Deflectable Tubular Delivery Device for Leadless Pacemaker Positioning

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Solution Overview

Problem

Current delivery systems for leadless cardiac pacemakers face challenges in navigating through tortuous anatomy and accurately positioning the device at an angle to the ventricular septum, which can lead to difficulties in deploying the device in thicker regions and increased risk of cardiac perforation.

Innovation Solution

A delivery device comprising an outer tubular member, an intermediate tubular member, and an inner tubular member, with deflectable sections and an active anchor element, allows for precise navigation and fixation to the ventricular septum, enabling the device to be deployed at an angle and securely anchored.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a conventional delivery system is used, then the device can be delivered through the vasculature, but it cannot accurately position the device at an angle to the ventricular septum

Engineering Contradiction:

Improvepositioning accuracyVSAvoidnavigation difficulty

Core Design Contradiction:

Measurement precisionVSEase of operation

Solution Approach 1:

The delivery system is divided into three independently deflectable tubular members (outer, intermediate, and inner), each capable of deflection in different planes. This segmentation allows precise control of the distal holding section's orientation and positioning at the ventricular septum by independently actuating each tubular member's deflection.

Inventive Principle:

Principle #1Segmentation

2Reliability

If the device is deployed in thicker regions of the ventricular septum, then pacing efficacy is improved, but the risk of cardiac perforation increases

Engineering Contradiction:

Improvepacing efficacyVSAvoidcardiac perforation risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The system replaces blind mechanical deployment with image-guided precision positioning. By using multiple deflectable tubular members that can be controlled to orient the device at specific angles to the ventricular septum, the system enables accurate placement in thicker regions while avoiding areas at risk for perforation, thereby improving reliability while reducing harmful effects.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Adaptability or versatility

If a simple delivery system is used, then device complexity is reduced, but the ability to navigate tortuous anatomy is compromised

Engineering Contradiction:

Improvenavigation capabilityVSAvoiddelivery system complexity

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The delivery system employs a nested structure where the inner tubular member is disposed within the intermediate tubular member, which is disposed within the outer tubular member. This nesting allows three independently deflectable sections to be integrated in a compact configuration, providing enhanced navigation capability through tortuous anatomy while maintaining a relatively compact and manageable device structure.

Inventive Principle:

Principle #7Nested doll (Nesting)

4Measurement precision

If the distal holding section is fixed during delivery, then positioning precision is improved, but the ability to adjust orientation is reduced

Engineering Contradiction:

Improvepositioning precisionVSAvoidorientation adjustment capability

Core Design Contradiction:

Measurement precisionVSAdaptability or versatility

Solution Approach 1:

The distal holding section is designed with dynamic deflection capabilities through three independently controllable tubular members. Each tubular member can be deflected in different planes, allowing the distal holding section to be dynamically adjusted to various orientations and positions. This dynamic control enables precise positioning while maintaining full adaptability for orientation adjustment during the delivery process.

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

The solution enables precise placement of the leadless pacemaker on the ventricular septum, reducing the risk of cardiac perforation and improving pacing efficacy by allowing controlled orientation and fixation, thus enhancing the delivery process.

Implementation Method 1

the outer tubular member may be configured to be deflectable in a first a plane

Methodology Applied

Scientific EffectDeflection:

Implementation Method 2

the intermediate tubular member may be configured to be deflectable in a second plane different from the first plane

Methodology Applied

Scientific EffectDeflection:

Implementation Method 3

the active anchor element may be configured to engage a tissue to temporarily fixate the distal holding section to the tissue

Methodology Applied

Scientific EffectMechanical anchoring:

Data Source

PatentUS10737092B2Delivery devices and methods for leadless cardiac devices

Publication Date: 2020.08.11 CARDIAC PACEMAKERS INC

AI summary

Delivery devices, systems, and methods for delivering implantable leadless pacing devices are disclosed. An example method for delivering the implantable leadless pacing device may include distally advancing an intermediate tubular member of a delivery system across the tricuspid valve and into the right ventricle. An outer tubular member of the delivery device may be torqued in a first direction to guide a distal holding section along the ventricular septum. The distal tip of the distal holding section may be releaseably secured to a tissue. After securing the distal tip of the distal holding section, the outer tubular member may be torqued in a second direction opposite to the first direction and the implantable leadless pacing device incrementally deployed.