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"Providing Automated Or Manual Guidance on Dynamic Patient Positioning Based on Measured Variables for Ventilation Control" in Patent Application Approval Process

2013 JAN 11 (NewsRx) -- By a News Reporter-Staff News Editor at Health & Medicine Week -- A patent application by the inventors Hutchinson, George (San Antonio, TX); Johnson, Royce W. (Universal City, TX), filed on June 19, 2012, was cleared for further review on December 27, 2012, according to news reporting originating from Washington, D.C., by NewsRx correspondents.

Patent serial number 527253 is assigned to Kci Licensing, Inc.

The following quote was obtained by the news editors from the background information supplied by the inventors: "The treatment of acute lung failure, acute lung injury (ALI), and acute respiratory distress syndrome (ARDS) is still one of the key problems in the treatment of severely ill patients in the intensive care unit. Despite intensive research over the past two decades, the negative implications of respiratory insufficiency are still affecting both the short and long term outcome of the patient. While different ventilator strategies have been designed to treat the oxygenation disorder and to protect the lungs from ventilator induced lung injury, additional therapeutic options have been evaluated.

"Dynamic body positioning (kinetic or axial rotation therapy) was first described by Bryan in 1974. This technique is known to open atelectasis and to improve lung function, particularly arterial oxygenation in patients with ALI and ARDS. Since kinetic rotation therapy is a non-invasive, relatively inexpensive method, and with very limited side effects, it can even be used prophylactically in patients whose overall health condition or severity of injury predispose them to lung injury and ARDS. It could be shown that the rate of pneumonia and pulmonary complications can be reduced while survival increases if kinetic rotation therapy is started early on in the course of a ventilator treatment. This therapeutic approach may reduce the invasiveness of mechanical ventilation (i.e., airway pressures and tidal volumes), the time on mechanical ventilation, and the length of stay on an intensive care unit.

"Kinetic rotation therapy in the sense of some exemplary embodiments of the present invention can be applied by use of specialized rotation beds which can be used in a continuous or a discontinuous mode with rests at any desired angle for a predetermined period of time. Examples of such beds are described in whole or in part in the following U.S. patents, all of which are incorporated herein by reference: U.S. Pat. Nos. 4,638,516; 4,763,643; 5,299,334; 4,947,496; 4,730,606; 4,868,937; 6,874,181; 6,112,349; 6,108,838; 6,671,905; 6,566,833; 6,715,169; 7,017,211, 6,934,986; 6,732,390; 6,728,983; 6,701,553; 7,137,160; 6,609,260; 6,862,761; 6,282,736; 6,526,610; 6,499,160; 6,691,347; and 6,862,759. Examples of such beds are also described in whole or in part in the following U.S. Patent Publications, all of which are incorporated herein by reference: 20060162076 and 20060037141. A rotation bed that is suitable for adaptation with some exemplary embodiments of the present invention is presently commercialized under the trademark 'ROTOPRONE', commercially available from Kinetics Concepts, Inc., of San Antonio, Tex. ('KCI').

"Kinetic rotation therapy in the sense of some exemplary embodiments of the present invention can be applied by use of specialized beds which comprise air cushions provided underneath the patient. Examples of such beds are described in whole or in part in the following U.S. patents, all of which are incorporated herein by reference: U.S. Pat. Nos. 5,142,719; 5,003,654; 5,603,133; 6,282,737; 5,152,021; 5,802,645; and 6,163,908. A rotation bed that is suitable for adaptation with some exemplary embodiments of the present invention is presently commercialized under the trademark 'BIODYNE', commercially available from KCI.

"A general effect of axial rotation in respiratory insufficiency is the redistribution and mobilization of both intra-bronchial fluid (mucus) and interstitial fluid from the lower (dependent) to the upper (non-dependent) lung areas, which will finally lead to an improved matching of local ventilation and perfusion, also known as V/Q match. As a consequence, oxygenation increases while intra-pulmonary shunt decreases. Lymph flow from the thorax is enhanced by rotating the patient. In addition, kinetic rotation therapy promotes the recruitment of previously collapsed lung areas, thus reducing the amount of atelectasis, at identical or even lower airway pressures. At the same time, now-opened lung areas are protected from the shear stress typically caused by the repetitive opening and closing of collapse-prone alveoli in the dependent lung zones. From H. C. Pape, et al.: 'Is early kinetic positioning beneficial for pulmonary function in multiple trauma patients'', Injury, Vol. 29, No. 3, pp. 219-225, 1998 it is known to use the kinetic rotation therapy which involves a continuous axial rotation of the patient on a rotation bed. See also Bein T, et al. Clinical Intensive Care 1995. Bein T, et al. Intensive Care Med 1998. Bein T, et al. Clinical Intensive Care 2000.

"It has been found that the kinetic rotation therapy improves the oxygenation in patients with impaired pulmonary function and with post-traumatic pulmonary insufficiency and ARDS.

"However, because the kinetic rotation therapy requires a specially designed rotation bed, it has not been found yet that kinetic rotation therapy justifies a broad employment. Further, kinetic rotation therapy has been utilized with standardized treatment parameters, typically equal rotation from greater than 45 degrees to one side to greater than 45 degrees to the other side, and 15 minute cycle times. These rotation parameters are rarely altered in practice due to a lack of conjoint ventilation effectiveness and rotation activity information. Similarly, the lack of conjoint information hampers practitioners from taking advantage of the beneficial effects of kinetic rotation therapy by reducing the aggressiveness of mechanical ventilation parameters employed to treat a rotated patient.

"Since positioning therapies such as kinetic rotation therapy and proning are lung-protective and improve oxygenation, ventilation drive parameters need to be adjusted downward in order take full advantage of the benefits of the positioning therapies. The question is how to do so effectively. Prior techniques have viewed ventilation and positioning as separate therapies to be independently titrated to patient needs and responses. For example, a great deal of literature exists on how to optimize PEEP levels based on lung mechanics data, imaging information, patient diagnoses, and other information. None of these methods, though, have recognized the role of positioning therapies in influencing the same measures used to tune ventilation. Similarly, positioning therapies have typically been prescribed upon patient diagnoses without regard to specific information about effectiveness of ventilation.

"U.S. application Ser. No. 10/594,400, filed Sep. 26, 2006, and PCT Application No. PCT/US2005/010741, filed Mar. 29, 2005 (published as WO 2005/094369), both of which are incorporated herein by reference, describe methods of combining information from both kinetic and ventilation therapies to allow conjoint analysis of the interaction of each on the other. The references disclose the use of various types of ventilation status information, including respirator measures, hemodynamic measures, and imaging data, in optimizing the two therapies in question.

"Instead of using the rotation beds described above for automatically turning and proning a patient to treat ARDS and other lung conditions, some institutions use manual turning of the patient to achieve a similar result. However, there is little guidance to such institutions on when to turn the patient, how long to leave the patient prone, whether leaving the patient at a rotational angle is beneficial, or whether adding a change in pitch is appropriate.

"Various methods for the automated control of ventilation are known to those of skill in the art. Examples of such methods which are suitable for use with exemplary embodiments of the present invention are described in Laubscher et al., 'An Adaptive Lung Ventilation Controller,' IEEE Transactions on Biomedical Engineering, Vol. 41, No. 1, pp. 51-59, 1994 ('Laubscher-1'), and Laubscher et al., 'Automatic Selection of Tidal Volume, Respiratory Frequency and Minute Ventilation in Intubated ICU Patients as Startup Procedure for Closed-Loop Controlled Ventilation,' Int. J. Clinical Monitoring and Computing, 11:19-30, 1994 ('Laubscher-2'), both of which are incorporated herein by reference. Laubscher-1 describes a closed loop ventilation method called Adaptive Lung Ventilation (ALV), which is based on a pressure controlled ventilation mode suitable for paralyzed, as well as spontaneously breathing, subjects. As explained in Laubscher-1, the clinician enters a desired gross alveolar ventilation (V'.sub.gA in l/min), and the ALV controller tries to achieve this goal by automatic adjustment of mechanical rate and inspiratory pressure level. The adjustments are based on measurements of the patient's lung mechanics and series dead space. Laubscher-2 describes a computerized method for automatically selecting startup settings for closed loop mechanical ventilation. An automated ventilation control algorithm that is suitable for adaptation with some exemplary embodiments of the present invention is presently commercialized under the trademark 'Adaptive Support Ventilation' or 'ASV', commercially available from Hamilton Medical, Inc., of Reno, Nev.

"Other methods of automated ventilation control which are suitable for use with exemplary embodiments of the present invention are described in U.S. Pat. No. 4,986,268 ('Tehrani'), which is incorporated herein by reference. Tehrani describes a method for automatically controlling a ventilator in which the ventilation and breathing frequency requirements of a patient are determined from measurements of several parameters, including the air viscosity factor of the patient's lungs, the barometric pressure, the lung elastance factor of the patient, measured levels of carbon dioxide and oxygen of the patient, and the metabolic rate ratio of the patient.

"One problem associated with hospitalized and particularly ventilated patients is pneumonia. The incidence of these pneumonias has been estimated at 9-40% (Safdar et al 2005). One cause of these pneumonias is foreign matter, and particularly infectious matter, entering the lungs. In the case of the ventilated patient this matter enters the lungs around, as well as through, the endotracheal tube used to ventilate the patient. This is generally referred to as ventilator-associated pneumonia.

"In addition to ventilator-associated pneumonia, non-ventilated patients are also prone to pneumonia. In these patients aspiration of fluids is often the cause of the pneumonia. This is called aspiration pneumonia. The fluid aspirated can be tracheal, oral, and/or gastric. Small studies by Garvey et al. (1989) and Apte et al. (1992) both show approximately 50% of these pneumonias could be traced to organisms of gastric origin.

"Increasingly rigorous and robust studies have shown the enormous cost, morbidity, and mortality of infections acquired in the intensive care unit in general and of ventilator-associated pneumonia in particular (Jackson and Shorr 2006).

"Any problems or shortcomings enumerated in the foregoing are not intended to be exhaustive but rather are among many that tend to impair the effectiveness of previously known techniques. Other noteworthy problems may also exist; however, those presented above should be sufficient to demonstrate that apparatuses and methods appearing in the art have not been altogether satisfactory and that a need exists for the techniques disclosed herein."

In addition to the background information obtained for this patent application, NewsRx journalists also obtained the inventors' summary information for this patent: "In certain exemplary embodiments, the prevent invention comprises a method of controlling the positioning of a patient in or on a patient support surface, comprising: (a) using an artificial ventilator to artificially ventilate one of the patient's lungs, (b) determining the status of the artificially ventilated lung by measuring one or more ventilation status measures, and © using one or more of the ventilation status measures to provide feedback for controlling the positioning of the patient. In some exemplary embodiments, the feedback is used for automated control of the positioning of the patient, which in some exemplary embodiments is accomplished using an apparatus comprising a bed that is rotatable about its longitudinal axis, while in other exemplary embodiments the automated control is accomplished using an apparatus comprising a bed that comprises air cushions provided underneath the patient. In still other exemplary embodiments, the feedback is used as guidance for manual control of the positioning of the patient, and in some exemplary embodiments the guidance comprises textual and/or graphical guidance statements.

"In certain exemplary embodiments, the ventilation status measures comprise respiratory measures, which in some exemplary embodiments comprise one or more of direct VO.sub.2, paO.sub.2, and pulmonary mechanics measures. In some exemplary embodiments, the pulmonary mechanics measures comprise one or more of upper and lower inflection points of the expiratory and inspiratory pressure-volume curves and the airway pressure at the point of maximal pressure-volume compliance (Pmax). In other exemplary embodiments, the ventilation status measures comprise hemodynamic measures, which in some exemplary embodiments comprise one or more of DO.sub.2, indirect VO.sub.2, SpO.sub.2, cardiac output, cardiac stroke work, stroke volume, diastolic volumes, pulmonary vascular resistance, pulmonary arterial wedge pressures, pulmonary vascular compliance, O.sub.2 extraction ratio, Qs/Qt shunt fraction, and extravascular lung water measures. In still other exemplary embodiments, the ventilation status measures comprise imaging data, which in some exemplary embodiments comprises one or more of electrical impedence tomography (EIT) data and computed tomography (CT) data.

"In yet another exemplary embodiment, the method further comprises using one or more of the ventilation status measures as feedback for controlling at least one ventilation parameter of the artificial ventilator. In still another exemplary embodiment, the position of the patient that is controlled is the pitch of the patient's body.

"In certain exemplary embodiments, the present invention comprises an apparatus for controlling the positioning of a patient in or on a patient support surface, comprising: (a) an artificial ventilator for artificially ventilating one of the patient's lungs, (b) measuring equipment for determining the status of the artificially ventilated lung by measuring one or more ventilation status measures, © one or more information processors that receive the one or more ventilation status measures from the measuring equipment and provide feedback for controlling the positioning of the patient. In some exemplary embodiments, the one or more information processors are computers. In other exemplary embodiments, the feedback is in the form of signals that can be provided to a control unit that controls a bed that is rotatable about its longitudinal axis. In still other exemplary embodiments, the feedback is in the form of signals that can be provided to a control unit that controls a bed that comprises air cushions provided underneath the patient. In yet another exemplary embodiment, the feedback is in the form of textual and/or graphical guidance statements that can be used for manual control of the positioning of the patient. In certain exemplary embodiments, the one or more information processors provide feedback for controlling at least one ventilation parameter of the artificial ventilator.

"In certain exemplary embodiments, the artificial ventilator used in the method or apparatus is controlled by the ALV algorithm and the ventilation status measures comprise the information that drives that algorithm, namely the measurements of the patient's lung mechanics and series dead space. In other exemplary embodiments, the artificial ventilator is controlled by an algorithm driven by one or more of the following ventilation status measures: the air viscosity factor of the patient's lungs, the barometric pressure, the lung elastance factor of the patient, measured levels of carbon dioxide and oxygen of the patient, and the metabolic rate ratio of the patient.

"Certain exemplary embodiments comprise a method of optimizing ventilation parameters for a patient. In certain exemplary embodiments, the method may comprise: using an artificial ventilator to artificially ventilate a lung of a patient; administering a first ventilation parameter at an initial value; placing the patient in a first position; obtaining a first value of a first physiological parameter when the first ventilation parameters is at the initial value and the patient is in the first position; varying the first ventilation parameter to a subsequent value; and obtaining a second value of the first physiological parameter when the first ventilation parameter is at the subsequent value. Exemplary embodiments may also comprise: placing the patient in a second position; obtaining a third value of the first physiological parameter when the patient is in the second position; defining a cost function based on the initial and subsequent values of the first ventilation parameter, the first and second positions of the patient, and the first, second and third values of the first physiological parameter; and calculating a minimum value of the cost function to determine an optimum value for the first ventilation parameter and for the position of the patient.

"Certain exemplary embodiments may also comprise: obtaining a first value of a second physiological parameter when the first ventilation parameter is at the initial value and the patient is in the first position; obtaining a second value of the second physiological parameter when the first ventilation parameter is at the subsequent value; obtaining a third value of the second physiological parameter when the patient is in the second position; and calculating a minimum value of a cost function to determine an optimum value for the first ventilation parameter and for the position of the patient, where the cost function is based on the initial and subsequent values of the first ventilation parameter, the first and second positions of the patient, and the first, second and third values of the first physiological parameter.

"In certain exemplary embodiments, the first and second physiological parameters comprise measurements of the patient's lung mechanics and series dead space. In other exemplary embodiments, the first and second physiological parameters are direct measurements that may be combined to yield a more comprehensive quantification of lung performance. In still other exemplary embodiments, the first position may be a different pitch than the second position. In specific exemplary embodiments, placing the patient in a second position comprises raising or lowering the head-end of the patient with respect to the foot-end of the patient. The first position may be a different rotational position than the second position in certain exemplary embodiments, and placing the patient in a second position may comprise rotating a support surface about its longitudinal axis, and/or adjusting an adjustable air cushion supporting the patient.

"Certain exemplary embodiments may comprise a control system to automatically adjust the first ventilation parameter and a position of the patient to approximately their optimum values. In certain exemplary embodiments, the first ventilation parameter and a position of the patient are manually adjusted by a caregiver to be administered at approximately the optimum values. Still other exemplary embodiments may comprise an indicator to indicate when the first ventilation parameter and a position of the patient are at approximately the optimum values.

"In certain exemplary embodiments, the first physiological parameter may comprise a respiratory parameter, direct VO.sub.2, paO.sub.2, or pulmonary mechanics measurements. In other exemplary embodiments, the first physiological parameter may comprise one or more of upper and lower inflection points of the expiratory and inspiratory pressure-volume curves and the airway pressure at the point of maximal pressure-volume compliance (Pmax). In still other exemplary embodiments, the first physiological parameter may comprise a hemodynamic parameter.

"In still other exemplary embodiments, the first physiological parameter may comprise one or more of DO.sub.2, indirect VO.sub.2, SpO.sub.2, invasive cardiac output, cardiac stroke work, stroke volume, right heart end diastolic volumes, pulmonary vascular resistance, pulmonary capillary pressures, pulmonary vascular compliance, O.sub.2 extraction ratio, Qs/Qt shunt fraction, and extravascular lung water measurements. In still other exemplary embodiments, the first physiological parameter may comprise imaging data, and the imaging data may comprise one or more of electrical impedence tomography (EIT) data and computed tomography (CT) data.

"In still other exemplary embodiments, the cost function may be defined using one or more of the following measurements: the air viscosity factor of the patient's lungs, the barometric pressure, the lung elastance factor of the patient, the measured levels of carbon dioxide and oxygen of the patient, and the metabolic rate ratio of the patient.

"Still other exemplary embodiments may comprise a method of optimizing treatment for a patient. In certain exemplary embodiments, the method may comprise a support surface configured for placement in a first position and a second position; an artificial ventilator configured to artificially ventilate a lung of the patient; measuring equipment configured to obtain values for one or more physiological parameters, ventilation parameters, and position parameters; a feedback system configured to send the values for the one or more physiological parameters, ventilation parameters, and position parameters to an analysis system, wherein the analysis system is configured to calculate a cost function based on the values for the one or more physiological parameters, ventilation parameters, and position parameters; and a control system configured to adjust the one or more ventilation parameters and position parameters to minimize the cost function.

"In certain exemplary embodiments, the support surface may be rotatable about its longitudinal axis, and/or the support surface may comprise adjustable air bladders. In still other exemplary embodiments, the control system may automatically adjust the one or more ventilation parameters and the position parameters to minimize the cost function. In specific exemplary embodiments, the control system may comprise manual adjustments by a caregiver and an audible or visible indicator that indicates when the one or more ventilation parameters and position parameters are adjusted so that the cost function is minimized. In certain exemplary embodiments, the support surface may be configured to adjust the pitch of the patient.

"Still other exemplary embodiments may comprise: using an artificial ventilator to artificially ventilate a lung of the patient; measuring a physiological parameter; and adjusting the pitch of the patient to optimize the physiological parameter. Certain exemplary embodiments may comprise measuring a ventilation parameter and adjusting the ventilation parameter and the pitch of the patient to optimize the physiological parameter. Still other exemplary embodiments may comprise defining a cost function based on the physiological parameter, the ventilation parameter and the pitch of the patient; determining a minimum value of the cost function; and adjusting the ventilation parameter and the pitch of the patient to minimize the value of the cost function."

URL and more information on this patent application, see: Hutchinson, George; Johnson, Royce W. Providing Automated Or Manual Guidance on Dynamic Patient Positioning Based on Measured Variables for Ventilation Control. U.S. Patent Serial Number 527253, filed June 19, 2012, and posted December 27, 2012. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser'Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=6345&p=127&f=G&l=50&d=PG01&S1=20121220.PD.&OS=PD/20121220&RS=PD/20121220

Keywords for this news article include: Chemicals, Chemistry, Pneumonia, Algorithms, Cardiology, Chalcogens, Lung Injury, Pulmonology, Legal Issues, Lung Diseases, Carbon Dioxide, Infectious Disease, Kci Licensing Inc., Inorganic Carbon Compounds, Respiratory Tract Diseases.

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