Navigation Array Fixation Device for Robotic Surgery

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Solution Overview

Problem

Current methods for securing optical navigation arrays to bones during robotic-assisted surgery, such as in Total Knee Arthroplasty, face challenges including the need for a rigid connection without rotation or translation, minimizing soft tissue and bone damage, and reducing the risk of nerve/vascular damage, while being minimally invasive and easily placed by one person without navigation.

Innovation Solution

A fixation device comprising a trocar, a cortical pin, and a dowel that prevents rotation of the pin in the bone, with a navigation array removably attached to the pin, allowing for precise alignment and registration in the navigation system.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If cortical pins are used to secure the navigation array to the bone, then a rigid connection is achieved, but the risk of infection and bone damage increases due to multiple incisions and pin placement

Engineering Contradiction:
Improverigid connection stabilityVSAvoidinfection risk and bone damage
Core Design Contradiction:
Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The fixation device is divided into separate functional components: a trocar for minimal incision access, a cortical pin for bone engagement, and a dowel for rotational stabilization. This segmentation allows each component to perform its specific function while minimizing overall trauma to the patient.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The cortical pin is inserted through the trocar, and the dowel is subsequently inserted through the cortical pin. This nested arrangement allows all components to be delivered through a single small incision, reducing soft tissue damage while achieving secure fixation.

Inventive Principle:
Principle #7Nested doll (Nesting)

2Stability of the object's composition

If multiple cortical pins are implanted to ensure rigid connection, then stability is improved, but the risk of nerve/vascular damage and bone weakening increases

Engineering Contradiction:
Improvefixation stabilityVSAvoidnerve/vascular damage risk
Core Design Contradiction:
Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The fixation system uses an asymmetric configuration where a single cortical pin combined with a perpendicular dowel creates rotational stability. This asymmetric arrangement provides equivalent stability to multiple pins while requiring only one bone penetration, thereby reducing risk to nerves and vessels.

Inventive Principle:
Principle #4Asymmetry

Solution Approach 2:

The trocar is inserted first to establish the correct trajectory and position before the cortical pin is deployed. This preliminary action ensures accurate placement in a single attempt, eliminating the need for multiple pin insertions that would increase surgical risk.

Inventive Principle:
Principle #10Preliminary action

3Productivity

If cortical pins are placed without a jig or navigation, then placement speed is improved, but placement precision and orientation accuracy deteriorate

Engineering Contradiction:
Improveplacement speedVSAvoidpin orientation precision
Core Design Contradiction:
ProductivityVSManufacturing precision

Solution Approach 1:

The trocar serves multiple functions: it acts as a guide for cortical pin insertion, provides structural support during the procedure, and enables navigation array attachment. This multi-functionality eliminates the need for separate jigs while maintaining placement precision.

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

Solution Approach 2:

The trocar acts as an intermediary tool that translates the surgeon's manual placement actions into precise, repeatable pin orientations. By serving as a mediating instrument, it enables accurate placement without requiring complex navigation systems or extensive surgeon experience.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Object-affected harmful factors

If a single incision is used for trocar insertion, then soft tissue damage is reduced, but the complexity of the insertion procedure increases

Engineering Contradiction:
Improvesoft tissue damageVSAvoidinsertion procedure complexity
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The insertion of the cortical pin and the dowel are combined into a single procedural sequence through the trocar. This merging of operations allows both fixation elements to be installed through one incision, reducing soft tissue damage while the modular design keeps the actual insertion mechanics straightforward.

Inventive Principle:
Principle #5Merging (Combining)

Data Source

PatentEP3977949B1Systems for fixating a navigation array
Publication Date: 2024.11.13 GLOBUS MEDICAL INC
  • EP3977949B1 patent drawingFigure 1
  • EP3977949B1 patent drawingFigure 2
  • EP3977949B1 patent drawingFigure 3

AI summary

A fixation device for securing a navigation array to a bony structure for use in a robotic-assisted surgery. The fixation device includes a trocar, a cortical pin configured to be inserted into the trocar, and a dowel configured to be attached to the cortical pin. The dowel is configured to prevent rotation of the cortical pin in the bony structure. The fixation device includes a navigation array configured to be removably attached to the cortical pin.