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
Engineering 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
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.
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.
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
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.
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.
3Reliability
If stationary equipment connected to mains supply is used, then venous compression is effective, but the device cannot support ambulatory movement
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.
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.
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
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.
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.
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
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
Data Source
Figure 1
Figure 1a~1b
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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.