Steerable Catheter Distal Tip Stability Aortic Support
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Solution Overview
Problem
Current steerable catheters for the right coronary artery lack a stable and supported distal tip design, which can lead to dislodgment during procedures, and there is a need for a three-dimensional steerable guide catheter that can accommodate various patient morphologies and provide adequate support for tools and instruments.
Innovation Solution
A three-dimensional steerable catheter with a preformed distal segment that includes a transition segment, an abutment segment to support the ascending aorta, and a preformed ostium entry section with specific angled segments to securely engage the ostium of the right coronary artery, allowing for torque transmission and stable positioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a steerable catheter is designed with a simple distal tip, then the catheter is easier to manufacture and less complex, but the distal tip becomes unstable and may dislodge during procedures
Solution Approach 1:
The distal shaft is divided into functionally distinct segments: a support section with an abutment segment for stabilizing against the aortic wall, and an ostium entry section with specifically angled segments for navigating into the coronary artery. This segmentation allows each part to perform its specialized function while maintaining overall structural integrity and stability during procedures.
2Adaptability or versatility
If a catheter uses a long distal tip, then the catheter can accommodate various patient morphologies and engage the ostium more effectively, but the catheter becomes harder to control and more complex
Solution Approach 1:
The catheter incorporates a preformed three-dimensional distal portion with specific geometric characteristics (angled segments at defined angles) that provide the necessary adaptability for various patient morphologies. The proximal shaft maintains uniform properties for ease of control, while the distal portion's localized complex geometry enables effective ostium engagement without compromising overall operability.
3Object-affected harmful factors
If the distal tip is made atraumatic with a long design, then patient trauma is reduced, but the distal tip lacks sufficient support and stability during procedures
Solution Approach 1:
The catheter employs an asymmetric distal shaft configuration where the abutment segment and ostium entry segments are positioned at specific asymmetric angles relative to the catheter axis. This asymmetric geometry provides both the atraumatic long distal tip design for patient safety and the structural support needed for stability, as the angled segments create mechanical leverage against the aortic wall and coronary ostium.
4Reliability
If a three-dimensional preformed distal portion is implemented, then the catheter can securely engage the ostium, but the manufacturing process becomes more complex and difficult
Solution Approach 1:
The distal shaft is preformed during manufacturing with the specific three-dimensional geometry including the abutment segment and angled ostium entry segments. This preliminary formation of the complex geometry ensures consistent, reliable ostium engagement while allowing the manufacturing process to be standardized. The preformed structure eliminates the need for complex post-manufacturing adjustments or assemblies.
Data Source
AI summary
A steerable three dimensional catheter to engage the ostium of a right coronary artery in a patient includes: a torque-transmitting proximal shaft that receives manipulation by a user outside a patient in whom the catheter is used; and a distal shaft that is responsive to torque transmitted by the proximal shaft. The distal shaft includes a preformed support section having at least a segment that abuts a posterior or left lateral interior surface of the ascending aorta of the patient. The distal shaft also includes a preformed ostium entry section extending from the support section. In one implementation, the ostium entry section transitions from the support segment abutting the aortic wall to a distal tip end by way of at least two differently directed angles.