Inflatable Intervertebral Implants for Spinal Fusion

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Solution Overview

Problem

Current orthopedic implants and methods for spinal fusion surgery face challenges in safely and accurately inserting implants between adjacent vertebral bodies, especially in degenerative cases, where the narrow disc space and lack of elasticity hinder proper placement and maintenance of interbody height, and existing mechanical tools can cause further injury or over-distraction.

Innovation Solution

Inflatable orthopedic implants that can be configured in a compact state for insertion and inflated with bone cement or other curable materials to form a rigid intervertebral support structure, allowing for minimally invasive deployment and maintenance of vertebral distraction, with optional features like adjustable angulation and textured surfaces for stability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Volume of moving object

If mechanical spreader devices are used to separate vertebral bodies, then the space between vertebrae is increased to enable cage placement, but the risk of vertebral fracture and over-distraction injury increases

Engineering Contradiction:
Improveintervertebral spaceVSAvoidvertebral fracture and over-distraction injury
Core Design Contradiction:
Volume of moving objectVSObject-affected harmful factors

Solution Approach 1:

The patent employs an inflatable balloon device that uses pneumatic pressure to gradually separate vertebral bodies. The balloon is inserted into the collapsed disc space and inflated with fluid or gas, creating controlled hydraulic/pneumatic pressure that gently distracts the vertebrae apart, avoiding the mechanical leverage forces that cause fracture with traditional spreaders.

Inventive Principle:
Principle #29Pneumatics and hydraulics

Solution Approach 2:

The invention changes the physical state and parameters of the distraction mechanism from rigid mechanical leverage to flexible pneumatic expansion. The balloon can be inflated to precise pressure levels and maintained at controlled volumes, allowing gradual adjustment of intervertebral space without sudden force application that could cause injury.

Inventive Principle:
Principle #35Parameter changes

2Ease of operation

If the disc space is narrowed due to severe degeneration, then the vertebral bodies lack elasticity, but this hinders the surgeon's ability to separate vertebrae to sufficient height for cage placement

Engineering Contradiction:
Improveability to separate vertebraeVSAvoiddisc space height
Core Design Contradiction:
Ease of operationVSVolume of moving object

Solution Approach 1:

The inflatable balloon is inserted into the collapsed disc space before any significant distraction occurs. This preliminary placement allows the balloon to act as an internal wedge that gradually expands the space from within, overcoming the lack of elasticity in degenerated disc tissues that would prevent external mechanical separation.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The pneumatic inflation mechanism provides continuous, controlled expansion force that can gradually overcome the rigidity of degenerated disc spaces. The fluid pressure distributes force evenly across the balloon surface, creating uniform distraction that is more effective than point-contact mechanical spreaders in stiff, degenerated spines.

Inventive Principle:
Principle #29Pneumatics and hydraulics

3Volume of moving object

If traditional fusion cages are inserted into narrow disc spaces, then the procedure requires extensive dissection and larger incisions, but this increases surgical invasiveness and tissue damage

Engineering Contradiction:
Improvedisc space accessibilityVSAvoidsurgical invasiveness and tissue damage
Core Design Contradiction:
Volume of moving objectVSObject-affected harmful factors

Solution Approach 1:

Instead of inserting a rigid cage into a narrow space and then trying to expand it, the invention inverts the sequence by first inserting a collapsible balloon through a small delivery catheter, then inflating the balloon within the confined space to create the necessary volume, and finally deploying the cage into the expanded space.

Inventive Principle:
Principle #13The other way round (Inversion)

Solution Approach 2:

The balloon is nested within a delivery catheter in a collapsed state for minimally invasive insertion through small incisions. Once positioned in the target disc space, the balloon is inflated within the catheter's confined space, then the cage is deployed into the newly created volume, with each component nested within or dependent on the previous one.

Inventive Principle:
Principle #7Nested doll (Nesting)

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 implants facilitate safe and accurate insertion of orthopedic devices between vertebral bodies, minimizing invasiveness and risk of injury, while maintaining vertebral distraction and promoting bone growth, thus addressing the challenges of degenerative disc spaces and improving surgical outcomes.

Implementation Method 1

the hollow body of the inflatable implant can be inflated with bone cement or other curable material. When the curable material hardens, the inflated implant can form a rigid intervertebral support structure

Methodology Applied
Scientific EffectPolymerization: Photopolymerisation

Data Source

PatentUS11129727B2Inflatable non-distracting intervertebral implants and related methods
Publication Date: 2021.09.28 DEPUY SYNTHES PROD INC
  • US11129727B2 patent drawing
  • US11129727B2 patent drawing
  • US11129727B2 patent drawing

AI summary

Inflatable orthopedic implants and related methods are disclosed herein, e.g., for deploying such implants within an intervertebral space for use in spinal fusion surgery, other intervertebral surgical procedures, or other surgical procedures. The inflatable intervertebral implant can include a hollow inflatable body that can be configured in a compact state for insertion into a target intervertebral space between a pair of adjacent vertebral bodies. Once the vertebral bodies are separated or distracted, e.g., using one or more inflatable distractors, the hollow body of the inflatable implant can be inflated with bone cement or other curable material. When the curable material hardens, the inflated implant can form a rigid intervertebral support structure (e.g., a fusion cage) capable of maintaining the vertebral distraction and thereby enabling removal of the distractors.