Enhanced Collagenase-Based System for Uterine Fibroid Treatment
Legal Citation
Summary of the Inventive Concept
A novel system and method for treating uterine fibroids, leveraging pH-adjusted buffers, temperature-controlled needles, protease inhibitors, and fibronectin-binding peptides to enhance collagenase efficacy and minimize off-target effects.
Background and Problem Solved
The original patent disclosed a method for treating uterine fibroids using purified collagenase. However, the existing approach has limitations, including suboptimal collagenase activity, inadequate tissue penetration, and potential off-target effects. The new inventive concept addresses these limitations by introducing pH-adjusted buffers, temperature-controlled needles, protease inhibitors, and fibronectin-binding peptides to enhance collagenase efficacy and minimize off-target effects.
Detailed Description of the Inventive Concept
The enhanced system comprises a collagenase composition with a pH-adjusted buffer to optimize enzymatic activity. The composition is delivered through a temperature-controlled needle to facilitate efficient tissue penetration. Additionally, a protease inhibitor is included to minimize off-target effects. In some embodiments, a fibronectin-binding peptide is added to enhance collagen degradation. The system also includes a biocompatible carrier for sustained release of the collagenase composition. A device for delivering the composition features a catheter with a porous membrane to facilitate localized delivery, and a pressure sensor to monitor injection force. Furthermore, a method for predicting treatment outcomes involves analyzing gene expression profiles of fibroid tissue to identify markers of collagenase responsiveness, and using machine learning algorithms to predict treatment efficacy.
Novelty and Inventive Step
The new claims introduce several novel and non-obvious features, including pH-adjusted buffers, temperature-controlled needles, protease inhibitors, and fibronectin-binding peptides, which collectively enhance collagenase efficacy and minimize off-target effects. These features are not anticipated by the original patent and represent a significant improvement over the existing approach.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept include using different pH-adjusted buffers, temperature-controlled needle designs, and protease inhibitors. Additionally, the fibronectin-binding peptide could be replaced with other collagen-binding peptides or molecules. The device for delivering the composition could also be modified to include different types of catheters, needles, or sensors.
Potential Commercial Applications and Market
The enhanced collagenase-based system has significant commercial potential in the medical device and pharmaceutical industries, particularly in the treatment of uterine fibroids. The target market includes hospitals, clinics, and medical centers specializing in women's health and reproductive medicine.
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 biotechnology focused on enzymatic tissue modification, specifically uterine fibroid treatment using collagenase-based interventions. Requires expertise in molecular biology, medical device design, enzyme engineering, and minimally invasive medical procedures
Person of Ordinary Skill (PHOSITA) Profile
A biomedical engineer or medical researcher with advanced degrees in biotechnology, experience in enzyme modification techniques, understanding of collagen degradation mechanisms, and familiarity with minimally invasive medical interventions
Obviousness Rationale
A person having ordinary skill would recognize that the PTD's variations represent predictable engineering improvements to the source patent's collagenase treatment method. The disclosed enhancements like pH-adjusted buffers, temperature-controlled delivery, and protease inhibitors are logical extensions of known techniques for optimizing enzymatic interventions. These modifications represent standard problem-solving approaches in biomedical engineering that would be apparent to a skilled practitioner seeking to improve tissue-specific enzymatic treatments.
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 |