Enhanced Prosthetic Valve System with Improved Safety and Performance
Legal Citation
Summary of the Inventive Concept
An enhanced prosthetic valve system featuring an expandable frame with improved durability, flexibility, and conformability, designed to reduce the risk of frame fracture, paravalvular leakage, and improve hemodynamic performance.
Background and Problem Solved
The original prosthetic valve patent has limitations in terms of frame durability, flexibility, and conformability, which can lead to frame fracture, paravalvular leakage, and compromised hemodynamic performance. The new inventive concept addresses these limitations by introducing novel frame designs, materials, and manufacturing processes that improve the overall safety and performance of the prosthetic valve system.
Detailed Description of the Inventive Concept
The enhanced prosthetic valve system features an expandable frame comprising a plurality of frame members designed to reduce the risk of frame fracture during deployment. The frame members have a unique geometry that allows for increased flexibility and conformability to the native valve orifice, improving the overall fit and performance of the prosthetic valve. The system also includes leaflets designed to have improved coaptation and reduced leaflet stress, thereby improving the overall durability and longevity of the prosthetic valve system. The novel material or process used in manufacturing the prosthetic valve further enhances frame durability and reduces material fatigue.
Novelty and Inventive Step
The new claims introduce novel frame designs, materials, and manufacturing processes that are not obvious from the original patent. The unique geometry of the frame members, the improved coaptation and reduced leaflet stress, and the novel material or process used in manufacturing the prosthetic valve are all new and non-obvious features that provide significant improvements over the original patent.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept could include varying the frame geometry, material, or manufacturing process to further optimize the prosthetic valve's performance and durability. Additional variations could include modifying the leaflet design or incorporating sensors or other features to enhance the prosthetic valve's functionality.
Potential Commercial Applications and Market
The enhanced prosthetic valve system has significant commercial potential in the medical device industry, particularly in the fields of cardiovascular disease treatment and minimally invasive surgical procedures. The improved safety and performance of the prosthetic valve system could lead to increased adoption and market share, as well as opportunities for expansion into new markets and applications.
CPC Classifications
| Section | Class | Group |
|---|---|---|
| A | A61 | A61F2/2418 |
| A | A61 | A61F2/24 |
| A | A61 | A61F2/2433 |
| A | A61 | A61F2/2439 |
| A | A61 | A61F2/2463 |
| A | A61 | A61F2/246 |
| A | A61 | A61F2/2436 |
| A | A61 | A61F2/2466 |
| A | A61 | A61F2002/9511 |
| A | A61 | A61F2210/0014 |
| A | A61 | A61F2210/0076 |
| A | A61 | A61F2220/005 |
| A | A61 | A61F2220/0016 |
| A | A61 | A61F2220/0025 |
| A | A61 | A61F2220/0033 |
| A | A61 | A61F2220/0058 |
| A | A61 | A61F2220/0075 |
| A | A61 | A61F2230/0054 |
| A | A61 | A61F2230/0067 |
| A | A61 | A61F2230/0069 |
| A | A61 | A61F2250/0039 |
| A | A61 | A61F2250/0069 |
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Cardiovascular medical devices, specifically transcatheter prosthetic heart valve systems, requiring advanced biomedical engineering, materials science, and interventional cardiology expertise
Person of Ordinary Skill (PHOSITA) Profile
A biomedical engineer or interventional cardiologist with advanced degree, specialized knowledge in medical device design, material properties, and cardiovascular implant technologies, familiar with transcatheter valve replacement techniques
Obviousness Rationale
A PHOSITA would recognize that the PTD's proposed modifications represent incremental improvements to the source patent's prosthetic valve design, utilizing standard engineering optimization techniques. The variations address known challenges in prosthetic valve performance through predictable design modifications that would be apparent to someone skilled in cardiovascular medical device development. The proposed changes represent logical extensions of existing technological approaches in transcatheter valve design.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,412 |
|---|---|
| Title | Prosthetic valve with expandable frame and associated systems and methods |
| Assignee(s) | EDWARDS LIFESCIENCES CORPORATION |