Leadless Pacemaker Delivery Cup for Coronary Sinus Anchoring
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Solution Overview
Problem
The difficulty in accurately positioning the distal tip of a delivery cup during the implantation of a leadless pacemaker in the coronary sinus, which can result in insecure or unsuccessful implantation due to slippage into the right ventricle, is exacerbated by the challenge of discerning the cup in sonogram images and the pacing capsule casting a shadow.
Innovation Solution
A catheter system with an inflatable balloon at the distal end is used to temporarily fix the delivery cup against the coronary sinus walls, allowing the pacing capsule to be deployed with tines that pierce and anchor into the target tissue, ensuring accurate implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If the distal tip of the delivery cup is used for implantation in the triangle of Koch, then the pacing capsule can be delivered to the target location, but the distal tip becomes difficult to discern in sonogram images and may slip into the right ventricle resulting in inaccurate placement
Solution Approach 1:
The delivery cup is equipped with a radiopaque marker that changes its radiopacity state based on inflation status. When inflated, the marker becomes radiopaque and visible on fluoroscopic imaging, allowing precise visualization of the delivery cup position. When deflated, the marker becomes radiolucent, reducing interference with imaging. This resolves the contradiction by making the delivery cup detectable when needed without permanent obstruction of the imaging field.
Solution Approach 2:
A radiopaque marker serves as an intermediary element between the delivery cup and the imaging system. The marker is coupled to the delivery cup and balloon, translating the invisible polymer material into a visible signal on fluoroscopic images. This intermediary allows the delivery cup position to be accurately detected without requiring the delivery cup itself to be directly visible.
2Reliability
If the delivery cup is maneuvered to the target tissue location, then implantation can proceed, but the delivery cup may slide away from the target tissue and enter the right ventricle causing insecure implantation
Solution Approach 1:
The balloon is inflated before deployment of the pacing capsule to pre-secure the delivery cup against the target tissue. This preliminary action of inflating the balloon creates a stable platform that prevents the delivery cup from sliding away during the subsequent deployment process, ensuring reliable implantation.
Solution Approach 2:
A compliant balloon filled with fluid (saline or contrast medium) is used to apply pressure against the target tissue. The pneumatic/hydraulic pressure from the inflated balloon secures the delivery cup in position, preventing slippage into the right ventricle and ensuring stable implantation throughout the deployment process.
3Adaptability or versatility
If a leadless pacemaker is implanted in the coronary sinus instead of the triangle of Koch, then alternative access to left ventricular pacing is achieved, but the delivery cup positioning becomes challenging due to anatomical constraints
Solution Approach 1:
The system allows for parameter changes in balloon inflation volume and pressure to adapt to different anatomical conditions in the coronary sinus. By adjusting these parameters, the delivery cup can be securely positioned in various locations within the coronary sinus, making the procedure adaptable to different patient anatomies while maintaining ease of operation.
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 method provides reliable and reproducible implantation of the pacing capsule in the coronary sinus, maintaining proximity to the left ventricular tissue and improving the effectiveness of cardiac therapy delivery.
Implementation Method 1
the balloon, when inflated, urges the delivery cup into position against a wall of the coronary sinus and temporarily anchors the delivery cup at the implant location
Data Source
AI summary
A system for delivery of a leadless pacemaker. The system includes a catheter with an elongate flexible tubular body with a proximal end and a distal end, wherein the distal end of the tubular body includes a delivery cup with an external surface having an inflatable compliant balloon; and a pacing capsule of the leadless pacemaker releasably retained in the delivery cup. The pacing capsule includes an arrangement of tines configured to deploy and pierce a target tissue at a desired pacing capsule implant site in a coronary sinus of a patient. The balloon, when at least partially inflated, is configured to urge the delivery cup against the target tissue during deployment of the pacing capsule.