Prostatic Urethral Implant Delivery for Precise Steerable Placement
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Solution Overview
Problem
The challenge lies in delivering implants accurately and minimally invasively into the prostatic urethra, which is complex due to its tortuous anatomy and patient-to-patient variability, making it difficult to achieve consistent and atraumatic placement.
Innovation Solution
A delivery system comprising a delivery device with multiple tubular components and a proximal control device, allowing for steerable and flexible deployment of self-expanding implants, including ring-shaped structures and anchor members, to navigate and expand within the urethra, ensuring precise placement and minimally invasive procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a rigid delivery system is used to maintain structural integrity during implant delivery, then the delivery device can support the implant, but it cannot navigate the tortuous bends of the urethra
Solution Approach 1:
The delivery system is divided into multiple tubular members (outer tubular member, inner tubular member, distal control member) that can move independently relative to each other. This segmentation allows the system to maintain structural integrity when needed while providing flexibility to navigate tortuous anatomy through controlled movement of individual segments.
Solution Approach 2:
The delivery system transitions from a static rigid structure to a dynamic system where tubular members can slide and rotate relative to each other. The inner tubular member can be rotated within the outer tubular member, and the distal control member can be advanced or retracted, allowing the system to adapt its configuration to navigate the tortuous bends of the urethra while maintaining the ability to provide structural support during implant deployment.
2Ease of operation
If the delivery device is made highly flexible to navigate tortuous anatomy, then it can pass through the urethra, but it loses the ability to maintain precise control over implant placement
Solution Approach 1:
The distal control member acts as an intermediary between the operator and the implant. It provides a controlled interface for deploying the implant while allowing the delivery system to navigate tortuous anatomy. The control member can be advanced or retracted to precisely position the implant at the desired location within the prostatic urethra, maintaining placement accuracy despite the flexibility needed for navigation.
Solution Approach 2:
The system replaces traditional mechanical control mechanisms with a more sophisticated multi-component tubular system that uses relative movement and interaction between components to achieve both navigation and precise control. The coordinated movement of the inner tubular member and distal control member within the outer tubular member provides fine control over implant deployment while maintaining the flexibility to navigate complex anatomy.
3Manufacturing precision
If a complex multi-component delivery system is used to achieve precise placement, then implant accuracy improves, but the device complexity increases
Solution Approach 1:
Each tubular member in the delivery system is designed to perform multiple functions. The outer tubular member provides structural support and houses the other components. The inner tubular member enables rotation and positioning control. The distal control member facilitates implant deployment and positioning. This multi-functionality reduces the need for additional separate components, managing overall system complexity while maintaining precise placement capability.
Solution Approach 2:
The delivery system uses a nested configuration where the inner tubular member is contained within the outer tubular member, and the distal control member is contained within the inner tubular member. This nesting arrangement allows multiple functional components to be integrated in a compact manner, reducing the overall complexity of the system while enabling precise control over implant placement through the coordinated movement of nested components.
4Object-affected harmful factors
If the implant is designed to self-expand for minimally invasive deployment, then the procedure becomes less traumatic, but control over the expansion timing and location becomes more difficult
Solution Approach 1:
The implant is pre-configured in a compressed state within the delivery system, ready for deployment. The self-expanding mechanism is prepared but not activated until the implant reaches the desired location in the prostatic urethra. The delivery system maintains the implant in its compressed state during navigation, then triggers expansion only when properly positioned, ensuring both minimally invasive deployment and precise control over expansion timing and location.
Solution Approach 2:
The implant utilizes a self-expanding mechanism that automatically expands upon release from the delivery system, eliminating the need for external expansion forces that could cause additional tissue trauma. The distal control member provides the final constraint that prevents premature expansion, and when released, the implant self-expands to its functional configuration, combining minimally invasive deployment with controlled expansion timing.
Data Source
AI summary
Systems, devices, and methods are provided for the delivery of an implant into the prostatic urethra. Embodiments of delivery systems can include a delivery device for insertion into the patient and a proximal control device for use in controlling release of the implant from the delivery device.