Integrated Venting Catheter with Axial Pacing Wire
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Solution Overview
Problem
Minimally invasive cardiac surgery faces challenges in maintaining stable heart rhythm during and after cardiopulmonary bypass surgery due to difficulties in placing pacing wires without increasing heart dissection or bleeding risk, and the complexity of exchanging catheters for pacing, which can lead to incorrect positioning, bending, knotting, or damage to heart structures.
Innovation Solution
A medical apparatus comprising a flexible venting catheter with an integrated pacing wire that can be axially moved between retracted and extended positions, allowing for intracardial pacing without the need for additional heart surface stitches, and featuring an inflatable balloon for easier catheter placement and a flexible pacing wire design to minimize tissue damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional pacing wires are sewn to the heart surface, then stable heart rhythm can be maintained, but the amount of heart dissection and bleeding risk increase
Solution Approach 1:
The invention extracts the pacing function from the heart surface by using a catheter delivered through the vasculature to the right ventricle, eliminating the need to sew pacing wires directly to the heart tissue. The pacing wire is advanced through the catheter into the right ventricle where it contacts the endocardial surface, providing pacing without requiring external heart dissection or stitching.
Solution Approach 2:
The invention introduces a catheter as an intermediary device that serves as a conduit for delivering the pacing wire into the right ventricle. The catheter is inserted through the vasculature (jugular vein → superior vena cava → right atrium → right ventricle) and provides a protected pathway for the pacing wire, eliminating the need for direct heart surface access through incisions.
2Ease of operation
If a separate introducing catheter is used to deliver the pacing wire, then the pacing wire can be positioned in the right ventricle, but the procedure complexity and time increase
Solution Approach 1:
The invention merges the venting catheter and pacing wire delivery catheter into a single integrated device. The pacing wire is contained within the venting catheter shaft, allowing both venting and pacing functions to be achieved with one catheter placement procedure, eliminating the need for separate catheter insertion and exchange operations.
Solution Approach 2:
The venting catheter is designed with multi-functionality, serving both as a pulmonary venting catheter (for blood drainage during bypass) and as a delivery catheter for the pacing wire. This universal design eliminates the need for dedicated introducing catheters and reduces procedural steps.
3Reliability
If the pacing catheter is advanced through the vasculature, then intracardial pacing can be achieved, but the risk of catheter bending, knotting, or heart damage increases
Solution Approach 1:
The invention nests the pacing wire within the protective sheath of the venting catheter during delivery. The pacing wire is contained inside the catheter shaft, which protects it from external forces that could cause bending or knotting. Only the distal tip of the pacing wire extends beyond the catheter tip to contact the heart tissue, while the rest of the wire remains protected within the catheter structure.
Solution Approach 2:
The catheter shaft acts as a protective cushion for the pacing wire during advancement through the vasculature and into the heart. This protective sheath prevents the pacing wire from being damaged by sharp angles, kinks, or excessive manipulation, reducing the risk of wire bending, knotting, or perforation of heart structures.
4Adaptability or versatility
If multiple catheters are used for venting and pacing, then both functions can be performed, but the procedure time and patient exposure time increase
Solution Approach 1:
The invention combines the venting catheter and pacing wire delivery system into a single integrated device. The pacing wire is pre-loaded within the venting catheter shaft, allowing both venting and pacing functions to be achieved during a single catheter placement procedure, eliminating the time required for separate catheter insertion and exchange operations.
Solution Approach 2:
The pacing wire is pre-positioned within the venting catheter during the catheter assembly process. This preliminary arrangement of the pacing wire inside the catheter allows for immediate pacing capability once the catheter is in place, eliminating the need for additional time to insert and position a separate pacing wire or catheter after venting is established.
Data Source
AI summary
An assembly of a pulmonary venting catheter and a pacing wire disposed therethrough whereby the pacing wire is extended from the distal end of the catheter tube during pacing mode, eliminating the need for exchanging the venting catheter with a pacing catheter to begin pacing after venting. The pacing wire includes a flexible distal end for a first conductor to conductively engage heart tissue after the pacing wire is extended from the catheter distal end; a second conductor, also exposed outside the catheter distal end, completes the circuit. The pacing wire is lockable in unextended and extended positions at the proximal end portion of the assembly. A method for venting and pacing a patient's heart during cardiac surgery is described, which includes retracting the catheter distal end from the pulmonary artery after venting mode, into the right ventricle during pacing mode, whereafter the pacing wire is extended for pacing.