Graft-Integrated Intravascular Catheter Fixation for Migration Control
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Solution Overview
Problem
Existing catheter fixation devices for intracardiac pumps, when externally secured to the skin, are prone to migration due to patient movement, leading to potential mispositioning and damage, which compromises the effectiveness of the pump's operation.
Innovation Solution
A graft-integrated fixation device that secures the catheter subcutaneously, reducing the distance between the fixation point and the target site, using a filament or clamp mechanism to stabilize the catheter within the conduit, thereby minimizing migration and ensuring proper positioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a catheter is secured externally to the patient's skin, then the fixation device is easy to apply, but the catheter is prone to migration due to patient movement
Solution Approach 1:
The fixation device is integrated into the graft structure itself, combining the graft and fixation functions into a single unified component. This eliminates the need for separate fixation devices and ensures the catheter is secured at the optimal location within the graft, preventing migration while maintaining ease of application during graft implantation.
Solution Approach 2:
The invention transitions from external skin fixation to internal subcutaneous fixation within the graft conduit. By moving the fixation point from the external surface to the internal lumen of the graft, the system achieves more reliable catheter stabilization while the graft itself remains externally accessible for application.
2Reliability
If the catheter is secured closer to the target site, then catheter stability is improved, but the distance for catheter insertion becomes longer
Solution Approach 1:
By integrating the fixation mechanism directly into the graft structure, the system allows the catheter to be secured at the optimal location within the graft lumen, closest to the target site, without requiring a longer external fixation device. The graft itself becomes the fixation mechanism, eliminating the need for additional length.
3Device complexity
If a traditional external fixation device is used, then the device structure is simple, but migration and mispositioning occur
Solution Approach 1:
The fixation function is merged into the graft structure, creating a unified device that maintains the relative simplicity of the graft while adding integrated fixation capabilities. This eliminates the need for complex external fixation devices and their associated components, achieving reliable catheter stabilization through the graft's inherent structure.
4Reliability
If the conduit diameter is reduced to fix the catheter, then catheter stability is improved, but catheter movability during insertion is reduced
Solution Approach 1:
The conduit provides a larger diameter during the insertion phase, allowing easy catheter movement and advancement. After the catheter is properly positioned, the fixation mechanism is activated to reduce the effective diameter and secure the catheter in place. This dynamic transition from open to secured state resolves the contradiction between insertion ease and final stability.
Solution Approach 2:
The conduit is designed with a larger diameter from the outset to facilitate easy catheter insertion and positioning. The fixation action is performed as a preliminary step after catheter placement but before final graft implantation, ensuring the catheter is secured in the optimal position before the conduit diameter is effectively reduced for long-term fixation.
Data Source
AI summary
A graft provided with a catheter fixation device for securing a catheter within a cardiovascular system of a patient. The graft having a proximal end, a distal end, and a sidewall defining a conduit having length extending between the proximal end and the distal end. A fixation device integrated into the graft, the fixation device being configured to transition a portion of the conduit from a first diameter, in which a catheter is movable along the length of the conduit, to a second diameter smaller than the first diameter, in which the catheter is fixed within the conduit. A method of delivering and stabilizing a medical device within a cardiovascular system of a patient is also provided.