Reorientable Puncture Needle With Tissue Expansion for TIPS Access
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
The creation of a TIPS shunt in patients with liver cirrhosis is often complicated due to difficulties in puncturing the portal vein on the first attempt, requiring multiple needle withdrawals and manual bending, which is time-consuming and risky, especially in congested diseased liver tissue with limited visualization.
Innovation Solution
A puncture device with a flexible sheath and tissue expansion means, such as a shape memory alloy or balloon, allows for reorientation of the puncture needle by expanding tissue to create space for repositioning without complete withdrawal, using a heating mechanism to activate the expansion means.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the puncture needle is withdrawn and manually bent for reorientation, then the needle can be repositioned for another puncture attempt, but the procedure time increases and the risk of surgeon injury increases
Solution Approach 1:
The puncture needle is designed with a dynamic reorientation mechanism that allows it to change its bending angle and direction while remaining inside the patient's vasculature. The needle includes a reorientation section with a first segment and a second segment that can be rotated relative to each other, enabling the needle tip to be repositioned without withdrawing the needle from the body.
Solution Approach 2:
A reorientation tool is introduced as an intermediary device to facilitate the reorientation of the puncture needle. The reorientation tool engages with the reorientation section of the needle and applies rotational force to change the needle's orientation. This intermediary mechanism allows precise control of needle repositioning without requiring manual manipulation outside the body.
2Ease of operation
If the puncture needle is completely withdrawn from the vasculature for reshaping, then the needle can be manually bent, but the risk of pathogen exposure to the surgeon increases
Solution Approach 1:
The puncture needle incorporates a dynamic reorientation section that enables bending and angle adjustment while the needle remains inside the patient's vasculature. This eliminates the need to withdraw the needle for reshaping, thereby keeping the needle tip contained within the sterile field and reducing the surgeon's exposure to blood-borne pathogens.
Solution Approach 2:
The manual mechanical bending process is replaced with a controlled reorientation mechanism that can be actuated through the sheath or with a reorientation tool. This substitution eliminates the need for the surgeon to manually handle and bend the needle outside the body, reducing direct contact with potential pathogens while maintaining the ability to reposition the needle tip.
3Ease of operation
If the puncture needle is rotated inside the congested liver tissue, then the needle orientation can be changed, but the rotation becomes difficult or impossible due to lack of space
Solution Approach 1:
The needle design includes a reorientation section with segments that can rotate relative to each other within a compact configuration. This dynamic structure allows the needle to change orientation without requiring large rotational movements in the congested tissue, as the reorientation occurs through segmental rotation rather than full needle rotation.
Solution Approach 2:
The puncture needle is divided into multiple segments including a first segment and a second segment connected at a reorientation section. This segmentation allows independent rotation of the second segment relative to the first, enabling orientation changes without requiring the entire needle to rotate within the congested liver tissue, thereby overcoming the space limitation.
4Productivity
If multiple puncture attempts are made without reorientation capability, then the procedure can be completed, but the number of needle withdrawals increases significantly
Solution Approach 1:
The puncture needle incorporates a dynamic reorientation mechanism that allows the needle tip to be repositioned by rotating the second segment relative to the first segment while the needle remains in place. This dynamic capability enables multiple puncture attempts to be made from a single insertion point, reducing the need for repeated needle withdrawals and improving procedural efficiency.
Solution Approach 2:
The puncture needle is designed with multi-functionality, serving both as a puncture instrument and as a repositionable tool. The reorientation section and segmented structure allow the same needle to perform multiple puncture attempts at different angles without requiring replacement or withdrawal, thereby improving productivity without proportionally increasing device complexity.
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
Reduces the number of needle withdrawals and minimizes the risk of injury by enabling reorientation of the puncture needle within the patient's vasculature, thus reducing procedure time and enhancing safety.
Implementation Method 1
the tissue expansion means comprises a shape memory alloy, wherein the shape memory alloy has a threshold temperature above which the shape memory alloy expands when heated
Implementation Method 2
the shape memory alloy has a threshold temperature above which the shape memory alloy expands when heated
Implementation Method 3
using a heating mechanism to activate the expansion means
Data Source
AI summary
The present invention relates to a puncture device that is arranged for being advanced to a puncture site through the human vasculature, the puncture device comprising: a puncture means, the puncture means comprising a distal end that is arranged for creating a puncture in a patient's tissue, a sheath, the sheath being arranged so as to surround the puncture means, the puncture means being slidably arranged inside the sheath, a tissue expansion means, the tissue expansion means being arranged so that it can be selectively activated, wherein in the activated state, the tissue expansion means pushes away the patient's tissue to thereby allow a re-orientation of the puncture means.