KR20220153019A - Systems and methods for injecting botulinum toxin or other drugs for medical treatment - Google Patents

Abstract

A method for injecting a drug into a patient, the method comprising: a) marking an indicator on the patient's skin to identify a location for drug injection; b) taking an image of the skin having the marking thereon; c) obtaining a customized cover having an opening in the cover, then inserting a marking device through the opening to mark the skin for the injection site.

Description

Systems and methods for injecting botulinum toxin or other drugs for medical treatment

This application is a continuation in part of Application Serial No. 16/570,515, filed on September 13, 2019, which claims priority from Provisional Application Serial No. 62/734,918, filed on September 21, 2018. The entire contents of each of these applications are incorporated herein by reference.

FIELD OF THE INVENTION This application relates to systems and methods for drug infusion, and more particularly to a custom patient mask to facilitate the infusion of a drug such as botulinum toxin, and to a process for forming the mask.

Botulinum toxin is a neurotoxin made from a toxin produced by the bacterium Clostridium botulinum. Doctors use these drugs in small doses in cosmetology to temporarily smooth facial wrinkles and improve appearance. Injections work by weakening or paralyzing certain muscles or blocking certain nerves. The effect lasts for about 3 to 12 months depending on the treatment target. Under trade names such as Botox (onabotulinumtoxinA, Allergan) and Dysport/Azzalure (abobotulinumtoxinA, Ipsen/Galderma), Xeomin/Bocouture (incobotulinumtoxinA, Merz) and Jeuveau (prabotulinumtoxinA, Evolus/Daewoong), along with several others in clinical trials. There are various types of botulinum toxin that are marketed.

Botulinum toxin is typically injected into the human face. The effect of current botulinum toxin injections on the glabellar line (line between the eyes) typically lasts 2 to 4 months, but this is patient and in some cases product-dependent, with some patients experiencing longer-lasting effects . Injection of botulinum toxin into the muscles beneath the facial folds causes relaxation of those muscles, resulting in smoothing of the overlying skin. Smoothing of wrinkles is usually seen 3-5 days after injection, with maximal effect typically a week after injection. The muscle can be treated repeatedly to maintain a smooth appearance.

Patients often report that their botulinum toxin (e.g. Botox, Dysport, Xeomin) injections into wrinkles/frown lines are the same at different practitioners' offices, or even in some cases by the same practitioner. Complain about how different it is due to the variability of the cases injected in the office. Such variability may, for example, alter the shape of one eyebrow, making them too arched, too flat, drooping, etc., or not providing the desired wrinkle reduction. This variability also results in a different appearance than the patient expected. Variability in patient anatomy and the muscles beneath the skin are the reasons for the variability in patient outcomes with infusions.

A need exists to achieve more consistent results for botulinum toxin injections. There is a further need for botulinum infusions that better meet individual patient goals. Such a system that delivers more consistent results and better conformance to the desire would be beneficial and also find use in other surgical applications/procedures. Such systems would also be beneficial if they could improve outcomes while improving convenience and reducing cost to the patient.

The present invention advantageously overcomes the problems and deficiencies of the prior art. The present invention provides various systems and methods for achieving more consistent results from botulinum toxin injection (or other drug injection). The present invention also provides various systems and methods that are more responsive to the patient's wishes. Such systems and methods include inputs of the anatomy of the patient's face and/or scalp (or other body regions), inputs of locations for injections, and/or creation of a 3D mask with injection locators in response to the inputs. provides In an alternative embodiment of the present invention, a 3D mask is created with openings for markers so that the surgeon can mark the patient's skin to provide consistent injection locations. Each of these systems and methods are discussed in detail below.

The present invention provides custom masks that, in their simplest form, provide a locator for fluid injection by a physician. The present invention may provide a locator or integral injection device for an injection device attachable to a custom mask in an alternative embodiment. The present invention, in an alternative embodiment, provides a custom mask with a locator for skin marking on a patient. These various embodiments are discussed in detail below.

The present invention also provides, in some embodiments, systems and methods that enable a non-physician patient to inject fluid, as discussed in detail below.

According to one aspect of the present invention, there is provided a method for creating a custom cover (mask) for injection of a drug into a patient, the method including a) an indicator for identifying a location for injection of a drug on the patient's skin ( marking the indicator: b) taking an image of the skin with the marking; and c) inputting the image to create a cover having an aperture corresponding to the marking on the skin, the aperture being dimensioned for insertion of a marker through the cover to enable repeated marking through the cover. extends through the cover.

According to another aspect of the present invention, a method for creating a custom cover for injection of a drug into a patient is provided based on the use of a custom cover formed by data input of a patient's anatomical features, the method comprising: a) Marking an indicator for identifying a location for drug injection on the patient's skin; b) taking an image of the skin with markings thereon to provide data input for the cover; and c) obtaining a customized cover having openings in the cover, then inserting a marking device through at least one of the openings to mark the skin for the injection site.

According to some embodiments, the method further includes marking the skin with various color markings to indicate different dosages of drug for injection.

In some embodiments, the method further includes removing the cover after marking is made through the opening with one or more marking devices and injecting a drug at the location of the marking.

In some embodiments, the cover has a designation integrally formed thereon or alternatively applied to the cover after the cover is formed to indicate the dosage, the method comprising: removing the cover; and injecting the drug into the patient according to the indicated dosage.

In some embodiments, the method further includes aligning the cover on the skin according to the at least one alignment marker on the cover.

In some embodiments, the method further includes editing the image to provide a calibrated image and uploading the calibrated image to provide a guide for forming the cover.

According to another aspect of the present invention, a method for providing consistent infusion of a drug through the skin of a patient is provided, the method comprising:

a) manually providing a first marking on the patient's skin to provide a locator for drug infusion;

b) taking a first image of the skin having a first marking thereon;

c) storing the first image;

d) injecting the drug into the patient at the location of the first marking;

e) after a period of time, evaluating the result of the injection of the drug and i) editing the first image to adjust one or more injection locations or ii) not editing the first image;

f) obtaining a cover made according to the edited or unedited first image, then placing the cover on the skin and manually applying a second marking through an opening in the cover; and

g) removing the cover and injecting the drug at the second marking.

In some embodiments, the method further includes uploading the edited or unedited first image to a web portal for linking with the device for making the cover.

According to another aspect of the present invention, a custom cover is provided for placement over a part of a patient's body, the cover being used by a health care provider to provide a marked location on the patient for infusion of one or more medications. It has a plurality of apertures extending therethrough configured and dimensioned for manual insertion of markers. The cover is made from a set of instructions generated from a software-based application processing an image of a patient's anatomical view with markings thereon. The cover is customized to the part of the body based on a software-based application and a plurality of openings are customized to the desired location of the marking through the cover for subsequent injection of one or more medications independent of the cover.

In some embodiments, the cover is configured for placement on a patient's face. In some embodiments, the cover includes one or more alignment markings for aligning the cover on the body. In some embodiments, the cover includes a dose indicator thereon.

In some embodiments, the image is web linked to a software application on the device that receives and processes data corresponding to the desired location of drug injection based on the manually marked location to provide a set of instructions for manufacturing the cover. It is entered (uploaded) on the site portal. In some embodiments, the image is manipulated prior to entry into the website portal; In another embodiment the image is uploaded to a website portal and then manipulated.

In some embodiments, the custom cover is formed by 3D printing.

In some embodiments, the cover is made based on human editing on a software program.

According to another aspect, a method of manufacturing a custom cover for placement over a portion of a patient's body is provided, comprising a set generated from a software-based application processing images of a patient's anatomical view consisting of locations marked thereon. interpreting the commands of the cover, customizing the cover to the part of the body based on the software-based application, and opening a plurality of openings in the cover for subsequent injection of one or more medications in the marking without the cover, i.e. independently of the cover. and tailoring to the desired location of the marking. The cover has a plurality of apertures extending therethrough configured and dimensioned for manual insertion of markers by a medical practitioner to provide marked locations on the patient for infusion of one or more medications once the cover is removed from the patient.

In some embodiments, the cover is directed to a software application on the device that receives and processes data corresponding to the desired location of drug injection by the patient, based on the manually marked location, to provide instructions for manufacturing the cover. It is made based on the image entered into the linked website portal.

According to another aspect of the present invention, a method for making a custom cover for placement over a part of a patient's body is provided. The cover is made with a plurality of apertures extending therethrough configured and dimensioned for manual insertion of markers by a medical practitioner to provide marked locations on the patient for infusion of one or more medications. The cover is made based on input of a set of commands generated from a software-based application processing an image of a patient's anatomical view with markings thereon. The cover is made to fit the part of the body based on a software-based application and a plurality of openings are made to fit the desired location of the marking through the cover for subsequent injection of one or more medications independent of the cover.

According to another aspect of the present invention there is provided a software-based system for enabling consistent infusion of a drug through a patient's skin, comprising: a) having a first marking thereon corresponding to a selection area for one or more injection sites; storing a first image of the skin; b) storing the corrected image, the corrected image based on either human input or software generated input to adjust one or more injection locations; and c) uploading the calibrated image for processing by the manufacturer to create a custom cover for placement on the patient's skin.

In some embodiments, the software provides instructions to the manufacturer for a cover having an aperture to receive only the markers for marking the patient's skin for direct injection in the marking.

In some embodiments, the corrected image is uploaded to a web portal for processing by the manufacturer. In some embodiments, the calibrated image is not editable by the manufacturer.

According to another aspect of the present invention, a cover (mask) for placement over a part of a patient's body is provided. The cover has a plurality of apertures extending therethrough for infusion of the drug into the body, the cover is fitted to a part of the body and the plurality of apertures are tailored to a desired location of injection of the drug through the apertures and into the body.

The opening is configured for passage of an injection needle through the cover and into the body in some embodiments. The cover may be configured for placement on a patient's face, a patient's abdomen, or other body areas such as the chest, arms, legs, or back.

In some embodiments, a plurality of injection devices are attached to the cover, and each injection device communicates with one of the plurality of apertures for injection of a drug through the apertures. The infusion device may in some embodiments be provided pre-filled with a drug.

In some embodiments, the cover includes a plurality of guides extending proximally from the cover having a lumen for receiving at least a portion of the injection device, the guides communicating with respective openings in the cover. In some embodiments, the guide is removably attachable to the cover; In another embodiment, the guide is integral with the cover.

According to another aspect of the present invention, a cover for placement over a part of a patient's body is provided. The cover has a plurality of openings for injection of the drug into the body, and the cover is tailored to a part of the body. The cover has a plurality of guides extending proximally from the cover in alignment with the opening, the guides having lumens configured to receive at least a portion of the injection device for infusion of the drug.

In some embodiments, the guide is removably attachable to the cover; In another embodiment, the guide is integral with the cover. The cover, in some embodiments, includes one or more alignment markings to align the cover on the body.

According to another aspect of the present invention, a system for drug infusion into a patient's anatomical region is provided. The system includes an input subsystem for providing data about the patient's area and an output subsystem for providing a custom cover for the patient's area, the custom cover enabling passage of a drug through the cover to the patient's area. has an opening that

In some embodiments, the input subsystem includes an image of the patient's area. This \image may be a digital photograph, created by a 3D scanner or by some other method.

In some embodiments, the input subsystem includes an app for receiving and processing data corresponding to the desired location of drug infusion by the patient. In some embodiments, the output subsystem includes 3D printing of a custom cover with pre-formed openings in the cover. In some embodiments, the input subsystem includes markings placed on the image or, alternatively, markings placed on the area prior to imaging, to provide an aperture (injection) locator.

The system may include a plurality of injection devices removably mountable to a cover for injection of medication into a patient's area.

According to another aspect of the present invention, a system for drug infusion into a patient's anatomical region is provided. The system includes an input subsystem for providing data about the patient's area and an output subsystem providing a custom cover for the patient's area, the custom cover enabling passage of markers through the cover to the patient's area. have an opening

According to another aspect of the present invention, a kit for injecting a drug into a patient is provided, comprising a) a cover for placement over a part of the body, the cover comprising a plurality of openings for injecting the drug into the body, the cover comprising: tailored to the patient -; and b) a plurality of injection devices for connection to the cover to inject the drug through the opening in the cover.

In some embodiments, the infusion device is pre-filled with drug.

According to another aspect of the present invention there is provided a method for creating a custom cover for providing a location area for infusion of medication into a patient, the method comprising the steps of:

a) processing the image of the patient's region;

b) identifying a location for an opening in the cover based on the image to identify a location for drug injection; and

c) creating a custom cover with openings.

In some embodiments, the method further includes taking an image of the region of the body for processing of the image.

In some embodiments, the method further comprises receiving an image of a region of the body obtained by an external source, the receiving occurring prior to processing the image. In some embodiments, images are taken via a digital camera; In another embodiment, images are taken through a scanner.

In some embodiments, creating the cover includes providing the 3D image for processing to perform step (a) above and 3D printing the custom cover. In some embodiments, the method includes shipping the cover to a doctor's office; In another embodiment, the method includes shipping the cover directly to the patient.

According to another aspect of the present invention, a method for creating a custom cover for injection of a drug into a patient is provided, the method comprising: a) using a 3D image to identify a location for a pre-formed opening in the cover for drug injection; identifying a location for an opening on the image; and b) creating a cover with openings. The method in some embodiments includes creating a cover having a plurality of guides for accommodating an injection device for injection of a drug.

According to another aspect of the present invention, a method for generating an input for a custom cover for infusion of a drug into a patient is provided, the method comprising: a) identifying a location for a pre-formed opening in the cover for drug infusion; identifying a location relative to the aperture; and b) saving the 3D image with the identified location.

In some embodiments, identifying the location for the opening includes marking the location directly on an area of the patient's body. In another embodiment, identifying a location for the opening includes marking the location on a 3D image of a region of the patient's body.

The method further includes passing the stored data to a system for generating a custom mask. In some embodiments, the system is a 3D printer. In some embodiments, the method includes taking a digital picture to create a 3D image.

According to another aspect of the present invention, there is provided a method for generating input for injection of a drug into a body region of a patient, comprising: a) identifying a body region location to identify a location for drug injection; b) saving the 3D image with the identified location; and c) projecting the image onto the body region. In some embodiments, the image is projected from the mobile device.

According to another aspect of the present invention, there is provided a method for creating a custom cover for injection of a drug into a patient, the method comprising the steps of a) marking an indicator on the patient's skin to identify a location for drug injection: b) taking an image of the skin with the marking; and c) using the image to create a cover having an aperture corresponding to the marking on the skin, the aperture extending through the cover to enable drug infusion through the cover.

In some embodiments, a method includes providing a coded designation adjacent an aperture to indicate a desired dose of drug infusion through the aperture. In some embodiments, the coded designation is integral with the cover. In another embodiment, the coded designation is applied to the cover after it is formed.

According to another aspect of the present invention, a method for creating a custom cover for drug infusion is provided, the method comprising the following steps:

e) receiving, by the device, input regarding cosmetic parameters from the patient;

f) identifying, by the device, a location for an opening to the customizable cover in response to receiving the input; and

g) Saving, by the device, the identified location on a 3D image included by the device.

In some embodiments, the method includes generating a 3D model from the stored image of step (c). The method may include printing via a 3D printer a cover from the 3D model. In some embodiments, receiving the input includes responding to questions regarding the patient's appearance purpose.

Preferred embodiment(s) of the present invention are described herein with reference to the drawings, wherein:
1A is a diagram of an overall system according to one embodiment of the present invention;
1B is a diagram of an overall system according to an alternative embodiment of the present invention;
FIG. 2A is a flow diagram illustrating the steps of the system of FIG. 1A in more detail;
FIG. 2B is a flow diagram illustrating the steps of the system of FIG. 1B in more detail;
2C is a flow diagram illustrating an alternative system of the present invention for use by a physician;
2D is a flow diagram illustrating an alternative system of the present invention for use by a patient without the role of a physician;
2e is a flow diagram illustrating an alternative system of the present invention;
2F is a flow diagram illustrating an alternative system of the present invention;
2g is a flow diagram illustrating an alternative system of the present invention;
2H is a flow diagram illustrating an alternative system of the present invention;
2i is a flow diagram illustrating an alternative system of the present invention;
2J is a block diagram illustrating the fabrication of a cover according to some embodiments of the invention;
2k is a flow diagram illustrating the software-based system of the present invention;
Figure 3 is a block diagram illustrating an alternate implantation method for a custom mask of the present invention;
Figure 4 is a block diagram illustrating the system of the embodiment of Figure 1A;
5A is a front perspective view of one embodiment of a customized forehead and side eye mask (cover) of the present invention having preformed holes;
5B is a front perspective view of an alternative embodiment of a custom mask of the present invention having alignment lines;
5C is a perspective view of an alternative embodiment of a cover of the present invention having a dose indicator.
6 is a front perspective view of an alternative embodiment of a customizable full face mask of the present invention;
7A is a front perspective view of another alternative embodiment of a customizable forehead and side eye mask of the present invention having an interchangeable mini-syringe attachable/mountable to the mask;
Fig. 7B is a perspective view of a mini-syringe used with the mask of Fig. 7A;
8 is a front perspective view of another alternative embodiment of a customizable forehead and side eye mask of the present invention having a pre-loaded syringe attached to the mask;
Figure 9 is a front perspective view of another alternative embodiment of the custom forehead and side eye mask of the present invention having an external implant mechanism;
10 is a front perspective view of another alternative embodiment of a customizable mask of the present invention positioned on a patient's forehead and scalp;
Fig. 11 is a rear perspective view of the custom mask of Fig. 10;
12A is a side perspective view of a mask according to one embodiment of the present invention;
FIG. 12B is an enlarged view of detail area AA identified in FIG. 12A showing a guide channel according to one embodiment of the present invention prior to attachment to a mask;
FIG. 12C is an enlarged view similar to FIG. 12B showing an alternative embodiment in which the guide channels are embedded in (integral with) the mask;
Fig. 12D is a perspective view showing the syringe (injection device) prior to insertion into the syringe guide channel (extending from a portion of the mask) of Fig. 12B;
Fig. 13 is a front view showing the syringe being inserted into the guide channel of Fig. 12B;
Fig. 14 is a cross-sectional view taken along line AA of Fig. 13;
Fig. 15 is a close-up view of detail area B in Fig. 13;
Figure 16 is a close up view similar to Figure 15 showing an alternative embodiment of the syringe guide channel of the present invention;
Fig. 17 is a perspective, close-up view of the guide channel of Fig. 12B prior to insertion into the mask;
Fig. 18 is a perspective, close-up view of the guide channel of Fig. 12B attached to a mask;
19 is a perspective view showing a syringe and needle guide channel according to an alternative embodiment of the present invention;
Fig. 20 is a front view showing the syringe being inserted into the guide channel of Fig. 19;
Fig. 21 is a cross-sectional view taken along line DD in Fig. 20;
22A is a side perspective view of a mask according to an alternative embodiment of the present invention;
Fig. 22B is an enlarged view of the detail area BB identified in Fig. 22A showing a guide channel according to an alternative embodiment of the present invention;
FIG. 22C is a perspective view showing the syringe prior to insertion into the syringe guide channel (extending from a portion of the mask) of FIG. 22B;
Figure 23 is a front view showing the syringe being inserted into the guide channel of Figure 22, with the needle shown in a retracted position;
Fig. 24 is a cross-sectional view taken along line FF in Fig. 23;
25 is a front perspective view of the abdominal mask (cover) of the present invention shown wrapped around a portion of a patient's body;
Fig. 26 is a rear perspective view of the abdominal mask of Fig. 25 showing the straps closed;
Figure 27 is a view similar to Figure 25 showing the syringe prior to insertion of the abdominal mask into the guide channel;
Figure 28 is a view similar to Figure 27 showing the syringe being inserted into the guide channel of the abdominal mask;
Fig. 29 is a front view of the abdominal mask of Fig. 25;
Fig. 30 is a top view of the abdominal mask of Fig. 25;
Fig. 31 is a close-up view of detail area H of Fig. 29 showing the guide channels and umbilical alignment holes of the mask of Fig. 25, further showing a syringe being inserted into one of the guide channels;
Fig. 32 is a cross-sectional view taken along line GG in Fig. 29;
Fig. 33 is a close-up view of detail area J in Fig. 32;
FIG. 34 is a view similar to FIG. 33 showing an alternative embodiment of a syringe guide channel having a shorter height to increase the depth of needle insertion;
35A is a side perspective view of a mask (cover) according to another alternative embodiment of the present invention;
FIG. 35B is an enlarged view of detail area KK identified in FIG. 35A showing a guide channel support (mask mating feature) according to one embodiment of the present invention, with the support shown prior to attachment to the mask;
Fig. 35c is an enlarged view similar to Fig. 35b showing an alternative embodiment in which the guide channel support is embedded in (integral with) the mask;
FIG. 35D is an enlarged view similar to FIG. 35B showing the syringe guide channel prior to insertion into the guide channel support of FIG. 35B;
35E is a perspective view of the support and syringe guide channel of FIG. 35D prior to insertion of the guide channel into the support;
Fig. 36 is a perspective view showing the syringe guide channel of Fig. 35E being inserted into the support of the mask;
Figure 37 is a perspective view showing the syringe prior to insertion into the guide channel of Figure 36;
Fig. 38 is a perspective view showing a syringe being inserted into the guide channel of Fig. 36;
FIG. 39 is a side view showing the syringe guide channel of FIG. 35D being clicked into the support (mating feature) of the mask;
Figure 40 is a top view of the syringe guide channel of Figure 35D;
Figure 41 is a cross-sectional view taken along line LL in Figure 40;
Figure 42 is a perspective view of the support of Figure 35d;
Figure 43 is a side view of the support of Figure 35d;
Fig. 44 is a top view of the support of Fig. 35D;
Figure 45 is a side view of the syringe being inserted into the guide channel of Figure 36;
Figure 46 is a cross-sectional view showing the syringe being inserted into the guide channel of Figure 36;
Figure 47 is a top view of the syringe and guide channel of Figure 45;
FIG. 48 is an enlarged view of detail area N in FIG. 46;

The present invention provides a patient mask having pre-formed holes for injection of botulinum toxin, or, in an alternative embodiment, another drug or agent, and a process for making such a mask. In some embodiments, the mask is formed to provide openings for insertion of markers to mark injection sites on the skin; In another embodiment, the mask is shaped to provide an opening for insertion of an injection needle. In some embodiments, the mask is printed at the doctor's office or health clinic and provided to the patient's doctor; In another embodiment, the mask is printed at a central location and sent to the doctor or provided directly to the patient who can bring the mask to the doctor. In yet another embodiment, the mask is printed at a central location and delivered directly to the patient along with a pre-filled syringe. In this latter embodiment, the patient is infusing the drug without the need for a physician; In the former embodiment, the patient relies on the physician to inject the medication. Each of these embodiments are discussed in detail below. Note that masks are also referred to herein as "covers" as they cover a part of a patient's body, and are thus not limited to covering the patient's face or forehead. Accordingly, the terms “mask” and “cover” are used interchangeably herein. The custom mask (cover) forms the output subsystem of the overall system of the present invention.

Note that infusion by physician as used herein is meant to be distinguished from infusion by patient. It should be understood that infusion by a physician (also considered "medical personnel") includes infusion by other medical personnel (other than by the patient himself), such as nurses, physician's assistants, pharmacists, and the like.

A variety of imaging devices can be used as a basis for custom masks. Examples of such imaging devices are described below.

In the embodiments described below, the location for injection may be provided by physician input, for example, the physician marks a specific location on the patient's face or forehead or marks the location on a 3D image. In an alternative embodiment, the app's software algorithm determines the injection location based on patient input in the app. In both cases, the mask is created to be tailored to the patient's anatomy and purpose. These various inputs form the input subsystem of the system of the present invention to provide data about the patient's anatomical region and desired injection location.

Masks can be of various shapes and configurations. Several examples are shown in the illustrated figures. The mask can be created by a variety of methods and in some embodiments has openings in desired locations for implantation. In some embodiments, the mask may also be created with an indicator of the recommended dosage at each injection site (orifice). A syringe for injection through a mask may be provided separately from or alternatively with the mask, each of these versions discussed below. In short, the custom mask of the present invention inherently facilitates infusion and provides a roadmap for drug or medication infusion to provide more consistent and improved results. Reuse of the mask on the patient provides a continuous roadmap for multiple injections, typically spaced over a defined period of time. For reuse on a patient, the mask can be wiped clean with, for example, an alcohol pad or disinfectant wipe.

It is noted that, as used herein, a syringe forms one type of infusion device, it being understood that other types of infusion devices may be used to inject medication.

Referring now to the drawings in which like reference numbers identify like structural features of the devices disclosed herein, FIGS. 1A and 2A illustrate one embodiment of the system/method process of the present invention and FIGS. 1B and 2B show this An alternative embodiment of the system/method process of the invention is illustrated. The methods differ in how data is collected for the formation of the custom mask of the present invention, however, in both systems, face/scalp masks are designed to meet individual patient needs and enable predictable and consistent cosmetic results of treatment. created with pre-formed holes for The discussion herein of FIG. 1A in FIG. 48 is, for convenience, discussed in terms of botulinum toxin for cosmetic treatment; However, it should be noted that the same systems and methods/processes can be used for injection of other fluids, eg drugs or pharmaceuticals, such as Kybella (deoxycholic acid). Thus, the present invention is not limited to botulinum injection. Also, a mask (cover) discussed below that is placed over the patient's face or forehead for an infusion locator or for a marker locator is discussed for that use providing an example of a cover for the patient for an infusion, the infusion locator It is understood that the cover for or for the marker locator may alternatively be placed on other areas of the body, such as over the abdomen as shown in Figures 25-34 for example, or other body areas such as the chest, limbs or back. do. It should also be understood that the injection devices and guide channels discussed herein may be used with any of the covers disclosed herein, or alternative embodiments of covers.

As used herein, the term "distal" refers to a component, region or section closer to the patient's body and the term "proximal" refers to a component, region or section more distant from the patient's body. Note that

Referring initially to FIG. 1A , a block diagram of a system of a first embodiment of the present invention is illustrated. In this embodiment, the patient takes a picture/picture and then enters personal information into a smart device, eg, an iPhone, iPad, tablet, etc., which is the patient's goals and desired results from treatment as directed in the app. includes These input photos and information regarding cosmetic parameters are then analyzed and processed by the app's algorithms (or, in an alternative embodiment, by a physician, supplier, or technician at a corporate remote site), which then transmits and processes It is used to create a three-dimensional (3D) representation on a smart device, which is saved for printing.

In the next step, the 3D representation is sent to a 3D printer, which prints a custom mask or mold for the patient according to the 3D representation. In response to patient input on the app, a custom mask is printed with openings for fluid injection (or for markers) as described in more detail below. Fluid injection can be performed in a variety of ways as shown in FIG. 3 discussed below.

A more detailed step of the system and method of FIG. 1A is shown in the flow diagram of FIG. 2A showing the process from start to finish. In a first step, the patient, using a smart device, takes a picture or series of pictures of his/her face and/or scalp and/or other body regions, depending on the desired location for the botulinum injection. In the next step, the patient answers a series of questions on the app about what the patient wants in connection with botulinum toxin injections, such as wrinkles, lifted eyebrows, natural appearance, and the like. In a subsequent step, the photos are uploaded for processing and software on the smart device (or in an alternative embodiment, a central server at the company's remote site) converts them into a 3D model. The 3D model is then input into a 3D printer, which in the next step prints a custom mask for the patient's face and/or scalp (or other body region) with pre-formed holes/openings to guide the injection; , holes are created in response to input on the app regarding injection. In some embodiments, a software algorithm identifies the location of the hole in response to patient input regarding a desired treatment outcome. In another embodiment, the physician or technician uses the patient's input to map the location of the injection hole onto a program. In either case, the custom mask can be created by the 3D printer and sent directly to the patient who can bring it to the doctor's office, or alternatively, the mask can be sent directly to the doctor/practitioner's office. In some versions, a doctor's office or health clinic may have a 3D printer so masks can be printed in the office or clinic. In any of these arrangements, when treatment is scheduled, the mask is placed on the patient and then injection of the botulinum toxin is made by the surgeon in a pre-formed hole in the mask according to the final step on the flow chart of FIG. 2A. Such systems improve predictability/consistency of treatment. Note that implantation can be according to the variation of FIG. 3 discussed below. Various features on the mask can aid implantation as discussed in detail below.

Injection through a mask can be performed in several ways, as shown in the diagram of FIG. 3: 1) A surgeon inserts a pre-formed hole (opening) in the mask using a fluid injection device that is inserted through the hole. directly through; 2) via a pre-loaded syringe extending into the mask that can be mounted on the mask (eg see FIG. 7 ); and/or 3) via a replaceable syringe mounted on the mask. These last two methods provide a more automated system. The pre-formed hole provides a locator for injection as well as informs the surgeon of the number of units to inject. Depth control of implantation may be provided by a mask as discussed below. Various masks are illustrated in the figure and discussed in more detail below.

In an alternative embodiment shown in the flow diagram of FIG. 2E, a projected image/hologram is used instead of a 3D printed mask. In this method/system, a physician marks a patient's face (or other body region) with a spot (dot) for fluid injection, eg, Botox injection. A picture of the face is taken with a mobile device or camera. The stored dot positions are then projected back onto the patient's face via a standalone projector or a project from a mobile device. The images with dot positions and color/unit doses are then projected back onto the person's face (like a hologram) the next time they have their implantation to ensure they are in the correct position. Thus, the system collects data from the dots on the face, stores the data, and then "re-marks" the face for the next injection, and creates a projected image/hologram instead of a 3D printed mask. entails how to use it.

1b and 2b illustrate an alternative embodiment of the present invention. In this embodiment, instead of using a smart device to create a 3D representation via a photo and patient input where software is sent to the 3D printer, a medical imaging device such as a three-dimensional scanner is used. In this system, the patient is moved to a designated location where a 3D scanner will create an image of the patient's face/scalp. A doctor or technician identifies a location for injection in response to a patient's request on a scanned image, and then the data (image and location mark) is a custom mask with holes formed at the injection location specified by the doctor or technician. is sent to the 3D printer to print it. The custom mask is then printed with a pre-formed hole for direct injection through the hole, via a preloaded syringe or via a replaceable syringe, as shown schematically in FIG. 3 . The mask may be shipped to the patient or to the practitioner's office, as in the embodiment of FIG. 2A. Accordingly, the method/system of FIGS. 1B and 2B differs from the system/method of FIGS. 1A and 2A in how data is generated and transmitted to the 3D printer. Fluid injection can be in a variety of ways as shown in the figures discussed below.

The custom mask formed in the manner of FIGS. 1B and 2B can in an alternative embodiment provide holes for the surgeon to insert markers to mark injection sites directly on the patient's skin, and the mask can be removed so that the patient Note that the markings on the skin of the (as described in conjunction with FIGS. 2G-2I ) provide a syringe and a locator for fluid injection. In this version, fluid injection is not performed through a mask, thereby providing full visibility to the surgeon during injection.

Thus, in some systems of the invention disclosed herein, the mask (cover) provides an opening (hole) for insertion of an injection needle. In an alternative system of the present invention, drug infusion is not performed through a mask. Instead, in this alternative system/method/process, the mask (cover) has an opening for insertion by a physician, or other medical personnel, of a marker or other locating device. In this embodiment, a mask is used to allow marking to be made, then the mask is removed and the surgeon has direct visualization of the patient's skin as the injection is made at the marked location. In this embodiment, the same mask can be used repeatedly on multiple office visits by a patient so that marks can be made through mask openings at the same location to provide a consistent location for drug infusion.

2C illustrates an embodiment in which a physician initially marks a location for injection of Botox (or other drug) directly onto a patient. This process/system is that instead of using 3D images to determine and mark mask opening locations, the opening locations are marked directly on the face of the patient's body, eg the forehead, and then the 3D It differs from other processes disclosed herein in that an image is taken along with the marking.

More specifically, in this process of FIG. 2C , dots are first placed by a provider, eg, a physician/clinician, on the patient's skin to designate the injection location and dosing. Next, an image (preferably a 3D image) is taken with the marked dots on the patient's body, and the dots are used as indicators for apertures in the custom mask. Injection of a drug, such as botulinum toxin, occurs at the marked location before the mask is made. The custom mask is not made until after the botulinum toxin injection has had enough time for it to work fully, eg one to two weeks, to ensure that the dots are placed in the correct location. Before making the mask, feedback (and potentially photos) is obtained from the patient or provider (perhaps via a questionnaire or input on a mobile app or website) to see how symmetrical the results are from injections 1-2 weeks ago. If the result is satisfactory and symmetrical and the patient is satisfied, then a mask will be made based on the markings (dots) written on the image. If it needs to be touched-up or if the patient is asymmetry, dots are moved/changed/added/as needed to provide what is a logical correction of the asymmetry (based on the known musculature under the skin). will be deleted After calibration, a mask can be made based on the calibration or another implant can be made with a 1-2 week follow up to evaluate the results to ensure they meet performance, eg cost, objectives. have. In either case, a custom mask is made according to the methods/processes disclosed herein.

Note that in the above process of FIG. 2C, optionally a first image of the patient can be taken prior to application of the dots to capture the face (or other body region) in a still and potentially animation free of any markings. . It can also be used to collect data on wrinkles and facial aging over time. These initial 3D images may be taken in the doctor's office or alternatively the patient may take a picture and bring or transmit the picture to the doctor's office.

The flow diagram of FIG. 2E provides an example of a mask (cover) hole, and instead of providing a site for injection by insertion of a syringe through the hole, it provides a locator or guide for the surgeon to mark. More specifically, in this embodiment, a custom mask will be made according to the various processes and various configurations disclosed herein and placed over the patient. The surgeon then inserts a marker through the hole to mark the injection site directly on the patient's skin. The mask is then removed, and the markings on the patient's skin provide a syringe and a locator for fluid injection. At a subsequent visit, the mask is placed back over the patient's skin, the surgeon inserts a marker through the hole to mark the site, then the mask is removed and injection is made at the marked location. Different colored markers may be used to correspond to different doses and/or different drugs.

2G-2I provide an example of how a surgeon uses a mask (cover) hole as a guide for marking instead of providing for insertion of a syringe through the hole for injection. The image(s) may be in accordance with various modalities (eg, digital photography, scans, etc.) for taking images as described herein, or in other alternative manners (eg, symmetrical and satisfactory to the patient). Note that it can be photographed by

First, referring to FIG. 2G , in a first step, markings such as dots made of markers are placed on the skin of a patient by a doctor (or other medical personnel) to provide a locator for drug injection, for example, injection of botulinum toxin. placed manually on the An image of the patient's skin, for example the face, together with the markings is then taken. Images are saved for later evaluation. The drug is then injected into the patient at the area of the marker on the skin. The patient then waits for an optional period, eg 2 weeks, and then returns to the doctor. At this point, the physician can evaluate the outcome of the first treatment with the initial infusion. If the results are satisfactory (e.g., symmetrical and the patient is satisfied), the first saved image is uploaded to a web portal for fabrication of a 3D mask (or, alternatively, sent directly for fabrication of a mask). On the other hand, if the result is unsatisfactory (eg needs to be a touchup or the patient is asymmetrical and the markings, eg dots need to be moved/changed/added/deleted), The first stored image is edited on the screen and the positions of the markers (eg dots) are adjusted appropriately. Once adjusted, the edited image is uploaded to a web portal for fabrication of a 3D mask (or alternatively sent directly for fabrication of a mask). It is noted that images may be taken according to various methods disclosed herein, and software applications (apps) enable editing, processing, and formatting of images for 3D printing (or other forms of manufacturing).

In the alternative embodiment of FIG. 2H, the steps are the same as in the method of FIG. 2G, except that a second image of the edited markings is taken. More specifically, in a first step, markings such as dots consisting of markers are manually applied by a doctor (or other medical personnel) onto a patient's skin to provide a locator for drug injection, e.g., injection of botulinum toxin. are placed An image of the patient's skin, for example the face, together with the markings is then taken. Images are saved for later evaluation. The drug is then injected into the patient at a marker on the skin. The patient then waits for a selection period, for example two weeks, and then returns to the doctor. At this point, the physician evaluates the outcome of the first treatment with the initial infusion. If the result is satisfactory, the first stored image is uploaded to the web portal for fabrication of the 3D mask. On the other hand, if the results are not satisfactory, a new marking is made on the skin and a second image is taken to replace the first stored image. This new second image is uploaded to the web portal for fabrication of the 3D mask. It is noted that images can be taken according to various methods disclosed herein, and software applications enable editing, processing, and formatting of images for 3D printing.

Marking in the foregoing embodiments is done in a non-rest position, such as a raised eyebrow, frown, etc., and then later evaluation can also be made in the non-rest position. An image, eg a scan, may be taken in a rest state in some embodiments.

In the above embodiment, the first image is edited if necessary or a second replacement image is taken. In an alternative embodiment shown in Figure 2i, a comparison image is taken. In this different approach, if the initial results are not satisfactory, a second image is taken and compared to the first image, and comparative analysis in software edits (adjusts) the first image to create the desired image for mask printing. More specifically, as shown in the flowchart, in a first step, a marking such as a dot consisting of a marker is placed on a patient by a doctor (or medical personnel) to provide a locator for drug injection, for example, injection of botulinum toxin. placed manually on the skin of the person. An image of the patient's skin, for example the face, together with the markings is then taken. Images are saved for later evaluation. The drug is then injected into the patient at a marker on the skin. The patient then waits for a selection period, eg 2 weeks, and then returns to the doctor. At this point, the physician can evaluate the outcome of the first treatment with the initial infusion. If the result is satisfactory, the first stored image is uploaded to the web portal for fabrication of the 3D mask. On the other hand, if the result is not satisfactory, a second image is taken and compared to the first stored image. These stored images are adjusted based on the new images and uploaded to a web portal for the manufacture of 3D masks. It is noted that images can be taken according to various methods disclosed herein, and software applications enable editing, processing, and formatting of images for 3D printing.

2J provides a diagram illustrating the process of mask fabrication for the method of FIGS. 2G-2I. In this diagram, the mask is made by 3D printing, however, it should be understood that the mask can be made by other methods as disclosed herein. The doctor's image of the patient with the marking as a locator for the injection is uploaded to the web portal. Based on these image(s), the manufacturer creates/manufactures the mask, for example via 3D printing. The mask is made with holes corresponding to the markings on the skin. A mask may be made with a dose indicator adjacent to the hole. Alternatively, the dose indicator is applied to the mask adjacent to the hole after fabrication. In either case, a hole in the mask is dimensioned to receive a marker therethrough so the surgeon marks the skin through the hole and then removes the mask for injection at the marking. Using the dose indicators on the mask, the doctor can insert different colored markers corresponding to different doses to mark the skin prior to removal of the mask for injection.

It is noted that the diagram in FIG. 2J shows an alternative where the image can be created and formatted and sent directly to the mask manufacturer without the use of a portal.

Note that the image may be processed and formatted on a mobile device or desktop, for example by a software application downloaded independently of a web portal. The image is then uploaded to the portal for access by the manufacturer, eg, a printer of the mask, or in an alternative embodiment, sent directly to the manufacturer. Alternatively, the image can be processed and formatted via a web app accessible on a web portal where it is then uploaded for access by the manufacturer. (The web portal may be designed to block access to software by the manufacturer and allow only access to images formatted for manufacturing, eg, printing). Stated another way, a custom cover can be made from a set of instructions provided from a software-based application processing an image of a patient's anatomical view consisting of the locations marked thereon. The cover is customized to the part of the body based on a software-based application and a plurality of openings in the cover are tailored to the desired location of the markings through the cover for subsequent injection of one or more medications independently of the cover, i.e., with the cover removed. . The software-based application can be downloaded to a computer or mobile device for the physician. In another embodiment, it is accessed or downloaded through a web portal. In another embodiment, the doctor sends the image to the manufacturer accessing or downloading the app.

In some embodiments, a method of manufacturing a custom cover for placement over a portion of a patient's body is provided, comprising a set of creations from a software-based application that processes images of a patient's anatomical view consisting of locations marked thereon. interpreting the commands of the cover, customizing the cover to the part of the body based on the software-based application, customizing a plurality of openings in the cover to the desired location of the markings, and independently of the cover. That is, receiving markers for subsequent injection of one or more drugs in an uncovered marking. The cover is made to have a plurality of apertures extending therethrough configured and dimensioned for manual insertion of markers by a medical practitioner to provide marked locations on the patient for infusion of one or more medications once the cover is removed from the patient. do. In some embodiments, the cover is directed to a software application on the device that receives and processes data corresponding to the desired location of drug injection by the patient, based on the manually marked location, to provide instructions for manufacturing the cover. It is made based on the image entered into the linked website portal.

In some embodiments, the mask may be made such that the openings accept the marker but not the implantation device. That is, the opening may be only for inserting a marker. For example, a cloth or other material may be provided in an opening into which a marker can be inserted but an injection device cannot be safely inserted. Other structures or configurations are also contemplated in these embodiments for contraindication and/or prevention of injection through the orifice. The mask may be fabricated with a label or indicator for non-injection through the mask, and such label/indicator may be created by software as part of the instructions for fabricating the mask.

A software-based system for enabling consistent infusion of medication through a patient's skin is outlined in the flowchart of FIG. 2K. The software system includes: storing a first image of skin having a first marking thereon corresponding to a selection area for one or more injection locations; b) storing the corrected image, the corrected image based on either human input or software generated input to adjust one or more injection locations; and c) uploading the calibrated image for processing by the manufacturer to create a custom cover for placement on the patient's skin.

In some embodiments, the software provides instructions to the manufacturer for a cover having an aperture to receive only the markers for marking the patient's skin for direct injection in the marking. The corrected image can be uploaded to a web portal, storage device, cloud storage, etc. for processing by the manufacturer. As noted herein, in some embodiments, the calibrated image may not be editable by the manufacturer.

In the alternative process of FIG. 2C, instead of first injecting the drug with a 1-2 week follow up, after the marking is made and the image is taken, the mask can be made so that the first infusion passes through the mask. have. This is a different approach as the implantation is done through a mask without direct visibility. Also in the approach, the mask will need to be made with an opening that can accommodate the implantation device.

In the above process, before the 3D scan is taken, coding of the marked position, eg color coding and/or number/symbol coating, can be made to designate the unit to be embossed or applied as a sticker on the mask mold. More specifically, when a physician/provider is marking a patient's face (or other body area) with dots to mark the location of a drug injection, e.g., botulinum toxin injection, they will do so at different doses based on a pre-determined height. Different color markers/pencils can be used to designate the dose. For example, a red dot may represent a dose of 4 units and a black dot may represent a dose of 2 units of a drug to be injected later through the mask. (Other dosages and other colors or symbols are also contemplated). Then, a 3D picture is taken with the dot on the body converted to the position of the hole (opening) on the mask. The number of units for a dot will then be specified on the final printed mask, either by engraving, embossing, stickers, or different colored resins (if the mask is made of resin) around each opening in the mask. The designation may be made integral with or integral with the mask or may be provided on the mask after fabrication, eg printing. This would be a dosing guide for the provider to inject later with the mask in place or at the marking with the mask removed in an alternative approach disclosed herein. Such coding to indicate dosage may also be used in embodiments where a patient is infusing a drug.

In an alternative embodiment, the surgeon is completely out of the loop and the patient handles the centralized location directly to obtain a mask and preferably a pre-filled syringe. The centralized location may be one or more corporate locations that print masks in response to patient input and provide drugs/medicaments directly to the patient for the patient to infuse. The specific steps of this embodiment are shown in Figure 2d as follows. The patient takes a picture outside the doctor's office, the patient answers questions on the smart device's app for appearance purposes, and the picture with the entered data is sent to a central location (eg, company). Dots are placed on the image via an algorithm (according to patient input) at a central location, a 3D model is created and a custom mask is printed with injection holes corresponding to the dots. The custom mask is then delivered to the patient with a syringe, separate from or attached to (or integral with) the mask, preloaded with fluid or empty and transportable with fluid, for injection by the patient. is transmitted As can be appreciated, in this method/system the patient interacts directly with the central location, taking the physician out of the loop. As multiple infusions are provided over a period of time, additional preloaded syringes, or additional syringes and additional fluids, may be periodically delivered to the patient for infusion through the same custom mask. The patient's progress can be continuously or periodically monitored visually or through analysis of additional photographs. It is noted that a guide channel for a syringe according to embodiments discussed herein may facilitate injection by a patient.

The diagram of FIG. 4 schematically illustrates the options of the system where a custom mask can be shipped to a doctor or to a patient, as shown by the dividing line in the diagram. Such options are also applicable to the 3D scanner embodiment of FIG. 2B and other embodiments disclosed herein. More specifically, as can be appreciated from the diagram, the patient takes a picture, answers questions about the purpose, and uploads the picture to an app where the software provides a 3D representation of the injection site. The custom mask is printed from the 3D representation and shipped directly to the patient or alternatively directly to the physician as described herein.

To facilitate imaging, a chinrest or other face support to align the face and prevent movement may be used to obtain a suitable 3D image.

As disclosed herein, the custom masks of various embodiments disclosed herein are made by a 3D printing process. However, it should be understood that the custom mask of the present invention can be alternately made by other processes such as injection molding, hand-made, and the like.

5-11 illustrate various embodiments of customizable masks of the present invention by way of example, it should be understood that masks of other shapes and sizes and covering sections of the face or scalp (or other body regions) may be provided. . Additionally, since the holes formed in the mask may vary from patient to patient, it should be understood that the holes illustrated in the masks of FIGS.

5A shows a first embodiment of a customized mask in the form of a forehead and side eye mask. These are the most common areas injected with botulinum toxin. A custom mask created by 3D printing (or created by other methods) as described above reduces variability and is reproducible by providing a custom mask of the forehead and the side of their eyes (crow's eye area). The mask is generally designated by the reference numeral 10 and has face and eye slits (openings) 16 . Mask 10 includes straps 12, 14 that extend around the head to help secure the mask to the patient's face, but provide other securement for mask 10 as well as other masks disclosed herein. ) devices are also contemplated and may include belts, Velcro, hooks, clasps, and the like. The mask 10 is aligned with the patient's eyebrows and also with the midline of the nose. Pre-formed (pre-drilled) holes 18 (few of which are labeled for clarity) are used to inject fluid through syringes or other fluid injection devices that are placed alone to access desired areas of the patient's forehead and face. is provided on the print mask 10 to provide a locator or guide for the

5B shows a forehead with vertical alignment lines 19a and overlaid horizontal alignment lines 19b on mask 19 such that the nose marks the midline of the mask and the lateral canthus marks the vertical orientation; An alternative embodiment of a side eye mask is illustrated. That is, alignment lines 19a, 19b help center mask 19 relative to the bridge of the nose and eyebrows, one line 19a going down the middle of the nose to align left and right and line 19b Line up top and bottom at the outer edge of the eye. Note that such alignment lines may be provided, eg overlaid, on other masks disclosed herein. The mask 19, similar to the mask of FIG. 5A, has straps (not shown), or other securing mechanisms, to secure the mask 19 over the eye slits and the patient's face and forehead. Hole 19c provides an injection site locator in the same manner as hole 18 of FIG. 5 .

5C illustrates an alternative embodiment of a mask with a central (midline) alignment marker between the eye opening and dose designation, eg, 2μ and 4μ.

6 illustrates an alternative embodiment of a mask forming a full face mask. Mask 20 is in the form of a full face mask with eye slits (openings) 26 and mouth and nose slits (openings 27) and straps 22, 24 extending around the head to hold mask 20 in place. ). Pre-formed holes (injection spots/locations) 28 are provided for the forehead, side eyes, nose, perioral and other areas of the face. As in the embodiment of FIG. 5A , a pre-formed (pre-drilled) hole 28 is provided through a syringe or other fluid injection device that is placed into the hole 28 to access desired areas of the patient's forehead and face. A print mask 20 is provided to provide a locator for fluid injection. Note that for clarity, in these and other embodiments, only a few of the holes are designated with reference numerals.

In embodiments described herein, straps, elastic bands, or other mechanisms may be provided to hold/secure the mask to the face. The mask may include, for example, a nose or chin securing structure or form the mask such that it extends under the chin or under the nose for additional securing. That is, the mask may be formed to extend to cover bony fixation points to enhance fixation.

5A, 5B and 6 show a pre-formed hole through which a surgeon inserts a syringe or other injection device directly through the hole for injection. In the alternative embodiment of FIG. 7 , instead of a pre-formed hole for receiving a standard syringe, an interchangeable mini-syringe is attached to the syringe mount 33 for multiple use. More specifically, a forehead and side eye mask, generally designated by reference numeral 30 , has a series of syringe mounts 33 extending outwardly from the mask 30 for attachment of a syringe 40 . Syringe mount 33 aids in alignment, eg, centering, of the syringe to improve accuracy and consistency of injection. Syringe 40 includes a needle and plunger for fluid injection. Syringe 40 is shown as one type of injection device that can be attached to syringe mount 33 . The mount (receiver) 33 may be configured to allow a snap-on attachment, screw-on attachment, or other method of attaching the syringe 40 to the mask 30 while at the desired (pre-selected) area for injection. The syringe is preferably pre-loaded (pre-filled) but may alternatively be empty and require filling with fluid prior to injection. Mask 30 is in the shape of mask 10 of FIG. 5 with straps 32 and 24 and eye slits (openings) 36 . It should be understood that a mount for the syringe is shown on mask 30 as an example but may be provided on mask 20 or on other masks disclosed herein.

In the alternative embodiment of FIG. 8 , instead of the pre-drilled hole of FIG. 5A for receiving a standard syringe, a pre-loaded syringe (or other injection device) is provided already mounted to the mask or built into the mask itself. More specifically, the forehead and side eye masks 50 are preferably pre-filled (only portions of which are labeled for convenience) mask 50 to hold a syringe 60 (or other injection device). It has a series of syringe mounts 53 extending outwardly from The mount (receiver) 53 is at the desired (pre-selected) area for injection and the syringe 60 is snapped on, screwed on or attached by other means of attachment to the syringe prior to delivery of the mask 50. In the embedded version, the syringe may be non-removably attached to the mask 50 . The syringe button can be pushed to cause the needle to go in and then automatically deflate. Mask 50 is in the form of mask 10 having straps 52 and 54 and eye slits (openings) 56 . It should be understood that the preloaded or embedded syringe is shown on mask 50 as an example, but may be provided on any of the other masks disclosed herein.

To facilitate insertion of a syringe into a preformed hole in the mask, a syringe guide channel may be provided on the mask. A guide channel (also referred to herein as a "channel guide" or "guide") centers the syringe thereby aligning the syringe to center the infusion. For example, if the mask has a 4mm hole, the needle can be aimed up, down or sideways, which will change the injection area. These guides ensure that syringes inserted through the mask are kept straight providing more control and consistency of injection. These guide channels are attached to the mask in different ways as described below. The guide channel provides a way to align the syringe without the needle getting in the way, without using a self-advance and self-retract mechanism for the needle. These guide channels may be integral with the mask (monolithic) or alternatively may be separate components that are attached or secured to the mask. In either case, the guide channel opening aligns with a pre-formed hole in the mask so that a syringe needle can be inserted through the mask for injection of fluid into the guide channel and into the patient's body. The guide channel may provide a guide for a conventional syringe or a designed syringe disclosed herein, which in some embodiments may be prefilled. An example of such a guide channel was discussed above with the mask 30 of the FIG. 7 embodiment. Various alternative embodiments of integrated and separate syringe guide channels are discussed below with reference to FIGS. 12A-48 .

Referring initially to FIGS. 12A-12D and 13-17 , a syringe guide channel 106 is illustrated. Guide channels 106 (also referred to herein as “channel guides”) extend upwardly (proximally) from the top surface 104a (also referred to herein as the top or proximal surface) of the mask 104 . As shown, the designated area 104 is, in this embodiment, a section of an overall mask cutaway for illustrative purposes as the guide channels are separate components attached to the mask 104 (FIG. 12A). See Details A-A). Note that two guide channels are shown in cut area 104a of mask 104 in FIG. 12B and guide channels are shown in area 104a in FIG. 12D , different numbers of guide channels are shown in mask 104 It should be understood that it may be provided for fixation on. The number of guide channels, in these and alternative embodiments disclosed herein, preferably corresponds to the number of pre-formed holes in the mask. Although the guide channel 106 is shown as being cylindrically shaped, other shapes/configurations and sizes are also contemplated.

The guide channel 106 is inserted, eg press-fitted, into a preformed hole 116 in the mask 104 . The guide channel 106 helps align the syringe to center the injection. Guide channel 106 includes a proximal opening 114 that communicates with a lumen extending through guide channel 106 . Guide channel 106 may be flexible and may be inserted through hole 116 in mask 104 so that circumferential cutout 112 (FIG. 17) is engaged by the circumferential wall of hole 116; The lower (lower/distal) portion 113 forms a flange or stop to prevent separation of the guide channel 106 from the mask 104 . As the guide channels 106 are provided as separate components, they are provided sterile and can be removed from the mask and discarded after use. Also, by being provided as separate units, they can be interchanged with guide channels of different sizes, shapes, depths, etc. For example, if a greater depth of implantation is required, a guide channel may be inserted to accommodate that increased depth.

The top surface 106a of the guide channel 106 forms a stop for an infusion syringe, eg a syringe. More specifically, the syringe designated by reference numeral 102 includes a flange 103 and a plunger 105 distally movable to inject fluid stored in the chamber 113 of the barrel 115 of the syringe 102. have The plunger 105 supports a needle 108 with a penetrating tip such that distal movement of the plunger 105 injects fluid from the syringe. Seal 109 seals the interior of the syringe as plunger 105 is pressed to deliver the drug.

Note that in an alternative embodiment, a mechanism may be provided to provide retractability of the syringe needle.

The height of the guide channel 106 controls the depth of implantation in this embodiment. This can be understood by comparing FIGS. 15 and 16 . A larger guide channel with height H1 as shown in FIG. 15 yields a shallower implantation depth D1 while a shorter guide channel 106' with height H2 as shown in FIG. 16 yields a deeper implantation depth (D2). These depths can be tailored for different patients or arranged in designated arrays for deeper injections in certain areas and shallower injections in other areas. By adjusting the height of the channel guide, the depth of injection can be controlled without changing any geometry of the syringe. Alternatively, however, it is also contemplated that the injection depth may be controlled by modifications to the syringe, eg, the distance the needle extends distally through the mask as a result of the syringe geometry. For example, various gauges and needle lengths can be used to deliver drugs more deeply or more superficially.

In use, the syringe guide channels 106 are each inserted into one of the preformed holes in the mask 104 and thereby secure it to the injection site. (Note that alternatively the mask may have removable guide channels already positioned in the mask). Syringe 102 is then inserted through opening 106 in guide channel 104 . The syringe 102 is inserted until the distal-most wall of the distal portion 111 contacts (adjacent to) the upper (proximal) surface 106a of the guide channel 106 . This depth is designated by D1. Thus, guide channel 106 provides a stop for syringe insertion and thus controls the depth of needle insertion to control the depth of injection. When attached to the guide channel 106, the needle 108 passes through the lumen of the guide channel 106 and past the distal surface 104b of the custom mask 104 and the distal surface 106b of the guide channel 106. extends past To inject the fluid, the plunger 105 is compressed, whereby the fluid, eg, medication or drug, is placed against the patient previously determined and positioned by the pre-formed custom patient mask created in the process discussed above. Inject to the pre-designated injection location. A marking or graduated line 107 may be provided on the outer wall of the barrel 115 for dispensing, ie, to track the amount of fluid in the syringe 102. Alternatively, the syringe may be color-coded to indicate dosing without the use of markings or may be prefilled or pre-calibrated to the required dose. Such marking, color coding or pre-filling may be used with other syringes disclosed herein. Insulin type syringes can also be calibrated for the correct dose to be used for injection at a designated location or hole. The syringe may be pre-filled or refillable. The exact total number of units can be placed onto the syringe based on the addition of all injection points.

In the embodiment of FIG. 12D , the distal end of syringe 102 is adjacent to the top of guide channel 106 . In the alternative embodiment of FIGS. 19-21 , a wider guide channel is provided so that the distal end of the syringe fits inside the guide channel. More specifically, the guide channels 124 of FIGS. 19-21 extend upwardly from the top surface (proximal surface) of the mask 104 and may be integral with the mask 104 (as in FIG. 12C) or (FIG. 12B). as in) may be a separate component with a fusible feature that is inserted through a pre-formed hole in the mask. Guide channel 124 is identical to guide channel 106 except for its increased width, ie diameter. Syringe 120 with plunger 125, seal 127, barrel 123 and fluid chamber 129 is passed through aperture 126 and through the lumen of channel guide 126 and through hole in mask 104. inserted through The syringe 120 is inserted until the bottom wall 123a of the barrel 123 contacts the wall 124a in the lumen of the guide channel 124, ie is adjacent. Thus, the distal portion of barrel 123 is within the boundaries of wall 124b of channel guide 124 . The wall 124a of the guide channel 124 serves as a stop to limit the depth of insertion of the syringe and thus the depth of extension of the needle, thereby controlling the depth of injection. Thus, with this wider channel guide design, the channel guide encapsulates the body of the syringe to guide passage of the needle. The depth of the needle is controlled by the design of the channel guide component and how far it allows the syringe to be inserted. The wall height H3 can be of various heights to provide different depths of insertion. It is also contemplated that the guide channels themselves may have adjustable walls to adjust the height of the individual guide channels to accommodate varying desired depths of insertion. Except for the foregoing, i.e., a wider opening for accommodating a syringe therein, the guide channel 124 is similar to the guide channel 106 of FIGS. Identical to guide channel 106 to be fully applicable to channel 124.

In the embodiment of FIG. 12B , the guide channels are inserted into and secured to pre-formed holes in the mask. In the alternative embodiment of FIG. 12C, the guide channels 106' are integral with the mask 104' and therefore do not require separate insertion in manufacture or by the user.

In an alternative embodiment, the guide channels are provided on a flat support and the support is attached to the mask. This differs from the previously described embodiment in which the guide channel is fixed directly to the mask. 22A-24 provide examples of such separate supports secured to the mask by adhesive. The support 130 has a top surface 130a from which a guide channel 132 proximally extends. On the bottom or distal surface 130b of the support 130, an adhesive is applied. Thus, the support 130 forms an adhesive pad that is secured to the mask 200 such that the openings 134 and lumens 134a in the guide channels align with the pre-formed holes in the mask. The syringe is identical to the syringe of FIG. 19 and is therefore labeled with the same reference number.

In use, the support 130 with the exposed adhesive bottom surface is adhesively secured to the mask such that the channel openings 133 align with the holes in the custom mask. Syringe 120 (with optional graduations 28) is inserted through the channel until the distal portion ends on wall 132b (similar to wall 124a of guide 124 in FIG. 21 ). This provides a stop for syringe insertion to control the depth of needle penetration. When inserted through the channel, needle 122 extends through lumen 132a and distally beyond support 130 into the body. Advancement of plunger 125 injects fluid from chamber 113 of syringe 120 . In some embodiments, the adhesive may be covered until ready for attachment where the cover may be peeled off to expose the adhesive surface.

The implantation depth D3 is controlled by the height H3 of the channel guide component H3 and this height can be varied to achieve different implantation depths. Alternatively, the needle height may be varied to achieve different depths of injection. Another way to control the depth is to vary the thickness of the mask, with thicker masks providing shorter implantation depths and thinner masks providing greater penetration depths.

Note that the guide channel 130 may alternatively be configured such that the syringe remains outside the guide channel (rather than being positioned within it) as in the embodiment of FIG. 15 . Also, although adhesives are disclosed for attachment, other methods for attaching the pad transport guide channels are also contemplated.

In the alternative embodiment of FIGS. 35A-48 , a mini-injector is inserted into a guide channel with a click-in or snap-in component. These clicks in the syringe guide can be inserted into mating features of the mask before or with the syringe.

More specifically, the syringe guide channel 158 has an opening 160 that communicates with a lumen to receive a syringe 161 . Guide channel 158 is inserted into mating feature 152, also referred to herein as a guide receiver. Receiver 152 may be integral with mask 150, as shown in FIG. 35C, or may be a separate component attached to the mask, as shown in FIG. 35B, which may be removable or permanently (non-removably) ) can be attached. (The figure illustrates a section of the mask in the same way as the detailed section 104a of mask 104 of FIG. 12A, so only two receiver/guide channels are shown in FIGS. 35A-35D and a single receiver and guide channel 35E to 38). If a separate component, receiver 152 may include a flange and a recess for insertion through a pre-formed hole in custom mask 150 . Whether an integral component or a separately attached component, receiver 152 extends proximally (outwardly) from top (proximal) surface 150a of mask 150 and defines guide channels 158 within its lumen. dimensioned to accommodate. A guide channel 158 is inserted through an opening 156 in the receiver 152 and into a lumen of the receiver, and projects proximally of the receiver 152 . The syringe guide 158 clicks into the receiver 152 via an inwardly spring-biased flexible tab 154. When the guide channel 158 is inserted into the receiver 152, it does so until the inner surface 154a aligns with the circumferential notch (recess) 162 of the guide channel 158 as shown in FIG. As its outer wall engages the inner surface 154a of the tab 154 it initially forces the tab 154 outward. When so aligned, the tab 154 can return to its initial position to secure the guide channel 158 to the receiver 152 . Thus, the flexible tabs 154 of the mating component 152 allow the user to insert new syringe guides and remove them once they have been used. The syringe guide 158 may include a collapsible material 159, such as a sterile sponge, within its lumen as shown in FIG. 41 .

The syringe guide 158 aligns the syringe 161 for injection in the correct position as can be seen in FIGS. 45 and 46 . As the user presses down on the syringe collar as syringe 161 is inserted into guide 158, collapsible material 159 is compressed (due to distal wall 161a), allowing needle 165 to enter tissue. It extends through the opening 157 in the wall 158a of the syringe guide 158 and through the lumen 153 of the receiver 152 and past the distal surface of the mask 150. Then, the user holds the handle (flange) 164 and presses the plunger 166 to inject the drug from the chamber 163 in the syringe 161. The collapsible material 159 allows the user to safely align multiple syringes without the needle contacting the skin and can bounce back after injection. A seal 167 similar to seal 127 of FIG. 21 may be provided in the barrel of syringe 161 .

As mentioned above, the customized mask (cover) of the present invention is not limited to covering the patient's face or forehead, but can be applied to other parts of the body. 25-34 illustrate such an alternative by way of example, showing a cover (mask) placed over a patient's abdominal section, contoured around a shape to align with the patient's body. A custom “abdomen mask” (cover) 140 includes a pre-formed opening for the injection site and is made according to the procedures described herein. Mask 140 may be used for example for abdominal fat melting/dissolving. Cover 140 may be integral with cover 140 as shown, i.e., directly embedded in cover 140, or alternatively, attached separately to the cover in the same manner as discussed above for other embodiments. It has a plurality of guide channels 144 in the. These guide channels 144 align with openings in the custom mask 140 to provide passage for the syringe. The guide channel 144 can control the depth of implantation. For example, in FIG. 33, a larger guide channel (H4) yields a shallower implant (D4) while a shorter guide channel (H5) in FIG. 34 yields a deeper implant (D5). The mask 140 may have different height channel guides to accommodate different depths of injection at different sites, or the length of the needles may be varied to achieve different depths of injection, or the thickness of the mask may be varied.

Cover 140 has distal and proximal surfaces 140a, 140b and includes a belly button alignment hole 146 with arrows to ensure that the user accurately aligns cover 140. 27 and 31 show the alignment hole 146 for the navel.

Strap 142 extends from the edge of cover 140 and wraps around the abdomen and is secured to area 143 by Velcro, although other methods for securing cover 140 or strap 142 may also be employed. Considered are, for example, clips, hooks, clasps, and the like. Strap 142 tightens cover 140 to the body.

In use, syringe 120 is inserted into guide channel 144 as shown in FIGS. 28 and 32 such that needle 122 extends through opening 144a and lumen 144b of guide 144. The syringe 120 is positioned at the wall 144c such that the wall 144c of the guide 144 provides a stop to suggest a depth of insertion of the syringe 120 and thus a depth of penetration of the needle 122 and injection of fluid. It's over. Once the syringe is inserted, the plunger 125 is depressed to inject fluid from the chamber 129 of the syringe.

In embodiments disclosed herein, the channel guide may be made from silicone or rubber of variable durometer to ensure safe passage of the needle without damaging the needle. The guide channel is preferably designed with a slight lead-in around the needle guide hole, which is preferably minimal, to reduce the possibility of a user hitting the mask with a needle and bending or breaking the needle.

In an alternative embodiment, the syringe alignment feature can be dimensioned to be much larger than the needle, in which case the entire body of the syringe will align before the needle even reaches the surface of the needle guide hole/mask.

In the embodiment of Figure 9, an embedded pneumatic mechanism or other mechanism is used to simultaneously deliver fluid from the syringe. The mask 70 has a series of holes 78 that receive an injection device and are connected via a channel 77 to an external fluid injection control device 80 . Only some of the holes 78 and channels 77 are labeled for clarity. A tube 83 extends from the control device 80 so that air (or other motive fluid) can be delivered through the channel 77 and to the injection device mounted in the hole 78 and extends from the channel 77 of the mask 70. ) is in fluid communication with In this way, instead of actuating each syringe by individually injecting each syringe by pushing with a finger, the control device 80 provides a system for actuating the syringes simultaneously. The tube mount 85 in the illustrated embodiment is on the side of the mask to provide fluid communication with a syringe mounted in a hole in the mask to perform the injection, but in alternative embodiments it may be provided in other areas of the mask. There will be. Mask 80 is in the form of mask 10 with straps 72, 74 and eye slits (openings) 76, but this “force” mechanism can be used with other masks disclosed herein. . The control unit 80 may be a pneumatic system or other mechanism for transmitting force to force the toxin from the syringe percutaneously through each hole. The injection device, for example a syringe, may be a preloaded syringe or a replaceable syringe as in the foregoing embodiments. The arrangement and communication of the interconnected channels 78 in FIG. 9 is just one example as the channels are arranged and communicate in different arrangements. Mask 70 is in the form of mask 10 having straps 72 and 74 and eye slits (openings) 76 . It should be understood that the system of FIG. 9 having an embedded channel is shown as an example as it may be provided on mask 20 or other masks disclosed herein. In an alternative embodiment, the injection control device 80, in addition to including a pump or other force mechanism, also includes a fluid, eg, a toxin, or alternatively includes a force mechanism and a toxin. Note that it may have other tubes connected to the source, channels, holes and/or syringes may be configured to control dosage.

As can be appreciated, the system and method/process of the present invention addresses three variables: a) a custom mask controls the implantation location; b) the injection device controls the amount of fluid injected; and c) the mask configuration (or alternatively, the implantation device configuration) controls the depth of implantation.

The custom mask of the present invention may have an identification such as the patient's name. Additionally, custom masks can have pre-printed doses (units) next to each guide hole to facilitate implantation. The dosage may be used to combine the data and create a mask, or alternatively may be based on the patient's answers to questions provided by the physician/practitioner. These reusable masks may then be shipped to the doctor's office or alternatively shipped to the patient and brought by the patient to the doctor's office as described above. The pre-printed information on the mask can then be used to guide implantation. This advantageously reduces variability in dosage as well as injection location.

As described above, the custom mask of the present invention may alternatively come with a small pre-filled syringe built into the mask with the reconstituted botulinum toxin. Dosages will be based on questions answered by the patient. These custom masks can also be shipped directly to the doctor's office or to the patient. This may expand patient access to such injections as any practitioner can apply a mask and push a button to inject with reproducible accuracy.

In some embodiments, a kit of syringes pre-loaded with medication may be shipped to a doctor's office or directly to a patient for home administration. The syringe may be disposable or reusable by being refillable. In some embodiments, a kit comprising a mask and infusion device (either pre-filled or empty shipped with separated fluid) may be shipped to a doctor's office or to a patient.

Not only does a custom mask allow for predictability, but the mask can be re-used in some embodiments so repeated treatments can be guaranteed to be in the same location. Additionally, delivery of medication to a physician or patient for use with a re-usable mask may vary depending on the outcome of previous injections.

In the foregoing embodiments, a physician or healthcare provider, such as a nurse, physician assistant, pharmacist, performs the infusion, however, it is contemplated in alternative embodiments that the patient may also perform the infusion. Thus, in this embodiment, the botulinum toxin is self-injected/self-administered by the patient. Thus, for example, instead of the step of injecting by a physician in the process of FIGS. 2A and 2B , the step of injecting will be performed by the patient. A pre-loaded syringe will facilitate patient infusion.

In an alternative embodiment, instead of a 3D scanner, the doctor takes a 2D picture in the office and makes recommended markings on the picture based on the doctor's knowledge of the patient and the patient's previous implants. The photo is then sent to another entity to do the 3D modeling and print the mask, which is then sent back to the doctor or directly to the patient.

As discussed above in the foregoing embodiments, custom masks are created via 3D printing, however, it is also contemplated that other method processes may be used to create 3D masks.

In the foregoing embodiment, a 3D customized mask for a patient is printed. In an alternative embodiment, instead of using such a 3D custom mask, mask templates of various sizes may be created for simplicity. Thus, mask templates of various sizes can be made, fitting close to the forehead/face size, rather than 3D fitting to the individual face. These templates can then be given to the doctor or patient and then brought to the doctor's office, where the doctor/practitioner can mark them, i.e., punch a hole, to determine whether the patient needs to inject or normally inject based on the occasion. You will be able to individualize them. Then this could be used as a template for itself or it could be used to create a more permanent template with or without a syringe embedded in it. Thus, such a mask could provide a customizable face/head template to guide the injection of botulinum toxin.

Color coding, number/symbol coding or other form of identification/designation of the marked locations may be entered prior to creation of the mask to inform the clinician of the number of units (doses) to be injected. Such dosage indicators may be embossed or otherwise printed onto the mask during creation such that the printing on the mask includes the dosage indicators or alternatively the dosage indicators may be applied as stickers to the mask after it is formed. For example, different colors can be printed on a clear mask or a decal can be applied to the mask by a technician/clinician.

In various embodiments, the present invention as described above is used for injection of botulinum toxin for cosmetic surgery. However, the concepts/systems of any of the embodiments disclosed herein may also be used for other procedures. The mask can be created in the same way as the system/process (or otherwise, eg, a template) disclosed herein, except that the mask can be created for placement on other areas, such as the scalp and forehead, for example. can be created 10 and 11 show as an example a mask that extends over the scalp and can be used for the treatment of migraine headaches. More specifically, the mask 90 covers the patient's scalp and has chin straps 92 and 93 for securing the mask 90 and a series of holes 94 for fluid injection. Injection may be via, for example, a replaceable syringe as in FIG. 7 , a pre-loaded syringe as in FIG. 8 , or an injection device as described above including the channel system of FIG. 9 . The present invention also contemplates the use of botulinum toxin on other parts of the body, such as the axilla for sweating.

It should be understood that different botulinum toxins may be injected. Botulinum toxin is a product of Clostridium botulinum . These growing bacteria produce the neurotoxin botulinum toxin, which inhibits the release of acetylcholine and causes flaccid paralysis of the affected muscles. There are several distinct types of botulinum toxins: A, B, C1, D, E, F, and G. The various types of botulinum toxins, along with several others in clinical trials, include Botox (onabotulinumtoxinA, Allergan) and Dysport /Azzalure (abobotulinumtoxinA, Ipsen/Galderma), Xeomin/Bocouture (incobotulinumtoxinA, Merz) and Jeuveau (prabotulinumtoxinA, Evolus/Daewoong). Revance Therapeutics, Inc. also offers the neuromodulator DaxibotulinumtoxinA (RT002) for infusion.

Although the botulinum toxin is described as a fluid injected through the mask of the foregoing embodiments, it is also contemplated that other fluids may be used for other therapeutic or surgical procedures. For example, Kybella (deoxycholic acid), used to reduce fat, can be used on multiple surface areas of the body to target areas of stubborn fat after a 3D printout of the mask has been made.

The various imaging methods and various manners for fabricating a mask disclosed herein are applicable to alternative masks of the present invention where markings are made through the mask and the mask is removed for drug injection, as well as injection needles passing through openings in the mask. It should be understood that it is applicable to the mask of the present invention provided.

While the above description includes many specifics, such specifics should not be construed as limitations on the scope of the present disclosure, but only as examples of preferred embodiments thereof. One skilled in the art will envision many other possible variations within the scope and spirit of this disclosure as defined by the claims appended hereto.

Claims (31)

A custom cover for placement over a part of a patient's body, the cover extending therethrough configured and dimensioned for manual insertion of a marker by a medical practitioner to provide a marked location on the patient for infusion of one or more medications. , wherein the cover is manufactured from a set of instructions generated from a software-based application processing an image of the patient's anatomical view consisting of locations marked thereon, the cover being manufactured from the software-based application and wherein the plurality of apertures are tailored to a desired location of a marking for subsequent injection of one or more medications independently of the cover. According to claim 1,
wherein the cover is configured to be placed over a patient's face. According to claim 1,
wherein the cover includes one or more alignment markings for aligning the cover on the body. According to claim 1,
wherein the cover includes a dose indicator thereon. According to claim 1,
wherein the drug to be injected is a botulinum toxin. According to claim 1,
wherein the image is linked to a software application on the device that receives and processes data corresponding to a desired location of drug infusion by the patient, based on the manually marked location, to provide instructions for manufacturing the cover. Cover, entered into the website portal. According to claim 1,
Wherein the customized cover is formed by 3D printing. According to claim 6,
wherein the image is manipulable prior to entry into a website portal and the website portal provides instructions for manufacturing the cover. According to claim 1,
wherein the image is uploaded to a web portal and manipulated to provide instructions for manufacturing the cover. According to claim 1,
wherein the cover is configured to prevent passage of an injection device through the opening. According to claim 1,
wherein the cover is manufactured based on human editing on the software-based application. According to claim 6,
wherein the website portal blocks access to the software to the manufacturer of the cover and allows access only to the formatted image. According to claim 1,
Where the image is asymmetrical, the image is editable on the screen and the edited image is uploadable to a website portal for manufacture of the cover. According to claim 1,
wherein the cover includes a structure that accepts a marker through the opening but prevents secure insertion of an injection device through the opening. According to claim 1,
The plurality of openings are only for insertion of markers, cover. A method of manufacturing a custom cover for placement over a portion of a patient's body, comprising the steps of: interpreting a set of commands generated from a software-based application processing an image of the patient's anatomical view consisting of locations marked thereon; , tailoring the cover to the part of the body based on the software-based application, fitting a plurality of openings in the cover to a desired location of a marking for subsequent injection of one or more medications in the marking without the cover. Including, method. According to claim 16,
wherein the cover is made based on an image entered into a website portal that is linked to a software application on a device that receives and processes data corresponding to the marking. According to claim 16,
wherein the website portal blocks access to the software to the manufacturer of the cover and allows access only to formatted images. A software-based system that enables consistent infusion of a drug through a patient's skin, the software system comprising:
a) saving a first image of said skin having a first marking thereon corresponding to a selected area for one or more injection locations;
b) storing the corrected image, the corrected image based on either human input or software generated input to adjust the one or more injection locations; and
c) uploading the corrected image for processing by a manufacturer to create a custom cover for placement on the skin of the patient. According to claim 19,
wherein the software provides instructions to the manufacturer for the cover having an aperture to receive only the markers for marking the patient's skin for direct injection in the marking. According to claim 19,
wherein the corrected image is uploaded to a web portal for processing by the manufacturer. According to claim 21,
The corrected image is not editable by the manufacturer. A method for injecting a drug into a patient based on the use of a customized cover formed by data input of an anatomical feature of the patient, the method comprising a) an indicator for identifying a location for drug injection on the skin of the patient marking: b) taking an image of the skin with the markings thereon to provide data input for the custom cover; c) obtaining a customized cover having openings in the cover, then inserting a marking device through at least one of the openings to mark the skin for an injection location. According to claim 23,
Marking the skin with various color markings to indicate different dosages of the drug for injection. According to claim 23,
The cover has a designation integrally formed thereon to indicate a dose, and the method includes the steps of removing the cover and injecting the drug into the skin according to the indicated dose. More inclusive, how. According to claim 23,
wherein the cover has a designation applied to the cover after the cover is formed, and wherein the method further comprises removing the cover and injecting the drug into the skin according to the indicated dosage. According to claim 23,
The method further comprises removing the cover after marking is made through the opening with one or more marking devices and injecting the drug at the location of the marking. According to claim 23,
aligning the cover on the skin according to one or more alignment markers on the cover. According to claim 23,
The method further comprising editing the image to provide a calibrated image and uploading the calibrated image to a web portal to provide a guide for forming the cover. A method for providing consistent infusion of a drug through the skin of a patient, the method comprising:
a) manually providing a first marking on the patient's skin to provide a locator for drug infusion;
b) taking a first image of the skin having the first marking thereon;
c) storing the first image;
a) injecting a drug into the patient at the location of the first marking;
e) after a period of time, evaluate the results of the injection of the drug, i) edit the first image to create a calibrated image for adjusting the injection at one or more injection locations, or ii) the first image not editing;
f) after obtaining a cover made according to the corrected image or the first image, placing the cover on the skin of the patient and manually providing a second marking through an opening in the cover; and
g) removing the cover and injecting the drug at the second marking. 31. The method of claim 30,
Uploading the corrected or unedited first image to a web portal for linking with a device for manufacturing the cover.

Images