Flexible Protection Tip for Intracardiac Capsule Implantation

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

The implantation of active implantable medical devices, such as leadless capsules, poses risks due to the size and form factor of existing systems, which can cause tissue alteration, cardiac perforation, and other injuries during endovenous and endocardial handling, particularly due to the thinness of the heart wall and the need for direct contact with a remotely steerable catheter.

Innovation Solution

A remotely steerable implantation accessory with a flexible protection tip and sub-catheter system that allows telescopic deployment and elastic deformation, reducing stress on the tissue and enabling visual monitoring during implantation, thereby minimizing the risk of injury and improving handling safety.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a remotely steerable catheter with rigid tip is used for implantation, then the capsule can be delivered to the implantation site, but the risk of tissue alteration and cardiac perforation increases due to direct contact with rigid structures

Engineering Contradiction:

Improvesafe delivery of capsuleVSAvoidtissue alteration and cardiac perforation

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies this principle by replacing the rigid tip with a flexible tip made of elastomeric material that can deform elastically during implantation. The flexible tip maintains the protective function while adapting to tissue contours, thereby preventing tissue alteration and cardiac perforation caused by rigid structures.

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The patent changes the physical parameter of the tip from rigid to flexible by selecting materials with appropriate elastic properties. This parameter change allows the tip to deform under stress rather than maintaining a fixed rigid shape, reducing harmful contact with cardiac tissue during the implantation process.

Inventive Principle:

Principle #35Parameter changes

2Object-affected harmful factors

If a flexible protection tip with elastic deformation capability is used, then the risk of tissue injury is reduced, but the complexity of the implantation accessory increases

Engineering Contradiction:

Improverisk of lesion or injuryVSAvoidcomplexity of implantation accessory

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The patent applies segmentation by dividing the catheter system into distinct functional segments: a remotely steerable catheter, a flexible protection tip, and a sub-catheter. This segmentation allows each component to be optimized independently - the tip for flexibility and safety, the catheter for steering control - while maintaining overall system functionality.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent implements nesting by housing the sub-catheter within the lumen of the remotely steerable catheter, and the capsule within the flexible protection tip. This nested arrangement allows compact delivery through the venous system while enabling sequential deployment of components during implantation.

Inventive Principle:

Principle #7Nested doll (Nesting)

3Reliability

If the capsule is firmly anchored in the heart wall, then secure implantation is achieved, but the difficulty of reversing or repositioning increases

Engineering Contradiction:

Improvesecure anchoring of capsuleVSAvoidreversibility of implantation

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The patent applies preliminary action by providing a retrieval catheter before implantation is finalized. This retrieval catheter can be positioned in advance to engage the capsule's retrieval features, allowing the operator to reverse or reposition the capsule if needed without requiring additional invasive procedures.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent introduces retrieval features as an intermediary mechanism between the capsule and the retrieval catheter. These features (such as engagement protrusions or loops) allow the retrieval catheter to temporarily grasp and manipulate the capsule, facilitating reversal or repositioning while the capsule remains firmly anchored to tissue.

Inventive Principle:

Principle #24Intermediary (Mediator)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The system significantly reduces the risk of lesion or injury during implantation while maintaining practitioner ease of use and visibility, ensuring safe and effective deployment of the capsule without compromising the smooth progression through the heart tissue.

Implementation Method 1

a flexible portion forming an articulation provides between the base and the cylindrical portion an elastic deformability in bending and in compression

Methodology Applied

Scientific EffectElasticity: Elasticity

Data Source

PatentUS11779774B2In situ implantation accessory for an autonomous intracardiac capsule

Publication Date: 2023.10.10 SORIN CRM

AI summary

An implantation accessory for an intracardiac capsule includes a catheter with a catheter body and a tubular protection tip disposed at a distal end of the catheter body. The tubular protection tip includes a flexible portion disposed between a base portion structured to couple the tubular protection tip to the catheter body and a cylindrical portion structured to house the intracardiac capsule.