Modular and Adaptive Introducer Sheath Systems for Enhanced Medical Device Insertion

Publication ID: 24-11857740_0010_PTD
Published: October 28, 2025
Category:Future Evolutions & Paradigm Shifts

Legal Citation

pr1or.art Inc., “Modular and Adaptive Introducer Sheath Systems for Enhanced Medical Device Insertion,” Published Technical Disclosure No. 24-11857740_0010_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857740_0010_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 present inventive concept discloses a next-generation introducer sheath system that integrates advanced features such as detachable sensor modules, self-adjusting mechanisms, hybrid materials, bio-inspired surfaces, and neural network-assisted insertion control. These innovations aim to revolutionize the medical device insertion process by enhancing precision, safety, and patient comfort.

Background and Problem Solved

The original patent disclosed an introducer sheath with a tab formed at the distal end, addressing the need for a medical device system that enables efficient and safe delivery of elongate devices. However, the original design has limitations in terms of real-time monitoring, adaptability, and insertion precision. The present inventive concept addresses these limitations by introducing a modular and adaptive introducer sheath system that provides real-time monitoring, self-adjusting capabilities, and precision control over the insertion process.

Detailed Description of the Inventive Concept

The modular and adaptive introducer sheath system comprises a multipurpose introducer sheath having a distal end and a proximal end, a lumen extending from the distal end to the proximal end, and a detachable sensor module integrated into the introducer sheath. The sensor module monitors insertion parameters in real-time, providing valuable feedback to the medical professional. The system also includes a self-adjusting introducer sheath with an adaptive seal mechanism that dynamically adjusts to accommodate varying diameters of the medical device. Additionally, the system incorporates a hybrid introducer sheath with a micro-actuator integrated into the introducer sheath, enabling precision control over the insertion process. Furthermore, the system features a bio-inspired introducer sheath with a surface texture mimicking natural tissues, enhancing the insertion experience and reducing patient discomfort. Finally, the system includes a neural network-assisted introducer sheath with a machine learning module integrated into the introducer sheath, predicting and adapting to insertion challenges in real-time.

Novelty and Inventive Step

The present inventive concept's modular and adaptive design, incorporating advanced features such as detachable sensor modules, self-adjusting mechanisms, hybrid materials, bio-inspired surfaces, and neural network-assisted insertion control, provides a significant departure from the original patent's design. The inventive step lies in the integration of these advanced features, which enables real-time monitoring, precision control, and adaptability in the medical device insertion process.

Alternative Embodiments and Variations

Alternative embodiments of the modular and adaptive introducer sheath system could include variations in the sensor module design, such as using different types of sensors or integrating multiple sensors. The self-adjusting mechanism could be implemented using different materials or actuation methods. The hybrid introducer sheath could incorporate different micro-actuators or control systems. The bio-inspired surface texture could be modified to mimic different natural tissues. The neural network-assisted introducer sheath could be trained using different machine learning algorithms or data sets.

Potential Commercial Applications and Market

The modular and adaptive introducer sheath system has significant commercial potential in the medical device industry, particularly in the fields of minimally invasive surgery, interventional cardiology, and urology. The system's advanced features and improved insertion precision could reduce complications, enhance patient outcomes, and increase procedural efficiency, making it an attractive solution for medical professionals and healthcare institutions.

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 insertion technologies, specifically introducer sheaths and medical device delivery systems, encompassing interventional medical procedures involving minimally invasive device insertion techniques

Person of Ordinary Skill (PHOSITA) Profile

A biomedical engineer or medical device designer with expertise in interventional medical technologies, advanced materials, sensor integration, and mechanical design of medical insertion devices, holding advanced degrees and 3-5 years of industry experience

Obviousness Rationale

A PHOSITA would recognize that the PTD's disclosed variations represent predictable technological extensions of the source patent's fundamental introducer sheath design, utilizing standard engineering approaches to enhance medical device functionality through modular sensor integration, adaptive mechanisms, and intelligent control systems that are well-established in medical device development.

Obvious Combinations & Variations

Source Patent Element
Introducer sheath with a lumen and distal/proximal ends
PTD Variation
Integrating a detachable sensor module to monitor insertion parameters
Obviousness Reasoning
Adding real-time monitoring sensors to medical devices is a known technique for improving procedural safety and precision, representing a predictable application of standard sensor integration methods
Source Patent Element
Basic introducer sheath design with fixed geometry
PTD Variation
Self-adjusting adaptive seal mechanism for accommodating varying device diameters
Obviousness Reasoning
Developing adjustable medical device interfaces is a common design approach to enhance versatility, using well-understood mechanical adaptation principles
Source Patent Element
Simple introducer sheath structure
PTD Variation
Micro-actuator integration for precision insertion control
Obviousness Reasoning
Incorporating micro-electromechanical control systems into medical devices is a standard engineering solution for improving device performance and precision
Source Patent Element
Standard smooth introducer sheath surface
PTD Variation
Bio-inspired surface texture mimicking natural tissue characteristics
Obviousness Reasoning
Biomimetic surface design is a recognized approach in medical device engineering for reducing patient discomfort and improving device interaction
Source Patent Element
Basic introducer sheath without advanced feedback mechanisms
PTD Variation
Neural network-assisted machine learning module for adaptive insertion
Obviousness Reasoning
Implementing intelligent control systems using machine learning is a predictable technological progression in medical device design, representing an obvious enhancement to existing insertion technologies
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857740 and the disclosed variations, a person of ordinary skill in the art would find the claimed modular and adaptive introducer sheath system variations to be obvious extensions of existing medical device insertion technologies, lacking non-obvious inventive characteristics and therefore constituting anticipatory prior art against potential future patent claims in this technical domain.

Original Patent Information

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