Resorbable Microneedles in Linear Surgical Stapler Cartridges
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Solution Overview
Problem
Current surgical technologies face challenges in effectively delivering therapeutic agents to the serosal layer of stapled tissues, particularly in colorectal anastomoses, due to limited access and difficulty in ensuring uniform application, leading to post-operative leakage and morbidity.
Innovation Solution
A linear surgical stapler equipped with a disposable cartridge containing resorbable microneedles that deploy therapeutic agents into the tissue layers simultaneously with staples, allowing for sustained release of medicants such as drugs, enzymes, or growth factors to enhance tissue viability and prevent leakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical staples are used to join tissue layers, then the tissue can be secured and joined together, but therapeutic agents cannot be effectively delivered to the serosal layer
Solution Approach 1:
The patent combines the staple application function with therapeutic agent delivery into a single integrated device. The cartridge contains both staples and microneedles that are deployed simultaneously, allowing the surgical instrument to perform both tissue joining and drug delivery functions in one operation, thereby resolving the contradiction between reliable tissue joining and therapeutic agent delivery capability.
Solution Approach 2:
The surgical stapler is designed with multi-functionality, serving both as a tissue joining device and a therapeutic agent delivery system. The cartridge assembly incorporates staples for mechanical closure and microneedles for drug delivery, enabling a single device to perform multiple functions that were previously required from separate instruments.
2Ease of operation
If therapeutic agents are applied to the outer surface of the anastomosis, then some treatment effect is achieved, but uniform application and effective delivery to the serosal layer cannot be ensured
Solution Approach 1:
The therapeutic agent delivery is segmented into multiple microneedles distributed across the cartridge surface. Each microneedle acts as an independent delivery channel, ensuring uniform distribution of the therapeutic agent across the tissue surface. This segmentation approach transforms the single-point application limitation into a distributed multi-point delivery system, achieving both ease of operation and application uniformity.
Solution Approach 2:
The patent replaces the manual or spray-based mechanical application method with a microneedle-based delivery system. The microneedles mechanically penetrate the tissue to deliver the therapeutic agent directly to the target site, eliminating the need for manual application techniques that struggle with uniformity and effectiveness.
3Reliability
If separate steps are used to apply sealants and staples, then each function can be optimized, but the surgical process becomes more complex and time-consuming
Solution Approach 1:
The patent merges the staple application process with the sealant or therapeutic agent application into a single simultaneous operation. The cartridge contains both staples and microneedles with therapeutic agents, which are deployed together in one firing action. This integration reduces the surgical process from multiple separate steps to a single unified operation, thereby reducing complexity while maintaining both sealing reliability and therapeutic effect.
Solution Approach 2:
The therapeutic agents are pre-loaded into the microneedles within the cartridge assembly before the surgical procedure. This preliminary preparation allows the therapeutic agent to be delivered immediately upon staple deployment, eliminating the need for separate post-stapling application steps and reducing overall procedural complexity.
4Reliability
If microneedles are used to deliver therapeutic agents, then effective tissue delivery is achieved, but the device structure becomes more complex
Solution Approach 1:
The microneedles are integrated into a flexible cartridge structure that can accommodate the delicate microneedle array. The cartridge design uses thin-walled chambers and flexible mounting structures that protect the microneedles during handling while allowing their deployment function, thereby managing the structural complexity introduced by the microneedle integration.
Solution Approach 2:
The microneedles are nested within the cartridge structure, with each microneedle housed in its own chamber or mounting position. This nested arrangement allows the complex microneedle delivery system to be compactly integrated into the existing cartridge framework, minimizing the increase in overall device complexity while maintaining delivery effectiveness.
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 stapler ensures effective delivery and release of therapeutic agents directly into the tissue, improving tissue viability and reducing post-operative leakage by deploying microneedles and staples in conjunction, thereby enhancing the healing process and reducing complications.
Implementation Method 1
allowing for sustained release of medicants such as drugs, enzymes, or growth factors to enhance tissue viability and prevent leakage
Implementation Method 2
A linear surgical stapler equipped with a disposable cartridge containing resorbable microneedles that deploy therapeutic agents into the tissue layers
Data Source
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AI summary
The present invention is directed to linear surgical staplers for joining tissue layers comprising a disposable cartridge installed in a first jaw connected to an opposing second jaw, said cartridge containing a plurality of deployable staples in arrays separated by a tissue resection slot and a plurality of resorbable medicant-releasing microneedles, said microneedles comprising elongated rods having a sharp tissue-penetrating distal end and a proximal end; said microneedles are releasably disposed on or within a tissue-facing surface of the cartridge, wherein the proximal end of the microneedles is supported on the cartridge. The present invention is also directed to methods of use of such stapler assembly devices.