Tubular Surgical Construct with Biologic Adjunct for Staple Line Sealing
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Solution Overview
Problem
Surgical staplers often cause leaks and inflammation due to staple holes, and biologic materials used to address these issues are difficult to maintain and manufacture effectively, lacking natural tissue characteristics and structural support.
Innovation Solution
A tubular surgical construct with a biocompatible adjunct material and medicants that provides structural support while allowing fluid flow, featuring a radially collapsible design and heterogeneous fiber lattice sections to promote tissue remodeling, and can be integrated with surgical staplers to secure the construct within tissue lumens.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If biologic materials are used to seal staple holes and reduce inflammation, then tissue healing is improved, but the materials are difficult to maintain at desired location and lack structural support
Solution Approach 1:
The patent combines biologic materials with a synthetic tubular construct to create a composite structure. The tubular construct provides structural support and positioning stability, while the biologic material layer provides sealing and healing benefits. This composite approach allows the biologic material to be delivered and maintained at the desired location without compromising its healing effectiveness.
Solution Approach 2:
The biologic material is configured as a thin film or coating on the tubular construct. This thin film configuration allows the biologic material to conform to the tissue surface while being supported by the underlying tubular structure, solving the positioning and structural support problems while maintaining the healing benefits.
2Reliability
If biologic materials are used to address staple hole leaks, then sealing effectiveness is improved, but manufacturing to desired shape and thickness is difficult
Solution Approach 1:
The biologic material is manufactured as a thin film with controlled thickness that can be conformally applied to the tubular construct. This thin film approach enables precise control over thickness and shape while maintaining the sealing effectiveness needed to address staple hole leaks.
Solution Approach 2:
The synthetic tubular construct serves as a manufacturable substrate that can be produced with precise geometry, to which the biologic material is then applied. This separates the manufacturing challenges (handled by the synthetic tubular construct) from the sealing requirements (handled by the biologic material layer).
3Productivity
If surgical staplers are used to close tissue openings, then tissue closure is achieved, but leaks occur through staple holes and tissue inflammation occurs
Solution Approach 1:
The biologic material acts as an intermediary substance applied to the tissue at the staple line. It fills and seals the holes created by staples while also providing anti-inflammatory effects, thereby eliminating leaks and reducing tissue inflammation without compromising the tissue closure achieved by the stapler.
Data Source
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AI summary
Tubular surgical constructs including adjunct material are provided. In general, a tubular construct can be configured to be applied to tissue of a patient. The tubular construct can be configured to be implantable and to be implanted within a tissue lumen. The tubular construct can be configured to radially expand and radially constrict. The tubular construct can have an adjunct material disposed thereon. The adjunct can have one or more medicants releasably retained therein. Each of the one or more medicants can be effective to provide a desired effect on tissue in a predetermined manner.