Suture Delivery Device for Hemostasis and Dilation

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Current suture-based vessel closure devices require previous dilation of the arteriotomy puncture and struggle to maintain hemostasis during device exchange and sheath removal, particularly in percutaneous procedures, which can lead to complications such as hematoma and embolic particles, especially in procedures like carotid artery interventions.

Innovation Solution

A suture-based vessel closure device that performs dilation and places sutures across the vessel access site, allowing for hemostasis before and after sheath placement, with the ability to maintain temporary hemostasis and provide rapid access to suture ends in case of inadvertent sheath removal, eliminating the need for separate dilation devices and reducing the risk of embolic particles.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If current suture-based vessel closure devices are used, then vessel closure can be achieved, but separate dilation devices are required and hemostasis cannot be maintained during device exchange

Engineering Contradiction:

Improvenumber of devices requiredVSAvoidhemostasis maintenance

Core Design Contradiction:

Device complexityVSReliability

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 simultaneously deliver sutures to the vessel wall, eliminating the need for separate dilation devices and reducing the number of device exchanges required during the procedure.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The device performs dilation as a preliminary action before suture placement. The dilating tip is positioned at the distal end of the delivery device and dilates the puncture site as the device is advanced into the vessel, preparing the access site before the suture delivery mechanism is activated.

Inventive Principle:

Principle #10Preliminary action

2Ease of operation

If device exchange is performed, then suture placement can be achieved, but hemostasis is lost and complications like hematoma may occur

Engineering Contradiction:

Improvesuture placement capabilityVSAvoidhematoma risk

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The device places sutures as a preliminary action before sheath removal. The sutures are delivered and positioned in the vessel wall while the delivery device is still in place, allowing the operator to tie the sutures and achieve hemostasis before removing the sheath, thereby preventing hematoma formation.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The device provides a transition sheath that remains in place during suture placement and tying. This sheath acts as a cushion or barrier that maintains hemostasis during the critical period when sutures are being manipulated and tied, preventing blood leakage and hematoma formation before final closure is achieved.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

3Productivity

If sheath removal is performed before suture tying, then procedural access is achieved, but hemostasis control is lost

Engineering Contradiction:

Improveprocedural access efficiencyVSAvoidhemostatic control

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The device enables suture placement and preliminary tying to be completed before sheath removal. The sutures are delivered, positioned, and can be tied while the transition sheath is still in place, establishing hemostatic control before the sheath is removed, thereby maintaining reliability throughout the procedure.

Inventive Principle:

Principle #10Preliminary action

4Length of moving object

If device length is reduced, then plaque zone incursion is minimized, but device functionality may be compromised

Engineering Contradiction:

Improvedevice component lengthVSAvoiddevice functionality

Core Design Contradiction:

Length of moving objectVSAdaptability or versatility

Solution Approach 1:

The device employs a nested structure where the suture delivery mechanism, capture rods, and dilating tip are all contained within the delivery device body. The sutures are stored within the device and deployed through a compact mechanism, allowing the entire system to be delivered through a small-gauge needle puncture without requiring long device components that would increase the risk of plaque zone incursion.

Inventive Principle:

Principle #7Nested doll (Nesting)

Data Source

PatentUS9011467B2Suture delivery device

Publication Date: 2015.04.21 BOSTON SCIENTIFIC SCIMED INC

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.