Patient device and method for updating same

Abstract

To provide a system and method for updating patient devices.SOLUTION: In a communication system 700, patient devices 720 to 740 include respiratory therapy devices that operate in accordance with instruction sets 726, such as software or firmware. A server computer 710 maintains a database of configuration data 718 indicating versions of software and firmware that is currently installed on the patient devices 720 to 740, transmits updated instructions 716 from over a network 4282, including a wireless network, and selects, for updating, particular patient devices of the patient devices 720 to 740 based on the configuration data 718. Upon performing an update, the patient devices 720 to 740 transmit configuration data 728 to the server 710.SELECTED DRAWING: Figure 7

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application is incorporated by reference in its entirety. This application claims the benefit of US Pat. No. 6,313,639, the entire disclosure of which is incorporated herein by reference. do.

[0002] The present technology provides 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 renewal. 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 penetrate deeper into the lungs. The primary function of the lungs 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 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 takes place are called respiratory regions. It is called "Respiratory Physiology" by John B. West, Lippincott Will Published by iams & Wilkins, 9th Edition, 2011.

[0005] There is a range of respiratory diseases. Some examples of respiratory diseases 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 systems 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, holding 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] Noninvasive ventilation (NIV) is a method of ventilation that allows patients to breathe adequately and / or receive adequate oxygen levels. It provides some or all of the work of breathing to help keep the upper airway open Ventilatory support is provided to the patient via a 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 determine the breaths 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-supported ventilation ( PSV), continuous positive airway pressure (CPAP) or positive end-expiratory pressure (PEEP).

[0011] 1.2.3 System The treatment 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, for example, provide a flow of breathable gas to aid in the respiratory It 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 mask to the mouth, a tube to the mouth or a tracheostomy tube to 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 the ambient pressure so that the treatment is effective, e.g. For example, gas is delivered at a positive pressure of about 10 cmH2O relative to ambient pressure. Other forms of therapy facilitate the delivery of gas to the airways at a positive pressure of approximately 10 cmH2O. The patient interface does not need to include a seal sufficient to

[0013] Designing a patient interface poses many challenges. The face is 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 as the The entire head may move during respiratory treatment.

[0014] These challenges have resulted in some masks being overly noticeable, aesthetically unpleasing, or cosmetically unsightly. They are expensive, poorly fitted, difficult to use, and may cause problems, especially when worn for long periods of time or when the patient is suffer from one or more of the following problems: For example, masks designed specifically for aviators, or as part of personal protective equipment. Masks that are suitable for anesthesia administration (e.g., filter masks), SCUBA masks, or Although the masks are suitable for their intended use, they should not be worn for long periods of time, e.g., several hours. This can be extremely unpleasant, especially if you have to wear a mask while sleeping.

[0015] Nasal CPAP therapy is particularly effective in treating certain respiratory conditions, so long as the patient complies with the treatment. If the mask is uncomfortable or difficult to use, patients may not comply with treatment. Difficulty cleaning masks, as it is often recommended to clean one's mask regularly If the mask is not clean (e.g., difficult to assemble or disassemble), patients may not clean their masks. This impacts patient compliance.

[0016] Masks intended for other applications (e.g., aviators) may not be appropriate for use in sleep-disordered breathing. Although masks designed for use in sleep-disordered breathing may not be suitable for other indications, 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 foam directly impacts the effectiveness and comfort of the patient interface. There is.

[0019] The patient interface is designed with consideration given to where the seal-forming part will come into contact with the face during use. In one form of patient interface, the patient interface is characterized in part by 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 The mask comprises an element that encloses the mouth area during use, for example forming a seal over the lower lip area of ​​the face. In one form of the patient interface, the seal-forming portion may be in communication 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 a variety of names given by their manufacturers, including nasal masks, full face masks, These include nasal pillows, nasal sprays and mouth-nose masks.

[0020] The location 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. For example, the patient's forehead It is not appropriate to use a goggle seal over the patient's nose.

[0021] One design is comfortable and effective for a variety of different face shapes and sizes As such, certain seal forming features can be designed for mass production. Until there is a mismatch between the seal 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 be filled with air or liquid and to seal against the face of the A resilient sealing element made of a cushion or 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 push against the face to form a seal. This requires additional force to be applied to the patient interface.

[0023] Another type of seal-forming feature is a thin flap of material located near the periphery of the mask. Contains a lap 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. Otherwise, additional force will be required to create a seal or the mask will leak. If the shape of the seal does not match that of the patient, it may wrinkle or bend during use. This can cause leakage.

[0024] Another type of seal-forming part is a sliding element, e.g. a nostril insertion. may include.

[0025] Another form of seal forming part uses an adhesive to achieve the seal. Some patients find it inconvenient to constantly apply and then remove it.

[0026] The following patent applications, assigned to ResMed Limited, include: The face seal forming part technology 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 poration It is.

[0028] ResMed Limited manufactures the following products that incorporate nasal pillows: SWIF T nasal pillow mask, SWIFTII nasal pillow mask, SWIFT LT nasal pillow mask, SWIFT FX Nasal Pillow Mask and LIBERTY Full Face Mask. Sold to RedMed The following patent applications describe nasal pillow masks: International Patent Application WO2004 / 073, 778 (which describes, among other things, the features of the RedMed SWIFT nasal pillow), U.S. Patent Application 2009 / 0044808 (specifically describing the features of the RedMed SWIFT LT nasal pillow), International Patent applications WO2005 / 063,328 and WO2006 / 130,903 (in particular Re Describing the features of the sMed LIBERTY full face mask), International Patent Application WO20 09 / 052,560 (describes, 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 for positive air therapy is The seal is thus positioned and subjected to the corresponding force of the air pressure. A variety of 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 ``not being able to do it.''

[0032] 1.2.5 Respiratory Pressure Therapy (RPT) Devices One known RPT used to treat sleep-disordered breathing is the S9 Another embodiment of the RPT device is the Sleep Therapy System. ResMed Stellar Adult and Pediatric Ventilators TM S Ventilators like Leeds are used for the treatment of NMD, OHS and COPD (but not limited to) Invasive and non-invasive non-dependent for various patients treating many diseases such as The RPT device can provide continuous ventilatory support. RPT devices are also known as flow generators.

[0033] ResMed Elisee™ 150 Ventilator and ResMed VS III (TM) ventilators are a range of invasive and non-invasive devices suitable for the treatment of a number of illnesses in adult and pediatric patients. These ventilators can be used with single or dual limb circulation devices. It provides 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 an airway of the patient. The outlet of the RPT device is connected to the air circuit, allowing airflow to be delivered at positive pressure to the patient's airway. 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 a controller based on the servo. and impeller. In some cases, a brake for the motor is incorporated to This overcomes the inertia of the rotor and impeller and reduces the blower speed more quickly. This allows the blower to achieve low pressure more quickly and in time, allowing the blower to blow air despite inertia. In some cases, the pressure generator is used as an alternative to controlling the motor speed. The device includes a valve that can discharge the generated air to 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. The controller is available with or without integrated data retrieval and display capabilities. The data storage capacity 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 as required. Typically, these are 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 a bed and are convenient for the patient. Only the flow of breathable gas delivered to the patient without humidifying and / or heating the surrounding area. For example, a room-based system can be configured to humidify and / or heat the Other devices (e.g. saunas, air conditioners, evaporative coolers) can also humidify the air the patient breathes, but 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. In addition, in cooler climates, warm air may be blown into the interface onto and around the patient's face. When it hits a wider area it is much more comfortable than cold air.

[0039] There are various types of respiratory humidifiers. The stand-alone type is 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 enough heat to keep patients comfortable. Humidifiers typically have a capacity of several hundred milliliters (ml). A water reservoir or tub for storing water; a heating element for heating the water in the reservoir; A gas supply that accepts gas from a control device that can change the level of the gas, a flow generator, or an RPT device. The gas inlet and the humidified gas outlet are connected to an air circuit that delivers the gas to the patient interface. The gas outlet includes a gas outlet adapted for

[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 tub and in thermal contact with the water tub. In this way, heat is transferred primarily by conduction. The airflow from the RPT device is directed to the water reservoir from the heater plate. The heated water in the tube passes through the air, resulting in water vapor being carried away by the air stream. The H4i™ and H5i™ humidifiers are examples of such heated passover humidifiers. and are used in conjunction with the RsdMed S8 and S9 CPAP devices, respectively.

[0041] Other humidifiers, e.g. 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 create an aerosol of water that is filtered out of particles before it leaves the humidifier. Use baffles or filters to allow air to circulate or evaporate. Wicking humidifiers Use absorbent materials such as sponges or paper to absorb water through capillary action The water absorbing material is placed in the air flow path or in the suction chamber so that evaporation in the absorbing 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 delivering heated water to a large surface area in a second direction. ResMed HumiCare™ D900 is designed to treat a wide variety of invasive and non-invasive It can be used with respiratory ventilators. 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 patient devices from the plurality of patient devices, each of the patient devices implementing a set of instructions. One or more of the following configuration data meet the criteria: and, if more than one update is provided, The simulation data indicates that the instruction updates are currently installed on said one or more patient devices. The instruction update to be provided to the one or more patient devices indicates that the one or more patient devices have not been updated. and selecting a new patient device. The method also includes selecting a new patient device for the one or more patient devices. transmitting said command updates and each of said one or more patient devices successfully receiving said command updates. and determining whether the command update has been installed. The configuration data includes information about one or more of the instructions that successfully installed the update. The patient information may be updated for each of the one or more patient devices.

[0044] In another embodiment, the instruction updates can include at least one of the following: Data specifying the location of an instruction update file; and which components of the device to apply said update to. a schedule time for each device to implement the update; If applicable, instructions on whether to request confirmation that the patient's treatment should be discontinued 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 to allow for the batching of 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 computing device, such as a clinician's or service personnel's computer, Further, the step of selecting an update command 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. and 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 is also meant to show that the instruction has never been corrupted or altered. The instruction update may be retransmitted to each device for which it was determined that the update was not successfully installed. This can be done.

[0046] According to yet another aspect, a patient device comprising: 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, The configuration update is successfully installed. The session 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 in 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 said patient device. and c) a version of the hardware. In addition, the instruction update includes the first part and and a second part, wherein the first component of the patient device is and a second component operates according to the first portion of the instruction update. It operates according to parts.

[0048] In another aspect, a method of updating a device for providing medical care includes: 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 updated instructions. generating a set of instructions for the first instruction set; and verifying that the update of the first instruction set has been performed. 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 validation 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 description 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 is supplied with air at positive pressure from an RPT device 4000. 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 system includes 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. Air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 through an air circuit 4170. [Figure 1c] The system includes a patient 1000 wearing a patient interface 3000 in the form of a full face mask and receiving a supply of air at 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> Diagram showing 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 cartilage, 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 an air circuit of an RPT device in accordance with one form of the present technology, with superior and inferior directions shown. [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 is a model of a typical respiratory waveform during human sleep. The horizontal axis represents time, and the vertical axis represents respiratory flow. With varying parameter values, a typical breath shows the following approximate values: tidal volume, Vt, 0.5L; inhalation time, Ti, 1.6s; peak inhalation flow, Qpeak, 0.4L / s; exhalation time, Te, 2.4s; peak expiratory flow, Qpeak, -0.5L / s. The total duration of a breath, Ttot, is about 4s. A human typically breathes at a rate of about 15 breaths per minute (BPM) using a ventilator device. Vent about 7.5L / s. A typical duty cycle, the ratio of Ti to Ttot, is about 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. 13 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, as disclosed herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0052] Before describing the present technology in further detail, it will be appreciated that the present technology may be modified in various ways as described herein. It should be understood that no limitation is intended to be imposed on the specific embodiments described herein. The terminology is for the purpose of describing only the particular embodiments discussed herein and is not intended to be limiting. It should be understood that there are no illustrations.

[0053] 4.1 Treatment system In one form, the technology includes a device for treating a respiratory disorder. The device includes a device for treating a respiratory disorder. The pressurized breathable gas is delivered through an air delivery tube leading to the patient interface 3000. The blood supply 1000 includes a flow generator or blower that supplies blood to the patient 1000 via the

[0054] 4.2 Treatment In one form, the technique includes applying positive pressure to an airway entrance of a 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 nasal obstruction by applying nasal continuous positive airway pressure to the patient. Methods for treating obstructive sleep apnea (OSA) are included.

[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: The seal forming structure 3100, the plenum chamber 3200, the positioning and stabilizing structure 33 00, vent 3400 and connection port 3600 for connection to air circuit 4170. In some configurations, the functional aspects are provided by one or more physical components. In some embodiments, a physical component may be provided in one or more In use, the seal-forming structure 3100 surrounds the airway entrance. The device is positioned so that air is delivered 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 chat function.

[0058] The seal-forming structure 3100 made by this technology is soft, flexible and elastic like silicone. It can be constructed from a variety of materials.

[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. The support flange may be relatively thicker than the sealing flange. The flange is disposed between the sealing flange and the peripheral edge of the plenum chamber 3200. The support flange 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 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. Each nasal spray or nasal pillow seals with a respective nostril of the patient's nose. The substrate is constructed and arranged to form a

[0061] A nasal pillow according to aspects of the present technology includes at least a portion thereof that seals under the patient's nose. a truncated cone forming a leg; a leg connecting the cone to the leg at a flexible area on the underside of 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 adapted to contact 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 adapted to contact the jaw area of ​​the patient's face during use. The seal forming portion forms a seal in the region.

[0064] 4.3.2 Plenum Chamber 3200 Preferably, the plenum chamber 3200 is in an area where a seal is formed during use. It has a periphery 3210 shaped to complement the surface contours of an average human face. In other words, the peripheral edge of the plenum chamber 3200 is placed close to the adjacent surface of the face. The actual contact with the face is provided by the seal-forming structure 3100. Preferably, the seal-forming The composite 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 (see, for example, FIG. 1b) In another embodiment, the plenum chamber 3200 is part of the nasal mask. The pleural cavity is in fluid communication with and / or surrounds the patient's nostrils and mouth. The mask 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 connected to one or more nostrils of the patient. The plenum chamber 3200 is in engagement with and / or fluid communication with the aperture. 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 present specification may be programmed to execute one or more of the control methodologies or algorithms described in the present specification. The RPT device preferably comprises a top 4012 of the outer housing 4010 and an outer housing The outer housing 4010 is formed on the lower portion 4014 of the housing 4010. In an alternative embodiment, the outer housing 4010 may include one or more panels 4015. Preferably, the RPT device 4000 includes one or more It includes a chassis 4016 that supports the internal components. In one embodiment, the air blower The rack 4020 is supported by or formed as 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 device capable of supplying positive air pressure (preferably by a blower 4142) 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 of the controllers described in, pressure device 4140, and 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 may be mounted on a PCBA 4202. 00 may contain one or more PCBA 4202.

[0071] The central computer of the RPT device 4000 may include one or more processors. The controller 4230 is configured to execute one or more algorithm modules. Preferably, the pre-treatment module, the treatment engine module, the pressure control The controller may include a fault condition module and, more preferably, a fault condition module. The controller may incorporate one or more of the vent control methodologies described throughout this specification. The device may further include a vent control module.

[0072] 4.4.1 RPT Device Mechanical and Pneumatic Components 4100 4.4.1.1 Air filters(s) 4110 An RPT device according to one form of the present technology includes an air filter 4110 or a plurality of filters. It may include 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 ion exchanger, see Figure 4b.

[0074] In one embodiment, the outlet air filter 4114, e.g., an antibacterial filter, is The air block 4020 is located between the outlet of the air block 4020 and the patient interface 3000. reference.

[0075] 4.4.1.2 Muffler(s) 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 a blower 4142 and a patient interface. 3000, see FIG. 4b.

[0077] 4.4.1.3 Pressure device 4140 In one form of the present technology, a pressure device 4140 that generates a positive air flow is controllable. A blower 4142. For example, the blower may be one or more fans housed in a volute. The blower preferably includes a brushless DC motor 4144 having an impeller. Positive pressure air of about 120 liters / min is delivered in the range of about 4cmH2O to about 20cmH2O. or other forms up to about 30cmH2O.

[0078] The pressure device 4140 is under the control of the therapy device controller 4240 .

[0079] 4.4.1.4 Converter(s) 4270 In one form of the present technology, one or more transducers 4270 are One or more transducers 4270 are located upstream at that point in the air path. The air conditioner is constructed and arranged to measure the air properties of the room.

[0080] In one form of the present technology, one or more transducers 4270 are downstream and upstream of the air circuit 4170. One or more transducers 427 0 is constructed and positioned to measure the properties of the air at that point in the air path.

[0081] In one form of the present technology, one or more transducers 4270 are connected to a patient interface. It 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. The anti-spillback valve is located between the humidifier 5000 and the water supply upstream, e.g. The electrical connector 4144 is constructed and arranged to reduce the risk of electrical leakage to the electrical connector 4144.

[0083] 4.4.1.6 Air Circuit 4170 An air circuit 4170 according to aspects of the present technology may include an air blower through which a flow of air or breathable gas passes. 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 air passageway. do.

[0085] In one form of the present technology, supplemental oxygen is discharged 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 provided in 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. 4010 。

[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 may be provided to power 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 includes a button to allow a worker 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 the operation settings of RPT device components such as vent placement. A button, switch or dial can be implemented using a physical device or a touch screen. In one embodiment, the button, switch, 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 positioned to allow the user to select one of the following 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 form, the central controller 4230 includes separate electronic components.

[0094] In another form of the present technology, the central controller 4230 is an x86 INTEL The processor is suitable for controlling the RPT device 4000 such as a processor.

[0095] A central control suitable for controlling an RPT device 4000 according to another form of the present technology. The processor of the controller is an ARM Cortex-M processor from ARM Holdings. processors based on ST MICROELECTRONICS You can use the STM32 series microcontrollers.

[0096] Another processor for controlling the RPT device 4000 according to a further alternative form of the present technology. The processor is selected from the ARM9-based family of 32-bit RISC CPUs. For example, the ST Microelectronics STR9 series microphones You can use the controller.

[0097] In one alternative embodiment of the present technology, a 16-bit RISC CPU is used as the processor for 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 signal(s) 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 technology, a central controller processor or multiple A processor such as the 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 include a plurality of respiratory therapy devices (e.g., a first respiratory therapy device, a second respiratory therapy device, a third respiratory therapy device, a fourth respiratory therapy device, a fifth respiratory therapy device, a sixth respiratory therapy device, a sixth respiratory therapy device, a seventh ... For the purpose of performing the above-mentioned operations, the RPT device 4000 may be integrated discretely from the flow generating components. 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 may 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 blanking circuit 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. Including 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, the memory 4260 may be located on the 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 l (SD) standard memory card-like removable memory 4260 included .

[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 having instructions thereon.

[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

[0112] 4.4.2.8.1 Flow rate The flow rate transducer 4274 based on 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 a second point, respectively.

[0113] When in use, a signal representing the total flow rate 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 air passage. 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 embodiment, the signal from the pressure transducer 4272 is transmitted to the central controller 42 30 are filtered before being received.

[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 to The data communication interface 4280 is preferably connected to the controller processor. The data communication interface 428 can be connected to a remote external communication network 4282. Preferably, the network is 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 communications network 4284 is connectable to a local external device 4288 .

[0118] In one embodiment, the data communication interface 4280 is connected to a central controller 423. 0. In another embodiment, the data communication interface 4280 is a 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) or fiber optics) or wireless protocols that connect to the Internet. That's fine.

[0120] In one embodiment, the local external communication network 4284 is a Bluetooth Utilizing one or more communications standards such as the IEEE 802.11b (registered trademark) or the Civil Infrared Protocol .

[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 must be operated by an appropriately authorized person, such as a clinician. can access it.

[0122] Preferably, the local external device 4288 is a personal computer, a mobile phone, a tablet, It may be a mouse or 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 haptic 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. The input signal is converted into instructions to display a signal or image.

[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 eight-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 directs the eight corresponding segments to display a particular character or symbol. Each indicates whether it should be activated.

[0126] 4.5 Communication 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 as limiting the scope or applicability 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 a network of any size, 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 position.

[0127] Each of the patient devices 720, 730 and 740 includes an RPT 4000 and a humidifier 5000. and one or more devices including a patient interface 3000. Further, 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 the patient interface 3000. In addition, 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 may also occur over a network 4282 via a computing device (not shown). The user device 720 is a personal computer that transmits data over the network 4282. It can communicate with the data.

[0128] Server 710 may include one or more processors 712, memory 714, and 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, and can store information accessible by the processor 712. It may also include data 718 that may be retrieved, manipulated, or stored by the processor 712. Memory can be any non-transitory storage device capable of storing information that can be accessed by a processor. Instructions 716 include instructions that are executed directly or indirectly by processor 712. With respect to the present invention, the terms "instruction", "application", "step" and "program" are used interchangeably herein. The functions, methods and routines of the instructions are described in detail below.

[0129] Data 718 may be retrieved, stored, or processed by processor 712 according to instructions 716. For example, the subject matter described herein is not limited to any particular data structure. Although not all data is stored in a computer register, the table can be It has fields and records, so it can be used as a relational database or an XML document. The data 718 can be a number, a description, a special code, a pointer, etc. Associations such as references to other memory-stored data, such as network locations The information may be any information sufficient to identify or calculate one or more 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 the patient devices 720, 730 and 740 are each in one block. Although the various components of each device are shown functionally, they 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 device Similarly, the processor 712 may include multiple processors, some or all of which may be Or all of them are located in a housing different from the housing of the server 710. Therefore, any reference to a processor, computer, computing device, or memory is Any processor, computer, computing device or memory device that may or may not operate It should be understood that this includes references to a collection of processors. Although described herein as occurring on a single computing device having a Other aspects include multiple devices that communicate information with each other, such as by communicating over a network 4282. The calculation can be performed by any suitable computing 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 code is used when the network is the Internet, the World Wide Web, or a specialised intranet. , it 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, allowing , 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 is connected to a storage system 750, a computing device 7282, and the like via a network 4282. 60 and one or more communication devices capable of communicating with patient devices 720, 730 and 740. As described in more detail below, the server 710 includes software and Firmware updates 716 are sent to the 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 a processor 762, a memory 764, and the instructions described above. 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 as a display (e.g., a monitor having a screen, a touch screen, a printer, projector, television, or other device capable of displaying information) and user input devices such as a device 768 (e.g., a mouse, keyboard, touch screen, or microphone) The present invention has all the components used in connection with a personal computing device.

[0134] 4.6 Example Method As described above, each of the patient devices 720, 730 and 740 shown in FIG. 4000, a humidifier 5000 and a patient interface 3000. In carrying out the above-described operations, the patient device 720, 30 and 740 implement the instruction set 726, which may include software or firmware. As explained in relation to Figure 4c, the RPT4000 can be used as a humidifier controller. Includes multiple controllers such as the 5250 Therapy Device Controller and the 4240 Therapy Device Controller. 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 includes 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 carried out.

[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 certain functionality. or to correct an identified problem in the operational behavior of one or more modules of the device. Thus, in some cases, updates may be related to modifying the effectiveness of the patient device. This is essential for efficient management and is essential for patient safety. Further instruction set 726 can be automatically updated through communication network 4282. In particular, the server 710 may transmit 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 manner, the patient device can easily The device can be upgraded or otherwise customized remotely, and the patient can easily connect the device to the clinician. There is no need to take the product to a service center.

[0136] In one embodiment, a particular patient device may be identified as being capable of receiving or receiving a particular update. For example, the server 710 may select a particular should receive the specified instruction set update 716, but the patient devices 730 and 740 do not. The server can then determine which specific patient devices should receive a particular update. 710 indicates the configuration of each of the patient devices 720, 730 and 740. The configuration data 718 can be stored in the form of 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 number and hardware version number The configuration data 718 may include any information previously associated with the patient. A record of the instruction set updates sent to the device and a record of whether the sent instruction set updates were successful. It also includes an indication of whether the configuration change was or was not applied to the user device. The Patient Data 718 is not limited to distinct information regarding one particular patient device, It can contain information that is applicable to multiple patient devices. For example, configuration Data 718 identifies the supplier or retailer of the patient device and the Alternatively, the update may include the location or area covered by the particular update. The system can be triggered by other factors such as correctable fault conditions.

[0137] The configuration data 718 is stored on 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 transmits the configuration data 728 to the server 710 via the 0 then reads the received configuration data 728 The patient device configuration data is stored in the 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 include a humidifier module 730. 23 firmware has been successfully updated from the first version to the second version. The notification can then be sent to the server 710. 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 The configuration data 728 is then 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 710. For example, a user of the computing device 760 may thereby The device 760 may specify a particular update 716 for a particular patient device 720, 730, or 740. The user can then access a website that provides an interface to a server 710 that can be configured to access the user's computer. To identify a patient device on which an update should be performed, the computing device 760 may select a patient device that meets certain criteria. For example, the memory 714 of the server 710 may be searched for a user device. The User may use the Software for all Patient Devices incorporating a particular software version or for a particular In another embodiment, the server 710 can be requested to identify a serial number within the range of Alternatively, the computing device 760 can request a list of all patient devices purchased from a particular retailer. do.

[0139] A user of the computing device 760 can identify the 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 A specific version of software or hardware that should be used can be identified. 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. The company requested that the company provide update 716 for module 723, which is the humidifier firmware update. The server 710 then selects The update 716 is 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 only if 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 click the 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 a communications server 710. The communication server then forwards this request to the download server. The update 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; Specify the data, such as host server, port, file name; large device updates schedule times to perform updates for each device so that updates 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 may cancel an upgrade that has not yet occurred. data structures and functionality that allow for batch upgrade requests in a single operation You can also 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 the 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. The validation data may include a checksum, cyclic redundancy, or the like. This may take the form of a length check or identification of the size of the update file. The patient device 720 may then receive the update 716, which includes the checksum. It compares 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 transmits 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. Such as a set of instructions 726 for a communication module 721 and a humidifier module 723. In another embodiment, the plurality of instruction sets for the components are modified. A specific instruction set 726 is implemented by multiple components, and this instruction set 72 A revision to 6 will result in revisions to multiple of these components. The transmission may also be sent to and applied by the update 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 modified more than once to ensure that the final version of the The above updates may be required. For example, 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 identification of other updates that must be installed in order to install the In another embodiment, the transmitted update 716 may include an update 716 installed on the Identification of the version or versions of Instruction Set 726 required to install 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 bidding status identified by the update 716. Based on that decision, the 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 a combination of the identified components, It can be determined whether the identified component meets the identified build standard. 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 may avoid installing the update 716 . In one embodiment, the patient device 720 does not include or use You can avoid installing only those parts of update 716 that relate to components that are not However, you can still 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 then 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 the schedule. The schedule is stored in the configuration data for each patient device. In this way, updates that apply to a large number of patient devices can be implemented in as little as a few weeks. or for an extended period of several months, and there is a network This reduces the load that must be transmitted at the time the update 716 is received by the patient device. If a renewal 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 sage or other kind of back-pat. 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 an update 716 that was about to occur. A user of the device 760 may update 716 on one or more patient devices 720, 73 0 and 740 to send a request to cancel. In response to the request from , the server 710 removes the particular update 716 from the list of scheduled updates. An update may have already been sent to one or more patient devices but has not yet been installed. If not, the server 710 may cancel one or more updates. Upon receiving the update cancellation, the patient devices 720, 730, and 740 may be removed from memory before the received update 716 is installed.

[0145] Alternatively, the transmission may be on a specific date, but each device may incorporate the updates 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 before installing for various reasons, such as when you receive an update. When a patient is receiving treatment from the patient device 720, the patient device 720 may install updates. You can wait until the patient has finished treatment before you can continue. This will prevent the patient from being interrupted. Or you can avoid the negative impact of installing updates. In an embodiment, the update may be installed while the patient device is in use. Specifically, when an update is being performed, specific For example, the update 716 may occur while the patient device is providing respiratory therapy. The update 716 is therefore only relevant to the communication module 721 and is 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 will display a notification that the patient device is being updated. This notice informs the patient that they should not turn off the patient device and that they should not 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 notification that the update has been installed. Requires confirmation from the patient before use. Additionally, over a period of time, many devices may become new. Download software, but the downloaded updates are not for marketing or For communication purposes, all devices can be installed on the same day.

[0146] According to one embodiment, a user of a computing device 760 may notify a server 710 of the status of an update 716. For example, the computing device 760 may be able to query the status of a particular update 716. You may 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 A list of patient devices and any errors that may have occurred 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 implemented by the patient device 720. 726. The server 710 can query the server 710 for a list of configurations. Configuration Data 718 to identify the information requested and The information is sent to a computing device 760, which generates a query and sends it to a 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 related to 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 receive a notification from the software currently accessible to the patient device. A set of instructions can be embedded in the device, such as in software or firmware. are related to the operation of multiple components within the patient device and need to be stored in a single location. If a set of instructions is implemented, the patient device can transmit data over the network in one or more The data can then be transmitted to further external devices (block 804). For example, the patient device 720 may 4282, one or more This transmission will include the date and time that the patient used the patient device. The patient device receives a transmission from an external device, such as a server 710, Determine whether a received transmission is related to one or more instruction set updates. For example, the patient device may receive update data from a specific address on a server (block 806). A transmission indicating that the update is available at a particular 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 to a checksum to verify that all updates have been received. The patient device further determines that the currently installed version of the instruction set is Determine whether the version matches one of the versions required to install the update. If it is determined that there is an error with 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 and 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 or adding to the instruction set. This includes replacing the original instruction set with an entirely new instruction set. As mentioned above, the updates include instruction sets for different components of the patient device. Contains fixes to various instruction sets, including: Checks the installation to determine if the installation was successful. This includes checking the The process also includes checking each of the components (block 814). The patient device then transmits 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 identity of a patient device that meets the above criteria. For example, 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 serial number of the patient device, and the versions of software and firmware currently installed by the patient device. The server receives a query based on multiple 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 controller 100 responds to the request (block 906).

[0151] The server then transmits one or more updates to the one or more patient devices. Receive a request for a calculation (block 908). For example, as described above, the computing device 760 may The patient devices 720, 730 and 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 update data (block 910) and retrieves the update 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 At the time (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 update 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 file stored in the identified location. The new file data is provided to the patient device without requiring the server 710 to access the new file data. 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 receive either a confirmation or a message that the update was successfully installed. If an error occurs in the communication, the server will resend the update data to each patient device that experienced the error. Alternatively, the actual update file (the new software) may be downloaded (block 912). The software is not pushed down to the device by the server 710 but is 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 incidental to the occurrence of one or more other conditions. For example, update data may be updated by the patient device after the device has delivered therapy for 200 hours. Therefore, block 9 can be used to indicate that There is a significant amount of time between block 12 and block 914. However, 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 transmitted update ( The update is reported as successful (block 916) and the update is reported as successful (block 918). If any more patient devices are successfully updated, the server 710 sends a message to the computing device 760. The update is complete when the user (e.g., a technician) is notified by sending a message. Sage will notify you of the specific patient device or group of patient devices that have successfully installed the update. Identify.

[0153] The instructions described in Figures 8 and 9 may be implemented in a single device, but may alternatively be implemented in 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 server 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 process. Further operations are shown in flowcharts 800 and 900. For example, the server may send updates to the therapy device in the same order that the updates are sent. If an update is needed, where to get it from (host, port, filename), and and how to verify it (e.g. checksum / CRC). The medical device communication module transmits the update file (command) from the specified host (server). This slightly different functional diagram shows how to download large amounts of software. If necessary, the load can be distributed from multiple servers, not just from server 710 as shown in FIG. In addition, the therapy device will indicate any transmission errors. The server itself can download update files (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 airflow relative to the atmosphere. to the entrance of the airway at a pressure that is within the range of the patient's respiratory 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 depending on the form, 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 composite silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of R is SILASTIC, manufactured by Dow Corning (this brand name). (It is included in the product range sold under the same brand name.) Another company that manufactures LSR is Wac Unless otherwise noted, 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. is.

[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 - Opening to atmosphere in a fail-safe manner reduces the risk of excessive CO2 rebreathing for the patient. Reduce.

[0160] Elbow: A conduit that directs the axis of air flow so that it changes direction around 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 generally circular cross section. The jets may have an oval or rectangular cross section.

[0161] Frame: The frame is a tensioned brace 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 adapted to connect the patient interface to the respiratory one or more devices configured to be placed and held in an appropriate location on the patient's face for delivery of treatment; A set of one or more braces, strings, and reinforcements. Some strings are It is formed of a soft, flexible, resilient material such as a laminated composite of foam and fabric.

[0163] Membrane: preferably substantially resistant to bending but resistant to stretching. " is interpreted to mean a typically thin element having a certain degree of uniformity.

[0164] Plenum chamber: The patient interface plenum chamber is e.g. A mask that encloses a volumetric space, such as a nose and mouth mask, nasal mask, or nasal pillow is taken to mean the portion of the patient interface that has a wall, the volume within which the patient is During use, the air is pressurized above atmospheric pressure. The shell is the patient interface plenum. In one embodiment, the patient's face area is supported by 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. The verb form ("to se") 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 bending, tensile and compressive stiffness. For example, a portion of the mask that forms a curved structural wall of the mask. Preferably, the shell 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] Reinforcement: A reinforcement is a component that increases the bending resistance of another component in at least one direction. 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. 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 embodiment, the swivel base comprises 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, during use, there is little or no air leakage from the swivel base.

[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 surrounding 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 files or records, anyone may There is no objection to the facsimile reproduction of the disclosure of . Whatever copyright is reserved.

[0173] Unless the context clearly indicates otherwise and unless a range of values ​​is given, Intervening values ​​are between the upper and lower limits of the range, up to 1 / 10 of the unit of the lower limit, and Any other stated or intervening values ​​in the stated ranges are encompassed within 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 range. 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 of the 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 disclosed that are incorporated herein by reference. Unless otherwise specified, such values ​​may be approximate and may vary based 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.

[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 manufacture of the present technology. can be used in testing, but a limited number of exemplary methods and materials are described herein.

[0176] If a particular material is identified as being used to construct the component, it must have similar properties Obviously alternative materials having the above characteristics may be used as substitutes. Unless otherwise stated, it is understood that any and all components described herein are manufacturable, Thus, they can be produced together or separately.

[0177] As used in this specification and the appended claims, the singular forms "a," "an," and "the" Please note that these terms include their plural forms 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 otherwise specified. The publications discussed herein are incorporated by reference to disclose and describe the The present invention is not intended to be limiting or limiting the scope of the present invention. " shall be interpreted as an admission that the invention is not entitled to antedate such publication by reason of prior invention. Further, the publication dates listed may be different from the actual publication dates, Each should be checked separately.

[0179] Moreover, in interpreting this disclosure, all terms shall 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 together with other elements, components, or steps that are not part of the or in combination.

[0180] The subject headings used in the Detailed Description are included solely for the reader's ease of reference and are not intended to be limiting. shall not be used to limit the subject matter found throughout the disclosure or claims. The subject headings shall not be used to construe the scope or limitations of the claims. stomach.

[0181] Although the technology described herein has been described with reference to specific embodiments, these embodiments may It should be understood that the present invention is merely illustrative of the principles and applications of the technology. Symbols may imply specific details that are not required to practice the technology. For example, The terms "first" and "second" are used unless otherwise noted, and are intended to be used interchangeably. It is not intended to imply any ordering but may be used to distinguish between distinct elements. Furthermore, although the process steps in a methodology may be described or illustrated sequentially, such Such an order is not required. Those skilled in the art will appreciate that such an order may be modified and / or It will be appreciated that the features may alternatively be performed simultaneously or synchronously. Accordingly, numerous modifications may be made to the exemplary embodiments without departing from the spirit and scope of the technology. It will be appreciated that other configurations may be devised without departing from the spirit and scope of the present invention. [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 Oxygen supplement 4200 Electrical Components 4202 PCBA 4210 Power supply 4220 input device 4230 Central Controller 4232 Watch 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 communication network 4284 local external communications 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 sets of instructions for operation of the patient device; One or more processors It is equipped with the one or more processors: Accessing a first set of one or more instruction sets for operation of the patient device; performing a first set of operations in accordance with the first set of instructions; 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 satisfies one or more criteria, the update data indicating one or more operations and whether an update to the first instruction set 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. A patient device as described in claim 1 or 2, wherein the one or more processors are configured to receive verification data and determine based on the verification data whether the update data was downloaded successfully.

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 A patient device according to any one of claims 1 to 3, configured as follows:

5. A patient device as described in any one of claims 1 to 4, wherein the update data indicates that the one or more operations can be performed by the patient device while an update of the first instruction set is being performed.

6. The patient device of claim 5, wherein the one or more operations include the patient device providing therapy.

7. A patient device as described in claim 1, wherein the one or more operations include providing therapy by the patient device, and the update data indicates that the one or more operations may be performed by the patient device while an update of a first instruction set is being performed.

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 set of instructions has occurred, the confirmation including a generated indication that the updated components of the patient device have been checked; A patient device according to any one of claims 1 to 7, configured so as to

9. The patient device of claim 8, wherein the one or more processors are configured to transmit configuration data indicating at least one software and firmware version 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 update the first instruction set based on a determination that the patient device meets the build standard.

11. A patient device as described in any one of claims 1 to 8, wherein the one or more processors are configured to transmit configuration data relating to the patient device to the remote computing device via the network.

12. A patient device as described in 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. A method for updating a patient device during 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, wherein the one or more computing devices receiving a query from a remote computing device, the query being configured to identify, at the one or more servers, one or more of the patient devices among 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 transmit 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.

23. A method of updating a patient device, comprising:

14. A method of updating a patient device as described in claim 13, wherein the update data indicates that the one or more actions can be performed by the one or more patient devices while the instruction update is installed.

15. The method of updating a patient device of claim 14, wherein the one or more actions include providing therapy via the one or more patient devices.

16. The method of updating a patient device as described in claim 13, wherein the one or more actions include the one or more patient devices providing therapy, and the instruction update indicates that the instruction update is not installed while the one or more patient devices are providing 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. The method of updating a patient device according to 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, based on the configuration data, an instruction update to be provided to the one or more patient devices from a plurality of updates.

19. The instruction update includes: data specifying the location of an instruction update file; instructions as to which components of the patient device the update should be applied to; A schedule time for performing the update on 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; The method of updating a patient device according to 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 of 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) the version of an instruction set currently installed on the patient device; c) the version of the hardware; and d) the 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. The method of updating a patient device according to 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.

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