Keyed Locking Medical Device Delivery System

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Solution Overview

Problem

Current medical devices for delivering replacement heart valves are invasive and pose challenges in treating defective heart valves, requiring either invasive surgeries or less invasive but inefficient percutaneous methods.

Innovation Solution

A medical device delivery system comprising an outer sheath and an inner catheter with a push-pull rod mechanism that shifts an implant from an elongated to an expanded configuration, locked by a buckle and post system, allowing for percutaneous delivery and deployment of a replacement heart valve with enhanced alignment and locking integrity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If percutaneous delivery method is used, then invasiveness is reduced, but delivery efficiency and reliability are worsened

Engineering Contradiction:
ImproveinvasivenessVSAvoiddelivery reliability
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The delivery system is divided into multiple functional components: outer sheath for containment, inner catheter for support, push-pull rod for actuation, and buckle mechanism for locking. This segmentation allows each component to be optimized for its specific function while working together to achieve reliable percutaneous delivery

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The implant is pre-assembled with the push-pull rod and buckle mechanism before delivery. The keyed portion is pre-formed on the push-pull rod to ensure proper alignment with the locking assembly during deployment, eliminating the need for complex alignment procedures during the minimally invasive procedure

Inventive Principle:
Principle #10Preliminary action

2Manufacturing precision

If keyed locking structures are added, then alignment precision and locking integrity are improved, but device complexity increases

Engineering Contradiction:
Improvealignment precisionVSAvoiddevice complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The push-pull rod features a keyed portion with a non-circular cross-sectional shape that corresponds to the interior passageway of the locking assembly. This asymmetric, keyed design ensures precise alignment and prevents rotation during implant deployment, achieving high alignment precision through simple geometric complementarity rather than complex mechanisms

Inventive Principle:
Principle #4Asymmetry

Solution Approach 2:

The locking assembly integrates multiple functions into a single component: it provides structural support, guides the push-pull rod through its keyed interior passageway, and executes the locking action when the post engages the buckle. This merging reduces the number of separate parts while maintaining alignment precision

Inventive Principle:
Principle #5Merging (Combining)

Data Source

PatentEP2779945B1Medical device with keyed locking structures
Publication Date: 2021.07.14 BOSTON SCIENTIFIC SCIMED INC
  • EP2779945B1 patent drawingFigure 1
  • EP2779945B1 patent drawingFigure 2
  • EP2779945B1 patent drawingFigure 3

AI summary

Medical device delivery systems and methods for making and using medical device delivery systems are disclosed. An example medical device delivery system may include an outer sheath (12). An inner catheter (14) may be disposed within the outer sheath. An implant (16) may be releasably coupled to the inner catheter. The implant may be configured to shift between a first elongated configuration and a second expanded configuration. A push-pull rod (84) for shifting the implant between the first configuration and the second configuration may be coupled to the inner catheter. A locking assembly may be disposed about the push-pull rod. At least a portion of an outer surface of the push-pull rod may have a non-circular cross-sectional shape. The locking assembly may have an interior passageway with a non-circular cross-sectional shape corresponding to the non-circular cross-sectional shape of the push-pull rod.