Inflatable Foot-Positioning Splint for PAD Muscle Oxygenation

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Solution Overview

Problem

Patients with peripheral arterial disease (PAD) experience walking impairment and pain due to insufficient oxygen supply to leg muscles, and existing treatments like walking programs and revascularization are costly or difficult to adhere to, especially for frail patients.

Innovation Solution

A splint with a leg and foot supporting portion and an inflatable device that rotates the foot relative to the leg, inducing an ischemic state to increase oxygen saturation levels, which the body continues to enhance after the ischemic state ends.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If surgery is performed for PAD treatment, then revascularization is achieved, but costs and risks of acute complications increase

Engineering Contradiction:
Improverevascularization effectivenessVSAvoidcosts and risks of acute complications
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent employs a disposable or non-reusable splint device that induces temporary ischemic states through mechanical positioning rather than permanent surgical intervention. The splint is designed for short-term use to trigger physiological adaptations without the need for expensive, invasive surgical procedures, thereby reducing both costs and surgical risks while achieving therapeutic revascularization effects

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

2Reliability

If long-term walking programs are implemented for PAD treatment, then muscle oxygenation is improved, but adherence becomes difficult for frail patients

Engineering Contradiction:
Improvemuscle oxygenation improvementVSAvoidadherence difficulty
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The splint device performs preliminary action by mechanically positioning the foot and ankle to induce ischemic states before actual walking occurs. This pre-conditioning triggers physiological adaptations (collateral vessel formation, muscle metabolic changes) that improve muscle oxygenation capacity in advance, making subsequent walking easier and more sustainable for frail patients without requiring them to maintain difficult long-term exercise adherence

Inventive Principle:
Principle #10Preliminary action

3Reliability

If the foot is rotated acutely toward the leg, then an ischemic state is induced to increase oxygen saturation, but the device complexity increases

Engineering Contradiction:
Improveoxygen saturation increaseVSAvoidsplint mechanism complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent extracts the complex actuation mechanism from the splint structure itself, using the patient's own body movements (dorsiflexion, plantarflexion, inversion, eversion) to drive the foot rotation that induces ischemic states. The splint contains only passive structural elements and positioning components, eliminating the need for motors, sensors, or control systems while still achieving the therapeutic ischemic effect through patient-initiated motion

Inventive Principle:
Principle #2Taking out (Extraction)

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 splint effectively increases oxygen saturation levels in patients with PAD, improving muscle oxygenation and aiding in the uptake of supplements, thereby enhancing walking ability and quality of life.

Implementation Method 1

The angle between the leg longitudinal axis and the foot longitudinal axis induces an ischemic state in the leg of the patient. The body of the patient reacts to the induced ischemic state by attempting to increase the patient's oxygen saturation levels.

Methodology Applied
Scientific EffectIschemia:

Data Source

PatentEP4135644B1Diagnostic and therapeutic splints
Publication Date: 2025.10.01 FLORIDA STATE UNIV RES FOUND INC
  • EP4135644B1 patent drawingFigure 1
  • EP4135644B1 patent drawingFigure 2
  • EP4135644B1 patent drawingFigure 3

AI summary

Various implementations include a method of decreasing oxygen saturation levels in a patient, including securing a leg and foot of the patient to a splint having a leg supporting portion, a foot supporting portion, and an inflatable device. The leg supporting portion includes a leg support body and leg support surface. The foot supporting portion includes a foot support body and foot support surface. The inflatable device rotates the foot support surface relative to the leg support surface from a first position to a second position. The angle between a leg longitudinal axis and a foot longitudinal axis is less in the second position than in the first position. The method further includes inflating the inflatable device to rotate the foot support surface from the first position to the second position and maintaining the second position to decrease oxygen saturation levels in the patient.