3D Printed Biodegradable Multipurpose Toe Separator for Dermatological Applications

Abstract

The present invention relates to a 3D printed biodegradable toe separator designed for various dermatological applications. The toe separator is intended to address issues such as soft corns, intertrigo, and other dermatological conditions affecting the toes. Fabricated from biodegradable materials, this device promotes environmental sustainability while providing comfort and effectiveness in clinical settings. The toe separator features multiple compartments to accommodate each toe, a textured surface for improved grip, a porous structure to enhance airflow, and customizable curvature to match individual foot anatomy. It also incorporates antimicrobial agents or therapeutic compounds for enhanced dermatological care, making it a multipurpose solution that combines therapeutic efficacy with ecological responsibility.

Specification

Description:Figure 1 depicts the design blueprint of the biodegradable toe separator.
7.a. Design for 3D Printing:
The toe separator is designed to be manufactured using additive manufacturing techniques, commonly known as 3D printing. The process involves layer-by-layer deposition of material to build the final object according to a computer-generated design. Below is a detailed description of the design aspects of 3D printing for the biodegradable poly-lactic acid (PLA) based toe separator:
Computer-Aided Design (CAD):
The design process begins with the creation of a digital model using computer-aided design (CAD) software.The CAD model defines the geometry, dimensions, and intricate features of the toe separator, ensuring precise replication in the physical object.
Slicing:
Once the CAD model is finalized, it undergoes a slicing process, where the digital model is divided into thin horizontal layers.Each layer, typically ranging from 0.1 to 0.3 millimeters in thickness, represents a cross-section of the final toe separator.
Printing Parameters:
The 3D printing parameters are carefully selected to optimize the printing process and ensure the quality of the finished product. Printing temperature: PLA filament is heated to its melting point, typically around 180-220°C, to achieve proper flow and adhesion between layers.
Layer height: The layer height determines the resolution of the printed object. A finer layer height results in smoother surfaces but may increase printing time.
Printing speed: The speed at which the printer moves and deposits material affects the overall printing time and surface finish.
Support Structures:
In cases where overhangs or unsupported features exist in the design, support structures may be generated automatically or manually added to provide stability during printing.Support structures are designed to be easily removable after printing, minimizing post-processing efforts.
Printing Process:
The 3D printer follows the sliced layers' instructions, depositing PLA filament onto the build platform according to the defined paths. As each layer is deposited, it fuses with the previous layer, gradually building up the toe separator's three-dimensional structure. The printing process continues until the entire object is completed, with the final result being a fully formed, biodegradable toe separator.


Quality Control:
Throughout the printing process, quality control measures are implemented to ensure dimensional accuracy, layer adhesion, and overall print quality. Visual inspection and periodic monitoring of printing parameters help identify and address any issues that may arise during printing. By leveraging the capabilities of 3D printing technology, the design of the biodegradable PLA toe separator enables precise manufacturing of complex geometries with minimal material waste, making it an innovative solution for dermatological applications. Figure 1 depicts the design of the Toe separator.
7.b. Human trial
Table 1 depicts the results of a human trial on 10 patients. The clinical trial evaluated the efficacy of a 3D printed biodegradable toe separator in treating soft corn and intertrigo across multiple visits over a six-week period. Here are the key findings and interpretations of the results:

Investigators Global Assessment (IGA):
The Investigators Global Assessment (IGA) scores reflect the overall assessment of the toe separator's effectiveness by the investigators. The majority of patients showed improvement in their condition over the course of the study, as evidenced by decreasing IGA scores from baseline to subsequent visits. This suggests that the toe separator effectively addressed the dermatological concerns associated with soft corn and intertrigo.
Grading for Target Lesion (GTL):
Grading for Target Lesion (GTL) scores indicate the severity of the target lesion before and after treatment. Patients experienced a reduction in GTL scores over time, indicating a decrease in the severity of the target lesion with the use of the toe separator. This demonstrates the therapeutic benefits of the toe separator in managing dermatological conditions.


Subject's Global Assessment (SGA):
Subject's Global Assessment (SGA) reflects patients' own assessment of treatment efficacy and satisfaction.Overall, patients reported positive experiences and satisfaction with the toe separator, as indicated by increasing SGA scores throughout the study.
This suggests that patients perceived improvement in their condition and were pleased with the outcomes achieved with the toe separator.
Toe Separator Preference Score (TSPS):
Toe Separator Preference Score (TSPS) measures patients' preference for the toe separator compared to other treatment options. Patients consistently rated the toe separator favourably, with higher TSPS scores indicating a strong preference for this treatment modality. This underscores the acceptance and desirability of the toe separator among patients, further supporting its potential for widespread adoption.
Practical Assessments (Ease, Time Taken, Feel on Skin, Usefulness):
Patients reported positive experiences with the toe separator in terms of ease of use, comfort on the skin, and perceived usefulness.Shorter time taken for application, comfortable feel on the skin, and perceived usefulness of the toe separator were noted, highlighting its practical benefits for patients.
Overall, the results of the clinical trial demonstrate the efficacy, safety, and patient preference for the 3D printed biodegradable toe separator in managing soft corn and intertrigo. These findings support the potential for patenting this innovative dermatological solution.

The images presented below depict the efficacy of the 3D printed biodegradable toe separator in treating dermatological conditions such as soft corn and intertrigo. These images provide visual evidence of the toe separator's effectiveness across different patients and visits throughout the longitudinal clinical trial.

Image 2 (Baseline vs. Week -4):
Image 2 showcases the progression of treatment from baseline to Week -4, demonstrating a visible reduction in the size and severity of the target lesion.
The improvement in the skin's appearance and texture is indicative of the toe separator's ability to alleviate symptoms and promote healing.
This aligns with the positive feedback provided by patients in their Subject's Global Assessment (SGA) scores, reflecting their satisfaction and perceived improvement in their condition.
The comparison reveals a gradual decrease in redness, irritation, and discomfort associated with the target lesion, signifying the sustained efficacy of the toe separator over time.
This visual representation reinforces the findings of the Toe Separator Preference Score (TSPS), indicating patients' preference for the toe separator as a treatment modality.
we also observe a remarkable transformation in the appearance of the affected area, with significant reduction in inflammation and restoration of healthy skin.
The before-and-after comparison highlights the transformative effect of the toe separator in resolving dermatological issues and improving overall skin health.
Image 3 illustrates the Method of application of toe separator in patients.
This visual evidence strengthens the patent application by demonstrating the tangible benefits and therapeutic value of the 3D printed biodegradable toe separator in clinical practice.

Conclusion:
The present invention provides a novel solution to the limitations of existing toe separators by offering a biodegradable, multipurpose design suitable for dermatological applications. The customizable nature of the separator ensures optimal comfort and effectiveness for patients with various toe conditions.
, Claims:Claim 1:
This invention is a 3D printed biodegradable multipurpose toe separator for dermatological applications comprising:
a) a flexible and biodegradable material capable of conforming to various toe shapes and sizes,
b) a plurality of separate compartments, each compartment designed to accommodate a toe securely and comfortably,
c) a textured surface within each compartment to enhance grip and prevent slippage of the toe,
d) a central bridge connecting adjacent compartments to maintain proper alignment and spacing between toes,
e) a porous structure facilitating airflow and moisture absorption to promote skin health, and
f) a curvature conforming to the natural curvature of toes to minimize discomfort and pressure points.

Claim 2:
The toe separator of claim 1, wherein the flexible and biodegradable material comprises a blend of biopolymers, such as polylactic acid (PLA), polycaprolactone (PCL), or polyhydroxyalkanoates (PHA).

Claim 3:
The toe separator of claim 1, wherein each compartment further comprises one or more raised ridges along its inner surface to gently massage the skin and improve blood circulation.

Claim 4:
The toe separator of claim 1, wherein the textured surface within each compartment is achieved through the incorporation of micro-patterns or nanostructures.

Claim 5:
The toe separator of claim 1, wherein the central bridge is anatomically shaped to accommodate the natural curvature of the foot and toes.


Claim 6:
The toe separator of claim 1, wherein the porous structure is achieved through a lattice or honeycomb pattern, providing both flexibility and structural integrity.

Claim 7:
The toe separator of claim 1, wherein the curvature is customizable based on the individual's foot anatomy through the use of 3D scanning and printing technologies.
Claim 8:
The toe separator of claim 1, further comprising antimicrobial agents or therapeutic compounds embedded within the biodegradable material to prevent infections and promote healing of dermatological conditions.

Claim 9:
The toe separator of claim 1, wherein the biodegradable material is capable of degrading within a specified timeframe, thereby minimizing environmental impact after disposal.

Claim 10:
The toe separator of claim 1, wherein the plurality of separate compartments are color-coded for ease of identification and application.

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