Tubular Soft Tissue Support Device with Anchoring and Compliant Portions

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Solution Overview

Problem

Current methods for treating mitral valve regurgitation, such as open heart surgery, come with significant disadvantages like longer recovery times and risks, while percutaneous approaches face challenges due to the dynamic nature of the beating heart and difficulty in direct imaging and stable implantation of devices.

Innovation Solution

A device comprising a tubular body with compliant and anchoring portions, where the anchoring portions have anchor members that can penetrate soft tissue, and the compliant portions can be adjusted to form a ring-like shape for secure attachment to the mitral valve annulus, allowing for percutaneous delivery and adjustment to support heart tissue.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If open heart surgery is used to attach prosthetic ring, then secure support of heart tissue is achieved, but recovery time increases and surgical risks increase

Engineering Contradiction:
Improvesecure support of heart tissueVSAvoidrecovery time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The device is divided into multiple anchoring portions with individual anchor members distributed along the tubular body, allowing percutaneous penetration and attachment at multiple points around the annulus. This segmentation enables minimally invasive delivery while achieving secure tissue support through distributed anchoring points.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The anchor members act as intermediaries that penetrate the soft tissue to secure the device to the annulus. These anchor members bridge the device and the tissue, providing reliable attachment without requiring open surgical exposure, thus enabling percutaneous delivery while maintaining secure support.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Loss of time

If percutaneous approach is used for device delivery, then recovery time is reduced and surgical risks are decreased, but stable implantation and direct imaging become difficult due to dynamic heart movement and blood flow

Engineering Contradiction:
Improverecovery timeVSAvoidstable implantation
Core Design Contradiction:
Loss of timeVSReliability

Solution Approach 1:

The device incorporates compliant portions with deformable members that can adjust to the dynamic movement of the beating heart and changing annulus geometry. This dynamic compliance allows the device to maintain stable attachment despite cardiac motion, solving the stability problem inherent in percutaneous approaches.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The deformable members in the compliant portions can change their physical state or configuration in response to mechanical forces from heart movement. This parameter change allows the device to adapt its shape and maintain contact with the moving annulus, ensuring reliable implantation despite the dynamic environment.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If anchor members are designed to penetrate soft tissue, then secure attachment to annulus is achieved, but device complexity increases

Engineering Contradiction:
Improvesecure attachment to annulusVSAvoiddevice structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The anchoring function is segmented into multiple discrete anchor members distributed along the device, with each anchor handling a portion of the attachment task. This segmentation simplifies the design of individual anchors while achieving reliable overall attachment through the collective action of multiple anchors.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The anchor members serve multiple functions: they provide structural support, enable percutaneous penetration, and secure attachment to the annulus. This multi-functionality reduces the need for separate components, thereby managing device complexity while achieving reliable attachment.

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

4Adaptability or versatility

If compliant portions with deformable members are included for adaptability, then adaptability to different annulus sizes is improved, but device complexity increases

Engineering Contradiction:
Improveadaptability to different annulus sizesVSAvoiddevice structure
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The compliant portions utilize deformable members that can flex and deform to accommodate different annulus sizes and geometries. This flexibility is achieved through the mechanical properties of the deformable members themselves, providing adaptability without requiring complex adjustable mechanisms.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The deformable members in the compliant portions are designed to dynamically adjust their configuration based on the size and shape of the annulus. This dynamic adaptability allows a single device design to fit various annulus dimensions, reducing the need for multiple device sizes while managing complexity.

Inventive Principle:
Principle #15Dynamics

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

Enables secure, minimally invasive support of heart tissue with reduced recovery time, improved accuracy, and adaptability to different annulus sizes, facilitating effective mitral valve repair.

Implementation Method 1

the compliant portions each comprising at least one deformable member extending between ends of the compliant portion, at least one of a distance and orientation between said ends being adjustable by application of a force on the tubular body

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 2

the anchoring portions each comprising at least one anchor member adapted to penetrate into soft tissue

Methodology Applied
Scientific EffectMechanical Force: Mechanical Force

Data Source

PatentUS10004600B2Device for soft tissue support and method for anchoring
Publication Date: 2018.06.26 CECERE RENZO
  • US10004600B2 patent drawing
  • US10004600B2 patent drawing
  • US10004600B2 patent drawing

AI summary

A device for supporting soft tissue includes a tubular body and is constituted of a sequence of compliant portions and anchoring portions. The anchoring portions each include anchor members adapted to penetrate into soft tissue. The compliant portions each include deformable members extending between ends of the compliant portion, at least one of a distance and orientation between said ends being adjustable by application of a force on the tubular body. The tubular body includes a ring-like shape reached at least by deformation of the compliant portions, the ring-like shape having the anchor members of the anchoring portions protruding circumferentially along a direction defined by a vector having a component being at least tangential to the curve of the ring-like shape, for the anchor members to penetrate the soft tissue. A method for anchoring the device to soft tissue is also provided.