Contoured Pushrod for Repeatable Oral Transmucosal Delivery

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Solution Overview

Problem

Existing drug delivery systems for small-volume opioid dosage forms face challenges in ensuring accurate and repeatable delivery due to issues like sensor errors, calibration drift, and inconsistent motion of moving parts, leading to potential misuse, diversion, and abuse, as well as improper delivery and lock-out errors.

Innovation Solution

A drug delivery apparatus featuring a pushrod designed to maintain consistent motion within the dispenser, with non-planar and contoured surfaces to reduce friction and wear, ensuring repeatable and accurate delivery of dosage forms over the device's lifetime, minimizing lock-outs and errors.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a pushrod is used to move dosage forms through a passageway, then delivery of the dosage form is achieved, but friction and wear cause inconsistent motion and binding over time

Engineering Contradiction:

Improvedelivery consistencyVSAvoidservice life

Core Design Contradiction:

ReliabilityVSDuration of action of moving object

Solution Approach 1:

The pushrod is replaced with a flexible catheter that can bend and flex to navigate the passageway. The catheter's flexible, curved design eliminates rigid contact points that cause friction and binding, allowing smooth passage through the delivery path without mechanical wear issues.

Inventive Principle:

Principle #14Spheroidality (Curvature)

Solution Approach 2:

The rigid mechanical pushrod system is replaced with a flexible catheter-based system. This substitution transitions from rigid mechanical contact to a more compliant delivery mechanism that can adapt to the passageway geometry, reducing friction and binding problems associated with rigid components.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Measurement precision

If sensors are used to detect dosage form passage, then delivery accuracy is improved, but sensor errors and calibration drift cause lock-out errors

Engineering Contradiction:

Improvedosage detection accuracyVSAvoiderror rate

Core Design Contradiction:

Measurement precisionVSReliability

Solution Approach 1:

The system creates an optical image or shadow of the dosage form as it passes through the passageway. This optical copy or shadow pattern provides a reliable visual record of dosage form passage that can be detected and verified, reducing dependence on sensors that are prone to calibration drift and errors.

Inventive Principle:

Principle #26Copying

Data Source

PatentUS11058856B2Systems, devices and methods for dispensing oral transmucosal dosage forms

Publication Date: 2021.07.13 VERTICAL PHARMA LLC

AI summary

An apparatus includes a housing and a pushrod. The housing defines a delivery passage and an exit port in fluid communication with the delivery passage. At least a portion of the pushrod is movably disposed in the delivery passage. A distal end portion of the pushrod is configured to move a drug dosage form through at least a portion of the delivery passage to convey the drug dosage form through the exit port when the distal end portion of the pushrod is moved from a first position to a second position. A surface of at least one of the pushrod or the housing defining the delivery passage is nonplanar, curved and/or contoured.