Twistable Transapical Closure Device for Heart Tissue
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Solution Overview
Problem
Transapical procedures pose risks when using sutures to close entry points in moving heart tissue due to the need for precise and secure closure without piercing through the tissue, especially during procedures on the beating heart.
Innovation Solution
A medical device with distal and proximal support structures, including anchor members, and a connection element that twists to form a seal, allowing the device to anchor within the tissue without the need for sutures, utilizing shape-memory alloys for biased configurations and a delivery system to deploy and secure the device.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If sutures are used to close the entry point in the beating heart, then the closure can be achieved, but the risk of piercing through moving heart tissue increases
Solution Approach 1:
The closure device is divided into multiple anchor members distributed around the entry point, with each anchor member independently engaging the tissue. This segmentation allows the closure force to be distributed across multiple contact points rather than concentrated at single suture piercing points, reducing the risk of tissue damage while maintaining closure reliability
Solution Approach 2:
The device introduces an intermediary structure (the anchor member assembly) between the closing force and the heart tissue. This intermediary distributes and softens the interaction force, allowing closure to be achieved through gradual engagement of multiple anchors rather than direct suture piercing, thereby reducing harmful tissue penetration while maintaining closure effectiveness
2Reliability
If sutures are used to close the entry point, then closure can be achieved, but the procedure time increases due to the need for precise manual suturing on moving tissue
Solution Approach 1:
The anchor members are pre-configured in a delivery system that positions them around the entry point before deployment. This preliminary positioning eliminates the need for time-consuming manual suturing operations on the beating heart, as the anchors are already arranged in their final engagement positions, reducing procedure time while maintaining closure security through pre-planned geometric arrangement
Solution Approach 2:
The anchor members are designed to self-engage with the tissue upon deployment, utilizing the natural tissue geometry and the elastic recovery of the anchors to automatically secure themselves without requiring precise manual manipulation. This self-service mechanism significantly reduces the time and skill required for closure while maintaining secure attachment
3Reliability
If a sealed closure is created within the device, then tissue engagement is secured, but the device complexity increases with additional components
Solution Approach 1:
The connection element serves multiple functions simultaneously: it connects the distal and proximal support structures, provides the sealing barrier, and enables the twisting mechanism for seal formation. By merging these functions into a single integrated component rather than separate elements, the device achieves reliable tissue engagement security without proportionally increasing overall device complexity
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
Enables fast and effective closure of anatomical apertures by engaging both interior and exterior tissue surfaces with anchor members, providing a secure seal without the risks associated with suture use, suitable for transapical and other heart procedures.
Implementation Method 1
the distal support structure can revert to an anchoring configuration from a delivery configuration... the proximal support structure can revert to an anchoring configuration from a delivery configuration... made of a shape-memory alloy, biased to a curled position when in an anchoring configuration
Implementation Method 2
the connection element can be configured to be twisted to create a seal within the medical device
Data Source
AI summary
Medical devices and methods for closing an anatomical aperture in a tissue are disclosed. The medical devices can include distal and proximal support structures, which can include a plurality of anchor members. A connection element can connect the distal and proximal support structures, and be configured to twist to create a seal within the medical device. In certain embodiments, a sheath about the medical device can be retracted to expose the distal support structure, which can allow it to revert to an anchoring configuration from a delivery configuration, such that the anchor members can engage an interior surface of the tissue. After twisting the connection element to form a seal, the sheath can be further retracted to expose the proximal support structure, which can allow it to revert to an anchoring configuration from a delivery configuration, such that the anchor members can engage an exterior surface of the tissue.