Suture Delivery Device Needle Deployment Mechanism

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Solution Overview

Problem

Current methods for closing vascular puncture sites after minimally invasive procedures are time-consuming and can cause patient discomfort, with risks of unintended total occlusion and thrombosis, and require accurate needle placement and reproducible deployment to secure sutures effectively.

Innovation Solution

A suture delivery device with automated actuators that positions and deploys needles at a piercing angle to penetrate tissue, captures the needles, and returns to a reduced profile for easy withdrawal, allowing for precise and reproducible suture placement to achieve hemostasis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If manual compression is used to achieve hemostasis, then hemostasis can be achieved, but the procedure takes significant time and causes patient discomfort

Engineering Contradiction:
Improvehemostasis achievementVSAvoidprocedure time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent replaces manual compression with an automated suture delivery device that uses mechanical needle penetration and suture material deployment to achieve hemostasis. The device delivers sutures through the puncture site to approximate tissue edges, eliminating the need for prolonged manual compression and significantly reducing procedure time while maintaining reliable hemostasis achievement

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If manual compression is used to close the opening, then hemostasis may be achieved, but considerable patient discomfort occurs

Engineering Contradiction:
Improvehemostasis achievementVSAvoidpatient discomfort
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the harmful mechanical compression force with a precise suture delivery mechanism. The device uses controlled needle penetration and suture placement to approximate tissue edges, achieving hemostasis without the sustained pressure and discomfort associated with manual compression methods

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Reliability

If manual compression is used, then hemostasis can be achieved, but unintended total occlusion and thrombosis can occur

Engineering Contradiction:
Improvehemostasis achievementVSAvoidthrombosis risk
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent replaces compression-based hemostasis with suture-based tissue approximation. By delivering sutures through the puncture site to close the opening from the inside, the device achieves hemostasis without the prolonged compression that can cause unintended total occlusion or thrombosis formation

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The device performs preliminary suture deployment through the puncture site before complete closure occurs. This allows controlled approximation of tissue edges while maintaining patency during the closure process, preventing the sudden total occlusion that can occur with compression methods

Inventive Principle:
Principle #10Preliminary action

4Productivity

If needles are deployed to pierce vessel wall, then suture delivery can be achieved, but accurate positioning with respect to vessel wall is required

Engineering Contradiction:
Improvesuture delivery capabilityVSAvoidneedle positioning accuracy
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The device performs preliminary positioning of the needle relative to the vessel wall before needle deployment. The system pre-aligns the needle at the correct angle and position, ensuring accurate penetration of the vessel wall at the intended suture location without requiring complex real-time adjustment during the procedure

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent uses an intermediary mechanism (such as a guide catheter or positioning assembly) that mediates between the operator and the needle. This intermediary component provides mechanical guidance and constraint to ensure the needle is positioned accurately relative to the vessel wall, reducing the skill requirement for precise manual positioning

Inventive Principle:
Principle #24Intermediary (Mediator)

5Adaptability or versatility

If suture delivering device is introduced through same opening, then minimal invasiveness is maintained, but device complexity increases

Engineering Contradiction:
Improveminimal invasivenessVSAvoiddevice structure
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent employs a nested structure where the needle and suture material are contained within the delivery catheter. The needle can be advanced through the catheter to the target site, deployed to pierce the vessel wall, and then retracted or detached while the catheter remains in place. This nested arrangement allows the complex suture delivery functionality to be introduced through the same minimal access opening used for the procedure

Inventive Principle:
Principle #7Nested doll (Nesting)

Data Source

PatentEP3251605B1Systems for suture delivery
Publication Date: 2021.03.31 TERUMO MEDICAL CORP
  • EP3251605B1 patent drawingFigure 1
  • EP3251605B1 patent drawingFigure 2
  • EP3251605B1 patent drawingFigure 3

AI summary

Systems and methods are provided for suturing tissue. An elongated deployment shaft carries a needle deployment assembly with needles carrying suture material and a stabilizer that is reconfigurable between an unexpanded insertion profile and an expanded profile. A catcher tube over the shaft having a catcher at a distal end may retain at least a portion of the needles carrying the suture material when the needles are passed through the tissue to be sutured into engagement with the catcher. A sheath over the catcher tube may sandwich tissue to be sutured against the stabilizer when expanded. A first actuator may move the catcher tube distally relative to the shaft to decrease a distance between the proximal end of the stabilizer and the distal end of the stabilizer to expand the stabilizer and may move the sheath distally relative to the shaft to sandwich the tissue. A second actuator may deflect the needles radially outward to move proximally to pass through the tissue to be sutured and engage the catcher and then return a portion of each not retained by the catcher to a distal position for withdrawal of the device.