Specialized Introducer Sheath Systems for Niche Environments
Legal Citation
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
| Section | Class | Group |
|---|---|---|
| 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 |
Section 103 Obviousness Analysis (PHOSITA)
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
Original Patent Information
| Patent Number | US 11,857,740 |
|---|---|
| Title | Introducer sheath |
| Assignee(s) | Boston Scientific Scimed, Inc. |