Tethering Assemblies for Implantable Medical Devices
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Solution Overview
Problem
The existing methods for securing compact implantable medical devices to delivery catheters are cumbersome and require tedious looping and threading of tethering members, which can be time-consuming and may not be suitable for separate packaging considerations.
Innovation Solution
A delivery system with an elongate tool and tethering member that includes a distal coupling feature and a retainer, allowing for a pull force to be applied to draw the tethering member into the catheter's lumen, securing the device and facilitating easier loading and positioning during implant procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional looping and threading methods are used to secure the device to the catheter, then the device can be securely fixed, but the process becomes tedious and time-consuming
Solution Approach 1:
The tethering member is pre-attached to the device holding member in a factory-prepared assembly, so that the operator receives a ready-to-use unit. This preliminary attachment eliminates the need for the operator to perform tedious looping and threading procedures during the implant procedure, significantly reducing procedural time while maintaining secure device fixation.
2Reliability
If the device is packaged separately from the catheter for shelf life considerations, then storage and sterilization are improved, but the ease of loading the device into the catheter is reduced
Solution Approach 1:
The patent combines the device, tethering member, and catheter into a single integrated assembly where the tethering member is pre-attached to the device holding member. This merging allows the device to be packaged separately for sterilization and shelf life, while the pre-established tethering connection simplifies the loading process during implantation, as the operator only needs to engage the pre-prepared assembly rather than performing complex tethering maneuvers.
Data Source
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Figure 3A
AI summary
A delivery system for an implantable medical device includes a tool and a tethering member extending side-by-side within an inner shaft thereof; the tool extends within a first lumen, being in sliding engagement therein, and includes a distal end coupling feature that protrudes from a distal end of the inner shaft; and the tethering member has a first segment extending within a second lumen, and a second segment extending from the first segment and distally from the distal end of the inner shaft to an end of the tethering member, which is configured to engage with a holding member of the device, and with which the coupling feature of the tool is configured to couple. A retainer may be joined to another end of the tethering member that protrudes from a proximal port of the system.