Enhanced Stented Prosthetic Heart Valve System with Variable Stiffness and Real-Time Monitoring

Publication ID: 24-11857413_0006_PTD
Published: October 28, 2025
Category:Direct Improvements & Enhancements

Legal Citation

pr1or.art Inc., “Enhanced Stented Prosthetic Heart Valve System with Variable Stiffness and Real-Time Monitoring,” Published Technical Disclosure No. 24-11857413_0006_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857413_0006_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. 11,857,413.

Summary of the Inventive Concept

An improved stented prosthetic heart valve system featuring variable stiffness regions, enhanced valve structure, and real-time monitoring capabilities to provide better patient outcomes and improved physician control.

Background and Problem Solved

Conventional prosthetic heart valves have limitations in terms of stiffness, valve structure, and monitoring capabilities. The present inventive concept addresses these limitations by introducing variable stiffness regions, enhanced valve structure, and real-time monitoring capabilities, thereby improving the overall performance and safety of prosthetic heart valves.

Detailed Description of the Inventive Concept

The enhanced stented prosthetic heart valve system comprises a stent frame with variable stiffness regions, allowing it to adapt to different anatomical locations within the heart. The valve structure is enhanced with a novel attachment mechanism that reduces leaflet flutter, and the system features real-time monitoring capabilities through sensors integrated into the stent frame. The sensors provide feedback to the physician, enabling more precise control and improved patient outcomes. The system can be deployed using a novel compression and expansion mechanism, ensuring improved radial force and reduced complications.

Novelty and Inventive Step

The new inventive concept introduces variable stiffness regions, enhanced valve structure, and real-time monitoring capabilities, which are not present in the original patent. These features provide a significant improvement over the prior art, offering better patient outcomes, improved physician control, and enhanced safety.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept could include varying the number and configuration of sensors, using different materials for the stent frame and valve structure, or integrating additional features such as anti-calcification coatings or drug-eluting capabilities.

Potential Commercial Applications and Market

The enhanced stented prosthetic heart valve system has significant commercial potential in the cardiovascular device market, with potential applications in heart valve replacement and repair procedures. The system's improved performance, safety, and monitoring capabilities make it an attractive solution for physicians and patients alike.

CPC Classifications

SectionClassGroup
A A61 A61F2/2418
A A61 A61F2250/0018
A A61 A61F2250/0029

Field of Art

Medical Device Engineering, specifically Cardiovascular Implant Design, focusing on prosthetic heart valve technologies with expertise in biomechanical engineering, material science, and minimally invasive surgical techniques

Person of Ordinary Skill (PHOSITA) Profile

A biomedical engineer or medical device designer with advanced degree, 5-10 years experience in cardiovascular implant design, familiar with stent frame technologies, valve deployment mechanisms, and surgical intervention strategies

Obviousness Rationale

A person skilled in the art would recognize that the PTD's variations represent predictable engineering improvements to the source patent's fundamental heart valve design. The disclosed enhancements like variable stiffness regions and integrated sensors are logical extensions of existing prosthetic valve technologies, applying known design principles to incrementally improve device performance and clinical outcomes.

Obvious Combinations & Variations

Source Patent Element
Stent frame configured to expand from compressed state for heart valve delivery
PTD Variation
Adding variable stiffness regions to adapt to different anatomical locations within the heart
Obviousness Reasoning
A PHOSITA would find it obvious to modify stent frame material properties to enhance anatomical conformance, as material science techniques for creating zone-specific mechanical properties are well-established in medical device design
Source Patent Element
Radiopaque markers for valve alignment during deployment
PTD Variation
Integrating sensors for real-time performance monitoring within stent frame
Obviousness Reasoning
Incorporating monitoring capabilities is a predictable technological progression, leveraging existing marker placement techniques to add diagnostic functionality using miniaturized sensor technologies
Source Patent Element
Stented prosthetic heart valve with uniform cell spacing
PTD Variation
Novel attachment mechanism for valve leaflets to reduce flutter
Obviousness Reasoning
Optimizing leaflet attachment represents a standard engineering approach to improving valve mechanical performance, utilizing known techniques of material bonding and geometric design
Source Patent Element
Deployment method involving compression and expansion
PTD Variation
Enhanced compression mechanism ensuring improved radial force
Obviousness Reasoning
Refining deployment mechanics is an expected iterative design process for medical devices, representing a predictable solution to known deployment challenges
Source Patent Element
Basic stent frame construction
PTD Variation
Laser-cutting stent frame from shape memory material with integrated sensors
Obviousness Reasoning
Applying advanced manufacturing techniques like laser cutting to create multifunctional medical device components is a standard approach in biomedical engineering design
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857413 and the comprehensive technical disclosure herein, a person having ordinary skill in the art would find the claimed variations of stented prosthetic heart valve design to be obvious and anticipated, lacking the requisite non-obviousness standard for patent protection under 35 U.S.C. ยง 103. The incremental technological improvements represent predictable engineering solutions within the established knowledge domain of cardiovascular medical device design.

Original Patent Information

Patent NumberUS 11,857,413
TitleStented prosthetic heart valve with variable stiffness and methods of use
Assignee(s)Medtronic Vascular Galway