Polyisobutylene Urethane Copolymers for Medical Device Insulation

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Solution Overview

Problem

Current polyurethane-based medical devices face degradation and biocompatibility issues due to environmental stress cracking and metal ion oxidation when inserted into the body, leading to insulation breaches and rapid battery depletion.

Innovation Solution

Development of polyisobutylene urethane, urea, and urethane/urea copolymers with polyisobutylene segments, additional polymeric segments, and diisocyanate residues, which offer enhanced biostability and biocompatibility, resisting oxidative, hydrolytic, and enzymatic degradation, and providing improved barrier properties.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If polyurethane-based materials are used for medical device insulation, then mechanical protection and electrical insulation are provided, but degradation occurs due to environmental stress cracking and metal ion oxidation

Engineering Contradiction:
ImprovebiostabilityVSAvoidoxidative degradation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent employs composite polymer structures combining polyisobutylene segments with urethane/urea linkages to create materials that exhibit both mechanical integrity and resistance to oxidative degradation. The composite nature of these polymers allows integration of different functional characteristics within a single material system, providing protection against both environmental stress cracking and metal ion oxidation.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The invention modifies the chemical composition parameters of medical device coatings by incorporating specific ratios of polyisobutylene, urethane, and urea segments. By adjusting these compositional parameters, the material achieves optimized resistance to oxidative and hydrolytic degradation while maintaining appropriate mechanical properties for medical applications.

Inventive Principle:
Principle #35Parameter changes

2Strength

If polyurethane coatings are applied to medical leads, then mechanical protection is provided, but insulation breaches occur due to degradation

Engineering Contradiction:
Improvemechanical protectionVSAvoidinsulation integrity
Core Design Contradiction:
StrengthVSReliability

Solution Approach 1:

The patent utilizes composite polymeric structures that integrate the mechanical strength characteristics of polyisobutylene with the chemical stability of urethane and urea linkages. This composite approach ensures that the coating maintains its protective function while resisting degradation that would compromise insulation integrity.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The invention applies different polymeric segments with specialized functions at different locations within the coating structure. The polyisobutylene segments provide mechanical flexibility and crack resistance, while the urethane/urea segments provide chemical stability and oxidation resistance, creating a multi-functional protective barrier.

Inventive Principle:
Principle #3Local quality

3Reliability

If conventional polymeric coatings are used on medical devices, then biocompatibility is achieved, but rapid battery depletion occurs due to insulation failure

Engineering Contradiction:
ImprovebiocompatibilityVSAvoidbattery life
Core Design Contradiction:
ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The patent employs composite polymeric coatings that maintain biocompatibility while providing enhanced long-term stability. The combination of polyisobutylene, urethane, and urea segments creates a durable barrier that prevents ion migration and insulation failure, thereby extending device operational life without compromising biocompatibility.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The invention creates a protective barrier coating that anticipates and prevents future degradation mechanisms. By incorporating oxidation-resistant and hydrolysis-resistant chemical structures in advance, the coating cushions against environmental attacks before they can compromise the insulation or cause battery depletion.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

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 polyisobutylene urethane, urea, and urethane/urea copolymers demonstrate enhanced resistance to degradation and improved biocompatibility, reducing the risk of insulation breaches and battery depletion, while maintaining mechanical properties and biostability.

Implementation Method 1

resisting oxidative, hydrolytic, and enzymatic degradation

Methodology Applied
Scientific EffectOxidation resistance: Oxidation

Implementation Method 2

resisting oxidative, hydrolytic, and enzymatic degradation

Methodology Applied
Scientific EffectHydrolysis resistance: Hydrolysis

Implementation Method 3

resisting oxidative, hydrolytic, and enzymatic degradation

Methodology Applied
Scientific EffectEnzymatic degradation resistance: Enzyme

Data Source

PatentUS8501831B2Polyisobutylene urethane, urea and urethane/urea copolymers and medical devices containing the same
Publication Date: 2013.08.06 CARDIAC PACEMAKERS INC
  • US8501831B2 patent drawing
  • US8501831B2 patent drawing
  • US8501831B2 patent drawing

AI summary

The present invention pertains to polyisobutylene urethane, urea and urethane/urea copolymers, to methods of making such copolymers and to medical devices that contain such polymers. According to certain aspects of the invention, polyisobutylene urethane, urea and urethane/urea copolymers are provided, which comprise a polyisobutylene segment, an additional polymeric segment that is not a polyisobutylene segment, and a segment comprising a residue of a diisocyanate. According to other aspects of the invention, polyisobutylene urethane, urea and urethane/urea copolymers are provided, which comprise a polyisobutylene segment and end groups that comprise alkyl-, alkenyl- or alkynyl-chain-containing end groups.