Acclimation Profile for Implantable Cardiac Device Therapy
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Solution Overview
Problem
Patients with abnormal intrinsic heart rates, such as those with bradycardia or chronotropic incompetence, often experience discomfort due to sudden changes in heart rate when implanted with medical devices like pacemakers, requiring frequent reprogramming visits which can be inconvenient and costly.
Innovation Solution
An acclimation profile is programmed into the implantable medical device to gradually adjust therapy parameters, such as lower rate limit and maximum tracking rate, over a defined period, allowing the patient to acclimate to the stimulation therapy, reducing initial discomfort and minimizing the need for physician visits.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If stimulation therapy is immediately applied at target parameters after device implantation, then therapeutic effect is achieved quickly, but patient experiences discomfort and distress due to sudden heart rate changes
Solution Approach 1:
The patent applies preliminary action by implementing an acclimation period before full therapy initiation. During this period, the device gradually introduces stimulation at increasing percentages of target parameters (e.g., 25%, 50%, 75%, 100% over successive days) to prepare the patient's cardiovascular system for full therapy, thereby reducing sudden discomfort while ensuring eventual therapeutic effectiveness
Solution Approach 2:
The patent applies dynamics by making therapy parameters time-dependent and adaptable. The device automatically adjusts stimulation parameters based on elapsed time since implantation, transitioning from conservative initial settings to full target parameters over the acclimation period. This dynamic adjustment allows the system to optimize between immediate therapeutic effect and patient comfort at different time points
2Reliability
If therapy parameters are immediately set to target values, then treatment effectiveness is maximized, but frequent reprogramming visits are required to manage patient discomfort
Solution Approach 1:
The patent applies self-service by enabling the device to automatically manage its own parameter adjustment schedule without external intervention. The acclimation profile is programmed into the device, allowing it to autonomously transition through parameter stages (25%, 50%, 75%, 100% of target) over time, eliminating the need for physician reprogramming visits during the acclimation period and reducing overall healthcare burden
3Productivity
If heart rate is rapidly increased to target levels, then cardiac performance is quickly optimized, but patient experiences alarm and distress especially during sleep
Solution Approach 1:
The patent applies preliminary action by preparing the patient's cardiovascular system in advance through gradual acclimation. Before full therapy is activated, the device introduces progressive levels of stimulation over multiple days, allowing the patient's body to adapt to increasing heart rate demands. This prevents sudden alarm during sleep when full therapy might otherwise be immediately applied
Solution Approach 2:
The patent applies periodic action by structuring the acclimation process into distinct time-based phases (e.g., Day 1 at 25%, Day 2 at 50%, Day 3 at 75%, Day 4 at 100%). This periodic progression allows the patient's system to reset and adapt between stages, reducing cumulative stress and alarm while systematically achieving optimal cardiac performance over time
Data Source
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AI summary
This document discusses, among other things, systems and methods to acclimate a patient to therapy from an implantable medical device. For instance, an implantable medical device can include pulse generation circuitry, sensing circuitry, and a controller. The pulse generation circuitry can generate electrical pulses. The sensing circuitry can be for sensing cardiac electrical activity of the patient. In an example, the controller can detect cardiac events that define pacing timing intervals and control the delivery of electrical pulses in accordance with a programmed mode. The controller can be programmed to provide instructions to the pulse generation circuitry to deliver electrical pulses to the heart of a patient. In an example, the electrical pulses can be based on a therapy parameter. The controller can be configured to adjust the therapy parameter according to an acclimation profile to acclimate the patient to a stimulation therapy.