Patient device and update method thereof
The patient interface with a flexible seal-forming structure and RPT device enhance fit and comfort, addressing compliance issues in nasal CPAP therapy by reducing leaks and improving therapeutic efficacy for respiratory disorders.
Patent Information
- Application Number
- JP2024101072
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2014-05-27
- Filing Date
- 2024-06-24
- Publication Date
- 2025-10-02
- Estimated Expiration
- 2035-05-27
AI Technical Summary
Existing respiratory devices, particularly patient interfaces for nasal CPAP therapy, face challenges such as poor fit, discomfort, and difficulty in use, leading to non-compliance due to aesthetic concerns, complexity in cleaning, and mismatch between the seal-forming part and the user's face, resulting in leaks and increased force requirements for sealing.
A patient interface with a soft, flexible seal-forming structure and a plenum chamber designed to complement the face's contours, combined with a positioning and stabilizing structure, along with an RPT device featuring a blower, sensors, and a central controller, enhances fit and comfort, reducing leaks and improving user compliance.
The improved patient interface and RPT device provide a more comfortable and effective treatment by minimizing leaks and enhancing user compliance, thus improving therapeutic outcomes for respiratory disorders like OSA.
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Abstract
Description
[Technical Field]
[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application is incorporated herein by reference in its entirety. This application claims the benefit of US Provisional Patent Application No. 2001 / 01999, the entire disclosure of which is incorporated herein by reference. do.
[0002] The technology is intended to provide one or more of the following: detection, diagnosis, treatment, prevention, and amelioration of respiratory-related diseases. In particular, the present technology relates to medical devices or instruments, their use and updates. do. [Background technology]
[0003] 1.2(2) Description of Related Art 1.2.1 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.
[0004] The airways contain a series of branching tubes that become narrower, shorter, and more numerous as they go deeper into the lungs. The lungs' primary function is gas exchange, where oxygen enters the venous blood from the air and carbon dioxide is transported The trachea divides into the left and right main bronchi, which then branch further and finally into the terminal bronchioles The bronchi constitute the conducting airways and are not involved in gas exchange. These become the bronchi and finally the alveoli. The alveolar regions of the lungs where gas exchange occurs are called respiratory zones. "Respiratory Physiology" by John B. West, Lippincott Will See iams & Wilkins, 9th edition, 2011.
[0005] There is a range of respiratory disorders. Some examples of respiratory disorders include obstructive sleep apnea (OSA). SA), Cheyne-Stokes respiration (CSR), Obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease These include chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD) or chest wall disease.
[0006] On the other hand, healthy individuals can take advantage of the system and devices to prevent the onset of respiratory diseases. It is possible.
[0007] 1.2.2 Treatment Nasal continuous positive airway pressure (CPAP) therapy is used to treat obstructive sleep apnea (OSA). This hypothesis is that continuous positive airway pressure acts as a pneumatic splint, pushing the soft palate and tongue forward. The idea is that by pushing it away from the posterior oropharyngeal wall, it will prevent obstruction of the upper airway.
[0008] Non-invasive ventilation (NIV) is a method of ventilation that allows patients to breathe adequately and / or receive adequate oxygen levels. It performs some or all of the work of breathing to help keep the airway open and to help keep the airway Ventilation support is provided to the patient via the patient interface. IV has been used to treat CSR, OHS, COPD, MD and chest wall disease.
[0009] Invasive ventilation (IV) provides ventilatory support to patients who can no longer breathe effectively on their own. Provided using a tracheostomy tube.
[0010] Ventilators can control the timing and pressure of breaths delivered to a patient and can also control the breathing that the patient takes. Patient control and monitoring methods are typically volume-controlled and pressure-cycled. Volume-controlled methods include, among others, pressure-regulated volume control (PRVC), volume ventilation (VV) and volume-controlled continuous mandatory ventilation (VC-CMV) techniques. AC, synchronized intermittent mandatory ventilation (SIMV), controlled mechanical ventilation (CMV), pressure-support ventilation ( PSV), continuous positive airway pressure (CPAP) or positive end-expiratory pressure (PEEP).
[0011] 1.2.3 System The therapy system consists of a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, and a patient interface. Includes interface and data management.
[0012] 1.2.4 Patient Interface The patient interface may interact with the respiratory device, for example, by providing a flow of breathable gas. can be used to connect the device to its user. The flow of breathable gas is delivered to the nose and / or is delivered via a mouth-to-mouth mask, a mouth-to-mouth tube, or a tracheostomy tube into the patient's trachea Depending on the treatment being applied, the patient interface may be sealed with, for example, the patient's face. The pressure may be sufficiently different from ambient pressure to provide therapeutic benefit, e.g. For example, the gas is delivered at a positive pressure of approximately 10 cmH2O relative to ambient pressure. Other forms of treatment facilitate the delivery of gas to the airways at a positive pressure of approximately 10 cm H2O. The patient interface does not need to include a seal sufficient for
[0013] Designing a patient interface poses many challenges. The face has a complex three-dimensional shape. The size and shape of the nose varies considerably between individuals. The head is made up of bones, cartilage, and soft tissue. Different regions of the face respond differently to mechanical forces. The jaw or mandible is located in the skull as well. The entire head may move during breathing treatment.
[0014] These challenges can lead to some masks being overly noticeable, aesthetically unpleasing, or conspicuous. High cost, poor fit, difficulty to use, and discomfort, especially with prolonged wear or suffer from one or more of the following problems: For example, masks designed specifically for aviators, or as part of personal protective equipment. masks (e.g., filter masks), SCUBA masks, or masks used for administering anesthetic agents Although the masks are suitable for their intended use, they are not recommended for long-term wear, e.g., several hours. This can be extremely uncomfortable, especially if you have to wear a mask while sleeping.
[0015] Nasal CPAP therapy is particularly effective in treating certain respiratory conditions, provided the patient complies with the treatment. If the mask is uncomfortable or difficult to use, the patient may not comply with treatment. Difficulty cleaning masks, as it is often recommended to clean one's mask regularly If the mask is difficult to assemble or disassemble (e.g., difficult to assemble or disassemble), patients may not clean their masks. This affects patient compliance.
[0016] Masks for other applications (e.g., aviators) are not appropriate for use in sleep-disordered breathing. Although masks designed for use with sleep-disordered breathing may not be suitable for other applications, It may be suitable for.
[0017] For these reasons, the patient interface for delivery of nasal CPAP during sleep is unique. It is a field.
[0018] 1.2.4.1 Seal forming part The patient interface includes a seal-forming portion that is in direct contact with the patient's face. The shape and configuration of the forming part of the suction cup directly impacts the effectiveness and comfort of the patient interface. There is.
[0019] The patient interface is designed with a focus on where the seal-forming part will come into contact with the face during use. In one form of patient interface, a sealing type The component can have two sub-sections, one for the left and one for the right nostril. In one form of the interface, the seal-forming portion is a single element that surrounds both nostrils during use. Such a single element may, for example, cover the upper lip area and the bridge of the nose area of the face. In one form of patient interface, the seal-forming portion may be designed as, for example It consists of elements that surround the mouth area during use, for example forming a seal over the lower lip area of the face. In one form of patient interface, the seal-forming portion may be in contact with both nostrils in use. These different types of patient interfaces may consist of a single element surrounding the mouth area. Masks are known by various names given by their manufacturers, including nasal masks, full face masks, These include nasal pillows, nasal sprays and mouth-nose masks.
[0020] The formation of an effective seal on an area of a patient's face depends on the shape, structure, and variability of the patient's face. may not be suitable for other areas due to different body temperatures and sensitivities, e.g., the patient's forehead It is not suitable for use with goggle seals covering the patient's nose.
[0021] One design is comfortable and effective for a variety of different face shapes and sizes Some seal-forming features can be designed for mass production, such as: Until there is a mismatch between the seal-forming part of the patient interface and the mass-produced patient interface, Or both must fit together to form a seal.
[0022] One type of seal-forming portion extends around the periphery of the patient interface and provides a seal-forming The patient interface is configured to engage the patient's face when a force is applied to the patient interface. The seal-forming portion is intended to seal against the face of the a cushion or a resilient sealing element made of an elastomer such as rubber This type of seal formation requires proper fit and may include a molded or formed surface. If not, there will be a gap between the seal-forming part and the face, and the part will have to work against the face to form a seal. This requires additional force to be applied to the patient interface.
[0023] Another type of seal-forming element is a thin piece of material located near the periphery of the mask. Contains a wrap seal that self-seals against the patient's face when positive pressure is applied inside the mask Unlike previous types of seal-forming parts, the fit between the face and the mask is not as good. If the mask is too tight, additional force is required to form a seal or the mask may leak. If the shape of the seal-forming area does not match that of the patient, wrinkles or creases may occur during use. This can cause leakage.
[0024] Another type of seal-forming part is a sliding element, e.g., a nostril insert. may include:
[0025] Another form of seal-forming part uses adhesive to achieve the seal. Some patients find it inconvenient to constantly apply and remove it.
[0026] The following patent applications, assigned to ResMed Limited, cover various patient interface technologies: The face seal forming technique is disclosed in WO1998 / 004,310, WO 2006 / 074,513, WO2010 / 135,785.
[0027] One type of nasal pillow is the Adam Circuit, manufactured by Puritan Bennett. Another nasal pillow or spray is the Puritan-Bennett Cor Title of U.S. Patent 4,782,832 (Trimble et al.) assigned to the corporation is.
[0028] ResMed Limited manufactured the following products incorporating nasal pillows: SWIF T nasal pillow mask, SWIFT II nasal pillow mask, SWIFT LT nasal pillow mask, SWIFT FX Nasal Pillow Mask and LIBERTY Full Face Mask. Sold to RedMed Nasal pillow masks are described in the following patent applications: International Patent Application WO2004 / 073, 778 (depicting, among other things, the features of the RedMed SWIFT Nasal Pillow), U.S. Patent Application 2009 / 0044808 (describes, among other things, the features of the RedMed SWIFT LT nasal pillow), International Patent applications WO2005 / 063,328 and WO2006 / 130,903 (in particular Re International patent application WO20 (describes the features of the sMed LIBERTY full face mask) 09 / 052,560 (listing, among other things, the features of the ResMed SWIFT FX nasal pillow).
[0029] 1.2.4.2 Positioning and stabilization The seal-forming part of the patient interface used in positive air therapy is The seal is thus positioned and subjected to the corresponding force of the air pressure. Various techniques have been used to maintain proper facial placement and sealing relationship.
[0030] One technique involves the use of adhesives, see, for example, U.S. Patent Publication US2010 / 0000534 See.
[0031] Another technique involves the use of one or more straps and a stabilizing harness. Many such harnesses suffer from one or more of the following problems: ill-fitting, bulky, uncomfortable, and awkward to use. I am troubled by the problem of ``chi-nai'' (not enough).
[0032] 1.2.5 Respiratory Pressure Therapy (RPT) Devices One known RPT used to treat sleep-disordered breathing is the S9, manufactured by ResMed. Another example of an RPT device is the Sleep Therapy System. ResMed Stellar adult and pediatric ventilators TM S Ventilators like Leeds are suitable for (but not limited to) NMD, OHS and COPD Invasive and non-invasive treatments for a variety of patients treating many diseases such as The RPT device is also known as a flow generator.
[0033] ResMed Elisee™ 150 Ventilator and ResMed VS III (TM) ventilators are a range of invasive and non-invasive devices suitable for treating a number of conditions in adult and pediatric patients. These ventilators can be single or dual limb circuits. It offers both channeled volumetric and pressure ventilation modes.
[0034] RPT devices typically use a pressure source such as a motor-driven blower or compressed gas reservoir. a generator configured to deliver a flow of air to the patient's airway. The outlet of the RPT device allows the air circuit to be connected to the patient's airway at a positive pressure. The patient interface is connected via the
[0035] RPT devices typically consist of an inlet filter, various sensors, and a microprocessor. The blower is a servo-controlled motor, volute, and and impeller. In some cases, a brake for the motor is incorporated to This overcomes the inertia of the rotor and impeller, allowing the blower speed to be reduced more quickly. This allows the blower to achieve low pressure more quickly in time, allowing the blower to blow air despite inertia. In some cases, the pressure generator may be used as an alternative to controlling the motor speed. It includes a valve that can discharge the generated air into the atmosphere as a means for changing the pressure discharged to the patient. Sensors include motor speed, mass flow and pressure transducers, among others. Measures outlet pressure. Controllers are available with or without integrated data retrieval and display capabilities. It may include unused data storage capacity.
[0036] [Table 1]
[0037] 1.2.6 Humidifier Delivery of a breathable gas flow without humidification may dry out the airways. The humidifier adjusts the humidity and / or temperature of the breathable gas stream relative to the ambient air, depending on the requirements. It is typically used to raise patients while they sleep or rest (e.g., in hospitals). As a result, medical humidifiers are preferably small enough to be placed next to the bed, and the patient Only the flow of breathable gas delivered to the patient without humidifying and / or heating the surrounding area can be configured to humidify and / or heat the air, e.g., a room-based system Other devices (e.g., saunas, air conditioners, evaporative coolers) can also humidify the air breathed by the patient, but these These systems tend to humidify and / or heat the entire room, causing discomfort to the occupants. Sometimes it happens.
[0038] Using a humidifier with a flow generator or RPT device and patient interface can Humidified gas is produced, which minimizes drying of the nasal mucosa and increases patient airway comfort. Additionally, in cooler climates, warm air may be blown into the interface onto the patient's face and surrounding area. When it hits a wider area, it is much more comfortable than cold air.
[0039] There are various types of respiratory humidifiers, including stand-alone types connected to the respiratory device via an air circuit. Some are designed to be incorporated into or connected to an associated breathing apparatus. Dynamic humidifiers can provide some relief, but heated humidifiers generally do not provide sufficient ventilation for patient comfort. Humidifiers typically have a capacity of several hundred milliliters (ml). a water reservoir or tub for heating the water in the reservoir; a heating element for heating the water in the reservoir; A gas receiving device that can change the level of gas from a flow generator or RPT device. The gas inlet and the humidified gas can be connected to the air circuit that delivers the gas to the patient interface. and a gas outlet adapted to
[0040] Heated pass-over humidification is a common form of humidification used in RPT devices. In such humidifiers, the heating element is located below the water tab and is in thermal contact with the water tab. In this way, heat is transferred primarily by conduction. The airflow from the RPT device is transmitted from the heater plate to the water reservoir. The heated water in the tube passes through the tube, resulting in water vapor being carried away by the air flow. The H4i™ and H5i™ humidifiers are examples of such heated pass-over humidifiers. and are used in conjunction with the RsdMed S8 and S9 CPAP devices, respectively.
[0041] Other humidifiers, such as bubble or diffusion humidifiers, jet humidifiers or wicking humidifiers In bubble or diffusion humidifiers, air passes under the water surface and bubbles up to the surface. Jet humidifiers produce an aerosol of water, which is filtered out of particles before it leaves the humidifier. Use baffles or filters to allow air to evaporate. Use absorbent materials such as sponges or paper to absorb water through capillary action The water absorbent material is positioned in the air flow path or in the evaporative zone so that evaporation within the absorbent material is carried away by the air flow. Place it adjacent to at least a portion of it.
[0042] An alternative form of humidification is provided by the ResMed HumiCare™ D900 Humidifier. This humidifier uses CounterStream™ technology to to a large surface area in a first direction, while heated water is supplied to a large surface area in a second direction. ResMed HumiCare™ D900 is designed for a variety of invasive and non-invasive procedures. It can be used with a standard ventilator. Summary of the Invention
[0043] Aspects of the present disclosure include a computer-implemented method for updating a patient device over a network. The method provides a method for configuring a plurality of patient devices. and accessing configuration data for the plurality of patient devices. The method also includes selecting one of the plurality of patient devices, each of which implements a set of instructions. One or more devices with configuration data that meets one or more criteria Identifying the patient device and, if more than one update is provided, The patient device currently installed on the patient device is configured with the following parameters: and (b) providing the instruction changes to the one or more patient devices indicating that the patient device has not been updated. and selecting a new one for the one or more patient devices. transmitting the command update and each of the one or more patient devices successfully and determining whether the computer has installed the instruction update. The configuration data is used to determine whether the one or more instructions successfully installed the update. The patient device information may be updated for each of one or more patient devices.
[0044] In another aspect, the instruction update may include at least one of the following: Data specifying the location of an instruction update file; and to which components of the device the update is to be applied. instructions on when to apply the update to each device; a scheduled time for each device to apply the update; If applicable, the patient's treatment will be stopped. Instructs you not to apply the update until it has been applied; allows you to cancel updates that have not yet occurred data structures and functionality; batch capabilities to request large numbers of updates in a single operation; and Checking the status of these updates in a single operation that indicates the status of said updates ability.
[0045] The one or more criteria and command update selection may be performed by a remote computing device (e.g., a remote computer). computing device), e.g., a clinician's or service personnel's computer, Further, the step of selecting an instruction update may be based on one or more of the transmissions. may be based on received input from a user of a remote computing device, the received input comprising a plurality of The instruction update includes transmitting verification data. wherein the verification data is used by the patient device to verify the received instruction update. In this case, the expression "completed" means that the update is It also means that the instruction update indicates that the The instruction update may be retransmitted to each device that was determined not to have been successfully installed. This can be done.
[0046] According to yet another aspect, a patient device includes: An indication is sent to the computing device indicating that the instruction set has been successfully installed. a message is sent to said one or more patient devices, Identifying that the instruction update was successfully installed. The patient data includes at least one of the following: a) a serial number; b) the patient device c) the version of the instruction set currently installed on the d) the area in which the patient device is being used; and e) the area in which the patient device has previously been used successfully. A record of said instruction updates that have or have not been applied.
[0047] According to yet another aspect, the plurality of patient devices are respiratory pressure therapy devices. The configuration data may include at least one of the following: a) a serial number; and b) a set of instructions currently installed on the patient device. c) a version of the hardware. In addition, the instruction update includes updating the first part and and a second part, wherein the first component of the patient device includes the instruction update. and a second component operates according to the first part of the instruction update. It operates according to the part.
[0048] In another aspect, a method of updating a device that provides medical care includes updating a patient device for operation. accessing a first instruction set using the first instruction set; and performing a first operation according to the first instruction set. and receiving update data from a remote computing device over a network. updating the first instruction set according to the update data to generate the updated instructions; generating a set of instructions and verifying that the first instruction set has been updated; transmitting the updated instruction set to a computing device; and performing a second set of operations in accordance with the updated instruction set. and applying.
[0049] The method includes receiving verification data and verifying that the received update data is complete. If the received update data is determined to be incomplete, The patient device transmits an error notification to the remote computing device and receives a second transmission of update data. It is possible.
[0050] The present technology is illustrated by way of example and not by way of limitation in the accompanying figures, in which: The same reference numbers refer to the same elements. [Brief explanation of the drawings]
[0051] [Figure 1a] 3.1 Treatment System: A diagram showing a system in accordance with the present technology. 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 in a humidifier 5000 and supplied to the patient 1000 through an air circuit 4170. [Figure 1b] The figure shows a system including a patient 1000 wearing a patient interface 3000 in the form of a nasal mask and receiving a supply of air at positive pressure from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 through an air circuit 4170. [Figure 1c] 1 shows a system including a patient 1000 wearing a patient interface 3000 in the form of a full face mask and receiving a supply of air under positive pressure from an RPT device. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 through an air circuit 4170. [Figure 2a] 3.2 Treatment 3.2.1 Respiratory System An overview of the human respiratory system including the nasal and oral cavities, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm. [Figure 2b] FIG. 1 shows an overview 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] 3.2.2 Facial Anatomy A front view of the face showing some features of the superficial anatomy, identifying the upper lip, upper vermilion, lower vermilion, lower lip, mouth width, endocanthion, alae of the nose, nasolabial folds, and cheilion. [Figure 3a] 3.3 Patient Interface: FIG. 1 shows an example of a patient interface known in the prior art. [Figure 4a] 3.4 Respiratory Pressure Therapy (RPT) Device FIG. 1 shows an RPT device in accordance with one form of the present technology. [Figure 4b] FIG. 1 is a schematic diagram of the air circuit of an RPT device in accordance with one form of the present technology, with superior and inferior directions indicated. [Figure 4c] FIG. 1 is a schematic diagram of electrical components of an RPT device in accordance with one form of the present technology. [Figure 5a] 3.5 Humidifier A diagram showing a humidifier according to one aspect of the present technology. [Figure 6a] [3.6 Respiratory Waveform] This figure shows a model of a typical respiratory waveform during human sleep. The horizontal axis represents time, and the vertical axis represents respiratory flow. As parameter values vary, a typical breath exhibits the following approximate values: tidal volume, Vt, 0.5 L; inhalation time, Ti, 1.6 s; peak inspiratory flow, Qpeak, 0.4 L / s; exhalation time, Te, 2.4 s; peak expiratory flow, Qpeak, -0.5 L / s. The total duration of a breath, Ttot, is approximately 4 s. A human typically breathes at a rate of approximately 15 breaths per minute (BPM) using a ventilator device. Vent is approximately 7.5 L / s. A typical duty cycle, Ti to Ttot, is approximately 40%. [Figure 7] 3.7 Data Management System An example communication system 700 used for collecting and transmitting patient data is shown. Each of the patient devices 720, 730 and 740 includes an RPT 4000, a humidifier 5000 and a patient interface 3000. [Figure 8] FIG. 10 illustrates a flowchart of operations performed by a patient device as disclosed herein with respect to an update instruction set implemented by the patient device. [Figure 9] FIG. 9 illustrates a flowchart 900 of operations that may be performed on a computing device, such as a server, disclosed herein. DETAILED DESCRIPTION OF THE INVENTION
[0052] Before describing the present technology in more detail, it is to be understood that the present technology is not limited to the variations described herein. It should be understood that no limitation is intended to the specific embodiments. The term "particular embodiment" is intended to describe only the particular embodiments discussed herein and is not intended to be limiting. It should be understood that there are no diagrams.
[0053] 4.1 Treatment System In one form, the technology includes a device for treating respiratory disorders. The device is configured to The patient interface 3000 is connected to a discharge tube that delivers pressurized breathable gas to the patient. The patient 1000 includes a flow generator or blower that supplies air to the patient 1000 via the air.
[0054] 4.2 Treatment In one form, the technique includes applying positive pressure to the airway entrance of the patient 1000. The present invention includes methods for treating respiratory disorders, including:
[0055] 4.2.1 Nasal CPAP for OSA In one form, the technology reduces obstructive airway pressure by applying nasal continuous positive airway pressure to the patient. This includes methods of treating obstructive sleep apnea (OSA).
[0056] 4.3 Patient Interface 3000 A non-invasive patient interface 3000 in accordance with one form of the present technology has the following functional aspects: Seal-forming structure 3100, plenum chamber 3200, positioning and stabilizing structure 33 00, vent 3400 and connection port 3600 for connection to air circuit 4170. In some forms, the functional aspects are provided by one or more physical components. In some embodiments, one physical component may be one or more During use, the seal-forming structure 3100 surrounds the airway entrance. It is positioned to supply air to the airway at positive pressure.
[0057] 4.3.1 Seal-forming structure 3100 In one form of the present technology, a seal-forming structure 3100 provides a seal-forming surface and It can provide a conversation function.
[0058] The seal-forming structure 3100 made by this technology is soft, flexible and elastic like silicone. It can be constructed with any material.
[0059] In one form, the seal-forming structure 3100 comprises a sealing flange and a support flange. Preferably, the sealing flange has a thickness of, for example, about 0.25 mm to about 0.4 mm. 5 mm, extending around the perimeter 3210 of the plenum chamber 3200 by approximately 1 mm. The support flange may be relatively thicker than the sealing flange. The flange is positioned between the sealing flange and the peripheral edge of the plenum chamber 3200. and extends around at least the periphery 3210. The support flange is a spring-like element. or includes a sealing flange that assists in flexing during use. The sealing flange responds immediately to the system pressure in the plenum chamber 3200. and acts on its underside to encourage a firm sealing engagement with the face.
[0060] In one form, the seal forming portion of the non-invasive patient interface 3000 comprises a pair of nasal nozzles. a nasal spray or nasal pillow, each nasal spray or nasal pillow sealing with each nostril of the patient's nose; The substrate is constructed and arranged to form a
[0061] Nasal pillows according to aspects of the present technology include: at least a portion of which seals under the patient's nose; a truncated cone forming a leg; a flexible area on the underside of the cone connecting the leg to the cone. The structure to which the surgical nasal pillows are attached includes a flexible region adjacent to the base of the leg. This creates a universal joint that can accommodate both the displacement and angular displacement of the structure where the truncated cone and nasal pillow are connected. For example, a truncated cone can be displaced axially towards the structure to which the legs are connected.
[0062] In one form, the non-invasive patient interface 3000 is positioned on the lip area of the patient's face during use. (i.e., upper lip)
[0063] In one form, the non-invasive patient interface 3000 is attached to the jaw area of the patient's face during use. The seal forming portion forms a seal in the area.
[0064] 4.3.2 Plenum Chamber 3200 Preferably, the plenum chamber 3200 is in the region where a seal is formed during use. It has a periphery 3210 shaped to complement the surface contours of an average human face. The peripheral edge of the plenum chamber 3200 is placed close to the adjacent surface of the face. Actual contact with the face is provided by seal-forming structure 3100. Preferably, the seal-forming The structural structure 3100 extends around the entire periphery 3210 of the plenum chamber 3200 during use. do.
[0065] In one form, the plenum chamber 3200 surrounds the patient's nares and / or In fluid communication therewith, the plenum chamber 3200 (e.g., as shown in FIG. 1b) In another form, the plenum chamber 3200 is part of the nasal mask. The pleural cavity surrounds and / or is in fluid communication with the patient's nostrils and mouth, where The air chamber 3200 is part of a full-face mask (e.g., as shown in Figure 1c). In yet another embodiment, the plenum chamber 3200 is positioned over one or more nostrils of the patient. 3200 is in engagement with and / or fluid communication with the aperture, where the plenum chamber 3200 is For example, as shown in Figure 29, it is part of the nasal pillow.
[0066] 4.3.3 Positioning and Stabilizing Structures 3300 Preferably, the seal-forming structure 3100 of the patient interface 3000 of the present technology is The inside is held in a sealing position by a positioning and stabilizing structure 3300 .
[0067] 4.4 RPT device 4000 An example RPT device 4000 suitable for implementing features of the present technology includes mechanical and pneumatic 4100 and electrical component 4200, The control methodology or algorithm described in the The RPT device preferably comprises an upper portion 4012 of the outer housing 4010 and an outer housing The outer housing 4010 is formed in two parts, one at the bottom 4014 of the housing 4010. In an alternative embodiment, the outer housing 4010 may be made up of one or more panels 4015. Preferably, the RPT device 4000 includes one or more It includes a chassis 4016 that supports the internal components. The rack 4020 is supported by or forms part of the chassis 4016. The T-device 4000 may include a handle 4018 .
[0068] The air passage of the RPT device 4000 preferably includes an inlet air filter 4112, an inlet muffler 4122, a pressure controllable (preferably by a blower 4142) that can supply positive pressure air The air passage includes one or more pressure A transducer 4272 and a flow sensor 4274 are included.
[0069] The preferred air block 4020 is a portion of the air passage located within the outer housing 4010. Includes.
[0070] The RPT device 4000 preferably includes a power supply 4210, one or more input devices 422 0, central controller 4230, therapy device controller 4240 and / or earlier Any controller described in , pressure device 4140, one or more protection circuits 4250, a converter 4270, a data communication interface 4280 and one or more The electrical component 4200 is a single printed circuit board. Alternatively, the RPT device 40 00 can contain one or more PCBAs 4202.
[0071] The central computer of the RPT device 4000, which may contain one or more processors. The controller 4230 is configured to execute one or more algorithm modules. Preferably, the pre-treatment module, treatment engine module, pressure control The controller may include a fault condition module and more preferably a fault condition module. The controller incorporates one or more of the vent control methodologies described throughout this specification. The system may further include a vent control module.
[0072] 4.4.1 RPT Device Mechanical and Pneumatic Components 4100 4.4.1.1 Air Filter(s) 4110 An RPT device in accordance with one form of the present technology may include an air filter 4110 or multiple filters. 4110.
[0073] In one form, the inlet air filter 4112 is connected to an air blower 4142. It is located at the beginning of the air passage upstream of the vent, see Figure 4b.
[0074] In one form, the outlet air filter 4114, e.g., an antibacterial filter, is It is located between the outlet of the air block 4020 and the patient interface 3000. reference.
[0075] 4.4.1.2 Mufflers (multiple) 4120 In one form of the present technology, an inlet muffler 4122 is located in the air path upstream of a blower 4142. See Figure 4b.
[0076] In one form of the present technology, the outlet muffler 4124 is connected to the blower 4142 and the patient interface. It is located in the air passage between the nozzles 3000. See Figure 4b.
[0077] 4.4.1.3 Pressure Device 4140 In one form of the present technology, a pressure device 4140 that generates a positive pressure air flow is controllable. A blower 4142 may be, for example, one or more fans housed in a volute. The blower preferably includes a brushless DC motor 4144 having an impeller. Positive pressure air of approximately 120 liters / min is delivered in the range of approximately 4cmH2O to approximately 20cmH2O. or other forms up to approximately 30cmH2O.
[0078] The pressure device 4140 is under the control of the therapy device controller 4240 .
[0079] 4.4.1.4 Converters 4270 In one form of the present technology, one or more transducers 4270 are connected to the pressure device 4140. One or more transducers 4270 are located upstream at that point in the air path. The device is constructed and arranged to measure the properties of the air in the room.
[0080] In one form of the present technology, one or more transducers 4270 are connected to the pressure device 4140. Located downstream and upstream of the air circuit 4170. One or more converters 427 0 is constructed and positioned to measure the properties of the air at that point in the airway.
[0081] In one form of the present technology, one or more transducers 4270 are connected to a patient interface. Can be placed proximal to 3000.
[0082] 4.4.1.5 Anti-spillback valves In one form of the present technology, an anti-spillback valve is provided between the humidifier 5000 and the air block 4020. This anti-spillback valve prevents water from flowing upstream from the humidifier 5000, e.g. The electrical wiring is constructed and arranged to reduce the risk of electrical wiring being leaked into the electrical wiring.
[0083] 4.4.1.6 Air Circuit 4170 An air circuit 4170 according to aspects of the present technology may be configured such that the flow of air or breathable gas is constructed and arranged to provide fluid flow between the block 4020 and the patient interface 3000 .
[0084] 4.4.1.7 Supplemental oxygen In one form of the present technology, supplemental oxygen 4180 is delivered to a point in the airway. do.
[0085] In one form of the present technology, supplemental oxygen is delivered upstream of the air block 4020.
[0086] In one form of the present technology, supplemental oxygen 4180 is delivered to the air circuit 4170.
[0087] In one form of the present technology, supplemental oxygen 4180 is delivered to a patient interface 3000. do.
[0088] 4.4.2 RPT Device Electrical Components 4200 4.4.2.1 Power supply 4210 In one form of the present technology, a power supply 4210 is connected to the external housing 401 of the RPT device 4000. In another form of the present technology, the power supply 4210 is internal to the RPT device 4000. The external housing 4010 is external to the
[0089] In one form of the present technology, the power supply 4210 provides electricity only to the RPT device 4000. In another form of the present technology, a power supply 4210 can be connected to the RPT device 4000 and the humidifier 5000. For vent placement as described throughout this specification, The power supply can also optionally power any actuators, controllers and / or is provided to the sensor.
[0090] 4.4.2.2 Input Device 4220 In one form of the present technology, the RPT device 4000 has buttons to allow the operator to interact with the device. It includes one or more input devices 4220 in the form of a button, switch, or dial. These are used to enter operational settings for RPT device components such as vent placement. A button, switch, or dial can be implemented either through a physical device or a touchscreen. In one embodiment, the button, switch, or Alternatively, the dial may be physically connected to the external housing 4010 or in another form. may be wireless communication with a receiver in electrical communication with the central controller 4230. stomach.
[0091] In one form, the input device 4220 allows the operator to enter values and / or menu options. The system is constructed and arranged to allow selection of options.
[0092] 4.4.2.3 Central Controller 4230 In one form of the present technology, the central controller 4230 receives input from the input device 4220. The signal(s) is received by the output device 4290 and / or the therapy device controller 424. 0.
[0093] In one form, the central controller 4230 is an application specific integrated circuit. In one embodiment, the central controller 4230 includes individual electronic components.
[0094] In another form of the present technology, the central controller 4230 is an x86 INTEL A processor suitable for controlling the RPT device 4000 such as a processor.
[0095] A central controller suitable for controlling an RPT device 4000 according to another form of the present technology. The processor in the controller is an ARM Cortex-M processor from ARM Holdings. processors based on ST Microelectronics processors. You can use the STM32 series microcontrollers.
[0096] Another processor controlling the RPT device 4000 according to a further alternative form of the present technology The processor is a member of the ARM9-based family of 32-bit RISC CPUs. For example, the ST Microelectronics STR9 series microphones You can use a controller.
[0097] In one alternative embodiment of the present technology, a 16-bit RISC CPU is used as the processor of the RPT device 4000. For example, the Texas Instruments It can use processors from the MSP430 family of microcontrollers.
[0098] The processor comprises one or more converters 4270 and one or more inputs It is configured to receive input signals from device 4220 .
[0099] The processor may transmit the output signal(s) to one or more output devices 4290, a therapy device Controller 4240, data communication interface 4280 and humidifier controller It is configured to provide 5250.
[0100] In some forms of the present technology, a central controller processor or multiple A processor such as One or more algorithms represented as computer programs stored in 4300, configured to implement one or more methodologies described herein. In some cases, as previously discussed, such processors However, in some embodiments, the present technology may be integrated into the processor ( The respiratory therapy delivery system may be configured to perform any of the methodologies described herein without directly controlling the delivery of respiratory therapy. Incorporating the RPT device 4000 discretely from the flow generating components for the purpose of For example, such a processor can process data from any of the sensors described herein. Analysis of stored data such as ventilator or other respiratory related events Any of the methodologies described herein may be implemented to determine the control settings of the component. Such a processor may be used to control the operation of any of the vent arrangements described herein. Any of the methodologies described herein can be practiced.
[0101] 4.4.2.4 Clock 4232 Preferably, the RPT device includes a clock 4232 connected to the processor.
[0102] 4.4.2.5 Therapy Device Controller 4240 In one form of the present technology, the therapy device controller 4240 is a central controller 4240. The pressure control module 4300 forms part of the algorithm 4300 executed by the processor of 230. The code is 4330.
[0103] In one form of the present technology, the therapy device controller 4240 includes a dedicated motor control collection For example, in one form, the MC33035 Brake Pad manufactured by ONSEMI A Siles DC motor controller is used.
[0104] 4.4.2.6 Protection circuit 4250 Preferably, the RPT device 4000 according to the present technology includes one or more protection circuits 425 Includes 0.
[0105] One form of protection circuit 4250 according to the present technology is an electrical protection circuit.
[0106] One form of protection circuit 4250 in accordance with the present technology is a temperature or pressure safety circuit.
[0107] 4.4.2.7 Memory 4260 In accordance with one form of the present technology, the RPT device 4000 includes a memory 4260, preferably non-volatile In some configurations, the memory 4260 is a battery-powered In some forms, the memory 4260 may include volatile RAM. It may contain M.
[0108] Preferably, memory 4260 may be located on PCBA 4202. The 0 can be in the form of EEPROM or NAND flash.
[0109] Additionally or alternatively, the RPT device 4000 may be, for example, a Secure Digital Includes removable memory 4260, similar to a memory card made with the (SD) standard. .
[0110] In one form of the present technology, the memory 4260 stores one or more algorithms. A computer, such as the system 4300, that implements one or more of the methodologies described herein. The computer program acts as a non-transitory computer-readable storage medium on which instructions for the computer program are stored.
[0111] 4.4.2.8 Converter 4270 The transducer may be internal or external to the RPT device. An external transducer may be placed, for example, in the air delivery circuit. The external transducer forms part of the air delivery circuit, such as the patient interface. Non-contact sensors such as Doppler radar motion sensors that transmit or transfer data to the RPT device The sensor may be in the form of a sensor.
[0112] 4.4.2.8.1 Flow rate The flow rate converter 4274 using this technology is, for example, the SDP600 series from SENSIRION. The pressure transducer may be based on a differential pressure transducer, such as a differential pressure transducer. and a pressure transducer connected to the first and second flow restricting elements. are connected to the second point.
[0113] In use, a signal representing the total flow Qt from the flow transducer 4274 is received by the processor. do.
[0114] 4.4.2.8.2 Pressure A pressure transducer 4272 according to the present technology is placed in fluid communication with the airway. An example of a converter is the HONEYWELL ASDX series sensor. The force transducer is a GENERAL ELECTRIC NPA series sensor.
[0115] When in use, the signal from the pressure transducer 4272 is received by the central controller processor. In one form, the signal from the pressure transducer 4272 is transmitted to the central controller 42 30 is filtered before receiving.
[0116] 4.4.2.8.3 Motor Speed In one form of the present technology, a motor speed signal 4276 is generated. 4276 is preferably provided by the therapy device controller 4240. The degree is generated by a speed sensor, such as a Hall effect sensor.
[0117] 4.4.2.9 Data Communication System 4280 In one form of the present technology, a data communication interface 4280 is provided, The data communication interface 4280 is preferably connected to the controller processor. Connectable to a remote external communications network 4282. Data communications interface 428 Preferably connectable to a local external communications network 4284. The remote external communication network 4282 is connectable to a remote external device 4286. Preferably, , the local external communication network 4284 is connectable to a local external device 4288 .
[0118] In one embodiment, the data communication interface 4280 is connected to the central controller 423 In another embodiment, the data communication interface 4280 is a part of the central It is a separate integrated circuit from the controller processor.
[0119] In one embodiment, the remote external communications network 4282 is the Internet (registered trademark). ). The data communication interface 4280 is a wired connection (e.g., Ethernet (registered trademark) (trademark) or fiber optic) or wireless protocols that connect to the Internet. That's fine.
[0120] In one embodiment, the local external communication network 4284 is Bluetooth ( Utilizes one or more communication standards such as the IEEE 802.11b / g or civil infrared protocols .
[0121] In one embodiment, the remote external device 4286 is connected to one or more computers, e.g., a network In one embodiment, the remote external device 4 The 286 may be a virtual computer rather than a physical computer. Even in this case, such remote external device 4286 may require the use of an appropriately authorized person, such as a clinician. can be accessed by anyone.
[0122] Preferably, the local external device 4288 is a personal computer, a mobile phone, a tablet, It may be a remote control.
[0123] 4.4.2.10 Optional displays and output devices, including alarms The output device 4290 according to the present technology may be one of a visual, audio, and tactile unit. or more. The visual display may be a liquid crystal display (LCD) Or it may be a light emitting diode (LED) display.
[0124] 4.4.2.10.1 Display Driver 4292 Display driver 4292 is intended to display on display 4294. It receives characters, symbols or images as input and displays these characters, symbols or images on the display 4294. converts the signal or image into instructions to display it.
[0125] 4.4.2.10.2 Display 4294 The display 4294 responds to commands received from the display driver 4292. In response, the display is configured to visually display characters, symbols, or images. The display 4294 may be an 8-segment display, in which case the display driver 42 92 converts each character or symbol, such as the number "0," into eight logic signals, One logic signal controls the eight corresponding segments to display a specific character or symbol. Each indicates whether it should be activated.
[0126] 4.5 Communications and Data Management Systems FIG. 7 illustrates an example communication system 700 in which aspects of the present disclosure can be implemented. This example should not be considered a limitation on the scope or utility of the disclosures described herein. In this example, the system 700 includes a server 710, patient devices 720, 730, and and 740, a storage system 750, and a computing device 7 60. Each of these devices communicates through a network 4282. The 700 can be adapted to any size network, e.g., three patient devices. Although only 720, 730 and 740 are shown, system 700 can be used with any number of patient devices. It may include a location.
[0127] Each of the patient devices 720, 730, and 740 is an RPT 4000, a humidifier 5000, and and one or more devices including a patient interface 3000. Furthermore, each of the patient devices 720, 730 and 740 may be operated by a different patient from a remote location. The patient device 720 includes a controller 4230 and a memory 4232. Although only 60 are shown, each patient device is an RPT 4000, a Humidifier 5000 and and may include any of the components described above with respect to patient interface 3000. Furthermore, the patient devices 720, 730 and 740 communicate with the server 710 via 4282. Although shown in direct communication with the patient device or computing device 760, each of the patient devices may also communicate with an external Communication can also occur over a network 4282 via a computing device (not shown). The personal device 720 is a personal computer that transmits data over the network 4282. It can communicate with the
[0128] Server 710 may include one or more processors 712, memory 714. and may incorporate other components typically found in general-purpose computing devices. The memory 714 of the server 710 stores instructions 712 that can be executed by the processor 712. 15. The memory 714 can store information accessible by the processor 712. It may also include data 718 that can be retrieved, manipulated, or stored by the processor 712. Memory can be any non-transitory memory that can store information that can be accessed by a processor. Instructions 716 include instructions that are executed directly or indirectly by processor 712. Regarding the The functions, methods and routines of the instructions are described in detail below.
[0129] Data 718 is retrieved, stored, or processed by processor 712 according to instructions 716. For example, the subject matter described herein is not limited by any particular data structure. Although not required, the data can be stored in computer registers and tables can be organized into many different formats. It has fields and records, so it can be used as a relational database or an XML document. The data 718 can be numbers, descriptions, special codes, pointers, etc. Associations, such as references to other memory-stored data, such as network locations This may be any information sufficient to identify or calculate one or more pieces of information. The processor 712 may include a conventional processor such as a CPU or It may be a hardware-based component such as a SIC.
[0130] FIG. 7 illustrates the processor, memory, and other components of a server 710, a computing device 76, and 0, and patient devices 720, 730 and 740 are each in one block. Although functionally illustrated, the various components of each device may have different physical housings. For example, the memory 714 may be contained within the housing of the server 710. A hard drive or other storage medium located in a separate housing from the Similarly, processor 712 may include multiple processors, some or all of which may be Or all are located in a housing different from that of the server 710. Therefore, any reference to a processor, computer, computing device, or memory processor, computer, computing device or memory device that may or may not operate It should be understood that this includes referring to a collection of processors. Although described herein as occurring on a single computing device with a Other aspects include multiple devices communicating information with each other, such as by communicating over a network 4282. The calculation can be performed by a numerical calculation device.
[0131] In many cases, the patient devices 720, 730, and 740 communicate with the network 4 using wireless communication. 282. However, the network 4282 and the intervening nodes described herein may The network may be the Internet, the World Wide Web, or a specialized intranet. , may be part of a wide area network, a local network or a mobile phone network A network can be interconnected using a variety of protocols and systems, such as , such as Ethernet, Wi-Fi, and HTTP, one or more Standard communication protocols such as proprietary protocols and various combinations of them While sending or receiving information as described above provides certain advantages, Other aspects of the described subject matter are not limited to any particular manner of transmitting information.
[0132] The server 710 communicates with the storage system 750, the computing device 720, and the like via the network 4282. 60 and one or more communication devices 720, 730, and 740. As described in more detail below, the server 710 includes software and Firmware updates 716 are sent to patient devices 720, 730 via the network 4282. and 740. The patient devices 720, 730 and 740 can then transmit the instruction set 726 according to the software and firmware of the server 710 Send to.
[0133] Computing device 760 may be configured similarly to server 710 and may include one or more processors Each such computing device includes: It may be a personal computing device intended for use by a clinician, and may include a central processing unit (CPU), data and Memory for storing instructions (e.g., RAM and internal hard drive), display 76 6 such displays (e.g., monitors with screens, touch screens, printers, etc.) projector, television, or other device capable of displaying information) and user input devices such as a device 768 (e.g., a mouse, keyboard, touchscreen, or microphone) It has all the components used in connection with a personal computing device.
[0134] 4.6 Example Method As noted above, each of the patient devices 720, 730, and 740 shown in FIG. 7 is an RPT 4000, a humidifier 5000 and one or more patient interfaces 3000 In performing the above operations, the patient device 720, 7 30 and 740 implement the instruction set 726, including software or firmware. As explained in connection with Figure 4c, the RPT4000 is a humidifier controller. Includes multiple controllers such as the Therapy Device Controller 5250 and Therapy Device Controller 4240. Each of these controllers can be configured with respect to a particular instruction set 726. Thus, each instruction set operates in a patient device that includes the components described above. For example, going back to Figure 7, if you have a number of modules, The patient device 720 shown includes a communications module 721, a humidifier module 723, and Each of these modules has a different instruction set 72 6 can be accessed and implemented. The instruction set 726 may be executed by one or more modules, including any of the modules described above. It can be administered.
[0135] The patient devices 720, 730 and 740 are used by their respective patients and are Updates to Kit 726 will become available and be required. These updates improve specific functionality. Improving or identifying problems in the operational aspects of one or more modules of the device Thus, in some cases, updates may be required to correct the effects of the patient device. This is essential for efficient management and patient safety. Further instruction set 726 can be automatically updated through communication network 4282. In particular, the server 710 may send one or more instruction set updates 716 to one or more Receive instruction set updates 716. Each patient device 720, 730 and 740 then receives the transmitted instruction set update The instruction set 726 can be modified in the manner indicated in 716. In this way, the patient device can easily It can be upgraded or otherwise customized remotely, and the patient can easily manage the patient device with the clinician. There is no need to take it to a service center.
[0136] In one embodiment, specific patient devices are identified as being capable of receiving or will receive specific updates. For example, the server 710 may select a patient device 720 as the one suitable for receiving data. should receive the specified instruction set update 716, but the patient devices 730 and 740 do not. The server can then decide to identify the specific patient device that will receive the specific update. 710 shows the configuration of each patient device 720, 730 and 740. The configuration data 718 can be stored in a serial number. Identification of the software and firmware versions currently installed by the patient device can be used to identify a specific patient device, including device and hardware version numbers The configuration data 718 may include any information previously stored in the patient's A record of the command set updates sent to the device and a record of whether the command set updates sent were successful. It also includes an indication of whether the configuration was applied or not to the user device. The Patient Data 718 is not limited to distinct information about one particular patient device, It can contain information that is applicable to multiple patient devices, e.g., configuration Data 718 identifies the supplier or retailer of the patient device and the Alternatively, the update may include the location or area where the particular update It can be triggered by other factors such as a fault condition that can be corrected by the system.
[0137] The configuration data 718 is sent to the patient device 720, 73 through a registration process. 0 and 740. For example, the patient device 720 is provided via the network 4282. The server 710 then sends the configuration data 728 to the server 710. 0 then receives the configuration data 728 and The patient device configuration data is stored in memory 714 as data 718. Registration of the configuration data 718 occurs the first time the patient uses the patient device. The configuration data 718 includes any changes that occur in the configuration data 728. For example, the patient device 720 may have its humidifier module 724 configured to update the humidifier module 724 on the server 710. 23 firmware has been successfully updated from the first version to the second version. The notification can be sent to the server 710, which then Update data 718 to see if the patient device 720 is currently running the humidifier module firmware version. 2. In one embodiment, the patient device 720 is At each startup, it checks its current configuration data 728 and Any changes in the configuration data 728 are reported to the server 710.
[0138] According to one embodiment, a user of the computing device 760 selects a particular patient device and sends the selected device to the server. 710. For example, a user of the computing device 760 may thereby The device 760 may specify a specific update 716 for a particular patient device 720, 730, and 740. The user can access a website that provides an interface to a server 710 that can be configured. To identify patient devices on which an update should be performed, the computing device 760 may search for patient devices that meet certain criteria. For example, searching the memory 714 of the server 710 for the user device. The user may use all patient devices incorporating a particular software version or a particular In another embodiment, the server 710 can be requested to identify a serial number within the range of The computing device 760 can request a list of all patient devices purchased from a particular retailer. do.
[0139] A user of a computing device 760 can identify a patient device to be updated via the server 710. If there is more than one possible update, the user can select the specific update to be provided to the patient device. To identify a specific update, the user must identify or select the new 716. Which components of the patient device should be updated and how they are implemented It can identify a specific version of software or hardware that should be used. For example, The user of the device 760 may request the server 710 to install a humidifier model on the patient devices 720 and 730. Request to provide update 716 for module 723, which is the humidifier firmware update The server 710 then selects The firmware version 3.1 is then sent to the patient devices 720 and 730. may be configured with newer or different settings than those currently implemented by the patient devices 720 and 730. These new settings are available when the patient devices 720 and 730 are running the latest firmware version. You can install it by installing version 3.1. Select Update 716 and The process of sending updates 716 can be performed by a single server 710, or alternatively by one or more For example, the computing device 760 may be implemented by the communication server 710. The communication server then sends this request to the download server. The server then sends the selected updates to the designated patient device.
[0140] The order renewal data may also include one of the following: where to obtain an order renewal form; Specifying data, such as host server, port, file name; bulk device updates schedule times to perform updates for each device so that the system can be effectively managed; whether the patient should be asked to confirm that the update is being applied until the patient's treatment is stopped; If necessary, you can cancel an upgrade that has not yet occurred. data structures and functionality that allow for batch upgrades; the ability to request large numbers of upgrades in a single operation In addition, you can check the status of these upgrades and which upgrades in the list are available in a single operation. Check later which ones were successful, which ones failed, which ones were not started, etc. ability.
[0141] When providing updates 716 to patient devices 720, 730, and 740, the server 710 It may also send validation data that can be used to verify that the update was successfully downloaded. Each update 716 includes validation data, which may include checksums, cyclic redundancies, etc. This may take the form of a length check or identification of the size of the update file. The patient device 720 can then receive the update 716, which includes the checksum. Compare the checksum with the new 716 to determine if all updates have been received. If the loaded update matches the checksum, the patient device installs the update and An indication that the installation was successful is sent to the server 710. However, if the download If the downloaded update does not match the checksum, the patient device will not install the update and An indication can be sent to the server 710 that the installation did not occur.
[0142] The server 710 sends updates for one or more components to the patient device 720. For example, a particular update 716 may be sent from the server 710 to the patient device 720, 726 for the communication module 721 and the humidifier module 723. In another embodiment, the plurality of instruction sets for the component are modified. A specific instruction set 726 is implemented by multiple components, and this instruction set 72 A single patient device update will trigger a change to these multiple components. The transmission may also include multiple updates 716 and be applied to the device 720. In this case, the server 710 can identify the order in which the updates occur. The device incorporates the updates 716 in the order specified by the server 710. A component of the patient device may be used more than once so that the final version of the The above updates may be required before installing version 3.0. The patient device 720 must download and install version 2.0 of the instruction set. Therefore, the configuration data 718 is used to determine whether a particular update 716 is currently installed. Identification of patient devices 720, 730 and 740 and specific updates 716 that can be installed This includes identifying any other updates that must be installed in order to install the In another embodiment, the transmitted update 716 may be including identification of the version or versions of Instruction Set 726 required to install the Prior to installing the update 716, the patient device 720 may The requested version identified in the request can be compared with the currently installed version. If the patient device 720 does not currently incorporate one of the versions listed, 20 can avoid installing update 716.
[0143] The patient device 720 may update the specified biometric information identified by the update 716. Determine whether the build standard is met and, based on that decision, Implement or avoid the installation of update 716. For example, the identified build standard is The patient device 720 includes the combination of components required for the update to be installed. , determine whether it uses the combination of identified components, etc. It can be determined whether the identified components meet the identified build standards. If the component is used in the patient device 720, these components are updated according to the update 716. However, if the patient device 720 does not have one or more of the identified components If not, the patient device 720 can avoid installing the update 716 . In one embodiment, the patient device 720 does not include or use You can avoid installing only the parts of update 716 that relate to components that are not However, you can proceed with installing the rest of Update 716.
[0144] According to one embodiment, the patient device can be updated on a schedule. For example, the computing device 760 The user can identify the date on which a particular patient device is due to receive a particular update 716. The server 710 can provide a schedule for updates, such as by dividing the time period by the number of updates. The update 710 can then send updates 716 according to a schedule. The schedule is configured in the configuration data 718 for each patient device. In this way, updates that apply to a large number of patient devices can be implemented within a few weeks, for example. or for an extended period of several months, and This reduces the load that must be transmitted at the time the patient device receives the update 716. If a renewal request is scheduled, the server 710 can send a renewal request. The renewal request can be sent via SMS message. This can take the form of a message or other touching message. Updated from server 710 Upon receiving the request, the patient device 720 responds with an indication that it is ready to receive the update. The update is then sent to the patient device 720 and installed. 0 can also cancel updates 716 that would have occurred. A user of the device 760 may request that a particular update 716 be sent to one or more patient devices 720, 730, 740, 750, 760, or 770. 0 and 740 can send a request to cancel. In response to the request, the server 710 removes a particular update 716 from the list of scheduled updates. If an update has already been sent to one or more patient devices but is not yet installed, If not, the server 710 may cancel one or more updates. Upon receiving the update cancellation, the patient devices 720, 730, and 740 can be removed from memory before the received update 716 is installed.
[0145] Alternatively, the transmission may be on a specific suitable date, but each device may incorporate the update at a specific later date. After receiving the update from the server 710, the patient device 720 may be instructed to download the update. You can wait for various reasons before installing, such as when you receive an update. When a patient is receiving treatment from the patient device 720, the patient device 720 installs updates. You can wait until the patient has finished treatment before proceeding. This will prevent the patient from being interrupted. Or you can avoid the negative impact of installing updates. In some embodiments, updates may be installed while the patient device is in use. Specifically, when an update is being performed, specific For example, update 716 may occur while the patient device is providing respiratory therapy. Therefore, updates 716 are only relevant to the communication module 721 and are not related to the operation being performed. Indicate that the device 720 may be installed while in use to provide respiratory therapy. During the installation, the patient device 720 displays a notification that the patient device is being updated. This notice will inform the patient that they should not turn off the patient device and that the patient device A message indicating that the patient should wait for the update to complete before using it in a particular way In one embodiment, the patient device 720 displays a message indicating that the update has been installed. Requires confirmation from the patient before use. Additionally, over a period of time, many devices may be replaced with new ones. Download software, but the downloaded updates are not marketing or For communication purposes, it can be installed on all devices on the same day.
[0146] According to one embodiment, a user of a computing device 760 notifies the server 710 of the status of an update 716. For example, the computing device 760 may query the status of a particular update 716. You can request identification of those patient devices that you have not received or have not yet installed. Additionally, the computing device 760 may include one or more updates 716 installed on all Regarding the list of patient devices and errors encountered with sending and installing Update 716 Additionally, the server 710 can request information from the computing device 760 about the specific patient device currently A list of current instruction sets, including software and firmware versions currently installed. For example, the computing device 760 may provide an instruction set embedded by the patient device 720. The server 710 can query the list of 726. Configuration Data 718 is accessed to identify the information being queried and The information is sent to the computing device 760, which generates the query and sends it to the website or by accessing some other server interface The server 710 receives the patient information from the server 710. The server 710 maintains the confidentiality of the patient information. To do so, the computing device 760 is required to provide identification information and a password for the query. Request.
[0147] FIG. 8 illustrates a flow diagram implemented by a patient device, such as patient device 720 of system 700. 8 shows a chart 800. As described above, the patient device can store and execute a set of instructions. In block 802, the patient device is configured to access the software currently accessible to the patient device. The instruction set can be embedded in the device as air or firmware. is related to the operation of multiple components within the patient device and must be stored in a single location. If a set of instructions is included, the patient device can send data over the network in one or more The data can be transmitted to further external devices (block 804). For example, the patient device 720 can and data regarding the patient's use of the patient device 720 via the network 4282. This transmission will include the date and time the patient used the patient device. The patient device receives a transmission from an external device, such as a server 710, Determine if a received transmission relates to one or more instruction set updates. For example, the patient device may request update data from a specific address on a server (block 806). A transmission indicating that the update is available at a specific location, such as a If not, the patient device may continue to implement the current instruction set (block 802). When an update instruction is received, the patient device downloads the update file at the identified address. Updates can be received, such as by request or access.
[0148] The patient device may determine if there are any errors with the update (block 808 For example, as described above, the patient device may compare updates with a checksum to ensure all updates have been received. The patient device further determines that the version of its currently installed instruction set is updated. Determine if it matches one of the versions required to install the If an error is determined to exist regarding the update, the patient device sends an error notification (block 810). For example, the patient device 720 may send a notification to the server 710 that an update is available. Indicates a checksum mismatch. The notification also includes a request to resend the update.
[0149] If no errors are detected with the update, the patient device installs the update (block 812). As mentioned above, an update may modify one or more instruction sets. Modifications can include removing parts of the instruction set, adding to the instruction set, etc. This includes replacing the original instruction set with an entirely new instruction set. As mentioned above, updates include instruction sets for different components of the patient device. Contains fixes to various instruction sets, including: Checks the installation to determine if it was successful. This includes checking the updated components. This also includes checking each of the components (block 814). The patient device then sends a notification of the error (block 810). Returning to block 802, the original instruction set is installed. If successful, the patient device sends a notification to an external device, such as the server 710, to update The patient device communicates that the new device has been installed (block 816). Access and implement the current instruction set, including any updated instruction sets. It is also possible.
[0150] FIG. 9 illustrates a computing device implementation of the disclosed system, including the server 710 of the system 700. 9 shows a flowchart 900 for implementing the present invention. In block 902, the server A query is received for the identification of a patient device that meets the above criteria. For example, as described above The server 710 receives a query from a computing device 760. Identification of all patient devices that meet one or more criteria provided by the device 760. The criteria can be the region in which the patient device is located, the patient device serial number, and the software and firmware versions currently installed by the patient device. The server may receive queries based on a number of aspects or features of the patient device, such as the In response to the request, the configuration data is accessed (block 904). The query is answered by transmitting data identifying the patient device for which the criteria are met. The system responds to the request (block 906).
[0151] The server then sends one or more updates to one or more patient devices. For example, as described above, the computing device 760 may receive a request for The patient devices 720, 730 and 760 satisfy criteria provided by the user of the computing device 760. The user then receives the list from the server 710 of the patient device 720, Select the specific updates 716 to send to 730 and 740. Once the request is received, the server accesses the updated data (block 910) and retrieves the updated data identified in the received request. The updated data is transmitted to the selected patient device (block 912). The functions in the update request may be performed in a different order. For example, the server may At some point (or even before) a request is received to identify the device with a particular configuration. and sends updates only to devices that meet the specified criteria. It is not necessary to perform block 910 to send updated data to the patient device. The server 710 receives the update data as an address indicating where the update file is stored. The location identified by the address may be on server 710 or elsewhere. In this way, the address of the update file is the actual update stored in the identified location. The new file data is provided to the patient device without requiring the server 710 to access it. Can be provided.
[0152] The server must also determine whether the update was successfully sent and / or installed. For example, the server may receive error notifications or You will either receive a confirmation or a message that the update was successfully installed. If a communication error occurs, the server will resend the updated data to each patient device that experienced the error. Alternatively, the actual update file (new software) can be downloaded (block 912). The software is not pushed down to the device by the server 710 but is instead handled by the file server. Updates to the patient device can be requested by the therapy device itself from the The occurrence of a condition that does not occur immediately may be contingent on the occurrence of one or more other conditions. For example, update data may be required for a patient device to update after the device has delivered therapy for 200 hours. Therefore, block 9 can be used to indicate that There is a significant time lapse between block 12 and block 914, but the transmission and installation were successful. If successful, the server updates the stored configuration data and indicates that one or more patient devices are currently incorporating the instructions corresponding to the sent update ( (block 916) and reports that the update was successful (block 918). If any more patient devices are successfully updated, the server 710 sends a message to the computing device 760. A message is sent to notify the user, e.g., a technician, that the update is complete. Sage will identify specific patient devices or groups of patient devices that have successfully installed the update. Identify.
[0153] The instructions described in Figures 8 and 9 may be implemented on a single device, but may alternatively be implemented on more than one device. For example, a personal computer can execute one or more of the above instructions. Thus, the patient device can communicate with a personal computer over a wireless network. The servers referenced in Figures 8 and 9 may also include multiple servers. Add various operations to flowcharts 800 and 900 for the specific operations shown, or , can be excluded from the various operations shown in flowcharts 800 and 900. For example, the server may send updates to the therapy device and If an update is needed, where to get it (host, port, filename) and and how to verify it (e.g. checksum / CRC). The medical device communication module receives the update file (command) from the specified host (server). This slightly different functional diagram requires a large software download. If necessary, the load can be distributed not only from server 710 as shown in FIG. Furthermore, the therapy device will indicate any transmission errors. The server itself can download updates (i.e., new software) without the intervention of the server 710. If an error is reported, the server may retry the operation as described above. It is possible to try again.
[0154] 4.7 Glossary In certain forms of the present technology, one or more of the following definitions may apply. In other forms of the term, alternative definitions may apply.
[0155] 4.7.1 General Air: To take in air and include it in the breathing gas, such as by including supplemental oxygen in air.
[0156] Continuous Positive Airway Pressure (CPAP) Therapy: CPAP therapy is a method of continuously providing positive pressure to the air relative to the atmosphere. and applying a pressure to the entrance of the airway that is within the range of the patient's breathing cycle. In some forms, the pressure at the entrance to the airways remains approximately constant throughout a single respiratory cycle. It varies by several centimetres underwater, being slightly higher during inhalation and slightly lower during exhalation. Therefore, the pressure at the airway entrance is slightly higher during expiration and slightly lower during inspiration. In the respiratory tract, the pressure varies during different respiratory cycles of the patient. It increases in response to the detection of signs of obstruction and decreases in the absence of signs of partial obstruction of the upper airway.
[0157] 4.7.2 Materials Silicone or Silicone Elastomer: Synthetic rubber. In this specification, silicone refers to liquid Refers to body silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of R is SILASTIC, manufactured by Dow Corning (this brand (It is included in the range of products sold under the same brand name.) Another company that manufactures LSR is Wac Unless otherwise specified, the preferred form of LSR is as per ASTM D2240. Thus, the Shore A (or Type A) indentation hardness measured ranges from about 35 to about 45. are.
[0158] Polycarbonate: A typically transparent thermoplastic polymer of bisphenol-A carbonate. -.
[0159] 4.7.3 Patient Interface Aspects Anti-Asphyxiation Valve (AAV): A component or subassembly of a mask system - and venting to atmosphere in a fail-safe manner reduces the risk of excessive CO2 rebreathing in the patient. Reduce.
[0160] Elbow: A conduit that directs the axis of air flow so that it changes direction through a corner. In one embodiment, the angle may be about 90 degrees. In another embodiment, the angle may be less than 90 degrees. The conduit may have a substantially circular cross section. The gits may have an oval or rectangular cross section.
[0161] Frame: The frame is a tensioned device between two or more connection points with the headgear. The mask frame is a non-airtight, load-bearing mask structure. However, some forms of mask frames may be airtight.
[0162] Headgear: Headgear is a positioning and stabilizing structure designed for use on the head. Preferably, the headgear is configured to connect the patient interface to the respiratory one or more devices configured to be placed and held in place on the patient's face for delivery of treatment; It includes a collection of one or more braces, strings, and stiffeners. Some strings are It is made of a soft, flexible, and resilient material such as a laminated composite of foam and fabric.
[0163] Membrane: Preferably, the membrane is substantially resistant to bending but resistant to stretching. is interpreted to mean a typically thin element with a
[0164] Plenum chamber: The patient interface plenum chamber is e.g. Enclosing a volumetric space such as a mask (i.e., nose and mouth mask), nasal mask, or nasal pillow is understood to mean the portion of the patient interface that has a wall, and within which the patient is During use, the air is pressurized above atmospheric pressure. The shell is the patient interface plenum. In one form, the patient's face area may be positioned over the cushion. or adjacent to one of the walls of the plenum chamber via a seal.
[0165] Seal: noun ("a seal") refers to the flow of air through the interface of two surfaces. It is interpreted as meaning a structure or barrier that is intentionally resistant to al") is interpreted to mean resisting the flow of air.
[0166] Shell: A shell is a curved structure that has stiffness in bending, tension, and compression. For example, a portion of the mask that forms a curved structural wall of the mask. Preferably, it is relatively thin compared to its overall size. In some embodiments, the shell has a cutout. Such walls do not have to be airtight, but preferably are.
[0167] Stiffeners: Stiffeners are materials that increase the bending resistance of another component in at least one direction. It is interpreted to mean a designed structural element (structural component).
[0168] Bracing: Bracing is used to increase the compressive resistance of another component in at least one direction. It is interpreted to mean a designed structural element (structural component).
[0169] Swivel: (noun) Rotating about a common axis, preferably independently and preferably under low torque In one form, the swivel includes at least In another embodiment, the swivel base may be constructed to rotate 360 degrees. It may be constructed to rotate at the following angles: The component subassembly preferably includes a pair of cylindrical conduits. Preferably, there is little or no air leakage from the swivel base during use.
[0170] Fixture: Fixture means a structural component designed to resist tension. It can be interpreted.
[0171] Vent: (noun) A device that flushes out exhaled carbon dioxide (CO2) and supplies oxygen (O2). To achieve this, the rate of air leakage from the mask interior or conduit into the ambient air is carefully controlled. A structure that can be used.
[0172] 4.8 Other notes A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner is , so long as it appears in the patent office's patent file or records, anyone may I have no objection to the facsimile reproduction of the disclosure of Whatever copyright is reserved.
[0173] Unless the context clearly dictates otherwise, and unless a range of values is stated, Intervening values are incremented to 1 / 10 of the unit of the lower limit and incremented between the upper and lower limits of the range. Any other stated or intervening value in the stated range is encompassed by the art. The upper and lower limits of these intervening ranges are not to be construed as limiting any specifically excluded limits in the stated ranges. Subject to limitations, the intervening ranges may be independently included and are encompassed within the scope of the present technology. If the range specified includes one or both limits, either or both of those included limits The range excluding the above is also included in the technology.
[0174] Furthermore, one or more values may be described as being incorporated herein as part of the technology. Unless otherwise specified, such values may be approximate and may vary depending on practical engineering practice. To the extent permitted or required by the implementation, such values may be used to any appropriate significant digit. I want you to understand that this is possible.
[0175] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology pertains. Any methods or materials similar or equivalent to those described herein may also be used in the practice or can be used in testing, but a limited number of exemplary methods and materials are described here.
[0176] If a specific material is identified as being used to construct a component, similar properties Obviously, alternative materials having the same properties may be used as substitutes. Unless otherwise specified, any and all components described herein are understood to be manufacturable, Thus, they can be manufactured together or separately.
[0177] As used in this specification and the appended claims, the singular forms "a," "an," and "the" , and their plural forms are included unless the context clearly dictates otherwise. It should be.
[0178] All publications mentioned herein are incorporated by reference in their entirety for purposes of illustration only and are not intended to be limiting unless expressly stated otherwise. The publications discussed herein are incorporated by reference to disclose and describe the for the purpose of disclosure prior to the filing date of this application. Nothing contained herein shall be construed as a substitute for the disclosure of any person skilled in the art. shall be construed as an admission that the invention is not entitled to antedate such publication by reason of prior invention. Furthermore, the publication dates stated may differ from the actual publication dates, and Each of these should be verified separately.
[0179] Moreover, in interpreting this disclosure, all terms should be used in the broadest reasonable manner consistent with the context. In particular, the words "comprise" and "comprising" should be interpreted as follows: shall be construed as referring to elements, components or steps in a non-exclusive manner. and the referenced element, component, or step is not explicitly referenced. It exists or is utilized with other elements, components, or steps that are not part of the or in combination.
[0180] Subject headings used in the detailed description are included solely for ease of reference for the reader and are not intended to be limiting. shall not be used to limit the subject matter found throughout the disclosure or claims. Subject headings shall not be used to construe the scope or limitations of any claim. stomach.
[0181] Although the technology described herein has been described with reference to particular embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the technology. In some cases, terms and symbols may imply specific details not required to practice the technology. For example, although the terms "first" and "second" are used unless otherwise specified, they are not intended to indicate any order but may be used to distinguish between distinct elements. Furthermore, while process steps in a methodology may be described or illustrated in order, such order is not required. Those skilled in the art will recognize that such order may be modified and / or features may be performed simultaneously or synchronously. Accordingly, it should be understood that numerous modifications may be made to the illustrative embodiments and that other configurations may be devised without departing from the spirit and scope of the technology. In order to maintain the disclosure of the present application as originally filed, the contents of claims 1 to 32 as originally filed are added below. (Claim 1) 1. A method for updating a device for providing medical care, comprising: accessing, by one or more processors, configuration data relating to a plurality of patient devices, each of the plurality of patient devices implementing a set of instructions; identifying, by the one or more processors, one or more patient devices from the plurality of patient devices having configuration data that meet one or more criteria; transmitting, by the one or more processors, instruction updates to the one or more patient devices over a network; updating, by the one or more processors, the configuration data for each of the one or more patient devices that have installed the instruction update; A method comprising: (Claim 2) 10. The method of claim 1, further comprising selecting, by the one or more processors, an instruction update to send to the one or more patient devices from a plurality of instruction updates based on the configuration data. (Claim 3) The method of claim 1 or 2, wherein the one or more criteria and the step of selecting the instruction update are based on one or more transmissions received from a remote computing device. (Claim 4) The instruction update includes: data specifying the location of the instruction update file; instructions as to which components of the device the update should be applied to; a scheduled time for each device to perform the update; an indication of whether confirmation that the update should be applied should be required; If applicable, a direction that said update should not be applied until the patient's treatment has ceased; data structures and functionality that allow for the cancellation of updates that have not yet occurred; Batch capabilities to request large numbers of updates in a single operation, and the ability to check the status of these updates in a single operation that indicates the status of said updates; The method according to any one of claims 1 to 3, comprising at least one of: (Claim 5) 5. The method of claim 1, wherein the plurality of patient devices are respiratory pressure therapy devices. (Claim 6) 6. The method of claim 1, wherein the step of transmitting the instruction update further comprises the step of transmitting verification data, the verification data being used by the patient device to verify that the instruction update was successfully downloaded. (Claim 7) 7. The method of claim 1, further comprising receiving, by the one or more processors, an indication from each of the one or more patient devices of whether the instruction update has been installed. (Claim 8) 8. The method of claim 7, further comprising the step of resending the instruction update to each patient device for which it is determined that the instruction update was not successfully installed. (Claim 9) 9. The method of claim 1, wherein the instruction update includes a first portion and a second portion, and a first component of the patient device operates according to the first portion of the instruction update and a second component operates according to the second portion of the instruction update. (Claim 10) 10. The method of claim 7, wherein an indication from each of the one or more patient devices indicates that the instruction set has been successfully installed, and further comprising the step of transmitting, by the one or more processors, a message identifying successful installation of the instruction update to the one or more patient devices. (Claim 11) 11. The method of claim 1, wherein the configuration data includes at least one of: a) a serial number; b) a version of the instruction set currently installed on the patient device; c) a hardware version; and d) a region in which the patient device is used. (Claim 12) The method of any one of claims 1 to 11, wherein the instruction updates include multiple updates to be applied to a single patient device. (Claim 13) 13. The method of any one of claims 1 to 12, wherein the configuration data includes a record of instruction updates previously applied, successfully or unsuccessfully, to a particular patient device from a plurality of patient devices. (Claim 14) 1. A method for updating a device for providing medical care, comprising: accessing, by one or more processors, a first set of instructions for operation of the patient device; performing, by the one or more processors, a first set of operations in accordance with the first set of instructions; receiving, by said one or more processors, update data from a remote computing device over a network; updating, by the one or more processors, the first instruction set according to the update data to generate an updated instruction set; transmitting, by the one or more processors, a confirmation to the remote computing device that the first instruction set update has occurred; performing, by the one or more processors, a second set of operations in accordance with the updated instruction set; A method comprising: (Claim 15) The method of claim 14 , wherein the patient device comprises a respiratory pressure therapy device. (Claim 16) 16. The method of claim 14, wherein receiving the update data further comprises receiving verification data, and determining whether the update data has been successfully downloaded based on the verification data. (Claim 17) if the received update data is determined to be incomplete, sending a notification of an error to the remote computing device; receiving a second transmission of update data; The method according to any one of claims 14 to 16, further comprising: (Claim 18) 18. The method of claim 14, wherein the update data includes a first portion and a second portion, and a first component of the patient device operates according to the first portion of the update data, and a second component operates according to the second portion of the update data. (Claim 19) 19. The method of claim 14, wherein the first instruction set and the updated instruction set comprise at least one of software and firmware. (Claim 20) 20. The method of claim 14, wherein the step of transmitting confirmation that the first instruction set update has occurred includes transmitting configuration data indicating versions of software and / or firmware currently installed on the patient device. (Claim 21) 21. The method of claim 14, further comprising determining whether the patient device meets a build standard identified by the instruction update, wherein updating the first set of instructions occurs based on a determination that the patient device meets the build standard. (Claim 22) 1. A system for updating devices that provide medical care, the system including one or more computing devices, the one or more computing devices comprising: accessing configuration data for a plurality of patient devices, each of which implements a set of instructions; identifying one or more patient devices from the plurality of patient devices having configuration data that meet one or more criteria; sending instruction updates to the one or more patient devices; updating the configuration data for each of the one or more patient devices that have installed the instruction update; The system is configured as follows: (Claim 23) 23. The system of claim 22, wherein the one or more computing devices are configured to select an instruction update to provide to the one or more patient devices from a plurality of updates based on the configuration data. (Claim 24) 24. The system of claim 22 or 23, wherein the one or more computing devices are further configured to receive one or more transmissions from a remote computing device, the one or more transmissions identifying the one or more criteria and the instruction update. (Claim 25) 25. The system of any one of claims 22 to 24, wherein the plurality of patient devices are respiratory pressure therapy devices. (Claim 26) The instruction update includes: Data specifying the location of the instruction update file, instructions as to which components of the device the update should be applied to; a scheduled time for performing the updates on each device; an indication of whether confirmation that the update should be applied should be requested; If applicable, a direction that the update not be applied until the patient's treatment has ceased; data structures and functionality that allow for the cancellation of updates that have not yet occurred; Batch capabilities to request large numbers of updates in a single operation, and the ability to check the status of these updates in a single operation that indicates the status of said updates; 26. The system according to claim 22, comprising at least one of: (Claim 27) 27. The system of claim 22, wherein the step of transmitting the instruction update further comprises the step of transmitting verification data to the one or more patient devices to verify that the received instruction update is complete. (Claim 28) 28. The system of claim 22, wherein the configuration data includes at least one of: a) a serial number; b) a version of the instruction set currently installed on the patient device; c) a version of the hardware; and d) a region in which the patient device is used. (Claim 29) 29. The system of any one of claims 22-28, wherein the one or more computing devices are further configured to resend the instruction update to each patient device for which it is determined that the instruction update was not successfully installed. (Claim 30) the one or more computing devices; receiving an indication from each of the one or more patient devices that the instruction update has been installed; sending a message to the one or more patient devices indicating successful installation of the instruction update; 30. The system according to claim 22, further configured as follows: (Claim 31) 31. The system of any one of claims 22 to 30, wherein the instruction updates include multiple updates to be applied to a single patient device. (Claim 32) 32. The system of claim 22, wherein the configuration data includes a record of instruction updates previously applied, successfully or unsuccessfully, to a particular patient device from a plurality of patient devices. [Explanation of symbols]
[0182] 700 Communication Systems 710 Server 712 processor 714 Memory 715 Command 716 instruction set update 718 Configuration Data 720 Patient equipment 721 Communication Module 723 Humidifier Module 725 Alarm Module 726 instruction set 728 Configuration Data 720 Patient equipment 730 Patient equipment 740 Patient equipment 750 Storage System 760 Computing equipment 762 processor 764 Memory 766 Display 768 User Input Devices 1000 patients 3000 Patient Interface 3100 Seal forming structure 3200 Plenum Chamber Around 3210 3300 Positioning and Stabilizing Structures 3400 Vent 3600 connection port 4000 RPT equipment 4010 Outer Housing 4012 Top of outer housing 4014 Lower part of outer housing 4015 Panel 4016 chassis 4018 Handle 4020 Air Block 4100 Air Components 4110 Air Filter 4112 Inlet Air Filter 4114 Outlet air filter 4120 Muffler 4122 Inlet muffler 4124 Exit muffler 4140 Pressure equipment 4142 Blower 4144 Motor 4144 Brushless DC Motor 4160 Back Valve 4170 Air Circuit 4180 Supplemental oxygen 4200 Electrical Components 4202 PCB Assembly PCBA 4210 Power supply 4220 input device 4230 Central Controller 4232 Clock 4240 Therapy Device Controller 4250 protection circuit 4260 memory 4270 Converter 4272 Pressure Transducer 4274 Flow Sensor 4276 Motor Speed Signal 4280 Data Communication System 4282 Remote External Communications Network 4284 Local External Communication Network 4286 Remote External Device 4288 local external device 4290 output device 4292 Display Driver 4294 display 4300 Algorithm 4330 Pressure Control Module 5000 humidifier 5250 Humidifier Controller
Claims
1. 1. A patient device for providing a medical treatment, comprising: a memory storing one or more instruction sets for operation of the patient device; One or more processors It is equipped with the one or more processors: accessing a first instruction set of one or more instruction sets for operation of the patient device; performing a first set of operations in accordance with said first instruction set; receiving update data over a network from a remote computing device, the update data being received based on the patient device being one of a plurality of patient devices having configuration data that meets one or more criteria, the update data indicating one or more operations and whether the first instruction set update may be implemented during performance of the one or more operations by the patient device; updating the first instruction set according to the update data to generate an updated instruction set; performing a second set of operations according to the updated instruction set; The patient device is configured to:
2. 10. The patient device of claim 1, wherein the patient device comprises a respiratory pressure therapy device.
3. 3. The patient device of claim 1, wherein the one or more processors are configured to receive verification data and determine, based on the verification data, whether the update data was successfully downloaded.
4. The one or more processors: If the received update data is determined to be incomplete, sending an error notification to the remote computing device; Receive a second transmission of update data 4. A patient device according to claim 1, configured to:
5. 5. A patient device according to any one of claims 1 to 4, wherein the update data indicates that the one or more operations may be performed by the patient device while the first instruction set update is being performed.
6. The patient device of claim 5 , wherein the one or more actions include the patient device providing a therapy.
7. 10. The patient device of claim 1, wherein the one or more operations include providing a therapy by the patient device, and the update data indicates that the one or more operations may be performed by the patient device while a first instruction set update is being implemented.
8. the one or more processors: generating an indication that the updated patient device components have been checked; sending a confirmation to the remote computing device that the update of the first instruction set has occurred, the confirmation including a generated indication that the updated components of the patient device have been checked; 8. A patient device according to any one of claims 1 to 7, configured to:
9. 10. The patient device of claim 8, wherein the one or more processors are configured to transmit configuration data indicating a version of at least one of software and firmware currently installed on the patient device.
10. 8. The patient device of claim 6 or 7, wherein the one or more processors are configured to determine whether the patient device meets a build standard specified by an instruction update, and to update the first instruction set based on a determination that the patient device meets the build standard.
11. 9. A patient device according to any preceding claim, wherein the one or more processors are configured to transmit configuration data relating to the patient device to the remote computing device over the network.
12. 10. The patient device of claim 9, wherein the one or more processors are configured to transmit the configuration data upon first use of the patient device and / or after checking the configuration data to determine changes to the configuration data.
13. 1. A method for updating a patient device during the delivery of a medical procedure, comprising: maintaining configuration data on one or more servers for each of a plurality of patient devices, each of which performs a set of instructions, on one or more computing devices; receiving, by the one or more computing devices, a query from a remote computing device configured to identify, at the one or more servers, one or more of the patient devices from the plurality of patient devices having configuration data that meets one or more criteria specified in the query; the one or more computing devices accessing configuration data based on the received query; the one or more computing devices identifying one or more patient devices from the plurality of patient devices having configuration data that meets the one or more criteria; the one or more computing devices sending an instruction update to the one or more identified patient devices, the instruction update indicating one or more operations and whether the instruction update may be installed during performance of the one or more operations by the one or more patient devices; The one or more computing devices update the configuration data for each of the one or more patient devices that have installed the instruction update.
10. A method of updating a patient device, comprising:
14. 14. The method of updating a patient device of claim 13, wherein the instruction update indicates that the one or more operations may be performed by the one or more patient devices while the instruction update is installed.
15. 15. The method of updating a patient device of claim 14, wherein the one or more actions include providing a therapy by the one or more patient devices.
16. 14. The method of updating a patient device of claim 13, wherein the one or more actions include the one or more patient devices delivering a therapy, and the instruction update indicates that the instruction update is not installed while the one or more patient devices are delivering a therapy.
17. the one or more computing devices receiving instructions from each of the one or more patient devices indicating that updated components of the patient device have been checked; The one or more computing devices update the configuration data for each of the one or more patient devices that have installed the instruction update based on the received instructions.
17. The method of updating a patient device of any one of claims 13 to 16, further comprising:
18. 18. The method of updating a patient device of any one of claims 13 to 17, further comprising the one or more computing devices selecting an instruction update to be provided to the one or more patient devices from a plurality of updates based on the configuration data.
19. The instruction update includes: data specifying the location of the instruction update file; instructions as to which components of the patient device the update should be applied to; a scheduled time for performing the update for each patient device; an indication of whether confirmation that the update should be applied should be requested; and data structures and functionality that allow for the cancellation of updates that have not yet occurred; Batch capabilities to request large numbers of updates in a single operation; the ability to check the status of these updates in a single operation that indicates the status of said updates; 19. The method of updating a patient device of any one of claims 13 to 18, further comprising at least one of:
20. 20. The method of updating a patient device of any one of claims 13 to 19, wherein transmitting the instruction update further comprises transmitting verification data for the one or more patient devices to verify that the received instruction update is complete.
21. 17. A method of updating a patient device according to any one of claims 11 to 16, wherein the configuration data includes at least one of: a) a serial number; b) an instruction set version currently installed on the patient device; c) a hardware version; and d) a region in which the patient device is being used.
22. the one or more computing devices receiving an indication from each of the one or more patient devices indicating that the instruction update has been installed; The one or more computing devices transmit a message indicating successful installation of the instruction update for the one or more patient devices.
22. The method of updating a patient device of any one of claims 13 to 21, further comprising:
23. The method of updating a patient device of any one of claims 13 to 21, further comprising the one or more computing devices receiving configuration data from each of the plurality of patient devices.
24. 23. A method of updating a patient device according to any one of claims 13 to 22, wherein the configuration data comprises a record of previous successful or unsuccessful command updates applied to a particular patient device from the plurality of patient devices.
Citation Information
Patent Citations
Medical service supporting device
JP2010198366A
Medical device update system
US20130104120A1
Medical device update system
WO2013059615A1