Surgery: splint – brace – or bandage – Orthopedic bandage – Splint or brace
Reexamination Certificate
2001-05-18
2003-09-30
Lucchesi, Nicholas D. (Department: 3624)
Surgery: splint, brace, or bandage
Orthopedic bandage
Splint or brace
C602S004000, C602S061000, C128S875000
Reexamination Certificate
active
06626856
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to compression splints for trauma and, more particularly, to a semi-rigid pelvic compression splint.
2. Prior Art
Pelvic compression splints of the prior art are typically fabricated from a solid piece of fabric or other material. While these splints have their advantages in order to ensure that the providers can see and access the anterior abdomen, pelvis, and ano-genital regions, the splint must be disengaged. Furthermore, these pelvic compression splints of the prior art cause compressive forces to be applied to the soft anterior abdominal/pelvic wall and not to the bony pelvis itself where it is most needed.
Each device that is used to compress and stabilize the pelvis has unique attributes and flaws. The principal devices in common use are the military and anti-shock trousers (MAST pants), and a variety of external frames that use pins to attach to the pelvis. The semi-rigid pelvic compression splint of the present invention is designed to combine the non-invasiveness and adjustability of the MAST garment with the medially-directed compression vectors and limb, femoral and anterior abdomino-pelvic exposure of the C-clamp, Pelvic Stabilizer and External Fixator.
MAST pants (military anti-shock trousers or the PASG (pneumatic anti-shock garment) were first used in the Vietnam era for shock resulting from military injuries. They are nylon pant suits with inflatable compartments. They are fit around the patient's legs and torso and extend from the ankle to the lower rib cage. They are closed with Velcro and the inflatable compartments are filled from inferior to superior. There are compartments running up the circumference of each leg, and a large compartment is located over the anterior pelvis and abdomen that extends to the rib cage. The original purpose of the MAST pants was to force blood out of the extremities, pelvis and lower abdomen and into the central circulation supplying the brain and cardiopulmonary system. This process was referred to as “auto-transfusion”, and it was initially believed that the pants worked through this mechanism to restore effective central circulation volume and save lives. It is now believed that blood pressure increases related to the MAST pants result from increased afterload, and that the increased intra-abdominal pressure generated by the MAST pants may “theoretically” reduce some bleeding in this area.
Whatever their affects on hemodynamics, the use of MAST pants has been called into question during the last ten years. Studies have shown that the device does not decrease morbidity and mortality in trauma-related hemorrhagic shock, and that it may be detrimental to patients with associated chest trauma. As a result, the routine use of MAST pants by EMS units has been largely phased out in the United States. Fortuitously, as this de-emphasis of MAST-pants application occurred, they were found to be effective in stabilizing and compressing the fractured pelvis in the EMS and ED setting. As a result MAST pants have had a second life as a limited part of certain pre-hospital and emergency department pelvic trauma resuscitation protocols.
Unfortunately, use of the MAST pants in the pelvic fracture is limited by their many disadvantages. They are only sparingly used in America and a 1995 study reported that only about 10% to 20% of British trauma centers used them, respectively, for pre-hospital and in-patient care. There are many reasons for this. They are somewhat difficult to place on a patient because they cover such a large part of the body, have many closures, and must be completely opened before the patient can be placed in them. Once the pants are fitted, they cover the entire area of the lower limbs, pelvis and abdomen up to the rib cage. The coverage of the legs is unwanted because it prevents assessment of the lower limbs, and compression of the lower limbs has been found to cause compartment syndromes.
Even if MAST pants could be used without attaching the leg pieces, the abdomino-pelvic component would still obscure the entire abdomino-pelvic region up to the rib cage. As noted above, restricting visibility and access to this area is a major disadvantage in trauma care because about half of all pelvic fracture patients also have serious intra-abdominal injuries that must be assessed in a timely fashion. These problems are further complicated by the fact that opening the pants must be done very slowly because there is often a large drop in blood pressure caused by the rapid decrease in afterload associated with garment removal.
Simply trimming MAST pants to a size that conforms to pelvic area would not make them ideal for pelvic compression and stabilization—another shortcoming of the MAST pants is that the compression vector of the abdomino-pelvic component is anterior to posterior. The pants use a large anterior inflatable compartment that compresses the anterior abdomen, increasing intra-abdominal pressure and decreasing the volume of the abdomen and pelvis. Any medially-directed compression is secondary to the dominant anterior-posterior compressive force of the device. Primary AP compression is not optimal for achieving partial reduction, compression, and stabilization of sacro-iliac disruption and pubic symphysis diastasis, and all recently developed invasive external frames primarily employ medially-directed compression vectors. While increasing intra-abdominal pressure may have some theoretical benefit, it has more physiologic costs than medially-directed compression. Both human and animal studies have shown that MAST pants reduce diaphragmatic excursion and compromise respiratory mechanics in critically ill patients. They may also worsen left ventricular function, especially in those with pre-existing heart disease. In addition, AP compression compromises skin integrity over crucial anterior and posterior operative approaches to the pelvis, impeding definitive repair of the injury. Finally, there is no way to achieve anterior-posterior compression without completely obscuring at least part of the anterior abdomen and pelvis.
The history of the MAST pants is interesting in this light, because limb and AP compression over the soft anterior abdomino-pelvic wall does seem to be more likely to squeeze blood into the upper torso than medially directed compression of the relatively rigid contours of the bony pelvis. Unfortunately, as noted above, the autotransfusion/increased afterload function of the device has not been found to be effective for improving outcomes in trauma. The later discovery that the device is helpful in pelvic fractures was fortunate, but the fact that MAST pants were not designed for pelvic stabilization has given them numerous features (described above) that severely limit their use in the multiply-injured blunt trauma patient with a potential pelvic fracture.
The invasive external pelvic compression/stabilization devices of the prior art include the External Fixator, C-Clamp, and Pelvic Stabilizer. The term “invasive” is used to mean that in order to use any of these devices, an orthopedic surgeon, or other specially trained provider must incise the patient's skin, dissect through fascial and/or muscle layers and place a pin into the bony pelvis.
These devices were all designed to stabilize and compress the pelvis before definitive operative repair can be done. Unlike the MAST pants, they were designed for this purpose and primarily provide medially-directed compression of the pelvis while allowing the trauma team to have access to the abdomen and extremities. As briefly mentioned above, all work on the same principle: an external compression frame is connected to the pelvis by means of transcutanous pins that are surgically placed into the iliac wings or posterior ileum. The frame is then adjusted to compress/stabilize and possibly reduce the pelvic disruption. The frame itself can then be swung inferiorly or superiorly to facilitate access to the abdomen or lower limbs.
The frames themselves vary. Th
Hamilton Lalita M.
Scully Scott Murphy & Presser
The Research Foundation of State University of New York
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