Surgery – Body protecting or restraining devices for patients or infants – Restrainers and immobilizers
Reexamination Certificate
2001-07-09
2002-08-20
Brown, Michael A. (Department: 3764)
Surgery
Body protecting or restraining devices for patients or infants
Restrainers and immobilizers
C005S624000, C005S625000
Reexamination Certificate
active
06435188
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to spinal backboards, and more particularly to a novel system for immobilizing a person's head on a spinal backboard.
Emergency Medical Technicians (EMTs) are often required to treat persons who have sustained possible spinal injuries. In such cases it is very important for the EMTs to immobilize the spinal column of the injured person in order to prevent further injury during treatment and transportation. All too often, however, the immobilization engaged by the EMTs is merely an illusion of spinal stabilization. Conventional devices used to immobilize a person consist of a spine board and various means with which to secure the patient's body and head. The person's body is typically fastened to the spine board (or backboard) by using seatbelt-style straps. The body straps usually connect to the backboard by using clips, which snap onto recessed pins, or by wrapping around various handhold slots and connecting back to themselves. The straps are then tightened to secure the person to the backboard. Three body straps are standard for each patient with straps placed at the chest, pelvis, and knees. The straps may be placed parallel to each other or they may crisscross over the patient to ensure stabilization. Another aspect of the spinal immobilization process is the immobilization of the injured person's head. Although this is the next step after securing the body, the head is always treated as a separate entity entirely. Once immobilized to a backboard, patients must be moved to the awaiting ambulance and then to a hospital gurney. Occasionally, patients must be rolled onto their sides. This is usually due to the patient being pregnant or due to airway maintenance issues such as active vomiting or excessive oral bleeding. Commonly, adhesive tape or Velcro straps are utilized during the immobilization process. Other devices such as cardboard head pads are also used by some EMTs when immobilizing a person's head. Such devices have numerous drawbacks.
Although emergency medical services (EMS) have been in existence in its modern form for approximately thirty years, spinal immobilization, more specifically cervical spinal immobilization, has essentially remained the same. The immobilization techniques and devices currently being utilized by most EMTs have pronounced limitations.
In that most spinal injuries are the result of motor vehicles accidents, EMT's often treat the injured person outdoors and in severe weather environments such as rain and/or snow. In such environments, the spine board becomes wet and/or otherwise contaminated and adhesive tape, which is used by many EMS agencies, may not securely immobilize the injured person's head. Furthermore, it takes a great deal of time to apply the adhesive tape to the person's head and around a spine board. One person must maintain in-line stabilization of the injured person's head while another EMT lifts the head end of the backboard. While the backboard is held up, a third EMT can apply the adhesive tape to the head and around the backboard. Although the adhesive tape may be secured appropriately, the integrity of immobilization is easily breached. Adhesive tape has a tendency to loosen with even the slightest shift in weight, whether during extrication from a second floor apartment or from the patient merely moving about. A person with an altered level of consciousness or head injury can easily dislodge the tape or remove it entirely without much effort. The adhesive tape is also ineffective when a person must be placed on his or her side. When a person who has been immobilized with the use of tape is turned onto his side, his head will always move laterally causing possible exacerbation of an existing injury. Even when adhesive tape is effective in securing a person's head, the tape will almost always become entangled in the person's hair causing further distress to the person. The adhesive tape also leaves residue on the backboard, which must be scrubbed to rid the device of potential pathogens or other disease causing agents.
Hook and loop fastener straps, commonly referred to under the trademark, Velcro, while more quickly applied, have their own inherent deficiencies. Hook and loop straps need loops to be applied to the spine board through which the straps can be fastened. This has, in the past, been accomplished by pre-loading spine boards with pads that have plastic loops incorporated into their design. By pre-loading pads, pre-hospital care providers almost assuredly provided areas in which pathogens could survive. Additionally, Velcro and other hook and loop fasteners have a tendency to retain blood, tissue, and other foreign matter. This retention quality is best demonstrated by pouring hydrogen peroxide over Velcro straps which have been in service for any length of time. Even the most thorough cleaning will usually reveal some hidden blood. This is a major cross-contamination issue, which has not yet been adequately addressed by the pre-hospital provider community. Another problem with Velcro is that hook and loop fasteners are easily removed by a patient with an altered level of consciousness or head injury. Additionally, because the hook and loop fasteners are not secured directly to the backboard, there is some ‘play’ inherent to the device. A person who has been immobilized with the use of hook and loop fasteners will slide laterally when the backboard is turned onto its side. This lateral movement compromises the entire immobilization and may further injure the person.
Cardboard head immobilizers are occasionally used to secure an injured person's head to a backboard. These devices are an inexpensive alternative to taping the person to the backboard. These cardboard devices, while offering more stabilization than tape alone, must still use adhesive to be secured to the backboard. Because of the use of adhesive, the cardboard immobilizers are dependent upon weather conditions, essentially making the device ineffective in wet or cold environments. The cardboard, while fluid resistant, may break down in adverse environments, such as during a heavy downpour, rendering the immobilizer ineffective. When these devices are secure to a person's head by the use of tape or hook and loop fasteners, the problems associated with the use of Velcro as described above arise. Cardboard immobilizers, while inexpensive, are single use only. There is no way to clean the cardboard. Also, a patient with an altered level of consciousness or a head injury can easily remove the cardboard device. Additionally, the cardboard immobilizers offer little or no stability when the patient is placed on his or her side, thereby compromising the integrity of the immobilization.
While creating a design that would benefit the field of Emergency Medical Services, Applicant addressed the issue of spinal immobilization. More specifically, Applicant concentrated on the immobilization of a person's head to a rigid spine board. Applicant set some parameters within which the design would focus. Spinal immobilization should be consistent regardless of the environment in which the procedure is performed. A person involved in a motor vehicle accident during a downpour at night should expect the same level of care as rendered to the person who fell on a warm, sunny day. Procedures used to provide pre-hospital care should not involve the risk of contaminating a patient with pathogens acquired from previous patients, as is often the case with hook and loop fasteners. Additionally, procedures utilized to render care should be quick and efficient so as to create the least amount of discomfort to the patient as possible with the least amount of manipulation. Once the patient has been immobilized, the integrity of the immobilization must be maintained even when manipulation of the backboard is necessary, such as when a person has to be moved from one floor level to another. When circumstances arise that call for the placement of the backboard on it
Brown Michael A.
McGonagle John P.
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