Biocompatible Polymer Adjunct for Drug Elution in Surgical Staplers
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Solution Overview
Problem
Surgical staplers often cause leaks and tissue inflammation due to the trauma of stapling, and biologic materials used to mitigate this lack natural tissue characteristics, making them difficult to manufacture and deploy effectively.
Innovation Solution
A staple cartridge assembly with a biocompatible adjunct material containing distinct reservoirs and a biocompatible polymer that releases medicants to promote tissue ingrowth and healing, minimizing leaks and inflammation by releasing medicants as the polymer degrades.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If biologic materials are used to mitigate leaks and inflammation, then tissue healing is improved, but manufacturing difficulty increases and structural support is insufficient
Solution Approach 1:
The patent combines biologic materials with synthetic polymers to create a composite adjunct material. The synthetic polymer provides structural support and manufacturability, while the biologic material provides therapeutic benefits for tissue healing and inflammation reduction. This composite approach resolves the contradiction by integrating the strengths of both material types.
Solution Approach 2:
The patent modifies the physical and chemical parameters of biologic materials by incorporating them into a polymer matrix with specific porosity, degradation rate, and mechanical properties. This allows the biologic material to maintain its therapeutic function while gaining the structural support and manufacturability needed for clinical use.
2Reliability
If biologic materials are used to reduce inflammation, then tissue characteristics are maintained, but location stability during stapling deteriorates
Solution Approach 1:
The synthetic polymer matrix provides mechanical stability and location stability during the stapling process, while the embedded biologic material maintains tissue characteristics and reduces inflammation. The composite structure ensures both stability and therapeutic function are achieved simultaneously.
Solution Approach 2:
The biologic material is distributed locally within specific regions of the polymer matrix, allowing it to maintain tissue characteristics at the tissue interface while the bulk polymer provides overall structural stability and location fixation during stapling.
3Reliability
If biologic materials are used to promote healing, then natural tissue characteristics are maintained, but structural support and flexibility deteriorate
Solution Approach 1:
The synthetic polymer component provides the necessary structural support, strength, and flexibility to withstand the stapling process, while the biologic material component promotes healing and maintains natural tissue characteristics. The composite structure allows both requirements to be met simultaneously.
Solution Approach 2:
The mechanical parameters of the biologic material are modified through incorporation into the polymer matrix, providing enhanced structural support while preserving its therapeutic function for promoting healing and maintaining tissue characteristics.
4Reliability
If thin biologic layers are manufactured, then tissue compatibility is improved, but manufacturing precision deteriorates
Solution Approach 1:
The synthetic polymer matrix provides a manufacturable structure with controlled thickness and shape, while the biologic material is incorporated as a thin layer or dispersion within the matrix. This composite approach allows precise control of geometric parameters while maintaining tissue compatibility.
Solution Approach 2:
The polymer matrix is formed as a thin film or shell with precisely controlled thickness, into which the biologic material is incorporated. This approach enables manufacturing of thin biologic layers with improved precision through established polymer processing techniques.
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 effectively reduces leaks and inflammation while maintaining natural tissue characteristics by releasing medicants to promote healing and tissue integration, enhancing the stapling process.
Implementation Method 1
disruption of the at least one polymer is configured to allow release of the vessels from the at least one of the reservoirs
Implementation Method 2
Each of the vessels can be configured to degrade over time in response to the exposure thereof to an environment external to the adjunct material into which the vessels are capable of migrating following the disruption of the at least one polymer
Implementation Method 3
the at least one medicant being is disposed within a plurality of vessels disposed within at least one of the reservoirs, and the at least one medicant is effective to provide a desired effect on tissue in-growth
Data Source
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AI summary
Adjunct material is provided that has multiple reservoirs formed therein and releasably carrying a plurality of vessels that each retain at least one medicant. An implantable adjunct has at least one bioabsorbable polymer configured to maintain the vessels within a reservoir. Disruption of the at least one bioabsorbable polymer allows release of the vessels from at least one of the reservoirs. A rate of the vessels' release can be controlled by a degradation rate of the at least one bioabsorbable polymer. The released vessels are, in turn, disrupted to thereby cause at least one medicant disposed therein to release and thus provide a desired effect on tissue in-growth.