Enhanced Prosthetic Heart Valve with Advanced Features
Legal Citation
Summary of the Inventive Concept
An improved prosthetic heart valve with novel features that enhance its performance, durability, and implantation procedure, addressing the limitations of existing prosthetic heart valves.
Background and Problem Solved
The original patent disclosed a prosthetic heart valve with an annular frame and a leaflet structure. However, the existing design has limitations, such as the need for precise suture placement, risk of calcification, and potential for turbulence. The new inventive concept addresses these limitations by introducing an adjustable suture system, anti-calcification coating, and novel leaflet geometry.
Detailed Description of the Inventive Concept
The enhanced prosthetic heart valve comprises an annular frame with an inflow end and an outflow end, radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration. The leaflet structure is positioned within the frame and secured thereto with a novel, adjustable suture system, allowing for post-implantation adjustments to optimize valve performance. Additionally, the leaflet structure may be treated with an anti-calcification coating to reduce calcification and improve durability. Alternatively, the leaflet structure may be designed with a novel, asymmetrical leaflet geometry that improves blood flow and reduces turbulence. The valve may be delivered using a novel, expandable sheath that facilitates smooth, low-friction delivery to a target site within a patient's heart.
Novelty and Inventive Step
The new claims introduce novel features that are not obvious from the original patent, including the adjustable suture system, anti-calcification coating, and novel leaflet geometry. These features provide significant improvements over the existing design, enhancing the valve's performance, durability, and implantation procedure.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept may include different materials for the leaflet structure, varying thicknesses for the anti-calcification coating, or modified geometries for the leaflet structure. Additionally, the valve may be designed for use in different anatomical locations or for pediatric applications.
Potential Commercial Applications and Market
The enhanced prosthetic heart valve has significant commercial potential in the cardiovascular medical device industry, offering improved performance, durability, and implantation procedure. The target market includes cardiologists, cardiothoracic surgeons, and medical device companies focused on heart valve replacement and repair.
CPC Classifications
| Section | Class | Group |
|---|---|---|
| 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 |
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Cardiovascular medical devices, specifically implantable prosthetic heart valves, requiring advanced knowledge of biomechanical engineering, surgical techniques, and materials science with expertise in medical device design and cardiovascular interventional procedures
Person of Ordinary Skill (PHOSITA) Profile
A biomedical engineer or cardiovascular medical device designer with advanced degree, 5-10 years experience, familiar with prosthetic valve technologies, surgical implantation techniques, and materials engineering for biological interfaces
Obviousness Rationale
A skilled practitioner would recognize that the PTD's variations represent predictable engineering improvements to the source patent's fundamental prosthetic valve design. The disclosed modifications such as adjustable suture systems, anti-calcification treatments, and asymmetrical leaflet geometries are logical extensions of existing cardiovascular device optimization strategies. These variations demonstrate incremental technical advancements that would be apparent to a person skilled in prosthetic heart valve development.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,411 |
|---|---|
| Title | Pericardial sealing member for prosthetic heart valve |
| Assignee(s) | EDWARDS LIFESCIENCES CORPORATION |