Cannula Delivery Catheter with Expandable Element

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Solution Overview

Problem

Current medical device delivery systems face challenges in safely and efficiently navigating through the vasculature due to size and rigidity issues, often causing damage and complications during access to the left atrium of the heart, with no simple and safe method to move these systems without causing tissue injury.

Innovation Solution

A medical device comprising an elongate body with an expandable element, such as a balloon, and a coaxial cannula, designed to provide support and flexibility for transseptal access, where the cannula's outer diameter is equal to or less than the expandable element's when inflated, allowing for safe and efficient navigation through the body.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the medical device delivery system is introduced into the vasculature, then access to the left atrium can be obtained, but the device may cause tissue damage, plaque dislodgement, or vascular puncture due to size and rigidity issues

Engineering Contradiction:
Improvesafe access to left atriumVSAvoidtissue damage and vascular injury
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The device is divided into separate components including an introducer catheter, expandable element, and cannula that can be sequentially deployed. This segmentation allows each component to perform its specific function while minimizing overall trauma to the vasculature during the step-by-step access procedure.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The expandable element is inflated beforehand to create a pilot opening in the septum before the cannula is advanced. This preliminary action prepares the path for the cannula, allowing it to pass through the septum without requiring excessive force that would cause tissue damage.

Inventive Principle:
Principle #10Preliminary action

2Ease of operation

If the medical device delivery system and cannula are separately introduced into the vasculature, then access can be achieved, but the devices can get stuck or cause plaque to come off the walls

Engineering Contradiction:
Improveseparate introduction of devicesVSAvoidplaque dislodgement and device entrapment
Core Design Contradiction:
Ease of operationVSObject-generated harmful factors

Solution Approach 1:

The cannula is nested within the expandable element during introduction. The expandable element acts as a protective sheath that guides the cannula through the vasculature and septum, preventing the cannula from contacting vascular walls and causing plaque dislodgement.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The expandable element serves as an intermediary between the introducer catheter and the cannula. It is inflated to create a stable passage and guide the cannula through the septum, mediating the interaction between the delivery system and the vascular tissue to prevent harmful effects.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If the medical device delivery system makes a hole in the septum larger than the cannula, then access to the left atrium is achieved, but it creates difficulties when trying to fixate the cannula into the septum

Engineering Contradiction:
Improveaccess to left atriumVSAvoidcannula fixiation
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The expandable element can be dynamically adjusted in size. It is inflated to a larger diameter to create access through the septum, then deflated to a smaller diameter that matches the cannula size, allowing the cannula to be properly fixated within the septal opening without excessive tissue disruption.

Inventive Principle:
Principle #15Dynamics

4Reliability

If various delivery tools are used to access the left atrium, then the procedure can be performed, but it takes a significant amount of time to clean and prepare the tools

Engineering Contradiction:
Improveleft atrium access procedureVSAvoidtool preparation time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

Multiple functions are merged into a single integrated device system. The introducer catheter, expandable element, and cannula work together as one coordinated system, eliminating the need for separate tool preparation and reducing the overall time required for the procedure.

Inventive Principle:
Principle #5Merging (Combining)

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

The device enables safe and efficient access to the left atrium by providing the necessary support and flexibility to avoid tissue damage, allowing for precise placement of the cannula without causing injury, thereby improving the safety and efficacy of cardiac treatment procedures.

Implementation Method 1

an expandable element being coupled to the distal portion of the elongate body and in fluid communication with the lumen, the expandable element defining a first end and a second end

Methodology Applied
Scientific EffectElastic expansion: Elasticity

Data Source

PatentUS11559669B2Cannula delivery catheter and procedure method
Publication Date: 2023.01.24 BOSTON SCIENTIFIC SCIMED INC
  • US11559669B2 patent drawing
  • US11559669B2 patent drawing
  • US11559669B2 patent drawing

AI summary

The medical device may comprise an elongate body having a proximal portion, a distal portion, and defining a lumen therethrough. Also, the medical device may include an expandable element coupled to the distal portion of the elongate body and in fluid communication with the lumen. The expandable element may define a first end and a second end, the second end being proximal to the first end. The medical device may further include a cannula surrounding at least a portion of the elongate body and the cannula may define a proximal end and a distal end. The distal end of the cannula may be disposed proximal and adjacent to the second end of the expandable element. An outer dimctcr diameter of the cannula may be substantially equal to or lesser than an outer diameter of the expandable element when inflated. The medical device may be maneuvered through a patient's body.