METHOD AND SYSTEM FOR SELECTIVE DELIVERY OF A SUBSTANCE TO A TARGETED SURFACE AREA OF THE BODY

Abstract

A medical device and method of use thereof that provides a new means for administering injectable compounds into a targeted area of skin on the body of a human in an automated or semi-automated way, which eliminates the human factors of subjectivity with regards to placement, depth, volume and coverage.

Claims

1. A process comprising lowering a headpiece onto a head of a patient, scanning the scalp of the patient, generating a hair location map, processing the map to select locations to inject a compound, lowering an injection array onto the head of the patient, injecting the compound into selected locations of the scalp, and raising the headpiece from the head of the patient.

2. The process of claim 2 further comprising displaying a hair growth simulation on a monitor, and revising the map.

Description

BRIEF DESCRIPTION OF THE DRAWING

[0018] FIG. 1A is a block diagram of a preferred embodiment of the medical device.

[0019] FIG. 1B is a block diagram of the device of FIG. 1A used in injecting a cannabinoid compound into the patient's scalp.

[0020] FIG. 2 is a flowchart of the operation of the preferred embodiment of the invention.

[0021] FIG. 3 is an illustration of the micro-injector array used in the preferred embodiments.

[0022] FIG. 4 illustrates a view of a typical micro-injector array from the needle tip end.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0023] FIG. 1A is a general block diagram of a preferred embodiment of the medical device 100. An imager 102 is provided to acquire a region of the area of interest on the patient. This may be a CCD or CMOS imager similar one found in a digital camera. Optionally, an array of imagers 102 may be provided, for example when a three dimensional part of the body 114 such as the scalp needs to imaged, as will be described above. A micro-injector array 104 is provided for injecting the injectable substance to targeted areas of the body. This includes a large number (e.g. hundreds or even thousands) of micro-injectors or micro-needles that are addressable in order to activate the desired ones when desired. A reservoir 112 of the material suitable for injection is in close proximity to the device for feeding the substance to the micro-injector array 104 so that the micro-injectors may selectively deliver the compound when desired. Processing circuitry 106 is connected to imager 102 and micro-injector array 104, for receiving imaging data, generating the injection map, displaying the injection map, receiving revisions to the injection map, and controlling the micro-injector array 104 for dispensing the compound, as well as other functions, is provided. The processing means 106 may be in a computer that may be a standalone device, or it may be embedded within or in close proximity to the imager 102 and micro-injector array 104. Also shown is a display 108, such as a touchscreen display, that allows for interactively displaying the target region of the body and allowing a user to modify the injection map as may be desired using the touchscreen or an input device 110 such as a pen, mouse or the like.

[0024] FIG. 1B is a block diagram of the first preferred embodiment of the device 100, useful for delivering a cannabinoid compound to targeted areas of the scalp 114 in an automated or semi-automated fashion in order to stimulate hair growth in those targeted areas. The modules described above with respect to FIG. 1A are repeated and/or adapted as described. The imager 102 and the micro-injector array 104 are located within a headpiece (not shown) that may be similar in form to a helmet or the like, suitable for placing on the patient's head 118. A reservoir 112 of the injectable substance of cannabinoid compound (or other material suitable for stimulating hair growth as known in the art) is provided in conjunction with the micro-injector array 104 so that the micro-injectors 116 may selectively deliver the compound when desired. The processing means 106 is connected to the imager 102 and the micro-injector array 104, for receiving imaging data, generating the injection map, displaying the injection map, receiving revisions to the injection map, and controlling the micro-injector array for dispensing the compound, as well as other functions. The display 108 and input 11 are provided outside the helmet so the patient and/or doctor may use them interactively as will be described.

[0025] The process of this first embodiment operates generally as shown in FIG. 2. The patient will sit in a comfortable position so that his head may be stabilized at step 202, such as with a neck brace or support. It is important for the patient to have his head remain as stationary as possible in order to ensure the accuracy of the procedure. Once the patient's head has been stabilized, then at step 204 the headpiece the comprises the imager 102 and micro-injector array 1024 is lowered or otherwise placed over the top of the patient's head 118. At step 206, the imager 102 will scan the scalp of the patient. As explained above, the imager 102 may be formed with one or more sensors such as CCD or CMOS sensors, such as those used in modern digital cameras. The sensors would be placed in juxtaposition with each other so as to form a contiguous sensing area that encompasses the scalp of the patient. It is desired to overlap the scalp to ensure that the image includes all of the areas of the head in which hair exists or would be desired to be grown. For example, in FIG. 1B, the scalp area imaged by the array 102 includes the area 114 where hair is in sufficient supply as well as where the patient is bald, shown in the middle of the scalp in this example. It may be desired for the patient to have his existing hair trimmed to a very short length so as to enable the imaging array 102 to obtain an accurate scan of the scalp.

[0026] After the scalp has been imaged, then at step 208 that data is input to the processing means 106, which analyzes the image data provided by the imager 102, and then generates a map of the scalp where hair is and is not located. At step 210, the map is processed in order to select the locations that need to be stimulated for growth with the injectable compound. Since the intent here is to only apply the cannabinoid compound in those desired areas where the hair does not exist, it is important to filter out the areas where hair already exists when generating the map.

[0027] The doctor or technician operating the device will input various parameters to generate a treatment algorithm, for example the depth of penetration of each micro-injector, the amount

[0028] Docket No.: 560-004RP of compound being injected at a particular micro-injector, the duration of each micro-injection, and the like. This is also referred to as automated micro-needling. The treatment algorithm may also provide for an injection pattern to yield optimal results. For example, it may be desired to activate all targeted micro-injectors at the same time, or it may be desired to activate certain ones at one time and then other ones that are offset at a different time, perhaps milliseconds apart. Micro-injections may be made on a repetitive basis in small amounts, rather than all at once. The dosage may be spread out over a region using nearby micro-injectors if desired. Different dosage amounts may be delivered by different micro-injectors, thus delivering different amounts of the compound to different targeted areas of the scalp, as may be desired. In addition, there may be a correlation between dosage density, tensile strength, and the like, that determine the quantity of the compound being injected as well as the density of the injections.

[0029] Telemetry may be used whereby the addressable micro-injectors are positioned on the head relative to specific facial or cranial biomarkers. For example, at least three points may be selected on the patient by which all subsequent locations for injections are derived from an analysis of those points.

[0030] The optional step 218, where the patient and/or technician may modify the map manually, may now be invoked. At step 218, the scalp image data and injection map that has been generated at step 210 are used to generate a display of a simulation of how the hair growth will appear. The display 108 may be a touchscreen display that will allow the patient or technician to interact and modify the injection map at step 220 so that the hair growth projection will also change in real time. This will allow the patient to fine-tune the injection parameters so as to obtain the exact look he or she would like. Once this iterative process has completed, the process returns to step 210.

[0031] At step 212, the array of micro-injectors that have been selected to inject the cannabinoid compound into the patient's scalp are lowered and placed into close proximity to the patient's scalp. At step 214, the compound is injected through the selected injectors into the scalp, and at step 216 the headpiece is raised or otherwise removed.

[0032] In the second preferred embodiment, the device 100 is used in a cosmetic surgery environment in order to selectively deliver silicone or the like in a targeted manner to the face or other areas of the body. If the patient desires the treatment to restore him to look like he did in his youth, then he may provide a photograph of his face from that prior time. This will be scanned or otherwise input and used as a standard by which the micro-injection procedure will attempt to match. Next, the patient lies down and the face is imaged by the imaging array 102 and then displayed to the patient and technician/doctor on the display 108.

[0033] The processor 106 will then analyze the scanned photograph and the acquired scanned image of the patient, and perform an algorithm that determines how the micro-injections should occur in order to restore the patient as closely as possible to the image from the photograph. Optionally or in addition, the desired areas of injection on the face are selected by the user on the display 108. After the initial injection map is generated, a simulation is run on the processor 106 and displayed on the display 108 in order to show the patient exactly how the injections will manifest on the face. The patient and/or technician may then continue to interact with the display 108 to modify the map in order to fine tune the results. Once the patient is satisfied with the simulation, the map is finalized.

[0034] Next, the micro-injector array 104 is lowered or otherwise caused to make close contact with the patient's face. The silicone compound will then be selectively delivered to only those targeted areas of the face that are indicated in the map. Once the targeted compound delivery is complete, the micro-injector array 104 is removed from the patient, and the treatment is complete.

[0035] The construction and operation of the micro-injector array 104 will now be described with respect to FIG. 3 and FIG. 4. The micro-injector array 104 is comprised of a multiplicity of micro-injectors 302 (also referred to as micro-needles). Shown in FIG. 3 are micro-injectors 302a, 302b, . . . 302n, wherein n is the total number of micro-injectors in the entire array. Only three micro-injectors 302 are shown, but it is understood that the multiplicity of micro-injectors will be implemented in a two-dimensional array as desired by the system designer. That is, the number of micro-injectors 302, placement, area of coverage, etc. will vary according to the specific application being implemented.

[0036] Each micro-injector 302 comprises a micro-needle 304, a control 306, an activator 308, a pressure sensor 310, and an imager 312. Additionally, each of the micro-injectors 302 is interconnected with the reservoir 112, which will hold the compound being injected into the patient.

[0037] The control 306 is an electronically addressable controller that enables the processor 106 to select the micro-injectors 302 in the array 104 that should be activated for a given treatment. Reference is now made to FIG. 4, which illustrates a view of a typical array 104 from the needle tip end. Each circle in the array represents an individual micro-injector 302, wherein the darkened tips graphically illustrate the specific micro-injectors 302 that have been selected by the processor 106 to deliver the compound to the patient in a given treatment, and the non-darkened tips indicate the specific micro-injectors 302 that have not been selected by the processor 106 to deliver the compound to the patient. Each of the micro-injectors 302 are selected via their address in the array 104 as known in the art.

[0038] The activator 308 is a mechanical activator, such as but not limited to a hydraulic device, that will cause the micro-injector 302 to move towards the patient's skin in order to deliver the compound from the reservoir when that micro-injector 302 is selected for delivery, and to raise the micro-injector 302 away from the patient's skin when delivery has been completed. The pressure sensor 310 operates to detect the pressure of the micro-needle 302 against the patient's skin, feed that pressure information to the processor 106 so that the processor may regulate the operation of the activator 308 and adjust the pressure of the micro-injector 302 against the patient's skin as may be desired for a given treatment.

[0039] The imager 312 provides an image of the target area of the patient to the processor 106 so it may aid in calculating the injection parameters (pressure, speed, duration) that are used by the processor in controlling the operation of each micro-injector 302. Optionally, the collection of imagers 312 may be used to perform the functions of the imager 102 (i.e. collect an initial image of the area to be treated such as the scalp). Or, as described above, a separate imager array may be used to perform this function.

[0040] In an alternative embodiment, multiple compound reservoirs 112 may be utilized. A micro-injector may be programmed to be obtain the injectable compound from any of the available reservoirs. This enables multi-therapy whereby different compounds can be injected through different injectors so that they work either independently or in collaboration with one another.