Steerable Cardiac Injection System for POAF Prevention
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Solution Overview
Problem
Post-operative atrial fibrillation (POAF) is a common complication of cardiac surgeries, affecting 20% to 50% of patients, and can lead to unfavorable post-surgical outcomes, including prolonged hospitalizations and increased morbidity and mortality. Current treatments may introduce additional patient trauma.
Innovation Solution
The method involves using a steerable delivery system to inject a treatment agent, such as calcium chloride or botulinum toxin, directly into ganglionated plexus sites within the cardiac tissue to induce neurotoxicity and inhibit hyperactivity of the cardiac autonomic nervous system, thereby reducing the occurrence of POAF.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current treatments for post-operative atrial fibrillation are used, then AF can be treated, but additional patient trauma is introduced
Solution Approach 1:
The treatment agent is injected into the ganglionated plexus sites during the cardiac surgery procedure itself, before the patient leaves the operating room. This preliminary action prevents AF from developing in the first place, eliminating the need for separate post-operative treatment procedures and associated trauma.
Solution Approach 2:
The AF prevention treatment is merged with the existing cardiac surgery workflow. The injection of treatment agent into ganglionated plexus sites is performed during the same surgical session as the primary cardiac procedure, combining two operations into one to reduce total patient trauma and hospitalization time.
2Reliability
If separate treatment procedures are performed for post-operative AF, then AF can be treated, but surgical time and hospitalization are prolonged
Solution Approach 1:
By performing the treatment during the initial cardiac surgery before discharge, the procedure eliminates the need for separate post-operative treatment sessions and reduces hospitalization time. The treatment is completed in advance, preventing AF from requiring later intervention.
Solution Approach 2:
The treatment procedure is merged with the primary cardiac surgery, combining the surgical intervention and AF prevention into a single operative session. This integration reduces total surgical time and eliminates the need for separate treatment procedures that would extend hospitalization.
3Reliability
If ganglionated plexus ablation is performed, then AF occurrence is reduced, but additional patient trauma is introduced
Solution Approach 1:
The mechanical ablation process (radiofrequency or cryoablation) is replaced with a chemical injection approach. Instead of using energy-based ablation devices that cause thermal or cold trauma to the ganglionated plexus, a treatment agent is injected to induce neurotoxicity, reducing AF occurrence with minimal tissue damage.
Solution Approach 2:
The treatment agent acts as a temporary, non-permanent solution that provides AF prevention without the need for complex, invasive ablation devices. The chemical agent is delivered via a simple injection and resolves the AF risk without requiring sustained mechanical or energy-based intervention.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This approach minimizes patient trauma by integrating the treatment into the existing cardiac surgical workflow, reducing surgical time, and targeting upstream triggers of POAF, potentially leading to improved post-surgical outcomes and reduced incidence of atrial fibrillation.
Implementation Method 1
inject a treatment agent, such as calcium chloride or botulinum toxin, directly into ganglionated plexus sites within the cardiac tissue to induce neurotoxicity and inhibit hyperactivity of the cardiac autonomic nervous system
Data Source
AI summary
One example provided a method for use with a cardiac procedure, including inserting a steerable delivery system into the body of a patient, the delivery system defining a lumen having an injection device disposed therein, and steering a distal end of the delivery system successively to each injection site of a plurality of cardiac injection sites, each injection site having a corresponding ganglionated plexi (GP) location. At each injection site, the method includes inserting a needle of the injection device into the injection site by extending the needle from a retracted position within the lumen to an extended position beyond the distal end, injecting a dosage volume of liquid treatment agent from the injection device into the injection site via the needle to treat the corresponding GP location to reduce potential occurrence of atrial fibrillation in response to the cardiac procedure, and retracting the needle into the lumen.


