Transapical Valve Delivery Tether Mechanism
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Solution Overview
Problem
Developing prostheses, such as replacement heart valves, that can be compactly delivered and controllably expanded for precise placement within the body while being securely anchored to intralumenal tissue without causing trauma, poses significant challenges, especially in accessing and deploying devices through tortuous vasculature or minimally invasive procedures.
Innovation Solution
A delivery system featuring a handle with a tether control knob and an outer hollow member that restrains the prosthesis in a collapsible configuration, allowing controlled expansion and anchoring through a tether mechanism that radially expands and retracts to secure the prosthesis at the desired location within the body.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If the prosthesis is compacted for delivery through minimally invasive procedures, then the trauma to the patient is reduced, but the ability to control deployment and secure anchoring becomes more difficult
Solution Approach 1:
The delivery system is divided into multiple functional segments: an outer delivery sheath for compact containment, an inner expandable frame with radial struts for structural support, and a tether mechanism for controlled deployment. This segmentation allows the prosthesis to be delivered in a compact state while enabling precise control during expansion and anchoring to the mitral valve annulus.
Solution Approach 2:
The prosthesis transitions from a static compacted state within the delivery sheath to a dynamic expanded state where the radial struts can be controllably deployed. The tether mechanism provides dynamic control, allowing the operator to progressively expand the frame and secure anchoring points to the annulus, transforming the device from a deliverable package to an anchored functional prosthesis.
2Volume of moving object
If the prosthesis is compacted for delivery, then the delivery device size is reduced, but the manufacturing precision and structural integrity become more challenging
Solution Approach 1:
The prosthesis is nested within the delivery sheath in a compact configuration, with the expandable frame containing the tissue valve, which is itself contained within the frame. This nested arrangement minimizes the overall delivery device size while maintaining the structural integrity of each component. The radial struts are designed to expand from this nested state without compromising their structural strength.
Solution Approach 2:
The radial struts are designed with shape memory or superelastic properties that allow them to transition from a compressed radial configuration during delivery to an expanded radial configuration at the implantation site. This parameter change enables the struts to maintain structural integrity during compaction for delivery while achieving the necessary structural strength and precision when expanded for anchoring and valve support.
3Reliability
If the prosthesis is expanded at the target location, then the anchoring capability is improved, but the risk of trauma to intralumenal tissue increases
Solution Approach 1:
The tether mechanism is pre-configured to engage with the radial struts before expansion begins. As the prosthesis is deployed, the tether progressively engages and secures anchoring points to the mitral valve annulus in advance of full expansion. This preliminary anchoring action ensures that the prosthesis is securely attached before complete expansion, reducing the risk of tissue trauma during the expansion process.
Solution Approach 2:
The tether acts as an intermediary mechanism between the expandable frame and the mitral valve annulus. Rather than directly expanding the frame against the tissue, the tether progressively engages and secures anchoring points, mediating the expansion process to minimize direct trauma to the annulus and surrounding intralumenal tissue while ensuring reliable anchoring.
Data Source
AI summary
Devices, systems and methods are described for implantation of a prosthesis within a lumen or body cavity and delivery systems for delivering the prosthesis to a location for implantation. A delivery system can include a tether connected to a single directional handle knob for release of the prosthesis within the lumen or body cavity and retraction of the tether towards the handle.