Breast Implant Removal Device with Sealing Ring
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Solution Overview
Problem
The removal of breast implants, especially ruptured or leaking ones, is challenging due to the fragility of the outer elastomeric shell and the tendency of silicone fill material to adhere to tissues and instruments, leading to difficulties in maintaining a vacuum seal and potential harm to the patient.
Innovation Solution
A device with a housing having a distal and proximal portion, a ring with a rolled inner edge and outer lip attached to the proximal portion, and a suction port is used to efficiently remove breast implants and fill material by creating a stable vacuum seal and guiding the implant through the incisions without causing further damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a liter saline bottle is used as housing to remove breast implant and fill material, then the implant and leaked material can be contained, but maintaining a vacuum seal becomes difficult due to the unrestrained movement of the bottle mouth
Solution Approach 1:
The device is divided into distinct functional components: a housing for containing the implant, a ring structure for sealing at the incision site, and a vacuum source. This segmentation allows each component to perform its specific function optimally, with the ring providing stable sealing while the housing contains the implant.
Solution Approach 2:
The ring is pre-positioned at the incision site to establish a stable seal before vacuum application begins. This preliminary positioning ensures that the vacuum seal is formed correctly from the start, preventing the sealing issues experienced with the saline bottle approach.
2Productivity
If digital grasping or clamp is used to remove implant, then removal can be attempted, but the outer elastomeric shell is likely to be further damaged or torn due to fragility
Solution Approach 1:
The device uses vacuum (pneumatic force) to grasp and remove the implant instead of mechanical grasping with fingers or clamps. The vacuum force distributes evenly across the implant surface, preventing localized stress concentrations that would cause shell tearing, while still providing sufficient grasping force for removal.
Solution Approach 2:
The device utilizes the flexibility of the implant's outer shell itself as part of the grasping mechanism. The vacuum applied through the ring causes the shell to conform to the ring's shape, allowing the shell to be drawn into the device without rigid mechanical contact that would cause damage.
3Reliability
If silicone fill material is present, then implant function is maintained, but the material adheres to tissues and instruments making removal and cleaning difficult
Solution Approach 1:
The device converts the adhesive property of silicone fill material from a harmful factor into a beneficial one. The vacuum force causes the sticky fill material to adhere to the inner surface of the housing rather than to surrounding tissues or instruments. This containment of the adhesive material within the housing eliminates the cleaning problems that would otherwise occur with tissue and instrument contamination.
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 allows for the consistent and efficient removal of breast implants and fill material, reducing the risk of further harm to the patient and enabling the inspection of the removed implant.
Implementation Method 1
a vacuum is applied at an opposite end of the bottle. The vacuum pressure is intended to draw the breast implant, including any free fill material from a ruptured or leaking breast implant, through the incisions and into the bottle
Data Source
AI summary
A device for removing a breast implant, fill material, and/or a capsule from a patient is provided. The device includes a housing having a distal portion and a proximal portion, and a suction port. Together, the distal and proximal portions define an interior chamber for receiving the breast implant. A ring is attached to an end of the proximal portion and the ring and the end of the proximal portion define an orifice through which the breast implant passes during removal. A related method includes the steps of exposing the breast implant and fill material, positioning a ring attached to an end of a housing against the exposed breast implant and fill material, the ring and the end of the housing defining an orifice through which the breast implant passes during removal, and applying suction to the housing sufficient to draw the breast implant through the orifice.