Adaptable Prosthetic Heart Valves for Extreme Environments

Publication ID: 24-11857411_0009_PTD
Published: October 28, 2025
Category:Specialized Variations & Niche Solutions

Legal Citation

pr1or.art Inc., “Adaptable Prosthetic Heart Valves for Extreme Environments,” Published Technical Disclosure No. 24-11857411_0009_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857411_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. 11,857,411.

Summary of the Inventive Concept

This inventive concept presents a family of prosthetic heart valves designed to operate effectively in extreme weather conditions, high-security environments, disaster relief situations, and high-altitude settings. These specialized valves address the limitations of traditional prosthetic heart valves, providing improved performance and reliability in unique operational environments.

Background and Problem Solved

Traditional prosthetic heart valves are designed for general use cases and may not perform optimally in extreme environments. The present inventive concept addresses this limitation by providing specialized valves that can withstand high winds, turbulent flow, low-pressure environments, and other challenging conditions. By adapting the valve design to these specific environments, the inventive concept enables improved patient outcomes and reduced complications.

Detailed Description of the Inventive Concept

The inventive concept encompasses a range of prosthetic heart valves, each tailored to a specific extreme environment. For example, the valve for extreme weather conditions features a stent or frame adapted to withstand high winds and turbulent flow, ensuring the valve remains functional during intense storms. The valve for high-security environments incorporates enhanced sterilization protocols and secure, encrypted communication systems to prevent unauthorized access or data breaches. The valve for disaster relief situations includes an outer skirt adapted to seal against damaged or irregular tissue, enabling minimally invasive implantation in emergency scenarios. The valve for high-altitude environments is designed to optimize blood flow at low atmospheric pressures, with an outer skirt adapted to maintain a secure seal in low-oxygen environments. A system for remote monitoring of prosthetic heart valves in extreme weather conditions completes the inventive concept, providing real-time performance data and alerts to ensure timely interventions.

Novelty and Inventive Step

The inventive concept's novelty lies in its adaptation of prosthetic heart valve design to specific extreme environments, addressing the limitations of traditional valves in these settings. The inventive step is the combination of specialized valve components and operational features that enable optimal performance in these unique environments, providing a significant improvement over existing valve designs.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept could include valves designed for other extreme environments, such as extreme temperatures, high-radiation areas, or underwater operations. Variations could also include different materials, coatings, or surface treatments to enhance valve performance in specific environments.

Potential Commercial Applications and Market

The inventive concept has significant commercial potential in the medical device industry, particularly in the areas of cardiovascular medicine and disaster relief. The target market includes hospitals, medical centers, and emergency response organizations operating in extreme environments. The valves could also be used in military or space exploration applications, where personnel may be exposed to unique environmental challenges.

CPC Classifications

SectionClassGroup
A A61 A61F2/2409
A A61 A61F2/2415
A A61 A61F2/2418
A A61 A61L27/3625
A A61 A61L27/50
A A61 A61L27/56
A A61 A61F2/2427
A A61 A61F2230/0054
A A61 A61F2240/001
A A61 A61F2250/0063
A A61 A61F2250/0069
A A61 A61L2430/20

Field of Art

Biomedical Engineering, specifically Cardiovascular Medical Devices, with a focus on implantable prosthetic heart valves and sealing technologies

Person of Ordinary Skill (PHOSITA) Profile

A biomedical engineer or medical device designer with expertise in cardiovascular implant design, material science, and surgical techniques, holding at least a master's degree with 3-5 years of specialized experience in prosthetic valve development

Obviousness Rationale

A PHOSITA would recognize that the proposed variations in environment-specific prosthetic heart valve designs represent predictable extensions of existing valve technologies, utilizing known design principles and material adaptations to address specific operational challenges. The core structural elements of the prosthetic valve remain fundamentally consistent with the source patent's design, with modifications that would be considered routine engineering adaptations for specific use cases. The proposed variations demonstrate incremental improvements that would be obvious to a skilled practitioner familiar with prosthetic valve design and environmental engineering challenges.

Obvious Combinations & Variations

Source Patent Element
Radially collapsible annular frame with adjustable configuration
PTD Variation
Adapting frame design to withstand high winds and turbulent flow conditions
Obviousness Reasoning
Material selection and structural reinforcement of existing valve frame design would be a predictable engineering solution for environmental adaptation
Source Patent Element
Outer skirt constructed from porcine pericardial tissue with specific thickness range
PTD Variation
Modifying outer skirt to seal against damaged or irregular tissue in disaster relief scenarios
Obviousness Reasoning
Adjusting material properties and sealing characteristics of existing valve skirt design represents a known technique for addressing specific implantation challenges
Source Patent Element
Valve structure with inflow and outflow ends
PTD Variation
Optimizing valve structure for blood flow at low atmospheric pressures in high-altitude environments
Obviousness Reasoning
Modifying fluid dynamics and valve geometry to address specific environmental conditions would be considered routine design optimization for a PHOSITA
Source Patent Element
Valve frame with potential for suture attachment
PTD Variation
Implementing encrypted communication and remote monitoring systems for valve performance tracking
Obviousness Reasoning
Integrating electronic monitoring capabilities into existing valve design represents a predictable technological advancement in medical device development
Source Patent Element
Implantable prosthetic valve with configurable structural elements
PTD Variation
Developing specialized valve variants for extreme temperature, radiation, or underwater environments
Obviousness Reasoning
Extending valve design principles to additional extreme environments represents a logical and predictable engineering approach to expanding device applicability
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857411 and the comprehensive technical disclosure herein, a person of ordinary skill in the art would find the proposed variations in prosthetic heart valve design to be obvious and lacking inventive step. The incremental modifications to existing valve technologies, including environmental adaptations, specialized sealing techniques, and performance optimization, represent predictable engineering solutions that would be readily apparent to a skilled practitioner in the field of cardiovascular medical device design.

Original Patent Information

Patent NumberUS 11,857,411
TitlePericardial sealing member for prosthetic heart valve
Assignee(s)EDWARDS LIFESCIENCES CORPORATION