Implantable Lead Fastener Lumen for Balloon Inflation Access
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Solution Overview
Problem
Existing implantable medical devices face challenges in inflating a balloon of an implantable medical lead during implantation due to lack of fluid communication features or difficulty accessing the inflation lumen, which can prolong surgery time and complicate the implantation process.
Innovation Solution
The system includes a fastener lumen that provides fluid communication between a pump and the inflation lumen of the implantable medical lead, allowing the balloon to be inflated while the lead is connected to the medical device, using a fastener to engage the lead within the device's housing and facilitate easy access to the inflation medium.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional implantable medical devices with metallic housings are used, then mechanical strength and hermetic sealing are improved, but the ability to inflate the balloon during implantation is worsened due to lack of fluid communication features
Solution Approach 1:
The fastener lumen is nested within the fastener structure itself, which is integrated into the housing. This nested design allows the inflation medium to travel through the fastener's internal pathway to reach the lead lumen and inflate the balloon, maintaining hermetic sealing while enabling balloon inflation during implantation.
Solution Approach 2:
The fastener lumen acts as an intermediary fluid pathway between the external pump and the lead lumen. It mediates the transfer of inflation medium through the housing structure without compromising the hermetic seal, allowing the balloon to be inflated while the lead is connected to the device.
2Reliability
If the lead is connected to the medical device during implantation, then electrical therapy delivery is improved, but balloon inflation becomes difficult due to lack of access to the inflation lumen
Solution Approach 1:
The fastener serves multiple functions: it mechanically secures the lead to the housing and simultaneously provides a fluid communication pathway (fastener lumen) for balloon inflation. This multi-functionality eliminates the need for separate access mechanisms, allowing both lead connection and balloon inflation to occur during the same implantation procedure.
Solution Approach 2:
The fastener lumen is pre-configured within the fastener structure before implantation. This preliminary design allows the surgeon to inflate the balloon immediately after securing the lead, without needing to perform additional steps to access the inflation lumen, thereby reducing overall surgery time.
3Ease of manufacture
If a polymeric enclosure is used instead of metallic, then ease of manufacture and hermetic sealing are improved, but structural strength may be reduced
Solution Approach 1:
The housing is constructed from polymeric materials that provide both ease of manufacture and adequate structural strength. The polymeric enclosure can be molded as a single piece with integrated features like the fastener opening and lead lumen, simplifying fabrication while maintaining the mechanical integrity needed to support the fastener and withstand implantation forces.
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
This method enables efficient inflation of the balloon during implantation, reducing surgery time and allowing for real-time monitoring of electrocardiogram signals without additional devices, and ensures hermetic sealing and mechanical integrity.
Implementation Method 1
the fastener lumen is in fluid communication with the lead lumen and the inflation lumen, such that a pump in fluid communication with the fastener lumen inflates the balloon
Data Source
AI summary
A system includes a lead with a balloon, wherein the lead defines an inflation lumen in fluid communication with the balloon. The system further includes an implantable medical device with a housing defining a fastener opening and a lead lumen. The lead lumen is configured to receive a proximal portion of the lead. The system further includes a fastener defining a fastener lumen. The fastener is configured to engage the fastener opening and the proximal portion of the lead to retain the proximal portion within the lead lumen. The fastener lumen is in fluid communication with the lead lumen and the inflation lumen, such that a pump in fluid communication with the fastener lumen inflates the balloon when the proximal portion of the lead is within the lead lumen.