Removable-Sheath Barbed Suture for Low-Trauma Insertion

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Solution Overview

Problem

Existing bi-directional knotless sutures are difficult to use in tight spaces and require rigid introducers that cause large tissue openings and trauma, limiting their applicability and flexibility.

Innovation Solution

A single-armed, flexible bi-directional knotless suture with a removable sheath that covers counter barbs to minimize tissue trauma, allowing installation through various paths without a rigid introducer.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a rigid hollow introducer is used to deliver bi-directional barbed sutures, then the barbed suture can be contained and protected during insertion, but the tissue opening size increases and tissue trauma is exacerbated

Engineering Contradiction:

Improvesuture containment and protectionVSAvoidtissue trauma

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the rigid hollow introducer with a flexible sheath that covers the barbed suture during insertion. This flexible sheath protects the barbs while allowing the suture to be delivered through a smaller gauge needle, thereby reducing tissue trauma while maintaining suture containment.

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The invention changes the physical parameter of the introducer from rigid to flexible, and from large-bore to small-bore needle delivery. This allows the same protective function to be achieved with reduced tissue disruption by using a thinner needle that can pass through tissue more easily.

Inventive Principle:

Principle #35Parameter changes

2Ease of operation

If a rigid hollow introducer is used to deliver bi-directional barbed sutures, then the barbed suture can be inserted into tissue, but the tissue opening size increases

Engineering Contradiction:

Improvesuture insertion capabilityVSAvoidtissue opening size

Core Design Contradiction:

Ease of operationVSArea of stationary object

Solution Approach 1:

The flexible sheath enables the barbed suture to be delivered through a smaller gauge needle while maintaining protection of the barbs. This reduces the size of the tissue opening required for insertion compared to using a rigid hollow introducer.

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The barbed suture is nested within the flexible sheath, which itself is delivered through a small gauge needle. This nested configuration allows the bulky barbed suture to pass through a much smaller opening by being contained within progressively smaller structures.

Inventive Principle:

Principle #7Nested doll (Nesting)

3Ease of operation

If a rigid hollow introducer is used, then the barbed suture can be delivered, but the suture positioning is pre-set to match the introducer shape

Engineering Contradiction:

Improvesuture deliveryVSAvoidsuture positioning flexibility

Core Design Contradiction:

Ease of operationVSAdaptability or versatility

Solution Approach 1:

The flexible sheath allows the suture to be positioned dynamically along various tissue fixation and closure paths, unlike the rigid introducer that imposes a pre-set positioning. The flexibility enables adaptation to different tissue geometries and surgical requirements.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The flexible nature of the sheath allows it to conform to different tissue paths and shapes during insertion, enabling the suture to be delivered along various trajectories and positioned with greater versatility compared to the constraint-imposing rigid introducer.

Inventive Principle:

Principle #30Flexible shells and thin films

4Reliability

If dual-armed bi-directional knotless sutures are used, then tissue fixation can be achieved, but the suture is difficult to use in tight spaces

Engineering Contradiction:

Improvetissue fixation capabilityVSAvoidusability in tight spaces

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The invention transitions from dual-armed to single-armed configuration, segmenting the suture delivery into a more manageable form. The single-armed design with flexible sheath protection allows easier navigation through tight surgical spaces while maintaining the bi-directional barbed fixation capability.

Inventive Principle:

Principle #1Segmentation

Data Source

PatentUS12458343B2Barbed suture with removable sheath

Publication Date: 2025.11.04 CILAG GMBH INTERNATIONAL

AI summary

A single-armed suture assembly includes a needle, a flexible suture, and a flexible sheath. The flexible suture is coupled with the needle. The flexible suture includes first and second portions. The first portion includes a plurality of first barbs having first tips extending away from the longitudinal path in either an insertion direction or in a counter insertion direction that is opposite to the insertion direction. The second portion includes a plurality of second barbs having second tips extending opposite to the first tips. The flexible sheath is configured to prevent one of the first or second tips that extend in the insertion direction from contacting tissue as the flexible sheath is being advanced in the insertion direction. The other of the first or second tips that extend in the counter insertion direction is configured to contact tissue as the flexible sheath is being advanced in the insertion direction.