Steerable Catheter Telescopic Tip for Secure Leadless Capsule Implantation

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Solution Overview

Problem

Current leadless capsules for heart rhythm monitoring and stimulation face challenges in precise and secure implantation, particularly due to their large size, which complicates reaching the heart chamber and apex, and existing steerable catheters may be too short or poorly shaped to dock with the ventricular apex, increasing the risk of tissue damage and incomplete anchoring.

Innovation Solution

A steerable catheter with a distally extending cylindrical tip housing the capsule, using a telescopic sub-catheter for precise deployment and a radial compression coil spring mechanism to secure and release the capsule, preventing tissue coring and ensuring complete anchoring without excessive torque, allowing for fine adjustment and secure implantation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a steerable catheter is used to deliver the leadless capsule to the heart chamber, then the capsule can be guided to the implantation site, but the catheter may be too short or poorly shaped to reach the ventricular apex, increasing the risk of incomplete anchoring

Engineering Contradiction:
Improveanchoring completenessVSAvoidcatheter length
Core Design Contradiction:
ReliabilityVSLength of moving object

Solution Approach 1:

The patent employs a nested catheter system where an inner catheter is inserted within an outer catheter. The inner catheter can be extended telescopically from the outer catheter to reach the ventricular apex when the outer catheter is insufficient in length. This nested configuration allows the system to adapt to varying anatomical requirements while maintaining reliable delivery of the leadless capsule to the implantation site.

Inventive Principle:
Principle #7Nested doll (Nesting)

2Reliability

If excessive torque is applied during capsule anchoring to ensure secure fixation, then complete anchoring is achieved, but tissue coring and damage occur

Engineering Contradiction:
Improveanchoring securityVSAvoidtissue damage
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent incorporates a radial compression coil spring mechanism that acts as a torque limiter during capsule anchoring. The spring is pre-compressed to a specific force that prevents excessive torque from being transmitted to the tissue when the anchoring member engages the ventricular wall. This cushioning effect ensures secure fixation while avoiding tissue coring and damage by absorbing excess mechanical energy.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

3Adaptability or versatility

If the capsule is delivered through a long catheter system, then it can reach difficult implantation sites, but the procedure becomes more complex and time-consuming

Engineering Contradiction:
Improveimplantation site accessibilityVSAvoidcatheter system complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent employs a dynamic, telescopic catheter system where the inner catheter can be extended or retracted relative to the outer catheter based on the specific implantation requirements. This dynamic configuration allows the operator to adjust the effective length and reach of the delivery system without committing to a fixed, overly complex design. The telescopic mechanism provides adaptability for various implantation sites while maintaining procedural efficiency.

Inventive Principle:
Principle #15Dynamics

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

Enables precise and secure implantation of leadless capsules with reduced risk of tissue damage, ensuring complete anchoring and easy retrieval, while maintaining a quick and cost-effective procedure comparable to conventional lead implantation.

Implementation Method 1

a disconnectable mechanism including a coil spring which exerts on the capsule a radial compression

Methodology Applied
Scientific EffectRadial compression: Compression

Data Source

PatentUS12186551B2Coupling system between a medical device and its implantation accessory
Publication Date: 2025.01.07 SORIN CRM
  • US12186551B2 patent drawing
  • US12186551B2 patent drawing
  • US12186551B2 patent drawing

AI summary

An implantation accessory includes a steerable catheter comprising, on a distal end, a tubular protection tip having an internal lumen configured to house an implantable medical device. The tubular protection tip includes a fastening mechanism comprising an elastic deformable component that engages a rigid component disposed within a cavity of the implantable medical device to secure the implantable medical device within the tubular protection tip. The elastic deformable component can provide radial compression about the rigid component, and application of a torsion torque to the tubular element during implantation of the implantable medical device causes the elastic deformable component to release the rigid component.