Ultrasonic Dottering Tool for Subcutaneous Lead Implantation

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Solution Overview

Problem

Existing subcutaneous implantation tools for cardiac rhythm management systems, such as the S-ICD System, face challenges in efficiently tunneling through subcutaneous tissue due to their non-steerable and blunt force dissection methods, which can lead to increased complexity and risk of complications during implantation.

Innovation Solution

A dottering tool with a catheter and multiple stylets equipped with actuating mechanisms, including electrical or pneumatic drivers, and a steerable design, allows for controlled reciprocating motion and directional tunneling through subcutaneous tissue, reducing tissue dissection complexity and improving implantation precision.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If blunt force dissection is used to advance the insertion tool through tissue, then the tool can penetrate subcutaneous tissue, but the tissue trauma and complexity of dissection increase

Engineering Contradiction:

Improvetissue penetration capabilityVSAvoidtissue trauma

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces traditional mechanical blunt force dissection with an ultrasonic transducer that uses ultrasonic vibrations to facilitate tissue penetration. The ultrasonic energy breaks down tissue bonds through cavitation and mechanical vibration, reducing trauma compared to conventional blunt dissection methods while maintaining effective tunneling capability

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The ultrasonic transducer operates with periodic oscillations at ultrasonic frequencies, creating repeated cycles of compression and rarefaction in the tissue. This periodic action facilitates gradual tissue separation and tunneling through subcutaneous layers, reducing the need for continuous blunt force application and minimizing tissue damage

Inventive Principle:

Principle #19Periodic action

2Device complexity

If the insertion tool is made non-steerable to simplify the design, then the device complexity is reduced, but the precision of lead placement decreases

Engineering Contradiction:

Improvetool design simplicityVSAvoidlead placement precision

Core Design Contradiction:

Device complexityVSManufacturing precision

Solution Approach 1:

The patent introduces a steerable catheter as an intermediary component that guides the insertion tool along a controlled path. The catheter's steerable tip allows precise navigation through subcutaneous tissue to the target location, while the main body of the device remains relatively simple. This separates the steering function from the implantation function, maintaining overall device simplicity while enabling precise lead placement

Inventive Principle:

Principle #24Intermediary (Mediator)

3Manufacturing precision

If multiple incisions are used for implantation to ensure proper lead placement, then the precision of implantation is improved, but the complexity of the procedure and risk of infection increase

Engineering Contradiction:

Improveimplantation precisionVSAvoidnumber of incisions

Core Design Contradiction:

Manufacturing precisionVSDevice complexity

Solution Approach 1:

The patent designs a multi-functional insertion tool that combines tunneling, steering, and lead deployment capabilities in a single device. The steerable catheter with ultrasonic transducer can create the tunnel, navigate to the target, and deploy the lead through one integrated system, eliminating the need for multiple separate incisions and procedures while maintaining precise implantation

Inventive Principle:

Principle #6Universality (Multi-functionality)

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 dottering tool facilitates easier and more precise tunneling through subcutaneous tissue, potentially reducing the number of incisions and minimizing tissue trauma, thereby enhancing the safety and efficiency of subcutaneous lead implantation in cardiac rhythm management systems.

Implementation Method 1

Some proposed alternatives for these insertion tools have included the use of an ultrasonic transducer to assist with tunneling

Methodology Applied

Scientific EffectUltrasonic vibration: Ultrasonic Vibration

Implementation Method 2

an actuator coupled to the plurality of stylets to drive the stylets in reciprocating motion past the distal end of the catheter

Methodology Applied

Scientific EffectReciprocating motion:

Data Source

PatentUS10842520B2Dottering tools for implanting medical devices

Publication Date: 2020.11.24 CARDIAC PACEMAKERS INC

AI summary

Insertion tools for medical applications. An illustrative example is an insertion tool for implanting a lead such as a subcutaneous defibrillation lead, which includes a handle at a proximal end, a catheter, and a distal end. A plurality of stylets having dottering tips are provided in the insertion tool. Reciprocating action of the dottering tips and/or stylets is imparted to dissect through subcutaneous tissue and create a tunnel for implantation of the lead.