Enhanced Treatment System for Uterine Fibroids using Optimized Collagenase Compositions and Delivery Methods
Legal Citation
Summary of the Inventive Concept
The present inventive concept relates to a novel system for treating uterine fibroids, featuring optimized collagenase compositions, targeted delivery methods, and real-time monitoring capabilities, providing improved efficacy, safety, and patient outcomes.
Background and Problem Solved
The original patent disclosed a method for treating uterine fibroids using purified collagenase. However, the existing method has limitations, including the risk of systemic absorption, inadequate localized tissue breakdown, and the need for improved delivery systems. The present inventive concept addresses these limitations by introducing advanced collagenase compositions, micro-needle array delivery, pH-optimized formulations, and real-time monitoring capabilities.
Detailed Description of the Inventive Concept
The new system comprises a collagenase composition having a concentration of 0.25-2.0 mg/mL, which is administered via a micro-needle array for targeted delivery to the fibroid tissue. The composition is formulated to minimize systemic absorption and maximize localized tissue breakdown, with a pH range of 6.5-7.5. Additionally, the system incorporates a collagenase-coated balloon catheter, which is expandable to compress the fibroid tissue and facilitate collagenase delivery. The composition may further include a proteoglycan-degrading enzyme, which synergistically breaks down fibroid tissue and promotes tissue remodeling. The system also features a fibroid tissue stiffness sensor, providing real-time feedback on treatment efficacy.
Novelty and Inventive Step
The new claims introduce several novel and non-obvious features, including the use of micro-needle arrays, pH-optimized formulations, collagenase-coated balloon catheters, and proteoglycan-degrading enzymes. These advancements provide improved efficacy, safety, and patient outcomes, distinguishing the present inventive concept from the original patent.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept may include varying the collagenase composition concentration, using different delivery methods such as jet injectors or syringes, or incorporating additional enzymes or bioactive molecules to enhance tissue breakdown and remodeling. Other variations may involve modifying the balloon catheter design or incorporating imaging modalities to enhance treatment monitoring.
Potential Commercial Applications and Market
The enhanced treatment system for uterine fibroids has significant commercial potential in the medical device and pharmaceutical industries, offering a novel solution for a common and debilitating condition affecting millions of women worldwide. The market potential includes hospitals, clinics, and medical centers, as well as potential partnerships with pharmaceutical companies and medical device manufacturers.
CPC Classifications
| Section | Class | Group |
|---|---|---|
| A | A61 | A61K9/48 |
| A | A61 | A61K9/0019 |
| A | A61 | A61K9/0034 |
| A | A61 | A61K9/1075 |
| A | A61 | A61K38/43 |
| A | A61 | A61K38/4886 |
| A | A61 | A61K45/06 |
| C | C12 | C12Y304/24003 |
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Medical device technologies for minimally invasive tissue treatment, specifically focusing on enzymatic breakdown of uterine fibroids, involving biotechnology, medical device engineering, and interventional medical procedures
Person of Ordinary Skill (PHOSITA) Profile
A medical researcher or interventional physician with expertise in enzyme-based tissue modification, medical device design, and minimally invasive surgical techniques, holding advanced degrees in biomedical engineering or medical sciences
Obviousness Rationale
A person having ordinary skill would recognize that the PTD's variations represent predictable engineering extensions of the source patent's core methodology of targeted collagenase delivery for uterine fibroid treatment. The disclosed micro-needle arrays, pH-optimized formulations, and additional enzymatic approaches represent standard design iterations that would be apparent to a skilled practitioner seeking incremental improvements in tissue-specific treatment modalities.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,685 |
|---|---|
| Title | Treatment method and product for uterine fibroids using purified collagenase |
| Assignee(s) | Duke University, BioSpecifics Technologies LLC |