Implant Delivery Handle Spine Recesses for Pull Wire Routing
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Solution Overview
Problem
Existing delivery apparatuses for prosthetic medical devices, such as prosthetic heart valves, struggle to effectively conform to the geometry of native tissue and may undesirably shift, leading to paravalvular leakage due to insufficient anchoring and sealing.
Innovation Solution
The delivery apparatus includes a spine assembly with axially extending recesses that allow a pull wire to be routed from the interior to the exterior, enhancing torque transmission and curvature control, while maintaining spine strength, and features a Y-shaped connector with a flushing port and suture lock assembly for secure implantation and de-airing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If the spine is made solid and continuous to transmit torque effectively, then torque transmission is improved, but the ability to route pull wires from interior to exterior is worsened
Solution Approach 1:
The spine is segmented by introducing axially extending recesses that are depressed radially into the spine from the outer surface. These recesses create discrete pathways for pull wires to be routed from the interior to the exterior of the spine, while the remaining solid portions of the spine maintain structural integrity for torque transmission.
Solution Approach 2:
The axially extending recesses act as intermediary structures that facilitate the routing of pull wires through the spine. The recesses provide a controlled pathway that allows wire insertion and manipulation without compromising the spine's overall structural strength or torque transmission capability.
2Ease of operation
If recesses are extended fully through the spine to route pull wires, then wire routing is improved, but the strength of the spine is worsened
Solution Approach 1:
The recesses extend only partially through the wall thickness of the spine, rather than completely through to the central lumen. This partial extension is sufficient to allow pull wire routing from the outer surface to the interior, while leaving enough material intact to maintain adequate structural strength and torque transmission properties.
3Reliability
If the delivery apparatus is made more complex to achieve better anchoring and sealing, then implantation security is improved, but device complexity is worsened
Solution Approach 1:
The spine serves multiple functions: it transmits torque from the handle to the distal end, provides a structural framework for the delivery apparatus, and incorporates recesses that facilitate pull wire routing for curvature control. This multi-functionality reduces the need for additional separate components.
Solution Approach 2:
The axially extending recesses are integrated directly into the spine structure rather than being separate components. This merging of the routing feature into the existing spine structure allows pull wire passage without adding separate routing mechanisms, thereby maintaining structural integrity while enabling wire routing.
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
The apparatus achieves improved anchoring and sealing of prosthetic heart valves by conforming to native tissue geometry, reducing paravalvular leakage and facilitating secure, controlled delivery and implantation.
Implementation Method 1
configured to transmit torque exerted on a handle of the delivery apparatus to a distal end of a shaft extending distally from the delivery apparatus via a spine assembly
Implementation Method 2
transmit torque exerted on a handle of the delivery apparatus to a distal end of a shaft extending distally from the delivery apparatus via a spine assembly
Data Source
AI summary
Devices and methods for handles of delivery apparatuses for prosthetic medical devices are disclosed. As one example, a handle for a delivery apparatus comprises an outer housing and a spine positioned within the outer housing. The spine comprises a central lumen, an axially extending recess that is depressed radially into the spine from an outer surface of the spine toward the central lumen, and a support wall separating the central lumen and the axially extending recess. The handle further comprises a pull wire that extends through the recess and out of a proximal end portion of the recess to a wire wrap coupled to the outer surface of the spine.