Heat-Moldable Splint With Negative Pressure Swelling Therapy

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Solution Overview

Problem

Swelling caused by trauma or pathologies such as lymphedema leads to discomfort, limited range of motion, and impedes medical treatment, requiring a system that can reduce swelling through decompression therapy and immobilization.

Innovation Solution

A splint with flexible tubes formed of different thermoplastic polymers, including a heat-moldable component that transitions from conformable to rigid states, combined with a negative pressure dressing for controlled swelling reduction and immobilization.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a rigid splint is used for immobilization, then the immobilization effectiveness is improved, but the ability to conform to the patient's anatomy and comfort is worsened

Engineering Contradiction:
Improveimmobilization effectivenessVSAvoidconformability to anatomy
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The splint utilizes thermoplastic material that changes its physical properties (from rigid to conformable) through temperature parameter changes. When heated, the material becomes soft and moldable to conform to the patient's anatomy; when cooled, it returns to a rigid state for effective immobilization.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The splint is constructed from composite materials including thermoplastic polymers with different softening points, allowing the material to exhibit both conformable and rigid characteristics. The composite structure enables phase transition between soft moldable state and hard immobilizing state.

Inventive Principle:
Principle #40Composite materials

2Ease of operation

If a custom-fitted rigid splint is used, then the conformability and comfort are improved, but the manufacturing complexity and time are worsened

Engineering Contradiction:
Improveconformability to anatomyVSAvoidmanufacturing process complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The splint is pre-formed as a rigid structure that can be temporarily softened through heating. This preliminary formation eliminates the need for complex custom manufacturing, while the heating step enables easy adaptation to the patient's anatomy without requiring sophisticated manufacturing processes.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

By using temperature parameter changes to transition the material between rigid and conformable states, the system simplifies the manufacturing process. The splint can be mass-produced in a standard rigid form and then easily adapted to individual patients through simple heating, avoiding complex custom fabrication.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If traditional immobilization methods are used, then the immobilization is achieved, but the swelling reduction and blood perfusion are worsened

Engineering Contradiction:
ImproveimmobilizationVSAvoidswelling and reduced blood perfusion
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The splint uses a flexible thermoplastic shell that can be molded to the patient's body contours. This flexible design allows for better distribution of pressure and improved blood flow compared to rigid traditional splints, while still providing effective immobilization when in the hardened state.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The thermoplastic material's ability to change physical state allows the splint to be applied in a conformable state that accommodates body contours and maintains circulation, then set in a rigid state for immobilization. This parameter change enables both swelling reduction through proper fit and effective immobilization.

Inventive Principle:
Principle #35Parameter changes

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 effectively reduces swelling and facilitates healing by increasing blood perfusion and lymphatic flow, allowing for improved access to underlying tissue and reduced recovery time.

Implementation Method 1

a second material positioned in the flexible tubes and having a lower softening or melting point than the first material. The web is conformable when the second material is above a softening point of the second material, and the web is rigid when the second material is below the softening point of the second material.

Methodology Applied
Scientific EffectPhase change: Phase Change

Implementation Method 2

a second material positioned in the flexible tubes and having a lower softening or melting point than the first material

Methodology Applied
Scientific EffectMelting: Melting

Implementation Method 3

a negative pressure dressing configured to define a sealed volume between a patient's skin and the negative pressure dressing when applied to the patient

Methodology Applied
Scientific EffectSuction: Suction

Implementation Method 4

a pump configured to be placed in pneumatic communication with the negative pressure dressing and operable to displace air from the sealed volume

Methodology Applied
Scientific EffectPressure gradient: Pressure Gradient

Data Source

PatentUS12478496B2Negative pressure therapy system with heat-moldable splint
Publication Date: 2025.11.25 KCI MFG UNLIMITED CO
  • US12478496B2 patent drawing
  • US12478496B2 patent drawing
  • US12478496B2 patent drawing

AI summary

A kit (1500) for negative pressure and immobilization therapy includes a negative pressure dressing (100) configured to define a sealed volume between a patient's skin and the negative pressure dressing when applied to the patient, a pump (200) configured to be placed in pneumatic communication with the negative pressure dressing and operable to displace air from the sealed volume, and a heat-moldable splint (900). The heat-moldable splint includes a plurality of flexible tubes formed of a first material and coupled together to form a web and a second material positioned in the flexible tubes and having a lower softening or melting point than the first material.