Segmented Aortic Counter Pulsation Device for Tortuous Anatomy
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Solution Overview
Problem
Current aortic counter pulsation cardiac assist devices, such as intra-aortic balloon pumps, face challenges in accommodating the three-dimensional tortuous shape of the aorta, leading to difficulties in positioning and prolonged use, especially for ambulatory patients, due to limited size, material durability, and increased risk of complications like stroke and abrasion.
Innovation Solution
The development of aortic counter pulsation cardiac assist devices with customizable, modular assemblies that utilize medical imaging to design and manufacture active segments to fit individual patient anatomy, featuring a semi-rigid shell with a flexible membrane and stent anchoring system, allowing for larger displacement volume, reduced risk of occlusion, and improved durability through segmentation and larger power conduits.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a temporary intra-aortic balloon pump is tightly furlled and wrapped for insertion through a narrow introduction sheath, then the device can be inserted via minimally invasive technique, but the material may be damaged leading to premature failure
Solution Approach 1:
The balloon pump is divided into multiple segments that can be independently furred and wrapped. This segmentation allows the device to be compacted for insertion while reducing stress concentration on any single material point, thereby preventing damage and premature failure during minimally invasive insertion.
Solution Approach 2:
The balloon pump utilizes flexible material construction that can withstand repeated furling and unfurling cycles without damage. The flexible shell design maintains structural integrity during insertion while allowing the necessary deformation for minimally invasive delivery through narrow sheaths.
2Quantity of substance
If the balloon pump volume is increased to provide adequate cardiac assistance for ambulatory patients, then the level of cardiac assistance is improved, but the device cannot be passed percutaneously via an introduction sheath
Solution Approach 1:
The large-volume balloon pump is divided into multiple segments that can be compressed individually for insertion. This allows the overall device to achieve a compact profile for percutaneous delivery while maintaining the large total volume necessary for adequate cardiac assistance in ambulatory patients when deployed.
Solution Approach 2:
The segmented balloon pump segments are nested within each other during insertion, similar to a nested doll structure. This nesting allows the large-volume device to be compacted to a small size for passing through the introduction sheath, then expanded to full volume for therapeutic effect.
3Device complexity
If a straight pumping chamber design is used, then the device structure is simple, but the chamber cannot accommodate tortuous aorta shapes
Solution Approach 1:
The pumping chamber is designed with dynamic flexibility, allowing it to change its shape and orientation in response to the tortuous anatomy of the aorta. This dynamic structure maintains functional simplicity while adapting to complex three-dimensional aortic geometries through its ability to flex and reconfigure.
Solution Approach 2:
The pumping chamber transitions from a simple linear arrangement to a three-dimensional configuration that can accommodate tortuous aorta shapes. By adding spatial dimensions and allowing the chamber to extend in multiple directions rather than just linearly, the device adapts to the complex geometry while maintaining structural simplicity.
4Duration of action of moving object
If the balloon pump is positioned in the descending aorta for long-term use, then the device can provide extended cardiac assistance, but the risk of complications like stroke and abrasion increases
Solution Approach 1:
The balloon pump utilizes a flexible shell with optimized material properties that reduces abrasion against the aortic wall during long-term positioning in the descending aorta. The flexible construction allows the device to conform to aortic movements without creating excessive friction or damage, thereby reducing complication risks while enabling extended cardiac assistance.
Data Source
AI summary
Disclosed herein are methods of making aortic counter pulsation cardiac assist devices for assisting cardiac function of a patient. The methods can comprise performing at least one medical imaging procedure on an aorta of the patient, selecting at least one active segment of the aortic counter pulsation cardiac assist device based on anatomic information resulting from the at least one medical imaging procedure, and assembling the at least one active segment to accommodate the anatomic information prior to surgical implantation. The methods can further comprise designing individual custom active segment modules to custom fit a patient, providing a series of different individual, pre-manufactured active segment modules that are assembled to custom fit the patient, or providing a range of stock segment configurations manufactured based on previously determined common configurations and selecting one for a particular patient.