Soft Tissue Access Support Device for Minimally Invasive Pericardial Entry
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Solution Overview
Problem
Accessing soft tissue compartments, such as the pericardial cavity, often requires puncturing and inserting devices, which can cause trauma and lead to bleeding or fluid drainage, necessitating hemostasis.
Innovation Solution
A soft tissue access support device comprising an elongated body with a sealing member and a support tube with a securement member, allowing for minimally invasive access and secure engagement with soft tissue surfaces to reduce trauma and bleeding.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If puncturing and inserting devices through soft tissue is performed, then access to soft tissue compartments is achieved, but trauma to the punctured tissue occurs requiring hemostasis
Solution Approach 1:
The device creates a controlled access opening through the soft tissue using a puncture element, and then immediately deploys a support tube with securement members to stabilize the tissue and prevent trauma before subsequent device manipulation occurs. This preliminary stabilization action prevents the need for additional hemostasis measures.
Solution Approach 2:
The support tube acts as an intermediary structure between the access opening and the internal cavity. It provides mechanical support and stabilization to the punctured tissue, creating a protected pathway that reduces trauma during device manipulation while maintaining access to the target compartment.
2Productivity
If conventional puncture and insertion methods are used, then device access is achieved, but additional hemostasis measures are required
Solution Approach 1:
The device combines the puncture element, support tube, securement members, and sealing members into a single integrated access device. This merging of functions allows simultaneous achievement of access creation and tissue stabilization, eliminating the need for separate hemostasis measures and reducing overall procedure complexity.
Solution Approach 2:
The access device performs multiple functions: creating the access opening, stabilizing the punctured tissue, preventing fluid leakage, and providing support for subsequent device manipulation. This multi-functionality eliminates the need for multiple separate devices and procedures, improving productivity while reducing complexity.
3Adaptability or versatility
If device manipulation occurs after puncturing tissue, then procedural tasks are completed, but trauma to the punctured tissue increases
Solution Approach 1:
The support tube is deployed and secured to the tissue immediately after puncture, creating a stabilized access pathway before any subsequent device manipulation occurs. This preliminary stabilization prevents trauma during the manipulation phase while maintaining full procedural flexibility.
Solution Approach 2:
The support tube serves as a protective intermediary that allows device manipulation to occur through the access opening without directly traumatizing the punctured tissue. The securement members anchor the support tube to the tissue, creating a stable foundation that isolates the manipulation activities from the vulnerable puncture site.
Data Source
AI summary
Disclosed are various devices and methods for providing tissue access support. One exemplary device embodiment includes an elongated body having distal and proximal ends and extending along a longitudinal axis and defining a first lumen therein. A sealing member is coupled adjacent to the distal end of the elongated body and structured to seal to a first surface of a pericardial tissue. A support tube is provided having distal and proximal ends and extending along a longitudinal axis and defining a second lumen therein, wherein the support tube is slidably arranged in the lumen of the elongated body between first and second sliding positions. A securement member is coupled to the support tube and structured to engage at least a second opposing surface of the pericardial tissue. A guidewire is positioned in the second lumen of the support tube and includes a puncturing tip shaped to penetrate pericardial tissue.