Published Technical Disclosure Archive

Adaptive Pericardial Sealing Member for Prosthetic Heart Valves

Publication ID: 24-11857411_0005_PTD
Published: October 28, 2025
Category:Future Evolutions & Paradigm Shifts

Legal Citation

pr1or.art Inc., “Adaptive Pericardial Sealing Member for Prosthetic Heart Valves,” Published Technical Disclosure No. 24-11857411_0005_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857411_0005_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

A next-generation prosthetic heart valve system featuring a self-healing, adaptive pericardial sealing member that ensures optimal valve performance and minimizes complications by dynamically responding to changes in the native annulus and patient's physiological environment.

Background and Problem Solved

The original patent, 'Pericardial sealing member for prosthetic heart valve', introduced a prosthetic valve with a pericardial sealing member. However, this design has limitations in terms of adaptability to the native annulus and patient-specific factors. The new inventive concept addresses these limitations by introducing a self-healing, adaptive pericardial sealing member that can conform to the unique anatomy of each patient and adapt to changes over time.

Detailed Description of the Inventive Concept

The new prosthetic heart valve system comprises a shape-memory alloy stent that can be programmed to conform to the unique anatomy of a patient's native annulus. The pericardial sealing member is enhanced with nanotechnology, promoting tissue regeneration and minimizing inflammation. The system also features a biohybrid pericardial sealing member that incorporates living cells and biomaterials, allowing for real-time monitoring and adaptation to changes in the patient's physiological environment. Additionally, the system includes a sensor-enabled pericardial sealing member that transmits data on valve performance and native annulus geometry, enabling remote monitoring and adjustment through a cloud-based algorithm.

Novelty and Inventive Step

The new claims introduce a paradigm shift in prosthetic heart valve design by incorporating self-healing, adaptive materials and nanotechnology-enhanced tissue regeneration. These features, combined with real-time monitoring and adaptation capabilities, provide a significant improvement over the original patent and existing prosthetic heart valve technologies.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept could include the use of different materials or geometries for the shape-memory alloy stent, variations in the nanotechnology-enhanced pericardial sealing member, or alternative sensing technologies for remote monitoring. Additionally, the system could be adapted for use in other implantable devices, such as pacemakers or implantable cardioverter-defibrillators.

Potential Commercial Applications and Market

The adaptive pericardial sealing member for prosthetic heart valves has significant commercial potential in the medical device industry, particularly in the areas of cardiovascular health and implantable devices. The technology could be licensed to major medical device manufacturers or developed into a proprietary product line, targeting a market projected to reach $1.5 billion by 2025.

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 valve technologies, requiring advanced knowledge of biomaterials, medical device engineering, tissue interface design, and surgical implantation techniques

Person of Ordinary Skill (PHOSITA) Profile

A biomedical engineer or medical device researcher with expertise in cardiovascular implants, advanced materials science, having a master's or doctoral degree, familiar with state-of-the-art prosthetic valve design, tissue integration strategies, and emerging nanotechnology applications in medical devices

Obviousness Rationale

A PHOSITA would recognize that the PTD's proposed variations represent predictable extensions of existing prosthetic heart valve technologies, utilizing known engineering principles of adaptive materials, sensor integration, and biomaterial enhancement to incrementally improve valve performance and patient outcomes. The proposed modifications leverage established design strategies in medical device engineering, applying well-understood nanotechnology and materials science concepts to address known limitations in existing prosthetic valve systems.

Obvious Combinations & Variations

Source Patent Element
Radially collapsible and expandable annular frame with pericardial tissue outer skirt
PTD Variation
Shape-memory alloy stent that can be programmed to conform to patient's native annulus anatomy
Obviousness Reasoning
Known shape-memory alloy technologies in medical devices make this variation a predictable design optimization, representing a routine engineering solution to improve patient-specific valve fitting
Source Patent Element
Pericardial tissue outer skirt with specific thickness parameters
PTD Variation
Nanotechnology-enhanced pericardial sealing member promoting tissue regeneration and minimizing inflammation
Obviousness Reasoning
Integrating nanotechnology for tissue interface enhancement is a well-established approach in biomedical engineering, representing an obvious incremental improvement to existing tissue sealing strategies
Source Patent Element
Prosthetic valve with suture-secured frame components
PTD Variation
Sensor-enabled pericardial sealing member transmitting performance data and native annulus geometry
Obviousness Reasoning
Incorporating electronic sensing capabilities into medical implants is a known technique, with numerous precedents in medical device design representing a straightforward technological extension
Source Patent Element
Implantable prosthetic valve with pericardial tissue components
PTD Variation
Biohybrid pericardial sealing member incorporating living cells and biomaterials for real-time adaptation
Obviousness Reasoning
Emerging tissue engineering approaches make biomaterial integration and cellular incorporation predictable design variations for improving implant performance and biocompatibility
Source Patent Element
Expandable frame designed for valve replacement
PTD Variation
Metamaterial-based pericardial sealing member dynamically altering mechanical properties in response to physiological factors
Obviousness Reasoning
Metamaterial design strategies represent a known approach to creating adaptive medical devices, with predictable engineering methods for achieving responsive material behaviors
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857411 and the disclosed technological variations, a person having ordinary skill in the art would find the proposed prosthetic heart valve system modifications obvious and anticipated, as they represent predictable engineering solutions utilizing known materials science, nanotechnology, and medical device design principles to incrementally enhance existing prosthetic valve technologies.

Original Patent Information

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