Specialized Prosthetic Heart Valves for Niche Markets
Legal Citation
Summary of the Inventive Concept
A novel family of prosthetic heart valves tailored to address specific, underserved patient populations and unique operational environments, building upon the foundational stented prosthetic heart valve technology.
Background and Problem Solved
Conventional prosthetic heart valves often fail to cater to patients with rare heart defects, pediatric patients, or those requiring specialized solutions for high-security, disaster relief, or extreme weather conditions. The original patent's stented prosthetic heart valve, while innovative, has limitations in addressing these niche markets. This new inventive concept adapts the original technology to meet the distinct needs of these underserved populations.
Detailed Description of the Inventive Concept
The inventive concept encompasses a range of specialized prosthetic heart valves, each designed to address specific challenges. For pediatric patients, the valve features a stent frame with a diameter expandable from 10 mm to 20 mm, allowing for low-pressure environments. For patients with rare heart defects, the valve is deployed using a steerable catheter to navigate complex anatomical structures. In high-altitude environments, the valve incorporates a specialized coating to reduce thrombogenicity, while in low-oxygen conditions, the valve structure is adapted for optimal performance. Additionally, a radiation-resistant material is used in the stent frame for patients with a history of radiation therapy, and a specialized retrieval device is designed for malfunctioning valve removal.
Novelty and Inventive Step
The inventive concept's novelty lies in its tailored approach to addressing specific, niche markets, which the original patent did not contemplate. The new claims introduce non-obvious modifications to the original technology, including specialized coatings, materials, and deployment methods, to create a family of prosthetic heart valves that cater to unique patient populations and operational environments.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept could include prosthetic heart valves for patients with other rare conditions, such as those requiring implantation in non-standard anatomical locations. Variations could also involve integrating sensors or other diagnostic tools to monitor valve performance and patient health.
Potential Commercial Applications and Market
The inventive concept has significant commercial potential in the medical device industry, particularly in the areas of pediatric cardiology, rare heart defect treatment, and high-altitude or extreme environment medical care. The specialized prosthetic heart valves could be marketed to hospitals, medical research institutions, and government agencies involved in disaster relief and high-security operations.
CPC Classifications
| Section | Class | Group |
|---|---|---|
| A | A61 | A61F2/2418 |
| A | A61 | A61F2250/0018 |
| A | A61 | A61F2250/0029 |
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Cardiovascular medical devices, specifically prosthetic heart valve design and implantation techniques, requiring advanced biomedical engineering and medical device design expertise
Person of Ordinary Skill (PHOSITA) Profile
A biomedical engineer or medical device designer with advanced degree, specialized knowledge in cardiovascular interventional technologies, understanding of materials science, surgical deployment techniques, and patient-specific medical device adaptations
Obviousness Rationale
A person having ordinary skill would recognize that the source patent's fundamental stented heart valve technology provides a flexible framework for targeted modifications addressing specific patient populations and environmental conditions. The PTD's variations represent predictable engineering adaptations using known techniques of material selection, coating technologies, and deployment method modifications. These extensions demonstrate standard design optimization approaches within prosthetic heart valve development.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,413 |
|---|---|
| Title | Stented prosthetic heart valve with variable stiffness and methods of use |
| Assignee(s) | Medtronic Vascular Galway |