Adaptable Prosthetic Heart Valves for Extreme Environments

Publication ID: 24-11857411_0004_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_0004_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857411_0004_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 specialized prosthetic heart valves designed to operate effectively in extreme environmental conditions, including high-altitude, high-security, disaster-stricken, high-temperature, and extreme cold weather scenarios.

Background and Problem Solved

The original patent disclosed a prosthetic heart valve with a pericardial sealing member. However, this design may not be suitable for use in extreme environments, where the valve may be subjected to increased pressure, stress, or temperature fluctuations. The new inventive concept addresses this limitation by introducing adaptable prosthetic heart valves that can withstand these extreme conditions, providing a reliable solution for patients in need of heart valve replacement in these environments.

Detailed Description of the Inventive Concept

The new prosthetic heart valves comprise an annular frame adapted to withstand increased pressure and stress, and a leaflet structure positioned within the frame and secured thereto. The leaflet structure is formed of high-strength, high-temperature-resistant, radiation-resistant, or cold-resistant materials, depending on the specific environment in which the valve will be used. The valves may also include additional features, such as portable, self-contained implantation devices or specialized deployment systems, to facilitate their use in extreme environments.

Novelty and Inventive Step

The new inventive concept's novelty lies in the adaptation of the prosthetic heart valve design to operate effectively in extreme environments, which is not addressed by the original patent. The inventive step involves the selection and integration of specialized materials and features that enable the valves to withstand these extreme conditions.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept could include prosthetic heart valves designed for use in other extreme environments, such as underwater or in space. Variations could also include different materials or designs for the annular frame and leaflet structure, or the incorporation of additional features, such as sensors or monitoring systems, to enhance the valve's performance and safety.

Potential Commercial Applications and Market

The adaptable prosthetic heart valves have significant commercial potential in the medical device industry, particularly in niche markets serving patients in extreme environments. Target industries could include military, aerospace, and disaster relief organizations, as well as hospitals and medical centers serving patients in high-altitude or extreme weather regions.

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

Cardiovascular medical devices, specifically implantable prosthetic heart valves, requiring expertise in biomaterials, surgical techniques, and mechanical engineering with advanced knowledge of material science and medical device design

Person of Ordinary Skill (PHOSITA) Profile

A biomedical engineer or medical device designer with advanced degrees, experience in cardiovascular implant design, understanding of material properties, surgical deployment techniques, and environmental adaptation strategies for medical devices

Obviousness Rationale

A PHOSITA would recognize that adapting prosthetic heart valve designs for extreme environments represents a predictable engineering variation that follows established design optimization principles. The core structural elements from the source patent remain fundamentally unchanged, with modifications focused on material selection and environmental resilience. These adaptations represent standard engineering problem-solving approaches within medical device design.

Obvious Combinations & Variations

Source Patent Element
Radially collapsible annular frame with leaflet structure
PTD Variation
Frame adapted to withstand increased pressure and stress in high-altitude environments
Obviousness Reasoning
Material selection and structural reinforcement are routine design modifications for environmental adaptation, representing a predictable engineering solution with expected results
Source Patent Element
Pericardial tissue outer skirt with specific thickness
PTD Variation
Leaflet structure formed from high-strength, temperature-resistant materials
Obviousness Reasoning
Substituting standard biological materials with engineered alternatives is a known technique for expanding device performance, following established material science principles
Source Patent Element
Suture-secured frame components
PTD Variation
Portable, self-contained implantation devices for remote deployment
Obviousness Reasoning
Developing specialized deployment systems represents a logical extension of existing medical device design, addressing practical implementation challenges in diverse environments
Source Patent Element
Implantable prosthetic valve with expandable configuration
PTD Variation
Radiation-resistant and cold-resistant valve configurations
Obviousness Reasoning
Modifying device materials to enhance environmental tolerance is a standard engineering approach with predictable design outcomes
Source Patent Element
Prosthetic valve with defined structural components
PTD Variation
Integration of monitoring systems and sensors for enhanced performance tracking
Obviousness Reasoning
Adding diagnostic capabilities represents an incremental improvement using known technological approaches within medical device engineering
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857411, the variations disclosed herein would be considered obvious to a Person Having Ordinary Skill In The Art, as they represent predictable engineering modifications to established prosthetic heart valve designs. The disclosed adaptations for extreme environments constitute routine problem-solving within cardiovascular medical device development, and therefore would not meet the non-obviousness requirements for patent protection.

Original Patent Information

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