Statin-Eluting Biodegradable Polymer for Bone Defect Repair

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Solution Overview

Problem

Current medical devices for bone repair, such as bone grafting, often rely on expensive growth factors that are unstable and not effective in providing a stable microenvironment for bone growth in bone defects, fractures, and voids.

Innovation Solution

Implantable medical devices containing a biodegradable polymer and a therapeutically effective amount of statin, which are designed to retain the statin at the bone defect site, facilitating bone healing by allowing influx of progenitor and bone cells, and are easy to manufacture and deliver, using a gel that hardens upon contact with tissue.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If growth factors are used to promote bone formation, then bone growth is stimulated, but the cost increases significantly

Engineering Contradiction:
Improvebone growth rateVSAvoidcost
Core Design Contradiction:
ProductivityVSQuantity of substance

Solution Approach 1:

The patent replaces expensive growth factors with statins, which are inexpensive, orally available drugs already in clinical use. The statin-containing medical device provides a cost-effective alternative that maintains therapeutic efficacy while dramatically reducing treatment costs.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The patent uses statins as a substitute for growth factors, creating a functional copy of the bone-stimulating effect through a different molecular mechanism. The statin-containing device replicates the bone formation promotion capability without requiring the expensive original growth factor molecules.

Inventive Principle:
Principle #26Copying

2Productivity

If growth factors are used to promote bone formation, then bone growth is stimulated, but the stability of the microenvironment deteriorates

Engineering Contradiction:
Improvebone growth rateVSAvoidmicroenvironment stability
Core Design Contradiction:
ProductivityVSStability of the object's composition

Solution Approach 1:

The patent replaces unstable, expensive growth factors with statins delivered through a stable biodegradable polymer matrix. The polymer provides a controlled release mechanism that maintains stable local concentrations, creating a more stable microenvironment for bone formation.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The patent changes the delivery parameters from direct growth factor application to statin release from a biodegradable polymer matrix. This parameter change provides controlled release kinetics, maintaining stable drug concentrations and creating a more stable microenvironment for bone growth.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If complex bone grafting procedures are performed, then bone repair is achieved, but the surgical complexity increases

Engineering Contradiction:
Improvebone repair effectivenessVSAvoidsurgical procedure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines the bone graft material with statin-containing biodegradable polymer into a single integrated device. This merging eliminates the need for separate growth factor applications and simplifies the surgical procedure while maintaining bone repair effectiveness.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent creates a universal medical device that provides both structural support (as a bone graft substitute) and pharmacological stimulation (through statin release). This multi-functional device simplifies the overall treatment approach by combining multiple functions into one implantable component.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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 enables faster bone healing by providing an osteoconductive environment, reducing healing time and costs, as the statin stimulates bone morphogenic protein expression and bone growth, and is delivered accurately through minimally invasive procedures.

Implementation Method 1

using a gel that hardens upon contact with tissue

Methodology Applied
Scientific EffectGel hardening: Gel

Implementation Method 2

the statin stimulates bone morphogenic protein expression and bone growth

Methodology Applied
Scientific EffectBone formation:

Data Source

PatentUS10363238B2Methods and compositions to enhance bone growth comprising a statin
Publication Date: 2019.07.30 WARSAW ORTHOPEDIC INC
  • US10363238B2 patent drawing
  • US10363238B2 patent drawing
  • US10363238B2 patent drawing

AI summary

Implantable medical devices and methods are provided that have one or more statins disposed therein. The medical devices may be implanted at near or in a bone defect to enhance bone growth. In some embodiments, the medical device provided allows for sustain release of the statin and facilitates bone formation and repair of the fracture site.