Shape-Memory Tissue Clamp for Heart Valve Regurgitation

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Solution Overview

Problem

Current tissue clamping devices are inadequate in effectively addressing mitral regurgitation and tricuspid valve issues, leading to inefficient blood flow regulation and potential life-threatening conditions such as heart failure and arrhythmia.

Innovation Solution

A tissue clamping device with a clamp mechanism comprising a supporting unit, interior and exterior clamping arms, and an agnail clip, formed from shape-memory alloy, which can be expanded or folded to securely clamp tissues, including heart valves, using a locking mechanism and elastic bracket for enhanced stability and clamping force.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional tissue clamping devices are used, then the structure is simple, but the clamping effectiveness and stability are insufficient

Engineering Contradiction:
Improveclamping stabilityVSAvoidclamp structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The clamp is divided into multiple independent arms (first interior clamping arm, first exterior clamping arm, second interior clamping arm, and second exterior clamping arm) that can be controlled separately. Each arm can be independently expanded or folded, allowing precise control over the clamping force distribution and enabling the device to adapt to different tissue shapes and sizes while maintaining stable clamping.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The clamp employs bendable connections between the supporting unit and clamping arms, allowing the structure to dynamically adjust its configuration. The bendable connections enable the clamp to transition between folded and expanded states, and to adapt its shape to match the contours of the tissue being clamped, thereby improving clamping effectiveness without requiring a completely rigid structure.

Inventive Principle:
Principle #15Dynamics

2Adaptability or versatility

If the clamp structure is simplified, then the device is easier to manufacture, but the ability to adapt to different tissue types is reduced

Engineering Contradiction:
Improvetissue adaptationVSAvoidclamp fabrication
Core Design Contradiction:
Adaptability or versatilityVSEase of manufacture

Solution Approach 1:

The clamp is designed with universal applicability through its modular structure and bendable connections, enabling it to clamp various tissue types including heart valves (mitral valve, tricuspid valve), arteries, and other soft tissues. The same basic clamp design can be used across different surgical procedures, eliminating the need for multiple specialized clamps and simplifying manufacturing by using standardized components.

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

Solution Approach 2:

The clamp's adaptability is achieved through parameter changes in its physical state rather than changing its fundamental structure. The bendable connections allow the clamp to change its geometric parameters (angle, curvature, expansion ratio) to match different tissue configurations. This enables a single manufactured design to accommodate various tissue types by adjusting its physical parameters during deployment.

Inventive Principle:
Principle #35Parameter changes

3Productivity

If conventional clamping methods are used, then the procedure is simple, but the regurgitation area reduction is insufficient

Engineering Contradiction:
Improvesurgical efficiencyVSAvoidregurgitation prevention
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The clamp is deployed in a pre-folded state through the vascular access site and only expands once positioned at the target tissue. This preliminary folded state allows for minimally invasive delivery, while the subsequent expansion at the precise location ensures effective clamping of the valve or artery to prevent regurgitation. The preliminary action of delivery does not compromise the reliability of the final clamping effect.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent replaces traditional mechanical clamping systems with a shape-memory alloy-based intelligent clamp. The shape-memory alloy material enables the clamp to automatically return to its expanded clamping state after being compressed during delivery, providing self-sustaining clamping force without requiring continuous external mechanical actuation. This substitution improves surgical efficiency by eliminating complex control mechanisms while maintaining reliable regurgitation prevention.

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 effectively reduces regurgitation areas in heart valves, improving blood flow regulation and preventing life-threatening conditions by providing a secure and adjustable clamping mechanism that adapts to different tissue types and patient needs.

Implementation Method 1

A tissue clamping device with a clamp mechanism comprising a supporting unit, interior and exterior clamping arms, and an agnail clip, formed from shape-memory alloy

Methodology Applied
Scientific EffectShape-memory alloy: Shape Memory Alloy

Data Source

PatentUS20230013416A1Tissue clamping devices
Publication Date: 2023.01.19 SHANGHAI NEWMED MEDICAL CO LTD
  • US20230013416A1 patent drawing
  • US20230013416A1 patent drawing
  • US20230013416A1 patent drawing

AI summary

A tissue clamping device including a clamp, a first connector, a second connector, and a clip is provided. The clamp may include a supporting unit, a first interior clamping arm, a first exterior clamping arm, a second interior clamping arm, and a second exterior clamping arm. The supporting unit may be connected to the first interior clamping arm, the first exterior clamping arm, the second interior clamping arm, and the second exterior clamping arm. The clamp may be connected to a portion between the first connector and the second connector. A relative movement of the first connector and the second connector may drive the first interior clamping arm and the second interior clamping arm to be expanded or folded relatively. The clip may include a first clip and a second clip, and the first clip and the second clip may be respectively expanded or folded.