Shape Memory Suture Anchors for Secure Lumen Coupling

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Solution Overview

Problem

Existing medical securing devices, such as sutures and anchors, often cause tissue damage, migrate over time, or are difficult to remove, posing challenges in securing and relocating medical devices within the body without permanent implantation.

Innovation Solution

The development of shape memory wire sutures with a proximal stop tab and sharp distal end that curve during deployment to partially penetrate the body lumen, and everting or inverting anchors that resemble a 'seagull' or have elliptical tines to grasp the lumen wall, allowing for secure anchoring while minimizing tissue exposure and enabling easy removal or repositioning.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a securing device (such as a medical suture, anchor, staple, or barb) entirely penetrates a body lumen, then the securing device can hold the medical device in place, but the sharpened portion of the securing device is exposed to surrounding tissue and may cause tissue damage

Engineering Contradiction:
Improvesecuring device holding capabilityVSAvoidtissue damage
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies inversion by designing an anchor that penetrates the lumen wall inward rather than outward. The sharp distal end penetrates the lumen wall to anchor the device, but the stop tab prevents further penetration, ensuring the sharp portion remains contained within the lumen wall rather than exposing to surrounding tissue. This inverted approach maintains securing reliability while eliminating tissue damage harm.

Inventive Principle:
Principle #13The other way round (Inversion)

2Reliability

If a securing device is deployed too tightly against a lumen wall, then the securing device may hold firmly, but the securing device may migrate through the lumen wall over time, freeing the implanted medical device from its proper location

Engineering Contradiction:
Improvesecuring device firmnessVSAvoidsecuring device position stability
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent applies dynamics by creating a balanced penetration system where the anchor can firmly engage the lumen wall initially, but the stop tab provides a dynamic limit that prevents over-penetration and migration. The stop tab acts as a dynamic constraint that allows firm anchoring while preventing the anchor from migrating through the lumen wall over time, thus maintaining position stability.

Inventive Principle:
Principle #15Dynamics

3Reliability

If a securing device is deployed to secure a medical device, then the medical device is held in place, but the securing device cannot be easily removed from the body lumen when removal is needed

Engineering Contradiction:
Improvemedical device anchoringVSAvoidsecuring device removability
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent applies segmentation by dividing the anchor into distinct functional segments: a sharp distal end for penetration, a body portion for anchoring, and a proximal stop tab for depth control and retrieval. This segmentation allows the anchor to be firmly deployed for reliable anchoring while the stop tab provides a defined interface for easy removal when needed, thus improving ease of operation without compromising anchoring reliability.

Inventive Principle:
Principle #1Segmentation

4Reliability

If a suture is used to couple a medical device to a body lumen, then the medical device is secured, but the suture may penetrate too deeply and expose the sharp distal end to surrounding tissue

Engineering Contradiction:
Improvemedical device couplingVSAvoidsurrounding tissue exposure to sharp portion
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies preliminary action by incorporating a stop tab on the suture before deployment. This stop tab preliminarily defines the maximum penetration depth, ensuring that when the suture is deployed to couple the medical device to the body lumen, the sharp distal end cannot penetrate too deeply and expose to surrounding tissue. The preliminary depth control prevents tissue exposure harm while maintaining reliable coupling.

Inventive Principle:
Principle #10Preliminary action

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

These devices provide secure anchoring of medical devices within the body while protecting surrounding tissue from damage and allowing for easy removal or repositioning, reducing the risk of migration and tissue injury.

Implementation Method 1

a suture may comprise a length of shape memory wire having a proximal stop tab, a body portion, and/or a sharp distal end. A suture may further curve or develop a curvature during deployment

Methodology Applied
Scientific EffectShape memory: Shape Memory Alloy

Data Source

PatentUS11547396B2Devices and methods for securing medical devices within an anatomy
Publication Date: 2023.01.10 WL GORE & ASSOC INC
  • US11547396B2 patent drawing
  • US11547396B2 patent drawing
  • US11547396B2 patent drawing

AI summary

The present disclosure includes a plurality of securing devices. For example, the present disclosure includes securing devices comprising sutures, everting anchors, and inverting anchors. The sutures and anchors disclosed herein may be capable of deployment to a depth within a body lumen, such that body tissue external to the body lumen is not damaged by the devices. Moreover, in various embodiments, the securing devices described herein may couple one or more medical devices (e.g., stents, grafts, and/or stent-grafts) to body tissue such as a body lumen.