Arteriotomy Suturing Device with Inflatable Balloon Snag

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Solution Overview

Problem

Current medical suturing systems for closing arteriotomies after vascular procedures are inefficient, requiring prolonged recovery times and increased risk of complications due to reliance on manual compression or other methods that do not consistently ensure reliable closure.

Innovation Solution

A suturing device with a handle, elongated body, and sliding shaft featuring an inflatable balloon and moveable needles that deploy and retract to position sutures within the arteriotomy, facilitating consistent and reliable closure of the vessel wall.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If manual compression or traditional suturing methods are used to close arteriotomies, then the procedure can be performed with simple equipment, but the recovery time is prolonged and the reliability of closure is reduced

Engineering Contradiction:
Improveclosure reliabilityVSAvoidrecovery time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The invention extracts the suture placement function from manual surgical procedures and integrates it into a catheter-based delivery system. The needles are pre-loaded within the catheter assembly and deployed automatically through the arterial wall, separating the suture placement function from traditional open surgical techniques and enabling minimally invasive closure with improved reliability and reduced recovery time.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The sutures are pre-positioned within the catheter assembly before insertion into the artery. The needles are pre-loaded and aligned for immediate deployment, and the suture ends are pre-configured to facilitate automatic knot formation. This preliminary preparation ensures consistent suture placement and reliable closure without requiring prolonged manual manipulation during the procedure.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If pre-closure stitches are positioned during the procedure, then hemostasis can be achieved around the interventional device, but the device complexity increases

Engineering Contradiction:
Improvehemostasis reliabilityVSAvoidsuturing device complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The invention merges multiple functions into a single integrated catheter assembly: the delivery catheter, the suture storage mechanism, the needle deployment system, and the knot formation mechanism are all combined in one device. This integration enables pre-closure stitch placement without requiring separate surgical instruments or multiple procedural steps, maintaining hemostasis reliability while managing device complexity through functional consolidation.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The catheter assembly is designed as a multi-functional device that can perform both the interventional procedure (such as angioplasty or stent placement) and the arteriotomy closure functions. The same catheter that delivers the interventional device also carries and deploys the sutures for pre-closure, eliminating the need for separate suturing equipment and reducing overall procedural complexity.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Ease of operation

If compression clamps or thrombotic plugs are used for arteriotomy closure, then the closure can be achieved without sutures, but the reliability and consistency of closure are compromised

Engineering Contradiction:
Improveclosure operation easeVSAvoidclosure consistency
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The invention replaces mechanical compression systems (such as compression clamps or manual pressure application) with a suture-based mechanical closure system. Instead of relying on external compression forces that may slip or fail, the sutures create internal mechanical tension that actively pulls the arterial wall edges together, providing more reliable and consistent closure that maintains ease of operation through automated deployment.

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

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 enables rapid and effective closure of arteriotomies, reducing recovery time and minimizing complications by ensuring consistent hemostasis and efficient suturing, thereby improving patient outcomes and procedural efficiency.

Implementation Method 1

an inflatable balloon operable to alternate between an inflated configuration in which the inflatable balloon is inflated and a deflated configuration in which the inflatable balloon is not inflated

Methodology Applied
Scientific EffectInflation/Deflation: Pressure Increase

Data Source

PatentEP3048991B1Suturing device for sealing an opening in a blood vessel or other biological structure
Publication Date: 2019.02.27 MEDTRONIC VASCULAR INC
  • EP3048991B1 patent drawingFigure 1
  • EP3048991B1 patent drawingFigure 2
  • EP3048991B1 patent drawingFigure 3

AI summary

A suturing device includes a handle, an elongated body, at least one suture snag, at least one pair of needles, and at least one suture pair. The suture snag is moveable between a deployed position in which two distal arm portions thereof radially extend away from the elongated body and a retracted position in which the two distal arm portions are disposed within the elongated body. The suture pair is slidingly disposed through the needle pair. The suturing device deploys the suture snag within a vessel adjacent to an arteriotomy, extends the needle pair through a vessel wall around the arteriotomy and through the deployed suture snag, extends the suture pair beyond the distal ends of the needle pair, and then utilizes the suture snag to capture the extended suture pair by retracting the suture snag to pull first or distal ends of the sutures back into the suturing device. An inflatable balloon or an expandable suture capture component may be alternatives to the suture snag for capturing the suture ends.