As a certified WOC nurse, an important aspect of my work is the prevention of hospital-acquired pressure ulcers (HAPUs). A successful HAPU-prevention program impacts both patient outcomes and the fiscal health of the organization. In order to implement effective pressure ulcer prevention programs, the WOC nurse must ensure that all relevant protocols are current and evidence-based, educate and motivate the staff to provide aggressive preventive care, and ensure that supplies and equipment used for pressure ulcer prevention are clinically and cost effective. In our agency, efforts to reduce heel pressure ulcers stimulated a critical review of available heel elevation products and resulted in development of a new heel elevation product. This "View From Here" column provides a review of the process involved in developing a new product and obtaining a patent for that product.
Background
Several years ago, our agency reviewed policies and procedures regarding HAPU prevention to ensure that they were based on best current evidence. In addition, our Skin Integrity Committee created a prevention bundle to provide guidance to the bedside nurse. Initiation of this bundle and other key measures decreased our overall HAPU rate significantly over a 3-year period.
A significant part of our PU prevention challenge arose from our orthopedic population. Our agency is recognized for its care of orthopedic patients, and I worked on the orthopedic unit as a staff nurse and remain familiar with the needs of this population. In 2008, I found that 10.18% of our HAPUs were located on the heels. Our Skin Integrity Committee, therefore, determined that a primary focus of our prevention program would be finding a solution to heel ulcers.
Heel elevation devices are recognized as a key element in an effective heel pressure ulcer prevention program.1 However, I have found that some of these devices are expensive, particularly when they are used for only a short time in the immediate postoperative period or thrown away at hospital discharge. Our facility admits approximately 2000 orthopedic patients per year and most require heel elevation for a brief period of time. In addition, I found that patient adherence was sometimes compromised, due to complaints of discomfort when wearing a heel protector. These factors led us to search for a product that was both economically and clinically effective for our patient population.
Design of the Solution
My first step in this search was to evaluate current practice and factors contributing to development of heel ulcers in our facility. I found that ineffective offloading of the heel was a key factor and the devices we were using at the time were not working. For example, I found that one device appeared ineffective at offloading the heel, and it created device-related ulcers in other areas. We removed this product from our formulary and added a product that proved effective in offloading the heel, but cost $130.00 per pair, which was considered too expensive for short-term use. We therefore decided to stock this product for patients who required long-term offloading of the heel, and developed a protocol to ensure appropriate use. However, we still needed to find a product for short-term use that effectively offloaded the heels and was comfortable and cost-effective.
We initially enlisted the help of a wound care product vendor to search for a heel boot that would satisfy our criteria, but ultimately decided we needed to design a product to meet our specific needs. This decision prompted me to think about what a solution might look like. The first step was to choose an appropriate material. I selected foam because it is inexpensive and easy to work with. I have used waffle foam heel cups over a period of years, but my clinical experiences suggests that this product does not always offload pressure on the heel effectively. I therefore decided to add a block of soft foam to the heel cup at a height that would offload the heel. After making sketches, I approached a company to make a prototype. When the prototype was delivered, it was taken to several agency committees for approval including the Skin Integrity Committee, the orthopedic unit-based clinical leadership team, and the products committee. After obtaining approval from all these committees, I asked the company to make 50 pairs in order to enable our staff to complete a clinical trial of the product.
The new heel elevation product (Econo-Foam Heel Protector, Skil-Care, Yonkers, New York) was trialed on the orthopedic unit. We conducted educational sessions on our orthopedic unit that included staff nurses, certified nursing assistants, and physical therapists. The product was trialed on all orthopedic patients and was evaluated compared to a commercially available waffle foam heel cup. The following criteria were evaluated: (1) effectiveness in floating the heel and relieving heel pressure, (2) elimination of hard or sharp surfaces, (3) patient comfort, (3) effectiveness in helping to heal skin breakdown, and (4) development of any new areas of skin breakdown with the use of the boot. Evaluations were reviewed by our products and value analysis committees because approvals of both committees are necessary prior to introducing new products in our facility. The device was approved for use, and we currently use more than 2000 pairs a month for patients at risk of heel breakdown due to surgery and immobility. The company making the boots for us priced them at $18.65 a pair. I believe that this price fulfilled our goal of developing a product that was cost-effective when used over a brief period of time. In addition, we found that our heel HAPU occurrence rate is currently 0.2%.
The Importance of a Patent
The success of this heel protector, combined with recognition that other health care providers may have experienced similar problems, led me to investigate securing a patent for the device that I had developed. Working for a large academic health system gave me the opportunity to work with individuals experienced in the field of patent work. Many people think that a patent is the right to make, use, or sell a product, but in actuality a patent is the ability to exclude others from doing so.2
I believe that many WOC nurses have developed new ways of solving problems for their patients, and some of these solutions may have led to patentable devices or products. When you realize you may have an idea for a new product, you should first write down the date you had this idea and pertinent details, including any illustrations that may better describe your idea. I encourage you should resist the urge to share your ideas at that point. My experience strongly suggests that there will be plenty of time to write about it later, while premature declaration of an idea in a publication or public forum will initiate the "grace period" countdown. The grace period is a 1-year limit on applying for a patent after it has been described in a public manner.3
After documenting your idea and the date you invented it, you should perform a patent search to determine if similar ideas already exist. We already knew from the first part of our development process that the product I developed did not exist. However, it was essential for me to formalize and document this search in order to meet the requirements of patent law. I worked with our patent department and they in turn secured legal counsel. Exhaustive patent searches were done by these professionals. If you do not have professionals available who can conduct a patent search, I advise you to avail yourself of the many resources available to help guide you through this process. Extensive resources are available at the US Patent and trademark Web site found at http://www.uspto.gov.
Our actual filing process began with a provisional application. This application does not require an oath or extensive paperwork, but it does mark the date of the initial invention so that no one else can claim the idea after this date. This application is not reviewed for purposes of approving the patent, but it is a critical document in that it marks the date and protects your idea.2
After filing the provisional application, you must wait 12 months before filing a nonprovisional application; this is a more extensive application that allows the inventor to say that the product is patent pending. Our application was more than 30 pages long and required us to describe the invention in detail. We were also required to supply drawings of the device (which must be supplied by the inventor); in my case this included detailed sketches and descriptions of the dimensions and the density of the foam used. The drawings were prepared with an automated computer-aided design program (AutoCAD). We chose this software program because it enabled us to ensure that illustrations were properly drawn to scale, which is a requirement for submission. Illustrations also may be hand drawn, but they must meet all the requirements that are provided on the US patent Web site. We conducted density studies on each piece of the boot and included details regarding foam densities in our application. This level of detail is important because it helps ensure that others cannot duplicate your invention.
I do not recommend attempting a patent application on your own, because it requires a great amount of skill and a thorough knowledge of patent regulations. I spent hours on the phone with our lawyers to complete the application correctly.
A nonprovisional application is evaluated by a patent examiner and the patent may be granted once all requirements described previously are met. Once the nonprovisional application is reviewed, the inventor will receive what is called an "action" (approval or rejection). If the patent is rejected, the action notice will detail the reasons for rejection of the application. Notification of a rejection, nevertheless, allows an opportunity to resubmit your application for reconsideration after addressing the reasons resulting in the rejection. Our provisional patent application was filed in February 2011 and our nonprovisional was filed in February 2012, per the requirements of the patent office. We are not expecting to hear any results for a least a year from the last filing. Whatever the results, I experienced an invaluable learning process that led to development that I believe has improved both clinical and fiscal outcomes in our facility. Based on my experiences, I hope that colleagues who find themselves assuming the role of an inventor will apply for patents experiencing the same successful results.
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