Tissue-Selective Abrader for Vertebral Height Restoration
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Solution Overview
Problem
Current treatments for vertebral compression fractures, such as vertebroplasty and kyphoplasty, face challenges with PMMA cement leakage, high pressure requirements, and inadequate control over vertebral body height restoration, leading to complications like pulmonary embolism and cortical bone damage.
Innovation Solution
A probe system with a high-speed, tissue-selective elastomeric rotational cutter and expandable abrasive surface is used to create controlled paths in vertebral cancellous bone, allowing for the introduction of in-situ hardenable bone cement to support the vertebra without explosive expansion forces, thereby reducing leakage risks and improving vertebral height restoration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If high pressure is used to force PMMA cement into cancellous bone, then cement infiltration is achieved, but PMMA leakage and cortical bone damage occur
Solution Approach 1:
The probe creates a controlled path or cavity in the cancellous bone before cement injection. This preliminary mechanical preparation removes the need for high-pressure forcing by pre-establishing a conduit, thereby preventing PMMA leakage and cortical bone damage while ensuring reliable cement infiltration.
Solution Approach 2:
The probe acts as an intermediary device between the cement and the cancellous bone. Instead of directly forcing cement at high pressure, the probe first creates a controlled pathway, serving as a mediator that enables cement introduction at lower pressures without causing harmful leakage or bone damage.
2Productivity
If high pressure is used to introduce bone cement, then cement delivery is achieved, but pulmonary embolism risk increases
Solution Approach 1:
The probe creates a controlled path in the cancellous bone before cement injection, establishing a safe conduit that allows cement delivery without requiring high pressures. This preliminary action prevents cement from being forced into vascular structures, thereby eliminating pulmonary embolism risk while maintaining productive cement delivery.
3Shape
If explosive expansion forces are used to create space in bone, then vertebral height restoration is achieved, but cortical bone damage occurs
Solution Approach 1:
The probe creates a controlled path or cavity before any expansion or cement injection. This preliminary preparation allows subsequent low-pressure introduction of bone support material to achieve vertebral height restoration without the explosive forces that cause cortical bone damage.
Solution Approach 2:
The invention replaces explosive mechanical expansion with a controlled mechanical probing and low-pressure introduction system. The probe creates the necessary space through controlled abrasion or cutting rather than explosive expansion, eliminating cortical bone damage while achieving vertebral height restoration.
4Reliability
If conventional vertebroplasty techniques are used, then vertebral fracture treatment is achieved, but inadequate control over vertebral body height restoration occurs
Solution Approach 1:
The probe creates a controlled path or cavity at a specific location and orientation before cement injection. This preliminary action provides precise control over where and how the bone support material is introduced, enabling accurate restoration of vertebral body height while maintaining reliable fracture treatment.
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 system provides controlled introduction of bone support material, reduces the risk of PMMA leakage, and allows for safer, more effective vertebral height restoration with lower pressures, minimizing complications and improving treatment outcomes.
Implementation Method 1
a probe carrying a tissue-selective elastomeric rotational cutter having an abrasive surface for abrading or cutting regions within vertebral cancellous bone
Implementation Method 2
the abrasive surface optionally being expandable in transverse sectional dimension
Data Source
AI summary
The invention provides instruments and methods for prophylactic treatment of an osteoporotic vertebral body or for treating a vertebral compression fracture (VCF). In one exemplary method, a probe system uses a high speed rotational elastomeric cutter having an optional expandable abrasive surface for abrading or cutting at least one path or region within vertebral cancellous bone. Irrigation and aspiration sources are included in the probe system for removing abraded bone debris. In one embodiment, the high speed rotational abrader uses a tissue-selective abrading surface that abrades or cuts bone but does not cut soft tissue. In another embodiment, an expandable abrading surface allows the treatment of bone with low pressures to create paths or spaces without explosive expansion forces known in prior art balloon procedures that are designed to crush and compact cancellous bone in a vertebra. After the creation of a path or space, an in-situ hardenable bone cement volume is introduced into each path or space to support the vertebra.


