Prosthetic Bladder Delivery Sheet for Controlled Insertion
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Solution Overview
Problem
Existing methods for inserting silicone breast prostheses into surgical cavities face challenges with control and precision, leading to potential damage and contamination risks, and existing devices often require additional tools and have sterility concerns.
Innovation Solution
A delivery sheet with a low coefficient of friction and positioning indicia, along with a malleable or rigid guide, is used to facilitate precise and controlled insertion of filled prosthetic bladders into surgical cavities without additional tools, reducing the risk of damage and contamination.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If existing manual insertion methods are used, then the implant can be inserted into the surgical cavity, but control and precision are difficult to maintain leading to potential damage
Solution Approach 1:
The patent introduces a delivery device as an intermediary tool between the surgeon and the implant. This device includes a delivery needle with a tapered tip and a retention flange that provides mechanical control and precision during insertion. The delivery device acts as a mediator that translates surgeon intent into precise implant placement while maintaining control throughout the procedure.
Solution Approach 2:
The patent employs visual indicators including positioning indicia on the delivery device and radiopaque markers on the implant itself. These visual elements enable precise positioning and verification of implant placement through direct visualization and imaging, enhancing both insertion precision and control reliability.
2Ease of manufacture
If existing insertion devices are used, then the implant can be delivered, but additional tools and joining operations are required increasing complexity
Solution Approach 1:
The patent combines multiple functions into a single integrated delivery device. The delivery needle, retention flange, and positioning features are merged into one component that performs insertion, retention, and positioning functions simultaneously. This eliminates the need for multiple separate tools and joining operations, reducing procedural complexity while maintaining ease of manufacture.
Solution Approach 2:
The delivery device is designed with universal applicability for different implant types and sizes. The tapered needle and adjustable retention mechanism can accommodate various implant configurations, eliminating the need for specialized tools for different scenarios and simplifying the overall procedure.
3Reliability
If conventional insertion techniques are used, then the implant can be inserted, but cross-contamination risk from apparatus preparation and transfer processes increases
Solution Approach 1:
The patent implements preliminary sterility measures by providing the delivery device and implant in a pre-sterilized, ready-to-use state. The device comes prepared with all necessary components attached and positioned, eliminating the need for separate preparation steps that could introduce contamination. The sterile barrier is maintained throughout the packaging and transfer process.
Solution Approach 2:
The patent employs a nested packaging structure where the implant is contained within a sterile inner packaging that is itself contained within the outer device packaging. This nested arrangement maintains sterility during storage and transfer, allowing the implant and delivery device to be transferred together as a single sterile unit without exposure to non-sterile environments.
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 enables easier and quicker insertion of silicone gel implants with reduced risk of biofilm and capsular contracture, improving surgical efficiency and patient outcomes by minimizing contamination and tissue stress.
Implementation Method 1
the delivery sheet can be selected to have a delivery surface... by appropriate material selection or by applying a coating such that the delivery surface possesses lubricity and a low coefficient of friction such that the prosthetic bladder easily slides along the delivery surface
Data Source
Figure 1A~2
Figure 3A~4B
Figure 5A~5C
AI summary
A prosthetic insertion apparatus and related methods of use in delivering filled prosthetic bladders through a skin incision and into a surgical cavity or pocket. The prosthetic insertion apparatus imparts control and retention properties to a surgical professional such the prosthetic bladder can be oriented and manipulated into the surgical cavity without risk of inadvertent dropping of the prosthetic bladder and without imparting damaging stress or torque to the bladder. Suitable materials can be utilized that are selected as having advantageous properties including lubricity, rigidity, easily sterilizable, and high strength.