Urethral Support Device with Shape Memory Polymer Connectors
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Solution Overview
Problem
Current urinary incontinence treatment devices, such as sub-urethral slings and bulking liquids, face challenges in anatomical fixation and tension adjustment, leading to suboptimal results and potential long-term efficacy issues.
Innovation Solution
A urethral support device with cross-linked polymer connectors having a glass transition temperature between 40-70 degrees Celsius, allowing for tissue ingrowth and adjustable length through extracorporeal heating, enabling post-implantation adjustment without surgical access.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a sub-urethral sling is surgically implanted to support the urethra, then immediate continence support is provided, but the implantation process is difficult and time-consuming, and anatomical fixation is imperfect
Solution Approach 1:
The connector is designed with dynamic length adjustment capability through the shape memory polymer. The connector can be elongated during implantation to facilitate positioning, then shortened through external heating to achieve proper tension adjustment. This dynamic property resolves the contradiction by making the device adaptable to anatomical variations without requiring complex surgical procedures.
Solution Approach 2:
The invention utilizes parameter changes in the shape memory polymer connector by changing its temperature to alter its length. The connector has a glass transition temperature between 40-70°C, allowing it to be heated externally to shorten its length and adjust tension. This parameter-based control simplifies the implantation process while maintaining reliable continence support.
2Reliability
If the device tension is adjusted during implantation, then anatomical fixation can be optimized, but the surgical procedure becomes more time-consuming and complex
Solution Approach 1:
The connector is pre-configured with shape memory properties and can be temporarily elongated to facilitate easy positioning during surgery. After implantation, the connector is shortened through external heating to achieve optimal tension. This preliminary configuration eliminates the need for complex intraoperative tensioning procedures, reducing surgical time while ensuring reliable anatomical fixation.
Solution Approach 2:
The invention replaces traditional mechanical tensioning mechanisms (screws, knots, anchors) with a thermal-responsive shape memory polymer system. The connector's length is adjusted by changing its temperature rather than through mechanical manipulation, which simplifies the surgical procedure and reduces operative time while achieving optimal anatomical fixation.
3Ease of operation
If a cross-linked polymer connector is elongated to an implant length greater than initial length, then ease of implantation is improved, but the connector length must be subsequently reduced to achieve proper tension
Solution Approach 1:
The connector utilizes phase transitions of the shape memory polymer, specifically the glass transition between 40-70°C. The polymer transitions from a rigid state at body temperature to a more compliant state when heated externally, allowing it to be shortened to the desired tension. This phase transition mechanism provides a simple, elegant solution for length adjustment without complex mechanical components.
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 device provides immediate continence support and allows for adjustable tension post-implantation, addressing the challenges of anatomical fixation and long-term efficacy by allowing for extracorporeal shortening of the connectors to enhance urethral support and reduce incontinence.
Implementation Method 1
At least one of the first connector and the second connector is a cross-linked polymer connector having a glass transition temperature between 40-70 degrees Celsius. The cross-linked polymer connector has an initial length that is elongated to an implant length that is greater than the initial length. Means for heating the cross-linked polymer connector from an extracorporeal location through intact skin is provided, thereby shortening the cross-linked polymer connector.
Implementation Method 2
The ferromagnet is attached around each cross-linked polymer connector between a midpoint of the cross-linked polymer connector and its respective anchor. The device includes means for shortening, through intact skin from an extracorporeal location, a length of the cross-linked polymer connector between the midpoint of the cross-linked polymer connector and its respective anchor.
Data Source
Figure 1A~1C
Figure 2A~2D
Figure 3A
AI summary
An incontinence treatment device includes a urethral support and first and second connectors. The urethral support extends between a first end and a second end and has porosity that is configured to allow tissue in-growth through the urethral support. The first connector is attached to the first end of the urethral support and the second connector is attached to the second end of the urethral support. At least one of the first connector and the second connector is a cross-linked polymer connector having a glass transition temperature between 40-70 degrees Celsius. The cross-linked polymer connector has an initial length that is elongated to an implant length that is greater than the initial length. Means for heating the cross-linked polymer connector from an extracorporeal location through intact skin is provided, thereby shortening the cross-linked polymer connector.