Modular Recapture Assembly for Leadless Pacemaker Retrieval

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Solution Overview

Problem

Current catheter systems for retrieving leadless cardiac pacemakers face challenges in minimizing the length of inflexible components and optimizing design for minimally invasive procedures, often requiring complex hardware stacks and additional steering support, which can lead to increased pressure and reduced device capacity during implantation and recapture.

Innovation Solution

A modular recapture assembly with a steerable cinch tube and centering device that can be inserted into the catheter system only when retrieval is necessary, featuring a tether with a deployable centering mechanism to align and secure the implant, reducing the need for a permanently stationed telescoping tube and minimizing the length of inflexible components.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a permanently stationed telescoping tube is retained within the catheter system for both implantation and recapture, then recapture capability is enabled, but the total length of rigid mated bodies increases placing added pressure on efforts to shorten device length

Engineering Contradiction:
Improverecapture capabilityVSAvoidtotal length of rigid mated bodies
Core Design Contradiction:
Adaptability or versatilityVSLength of stationary object

Solution Approach 1:

The system is divided into separate functional modules: a delivery catheter for implantation and a recapture catheter for retrieval. Each catheter is optimized for its specific function, eliminating the need for a permanently stationed telescoping tube that would increase overall length. The recapture catheter can be introduced separately when recapture is needed, maintaining versatility while minimizing device length during each procedure.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system transitions from a static, permanently stationed telescoping tube to a dynamic configuration where the recapture catheter can be introduced and removed as needed. This dynamic approach allows the system to adapt to different procedural needs (implantation vs. recapture) without permanently increasing the baseline device length, as the recapture components are only present when required.

Inventive Principle:
Principle #15Dynamics

2Adaptability or versatility

If a snare and cinch tube are introduced within the inner lumen of the telescoping tube to enable recapture, then recapture functionality is expanded, but the cross-sectional profile of the catheter system increases

Engineering Contradiction:
Improverecapture functionalityVSAvoidcross-sectional profile of catheter system
Core Design Contradiction:
Adaptability or versatilityVSArea of stationary object

Solution Approach 1:

The recapture functionality is segmented into a separate recapture catheter that contains the snare and cinch tube mechanisms. This separate catheter has its own optimized cross-sectional profile and does not need to accommodate additional components within its lumen. The modular design allows each catheter to have an optimized, minimized profile suitable for its specific function.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The recapture catheter acts as an intermediary device that can be introduced through the delivery catheter or separately to perform recapture operations. This intermediary approach allows the snare and cinch tube to be delivered through a dedicated pathway with an optimized profile, rather than forcing them through the inner lumen of a permanently stationed telescoping tube, thereby minimizing the overall cross-sectional requirements.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Device complexity

If the recapture system lacks additional built-in steering support, then device complexity is reduced, but the ability to reestablish tethered connections when offset and distance are excessive is compromised

Engineering Contradiction:
Improvesteering support mechanismVSAvoidability to reestablish tethered connections
Core Design Contradiction:
Device complexityVSEase of operation

Solution Approach 1:

The recapture catheter is designed with multi-functionality, incorporating both steering capabilities and tethered connection mechanisms within a single device. This universal design allows the catheter to navigate to the implant (steering function) and then establish tethered connections (recapture function) without requiring separate complex systems, thereby maintaining ease of operation while managing device complexity.

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

Solution Approach 2:

The steering support and tethered connection establishment functions are merged into the recapture catheter system. The catheter includes integrated features that allow it to both navigate to the implant and establish secure connections, combining what could be separate functions into a unified device that improves ease of operation without proportionally increasing complexity.

Inventive Principle:
Principle #5Merging (Combining)

Data Source

PatentEP3758796B1Recapture assembly for a catheter system and catheter system for retrieval of an implant
Publication Date: 2023.10.11 BIOTRONIK SE & CO KG
  • EP3758796B1 patent drawingFigure 1~2
  • EP3758796B1 patent drawingFigure 3~4
  • EP3758796B1 patent drawingFigure 5a~5b

AI summary

The disclosure refers to a catheter system and a recapture assembly for the catheter system which serves to expand the system's functionality to support highly-articulated implant recapture. The recapture assembly comprises:a cinch tube (30, 40) with a centering device provided at the distal end of the cinch tube (30, 40) and a tether(32) located within the cinch tube (30, 40) adapted to be telescoped relative to the cinch tube (30, 40).Also, a method for retrieval of the implant (1) comprising a hitch-like element at its proximal end by the catheter system is disclosed.