Handheld Crimper With Removable Dies for Implant Loading
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Solution Overview
Problem
Current methods for crimping implantable medical devices, such as iris style crimpers, are cumbersome, costly, and difficult to sterilize due to their single-use nature and complex design, requiring multiple steps and specialized equipment, which complicates the process of compressing and loading devices onto delivery devices.
Innovation Solution
A portable crimper with a pivotable arm mechanism and removable dies that allows for top-loading and alignment of implantable medical devices, enabling efficient conversion from an uncompressed to a compressed state, with increased visibility and ease of sterilization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If iris style crimpers are used for crimping implantable medical devices, then the crimping function can be performed, but the device becomes unwieldy and costly due to single-use requirement and complex design
Solution Approach 1:
The crimper is divided into separate modular components: a handle assembly and a crimper die assembly that can be detached from one another. This segmentation allows the complex crimping function to be isolated in a replaceable die component while the handle remains simple and reusable, reducing overall device complexity and cost.
Solution Approach 2:
The crimper die is extracted as a separate removable component from the handle assembly. This allows the complex, single-use portion (the die) to be separated from the reusable handle, enabling sterilization of the handle and disposal or replacement of the die after a single use, thereby reducing the complexity burden on the entire device.
2Reliability
If iris style crimpers are used for crimping implantable medical devices, then the crimping function can be performed, but sterilization becomes difficult due to complex design and single-use nature
Solution Approach 1:
By segmenting the crimper into handle and die components, the sterilization process can be applied differently to each: the handle can be sterilized and reused, while the die can be disposed of or sterilized separately, simplifying the overall sterilization workflow.
Solution Approach 2:
The die is extracted as a disposable component that can be pre-packaged in sterile condition and attached to a non-sterile handle at the point of use, eliminating the need to sterilize the entire crimper assembly and simplifying the sterilization process.
3Ease of operation
If top loading design is implemented, then visibility and alignment are improved, but device complexity increases
Solution Approach 1:
Instead of inserting the medical device from the closed end of the crimper (traditional approach), the design allows top-loading from the open end, enabling the operator to visually align the device with marker bands before crimping, thereby improving ease of operation without significant complexity increase.
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 provides a cost-effective, portable, and efficient method for compressing and loading implantable medical devices, reducing manufacturing costs and simplifying the crimping process while ensuring proper alignment and sterilization.
Implementation Method 1
The pivot connection enables the first arm and the second arm to rotate about the pivot connection from an open state to a closed state. When the first arm and the second arm transition from the open state to the closed state, the first tapered channel and the second tapered channel form a chamber that is configured to crimp the expandable medical device from the uncompressed state to the compressed state.
Implementation Method 2
When the first arm and the second arm transition from the open state to the closed state, the first tapered channel and the second tapered channel form a chamber that is configured to crimp the expandable medical device from the uncompressed state to the compressed state.
Data Source
AI summary
A crimper includes a first arm that includes a first crimper die that defines a first tapered channel. The crimper also includes a second arm coupled to the first arm at a pivot connection. The second arm includes a second crimper die that defines a second tapered channel. The pivot connection enables the first arm and the second arm to rotate about the pivot connection from an open state to a closed state. The first arm and second arm rotate at an angle relative to one another to allow loading of the expandable medical device into the first tapered channel or the second tapered channel and to allow positioning of the expandable medical device relative to a delivery device. When transitioning, the first tapered channel and the second tapered channel form a chamber that is configured to crimp the expandable medical device from the uncompressed state to the compressed state.