Segmented Nerve Cap Structure for Neuroma Pain Isolation

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Solution Overview

Problem

Current methods for preventing and alleviating neuroma-related pain are inadequate, as they often complicate surgery, fail to effectively limit neuroma size, and allow for haphazard nerve fiber arrangements that lead to abnormal activity and pain amplification.

Innovation Solution

A cylindrical cap with internal dividers that partitions nerve structures into separate channels, combined with a biomaterial that remodels into a tissue cushion, to limit neuroma size and isolate it from stimulation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If the nerve stump is buried into muscle or bone to isolate the neuroma, then the neuroma is protected from mechanical stimulation and pain is reduced, but the surgery becomes greatly complicated and requires significant additional dissection of healthy tissue

Engineering Contradiction:
Improvemechanical stimulation of neuromaVSAvoidsurgical complexity
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

A cylindrical device made of biomaterial serves as an intermediary structure that encapsulates the nerve stump. This device provides the isolation and protection from mechanical stimulation without requiring burial into muscle or bone, thereby avoiding the need for significant additional dissection of healthy tissue while still achieving the protective function.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The cylindrical device is divided into multiple segments or chambers internally, creating separate channels that partition the nerve fibers. This segmentation prevents haphazard regeneration and reduces cross-talk between axons, addressing the disorganized structure problem while maintaining a relatively simple overall device structure.

Inventive Principle:
Principle #1Segmentation

2Volume of stationary object

If suture ligation is used to block axon exit and form scar tissue, then the neuroma size is limited, but a painful neuroma forms behind the ligation and the ligated nerve is not positioned to minimize mechanical stimulation

Engineering Contradiction:
Improveneuroma sizeVSAvoidpainful sensation
Core Design Contradiction:
Volume of stationary objectVSObject-affected harmful factors

Solution Approach 1:

The cylindrical biomaterial device acts as an intermediary that physically contains and isolates the nerve stump, preventing the formation of painful neuromas behind ligation sites. The device structure itself provides the containment function rather than relying on scar tissue formation, thereby limiting neuroma size while avoiding the harmful effect of painful neuroma formation.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The device provides localized containment and isolation exactly where the nerve stump is positioned, with internal partitions creating specific zones for different nerve fibers. This localized approach limits neuroma size while the overall device positioning can be optimized to minimize mechanical stimulation, addressing both size limitation and pain reduction.

Inventive Principle:
Principle #3Local quality

3Object-affected harmful factors

If silicone or rubber tubes are used to cover the nerve stump, then the neuroma is isolated, but insertion is difficult and can further damage the nerve end, and the neuroma remains as a single mass where stimulation creates a cascade effect

Engineering Contradiction:
Improvemechanical stimulationVSAvoidinsertion difficulty
Core Design Contradiction:
Object-affected harmful factorsVSEase of manufacture

Solution Approach 1:

The cylindrical device incorporates internal partitions or dividers that create multiple separate channels within the tube structure. This segmentation allows nerve fibers to be organized into distinct pathways, preventing the cascade effect where stimulation of one area affects the entire neuroma mass. The segmented structure also facilitates easier insertion by providing a more gradual transition for the nerve tissue.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device is constructed from flexible biomaterial that can be molded into a cylindrical shape, providing a soft, compliant structure that is easier to insert than rigid silicone or rubber tubes. The flexibility of the biomaterial allows it to conform to the nerve tissue during insertion, reducing the risk of further nerve damage while maintaining the isolation function.

Inventive Principle:
Principle #30Flexible shells and thin films

4Object-affected harmful factors

If the nerve is cut back to create an epineurium sleeve, then the nerve stump is covered, but the procedure complicates surgery and does not effectively prevent haphazard nerve fiber arrangement

Engineering Contradiction:
Improvenerve fiber disorganizationVSAvoidsurgical procedure complexity
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The cylindrical biomaterial device serves as an intermediary structure that replaces the need for complex epineurium sleeve manipulation. The device provides a pre-formed structured environment that guides nerve fiber organization without requiring the surgeon to perform additional dissection and manipulation of healthy tissue to create an epineurium sleeve.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The internal partitions of the cylindrical device create defined channels that guide nerve fiber regeneration in an organized manner. This segmentation structure is more effective at preventing haphazard arrangement than an epineurium sleeve, as the rigid partitions provide physical guidance for fiber alignment while the overall device structure remains relatively simple to implant.

Inventive Principle:
Principle #1Segmentation

Data Source

PatentEP4371585B1Materials and methods for protecting against neuromas
Publication Date: 2026.03.11 AXOGEN CORP
  • EP4371585B1 patent drawingFigure 1A~2C
  • EP4371585B1 patent drawingFigure 3A~5B
  • EP4371585B1 patent drawingFigure 6A~6C

AI summary

The subject invention provides devices and methods for alleviating discomfort associated with neuroma formation. The devices and methods of the invention effectively use the body's natural response of reconstructing implanted biomaterials to minimize the size of, isolate, and protect a neuroma. In preferred embodiments, the subject device is a cylindrical cap, wherein the internal chamber of the cylindrical cap physically partitions the nerve to enable an arrangement of nerve fibers (as opposed to haphazardly arranged nerve fibers often produced in neuromas). Tabs arranged on the outside of the cap can be used to manipulate the cap into place on a nerve. The open end can also be configured with flaps that can be used to widen the open end for easier insertion of the nerve into the cap. In addition, the cap's material remodels into a tissue cushion after implantation, which protects the neuroma from being stimulated and inducing pain.