Enhanced Therapeutic Composition of Intranasal Lidocaine with Improved Ergonomics and Precision Metering

Publication ID: 24-11857520_0001_PTD
Published: October 28, 2025
Category:Direct Improvements & Enhancements

Legal Citation

pr1or.art Inc., “Enhanced Therapeutic Composition of Intranasal Lidocaine with Improved Ergonomics and Precision Metering,” Published Technical Disclosure No. 24-11857520_0001_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857520_0001_PTD
This technical disclosure describes improvements that would be readily apparent to a Person Having Ordinary Skill In The Art (PHOSITA) when considered in combination with the foundational architecture disclosed in U.S. Patent No. 11,857,520.

Summary of the Inventive Concept

The present inventive concept discloses an improved therapeutic composition of intranasal lidocaine with a preservative-free nasal spray formulation and a mechanical multi-dose nasal spray pump device featuring an enhanced ergonomic design, precision metering system, and built-in timer for consistent dosing intervals to treat pain associated with tri-geminal neuralgia, facial neuropathic pain, facial cancer induced neuropathic pain, migraine pain, and cluster headache pain.

Background and Problem Solved

The original patent disclosed a preservative-free intranasal composition in multi-dose or bi-dose or unit-dose spray container to treat pain associated with tri-geminal neuralgia, facial neuropathic pain, facial cancer induced neuropathic pain, migraine pain, and cluster headache pain. However, the original patent did not address the limitations of user comfort and ease of use, precision metering, and consistent dosing intervals, which are critical factors in ensuring effective treatment. The present inventive concept addresses these limitations by introducing an improved ergonomic design, precision metering system, and built-in timer to provide enhanced user comfort, accurate dosing, and consistent treatment outcomes.

Detailed Description of the Inventive Concept

The improved therapeutic composition of intranasal lidocaine comprises a preservative-free nasal spray formulation and a mechanical multi-dose nasal spray pump device. The device features an enhanced ergonomic design that provides improved user comfort and ease of use, reducing fatigue and discomfort during prolonged treatment periods. The precision metering system ensures accurate dosing of the formulation, and the built-in timer enables consistent dosing intervals, thereby optimizing treatment outcomes. The formulation itself is a supersaturated solution of lidocaine in a pharmaceutically acceptable solvent carrier, with a pH-adjusting agent to maintain the pH between about 3 and about 6. The device is designed to detect the presence of the formulation and prevent accidental actuation, with a visual indicator to display the number of remaining doses.

Novelty and Inventive Step

The present inventive concept introduces several novel features that distinguish it from the original patent, including the improved ergonomic design, precision metering system, and built-in timer. These features provide a significant improvement in user comfort, accurate dosing, and consistent treatment outcomes, thereby addressing the limitations of the original patent. The combination of these features and the preservative-free nasal spray formulation constitutes a non-obvious inventive step that provides a significant advancement in the treatment of pain associated with tri-geminal neuralgia, facial neuropathic pain, facial cancer induced neuropathic pain, migraine pain, and cluster headache pain.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept could include variations in the ergonomic design, precision metering system, and built-in timer to accommodate different user needs and preferences. For example, the device could be designed with adjustable ergonomic features, such as interchangeable grip sizes or angles, to accommodate users with different hand sizes or preferences. The precision metering system could be modified to accommodate different dosing regimens or formulations, and the built-in timer could be replaced with a manual or automated dosing schedule. Additionally, the inventive concept could be adapted for use with other locally active sodium channel blockers or pain relief medications.

Potential Commercial Applications and Market

The present inventive concept has significant commercial potential in the pharmaceutical and medical device industries, particularly in the areas of pain management and neuroscience. The improved therapeutic composition of intranasal lidocaine could be marketed as a premium product for treating pain associated with tri-geminal neuralgia, facial neuropathic pain, facial cancer induced neuropathic pain, migraine pain, and cluster headache pain. The device's enhanced ergonomic design, precision metering system, and built-in timer could provide a competitive advantage in the market, attracting users who value ease of use, accuracy, and consistent treatment outcomes.

CPC Classifications

SectionClassGroup
A A61 A61K31/167
A A61 A61K9/0043
A A61 A61M11/00
A A61 A61M2210/0618

Field of Art

Medical device design and pharmaceutical formulation, specifically intranasal drug delivery systems for neuropathic pain management, involving expertise in pharmacology, device engineering, and drug delivery mechanisms

Person of Ordinary Skill (PHOSITA) Profile

A professional with advanced degrees in pharmaceutical sciences or biomedical engineering, experienced in developing medical spray devices, understanding drug formulation principles, and optimizing drug delivery mechanisms

Obviousness Rationale

A person skilled in the art would recognize that the PTD's enhancements represent predictable design improvements to the source patent's intranasal lidocaine delivery system. The proposed modifications of ergonomic design, precision metering, and built-in timer are logical extensions of existing medical device engineering principles. These variations address known usability challenges in multi-dose nasal spray devices and would be considered routine optimization by a skilled practitioner.

Obvious Combinations & Variations

Source Patent Element
Preservative-free nasal spray formulation for treating neuropathic pain
PTD Variation
Adding precision metering system and built-in timer to control dosage consistency
Obviousness Reasoning
Dosage control is a standard design consideration in medical delivery devices, representing a predictable solution to improve treatment reliability
Source Patent Element
Multi-dose nasal spray pump device delivering lidocaine
PTD Variation
Enhanced ergonomic design with adjustable grip and user comfort features
Obviousness Reasoning
Ergonomic improvements are a known technique in medical device design to increase patient compliance and ease of use
Source Patent Element
Supersaturated lidocaine formulation for pain treatment
PTD Variation
Adding pH-adjusting agent to maintain formulation stability between pH 3-6
Obviousness Reasoning
pH optimization is a standard pharmaceutical formulation technique to enhance drug stability and absorption
Source Patent Element
Intranasal spray for targeting trigeminal nerve pain
PTD Variation
Specialized nozzle design to improve targeted nerve region delivery
Obviousness Reasoning
Targeted drug delivery is a predictable engineering solution to improve treatment precision
Source Patent Element
Unit-dose nasal spray formulation
PTD Variation
Adding sensor to prevent accidental actuation and visual dose tracking
Obviousness Reasoning
Safety mechanisms and dose tracking are routine design improvements in medical device technology
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857520, the variations disclosed in this publication would be considered obvious to a person having ordinary skill in the art of intranasal drug delivery systems. The incremental improvements in device ergonomics, dosage control, and formulation optimization represent predictable extensions of the prior art, thereby rendering potential derivative claims obvious under 35 U.S.C. ยง 103.

Original Patent Information

Patent NumberUS 11,857,520
TitleTherapeutic composition of intranasal lidocaine
Assignee(s)Nortic Holdings Inc.