Collapsible Biologic Construct Delivery System for Arthroscopic Joint Surgery
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Solution Overview
Problem
Current delivery instrumentation for biologic constructs in arthroscopic surgery is inadequate, often causing damage to fragile implants during insertion and complicating suture management, leading to increased costs and procedural risks.
Innovation Solution
A system comprising a frame for preparing the graft outside the body, a fluid-tight seal system for passing large, soft constructs without damage, a means for deploying and orienting the construct within the body, and a suture management system, including a 'kite' graft repair and delivery system with a collapsible frame and clamps, a 'coin purse' cannula for passing larger objects, and a sphincter seal for preventing fluid leakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional delivery instrumentation is used to pass biologic constructs, then the procedure can be performed with standard equipment, but the fragile implant is damaged or torn during insertion
Solution Approach 1:
The biologic construct is nested within a protective delivery device that includes an inner shaft and outer sheath. The construct is loaded into the inner shaft, which is then inserted through the outer sheath and into the joint space, protecting the fragile implant throughout the delivery process.
Solution Approach 2:
A fluid seal acts as an intermediary between the delivery instrumentation and the biologic construct. The seal allows sutures and instruments to pass through while maintaining fluid-tight closure and protecting the construct from mechanical damage during insertion.
2Reliability
If fluid-tight seals are used to maintain joint fluid pressure, then fluid leakage is prevented, but sutures and biologic constructs cannot pass through the seal
Solution Approach 1:
The fluid seal is designed with dynamic characteristics that allow it to transition between a closed fluid-tight state and an open state that accommodates passage of sutures and instruments. The seal can be temporarily opened to allow construct insertion, then closed to maintain fluid pressure during the procedure.
Solution Approach 2:
The delivery system is segmented into multiple components including an inner shaft, outer sheath, and fluid seal that can independently function. The inner shaft can pass through the fluid seal while the outer sheath maintains the seal, allowing both fluid-tight closure and instrument passage.
3Ease of operation
If biologic constructs are hand-held with hemostats during preparation, then the implant can be manipulated outside the body, but suture management becomes difficult and time-consuming
Solution Approach 1:
The delivery device combines multiple functions including construct holding, suture management, and implant delivery into a single integrated system. Sutures are attached to the construct while it is secured in the delivery device, allowing simultaneous management of both the implant and sutures without requiring separate hemostats.
Solution Approach 2:
The delivery device serves multiple purposes: it holds the biologic construct during preparation, manages sutures during attachment, protects the construct during insertion, and facilitates deployment within the joint space. This multi-functional design eliminates the need for multiple separate instruments.
4Adaptability or versatility
If large biologic constructs are inserted through standard cannulas, then the procedure can be performed with conventional equipment, but the construct is damaged or cannot be passed through the cannula
Solution Approach 1:
The large biologic construct is nested within a collapsible delivery frame that fits through standard arthroscopic cannulas. The frame collapses to a compact size for insertion through the cannula, then expands within the joint space to support and deploy the construct.
Solution Approach 2:
The delivery frame is designed to dynamically change from a collapsed low-profile configuration for cannula passage to an expanded configuration that supports the large biologic construct within the joint space. This dynamic transformation allows compatibility with standard equipment while accommodating large implants.
Data Source
AI summary
Methods and devices for prepping and delivering a biologic construct repair for shoulder and joint surgery into an arthroscopic workspace.