Description:3D printing of customized drug delivery systems for personalized treatment of diabetes mellitus
Field of the Invention
[0001] The present disclosure relates to additive manufacturing of therapeutic devices, more particularly, to 3D printing of customized drug delivery systems for personalized treatment of diabetes mellitus.
Background
[0002] The background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.
[0003] Diabetes mellitus represents a chronic metabolic disorder characterized by persistent hyperglycemia, resulting from impaired insulin secretion, defective insulin action, or a combination thereof. Current therapeutic regimens for diabetes primarily rely on subcutaneous injections of insulin, oral hypoglycemic agents, and lifestyle management. Although such treatments are clinically effective to some extent, they remain limited by inconsistent pharmacokinetics, poor patient compliance, and lack of personalization. For example, insulin injections typically provide systemic delivery without regard to individual glycemic fluctuations, thereby exposing patients to risks of both hypoglycemia and prolonged hyperglycemia.
[0004] Traditional drug delivery systems, including polymeric implants, microcapsules, and osmotic pumps, have been investigated to improve insulin release profiles. However, such systems are often manufactured in standardized designs, lacking adaptability to interpatient variability in insulin sensitivity, dietary habits, and glucose metabolism. Furthermore, conventional fabrication methods restrict the structural complexity of drug carriers, preventing fine-tuned control over release kinetics. Recent advancements in personalized medicine have highlighted the importance of integrating patient-specific biological data into therapeutic design, yet manufacturing technologies have not adequately addressed this need.
[0005] Three-dimensional printing, also known as additive manufacturing, has emerged as a transformative technology enabling fabrication of complex, patient-specific devices directly from digital models. Applications in biomedical engineering have demonstrated 3D printing of prosthetics, tissue scaffolds, and customized implants. However, its application in drug delivery for diabetes remains underexplored, particularly in the domain of personalized insulin administration. Major challenges persist regarding stability of bioactive molecules during the printing process, reproducibility of dosage, and integration of clinical data into device design.
[0006] Accordingly, there exists a pressing need for a system that integrates patient-specific glycemic data, computer-aided design of delivery devices, and additive manufacturing of biodegradable polymer-drug composites into a unified platform. Such a system must provide precise structural control, dosage uniformity, and real-time quality verification, while offering flexibility in designing oral, transdermal, and implantable drug delivery formats tailored to individual diabetic patients.
Summary
[0007] The following presents a simplified summary of various aspects of this disclosure in order to provide a basic understanding of such aspects. This summary is not an extensive overview of all contemplated aspects, and is intended to neither identify key or critical elements nor delineate the scope of such aspects. Its purpose is to present some concepts of this disclosure in a simplified form as a prelude to the more detailed description that is presented later.
[0008] The following paragraphs provide additional support for the claims of the subject application.
[0009] The disclosure pertains to a three-dimensional printing system for customized drug delivery systems tailored for diabetes mellitus management is provided. The system includes a digital formulation module configured to integrate patient-specific clinical data, including glycemic index and insulin sensitivity. A computer-aided design module generates device geometries that regulate drug release kinetics, incorporating channels, pores, or multi-compartment structures for differential release. A multi-nozzle 3D printer, equipped with sterile enclosures and temperature-controlled heads, fabricates polymeric matrices co-loaded with insulin or other antidiabetic drugs. The printer processes biocompatible and biodegradable polymers, including polylactic acid, polycaprolactone, or hydrogel composites, in combination with therapeutic agents and stabilizing excipients.
[00010] The system further includes a quality control interface utilizing optical coherence tomography, thermal sensors, and infrared spectroscopy for non-invasive verification of dosage accuracy and structural fidelity. The printed devices may be configured in multiple formats. In one embodiment, the device is an oral capsule with multilayered shells for controlled gastrointestinal release. In another embodiment, the device is a transdermal microneedle patch for minimally invasive drug administration. In a further embodiment, the device is a subcutaneous implantable reservoir for long-term basal insulin release.
[00011] The method flow includes inputting patient-specific glucose variability data, generating a personalized design file, manufacturing the delivery device through layer-by-layer deposition, and verifying quality parameters in real time. Upon administration, the device provides sustained and tailored release of insulin, reducing risks of glycemic fluctuations and improving treatment compliance. By integrating digital health records, additive manufacturing, and therapeutic monitoring, the system establishes a comprehensive platform for personalized diabetes management.
Brief Description of the Drawings
[00012] The features and advantages of the present disclosure would be more clearly understood from the following description taken in conjunction with the accompanying drawings in which:
[00013] FIG. 1 illustrates a block diagram of the 3D printing system for customized drug delivery devices showing interrelation of digital formulation module, computer-aided design module, multi-nozzle printer, formulation cartridge, and quality control interface, in accordance with the embodiments of the present disclosure.
[00014] FIG. 2 illustrates a sequence diagram showing therapeutic operational flow beginning with acquisition of patient-specific glucose data, followed by CAD generation, additive manufacturing, real-time monitoring, and patient administration of a personalized device, in accordance with the embodiments of the present disclosure.
[00015] FIG. 3 illustrates a deployment architecture diagram showing integration of external data sources such as electronic health records and continuous glucose monitoring with internal modules including formulation design, additive manufacturing, and therapeutic monitoring, culminating in administration of oral, transdermal, or implantable drug delivery formats, in accordance with the embodiments of the present disclosure.

Detailed Description
[00016] In the following detailed description of the invention, reference is made to the accompanying drawings that form a part hereof, and in which is shown, by way of illustration, specific embodiments in which the invention may be practiced. In the drawings, like numerals describe substantially similar components throughout the several views. These embodiments are described in sufficient detail to claim those skilled in the art to practice the invention. Other embodiments may be utilized and structural, logical, and electrical changes may be made without departing from the scope of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present invention is defined only by the appended claims and equivalents thereof.
[00017] The use of the terms “a” and “an” and “the” and “at least one” and similar referents in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The use of the term “at least one” followed by a list of one or more items (for example, “at least one of A and B”) is to be construed to mean one item selected from the listed items (A or B) or any combination of two or more of the listed items (A and B), unless otherwise indicated herein or clearly contradicted by context. The terms “comprising,” “having,” “including,” and “containing” are to be construed as open-ended terms (i.e., meaning “including, but not limited to,”) unless otherwise noted. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein, is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.
[00018] Pursuant to the "Detailed Description" section herein, whenever an element is explicitly associated with a specific numeral for the first time, such association shall be deemed consistent and applicable throughout the entirety of the "Detailed Description" section, unless otherwise expressly stated or contradicted by the context.
[00019] The disclosed system for three-dimensional printing of customized drug delivery devices for personalized treatment of diabetes mellitus is described in expanded technical detail. The system operates as a unified platform comprising multiple modules configured to cooperate in generating patient-specific therapeutic devices. The digital formulation module serves as the initial stage. Said module acquires clinical parameters including continuous glucose monitoring data, insulin sensitivity indices, dietary logs, and pharmacokinetic measurements from electronic health records. The data is processed through computational algorithms that determine patient-specific dosage requirements and therapeutic release profiles. Each calculation is translated into numerical parameters defining quantity of insulin, desired release rate, and duration of therapeutic coverage.
[00020] The processed data is transferred into the computer-aided design module. Said design module generates a geometric model of the drug delivery device. The model incorporates structural features including multilayer shells, micro-channels, porous lattices, and compartmentalized cores. Each feature is mathematically determined to regulate diffusion, polymer degradation, or dissolution rates. For example, a capsule may include alternating hydrophilic and hydrophobic layers, thereby providing staged release of rapid-acting and long-acting insulin formulations. The CAD file is optimized for compatibility with additive manufacturing hardware and exported as a three-dimensional print file.
[00021] The additive manufacturing process is conducted through a multi-nozzle 3D printer. Said printer comprises extrusion heads configured to process polymer-drug composites while maintaining bioactivity of insulin. The print chamber is sterile and temperature-controlled, thereby preventing denaturation of therapeutic proteins. Layer-by-layer deposition of polymer-drug mixtures results in a construct with precise geometric fidelity. Each deposition step is monitored by optical sensors that verify layer thickness, uniformity, and alignment. Thermal sensors monitor print head temperatures, ensuring stability of insulin molecules. Infrared spectroscopy may be applied in real time to verify uniform drug distribution across deposited layers.
[00022] Upon completion of fabrication, the quality control interface validates the final construct. Structural integrity is assessed through optical coherence tomography, dosage uniformity is confirmed through non-destructive spectroscopy, and overall mass balance is verified through integrated microbalance systems. Only validated constructs are released for clinical administration.
[00023] In one embodiment, the printed device is configured as an oral capsule. The capsule comprises multilayer shells fabricated from biodegradable polymers such as polylactic acid. The inner layer incorporates fast-acting insulin for immediate glycemic control, while the outer shell comprises slow-degrading polymers containing long-acting insulin. As the capsule enters the gastrointestinal tract, sequential degradation of layers provides staggered release profiles. The technical benefit of this embodiment lies in mimicking physiological insulin dynamics, thereby reducing postprandial hyperglycemia while sustaining basal insulin levels.
[00024] In another embodiment, the device is fabricated as a transdermal patch incorporating microneedle arrays. Each microneedle is 3D printed with biodegradable polymers and loaded with insulin. Upon application, the microneedles penetrate the stratum corneum, dissolve within dermal tissue, and release insulin directly into systemic circulation. The technical benefit of this embodiment is minimally invasive administration, eliminating the discomfort associated with repeated injections and improving patient compliance.
[00025] In a third embodiment, the device is fabricated as a subcutaneous implantable reservoir. Said reservoir comprises porous lattice walls fabricated from polycaprolactone, with insulin embedded in polymeric matrices. Drug release occurs through combined mechanisms of diffusion and polymer degradation, thereby sustaining basal insulin coverage for extended durations up to several weeks. The technical benefit is reduction of dosing frequency, improved patient adherence, and stable maintenance of glycemic control.
[00026] Alternative operational flows are further described. In one flow, digital data from continuous glucose monitoring is updated daily, enabling recalibration of the design module and printing of revised capsules tailored to fluctuating insulin needs. In another flow, pharmacokinetic monitoring identifies patient-specific absorption rates, leading to modification of microneedle geometry or polymer composition in subsequent production cycles. In a further flow, therapeutic outcome data from biomarkers such as glycated hemoglobin is integrated into the digital formulation module, influencing long-term customization of implantable reservoirs.

[00027] The disclosed system reiterates data processing flows across different clinical scenarios. In acute hyperglycemic episodes, rapid printing of oral capsules containing high doses of fast-acting insulin is performed. In chronic management, implantable reservoirs are produced to provide sustained insulin release. In pediatric patients, microneedle patches with reduced polymer load are fabricated to minimize invasiveness. Each operational flow demonstrates the adaptability of the system in addressing diverse clinical contexts.
[00028] Thus, the three-dimensional printing system integrates patient-specific data acquisition, computational modeling, additive manufacturing, and real-time quality verification into a cohesive therapeutic platform. The multiplicity of embodiments demonstrates structural versatility, operational flexibility, and clinical applicability. The system delivers technical benefits including improved pharmacokinetics, enhanced compliance, minimized invasiveness, and reduced risks of glycemic variability. The disclosed approach establishes a transformative paradigm in the field of personalized diabetes therapy by uniting digital health integration with advanced additive manufacturing.
[00029] Figure 1 represents a block diagram depicting the structural arrangement of functional modules within the disclosed system. The figure demonstrates a digital formulation module configured to acquire patient-specific glycemic data and pharmacokinetic parameters. Said module is directly connected to a computer-aided design unit, wherein computational models generate geometrical device structures optimized for controlled drug release. The CAD module is operatively linked to a multi-nozzle printer that simultaneously processes polymer matrices and therapeutic agents. A formulation cartridge provides input materials comprising biodegradable polymers and insulin, which are conveyed to the printer for deposition. A quality control interface is arranged downstream of the printer to ensure structural fidelity and dosage uniformity before patient use. The block arrangement provides a clear illustration of sequential and parallel connections between design, manufacturing, and validation modules. By structuring the system in modular blocks, the architecture demonstrates integration of digital personalization, additive manufacturing, and validation functions. Technical benefits include streamlined data flow, minimized risk of error, and seamless production of personalized drug delivery devices within clinical settings.
[00030] Figure 2 represents a sequence diagram describing temporal flow of operations in the disclosed therapeutic system. The flow begins with acquisition of patient data, which is processed by the digital formulation unit to generate dosage and release parameters. The sequence then proceeds to CAD generation of a device geometry, wherein release kinetics are defined through microchannel and layered-shell design. The subsequent stage involves additive manufacturing through the 3D printer, monitored in real time by sensors embedded within the quality control interface. Upon completion of fabrication, validation of dosage and construct fidelity occurs. Finally, the device is administered to the patient through an oral capsule, transdermal patch, or implantable reservoir. The temporal arrangement of stages emphasizes clinical workflow continuity. By presenting a linear progression from data input to therapeutic administration, the figure demonstrates an end-to-end framework. Each sequential stage builds upon preceding operations, ensuring that personalization, structural precision, and patient-specific therapeutic effect are integrated into one coherent cycle.
[00031] Figure 3 represents a deployment architecture diagram illustrating integration of external and internal elements. External data sources include electronic health records and continuous glucose monitoring devices, which supply input parameters to the digital formulation module. Said module interacts with an internal computational controller that manages both CAD generation and additive manufacturing. The manufacturing environment incorporates sterile print chambers and multi-nozzle extrusion heads supplied by formulation cartridges containing polymers and insulin composites. Downstream quality control units provide feedback loops to both the computational controller and clinical dashboard. The deployment extends into therapeutic outcomes, with three branches showing oral capsules, transdermal microneedle patches, and implantable reservoirs. Clinical monitoring nodes ensure adaptive redesign of subsequent devices. The deployment arrangement highlights system integration within a healthcare ecosystem. By connecting external clinical data streams with internal design and fabrication processes, the system enables closed-loop personalization. The technical benefit lies in seamless translation of patient-specific information into manufacturable therapeutic devices that remain adaptable across multiple delivery routes.
[00032] Operations in accordance with a variety of aspects of the disclosure is described above would not have to be performed in the precise order described. Rather, various steps can be handled in reverse order or simultaneously or not at all.
[00033] While several implementations have been described and illustrated herein, a variety of other means and/or structures for performing the function and/or obtaining the results and/or one or more of the advantages described herein may be utilized, and each of such variations and/or modifications is deemed to be within the scope of the implementations described herein. More generally, all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings is/are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific implementations described herein. It is, therefore, to be understood that the foregoing implementations are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, implementations may be practiced otherwise than as specifically described and claimed. Implementations of the present disclosure are directed to each individual feature, system, article, material, kit, and/or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and/or methods, if such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent, is included within the scope of the present disclosure.
 

Claims
I/We Claim:
1. A three-dimensional printing system for customized drug delivery devices adapted for personalized treatment of diabetes mellitus, comprising: a digital formulation module configured to generate patient-specific drug profiles based on glycemic index, insulin sensitivity, and pharmacokinetic parameters; a computer-aided design module configured to design a drug delivery geometry incorporating channels, pores, and compartments tailored to drug release kinetics; a 3D printer comprising multi-nozzle extrusion heads adapted to process biocompatible polymers and therapeutic agents simultaneously; a formulation cartridge comprising biodegradable polymer matrices selected from polylactic acid, polycaprolactone, or hydrogel composites integrated with insulin or other antidiabetic agents; and a quality control interface configured to monitor layer-by-layer deposition accuracy and therapeutic dosage uniformity through optical and thermal sensors, wherein the resulting drug delivery system provides controlled release of insulin over a patient-specific timeframe.
2. The system of claim 1, wherein the digital formulation module incorporates continuous glucose monitoring data and electronic health record integration, thereby enabling real-time personalization of drug delivery devices in accordance with dynamic patient glucose variability.
3. The system of claim 1, wherein the computer-aided design module generates multi-compartment geometries configured to sequentially release fast-acting and long-acting insulin formulations, thereby mimicking physiological pancreatic release dynamics in diabetic patients.
4. The system of claim 1, wherein the 3D printer is equipped with temperature-controlled print heads and sterile enclosures, thereby enabling preservation of insulin bioactivity during additive manufacturing of polymer-drug composites.
5. The system of claim 1, wherein the formulation cartridge further comprises excipients selected from stabilizers, permeation enhancers, and pH-responsive polymers, thereby enabling extended stability and selective release of therapeutic agents in gastrointestinal environments.
6. The system of claim 1, wherein the quality control interface incorporates optical coherence tomography sensors, microbalance weight monitors, and infrared spectroscopy modules, thereby providing non-destructive verification of structural fidelity, layer density, and uniform distribution of insulin within printed constructs.
7. The system of claim 1, wherein the drug delivery device is configured as an oral capsule comprising multilayered polymeric shells and embedded micro-channels, thereby achieving controlled degradation and sustained insulin release after gastrointestinal absorption.
8. The system of claim 1, wherein the drug delivery device is configured as a transdermal patch comprising microneedle arrays fabricated by 3D printing, wherein each microneedle is loaded with insulin and configured to dissolve after insertion into epidermal tissue, thereby enabling minimally invasive administration of therapeutic agents.
9. The system of claim 1, wherein the drug delivery device is configured as an implantable subcutaneous reservoir comprising porous lattice walls fabricated from biodegradable polymers, wherein insulin is embedded within the matrix and released gradually through diffusion and polymer degradation, thereby maintaining basal insulin levels for extended durations.
10. The system of claim 1, wherein the integration of patient-specific design, additive manufacturing, and real-time quality control establishes an adaptive therapeutic platform capable of personalized drug release, thereby addressing interpatient variability in diabetes management and reducing risks of hypo- or hyperglycemic episodes.

3D printing of customized drug delivery systems for personalized treatment of diabetes mellitus
Abstract
A three-dimensional printing system for customized drug delivery devices adapted for diabetes mellitus treatment is disclosed. The system comprises a digital formulation module generating patient-specific profiles, a computer-aided design module producing tailored device geometries, and a 3D printer processing biocompatible polymers and insulin-loaded composites. A quality control interface verifies deposition accuracy and dosage uniformity. The fabricated devices may be configured as oral capsules, transdermal microneedle patches, or implantable reservoirs, each delivering insulin through controlled release kinetics. Patient-specific clinical data including glucose variability is integrated to achieve adaptive designs. The system provides personalized, sustained, and minimally invasive drug administration, thereby improving compliance and reducing glycemic fluctuations. Integration of structural customization, real-time quality monitoring, and flexible therapeutic formats establishes a transformative framework for individualized diabetes therapy.
Fig. 1

  , Claims:Claims
I/We Claim:
1. A three-dimensional printing system for customized drug delivery devices adapted for personalized treatment of diabetes mellitus, comprising: a digital formulation module configured to generate patient-specific drug profiles based on glycemic index, insulin sensitivity, and pharmacokinetic parameters; a computer-aided design module configured to design a drug delivery geometry incorporating channels, pores, and compartments tailored to drug release kinetics; a 3D printer comprising multi-nozzle extrusion heads adapted to process biocompatible polymers and therapeutic agents simultaneously; a formulation cartridge comprising biodegradable polymer matrices selected from polylactic acid, polycaprolactone, or hydrogel composites integrated with insulin or other antidiabetic agents; and a quality control interface configured to monitor layer-by-layer deposition accuracy and therapeutic dosage uniformity through optical and thermal sensors, wherein the resulting drug delivery system provides controlled release of insulin over a patient-specific timeframe.
2. The system of claim 1, wherein the digital formulation module incorporates continuous glucose monitoring data and electronic health record integration, thereby enabling real-time personalization of drug delivery devices in accordance with dynamic patient glucose variability.
3. The system of claim 1, wherein the computer-aided design module generates multi-compartment geometries configured to sequentially release fast-acting and long-acting insulin formulations, thereby mimicking physiological pancreatic release dynamics in diabetic patients.
4. The system of claim 1, wherein the 3D printer is equipped with temperature-controlled print heads and sterile enclosures, thereby enabling preservation of insulin bioactivity during additive manufacturing of polymer-drug composites.
5. The system of claim 1, wherein the formulation cartridge further comprises excipients selected from stabilizers, permeation enhancers, and pH-responsive polymers, thereby enabling extended stability and selective release of therapeutic agents in gastrointestinal environments.
6. The system of claim 1, wherein the quality control interface incorporates optical coherence tomography sensors, microbalance weight monitors, and infrared spectroscopy modules, thereby providing non-destructive verification of structural fidelity, layer density, and uniform distribution of insulin within printed constructs.
7. The system of claim 1, wherein the drug delivery device is configured as an oral capsule comprising multilayered polymeric shells and embedded micro-channels, thereby achieving controlled degradation and sustained insulin release after gastrointestinal absorption.
8. The system of claim 1, wherein the drug delivery device is configured as a transdermal patch comprising microneedle arrays fabricated by 3D printing, wherein each microneedle is loaded with insulin and configured to dissolve after insertion into epidermal tissue, thereby enabling minimally invasive administration of therapeutic agents.
9. The system of claim 1, wherein the drug delivery device is configured as an implantable subcutaneous reservoir comprising porous lattice walls fabricated from biodegradable polymers, wherein insulin is embedded within the matrix and released gradually through diffusion and polymer degradation, thereby maintaining basal insulin levels for extended durations.
10. The system of claim 1, wherein the integration of patient-specific design, additive manufacturing, and real-time quality control establishes an adaptive therapeutic platform capable of personalized drug release, thereby addressing interpatient variability in diabetes management and reducing risks of hypo- or hyperglycemic episodes.