Surgery: kinesitherapy – Kinesitherapy – Device with applicator having specific movement
Reexamination Certificate
2000-10-02
2004-05-18
Donnelly, Jerome W. (Department: 3764)
Surgery: kinesitherapy
Kinesitherapy
Device with applicator having specific movement
Reexamination Certificate
active
06736787
ABSTRACT:
FIELD OF THE INVENTION
The invention is related to an apparatus and method for applying varying pressure waveforms to a limb of a human patient in order to help prevent deep vein thrombosis (DVT), pulmonary embolism (PE) and death.
BACKGROUND OF THE INVENTION
Limb compression systems of the prior art apply and release pressure on a patient's extremity to augment venous blood flow and help prevent deep vein thrombosis (DVT), pulmonary embolism (PE) and death. Limb compression systems of the prior art typically include: a source of pressurized gas; one or more pneumatic sleeves for attaching to one or both of the lower limbs of a patient; and an instrument connected to the source of pressurized gas and connected to the sleeves by means of pneumatic tubing, for controlling the inflation and deflation of the sleeves and their periods of inflation and deflation. In U.S. Pat. No. 3,892,229 Taylor et al. describe an early example of one general type of limb compression system of the prior art known as an intermittent limb compression system; such systems apply pressure intermittently to each limb by inflating and deflating a single-bladder sleeve attached to the limb. In U.S. Pat. No. 4,013,069 Hasty describes an example of a second general type of limb compression system of the prior art, known as a sequential limb compression system; such systems apply pressure sequentially along the length of the limb by means of a multiple-bladder sleeve or multiple sleeves attached to the same limb which are inflated and deflated at different times. Certain intermittent and sequential limb compression systems of the prior art are designed to inflate and deflate sleeves thereby producing pressure waveforms to be applied to both limbs either simultaneously or alternately, while others are designed to produce pressure waveforms for application to one limb only.
One major concern with all pneumatic limb compression systems of the prior art is that the therapy actually delivered by these systems may vary substantially from the expected compression therapy. For example, a recent clinical study designed by one of the inventors of the present invention, and involving the most commonly used sequential pneumatic limb compression systems of the prior art, showed that the pneumatic limb compression therapy actually delivered to 49 patients following elective total hip replacement surgery varied widely from therapy expected by the operating surgeons in respect of key parameters of the therapy shown in the clinical literature to affect patient outcomes related to the incidence of deep venous thrombosis, pulmonary embolism and death. The study methodology involved continuous monitoring of the varying pressure of the compressed air in the pneumatic sleeves of these systems, permitting the values of key parameters of pneumatic compression therapy actually delivered to patients to be directly monitored throughout the prescribed period of therapy and compared to the expectations of operating surgeons. The results of this clinical study indicated that the expected therapy was not delivered to any of the 49 patients monitored: therapy was only delivered an average of 77.8 percent of the time during the expected periods of therapy; the longest interruptions of therapy in individual subjects averaged 9.3 hr; and during 99.9 percent of the expected therapy times for all 49 patients monitored in the study, values of key outcomes-related parameters of the therapy actually delivered to the patients varied by more than 10 percent from desired values. These parameters included rates of pressure rise and maximum pressures actually delivered through the sleeves. The unanticipated range of variations that was found in this clinical study between expected and delivered pneumatic compression therapy, within individual patients and across all patients, may be an important source of variations in patient outcomes in respect of the incidence of deep vein thrombosis, pulmonary embolism and death, and may be an important confounding variable in comparatively evaluating reports of those patient outcomes. The present invention addresses many of the limitations of prior-art systems that have led to such unanticipated and wide variations between the expected therapy and the therapy actually delivered to patients.
Due to errors and limitations associated with estimation of the pressure applied by a sleeve to a limb, prior-art systems have not had the capability of accurately producing a desired pressure waveform in combination with sleeves having differing designs and varying pneumatic volumes, or when sleeve application techniques vary and the resulting sleeve snugness varies, or when sleeves are applied to limbs of differing sizes, shapes and tissue characteristics. As a result, substantial variations often arise between the desired and actual pressure waveforms delivered by limb compression systems of the prior art.
Many limb compression systems of the prior art are not capable of producing a desired pressure waveform in a pneumatic sleeve attached to a limb under varying operational and clinical circumstances such as movement of the limb, movement of the sleeve relative to the limb and varying snugness of sleeve application, in part because they do not generate a signal indicative of the actual pressure in the sleeve suitable for permitting a feedback control system to produce the desired pressure waveform. Some limb compression systems known in the prior art attempt to estimate sleeve pressure in an inexpensive and convenient manner, based on a variety of apparatus and methods. These systems do not measure pressure directly in the pneumatic sleeve applied to the limb but instead estimate sleeve pressure indirectly and remotely from the sleeve. For example, in U.S. Pat. No. 5,031,604 Dye describes a system in which sleeve pressure is estimated by measuring pneumatic pressure near the instrument end of the tubing connecting the instrument to the sleeve. As another example, Arkans in U.S. Pat. No. 4,375,217 describes a system in which the static pressure in the sleeve is estimated at a location on the tubing between the instrument and the sleeve. All such apparatus and methods which estimate sleeve pressure by measuring a pneumatic pressure remotely from the sleeve suffer from a significant disadvantage, which makes them unsuitable for incorporation into an instrument for producing a desired pressure waveform in the sleeve: the accuracy of the estimates of pressure made by such systems is significantly affected by variations in the length and flow resistance of the tubing attached to the sleeve, and by variations in sleeve design, sleeve inflation volume and sleeve application technique. For example, the inventors of the present invention have determined that variables related to the design and size of the sleeve, as well as the snugness of application of the sleeve, can result in discrepancies at any instant of well over 50 percent between the remotely estimated sleeve pressure and the actual pressure in the sleeve. As a separate consideration regarding the flow resistance of the tubing employed in prior-art systems which measure pressure in this manner, it has been necessary to locate such systems close to the patient to minimize flow resistance in the tubing, resulting in unnecessary noise and clutter around the patient.
Other systems known in the prior art interrupt the flow of gas in the tubing in an effort to estimate sleeve pressure by measuring pneumatic pressure at the instrument end of the tubing under zero-flow conditions. One such system is the Jobst Athrombic Pump System 2500 (Jobst Institute Inc., Charlotte N.C.). However, estimates of sleeve pressure made in this manner cannot practically be incorporated into limb compression systems for producing pressure waveforms having large amplitudes and short cycle periods. Also, more generally, such systems suffer from the disadvantage that pressure estimates are available discontinuously and are not suitable for real-time control of the pressure in the sleeve to produce a d
Jameson Michael
McEwen James Allen
Donnelly Jerome W.
ipsolon llp
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