Systems and methods for processing patient data during diagnosis and treatment

Abstract

A system and method for processing patient data during the diagnosis and treatment of a patient's sleep disordered breathing. The system and method includes providing diagnostic and treatment device providers with a simple and fast means to generate a clinical diagnosis from a diagnostic device and transfer the patient's records and diagnostic data to a treatment provider responsible for the patient's ongoing care. The patient can be automatically assigned a treatment device with a predetermined treatment setting based on the patient's records and diagnostic data.

Description

[Technical Field]

[0001] The techniques of this disclosure relate to the diagnosis and treatment of respiratory-related disorders. [Background technology]

[0002] The human respiratory system and its diseases The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to a patient's airways.

[0003] The airways contain a series of branching tubes that become thinner and shorter the deeper they go into the lungs. The lungs' main function is gas exchange, transferring oxygen from the air into the venous blood. The trachea divides into the left and right main bronchi, The left and right main bronchi further divide and eventually become the terminal bronchioles. The bronchi form the air-breathing airways. The airways further divide into respiratory bronchioles and finally into the lungs. The alveolar region of the lung is where gas exchange takes place and is called the respiratory region. John B. West, Lippi See ncott Williams & Wilkins, 9th edition (published 2011) I want to be done that.

[0004] There are various breathing disorders. Some examples of breathing disorders include obstructive sleep apnea (OSA). A), Cheyne-Stokes respiration (CSR), Obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease If you have pulmonary disease (COPD), neuromuscular disease (NMD), or chest wall disease.

[0005] Systems and devices can be used by otherwise healthy people to prevent respiratory problems from developing .

[0006] Diagnosis and treatment The interaction between patients and the health system generally occurs at two stages: diagnosis and treatment (also called "treatment"). It consists of two main stages or phases.

[0007] The diagnostic phase involves examining the patient and diagnosing their condition. In this case, both the provider of diagnosis and the provider of treatment are qualified to be called a physician or doctor. This may be a healthcare professional who provides the care, or a supporting professional called a clinician. Instead of administering sleep tests in a sleep lab or sleep clinic, diagnostic providers use portable, take-home Increasingly, testing devices are being used to diagnose sleep-disordered breathing in patients. Once this is done, the patient can receive the appropriate treatment.

[0008] The application of respiratory therapy defines a treatment phase, which involves managing the patient's condition and / or The C used in such treatment is The service of supplying PAP equipment and monitoring the progress of patient treatment is provided by Home Medical Equipment (HM). E) May be provided by a treatment provider such as a company. The company's treatment provider sets up the device according to the prescription instructions and puts the patient through the program. Patient adherence to current treatment and progress of the patient's treatment can be monitored. Patients with sleep apnea are diagnosed via a home sleep test by a diagnostic provider and receive treatment at home. Nasal continuous positive airway pressure (CPAP) for respiratory therapy You may be prescribed a therapy device, such as a "pressure" therapy device, which operates at a specific pressure. The patient's care provider will provide the equipment and the pressure and Other settings may be configured. Alternatively, the therapy device may be configured to use the diagnostic prescription issued by the diagnostic provider. It may also be set to automatically perform initial setup based on your settings.

[0009] Therefore, the treatment provider may be responsible for preparing the patient for treatment. This may involve selecting a treatment mask, humidifier, conduit, and other accessories. This selection may or may not be specified in the prescription issued by the diagnostic provider. Apart from the initial setup, the treatment provider also monitors treatment data from the delivery of the patient's treatment. If the patient's progress in treatment is unsatisfactory or there are other problems with treatment In this case, the treatment provider should refer the patient back to the diagnostic provider for review and modification of treatment. This may also occur.

[0010] Insurance company or other assessing or reimbursing entity's computer 103 often require proof that a diagnosis was made properly before paying for it. To determine if a patient has been properly diagnosed, the diagnostic provider may use a home sleep testing device. (also referred to herein as diagnostic equipment) A medical certificate signed by a licensed physician must be available. Companies often find that once a patient is diagnosed with a medical condition, they do not respond well to the prescribed treatment. You want to track whether the patient continues to receive treatment and whether they continue to receive that treatment. It is very difficult to track patients as they transition between diagnostic and treatment providers. This can be inefficient and time-consuming due to the need for multiple patient records (e.g., patient management at the diagnostic stage). and other records made during the treatment phase) using different software packages. Because they are created in different software environments, such migrations can be inconvenient and disruptive. Communication between these two stages currently involves paper records and / or faxes. This allows for easy communication between the patient, the diagnostic provider, and the treatment provider. This can cause inconvenience to the service provider and can also lead to errors in patient records.

[0011] system The treatment system is a Respiratory Pressure Therapy (RPT) device. , an air circuit, a humidifier, a patient interface, and data management.

[0012] Patient Interface The patient interface may, for example, provide a flow of breathable gas to the respiratory system. The flow of breathable gas is transmitted through the mask. into the nose and / or mouth, into a tube leading to the mouth, or into the user's trachea Depending on the treatment being applied, the patient interface may be: For example, a seal is formed against the patient's facial area to provide treatment, such as a positive pressure of about 10 cmH2O. It may be helpful to deliver the gas at a pressure that is sufficiently different from ambient pressure to perform the For other forms of therapy, such as delivery of oxygen, the patient interface should be approximately 10 cm It may not contain a sufficient seal to help deliver a positive pressure supply of H2O to the airways. be.

[0013] Designing a patient interface poses several challenges. The face has a complex three-dimensional shape. The size and shape of the nose varies greatly among individuals. The head is made up of bone, cartilage, and soft tissue. Various areas of the face respond differently to mechanical forces because they contain: The skull can move relative to the other bones. The entire head moves during one breathing session. There is a possibility of movement.

[0014] As a result of these challenges, some masks are intrusive, unsightly, or expensive. cost, poor fit, especially when worn for long periods of time or when the patient is not in the system It has some drawbacks, such as being difficult to use and uncomfortable for those unfamiliar with it. respirators or respirators designed as part of personal protective equipment (e.g., filter respirators) , scuba masks, and masks for administering anesthetics are not acceptable for their intended use. However, it is still not desirable to wear it for long periods of time, for example, several hours. This is even more so when wearing a mask while sleeping.

[0015] Nasal CPAP therapy is highly effective in treating certain breathing disorders, provided patients adhere to treatment. If the mask is uncomfortable or difficult to use, patients may not adhere to treatment. Patients are often advised to wash their masks regularly, so cleaning the mask is recommended. If the mask is difficult to use (e.g., difficult to assemble and disassemble), patients may not clean it. This may affect patient compliance.

[0016] Masks intended for other uses (e.g., aviator masks) are used to treat sleep-disordered breathing. masks designed for use in the treatment of sleep-disordered breathing may not be suitable for , and may be suitable for other applications.

[0017] For these reasons, masks for delivering nasal CPAP during sleep have formed a unique category. do.

[0018] Sealing forming part The patient interface may include a seal-forming portion. The seal-forming portion is in direct contact with the patient's face. Because contact with the patient is essential, the shape and contour of the seal-forming area must be carefully considered to ensure the effectiveness and comfort of the patient interface. may have a direct impact on

[0019] The patient interface is determined, in part, by the design of where the seal-forming portion engages the face during use. Some forms of patient interface may be characterized by their intended purpose. The stop-forming portion consists of two lower portions that engage with the left and right nostrils, respectively. In this type of patient interface, the seal-forming portion is a single element that surrounds both nostrils during use. Such a single element may be located, for example, above the upper lip region and the bridge of the nose region of the face. In some forms of patient interface, the seal-forming portion may be designed to: For example, the device may comprise an element that encloses the mouth area during use by forming a seal over the lower lip area of ​​the face. In some forms of patient interface, the seal-forming portions are positioned in both the nostril and mouth areas during use. These various patient interfaces include nasal masks, face masks, and face masks, nasal pillows, nasal puffs, and oral / nasal masks, etc., depending on the manufacturer. It may be known by a variety of names.

[0020] Seal-forming portions that may be effective in certain areas of the patient's face may include, for example, different areas of the patient's face. Due to different shapes, structures, variations, and irritation-responsive areas, they may not be suitable in other areas. For example, a seal on swimming goggles that covers the patient's forehead is not suitable for use on the patient's nose. There is a possibility.

[0021] Certain seal forming parts may be designed for mass production, with one design being used for a wide range of applications. The design is tailored to the shape and size of the patient's face, ensuring comfort and effectiveness. To the extent that there is a misalignment between the seal-forming portion of a mass-produced patient interface, To achieve this, either the shape of the face or the seal-forming portion, or both, must accommodate.

[0022] One type of seal-forming portion extends around the periphery of the patient interface and -When force is applied to the face, it is intended to press and seal against the user's face. The seal-forming portion faces and engages the face of the user. The molded or formed surface of a cushion or a resilient sealing element made of elastomer such as rubber This type of seal formation may cause the seal formation and the face to become inconsistent if the fit is not adequate. This creates a gap between the patient and the face, and requires additional pressure on the patient interface to achieve a seal. This kind of power will be necessary.

[0023] Another type of seal-forming part is a flap of thin material that fits around the perimeter of the mask. By incorporating a shaped seal, the mask is able to resist pressure against the user's face when positive pressure is applied inside the mask. Provides a self-sealing effect. Like the seal-forming part of the previous model, it provides a good fit between the face and the mask. If not, additional force may be required to achieve a seal, which may otherwise In addition, the shape of the seal must match the shape of the patient. Otherwise, it may wrinkle or fold during use, which could result in leakage.

[0024] Another type of seal-forming part may be a friction-fit element that is inserted into the nostril, for example. There may be cases where this is prepared.

[0025] Another form of seal-forming part may use an adhesive to achieve the seal. Some people find it inconvenient to constantly apply and remove adhesive from their face.

[0026] The technology in the seal-forming portion of some patient interfaces is ResMed Limit The following patent applications, WO1998 / 004,310 and WO2006 / 074, assigned to ,513, and WO2010 / 135,785.

[0027] One form of nasal pillow is the Adam C manufactured by Puritan Bennett. Another nasal pillow or nasal puff is found in the Puritan-Bennet U.S. Patent No. 4,782,832 (assigned to Trimble Corporation) This has been the subject of several studies (e.g., le et al.).

[0028] ResMed Limited is developing its next product, the SWIFT Nasal Pillow, which uses a nasal pillow. Masks, SWIFT II nasal pillow mask, SWIFT LT nasal pillow mask, SWIF Manufactures the T FX nasal pillow mask and the LIBERTY full face mask. The following patent applications, assigned to esMed Limited, and international patent application WO2004 / 073,778 (specifically describing aspects of the ResMed SWIFT nasal pillow), U.S. Pat. Patent Application No. 2009 / 0044808 (particularly for the ResMed SWIFT LT nasal pillow) (described in detail in connection with embodiments thereof), International Patent Application WO2005 / 063,328, and WO2006 / 130,903 (especially regarding the ResMed LIBERTY full face mask) International Patent Application WO2009 / 052,560 (in particular ResMed SWIFT FX Nasal Pillows (describes aspects of the nasal pillows mask) describes a nasal pillows mask.

[0029] Positioning and Fixation The seal-forming portion of the patient interface used in positive air pressure therapy has a corresponding The air pressure will try to break the seal. Various techniques are used to maintain a sealed relationship between the parts.

[0030] One such technique is the use of adhesives. See, e.g., U.S. Patent Application Publication No. 2010 / 004999. See issue 000534.

[0031] Another technique is to use one or more strings and fasteners. Many of them have drawbacks such as poor fit, bulkiness, discomfort, and difficulty to handle. .

[0032] Respiratory pressure therapy (RPT) equipment One of the best-known RPT devices used to treat sleep-disordered breathing is ResMed. Another example of RPT equipment is a ventilator. Ventilation, including the esMed Stellar™ series of adult and pediatric ventilators The device treats multiple diseases including but not limited to NMD, OHS, and COPD Therefore, it is possible to provide invasive and non-invasive independent ventilatory support to a wide range of patients. RPT devices are also called ventilators.

[0033] ResMed Elisee™ 150 Ventilator and ResMed VS II The I™ Ventilator is an invasive, non-invasive device suitable for adult or pediatric patients to treat multiple illnesses. These ventilators can provide both ventilatory and non-invasive support for dependent ventilation. Volumetric and barometric ventilation modes are available using a single limb or double limb circuit. Provide the

[0034] RPT equipment typically includes a pressure generator such as a motor-driven blower or compressed gas reservoir. configured to deliver a flow of air to the patient's airway. The outlet of the RPT device may be supplied by positive pressure to the patient's airway via an air circuit. It is connected to a patient interface as described above.

[0035] RPT equipment typically utilizes an inlet filter, various sensors, and a microprocessor. The blower also includes a servo-controlled motor, a volute, and an impeller. In some cases, a motor braking mechanism is implemented to regulate the blower speed. By lowering the The braking allows the blower to move in time to synchronize with the exhalation, despite its inertia. In some cases, the pressure generator can achieve a low pressure condition more quickly. Instead of controlling the pump speed, the generated air is used as a means to vary the pressure delivered to the patient. The sensor may also include a valve that allows the pressure to be vented to the atmosphere. Among other things, it measures motor speed, mass flow rate, and outlet pressure, as well as other components such as the controller. The camera may include data storage capacity and incorporate data retrieval and display capabilities. It may or may not be included.

[0036] Table of noise output levels of conventional equipment (using the test method specified in ISO3744) (Only one specimen was measured at 10 cmH2O in CPAP mode).

[0037] [Table 1]

[0038] humidifier Delivery of breathable gas streams without humidification may cause drying of the airways. Typically, medical humidifiers are used when the patient is sleeping or resting (e.g. in a hospital). to determine the humidity and / or As a result, medical humidifiers tend to be small enough to be placed next to the bed. Preferably, the solution is delivered to the patient without humidifying and / or heating the patient's environment. Preferably, the device is configured to humidify and / or heat only the flow of breathable gas. For example, systems for use in rooms (e.g. saunas, heating and cooling systems, evaporative coolers, etc.) These devices can humidify the air the patient breathes, but also humidify and / or heat the entire room. , which can cause discomfort to those in the room.

[0039] Use of a humidifier in conjunction with a ventilator or RPT device and patient interface is recommended. This produces humidified gas that minimizes drying of the nasal mucosa and increases patient airway comfort. Also, in cold climates, the entire facial area in and around the patient interface should be warmed. The breeze is more comfortable than cold air.

[0040] Respiratory humidifiers come in many forms and are standalone devices that are connected to the respiratory apparatus via an air circuit. equipment, or which is integral with or connected to an associated breathing apparatus Known passive humidifiers can also provide some relief. However, a heated humidifier is typically used to provide sufficient humidity and humidity in the air for patient comfort. Humidifiers typically contain a water reservoir with a capacity of several hundred milliliters (ml). a tank or container, a heating element to heat the water in the reservoir, and a control that can vary the degree of humidification. an intake port that receives gas from a control device, ventilator or RPT device, and and an exhaust port adapted to be connected to an air circuit delivering air to the patient interface. do.

[0041] Heated-through humidification is one of the common forms of humidification used in RPT devices. In this humidifier, the heating element is incorporated into a heating plate that is located below the water reservoir and in thermal contact with the water bath. Therefore, heat is transferred from the heating plate to the water tank mainly by conduction. The airflow from the RPT equipment passes over the heated water in the water reservoir, resulting in ResMed H4i™ and H The 5i™ Humidifier is an example of such a heated-through humidifier, and each Used in conjunction with the S8 and S9 CPAP machines.

[0042] Other humidifiers, such as bubble or diffusion humidifiers, jet humidifiers, or capillary humidifiers In bubble or diffusion humidifiers, air is passed under the surface of the water, The jet humidifier produces tiny water particles that are then blown into the air by a baffle or filter. Use a filter to remove or vaporize particles before they leave the humidifier. Capillary humidifiers use absorbent materials such as sponges or paper to absorb water through capillary action. The water-absorbing material is disposed in or near at least a portion of the airflow path to absorb water in the water-absorbing material. is evaporated and entrained in the air stream.

[0043] An alternative form of humidification is the Re humidifier, which uses CounterStream™ technology. This technology, provided by the sMed HumiCare™ D900 humidifier, The airflow is directed in a first direction over a large surface area, while the heated water is directed in a second direction. ResMed HumiCare (commercially available) delivers a large surface area in a second direction opposite to the first. The D900 Humidifier can be used with a wide range of invasive and non-invasive ventilation devices. do. Summary of the Invention

[0044] The disclosed technology is useful for diagnosing and treating patients with sleep-disordered breathing and associated respiratory insufficiency. Currently, the diagnostic and therapeutic phases of patient management are somewhat separate and inconsistent. What is needed is a system that connects diagnostic and treatment providers to the same patient database, Easily generate and manage patient diagnostic information and prescribe ventilators (referred to herein as "therapeutic devices"). It is a comprehensive electronic system that allows direct transfer of information to a network (also known as a "network").

[0045] Therefore, the disclosed technology comprehensively processes patient data during the diagnostic and treatment stages. In particular, the present invention relates to a method and system for managing the system described herein. The system generates clinical diagnoses from diagnostic devices and distributes patient records and diagnostic data to ongoing patient care. The diagnostic provider provides a simple and fast means to transfer the patient's medical records directly to the care provider responsible for the patient's care. and medical equipment providers.

[0046] According to one aspect of the present technology, a server includes a memory configured to store medical device data. The system includes a processor in communication with the memory.

[0047] The processor receives diagnostic and treatment data for a plurality of medical device users. , configured to process diagnostic report data and therapeutic device usage data. A successful data download is determined when diagnostic data received from the device is stored for a given duration. based on whether it contains clinical information and fits within acceptable clinical boundaries Adherence to treatment may be determined by the received medical device usage data and the continued use of the device. It may be based on meeting a predetermined criterion of use, such as the number of hours, or another predetermined criterion.

[0048] The processor may also receive requests for diagnostic steps from diagnostic providers or health care providers and medical Receive compliance status for one or more patients using a medical device and It is configured to transfer patient access rights from one provider to another.

[0049] In accordance with another aspect of the present technology, the medical device may be a diagnostic home sleep study device or a respiratory therapy device. It may be one of the treatment devices used (e.g., a ventilator). The memory may further be configured to store a device identifier, such as a unique ID number, The medical device data for each of the number of medical device users includes a device identifier, such as a unique device identifier. The server processor further processes the medical device usage data based on the received device identifier. The medical device may be configured to associate a medical device user with the medical device based on the

[0050] In another aspect of the present technology, the processor of the server is configured to: Medical device diagnostic data from humans is analyzed based on changes in analytical parameters determined by the user. The method is further configured to regenerate the image data.

[0051] In another aspect, a clinical diagnosis summary report can be provided, which can be used to assess the The report is in a format that allows the entity to accept it as proof of diagnosis. For example, reports may include summary statistics from diagnostic test data, physician interpretations of test results, and An electronic signature may be included as proof of inspection or approval.

[0052] In another aspect, a prescription can be provided based on a clinical diagnostic report. Providers supply the equipment, configure the equipment for treatment, and monitor the schedule for reimbursement. For example, a prescription can be prepared for a specified treatment device ( CPAP), a list of accessories (e.g., mask type), pressure settings on the device, and This document may include a medical record and electronic signature. This document is used by the treatment provider to collect and administer the listed treatment items. It can be legally supplied to patients.

[0053] In another aspect of the present technology, diagnostic and compliance displays are generated and displayed on the user's screen in a selectable manner. It is displayed as an icon.

[0054] In another aspect, a compliance report can be provided. The report can be provided by the assessing entity. The report can be in a format that is acceptable to the organization as evidence of compliance. For example, The chart may include a numerical or pictorial indication of compliance.

[0055] In another aspect of the present technology, a health care professional associated with a diagnostic provider may and one or more medical professionals from whom diagnostic information is available on the website. The device user (patient) can be selected and the user can be a qualified Select a treatment provider from a list of organizations and send the selected patient's diagnostic information to the selected organization. The user at the treatment provider may then use one or more of the transferred Notification of the availability of diagnostic information for each medical device user and the treatment of that patient Receive prescription information needed to set up your treatment.

[0056] According to another aspect, a method for processing patient data during the diagnosis and treatment of sleep disordered breathing is provided. The method may include having one or more computing devices provide electronic patient records of the patient. generating a patient record and performing one or more computer-aided diagnostic steps on the patient. storing data relating to the diagnosis in an electronic patient record by the imaging device; A number of computing devices provide access to electronic patient records to healthcare professionals involved in the diagnosis. and providing a patient with one or more computing devices during the patient's treatment. The device provides the treating healthcare professional with access to the electronic patient record; or multiple computing devices updating electronic patient records to store data related to treatment. and including the step of:

[0057] In another aspect, the method comprises the step of: Storing the port and / or prescription in an electronic patient record. Once the phase is complete, the treating medical professional will be notified and the patient's diagnostic data and and / or prescription data. settings from the electronic patient record and use them to automatically configure therapy devices for the patient. Automatic configuration can be performed via a network connection or a memory card. It also allows for the storage, processing and access of data during the diagnostic and therapeutic phases. The process is performed on a single software platform and a single physical system of servers. It can be done.

[0058] Once an electronic patient record is created, the medical professionals involved in either the diagnostic or treatment phase can be given access to electronic patient records at both the diagnostic and treatment stages. The diagnostic step may include receiving data from a diagnostic device, and the therapeutic step may include receiving data from a therapeutic device. The method may include receiving data from a medical device, the therapeutic medical device being configured to It is a ventilator for

[0059] According to another aspect, the disclosed method includes one or more computing devices: receiving medical device data of a plurality of medical device users; a computing device storing medical device data; The medical device may access the medical device data based on predetermined criteria related to the medical device identification data. determining whether to treat the data as diagnostic information or compliance information; If the medical device data is processed as diagnostic data, generating diagnostic information based on predetermined analytical criteria by the imaging device; The computing device transmits at least one of the clinical diagnostic reports to an associated treatment provider. enabling electronic transmission of the diagnostic report based on the diagnostic information; , steps and one or more computing devices associated with the diagnostic report. and transmitting the treatment settings to the selected treatment device.

[0060] According to another aspect, the step of receiving the medical device data includes uploading the medical device data to one of the medical devices. The method further includes receiving a signal indicating that data is available for download. It could be a home sleep testing device or a ventilator used for respiratory treatment.

[0061] The generated diagnostic report includes statistical displays to aid in diagnosis and is also useful for healthcare professionals. The diagnostic report can provide an area where the patient can enter their own clinical interpretation. The prescription may also include a prescription for one or more therapeutic devices and instructions for the patient to use. and one or more treatment settings. The diagnostic report for the treatment is available via a web browser. as HTML or in Portable Document Format (PDF )

[0062] The method includes the steps of assigning a treatment provider to a patient who is ready to receive treatment; forwarding the patient's diagnostic information to an assigned treatment provider; and The method may also include electronically importing the treatment settings into a treatment device used by the patient.

[0063] In another aspect, a method for providing comprehensive electronic diagnostic and treatment data for a plurality of sleep disordered breathing patients is provided. The managing device includes a memory configured to store medical data and in communication with the memory. The processor may include one or more processors. receives medical device data of multiple medical device users and corresponds the received medical device data and associate the received medical device data with the patient record associated with the device, whether the data is diagnostic or usage data. The received medical device data is determined to be diagnostic data or usage status data. and updating the patient record according to the determination of whether the data is relevant to the care delivery within the care provider's system. and receiving a request from a diagnostic provider to display the list of diagnostic providers from a plurality of medical devices. by receiving diagnostic data from the generate summary statistics from the clinical user, receive requests generated by the clinical user, and respond to those requests The system can be configured to send a diagnostic report containing summary statistics.

[0064] The processor also stores a list of medical devices and accessories and allows the clinical user to select the list. receiving a request for display of the clinical setting information generated by the clinical user; Receives text generated by clinical users and provides an inventory of selected items and clinical settings. Send prescriptions for treatment reports showing the settings and diagnosis in the patient record by the selected treatment provider Securely grant access to patient records and prescription data, and provide access to available patient lists for care providers dynamically update the patient list with at least one patient record and display the added patient record in the patient list. and, depending on the treatment provider user's selection, patient information, diagnostic reports, and treatment reports. Securely view prescriptions associated with the port and assign the patient a Therapeutic Device ID associated with that prescription. Configure the device to receive requests for prescriptions and automatically transfer clinical setting information from prescriptions to memory. It is possible.

[0065] The techniques of the present disclosure are illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings, in which like reference numerals refer to: refers to the same element. [Brief explanation of the drawings]

[0066] [Figure 1A] Treatment System: A diagram of a system according to the technology of the present disclosure. A patient 1000 wearing a patient interface 3000 in the form of nasal pillows receives a supply of air at positive pressure from an RPT device 4000. The air from the RPT device is humidified by a humidifier 5000 and passes to the patient 1000 through an air circuit 4170. [Figure 1B] This is a diagram of a system including a patient 1000 wearing a patient interface 3000 in the form of a nasal mask, who receives a supply of air at positive pressure from an RPT device 4000. The air from the RPT device is humidified by a humidifier 5000 and passes to the patient 1000 through an air circuit 4170. [Figure 1C] 1 is a diagram of a system including a patient 1000 wearing a patient interface 3000 in the form of a full face mask, the patient receiving a supply of air at positive pressure from an RPT device. The air from the RPT device is humidified by a humidifier 5000 and passes to the patient 1000 through an air circuit 4170. [Figure 2A] Treatment Respiratory System A diagram showing an overview of the human respiratory system, including the nasal and oral cavities, larynx, vocal folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm. [Figure 2B] 1 is a diagram of the human upper respiratory tract, including the nasal cavity, nasal bones, lateral nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal folds, esophagus, and trachea. [Figure 2C] Facial Anatomy: A front view of the face with several superficial anatomical features identified, including the upper lip, upper vermilion border, lower vermilion border, lower lip, mouth width, inner corners of the eyes, alae of the nose, nasolabial folds, and cheilion. [Figure 3A] <Patient Interface> FIG. 1 shows an example of a patient interface known in the prior art. [Figure 4A] Respiratory Pressure Therapy (RPT) Device FIG. 1 is a diagram of an RPT device in accordance with one aspect of the disclosed technology. [Figure 4B] 1 is a schematic diagram of a pneumatic circuit of an RPT device in accordance with one aspect of the disclosed technology, showing upstream and downstream directions. [Figure 4C] FIG. 1 is a schematic diagram of electrical components of an RPT device in accordance with one aspect of the disclosed technology. [Figure 5A] <Humidifier> FIG. 1 is a diagram of a humidifier according to one aspect of the technology of the present disclosure. [Figure 6A] <Respiration Waveform> This diagram shows a typical respiratory waveform for a sleeping person, with the horizontal axis representing time and the vertical axis representing respiratory flow. While parameter values ​​may vary, a typical breath has the following approximate values: tidal volume (Vt) 0.5 L, inspiratory time (Ti) 1.6 seconds, peak inspiratory flow (Qpeak) 0.4 L / sec, expiratory time (Te) 2.4 seconds, and peak expiratory flow (Qpeak) -0.5 L / sec. The total duration of the breath, Ttot, is approximately 4 seconds. A person typically breathes at a rate of approximately 15 breaths per minute (BPM), resulting in a ventilation volume, Vent, of approximately 7.5 L / sec. A typical duty cycle, Ti to Ttot, ratio, is approximately 40%. [Figure 7] Managing Diagnostic and Therapeutic Data FIG. 1 is a diagram of a system 100 that can be used to diagnose and treat sleep disordered breathing in a patient. [Figure 8] 1A-1C are diagrams of various web pages that can be displayed according to aspects of the disclosed system. [Figure 9] 1A-1C are diagrams of various web pages that can be displayed according to aspects of the disclosed system. [Figure 10]1A-1C are diagrams of various web pages that can be displayed according to aspects of the disclosed system. [Figure 11] 1A-1C are diagrams of various web pages that can be displayed according to aspects of the disclosed system. [Figure 12] 1A-1C are diagrams of various web pages that can be displayed according to aspects of the disclosed system. [Figure 13] 1A-1C are diagrams of various web pages that can be displayed according to aspects of the disclosed system. [Figure 14] 1A-1C are diagrams of various web pages that can be displayed according to aspects of the disclosed system. [Figure 15] 1 is a schematic diagram of an embodiment of the disclosed system and method. DETAILED DESCRIPTION OF THE INVENTION

[0067] Before describing the techniques of the present disclosure in more detail, it is important to note that the techniques are not limited to the specific examples described herein. It should be understood that the present disclosure is not limited to the above and examples may vary. The terminology used is intended only to describe the specific examples discussed herein and is not restrictive. It should also be understood that there is no limiting intent.

[0068] Treatment System In one form, the system includes a device for treating respiratory disorders. The device includes a pressurized supply of air, such as air. The breathable gas is delivered to the patient interface 3000 via an air delivery tube. It may include a ventilator or blower that supplies air to the patient 1000 .

[0069] treatment In one aspect, the disclosed technology includes a method of treating disordered breathing, the method comprising: The method includes applying positive pressure to the entrance of the airway of the patient.

[0070] Nasal CPAP for OSA In one form, the disclosed technology provides a method for providing continuous positive airway pressure (CPAP) to a patient, the method comprising: A method for treating obstructive sleep apnea in a patient is provided.

[0071] Patient Interface 3000 The non-invasive patient interface 3000 according to one aspect of the disclosed technology has the following functional states: the seal-forming structure 3100, the plenum chamber 3200, the positioning and fixing structure The structure 3300, the vent 3400, and the connection port 3600 connected to the air circuit 4170 are provided. In some cases, a function is provided by one or more physical components. In some cases, one physical component may perform one or more functions. In use, the seal-forming structure 3100 surrounds the entrance to the patient's airways. The device is positioned to accommodate the airway, thereby helping to deliver air at positive pressure to the airway.

[0072] Sealing formation structure 3100 In one form of the disclosed technology, the seal-forming structure 3100 provides a seal-forming surface and additionally It is possible to provide a conversation function.

[0073] The seal-forming structure 3100 according to the technology of the present disclosure is made of a soft, flexible and elastic material such as silicone. It can be constructed from materials with

[0074] In one form, the seal-forming structure 3100 comprises a sealing flange and a support flange. Preferably, the sealing flange extends around the outer edge 3210 of the plenum chamber 3200. A relatively thin part having a thickness of less than about 1 mm, for example, about 0.25 mm to about 0.45 mm. The support flange may be relatively thick compared to the sealing flange. The retaining flange is disposed between the sealing flange and the edge of the plenum chamber 3200. The support flange extends around at least a portion of the circumference of the portion 3210. element or includes a spring-like element to support the sealing flange in use. This prevents the sealing flange from bending. Instantaneous response to system pressure in the plenum chamber 3200 acting on the underside of the sealing flange This can encourage the lower surface into tight sealing engagement against the face.

[0075] In one form, the seal-forming portion of the non-invasive patient interface 3000 comprises a pair of nasal flaps. Each nasal puff or nasal pillow is connected to each nostril of the patient's nose. Constructed and arranged to form a seal therebetween.

[0076] A nasal pillow according to one aspect of the disclosed technology has at least a portion thereof sealed under the patient's nose. a stem portion and a flexible region on the underside of the cone connecting the cone to the stem portion. Also, the structure to which the nasal pillows of the disclosed technology are connected includes a flexible region adjacent to the base of the stem. The flexible areas act in unison to regulate the relative movement of the truncated cone and the structure to which the nasal pillows are attached. This facilitates universal joint structures that accommodate both displacement and angle. For example, a truncated cone The shank can be displaced axially towards the structure to which it is connected.

[0077] In one form, the non-invasive patient interface 3000 is positioned on the patient's face in the upper lip area during use. The seal-forming portion forms a seal in the upper lip.

[0078] In one form, the non-invasive patient interface 3000 is adapted to contact the jaw area of ​​the patient's face during use. The seal forming portion forms a seal in the area.

[0079] Plenum Chamber 3200 Preferably, the plenum chamber 3200 is configured to fit a standard human face such that a seal is formed during use. The outer edge 3210 is shaped to complement the surface contour of the area to be covered. In the embodiment, the edge of the plenum chamber 3200 is positioned in close proximity to the adjacent facial surface. The actual contact with the face is provided by the seal-forming structure 3100. Preferably, the seal-forming In use, the composite structure 3100 extends over the outer periphery 3210 of the plenum chamber 3200. It extends.

[0080] In one form, the plenum chamber 3200 is part of a nasal mask (e.g., as shown in FIG. 1B). If so, the plenum chamber 3200 may surround and / or be in communication with the patient's nares. In another embodiment, the plenum chamber 3200 may be in fluid communication with the full face mask. If part of a mask (e.g., as shown in FIG. 1C), the plenum chamber 3200 may be positioned between the patient's nose and The nozzles may surround the nostrils and mouth and / or be in fluid communication with the patient's nostrils and mouth. In yet another embodiment, when the plenum chamber 3200 is part of the nasal pillows, the plenum chamber The chamber 3200 engages and / or is in fluid communication with one or more of the patient's nostrils. It is possible.

[0081] Positioning and Fixing Structure 3300 Preferably, the seal-forming structure 3100 of the patient interface 3000 of the disclosed technology , in use, is held in a sealed position by positioning and fixing structure 3300.

[0082] RPT equipment 4000 An example of an RPT device 4000 that may be suitable for implementing aspects of the technology of this disclosure is 4100, and electrical components 4200. and programmed to implement one or more of the control methodologies or algorithms described in The RPT device can have an outer housing 4010, and the outer housing 4010 can The outer housing 4010 preferably has an upper portion 4012 and a lower portion 4013 of the outer housing 4010. 014. In an alternative embodiment, the outer housing 4010 may be formed from one or more Preferably, the RPT device 4000 includes a plurality of panels 4015. 40. In one embodiment, the pneumatic A block 4020 is supported by or formed as part of the base 4016. The RPT device 4000 may also include a handle 4018.

[0083] The air pressure path of the RPT device 4000 preferably includes an intake filter 4112, an inlet silencer 4122, a controllable pressure device 4140 (preferably a pump) capable of supplying air at positive pressure. a wind device 4142), and an outlet silencer 4124. One or more flow sensors 4 272 and pressure sensor 4274 are included in the pneumatic path.

[0084] The preferred pneumatic block 4020 is a portion of the pneumatic path located within the outer housing 4010. Includes.

[0085] The RPT device 4000 preferably includes a power source 4210, one or more input devices 422 0, central controller 4230, treatment device controller 4240 and / or the above controllers a pressure device 4140, one or more protection circuits 4250, a memory 4 260, transducer (also called sensor) 4270, data communication interface 4 280, and one or more output devices 4290. The electrical component 4200 , can be mounted on a single printed circuit board assembly (PCBA) 4202. Alternatively, the RPT device 4000 may include two or more PCBAs 4202.

[0086] The central controller 4230 of the RPT device 4000 includes one or more processors. Preferably, the system includes a pre-treatment module, a treatment engine module, a pressure control module, and and preferably a fault condition module. The central controller 423 can be programmed to execute the algorithmic modules. The invention may further be configured using one or more of the emission control methodologies described throughout this specification. The system may include an emission control module capable of configuring the system.

[0087] Mechanical and Pneumatic Components of RPT Equipment 4100 Air Filter 4110 The RPT device according to one embodiment of the technology of the present disclosure includes an air filter 4110 or a plurality of air It may include a filter 4110.

[0088] In one form, an intake filter 4112 is located at the beginning of the air pressure path, upstream of the blower 4142. See Figure 4B.

[0089] In one form, an exhaust filter 4114, for example an antibacterial filter, is provided in the pneumatic block 4020. It is located between the outlet and the patient interface 3000. See Figure 4B.

[0090] Silencer 4120 In one embodiment of the disclosed technique, the inlet side silencer 4122 is disposed above the blower 4142 of the air pressure path. See Figure 4B.

[0091] In one embodiment of the disclosed technology, the outlet side silencer 4124 is connected to the air pressure path blower 4142. It is placed between the patient interface 3000. See Figure 4B.

[0092] Pressure Device 4140 In a preferred form of the disclosed technology, the pressure device 4140 that generates the positive pressure air flow is controllable. For example, the blower may be one or more blowers housed in a volute. The blower may include a brushless DC motor 4144 with multiple impellers. For example, the supply of air at about 120 liters / minute can be adjusted to about 4 cmH2O to about 20 cmH2O. Deliver at a positive pressure in the range of 0 or up to approximately 30 cm H2O in other forms can be done.

[0093] The pressure device 4140 is under the control of the treatment device controller 4240 .

[0094] Transducer 4270 In one form of the disclosed technology, one or more transducers 4270 are connected to a pressure device 4 140. One or more transducers 4270 are located upstream of the pneumatic path. It is constructed and arranged to measure the properties of the air at that location.

[0095] In one form of the disclosed technology, one or more transducers 4270 are 4140 and upstream of the air circuit 4170. The instrument 4270 is constructed to measure the properties of the air at that point in the air pressure path. , will be placed.

[0096] In one form of the disclosed technology, one or more transducers 4270 are connected to a patient interface. The surface 3000 is placed near the surface 3000.

[0097] Check valve 4160 In one embodiment of the disclosed technology, a check valve is provided between the humidifier 5000 and the air pressure block 4020. The check valve is located between the humidifier 5000 and the motor 4144. constructed and positioned to reduce the risk of

[0098] Air Circuit 4170 The air circuit 4170 according to one aspect of the disclosed technology is configured to pneumatically supply air or breathable gas to to allow flow between block 4020 and patient interface 3000 constructed and placed.

[0099] Oxygen delivery In one form of the disclosed technology, supplemental oxygen 4180 is delivered to a point in the pneumatic pathway.

[0100] In one form of the disclosed technology, supplemental oxygen 4180 is delivered upstream of pneumatic block 4020. can be.

[0101] In one form of the disclosed technology, supplemental oxygen 4180 is delivered to the air circuit 4170.

[0102] In one form of the disclosed technology, supplemental oxygen 4180 is delivered to the patient interface 3000. will be done.

[0103] Electrical Components of RPT Equipment 4200 power supply 4210 In one form of the disclosed technology, the power supply 4210 is connected to the external housing 4010 of the RPT device 4000. In another form of the disclosed technology, the power supply 4210 is external to the RPT device 4000. It is located outside the main housing 4010.

[0104] In one form of the disclosed technology, the power supply 4210 provides power only to the RPT device 4000. In another embodiment of the disclosed technology, the power supply 4210 is connected to the RPT device 4000 and the humidifier 5000. The power supply optionally provides power for the exhaust mechanisms described throughout this specification. It may also provide power to actuators, controllers, and / or sensors for do.

[0105] Input Device 4220 In one embodiment of the technology of the present disclosure, the RPT device 4000 is a device that allows a person to interact with the device. One or more input devices 4220 in the form of buttons, switches, or dials, such as These include the input of settings for the operation of components of RPT equipment such as ventilation mechanisms. If the button, switch, or dial is a physical device, It can also be a software device that can be accessed via a touch screen. In one form, the switch or dial is physically connected to the outer housing 4010 or Alternatively, the central controller 4230 may include a receiver in electrical communication with the central controller 4230 and a wireless Communicate.

[0106] In one form, the input device 4220 allows a person to select values ​​and / or menu options. It is constructed and positioned so that

[0107] Central Controller 4230 In one embodiment of the technology of the present disclosure, the central controller 4230 receives an input from the input device 4220. Receives and outputs signals to the output device 4290 and / or the therapy device controller 4240 A dedicated electronic circuit configured to provide a signal.

[0108] In one form, the central controller 4230 is an application specific integrated circuit. The central controller 4230 is made up of several individual electronic components.

[0109] In another aspect of the disclosed technology, the central controller 4230 is an x86 INTEL processor. The processor is suitable for controlling the RPT device 4000, such as a processor.

[0110] A central controller suitable for controlling an RPT device 4000 according to another aspect of the disclosed technology is The processor in the 4230 is an ARM Cortex-M from ARM Holdings. There are processors based on ST Microelectronics processors. CS's STM32 series microcontrollers can be used.

[0111] Another embodiment of the presently disclosed technology is suitable for controlling an RPT device 4000. The processor is selected from the ARM9 family of 32-bit RISC CPUs. For example, STR9 from ST MICROELECTRONICS A series microcontroller can be used.

[0112] In a particular alternative embodiment of the disclosed technology, a 16-bit RISC CPU is integrated into the RPT device 40. 00 processor. For example, TEXAS INSTRUME Uses a processor from the MSP430 microcontroller family manufactured by NTS It is possible.

[0113] The processor may include one or more transducers 4270 and one or more It is configured to receive an input signal from an input device 4220 .

[0114] The processor includes an output device 4290, a treatment device controller 4240, a data communication interface humidifier controller 5250. is configured to provide:

[0115] Depending on the form of the technology of the present disclosure, the processor of the central controller 4230 or multiple Such a processor may store data in a non-transitory computer-readable storage medium such as memory 4260. One or more algorithms 430 represented as stored computer programs 0. In some cases, such a processor may be integrated with the RPT device 4000, as previously mentioned. However, some forms of the disclosed technology may directly control the delivery of respiratory therapy. of the RPT device 4000, such as to perform the methodologies described herein without controlling The processor may be implemented separately from the flow generating component. For example, The processor determines the control settings of the ventilator or controls the flow of the signals from the sensors, such as those described herein. For the purpose of determining other respiratory related events by analyzing stored data from Similarly, such a processor may be capable of performing the methodologies described herein. Implementing the methodology described herein for the purpose of controlling the operation of the ventilation mechanisms described herein. It is possible.

[0116] Clock 4232 Preferably, the RPT device 4000 includes a clock 4232 connected to the processor. .

[0117] Treatment Device Controller 4240 In one form of the disclosed technology, the treatment device controller 4240 is a central controller 42 The pressure control module is part of the algorithm 4300 executed by the processor 30. The code is 4330.

[0118] In one form of the disclosed technology, the therapy device controller 4240 is a dedicated motor control integrated For example, in one form, the MC33035 brushless inverter manufactured by ONSEMI A DC motor controller is used.

[0119] protection circuit 4250 Preferably, the RPT device 4000 according to the technology of the present disclosure includes one or more protection circuits 4 It has 250.

[0120] One form of the protection circuit 4250 according to the technology of the present disclosure is an electrical protection circuit.

[0121] One form of protection circuit 4250 according to the techniques of this disclosure is a temperature or pressure safety circuit.

[0122] Memory 4260 According to one aspect of the disclosed technology, the RPT device 4000 includes a memory 4260, preferably In some embodiments, memory 4260 may be static, battery-powered, or non-volatile memory. In some embodiments, the memory 4260 may include volatile RAM.

[0123] Preferably, the memory 4260 is located on the PCBA 4202. The memory 4260 is It can be in the form of EPROM, or NAND flash.

[0124] Additionally or alternatively, the RPT device 4000 may include a removable form factor. Memory 4260, manufactured according to the Secure Digital (SD) standard, for example Includes a memory card.

[0125] In one form of the disclosed technology, the memory 4260 is a non-transitory computer-readable storage medium. 4300, which may act as a Computer program instructions representing one or more methodologies to be implemented are stored.

[0126] Transducer 4270 The transducer may be internal to the device or external to the RPT device. The external transducer is located, for example, in the air delivery circuit, e.g., the patient interface. External transducers may transmit data to the RPT device. This can be in the form of a non-contact sensor such as a Doppler radar movement sensor that transmits or forwards can be done.

[0127] flow rate The flow sensor 4272 according to the disclosed technology is a differential pressure transducer, e.g., SENS It can be based on IRION's SDP600 Series differential pressure transducer. The differential pressure transducer is in fluid communication with the pneumatic circuit, and each of the pressure transducers One of them is connected to the first location and the second location of each of the flow restricting elements.

[0128] In use, a signal representing the total flow rate Qt is received by the processor from the flow sensor 4272. do.

[0129] pressure The pressure transducer 4274 according to the disclosed technology is in fluid communication with the pneumatic circuit. An example of a suitable pressure transducer is the HONEYWELL ASDX series. A suitable alternative pressure transducer is the GENERAL ELEC This is a TRIC NPA Series sensor.

[0130] In use, the signal from the pressure transducer 4274 is transmitted to the processor of the central controller. In one form, the signal from the pressure transducer 4274 is filtered. The data is then sent to the central controller 4230.

[0131] Motor Speed In one form of the disclosed technique, a motor speed signal is generated. The motor speed signal is preferably The motor speed may be determined by, for example, the Hall effect. The velocity can be generated by a velocity sensor 4276 such as a velocity sensor.

[0132] Data communication interface 4280 In a preferred embodiment of the technology of the present disclosure, a data communication interface 4280 is provided. , connected to the processor of the central controller. Preferably, it is connectable to a remote external communications network 4282. The interface 4280 is preferably connected to a local external communications network 4284. Preferably, the remote external communication network 4282 is connected to the remote external device 42 86. Preferably, the local external communication network 4284 is It can be connected to external devices 4288 of the Kal.

[0133] In one embodiment, the data communication interface 4280 is connected to the processor of the central controller 4230. In another form, data communications interface 4280 is part of a central processor. The processor is a separate integrated circuit from the controller's processor.

[0134] In one embodiment, the remote external communications network 4282 is the Internet. The communication interface 4280 is used for wired communication (for example, Ethernet or optical fiber). You can connect to the Internet using a can.

[0135] In one embodiment, the local external communication network 4284 is a Bluetooth (registered It utilizes one or more communication standards such as the IEEE 802.11b / g and consumer infrared protocols.

[0136] In one embodiment, the remote external device 4286 may be one or more computers, e.g., a network In one embodiment, the remote external device 4286 is a group of computers connected via a network. It can be a virtual computer rather than a physical computer. Such remote external devices 4286 must be accessible only by appropriately authorized personnel, such as clinicians. There are things that can be done.

[0137] Preferably, the local external device 4288 is a personal computer, a mobile phone, a tablet, or the like. Bullet or remote control device.

[0138] Output devices, including optional displays and alarms The output device 4290 according to the technology of the present disclosure is one of devices that utilizes visual, audio, and tactile senses. Visual displays can take one or more forms. Light-emitting diode (LED) displays, etc.

[0139] Display Driver 4292 The display driver 4292 generates characters and symbols to be displayed on the display 4294. , or takes images as input and converts them into commands, which are then displayed The characters, symbols, or images are displayed on the display 4294.

[0140] Display 4294 The display 4294 responds to commands received from the display driver 4292. In response to the display, the display is configured to visually display characters, symbols, or images. The Play 4294 is an 8-segment display, in which case the display driver 4 292 uses each character or symbol, such as the number "0," to represent a specific character or symbol. The 8-segment FET is then converted into eight logic signals that indicate whether each of the eight segments should be turned on or off.

[0141] Communications and Data Management Systems 7 illustrates an example system 100 in which aspects of the present disclosure can be implemented. should not be construed as limiting the scope of the disclosure or the utility of the features described therein. The system is compatible with and processes data from both diagnostic and therapeutic devices. As mentioned above, the patient's medical diagnostic equipment 101 may measure the patient's sleep-related respiratory Therapeutic device 105 may be any sleep study device used in connection with diagnosing a sleep disorder. The device may be any device used in connection with providing treatment for sleep-related breathing disorders. The isolating device 101 and the treatment device 105 each comprise an RPT device 40 as described herein. 00, a humidifier 5000, and a patient interface 3000. Upon receiving data from the medical device, the system converts the received medical device data into the corresponding patient In addition to linking records, the medical device data received can be used as diagnostic usage data. and, depending on the determination, The data can be configured to update the patient record based on one or more criteria. The identity of the data can be tied to the data itself or to the device ID on which it is received. If the medical device data is determined to be diagnostic data, the system: Processing the diagnostic data to generate a diagnostic report and / or prescription based on predetermined analytical criteria. The system may further be configured to generate a diagnostic report and / or displays the prescription to the diagnostic provider for review and provides a diagnostic report or treatment based on the diagnostic data. The system may be configured to allow electronic transfer of treatment prescriptions to treatment providers.

[0142] The system 100 collects patient health information (including demographic and medical data). ) seamlessly from diagnosis to patient treatment, directly within the same system and in a single patient record To facilitate this workflow, the system 100 provides the following: It can have functional features.

[0143] Upload and analyze treatment management data within the same software system as diagnostic data. Ability to manage both diagnostic and therapeutic management This allows a single software system to be used for all the different software. This may help avoid formatting issues when moving between applications. There is.

[0144] Ability to share patient diagnostic records with users involved in treatment management, thereby Participating users will be able to integrate patient treatment into a common patient record that includes patient diagnostic reports and prescription data. Treatment and adherence data can be directly stored.

[0145] Both diagnostic data and treatment setting information from the initial prescription data stored in the patient record the ability of treatment providers to access the records and, in turn, Automatically configure therapy devices via cable, wireless connection, or memory card It is possible.

[0146] When a patient uses the medical diagnostic device 101, the diagnostic data is stored in the storage medium 112, also called memory. The diagnostic data 111 can be recorded. The diagnostic data 111 can include the date, time, and duration of the test. , data on the patient's sleep study and recorded respiratory flow data, respiratory effort data, oxygen Physiological data obtained during the examination, such as measurement and pulse data or other clinical information The memory 112 may store information accessible to the processor. It may be of a non-transitory type that can be read using a computer-readable medium or an electronic device. Other media that store data that can be read, such as hard drives and memory cards , ROM, RAM, DVD or other optical disks, and other writable memory and read-only memory.

[0147] The server 201 includes a processor 210 and a storage device for storing data 230 and instructions 234. The memory 220 is accessible by the processor 210. 210. The processor 210 may store various information, such as a The memory 220 includes instructions 234 that are used in other ways. It can be of a non-transitory type that can store information, such as a computer-readable medium , other media for storing data that can be read using electronic devices, such as hard disks. Hard drives, memory cards, ROM, RAM, DVDs or other optical disks, and other The system and method include various writeable and read-only memories. It may include combinations of the above, whereby different parts of the instructions and data are different It is stored on any type of media.

[0148] Instructions 234 may be instructions (such as machine code) that are executed directly by the processor, or indirectly It can be a set of instructions (such as a script) that are executed. For example, the instructions The computer program may be stored as computer code on a computer-readable medium. "Instructions" and "programs" may be used interchangeably herein. It may be stored in object code form for direct processing by a processor, or may be Interpreted or pre-compiled scripts and independent source code modules It can also be stored in other computer languages, including collections of instructions, methods, The code and routines are described in more detail below. Instruction 234 is a communication mm) server 240, Easy Care Online (ECO) server 250, and and instructions to operate one or more virtual servers, such as a communication abstraction layer (CAL) server 260. It may also include ordinances.

[0149] The communication server (Comm) is responsible for communicating with the wireless therapy device and checking the device output. The main role of the communication server is to communicate with artificial intelligence via communication modules and built-in communication devices. Communicating with the ventilator, inspecting incoming wireless data, and transmitting it to the CAL server This may involve converting the wireless data into a readable format.

[0150] The CAL server is responsible for communicating with the treatment device. The main role of the CAL server is to Obtain daily summary data for active patients and obtain and change device settings and converting raw therapeutic device data into an easily processable format. It may include.

[0151] The ECO Server is responsible for the application functions within the system. The main role of the ECO Server is The division presents patient and device information within the user interface and provides patient health status information. to describe and manage the application and to run the processes associated with the application. include.

[0152] Data 230 may be retrieved, stored, or transformed by processor 210 according to instructions 234. For example, the present system and method may be modified according to any particular data structure. Data may be stored in, but not limited to, a computer register, multiple different fields and records It can be stored in a relational database, an XML document, or a flat file, which is a table with The data can also be stored in any computer-readable format. Data may include any information that helps to identify related information, such as Such information may include, for example, numbers, descriptive text, proprietary code, or other areas of the same memory. or in another memory (including other locations accessible through other network connections). This may include references to stored data or information used in functions that calculate related data. The data 230 includes a Comm database 231, a CAL database 232, and an ECO database 233, and one or more databases, including the HST database 235 These databases can store various types of data. For example, , Comm database 231, CAL database 232, and ECO database 233 may store data associated with each server, as described above. The HST database can store diagnostic data received from the diagnostic equipment 101. can be done.

[0153] The processor 210 may be any conventional processor, such as a commercially available processor. Alternatively, the processor may be a dedicated device such as an ASIC or FPGA. , assuming that the processor, memory, and other elements of server 201 are in the same block. Although functionally illustrated, those skilled in the art will appreciate that the processor and memory may in fact be multiple processors. It may consist of a processor and memory, which may or may not be housed in the same physical enclosure. It will be appreciated that this may not be the case. For example, the memory may be different from the server 201. It may be a hard drive or other storage media in a different enclosure. A reference to processors or computers that operate simultaneously and may even be co-located It may or may not include reference to a processor or computer or collection of memory. It is understood that a single processor may be used to perform the steps described herein. Instead, some components, such as the steering component and the deceleration component, each have their own It can have its own processor that only performs calculations related to its specific functions. Therefore, the server 201 may be called a "system" or an "apparatus."

[0154] Computers 102, 103, and 104 are commonly used in connection with computers. Such components may include all components that are required for the operation of the computer, including a central processing unit (CP U), data 120 and 121 and instructions 130 and 131 (e.g., web pages a web browser that displays HTML or a PDF (portable document format) reader) memory (e.g., RAM or internal hard drive) for storing the information, an electronic display 110, and and 115 (e.g., a monitor with a screen, a small LCD touch screen, or other device for displaying information) other electrical devices operable in this manner), user input 160 and 161 (e.g., mouse, keyboard, keyboard, touch screen, and / or microphone).

[0155] The memory 112 can be accessed by connecting a USB data cable to another computer. Therefore, in such a case, the diagnostic equipment 101 may be located inside the diagnostic equipment 101. The term "medical device" refers to diagnostic data collected from medical devices, such as home sleep testing devices. desktop and mobile computers that retain usage data, including This can be broadly interpreted as including personal computers such as The server 201 and the computers 101 to 104 are connected via a network 150. However, two or more devices in the system 100 may be connected to each other via separate networks, or can be connected via the Internet.

[0156] In one example, an ECO server 250 and its associated ECO database 233, C omm server 240 and its associated Comm database 231, and CAL One of the servers 260 and its associated CAL database 232 It may reside on a device located remotely from other servers. 40, Comm database 231, CAL server 260, and CAL database 2 There may be at least two such servers on one device, e.g., 32.

[0157] Exemplary Methods Patients may need to obtain a medical order from their treating physician in order to undergo testing. The patient may be referred for a sleep study, in which case the patient is provided with diagnostic information for the sleep study. Equipment 101 may be provided. Diagnostic equipment 101 is a polysomnography (PSG) data, polygraph data, oximetry data, pneumatic or inductive respiratory plethysmography data Respiratory effort data based on RIP, respiratory flow data, audio signal data, and Any one of the following types of data can be collected:

[0158] Patient records are kept at the diagnostic stage when the patient is admitted to undergo diagnostic testing. The patient record is first created by the patient's details (name, sex, age, address, Patient information, such as contact details, symptoms, treating physician, insurance provider, and type of insurance coverage or any data related to the patient's condition. The diagnostic provider's computer 104 transfers the data to the ECO database on the server 201. The computer 104 is not a personal computer, but is located in the diagnostic provider's clinic. It will be understood that this may also be the administrative computer used. The computer is responsible, at least in part, for the specific patient examination and diagnosis. The computer may be operated by a data manager at the computer's location, rather than by a diagnostic physician. For example, such a manager may be responsible for creating patient records. do.

[0159] During the actual examination, the diagnostic equipment collects diagnostic data that indicates the respiratory condition the patient may have. and patient details, including, for example, the type and model of diagnostic equipment and details of the diagnostic physician who ordered the test. Collect details and other information such as the date and time of use.

[0160] During the actual test, the diagnostic equipment stores diagnostic test data 111 in memory 112. A user of the system 100, such as a user of the provider computer 104, may use the medical diagnostic equipment 102. The memory 112 of the diagnostic provider computer can be accessed remotely. The user of the computer 104 removes the portable memory card from the device 101 and transfers the data to the computer. It can also be downloaded to the computer 104 via a USB cable. 101 to a diagnostic provider computer 104 to access the device memory 112. Then, using the web browser 131 of the diagnostic provider computer 104, , contacts server 201 and retrieves one or more of databases 231, 232, 233, and 235. One or more diagnostic data 111 may be uploaded.

[0161] The diagnostic data 111 provided from the diagnostic device 101 to the server 201 is stored in the CAL database. The CAL database 232 stores the data as it is transmitted. For example, by assigning a device ID to each diagnostic device 101, the type of patient device that has been used can be identified. The device ID can be provided to the server 201 along with the diagnostic data. The diagnostic data can be stored in a database by the server 201, uses the device ID to associate the received data with the appropriate patient diagnostic device 101. Usage data obtained from the therapy device 105 can be processed in a similar manner.

[0162] In some cases, patients must meet a set time limit to be eligible for treatment for sleep-disordered breathing. The patient must use medical diagnostic equipment for a period of time and show certain clinical symptoms. For example, Patients who are ordered to undergo a home sleep study should ask their doctor for a prescription for CPAP treatment. Use of diagnostic equipment for at least 4 hours and an Apnea-Hypopnea Index (AHI) of greater than 5 Prescription (prescription data or prescribing information and The data (also referred to as the HST database 235) can be stored in the HST database 235. This allows us to track patient compliance with the use of diagnostic devices. , which can assist doctors in making diagnoses.

[0163] Once the patient is tested, a diagnosis is issued by the diagnostic provider, which is then passed to the system 100. , and more specifically, may be based on diagnostic information generated by the testing / diagnostic device 101. Depending on the patient's diagnosis, the diagnostic provider, more specifically the diagnosing physician, may prescribe treatment. Diagnostic providers may enter their clinical interpretation of diagnostic data into the patient record. The ECO database also includes clinical trials for several therapeutic devices105. A list of options can be maintained, and the diagnosing physician can select the appropriate treatment device from among them. 105 to a patient. When assigning such a device, the ECO server 250 selects the appropriate preset from the ECO database and the diagnostic provider enters the appropriate field. and support data for patient and device types. The information can be stored in the ECO database 233 of the server 201, for example.

[0164] In some cases, compliance standards for testing are typically defined by the reimbursing agency and are used to make diagnostics. The users of the system, such as sleep specialists and clinicians (users of the diagnostic computer 104) at the facility, For example, the usage data obtained from the diagnostic equipment 101 can be set in the system 100. The study was conducted if the patient underwent at least a 4-hour test, had obstructive sleep apnea, and had an AHI of 20. indicates that the patient has had a history of CPAP therapy and may therefore be eligible for CPAP treatment. A qualified health care professional, such as a licensed healthcare professional, may use a computer 104 to access a web browser 106. 31, a prescription was written for treatment with a CPAP device at a pressure of 14 cmH2O. The diagnostic computer 104 sends the prescription data to the server 201, 201 stores prescription data in a database such as the ECO database 233. , become part of the patient's record.

[0165] The patient, who has been prescribed treatment, may communicate with the diagnostic provider, for example, by the diagnostic computer 104. Instead, the proposed system allows patients to access the treatment equipment. including usage and configuration data so that the device can be configured Provides the care provider computer 102 with access to the patient's records. For example, Patients diagnosed with sleep apnea should provide their patient information and prescription to the person providing them with a CPAP device. The system 100 must be used to transmit the data to an assigned care provider who can provide the data. and allocation of a trusted treatment provider, access to a treatment provider, and diagnosis provider to treatment delivery. Instead of creating a new patient record, this can facilitate the transfer of data to the patient. In addition, instead of transferring patient records, this system The system allows care providers to access the current patient record created and updated during the diagnostic phase. Depending on the mechanism, the care provider may have access to the entire patient record. If so, patient identification data, diagnostic data, diagnostic reports, treatment prescriptions, and initial In some cases, access to only part of the device configuration data is permitted. Access can be either open access with full functionality or restricted access only. Such limited access may include, for example, viewing and / or modifying diagnostic data. You may be able to upload or download the data, but you may not be able to change the data.

[0166] In some cases, the diagnostic provider's access rights may be changed by the treating provider. Once the records are made accessible to the treating provider, the treating provider may provide the patient with the diagnostic Depending on the organization, diagnostic providers may allow ongoing access to patient records. Even if access to all records is granted, patient data, including patient identification and diagnostic data, They may only be given access to a portion of the data and may not have access to patient treatment data. In addition, access to each data is available as open access with full functionality. , or only restricted access. Such restricted access may include, for example, Treatment data may be viewed and / or downloaded, but not modified. It may not be possible.

[0167] Therefore, once an electronic patient record is created, it is necessary to have both an electronic patient record at the diagnosis and treatment stages. Different levels of access to records may be granted to medical personnel involved in either the diagnosis or treatment phase. can be given to workers.

[0168] Healthcare professionals at the diagnostic provider's location monitor the status of the patient's diagnostic data. , contacting the server 201 via a website accessed by the diagnostic computer 104. For example, a healthcare professional can , accessing patient data via web page 800 ("dashboard") shown in FIG. 8 The web page 800 may be used to display information about an active participant currently undergoing an at-home sleep study. A list of available patients can be maintained, which indicates the status of the patient's diagnostic tests. It includes a status indicator. Different icons represent different patient statuses. For example: The bed icon means the patient is still undergoing examination. The icon changes color to indicate that the patient has progressed to the diagnostic reporting stage. Can be used to indicate whether a report has already been published or has not yet been published Similarly, the "Rx" icon indicates that the patient's diagnostic report is complete and the patient is in the prescription stage. This means that the prescription has been issued or has not yet been issued using a different color. Finally, icon 871 indicates whether the patient has been issued a "Patient Record" This can mean that the project is in the "confirmed" stage.

[0169] As shown in Figure 9, patient Noemy Harber received the examination, diagnostic report, and treatment. Icon Rx is ready to provide a diagnostic report and prescription for Noemy. The patient record is finalized as indicated by the status indicator 872. Such final confirmation is made by the patient's name and is ready for transmission. They may verify your name, phone number, and insurance provider details.

[0170] A diagnostic provider associated with the diagnostic computer 104 determines whether the patient needs to receive treatment. If the diagnosis provider determines that the diagnosis is correct, the diagnosis provider can click icon 871. Thus, when icon 871 is selected, a pop-up window 973 is displayed. Pop-up window 973 is then used to share patient information with the The diagnostic provider can then send the results to the selected treatment provider who will then provide the diagnostic results. Use the drop-down menu 974 to select a specific provider from a list of providers. To do this, the diagnosis provider computer 104 sends a message to the ECO server. and request data about the provider that is available within the provider's system. The ECO server then provides the data upon request, and the data is then transmitted to the web browser. The message is then imported into the menu 974 of the user interface 131. By clicking the send button 976, This allows healthcare professionals to immediately confirm their choices and retain ownership of patient records. Initiates a command to the ECO Server to transfer the patient to a designated care provider in the New 974. Clicking the submit button 976 transfers ownership of the patient to the treatment provider. , the patient's status in the dashboard will change to "Results Sent". Healthcare professionals can quickly and easily move their patients directly into their care provider's inbox without manually transferring paper records via fax, mail, or patient It's done.

[0171] In some cases, the ECO server 250 may be configured to operate through a web browser (e.g., the instructions 130). and, via the network 150, the patient's treatment is carried out in accordance with the prescription of the doctor who is the diagnostic provider. The therapy provider computer provides the usage and therapy configuration data necessary to configure the therapy device 105. For example, a diagnosis and treatment prescription can be automatically provided to the server 102. When created by a diagnostic provider and assigned to a treatment provider in ECO Server 2 50 to notify the treatment provider, so that the treatment provider can Immediately know that you have been transferred to a supervised care facility with the necessary care settings. The device is delivered to the patient via an internet connection. Automatically transfer directly to the therapy device 105 or transfer to the SD card or therapy device interface. It can be entered manually via the

[0172] The treatment provider will receive an email or SMS message informing the patient that they have been referred. automatically notified by the message service or through the server 201 by contacting the provider computer 102. For example, the treatment provider or The administrator at the treatment provider's office can access the above information via web page 900 shown in FIG. The patient information transferred to the web page 900 can be accessed. Name 970, referring diagnostic provider 982, contact details 983, diagnostic and prescription information 984 , insurance company data 986, approval status 987, or other relevant patient information. The treatment provider may use web page 900 to accept a patient referral. For example, a treatment provider can set the status of "accepted / rejected" to You can select patients with whom you have a referral and then designate the patient referral as either Accepted or Rejected. Once the provider accepts the requested patient, the provider computer 102 sends a message to the ECO server and adds the corresponding patient ID to the ECO database. The ECO server can then request the appropriate patient health information. Provide patient demographic and treatment setting data, and make that data available and use that data to populate the data fields required to set up a new patient's therapy device. This system can be pre-filled, so the number of patients available to the treatment provider is Dynamically update the list with new patient records and add additional records to the provider's patient list. 11 shows a web page 910 configured to initiate a display of the patient record. Here, patient Noemy Harber is given various treatment devices according to her prescription. The healthcare professional can assign the You can change the assigned equipment or identify additional therapy devices or components. and add the equipment or component to the patient list by selecting the "Add" icon 1104. can be assigned to a person.

[0173] As shown in Figure 10, details of Noemy Harber's patient record are available on the provider console. The website, telephone number, and other information are available for viewing by administrative staff using the computer 102. After contacting the patient via email, phone, or other means, the administrator will For example, an administrator can schedule a time for the system to accept a request. Click and use the dialog box 985 to assign patients to clinical users and create new New patients can be moved to the provider work queue. The provider work queue The work queue web page is shown in Figure 12 as web page 920. Adherence icon 1202 and non-adherence icon 1203 indicate whether the patient is adhering to the prescribed treatment. icon 1204. The work queue displays the date and time the compliance data was last updated. Statistics regarding time and patient therapy equipment usage can also be displayed. The 920 work queue can be securely accessed by clinicians, administrators, or both. Secure access ensures that unauthorized persons cannot access patient data. For example, the server 201 in FIG. 7 may transmit patient data using a The server 201 may request a password before transmitting the data. This may prevent unauthorized devices from viewing the data.

[0174] Health care professionals may access Noemy Harb via web page 920 shown in FIG. Assign and set the er treatment equipment, click on Noemy Harber's name, and 13, by opening the patient record shown as web page 930, the patient can be monitored for ongoing monitoring. You can also configure Noemy Harber settings by using the Patient Records on Web Page 930. As seen in the section, the patient information required to set up the patient for ongoing monitoring Patient information includes diagnostic provider information such as patient demographics, insurance information, and device treatment preferences. Patient data available from the ECO database 233 can be pre-populated. As mentioned above, a prescribed CPAP therapy device with a humidifier is automatically assigned to the patient. In this way, healthcare professionals can quickly prepare patients for treatment. This is easy to do and eliminates the need to manually re-enter patient data from paper prescriptions. It also reduces the rate of patients who do not show up to their treatment provider for treatment. Notes, prescriptions, and diagnostic reports are stored in the patient record, as shown in web page 940 of FIG. This information can be viewed in the notes section of the record.

[0175] Returning to FIG. 7, the server 201 is accessed via the care provider computer 102. The treating healthcare professional receives the diagnostic and adherence summary reports generated by the server 201. This allows the assessment entity to provide a diagnostic report and and / or compliance reports from the care provider computer 102 via the network 150. and transmitting it to an external party, such as the redeeming entity's computer 103. Diagnostic and / or compliance reports may be sent via email. This can be sent in a number of ways, including as a diagnostic The reports and compliance reports are stored on the care provider computer 102 or server 201. The assessing entity issues a diagnostic report via the reimbursing entity's computer 103. Requests for reports and / or compliance reports may be sent to either the computer 102 or the server 201. It can also be sent transparently.

[0176] Figure 15 provides a schematic representation of the above system and method. As can be seen from Figure 15, A single patient record is maintained regardless of whether the patient is in the diagnostic or treatment phase of patient management. Create it, store it on a single data platform, and use it in a single software system. The data platform can be updated and accessed using multiple It can be located on multiple remote servers or on a single physical system of servers, thereby This allows for comprehensive electronic management of data related to both the diagnostic and treatment stages. Give healthcare professionals at both the diagnostic and therapeutic management stages access to the records. Healthcare professionals can access general patient data, diagnostic data, device usage data, Related to at least one of the following: compliance data, device parameters, diagnostic reports, device prescriptions, etc. You can store and access related data, eliminating the need to create multiple records. This reduces the time and effort required to create the system and minimizes the chance of error. has the following characteristics:

[0177] The data is stored in the same software management tool as the treatment management stage data, and possibly on the same server. Download to diagnostic data and upload from diagnostic data in logical sets the ability to view and analyze data, allowing diagnostic and treatment providers to gain access to patient data. Have a single point of access and use two different data platforms, or This will improve convenience for both parties as there will be no need to have different passwords. Here, the term "data platform" refers to the hardware configuration and the software used. The redemption entity 103 service provider Providers also have access to both patient diagnostic and treatment data to determine the treatments prescribed to them. Compliance with diagnostic and treatment requirements must be evaluated. The Identity 103 also requires a single password, a single entry point, and a single password to access both types of data. Benefit from the use of a single data platform that is used to

[0178] Diagnostic data, diagnostic reports, prescription information, and therapeutic device usage and adherence data directly uploaded to the original patient record created and captured during the diagnostic data management phase. The ability to prod.

[0179] Device setting data from prescriptions issued by sleep specialists can be sent directly to the patient record Ability to re-record equipment configuration data without having to re-record it manually or re-create it electronically. This allows the data to be accessed and downloaded from the treatment provider without the need for a separate account. This contrasts with the current situation where patients must take their prescriptions to their care provider. At best, the diagnostic provider may not be able to send the prescription to the doctor by fax or other means. The prescription must be transferred to the provider, who must read the prescription and manually enter the settings into the device. In the proposed system, the diagnostic provider stores the prescription in the patient's record and the patient's record Prescriptions stored on the card are accessed directly by the provider. The settings are automatically downloaded to the card. It can be loaded or sent wirelessly to the device when it is configured.

[0180] Other notes Unless otherwise defined, all technical and scientific terms used herein are and have the same meaning as commonly understood by those skilled in the art to which this technology belongs. Methods and materials similar or equivalent to those described in the present disclosure may be used in the practice of the techniques of the present disclosure. Although a limited number of exemplary methods and tests can be used in and materials are described.

[0181] As used in this specification and the appended claims, unless the context clearly dictates otherwise Please note that the singular forms "a," "an," and "the" include their plural equivalents. sea ​​bream.

[0182] The subject headings used in the detailed description are included solely for ease of reference to the reader. and should not be used to limit the subject matter found in the entire disclosure or claims. Subject headings should not be used to interpret the scope of claims or claim limitations. should not be used.

[0183] The techniques herein have been described with reference to specific examples, but these examples are illustrative of the principles and applications of the techniques. It should be understood that in some instances the terms and symbols are merely illustrative of the present invention. The terms "first" and "second" may imply specific details that are not essential to the performance of the procedure. "Second" and "third" may be used, but unless otherwise specified, this is not intended to indicate ordering. In addition, the methodology process may be used to distinguish between separate elements. Although the steps may be described or illustrated in a certain order, such ordering is not required. Such ordering may alter and / or alter several aspects of the Those skilled in the art will recognize that the above operations may be performed simultaneously, or even synchronously.

[0184] Therefore, various modifications may be made to the exemplary embodiments without departing from the spirit and scope of the present technology. It is understood that numerous variations may be made and other configurations may be devised.

Claims

1. 1. A method for processing patient data during diagnosis and treatment of sleep disordered breathing, comprising: generating an electronic patient record for the patient by one or more computing devices; 、 During the patient diagnosis phase, the one or more computing devices storing the diagnostic data in a child patient record; The one or more computing devices provide a diagnostic provider with access to the electronic patient record. granting access rights; During the treatment of the patient, the one or more computing devices providing a provider with access to the electronic patient record; The one or more computing devices update the electronic patient record to include treatment data. Steps to include data and The method comprising:

2. The method further comprises: and storing the prescription in the electronic patient record.

3. Once the diagnostic step is complete, the method further comprises: electronically notifying the care provider of a new patient; The treatment provider has access to at least one of the patient's diagnostic data and prescription data. Steps to give to the donor The method of claim 1 or 2, further comprising:

4. Treatment settings in a treatment prescription are retrieved from the electronic patient record and used to administer the treatment for the patient.

4. The method according to claim 1, wherein the method is used for automatically configuring a medical device. 。

5. 5. The automatic configuration is performed via a network connection or a memory card. The method described below.

6. storing said electronic patient record during said diagnostic phase; and and updating the electronic patient record, performed on a single data platform.

6. The method according to any one of claims 1 to 5.

7. storing said electronic patient record during said diagnostic phase; and and updating said electronic patient record, said steps being performed on a single physical system of a server.

7. The method according to any one of claims 1 to 6.

8. Once the electronic patient record is created, the electronic patient record may be used to and (b) providing access to said electronic patient record at both the diagnosis and treatment stages to healthcare professionals who are involved in said diagnostic and treatment activities.

8. The method according to claim 1, wherein the access rights are given.

9. The diagnostic step includes receiving data from a diagnostic device, and the therapeutic step includes receiving data from a therapeutic device. receiving data from a therapeutic device, the therapeutic device being a ventilator for respiratory therapy; 9. The method according to claim 1, wherein

10. An electronic system for comprehensively managing diagnostic and treatment data for multiple sleep-disordered breathing patients. It is one or more memories configured to store an electronic patient record including patient data; 、 one or more processors in communication with the memory; It is equipped with the one or more processors: Receive diagnostic data and store it in the patient record, and store it in the electronic patient record during the diagnostic phase of patient management. Give diagnostic providers access to records, Receive and store treatment data in the electronic patient record, and administer the electronic record during the treatment phase of the patient's care. Give treating providers access to child patient records An electronic system configured to:

11. At least one of the one or more processors is and storing reports and prescriptions generated on any of the floors in the electronic patient record.

11. The electronic system of claim 10, wherein:

12. After the diagnostic stage, at least one of the one or more processors and enabling the sending of notifications to healthcare providers and the recording of said patient's diagnostic data, prescription data, and treatment. a claim configured to grant said treatment provider access to at least one of said data; Item 12. The electronic system according to item 10 or 11.

13. At least one of the one or more processors may update the electronic patient record with a prescription for treatment. and automatically configures the patient's therapy device using the therapy settings.

13. An electronic system according to any one of claims 10 to 12, comprising:

14. 10. The method of claim 1, wherein the automatic configuration is performed via a network connection or a memory card.

3. The electronic system according to claim 3.

15. The electronic system uses a single data platform for both the diagnostic and therapeutic stages. at least one of the one or more processors configured to operate on a form; configured to receive treatment data from a treatment device of the patient during the treatment phase.

15. The electronic system according to any one of claims 10 to 14.

16. The electronic system processes data from both the diagnostic and therapeutic stages.

16. The method of claim 10, further comprising one or more servers configured Electronic systems.

17. When the electronic patient record is created, at least one of the one or more processors to a provider involved in either said diagnostic step or said therapeutic step, and configured to provide access to the electronic patient record for the phase of care.

17. An electronic system according to any one of claims 1 to 16.

18. The at least one processor processes data from a diagnostic device during the diagnostic stage. , the treatment stage is configured to process data from a treatment device, the treatment device including:

18. The electronic device according to any one of claims 10 to 17, which is a ventilator used in respiratory therapy. system.

19. 1. A method for providing diagnosis and treatment of sleep disordered breathing, comprising: A system in which one or more computing devices receive medical device data for multiple patients. Tep and storing the medical device data on the one or more computing devices. Pu and, The one or more computing devices may store information related to the medical device's identification data. and processing the medical device data as diagnostic data or as therapeutic data based on predetermined criteria. determining whether to process the data as medical data; If the medical device data is determined to be diagnostic data, the one or more computers generating diagnostic information based on predetermined analytical criteria by the computing device; The one or more computing devices provide a diagnostic report to a treatment provider and and enabling electronic transfer of at least one of the diagnostic and therapeutic prescriptions. a port and / or the prescription based on the diagnostic data; the one or more computing devices transmitting the treatment settings to the treatment device. wherein the treatment setting is related to at least one of the diagnostic report and the prescription. Attached, step and The method comprising:

20. The step of receiving the medical device data includes uploading the medical device data to one of the medical devices.

20. The method of claim 19, further comprising receiving a signal that data is available.

21. The medical device is claimed to be a home sleep testing device or a ventilator used in respiratory therapy.

21. The method according to claim 19 or 20.

22. The diagnostic report generated is including summary statistics of the diagnostic data; Either the diagnostic report or the prescription is displayed to the diagnostic provider for review. Provide an area where diagnostic providers can enter their own clinical interpretation when 22. The method of any one of claims 19 to 21.

23. The diagnostic report may include one or more treatment devices and a diagnostic report to be used for each patient.

23. The method of claim 22, further comprising a treatment prescription that identifies one or more treatment settings.

24. Diagnostic reports are delivered to your web browser as HTML or as a Portable Doc 24. Any one of claims 19 to 23, displayed as PDF. The method described in paragraph .

25. enabling a treatment provider to be assigned to a patient who is ready to receive treatment; 、 Transfer the patient's diagnostic data to the assigned treatment provider or allowing access to the disconnected data; and a step of electronically loading treatment settings from said diagnostic data into a treatment device used by said patient. Top and 25. The method of any one of claims 19 to 24, comprising:

26. A device that comprehensively manages diagnostic and treatment data for multiple sleep-disordered breathing patients. There was, a memory configured to store medical data; one or more processors in communication with the memory; It is equipped with the one or more processors: receiving medical device data for multiple patients; Associating the received medical device data with a corresponding patient record; Determine whether the received medical device data is diagnostic data or usage data death, The received medical device data is diagnostic data or treatment usage data. and updating said patient record according to said determination of whether An apparatus configured to:

27. the one or more processors: storing a list of treatment providers within a treatment provider system; receiving a request from a diagnostic provider to display said list; 27. The apparatus of claim 26, configured to:

28. the one or more processors: receiving diagnostic data from the plurality of medical devices; generating summary statistics by processing the diagnostic data using a set of predetermined analytical criteria; Accomplished, receiving a request generated by a diagnostic provider; Responding to the request, transmitting a diagnostic report including the summary statistics.

28. The apparatus according to claim 26 or 27, configured to:

29. the one or more processors: Store the diagnostic report, storing a prescription including at least a selection of a therapy device and therapy device settings; storing notes generated by the diagnostic provider; Sending the diagnostic report, the prescription, and the notes to a selected care provider.

29. The apparatus of any one of claims 26 to 28, further configured to:

30. the one or more processors: providing the selected care provider with access to diagnostic and / or prescription data in the patient record; Allow access, The list of patients available to the treatment provider is updated with at least one new patient record. Dynamically updated with records, Display the new patient record in the patient list 30. The apparatus of claim 29, configured to:

31. the one or more processors: displaying patient information and prescriptions for said treatment in response to a treatment provider's selection; receiving a request to assign a treatment device ID corresponding to the prescription to a patient; Automatically transferring clinical setting information from the prescription to the memory of the treatment device.

31. Apparatus according to any one of claims 26 to 30, configured to:

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