Asymmetric Inflatable Body for Bone Fracture Reduction
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Solution Overview
Problem
Current inflatable devices for treating bone fractures face challenges in precise placement due to their round shape, leading to potential misalignment or under/over reduction of bone fragments, especially in limited surgical environments.
Innovation Solution
A bone reduction device with a fillable cavity and a stylet that allows for precise orientation and inflation to form a flat horizontal surface, facilitating proper placement and alignment of bone fragments, and featuring a higher durometer material for controlled expansion and radio-opaque markers for imaging guidance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a round inflatable device is used, then the device is simple in structure and easy to manufacture, but precise placement beneath the deepest point of depression is difficult leading to misalignment or under/over reduction
Solution Approach 1:
The inflatable body is changed from a round/spherical shape to an asymmetric shape with a defined horizontal surface and a deepest point opposite the horizontal surface. This asymmetric geometry enables precise placement beneath the deepest point of bone depression while maintaining structural simplicity, resolving the contradiction between placement precision and device complexity
Solution Approach 2:
The inflatable body incorporates a horizontal surface at a specific location rather than being uniformly round. This localized geometric feature provides a reference plane for accurate positioning and ensures consistent contact with the bone surface at the deepest point of depression, improving placement precision without significantly increasing overall device complexity
2Manufacturing precision
If the inflatable body expands freely, then inflation is simple and quick, but the surface becomes uneven causing inconsistent pressure on bone fragments
Solution Approach 1:
A restraining member is attached to the inner surface of the inflatable body at the location opposite the horizontal surface. This localized restraint structure prevents excessive expansion in that specific region, maintaining a flat horizontal surface during inflation while allowing the rest of the body to expand freely, thus achieving surface flatness without complex overall expansion control mechanisms
Solution Approach 2:
The restraining member is pre-attached to the inflatable body before inflation occurs. This preliminary structural preparation ensures that when inflation takes place, the horizontal surface remains flat and provides consistent pressure distribution from the outset, eliminating the need for complex active control systems during the inflation process
3Manufacturing precision
If the inflatable body is made entirely of soft material, then insertion through cannula is easy, but the body expands too much making precise depth control difficult
Solution Approach 1:
The inflatable body incorporates a restraining member made of stiffer material attached to its inner surface. This localized stiffening at the deepest point region provides depth control and prevents over-expansion, while the rest of the inflatable body remains soft and flexible for easy insertion through the cannula, resolving the contradiction between depth control precision and insertion ease
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 accurate realignment and stabilization of bone fragments with consistent pressure, improving surgical efficiency and reducing the risk of misalignment or incomplete correction of fractures.
Implementation Method 1
A portion of the inflatable body wall having a higher durometer reading causing it to inflate less than the rest of the inflatable body so as to form a substantially flat horizontal surface
Implementation Method 2
An inflatable body having a wall configured to define a fillable cavity attached to the distal end of the fill tube wherein the fillable cavity is in fluid communication with the lumen of the fill tube
Data Source
AI summary
A device and method for treating bone fractures/lesions using an inflatable body is provided. The inflatable body includes a balloon having a substantially flat horizontal surface for quick easy insertion into bone beneath the fracture so as to align misaligned fragments of the fracture and/or to collapsed bone. The body has a shape and size to compress at least a portion of the cancellous bone to form a cavity in the cancellous bone and/or to restore the original position of the outer cortical bone, if fractured or collapsed. The inflatable body has a stylet attached to it's distal end so that once the inflatable body is deflated it can be twisted about the stylet to have a smaller profile so as to be easily withdrawn from the bone.