Hemostasis Torque Assembly Snap-Fit Coupling

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Solution Overview

Problem

Current medical devices face challenges in controlling the axial and rotational displacement of guidewires within the cardiovascular system, leading to complications during medical procedures, such as bleeding and improper placement of catheters, due to the lack of effective mechanisms for secure and precise manipulation.

Innovation Solution

A hemostasis torque assembly with a snap-fit torque device that selectively secures and engages guidewires, allowing for controlled translation and rotation, while maintaining the positional relationship between the guidewire and catheter, thereby facilitating easy insertion and removal while limiting fluid loss.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a traditional hemostasis valve is used without a torque device, then the device structure remains simple, but the control over guidewire axial and rotational displacement is insufficient leading to bleeding and improper catheter placement

Engineering Contradiction:
Improvecontrol over guidewire displacementVSAvoidstructure of hemostasis valve
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The hemostasis valve is divided into separate functional modules: the base valve structure and the detachable torque device. This segmentation allows the torque control functionality to be added only when needed, improving guidewire displacement control while keeping the base valve simple for cases where torque control is not required.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The torque device is designed with universal coupling mechanisms that can be attached to the hemostasis valve when torque control is needed, and detached when not needed. This multi-functionality allows the same base valve to serve both simple hemostasis and controlled torque applications.

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

2Reliability

If a permanently attached torque device is used, then control over guidewire manipulation is improved, but the ease of insertion and removal of the catheter system is reduced

Engineering Contradiction:
Improvecontrol over guidewire manipulationVSAvoidinsertion and removal of catheter system
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The coupling between the torque device and hemostasis valve is designed to be dynamic rather than fixed. The torque device can be selectively attached and detached from the valve, allowing the system to transition between different operational states. This dynamic coupling enables easy insertion and removal while maintaining torque control capability when needed.

Inventive Principle:
Principle #15Dynamics

3Reliability

If the torque device is always coupled to the hemostasis valve, then precise control over guidewire position is maintained, but the loss of time during assembly and disassembly of the complete system increases

Engineering Contradiction:
Improveprecision of guidewire position controlVSAvoidassembly and disassembly time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The torque device is pre-assembled with the catheter system in a ready-to-attach state, but remains detached from the hemostasis valve until needed. This preliminary preparation allows for rapid attachment when torque control is required, reducing assembly time while maintaining precision control capability.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The torque device is extracted from the permanent structure and made detachable, allowing it to be removed from the system when not needed. This extraction reduces unnecessary assembly and disassembly operations, saving time while preserving the ability to attach the torque device when precise control is required.

Inventive Principle:
Principle #2Taking out (Extraction)

4Manufacturing precision

If a complex torque control mechanism is integrated into the hemostasis valve, then guidewire manipulation precision is improved, but the device complexity and difficulty of manufacture increase

Engineering Contradiction:
Improveguidewire manipulation precisionVSAvoidmanufacture of hemostasis valve
Core Design Contradiction:
Manufacturing precisionVSEase of manufacture

Solution Approach 1:

The torque control mechanism is segmented into a separate detachable device rather than being integrated into the hemostasis valve body. This allows each component to be manufactured independently using optimized processes, improving manufacturing precision for the torque control functions while simplifying the manufacture of the base valve.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

A coupling interface acts as an intermediary between the torque device and hemostasis valve, allowing precise torque control to be transmitted from the simple torque device to the valve system. This intermediary approach enables high manufacturing precision in torque control without requiring complex integration into the valve manufacturing process.

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentUS10926076B2Hemostasis torque assembly
Publication Date: 2021.02.23 MERIT MEDICAL SYSTEMS INC
  • US10926076B2 patent drawing
  • US10926076B2 patent drawing
  • US10926076B2 patent drawing

AI summary

The present disclosure relates to a hemostasis valve with a selectively coupled torque device. The hemostasis valve may include a first mating interface, and the torque device may comprise a second mating interface. The first interface may comprise a groove that retains the second interface, which may comprise a ridge. An axial force may couple and decouple the interfaces. The interfaces may be configured to allow the torque device to rotate relative to the hemostasis valve when in a coupled position.