Diabetic Footwear with Pneumatic Bladder for Venous Drainage

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Solution Overview

Problem

Existing footwear and methods for patients with diabetes and Charcot foot fail to effectively stimulate blood flow and provide ambulatory solutions, often requiring cumbersome devices that do not concentrate pressure on soft tissue areas, leading to reduced mobility and increased risk of ulcers.

Innovation Solution

A shoe with a blood flow stimulating element that uses a fluid reservoir and micro-electric pump to activate a bladder that abuts the plantar plexus, operating independently of the pump's filling action, with sensors to control the timing and pressure for optimal venous drainage and arterial flow, allowing for ambulatory movement without the need for bulky boots.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If cumbersome boots are used to apply pressure to the foot and leg, then venous return is improved, but mobility is reduced and the device becomes impractical for ambulatory use

Engineering Contradiction:
Improvevenous returnVSAvoidmobility
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The invention divides the compression function into separate inflatable chambers positioned at specific locations (foot, ankle, calf) that can be independently controlled. This segmentation allows the device to provide targeted compression without requiring a bulky encasing boot, enabling ambulatory use while maintaining venous return benefits.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention replaces the traditional mechanical compression system (bulky boots with rigid structures) with a pneumatic system using inflatable chambers and a portable compressor. This substitution reduces the mechanical bulk and weight of the device while maintaining the physiological effectiveness of compression for improving venous return.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If pressure is applied uniformly across the foot and leg, then venous return is assisted, but the pressure is not concentrated in the soft tissue areas where it is most effective

Engineering Contradiction:
Improvevenous returnVSAvoidpressure concentration
Core Design Contradiction:
ReliabilityVSManufacturing precision

Solution Approach 1:

The invention places inflatable chambers at specific locations (foot, ankle, calf) and uses individual control valves to regulate pressure in each chamber independently. This allows pressure to be concentrated in the soft tissue areas where it is most effective for venous return, rather than applying uniform pressure across the entire limb.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The invention allows independent adjustment of pressure parameters in different chambers through individual control valves. This enables optimization of pressure concentration in specific soft tissue areas while maintaining appropriate pressure levels in other regions, improving the precision of pressure application.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If stationary equipment connected to mains supply is used, then venous compression is effective, but the device cannot support ambulatory movement

Engineering Contradiction:
Improvevenous compressionVSAvoidambulatory capability
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The invention replaces the stationary mains-powered compression system with a portable pneumatic system using an electric compressor and battery-powered control unit. This substitution enables the device to provide effective venous compression while being mobile and suitable for ambulatory use.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The invention integrates multiple functions into a single portable device: the compressor provides both compression therapy and can be used to inflate the chambers, the control unit manages pressure regulation and timing, and the system can be used during both stationary and ambulatory periods. This multi-functionality eliminates the need for separate stationary equipment.

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

4Stability of the object's composition

If complete non-weight-bearing is enforced using casts or boots, then bone healing is promoted, but blood flow is reduced increasing ulcer risk

Engineering Contradiction:
Improvebone healingVSAvoidblood flow
Core Design Contradiction:
Stability of the object's compositionVSReliability

Solution Approach 1:

The invention uses periodic inflation and deflation of the chambers to provide intermittent compression during ambulatory activity. This periodic action promotes blood flow during weight-bearing periods while the off-loading boot provides structural support for bone healing, thus balancing both requirements without prolonged immobilization.

Inventive Principle:
Principle #19Periodic action

Solution Approach 2:

The invention transitions from static complete non-weight-bearing (casts or rigid boots) to dynamic protected weight-bearing using an off-loading boot combined with periodic compression. This dynamic approach allows controlled ambulation that maintains blood flow while the boot structure continues to protect and support bone healing.

Inventive Principle:
Principle #15Dynamics

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 shoe provides constant venous drainage assistance and improved arterial blood flow, reducing the risk of ulcers and amputation, while allowing for ambulatory movement and non-weight-bearing support, even in immobile patients, thus addressing the limitations of prior art limb compression devices and footwear.

Implementation Method 1

A shoe with a blood flow stimulating element that uses a fluid reservoir and micro-electric pump to activate a bladder

Methodology Applied
Scientific EffectPump: Pump

Implementation Method 2

pressure was applied to the foot and leg - which are extremely cumbersome... did not concentrate the pressure in those areas in which it was most effective, namely, the soft tissue areas of the foot and leg

Methodology Applied
Scientific EffectPressure: Pressure Increase

Data Source

PatentEP2675315B1Improvements in or relating to footwear
Publication Date: 2020.05.27 THE DIABETIC BOOT COMPANY LTD
  • EP2675315B1 patent drawingFigure 1
  • EP2675315B1 patent drawingFigure 1a~1b
  • EP2675315B1 patent drawingFigure 2~3

AI summary

The present invention relates to footwear and in particular, but not necessarily restricted thereto, relates to footwear for those with diabetes and, in particular, with ulcers of the sole. The present invention seeks to address some of the problems encountered by prior art limb compression devices and methods. In particular the present invention seeks to provide a boot which can stimulate blood flow. A further object to the invention is to provide a boot with a sole which is adaptable to conform with various shapes and conditions of human feet. The present invention also seeks to provide a new type of footwear that has a therapeutic benefit for diabetic patients with circulatory problems in their foot, and also enables the technique of "off loading" the foot to assist in the healing of any wounds present. The present invention relates to a method for aiding arterial and venous flow from the limb of an ambulatory patient comprising the step of applying pressure to one or more areas of the soft tissue of an underside portion of the foot.