Fractional Sublingual Medication Delivery Device

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Solution Overview

Problem

Current sublingual medication delivery methods, such as multi-dose sprayers for nitroglycerin and nifedipine, often result in rapid absorption of full doses, leading to undesirable side effects like syncope and hemodynamic instability, and do not allow for fractional dosing, which is critical in medical emergencies where rapid absorption is needed but may cause severe complications.

Innovation Solution

A medical device that dilutes medications like nitroglycerin and nifedipine into a liquid solution, allowing for fractional dosing over time, reducing the risk of severe side effects by gradual absorption, and includes a cylindrical container with a spray dispenser and medication delivery means for solubilizing tablets or liquid capsules, enabling sublingual administration of therapeutic doses in controlled volumes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Speed

If a full therapeutic dose of medication is administered sublingually at once, then rapid absorption into the bloodstream is achieved, but severe side effects such as syncope and hemodynamic instability occur

Engineering Contradiction:
Improveabsorption speedVSAvoidside effects
Core Design Contradiction:
SpeedVSObject-affected harmful factors

Solution Approach 1:

The patent divides a single therapeutic dose into multiple fractional doses administered sequentially over time. The device includes a multi-chamber container system that holds separate compartments, each containing a fraction of the total dose, allowing controlled sequential administration rather than a single bolus dose.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device incorporates a dynamic dosing mechanism that allows adjustment of administration rate and timing between doses. The system can adapt the dosing schedule based on patient response, enabling flexible control over absorption kinetics to balance therapeutic efficacy with safety.

Inventive Principle:
Principle #15Dynamics

2Ease of operation

If a multi-dose sprayer is used to deliver liquid medication, then convenience of administration is improved, but dose accuracy deteriorates due to volume variation by more than 50%

Engineering Contradiction:
Improveadministration convenienceVSAvoiddose accuracy
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

Instead of using a single multi-dose sprayer with variable dosing, the patent segments the medication into multiple single-use chambers, each pre-filled with an accurate fractional dose. This eliminates the dosing variability inherent in multi-dose sprayers while maintaining ease of administration through the same spray delivery mechanism.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device changes the dosing parameter from variable volume delivery (multi-dose sprayer) to fixed volume delivery (pre-measured chambers). Each chamber is designed to deliver a precise volume, ensuring dose accuracy while maintaining the convenience of spray administration.

Inventive Principle:
Principle #35Parameter changes

3Loss of time

If medication is administered as a single bolus dose, then therapeutic effect is achieved quickly, but safety deteriorates due to rapid full dose absorption

Engineering Contradiction:
Improvetime to therapeutic effectVSAvoidsafety
Core Design Contradiction:
Loss of timeVSReliability

Solution Approach 1:

The patent segments the total therapeutic dose into multiple smaller fractions administered in sequence. This maintains rapid onset of therapy by delivering the first fraction immediately while distributing the remaining dose over time, preventing the safety issues associated with rapid full-dose absorption.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device is pre-loaded with multiple fractional doses before administration begins. This preliminary preparation allows the first dose to be administered immediately for rapid therapeutic effect, while the structured sequence of subsequent doses ensures safe gradual delivery without requiring complex real-time calculations.

Inventive Principle:
Principle #10Preliminary action

4Ease of operation

If a single dose tablet is used for sublingual administration, then simplicity of use is improved, but adaptability deteriorates because the dose cannot be divided into fractions

Engineering Contradiction:
Improvesimplicity of useVSAvoiddosing flexibility
Core Design Contradiction:
Ease of operationVSAdaptability or versatility

Solution Approach 1:

The patent transforms a single tablet into multiple separable fractional doses using a device with multiple chambers. Each chamber can be independently activated, allowing the medication to be divided into fractions while maintaining the simplicity of tablet-form administration and eliminating the need for manual crushing or splitting.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device acts as an intermediary between the single tablet and the patient's sublingual mucosa. It mechanically divides the tablet into fractional portions and controls their sequential delivery, providing dosing flexibility without requiring the patient to perform complex manipulation.

Inventive Principle:
Principle #24Intermediary (Mediator)

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

Enables safe and controlled absorption of medications, reducing the risk of severe drops in blood pressure and syncope by allowing gradual administration of therapeutic doses, thereby improving patient safety in medical emergencies.

Implementation Method 1

a medication delivery means for dissolving a tablet or liquid capsule in the solvent to form a medication solution

Methodology Applied
Scientific EffectDissolution: Solvation

Implementation Method 2

a spray dispenser for sublingual administration of the medication solution in a fraction of a therapeutic dose

Methodology Applied
Scientific EffectSpray atomization: Aerosol

Data Source

PatentUS11607508B1Device for sublingual application of a therapeutic dose of medication in fractions
Publication Date: 2023.03.21 STAT CAPSULE INC
  • US11607508B1 patent drawing
  • US11607508B1 patent drawing
  • US11607508B1 patent drawing

AI summary

A sublingual type medication delivery device includes a container body having a predetermined volume of solvent with a spray dispenser attached at one end of the container and at the opposite end of the container is a housing which contains medication to be discharged into the container and mixed with the solvent to form a diluted medication for fractional delivery of the medication over a period of time. The housing can either be a tablet crusher for introducing medicament in solid form into the container or the housing can be a capsule having liquid medicament that is delivered through a needle that pierces the capsule wall.