Meltable Polymeric Bone Implant Injection System
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Solution Overview
Problem
Current bone anchor implants are rigid and manufactured in fixed shapes, which do not accommodate individual patient anatomical differences, and lack the ability to fill voids with arbitrary shapes or sizes in bony structures effectively.
Innovation Solution
A polymeric implant material and injection system that melts a low-flowing point material, such as polycaprolactone, to be infused into the bone, where it solidifies and forms an anchor or fills voids, using a handle with a heating element to transform the material into a flowable state for in situ solidification.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If rigid prefabricated anchors with fixed shapes are used, then manufacturing precision and structural strength are improved, but adaptability to individual patient anatomies and ability to fill arbitrary voids deteriorates
Solution Approach 1:
The patent applies parameter changes by transforming the implant material from solid to liquid state through temperature control. The polymeric material is heated above its glass transition temperature to become flowable, allowing it to adapt to arbitrary bone void shapes, then cooled to solidify in the desired configuration. This dynamic parameter change enables both manufacturing precision (through controlled solidification) and anatomical adaptability (through flowable state injection).
Solution Approach 2:
The patent utilizes phase transitions of the polymeric material between solid and liquid states. The material transitions from a solid pre-formed state to a liquid flowable state during injection, allowing it to conform to patient-specific anatomies and arbitrary void shapes. Upon cooling in the target location, it transitions back to solid, providing structural strength while maintaining the adapted shape. This phase transition mechanism resolves the contradiction between fixed manufacturing precision and flexible adaptability.
2Adaptability or versatility
If heating is applied to melt polymeric material for infusion, then flowability and adaptability are improved, but risk of necrotic damage to bone increases
Solution Approach 1:
The patent applies local quality by concentrating the heating action only at the injection tip where the polymeric material needs to be melted for infusion. The heating element is localized to the distal end of the injection system, melting material only in the immediate vicinity of the bone void. This localized heating approach allows the material to become flowable for adaptation while minimizing thermal exposure to surrounding bone tissue, thereby reducing necrosis risk.
Solution Approach 2:
The patent implements the skipping principle by rapidly injecting the melted polymeric material through the injection system directly into the bone void before significant heat transfer to surrounding bone can occur. The quick injection process minimizes the duration of thermal exposure to bone tissue, allowing the material to be infused in its flowable state while preventing prolonged thermal damage that would cause necrosis.
3Device complexity
If prefabricated anchors with fixed shapes are used, then device complexity is reduced, but ability to fill voids with arbitrary shapes and sizes deteriorates
Solution Approach 1:
The patent uses parameter changes (temperature-induced phase transition) to enable a single relatively simple polymeric material system to adapt to voids of arbitrary shapes and sizes. The material's flowability parameter is dynamically adjusted through heating, allowing it to conform to any void geometry without requiring complex pre-formed implant designs for each specific case.
Solution Approach 2:
The patent applies universality by creating a single polymeric material system that can serve multiple functions: it can be heated to become flowable for injecting into various void configurations, then cooled to solidify and provide anchoring or void filling. This universal material approach replaces the need for multiple specialized prefabricated anchors designed for specific void geometries, maintaining device simplicity while achieving broad adaptability.
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 allows for the creation of implants that conform to the underlying bone structure, reducing necrotic damage and providing effective anchoring or filling of voids without pre-determined shapes, while being biocompatible and adaptable to individual anatomies.
Implementation Method 1
the implant material can be melted so as to be infused into the desired area
Implementation Method 2
A heater located proximate to the distal end of the container; and a quantity of meltable material within the container and located proximate to the heater
Implementation Method 3
the cooling effect of the heat transfer from the polymeric material to the body. Cooling to below 60 degrees Centigrade solidifies the polymeric material
Implementation Method 4
the distal end of the shaft includes an electrical resistance heater that is used to heat and melt the implant material
Data Source
AI summary
An implant injection system and method for introducing a bone implant material into a patient's bone to serve as an anchor or to fill a void in the bone. The system and method provide a quantity of meltable material which is melted in situ so that the melted material can flow and diffuse into, and be anchored to, the cancellous bone portion beneath the cortical bone layer. The flowing of the bone implant material can be accomplished by a heater located at the distal end of the implant injection system. The implant material may be provided in multiple layers with an inner layer having a lower flowing temperature than the outer layers. There can also be a looped suture that passes though the meltable material, with the free ends of the suture extending outwardly to be tied to soft tissue to affix the soft tissue to the bone.