Implantable Lead With Extensible Needle Electrode and Screw-Thread Repositioning

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Solution Overview

Problem

Current cardiac rhythm management systems face challenges in accurately mapping and stimulating the bundle of His in the heart, often requiring repeated myocardial penetration and risking tissue damage due to the inefficiency of existing lead designs and fixation methods.

Innovation Solution

The development of an electrode assembly with a housing and needle electrode, featuring internal and external screw threads, an active fixation device with tines or a helix, and a rotatable coupler, allowing for precise placement and secure fixation of the lead within the myocardium, enabling faster and less harmful mapping and stimulation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If repeated myocardial penetration is used for mapping and stimulation, then mapping and stimulation can be performed, but tissue damage increases and the process becomes inefficient

Engineering Contradiction:

Improvemapping efficiencyVSAvoidtissue damage

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

The lead incorporates pre-configured fixation features (screw threads, tines, or helix) that enable secure attachment to the myocardium in a single penetration event. The electrode is pre-positioned within the lead body, allowing immediate functional deployment without requiring repeated insertions for repositioning or stabilization.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The active fixation device automatically secures the lead to the myocardium through self-biting tines or helical engagement upon single penetration, eliminating the need for manual repositioning or additional fixation steps. The design enables the lead to self-stabilize at the target site during the mapping and stimulation procedures.

Inventive Principle:

Principle #25Self-service

2Reliability

If existing lead fixation methods are used, then the lead can be secured to the myocardium, but the process is time-consuming and may cause additional tissue trauma

Engineering Contradiction:

Improvefixation securityVSAvoidimplantation time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The fixation mechanisms (screw threads, tines, or helix) are pre-integrated into the lead structure before implantation. Upon single myocardial penetration, these pre-configured features immediately engage with the tissue to secure the lead, eliminating the need for separate fixation steps or prolonged adjustment periods during the implantation procedure.

Inventive Principle:

Principle #10Preliminary action

3Adaptability or versatility

If the electrode is fixed in position within the lead, then the lead structure is simple, but the electrode cannot be repositioned for accurate mapping

Engineering Contradiction:

Improveelectrode repositioning capabilityVSAvoidlead structure complexity

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The electrode is mounted on a movable assembly that allows dynamic repositioning along the lead axis. The electrode can be extended outward for mapping and stimulation, then retracted into the lead body for securement. This dynamic configuration enables both accurate positioning and simplified final structure.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The electrode is nested within the lead body when not in use, similar to a doll within a doll structure. The electrode can be extended from the lead for functional deployment, then retracted back into the lead housing for securement and protection, allowing repositioning capability without permanent structural complexity.

Inventive Principle:

Principle #7Nested doll (Nesting)

4Measurement precision

If multiple fixation attempts are made to achieve accurate positioning, then positioning accuracy improves, but the risk of tissue damage and procedure time increase

Engineering Contradiction:

Improvepositioning accuracyVSAvoidtissue damage

Core Design Contradiction:

Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

Inventive Principle:

Principle #10Preliminary action

Data Source

PatentUS12083337B2Implantable lead with extensible electrode and repositioning features

Publication Date: 2024.09.10 CARDIAC PACEMAKERS INC

AI summary

An electrode assembly for the positioning of an electrode of an implantable medical lead includes a housing and an electrode subassembly. The housing includes a proximal end for connecting to the lead and a distal end. The housing defines a housing lumen extending between the proximal end and the distal end. The housing lumen includes internal screw threads extending along at least a portion of the housing lumen. The electrode subassembly is disposed at least partially within the housing lumen. The electrode subassembly includes a needle electrode and a coupler. The needle electrode is disposed coaxially with the longitudinal axis of the housing lumen. The coupler is disposed at a proximal end of the needle electrode. The coupler includes external screw threads engaged with the internal screw threads of the housing lumen such that rotation of the coupler moves the needle electrode along the longitudinal axis of the housing lumen.