Implantable Device Altitude Pressure Adaptation

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Solution Overview

Problem

Implantable medical devices, such as artificial urinary sphincters, can malfunction due to pressure variations caused by changes in altitude, posing risks to patients at high altitudes or underwater, as they operate within a specific fluid pressure range and may not adapt to extreme conditions.

Innovation Solution

A medical device with a sealed housing, an inflatable element, a fluidic circuit, and a control unit that measures absolute pressure and altitude to adjust fluid volume in the circuit, ensuring the device operates within safe pressure ranges by reducing or increasing fluid volume based on altitude changes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If the device operates with a fixed fluid volume in the reservoir, then the device structure is simple, but the device cannot adapt to pressure variations caused by altitude changes

Engineering Contradiction:
Improveadaptability to altitude changesVSAvoiddevice structure complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The reservoir is designed with a movable partition that can dynamically adjust the fluid volume between two chambers. This dynamic structure allows the device to adapt to varying external pressures at different altitudes by automatically redistributing fluid volume, transforming a static fixed-volume system into a dynamic adjustable-volume system.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The device changes the physical parameter of fluid volume in the reservoir in response to altitude changes. By detecting external pressure variations and adjusting the fluid volume accordingly, the system maintains optimal operating conditions across different environmental conditions without requiring complete redesign for each scenario.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If the device uses a fixed fluid pressure range, then the device design is straightforward, but the device may malfunction when pressure fluctuates outside this range

Engineering Contradiction:
Improvedevice reliability under pressure variationsVSAvoidpressure control mechanism complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The device incorporates a sensor that continuously monitors external pressure and provides feedback to the control unit. This feedback mechanism enables the system to detect when external pressure deviates from the normal operating range and automatically activates the movable partition to adjust fluid volume, thereby maintaining reliable operation under varying pressure conditions.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The movable partition is pre-configured to respond to pressure changes by automatically adjusting fluid volume before malfunction occurs. The system takes preliminary action by having the partition ready to move and the control unit programmed to react to pressure variations, preventing malfunction rather than correcting it after the fact.

Inventive Principle:
Principle #10Preliminary action

3Adaptability or versatility

If the reservoir volume is increased to accommodate pressure variations, then the device can handle a wider pressure range, but the device size increases

Engineering Contradiction:
Improvepressure range adaptabilityVSAvoiddevice volume
Core Design Contradiction:
Adaptability or versatilityVSVolume of moving object

Solution Approach 1:

The reservoir is segmented into two separate chambers divided by a movable partition. This segmentation allows the same overall device volume to accommodate a wider range of pressure conditions by redistributing fluid between the two chambers, effectively doubling the adaptive volume range without increasing the external dimensions of the device.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

One fluid chamber is effectively nested within the other by using the movable partition to create overlapping volume spaces. When the partition moves, one chamber expands while the other contracts, allowing the device to maintain a compact overall size while providing the functional equivalent of a much larger adjustable volume.

Inventive Principle:
Principle #7Nested doll (Nesting)

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

Prevents device malfunction and ensures patient safety by dynamically adjusting fluid pressure in response to altitude changes, maintaining optimal operation during activities like high-altitude travel or diving.

Implementation Method 1

at least one sensor adapted to measure an absolute fluid pressure in the fluid circuit, a force exerted on the reservoir, a gas pressure in the housing, an atmospheric pressure or a value relative to an altitude of the patient

Methodology Applied
Scientific EffectPressure measurement:

Implementation Method 2

an actuator arranged in the housing and mechanically coupled to the fluid reservoir to selectively vary the volume of fluid in said reservoir

Methodology Applied
Scientific EffectMechanical force: Mechanical Force

Implementation Method 3

a fluid circuit comprising a fluid reservoir having a variable fluid volume arranged in the housing and tubing providing a fluid connection between said reservoir and said inflatable element

Methodology Applied
Scientific EffectFluid pressure: Pressure Increase

Data Source

PatentEP4259038B1Implantable medical device
Publication Date: 2024.11.27 UROMEMS
  • EP4259038B1 patent drawingFigure 1~2
  • EP4259038B1 patent drawingFigure 3~4

AI summary

The invention relates to a medical device comprising: - a sealed casing (1), suited to being implanted in the body of a human or animal patient, - an inflatable element (3), - a fluidic circuit comprising a fluid reservoir (5) having a variable fluid volume and arranged inside the casing with a tube (2) between the reservoir and the inflatable element, - an actuator arranged inside the casing to selectively vary the volume of fluid in the reservoir, - a control unit (100) configured to control the actuator, - at least one sensor suited to measuring an absolute gauge pressure of the fluid in the fluidic circuit, a force exerted on the reservoir, a gas pressure inside the casing, an atmospheric pressure or a value relating to an altitude of the patient, the control unit (100) being configured so as: - on the basis of a measurement from said sensor while the actuator is inactive, to detect a differential between a value relating to an altitude of the patient and a reference value, and - as a function of said differential, to determine the command to be issued to the actuator so as to control the pressure of fluid in the fluidic circuit.