Vertebral Fracture Containment Jacket for Cement Leakage Prevention
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Solution Overview
Problem
Current treatments for vertebral fractures, such as vertebroplasty and kyphoplasty, face challenges with bone cement leakage and inadequate vertebral height restoration, necessitating a solution for effective stabilization and height maintenance.
Innovation Solution
An apparatus comprising an inflation device for cavity creation and an inflation and containment device that uses balloons and a containment jacket to restore vertebral height and prevent cement leakage, involving the inflation of balloons to compact cancellous bone, create a cavity, and maintain vertebral height while containing cement within the vertebral body.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If vertebroplasty is used to stabilize vertebral fractures, then fracture stabilization is achieved, but bone cement leakage occurs leading to complications
Solution Approach 1:
The patent introduces a containment device as an intermediary between the bone cement and the vertebral body. This containment device includes a delivery catheter and a containment structure that guides and restricts the flow of bone cement, preventing it from leaking into surrounding tissues while still allowing effective fracture stabilization. The intermediary device acts as a controlled interface that manages the harmful leakage issue.
Solution Approach 2:
The containment device utilizes flexible membranes and thin-film structures that can conform to the vertebral cavity shape. These flexible shells create a contained environment for bone cement injection, allowing the cement to be deposited in a controlled manner without breaching the vertebral boundaries. The flexibility of the thin-film containment structure adapts to the irregular geometry of the fracture site while maintaining containment integrity.
2Shape
If kyphoplasty is used to treat vertebral fractures, then cavity creation and height restoration are achieved, but bone cement leakage still occurs
Solution Approach 1:
The containment device is deployed and positioned within the vertebral body before bone cement injection. This preliminary placement of the containment structure prepares the site by establishing boundaries for cement flow, ensuring that when cement is injected later, it remains contained within the desired vertebral space. The preliminary containment setup prevents leakage before the harmful effect can occur.
Solution Approach 2:
The containment device serves as an intermediary structure between the injection system and the vertebral body. It provides a controlled interface that allows height restoration through cavity expansion while simultaneously preventing bone cement from escaping into surrounding tissues. The intermediary containment structure manages both the beneficial height restoration and the harmful leakage prevention.
3Shape
If balloon inflation is used to create cavity and restore height, then vertebral height is restored, but device complexity increases
Solution Approach 1:
The patent combines the cavity creation function and the containment function into a single integrated device. The containment device includes both the inflation balloon for cavity creation and height restoration, and the containment structure for cement leakage prevention, all in one unified system. This merging reduces the number of separate devices needed and simplifies the overall procedural complexity.
Solution Approach 2:
The containment device is designed with multi-functionality, serving as both a cavity creation tool through balloon inflation and a containment structure for cement injection. The same device performs multiple functions: expanding the vertebral body to restore height, creating a controlled cavity, and providing boundaries for cement deposition. This universality reduces device complexity by eliminating the need for separate specialized tools.
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 solution effectively stabilizes vertebral fractures by restoring height and minimizing cement leakage, ensuring the vertebral body's structural integrity through controlled cavity creation and cement containment.
Implementation Method 1
the first balloon may inflate, for example, to compact the cancellous bone 14 in the interior portion of the vertebral body 10
Implementation Method 2
The containment jacket may be attached to the distal end of the exterior tube such that the containment jacket encloses the distal end of the exterior tube
Data Source
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AI summary
Methods and apparatus for treating bones, including, in one or more embodiments, methods and apparatus for treatment of vertebral fractures that include an inflation device for cavity creation and an inflation and containment device for maintaining vertebral height and cement containment. Methods for treating a bone comprising: creating a cavity in the bone; inflating a containment jacket in the cavity; inflating a balloon within the containment jacket so that the balloon occupies a first portion of the containment jacket; introducing a first filler material into a second portion of the containment jacket, wherein the second portion of the containment jacket is not occupied by the balloon; removing the balloon from the containment jacket; and introducing a second filler material into the first portion of the containment jacket.