Expandable Extracellular Matrix Hemostatic Closure Member
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Solution Overview
Problem
Current vessel closure methods, such as external compression and suturing devices, are inadequate for achieving quick and reliable hemostasis, especially for larger puncture sites, and existing fallopian tube occlusion methods are invasive and prone to complications like migration or dislodgment.
Innovation Solution
A closure apparatus and delivery system using an expandable hemostatic member composed of an extracellular matrix material, like small intestinal submucosa, which absorbs blood to expand and provide structural integrity, allowing for precise placement and effective sealing of vessels and fallopian tubes without pre-measuring the tissue channel.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If external manual or mechanical compression is applied to achieve hemostasis, then hemostasis can be achieved, but it requires constant firm pressure for up to 30 minutes and the site remains vulnerable to further bleeding
Solution Approach 1:
The closure member is divided into multiple segments or struts that can independently expand to engage the vessel wall, allowing the hemostatic function to be distributed across multiple contact points rather than relying on single-point compression
Solution Approach 2:
The closure member acts as an intermediary device between the puncture site and the external compression force, providing internal support and sealing that reduces or eliminates the need for prolonged external compression
2Reliability
If suturing devices are used to close the puncture site, then relatively quick and reliable hemostasis is achieved, but it requires much skill and experience and device complexity has led to failures
Solution Approach 1:
The invention replaces the complex mechanical suturing system with a simpler deployment mechanism that uses radial expansion force rather than needle penetration and knot tying, reducing the skill requirement while maintaining reliability
Solution Approach 2:
Instead of pulling tissue together with needles and threads (suturing), the closure member pushes outward against the vessel wall from the inside, inverting the traditional approach to achieving vessel closure
3Reliability
If needles are used to penetrate the arterial wall to form a knot, then hemostasis is achieved, but there is risk of needles penetrating completely through the opposite wall and inadvertently closing off the vessel
Solution Approach 1:
The invention extracts the need for needle penetration entirely from the closure process, using a non-invasive expansion mechanism that applies force from within the vessel lumen without penetrating the vessel wall
Solution Approach 2:
The closure member serves as an intermediary that provides controlled radial force distribution, preventing direct needle-to-wall contact that could cause complete penetration and inadvertent vessel occlusion
4Device complexity
If collagen plugs are used to seal the puncture site, then a simpler and lower cost alternative is provided, but they are of limited use in closing larger puncture sites
Solution Approach 1:
The closure member is designed to be dynamically adjustable in size through radial expansion, allowing a single device to adapt to various puncture site sizes rather than requiring multiple fixed-size collagen plugs
Solution Approach 2:
The closure member combines multiple materials with different properties (structural support materials and hemostatic materials) to achieve both the simplicity of collagen plugs and the versatility to handle larger puncture sites
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 achieves rapid and effective hemostasis in larger vessels and fallopian tubes, reducing complications and allowing for subsequent access without fibrotic tissue formation, while being biocompatible and compatible with existing medical instrumentation.
Implementation Method 1
a first material, such as a foam material, which is capable of absorbing blood to expand several times (e.g., 6-10x) its diameter to cause hemostasis
Data Source
AI summary
An absorbable and expandable closure member used to occlude or exclude a body lumen or cavity, such as a blood vessel, fallopian tube, duct, aneurysmal sac, etc., comprising a closure member comprising one of more sheets of a biomaterial that are rolled, stacked, or folded to form a multilayer construct of a generally cylindrical configuration for deployment through a delivery system, either as a singularly or part of a multiplicity of closure members. The biomaterial is derived from a source material, such as small intestinal submucosa or another remodelable material (e.g., an extracellular matrix) having properties for stimulating ingrowth of adjacent tissue into the biomaterial deployed within the bodily lumen. The closure member is deployed to the bodily lumen from a delivery sheath, cartridge, and/or over a inner guiding member, such as a wire guide or catheter.