Bioabsorbable Metal Staples with Composite Coatings for Tissue Healing
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Solution Overview
Problem
Surgical staples made of bioabsorbable materials face challenges in maintaining structural integrity during the biocorrosion timeframe to ensure adequate tissue healing, while also being safe and compatible with electrosurgical instruments.
Innovation Solution
Development of bioabsorbable metal staples with specific coatings and designs that enhance their structural integrity and biocorrosion properties, including coatings that slow absorption and ensure tissue healing without toxicity concerns.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of moving object
If bioabsorbable materials are used for surgical staples, then the staples can dissolve and release tissue after sufficient time, but the staples may lose structural integrity before adequate tissue healing occurs
Solution Approach 1:
The staple is constructed from a composite structure comprising an inner core material and an outer coating material. The inner core provides structural strength and stiffness to maintain integrity during healing, while the outer coating controls the biocorrosion rate to achieve desired dissolution timing. This composite approach allows independent optimization of both mechanical properties and degradation characteristics.
Solution Approach 2:
The patent utilizes phase change materials, specifically materials that undergo martensitic transformation, to alter the mechanical properties of the staple over time. The phase transformation allows the staple to maintain austenitic phase (soft, ductile) during insertion and then transform to martensitic phase (hard, strong) after deployment, providing temporal control over mechanical properties to ensure both ease of insertion and subsequent structural integrity.
2Reliability
If bioabsorbable materials are used for surgical staples, then the staples can be safely absorbed by the body, but the material selection is limited by toxicity concerns and compatibility requirements
Solution Approach 1:
By combining biocompatible inner core materials with biocompatible outer coating materials, the invention expands the range of usable materials. Each layer can be independently selected from materials with proven biocompatibility, allowing optimization of specific properties (strength, corrosion rate, elasticity) without compromising overall safety. The coating acts as a barrier that protects the inner material from direct tissue contact while still allowing controlled degradation.
3Reliability
If stents with dissolvable coatings are used, then biocorrosion resistance is improved, but the underlying structure remains resistant to biocorrosion rather than dissolving
Solution Approach 1:
The staple is divided into functional segments: an inner core that provides structural support and an outer coating that controls biocorrosion. This segmentation allows the outer layer to be optimized for controlled dissolution while the inner core maintains structural integrity throughout the healing period. The layered structure enables the staple to provide temporary support followed by complete absorption, unlike stents that rely only on surface coatings.
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 bioabsorbable metal staples effectively maintain structural integrity during the healing process, ensuring proper tissue healing and safety, while being compatible with electrosurgical instruments.
Implementation Method 1
the staples can be made of a bioabsorbable material such that the staples can dissolve and release the tissue after a sufficient amount of time has elapsed following the surgical procedure
Data Source
AI summary
Stapling devices and staple cartridges are disclosed. A stapling device can include a jaw configured to sequentially receive a plurality of dissimilar staple cartridges having different bioabsorbable components. An adjustment module can implement a firing control algorithm based on which dissimilar staple cartridge is received in the jaw. A staple cartridge can include staples comprised of a bioabsorbable metal alloy and configured to degrade at a staple degradation rate over an expected staple life in the patient. A staple cartridge can also include an implantable layer comprised of a bioabsorbable polymer and configured to degrade at a layer degradation rate over an expected layer life in the patient. The staple degradation rate and the implantable degradation rate can be different. The implantable layer can mechanically support at least a portion of a staple for a time in the expected staple life.


