Description:DISCLAIMER
[001] Portions of this patent document may contain material that may be subject to Copyright or Trademark protection. The owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the Patent and Trademark Office file or records, but otherwise reserves all copyright rights and trademarks whatsoever. All copyrights and trademarks are owned by Indian Institute of Science, Bangalore.

TECHNICAL FIELD
[002] The present disclosure relates generally to the field of medical devices and drug delivery systems. In particular, the present disclosure relates to an applicator for facilitating application of microneedle patches onto a target area of a subject for various medical and therapeutic purposes.

BACKGROUND
[003] The background information provided hereunder is instructive for understanding the present disclosure but does not necessarily constitute prior art with respect to any of the embodiments of the present disclosure described herein.
[004] The use of microneedles for drug delivery and disease monitoring has gained significant attention in recent years due to their capability to provide targeted and minimally invasive interventions. However, one of the major challenges faced in this field is ensuring precise and reproducible application of microneedle patches onto a skin surface. This challenge has spurred the development and widespread adoption of specialized applicators designed explicitly for microneedle applications.
[005] Applicators are instrumental in ensuring a uniform application force across multiple needles, which is crucial for effective skin penetration. This uniform force distribution is essential for achieving consistent and reproducible results, especially in drug delivery applications where accurate dosing is critical. The applicators are employed with various types of microneedles, including hollow, dissolvable, and coated varieties. Regardless of the microneedle type, the success of microneedle penetration depends heavily on the force applied during the application. It is vital to vary the force and impact velocity according to the microneedle dimensions and the characteristics of the skin surface to optimize penetration depth and ensure patient comfort.
[006] However, conventional applicators fail to vary the application force and are single-use applicators. The single-use applicator features a preloaded patch component, which fits into a complementary component, and the preloaded patch component may be pressed onto the target area. Further, few conventional microneedle applicators are provided for skincare treatment. This dual-action applicator may create tiny punctures in the skin while simultaneously delivering skincare serums, vitamins, or other solutions in real time, which may be harmful to the skin.
[007] Therefore, there is, a need for an improved applicator for facilitating application of microneedle patches onto the target area at least to overcome the above-mentioned deficiencies.

OBJECTS OF THE PRESENT DISCLOSURE
[008] Some of the objects of the present disclosure which are sought to be achieved by at least one embodiment herein described are enlisted hereunder.
[009] An object of the present disclosure is to provide an applicator for facilitating seamless and efficient application of microneedle patches onto a target area of a subject.
[010] An object of the present disclosure is to provide an applicator that ensures optimal performance by ensuring accurate piercing of the microneedle patches into a transdermal region of the subject.
[011] An object of the present disclosure is to provide an applicator that applies a uniform and controlled force across an entire array, ensuring consistent penetration of microneedles.
[012] Still another object of the present disclosure is to provide an applicator in which a force exerted is meticulously adjusted to achieve a desired depth with minimal discomfort to a user while preserving a structural integrity of the microneedles.
[013] Yet another object of the present disclosure is to provide an applicator that ensures a balance between force application and user comfort, thereby achieving optimized performance and usability.
[014] Other objects and advantages of the present disclosure will be more apparent from the following description, which is not intended to limit the scope of the present disclosure.

SUMMARY
[015] This section is provided to introduce certain objects and aspects of the present disclosure in a simplified form that are further described below in the detailed description. This summary is not intended to identify the key features or the scope of the claimed subject matter.
[016] In an aspect, the present disclosure relates to an applicator for applying a microneedle patch onto a target area of a subject. The applicator includes an outer body includes at least a cap portion and a base portion. The applicator includes an inner body including a groove along a length of the inner body. The applicator includes a central shaft conformed to one or more features of the groove. The central shaft is loaded with a spring mechanism. The applicator includes a microneedle assembly including a microneedle patch, positioned at the base portion of the outer body. The cap portion is pulled outward and rotated in a clockwise direction to a predefined angle, such that the spring mechanism is compressed to initiate release of the central shaft. Upon rotating the cap portion in the clockwise direction, the cap portion is rotated in a counterclockwise direction to the predefined angle to facilitate expansion of the spring mechanism, such that the central shaft is extended towards the base portion to apply the microneedle patch onto a target area.
[017] In an embodiment, the outer body may include one or more guideways on an internal surface of the outer body to facilitate linear motion of the inner body within the outer body at different distances.
[018] In an embodiment, the distances may be calibrated to compress the spring mechanism, and generate an insertion force for applying the microneedle patch onto the target area based on at least a dimension of the microneedle patch.
[019] In an embodiment, the one or more guideways may be configured to modulate the insertion force of the microneedle patch onto the target area based on at least the dimension of the microneedle patch.
[020] In an embodiment, the inner body may be configured to rotate or move within the outer body.
[021] In an embodiment, the inner body may be equipped with one or more sliders that move along the one or more guideways to enable controlled linear and rotary movement of the central shaft.
[022] In an embodiment, the one or more sliders may move along the one or more guideways to enable the central shaft to contact the microneedle patch.
[023] In an embodiment, when the central shaft is extended towards the base portion, a potential energy may be transferred from the central shaft to the microneedle patch to apply the microneedle patch onto the target area.
[024] In an embodiment, the microneedle assembly may be aligned to ensure optimal contact between the central shaft and the microneedle patch.
[025] In an embodiment, the central shaft may be operatively connected to the cap portion using one or more securing members.

BRIEF DESCRIPTION OF DRAWINGS
[026] The accompanying drawings, which are incorporated herein, and constitute a part of this disclosure, illustrate exemplary embodiments of the disclosed methods and systems which like reference numerals refer to the same parts throughout the different drawings. Components in the drawings are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the present disclosure. Some drawings may indicate the components using block diagrams and may not represent the internal circuitry of each component. It will be appreciated by those skilled in the art that disclosure of such drawings includes the disclosure of electrical components, electronic components, or circuitry commonly used to implement such components.
[027] FIGs. 1A and 1B illustrate exemplary exploded views of an applicator (100) for applying a microneedle patch onto a target area of a subject, in accordance with an embodiment of the present disclosure.
[028] FIGs. 2A-2C illustrate different views of an outer body of the applicator (100), in accordance with an embodiment of the present disclosure.
[029] FIGs. 3A-3D illustrate different views of an inner body of the applicator (100), in accordance with an embodiment of the present disclosure.
[030] FIG. 4 illustrates a perspective view depicting a connection between a cap portion and a central shaft of the applicator (100), in accordance with an embodiment of the present disclosure.
[031] The foregoing shall be more apparent from the following more detailed description of the disclosure.

DETAILED DESCRIPTION
[032] In the following description, for the purposes of explanation, various specific details are set forth in order to provide a thorough understanding of embodiments of the present disclosure. It will be apparent, however, that embodiments of the present disclosure may be practiced without these specific details. Several features described hereafter can each be used independently of one another or with any combination of other features. An individual feature may not address all of the problems discussed above or might address only some of the problems discussed above. Some of the problems discussed above might not be fully addressed by any of the features described herein.
[033] The ensuing description provides exemplary embodiments only and is not intended to limit the scope, applicability, or configuration of the disclosure. Rather, the ensuing description of the exemplary embodiments will provide those skilled in the art with an enabling description for implementing an exemplary embodiment. It should be understood that various changes may be made in the function and arrangement of elements without departing from the spirit and scope of the disclosure as set forth.
[034] Specific details are given in the following description to provide a thorough understanding of the embodiments. However, it will be understood by one of ordinary skill in the art that the embodiments may be practiced without these specific details. For example, circuits, systems, networks, processes, and other components may be shown as components in block diagram form in order not to obscure the embodiments in unnecessary detail. In other instances, well-known circuits, processes, algorithms, structures, and techniques may be shown without unnecessary detail to avoid obscuring the embodiments.
[035] Also, it is noted that individual embodiments may be described as a process that is depicted as a flowchart, a flow diagram, a data flow diagram, a structure diagram, or a block diagram. Although a flowchart may describe the operations as a sequential process, many of the operations can be performed in parallel or concurrently. In addition, the order of the operations may be re-arranged. A process is terminated when its operations are completed but could have additional steps not included in a figure. A process may correspond to a method, a function, a procedure, a subroutine, a subprogram, etc. When a process corresponds to a function, its termination can correspond to a return of the function to the calling function or the main function.
[036] The word “exemplary” and/or “demonstrative” is used herein to mean serving as an example, instance, or illustration. For the avoidance of doubt, the subject matter disclosed herein is not limited by such examples. In addition, any aspect or design described herein as “exemplary” and/or “demonstrative” is not necessarily to be construed as preferred or advantageous over other aspects or designs, nor is it meant to preclude equivalent exemplary structures and techniques known to those of ordinary skill in the art. Furthermore, to the extent that the terms “includes,” “has,” “contains,” and other similar words are used in either the detailed description or the claims, such terms are intended to be inclusive in a manner similar to the term “comprising” as an open transition word without precluding any additional or other elements.
[037] Reference throughout this specification to “one embodiment” or “an embodiment” or “an instance” or “one instance” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
[038] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. As used herein, the singular forms “a”, “an”, and “the” are intended to include the plural forms as well, unless the context indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items.
[039] The present disclosure relates generally to the field of medical devices and drug delivery systems. In particular, the present disclosure relates to an applicator for facilitating application of microneedle patches onto a target area of a subject for various medical and therapeutic purposes.
[040] The present disclosure discloses an applicator to facilitate seamless and efficient application of microneedle patches onto a target area, for example, but not limited to, limbs or torso of a subject, for example, a human. The applicator is configured to ensure an optimal performance by ensuring accurate piercing of microneedles into a transdermal region. During application, the applicator applies a uniform and controlled force across an entire array, ensuring consistent penetration of the microneedles. Moreover, the force exerted is meticulously adjusted to achieve a desired depth with minimal discomfort to a user while preserving a structural integrity of the microneedles. Therefore, a balance is maintained between the force application and the user comfort, and the performance and usability of the microneedle patch applicator are optimized.
[041] Various embodiments of the present disclosure will be explained in detail with reference to FIGs. 1A-4.
[042] With reference to FIGs. 1A-4, an applicator (100) may be configured for applying a microneedle patch (110a) onto a target area of a subject. The target area may be for example, but not limited to, limbs, torso, neck, arms, etc. The subject may be for example, but not limited to, a human.
[043] The applicator (100) may include an outer body (102), an inner body (104), a central shaft (106), a spring mechanism (108), and a microneedle assembly (110). In an embodiment, the outer body (102) may include a cap portion (102a), a middle portion, and a base portion (102b). The cap portion (102a), the middle portion, and the base portion (102b) may be assembled using, for example, M3 bolts. The cap portion (102a), the middle portion, and the base portion (102b) may be assembled through concealed threads provided by insert nuts in the base portion (102b). In an embodiment, the microneedle assembly (110) may be positioned at the base portion (102b) of the outer body (102). The microneedle assembly (110) may include a microneedle patch (110a). The microneedle patch may include one or more microneedles.
[044] In an embodiment, the outer body (102) may include one or more guideways (102c), as illustrated in FIGs. 2B and 2C. The one or more guideways (102c) may be provided on an internal surface of the outer body (102). The one or more guideways (102c) may be configured to facilitate linear motion of the inner body (104) within the outer body (102) at different distances. In an embodiment, the distances may be calibrated to compress the spring mechanism (108), thereby generating an insertion force for applying the microneedle patch (110a) onto the target area. The generation of the insertion force may be based on a dimension, for example, a length of the microneedle patch (110a). The length of the microneedle patch (110a) may be ranging from, for example, but not limited to, 600µm to 1200µm. The insertion force may be meticulously adjusted to achieve a desired depth with minimal discomfort to a user while preserving a structural integrity of the microneedles.
[045] Therefore, by changing the length of compression of the spring mechanism (108), a contact force exerted on the microneedle patch (110a) during application may be manipulated. Furthermore, the one or more guideways (102c) may allow rotary motion of the central shaft (106) up to, for example, 90° about an axis for locking and quick releasing actions of the central shaft (106). In an embodiment, the one or more guideways (102c) may be configured to modulate or adjust the insertion force of the microneedle patch (110a) onto the target area based on the length of the microneedle patch (110a).
[046] In an embodiment, the inner body (104) may be configured to rotate within the outer body (102), as illustrated in FIGs. 3A-3D. In an embodiment, the inner body (104) may include a groove (104a) along a length of the inner body (104). The inner body (104) may be equipped with one or more extrusions. The one or more extrusions may serve as one or more sliders (104b). The one or more sliders (104b) may move along the one or more guideways (102c) to enable controlled linear and rotary movement of the central shaft (106). In an embodiment, the one or more sliders (104b) may move along the one or more guideways (102c) to enable the central shaft (106) to contact the microneedle patch (110a).
[047] In an embodiment, the central shaft (106) may be conformed to one or more features of the groove (104a). The one or more features may include, but not limited to, a size and a shape of the groove (104a). In an embodiment, the central shaft (106) may be loaded with the spring mechanism (108). In an embodiment, the central shaft (106) may be operatively connected to the cap portion (102a) using one or more securing members (112). The one or more securing members (112) may be for example, but not limited to, bolts, nuts, mounts, etc.
[048] In an embodiment, the microneedle assembly (110) may be aligned to ensure optimal contact between the central shaft (106) and the microneedle patch (110a).
[049] In an embodiment, the cap portion (102a) may be pulled linearly outward and rotated in a clockwise direction to a predefined angle, for example, 90°, such that the spring mechanism (108) may be compressed to initiate release of the central shaft (106). Upon rotating the cap portion (102a) in the clockwise direction, the cap portion (102a) may be rotated in a counterclockwise direction to the predefined angle, for example, 90°, to facilitate expansion of the spring mechanism (108). Therefore, the central shaft (106) may be extended towards the base portion (102b) to apply the microneedle patch (110a) onto the target area. This process may ensure ideal penetration of the microneedles into the skin, facilitating efficient drug delivery onto the target area.
[050] In an embodiment, when the central shaft (106) is extended towards the base portion (102b), a potential energy may be transferred from the central shaft (106) to the microneedle patch (110a) to efficiently apply the microneedle patch (110a) onto the target area.
[051] In an embodiment, as illustrated in FIG. 4, the cap portion (102a) may be configured to facilitate the application of the microneedle patch (110a) to the target area. In an embodiment, the central shaft (106) may be configured with the spring mechanism (108) between a bottom face (116) and a central platform (114). In an embodiment, the extrusion of the inner body (104) may be concentric. In an embodiment, the extrusion of the inner body (104) may serve as a stable base, for effectuating the spring mechanism (108) through the central shaft (106).
[052] Therefore, the outer body (102), the inner body (104), the central shaft (106), the spring mechanism (108), and the microneedle assembly (110) may be assembled to contribute to an ergonomic single hand-held device, enabling a patient or the user to apply the microneedle patch (110a), for example, a drug delivery patch easily and conveniently.
[053] The applicator (100) may be used to apply the microneedle patch (110a) to deliver the drug through the skin (transdermal drug delivery) to target any disease or for medication. The applicator (100) may be reused. The application force of the microneedle patch (110a) may be varied precisely depending on the microneedle used. The applicator (100) may be used to apply the microneedles of any material, by varying the force according to a material strength and penetration characteristics. The force may be adjusted or varied by the user prior to usage of the applicator (100). The applicator (100) may be also used for collagen stimulation.
[054] The applicator (100) may be used to deliver any drug through the skin (transdermal drug delivery) as long as the microneedles or the microneedle patch (110a) are conformal to a slot provided in the base portion (102b) of the outer body (102). Additionally, any conformal microneedle patch capable of monitoring biomarkers may also be administered through the proposed applicator. The applicator (100) may be reused.
[055] The applicator (100) may be configured to apply any number of microneedles arrays that may be housed in the microneedle patch of a same form factor. The applicator (100) may allow manipulation of the application force, enabling the user to apply the microneedle patch (110a) with arrays of numerous lengths using the same device. Therefore, the microneedle patch (110a) may be made user-specific and application-specific. The applicator (100) may be configured for multiple uses. By replacing the microneedle patch (110a), the user may reuse the same applicator for prolonged drug delivery. The entire components of the applicator (100) may be fabricated and assembled using additive manufacturing techniques. Therefore, a modular design of the applicator (100) may be customized according to the user’s application.
[056] Although FIGs. 1A-4 shows exemplary components of the applicator (100), in other embodiments, the applicator (100) may include fewer components, different components, differently arranged components, or additional functional components than depicted in FIGs. 1A-4. Additionally, or alternatively, one or more components of the applicator (100) may perform functions described as being performed by one or more other components of the applicator (100).
[057] While considerable emphasis has been placed herein on the preferred embodiments, it will be appreciated that many embodiments can be made and that many changes can be made in the preferred embodiments without departing from the principles of the disclosure. These and other changes in the preferred embodiments of the disclosure will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be implemented merely as illustrative of the disclosure and not as a limitation.

ADVANTAGES OF THE PRESENT DISCLOSURE
[001] The present disclosure described herein above provides certain technical advancements over the existing prior art including, but not limited to:
[058] The present disclosure provides an applicator for facilitating seamless and efficient application of microneedle patches onto a target area of a subject.
[059] The present disclosure provides an applicator that ensures optimal performance by ensuring accurate piercing of the microneedle patches into a transdermal region of the subject.
[060] The present disclosure provides an applicator that applies a uniform and controlled force across an entire array, ensuring consistent penetration of microneedles.
[061] The present disclosure provides an applicator in which a force exerted is meticulously adjusted to achieve a desired depth with minimal discomfort to a user while preserving a structural integrity of the microneedles.
[062] The present disclosure provides an applicator that ensures a balance between force application and user comfort, thereby achieving optimized performance and usability.
[063] The present disclosure enables the user to apply the microneedle patch, for example, a drug delivery patch easily and conveniently.
[064] The present disclosure provides an applicator that is designed to be a single-handed device.
[065] The present disclosure provides an applicator that applies any number of microneedles arrays that may be housed in the microneedle patch of a same form factor.
[066] The present disclosure provides an applicator that allows manipulation of the application force, enabling the user to apply the microneedle patch with arrays of numerous lengths using the same device. Therefore, the microneedle patch may be made user-specific and application-specific.
[067] The present disclosure provides an applicator that may be configured for multiple uses. By replacing the microneedle patch, the user may reuse the same applicator for prolonged drug delivery.
[068] The present disclosure provides an applicator in which entire components may be fabricated and assembled using additive manufacturing techniques. Therefore, a modular design of the applicator may be customized according to the user’s application.
, Claims:1. An applicator (100) for applying a microneedle patch (110a) onto a target area of a subject, comprising:
an outer body (102) comprising at least a cap portion (102a) and a base portion (102b);
an inner body (104) comprising a groove (104a) along a length of the inner body (104);
a central shaft (106) conformed to one or more features of the groove (104a), wherein the central shaft (106) is loaded with a spring mechanism (108); and
a microneedle assembly (110) comprising a microneedle patch (110a), positioned at the base portion (102b) of the outer body (102),
wherein the cap portion (102a) is pulled outward and rotated in a clockwise direction to a predefined angle, such that the spring mechanism (108) is compressed to initiate release of the central shaft (106), and
wherein upon rotating the cap portion (102a) in the clockwise direction, the cap portion (102a) is rotated in a counterclockwise direction to the predefined angle to facilitate expansion of the spring mechanism (108), such that the central shaft (106) is extended towards the base portion (102b) to apply the microneedle patch (110a) onto a target area.
2. The applicator (100) as claimed in claim 1, wherein the outer body (102) comprises one or more guideways (102c) on an internal surface of the outer body (102) to facilitate linear motion of the inner body (104) within the outer body (102) at different distances.
3. The applicator (100) as claimed in claim 2, wherein the distances are calibrated to compress the spring mechanism (108), and generate an insertion force for applying the microneedle patch (110a) onto the target area based on at least a dimension of the microneedle patch (110a).
4. The applicator (100) as claimed in claim 2, wherein the one or more guideways (102c) are configured to modulate an insertion force of the microneedle patch (110a) onto the target area based on at least a dimension of the microneedle patch (110a).
5. The applicator (100) as claimed in claim 1, wherein the inner body (104) is configured to move or rotate within the outer body (102).
6. The applicator (100) as claimed in claim 2, wherein the inner body (104) is equipped with one or more sliders (104b) that move along the one or more guideways (102c) to enable controlled linear and rotary movement of the central shaft (106).
7. The applicator (100) as claimed in claim 6, wherein the one or more sliders (104b) move along the one or more guideways (102c) to enable the central shaft (106) to contact the microneedle patch (110a).
8. The applicator (100) as claimed in claim 1, wherein when the central shaft (106) is extended towards the base portion (102b), a potential energy is transferred from the central shaft (106) to the microneedle patch (110a) to apply the microneedle patch (110a) onto the target area.
9. The applicator (100) as claimed in claim 1, wherein the microneedle assembly (110) is aligned to ensure optimal contact between the central shaft (106) and the microneedle patch (110a).
10. The applicator (100) as claimed in claim 1, wherein the central shaft (106) is operatively connected to the cap portion (102a) using one or more securing members (112).