Surgery: kinesitherapy – Kinesitherapy – Device with applicator having specific movement
Reexamination Certificate
1999-10-05
2001-09-18
DeMille, Danton D. (Department: 3764)
Surgery: kinesitherapy
Kinesitherapy
Device with applicator having specific movement
C601S152000
Reexamination Certificate
active
06290662
ABSTRACT:
FIELD OF THE INVENTION
This invention relates generally to body massaging appliances and, more particularly, to a portable, self-contained apparatus for deep vein thrombosis prophylaxis.
BACKGROUND OF THE INVENTION
Persons undergoing surgery, anesthesia and extended periods of bed rest or other inactivity are often susceptible to a condition known as deep vein thrombosis, or DVT, which is a clotting of venous blood in the lower extremities and/or pelvis. This clotting occurs due to the absence of muscular activity in the lower extremities required to pump the venous blood (stasis), local vascular injury or a hypercoaguble state. The condition can be life-threatening if a blood clot migrates to the lung, resulting in a “pulmonary embolus” or otherwise interferes with cardiovascular circulation.
It is known that this condition may be controlled or alleviated by applying intermittent pressure to a patient's legs to assist in blood circulation (venous return). Many devices have been proposed, including compression boots and other inflation tube devices, but heretofore all of the proposed solutions have been complex, or bulky, or both, and in each case, certainly not portable and self-contained.
One reason why currently available devices are large and complex is due to the fact that the precise level of pulsatile activity required to manage the condition is largely unknown. Commercial devices may therefore provide a more complex massaging action than is necessary. As a result, many existing devices include a plurality of inflatable chambers, spaced at intervals along the leg of a patient, with complex sequencing means being used to provide a vertical pumping action to direct blood flow through the leg and into the torso. Apart from the fact that such sophistication may be unnecessary in many cases, the use of a complex sequential pumping operation requires the use of a heavy and expensive drive unit, precluding portability. Devices of this type are described in U.S. Pat. Nos. 4,013,069; 4,453,538; 4,702,232; 4,841,956; 4,941,458; 5,014,681; 5,263,473; and 5,674,262, and elsewhere.
Although less complex inflation devices have been disclosed, the descriptions rely upon conventional non-portable compressed-air sources. A case in point is U.S. Pat. No. 4,153,050, which describes a DVT stocking used in conjunction with a fillable bladder having only a few chambers. The result is a less complex structure, however, even in this case, the bladders are interconnected to a remote air supply through an interconnecting conduit. No mention is made of true device self-containment and portability.
The need therefore remains, for a portable, self-contained, preferably wearable, device to prevent DVT and like venous conditions. Such a device would also improve upon current devices which, being cumbersome in nature, lead to poor compliance on the part of the user, and are accordingly less effective. Additionally, existing devices, which must be tethered to pneumatic control units, are difficult to apply to the same extremity associated with a particular surgical procedure. For example, it is difficult to apply existing devices to the leg associated with same side hip surgery due to the required interconnections.
SUMMARY OF THE INVENTION
The subject invention improves upon the prior-art by providing an entirely self-contained, patient-worn apparatus for deep vein thrombosis (DVT) prophylaxis, and related conditions. According to a preferred embodiment, an inflatable/deflatable bladder is disposed against an extremity such as the upper calf, foot or within a cast. To treat edema, an inflatable/deflatable bladder may be disposed against at least a portion of the hand. A generally inelastic member is preferably used to fully enclose the bladder and associated body part, such that compressive forces are directed substantially entirely against the body part of the patient when the bladder expands, thereby conserving the power and reducing the volume of pneumatic compression required to operate the device. Given this conservation of energy, the invention may be battery operated from a source immediately proximate to the bladder arrangement, enabling the entire device to be self-contained and, in fact, worn by the patient. The reduced volume also allows the use of miniaturized components including the compressor motor and compressor.
The miniature pump is preferably capable of inflating the bladder to a desired level of pressure so as to augment venous return. A valve may be provided as a pressure release mechanism or, preferably, a natural bleeding of the system is relied upon for decompression following an inflation cycle. The electronics used to drive the compressor, which may be of the type used in commercial blood-pressure measurement cuffs, may be very simple, including a solid-state timer coupled to a relay or other appropriate switching means.
A distinct advantage of the invention is that the device may be worn at all times, including the limb being operated upon during surgery. In an alternative embodiment, to further increase battery life, a sensor may be provided to detect movement of the limb (from which muscle contractions may be implied), such that, should the patient be walking or otherwise active, the pumping action is terminated. One or more mercury switches or other appropriate movement sensors may be utilized for such purpose.
The inventive apparatus may additionally be programmed to decrease the rate of inflation/deflation as a function of time, since it is known that the patient is most vulnerable during and immediately after surgery. Thus, the inventive apparatus may automatically be programmed to facilitate a relatively high inflation/deflation rate during a surgical procedure, but then taper off to a more infrequent cycling as a function of time.
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Colestock Harry E.
Morris John K.
DeMille Danton D.
Gifford Krass Groh Sprinkle Anderson & Citkowski PC
Morris John K.
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