Bone Staple Extrusion Instrument Shape Memory Compression
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Solution Overview
Problem
Existing bone staple technologies face challenges in ease of use, manufacturing complexity, cost, and reliability, particularly in providing predictable bone compression and healing, as they often require complex instruments, temperature control, and can lead to delayed or non-healing due to incomplete shape change or deformation during implantation.
Innovation Solution
A bone staple extrusion instrument that stores mechanical energy and changes shape to spontaneously compress or pull apart bones without substantial plastic deformation, using a cartridge with a movable actuator to restrain and release the staple, allowing it to move from a parallel to a non-parallel configuration, thereby applying consistent compression force.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If complex instruments with temperature control are used to implant staples, then the shape change and bone compression can be controlled, but the device complexity and cost increase significantly
Solution Approach 1:
The patent extracts the temperature control mechanism from the implantation instrument, using only simple mechanical extrusion force. The staple's shape change is achieved through its inherent shape memory properties activated by body temperature, eliminating the need for complex external heating devices while maintaining reliable bone compression.
Solution Approach 2:
The staple serves itself by utilizing its own shape memory properties and the body's natural temperature to achieve shape change and bone compression. The instrument only provides simple mechanical extrusion, allowing the staple to self-activate and self-compress the bone without requiring complex temperature control systems.
2Ease of operation
If simple extrusion instruments are used to implant staples, then the ease of operation improves, but the ability to control staple shape change and bone compression decreases
Solution Approach 1:
The staple is pre-programmed with its shape memory characteristics during manufacturing, so that when extruded with simple force, it automatically undergoes the correct shape change sequence to achieve reliable bone compression. The complex shape transformation logic is built into the staple itself before implantation.
Solution Approach 2:
The staple's physical parameters (shape, phase, dimensions) are designed to change automatically in response to the extrusion force and body temperature. The instrument applies simple mechanical force that triggers a cascade of parameter changes in the staple, from martensitic to austenitic phase transformation, resulting in consistent bone compression.
3Manufacturing precision
If staples require manipulation during implantation, then the shape change can be controlled, but the ease of operation and surgical time decrease
Solution Approach 1:
The patent removes the manipulation step from the implantation process. The staple is loaded in its pre-formed shape and implanted through simple extrusion without requiring surgeons to manually bend, stretch, or manipulate it, thereby maintaining shape control while dramatically improving surgical efficiency.
Solution Approach 2:
The staple performs its own shape transformation automatically after extrusion, using its shape memory properties and body heat. This eliminates the need for surgeon manipulation while ensuring precise shape change and reliable bone compression, improving both efficiency and consistency.
4Reliability
If complex instruments are used to stretch and hold staples, then the staple retention during implantation is improved, but the cost and device complexity increase
Solution Approach 1:
The patent extracts the stretching and holding functions from the implantation instrument. The staple is pre-loaded in its stretched configuration within the instrument's chamber, and simple extrusion force is applied during implantation. The staple's elasticity and shape memory properties maintain its configuration until extrusion, eliminating the need for complex stretching mechanisms.
Solution Approach 2:
The staple is pre-stretched and pre-positioned within the instrument chamber before implantation. This preliminary preparation ensures the staple is ready for immediate extrusion and shape change, maintaining reliable retention without requiring complex active holding mechanisms during the surgical procedure.
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 simplifies the implantation process, reduces the need for complex instruments, and ensures consistent bone compression, enhancing healing by maintaining mechanical energy storage and predictable shape change, thus overcoming the limitations of prior art.
Implementation Method 1
The bone staple is operable for moving from the first position to the second position without substantial plastic deformation of the bone staple
Implementation Method 2
The bone staple comprises a bridge and legs. The bone staple is in the first position when the legs of the bone staple are substantially parallel. The bone staple is in the second position when the legs of the bone staple are substantially non-parallel
Implementation Method 3
a cartridge that can restrain a bone staple such that the bone staple is maintained in a first position
Implementation Method 4
an extruder operatively connected to the cartridge. The extruder is operable for moving relative to the cartridge to cause extrusion from the cartridge of the bone staple being restrained by the cartridge
Data Source
AI summary
A bone staple extrusion instruments used for fixation of bone and soft tissue of the musculoskeletal system and the methods for their use and manufacture. The bone staple extrusion instruments are used for insertion of staples into bones, which staples change shape through their metallurgic properties and the release from the bone staple extrusion instruments. In some embodiments, the bone staples pull together and compress bone once released from the bone staple extrusion instruments. In other embodiments, the staples push outward to place the bones in tension once released from the bone staple extrusion instrument.