Articulable Beak Excisional Device for Single-Insertion Tissue Removal

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Solution Overview

Problem

Current medical devices for vascular and skeletal procedures lack the capability to efficiently remove and analyze solid, contiguous, and fragmented materials, liquids, and semi-solids during a single insertion, particularly in chronic total occlusion and vascular anomaly treatments, with limitations in minimally invasive and reliable cardio-vascular and orthopedic interventions.

Innovation Solution

Development of excisional devices with articulable beaks and collar assemblies that enable cyclic opening and closing for tissue removal, utilizing a combination of rotational and axial movements to facilitate tissue coring, morcellation, and transport, with mechanisms for vacuum and flush systems to collect and transport specimens.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If current medical devices are used for vascular procedures, then the procedure can be performed, but the device cannot efficiently remove and analyze solid, contiguous, and fragmented materials, liquids, and semi-solids during a single insertion

Engineering Contradiction:
Improvecapability to remove various tissue typesVSAvoidreliability of single insertion procedure
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The excisional device is designed with multiple work elements including rotational cutting elements, reciprocating saw blades, and aspiration capabilities that can handle solid, contiguous, fragmented, liquid, and semi-solid materials. This multi-functional design allows a single device to perform various tissue removal tasks during one insertion procedure, resolving the contradiction between versatility and reliability.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The device incorporates separable work elements that can be selectively deployed or engaged depending on the specific tissue type and removal requirement. This segmentation allows the device to adapt to different procedural needs while maintaining a unified system structure, enabling reliable single-insertion procedures for diverse tissue types.

Inventive Principle:
Principle #1Segmentation

2Reliability

If multiple procedures are performed to clear chronic total occlusions, then more thorough clearing can be achieved, but the procedure time and patient trauma increase

Engineering Contradiction:
Improveeffectiveness of occlusion clearingVSAvoidtotal procedure time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The excisional device maintains continuous tissue removal capability through coordinated rotation of cutting elements and simultaneous aspiration of removed material. This continuous action allows thorough clearing of chronic total occlusions in a single uninterrupted procedure, eliminating the need for multiple sequential procedures and reducing total procedure time.

Inventive Principle:
Principle #20Continuity of useful action

Solution Approach 2:

The device is pre-configured with multiple work elements and aspiration systems ready for immediate deployment upon insertion. This preliminary preparation ensures that all necessary components are in place to perform complete occlusion clearing during the single insertion, avoiding the need for additional procedural steps.

Inventive Principle:
Principle #10Preliminary action

3Adaptability or versatility

If larger devices are used to remove all tissue types, then removal capability is improved, but the invasiveness of the procedure increases

Engineering Contradiction:
Improvetissue removal capabilityVSAvoidinvasiveness of insertion
Core Design Contradiction:
Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The excisional device employs nested work elements where smaller cutting elements and aspiration components are housed within a compact delivery catheter. The device can be inserted through a small access point and then deployed to perform comprehensive tissue removal, achieving high versatility without increasing the initial invasiveness of the insertion procedure.

Inventive Principle:
Principle #7Nested doll (Nesting)

4Adaptability or versatility

If complex mechanisms are added to enable cyclic beak opening and closing, then tissue coring and morcellation capability is improved, but device complexity increases

Engineering Contradiction:
Improvetissue processing capabilityVSAvoidmechanism complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The device combines the cyclic opening and closing mechanism of the articulable beaks with the rotational drive system in an integrated manner. The same rotational motion that drives the cutting elements also actuates the beak mechanism through mechanically coupled components, achieving enhanced tissue processing capability without proportionally increasing device complexity.

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

Enables efficient removal and analysis of various tissue types during a single insertion, improving the effectiveness of vascular and skeletal procedures by enhancing the capability to clear chronic total occlusions and other vascular anomalies, while being adaptable for multiple applications including cardio-vascular and orthopedic interventions.

Implementation Method 1

The collar assembly may be configured to rotate in synchronism or differentially to cause the articulable beak to open, close, extend, and retract

Methodology Applied
Scientific EffectMechanical motion:

Implementation Method 2

Flush and vacuum tissue transport mechanisms may be incorporated

Methodology Applied
Scientific EffectSuction: Suction

Data Source

PatentUS12004727B2Soft and hard tissue excisional devices and methods
Publication Date: 2024.06.11 TRANSMED7 LLC
  • US12004727B2 patent drawing
  • US12004727B2 patent drawing
  • US12004727B2 patent drawing

AI summary

A device may comprise a work element, an outer tube co-axially disposed around a portion of the work element and a collar assembly. The work element may be configured to rotate and define proximal and distal ends, and may comprise a body portion, one or more articulable beak(s) configured to cut tissue, and a beak actuation portion. The collar assembly may be coupled to the work element away from the articulable beak(s), and may comprise a distal collar element coupled to the body portion, a middle collar element coupled to the outer tube and a proximal collar element coupled to the beak actuation portion. The distal collar element may comprise a first peripheral surface that extends around the distal collar element and that faces the proximal end and the middle collar element may comprise a second peripheral surface that that extends around the middle collar element, faces the distal end and at least partially contacts the first peripheral surface. The first and second peripheral surfaces each may comprise a smooth undulating surface that comprises a plurality of peaks and valleys. The distal, middle and proximal collar elements may be configured to control opening, closing, extending and retracting the articulable beak(s) by rotating in synchronicity, rotating differentially and/or moving toward the distal or proximal ends.