Slidable Fixation Device for Leadless Medical Implant
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Solution Overview
Problem
Existing medical implant delivery systems face challenges in securely fixing leadless implants to heart tissue, particularly due to the difficulty in testing implantation sites and repositioning without causing injury, as the anchoring structure deployment can be injurious and limits pre-deployment site evaluation.
Innovation Solution
A percutaneous delivery system with a slidable fixation device featuring an annular collar and self-expanding tines that are constrained during delivery and deploy to securely engage heart tissue, allowing for pre-deployment site testing and easy repositioning, utilizing a shape memory material like nitinol for the tines.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a distal anchoring structure is deployed to secure the implant, then fixation reliability is improved, but the ability to test implantation site and reposition is lost
Solution Approach 1:
The fixation device is segmented into multiple independent tines that can be deployed individually or in sequence. This allows partial deployment for testing while maintaining the option for complete fixation if needed, resolving the contradiction between reliable fixation and flexibility for site testing.
Solution Approach 2:
The delivery system allows preliminary testing of the implantation site with the electrode before deploying the anchoring tines. This preliminary action enables verification of proper positioning and electrical contact while the implant remains movable, after which full fixation is achieved by deploying the tines.
2Ease of operation
If a rigid delivery sheath is used to deliver the implant, then delivery control is improved, but tissue injury risk increases
Solution Approach 1:
The delivery sheath transitions from a rigid structure during delivery to a flexible state during implantation. The sheath may include compliant materials or mechanisms that allow it to flex and conform to tissue contours, reducing scraping and injury risks while maintaining delivery control.
Solution Approach 2:
The delivery sheath properties change dynamically during the procedure - rigid during delivery for control, then becoming more flexible or retractable during implantation to reduce tissue injury. This dynamic adaptation resolves the contradiction between delivery control and tissue safety.
3Object-affected harmful factors
If the anchoring structure is housed within the delivery sheath, then patient safety during delivery is improved, but deployment complexity increases
Solution Approach 1:
The anchoring tines are nested within the delivery sheath in a compact configuration during delivery, protecting them and the patient. During deployment, the tines are released in a controlled sequence from the nested state, allowing safe delivery while managing deployment complexity through systematic release mechanisms.
Solution Approach 2:
The anchoring structure is extracted from the delivery sheath in a controlled manner during deployment. This separation allows the anchoring elements to be released while the sheath remains in place or is slowly retracted, managing the complexity of the deployment process while maintaining patient safety.
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
The system enables secure fixation of medical implants to heart tissue while allowing for pre-deployment site testing and easy repositioning, reducing the risk of injury and ensuring optimal implant placement.
Implementation Method 1
utilizing a shape memory material like nitinol for the tines
Implementation Method 2
as the tines penetrate or otherwise engage body tissue they tend to splay outwardly from the medical implant and curve backwards toward the collar
Data Source
AI summary
A fixation device for retaining a leadless medical implant to tissue includes an array of elongate tines having self-expanding distal portions. The fixation tines may be advanced between an implant body and an outer jacket to deploy the tines from a delivery configuration in which the tines are constrained by the outer jacket to an expanded configuration in which the distal end portions of the tines are released from the outer jacket. The implant and fixation device are contained within a sheath for delivery to the treatment site and a pusher within the sheath advances the fixation device relative to the implant body and deploys the tines. A distal end of the implant having an electrode may form a distal tip of the delivery system, and a potential implantation site may be tested prior to deployment of the fixation device to allow for easy repositioning of the implant.