Radial Artery Sheath Retention via Inflatable Cuff and Ring

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Solution Overview

Problem

Existing artery sheath devices fail to securely retain a radial artery sheath during cardiac catheterization procedures, leading to potential dislodgment and bleeding complications, especially when multiple catheters are inserted or removed.

Innovation Solution

A wearable inflatable cuff with a removably attachable inflatable ring that secures the radial sheath in place, using a lock mechanism to ensure the sheath remains inserted and applies pressure to prevent bleeding upon removal.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a radial artery sheath device is used during cardiac catheterization procedures, then the sheath can be inserted into the radial artery for catheter access, but the sheath may become dislodged or migrate from the incision site during multiple catheter insertions and removals

Engineering Contradiction:
Improvesheath retentionVSAvoiddevice structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The device is divided into distinct functional segments: an inflatable cuff for securing the sheath at the incision site, an inflatable ring for retaining the sheath within the incision, and a lock mechanism for attachment. Each segment performs a specific function, allowing the sheath to be securely retained without requiring a monolithic complex structure.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device uses inflatable elements that can be dynamically adjusted during the procedure. The cuff and ring can be inflated to different pressures as needed, providing adaptive retention force that responds to the procedural requirements while maintaining sheath position.

Inventive Principle:
Principle #15Dynamics

2Stability of the object's composition

If the radial sheath is secured tightly in place to prevent dislodgment, then sheath stability is improved, but removal of the sheath becomes difficult and may cause tissue damage

Engineering Contradiction:
Improvesheath position stabilityVSAvoidsheath removal
Core Design Contradiction:
Stability of the object's compositionVSEase of operation

Solution Approach 1:

The inflatable cuff and ring provide dynamic retention that can be easily adjusted. During removal, the inflation pressure is simply reduced and the elements are deflated, allowing the sheath to be withdrawn smoothly without resistance or tissue damage. The same elements that provide strong retention during the procedure become compliant during removal.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The retention force is controlled by changing the inflation pressure parameter. High pressure provides strong retention during the procedure, while low pressure or deflation allows easy removal. This parameter change enables the device to transition between opposing states of strong retention and easy removal.

Inventive Principle:
Principle #35Parameter changes

3Object-generated harmful factors

If compression is applied to the incision site to stop bleeding, then hemostasis is achieved, but the compression may interfere with catheter manipulation and sheath positioning

Engineering Contradiction:
Improvebleeding controlVSAvoidcatheter manipulation
Core Design Contradiction:
Object-generated harmful factorsVSEase of operation

Solution Approach 1:

The compression function is segmented into a separate inflatable cuff that can be independently controlled from the sheath retention elements. This allows compression to be applied at the incision site for hemostasis while the sheath remains accessible through the ring for catheter manipulation, resolving the conflict between bleeding control and procedural access.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Compression is applied locally at the incision site through the cuff, while the sheath passage area through the ring remains open and accessible. This localized application of compression achieves hemostasis without interfering with catheter manipulation and sheath positioning during the procedure.

Inventive Principle:
Principle #3Local quality

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 solution effectively secures the radial sheath during procedures, allowing for multiple catheter insertions and removals without dislodgment, while ensuring hemostasis by applying pressure to the incision site post-procedure.

Implementation Method 1

The cuff is inflatable to compress an incision in the patient's wrist to achieve homeostasis for stopping bleeding

Methodology Applied
Scientific EffectCompression: Compression

Implementation Method 2

The ring is inflatable for compressing the radial sheath in the ring to inhibit the radial sheath from being removed from the incision

Methodology Applied
Scientific EffectCompression: Compression

Data Source

PatentUS11638588B2Radial artery sheath assembly
Publication Date: 2023.05.02 BITAR FAHED
  • US11638588B2 patent drawing
  • US11638588B2 patent drawing
  • US11638588B2 patent drawing

AI summary

A radial artery sheath assembly includes a cuff that is wearable around a patient's wrist and a receiver is integrated into the cuff. The cuff is inflatable to compress an incision in the patient's wrist to achieve homeostasis for stopping bleeding. A ring is removably attachable to the cuff and a radial sheath is extendable through the ring to retain the radial sheath in the incision in the user's wrist when the ring is attached to the cuff. The ring is inflatable for compressing the radial sheath in the ring to inhibit the radial sheath from being removed from the incision. A lock is coupled to the ring and the lock releasably engages the receiver in the cuff for attaching the ring to the cuff.