Soft Tissue Anchor Expansion for Stable Pericardial Transection
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Solution Overview
Problem
Patients with heart failure with preserved ejection fraction (HFpEF) experience exaggerated pericardial restraint, leading to lower filling volume and increased left heart pressure, causing significant breathing difficulties during minimal activity. Currently, there is no therapeutic option specifically targeting pericardial restraint in HFpEF.
Innovation Solution
A device comprising an elongated body with an anchor at its distal end is used to anchor to soft tissue, providing stability for medical procedures such as pericardial transection. The anchor can transition from a compressed state to an expanded state to secure itself to the tissue, allowing for precise guidance and stability of medical devices within the pericardial cavity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If an anchor device is deployed to secure the elongated body to soft tissue, then stability and guidance precision are improved, but device complexity increases
Solution Approach 1:
The anchor device employs a dynamic expansion mechanism that transitions from a compressed delivery state to an expanded deployed state. The body of the anchor device expands radially after detachment from the elongated body, transforming the delivery system from a compact configuration to a stable anchored configuration. This dynamic transformation allows the device to achieve reliability through expansion while maintaining相对较低的 complexity during delivery.
2Strength
If the anchor device expands to secure attachment to tissue, then anchoring strength is improved, but the risk of tissue damage increases
Solution Approach 1:
The system performs preliminary detachment of the anchor device from the elongated body before expansion. The detachable connection allows the anchor device to separate from the delivery system and expand in a controlled manner away from the tissue insertion point. This preliminary separation prevents the elongated body from constraining the expansion process and reduces the risk of tissue damage during the anchoring process.
Solution Approach 2:
The anchor device body is designed as a flexible expandable structure that can radially expand to engage with tissue. The flexible nature of the expandable body allows it to conform to tissue surfaces while distributing attachment forces, thereby achieving strong anchoring without concentrated stress points that could cause tissue damage.
3Ease of operation
If the anchor device remains in a compressed state during delivery, then ease of insertion is improved, but anchoring capability deteriorates
Solution Approach 1:
The anchor device transitions dynamically from a compressed delivery state to an expanded functional state. During delivery, the body remains compressed within the elongated body, facilitating easy insertion through catheters or access sheaths. Upon deployment, the body expands radially to provide sufficient anchoring capability. This dynamic state transformation resolves the contradiction between ease of insertion and anchoring capability.
4Manufacturing precision
If the elongated body is made rigid for stability during pericardial transection, then cutting precision is improved, but flexibility for navigation deteriorates
Solution Approach 1:
The system segments the functional requirements into two separate components: the elongated body for navigation and the anchor device for stability. The elongated body maintains flexibility to navigate through the pericardial cavity and position the anchor at the target site. Once positioned, the anchor device expands to provide rigid stability for the pericardial transection procedure. This segmentation allows each component to optimize its properties without compromising the other.
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 device enables controlled cutting of pericardial tissue with precision, reducing the physiological constraints caused by pericardial restraint in HFpEF patients, thereby alleviating symptoms such as exertional dyspnea.
Implementation Method 1
the bladder is inflated to thereby press the anchor against the soft tissue
Data Source
AI summary
Provided is a device for use in medical procedures comprising an elongated body with one or more anchor devices associated with a distal end of the elongated body, whereby the distal end of the elongated body can operably be connected to soft tissue of a subject as part of a medical procedure. The elongated body, in some embodiments, is used as a guide to a medical device, such as a pericardial transection device used for forming cuts in pericardial tissue of a heart, whereby the elongated body provides for guidance and stability when the pericardial transection device is in use. Also provided are various soft tissue anchors, medical kits, and procedures for anchoring an elongated body in soft tissue via use of an anchor device, as well as use of an anchored elongated body in medical procedures such as transection procedures associated with the pericardium.