Delivery-Activated Inflatable Members for Spinal Cord Lead Stability

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Solution Overview

Problem

Existing neurological stimulation systems, such as spinal cord stimulation leads, face challenges with lead migration post-implantation, compromising treatment efficacy due to instability and requiring invasive surgical procedures for large paddle leads.

Innovation Solution

The use of delivery-activated inflatable members integrated with lead bodies, which expand to secure the lead in place after implantation, utilizing self-expanding materials or fluid inflation to maintain position and prevent migration, allowing for percutaneous implantation with reduced invasiveness.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If large paddle leads are used to cover more neurological structures and improve stability, then treatment stability is improved, but implantation invasiveness increases and patient complications arise

Engineering Contradiction:

Improvetreatment stabilityVSAvoidimplantation invasiveness

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The lead is divided into modular components: a cylindrical lead body for percutaneous delivery and separate inflatable members that expand at the implantation site. This segmentation allows the lead to be delivered through a smaller access point while achieving the stability of a larger implant structure.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The inflatable members are pre-positioned in a collapsed state within the lead body during delivery, and then activated to expand after reaching the target location. This preliminary positioning allows the system to benefit from both the small delivery profile and the large final stability structure.

Inventive Principle:

Principle #10Preliminary action

2Object-affected harmful factors

If cylindrical leads are used for percutaneous implantation to reduce invasiveness, then implantation invasiveness is reduced, but lead stability and resistance to migration deteriorate

Engineering Contradiction:

Improveimplantation invasivenessVSAvoidlead stability

Core Design Contradiction:

Object-affected harmful factorsVSReliability

Solution Approach 1:

The lead transitions from a static cylindrical structure to a dynamic structure with inflatable members that can change volume. The inflatable members are collapsed during delivery for minimal invasiveness and then expanded after implantation to provide stability and prevent migration.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The lead incorporates inflatable members that use pneumatic pressure to expand from a collapsed delivery state to an expanded functional state. This pneumatic mechanism allows the lead to achieve stability without requiring a large initial implantation structure.

Inventive Principle:

Principle #29Pneumatics and hydraulics

3Reliability

If inflatable members are expanded to secure the lead in place to prevent migration, then lead stability is improved, but device complexity increases

Engineering Contradiction:

Improvelead stabilityVSAvoiddevice complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The inflatable members are integrated directly into the lead body structure, merging the stabilization function with the delivery device. This integration reduces the need for separate stabilization components and simplifies the overall device architecture while maintaining the ability to prevent migration.

Inventive Principle:

Principle #5Merging (Combining)

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 inflatable members effectively secure the lead bodies in the desired position, enhancing treatment stability and reducing the risk of migration, while enabling less invasive implantation procedures, thus improving the efficacy and safety of neurological stimulation.

Implementation Method 1

The inflatable member has a collapsed configuration and an expanded configuration. The inflatable member is made of a self-expanding material or is inflatable with fluid.

Methodology Applied

Scientific EffectSelf-expanding material:

Implementation Method 2

The inflatable member is made of a self-expanding material or is inflatable with fluid.

Methodology Applied

Scientific EffectFluid inflation:

Data Source

PatentUS8712552B2Treatment devices with deliver-activated inflatable members, and associated systems and methods for treating the spinal cord and other tissues

Publication Date: 2014.04.29 NEVRO CORP

AI summary

The present application includes treatment systems having delivery-activated inflatable members, and associated systems and methods for treating the spinal cord and other tissues. A treatment system in accordance with one embodiment includes a lead body having an opening, an inner surface position around the opening, and an inflatable member carried by the lead body, with at least one of the inflatable member and the lead body including a frangible portion accessible from the opening. The inflatable member can have an expandable interior volume bounded at least in part by the frangible portion. The system can further include a delivery device received in the opening of the lead body and positioned to open a passage through the frangible portions between the interior volume of the inflatable member and the opening of the lead body when the delivery device is removed from the opening of the lead body.