Method of providing a personal drug infusion system

Abstract

A method for providing a personal drug infusion system is disclosed. The method comprises the steps of determining at least one anthropometric characteristic from a person and providing a plurality of types of personal drug infusion systems. Each type of personal drug infusion system is configured to be suitable for a body part of a person intended to receive an injectable drug and includes a drug injection location set comprising at least one defined drug injection location corresponding to a drug injection location of said body part when said personal drug infusion system is placed on said body part. Each type of personal drug infusion system is associated with a defined anthropometric characteristic range different from that of another type of personal drug infusion system and also has a drug injection location set different from the drug injection location set of said personal drug infusion system. The method further comprises the steps of selecting one of a plurality of already manufactured personal drug infusion system types using the determined anthropometric characteristic and said defined anthropometric characteristic range, and providing the selected personal drug infusion system type to a person.

Description

Technology Field

[0001] The present disclosure relates to a method for providing a personal drug infusion system and a personal drug infusion system provided by said method. Background Technology

[0002] In some treatment procedures, it is necessary to inject medication into body tissues at one or more specific locations. These injections are typically administered by a medical professional or by a clinician under the supervision of a medical professional.

[0003] For example, some cosmetic procedures require the injection of neuromodulators into specific body parts, and these neuromodulators may include botulinum toxin; for instance, they are injected at designated locations to treat glabellar lines, lateral canthal lines (crow's feet), and horizontal forehead lines.

[0004] In addition, neuromodulators such as botulinum toxin are known to be used to treat primary axillary hyperhidrosis (PAH) by injecting into multiple injection sites set in the hyperhidrotic areas of each axilla.

[0005] In addition, neuromodulators such as botulinum toxin are also known to be used to treat migraines by paralyzing specific muscles in the head and neck, thereby preventing muscle spasms that can cause migraines.

[0006] The migraine treatment process generally involves injecting a neuromodulator, specifically botulinum toxin, into several predetermined injection sites formed on the face, corresponding to the locations of the corrugator supercilii muscle, the procerus muscle, and the frontalis muscle. This treatment process typically adheres to the injection protocols based on the PREEMPT (Phase III Research Evaluating Migraine Prophylaxis Therapy) study.

[0007] In some treatments using botulinum toxin injections, the effect of the toxin diminishes over time, so patients generally receive repeated treatment injections every two to four months. Therefore, patients typically need to visit a clinician or medical professional regularly to receive injections.

[0008] However, it is known that patient satisfaction with neuromodulator injections may vary due to differences in the injection sites selected during different visits. Furthermore, although the treatment process itself can be completed within a very short time, requiring patients to visit medical professionals or clinicians regularly is not only cumbersome and time-consuming but is also generally disadvantageous in terms of sterility.

[0009] To provide a more repeatable injection pattern, a mask that is worn to fit a part of the human body can be configured, and said mask defines a suitable location for injecting medication when worn. Such a mask can be used by a clinician or the patient themselves, for example, allowing the patient to self-administer medication.

[0010] U.S. Published Patent Applications No. US 2020 / 0093997 and No. US 2020 / 0179618 disclose configurations for a cover to cover a part of a patient's body and for drug injection, respectively, and U.S. Patent No. US 9,199,044 discloses a wearable device comprising needle access regions arranged according to a treatment pattern.

[0011] However, since each of the configurations proposed in US 2020 / 0093997, US 2020 / 0179618 and US 9,199,044 is customized for individual users, the process of producing masks is cumbersome and costly, and business models relying on ad hoc production are also less cost-effective and practical.

[0012] The mask described above has several disadvantages in terms of design, structure, and related technology, as follows.

[0013] 1. Complexity and Cost of Bespoke Manufacturing. Conventional bespoke solutions require a complex and time-consuming manufacturing process, and their high costs make them unsuitable for mass production. Because these devices rely on individual customization, production costs are excessively high and manufacturing process efficiency is low, making widespread commercial application difficult.

[0014] 2. Limited commercial utility. The commercial utility of the above devices is limited due to their customized nature. Since it requires significant cost and time to manufacture each mask to fit a specific user, it is difficult to supply them economically to a wider market. Furthermore, because they rely on a custom manufacturing process, mass pre-production is difficult, which leads to longer lead times and reduced product availability.

[0015] 3. Dependence on medical professionals. Some conventional technologies require medical professionals or clinicians to administer injections directly using external syringes or other methods. Since patients must rely on medical professionals for every treatment, their autonomy and convenience are diminished. Furthermore, injections administered by clinicians increase treatment costs and procedural complexity, and pose a problem of reduced accessibility to treatment for patients who require more frequent or regular treatment, or for patients who have difficulty accessing appropriately qualified medical professionals or clinicians.

[0016] 4. Inconvenience and Risks of Reconstitution. Since botulinum toxin has low stability and a short shelf life after reconstitution, proper storage and reconstitution are crucial. However, existing technologies often require cumbersome reconstitution procedures, which increase the risk of contamination and handling errors. Furthermore, the use of external syringes and manual preparation processes cause inconvenience for both patients and clinicians, reduce sterility, and intensify the dependence on clinicians in healthcare institutions to administer the drug themselves.

[0017] Meanwhile, apart from injecting botulinum toxin into the appropriate site, proper storage and reconstitution of the toxin are also very important. For example, botulinum toxin is known to denature easily, generally require handling via a cold chain, must be reconstituted at an appropriate dilution ratio, and has a limited usable period after reconstitution.

[0018] Since it is desirable to reconstitute the botulinum toxin immediately before injection, the injection device may be configured to store the two components of the toxin separately and to form an injectable botulinum toxin by mixing the two components using a manual method or a device operated by a pressurized fluid.

[0019] However, this manual method generally has the problem that injection is only possible if the user first understands the necessary procedures for reconfiguration and performs them directly, while the method using pressurized fluid has the problem of an overly complex structure and high manufacturing costs. The problem to be solved

[0020] Therefore, the object of the present disclosure is to propose a method for providing a new personal drug infusion system that utilizes automation while not relying on a clinician for drug injection.

[0021] The present disclosure describes a method for collecting data input values ​​required for a sizing algorithm from a patient's face and assigning one of a plurality of standard-size masks to be applied to the patient's face based on said input values. This approach is significantly different from methods of manufacturing individually customized masks and provides a more cost-effective and commercially feasible solution.

[0022] In conventional technology, standardization is not achieved, making it impossible to efficiently select a mask to apply to a patient's face based on a predetermined set of sizes. The individual custom manufacturing method of conventional technology requires a separate production process for each patient, resulting in significant time and cost. This approach fails to support the efficient mass supply of masks, which is an essential factor for widespread distribution and commercial success.

[0023] The method of the present disclosure reduces manufacturing costs and improves commercial feasibility by utilizing pre-manufactured masks of standard sizes. Furthermore, the drug infusion system associated with this method is designed for self-administration, allowing patients to inject drugs directly without the assistance of a clinician, thereby increasing convenience and reducing overall treatment costs. Additionally, by integrating an in-situ drug delivery mechanism within the mask, the usage procedure is simplified and the risk of contamination and handling errors is minimized.

[0024] Furthermore, the method of the present disclosure utilizes a standardized set of masks, and in some embodiments, includes a machine learning feedback loop to enable easy reassignment of new masks within the standard set. This method can accommodate changes in the patient's facial structure due to aging or other factors, as well as the patient's preferred treatment outcomes. Additionally, by continuously improving the mask assignment process through machine learning, consistent accuracy and patient satisfaction can be ensured without the need for expensive custom fabrication.

[0025] Accordingly, the method of the present disclosure solves the major problems of the prior art by providing a standardized, cost-effective, and easy-to-use drug infusion therapy solution. This method enhances patient autonomy, reduces treatment costs, and increases accessibility to treatment, serving as a practical and scalable alternative in various medical and cosmetic fields.

[0026] The present disclosure provides a method for providing a personal drug injection system, said method comprising the following.

[0027] A step of determining at least one anthropometric characteristic from a person;

[0028] A step of providing a plurality of types of personal drug infusion systems;

[0029] Here, the personal drug infusion system of each personal drug infusion system type is,

[0030] It is configured to fit the body part of a person intended to receive an injectable drug, and

[0031] The personal drug injection system includes a drug injection location set comprising at least one defined drug injection location corresponding to a drug injection location of the body part when the personal drug injection system is placed on the body part, and

[0032] In addition, each personal drug infusion system type corresponds to a defined range of anthropometric characteristics different from other personal drug infusion system types, and

[0033] Each type of personal drug infusion system has a different set of drug infusion sites than other types of personal drug infusion systems,

[0034] A step of selecting one of a plurality of personal drug infusion system types using the determined anthropometric characteristics and the range of anthropometric characteristics defined above; and

[0035] It includes the step of providing a selected type of personal drug infusion system to the person.

[0036] The inventors recognized that there is a certain tolerance for the location of drug injection into a patient's muscle. Based on this, they discovered that by mass-producing only a limited number of personal drug infusion system types, the appropriate system type could be selected according to the anthropometric characteristics obtained from the patient. This approach offers significant economic advantages as it eliminates the need to individually manufacture customized personal drug infusion systems for each patient.

[0037] In one embodiment, the at least one anthropometric characteristic includes the intercanthal separation distance.

[0038] In one embodiment, the at least one anthropometric characteristic includes the distance between the inner edges of the orbital ridge.

[0039] In one embodiment, the method is,

[0040] A step of determining at least one first anthropometric characteristic from a person;

[0041] A step of determining at least one second anthropometric characteristic using at least one first anthropometric characteristic determined; and

[0042] The method includes the step of selecting one of a plurality of personal drug infusion system types using at least one determined second anthropometric characteristic and a defined range of anthropometric characteristics.

[0043] In one embodiment, the first anthropometric characteristic includes the distance between the inner corners of the eyes.

[0044] In one embodiment, the second anthropometric characteristic includes the distance between the medial margins of the orbital ridges.

[0045] In one embodiment, the method includes the step of obtaining a 3D representation of at least a part of a human body and determining at least one anthropometric characteristic. The 3D representation may be obtained using a LIDAR scanner, and the method may include the step of analyzing the 3D representation to determine at least one anthropometric characteristic.

[0046] In one embodiment, the method includes the step of taking an image of at least a part of a human body and analyzing the image to determine at least one anthropometric characteristic.

[0047] In one embodiment, the method includes the step of determining an anthropometric characteristic by directly measuring at least one anthropometric characteristic.

[0048] In one embodiment, the method uses machine learning to predict at least one anthropometric characteristic or to select one of a plurality of personal drug infusion systems. The machine learning may include one or more convolutional neural networks (CNNs) trained using data representing a plurality of body part representations and at least one anthropometric characteristic associated with each body part representation. The training of the CNNs may be supervised or unsupervised.

[0049] In one embodiment, at least one personal drug infusion system has at least some parts that are rigid.

[0050] In one embodiment, at least one personal drug infusion system has at least a part that is flexible.

[0051] In one embodiment, at least one personal drug infusion system includes at least one stationary drug infusion device.

[0052] In one embodiment, at least one personal drug infusion system includes at least one removable and attachable drug infusion device.

[0053] In one embodiment, at least one personal drug infusion system includes at least one alignment component positioned to facilitate proper alignment of the personal drug infusion system to a part of the human body.

[0054] In one embodiment, the alignment component is configured to engage with a defined feature of a human body part, and when the alignment component engages with the defined feature, the personal drug injection system is accurately aligned with the body part. The defined feature may be the lower surface of a human orbital ridge.

[0055] In one embodiment, the alignment component includes a visual feature of a personal drug infusion system, and the personal drug infusion system can be aligned by visually aligning the visual feature with a defined feature of a human body part. The visual feature may include a lower flat surface of the personal drug infusion system, and the defined feature may include an inner edge below a brow ridge.

[0056] In one embodiment, the body part may include at least a part of a person's face.

[0057] In one embodiment, where the body part is part of the face, the personal drug injection system includes a mask device that covers at least part of the face.

[0058] In one embodiment, a personal drug infusion system may include a plurality of drug infusion system modules that can be connected to each other.

[0059] In one embodiment, the drug injection system module includes a forehead module and a crow's feet module attached to the forehead module to form a crow's feet treatment pattern.

[0060] In one embodiment, the at least one drug comprises a neuromodulator such as botulinum toxin or a synthetically derived analogue of botulinum toxin.

[0061] In one embodiment, the treatment process is a cosmetic treatment process for glabellar lines, in which a neuromodulator is injected into the corrugator and nasal muscles of a person. The at least one defined drug injection site may be a drug injection pattern determined according to an injection protocol prescribed by an FDA-approved botulinum toxin preparation.

[0062] In one embodiment, the treatment process is a cosmetic treatment process for lateral canthal lines (crow's feet), in which a neuromodulator is injected into the lateral orbicularis oculi muscles of a person. The at least one defined drug injection site may be a drug injection pattern determined according to an injection protocol defined by an FDA-approved botulinum toxin preparation.

[0063] In one embodiment, the treatment process is a cosmetic treatment process for horizontal forehead lines, in which a neuromodulator is injected into the human frontal muscle. The at least one defined drug injection site may be a drug injection pattern determined according to an injection protocol defined by an FDA-approved botulinum toxin preparation.

[0064] In one embodiment, the treatment process is a treatment process for primary axillary hyperhidrosis (PAH), in which a neuromodulator is injected intradermally. The at least one defined drug injection site may be a drug injection pattern determined according to Allergan’s Botox® injection protocol.

[0065] In one embodiment, the treatment process is a migraine treatment process in which botulinum toxin is injected into the human corrugator, soleus, and frontal muscles. The at least one defined drug injection site may be a drug injection pattern determined according to an injection protocol consistent with the PREEMPT (Phase III Research Evaluating Migraine Prophylaxis Therapy) study.

[0066] In one embodiment, the plurality of personal drug infusion systems includes three or five personal drug infusion systems, and each personal drug infusion system corresponds to a defined range of different anthropometric characteristics.

[0067] Additionally, the present disclosure provides a personal drug infusion system provided according to a first aspect of the present disclosure, said personal drug infusion system configured to fit a body part of a person intended to receive an injectable drug, and includes at least one defined drug infusion location corresponding to a drug infusion location of said body part when the personal drug infusion system is placed on said body part.

[0068] In one embodiment, the personal drug infusion system includes at least one fixed or detachable drug infusion device.

[0069] At least one drug infusion device may include a first chamber for receiving a first substance and a second chamber for receiving a second substance, and fluid communication between the first chamber and the second chamber is blocked while a removable packaging member is engaged with the drug infusion device, and fluid communication between the first chamber and the second chamber is enabled when the packaging member is removed from the drug infusion device.

[0070] In one embodiment, at least one of the first chamber and the second chamber comprises a plunger and a biasing device that elastically biases the plunger toward the inside of the first or second chamber. While the packaging member is coupled to the drug injection device, inward movement of the plunger by the biasing device is prevented, and when the packaging member is removed, inward movement of the plunger by the biasing device is allowed, so that the first material and the second material can be mixed upon removal of the packaging member.

[0071] Additionally, the present disclosure provides a method (Method A) for providing a personal drug infusion system, said method comprising the following:

[0072] A step of obtaining at least one anthropometric characteristic value through interaction between said physical instrument and a body part of a person intended to receive an injectable drug, using said physical instrument;

[0073] A step of providing at least three types of personal drug infusion systems, wherein each type of personal drug infusion system is configured to fit the body part, and the at least three types of personal drug infusion systems include the following:

[0074] A first personal drug injection system type having a first drug injection location set including at least one defined drug injection location corresponding to a drug injection location when the first personal drug injection system is placed on a part of a person's body, and the first personal drug injection system type corresponding to a defined range of a first anthropometric characteristic value;

[0075] A second personal drug infusion system type having a second drug infusion position set including at least one defined drug infusion position corresponding to a drug infusion position when the second personal drug infusion system is placed on a part of a person's body, wherein the second drug infusion position set is different from the first drug infusion position set of the first personal drug infusion system type, and the second personal drug infusion system type is a type corresponding to a defined range of a second anthropometric characteristic value different from a defined range of a first anthropometric characteristic value; and

[0076] A third personal drug injection system type having a third drug injection location set including at least one defined drug injection location corresponding to a drug injection location when the third personal drug injection system is placed on a part of a person's body, wherein the third drug injection location set is different from the first and second drug injection location sets, and the third personal drug injection system type is a type corresponding to a defined range of a third anthropometric characteristic value that is different from the defined ranges of the first and second anthropometric characteristic values;

[0077] A step of determining whether an anthropometric characteristic value obtained from a person falls within a defined range of a first, second, or third anthropometric characteristic value and selecting one of at least three personal drug infusion system types; and

[0078] It includes the step of providing a selected type of personal drug infusion system to a person.

[0079] In addition, the present disclosure provides a method for administering a neuromodulator drug to a human patient, and said method comprises the following.

[0080] A step of placing a personal drug injection system type selected according to Method A at a defined location on the face of a human patient, wherein the set of drug injection locations of the personal drug injection system type corresponds to a process of treating glabellar lines by injecting a neuromodulator into the corrugator and nasal muscles of the human patient; and

[0081] The method includes the step of injecting a neuromodulator into the corrugator and soleus muscles of a human patient using an injection device placed at a drug injection site corresponding to the set of drug injection locations.

[0082] Additionally, the present disclosure provides a method for administering a neuromodulator to a human patient, the method comprising the steps of placing a personal drug infusion system selected according to Method A at a defined location on the face of a human patient, such that the set of drug infusion locations corresponds to a treatment process for crow's feet, and injecting a neuromodulator into the lateral portion of the orbicularis oculi muscle using the infusion device.

[0083] Additionally, the present disclosure provides a method for administering a neuromodulator drug to a human patient, the method comprising the steps of placing a personal drug injection system selected according to Method A at a defined location on the face, such that the set of drug injection locations corresponds to a process for treating a horizontal forehead wrinkle, and injecting the neuromodulator into the frontal muscle using the injection device.

[0084] Additionally, the present disclosure provides a method for administering a neuromodulator to a human patient, the method comprising the steps of placing a personal drug infusion system selected according to Method A at a defined location on the face, such that the set of drug infusion locations corresponds to a treatment process for primary axillary hyperhidrosis (PAH), and injecting the neuromodulator intradermally using the infusion device.

[0085] Additionally, the present disclosure provides a method for administering a neuromodulator to a human patient, the method comprising the step of placing a personal drug injection system selected according to Method A at a defined location on the face, wherein the set of drug injection locations is configured to inject botulinum toxin into the corrugator muscle, nasal muscle, and frontal muscle in response to a migraine treatment process, and injecting a neuromodulator into the muscles using an injection device corresponding to the set of drug injection locations.

[0086] According to one embodiment, a selection set comprising three to five different personal drug infusion system types is provided, each personal drug infusion system type is configured to be suitable for a part of the human body, and the selection set includes the following.

[0087] A first personal drug injection system type having a first drug injection location set comprising at least one defined drug injection location corresponding to a drug injection location of a body part when the first personal drug injection system is placed on a body part of a person, wherein the first personal drug injection system type is associated with a first defined range of anthropometric characteristic values;

[0088] A second personal drug injection system type having a second drug injection location set comprising at least one defined drug injection location corresponding to a drug injection location of a body part when the second personal drug injection system is placed on a body part of a person, wherein the second drug injection location set is different from the first drug injection location set of the first personal drug injection system type, and the second personal drug injection system type is associated with a second defined range of anthropometric characteristic values ​​that is different from the first defined range of anthropometric characteristic values; and

[0089] A third personal drug injection system type has a third drug injection location set comprising at least one defined drug injection location corresponding to a drug injection location of a body part when the third personal drug injection system is placed on a body part of a person, wherein the third drug injection location set is different from both the first drug injection location set of the first personal drug injection system type and the second drug injection location set of the second personal drug injection system type, and the third personal drug injection system type is associated with a third defined range of anthropometric characteristic values ​​that is different from both the defined first range of anthropometric characteristic values ​​and the defined second range of anthropometric characteristic values. Brief explanation of the drawing

[0090] The methods, apparatus, and related embodiments of the present disclosure are described by way of example with reference to the accompanying drawings. FIG. 1 is a schematic diagram of a part of a human head showing the muscles associated with the body part of a person intended to receive an injectable drug as part of an exemplary treatment process. Figure 2 is a schematic diagram of a human head illustrating an injection pattern associated with an exemplary treatment process. FIG. 3 is a diagram illustrating an exemplary process of determining an injection site according to a predetermined injection pattern associated with an exemplary treatment process. FIG. 4 is a diagram illustrating exemplary anthropometric characteristics of a person used to determine an infusion pattern associated with an exemplary treatment process and to select one of a plurality of personal drug infusion systems. Figure 5 is a drawing illustrating the corrugator muscle of a person intended to receive an injectable drug during an exemplary treatment process. FIG. 6 is a diagram illustrating exemplary anthropometric characteristics for various race and gender groups, and exemplary anthropometric characteristic ranges in an embodiment including three anthropometric characteristic ranges. FIG. 7 is a diagram illustrating exemplary anthropometric characteristics for various race and gender groups, and exemplary anthropometric characteristic ranges in an embodiment including five anthropometric characteristic ranges. FIG. 8 is a schematic diagram of an exemplary personal drug injection system used in an exemplary treatment process of injecting drugs into a defined facial area. FIG. 9 is a drawing illustrating an exemplary personal drug infusion system having substantial rigidity. FIG. 10 is a drawing illustrating an exemplary personal drug infusion system that is substantially flexible. FIG. 11 is a schematic diagram illustrating the exemplary personal drug injection system of FIG. 8 mounted on a person's face. FIG. 12 is a schematic diagram illustrating an exemplary configuration for dispensing a single drug to multiple drug injection sites in an exemplary personal drug infusion system. FIG. 13 is a schematic diagram illustrating an exemplary drug infusion device used in the exemplary personal drug infusion system of FIG. 8 to 10, illustrating a pre-activated configuration in a packaged state. FIG. 14 is a schematic diagram illustrating the drug infusion device of FIG. 13, showing the state before drug delivery, with the packaging removed and activated. FIG. 15 is a schematic diagram illustrating the drug infusion device of FIG. 13 and FIG. 14, showing the state of use after drug delivery is completed. FIG. 16 is a flowchart illustrating one embodiment of a method for providing a personal drug infusion system. Specific details for implementing the invention

[0091] The present disclosure relates to a method for providing a personal drug injection system to a person. The personal drug injection system is a type of system configured to deliver a drug to one or more defined locations on a person's body according to a predetermined treatment process, and is configured to deliver the drug by providing at least one defined drug injection location to the personal drug injection system, which corresponds to the location of the drug injection site of the body part when the personal drug injection system is placed at a defined location on a body part.

[0092] In some treatment procedures, drugs may be injected into body tissues at one or more specific locations defined according to the treatment protocol. For example, neuromodulators such as botulinum toxin can be injected to paralyze specific muscles in the head and neck, thereby preventing muscle spasms that may trigger migraines; additionally, neuromodulators can be used in cosmetic procedures to treat glabellar lines, lateral canthal lines (crow's feet), and horizontal forehead lines by injecting them to paralyze specific facial muscles and inhibit movement.

[0093] Currently, it is common for a person to visit a medical professional or clinician regularly, for example, every 12 weeks, to receive botulinum toxin injection treatment.

[0094] The migraine treatment process involves injecting botulinum toxin into several defined injection sites formed on the human face, corresponding to the locations of the corrugator, soleus, and frontal muscles. This treatment process can be performed according to an injection protocol that aligns with the PREEMPT (Phase III Research Evaluating Migraine Prophylaxis Therapy) study developed by Blumenfeld.

[0095] Since botulinum toxin is a substance toxic to the human body, special caution is required to ensure the toxin is delivered to the precise location. For this reason, botulinum toxin injections have generally been administered only by clinicians under the guidance or supervision of medical professionals.

[0096] However, despite the risks associated with botulinum toxin injections, the inventors recognized that there is a certain degree of tolerance regarding the injection site within the relevant muscle, and that the desired therapeutic effect can be achieved as long as the drug is injected into the muscle, even if the actual injection site differs slightly. This implies that injections do not necessarily need to be performed by medical professionals, and that it is possible to realize a configuration where the patient self-administers the drug. Furthermore, this substantial tolerance eliminates the need to individually create customized drug injection templates that define different injection sites for each patient; instead, it means that a relatively small number of injection templates is sufficient to accommodate the positional differences of the corrugator, soleus, and frontal muscles.

[0097] This realization holds significant meaning. Specifically, by selecting the system with the most suitable drug infusion pattern from a limited number of systems based on one or more anthropometric characteristics obtained from a human, it is possible to implement an efficient, safe, and cost-effective drug infusion pattern-based treatment process. More importantly, since providing only a small number of different drug infusion systems allows for their pre-manufacturing, safe self-injection becomes a realistic possibility simply by selecting and providing an appropriate system based on one or more anthropometric measurements obtained from a human.

[0098] For example, three drug infusion systems with different drug infusion patterns may be provided, and one of them may be selected based on one or more anthropometric characteristics obtained automatically or manually from a person. However, the number of drug infusion systems provided is not limited thereto, and, for example, five drug infusion systems may be provided.

[0099] For example, in the migraine treatment process according to the above PREEMPT study, the distance between the medial edges of the orbital ridge (orbital ridge medial edge separation) is used as an anthropometric characteristic, which is estimated by determining the distance between the medial canthals of a person.

[0100] However, it will be understood that any appropriate anthropometric characteristics may be utilized. The important point is that such anthropometric characteristics can be acquired from the patient automatically or manually, and the drug injection site in the treatment is determined based on the acquired anthropometric characteristics.

[0101] Furthermore, while this embodiment focuses on a migraine treatment process involving the administration of a neuromodulator such as botulinum toxin according to the PREEMPT protocol, the method of this disclosure can be applied to any treatment process involving the injection of a drug at one or more defined locations, provided that a certain tolerance exists at the injection site. For example, the method of this disclosure can be applied not only to the treatment of conditions associated with excessive muscle movement, such as cerebral palsy, post-stroke spasticity, post-spinal cord injury spasticity, and spasms of the head and neck, but also to cosmetic procedures for reducing frown lines, forehead wrinkles, and lateral canthal wrinkles.

[0102] FIG. 1 shows a part of a human head illustrating the target muscles for injecting botulinum toxin according to the PREEMPT study. The relevant muscles include the soleus muscle (12), a pair of corrugator muscles (14), and a pair of frontal muscles (16).

[0103] A human head (18) illustrating an exemplary botulinum toxin injection pattern (20) is illustrated in FIG. 2, and the process of determining the injection location of the injection pattern (20) according to the PREEMPT protocol is illustrated in FIG. 3 and FIG. 4.

[0104] In this embodiment, regarding the treatment example according to the PREEMPT study, as an anthropometric characteristic, the intercanthal separation (32) is determined first, and the estimated orbital ridge medial edge separation is determined automatically or by directly measuring the intercanthal separation. The intercanthal separation (32) corresponds to the distance between the innermost positions of a person's two eyes, and the orbital ridge medial edge separation (34) is the distance between the medial edges of a person's orbital ridge. The positions of the medial edges of the orbital ridge constitute an anthropometric position (22) on a person's face, and the anthropometric position (22) is used to identify the first injection site of the injection pattern according to the PREEMPT protocol.

[0105] It is known that in humans, the distance between the medial edges of the orbital ridges is generally 0 to 5 mm shorter than the distance between the medial canthus. In this embodiment, it is assumed that the distance between the medial edges of the orbital ridges is 5 mm shorter than the distance between the medial canthus, and thus the lateral location of each anthropometric position (22) is estimated to be 2.5 mm inward from the medial canthus.

[0106] As shown in Figure 3, the following injection patterns are defined according to the PREEMPT protocol.

[0107] A pair of first injection positions (24) are defined based on a determined anthropometric position (22), and in this embodiment, each first injection position (24) is positioned 15 mm vertically upward from the corresponding anthropometric position (22) to correspond to the expected position of the human corrugator muscle.

[0108] The second injection position (26) is defined based on the first injection position (24), and in this embodiment, it is positioned at the center of a virtual line connecting a pair of first injection positions (24) to correspond to the expected position of a person's nose.

[0109] A pair of third injection positions (28) are defined based on the second injection position (26), and in this embodiment, each third injection position (28) is positioned 15 mm vertically upward from the corresponding first injection position (24) to correspond to the expected position of the inner side of the human frontal muscle.

[0110] A pair of fourth injection positions (30) are defined based on the third injection position (28), and in this embodiment, each fourth injection position (30) is positioned 15 mm horizontally outward from the corresponding third injection position (28) to correspond to the expected position of the outer part of the human frontal muscle.

[0111] However, the present disclosure is not limited thereto, and it will be understood that any injection pattern suitable for the treatment process, including any approved cosmetic procedure protocol, may be applied.

[0112] The distance between the medial canthus varies from person to person, and accordingly, the distance between the corrugator muscles also varies.

[0113] Since each injection position of the injection pattern is determined by the position of the anthropometric position (22), the spacing between the anthropometric positions (22) varies according to the distance between the inner corners of the eyes. Accordingly, the distance between the first (24), second (26), third (28), and fourth (30) injection positions on the left and the first (24), second (26), third (28), and fourth (30) injection positions on the right also varies according to the change in the distance between the inner corners of the eyes.

[0114] FIG. 5 is a schematic diagram illustrating the left corrugator muscle (40) of a person, which extends generally diagonally along the upper part of the left eye. In this embodiment, the corrugator muscle (40) is injected at a first injection site (24) determined based on an anthropometric position (22) corresponding to the edge of the orbital ridge.

[0115] The inventors have discovered that satisfactory treatment results are obtained simply by injecting the drug into the corrugator muscle (40) during the treatment process according to the PREEMPT clinical program. In this embodiment, the first injection location is intended to be located 15 mm above the identified anthropometric location (22). For an average corrugator muscle (40), this corresponds to a tolerance of about 5.75 mm, which can be represented by a tolerance circle (42) with radius r = 5.75 mm shown in FIG. 5. Based on these facts, the inventors have reached the conclusion that even with various injection patterns where the spacing between the left and right injection locations differs, each person can obtain safe and satisfactory cosmetic treatment results, and there is no need to manufacture a customized drug injection system or individual injection pattern different for each patient.

[0116] In this embodiment, since the treatment process involves injecting a drug around and above the human eye, the drug injection system defining the drug injection pattern includes a mask device, which is configured to form a predetermined injection pattern when mounted on a reference position on the human face. The mask device may be positioned at a reference position by engaging with one or more facial features, such as the inner edge of the orbital ridge, for example, or by forming one or more alignment features or alignment markers on the mask device to visually align them with the facial features. It is very important that the mask device is accurately aligned with the facial features. This is because the mask device defines an injection pattern suitable for the person, and accurate drug injection according to the injection pattern depends on the mask being accurately aligned with the corrugator muscle (40).

[0117] Referring to FIG. 6, the mask device chart (50) illustrates exemplary anthropometric characteristics (52) for various race and gender groups (54), and in this embodiment, the anthropometric characteristic represents the distance between the inner corners of the eyes. The mask device chart (50) also illustrates a plurality of, in this embodiment, three, defined anthropometric characteristic ranges, which are each defined as 'small' (56), 'medium' (58), and 'large' (60). Each range has a respective median value line (57, 59, 61). In this embodiment, the small anthropometric characteristic range is 22.5 mm to 30 mm and the median is 26.25 mm, the medium anthropometric characteristic range is 30 mm to 37.5 mm and the median is 33.75 mm, and the large anthropometric characteristic range is 37.5 mm to 45 mm and the median is 41.25 mm.

[0118] Based on these three anthropometric characteristic ranges of FIG. 6, three drug infusion systems, namely, three mask devices in this embodiment, are fabricated. Each mask device defines a set of injection locations corresponding to an infusion pattern suitable for people falling within a specific range of interocular distance. Thus, each mask type corresponds to a different range of interocular distance and has a different set of injection locations.

[0119] Based on the three anthropometric characteristic ranges defined in FIG. 6, three drug infusion systems, in this embodiment, three mask devices are fabricated. Each mask device defines a set of injection locations corresponding to an infusion pattern suitable for people belonging to one of the three defined intercanthal separation ranges. Accordingly, a plurality of, in this embodiment, three mask types are fabricated, each mask type being associated with a defined intercanthal separation range and also associated with a different set of injection locations.

[0120] The anthropometric characteristic (52) illustrated in FIG. 6 is based on the value of the corresponding medial canthal distance estimated by adding 5 mm to the orbital ridge separation distance. This is intended to use the medial canthal distance, rather than the orbital ridge separation distance, as an anthropometric characteristic to determine the selection of the mask device type. This is because the medial canthal distance can be measured more easily from a person than the orbital ridge separation distance.

[0121] By using the classification defined in the mask device chart (50), a mask device type suitable for a person can be selected based on the inner corner distance obtained from the person.

[0122] FIG. 6 illustrates three anthropometric characteristic ranges used to classify a person into one of three mask device size categories based on a determined medial canthal distance, but it will be understood that an appropriate number of anthropometric characteristic ranges and a corresponding appropriate number of different mask device sizes may be employed. For example, as illustrated in FIG. 7, the mask device chart (66) illustrates exemplary anthropometric characteristics (52) for various ethnic and gender groups (54), in this embodiment medial canthal distance, and five anthropometric characteristic ranges (68, 70, 72, 74, 76, 78) defined for the patient's medial canthal distance.

[0123] In the example of five ranges, the first range (68) is 15.5 mm to 22.5 mm (median 19 mm), the second range (70) is 22.5 mm to 29.5 mm (median 26 mm), the third range (72) is 29.5 mm to 36.5 mm (median 33 mm), the fourth range (74) is 36.5 mm to 43.5 mm (median 40 mm), and the fifth range (76) is 43.5 mm to 49.5 mm (median 47 mm).

[0124] The anthropometric characteristics used to select a drug infusion mask device having a suitable infusion pattern among a plurality of drug infusion mask devices can be determined in any appropriate manner, including by using a physical instrument such as a measuring ruler, measuring tape, calipers, optical device, etc.

[0125] For example, the above anthropometric characteristics can be automatically determined by obtaining a 3D representation of at least a part of a person's face. For example, a 3D representation of a person's face can be obtained using a LIDAR scanner that can be linked with a smartphone, and a suitable software application implemented on the smartphone can be used to calculate the estimated medial canthal distance based on the LIDAR face representation.

[0126] In another example, the aforementioned anthropometric characteristics may be determined based on a photographic representation of at least a portion of a human face. For example, by analyzing the photograph using a suitable software application implemented on a smartphone or the like, the estimated medial canthal distance can be determined based on appropriate identifiable facial features, such as the relative locations of facial features and the relative sizes of facial features.

[0127] In another example, the above anthropometric characteristics can be determined by directly measuring the anthropometric characteristics using, for example, a ruler or a measuring tool.

[0128] In another example, the aforementioned anthropometric characteristics can be predicted using machine learning. For instance, a convolutional neural network (CNN) trained using multiple facial representations (e.g., photographs) and ground truth data representing the anthropometric characteristics corresponding to each facial representation can be used. The training of the CNN can be performed using supervised learning or unsupervised learning. In the case of supervised learning, one or more anthropometric features, such as orbital ridge edges, are marked on the facial representation, whereas in the case of unsupervised learning, anthropometric features are not marked on the facial representation. In actual use, a user can obtain their facial representation by, for instance, taking a photograph with a smartphone, and the facial representation is provided as input to the neural network. The neural network then generates an output value that predicts the mask device most suitable for the user. In addition, the machine learning described above may be further trained to select an appropriate mask device based on acquired or predicted anthropometric characteristics. Additionally, a feedback loop may be provided, and accordingly, the mask selection performed by the machine learning may be modified based on user feedback regarding the performance of the mask.

[0129] In the above embodiment, an example was described in which a personal drug injection system is configured to fit a part of a human face to provide an injection pattern for migraine treatment. As a variation, the personal drug injection system may be configured such that one or more personal drug injection modules are detachably coupled to each other to form a desired configuration suitable for a specific treatment and an injection pattern corresponding to that treatment. For example, a module for treating lateral canthal lines may be coupled to a forehead treatment module to form an injection pattern for treating lateral canthal lines (crow's feet).

[0130] The specific embodiment described above illustrates a migraine treatment process involving the administration of a neuromodulator according to the PREEMPT protocol, but is not limited thereto and various other treatment processes may be considered.

[0131] For example, the treatment process may be a cosmetic treatment for glabellar lines, in which case a neuromodulator is injected into the corrugator and nasal muscles. The applied injection pattern can be established according to any appropriate injection protocol, for example, determined according to the injection protocol specified by the FDA-approved botulinum toxin preparation.

[0132] In another example, the treatment process may be a cosmetic treatment for lateral canthal lines, in which a neuromodulator is injected into the human lateral orbicularis oculi muscle. The injection pattern applied may be determined according to injection protocols specified by FDA-approved botulinum toxin preparations, etc.

[0133] In another example, the treatment process may be a cosmetic treatment for horizontal forehead lines, involving the injection of a neuromodulator into the human frontal muscle. The injection pattern applied may be determined according to injection protocols specified by FDA-approved botulinum toxin preparations.

[0134] In another example, the treatment process may be for primary axillary hyperhidrosis (PAH), in which a neuromodulator is injected intradermally.

[0135] The applicable injection pattern can be set according to any appropriate injection protocol, for example, according to the injection protocol specified by Allergan for Botox® injection.

[0136] Referring to FIG. 8, an exemplary drug injection system in the form of a mask device (80) is illustrated. The mask device (80) may be flexible, rigid, or partially flexible and partially rigid, and importantly, the drug injection mask is configured to define a set of injection locations corresponding to a drug injection pattern suitable for a treatment process when placed at a specific location on a part of a person's body (in this example, the face), and to have a size appropriate for the person. The drug injection mask (80) may include physical components for aligning the mask to the face by engaging with facial features such as an orbital ridge, and may also include one or more alignment features or alignment markers used by the user to visually align the mask to the correct position on the face.

[0137] As illustrated in FIG. 8, an exemplary mask (80) includes a predetermined pattern (82) of injection locations (84), each injection location (84) defines a location for injecting a drug according to a treatment process.

[0138] In any injection device, the mask may include, for example, a substrate (85), which may support an injection location, or an injection location (e.g., injection location (84)) may be embedded or disposed within the substrate. In some embodiments, one or more or all injection locations may have injectors formed integrally with the substrate. Additionally, one or more or all injectors may contain a drug.

[0139] Each injection location may include a drug injection device and may be configured to accommodate a suitable drug injection device, for example, so that the drug injection device is engaged with the drug injection device and held against the mask (80).

[0140] In this embodiment, each injection position is configured to accommodate and engage with a drug injection device, examples of which are illustrated in FIGS. 13 to 15 and described below.

[0141] In this embodiment, a predetermined pattern (82) of the injection location (84) corresponds to a migraine treatment process using the PREEMPT clinical program protocol, but it will be understood that any injection pattern suitable for any treatment process may be applied.

[0142] For example, as illustrated in FIG. 9, the mask device (86) is substantially rigid and can be manufactured, for example, using a 3D printer. Identical or similar components are denoted by the same reference numerals.

[0143] The rigid mask device (86) includes an alignment component (89) having two spaced pads (91), and the alignment component (89) is configured so that the mask device (86) is accurately aligned with the person's face when the spaced pads (91) engage with the lower side of the person's orbital ridge.

[0144] In this example, the rigid mask device (86) may further include a resilient layer (87) that can be formed, for example, from a silicon material.

[0145] As an alternative example, the mask device (90) illustrated in FIG. 10 is substantially flexible. Identical or similar components are denoted by the same reference numerals. The mask device (90) includes a first mask component (92) that defines an injection location and a second flexible mask component (94) formed, for example, of silicone to provide structural rigidity. In such a configuration, the mask can be removed from a person's face due to the flexibility of the mask device (90), so an adhesive region (95) can be used.

[0146] In this example, the mask device (90) is manually aligned with the human face by aligning the lower flat surface (96) of the mask device with the inner edge of the lower side of the human brow ridge, but it will be understood that any suitable alignment method may be applied.

[0147] In this example, the first component (92) is printed with a 3D printer, and the second component (94) is formed from a silicone sheet. Then, the first and second components (92, 94) are placed in a mold for a 3D printer, and the third component is overmolded using two-part curing silicone rubber.

[0148] Each drug infusion mask device (80, 86, 90) may be equipped with an integral drug reservoir, so that each drug infusion device can be individually filled with drug and individually activated.

[0149] The surface of the integrated drug storage unit and the storage unit in contact with the drug may comprise a cyclic olefin copolymer (COC), a cyclic olefin polymer (COP), or a combination thereof. For example, the inner surface of the storage unit that receives the drug may be coated with COC, COP, or a combination thereof.

[0150] The substrate of the drug infusion mask device (e.g., 80, 86, 90) may comprise, be composed of, or substantially composed of, a polymer (e.g., ABS, polyethylene (including high-density polyethylene), polypropylene, polyalkylene oxide such as polyethylene glycol, PVC, polyfluoroalkylene, polyvinyl alcohol, polyvinyl alcohol ester, acrylic resin (e.g., polymethyl acrylate), polymethyl methacrylate, nylon, polycarbonate, PET, PETG, polystyrene, fluoropolymer, polyester, polyimide, thermoplastic plastic or copolymer thereof), a metal (e.g., copper, iron, aluminum, cobalt, titanium, magnesium, manganese or alloys thereof), wood, wax, cellulose material or cellulose derivative, etc.

[0151] In some embodiments, the substrate thickness of the drug infusion mask device may be about 8 to 30 mm, 8 to 12 mm, 12 to 16 mm, 16 to 20 mm, 20 to 25 mm, 25 to 30 mm, 8 to 10 mm, 10 to 12 mm, 12 to 14 mm, 14 to 16 mm, 16 to 18 mm, 18 to 20 mm, 20 to 22 mm, 22 to 24 mm, 24 to 26 mm, 26 to 28 mm, or 28 to 30 mm.

[0152] In some embodiments, the drug injection mask device may have 3 to 7 injection locations. Two of these injection locations are referred to as the first outside injection location and the second outside injection location, respectively. The first outside injection location and the second outside injection location are the injection locations located furthest horizontally from the center of the drug injection mask. In FIG. 11, for illustrative purposes, the first outside injection location is shown as injection location (84A) and the second outside injection location is shown as injection location (84B).

[0153] In the case of a drug injection mask having 3 to 7 injection locations, two of these drug injection locations can be referred to as the first intermediate injection location and the second intermediate injection location, respectively. The first intermediate injection location and the second intermediate injection location are positioned in a horizontal position closer to the center of the drug injection mask than the first outer injection location and the second outer injection location. In FIG. 11, as an example for explanation, the first intermediate injection location is shown as injection location (84C) and the second intermediate injection location is shown as injection location (84D).

[0154] In the case of a drug injection mask having three to seven injection locations, one of these drug injection locations may be referred to as a middle injection location. The middle injection location may be positioned at or near the horizontal center of the drug injection mask, or at or near the horizontal center of a person's face. In FIG. 11, the middle injection location is illustrated as an injection location (84E) as an example for illustrative purposes.

[0155] In some embodiments, the drug injection mask may include a first outer injection position, a second outer injection position, a first intermediate injection position, a second intermediate injection position, and a central injection position.

[0156] In some embodiments, the first outside injector may be integrally formed with the substrate at the first outside injection site. Additionally, the first outside injector may contain a drug.

[0157] In some embodiments, the second outside injector may be integrally formed with the substrate at the second outside injection site. Additionally, the second outside injector may contain a drug.

[0158] In some embodiments, the first intermediate injector may be integrally formed with the substrate at the first intermediate injection site. Additionally, the first intermediate injector may contain a drug.

[0159] In some embodiments, a second intermediate injector may be integrally formed with the substrate at a second intermediate injection site. Additionally, the second intermediate injector may contain a drug.

[0160] In some embodiments, the middle injector may be integrally formed with the substrate at the central injection location. Additionally, the middle injector may contain a drug.

[0161] In some embodiments, the first outer injector, the second outer injector, the first intermediate injector, the second intermediate injector, and the central injector may all contain a drug.

[0162] The first outer injector, the second outer injector, the first intermediate injector, the second intermediate injector, and the central injector may be any suitable injector. The injectors illustrated in FIGS. 13 to 15 are non-limiting examples of suitable injectors.

[0163] Drug Injection Mask Type A

[0164] Some drug injection masks comprising a first outer injection position (optionally including a first outer injector integrally formed with the substrate at this position), a second outer injection position (optionally including a second outer injector integrally formed with the substrate at this position), a first intermediate injection position (optionally including a first intermediate injector integrally formed with the substrate at this position), a second intermediate injection position (optionally including a second intermediate injector integrally formed with the substrate at this position), and a central injection position (optionally including a central injector integrally formed with the substrate at this position) may be referred to as drug injection mask type A for convenience.

[0165] In drug injection mask type A, the horizontal distance between the first outer injection position and the second outer injection position may be about 50 to 60 mm, about 50 to 53 mm, about 53 to 56 mm, about 56 to 60 mm, or about 54 mm.

[0166] In some embodiments of drug infusion mask type A, the horizontal distance between the first outer injection position and the first intermediate injection position may be about 12 to 15 mm, about 13 to 14 mm, or about 13.3 to 13.7 mm. In some embodiments of drug infusion mask type A, the horizontal distance between the second outer injection position and the second intermediate injection position may be about 12 to 15 mm, about 13 to 14 mm, or about 13.3 to 13.7 mm.

[0167] In some embodiments of drug infusion mask type A, the horizontal distance between the first intermediate injection position and the central injection position may be about 12 to 15 mm, about 13 to 14 mm, or about 13.3 to 13.7 mm. In some embodiments of drug infusion mask type A, the horizontal distance between the second intermediate injection position and the central injection position may be about 12 to 15 mm, about 13 to 14 mm, or about 13.3 to 13.7 mm.

[0168] In some embodiments of drug injection mask type A, the vertical position of the first outer injection position may be within 30 mm or within 20 mm from the vertical position of the first intermediate injection position, and may be, for example, about 2 to 7 mm, 7 to 12 mm, 12 to 17 mm, 2 to 4 mm, 4 to 6 mm, 6 to 9 mm, 9 to 12 mm, 12 to 14 mm, 14 to 16 mm, or 14 to 17 mm away.

[0169] In some embodiments of drug injection mask type A, the vertical position of the first outer injection position may be within 30 mm or within 20 mm from the vertical position of the central injection position, and may be, for example, about 2 to 7 mm, 7 to 12 mm, 12 to 17 mm, 2 to 4 mm, 4 to 6 mm, 6 to 9 mm, 9 to 12 mm, 12 to 14 mm, 14 to 16 mm, or 14 to 17 mm away.

[0170] In some embodiments of drug injection mask type A, the vertical position of the first intermediate injection position may be within 30 mm or within 20 mm from the vertical position of the central injection position, and may be, for example, about 2 to 7 mm, 7 to 12 mm, 12 to 17 mm, 2 to 4 mm, 4 to 6 mm, 6 to 9 mm, 9 to 12 mm, 12 to 14 mm, 14 to 16 mm, or 14 to 17 mm away.

[0171] In some embodiments of drug injection mask type A, the vertical position of the second outer injection position may be within 30 mm or within 20 mm from the vertical position of the second intermediate injection position, and may be, for example, about 2 to 7 mm, 7 to 12 mm, 12 to 17 mm, 2 to 4 mm, 4 to 6 mm, 6 to 9 mm, 9 to 12 mm, 12 to 14 mm, 14 to 16 mm, or 14 to 17 mm away.

[0172] In some embodiments of drug injection mask type A, the vertical position of the second outer injection position may be within 30 mm or within 20 mm from the vertical position of the central injection position, and may be, for example, about 2 to 7 mm, 7 to 12 mm, 12 to 17 mm, 2 to 4 mm, 4 to 6 mm, 6 to 9 mm, 9 to 12 mm, 12 to 14 mm, 14 to 16 mm, or 14 to 17 mm away.

[0173] In some embodiments of drug injection mask type A, the vertical position of the second intermediate injection position may be within 30 mm or within 20 mm from the vertical position of the central injection position, and may be, for example, about 2 to 7 mm, 7 to 12 mm, 12 to 17 mm, 2 to 4 mm, 4 to 6 mm, 6 to 9 mm, 9 to 12 mm, 12 to 14 mm, 14 to 16 mm, or 14 to 17 mm away.

[0174] Drug Injection Mask Type B

[0175] Some drug injection masks comprising a first outer injection position (optionally including a first outer injector integrally formed with the substrate at this position), a second outer injection position (optionally including a second outer injector integrally formed with the substrate at this position), a first intermediate injection position (optionally including a first intermediate injector integrally formed with the substrate at this position), a second intermediate injection position (optionally including a second intermediate injector integrally formed with the substrate at this position), and a central injection position (optionally including a central injector integrally formed with the substrate at this position) may be referred to as drug injection mask type B for convenience.

[0176] In drug injection mask type B, the horizontal distance between the first outer injection position and the second outer injection position may be about 55–65 mm, about 55–58 mm, about 58–61 mm, about 61–65 mm, or about 59 mm.

[0177] In some embodiments of drug infusion mask type B, the horizontal distance between the first outer injection position and the first intermediate injection position may be about 13 to 16 mm, about 14 to 15 mm, or about 14.5 to 15 mm. In some embodiments of drug infusion mask type B, the horizontal distance between the second outer injection position and the second intermediate injection position may be about 13 to 16 mm, about 14 to 15 mm, or about 14.5 to 15 mm.

[0178] In some embodiments of drug infusion mask type B, the horizontal distance between the first intermediate injection position and the central injection position may be about 13 to 16 mm, about 14 to 15 mm, or about 14.5 to 15 mm. In some embodiments of drug infusion mask type B, the horizontal distance between the second intermediate injection position and the central injection position may be about 13 to 16 mm, about 14 to 15 mm, or about 14.5 to 15 mm.

[0179] In some embodiments of drug injection mask type B, the vertical position of the first outer injection position may be within 30 mm or within 20 mm from the vertical position of the first intermediate injection position, and may be spaced apart, for example, about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0180] In some embodiments of drug injection mask type B, the vertical position of the first outer injection position may be located within 30 mm or within 20 mm relative to the vertical position of the central injection position, and may have a vertical separation distance of, for example, about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0181] In some embodiments of drug injection mask type B, the vertical position of the first intermediate injection position may be located within 30 mm or within 20 mm relative to the vertical position of the central injection position, and may have a vertical separation distance of, for example, about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0182] In some embodiments of drug injection mask type B, the vertical position of the second outer injection position may be located within 30 mm or within 20 mm relative to the vertical position of the second intermediate injection position, and may have a vertical separation distance of, for example, about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0183] In some embodiments of drug injection mask type B, the vertical position of the second outer injection position may be located within 30 mm or within 20 mm relative to the vertical position of the central injection position, and may have a vertical separation distance of, for example, about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0184] In some embodiments of drug injection mask type B, the vertical position of the second intermediate injection position may be located within 30 mm or within 20 mm relative to the vertical position of the central injection position, and may have a vertical separation distance of, for example, about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0185] Drug Injection Mask Type C

[0186] Some drug injection masks include a first outer injection position (optionally including a first outer injector integrally formed with the substrate at this position), a second outer injection position (optionally including a second outer injector integrally formed with the substrate at this position), a first intermediate injection position (optionally including a first intermediate injector integrally formed with the substrate at this position), a second intermediate injection position (optionally including a second intermediate injector integrally formed with the substrate at this position), and a central injection position (optionally including a central injector integrally formed with the substrate at this position), and may be referred to as drug injection mask type C for convenience.

[0187] In drug injection mask type C, the horizontal distance between the first outer injection position and the second outer injection position may be about 58–68 mm, about 58–62 mm, about 62–64 mm, about 64–68 mm, or about 63 mm.

[0188] In some embodiments of drug infusion mask type C, the horizontal distance between the first outer injection position and the first intermediate injection position may be about 14 to 17 mm, about 15 to 16 mm, or about 15.5 to 16 mm. In some embodiments of drug infusion mask type C, the horizontal distance between the second outer injection position and the second intermediate injection position may also be about 14 to 17 mm, about 15 to 16 mm, or about 15.5 to 16 mm.

[0189] In some embodiments of drug infusion mask type C, the horizontal distance between the first intermediate injection position and the central injection position may be about 14 to 17 mm, about 15 to 16 mm, or about 15.5 to 16 mm. In some embodiments of drug infusion mask type C, the horizontal distance between the second intermediate injection position and the central injection position may also be about 14 to 17 mm, about 15 to 16 mm, or about 15.5 to 16 mm.

[0190] In some embodiments of drug injection mask type C, the vertical position of the first outer injection position may be located within 30 mm or within 20 mm from the vertical position of the first intermediate injection position, and may have a difference of, for example, about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0191] In some embodiments of drug injection mask type C, the vertical position of the first outer injection position may be located within 30 mm or within 20 mm from the vertical position of the central injection position, and may have a difference of, for example, about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0192] In some embodiments of drug injection mask type C, the vertical position of the first intermediate injection position may be located within 30 mm or within 20 mm from the vertical position of the central injection position, and may have a difference of, for example, about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0193] In some embodiments of drug injection mask type C, the vertical position of the second outer injection position may be located within 30 mm or within 20 mm from the vertical position of the second intermediate injection position, and may have a difference of, for example, about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0194] In some embodiments of drug injection mask type C, the vertical position of the second outer injection position may be located within 30 mm or within 20 mm from the vertical position of the central injection position, and may have a difference of, for example, about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0195] In some embodiments of drug infusion mask type C, the vertical position of the second intermediate injection position may be located within 30 mm or within 20 mm from the vertical position of the central injection position, and may have a difference of, for example, about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0196] Drug Injection Mask Type D

[0197] Some drug injection masks include a first outer injection position (optionally including a first outer injector integrally formed with the substrate at this position), a second outer injection position (optionally including a second outer injector integrally formed with the substrate at this position), a first intermediate injection position (optionally including a first intermediate injector integrally formed with the substrate at this position), a second intermediate injection position (optionally including a second intermediate injector integrally formed with the substrate at this position), and a central injection position (optionally including a central injector integrally formed with the substrate at this position), and may be referred to as drug injection mask type D for convenience.

[0198] In drug injection mask type D, the horizontal distance between the first outer injection position and the second outer injection position may be about 62–72 mm, about 62–66 mm, about 66–68 mm, about 68–72 mm, or about 67 mm.

[0199] In some embodiments of drug injection mask type D, the horizontal distance between the first outer injection position and the first intermediate injection position may be about 15 to 18 mm, about 16 to 17 mm, or about 16.5 to 17 mm. Additionally, the horizontal distance between the second outer injection position and the second intermediate injection position may also be about 15 to 18 mm, about 16 to 17 mm, or about 16.5 to 17 mm.

[0200] In some embodiments of drug infusion mask type D, the horizontal distance between the first intermediate injection position and the central injection position may be about 15 to 18 mm, about 16 to 17 mm, or about 16.5 to 17 mm. In some embodiments of drug infusion mask type D, the horizontal distance between the second intermediate injection position and the central injection position may also be about 15 to 18 mm, about 16 to 17 mm, or about 16.5 to 17 mm.

[0201] In some embodiments of drug injection mask type D, the vertical position of the first outer injection position may be located within 30 mm or within 20 mm from the vertical position of the first intermediate injection position, and may have a difference of, for example, about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0202] In some embodiments of drug injection mask type D, the vertical position of the first outer injection position may be located within 30 mm or within 20 mm from the vertical position of the central injection position, and may have a difference of, for example, about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0203] In some embodiments of drug infusion mask type D, the vertical position of the first intermediate injection position may be located within 30 mm or within 20 mm from the vertical position of the central injection position, and may have a difference of, for example, about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0204] In some embodiments of drug injection mask type D, the vertical position of the second outer injection position may be located within 30 mm or within 20 mm from the vertical position of the second intermediate injection position, and may have a difference of, for example, about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0205] In some embodiments of drug injection mask type D, the vertical position of the second outer injection position may be located within 30 mm or within 20 mm from the vertical position of the central injection position, and may have a difference of, for example, about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0206] In some embodiments of drug infusion mask type D, the vertical position of the second intermediate injection position may be located within 30 mm or within 20 mm from the vertical position of the central injection position, and may have a difference of, for example, about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0207] Drug Injection Mask Type E

[0208] A drug injection mask comprising a first outer injection position (optionally including a first outer injector integrally formed with the substrate at this position), a second outer injection position (optionally including a second outer injector integrally formed with the substrate at this position), a first intermediate injection position (optionally including a first intermediate injector integrally formed with the substrate at this position), a second intermediate injection position (optionally including a second intermediate injector integrally formed with the substrate at this position), and a central injection position (optionally including a central injector integrally formed with the substrate at this position) may be referred to as drug injection mask type E for convenience.

[0209] In drug injection mask type E, the horizontal distance between the first outer injection position and the second outer injection position may be about 68–78 mm, about 68–72 mm, about 72–74 mm, about 74–78 mm, or about 73–74 mm.

[0210] In some embodiments of drug infusion mask type E, the horizontal distance between the first outer injection position and the first intermediate injection position may be about 16 to 20 mm, about 18 to 19 mm, or about 18 to 18.5 mm. In some embodiments of drug infusion mask type E, the horizontal distance between the second outer injection position and the second intermediate injection position may be about 16 to 20 mm, about 18 to 19 mm, or about 18 to 18.5 mm.

[0211] In some embodiments of drug infusion mask type E, the horizontal distance between the first intermediate injection position and the central injection position may be about 16 to 20 mm, about 18 to 19 mm, or about 18 to 18.5 mm. In some embodiments of drug infusion mask type E, the horizontal distance between the second intermediate injection position and the central injection position may be about 16 to 20 mm, about 18 to 19 mm, or about 18 to 18.5 mm.

[0212] In some embodiments of drug injection mask type E, the vertical position of the first outer injection position may be located within 30 mm or within 20 mm from the vertical position of the first intermediate injection position, and may be spaced apart by, for example, about 2 to 7 mm, 7 to 12 mm, 12 to 17 mm, 2 to 4 mm, 4 to 6 mm, 6 to 9 mm, 9 to 12 mm, 12 to 14 mm, 14 to 16 mm, or 14 to 17 mm.

[0213] In some embodiments of drug injection mask type E, the vertical position of the first outer injection position may be located within 30 mm or within 20 mm from the vertical position of the central injection position, and may be spaced apart by, for example, about 2 to 7 mm, 7 to 12 mm, 12 to 17 mm, 2 to 4 mm, 4 to 6 mm, 6 to 9 mm, 9 to 12 mm, 12 to 14 mm, 14 to 16 mm, or 14 to 17 mm.

[0214] In some embodiments of drug injection mask type E, the vertical position of the first intermediate injection position may be located within 30 mm or within 20 mm from the vertical position of the central injection position, and may be spaced apart by, for example, about 2 to 7 mm, 7 to 12 mm, 12 to 17 mm, 2 to 4 mm, 4 to 6 mm, 6 to 9 mm, 9 to 12 mm, 12 to 14 mm, 14 to 16 mm, or 14 to 17 mm.

[0215] In some embodiments of drug injection mask type E, the vertical position of the second outer injection position may be located within 30 mm or within 20 mm from the vertical position of the second intermediate injection position, and may be spaced apart by, for example, about 2 to 7 mm, 7 to 12 mm, 12 to 17 mm, 2 to 4 mm, 4 to 6 mm, 6 to 9 mm, 9 to 12 mm, 12 to 14 mm, 14 to 16 mm, or 14 to 17 mm.

[0216] In some embodiments of drug injection mask type E, the vertical position of the second outer injection position may be located within 30 mm or within 20 mm from the vertical position of the central injection position, and may be spaced apart by, for example, about 2 to 7 mm, 7 to 12 mm, 12 to 17 mm, 2 to 4 mm, 4 to 6 mm, 6 to 9 mm, 9 to 12 mm, 12 to 14 mm, 14 to 16 mm, or 14 to 17 mm.

[0217] In some embodiments of drug injection mask type E, the vertical position of the second intermediate injection position may be located within 30 mm or within 20 mm from the vertical position of the central injection position, and may be spaced apart by, for example, about 2 to 7 mm, 7 to 12 mm, 12 to 17 mm, 2 to 4 mm, 4 to 6 mm, 6 to 9 mm, 9 to 12 mm, 12 to 14 mm, 14 to 16 mm, or 14 to 17 mm.

[0218] Drug Injection Mask Type F

[0219] A drug injection mask comprising a first outer injection position (optionally including a first outer injector integrally formed with the substrate at this position), a second outer injection position (optionally including a second outer injector integrally formed with the substrate at this position), a first intermediate injection position (optionally including a first intermediate injector integrally formed with the substrate at this position), a second intermediate injection position (optionally including a second intermediate injector integrally formed with the substrate at this position), and a central injection position (optionally including a central injector integrally formed with the substrate at this position) may be referred to as drug injection mask type F for convenience.

[0220] In some embodiments of drug infusion mask type F, the horizontal distance between the first outer injection position and the central injection position may be about 28 to 32 mm, about 29 to 30 mm, or about 29.5 mm. In some embodiments of drug infusion mask type F, the horizontal distance between the second outer injection position and the central injection position may be about 28 to 32 mm, about 29 to 30 mm, or about 29.5 mm.

[0221] In some embodiments of drug infusion mask type F, the horizontal distance between the first intermediate injection position and the central injection position may be about 10 to 14 mm, about 11 to 12 mm, or about 11.5 to 12 mm. In some embodiments of drug infusion mask type F, the horizontal distance between the second intermediate injection position and the central injection position may be about 10 to 14 mm, about 11 to 12 mm, or about 11.5 to 12 mm.

[0222] In some embodiments of the drug injection mask type F, the vertical position of the first outer injection position may be located within about 30 mm or within about 20 mm relative to the vertical position of the first intermediate injection position, for example, within a range of about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0223] In some embodiments of the drug injection mask type F, the vertical position of the first outer injection position may be located within about 30 mm or within about 20 mm relative to the vertical position of the central injection position, for example, within a range of about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0224] In some embodiments of the drug injection mask type F, the vertical position of the first intermediate injection position may be located within about 30 mm or within about 20 mm relative to the vertical position of the central injection position, for example, within a range of about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0225] In some embodiments of the drug injection mask type F, the vertical position of the second outer injection position may be located within about 30 mm or within about 20 mm relative to the vertical position of the second intermediate injection position, for example, within a range of about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0226] In some embodiments of the drug injection mask type F, the vertical position of the second outer injection position may be located within about 30 mm or within about 20 mm relative to the vertical position of the central injection position, for example, within a range of about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0227] In some embodiments of the drug injection mask type F, the vertical position of the second intermediate injection position may be located within about 30 mm or within about 20 mm relative to the vertical position of the central injection position, for example, within a range of about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0228] Drug Injection Mask Type G

[0229] A drug injection mask comprising a first outer injection position (optionally including a first outer injector integrally formed with the substrate at this position), a second outer injection position (optionally including a second outer injector integrally formed with the substrate at this position), a first intermediate injection position (optionally including a first intermediate injector integrally formed with the substrate at this position), a second intermediate injection position (optionally including a second intermediate injector integrally formed with the substrate at this position), and a central injection position (optionally including a central injector integrally formed with the substrate at this position) may be referred to as drug injection mask type G for convenience.

[0230] In some embodiments of drug infusion mask type G, the horizontal distance between the first outer injection position and the central injection position may be about 30 to 34 mm, about 31 to 32 mm, or about 31.5 mm. In some embodiments of drug infusion mask type G, the horizontal distance between the second outer injection position and the central injection position may be about 30 to 34 mm, about 31 to 32 mm, or about 31.5 mm.

[0231] In some embodiments of drug infusion mask type G, the horizontal distance between the first intermediate injection position and the central injection position may be about 14 to 17 mm, about 14.5 to 15.5 mm, or about 15 mm. In some embodiments of drug infusion mask type G, the horizontal distance between the second intermediate injection position and the central injection position may be about 14 to 17 mm, about 14.5 to 15.5 mm, or about 15 mm.

[0232] In some embodiments of the drug injection mask type G, the vertical position of the first outer injection position may be located within about 30 mm or within about 20 mm relative to the vertical position of the first intermediate injection position, for example, within a range of about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0233] In some embodiments of the drug injection mask type G, the vertical position of the first outer injection position may be located within about 30 mm or within about 20 mm relative to the vertical position of the central injection position, for example, within a range of about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0234] In some embodiments of the drug injection mask type G, the vertical position of the first intermediate injection position may be located within about 30 mm or within about 20 mm relative to the vertical position of the central injection position, for example, within a range of about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0235] In some embodiments of the drug injection mask type G, the vertical position of the second outer injection position may be located within about 30 mm or within about 20 mm relative to the vertical position of the second intermediate injection position, for example, within a range of about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0236] In some embodiments of the drug injection mask type G, the vertical position of the second outer injection position may be located within about 30 mm or within about 20 mm relative to the vertical position of the central injection position, for example, within a range of about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0237] In some embodiments of the drug injection mask type G, the vertical position of the second intermediate injection position may be located within about 30 mm or within about 20 mm relative to the vertical position of the central injection position, and may be located within, for example, a range of about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0238] Drug Injection Mask Type H

[0239] A drug injection mask comprising a first outer injection position (optionally including a first outer injector integrally formed with the substrate at this position), a second outer injection position (optionally including a second outer injector integrally formed with the substrate at this position), a first intermediate injection position (optionally including a first intermediate injector integrally formed with the substrate at this position), a second intermediate injection position (optionally including a second intermediate injector integrally formed with the substrate at this position), and a central injection position (optionally including a central injector integrally formed with the substrate at this position) may be referred to as drug injection mask type H for convenience.

[0240] In some embodiments of the drug infusion mask type H, the horizontal distance between the first outer injection position and the central injection position may be about 32 to 36 mm, about 33 to 34 mm, or about 33.5 mm. In some embodiments of the drug infusion mask type H, the horizontal distance between the second outer injection position and the central injection position may be about 30 to 34 mm, about 31 to 32 mm, or about 31.5 mm.

[0241] In some embodiments of drug infusion mask type H, the horizontal distance between the first intermediate injection position and the central injection position may be about 16 to 20 mm, about 17 to 19 mm, or about 18 mm. In some embodiments of drug infusion mask type H, the horizontal distance between the second intermediate injection position and the central injection position may be about 16 to 20 mm, about 17 to 19 mm, or about 18 mm.

[0242] In some embodiments of the drug injection mask type H, the vertical position of the first outer injection position may be located within about 30 mm or within about 20 mm relative to the vertical position of the first intermediate injection position, for example, within a range of about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0243] In some embodiments of the drug injection mask type H, the vertical position of the first outer injection position may be located within about 30 mm or within about 20 mm relative to the vertical position of the central injection position, for example, within a range of about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0244] In some embodiments of the drug injection mask type H, the vertical position of the first intermediate injection position may be located within about 30 mm or within about 20 mm relative to the vertical position of the central injection position, for example, within a range of about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0245] In some embodiments of the drug injection mask type H, the vertical position of the second outer injection position may be located within about 30 mm or within about 20 mm relative to the vertical position of the second intermediate injection position, for example, within a range of about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0246] In some embodiments of the drug injection mask type H, the vertical position of the second outer injection position may be located within about 30 mm or within about 20 mm relative to the vertical position of the central injection position, for example, within a range of about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0247] In some embodiments of the drug injection mask type H, the vertical position of the second intermediate injection position may be located within about 30 mm or within about 20 mm relative to the vertical position of the central injection position, for example, within a range of about 2 to 7 mm, about 7 to 12 mm, about 12 to 17 mm, about 2 to 4 mm, about 4 to 6 mm, about 6 to 9 mm, about 9 to 12 mm, about 12 to 14 mm, about 14 to 16 mm, or about 14 to 17 mm.

[0248] In the alternative configuration shown in FIG. 12, drug infusion devices can be connected to a common drug source (97) using a common infusion configuration (98). Identical or similar components are given the same reference numerals.

[0249] In this configuration, the drug is extracted from a common drug source (97) and supplied to a plurality of drug injection devices (100) as part of the drug injection process.

[0250] For example, when using a neurotoxin such as botulinum toxin, the toxin may be in any suitable form, including lyophilized, freeze-dried, or in-solution.

[0251] Drug infusion devices may be designed to allow for in situ reconstitution of the drug, or they may be designed to accommodate drugs that do not require mixing with other components prior to infusion. For example, liquid solution formulations such as Alluzience® may be used.

[0252] Referring to FIG. 13, an example drug infusion device (100) is illustrated.

[0253] In this embodiment, the drug infusion device (100) is used for a drug containing two components stored separately, which are mixed together immediately before being injected into a person to form an injectable drug. However, it will be understood that the drug infusion device (100) may be configured to accommodate a single-component drug that does not require mixing prior to injection.

[0254] The drug injection device (100) includes a housing (102) forming a first chamber (104) having a first chamber opening (105) and a second chamber (106) having a second chamber opening (107).

[0255] The first plunger (108) is slidably received in the first chamber (104) and includes a first plunger head (110) and a first plunger end (111). The first plunger (108) is elastically biased to move inward toward the first chamber (104), and in this embodiment, is biased by a bias device having the form of a coil spring (130).

[0256] The second plunger (112) is slidably received in the second chamber (106) and includes a second plunger head (114) and a second plunger end (113). A needle (115) is mounted on the second plunger head (114) and extends from it.

[0257] The first material (116) is contained in the first chamber (104), and the second material (118) is contained in the second chamber (106), and the device (100) is configured so that the first material (116) and the second material (118) do not come into contact with each other until the user operates the device (100). In this embodiment, operation of the device (100) is achieved by providing a detachable packaging member (120). The packaging member (120) includes a plunger stop (122) positioned between the first plunger end (111) and the housing (102), thereby preventing the first plunger (108) from moving inward into the first chamber (104) by the action of the coil spring (130). Additionally, a flexible membrane (132) extends across the first chamber opening (105), and the packaging member (120) includes an outlet seal (124). The outlet sealing portion (124) presses the flexible membrane (132) toward the first chamber opening (105) to seal the first chamber opening (105) and prevents the first material (116) from leaking out of the first chamber (104). In this embodiment, the outlet sealing portion (124) is a nipple-shaped member and extends into the first chamber opening (105), and presses the flexible membrane (132) so as to be in close contact with the first chamber opening (105) while the packaging member (120) is engaged with the housing (102).

[0258] As illustrated in FIG. 14, when the user removes the packaging member (120), the outlet seal (124) is separated from the first chamber opening (105) to form a fluid passage (134) between the first chamber opening (105) and the second chamber opening (107). Additionally, since the plunger stopper (122) is no longer present between the housing (102) and the first plunger end (111), the first plunger (108) moves inward toward the first chamber (104) by the action of the coil spring (130). Accordingly, the first material (116) moves from the first chamber (104) to the second chamber (106) through the fluid passage (134) and is mixed with the second material (118).

[0259] In this embodiment, the first substance is a saline solution, and the second substance is a mixture of botulinum toxin powder, sodium chloride, and albumin. However, it will be understood that any suitable first and second substance may be used according to the proposed treatment process.

[0260] In this embodiment, the injection device (100) is configured to deliver about 0.1 mL of physiological saline and about 0.07 mg of a mixture of botulinum toxin powder, sodium chloride, and albumin. The mixture may contain 0.045 mg of sodium chloride, 0.025 mg of albumin, and 0.25 ng of botulinum toxin.

[0261] As illustrated in FIG. 15, after the first substance and the second substance are mixed to form an injectable drug, the drug is injected by applying manual force to the second plunger (112) as indicated by arrow A. By this action, the second plunger (112) moves inward toward the second chamber (106), and the drug is injected into a person through the needle (115).

[0262] In any part of the injection device that comes into contact with the drug, the silicone component may comprise bromobutyl silicone coated with poly(ethene-co-tetrafluoroethene) (ETFE). The ETFE coating may help prevent oxygen radicals from penetrating the silicone and denaturing the toxin over time.

[0263] For example, any plunger such as the first plunger (108) and the second plunger (112) described in this specification may include ETFE-coated bromobutyl silicone.

[0264] As another example, any fluid channel between two chambers containing drugs, such as the fluid channel (134) between the first chamber (104) and the second chamber (106), may be formed within a wall containing ETFE-coated bromobutyl silicone.

[0265] FIG. 16 shows a flowchart (138) illustrating steps (139) to (156) of an exemplary method of providing a drug injection system to a person.

[0266] The above method first includes the step of determining one or more relevant anthropometric characteristics from a person. In this embodiment, the distance between the medial canthals is determined, which is used to determine the position of the medial edge of the person's orbital ridge (steps (139) to (142)).

[0267] In this embodiment, the distance between the inner corners of the eye is determined using a LiDAR scanner equipped on a smartphone and a related software application running on the smartphone. The LiDAR scanner generates a point cloud representation of a human face, and the software application on the smartphone uses this to calculate the distance between the inner corners of the eye.

[0268] Based on the determined distance between the inner corners of the eye, a mask device (80, 86, 90) having an injection pattern suitable for that distance is selected (steps (144) and (146)). The selected mask device (80, 86, 90) is then provided to a person, for example, by mail (steps (148) and (150)).

[0269] After washing and disinfecting the person's face, the mask (80, 86, 90) is placed on the face and aligned with the face. For example, the mask (80) is aligned to the inner edge of the person's orbital ridge (steps (152) and (154)). Then, the user injects a drug into the required injection site defined by the injection pattern (82) of the mask (80) using the injection device provided in the mask (step (156)). Afterward, the user provides feedback regarding whether the size of the mask (80) is appropriate or if adjustment is needed (step (160)). This feedback is used to adjust the algorithm.

[0270] The following documents are incorporated herein by reference in their entirety.

[0271] Australian patent application No. AU2024900090 filed on January 12, 2024, and U.S. provisional patent application No. 63 / 688,241 filed on August 28, 2024.

[0272] In the following claims and the foregoing detailed description, variations such as “comprise” or “comprises, comprising” are used in a comprehensive sense, unless otherwise required by the context, express expression, or necessary meaning. That is, this specifies the presence of the described components and does not exclude the presence or addition of additional components in the various embodiments.

[0273] Wherever any prior art literature is referred to in this specification, such reference shall not be construed as an acknowledgment that such literature constitutes part of the art generally known to a person skilled in the art in the United States or any other country.

[0274] All modifications and variations obvious to those skilled in the art are deemed to be included within the scope of the present invention.

Claims

Claim 1 A drug infusion device comprising a first chamber for receiving a first substance and a second chamber for receiving a second substance, wherein fluid communication between the first chamber and the second chamber is blocked when a removable packaging member is attached to the drug infusion device, and fluid communication between the first chamber and the second chamber is enabled when the removable packaging member is removed from the drug infusion device. Claim 2 A drug injection device according to claim 1, wherein at least one of the first chamber and the second chamber comprises a biasing device configured to pressurize the first plunger and the inner direction of the first or second chamber, and when the packaging member is attached to the drug injection device, the inward movement of the first plunger by the biasing device is prevented, and when the packaging member is removed from the drug injection device, the inward movement of the first plunger by the biasing device is enabled, so that the first substance and the second substance are mixed by the removal of the packaging member. Claim 3 In paragraph 2, the above biasing device is a spring, a drug injection device. Claim 4 A drug injection device according to claim 2 or 3, wherein the other of the first chamber and the second chamber comprises a second plunger and a needle, and after the first substance and the second substance are mixed, the mixed substance is discharged through the needle by moving the second plunger inward. Claim 5 A drug infusion device according to any one of claims 1 to 4, wherein the first chamber includes a first chamber opening and the second chamber includes a second chamber opening, and the drug infusion device includes a flexible membrane disposed to cover at least one of the first chamber opening and the second chamber opening, and the removable packaging member engages with the flexible membrane and the first chamber opening and / or the second chamber opening to block fluid communication between the first chamber and the second chamber while the packaging member is attached. Claim 6 A drug injection device according to claim 5, wherein the detachable packaging member comprises a protruding stop portion, and the protruding stop portion presses the flexible membrane toward the first chamber opening and / or the second chamber opening to seal the first chamber opening and / or the second chamber opening when the packaging member is attached. Claim 7 A method for providing a personal drug infusion system comprises: a step of obtaining at least one anthropometric characteristic value through interaction between a physical instrument and a body part of a person scheduled to receive an injectable drug using a physical instrument; a step of providing at least three personal drug infusion system types, wherein each personal drug infusion system type is configured to fit the body part of the person, and the at least three personal drug infusion system types include: a first personal drug infusion system type having a first drug infusion location set comprising at least one defined drug infusion location corresponding to the location of a drug infusion site on the body part of the person when the first personal drug infusion system type is placed on the body part of the person, and a first personal drug infusion system type associated with a first defined anthropometric characteristic value range; and a second personal drug infusion system type having a second drug infusion location set comprising at least one defined drug infusion location corresponding to the location of a drug infusion site on the body part of the person when the second personal drug infusion system type is placed on the body part of the person, and the second drug infusion location set A second personal drug infusion system type that is different from the first drug infusion location set of the first personal drug infusion system type and is associated with a second defined anthropometric characteristic value range that is different from the first defined anthropometric characteristic value range;A step of providing at least three personal drug infusion system types, wherein the third personal drug infusion system type comprises a third drug infusion location set including at least one defined drug infusion location corresponding to the location of a drug infusion site on a human body part when the third personal drug infusion system type is placed on a human body part, wherein the third drug infusion location set is different from the first drug infusion location set of the first personal drug infusion system type and the second drug infusion location set of the second personal drug infusion system type, and wherein the third personal drug infusion system type is associated with a third defined anthropometric characteristic value range that is different from both the first defined anthropometric characteristic value range and the second defined anthropometric characteristic value range; and selecting one of the at least three personal drug infusion system types by determining whether the anthropometric characteristic value obtained from a person falls within the first defined anthropometric characteristic value range, the second defined anthropometric characteristic value range, or the third defined anthropometric characteristic value range. A method for providing a personal drug infusion system, comprising the steps of: providing a selected personal drug infusion system type to the person. Claim 8 A method for providing a personal drug infusion system, wherein, in claim 7, at least one anthropometric characteristic value includes the intercanthal separation distance. Claim 9 A method for providing a personal drug injection system, wherein, in claim 8, at least one anthropometric characteristic value includes the distance between the inner edges of a person's orbital ridge. Claim 10 A method for providing a personal drug infusion system, comprising, in any one of claims 7 to 9, a step of determining at least one first anthropometric characteristic value through interaction with a body part of a person using the physical device; a step of determining at least one second anthropometric characteristic value using the first anthropometric characteristic value; and a step of selecting one of at least three personal drug infusion system types using the second anthropometric characteristic value and the first anthropometric characteristic value. Claim 11 A method for providing a personal drug injection system, comprising the step of determining at least one anthropometric characteristic value by obtaining a three-dimensional representation of at least one part of the body through interaction between the physical device and a part of the human body, in any one of claims 7 to 10. Claim 12 A method for providing a personal drug injection system, wherein, in claim 11, the three-dimensional representation is obtained by interaction between a LIDAR scanner and a part of a person's body, and the method includes the step of analyzing the three-dimensional representation to determine at least one anthropometric characteristic value. Claim 13 A method for providing a personal drug injection system, comprising the step of determining an anthropometric characteristic value by taking an image of at least a part of a person's body and analyzing the image to determine the at least one anthropometric characteristic value in any one of claims 7 to 10. Claim 14 A method for providing a personal drug injection system, comprising the step of determining the anthropometric characteristic value by directly measuring the at least one anthropometric characteristic value using the physical device in any one of claims 7 to 10. Claim 15 A method for providing a personal drug infusion system, comprising the step of predicting at least one anthropometric characteristic value using machine learning in any one of claims 7 to 14, and / or selecting one of at least three personal drug infusion system types. Claim 16 A method for providing a personal drug injection system according to claim 15, wherein the machine learning uses at least one convolutional neural network (CNN) learned using data representing a plurality of body part representations and at least one anthropometric characteristic value corresponding to each body part representation. Claim 17 A method for providing a personal drug infusion system, wherein, in any one of claims 7 to 16, at least one personal drug infusion system has at least partially rigidity. Claim 18 A method for providing a personal drug infusion system according to any one of claims 7 to 17, wherein at least one personal drug infusion system is at least partially flexible. Claim 19 A method for providing a personal drug infusion system, comprising the step of providing at least one fixed drug infusion device to at least one personal drug infusion system type in any one of claims 7 to 18. Claim 20 A method for providing a personal drug infusion system, comprising the step of providing at least one removable drug infusion device to at least one personal drug infusion system type in any one of claims 7 to 18. Claim 21 A method for providing a personal drug infusion system, comprising the step of providing at least one alignment component to at least one personal drug infusion system type in any one of claims 7 to 20, which facilitates proper alignment of the personal drug infusion system type to a human body part. Claim 22 A method for providing a personal drug injection system according to claim 21, wherein the alignment component is configured to engage with a predetermined feature of a human body part, and when the alignment component engages with the predetermined feature of the body part, the personal drug injection system type is correctly aligned with the body part. Claim 23 A method for providing a personal drug injection system, wherein the above-mentioned specific feature is the lower surface of a person's orbital ridges. Claim 24 A method for providing a personal drug infusion system according to claim 21, wherein the alignment component includes a visual feature of the personal drug infusion system type, and the personal drug infusion system type is usable to align the personal drug infusion system type to the body part by visually aligning the visual feature with a predetermined feature part of the human body part. Claim 25 A method for providing a personal drug injection system according to claim 24, wherein the visual feature comprises a lower flat surface of the personal drug injection system type, and the predetermined feature comprises an inner edge of the lower surface of a person's brow ridge. Claim 26 A method for providing a personal drug injection system, wherein, in any one of claims 7 to 25, the human body part may include at least a part of the human face. Claim 27 In claim 26, a method for providing a personal drug injection system comprising a mask device that covers at least a portion of a person's face. Claim 28 A method for providing a personal drug infusion system, wherein, in any one of claims 7 to 27, the injectable drug comprises a neuromodulator. Claim 29 In paragraph 28, a method for providing a personal drug injection system, wherein the neuromodulator comprises botulinum toxin. Claim 30 In paragraph 29, a method for providing a personal drug injection system in which the neuromodulator is a synthetically derived analogue of botulinum toxin. Claim 31 A method for providing a personal drug infusion system, wherein, in any one of claims 7 to 30, the personal drug infusion system type comprises a plurality of drug infusion system modules that can be connected to each other. Claim 32 A method for administering a neuromodulator to a human patient, comprising the step of placing a selected personal drug injection system type of claim 7 at a predetermined location on the face of the human patient, wherein the set of drug injection locations of the personal drug injection system type corresponds to a cosmetic treatment process for glabellar lines, said treatment process comprising injecting the neuromodulator into the corrugator muscles and procerus muscles of the human patient; and the step of injecting the neuromodulator into the corrugator muscles and procerus muscles of the human patient using an injection device placed at drug injection site locations associated with said set of drug injection locations. Claim 33 In paragraph 32, the drug injection site locations associated with the set of drug injection sites are a method of administering a neuromodulator drug, wherein the drug injection patterns are determined according to the injection protocol defined by Allergan for the treatment of glabellar lines using FDA-approved botulinum toxin drugs. Claim 34 A method for administering a neuromodulator to a human patient, comprising the step of placing a selected personal drug injection system type of claim 7 at a predetermined location on the face of the human patient, wherein the set of drug injection locations of the personal drug injection system type corresponds to a cosmetic treatment process for lateral canthal lines, said treatment process comprising injecting the neuromodulator into the lateral orbicularis oculi muscle of the human patient; and the step of injecting the neuromodulator into the lateral orbicularis oculi muscle of the human patient using an injection device placed at drug injection site locations associated with said set of drug injection locations. Claim 35 In paragraph 34, the drug injection site locations associated with the above-mentioned set of drug injection sites are a method of administering a neuromodulator drug, which is a drug injection pattern for treating crow's feet using an FDA-approved botulinum toxin drug. Claim 36 A method for administering a neuromodulator to a human patient, comprising the step of placing a selected personal drug infusion system type of claim 7 at a predetermined location on the face of the human patient, wherein the set of drug infusion locations of the personal drug infusion system type corresponds to a cosmetic treatment process of horizontal forehead lines, said treatment process including injecting the neuromodulator into the frontalis muscle of the human patient; and the step of injecting the neuromodulator into the frontalis muscle of the human patient using an infusion device placed at drug injection site locations associated with said set of drug infusion locations. Claim 37 In paragraph 36, the drug injection site locations associated with the above-mentioned set of drug injection sites are a method of administering a neuromodulator drug, which is a drug injection pattern defined by Allergan for the treatment of horizontal forehead wrinkles using an FDA-approved botulinum toxin drug. Claim 38 A method for administering a neuromodulator to a human patient, comprising the step of placing a selected personal drug infusion system type of claim 7 at a predetermined location on the face of the human patient, wherein the set of drug infusion locations of the personal drug infusion system type corresponds to a treatment process for primary axillary hyperhidrosis (PAH), said treatment process comprising injecting the neuromodulator intradermally; and the step of injecting the neuromodulator intradermally to the human patient using an infusion device placed at drug injection site locations associated with said set of drug infusion locations. Claim 39 In paragraph 38, a method for administering a neuromodulator drug, wherein the drug injection site locations associated with the set of drug injection sites are a drug injection pattern defined for the treatment of primary axillary hyperhidrosis (PAH) using an FDA-approved botulinum toxin drug. Claim 40 A method for administering a neuromodulator to a human patient, comprising the step of placing a selected personal drug injection system type of claim 7 at a predetermined location on the face of the human patient, wherein the set of drug injection sites of the personal drug injection system type corresponds to a migraine treatment process of injecting botulinum toxin into the corrugator supercilii muscle, procerus muscle, and frontalis muscle of a human; and the step of injecting the neuromodulator into the corrugator supercilii muscle, procerus muscle, and frontalis muscle of a human using an injection device placed at drug injection site locations associated with the set of drug injection sites. Claim 41 In paragraph 40, a method for administering a neuromodulator drug, wherein the drug injection site locations associated with the set of drug injection sites are drug injection patterns determined according to an injection protocol consistent with the Phase II research PREEMPT (Evaluating Migraine Prophylaxis Therapy) study. Claim 42 A method for providing a personal drug infusion system according to claim 7, wherein the drug is formed by reconstitution from a plurality of components or is an in-solution formulation that does not require reconstitution. Claim 43 A personal drug infusion system provided by the method of any one of claims 7 to 31, wherein the personal drug infusion system is configured to fit a body part of a person intended to receive an injectable drug, and comprises at least one defined drug injection site corresponding to the location of the drug injection site of the body part when the personal drug infusion system is placed on the body part of the person. Claim 44 In paragraph 43, the personal drug infusion system comprises at least one fixed or detachable drug infusion device. Claim 45 A selection set comprising three to five different personal drug infusion system types, wherein each personal drug infusion system type is configured to be suitable for a human body part, and the selection set comprises: a first personal drug infusion system type having a first drug infusion location set including at least one defined drug infusion location corresponding to the location of the drug infusion site of the body part when the first personal drug infusion system is placed on the human body part, wherein the first personal drug infusion system is associated with a defined first anthropometric characteristic value range; and a second personal drug infusion system type having a second drug infusion location set including at least one defined drug infusion location corresponding to the location of the drug infusion site of the body part when the second personal drug infusion system is placed on the human body part, wherein the second drug infusion location set is different from the first drug infusion location set of the first personal drug infusion system type, and the second personal drug infusion system type is associated with a defined second anthropometric characteristic value range different from the defined first anthropometric characteristic value range. Personal drug infusion system type;A selection set comprising a third personal drug infusion system type, wherein the third personal drug infusion system type has a third drug infusion location set including at least one defined drug infusion location corresponding to the location of the drug infusion site of the body part when the third personal drug infusion system is placed on a body part of a person, wherein the third drug infusion location set is different from both the first drug infusion location set of the first personal drug infusion system type and the second drug infusion location set of the second personal drug infusion system type, and wherein the third personal drug infusion system type is associated with a defined third anthropometric characteristic value range that is different from both the defined first anthropometric characteristic value range and the defined second anthropometric characteristic value range. Claim 46 In paragraph 45, the first personal drug infusion system type is a selection set that is at least partially rigid. Claim 47 In paragraph 45, the first personal drug infusion system type is a selection set that is at least partially flexible. Claim 48 In any one of paragraphs 45 to 47, the first personal drug infusion system type further comprises at least one fixed drug infusion device, a selectable set. Claim 49 In any one of paragraphs 45 to 47, the first personal drug infusion system type further comprises at least one removable drug infusion device, a selectable set. Claim 50 A selection set according to any one of claims 45 to 49, wherein the first personal drug infusion system type further comprises at least one alignment component configured to facilitate proper alignment of the personal drug infusion system type to a human body part. Claim 51 In any one of paragraphs 45 to 50, the second personal drug infusion system type is at least partially rigid, a selectable set. Claim 52 In any one of claims 45 to 50, the second personal drug infusion system type is at least partially flexible, a selectable set. Claim 53 In any one of paragraphs 45 to 52, the second personal drug infusion system type further comprises at least one fixed drug infusion device, a selectable set. Claim 54 In any one of paragraphs 45 to 52, the second personal drug infusion system type further comprises at least one removable drug infusion device, a selectable set. Claim 55 A selection set according to any one of claims 45 to 54, wherein the second personal drug infusion system type further comprises at least one alignment component configured to facilitate proper alignment of the personal drug infusion system type to a human body part. Claim 56 In any one of paragraphs 45 to 55, the third personal drug infusion system type is at least partially rigid, a selectable set. Claim 57 In any one of paragraphs 45 to 55, the third personal drug infusion system type is at least partially flexible, a selectable set. Claim 58 In any one of paragraphs 45 to 57, the third personal drug infusion system type further comprises at least one fixed drug infusion device, a selectable set. Claim 59 In any one of paragraphs 45 to 57, the third personal drug infusion system type further comprises at least one removable drug infusion device, a selectable set. Claim 60 A selection set according to any one of claims 45 to 59, wherein the third personal drug infusion system type further comprises at least one alignment component configured to facilitate proper alignment of the personal drug infusion system type to a human body part.

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