Coil Closure Device for Tissue Puncture Sealing
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Solution Overview
Problem
Current tissue sealing devices are inadequate for temporary and efficient closure of tissue punctures, particularly in procedures like cardiac surgery, as they often require re-access and do not provide a simple, quick, and effective means for sealing tissue walls without causing further damage.
Innovation Solution
A system comprising a coiled closure device with an increasing radius that compresses tissue inwardly to seal punctures, combined with a supporting element to prevent expansion, and a flange for engagement with a delivery instrument, allowing for temporary closure and re-access through a re-accessible valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a simple sealing device is used to close a tissue puncture, then the closure process is quick and easy, but the device cannot provide temporary closure with re-access capability
Solution Approach 1:
The sealing device is divided into two functional components: a sealing element that closes the puncture and a supporting element that maintains structural integrity. This segmentation allows the device to provide simple closure while simultaneously enabling temporary sealing with re-access capability through the engagement element mechanism.
Solution Approach 2:
The device incorporates an engagement element that can be dynamically engaged or disengaged from the supporting element. This dynamic feature allows the puncture to be sealed temporarily while preserving the ability to re-access the site by disengaging the element, thus providing both simplicity and versatility.
2Reliability
If a sealing device compresses tissue to close a puncture, then the puncture is effectively sealed, but the device may cause tissue damage
Solution Approach 1:
The sealing element utilizes a flexible, compliant structure that conforms to the tissue geometry and applies distributed compression forces. This flexible design achieves reliable puncture sealing while minimizing localized tissue damage through even pressure distribution across the sealing surface.
Solution Approach 2:
The device employs materials and structural parameters that allow controlled compression forces. By optimizing the compliance and mechanical properties of the sealing element, the device achieves effective tissue compression for sealing while maintaining forces within safe limits to prevent damage.
3Reliability
If a sealing device is designed for permanent closure, then the puncture is fully sealed, but re-access to the procedure site becomes difficult
Solution Approach 1:
The engagement element is designed with dynamic engagement and disengagement capabilities. When engaged, it provides complete puncture closure with reliable sealing. When disengaged, it allows easy re-access to the procedure site, thus enabling the device to transition between permanent-sealing mode and temporary-sealing mode as needed.
Solution Approach 2:
The engagement element acts as an intermediary mechanism between the sealing element and the external environment. It mediates between the need for complete closure and the need for re-access capability, allowing the device to provide either permanent or temporary closure based on engagement status.
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 system effectively seals tissue punctures by compressing the tissue inwardly, preventing further expansion and allowing for temporary or permanent closure, while enabling re-access without causing significant tissue damage, thus addressing the limitations of existing devices.
Implementation Method 1
a closing element adapted for at least partial insertion into the tissue wall and sized and shaped to compress at least a portion of the tissue wall to close the puncture
Implementation Method 2
at least one supporting element adapted for insertion into at least a portion of a tissue wall proximate a puncture to prevent expansion of the puncture
Data Source
Figure 1~2
Figure 3A~3B
Figure 3C
AI summary
Embodiments of the invention provide systems, apparatus, device and methods for sealing a puncture in a tissue wall. According to one aspect, the system includes at least one supporting element for insertion into or placement on at least a portion of a tissue wall proximate a puncture to prevent expansion of the puncture; and a closing element adapted for at least partial insertion into the tissue wall and shaped to compress at least a portion of a tissue wall in an inward direction to close the tissue puncture when inserted at least partially into the tissue wall.