Expandable Anchoring System for Electrical Stimulation Leads

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Solution Overview

Problem

Implantable electrical stimulation systems face challenges in securely anchoring leads to prevent migration and ensure consistent delivery of therapeutic electrical pulses, particularly in tissues like muscle and nerves.

Innovation Solution

A stimulation lead anchoring system featuring a lead anchor with a removable inner core that expands to facilitate positioning and secure the lead, and a tool for easy insertion and removal, allowing for adjustable placement and fixation of the anchor along the lead.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a traditional lead anchor is used, then the lead can be anchored to tissue, but the anchor cannot be easily repositioned or removed

Engineering Contradiction:

Improveease of repositioningVSAvoidlead anchoring security

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The anchor is divided into two functional parts: an expandable anchor body for secure tissue engagement and a removable inner core for facilitating lead insertion and repositioning. This segmentation allows the outer anchor structure to remain fixed in tissue while the inner core can be removed to enable lead adjustment, resolving the contradiction between secure anchoring and ease of repositioning

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The anchor transitions from a static structure to a dynamic system where the inner core can be selectively removed or retained. When the inner core is present, the anchor can be repositioned; when removed, the anchor provides secure fixation. This dynamic configuration resolves the contradiction by allowing the system to switch between ease of operation and anchoring security as needed

Inventive Principle:

Principle #15Dynamics

2Reliability

If the anchor is made secure and fixed, then lead migration is prevented, but adjustment and repositioning become difficult

Engineering Contradiction:

Improvelead anchoring securityVSAvoidadjustability

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The inner core is pre-installed in the anchor before lead implantation, enabling the anchor to be easily positioned and adjusted during the initial implantation procedure. After the lead is properly positioned, the inner core is removed to provide secure anchoring. This preliminary action allows both adjustability during implantation and security during operation

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The inner core serves as a temporary component that is discarded (removed) after serving its purpose of facilitating lead insertion and positioning. Its removal provides the secure anchoring needed for long-term operation, while its temporary presence during implantation provides the adjustability needed for proper lead placement

Inventive Principle:

Principle #34Discarding and recovering

3Ease of manufacture

If the anchor structure is simplified, then manufacturing is easier, but the ability to facilitate lead insertion and secure anchoring is reduced

Engineering Contradiction:

Improveanchor manufacturing simplicityVSAvoidlead insertion facilitation

Core Design Contradiction:

Ease of manufactureVSEase of operation

Solution Approach 1:

The inner core is nested within the anchor body, with the core having a diameter smaller than the anchor's internal diameter. This nested configuration allows both components to be manufactured using simple extrusion or molding processes, while the resulting structure facilitates lead insertion by providing a tapered guidance pathway from the smaller core to the larger anchor opening

Inventive Principle:

Principle #7Nested doll (Nesting)

Data Source

PatentUS10835739B2Electrical stimulation leads and systems with elongate anchoring elements and methods of making and using

Publication Date: 2020.11.17 BOSTON SCI NEUROMODULATION CORP

AI summary

A stimulation lead anchoring system includes a lead anchor and a removable inner core. The lead anchor includes an anchor body that includes a lead lumen that extends longitudinally along the anchor body and is configured and arranged to receive a portion of an electrical stimulation lead. The removable inner core includes a core body that includes an inner lumen that extends longitudinally along the core body. The lead anchor and removable inner core are configured and arranged to expand the anchor body when a portion of the core body is inserted into the lead lumen to facilitate receiving the portion of the electrical stimulation lead into the lead lumen and inner lumen and slidably positioning the lead anchor along the lead. The anchor body is configured and arranged to engage the portion of the electrical stimulation lead upon withdrawal of the core body from the lead lumen.