Nested Pericardial Access Needle System for Safe Puncture
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Solution Overview
Problem
Current methods for accessing the pericardial space through the pericardium are challenging, particularly for inexperienced users, as they require precise puncture of the pericardium without damaging the heart, and existing needles are either too flexible or risk puncturing the heart due to their size and rigidity.
Innovation Solution
The development of access devices comprising concentrically arranged elongate members with a locking mechanism, where a smaller inner needle is advanced through a larger outer member to pierce the pericardium, minimizing the risk of heart damage and allowing for the introduction of a guide wire for further device placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a smaller diameter needle is used to access the pericardial space, then the risk of puncturing the heart is decreased, but the needle becomes more flexible and difficult to steer
Solution Approach 1:
The patent employs a nested configuration where an inner needle (smaller diameter) is positioned within an outer needle (larger diameter). The inner needle provides the piercing function with reduced heart puncture risk, while the outer needle provides structural support and steerability. The outer needle acts as a protective sheath that guides the inner needle to the target site.
Solution Approach 2:
The needle system is divided into separate functional segments: an inner needle for piercing and a outer needle for support and steering. This segmentation allows each component to be optimized independently - the inner needle can be thin and flexible for safety, while the outer needle can be stiffer for controllability.
2Ease of operation
If a larger diameter needle is used to access the pericardial space, then the needle is more rigid and easier to steer, but the risk of puncturing the heart increases
Solution Approach 1:
The outer needle with larger diameter is nested within the handling system, providing the necessary rigidity and steerability during advancement. However, the actual piercing is performed by the inner needle that extends beyond the outer needle tip, ensuring that the heart-piercing function is separated from the steering function.
Solution Approach 2:
The outer needle serves as an intermediary element that facilitates the delivery of the inner needle to the target site. It provides the mechanical support needed for steering and positioning, while the inner needle performs the actual tissue penetration with minimal risk.
3Object-affected harmful factors
If a smaller needle is used to access the pericardial space, then the risk of puncturing the heart is decreased, but the ability to advance a guide wire and treatment device is limited
Solution Approach 1:
The nested needle configuration creates a delivery system where the inner needle can be advanced through the outer needle to create the initial access channel. After piercing, the inner needle and outer needle can be withdrawn together, leaving a tract through which guide wires and treatment devices can be advanced, combining the safety of a small piercing needle with the capability to deliver larger devices.
Solution Approach 2:
The inner needle performs the preliminary action of piercing the pericardium with minimal trauma. Once the puncture is established, the needle system is withdrawn and larger guide wires and devices can be introduced through the created tract, separating the piercing function from the device delivery function.
4Reliability
If conventional needles are used with tactile feedback, then experienced users can avoid puncturing the heart, but inexperienced users may accidentally advance the needle into the heart
Solution Approach 1:
The nested needle design provides inherent safety through its structure. The inner needle is contained within the outer needle during advancement, providing visual and tactile confirmation of proper positioning. The outer needle acts as a protective barrier that prevents inadvertent deep penetration by the inner needle, reducing reliance on operator experience.
Data Source
AI summary
Described here are devices, systems, and methods for accessing the pericardial space through the pericardium. The access devices may include a plurality of elongate members having lumens that may be advanced together through the body to the pericardium. The elongate members may have different lengths and may be slideably positioned one within the lumen of another. At least one of the elongate members may comprise a distal tip configured to pierce tissue. In some instances, the access devices may also comprise a locking member to constrain the position of one elongate member relative to another.