The present disclosure generally relates to aesthetic treatment systems and methods.
There is a continuing need for an effective approach to improving the appearance of the surface of skin. In one or more approaches, it is desirable to treat cellulite, also known as gynoid lipodystrophy, nodular liposclerosis, edematofibrosclerotic panniculopathy, panniculosis, adiposis edematosa, demopanniculosis deformans or status protrusus cutis. Additionally, there is a need for treatment devices for use in scar release, acne subcision, facial fold and/or facial lift procedures. Moreover, there is a need for proactive treatment modalities that prevent future or reoccurrence of skin discontinuities and which are easy and effective to use.
It has been reported that more than 85% of women have cellulite thus suggesting that cellulite is a physiologic rather than pathologic condition. The existence of fat in the reticular dermis alone is not thought to cause cellulite. Cellulite can be described as the herniation of subcutaneous fat within fibrous connective tissue that is expressed as dimpling of the skin. This fat loading can lead to stress on connective tissue located between fat lobules. Such dimpling is more common in women than men due to the orientation of subcutaneous fibrous structures defining chambers containing fat cells. In fact, it is this structure that is believed to cause the appearance of cellulite more than being overweight. Often, cellulite appears on the pelvic region including the buttocks, lower limbs and abdomen.
Subdermal fat layers below the epidermis are contained between dermal layers connected by septa which act as connective tissue between the dermal layers. In men, the septa are arranged more randomly and densely oriented in a more criss-crossed configuration while the septa in women are generally more parallel in arrangement. Also, men have thicker dermis and more angled septa relative to the skin surface whereas women have relatively thinner dermis which thins with age, and septa that are perpendicular to the skin surface. Moreover, women with cellulite have exhibited thickening of the septa in the regions of cellulite and tensioning of septa highlights cellulite. In women, fat storage in adipose tissue has a biological purpose in that it is maximized ensuring adequate caloric availability for pregnancy and lactation. An increase in fluid retention or proliferation of adipose tissue in such subdermal fat layers can further result in the appearance of cellulite where the septa is maintaining a first distance between dermal layers, thus creating dimples, whereas pockets between septa bulges. Over time, the septa may stretch, then eventually contract and harden thus retaining tissue layers at fixed distances, but pockets between such septa may be expanded thus adding to the appearance of cellulite.
Various approaches have been taken to treat or address cellulite. Early treatments involved attempts at increasing circulation and fat oxidation in areas exhibiting cellulite. Here, substances such as hyaluronic acid and aminophylline were injected in the target areas to reduce cellulite. Other approaches involved electroporating the target areas followed by the application of mesotherapy, or applying dermological creams or other supplements to cellulite. These approaches could be supplemented by massage or massage was used alone for the purpose of promoting increased fat reabsorption or drainage of fluids and toxins in the treated areas. Ultrasound has also been proposed to disrupt subcutaneous tissues and fat and has been used in combination with liposuction. Low acoustic pressure in combination with the infiltration of microbubbles has also been employed to reduce the appearance of cellulite, as has the use of other energies such as lasers and radio frequency. Such approaches have been characterized by limited or unpredictable results. More recently, the cutting of septa with blades or needles in the subdermal region has been employed. Prior approaches have been found to be labor intensive and very traumatic to the tissue leading to numerous skin entry sites, bleeding, bruising, tough tissue nodules, long, painful recoveries and inconsistent results.
There is also a significant need for devices to treat scars and acne, or for use in facial fold and/or facial lift procedures. In conventionally available procedures, treatment devices are required to be inserted within tissue close to the interventional site, and travel within tissue to the site results in cutting or disrupting non-target tissue. There is thus a need for a treatment device that can be placed into tissue at more cosmetically desirable locations where the treatment device includes a blade that is only exposed once it reaches the treatment tissue. In addition, there is benefits associated with using a single entry site to treat multiple target locations through the single entry site since safe and minimally traumatic navigation between entry and the targeted tissue is desirable.
Accordingly, there is a need for effective and efficient approaches to improving the aesthetic appearance of skin including treating, minimizing or eliminating trauma. These approaches should be associated with predictable results and be relatively easy to employ.
The present disclosure addresses these and other needs.
Briefly and in general terms, the present disclosure is directed towards aesthetic treatment systems and methods involving an apparatus that facilitates and methods involving, depending on the system used and force applied by the user, stretching, re-orienting, disrupting, cutting, slicing, and/or tearing tissue. In one aspect, the treatment approach involves a tissue cutting or slicing system. In another aspect, tissue cutting or slicing is combined with disruption and/or localized removal of fat.
In one embodiment, a cellulite treatment device is mounted at a distal end portion of a shaft and is sized and shaped to be advanced between tissue layers. In one particular aspect, fibrous septa that connect superior and inferior fascia plateaus within skin can be crossed with the treatment device using one or more of an array of tools to engage, and depending on the tool used and force applied by the user, stretch, re-orient, tear, disrupt, cut or slice septa. By doing so, the target subcutaneous connective tissue associated with the surface defect can be directly modified with minimal impact to surrounding blood vessels and lymphatic system and fat can be more evenly distributed and skin can assume a smoother appearance.
In various aspects, a handle assembly is provided to actuate a treatment device. In one or more approaches, the handle assembly includes an actuatable assembly that controls configuring a treatment device into one or more of home or sheath, open or hook, and active or cut configurations. The actuatable assembly can include one or more of a slider, an active or cut button and a return home button. Alternatively, the handle assembly includes structure that facilitates an automatic return to home upon completion of stretching, re-orienting, tearing, disrupting, cutting or slicing of septa or other tissues.
In one or more aspects, a cellulite treatment system embodies a tool facilitating an ability to reach and treat all target cellulite appearance areas through a single skin entry on each side of the patient or a limited number of entries through the skin. In certain aspects, such tool is sized, shaped and configured (e.g. less than or equal to about three millimeters diameter, more preferably less than or equal to about 2 millimeters, and blunt dissection tip) to be placed within and advanced between tissue layers on its own and without assistance from external skin stabilizing structure, such as a suction device. Entry points through the skin such as high on the hip under where a bikini or underwear strap would be and along creases or transitions between buttocks and thighs (for example, gluteal crease) are employed. Identification and assessment of target septa is accomplished by pushing, pulling or otherwise tensioning septa in areas believed to be associated with the appearance of cellulite on the outside of skin. It has been recognized that septa causing a dimple or depression are located at various angles and locations relative to the dimple or depression observed on the skin and are not necessarily directly below such appearances of cellulite, and the treatment system and method is configured to identify the septa responsible for the appearance of cellulite that has been marked on the skin and target treatment on those septa and leave adjacent septa, blood vessels, etc. intact. Moreover, a range such as a small subset or a larger number of septa can be the structure causing a particular depression or dimple.
In one method, anesthetic is injected into the treatment site transcutaneously or subcutaneously, a cellulite treatment system is inserted subcutaneously across the treatment site and used to identify the septa responsible for a depression or dimple by pushing or pulling on various septa to cause a depression in the skin in the target area, and a cutting or slicing device or septa disruption structure is placed subcutaneously at the treatment site and employed to engage and cut or slice or break the septa tissue. In one particular aspect, the patient is directed to clench their buttocks and/or leg muscles to help facilitate identifying target areas and after septa treatment confirm release of septa that create dimples or depressions. Alternatively, the physician can press in a cranial to caudal direction on the skin above the treatment target or pull from below the treatment target. Remote imaging or ultrasonic or fluoroscopic energy can be employed to observe the procedure. A resizing or alternative configuration of the treatment structure can be employed to complete the treatment of a particular area. The treatment device is then repositioned to treat additional areas. The treatment device can be configured to treat a plurality of areas simultaneously or in succession without removing from the patient or a spot treatment approach can be taken. Additionally, through one or more entry points, various treatment trajectories are directed and in certain applications a steerable introducer is used to access treatment areas. Further, anti-inflammatory, collagenase, deoxycholic acid, salicylic acid, glycolic acid, hyaluronic acid, tranexamic acid or cellulite treatment medicants can be employed at the interventional site separately or directly by the interventional device or other procedural instrumentation. Aspects of the current invention include specific identification of the septa responsible for the cellulite appearance, severing or separation of those septa, confirmation intra-operatively that the separation of those septa was accomplished and the prevention of the re-appearance of the cellulite.
In various aspects, the treatment device can include one or more of cutting structure that cooperates with a septa or connective tissue hooking or engaging element to one or more hook or engage then cut, slice, tear or disrupt septa or connective tissue. One or more of the septa or connective tissue hooking element and the septa or connective tissue cutting element is convertible from a hooking configuration to a cutting configuration and from a cutting configuration to a hooking configuration or to a stored configuration. The treatment device can further include various approaches to blocking structure that selectively blocks one or more cutting elements. In another particular approach, the treatment device is embodied in an elongate member insertable through the skin capable of expanding at least one region from a smaller state to a wider state, and when in the wider state is configurable to both hook and cut, slice or disrupt target septa or connective tissue. In one specific approach, a treatment device is embodied in an assembly including an elongate member that is configurable to present a hooked cutting structure for use in treating cellulite, scar or connective tissue existing in tissue planes, and includes a damper that reduces noise and slows the return of the device to a home configuration.
The cellulite treatment system also involves in certain approaches, illumination such as a bright light configured at or emitted through a tip of treatment structure or placed along or at strategic locations along treatment structure for the purposes of tracking advancement of the tool to the treatment site and locating intra-dermal structures at the treatment site. In this way, direct observation of the treatment device by transillumination through the skin is provided and positioning, depth and performance thereof subcutaneously is readily available to an operator.
In one or more further aspects, the disclosed devices can be used in scar release, acne subcision, facial fold and/or facial lift procedures, or in any area where tissue disruption is needed in the subcutaneous space between tissue layers of the body. Transillumination can be used or specific devices or systems can lack transillumination structures or assemblies. In various approaches, a treatment device can be placed into tissue at more cosmetically desirable locations where the treatment device includes a blade that is only exposed once it reaches the treatment tissue. In addition, a single entry site can be used to treat multiple target locations through the single entry site since safe and minimally traumatic navigation between entry and the targeted tissue is possible.
These and other features of the disclosure will become apparent to those persons skilled in the art upon reading the details of the systems and methods as more fully described below.
Before the present systems and methods are described, it is to be understood that this disclosure is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present disclosure will be limited only by the appended claims.
Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the disclosure. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the disclosure, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the disclosure.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present disclosure, the preferred methods and materials are now described.
It must be noted that as used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “the system” includes reference to one or more systems and equivalents thereof known to those skilled in the art, and so forth.
With reference to
Once a treatment approach is planned, the patient lies down on their stomach on the treatment table. Alternatively, because of the minimally invasiveness of the current approach, a patient can be treated while standing, particularly for a small number of treatment targets, or while standing and leaning forward on a support and alternatively between standing and leaning forward so that gravity can help identify and confirm treatment of the targeted septa. The patient can also be asked to lunge or clench muscles to aid in identifying treatment sites. Moreover, the measurement device creates a complete three-dimensional map of all cellulite relative to normal skin. By dating and comparing improvement of volume of divots or dimples versus normal idealized surfaces, the operator calculates total and local volume benefits of therapy and track improvement over time.
In one specific approach, as shown in
Turning now to
In certain aspects, there can be a single entry site or two entry sites on each side of the patient, one high on the hip and another along the crease or transition between the buttocks and thigh, or at the inner thigh. Such locations are characterized in that they can be easily hidden either naturally or by clothing. Treatment targets, depressions and dimples that have been marked on the skin surface while the patient is standing often go away when the patient lies down on their stomach because gravity acts on the skin and underlying connective tissue in a different direction such that the ink mark 204 is apparent, but the dimple or depression is not. The disclosed interventional devices are configured such that a user can approach a target location and first use the interventional device to push, pull or otherwise tension septa in a target area under the skin to identify the specific septa impacting the target and/or which is the cause of the appearance of cellulite. In other words, pulling or pushing is performed on the septa under the skin to find the one(s) that create the dimple or depression in the skin surface. Notably, enough force is employed in pulling or pushing septa to create a dimple or depression on skin and an assessment is made to determine if the created dimple or depression corresponds to targeted dimples or depressions that have been marked for treatment. If so, then the engaged septa are treated as described herein and this approach is repeated for all targeted treatment areas. The operator also confirms that all the septa associated with a targeted dimple or depression have been treated with the treatment device so that all of the septa associated with targeted dimples or depressions have been completely released.
With reference to
For some treatment targets, taking an approach from an entry located inferior the treatment target, advancing the end of the interventional device beyond the treatment target and then pulling inferiorly (effectively the “down” direction if the patient was standing) can provide a better approach, for example, for treatment targets on the leg, to re-create the dimple when the patient is lying down. One or more strain gauges can be incorporated within the treatment device to help identify target septa as well as to assess the progress and completion of treating septa. This facilitates targeting of key septa in a less impactful way, ideally minimizing bruising or other issues associated with cutting or disrupting a large area around the target. There are thus herein shown various approaches to treating cellulite expressed as dimples or depressions 200 in the skin surface. Moreover, the handle portion can be employed to create an indentation in skin through which interventional devices can be inserted subcutaneously. A treatment regimen is selected for inserting interventional instruments based upon the subject's anatomy as it relates to the septa 350 connecting tissue layers that define the chambers retaining fatty or other tissues. If desired, while anesthetic and/or sedation is taking effect, ultrasound can be used to assess the subcutaneous trajectory and depth of the various connective tissue bands responsible for the surface unevenness. The ultrasound evaluation can help with the particular trajectory selected for the desired depth. The ultrasound evaluation can also help with positioning the distal end portion of the treatment instrument strategically at the connection point between the connective tissue and the dermis or the facia.
As shown in
In one aspect, local anesthetic is applied to the treatment site subcutaneously. In one approach, a long anesthesia needle (for example, 3.5 or 6 inches in length) is tunneled beyond a marked treatment site and anesthetic is administered under the marked area and along the tunneling pathway. It may be desirable to apply additional local anesthesia using a short needle transcutaneously to ensure that anesthetic extends beyond the marked target area. A distal end portion of a cellulite treatment assembly 220 is then inserted through the skin and the blunt tip is guided up into close proximity of the dermis as the tip can be tracked using the light source 352 at the distal end of the assembly as it is advanced toward septa 350 (
In another approach to precisely target and perform cellulite treatment procedures, a separate light source having a broad spread of light can be inserted into the target area through a separate incision or the same point that is less superficial to the skin layer. The treatment device is then advanced over this separate light source to identify where the treatment device is positioned through backlighting. By separating the light source from the treatment device, the treatment device can be less complicated, have fewer parts and constraints and can present a smaller profile requiring smaller incision sites and is easier to advance within tissue. Moreover, the treatment device would be subject to fewer electrical testing requirements and will potentially exhibit fewer electrical problems. In alternative or related approaches, a magnet can be incorporated into the treatment device and a magnet film can be placed over the skin to provide tracking of the treatment device. Also, a vein viewer-like apparatus can be employed to visualize reflectivity of a treatment device coated to demonstrate high reflectivity to identify device location, or near-IR light is employed to detect temperature differences between the treatment device and the patient's skin to thus identify treatment device positioning.
Using palpation, direct visualization (for example, transillumination or endoscopic) or non-invasive visualization (for example, ultrasound or fluoroscopic) or other means for determining the position of the interventional tool such as markings along the length of the instruments and its path within tissue, or providing the interventional instrumentation with radiopaque markers, the tool is placed at a site below where cellulite (for example a dimple) is seen on the subject's skin. The treatment device is advanced through septa 350 and to where the treatment device 225 is in a position best suited to accomplish the identification of target septa and the cellulite removal or minimization treatment. As shown in
It is noted that septa causing a dimple or depression may be coming from various angles and locations relative to the dimple or depression seen on the skin rather than being directly below the dimple or depression, and may be due to one or only a few septa or a large number of septa that remotely cause the depression or dimple. Thus, so engaging certain septa will be reflected in some change in the dimple or depression on the skin. A determination is made concerning the correspondence with marks 204 made on the skin and the dimples being formed or re-formed. If the initial septa 350 that the user presses on or pulls on using the tool do not recreate a dimple or depression in the marked area 204, then the user releases those initial septa that were engaged and repositions the tool at different septa and presses on or pulls again. This is repeated until the septa responsible for a dimple or depression in the marked location are identified (
After the proper septa have been severed, disrupted, stretched, or re-oriented, the treatment element 225 is moved back to its initial collapsed configuration. The treatment element is then advanced beyond the marked treatment location, the treatment element (e.g., hook) is deployed and then pulled back under the marked treatment location to confirm that all of the septa responsible for causing the marked dimple or depression have been separated intra-operatively. Again, multiple passes are taken to ensure that all cellulite-creating septa, including secondary septa are cut. If they have not been, the tool is manipulated to sever, disrupt, stretch, or re-orient additional septa. An approach is taken working right to left through an entire marked margin area and the steps are repeated until all of the septa responsible for creating the marked dimple or depression have been severed or sufficiently stretched and the dimple or depression cannot be re-created intra-operatively using the tool. Alternatively, or additionally, to check that the marked treatment targets have been adequately separated, treatment can be conducted with the patient lying down and the patient can then be asked to stand up off of the procedure table to let gravity act on the body to see whether marked treatment areas have been treated. Where the patient is asked to stand, steps are taken to maintain a sterile field and appropriate draping is provided to the patient. Where necessary, further treatment can be conducted on the unresolved areas. Such manipulation results in selective rupture, tearing, cutting or slicing of targeted septum 350, and the removal or minimization of dimples and the appearance of cellulite on skin (
With reference now to
The distal end 312 portion (
Various further alternative approaches to cellulite treatment systems can be employed. With reference again to
Turning to
With reference to
As shown in
Also configured within the handle assembly 400 is a damper assembly 480. The damper assembly 480 includes a damper arm 482 and one or more dampers 484. Although the component parts of the damper assembly can assume various constructions, as shown, the damper arm 482 includes diverging projections 485 and is configured to be pivotable within the handle 400 relative to the damper 484. The damper 484 includes a disc-like portion 486 that functions like a brake as it engages structure of the damper arm 482. The damper assembly 480 is operatively associated with the slider 450 to control the return of the handle 400 to a home state. The damper assembly 480 slows the return of the slider 450 to a proximal position to provide a slow close feature or functionality. The damper assembly 400 also reduces noise associated with the return of the slider 450 to a home position. In this way, a treatment procedure involving this damper feature is more controlled and facilitates avoiding startling a patient with noises emanating from the treatment device during a procedure.
In a home state (
At this point, the treatment device is deployed to present a hook configuration but a blade or cutter of the treatment device is covered or undeployed. Next, when the cut button 454 is depressed (
Upon releasing the cut button 454, the second projection 472 unlatches, allowing the slider 450 to return to its proximal position and the cut button 454 to return to its undepressed configuration. The return of the slider 450 to its home position is facilitated by the energy provided by the spring 452 associated with the slider 450. The damper assembly 480 slows and quiets the return action of the slider 450 through the engagement of the damper arm 482 with the damper 484. Such control is provided when the slider 450 engages another projection 485 to rotate the damper arm 482 through its engagement with the damper 484, and frictional forces slows the action of the slider 450. The treatment device thus automatically returns to the stowed configuration and the handle assembly 400 is in the home state (
After completing treatment of one target area employing one or more of the disclosed treatment devices, the procedures described herein can repeated to treat other target areas. Accordingly, the same devices can be employed to access tissue layers below other sites or depressions existing in skin. Notably, in one embodiment, the devices are capable of anesthetic delivery as needed or desired when progressing to additional or new locations. There is thus provided a system configured to treat all target areas on the body through a limited number of small entry sites, including through a single entry site on each side of the patient. It is to be recognized that the system can further include structure permitting the assembly to be steerable to subcutaneous treatment sites. In such an embodiment, the device would be configured to define longitudinally flexible material, and the instrumentation would be steered to the desired position within tissue. Moreover, in certain applications, the device has a stiffness that varies along its length. In another embodiment, the treatment and fat collection devices are embodied in deflectable catheters.
In each of the disclosed approaches and apparatus, should engagement of such septa result in some change in the dimple or depression expressed on the skin, the treatment structures are manipulated to disrupt, cut or slice the tissue. Thus, the treatment structures are opened and tissue is placed between its cutting structure. Next, the cutting structures are advanced against or caused to be closed about the tissue to thereby cut, slice or sever the tissue, thus relieving the tension between tissue layers and eliminating or minimizing the appearance of the unwanted feature on the skin. Actuation is accomplished from a proximal end of the treatment device such as by pulling a wire or advancing and pushing an elongate member associated with the scissor arrangement. Illumination can be provided by a light configured proximal of the treatment or fat collection devices so that transillumination can be employed to track the location of the distal portion of the treatment assembly. Additionally, or alternatively, in each disclosed embodiment, illumination can be via a lightguide from an external light source or via one or more LEDs. Illumination aids the user both with locating the treatment device as well as proper depth placement as transillumination decreases with increasing tool depth. In one aspect, the amount of illumination is set to ensure proper depth of a treatment device or structure, the level of illumination targeted being adjusted for skin type, thickness, presence of fat and pigment.
In employing one or more of the disclosed embodiments in a treatment procedure, there is an expectation that there are instances where it is preferable to not disrupt a hooked tissue, and in such a case it is desirable to release or disengage the hooked tissue. In certain approaches, to release or disengage, the treatment device would be advanced or twisted away from the hooked tissue. It is thus recognized that a challenge exists in that there may be additional tissue in the area which could be unintentionally re-engaged by the treatment device when it is in a hooking configuration, and stowing of the treatment device may be inhibited by adjacent patient anatomy.
Accordingly, various approaches to aesthetic treatment methods and apparatus are presented. The disclosed approaches are configured to provide an effective and focused approach to treating, minimizing and preventing unwanted skin features. The disclosed approaches can also be used to repair and reduce the appearance of unwanted features in a targeted manner. Further, the disclosed proactive treatment modalities are easy and effective to use.
Some of the specific aspects of the present disclosure include one or more of focal treatment of just the tissue responsible for causing unwanted features in the skin; minimizing bruising; accessing all treatment targets from limited, cosmetically acceptable entries; capture and retention of tissue while separating the tissue; intra-operative confirmation of the treated target; needle-diameter sized tools for small openings; and transillumination identification of tool tip location.
While the present disclosure has been described with reference to the specific embodiments thereof, it should be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the true spirit and scope of the disclosure. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process step or steps, to the objective, spirit and scope of the present disclosure. All such modifications are intended to be within the scope of the present disclosure.
This application is a continuation-in-part of U.S. application Ser. No. 17/154,232, filed Jan. 21, 2021, which is a continuation-in-part of International Application Serial No. PCT/US19/42871, filed Jul. 22, 2019, which claims priority to each of U.S. Application Ser. No. 62/825,447, filed Mar. 28, 2019, U.S. Application Ser. No. 62/802,368, filed Feb. 7, 2019, U.S. Application Ser. No. 62/798,515, filed Jan. 30, 2019, U.S. Application Ser. No. 62/736,016, filed Sep. 25, 2018, and U.S. Application Ser. No. 62/702,314, filed Jul. 23, 2018, the entire disclosures of each of which are expressly incorporated herein by reference.
Number | Date | Country | |
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62702314 | Jul 2018 | US | |
62736016 | Sep 2018 | US | |
62798515 | Jan 2019 | US | |
62802368 | Feb 2019 | US | |
62825447 | Mar 2019 | US |
Number | Date | Country | |
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Parent | 17154232 | Jan 2021 | US |
Child | 18137018 | US | |
Parent | PCT/US2019/042871 | Jul 2019 | US |
Child | 17154232 | US |