Integrated Balloon Cement Catheter for Calcaneus Fracture Height Restoration
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Solution Overview
Problem
Current medical devices, such as Inflatable Bone Tamps (IBTs), are inadequate for reorienting calcaneus fractures due to their flat surface design, requiring multiple balloons and losing height restoration when bone cement is deployed, as they need to be deflated and removed before cement can be applied.
Innovation Solution
A catheter system integrating an inflatable balloon and a bone filler delivery port, allowing bone cement to be deposited while the balloon is inflated, forming a shell that maintains height restoration after deflation, and enabling additional cement to be added once cured.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a single Inflatable Bone Tamp is used, then the device structure is simple, but it is insufficient to reorient the calcaneus surface to proper orientation
Solution Approach 1:
The balloon is divided into multiple independent chambers (first chamber, second chamber, third chamber) that can be inflated separately or simultaneously. This segmentation allows the balloon to create complex three-dimensional expansion patterns that can reorient angled calcaneus surfaces effectively, while still using a single integrated device rather than multiple separate balloons.
2Manufacturing precision
If multiple balloons are used to reorient calcaneus surface, then surface orientation is improved, but device complexity increases
Solution Approach 1:
Multiple balloon chambers are merged into a single integrated balloon structure with shared walls and a common inflatable framework. The first, second, and third chambers are connected through internal partitions, allowing them to function as one unified device that can be inserted through a single cannula, thereby achieving complex surface reorientation without the procedural complexity of multiple separate balloons.
Solution Approach 2:
The single balloon structure serves multiple functions: it can expand in different directions through different chambers, create various three-dimensional shapes, and adapt to different fracture patterns. The balloon also integrates both the expansion function and the cement delivery function, eliminating the need for separate devices for height restoration and cement injection.
3Ease of operation
If IBT is deflated and removed before bone cement deployment, then bone filling can be performed, but height restoration is lost
Solution Approach 1:
The balloon and bone cement delivery system are merged into a single integrated device. The balloon chambers and delivery ports are positioned such that cement can be injected through the inflated balloon structure, allowing simultaneous maintenance of height restoration and completion of bone filling procedure without requiring balloon deflation or removal.
Solution Approach 2:
Bone cement is delivered through the inflated balloon chambers before the balloon is deflated. The cement is injected into the bone defects while the balloon maintains the restored height, ensuring that the height correction is preserved when the cement sets. This preliminary cement delivery through the inflated structure eliminates the need to deflate first.
4Duration of action of moving object
If balloon is kept inflated during bone cement delivery, then height restoration is maintained, but device complexity increases
Solution Approach 1:
The balloon structure and cement delivery system are combined into one integrated device where the balloon chambers serve as both expansion elements for height restoration and as conduits for cement delivery. The delivery ports are positioned within or through the balloon structure, allowing cement injection while the balloon remains inflated, thereby maintaining height without requiring additional separate delivery devices.
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
This solution effectively maintains bone height restoration by allowing bone cement to cure in place, forming a stable eggshell-like structure that supports the bone even after the balloon is removed, addressing the limitations of existing IBTs in treating calcaneus fractures.
Implementation Method 1
Inflating the balloon such that the balloon applies a force capable of compacting cancellous bone and moving fractured bone
Implementation Method 2
Allowing for the bone filler material to cure such it forms a shell of bone filler material at the distal end of the balloon
Data Source
AI summary
A bone filling device includes a catheter that defines a longitudinal axis and extends between a proximal end and a distal end. A first lumen extends along the longitudinal axis of the catheter and defines a first passageway. A second lumen extends along the longitudinal axis of the catheter and defines a second passageway. An inflatable body includes a wall that defines a fillable cavity. The fillable cavity is in fluid communication with the first passageway. A bone filler delivery port is continuous with the second passageway and is configured to dispense bone filling material.