an integrated bed that addresses microclimate management, pulmonary management, and immobility in care settings. “This bed is as much of a medical device as other actively therapeutic devices. It's not just a piece of furniture,” says Wiklund.

Both the frame and the mattress have been designed to serve bariatric patients weighing up to 500 lb. The system addresses patient-base concerns, including mitigating pressure ulcers, lung infections, and falls. For these reasons, Wiklund has high praise for the bed. “This modern-looking bed meets a critical need in the patient-care world—accommodating large individuals who do not fit in conventionally sized hospital beds,” he says. “Clearly, designing such a bed takes a keen knowledge of bariatric patients' physical dimensions, mobility, and special needs.”

Engineering features were designed to help both patients and caregivers. The movement of a bariatric patient puts the caregiver and the patient at risk for injury. Designers included a deflate function that decreases air pressure in the seat and foot section to allow the patient to get 6 in. closer to the ground than a normal hospital bed. A cradle transition feature minimizes sliding and provides stability when egress or ingress is needed. This makes the patient less likely to need the support of the caregiver while exiting from bed. Bariatric patients may also find it difficult to move or reposition themselves without aid. A triangular trapeze hangs above the bed, providing support that patients can grasp when moving or repositioning.

Possibly the most significant design factor of the Total­Care is its mattress. Adipose tissue and skin folds can generate excessive heat and moisture that, along with friction, pressure, shear, and immobility, promote the generation of pressure ulcers while on a mattress. The bed features microclimate management, which wicks heat and moisture underneath the patient to the head of the mattress and expels them to the atmosphere. In addition, the mattress can be calculated to adjust to individual patients to optimize interface pressure. Bladders in the mattress can be inflated and deflated to minimize surface area that comes in contact with the patient.

Conclusion

Whether the goal is to combine several treatment steps into one device, make a device more portable, or to make furniture active, the approach must be from the user's perspective. Giving users more control means designing around limitations. Users are more likely to accept some limitations if the trade-off leads to increased mobility and better patient care. Getting users to buy in to a device early could help mitigate those design trade-offs. “Design of such a product is not necessarily difficult, but doing it well requires that engineers communicate with the end-users,” says Jackson.

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