Expandable Bladder Access Sheath for Minimizing Urethral Trauma

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Solution Overview

Problem

Current minimally invasive techniques for accessing the bladder, such as transurethral bladder calculi treatment, face challenges including urethral trauma, prolonged procedure times, and high costs due to the need for expensive equipment like the Holmium:YAG laser, while also risking accidental damage to internal organs.

Innovation Solution

A bladder access apparatus featuring an annular body with expandable tubular sheaths and a method involving a transurethral, suprapubic approach that includes forming an opening through the bladder and abdominal wall using a cutting tip and expanding sheath, allowing for larger diameter access and reducing procedural time and trauma.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If transurethral bladder calculi treatment is performed using conventional instruments, then access to the bladder is achieved, but urethral trauma and prolonged procedure time occur

Engineering Contradiction:
Improveease of bladder accessVSAvoidprocedure time
Core Design Contradiction:
Ease of operationVSLoss of time

Solution Approach 1:

The access device is divided into multiple segments including an inner sheath, outer sheath, and expandable elements that can be deployed independently. This segmentation allows for controlled expansion and deployment, enabling rapid access while minimizing urethral trauma through precise, staged instrumentation.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The access device incorporates dynamic elements including an expandable sheath that transitions from a compressed state for insertion to an expanded state for access. This dynamic expansion mechanism allows the device to adapt to different anatomical conditions while significantly reducing procedure time compared to static conventional instruments.

Inventive Principle:
Principle #15Dynamics

2Ease of operation

If conventional transurethral treatment instruments are used, then bladder access is achieved, but significant urethral trauma occurs

Engineering Contradiction:
Improveease of bladder accessVSAvoidurethral trauma
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The access device utilizes flexible sheath structures that can be smoothly inserted through the urethra without causing trauma. The flexible material allows the device to conform to the urethral anatomy while maintaining structural integrity, preventing damage to the urethral tissue during insertion and manipulation.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The expandable access device acts as an intermediary tool that facilitates bladder access without requiring direct manipulation of rigid instruments through the urethra. The controlled expansion mechanism and flexible sheath protect the urethra from trauma while still enabling effective access to the bladder for treatment procedures.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If expensive equipment like Holmium:YAG laser is used for transurethral treatment, then bladder calculi can be broken, but equipment cost and procedure time increase

Engineering Contradiction:
Improvestone fragmentation capabilityVSAvoidequipment cost
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The access device is segmented into functional components including an inner sheath for instrument passage, an outer sheath for protection and guidance, and expandable elements for access creation. This segmentation allows for a modular system that can be configured for different treatment needs, reducing reliance on expensive specialized equipment while maintaining effective stone treatment capability.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The access device is designed as a universal system that can accommodate multiple treatment approaches and instrument types through its expandable structure. This multi-functionality allows the same basic device to serve various purposes including access creation, stone fragmentation, and instrumentation, thereby reducing overall equipment costs and procedure complexity.

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

4Productivity

If mechanical dilation with Amplatz dilators is used, then percutaneous bladder access is achieved, but risk of perforating rectum or vagina increases

Engineering Contradiction:
Improveaccess creation speedVSAvoidsafety against organ perforation
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The access device incorporates feedback mechanisms including visual indicators and tactile sensors that provide real-time information about the device's position and the surrounding tissue conditions. This feedback allows the operator to adjust the expansion and deployment parameters to prevent perforation of adjacent organs while maintaining efficient access creation.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The device utilizes dynamic expansion and deployment mechanisms that can be controlled in real-time based on tissue resistance and anatomical conditions. This dynamic control allows the access device to adapt to varying anatomical structures, preventing perforation of the rectum or vagina while maintaining high productivity in access creation.

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 solution significantly reduces procedure time by up to 70% and hospital stay, providing a more reliable and rapid method of tract creation with the largest available working sheath size, minimizing trauma and internal organ risks.

Implementation Method 1

The sheath has a first diameter and is expandable to an enlarged second diameter

Methodology Applied
Scientific EffectElastic expansion: Elasticity

Implementation Method 2

an elongate, resilient strip is slidably received in each of the hollow channels with one end of the strips having a gripping member operably attached thereto. Each of the gripping members extends outwardly from one of the slots for sliding movement along the slots between locked and unlocked positions

Methodology Applied
Scientific EffectElastic deformation: Elasticity

Data Source

PatentEP2195066B1Method of accessing a bladder and associated apparatus therefor
Publication Date: 2014.10.22 SWAN VALLEY MEDICAL INC
  • EP2195066B1 patent drawingFigure 1
  • EP2195066B1 patent drawingFigure 2
  • EP2195066B1 patent drawingFigure 3~4

AI summary

A bladder access apparatus and method of provided access into a bladder through a abdominal wall therewith is provided. The apparatus has an annular body extending between opposite ends with a through passage extending between the ends. A tubular sheath is attached to one end of the body in coaxial alignment with the through passage. The sheath is expandable from a first diameter to an enlarged second diameter. The apparatus has an elongate stylet with a rod sized for receipt in the sheath. The rod has a length greater than the tubular sheath and a diameter substantially the same as the first diameter of the sheath. The apparatus includes a rigid, tubular body having an outer diameter corresponding substantially to the second diameter of the sheath and a rigid, cylindrical member sized for sliding receipt in the tubular body.