Surgery: splint – brace – or bandage – Orthopedic bandage – Splint or brace
Reexamination Certificate
2000-08-16
2003-04-29
Pothier, Denise M. (Department: 3764)
Surgery: splint, brace, or bandage
Orthopedic bandage
Splint or brace
C602S005000, C128S099100
Reexamination Certificate
active
06554784
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to emergency treatment of a fractured pelvis. In particular, the invention provides a non-invasive sling device for reducing a fractured pelvis in a manner that minimizes internal bleeding.
BACKGROUND OF THE INVENTION
Many people die from internal bleeding due to a fractured pelvis. Achieving rapid hemodynamic stability in patients who have a fractured pelvis decreases the mortality rate substantially. Unfortunately, currently there is no satisfactory method or device that may readily be utilized to stabilize a fractured pelvis in emergency situations outside a hospital. Pelvic stabilization at an emergency site within the first hour after the fracture occurs is critical and may often determine whether the patient lives or dies.
Reduction and stabilization of the pelvis is thought to be the most effective means to control bleeding for the following reasons. First, it decreases fracture fragment motion to prevent dislodgment of hemostatic clots and further tissue damage. Second, fracture reduction reopposes bleeding osseous surfaces, thus decreasing blood loss. Third, reduction decreases pelvic volume, thereby tamponading hemorrhage from the fracture and retroperitoneal tissue. Despite these widely recognized benefits, no adequate pelvic stabilization device for early management of pelvic fractures is currently available.
The current standard of care for treating pelvic trauma consists of fluid resuscitation, including appropriate use of blood products, angiography if necessary, and early invasive or non-invasive pelvic stabilization. Non-invasive pelvic stabilization techniques have been used. For example, a sheet may be wrapped around the pelvis and tied. Alternatively, a vacuum-type splinting device, or a pneumatic anti-shock garment may be used. These non-invasive techniques have a number of significant problems. One problem is that successful use and application of the device is quite dependent on the emergency caregiver. The person applying the device may not know how much compressive force to apply circumferentially around the pelvis. If too much force is applied, then the pelvis may be overly compressed causing significant complications. On the other hand, insufficient compressive force may leave the fractured pelvis unreduced, and therefore fail to adequately control internal bleeding.
Another problem with non-invasive pelvic stabilization devices that are currently used is that they typically prohibit or restrict vital access to the abdomen, perineum, and lower extremity. Furthermore, prolonged application of devices such as the pneumatic anti-shock garment has been associated with significant complications, such as compartment syndrome of the lower limbs.
Invasive pelvic stabilization methods utilize external fixation, pelvic C-clamps, and open reduction and subsequent internal fixation. External fixation devices can effectively reduce and stabilize the pelvis and are relatively simple to apply. However, their utility is limited most commonly to the operating room setting. The invasive pelvic stabilization methods generally are not appropriate for application at an emergency scene where unstable pelvic ring disruptions require rapid pelvic reduction and temporary stabilization.
Open reduction and internal fixation is the ultimate form of treatment for a fractured pelvis, and is considered the gold standard for accuracy of reduction, protection of neurovascular structures, and rigidity of fixation. However, its invasive nature makes it inappropriate for use in an emergency situation, such as the scene of a car accident, on the side of a mountain, or at a remote location of a traumatic fall.
Accordingly, an object of the invention is to provide a method and apparatus for pelvic reduction and stabilization that is non-invasive.
Another object is to provide a method and apparatus for pelvic reduction and stabilization that is capable of even and incremental application of hoop stress to both hemi-pelves while avoiding reactive forces that potentially can decrease the quality of reduction.
Another object of the invention is to provide a method and apparatus for pelvic reduction and stabilization that applies and maintains hoop stress around the pelvis at a preset and safe level, while avoiding the application of excessive hoop stress.
A further object of the invention is to provide a method and apparatus for stabilization of a fractured pelvis that can be applied in a rapid and simple manner by a single person without extensive training.
Still another object of the invention is to provide a method and apparatus for stabilizing a fractured pelvis that can be applied at an emergency site without the need for additional complex or heavy equipment.
Another object of the invention is to provide a method and apparatus for stabilizing a fractured hip in a nonintrusive manner, while allowing vital access to conduct other important emergency procedures on the patient.
Another object of the invention is to provide a method and apparatus that permits stable pelvic reduction prior to and during the application of a pelvic external fixator in the clinical setting.
SUMMARY OF THE INVENTION
The invention provides beneficial methods and apparatus for stabilizing a fractured pelvis in an emergency setting without requiring use of complex or invasive equipment. The invention may be used and carried out by a single person without extensive training or expertise.
The invention provides a sling device for stabilizing a fractured pelvis. A buckle is connected to a strap member to form a closed loop. The buckle has at least one automatic locking mechanism that allows the strap member to be tightened around a fractured pelvis until a predetermined threshold force is reached. The closed loop then maintains a substantially constant circumference until the strap member is released from the buckle.
The invention also provides a sling device including a belt member with two end portions. A buckle has two substantially identical belt-engaging mechanisms. Each belt engaging mechanism is configured to receive an end portion of the belt member so that the belt member can be tightened symmetrically around a person's pelvis by pulling on the end portions of the belt member simultaneously.
In a preferred embodiment of the invention, the belt member is secured with a buckle including at least one rotating cylinder. The rotating cylinder has an outer surface that contacts a portion of the belt member that at least partially wraps around the cylinder. The belt portion frictionally grips the outer surface of the cylinder so that when rotation of the cylinder is locked, the belt member is prevented from slipping over the outer surface of the immobilized cylinder.
The invention also provides a method of stabilizing a fractured pelvis. First, a belt is secured around a person's fractured pelvis. The tension of the belt is then automatically set at a level that has been predetermined to substantially reduce a fracture pelvis without excessive compression. In a preferred embodiment of the invention, the tension level of the belt is automatically set in the range of approximately 150 N to 250 N.
The invention also includes a method of securing a pelvic fixator in an emergency situation. The fractured pelvis is first temporarily stabilized by tightening a belt device around the pelvis. A pelvic fixator may subsequently be applied while the belt is secured around the person's pelvis.
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Bottlang Michael
Krieg James C.
Long William B.
Madey Steven M.
Kolisch & Hartwell, P.C.
Legacy Emanuel Hospital & Medical Health Center
Pothier Denise M.
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