Sheath Splitting Structure for Controlled Off-Pump Device Deployment
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Solution Overview
Problem
Existing vascular surgery procedures, such as on-pump and hybrid repairs, are associated with high mortality, morbidity, and complications, and off-pump procedures face challenges with access for endovascular devices, particularly in patients with connective tissue disorders.
Innovation Solution
A sheath splitting apparatus with movable arm members and guide elements that facilitate the deployment of medical devices off-pump by splitting the sheath material into two tails, using resilient and hingeable arm members to control the sheath removal process, minimizing blood loss and device damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If off-pump procedure is performed to reduce mortality and complications, then patient outcomes are improved, but access for endovascular device becomes problematic
Solution Approach 1:
The sheath is divided into multiple segments or tails that can be independently manipulated. The sheath splitting apparatus separates the single sheath into multiple smaller sheath tails, allowing each to be managed separately during off-pump deployment, thus improving access while maintaining the benefits of off-pump procedure
Solution Approach 2:
The apparatus employs movable arm members that can dynamically adjust their position and configuration during the procedure. The arms can move between retracted and extended positions, and between closed and open configurations, adapting to different stages of device deployment and sheath removal
2Ease of operation
If movable arm members are used to facilitate sheath splitting, then sheath removal control is improved, but device complexity increases
Solution Approach 1:
The arm members are designed with self-actuating capabilities through resilient material properties. The arms automatically deflect inward under the action of sheath material being pulled, utilizing the force of sheath removal itself to drive the splitting action, rather than requiring separate actuation mechanisms
Solution Approach 2:
The arm members are made of resiliently deformable material that changes its physical state based on applied forces. The material transitions from a flexible state during sheath removal to a more rigid state when supporting the deployed device, adapting its mechanical properties to different procedural phases
3Reliability
If arm members are positioned radially outwardly to accommodate device expansion, then device deployment safety is improved, but blood loss risk increases
Solution Approach 1:
The arm members are pre-configured with outwardly splayed profiles at their proximal ends that anticipate and accommodate the radial expansion of the device. This preliminary configuration prevents the arms from interfering with device expansion while minimizing gaps that could allow blood loss
Solution Approach 2:
The arm members serve as intermediary structures between the sheath splitting function and the device support function. Their outwardly splayed profiles act as a buffer zone that accommodates device expansion while maintaining control over the sheath tails, preventing both device damage and excessive blood loss
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
Enables off-pump deployment of medical devices with reduced blood loss and device damage, allowing for controlled expansion and minimization of complications.
Implementation Method 1
at least a section of each arm member is formed of resiliently deformable material... each arm member is configured to deflect radially inwardly under the action of sheath material being pulled along the sheath pathway
Implementation Method 2
allowing blood flow through the medical device, the blood flow forcing the or each arm to deflect radially outwardly
Data Source
AI summary
The present invention concerns a sheath splitting apparatus for use with a medical device delivery system for deploying a sheathed medical device. The sheath splitting apparatus comprising: a body 3 having a medical device pathway 11 for receiving a medical device, and one or more arm members having one or more guide elements 12 defining a sheath pathway for guiding sheath material removed from the sheathed medical device. At least a section of the one or more arm members is movable towards and away from the longitudinal axis of the medical device pathway.