Pericardial Access Device with Adjustable Piercing Depth

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Solution Overview

Problem

Current methods for accessing the pericardial space through the pericardium are challenging, especially for inexperienced physicians, as they rely on tactile feedback to avoid puncturing the heart, and conventional needles can accidentally advance into the myocardium, posing a risk of damage.

Innovation Solution

The development of access devices featuring a piercing member with a proximal shoulder and a distal contact surface, where the piercing member extends a controlled distance beyond the contact surface, engaging the pericardium to minimize the risk of myocardial puncture, and optionally includes a guide wire for further access, with adjustable mechanisms to enhance precision.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional needles are used to access the pericardium, then direct access to the pericardial space is achieved, but the risk of accidentally puncturing the heart increases

Engineering Contradiction:

Improvesafety of pericardial accessVSAvoidrisk of myocardial puncture

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The pericardium is grasped or suctioned before puncture to stabilize it and create a safe access path. This preliminary action allows the physician to tent the pericardium forward, ensuring that the needle will pierce the pericardium rather than the heart, thereby reducing the risk of myocardial damage while maintaining direct access to the pericardial space

Inventive Principle:

Principle #10Preliminary action

2Ease of operation

If tactile feedback is used to advance the needle, then the physician can accommodate heart displacement, but inexperienced physicians may accidentally advance the needle into the heart

Engineering Contradiction:

Improveability to accommodate heart movementVSAvoidsafety for inexperienced operators

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

A specialized access device with a needle, hub, and flange acts as an intermediary system that combines tactile feedback capability with built-in safety features. The device allows experienced physicians to maintain tactile control for accommodating heart movement while providing structural safeguards that prevent inexperienced physicians from accidentally penetrating the myocardium, thus resolving the contradiction between operational ease and safety reliability

Inventive Principle:

Principle #24Intermediary (Mediator)

3Ease of operation

If the piercing member extends beyond the contact surface, then direct access to pericardial space is enabled, but the risk of heart puncture increases

Engineering Contradiction:

Improveaccess to pericardial spaceVSAvoidrisk of myocardial damage

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The access device features a needle with a hub and flange structure where different parts have different functions. The needle tip extends beyond the contact surface to enable pericardial penetration, while the hub and flange provide a larger contact surface that distributes force and prevents excessive advancement. This local differentiation of function allows direct access while minimizing the risk of heart puncture

Inventive Principle:

Principle #3Local quality

Data Source

PatentUS9339295B2Pericardial access devices and methods

Publication Date: 2016.05.17 SENTREHEART LLC

AI summary

Described here are devices and methods for accessing the pericardial space. The access devices may include a piercing member such as a needle and a proximal shoulder having a contact surface for contacting the pericardium as the piercing member pierces the pericardium. In some instances, the distance between the piercing member and the proximal shoulder may be adjustable.