Surgery – Body protecting or restraining devices for patients or infants – Restrainers and immobilizers
Reexamination Certificate
1999-12-14
2001-05-01
Brown, Michael A. (Department: 3764)
Surgery
Body protecting or restraining devices for patients or infants
Restrainers and immobilizers
C128S870000, C128SDIG008, C005S630000
Reexamination Certificate
active
06223749
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a cervical board which is designed to provide motion restriction of a patient's cervical spine during an emergency medical or trauma situation.
Spinal trauma, if not recognized and properly managed in the field, can result in irreparable damage and potentially leave a patient paralyzed for life. Therefore, the initial treatment administered to a patient by emergency medical personnel can be critical to the future well-being of the patient. The cervical spine is comprised of the first seven vertebra of the spinal column, and is intended to bend, twist, and flex, all while supporting the head.
When it is suspected that a patient may have suffered injury to the cervical spine or neck region, or may be at risk for cervical spine injury during treatment, it is critical that emergency medical personnel immobilize the patient's head during treatment and transport to prevent the exacerbation or occurrence of such injury. The consequences of moving a patient with a missed spinal injury, or allowing him to move, can be devastating. Failure to properly immobilize a fractured spine, can result in a life threatening or life impairing injury.
Therefore any patient who has sustained an injury indicative of cervical spinal loading or stretching, significant injury above the clavicles, significant blunt trauma to the torso, head injury resulting in an altered level of consciousness, or a major fall should be presumed to have a cervical spine injury. Any such patient should be immobilized in a neutral in-line position before he is even slightly moved. Many of the emergency medical devices found in the prior art, however do not sufficiently restrict movement of the head and cervical spine and thus require supplemental means for achieving adequate mobilization.
Typically, the patient is fitted with a cervical collar by an emergency medical technician, while another emergency medical technician stabilizes the patient's head manually. When a patient is wearing a cervical collar, he does not have a stabilized or immobilize neck. True spinal immobilization occurs only when the patient is placed on a back board with their shoulders and hips strapped or taped down and the head is both taped down and stabilized laterally. Lateral stabilization presently occurs by wedging a pair of tapered blocks on either side of the head to prohibit lateral movement. Only after true spinal immobilization occurs may the emergency medical technician release his manual stabilization.
While a patient, wearing a cervical collar and secured to a backboard, is considered to be immobilized, a system of this type has inherent weaknesses. The patient's body is typically secured to the backboard by straps, while the head is taped to the backboard. Strapping a patient to a backboard does not immobilize their body; the slick surface of many backboards, allows for some body movement or sliding. Movement of the body while the head is in a fixed position compromises the cervical spine.
Also, the size and shape of a back board prohibit its use as an initial means of stabilization within a vehicle or other situations where space is at a premium. Therefore when extracting a patient from a vehicle, a cervical collar and manual stabilization are often the standard of care given a patient. A patient goes through a wide range of motions as they are extracted from a vehicle or confined space. A cervical collar by itself does not provide adequate cervical spine protection. The head can still move laterally, longitudinally and/or rotate. And as stated previously the slightest movement of the head and relation to the neck and cervical spine can cause irreparable damage. Once the patient has been extracted from the vehicle, they can be placed on a back board and properly stabilized.
Once a patient is secured to a backboard, the cervical collar may become a hindrance. The cervical collar provides limited access to the patient's neck. This increases the difficulty of performing a tracheotomy, starting intravenous infusions in the external jugular veins or treating neck trauma. Additionally, the cervical collar uses the patient lower jaw as an anchor point, thereby restricting movement. This inhibits communication between the emergency medical personnel and the patient, limits oral access, and creates a life threatening situation if the patient aspirates vomit.
Other devices, while also providing adequate immobilization of the head and cervical spine once the patient has been moved to a open work area, do not provide adequate access to the patients ears to permit emergency medical personnel to perform a complete diagnosis of the patient's condition. If it is believed that injury has occurred to the head or neck region, it is desirable that emergency medical personnel have access to the patients ears to observe fluid discharge from the ear. Also, along with limiting visibility of the ear, the patients hearing is obstructed.
A further weakness of the cervical collar surfaces once the patient arrives at the hospital. If there is strong suspicion that the patient may have a cervical spine injury he will remain on the backboard with the head restraint device in place. This occurs because the backboard and head restraint device are providing, in conjunction with one another, cervical spine motion restriction. The patient may remain on the backboard for hours while their cervical spine injury is assessed, which raises the concern of localized pressure injury to the patient. A patient on a backboard is typically in an unnatural position lying flat on his back, restrained from head to toe, on a hard, un-padded surface, with his head on the same plane as his shoulders. He cannot move or adjust position as he would if he were not restrained. When kept in this position for any length of time he will experience localized pressure, restricted blood flow and discomfort at any point that his body is in contact with the backboard. Restraining the patient's head on the same plane as his shoulders may cause hypo-flexion or hyper-extension of the cervical spine. It is desirable to get the patient of the backboard as soon as possible in order to avoid localized pressure and cervical spine hypo-flexion or hyper-extension complications.
Accordingly, there is a need for a head and neck immobilizer which can secure a patient's head and neck in a manner that prevents rotational, flexion and/or extension motion, while providing access to the patients neck, mouth and ears. This device should also be simple, quick and easy to apply to a patient in an emergency situation.
SUMMARY OF THE INVENTION
The invention, as claimed, is intended to provide a remedy. It provides cervical spine immobilization by securing a patient's head and neck in a manner which prevents rotational, flexion and/or extension motion while also providing access to the patient's neck, mouth and ears. The present invention allows a user to quickly and conveniently place and secure a cervical board to a patient with a suspected neck injury and thereby immobilize the patient's cervical spine.
The inventive cervical board is of a one piece design and comprises a head support with acruate side walls which prevents lateral movement of the patient's head, a support member which extends downwardly from the lower most portion of the head support and flanges out to form a back support which has a pair of shoulder restraints on opposite sides of the center line of the device.
The back support is approximately the width of a patient's back at its upper most portion and then tapers down in a manner which conforms with the shape of a person's torso. The support member and upper portion of the back support should be of sufficient strength and rigidity to resist any torque or twisting moments placed upon the device by lifting or other movement by the patient. When in use the lower edge of the back support should rest below the scapulas of the patient.
The shoulder restraints extend forward and do
Brown Michael A.
Heslin & Rothenberg, P.C.
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