Specialized Introducer Sheath Systems for Niche Environments

Publication ID: 24-11857740_0009_PTD
Published: October 28, 2025
Category:Specialized Variations & Niche Solutions

Legal Citation

pr1or.art Inc., “Specialized Introducer Sheath Systems for Niche Environments,” Published Technical Disclosure No. 24-11857740_0009_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857740_0009_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. 11,857,740.

Summary of the Inventive Concept

The inventive concept adapts the introducer sheath for specific, narrow markets or unique operational environments, addressing the limitations of the original patent in extreme conditions.

Background and Problem Solved

The original patent disclosed an introducer sheath for delivering medical devices, but its design limitations hinder its use in high-altitude environments, high-security facilities, disaster relief operations, extreme weather conditions, or remote/austere environments. The new inventive concept addresses these limitations by introducing specialized variations and niche solutions.

Detailed Description of the Inventive Concept

The new inventive concept comprises a family of introducer sheath systems tailored to specific environments. For high-altitude environments, the introducer sheath features a reinforced tab to withstand extreme pressure variations. In high-security facilities, the method involves inserting the introducer sheath through a secure port and deploying the medical device. In disaster relief operations, the introducer sheath has a water-resistant coating to protect against environmental contaminants. For extreme weather conditions, the introducer sheath features a thermally insulated portion to maintain a stable temperature. In remote or austere environments, the method involves deploying the introducer sheath through a ruggedized port and inserting the medical device.

Novelty and Inventive Step

The new claims introduce novel features and methods that are not obvious from the original patent, including the reinforced tab, secure port, water-resistant coating, thermally insulated portion, and ruggedized port. These specialized variations and niche solutions provide a non-obvious improvement over the original patent.

Alternative Embodiments and Variations

Alternative embodiments may include introducer sheaths with adjustable tabs, modular secure ports, or adaptive thermal insulation. Variations may also include introducer sheaths designed for specific medical devices or procedures.

Potential Commercial Applications and Market

The inventive concept has significant commercial potential in various industries, including medical device manufacturing, disaster relief, and high-security facilities. The target markets include hospitals, medical research institutions, and government agencies operating in extreme environments.

CPC Classifications

SectionClassGroup
A A61 A61M25/0668
A A61 A61B17/221
A A61 A61B17/3417
A A61 A61M25/0074
A A61 A61M25/0097
A A61 A61B17/3415
A A61 A61B17/3431
A A61 A61B90/40
A A61 A61B2017/3409
A A61 A61M2025/0681
A A61 A61N2001/0578

Field of Art

Medical device engineering, specifically interventional medical device design for minimally invasive procedures, focusing on introducer sheaths and delivery systems for medical instruments across various clinical environments

Person of Ordinary Skill (PHOSITA) Profile

A biomedical engineer with expertise in medical device design, familiar with surgical instrument deployment techniques, material science applications in medical technologies, and adaptable device configurations for different operational contexts

Obviousness Rationale

A person having ordinary skill would recognize that the source patent's fundamental introducer sheath design provides a flexible template for environmental adaptations. The PTD's variations represent predictable engineering modifications that address known challenges in medical device deployment across different operational scenarios. These adaptations utilize standard design techniques like material selection, coating technologies, and structural reinforcement that are well-understood within medical device engineering.

Obvious Combinations & Variations

Source Patent Element
Introducer sheath with configurable distal end tab
PTD Variation
Reinforced tab for high-altitude pressure variations
Obviousness Reasoning
Modifying tab material/structure to withstand environmental stress represents a routine design optimization using known material engineering principles
Source Patent Element
Medical device delivery system with insertion device port
PTD Variation
Secure port and ruggedized port configurations
Obviousness Reasoning
Adapting port geometries for specific operational environments is a predictable design choice using standard mechanical engineering techniques
Source Patent Element
Basic introducer sheath lumen configuration
PTD Variation
Water-resistant coating and thermally insulated portion
Obviousness Reasoning
Applying protective coatings and thermal management techniques are standard approaches for enhancing medical device performance in challenging environments
Source Patent Element
Medical device insertion methodology
PTD Variation
Specialized deployment methods for high-security and remote environments
Obviousness Reasoning
Procedural adaptations that modify device insertion techniques represent predictable problem-solving within medical device engineering
Source Patent Element
Introducer sheath with frangible portion
PTD Variation
Modular design with adjustable environmental adaptation features
Obviousness Reasoning
Creating modular medical device components with interchangeable environmental adaptation features is a known design strategy for increasing device versatility
35 U.S.C. § 103 Summary: Based on US Patent 11857740, the present publication demonstrates that a person having ordinary skill in medical device engineering would find the disclosed environmental adaptations of the introducer sheath system obvious and predictable extensions of existing medical device design principles, thereby rendering potential claims to such variations unpatentable under 35 U.S.C. ยง 103.

Original Patent Information

Patent NumberUS 11,857,740
TitleIntroducer sheath
Assignee(s)Boston Scientific Scimed, Inc.