Surgery – Body protecting or restraining devices for patients or infants – Restrainers and immobilizers
Reexamination Certificate
2000-06-23
2001-10-30
Brown, Michael A. (Department: 3764)
Surgery
Body protecting or restraining devices for patients or infants
Restrainers and immobilizers
C128S845000, C128S846000, C005S621000, C005S624000
Reexamination Certificate
active
06308712
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to an apparatus for restraining for medical patients. More particularly, the present invention relates to an apparatus for restraining medical patients while providing a sterile field during the performance of a medical procedure, such as a lumbar puncture procedure.
BACKGROUND OF THE INVENTION
A variety of medical procedures require the patient to be restricted in movement. For example, a particular need exists for immobilizing a patient when performing a procedure which requires exact placement and insertion of an invasive needle or probe into the patient's body. This is especially important in medical procedures where the placement of the probe or needle involves the risk of serious injury or damage from an inadvertent motion by the patient. Notable among such procedures are spinal tap or lumbar puncture procedures, involving the insertion of a needle into the spinal canal through the spaces between lumbar vertebrae where any motion of the patient while the needle is being inserted into the body runs a serious risk of spinal damage. Lumbar puncture procedures, which are required for obtaining spinal fluid samples for diagnostic procedures, present a risk of damage to the patient's spinal cord if any movement of the patient occurs during the procedure. Since spinal taps are very uncomfortable, the risk of such motion is particularly severe in children. Moreover, such procedures are done without anesthesia, which compounds the problem of unwanted movement in children. This movement increases the possibility of the puncture instrument contacting the spinal nerves of the patient, thereby causing an involuntary reflex response.
As a result, it is necessary to restrain the patient from moving during the medical procedure. Securing the patient against movement requires that the apparatus positively secure the child against both in response to pain and to involuntary muscle reflex responses. However such restraints cannot be of the type that so bind the child that a panic response ensues, or that unduly heightens the fears of the child.
Various immobilizers have been developed for holding patients, including small children, in a proper position for an operation, such as a spinal tap. One example of such an immobilizer is described in U.S. Pat. No. 5,337,982, in which a pediatric lumbar puncture immobilizer is described having a series of supports mounted thereto to restrain the patient positioned thereon. While the pediatric lumbar puncture immobilizer effectively works to securely restrain the patient in a non-threatening manner, this design does not teach a means for providing a sterile field for the lumbar puncture or “spinal tap” to be performed.
Accordingly, what is needed and is not taught by the prior art is an immobilizing apparatus that provides a sterile field for a physician to perform a medical procedure while restraining the patient from undesired movement that could injure the patient.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide an apparatus that will immobilize a patient to allow a physician to safely operate on the patient.
It is a further object of the present invention to provide an apparatus maintaining a sterile field surrounding the point of the medical procedure performed on the patient.
It is a further object of the present invention to provide a disposable sterile insert member that works in conjunction with a immobilizing apparatus that is easily replaceable to provide a sterile field surrounding the point of the medical procedure performed on the patient.
It is a further object of the present invention to provide a disposable sterile insert member having an attached pair of sterile sheets to maintain a sterile environment around the patient and physician.
These and other objects and advantages of the invention will become apparent from the following detailed description of the preferred embodiment of the invention. The present immobilizing apparatus includes a base platform on which is mounted a series of restraining members, with a disposable sterile insert member provided to engage the restraining members and the base platform to maintain a sterile and hygienic surface for performing the desired medical procedure. The sterile insert member includes a base member with two arm members attached to the ends of the base member. The sterile insert member thereby provides a sterile window surrounded by the base member and arm members to perform the medical procedure. The restraining members include a lower back support, an upper back support, an abdominal stabilizer, a cervical stabilizer, and a knee stabilizer. The lower and upper back supports are fixedly mounted to the base platform, while the abdominal stabilizer, cervical stabilizer and knee stabilizer are each slidably mounted to the base platform to be adjusted to fit each individual patient. Between the lower and upper back supports is a lumbar opening, and the sterile insert member is designed to fit snugly in this lumbar opening. The sterile insert member is thereby positioned between the lower and upper back supports such that a sterile field surrounds the area of the medical procedure to be performed on the patient. After the medical procedure has been performed, the sterile insert member may then be disposed of as desired by the physician and replaced with another sterile insert member for the next medical procedure for the subsequent patient.
In operation, the patient is positioned between the upper and lower support members and the abdominal stabilizer, with the abdominal stabilizer moveable to provide a comfortable yet time restraint of the patient. The cervical and knee stabilizers are further adjusted to provide the desired position for the patient for the medical procedure being performed. Finally, the sterile insert member is inserted between the upper and lower back supports at a position proximate to the area of the patient being operated upon. As a result, the sterile insert member will provide the sterile field surrounding the point of the medical procedure performed on the patient.
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Brown Michael A.
Burr & Forman LLP
Holland Christopher A.
Veal Robert J.
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