Bioabsorbable Twist-Seal Vascular Closure Device
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current wound closure methods are inadequate for effectively and minimally invasively sealing large vascular access sites, such as those greater than 14 French in diameter, and are complex for heart wall access sites, often requiring invasive follow-up procedures.
Innovation Solution
A percutaneous wound closure device featuring a bioabsorbable, shape-memory ring and elastic tube with a collapsible design for easy deployment, which expands to seal large arteriotomy holes and heart wall access sites, using a delivery sheath and pusher tool for precise placement and a twist seal mechanism to secure the closure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional needle and suture methods or stapling methods are used, then small arteriotomy holes (smaller than 8 French) can be occluded, but large vascular access sites (larger than 14 French) cannot be effectively closed
Solution Approach 1:
The device employs a nested structure where the sealing membrane is positioned within the loop formed by the shape-memory ring. The delivery sheath contains the compressed device during implantation, and the plug is inserted through the tubular section. This nested arrangement allows the device to be delivered through a catheter while maintaining the functionality needed to seal large access sites.
Solution Approach 2:
The shape-memory ring undergoes a parameter change from a compressed state during delivery to an expanded state after implantation. The ring is heated to body temperature, causing it to transform from its constrained configuration in the delivery sheath to its unconstrained configuration, forming a loop that secures the sealing membrane against the vessel wall.
2Ease of operation
If percutaneous closure methods are used for large access sites, then minimally invasive procedures are enabled, but current methods are inadequate for sites larger than 14 French
Solution Approach 1:
The device incorporates dynamic elements including the shape-memory ring that transforms from compressed to expanded configuration, and the elastic tubular section that can be compressed and expanded. The twisting mechanism dynamically transitions the device from an implantable configuration to a deployed sealing configuration, enabling reliable closure of large access sites through a percutaneous approach.
Solution Approach 2:
The device utilizes composite materials including the shape-memory alloy ring, the elastic tubular section, and the sealing membrane. These materials are combined to create a device that can be delivered percutaneously while providing reliable sealing for large access sites. The bioabsorbable components degrade over time, leaving no permanent foreign objects.
3Adaptability or versatility
If complex sealing devices and methods are used for heart wall access sites, then access can be obtained, but the procedures are complicated and relatively ineffective
Solution Approach 1:
The device is designed with universal applicability to seal various types of access sites including both vascular access sites and heart wall access sites. The shape-memory ring and sealing membrane combination provides a multi-functional solution that can be deployed through different delivery approaches and effectively seals different tissue types without requiring procedure-specific device variations.
4Reliability
If traditional closure methods are used, then small holes can be sealed, but invasive follow-up procedures are still required
Solution Approach 1:
The device incorporates self-service features including the shape-memory ring that automatically transforms to its functional configuration upon implantation, and the bioabsorbable components that self-degrade over time. The twisting mechanism allows the operator to easily deploy the device without complex manipulation, and the device performs its sealing function autonomously once positioned.
Solution Approach 2:
The device employs bioabsorbable materials for the ring, tubular section, and sealing membrane that gradually degrade and are absorbed by the body over time. This eliminates the need for permanent foreign objects and allows for natural tissue healing without requiring follow-up procedures to remove or adjust the device. The plug may be temporarily retained or removed depending on the specific application.
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 provides a fast, safe, and effective closure of large vascular and heart access sites without the need for suturing or stapling, allowing for efficient re-access if hemostasis is not initially achieved, with bioabsorbable materials ensuring no foreign objects are left behind during healing.
Implementation Method 1
a shape-memory ring (11) made of a bioabsorbable material. The implant (1) is collapsible to a smaller size for advancement through a delivery means
Implementation Method 2
The implant (1) includes an elastic tubular section (12)... The second portion (19) is twisted or rotated circumferentially around the longitudinal axis of the implant (1) relative to the first portion (18) to create a twist seal (13)
Implementation Method 3
The ring (11) and the tubular section (12) are made of or include a bioabsorbable material... with bioabsorbable materials ensuring no foreign objects are left behind during healing
Data Source
Figure 1~2
Figure 3~4
Figure 5~6
AI summary
A wound closure device comprises a first frame and a flexible tubular section connected to the first frame, the first frame implantable through a wound in a patient's skin into a lumen of a blood vessel with a portion of the tubular section extending out through the skin. The tubular section has a first portion and a second portion, a wall of the tubular section defining a coaxial inner bore. Twisting the first portion relative to the second portion of the tubular section closes the bore is closed in an area of the tubular section between the first and second portions, thereby closing the wound. Also disclosed is an embodiment for closing an opening in a heart, as well as a delivery device, systems, and methods.