Split Sheath Dilator for Subcutaneous Implantation
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Solution Overview
Problem
Implanting subcutaneous implantable medical devices, such as implantable loop recorders, is challenging due to difficulties in proper placement, leading to complications like prolonged healing time, suboptimal device performance, and increased risk of infection, especially for less experienced physicians, and often requires expensive equipment like fluoroscopy.
Innovation Solution
A tool comprising a dilator and sheath system that facilitates the creation of a subcutaneous pocket and tunnel for device placement, allowing for minimally invasive implantation with reduced tissue trauma and minimizing the need for fluoroscopy, featuring a dilator with an atraumatic tip and a sheath that splits to accommodate the device, enabling precise placement and easy removal without causing tissue damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If traditional surgical tools (forceps, scissors, or finger) are used to form subcutaneous pocket and tunnel, then the procedure can be performed with simple equipment, but the implantation becomes difficult and time-consuming with increased risk of tissue tearing and bleeding
Solution Approach 1:
The patent introduces a specialized implantation tool as an intermediary device between the surgeon and the implantable device. This tool includes a tunneling element with a cutting tip that mechanically separates tissue to create the subcutaneous pocket and tunnel, and a delivery element that guides the implantable device into position. This intermediary tool simplifies the implantation process by providing structured guidance and automated tissue separation, reducing the skill level required while maintaining equipment simplicity.
Solution Approach 2:
The implantation tool is segmented into distinct functional elements: a tunneling element with cutting tip for creating the pathway, a delivery element for inserting the implantable device, and a retrieval element for removing the tool. This segmentation allows each element to perform its specific function efficiently, making the overall implantation process easier while keeping the equipment relatively simple.
2Quantity of substance
If traditional manual implantation methods are used, then equipment cost is low, but procedure time is extended and risk of infection increases
Solution Approach 1:
The implantation tool performs preliminary actions by automatically creating the subcutaneous pocket and tunnel through mechanical tissue separation before the implantable device is inserted. The cutting tip预先 separates the tissue along the desired pathway, eliminating the need for manual dissection during the actual implantation. This preliminary tissue preparation significantly reduces procedure time while the tool remains relatively inexpensive compared to fluoroscopy equipment.
Solution Approach 2:
The patent employs a rapid insertion technique where the implantable device is pushed through the pre-created tunnel in a single swift motion using the delivery element. This 'rushing through' approach minimizes the time the surgical field remains open and reduces exposure to potential contaminants, thereby shortening procedure time and lowering infection risk without requiring expensive equipment.
3Measurement precision
If fluoroscopy is used to verify antenna positioning, then positioning accuracy is improved, but equipment cost and procedure complexity increase significantly
Solution Approach 1:
The patent replaces the complex fluoroscopy imaging system with a simpler mechanical guidance system. The implantation tool includes visual markers or alignment features on its elements that allow the surgeon to visually verify correct positioning of the implantable device and antenna without requiring expensive imaging equipment. This mechanical/visual substitution maintains adequate positioning accuracy while dramatically reducing equipment complexity and cost.
4Device complexity
If the sheath does not split, then the sheath structure is simpler, but the implantable device cannot be removed or repositioned if needed
Solution Approach 1:
The sheath is designed with a split configuration that allows it to dynamically change from a closed protective structure during insertion to an open structure during device removal or repositioning. The split portions can be separated to release the implantable device while maintaining structural integrity during the implantation process. This dynamic design provides adaptability without requiring overly complex mechanisms, as the split is a simple structural feature rather than a complex actuating system.
Data Source
AI summary
In various examples, an apparatus is configured for subcutaneously inserting an implantable device within a patient. The apparatus includes a dilator portion including a dilator including a dilator length. The dilator portion is configured to separate tissue to create a subcutaneous pocket within the patient sized and shaped to accommodate an implantable device within the subcutaneous pocket. A sheath portion includes a sheath sized and shaped to accommodate the dilator within a sheath lumen. The sheath is configured to accommodate an antenna of the implantable device with the dilator removed from within the sheath. The sheath includes a sheath length that is at least substantially as long as an antenna length. The sheath is configured to separate to allow removal of the sheath around the implantable device to remove the sheath from and leave the implantable device within the subcutaneous pocket within the patient.