Pacemaker Delivery via Cold Fluid Temperature Control
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Solution Overview
Problem
Current interventional medical systems face challenges in efficiently delivering implantable cardiac pacemakers to implant sites due to mechanical and MRI compatibility issues, necessitating the development of systems that can facilitate easier and more efficient deployment.
Innovation Solution
An interventional medical system comprising a loading assembly and a delivery catheter, where the loading assembly includes a deployment member and a capsule with a chamber to hold the pacemaker, allowing the device to be pulled into the capsule and then pushed into the catheter lumen, utilizing a cold fluid to maintain the fixation member's extended condition for secure implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a standard guiding catheter is used to deliver the implantable medical device through the venous system, then the device can be delivered to the implant site, but the delivery process becomes complex and time-consuming
Solution Approach 1:
The implantable medical device is nested within a delivery catheter, which is in turn nested within a loading assembly. This multi-level nesting allows the device to be compactly stored and efficiently delivered through the venous system without requiring complex external manipulation equipment, thereby improving delivery efficiency while maintaining manageable system complexity
Solution Approach 2:
The delivery system is segmented into distinct functional modules: a loading assembly for device preparation, a delivery catheter for transport, and an implantation mechanism for deployment. This segmentation allows each component to be optimized independently and simplifies the overall delivery process by breaking it into manageable steps, reducing both time and complexity
2Reliability
If the fixation member fingers are kept in the extended condition during delivery, then secure tissue engagement is achieved, but the device cannot be properly loaded into the narrow catheter lumen
Solution Approach 1:
The fixation member fingers are designed to dynamically change their configuration between extended and retracted states. During loading, the fingers are held in a retracted state to fit within the narrow catheter lumen. Upon deployment, they automatically extend to engage the tissue securely. This dynamic behavior resolves the contradiction between loading ease and fixation security
Solution Approach 2:
The physical state of the fixation member fingers is changed by controlling their temperature. The fingers are maintained at a lower temperature during loading to keep them in the extended condition for secure engagement, then warmed during deployment to allow proper loading into the catheter lumen. This parameter change (temperature control) enables both secure fixation and easy loading
3Object-affected harmful factors
If the device is delivered through a narrow catheter lumen, then minimally invasive implantation is achieved, but the fixation member fingers must be compressed which complicates the structure
Solution Approach 1:
The fixation member fingers are constructed from flexible materials that allow them to be temporarily compressed during catheter traversal and then return to their original extended configuration upon deployment. This flexibility enables minimally invasive delivery through narrow catheters without requiring complex compression mechanisms or structural modifications to the fixation fingers themselves
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
Enables efficient and precise delivery of the pacemaker to the implant site, ensuring secure engagement with tissue and reducing the complexity of the implantation process while maintaining mechanical and MRI compatibility.
Implementation Method 1
a temperature in the chamber is lowered... a relatively cold fluid, which keeps the device fixation member fingers in the extended condition, is infused through the device delivery lumen
Data Source
AI summary
A system for delivering an implantable medical device includes a loading assembly and a catheter. The loading assembly includes a deployment member and a sidewall defining a chamber into which the device may be pulled through a distal opening thereof, so that the sidewall holds fingers of the device's fixation member in an extended condition while a temperature in the chamber is lowered. When the chamber is connected to the catheter, advancing the deployment member pushes the device, with fixation fingers in the extended condition, into a delivery lumen of the catheter. With the catheter positioned within a patient, the device can be pushed into a distal portion of the catheter while a relatively cold fluid is infused through the delivery lumen. While holding the deployment member in place, retracting the catheter exposes the device fixation fingers out from the lumen, for engagement with tissue at the implant site.