Catheter Sleeve Mechanism for Heart Valve Stent Positioning

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Solution Overview

Problem

Current medical technologies lack a reliable and minimally invasive system for transarterial or transfemoral implantation of self- or balloon-expandable heart valve stents with a heart valve prosthesis, which often results in incorrect positioning and increased risk of complications, especially in patients requiring non-traditional surgical approaches due to age or other factors.

Innovation Solution

A catheter system with a handle that includes a stent holder and sleeve-shaped members for precise control of an expandable heart valve stent, allowing for controlled deployment and positioning within the body, enabling predictable and minimally invasive implantation without the need for a heart-lung machine.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a conventional instrument with multiple independently operable deployment elements is used to deploy a cardiac valve prosthesis, then the radial expansion of different portions can be controlled independently, but the device complexity increases and the implantation procedure becomes complicated and difficult

Engineering Contradiction:
Improvepositioning accuracyVSAvoidinstrument complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The catheter shaft is divided into multiple functional segments: a guiding means for navigation, a stent holder for securing the prosthesis, and multiple sleeve-shaped members that can be independently moved to control deployment of different stent portions. This segmentation allows independent control of deployment while keeping each component relatively simple in structure.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent employs a nested structure where sleeve-shaped members are positioned within the catheter shaft and can slide relative to each other and the shaft. The sleeves are nested within the catheter structure, allowing compact packaging of multiple control mechanisms while maintaining the ability to independently manipulate each sleeve for precise stent deployment control.

Inventive Principle:
Principle #7Nested doll (Nesting)

2Ease of operation

If transarterial or transfemoral access is used for minimally invasive implantation, then patient trauma is reduced and surgical efficiency is improved, but the risk of incorrect positioning increases and the procedure becomes more challenging

Engineering Contradiction:
Improveminimally invasive accessVSAvoidpositioning accuracy
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The catheter system incorporates radiopaque markers on the stent and catheter components that provide visual feedback during fluoroscopic guidance. This allows the operator to monitor the position and deployment status of the stent in real-time through imaging, ensuring accurate positioning even during minimally invasive transarterial or transfemoral access procedures.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The stent is pre-mounted and secured to the catheter tip within the stent holder before insertion into the patient's body. This preliminary preparation ensures that the stent is correctly positioned on the delivery system prior to navigation through the vascular system, reducing the risk of positioning errors during the minimally invasive procedure.

Inventive Principle:
Principle #10Preliminary action

3Adaptability or versatility

If self-expanding or balloon-expanding stent systems are used, then heart valve prosthesis implantation can be achieved without open surgery, but the implantation procedure remains complicated and expensive

Engineering Contradiction:
Improveexpansion method flexibilityVSAvoidimplantation system complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The catheter system is designed with multi-functional components that can accommodate both self-expanding and balloon-expanding stent types. The sleeve-shaped members and stent holder can work with different stent mechanisms, providing universal applicability across multiple stent deployment methods without requiring separate specialized instruments for each expansion type.

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

Data Source

PatentEP2387977B1Catheter system for introducing an expandable heart valve stent into the body of a patient
Publication Date: 2013.11.06 JENAVALVE TECH INC
  • EP2387977B1 patent drawingFigure 1
  • EP2387977B1 patent drawingFigure 2
  • EP2387977B1 patent drawingFigure 3a~3b

AI summary

The invention relates to catheter system for introducing an expandable heart valve stent (150) into the body of a patient, the catheter system comprising: a catheter tip (10) having a seat portion for accommodating the stent (150) in its collapsed state and a stent holder (15) for releasably fixing the stent (150), wherein the seat portion is constituted by a first sleeve-shaped member (11) and a second sleeve-shaped member (21), said sleeve-shaped members (11, 21) being moveable relative to each other and relative to the stent holder (15), and a catheter shaft (30) for connecting the catheter tip (10) to a handle (70). The catheter shaft (30) comprising: first force transmitting means (31) connected to the first sleeve-shaped member (11), second force transmitting means (41) connected to the second sleeve-shaped member (21) and a distal end section connectable to second operating means (81) of the handle (70), and guiding means (51) having a passageway extending there between, wherein the first and second force transmitting means (31, 41) are at least partly received within the passageway such as to be moveable relative to the guiding means (51), and wherein the proximal end of the guiding means (51) terminates distal to the catheter tip (10).