Patent Application
20210186811
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 intravenously. Such drugs are commonly housed within a bag or vial. Dispensing of the drug intravenously typically requires that the bag or vial be suspended in an inverted orientation so that the port or septum through which the drug is accessed is facing downwardly. This orientation enables the drug to freely flow under the force of gravity when an IV line is coupled thereto.
Blinded testing of a drug during clinical trials requires that the drug be shielded so that the drug cannot be analyzed by the patient or the person administering the drug. Blinding shields are commonly used on vials where the vials are configured to receive a needle from a syringe to withdraw the therapeutic drug for administering. However, because of the complexity of vials that need to be suspended in an inverted orientation for intravenous delivery, blinding shells have not been developed for such vials.
Furthermore, a shortcoming of many conventional blinding shells is that different sized blinding shells are typically configured to house different sized vials. The problem is that if it is necessary to switch vial configurations or if it is necessary to concurrently send multiple vials for use on a patient, where the vials are different configurations, the patient and/or person administering may potentially notice the different configurations of blinding shells that are used to enclose the different sized vials. In turn, the patient and/or person administering may deduce that, because there are differences in the configurations of the blinding shells, the trial product contained therein has changed or has certain properties, thereby dimensioning the efficacy of the blinded trial.
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 a first independent aspect of the disclosure, a vial blinding assembly includes:
In one embodiment, the retainer includes an inwardly projecting flange that encircles an aperture that is aligned with the septum, the shield wall extending over at least a portion of the flange so that the access opening is aligned with the aperture.
In another embodiment, the flange has an outside face and the shield wall covers at least 80%, 85%, 90%, 95%, or 97% of the outside face of the flange.
In another embodiment, the blinding shell covers all of the vial except for the septum.
In another embodiment, the blinding shell covers all of the vial except for what can be seen through the access opening.
In another embodiment, the access opening has a maximum diameter that is less than 10 mm, 7 mm, 5 mm, or 3 mm.
In another embodiment, the access opening is circular.
Another embodiment includes means for securing the first shell portion to the second shell portion so that the vial is captured within the cavity of the blinding shell.
In another embodiment, the means for securing comprises a projection extending from the first shell portion that is press fit into a coupling hole formed on the second shell portion.
In another embodiment, the coupling hole comprise a blind pocket.
In another embodiment, the blinding shell is comprised of a plastic.
In another embodiment, the blinding shell is opaque.
In another embodiment, the blinding shell has an exterior surface, a distance between the interior surface and the exterior surface being less than 3 mm, 1 mm or 0.5 mm.
In another embodiment, the first shell portion and the second shell portion are hingedly coupled together by a hinge.
In another embodiment, the hinge comprises a living hinge that is integrally formed as a unitary member with the first shell portion and the second shell portion.
In another embodiment, a hanging tab outwardly projects from the floor, the hanging tab having a mounting hole laterally extending therethrough.
In another embodiment, the hanging tab outwardly projects along a central longitudinal axis of the cavity.
In another embodiment, the encircling sidewall comprises:
In another embodiment, a flexible seal extends between the first shell portion and a second shell portion and is secured thereto by an adhesive.
Another embodiment further includes:
In another embodiment, the first closure tab and the second closure tab are disposed within a common plane.
In another embodiment, the first closure tab comprises:
Another embodiment includes:
Another embodiment includes a flexible seal extending between the first closure tab portion and the second closure tab portion and being secured thereto by an adhesive.
Another embodiment includes:
In another embodiment, a hanging tab outwardly projects from the first floor portion, a mounting hole laterally extending through the hanging tab.
Another embodiment includes:
Another embodiment includes
In a second independent aspect of the disclosure, a vial blinding assembly includes:
In another embodiment, the hanging tab outwardly projects along a central longitudinal axis of the cavity.
In another embodiment, the hanging tab is planar.
In another embodiment, the hanging tab extends between a first side of the sidewall and an opposing second side of the sidewall.
In another embodiment, the hanging tab comprises:
In another embodiment, a vial is disposed within the cavity of the blinding shell.
In another embodiment, the blinding shell covers all of the vial except for what can be seen through the access opening.
In another embodiment, means are provided for securing the first shell portion to the second shell portion so that a vial can be captured within the cavity of the blinding shell.
In another embodiment, the first shell portion and the second shell portion are hingedly coupled together by a hinge, the hinge comprising a living hinge that is integrally formed as a unitary member with the first shell portion and the second shell portion.
A third independent aspect of the disclosure includes a method for using a vial blinding assembly, the method comprising:
In another embodiment, moving at least one of the first shell portion or the second shell portion comprises a projection forming a portion of the first shell portion being press fit into a coupling hole formed on the second shell portion so that a secure friction fit connection is formed therebetween.
In another embodiment, the coupling hole expands as the projection is received therein.
In another embodiment, the first shell portion and the second shell portion cover all of the vial except for what can be seen through the access opening.
Another embodiment includes shipping the first shell portion and the second shell portion with the vial captured therebetween as part of a blinded study of a liquid trial product disposed within the vial.
In a fourth independent aspect of the disclosure, a method for a vial blinding assembly includes:
Another embodiment includes, suspending the blinding shell by the hanging tab so that the vial is inverted with the septum facing downward.
Another embodiment includes, coupling the hanging tab to an IV stand.
Another embodiment includes, passing a needle through the septum so that the needle communicates with a liquid trial product disposed within the vial, an IV line being fluid coupled with the needle.
Another embodiment includes, administering the liquid trial product to a patient intravenously as part of a blinded study of the liquid trial product.
Another embodiment includes, moving at least one of the first shell portion or the second shell portion comprises a projection forming a portion of the first shell portion being press fit into a coupling hole formed on the second shell portion so that a secure friction fit connection is formed therebetween.
In another embodiment, the blinding shell covers all of the vial except for what can be seen through the access opening.
In a fifth independent aspect of a disclosure, a kit includes:
In another embodiment, the first vial has a different configuration than the second vial.
In another embodiment, the first blinding shell and the second blinding shell are opaque.
Another embodiment includes:
In a sixth independent aspect of the disclosure includes, a method includes:
In another embodiment, the first vial has a different configuration than the second vial.
In another embodiment, the first blinding shell and the second blinding shell are opaque.
In another embodiment:
Another embodiment includes, delivering the first blinding shell housing the first vial and the second blinding shell housing the second vial to a location for administering the liquid trial product in a blinded study.
Each of the above independent aspects may include any of the features, options and possibilities set out in this document, including those under each of the above independent aspects.
Various embodiments of the present disclosure will now be discussed with reference to the appended drawings. It is appreciated that these drawings depict only typical embodiments of the disclosure 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 and kits. In general, the vial blinding assemblies include a vial holding a liquid trial product and a blinding shell that is opaque and selectively covers the vial. The blinding shell can be hinged and can include a mounting tab projecting from a floor thereof to enable the vial to be suspended in an inverted orientation, such as on an IV stand. By suspending the vial inverted, the liquid trial product can be administered to a patient intravenously under the force of gravity. The blinding shell functions to help preclude or limit those receiving or administering the liquid trial product from the vial from detecting any properties of the vial or the liquid trial product contained therein so that the fidelity and efficacy of the blinded study is maintained.
Depicted in
Described in further detail, blinding shell 12A, as shown in
Returning to
As shown in
Mounting hole 38 is configured to receive a hanger so as to enable suspending of vial blinding assembly 10. For example, a hanger 42 can be attached to or be part of an IV stand for suspending vial blinding assembly 10 from the IV stand. Hanger 42 can be a hook, loop, strap, bar, rod, hanger or other structure that can be received within mounting hole 38. Mounting hole 38 can be triangular, circular, polygonal or have other configurations. Commonly, mounting hole 38 will have a maximum diameter that is greater than 4 mm, 6 mm, 8 mm, 13 mm, or 18 mm or is in a range between any two of the foregoing values. Other dimensions can also be used.
Sidewall 22 can be further defined as comprising an annular body 44 that extends between a first end 47 and second end 26. At least a portion of body 44 typically has a cylindrical configuration and bounds or encircles a portion of cavity 18. Sidewall 22 also includes an annular neck 46 that inwardly constricts from first end 47 of body 44 to first end 24/shield wall 28. Neck 46 also bounds or encircles a portion of cavity 18. Outwardly projecting from opposing sides of neck 46 is a first closure tab 48 and an opposing second closure tab 50. Closure tabs 48 and 50 are typically planer and extend along the length of neck 46 from body 44 to shield wall 28. However, it is not necessary that closure tabs 48 and 50 extend along the full length of neck 46. Closure tabs 48 and 50 are typically disposed in a common plane and are typically disposed in a plane that is common with hanging tab 36 and/or passes through central longitudinal axis 21.
As depicted in
Sidewall portion 22A can also be defined as comprising a body portion 44A that extends from first end 47 to second end 26 and that bounds a portion of cavity portion 18A. A neck portion 46A extends from first end 47 to shield wall portion 28A and inwardly constricts as it extends therebetween. Outwardly projecting from opposing sides of neck portion 46A is a closure tab portion 48A and a closure tab portion 50A. Closure tab portions 48A and 50A can be planar and disposed within a common plane.
Shell portion 54B can have the same or substantially the same configuration as shell portion 54A. As such, the same discussion and elements as discussed above with regard to shell portion 54A are likewise applicable to shell portion 54B. Furthermore, like elements between shell portion 54A and 54B are identified by like reference characters except that the reference characters of shell portion 54B include the suffix “B.” In general, each of shell portions 54A and 54B form equal halves of blinding shell 12A. Thus, when shell portions 54A and 54B are coupled together in a closed position, as discussed below in further detail, sidewall portions 22A and 22B combine to form sidewall 22; cavity portions 18A and 18B combine to form cavity 18; shield wall portions 28A and 28B combine to form shield wall 28; notches 30A and 30B combine to form access opening 30; floor portions 32A and 32B combine to form floor 32; hanging tab portions 36A and 36B combine to form hanging tab 36; body portions 44A and 44B combine to form body 44; neck portions 46A and 46B combine to form neck 46; closure tab portions 48A and 48B combine to form closure tab 48; and closure tab portions 50A and 50B combine to form closure tab 50. Furthermore, because shell portions 54A and 54B form equal halves of blinding shell 12A, the prior discussions with regard to sidewall 22, cavity 18, shield wall 28, access opening 30, floor 32, hanging tab 36, body 44, neck 46, closure tab 48, and closure tab 50 is also applicant to their related portions unless self-evident otherwise.
Hinge 56 extends between inside edges 60A and 60B and enables shell portions 54A and 54B to move between an open position, as shown in
In one embodiment of the present disclosure, means are also provided for securing first shell portion 54A to second shell portion 54B in the closed position so that vial 14 is captured therebetween. By way of example and not by limitation, as depicted in
Closure tab portion 48B of second shell portion 54B also has an interior surface 81B and an opposing exterior surface 82B. A projection 86B outwardly projects from interior surface 81B. In the embodiment depicted, projection 86B has a cylindrical body 88B that upstands from interior surface 81B and extends to a rounded perimeter edge 90B. Projection 86B is configured so that when blinding shell 12A is folded toward the closed position, projection 86B aligns with coupling hole 84A. Furthermore, projection 86B is configured relative to coupling hole 84A so that a manual press fit connection can be made between projection 86B and coupling hole 84A. Specifically, the maximum diameter of projection 86B is slightly larger than the height and/or width of coupling hole 84A. As such, as blinding shell 12A is folded together toward the closed position so that projection 86B aligned with coupling hole 84A, projection 86B can be manually press fit into coupling hole 84A so as to move blinding shell 12A into the fully closed position. Pressing projection 86B into coupling hole 84A forces interior surface 85A of coupling hole 84A to outwardly flex or bend so as to form a secure friction fit between projection 86B and interior surface 85A of coupling hole 84A. Rounded perimeter edge 90B of projection 86B enables easy alignment and insertion of projection 86B into coupling hole 84A.
In the present embodiment, the connection of projection 86B into coupling hole 84A does not make a permanent connection. That is, projection 86B can be removed from coupling hole 84A by applying sufficient manual force. However, the press fit connection is sufficient to prevent unintended removal of projection 86B from coupling hole 84A, i.e., prevent unintended movement of blinding shell 12 from the closed position to the open position. However, in some embodiments, pressing projection 86B into coupling hole 84A can produce at least some plastic deformation of interior surface 85A of coupling hole 84A, thereby providing some permanent and visible indication of an initial closing. In other embodiments, the connection between projection 86B and coupling hole 84A can be a permanent connection, i.e., cannot be separated without some permanent deformation or destruction of a portion of blinding shell 12A. For example, this can be accomplished by using an adhesive between projection 86B and coupling hole 84A. In other embodiments, a rib, barb, or other mechanical structure can be formed on projection 86B that mates with a corresponding structure on coupling hole 84A so as to produce a permanent connection between the two members.
It is appreciated that the corresponding sizes and shapes of projection 86B and coupling hole 84A can be modified into a variety of different configurations, i.e., sizes and shapes, that still produce the desired friction fit connection when projection 86B is received within coupling hole 84A. For example, coupling hole 84A could have a circular transvers cross section while projection 86B has a polygonal transverse cross section, such as octagonal with rounded perimeter edge 90B, that is sized so that the desired friction fit connection is formed when the projection is received within the coupling hole. Other complementary configurations can also be used. Although not always required, projection 86B is commonly formed as a solid member, i.e., no pockets or cavities formed thereon, so that projection 86B does not collapse or expand while being pressed into coupling hole 84A.
As depicted in
Furthermore, hanging tab portion 36A has an interior surface 93A and an opposing exterior surface 94A while hanging tab portion 36B has an interior surface 93B and an opposing exterior surface 94B. A projection 86A2 outwardly projects from interior surface 93A on one side of mounting hole 38 while a coupling hole 84A2 extends through interior surface 93A an into an enclosure 80A2 on the opposing side of mounting hole 38. Projection 86A2 and coupling hole 84A2 are configured to make the same press-fit connection with a coupling hole 84B2 and a projection 86B2 that are formed on interior surface 93B of hanging tab portion 36B on opposing sides of mounting hole 38 when shell portions 54A and 54B are moved to the closed position Again, all of the previously discussion alternatives with regard to the projections and coupling holes can be used. It is appreciated that shell portions 54A and 54B can be formed with 1, 2, 3, 4, 5, 6, or more combinations of spaced apart projections 86 and coupling holes 84. The number of projections 86 and coupling holes 84 used is in part dependent upon the size of vial 14 and, in turn, the size of blinding shell 12A. One goal is to have sufficient projections 86 and coupling holes 84 to ensure that there is no accidental separation between shell portions 54A and 54B and to help ensure that shell portions 54A and 54B cannot be easily flexed or bent to enable peeking at vial 14 between shell portions 54A and 54B. In other embodiments, each of projections 86 and coupling holes 84 can be switched between the different shell portions 54A and 54B or all of projection 86 can be formed on one shell portion 54 while all of the coupling holes are formed on the other shell portion 54.
Once blinding shell 12A is moved to the closed position and projections 86 are received within coupling holes 84, one, two, three, or more seals 92, as shown in
In other alternative embodiments, a variety of other structures and techniques can be used for securing first shell portion 54A to second shell portion 54B in the closed position so that vial 14 is captured therebetween. By way of example and not by limitation, projections 86 and coupling holes 84 can be eliminated and be replaced with adhesive, adhesive strips, or other types of fasteners such as clamps, crimps, screws, or the like.
Turning to
Bottle 104 includes a body 114 having a circular floor 116 with cylindrical sidewall 118 upstanding therefrom. Bottle 60 also includes a neck 120 that is constricted relative to sidewall 118. An annular shoulder 122 inwardly slopes from an upper end of sidewall 118 to neck 120. Shoulder 122 inwardly slopes at an angle relative to a central longitudinal axis 124 of bottle 104. Neck 120 terminates at an end face 126. End face 126 encircles an inlet opening 128 that communicates with chamber 110. An annular flange 130 radially outwardly projects from annular neck 120 adjacent to end face 126. Bottle 104 is typically made of glass or serializable plastic and is commonly transparent.
With continued reference to
Stopper 106 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 104. The material for stopper 106 is also selected so that a needle of a syringe can effectively pass through septum 138 for withdrawing a portion of liquid trial product 112 that is housed within bottle 104 and is self-sealing once the needle is withdrawn.
During assembly, stem 144 is advanced into inlet opening 128 until rim portion 137 comes to rest on top of end face 126 of neck 120. In this configuration, exterior surface 146 of stem 144 sits against the interior surface of neck 120 to help effect a seal therebetween. Bottom surface 142 of septum 138 is aligned with and communicates with chamber 110.
Stopper 106 is secured to bottle 104 by retainer 108. Retainer 108 comprises a circular collar 150 having a first end 156 and an opposing second end 158. Collar 150 encircles a cavity 152 that is configured to receive stopper 106 and at least a portion of neck 120 of bottle 104. Retainer 108 further comprises an annular flange 154 that radially inwardly projects from second end 158 of collar 150. Flange 154 terminates an inner face 160 that encircles an aperture 162. Retainer 64 is generally formed from a bendable material, such as a metal, and is typically formed from aluminum.
During assembly, stopper 106 is positioned on bottle 104 so as to cover inlet opening 128, as discussed above. Retainer 108 is then advanced over stopper 106. Specifically, collar 150 is advanced over stopper 106 and over flange 130 of bottle 104 until flange 154 of retainer 108 rests on top of stopper 106 and first end 156 of collar 150 extends below flange 130 of bottle 104. Retainer 108 is then crimped onto bottle 104 by radially inwardly bending first end 156 of collar 150 below flange 130 of bottle 104. This crimping of retainer 108 functions to compress stopper 106 against end face 126 of bottle 104 to produce a liquid tight seal therebetween and also prevents manual separation of retainer 108 and stopper 106 from bottle 104 without the use of a tool or at least partial destruction of retainer 108. The crimping of retainer 108 is typically achieved by a crimper that is passed over retainer 108 and then manipulated to radially inwardly compress first end 156 of collar 150. Such crimpers are known in the art.
In the assembled configuration, top surface 140 of septum 138 is openly exposed through aperture 162 of retainer 108. When it is desired to access liquid trial product 112 within vial 14, a needle can be passed through septum 138 and into chamber 110 of bottle 104 to withdraw a portion of liquid trial product 112.
It is appreciated that retainer 108 can have a variety of different configurations and can be used in a variety of different ways and still function to secure stopper 106 to bottle 104. By way of example and not by limitation, in contrast to being crimped onto bottle 104, retainer 108 could be formed to produce a snap-fit connection with bottle 104 or could be formed in two halves that are clamped together about neck 120. In still other embodiments, the retainer could be attached by adhesive, press fit, or constriction under heating, e.g., shrink wrapping. It is also appreciated that stopper 106 and vial 14 can have different configurations, i.e., sizes and shapes.
As previously noted, in general, vial 14 is configured to fit within cavity 18 of blinding shell 12A so that vial 14 is housed or captured within cavity 18 of blinding shell 12A when blinding shell 12A is moved into the closed position. More specifically, vial 14 typically has a configured that is generally complementary to cavity 18 so that there is minimal movement or play of vial 14 relative to blinding shell 12A when blinding shell 12A is in the closed position. For example, with reference to
As previously discussed, one of the objectives of blinding shell 12A is to cover vial 14 as part of a blinded study so that the patient receiving the liquid trial product 112 and/or the person administering the liquid trial product 112 are unable to see vial 14 or liquid trial product 112. The coving of vial 14 limits the ability of the patient and/or person administering to deduce or attempt to deduce any properties or changes in liquid trial product 112, thereby improving the efficacy and fidelity of the blinded study. To that end blinding shell 12A is opaque. This can be accomplished by either forming blinding shell 12A from an opaque material or by applying an opaque coating or covering, 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 12A is blacked out. In one embodiment, blinding shell 12A is 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 12A can be formed from a metal, fiberglass, composite or the like.
It is typically preferred that blinding shell 12A cover as much of vial 14 as possible while still permitting withdrawal of liquid trial product 112 through septum 138. Accordingly, as shown in
To facilitate use of blinding shell 12A in a blinded study, blinding shell 12A is moved to the open position, as shown in
During administering of liquid trial product 112, vial blinding assembly 10/blinding shell 12/vial 14 can be suspended in an inverted position so that septum 138 of vial 14 and shield wall 28 are facing downward and hanging tab 36 is projecting upward. In one method of suspending, hanger 42 or some other structure is secured to hanging tab 36 by passing through mounting hole 38 and is then connected to a stand, such as an IV stand, or some other support structure. In other methods, a portion of the stand, such as an IV stand, or other support structure forms hanger 42 and is directly passed through mounting hole 38 to suspend vial blinding assembly 10/blinding shell 12/vial 14 in the inverted position. In yet other embodiments, clamps, clips, or other fasteners can be used to couple hanging tab 36, with or without passing through mounting hole 38, to a stand or other supporting structure. As such, in some embodiments, mounting hole 38 can be eliminated from hanging tab 36.
Either prior to or after suspending blinding assembly 10/blinding shell 12/vial 14 in the inverted position, a needle 166 connected to an IV line 168 is passed through access opening 30 and exposed septum 138 so as to access liquid trial product 112. The IV line 168 can then be fluid coupled to a patient using conventional methods for intravenous delivery of liquid trial product 112 to the patient under the force of gravity.
Although vial 14 is disposed within blinding shell 12 that is specifically adapted for suspending vial 14 in an inverted orientation, it is not necessary that liquid trial product 112 be delivered intravenously. For example, liquid trial product 112 can also be dispensed through a syringe by simply passing the needle of the syringe through septum 138, drawing a portion of liquid trial product 112 into the syringe through the needle, withdrawing the needle from septum 138, and then delivering the withdrawn liquid trial product 112 to the patient by either injecting the liquid trial product 112 into the patient using the syringe or using other conventional delivery methods. Where a syringe is being used, it is not necessary to suspend blinding assembly 10/blinding shell 12A; vial 14 in an inverted position.
In some situations, it may be necessary to administer liquid trial product 112 to a patient from vials having different configurations, i.e., different sizes and/or shapes. For example, different suppliers of liquid trial product 112 may use vials of different configurations, different types of liquid trial product 112 may be stored in vials of different configurations, or a single supplier may switch vial configurations between the production of different batches of liquid trial product 112. Other causes may also exist for the need to administer liquid trial product 112 to a patient from vials of different configurations. Although the liquid trial product 112 may be administered to a patient from vials of different configurations, in some blinded studies it may be preferred that the patient and/or the administering person not be able to discern that the vials have different configurations. To this end, blinding shells can be formed that have internal cavities of different configurations, i.e., different sizes and/or shapes, to accommodate vials of different configurations, but have exterior surfaces with identical configurations. For example, depicted in
Also shown in
However, from the outside, as depicted in
Although
In view of the above, in one embodiment a kit can be provided that includes blinding shell 12A having cavity 18 and vial 14 disposed therein and that also includes blinding shell 12B having cavity 18 and vial 14A disposed therein. In the kit, cavities 18 and vials 14 and 14A of blinding shells 12A and 12B each have different configuration. However, the exteriors of blinding shells 12A and 12B are identical. The kit can also include at least 3, 4 or more additional blinding shells having a cavity with a vial disposed therein wherein the cavities and vials can be the same or different configurations. Again, however, the exteriors of each of the blinding shells are identical. The kit can be shipped or transported to a patient, medical facility or administering person for dispensing the liquid trial product 112 contained within the vials to a patient as part of a blinded study. Where the blinding shells and vials are being shipped in a disassembled state, the kit can comprise two or more blinding shells having cavities of different configurations and two or more vials having different configurations wherein the vials are configured to be received within the cavities of corresponding blinding shells and wherein the exterior of all of the blinding shells have the same configuration.
A method is also provided that includes inserting vial 14 within cavity 18 of blinding shell 12A and inserting vial 14A within cavity 18 of blinding shell 12B where the cavities and vials are of different configurations. However, the exteriors of blinding shells 12A and 12B are identical. At least 3, 4, or more additional vials can be inserted within blinding shells where the cavities thereof and vials are of the same or different configurations. Again, however, the exteriors of each of the blinding shells are identical. In one method, the now assembled vial blinding assemblies can now be administered to a patient as part of a blinded study. In other methods, either in combination or sequentially, blinding shells 12A and 12B with vials 14 and 14A therein can then be sent to a patient, medical facility, or administering person for dispensing the liquid trial product 112 contained within the vials to a patient as part of a blinded study. The blinding shells with vials can be sent to the same patient, medical facility or administering person or to different patients, medical facilities or administering persons.
Depicted in
Blinding shell 12C also differs from blinding shell 12A in that closure tab portions 48A and 48B have been replaced with modified closure tab portions 178A and 178B that combine to form a closure tab 178. Closure tab portions 178A and 178B differ from closure tabs 48A and 48B by extending along the length of sidewall 22 and body 44 and also by extending outward beyond exterior surface 20 of body 44. That is, with the removal of hanging tab 36, there is no longer a mechanism for securing together second end 26 shell portions 54A and 54B of blinding shell 12C. As such, closure tab portions 178A and 178B are added and configured so that projections 86 and coupling holes 84 can be formed thereon, respectively, at second end 26. As such, as blinding shell 12C is moved to the closed position so as to enclose a vial 14 therein, the opposing ends of blinding shell 12C can be secured together using the press fit connections as previously discussed. As needed, any number of projections 86 and coupling holes 84 can be formed along the length of closure tab portions 178A and 178B. Again, once blinding shell 12C is moved to the closed position, one or more seals 92 can be applied that extend between shell portions 54A and 54B, such as between closure tab portions 178A and 178B. All previously discussed alternatives for projections 86 and coupling holes 84 discussed above with regard to blinding shell 12A are also applicable to blinding shells 12B and 12C.
It is appreciated that vial blinding assemblies and blinding shells, along the alternatives thereof and the components thereof, as discussed herein, have unique and beneficial advantages. For example, the blinding shells are easy and relatively inexpensive to produce and can be securely attached with minimal effort. Furthermore, the blinding shells are opaque and fully cover the vial, except for the septum and potentially a small adjacent area. As such, the blinding shells are highly effective in blinded studies in that they preclude any visual exposure of the liquid trial product being tested and substantially preclude visual expose of the vial. In particular, embodiments of the blinding shell are effective at covering the retainer that secures the stopper and, more particularly, the flange or terminal end face of the retainer that encircles the aperture through which the septum of the stopper is accessed.
Embodiments of the blinding shell are also unique in that they include a hanging tab which enables easy inverted suspension of the vial for intravenous delivery of the liquid trial product. Finally, embodiments of the blinding shells can be produced with cavities of different configurations for holding vials of different configurations but have identical exterior configurations. This design helps to ensure that patients and/or those who are administering are unable to detect whether vials of different configurations are being used and thus help to improve the fidelity and efficacy of the blinded studies. Other benefits and advantages also exist.
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 of U.S. Provisional Application No. 62/952,682, filed Dec. 23, 2019, which is incorporated herein by specific reference.
| Number | Date | Country | |
|---|---|---|---|
| 62952685 | Dec 2019 | US |
