Interactive pressure support system and method

Surgery – Respiratory method or device – Means for supplying respiratory gas under positive pressure

Reexamination Certificate

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Details

C128S204180, C128S204230

Reexamination Certificate

active

06564797

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention pertains to an interactive pressure support system and to a method of treating a breathing disorder using same, and, in particular, to a system that provides a pressure therapy to a patient while also providing an interactive capability so that the patient can answer questions or perform tasks that ascertain the effectiveness of the pressure therapy in treating the patient's breathing disorder.
2. Description of the Related Art
There are many medical ailments that are diagnosed and/or monitored using a questionnaire or cognitive test taken by the patient. For example, a common method to determine whether a patient suffers from a sleep disorder, such as obstructive sleep apnea (OSA), is to measure the patient's sleep propensity. The patient's sleep propensity and/or changes in the sleep propensity can also be used to determine the severity of the disorder and/or monitor the changes in the patient's condition. One conventional technique for measuring a patient's sleep propensity is through the use of the Epworth Sleepiness Score (ESS). The ESS is determined based on the patient's retrospective reports of dozing behavior in a variety of situations commonly encountered in normal daily life. These retrospective reports are elucidated from the patient via a series of questions. The patient's responses to these questions are tabulated and used to determine the ESS to evaluate his or her sleep propensity.
Currently, the Epworth Test is typically administered on paper. To do so, the written test must be physically supplied to the patient and collected after the patient completes the questions. The test administrator manually tabulates (or uses a computer to tabulate) the responses provided by the patient and calculates the ESS based on the patient's responses. It can be appreciated that the administrative requirements, such as the distribution, collection, time stamping, tabulation, scoring, storing and record keeping, required by this conventional testing technique place a significant burden on the test givers. This burden increases with the number of patient's taking the test as well as the number of times the test is administered to each patient. Typically the same patient will take the Epworth test multiple times during his or her treatment in order to monitor the effectiveness of the treatment therapy. It can thus be appreciated that patient follow-up to determine, for example, the effectiveness of a therapy intended to treat a sleep or breathing disorder, is a relatively expensive and burdensome process.
Another conventional technique that measures a patient's reaction time and cognitive alertness, which are generally understood to be indicative of a patient's sleep propensity, is the Vigilance test. This test is typically administered using a personal computer (PC) and requires that the patient provide responses via the input devices associated with the PC to displayed indica. The patient's reaction time in providing the response and/or the accuracy of the response to the displayed indica are measured and stored to determine the patient's level of alertness. For example, the patient is shown a recognizable object on the PC display, and the patient's reaction time in identifying the object and the accuracy of the identification are measured.
Because this test typically requires a PC to administer, it can only be administered at a facility where an appropriately programmed PC is located, which requires that the patient travel to a place where such a PC is located. Alternatively, an appropriately programmed PC can be provided to the patient. However, this latter alternative represents a significant cost in furnishing the PC to the patient and requires training the patient on the use of such a relatively complicated device. It can thus be appreciated that either alternative for administering the Vigilance test represents a significant burden on either the patient or the test administrator.
SUMMARY OF THE INVENTION
Accordingly, it is an object of the present invention to provide a device and method for providing a pressure support treatment and for administering a questionnaire or cognitive test to a patient that overcomes the shortcomings of conventional techniques. This object is achieved, according to one embodiment of the present invention, by providing an interactive pressure support system that includes a pressure generating system adapted to provide a pressure therapy to a pulmonary system of a patient and an interactive system associated with the pressure generating system. The interactive system includes an output device that provides information, such as questions or symbols, to the patient and an input device that receives information from the patient, such as responses to the questions or reactions to the symbols presented. The interactive system also includes a control unit that controls the operation of the output device and the input device to present the interrogative information to the patient properly and to collect the responses from the patient provided via the input device.
This single system combines the patient therapy function of the pressure support device with the patient evaluation function of the questionnaire or cognitive test administered by the interactive system. This dual function system reduces the administrative burden and costs of providing the questionnaire or cognitive test because the test is performed using the same device the patient is given to treat the disorder, and the testing procedure and results collection, calculation, storage, and communication functions are performed in an automated fashion using the processing capabilities already present in many pressure support devices. Furthermore, because the test is incorporated into the same device that the patient is given to treat the condition being monitored by the test, the patient is likely to be motivated to perform the test correctly and diligently, as well as being familiar with the device used to administer the test, thereby requiring less training to perform the testing function than if the patient is provided with an entirely different testing system.
In further embodiments of the present invention, the control unit performs additional functions, such as tabulating the results provided by the patient and calculating scores indicative of the patient's condition, e.g., the ESS indicative of the patient's sleep propensity. In other embodiments, a memory unit is provided that enables the interactive pressure support system to store a number of different types of tests and the results provided by the patient upon taking the tests, including the results from repeated tests and information identifying the time/date the test was administered. In yet another embodiment, a communication unit is provided that permits communication of data between the interactive system and a remote location so that new test data can be provided to the interactive pressure support system and/or information collected by the system can be provided to the remote location, for example.
It is yet another object of the present invention to provide a method of treating and monitoring the treatment of a breathing disorder that does not suffer from the disadvantages of conventional techniques. This object is accomplished by providing a method that includes the steps of: (1) providing a device that administers a pressure therapy to a patient and includes an interactive capability, (2) causing the device to provide information to the patient, such as questions or symbols, and (3) acquiring, via the device, information from the patient, such as responses to the questions or reactions to the symbols presented. In further embodiments of the present invention, the above method also includes storing different information to provide to the patient and storing the results provided by the patient based thereon, as well as the results of repeated testing of the patient. Still

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