Interspinous Spacer Insertion Instrument with Nested Shafts

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Solution Overview

Problem

Current surgical techniques for implanting interspinous spacers require larger incisions, which can lead to longer recovery times and more tissue damage, highlighting the need for minimally invasive instruments that can effectively deliver and deploy spacers between adjacent spinous processes of the spine.

Innovation Solution

A spacer insertion system comprising an instrument with a handle, an inner shaft, an outer shaft, and a control mechanism that allows for relative translational motion to clamp and release prongs onto an interspinous spacer, enabling its deployment and undeployment through a minimally invasive approach, utilizing a driving tool for incremental and continuous configuration changes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional surgical techniques are used to implant interspinous spacers, then the spacer can be securely implanted, but larger incisions are required causing more tissue damage and longer recovery times

Engineering Contradiction:
Improvesecure implantationVSAvoidtissue damage
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The instrument employs nested shafts where an inner shaft is positioned within an outer shaft. The inner shaft carries the spacer while the outer shaft provides structural support and guidance. This nesting allows the spacer delivery system to pass through a small incision while maintaining structural integrity for secure implantation.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The instrument is divided into functional segments: a handle assembly, an outer shaft, an inner shaft, and a spacer. This segmentation allows each component to perform its specific function while enabling the overall system to be delivered through a minimally invasive approach. The prongs on the inner shaft can be independently deflected to engage or release the spacer.

Inventive Principle:
Principle #1Segmentation

2Object-affected harmful factors

If a minimally invasive instrument is used to deliver the spacer, then tissue damage is reduced, but the instrument must be sufficiently small to pass through limited incisions

Engineering Contradiction:
Improvetissue damageVSAvoidinstrument size
Core Design Contradiction:
Object-affected harmful factorsVSLength of moving object

Solution Approach 1:

The inner shaft containing the spacer is nested within the outer shaft. This allows the instrument to maintain a compact profile during delivery through the incision, while the outer shaft provides the necessary structural support and guidance. The nested configuration enables the instrument to be small enough for minimally invasive delivery.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The instrument incorporates dynamic elements including the ability of the inner shaft to move relative to the outer shaft, and the deflection of prongs from a retracted to an extended position. This dynamic capability allows the instrument to transition from a compact delivery state to an expanded implantation state, providing full functionality through a small incision.

Inventive Principle:
Principle #15Dynamics

3Difficulty of detecting and measuring

If the instrument shafts are made radiopaque for imaging visibility, then the instrument can be tracked during surgery, but the radiopaque materials may interfere with imaging of the spacer

Engineering Contradiction:
Improveinstrument trackingVSAvoidimaging clarity
Core Design Contradiction:
Difficulty of detecting and measuringVSLoss of information

Solution Approach 1:

The instrument employs selective radiopacity where only specific portions (such as the outer shaft or handle assembly) are made radiopaque while the inner shaft and spacer remain radiolucent. This local differentiation allows the surgeon to track the instrument position while maintaining clear imaging of the spacer and surrounding anatomical structures without interference from the delivery instrument.

Inventive Principle:
Principle #3Local quality

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 system facilitates minimally invasive procedures by allowing for the precise deployment and removal of interspinous spacers, reducing tissue intrusion and recovery time, while providing incremental and continuous deployment options for accurate positioning and pain relief.

Implementation Method 1

An inner shaft is located inside the outer shaft and configured for relative translational motion with respect to the outer shaft. A control is configured to effect the relative translational motion wherein the relative translational motion causes one of the outer or inner shafts to move with respect to the other and thereby deflect at least one prong

Methodology Applied
Scientific EffectRelative translational motion: Displacement

Implementation Method 2

the translational motion causes one of the outer or inner shafts to move with respect to the other and thereby deflect at least one prong of said pair of prongs formed on one of the inner or outer shafts. Such inward deflection of the at least one prong causes engagement with the juxtapositioned spacer and outward deflection of the at least one prong causes release of the spacer

Methodology Applied
Scientific EffectProng deflection: Elasticity

Implementation Method 3

a wing rotatably connected to the body portion (68), wherein the wing is configured to cradle an adjacent spinous process of a patient's spine when the spacer is inserted into an interspinous space

Methodology Applied
Scientific EffectRotational connection: Hinge

Implementation Method 4

A driver having a distal portion configured to reversibly arrange the spacer between and including at least one deployed configuration and at least one undeployed configuration

Methodology Applied
Scientific EffectReversible arrangement: Mechanical Force

Data Source

PatentEP2219538B1Spacer insertion instrument
Publication Date: 2022.07.06 VERTIFLEX CO
  • EP2219538B1 patent drawingFigure 1
  • EP2219538B1 patent drawingFigure 2
  • EP2219538B1 patent drawingFigure 3~5

AI summary

A percutaneous and minimally invasive instrument for inserting an interspinous process spacer into a patient is disclosed. The instrument includes a first assembly connected to a handle assembly. The first assembly includes an inner shaft located inside an outer shaft and configured for translational motion with respect to the outer shaft. The relative translational motion causes one of the outer or inner shafts to move with respect to the other and thereby deflect at least one prong formed on one of the inner or outer shafts wherein such deflection causes engagement with a juxtapositioned interspinous spacer. The instrument further includes a driver configured for removable insertion into a proximal end of a passageway of the instrument. The driver has a distal spacer engaging portion configured to engage that part of the spacer requiring activation for deployment of the spacer from an undeployed configuration to a deployed configuration and vice versa.