Verilux, Inc.

Nextern, Inc.

Nextern Innovation, LLC

Sleep Number Corporation

Deepwell Dtx

White Bear Medical, LLC

Whitte Bear Medical LLC

Ryan J Douglas

Casey R Carlson

Dennis Berke

David Bontrager

Anthony John Shakal

Richard Farrell

Nicholas Harmon

Steven Gigl

Jonathan T Lawson

Davis Flanagan

Brian Loushine

Steven M Gigl

James Kinney

Michael S Wilson

Jalen S Douglas

Matthew J Douglas

Courtland Farrell

Parker J Douglas

Ken Vojacek

Joseph Cameron

An apparatus can include a housing defining a housing interior, an air pump positioned in the housing interior, and a plurality of resilient connectors connecting the air pump to the housing with the resilient connectors in tension so as to reduce transmission of vibration from the air pump to the housing during operation of the air pump.

Pump housing with vertically supported vibration isolators

Apparatus and associated methods relate to a risk trace matrix engine for managing database associations, in a quality management system (QMS), between risk mitigations and features of a system having a risk-based profile. In an illustrative example, metadata may be created to associate risk mitigations with elements of a product and then metadata may be stored in a database during the design or operating lifecycle of the product, for example. The engine may dynamically build one or more trace matrices for the product design, each matrix associating risk mitigations to elements of the product design documentation. In response to any modifications that may relate to the component's specifications, for example, the engine may retrieve associated metadata and generate notifications prompting for user verification. In various implementations, such engines may advantageously reduce the risk by automatically generating traceability via a matrix of associations between features and components, which may be hardware and/or software components.

FDA compliant quality system to risk-mitigate, develop, and maintain software-based medical systems

Systems, and methods relate to a medical device receiving a treatment parameter operating point within a first operating region defined by a first set of operating points for which automatic incremental adjustment of a parameter in the current operation is permitted. In an illustrative example, incremental adjustment may use artificial intelligence based on patient feedback and sensor measurement of outcomes. Some exemplary devices may receive a request to alter the current treatment parameter operating point to a second treatment parameter operating point outside the first operating region and in a second operating region in a known safe operation zone, bounded by a known unsafe zone unavailable to the user. In the second operating region, some examples may restrict the step size of incremental adjustments requested by the user. Data may be collected for cloud-based analysis, for example, to facilitate discovery of more effective treatment protocols.

Dynamically controlled treatment protocols for autonomous treatment systems

Apparatus and methods relate to a pneumatic compression therapy device configured to suggest content to the patient based on a determined disease state, the content pertaining to suggested changes in lifestyle based on a standard of care. In an illustrative embodiment, the suggested changes may include modifications to treatment location, treatment time, diet, eating habits, or sleeping schedule. Various examples may further sample the patient's health and automatically adjust a treatment parameter within a predetermined parameter range based on a history of measured parameters, such as limb volume, for example. In coordination with the therapeutic treatment, the therapy device may deliver suggested content to guide the patient to make more healthful lifestyle choices to reduce recovery time and improve patient health outcomes.

Responsive whole patient care compression therapy and treatment system

Apparatus and associated methods relate to management of therapeutic digital assets in a non-medical environment. In an illustrative example, non-medical digital asset(s) (NMDAs) may be evaluated relative to one or more therapeutic modalities. A corresponding therapeutic digital asset (TDA) may, for example, be generated for each therapeutically associated NMDA. The TDA may, for example, be traceably associated with corresponding risks and/or risk mitigations. Each TDA may be associated, for example, with a test profile corresponding to a risk and/or risk mitigation. A TDA may be released into a non-medical digital content delivery environment (DCDE), for example. The TDA may, for example, be monitored in the DCDE to maintain verification and/or validation (VV). A change in the DCDE affecting VV of the TDA may, for example, result in deactivation of the TDA in the DCDE. Various embodiments may advantageously permit VV of selected digital assets in a non-medical environment.

Immersive medicine translational engine for development and repurposing of non-verified and validated code

A valve can include a solenoid coil, a plunger having a core configured to respond to a magnetic field generated by the solenoid coil, and a valve disc. The valve disc can be positioned at a head of the core and configured to cushion impact when the valve is closed. A projection can be positioned and configured to cushion impact when the valve is opened. The valve can be used in an air bed system in fluid connection between an air pump and an inflatable air chamber of a mattress.

Noise reducing plunger

Apparatus and associated methods relate to a catheter manipulation handle with user interface controls for steering a catheter in situ while providing an augmented (e.g., motorized, powered and tunable precision steering, and perforation safeguards) control and feedback user experience. In an illustrative example, the catheter manipulation handle may provide motor assisted operation to automatically rotate and/or deflect a distal tip of the catheter to steer and guide the distal tip to a target location in the patient's vasculature system. The augmented feedback may include, for example, haptic feedback via the handle. Haptic, audible, and/or visual feedback via the handle may indicate, for example, proximity or engagement of the distal tip with sensitive tissue. In some examples, the handle's augmented operation may advantageously amplify feedback signals to enhance the user's perception of the patient's safety with respect to the safe passage of the distal tip through the patient's vasculature.

Robotically augmented catheter manipulation handle

Apparatus and associated methods relate to an adaptable microenvironment for cellular and biological processing in a traceable, transportable unit. In an illustrative example, an apparatus consists of one or more portable cell tissue containment modules that may be removably interconnected to perform a processing step and/or transfer the stored medium to another module. Associated apparatus and methods are proposed to ensure non-contaminating mechanical or fluid communication between a plurality of modules or between a module and peripheral equipment, to limit process errors such as steps performed out of order, and to intrinsically manage identification of tissue samples with accompanying process data in a manner that decreases risk of mislabeling or otherwise mishandling a sample at all stages of the production and treatment process.

Portable controlled micro-environment device for modular bio-processing

Apparatus and associated methods relate to a wearable compression therapy system for ambulatory therapy, the system including a wearable garment having one or more inflatable chambers, and a pneumatic engine locally coupled to the garment to provide control and inflation of the one or more inflatable chambers. In an illustrative embodiment, the pneumatic engine may control a pump and one or more valves to inflate the inflatable chambers. The valves and pump may be coordinated according to a pre-programmed profile. In some embodiments, the pneumatic engine may have a wireless interface configured to receive control signals from a remote mobile device untethered from the garment. The pneumatic engine may send to the remote mobile device signals indicative of sensed conditions of the compression therapy system. In some embodiments, the pneumatic engine may include a power source that advantageously permits the user to be untethered from a source of power.

Wearable active-compression therapy and treatment

Apparatus and associated methods relate to a Self-Validating System (SVS) which includes an Electronic Self-Validating Module (ESVM) that may be employed within a medical device, operable to receive and to transmit wireless transmissions to and from a personal electronic mobile device, the mobile device executing a Self-Validating Medical Device Remote Control (SVMDRC) application, also known as the mobile app, operable to control the ESVM, the mobile device and the ESVM further executing a pre-determined sequence of instructions at a pre-determined frequency, operable to perform a set of safety (validation) checks on the mobile device, and the ESVM. In an illustrative example, changes (updates) to the mobile device's operating system, the app, or the hardware on the mobile device may be detected by the mobile device, and may advantageously re-validate the mobile device automatically.

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Seattle, WA, United States of America

Ryan J Douglas