Introducer with Longitudinal Gap for Prosthetic Valve Insertion

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Solution Overview

Problem

Current methods for implanting prosthetic heart valves are complex and prone to tissue damage and leakage, particularly due to the need for large incisions and the difficulty in passing valves through small openings without causing lacerations.

Innovation Solution

An introducer device with a longitudinally extending gap and a tapered distal portion that allows for radial expansion and dilation of the incision, enabling the prosthetic valve to be advanced through a smaller incision without tilting, and facilitates easy placement and removal of sutures and delivery devices.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Area of stationary object

If a transverse incision is made in the aorta to implant a prosthetic valve, then the incision can be smaller than the valve cross-section, but the valve insertion becomes complex and may cause tissue laceration

Engineering Contradiction:

Improveincision sizeVSAvoidvalve insertion difficulty

Core Design Contradiction:

Area of stationary objectVSEase of operation

Solution Approach 1:

The introducer acts as an intermediary device that facilitates valve passage through the incision. The introducer is inserted through the incision first, then the valve is advanced through the introducer's central lumen, serving as a mediator that enables the valve to pass through the smaller incision without direct forcing

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The prosthetic valve is nested within the introducer device for passage through the incision. The valve is positioned inside the introducer's central lumen, allowing both devices to be maneuvered together through the incision site, similar to nested dolls

Inventive Principle:

Principle #7Nested doll (Nesting)

2Area of stationary object

If a transverse incision is made in the aorta, then the incision size is reduced, but the risk of tissue laceration and leakage increases

Engineering Contradiction:

Improveincision sizeVSAvoidtissue laceration and leakage risk

Core Design Contradiction:

Area of stationary objectVSObject-affected harmful factors

Solution Approach 1:

The introducer serves as a protective sheath that cushions and protects the tissue incision during valve insertion. The introducer's body shields the incision edges from direct contact with the valve and sutures, preventing laceration before it can occur

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

Solution Approach 2:

The introducer acts as an intermediary protective barrier between the surgical instruments (valve, sutures) and the tissue incision, mediating their interaction to prevent harmful effects like laceration and leakage

Inventive Principle:

Principle #24Intermediary (Mediator)

3Ease of operation

If an oblique or hockey stick shaped incision is made, then the opening is larger for valve passage, but the incision is more difficult to close and more prone to leakage

Engineering Contradiction:

Improvevalve passage easeVSAvoidincision closure and leakage prevention

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The function of creating a large opening for valve passage is extracted from the incision itself and transferred to the introducer device. The incision can therefore be smaller and simpler (transverse) because the introducer provides the necessary passage way, separating the valve passage function from the incision closure function

Inventive Principle:

Principle #2Taking out (Extraction)

4Area of stationary object

If the valve is inserted at an angle relative to the incision plane (shoehorn technique), then the valve can pass through the smaller incision, but the procedure complexity increases

Engineering Contradiction:

Improveincision sizeVSAvoidinsertion procedure complexity

Core Design Contradiction:

Area of stationary objectVSDevice complexity

Solution Approach 1:

The introducer provides a three-dimensional tunnel or pathway through which the valve can advance in a straight line rather than at an angle. This transforms the insertion from a two-dimensional angled maneuver through the incision plane to a one-dimensional linear advancement through the introducer's central lumen

Inventive Principle:

Principle #17Another dimension (Dimensionality change)

Data Source

PatentEP2456363B1Introducer for prosthetic device

Publication Date: 2018.01.24 EDWARDS LIFESCIENCES CORP

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AI summary

The present disclosure concerns embodiments of an introducer that is adapted to facilitate insertion of a prosthetic device, such as a prosthetic heart valve, into a patient's vasculature. In one embodiment, the introducer comprises an elongated body defining a central lumen extending between distal and proximal ends of the body. The introducer body can also have a longitudinally extending gap extending along the length of the body between the distal end proximal ends. The gap in the introducer allows a user to place the introducer around implant sutures by passing the sutures through the gap and into the central lumen. Similarly, the gap allows the introducer to be easily removed from the sutures and/or a delivery device by passing them outwardly through the gap.