Bioresorbable Hemostatic Pad on Non-Resorbable Scaffold

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Solution Overview

Problem

Current hemostatic devices face challenges in achieving rapid hemostasis, maintaining mechanical stability during surgical procedures, and handling deep wounds effectively, especially in field applications where positioning and tamponade are difficult.

Innovation Solution

A bioresorbable hemostatic pad releasably supported on a non-resorbable scaffold, with a water-soluble adhesive for secure attachment and easy release upon contact with body fluids, providing improved handling and adherence to wounds while allowing the scaffold to be removed after initial tamponade.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a bioresorbable hemostatic pad is used alone without a scaffold, then the hemostatic agent can be applied directly to the wound, but the device lacks mechanical stability and is difficult to position and maintain during surgical procedures

Engineering Contradiction:

Improveease of applicationVSAvoidmechanical stability

Core Design Contradiction:

Ease of operationVSStrength

Solution Approach 1:

A non-resorbable scaffold is introduced as an intermediary support structure that provides mechanical stability during the surgical procedure. The scaffold temporarily holds the hemostatic pad in position and can be removed after the hemostatic agent has been delivered, solving the contradiction between ease of application and mechanical stability

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The device is segmented into two functional components: a resorbable hemostatic pad for delivering the therapeutic agent and a non-resorbable scaffold for providing mechanical support. This segmentation allows each component to optimize its specific function while working together

Inventive Principle:

Principle #1Segmentation

2Strength

If a non-resorbable scaffold is used to support the hemostatic pad, then mechanical stability is improved, but the scaffold must be removed after use adding procedural steps

Engineering Contradiction:

Improvemechanical stabilityVSAvoidprocedural complexity

Core Design Contradiction:

StrengthVSDevice complexity

Solution Approach 1:

The non-resorbable scaffold is designed as a disposable, temporary support structure that is discarded after use. This approach accepts the added procedural step of removal as a trade-off for achieving the necessary mechanical stability during the critical hemostatic phase

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

3Stability of the object's composition

If the hemostatic pad is firmly attached to the scaffold, then the pad stays in place during application, but the pad cannot be released after achieving hemostasis

Engineering Contradiction:

Improveattachment stabilityVSAvoidrelease capability

Core Design Contradiction:

Stability of the object's compositionVSEase of operation

Solution Approach 1:

The attachment mechanism transitions from a static firm bond to a dynamic releasable connection. The adhesive or mechanical attachment allows the pad to be securely held during application and delivery, then enables release after hemostasis is achieved, adapting to different procedural phases

Inventive Principle:

Principle #15Dynamics

4Loss of time

If current hemostatic products are used, then hemostasis can be achieved in 4-10 minutes, but blood loss continues during this time and handling characteristics are poor

Engineering Contradiction:

Improvetime to achieve hemostasisVSAvoidhandling characteristics

Core Design Contradiction:

Loss of timeVSEase of operation

Solution Approach 1:

The scaffold provides preliminary structural support and positioning capability before the hemostatic action begins. This preliminary mechanical stabilization allows for better handling during application and maintains device integrity throughout the 4-10 minute hemostatic process, reducing blood loss while improving operator control

Inventive Principle:

Principle #10Preliminary action

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 enables faster hemostasis, improved mechanical stability, and ease of application in deep wounds, ensuring the hemostatic pad remains in place without the scaffold, reducing blood loss and simplifying surgical procedures.

Implementation Method 1

a water-soluble adhesive for secure attachment and easy release upon contact with body fluids

Methodology Applied

Scientific EffectAdhesion: Adhesive

Data Source

PatentUS11254061B2Scaffolds for implanting absorbable hemostats in field conditions

Publication Date: 2022.02.22 ETHICON INC

AI summary

The present invention relates generally to agents and devices for promoting hemostasis and, more particularly, to bioresorbable hemostatic pads or patches releasably supported on non-resorbable scaffolds for ease of delivery in the field. A sealant and/or hemostat delivery device comprises a resorbable hemostatic pad having a wound facing side and an opposite back side, with a hemostatic and/or wound sealing agent disposed on the wound facing side; a non-resorbable scaffold having an attachment zone on said scaffold; wherein said hemostatic pad is releasably attached with the back side to the attachment zone. The bond between the scaffold and the resorbable hemostatic pad or wound dressing is either (i) severed prior to removal of the scaffold or (ii) is weakened due to the adhesive bonding them together being moisture-deactivated, or (iii) is released by mechanical disentanglement.