Sub-sternal Tunneling Tool for Extravascular Lead Implantation
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Solution Overview
Problem
Existing methods for accessing extravascular spaces, such as the sub-sternal space, are challenging due to the risk of injuring sub-sternal structures or the chest cavity, especially when vascular access is difficult or when transvenous leads become fibrosed, making lead revision and extraction procedures complicated.
Innovation Solution
The development of specialized tools with a straight guide member and a tunneling member, biased towards each other, which are used to create a sub-sternal tunnel by controlling the angle of entry and advancement, minimizing the risk of injury and facilitating the placement of medical devices like implantable medical electrical leads.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If transvenous leads are used for cardiac therapy, then vascular access is required, but this becomes difficult when vascular access is limited or leads become fibrosed
Solution Approach 1:
The access route is divided into two independent segments: a subcutaneous tunnel created by the tunneling tool, and a sub-sternal space created by the retractor system. This segmentation allows each segment to be optimized independently, enabling access to extravascular spaces without requiring difficult vascular access
Solution Approach 2:
The sub-sternal space acts as an intermediary extravascular space between the subcutaneous tissue and the heart. Leads are routed through this intermediate space rather than directly through veins, providing an alternative pathway when vascular access is limited or leads become fibrosed
2Productivity
If direct access to sub-sternal space is attempted, then implantation can be achieved, but risk of injuring sub-sternal structures or chest cavity increases
Solution Approach 1:
The tunneling tool creates a predetermined subcutaneous tunnel and the retractor system creates a controlled sub-sternal space before lead insertion. These preliminary actions establish safe pathways that guide subsequent lead placement, preventing direct trauma to sub-sternal structures and chest cavity organs
Solution Approach 2:
The retractor system introduces an intermediary mechanical structure that maintains controlled access to the sub-sternal space. This intermediary device allows visualization and manipulation within the space while protecting surrounding organs, enabling safe implantation without direct injury risk
3Ease of repair
If lead revision or extraction is performed on fibrosed transvenous leads, then lead replacement is possible, but the procedure becomes challenging
Solution Approach 1:
The extravascular implantation approach using subcutaneous tunnel and sub-sternal space creates a new, non-fibrosing pathway for leads. This alternative route avoids the fibrosis problem that complicates lead revision, effectively providing a disposable-like solution where the access pathway itself can be replaced without complex extraction procedures
Solution Approach 2:
The implantation system is segmented into removable components: the tunneling tool creates a permanent tunnel, the retractor system provides temporary controlled access, and leads are independently implantable. This segmentation simplifies revision procedures compared to integrated transvenous systems, as each component can be addressed separately
Data Source
AI summary
This disclosure provides tools and implant techniques utilizing such tools to gain access to and implant a medical device, such as a medical electrical lead, within extravascular spaces. In one example, this disclosure provides a tool for creating a sub-sternal tunnel in a patient. The tool comprises a relatively straight guide member extending from a first end thereof to a second end thereof, a tunneling member extending from a first end thereof to a tip thereof, the tunneling member extending alongside and coplanar with the guide member, the first end of the tunneling member and the first end of the guide member being joined together, and a handle coupled to the guide member.