Patent Application
20210094743
The present disclosure relates to blinding shells that can be used to cover vials during blinded studies of therapeutic drugs and to related methods.
A large number of therapeutic drugs are provided in liquid form and are administered using a syringe. Such drugs are commonly housed within a vial. Dispensing of the drug typically requires passing a needle through a stopper of the vial and withdrawing a dosage of the drug into the syringe. The needle is then retracted from the vial and subsequent inserted into a patient for dispensing of the drug. Blinded testing of such drugs during clinical trials requires that the vials be shielded so that the drug cannot be analyzed by the patient or the person administering the drug.
In one approach to shielding the vial, the vial is enclosed within an opaque blinding shield having a small opening that is aligned with the stopper of the vial. During use, a needle of a syringe is simply passed through the opening of the blinding shield and through the stopper so that the drug, comparator or placebo being used in the blinded study can be withdrawn into the syringe and subsequently dispensed.
Although such blinding shields are effective at shielding a vial, they have a number of shortcomings. For example, because the stopper of the vial is disposed within the blinding shield and cannot be accessed, it is not possible (or at least not practical) to clean the stopper where the needle passes, either prior to initial use or between subsequent uses. As such, there is an increased risk of contamination of the dosage being tested.
Furthermore, vials commonly come in different heights. However, using blinding shields of different heights to properly fit the vials of different heights complicates production of the blinding shields and can complicates the packaging and storage of such blinding shields. In addition, using blinding shields of different sizes can defeat the blinded study by suggesting or implying differences in what is being housed in different vials of different sized blinding shields.
Accordingly, what is needed are blinding shields and assemblies that overcome all or some of the above shortcomings and other problems known in the art.
In one embodiment of the present disclosure, a vial blinding assembly includes:
In another embodiment, the sidewall of the tubular blinding shell comprises an annular shoulder that inwardly extends.
In another embodiment, the sidewall of the tubular blinding shell comprises:
In another embodiment, the annular shoulder of the sidewall blocks the annular shoulder of the bottle from passing out through the access opening.
In another embodiment, the lower portion, the upper portion and the annular shoulder of the blinding shell comprise a single, integral, unitary member as opposed to two or more members that are connected together.
In another embodiment, at least a portion of the lower portion is cylindrical and at least a portion of the upper portion is cylindrical.
In another embodiment, the tubular blinding shell is opaque.
In another embodiment, the floor plug couples with the blinding shell by a snap fit connection so that the floor plug cannot be manually separated blinding shell.
In another embodiment, the floor plug is fully or at least partially disposed within the compartment of the blinding shell.
In another embodiment, the vial blinding assembly further includes:
In another embodiment, the floor plug has a top surface disposed within the compartment of the blinding shell and an opposing bottom surface, the floor plug having a maximum thickness extending between the top surface and the bottom surface that is greater than 0.5 cm, 1 cm, 1.5 cm or 2 cm.
In another embodiment, the floor plug has a top surface disposed within the compartment of the blinding shell and an opposing bottom surface, the floor plug having a maximum thickness extending between the top surface and the bottom surface that is less than 0.5 cm, 0.3 cm, or 0.2 cm.
In another embodiment, the floor plug has a planar top surface disposed within the compartment of the blinding shell, the vial resting directly on the planar top surface of the floor plug.
In another embodiment, the second end of the blinding shell terminates at an annular lip that radially encircles the retainer.
In another embodiment, the annular lip of the blinding shell has an inside diameter and the retainer has a maximum outside diameter, the difference between the inside diameter of the annular lip and the maximum outside diameter of the retainer being less than 1 cm or 0.5 cm.
In another embodiment, the floor plug is opaque.
In another embodiment, the retainer comprises:
In another embodiment, the vial blinding assembly further includes a cap removably coupled to the retainer so as to cover the aperture of the retainer and the top surface of the septum.
In another embodiment, a liquid trial product is disposed within the chamber of the bottle.
In another embodiment, the liquid trial product comprises an active drug product that is under investigation, a related placebo product, a control product, or a comparator product.
In another embodiment, the vial is seated directly on the floor plug.
In another embodiment, one or more inserts is disposed between the floor plug and the vial.
In another independent aspect of the present disclosure, a method for assembling a vial blinding assembly includes:
In another embodiment, the step of securing the floor plug comprises selecting the floor plug from a plurality of floor plugs, each of the plurality of floor plugs having a top surface and an opposing bottom surface with a maximum thickness extending therebetween, each of the plurality of floor plugs having a different maximum thickness.
In another embodiment, the vial rests directly on the top surface of the floor plug when the floor plug is secured to the blinding shell.
In another embodiment, the step of securing the floor plug comprises coupling the floor plug to the blinding shell by a snap fit connection so that the floor plug cannot be manually separated from the blinding shell.
In another embodiment, the step of securing the floor plug comprises inserting the floor plug into the compartment of the blinding shell through the inlet opening.
Another embodiment includes removing a cap secured to the retainer so as to openly expose the septum of the stopper.
In another embodiment, the method further includes:
In another embodiment, the step of cleaning the top surface of the septum comprises applying a sterilizing agent to the top surface of the septum.
In another embodiment, the step of cleaning the top surface of the septum comprises using a pad to manually apply a sterilizing agent to the top surface of the septum.
Another embodiment further includes:
In another embodiment, the liquid trial product comprises an active drug product that is under investigation, a related placebo product, a control product, or a comparator product.
Another embodiment further includes positioning an insert into the compartment of the blinding shell so that the insert is disposed between the vial and the floor plug when the floor plug is secured to the blinding shell.
In another embodiment, the insert is selected from a plurality of inserts each having a different thickness.
It is appreciated that each of the features recited above and otherwise disclosed herein can be mixed and matched to produce a variety of other embodiment contemplated within the present disclosure.
Various embodiments of the present invention will now be discussed with reference to the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope.
Before describing the present disclosure in detail, it is to be understood that this disclosure is not limited to parameters of the particularly exemplified systems, methods, apparatus, products, processes, compositions, and/or kits, which may, of course, vary. It is also to be understood that the terminology used herein is only for the purpose of describing particular embodiments of the present disclosure, and is not necessarily intended to limit the scope of the disclosure in any particular manner. Thus, while the present disclosure will be described in detail with reference to specific embodiments, features, aspects, configurations, etc., the descriptions are illustrative and are not to be construed as limiting the scope of the claimed invention. Various modifications can be made to the illustrated embodiments, features, aspects, configurations, etc. without departing from the spirit and scope of the invention as defined by the claims. Thus, while various aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated.
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 the present disclosure pertains. While a number of methods and materials similar or equivalent to those described herein can be used in the practice of the present disclosure, only certain exemplary materials and methods are described herein.
Various aspects of the present disclosure, including devices, systems, methods, etc., may be illustrated with reference to one or more exemplary embodiments or implementations. As used herein, the terms “alternative embodiment” and/or “exemplary implementation” means “serving as an example, instance, or illustration,” and should not necessarily be construed as preferred or advantageous over other embodiments or implementations disclosed herein. In addition, reference to one or more embodiments is intended to provide illustrative examples without limiting the scope of the invention, which is indicated by the appended claims rather than by the following description.
It will be noted that, as used in this specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the content clearly dictates otherwise. Thus, for example, reference to an “insert” includes one, two, or more inserts. As used throughout this application the words “can” and “may” are used in a permissive sense (i.e., meaning having the potential to), rather than the mandatory sense (i.e., meaning must). Additionally, the terms “including,” “having,” “involving,” “containing,” “characterized by,” variants thereof (e.g., “includes,” “has,” and “involves,” “contains,” etc.), and similar terms as used herein, including the claims, shall be inclusive and/or open-ended, shall have the same meaning as the word “comprising” and variants thereof (e.g., “comprise” and “comprises”), and do not exclude additional, un-recited elements or method steps, illustratively.
Various aspects of the present disclosure can be illustrated by describing components that are coupled, attached, connected, and/or joined together. As used herein, the terms “coupled”, “attached”, “connected,” and/or “joined” are used to indicate either a direct connection between two components or, where appropriate, an indirect connection to one another through intervening or intermediate components. In contrast, when a component is referred to as being “directly coupled”, “directly attached”, “directly connected,” and/or “directly joined” to another component, no intervening elements are present or contemplated. Thus, as used herein, the terms “connection,” “connected,” and the like do not necessarily imply direct contact between the two or more elements. In addition, components that are coupled, attached, connected, and/or joined together are not necessarily (reversibly or permanently) secured to one another.
As used herein, directional and/or arbitrary terms, such as “top,” “bottom,” “front,” “back,” “left,” “right,” “up,” “down,” “upper,” “lower,” “inner,” “outer,” “internal,” “external,” “interior,” “exterior,” “proximal,” “distal” and the like can be used solely to indicate relative directions and/or orientations and may not otherwise be intended to limit the scope of the disclosure, including the specification, invention, and/or claims.
Where possible, like numbering of elements have been used in various figures. In addition, similar elements and/or elements having similar functions may be designated by similar numbering (e.g., element “10” and element “210.”) Furthermore, alternative configurations of a particular element may each include separate letters appended to the element number. Accordingly, an appended letter can be used to designate an alternative design, structure, function, implementation, and/or embodiment of an element or feature without an appended letter. Similarly, multiple instances of an element and or sub-elements of a parent element may each include separate letters appended to the element number. In each case, the element label may be used without an appended letter to generally refer to instances of the element or any one of the alternative elements. Element labels including an appended letter can be used to refer to a specific instance of the element or to distinguish or draw attention to multiple uses of the element. However, element labels including an appended letter are not meant to be limited to the specific and/or particular embodiment(s) in which they are illustrated. In other words, reference to a specific feature in relation to one embodiment should not be construed as being limited to applications only within said embodiment.
It will also be appreciated that where a range of values (e.g., less than, greater than, at least, and/or up to a certain value, and/or between two recited values) is disclosed or recited, any specific value or range of values falling within the disclosed range of values is likewise disclosed and contemplated herein. Thus, disclosure of an illustrative measurement or distance less than or equal to about 10 units or between 0 and 10 units includes, illustratively, a specific disclosure of: (i) a measurement of 9 units, 5 units, 1 units, or any other value between 0 and 10 units, including 0 units and/or 10 units; and/or (ii) a measurement between 9 units and 1 units, between 8 units and 2 units, between 6 units and 4 units, and/or any other range of values between 0 and 10 units.
It is also noted that systems, methods, apparatus, devices, products, processes, compositions, and/or kits, etc., according to certain embodiments of the present disclosure may include, incorporate, or otherwise comprise properties, features, aspects, steps, components, members, and/or elements described in other embodiments disclosed and/or described herein. Thus, reference to a specific feature, aspect, steps, component, member, element, etc. in relation to one embodiment should not be construed as being limited to applications only within said embodiment. In addition, reference to a specific benefit, advantage, problem, solution, method of use, etc. in relation to one embodiment should not be construed as being limited to applications only within said embodiment.
The headings used herein are for organizational purposes only and are not meant to be used to limit the scope of the description or the claims. To facilitate understanding, like reference numerals have been used, where possible, to designate like elements common to the figures.
The present disclosure is directed to vial blinding assemblies used in blinded studies of therapeutic drugs and related methods. In general, the vial blinding assemblies include a vial holding a liquid trial product and a tubular blinding shell with floor plug that cover the vial. The tubular blinding shell with floor plug function to help preclude those receiving or administering the liquid trial product from the vial from detecting any properties of the liquid trial product within the vial so that the fidelity and efficacy of the blinded study is maintained.
Depicted in
With continued reference to
Interior surface 27 and exterior surface 29 of blinding shell 14 are shown as having substantially complimentary configurations. As such, the thickness of sidewall 18 is substantially constant as it extends from first end 22 to second end 24. As depicted, interior surface 27 and exterior surface 29 of lower portion 34 have cylindrical configurations. Likewise, interior surface 27 and exterior surface 29 of upper portion 36 have cylindrical configurations. Interior surface 27 and exterior surface 29 of shoulder 38 have frustoconical configurations. As discussed below in more detail, interior surface 27 of blinding shell 14 inwardly constricts at shoulder 38 to both retain and cover vial 12 within blinding shell 14. However, exterior surface 29 of blinding shell 14 need not constrict at second end 24. For example, exterior surface 29 of blinding shell 14 could have a transverse cross section orthogonally passing through central longitudinal axis 40 that is constant between opposing ends 22 and 24. The transverse cross section could be circular, square, polygonal or have other configurations. Likewise, exterior surface 29 can vary continuously or at a variety of spaced apart locations relative to interior surface 27. However, having interior surface 27 and exterior surface 29 have complementary configurations can simplify production and minimize material costs.
As discussed below in greater detail, an annular recess 42 is formed on interior surface 27 of sidewall 18 at first end 22. In one embodiment, annular recess 42 has a tapered transverse cross section that helps to facilitate a secure snap-fit connection with floor plug 16, as discussed below. However, other configurations of slots can also be used.
In one embodiment, blinding shell 14 has a height H1 extending between lips 26 and 30 that is typically at least or smaller than 4 cm, 5 cm, 6 cm, 8 cm, 10 cm or is in a range between any two of the foregoing values. Other dimensions can also be used. In addition diameter D1 is typically at least or smaller than 1 cm, 1.5 cm, 2 cm, 2.5 cm, 3 cm, 4 cm or is in a range between any two of the foregoing values. Other dimensions can also be used.
As depicted in
Floor plug 16 is configured to produce a snap-fit connection with blinding shell 14 and is sized to that floor plug 16 completely spans across compartment 20 when connected to blinding shell 14. Specifically, annular ridge 54 has a frustoconical top surface 56 that slopes outward and back toward bottom surface 50. The outer diameter annular ridge 45 is slightly larger than the in inner diameter of lip 26 at first end 22 of blinding shell 14. During assembly, floor plug 16 is pressed into inlet opening 28 with top surface 56 pressing against lip 26. As force is applied to floor plug 16, the sloping of top surface 56 causes a slight outward expansion of lip 26, allowing ridge 54 to move or snap-fit into recess 42. Blinding shell 14 then resiliently contracts capturing annular ridge 54 within recess 42, thereby securing floor plug 16 to blinding shell 14 and completely covering inlet opening 28.
In one embodiment, the connection between floor plug 16 and blinding shell 14 can be considered a permanent attachment in that floor plug 16 cannot be manually removed from blinding shell 14 without the use of a tool or causing partial failure to floor plug 16 or blinding shell 14. The permanent attachment of floor plug 16 to blinding shell 14 helps to maintain the fidelity of the blinding study by ensuring that once vial 12 is captured within blinding shell 14 by the attachment of floor plug 16, vial 12 has not been accessed, tampered with or otherwise inspected though the removal of floor plug 16.
It is appreciated that other approaches can also be used for coupling floor plug 16 to blinding shell 14. For example, annular ridge 54 and recess 42 can be reversed. In other embodiments, floor plug 16 could be cup shaped and first end 22 of blinding shell 14 could snap fit into the recess of floor plug 16. In yet other embodiments, floor plug 16 could permanently attach to blinding shell 14 by welding, adhesive, press fitting or the like. Other techniques can also be used. However, the snap fit connection has a number of advantages, including ease of production and assembly.
Both blinding shell 14 and floor plug 16 are opaque. This can be accomplished by either forming blinding shell 14 and floor plug 16 from an opaque material or by applying an opaque coating, such as a paint or printing, or an opaque layer, such as an adhesive sticker covering. Other approaches can also be used so that blinding shell 14 and floor plug 16 are blacked out. In one embodiment, blinding shell 14 and floor plug 16 are molded or otherwise formed from a plastic such as Acrylonitrile Butadiene Styrene (ABS). ABS is an opaque thermoplastic and amorphous polymer. Other plastics/polymers can also be used. In still other embodiments, blinding shell 14 and floor plug 16 can be formed from a metal, glass, fiberglass, composite or the like.
As is shown in
Bottle 60 includes a body 66 having a circular floor 68 with cylindrical sidewall 70 upstanding therefrom. Bottle 60 also includes a neck 72 that is constricted relative to sidewall 70. An annular shoulder 74 inwardly slopes from an upper end of sidewall 70 to neck 72. As with shoulder 38 of blinding shell 14, shoulder 74 likewise inwardly slopes at an angle relative to a central longitudinal axis 73 of bottle 60. The angle of slope of shoulder 74 can be the same as discussed above with shoulder 38. As depicted in
With continued reference to
Stopper 62 is typically formed a single, integral, unitary member, as opposed to two or more members connected together, and is typically made from a rubber or elastomeric material that can produced a liquid tight seal with bottle 60. The material for stopper 62 is also selected so that a needle of a syringe can effectively pass through septum 88 for withdrawing a portion of liquid trial product 67 (
During assembly, stem 90 is advanced into opening 78 until rim portion 86 comes to rest on top of end face 75 of neck 72. In this configuration, exterior surface 96 of stem 90 sits against the interior surface of neck 72 to help effect a seal therebetween. Bottom surface 94 of septum 88 is aligned with chamber 65.
Stopper 62 is secured to bottle 60 by retainer 64. As also depicted in
Downwardly projecting from bottom face 118 of cover 114 are a plurality of bendable fingers 124. Fingers 124 removably secure cap 112 to retainer 64 by passing through aperture 110 of retainer 64 and folding around inner face 108 so as to engage a bottom face 81 of flange 106. Retainer 64 and cap 112 are formed from a bendable material, such as a metal, and are typically formed from aluminum. In one embodiment, cap 112 is known as a flip-off cap.
With reference to
When it is desired to access liquid trial product 67 within vial 10, cap 112 can be removed from retainer 64 by manually, upwardly pressing against lip 122, such as with a user's thumb or other fingers. No tool is required. As the upward force is applied relative to retainer 64, fingers 124 bend so as to release cap 112 from retainer 64, as shown in
It is appreciated that retainer 64 can have a variety of different configurations and can be used in a variety of different ways and still function to secure stopper 62 to bottle 60. By way of example and not by limitation, in contrast to being crimped onto bottle 60, retainer 64 could be formed to produce a snap-fit connection with bottle 60 or could be formed in two halves that are clamped together about neck 72. In still other embodiments, the retainer could be attached by adhesive, press fit, or constriction under heating, e.g., shrink wrapping.
It is also note that cap 112 is not required and can be eliminated. However, if cap 112 is used, cap 112 can be removably secured to retainer 64 in a variety of other ways. For example, cap 112 can be attached by a single use adhesive strip or by using other forms of projects that replace fingers 124 (
With reference to
In the fully assembled configuration as shown in
For example, cap 112, retainer 64, and stopper 62 all have a maximum outside diameter that is smaller than inside diameter D3 (
Shoulders 38 and 74 are typically disposed at complementary angles so as to enable a close tolerance fit therebetween and to avoid or minimize any high stress contact points between bottle 60 and blinding shell 14. Furthermore, the difference between the outer diameter of body 66/sidewall 70 of bottle 60 and inner diameter D1 of blinding shell 14 is typically less than 1 cm and commonly less than 0.5 cm so as to minimize unwanted movement or play of bottle 60 within blinding shell 14.
In addition, vial 12 and blinding shell 14 are typically configured so that top surface 92 of septum 88 and lip 30 of blinding shell 14 are separated by a linear height H2 that is at least or less than 0.5 cm, 0.75 cm, 1 cm, 1.5 cm, or 2 cm or is in a range between any two of the foregoing dimensions. Commonly, H2 is in a range between 0.5 cm and 2 cm and more commonly between 0.5 cm and 1.5 cm. The spacing of H2 is designed to enable easy access to cap 112 for removal and easy access to top surface of 92 of septum 88 for cleaning. However, retainer 64 is configured so that in the assembled configuration, first end 100 of collar 99 extends into compartment 20 of blinding shell 14 and below lip 30 of blinding shell 14. As a result, when vial 12 is disposed within blinding shell 14, bottle 60 is completely covered by the combination of blinding shell 14, retainer 64, stopper 62 and floor plug 16 except for an annular gap 130 that is formed between lip 30 of blinding shell 14 and retainer 64. To minimize gap 130 so as to eliminate any ability to view or detect properties of liquid trial product 67 through gap 130, the difference between the outside diameter D5 of retainer 64 and the inside diameter D3 (
During use, liquid trial product 67 is dispensed into chamber 65 of bottle 60. Stopper 62 is then seated on bottle 60, as discussed above, following which retainer 64 is advanced over stopper 62 and secured to bottle 60, as discussed above, so that stopper 62 is sealed to bottle 60. The assembled vial 12 housing liquid trial product 67 is then placed within blinding shell 14 and secured therein by the attachment of floor plug 16, as discussed above, thereby forming vial blinding assembly 10 as depicted in
Depending on a number of different factors, vials 12 used in a blinded study may come in different sizes. For example, a single blinded study may include an active drug product that is under investigation, a related placebo product, and a control product that are each prepackaged in a different facility using different sized vials. In other situations, vial sizes may change during different fill runs or when new vials are purchased. Independent of the cause, it is commonly desirable for all vials used in a blinded study to be presented in blinding shells that all appear to have the same identical configuration, i.e., size and shape, when viewed from the outside so that all vials appear to be identical. This helps to ensure that those administering or being administered liquid trial product 67 do not make assumptions or judgements as to what is being administered based on the size, shape or other properties of vial 12 and/or blinding shell 14.
To that end, depicted in
During assembly, as shown in
In contrast to having a plurality of floor plugs that each have a different thickness to compensate for vials having different heights, a single floor plug can be used in combination with inserts of different thicknesses. For example, depicted in
It is appreciated that vial blinding assembly 10 along the alternatives thereof and the components thereof have unique and beneficial advantages. For example, because the retainer and stopper at least partially project out of the blinding shell, a removable cap can be used to cover the septum prior to the initial use of the vial. Use of the cap helps to ensure that there has been no prior tampering to the liquid trial product housed within the vial and helps to keep the septum clean. Furthermore, once the cap is removed, the top surface of the septum is openly exposed so that it can be easily and repeatedly cleaned by applying a sterilizing agent, thereby helping to minimize contamination of the liquid trial product.
In addition, the ability to use a single blinding shell with floor plugs having different thicknesses or with a single sized floor plug but with inserts of different thicknesses, enables vial blinding assemblies to be produced with different sized vials where all vial blinding assemblies have the same, identical exterior configuration. Having vial blinding assemblies that all have the same exterior configuration, independent of the size of the vial, improves the efficacy of the blinded trial. The assembly also eliminates or limits the need to produce and/or store blinding shells of different configurations.
Various alterations and/or modifications of the inventive features illustrated herein, and additional applications of the principles illustrated herein, which would occur to one skilled in the relevant art and having possession of this disclosure, can be made to the illustrated embodiments without departing from the spirit and scope of the invention as defined by the claims, and are to be considered within the scope of this disclosure. Thus, while various aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated. While a number of methods and components similar or equivalent to those described herein can be used to practice embodiments of the present disclosure, only certain components and methods are described herein.
It will also be appreciated that systems, processes, and/or products according to certain embodiments of the present disclosure may include, incorporate, or otherwise comprise properties features (e.g., components, members, elements, parts, and/or portions) described in other embodiments disclosed and/or described herein. Accordingly, the various features of certain embodiments can be compatible with, combined with, included in, and/or incorporated into other embodiments of the present disclosure. Thus, disclosure of certain features relative to a specific embodiment of the present disclosure should not be construed as limiting application or inclusion of said features to the specific embodiment. Rather, it will be appreciated that other embodiments can also include said features without necessarily departing from the scope of the present disclosure.
Moreover, unless a feature is described as requiring another feature in combination therewith, any feature herein may be combined with any other feature of a same or different embodiment disclosed herein. Furthermore, various well-known aspects of illustrative systems, processes, products, and the like are not described herein in particular detail in order to avoid obscuring aspects of the example embodiments. Such aspects are, however, also contemplated herein.
The present disclosure may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. While certain embodiments and details have been included herein and in the attached disclosure for purposes of illustrating embodiments of the present disclosure, it will be apparent to those skilled in the art that various changes in the methods, products, devices, and apparatus disclosed herein may be made without departing from the scope of the disclosure or of the invention, which is defined in the appended claims. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.
This application claims the benefit to U.S. Provisional Application No. 62/908,113, filed Sep. 30, 2019, which is incorporated herein by specific reference.
| Number | Date | Country | |
|---|---|---|---|
| 62908113 | Sep 2019 | US |
