Artificial Sphincter with Semi-Conical Elements

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Solution Overview

Problem

Existing artificial sphincters fail to maintain a stable and effective seal around the urethra due to instability and progressive sclerosis, leading to non-ideal contact and loss of functionality over time.

Innovation Solution

The artificial sphincter comprises two elongated, hollow elements with semi-cylindrical contact surfaces and a semi-conical shape, made of biocompatible materials, covered with pyrolytic turbostratic carbon, and connected by a biocompatible fabric strip to ensure stable positioning and pressure regulation, preventing deformation and stenosis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If two hollow balls are used as artificial sphincter elements, then the device can exert pressure on the urethra to ensure seal, but the balls are unable to remain in the assigned position for a long period and determine non-ideal contact with the patient's urethra

Engineering Contradiction:
Improveseal effectivenessVSAvoidposition stability
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The artificial sphincter is divided into two separate elongated elements that can be independently positioned and adjusted. Each element can be separately implanted around the urethra, allowing for optimized positioning and contact with the urethral tissue, thereby maintaining reliability while improving position stability.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The spherical shape of traditional balls is replaced with elongated elements featuring curved contact surfaces that conform to the cylindrical geometry of the urethra. This curvature adaptation enables better surface contact and distribution of pressure, ensuring both effective sealing and stable positioning over time.

Inventive Principle:
Principle #14Spheroidality (Curvature)

2Ease of operation

If a ring is used to wind around the urethra, then the device can be fillable with physiological solution for pressure regulation, but the ring progressively tends to be sclerosed, losing the necessary seal and functionality

Engineering Contradiction:
Improvepressure regulationVSAvoidseal maintenance
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The rigid or semi-rigid ring structure is replaced with flexible elongated elements made of elastomeric materials. These flexible shells can be filled with physiological solution through catheters while maintaining their ability to conform to the urethra and resist sclerosis, thereby preserving both ease of pressure regulation and long-term seal reliability.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The elements are constructed from composite materials combining elastomeric polymers with biocompatible coatings or layered structures. This composite construction prevents sclerosis by creating a material architecture that resists calcification and tissue ingrowth, while maintaining flexibility for pressure regulation and durable sealing capability.

Inventive Principle:
Principle #40Composite materials

3Productivity

If traditional artificial sphincter elements are used, then the device can regulate urine flow, but the elements move and determine non-ideal contact with the patient's urethra over time

Engineering Contradiction:
Improveurine flow regulationVSAvoidcontact stability
Core Design Contradiction:
ProductivityVSStability of the object's composition

Solution Approach 1:

The elongated elements are designed with multiple functions: they provide sealing contact with the urethra, maintain stable positioning through their geometry and connection members, and enable pressure regulation. This multi-functionality ensures both effective urine flow regulation and stable contact over time.

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

Solution Approach 2:

Connection members act as intermediaries between the two elongated elements, securing them in fixed relative positions. These intermediaries prevent movement and maintain ideal contact with the urethra, while allowing the elements to independently perform their sealing and pressure regulation functions.

Inventive Principle:
Principle #24Intermediary (Mediator)

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 solution provides a stable and effective seal along the urethra, maintaining correct positioning and functionality over time, with the semi-conical shape facilitating easy anchoring and the carbon layer preventing attachment and deformation, ensuring reliable urine flow regulation.

Implementation Method 1

Ogni superficie di contatto 3 è coperta con un layer di carbonio pirolitico turbostratico, in modo tale da prevenire dette superfici di contatto 3 dall'attaccarsi all'uretra del paziente

Methodology Applied
Scientific EffectNon-stick property of carbon coating: Diamond-like Carbon

Implementation Method 2

Gli elementi 2 sono internamente cavi in modo tale da permettere di contenere un fluido pressurizzato... Gli elementi 2 esercitano, sull'uretra del paziente attraverso le superfici di contatto 3, una pressione

Methodology Applied
Scientific EffectFluid pressure: Pressure Gradient

Data Source

PatentEP3160386B1Artificial sphincter
Publication Date: 2018.04.25 SAMBUSSETI ANTONIO
  • EP3160386B1 patent drawingFigure 1~2
  • EP3160386B1 patent drawingFigure 3~4

AI summary

An artificial sphincter comprises at least two elements (2) associated with each other and hollow for containing a pressurized fluid; said elements (2) being adapted to be arranged on the sides of the urethra of a patient and have a substantially semi-conical shape; each element (2) has a respective contact surface (3) with the urethra of substantially semi-cylindrical shape.