PORTABLE DEVICE FOR MONITORING AND REPORTING OF MEDICAL INFORMATION FOR THE EVIDENCE -BASED MANAGEMENT OF PATIENTS WITH CHRONIC RESPIRATORY DISEASE

• US 20130184540A1
• Filed: 08/09/2010
• Published: 07/18/2013
• Est. Priority Date: 08/09/2010
• Status: Active Grant

• Current Assignee: Mir Srl Medical International Research
• Original Assignee: Mir Srl Medical International Research
• Inventors: Boschetti Sacco, Paolo, Saltini, Cesare, Calzetta, Luigino
• Granted Patent: US 10,201,308 B2
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 2560/0431 Portable apparatus, e.g. comprising a handle or case
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/4884 inducing physiological or psychological stress, e.g. applications for stress testing
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

An integrated tele-health system/device for monitoring and reporting medical information for the evidence-based management of patients with chronic respiratory disease. The device includes a central unit which measures and collects information related to the state of health of the patient, and is provided with elements for wireless or cable transmission of the collected data using a microprocessor based system with a touch screen display, USB communication port and Bluetooth. The device further includes: a removable sensor for the measurement of respiratory air flow and volume, a removable pulse oximetry sensor and a motion sensor. Stored data can be then delivered through landline, broadband, wireless and cell-phone technology to be received by a web server and can then be accessed by medical staff. Being completely portable, the device is provided with a battery of known type, which can be substituted by the user or can be rechargeable.

Claims

1-16. -16. (canceled)

17. Device for monitoring and reporting of medical information for the evidence-based management of patients with chronic respiratory disease, said device being portable and substantially comprising a central unit (1) which measures and collects information related to the state of health of the patient, a removable sensor for the measurement of respiratory air flow and volume with special connecting means, a removable pulse oximetry sensor and motion sensor/detector means, characterized in that it is provided with means for measuring simultaneously a parameter called oxygen saturation or % SpO₂ (pulse oximetry) as well as a physical activity of the patient (accelerometry), wherein the central unit (1) is able to calculate a CS index or O2_Gap representing the quantity of oxygen expressed in L/min which must be given to the patient in order that the patient can complete a 6-minute walking test or 6MWT without desaturating below the level of 90% SpO2, and also without desaturating below the level of 82% SpO2 for the patients who require 6 L/min of oxygen in order to complete the test, said central unit (1) showing said CS index on a display at the end of a measurement session.

18. Device according to claim 17, characterized in that said CS index or O2_gap is calculated by using the following equation:

19. Device according to claim 17, characterized in that it is provided with means for wireless or cable transmission of the collected/stored information using a microprocessor based system comprised in said central unit (1);

said information related to the patient being delivered through landline, broadband, wireless and cell-phone technology to be received by web server and can then be accessed by medical staff.

20. Device according to claim 17, characterized in that it is provided with an input/output touch screen display, USB communication port and/or Bluetooth and/or wireless communication means.

21. Device according to claim 17, characterized in that said motion sensor/detector means comprise motion detectors and activity monitors for evaluation of a plausible daily activity of the patient in any setting.

22. Device according to claim 21, characterized in that said motion sensor/detector means comprise a triaxial accelerometer for “

activity monitor”

, that is suitable to discriminate between low, moderate and high overall activity levels as well as to categorise individuals as sedentary, moderately active or active and it is also able to detect a variety of body positions and physical activities;

the output of the accelerometer being measured in the three dimensions −

X=anteroposterior, Y=vertical, Z=mediolateral vectors—

and being then integrated by the central unit (1) to represent movement as velocity over time using the square root of the sum of squares of each individual vector.

23. Device according to claim 17, characterized in that the collecting/storing information relating to the patient comprise the acquisition of physiologic measurements such as the distance walked and the reduction of the oxygen level in the blood during the exercise.

24. Device according to claim 22, characterized in that it is provided with means for measuring simultaneously the % SpO₂ (pulse oximetry) as well as the physical activity (accelerometry), wherein the central unit (1) is able to calculate a Desaturation Area/Movement index and to store and show it on a display at the end of a measurement session;

said index representing the area under the % SpO₂ curve, including the baseline value at rest of the % SpO₂ value and the graph of the % SpO₂ during exercise, for instance during the 6-minute walking test, obtained in relation to a total movement recorded in all three directions by the accelerometer activity during the test.

25. Device according to claim 17, characterized in that the central unit. (1) comprises an electrical and mechanical connection assembling system (12, 13) connecting to a removable spirometry sensor (7) for the measurement of respiratory air flow and volume thereby obtaining that when spirometry testing is not required the device is absolutely and completely operational for providing its other functions to the user.

26. Device according to claim 25, characterized in that when the spirometry sensor has been connected. to the central unit (1) through the electrical and mechanical connection assembling system. comprising an associated conjugated connector (12) with conjugate contact elements (13), spirometry tests can be carried out to determine the most important. spirometry parameters like the PEF, FEV1, FEF25%-75%, thereby obtaining that at the end of the test, the central unit (1) displays the results and compares them to the reference values which have been set by the doctor during the device setup, further providing to the patient suitable various messages about his/her state of health, when the test is finished the spirometry sensor head being removed from the central unit (1).

27. Device according to claim 17, characterized in that the central unit (1) can be placed within. a belt worn close to the body on the waist, wrist or ankle of the patient, and then a finger probe which is removably connected to the central unit (1) is worn for the pulse oximetry test, for measuring both the % SpO₂ and a Pulse Rate (PPM), thereby obtaining that the test can be carried out at rest, or during physical exercise or even overnight during sleep;

wherein at the same time as the pulse oximetry is measured and recorded, a trixdal accelerometer which is integrated into the central unit (1) , carries out the function of activity monitor as well as motion detector.

28. Device according to claim 22, characterized in that said central unit (1) comprises data processing and storing means and the triaxial accelerometer, so that when the patient walks then the number of paces can be detected and recorded as well as the physical activity in each of the three directions, while when the patient sleeps then the position. of the body can be recorded during sleep:

face up, face down, right side or left side etc., as well as the movements during the complete test per

29. Device according to claim 28, characterized in that said data processing means are suitable for linking a level of fall of the % SpO₂ or desaturation during sleep, and above all any rapid desaturation caused by sleep apnea, to a body position, even minimum periods during sleeping hours when the patient stands up or walks being furthermore identified as waking hours and thus excluded from the sleep analysis.

30. Device according to claim 17, characterized in that it comprises means for transmission of the collected data of a patient to a we server so that said data can Then be seen by a doctor and thus the doctor can vary the therapy as required very quickly indeed;

in some cases, these patients being treated with oxygen at home in order to compensate any desaturation.

31. Method of using the device according to claim 17 for the analysis of a six minute walk test (6MWT), said device being provided with means for calculating a CS index representing the quantity of oxygen expressed in L/min which must be given to the patient in order that the patient can complete the 6-minute walking test or 6MWT without desaturating below the level of 90% SpO₂, and also without desaturating below the level of 82% SpO₂ for the patients who require 6 L/min of oxygen in order to complete the test, the method being carried. out in the following clinical applications

the Calculation of the requirement of oxygen during exercise using the 6MWT for the prescription of long term oxygen therapy (LTOT);

and/or

the Calculation of the oxygen requirement using the 6MWT in the field of rehabilitation therapy; and

/or

the Calculation of the severity of a lung disease such as COPD, pulmonary fibrosis and other respiratory conditions, and for treatments of pulmonary conditions using the 6MWT for the calculation of the disease prognosis in a patient and for the evaluation of the results of a course of therapy in a patient.