Ambulatory Therapy Device Patient Response Delay Mechanism
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Solution Overview
Problem
Ambulatory medical devices struggle to accurately determine when to deliver therapy, particularly in cases where patients need to delay therapy due to conditions undetected by the device, and are not configured to handle patients with poor dexterity or fine motor skills.
Innovation Solution
The ambulatory medical device includes sensors, treatment elements, and response mechanisms that allow patients to delay therapy by changing the state of a response mechanism within a predetermined time, using visual and audible stimuli, and is configurable to operate in modes requiring single or dual button activation based on patient dexterity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Speed
If the ambulatory medical device automatically detects cardiac abnormalities and delivers therapy without patient response verification, then the therapy delivery speed is improved, but the reliability of therapy delivery deteriorates due to false positives and inability to detect patient responsiveness
Solution Approach 1:
The device incorporates a response mechanism that provides feedback by detecting patient responsiveness through button presses or other user inputs. This feedback loop allows the device to verify whether the patient is conscious and should receive therapy before automatically delivering treatment, thereby resolving the contradiction between fast automatic delivery and reliable accurate delivery.
Solution Approach 2:
The device performs preliminary assessment of patient responsiveness through the response mechanism before committing to therapy delivery. This preliminary action of checking patient consciousness status prevents false positive therapy deliveries while maintaining the capability for rapid treatment when the patient is unresponsive.
2Measurement precision
If the ambulatory medical device uses complex response mechanisms requiring precise motor actions, then the ability to detect patient responsiveness is improved, but the ease of operation deteriorates for patients with poor dexterity or fine motor skills
Solution Approach 1:
The device offers multiple configurable response mechanisms with varying levels of motor skill requirements. Patients can select or be assigned response mechanisms that match their dexterity capabilities, such as large buttons, voice commands, or automated sensors, thereby maintaining accurate responsiveness detection while accommodating different operational ease requirements.
Solution Approach 2:
The response mechanism is made adaptable and configurable rather than fixed. The system can dynamically adjust the type of response required based on patient needs, allowing those with poor dexterity to use alternative methods while maintaining the same level of responsiveness detection accuracy.
3Reliability
If the ambulatory medical device delays therapy delivery to verify patient responsiveness, then the reliability of therapy delivery is improved, but the loss of time increases which may be critical in emergency situations
Solution Approach 1:
The device implements periodic sampling of patient responsiveness during a configured time window rather than continuous verification. This allows the system to efficiently check for patient response at intervals, minimizing time loss while maintaining reliable detection of patient consciousness status to prevent false positive therapy deliveries.
Data Source
AI summary
An ambulatory medical device capable of delivering therapy to a patient includes at least one sensor, at least one treatment element, and at least one response mechanism having first and second states and configured to be actuated by the patient. The device also includes a controller including at least one processor configured to detect a value indicative of a health disorder, request that the patient change a state of the response mechanism(s) from the first to second state within a first predetermined period of time, delay the therapy, monitor the response mechanism(s)' state for a second predetermined period of time and request that the patient change the response mechanism(s) from the second to first state, and further delay the therapy in response to detection of a change in the response mechanism(s)' state or prepare to deliver the therapy to the patient in response to the response mechanism(s)' state not changing.