Suture Delivery Device for Hemostatic Vessel Closure
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Solution Overview
Problem
Current percutaneous suture-based vessel closure devices require previous dilation of the arteriotomy puncture and are challenging to use for pre-closure, as they need to be placed after the procedural sheath has been inserted and removed, making it difficult to maintain hemostasis during device exchange and requiring additional components that may risk embolic particles, especially in procedures like carotid artery interventions.
Innovation Solution
A suture-based vessel closure device that can perform dilation and place sutures across the vessel access site without prior dilation, allowing for hemostasis before, during, and after sheath placement, with the option to apply sutures before or after sheath insertion, and providing rapid access to suture ends in case of inadvertent sheath removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current percutaneous suture-based vessel closure devices are used, then hemostatic closure can be achieved, but previous dilation of the arteriotomy puncture is required and device exchange is difficult
Solution Approach 1:
The patent combines the dilation function and suture placement function into a single integrated device. The delivery device includes a dilating tip that can dilate the arteriotomy puncture and the same device can then place the suture, eliminating the need for separate dilation devices and simplifying the device exchange procedure.
Solution Approach 2:
The device performs preliminary dilation of the arteriotomy puncture before suture placement. The dilating tip is used to prepare the puncture site in advance, creating a larger opening that facilitates subsequent suture deployment without requiring additional dilation steps or device exchanges.
2Reliability
If suture placement is performed after sheath removal, then hemostasis can be achieved, but maintaining hemostasis during device exchange is difficult
Solution Approach 1:
The device enables preliminary suture placement before sheath removal, so that the suture is already in position and can be immediately activated to maintain hemostasis during sheath exchange or removal, eliminating the time delay and difficulty associated with maintaining hemostasis during device exchange.
Solution Approach 2:
The suture acts as an intermediary hemostatic mechanism that can be deployed early and remains in place during sheath exchange, providing continuous hemostatic coverage without requiring the operator to manually maintain compression or use additional hemostatic devices during the exchange process.
3Adaptability or versatility
If additional components are added to current devices, then functionality is improved, but risk of embolic particles increases
Solution Approach 1:
The patent merges multiple functions (dilation, suture placement, and delivery) into a single integrated device, eliminating the need for multiple separate components and additional device exchanges. This reduces the overall number of components in the system and minimizes the risk of embolic particles from additional components or exchange procedures.
Solution Approach 2:
The delivery device is designed with multi-functionality, serving as both a dilator and a suture placement device. This universal design eliminates the need for separate specialized components for each function, reducing component count and the associated embolic risk while maintaining full functionality.
4Reliability
If rapid access to suture ends is provided, then hemostatic control is improved, but device complexity increases
Solution Approach 1:
The suture ends are extracted or pulled through the delivery device and made accessible outside the body before the procedure is complete. This allows rapid access to the suture ends for tying or activation without requiring complex internal mechanisms, while still providing improved hemostatic control compared to traditional methods.
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 achieves reliable hemostatic closure of the access site, reducing the risk of hematoma and embolic complications by allowing for temporary hemostasis management and rapid control of sutures, even in challenging procedures like carotid artery interventions.
Implementation Method 1
a distal tip adapted to dilate an opening of an arteriotomy into the artery
Data Source
AI summary
A suture-based vessel closure device can perform the dilation of an arteriotomy puncture and does not require previous dilation of the arteriotomy puncture by a separate device or by a procedural sheath dilator. The suture-based vessel closure device can place one or more sutures across the vessel access site such that, when the suture ends are tied off after sheath removal, the stitch or stitches provide hemostasis to the access site.