Patent Grant
11957866
The present invention relates to blinding caps used to cover rigid needle shields and to syringe assemblies that incorporate such blinding caps.
Clinical trials for some pharmaceutical drugs require that the drug dosage and corresponding placebo dosage be delivered in a blinded study through the use of pre-filled syringes. Each syringe comprises a syringe barrel that houses the dosage, a needle projecting from the syringe barrel, and a plunger rod with correspond stopper that is used to dispense the dosage out of the syringe barrel through the needle. For safety reasons, a rigid needle shield is removable attached to the syringe barrel and covers the needle when the syringe is not in use. At the time of injection, the rigid needle shield is simply pulled off of the syringe barrel to expose the needle.
As part of the protocols for the blinded study, a plurality of syringes are each preloaded with a single dose of the drug, comparator or placebo prior to shipping for use. The syringe barrels are typically blacked out so that the recipient and person delivering the dosage are blind as to any visual properties of the dosage. This is particularly helpful in avoiding any perceived distinctions between the drug and either the comparator, the placebo or both.
Although blacking out the syringe barrels is helpful in avoiding any detection or believed detection as to a quality of a dosage or differences between dosages, the syringes are often filled at different facilities and/or in different batches. Because rigid needle shields are not standardized, syringes filled at different facilities or in different batches may have rigid needle shields that have different appearances. For example, rigid needle shields may differ based on configuration, size, and/or color. Perceived differences in rigid needle shields by a recipient may be an indication to the recipient as to differences in the dosages. Furthermore, even if there are no differences in the dosages being delivered, such perceived differences in rigid needle shields may cause the recipient to believe that there are differences in the dosages being delivered Eliminating the ability of both the recipient and the person delivering a dosage to determine differences in the dosages or to believe that there are differences in the dosage can be vital to the efficacy and fidelity of the clinical trial.
Accordingly, what is needed in the art are syringe assemblies and parts thereof that overcome all or some of the above shortcomings.
In a first independent aspect of the present invention, a blinding cap is provided for covering a rigid needle shield that is covering a needle of a syringe, the blinding cap comprising:
In one embodiment, the flange is configured so that when the blinding cap covers a rigid needle shield that covers a needle, the flange is disposed proximally behind a proximal end face of the rigid needle shield for use in removing the rigid needle shield from off the needle.
In another embodiment, the chamber has a cylindrical configuration.
In another embodiment, the chamber is completely enclosed except for the opening that communicates with the chamber.
In another embodiment, the body has an exterior surface with a cylindrical configuration.
In another embodiment, the sleeve and the body share a common central longitudinal axis.
In another embodiment, the channel has a cylindrical configuration.
In another embodiment, the sleeve has an exterior surface with a cylindrical configuration.
In another embodiment, the chamber and the channel share a common central longitudinal axis.
In another embodiment, the first flange is annular and the opening centrally extends therethrough.
In another embodiment, a second flange radially inwardly projecting from the body into the chamber, the second flange being spaced apart from the first flange.
In another embodiment, the body includes:
In another embodiment, the first flange radially inwardly projects from the proximal end wall or the sidewall.
In another embodiment, the sleeve projects proximally away from the proximal end wall.
In another embodiment, the chamber of the body has a diameter and the channel of the sleeve has a diameter, the diameter of the chamber being larger than the diameter of the channel.
In another embodiment, the body has an outer diameter and the sleeve has an outer diameter, the outer diameter of the body being larger than the outer diameter of the sleeve.
In another embodiment, the body and the sleeve are opaque.
In another embodiment, the blinding cap further includes:
In another embodiment, the blinding cap further includes:
In another embodiment, the first cap portion and the second cap portion are separate and discrete members.
In another embodiment, the first cap portion and the second cap portion are connected together by a hinge.
In another embodiment, the first cap portion and the second cap portion are connected together by a living hinge and are formed as single integral continuous member.
In another embodiment, the means for securely coupling together the first cap portion and the second cap portion comprises a projection extending from first cap portion and a recess formed on the second cap portion, the recess being configured to receive the projection so as to secure the first cap portion to the second cap portion.
In another embodiment, the blinding cap further includes:
In another aspect of the present invention, a syringe assembly includes:
In a second independent aspect of the present invention, a syringe assembly includes:
In one embodiment, the cavity is recessed into the rigid needle shield through the proximal end face.
In another embodiment, the blinding cap includes:
In another embodiment, a slot is formed between a proximal end face of the rigid needle shield and a portion of the distal end of the syringe, the flange being received with in the slot.
In another embodiment, the blinding cap completely encircles the rigid needle shield.
In another embodiment, the blinding cap is opaque.
In another embodiment, the blinding cap further includes an annular sleeve projecting from the proximal end of the body, the sleeve encircling a portion of the distal end of the syringe barrel.
In another embodiment, the sleeve has an outer diameter and the body has an outer diameter, the outer diameter of the body being larger than the outer diameter of the sleeve.
In another embodiment, the flange is annular and bounds a central opening.
In another embodiment, the blinding cap includes:
In another embodiment, the first cap portion and the second cap portion are separate and discrete members.
In another embodiment, the first cap portion and the second cap portion are connected together by a hinge.
In another embodiment, the first cap portion and the second cap portion are connected together by a living hinge and are formed as single integral continuous member.
In another embodiment, the syringe assembly further includes:
In another embodiment, the means for securely coupling together the first cap portion and the second cap portion comprises a projection extending from first cap portion and a recess formed on the second cap portion, the recess being configured to receive the projection so as to secure the first cap portion to the second cap portion.
The second aspect of the invention may include any of the features, options and possibilities set out elsewhere in this document, including in the above first aspect and in later discussed aspects.
In a third independent aspect of the present invention, a method for assembling a syringe assembly includes:
In another embodiment, the blinding cap covers at least a portion of the distal end of the syringe barrel.
In another embodiment, the blinding cap includes:
In another embodiment, the method further includes attaching a seal that extends between the blinding cap and the syringe barrel.
In another embodiment, the method further includes pulling the blinding cap distally relative to the syringe barrel so that the portion of the blinding cap engages against the proximal end face of the rigid needle shield and separates the rigid needle shield from the syringe barrel.
The third aspect of the invention may include any of the features, options and possibilities set out elsewhere in this document, including in the above first and second aspect and in later discussed aspects.
In a fourth independent aspect of the present invention, a method for assembling a syringe assembly includes:
In another embodiment, the rigid needle shield is disposed within the blinding cap as the rigid needle shield is separated from the syringe barrel.
In another embodiment, the step of securing the blinding cap comprises sandwiching the rigid needle shield between two portions of the blinding cap.
In another embodiment, the step of securing the blinding cap comprises blinding cap covering at least a portion of the distal end of the syringe barrel.
In another embodiment, the blinding cap includes:
The fourth aspect of the invention may include any of the features, options and possibilities set out elsewhere in this document, including in the above first, second, and third aspects.
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 particularly exemplified apparatus, systems, methods, or process parameters that 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 invention, and is not intended to limit the scope of the invention in any manner.
All publications, patents, and patent applications cited herein, whether supra or infra, are hereby incorporated by reference in their entirety to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.
The term “comprising” which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps.
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 a “flange” includes one, two, or more flanges.
As used in the specification and appended claims, directional terms, such as “top,” “bottom,” “left,” “right,” “up,” “down,” “upper,” “lower,” “proximal,” “distal” and the like are used herein solely to indicate relative directions and are not otherwise intended to limit the scope of the invention or claims.
Where possible, like numbering of elements have been used in various figures. Furthermore, multiple instances of an element and or sub-elements of a parent element may each include separate letters appended to the element number. For example two instances of a particular element “10” may be labeled as “10A” and “10B”. In that case, the element label may be used without an appended letter (e.g., “91”) to generally refer to instances of the element or any one of the elements. Element labels including an appended letter (e.g., “10A”) can be used to refer to a specific instance of the element or to distinguish or draw attention to multiple uses of the element. Furthermore, an element label with 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. Likewise, an element label with an appended letter can be used to indicate a sub-element of a parent element. For instance, an element “12” can comprise sub-elements “12A” and “12B.”
Various aspects of the present devices and systems may be illustrated by describing components that are coupled, attached, and/or joined together. As used herein, the terms “coupled”, “attached”, 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”, and/or “directly joined” to another component, there are no intervening elements present. Furthermore, as used herein, the terms “connection,” “connected,” and the like do not necessarily imply direct contact between the two or more elements.
Various aspects of the present devices, systems, and methods may be illustrated with reference to one or more examplary embodiments. As used herein, the term “embodiment” means “serving as an example, instance, or illustration,” and should not necessarily be construed as preferred or advantageous over other embodiments disclosed herein.
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. Although a number of methods and materials similar or equivalent to those described herein can be used in the practice of the present disclosure, the preferred materials and methods are described herein.
In general, the present invention is directed to syringe assemblies and blinding caps that form part of the syringe assemblies. The blinding cap coves a rigid needle shield coupled to a syringe as part of a blinded testing protocol. Specifically, the blinding cap covers the rigid needle shield and, in some embodiments, a distal end of a syringe barrel so as to prevent a patient and a person delivering a dosage from discerning differences between rigid needle shields. Discerning differences in rigid needle shields could cause the patient to determine differences in dosages being administered or to be believe that there are differences in the dosages being administered, thereby influencing the results of the blinded study. The blinding cap also assists in removal of the rigid needle shield from the syringe.
Depicted in
Projecting from body 20 at distal end 28 is an elongated stem 34. Stem 34 has a transverse cross section with a diameter that is smaller than a diameter of the transverse cross section of body 20. As discussed below, stem 34 is configured to receive and engage needle shield 8. Syringe barrel 12, or at least body 20, is typically made of a transparent or semi-transparent material such as clear plastic or glass. In this embodiment, however, syringe barrel 12 is blacked out, i.e., made opaque, so that the liquid dosage cannot be seen through syringe barrel 12. This can be accomplished by applying a layer, coating, or structure over syringe barrel 12. For example, syringe barrel 12 could be painted or a printing could be applied. In other embodiments, an adhesive layer, wrap, or some other structure could be placed over syringe barrel 12. Other approaches can also be used so that syringe barrel 12 is blacked out. In other embodiments, syringe barrel 12 can be made of an opaque material.
Projecting from stem 34 of syringe barrel 12 along a central longitudinal axis 37 of body 20 is a tubular needle 36. Needle 36 has a proximal end 33 that communicates with compartment 30 of syringe barrel 12 and an opposing distal end 35 that terminates at a sharpened tip 38. Needle 36 is typically made of metal. In the embodiment depicted, needle 36 is permanently attached to syringe barrel 12, such as by being molded into stem 34 or by being attached by an adhesive. In alternative embodiments, needle 36 can be removably and/or mechanically attached to stem 34 or the combination of needle 36 and stem 34 can be removably and/or mechanically attached to body 20. For example, stem 34 and needle 36 can be formed with complementary halves of a luer-lock or snap-fit connection that permits fluid coupling therebetween. Other types of fluid connections can also be used.
Needle shield 8 has a proximal end 40 that terminates at a proximal end face 41 and an opposing distal end 42 that terminates at a distal end face 48. Needle shield 8 has an interior surface 43 that bounds a cavity 44. An opening 45 is formed on proximal end face 41 that communicates with cavity 44. Expressed in other terms, cavity 44 is recessed into needle shield 8 through proximal end face 41. Cavity 44 is configured to receive needle 36 and at least a portion of stem 34 so that a releasable friction tight engagement is formed between interior surface 43 and stem 34.
When needle shield 8 is attached to syringe barrel 12 by the friction tight engagement, needle 36 is safely enclosed within cavity 44. Needle shield 8 typically has a portion comprised of a rigid plastic that prevents needle 36 from puncturing therethrough and a more flexible or elastomeric portion that engages with stem 34. Needle shield 8 is selectively removed from syringe barrel 12 by simply pulling needle shield 8 distally relative to syringe barrel 12. In alternative embodiments, a mechanical connection can be used to secure needle shield 8 to syringe barrel 12. For example, needle shield 8 and stem 34 can be formed with complementary halves of a luer-lock connection that permit coupling therebetween. In this embodiment, needle shield 8 is removed by first rotating needle shield 8 relative to syringe barrel 12 and then pulling needle shield 8 distally relative to syringe barrel 12. Other types of connection can also be used.
Slidably disposed within compartment 30 of syringe barrel 12 is a stopper 14. Stopper 14 has an annular side face 50. Encircling and radially outwardly projecting from side face 50 are one or more lip seals 56. Lip seals 56 maintain a liquid tight seal against interior surface 22 of syringe barrel 12 as stopper 14 longitudinally moves within compartment 30. Accordingly, as stopper 14 advances towards distal end 28 of syringe barrel 12, the liquid dosage within compartment 30 is dispensed out through needle 36. Stopper 14 is typically comprised of an elastomeric material that enables a slidable, sealed engagement between stopper 14 and syringe barrel 12. Other materials that will achieve the desired functional operation can also be used.
A plunger rod 16 comprises an elongated shaft 62 that extends between a proximal end 64 and an opposing distal end 66. Disposed at proximal end 64 of shaft 62 is a thumb rest 68. Distal end 66 is coupled with stopper 14. Plunger rod 16 is typically molded from a polymeric material, but other materials can also be used. By manually pressing on thumb rest 68, plunger rod 16 and stopper 14 are advanced distally within syringe barrel 12 which in turn causes the liquid dosage within compartment 30 to dispense out through needle 36.
As previously mentioned, blinding cap 10 can be used for both covering needle shield 8 and assisting in the removal of needle shield 8 from syringe 6. Blinding cap 10 can also be used for covering at least a portion of distal end 28 of syringe barrel 12. Blinding cap is shown in
Body 90 is further described as having a sidewall 102 that extends between a proximal end 104 and distal end 76. Sidewall 102 is annular and has an interior surface 106 that encircles chamber 96 and an opposing exterior surface 108. Disposed at distal end 76 of sidewall 102 is a distal end wall 110. A proximal end wall 112 is formed at proximal end 104 of sidewall 102. Chamber 96 is at least partially bounded by sidewall 102, distal end wall 110, and proximal end wall 112. In the depicted embodiment, chamber 96 has a cylindrical configuration that is sized to receive needle shield 8. However, other configurations that will receive needle shield 8 can also be used. Body 90 and sidewall 102 are also depicted as having a cylindrical configuration. Again, other configurations can also be used.
Sleeve 92 outwardly projects from proximal end wall 112. More specifically, sleeve 92 is typically centered on proximal end wall 112 so that chamber 96 and channel 100 share a common central longitudinal axis 114. Channel 100 is configured to receive at least a portion of distal end 28 of syringe barrel 12/body 20 (
In one embodiment of the present invention, a flange radially inwardly projects from body 90 into chamber 96 at proximal end 104. In the depicted embodiment, annular flange 84 (
Turing to
Described in further detail, first body portion 120A comprises a first sidewall portion 124A having interior surface 106 and exterior surface 108 that extend longitudinally between proximal end 104 and distal end 76. First sidewall portion 124A has a semi-cylindrical configuration that extends laterally between a first edge 126A and an opposing first edge 128A. Edges 126A and 128A also extend longitudinally between proximal end 104 and distal end 76. First body portion 120A further includes a first distal end wall portion 130A at distal end 76 and a first proximal end wall portion 132A at proximal end 104. Projecting proximally from first proximal end wall portion 132A is a first sleeve portion 134A having interior surface 98 that bounds a first channel portion 136A. First sleeve portion 134A and first channel portion 136A are each depicted has having a semi-cylindrical configuration. Again, other configurations can also be used. A first flange portion 138A radially inwardly projects from first proximal end wall portion 132A into first chamber portion 122A.
Except as discussed below, in the depicted embodiment second cap portion 70B has the same configuration and structural elements at first cap portion 70A. As such, the above prior discussion of parts, configuration, elements and alternatives of first cap portion 70A are applicable to second cap portion 70B. Like elements between first cap portion 70A and second cap portion 70B are identified by like reference characters except that all corresponding reference characters on second cap portion 70B includes the suffix “B” as opposed to “A”. Furthermore, the prefix “first” used in association with the named parts of first cap portion 70A is changed to “second” in association with the corresponding named parts of second cap portion 70B. For example, second cap portion 70B includes a second body portion 120B that bounds a second chamber portion 122B. Second body portion 120B comprises a second sidewall portion 124B having a semi-cylindrical configuration that extends laterally between a second edge 126B and an opposing second edge 128B. Second body portion 120B further includes a second distal end wall portion 130B at distal end 76 and a second proximal end wall portion 132B at proximal end 104. Projecting proximally from second proximal end wall portion 132B is a second sleeve portion 134B that bounds a second channel portion 136B. A second flange portion 138B radially inwardly projects from first proximal end wall portion 132B into second chamber portion 122B.
In one embodiment of the present invention, means are provided for securely coupling together first cap portion 70A and second cap portion 70B to form the assembled blinding cap 10. By way of example and not by limitation, an elongated rib 144A outwardly projects from and along the length of first edge 126A of first sidewall portion 124A of first cap portion 70A. Rib 144A has an inside face 146 facing towards first chamber portion 122A and an opposing outside face 148.
A detent 150 outwardly projects from outside face 148. In this embodiment, detent 150 is elongated and extends along the length of outside face 148. A rib 144B also outwardly projects from and extends along the length of first edge 128A of sidewall portion 124A. Rib 144B can be the same size and configuration as rib 144A and can include detent 150 on an outside face thereof. In the current embodiment, however, rib 144B is shorter in height than rib 144A and does not include detent 150.
In contrast to outwardly projecting ribs 144 on first cap portion 70A, corresponding elongated notches are formed on the second cap portion 70B and are configured to receive ribs 144A and 144B. Specifically, a first notch 156A is recessed into second edge 128B along interior surface 94. First notch 156A is elongated and is complimentary to and configured to receive first rib 144A. First notch 156A is bounded by an inside face 162 having an elongated slot 160 formed thereon that is configured to receive detent 150.
A second notch 156B is formed into edge 126B along interior surface 94. Notch 156B is likewise elongated and is complimentary to and configured to receive second rib 144B. During assembly cap portions 70A and 70B are securely together by advancing ribs 144A and 144B into notches 156A and 156B, respectively, so as to form blinding cap 10. As a result of detent 150 fitting into slot 160, cap portions 70A and 70B are securely snap-fit together, thereby preventing any unintentional separation.
It is appreciated that ribs 144 and notches 156 are only one example of means for securely coupling together first cap portion 70A and second cap portion 70B and that a variety of other securing mechanism can also be used. By way of example and not by limitation, in one alternative embodiment, one of the ribs 144 from cap portion 70A and one of the notches 156 from cap portion 70B could be switched so that each cap portion 70 has one notch and one rib. In another alternative, detent 150 and slot 160 can have a variety of different configurations. For example, one or more detents having a circular, polygonal or other configuration can be received within a recess having a complementary configuration for producing a snap-fit configuration. Furthermore, it is appreciated ribs 144 and notches 156 are only one example of projections and complementary recesses that can be used for coupling together cap portions 70A and 70B. In other embodiments, other configurations of projections and recesses can be used. For example, complementary barbs and sockets or complementary pegs and sockets can be used. Furthermore, one or more pawls could be formed on one of cap portions 70 while one or more teeth could be formed on a corresponding location of the other cap portion so as to form a ratchet that couples cap portions 70A and 70B together.
In another alternative, an adhesive can be used to secure cap portions 70A and 70B together. In yet another alternative embodiment, one or more fasteners such as a screw, spike, pin, or staple could be advanced through a portion of cap portions 70A and 70B to secure them together. In one embodiment, cap portions 70A and 70B could be configured to be mechanically press fit together. In still another embodiment, a fastener could be place around a portion of the assembled cap portions 70A and 70B to securely hold them together. For example, a clamp, crimp, tape, shrink wrap, pull tie, or the like could be secured around assembled cap portions 70A and 70B. Other mechanisms can also be used for securely coupling together first cap portion 70A and second cap portion 70B to form the assembled blinding cap 10.
Blinding cap 10 is typically molded from a plastic material although other materials can also be used. Blinding cap 10 is opaque so that needle shield 8 cannot be seen through blinding cap 10. In one embodiment, the material used to make blinding cap 10 can be opaque. In another embodiment, the material used to make blinding cap 10 to be translucent or semi-translucent but a covering, coating, tape, etching, printing, painting or other material, structure or process can be used is make blinding cap 10 opaque.
Turning to
Next, cap portion 70B is coupled with cap portion 70A, as discussed above, so that needle shield 8 and distal end 28 of syringe barrel 12 are captured and enclosed between cap portions 70A and 70B which now form blinding cap 10. More specifically, with reference to
In this assembled configured, needle shield 8 is completely covered by the combination of blinding cap 10 and syringe barrel 12 so that neither a patient nor others handling syringe assembly 4 can discern differences based on needle shield 8. Sleeve 92 can serve a couple of different functions. For example, sleeve 92 helps to cover/hide proximal end face 41 of needle shield 8. However, sleeve 92 also helps to cover/hide distal end 28 of syringe barrel 12 and, more specifically, stem 34 and the distal end of body 20. Different syringes may have different configurations and different couplings between syringe barrel 12 and needle 36 (
It is noted that needle shield 8 can be freely disposed within chamber 96 of blinding cap 10 so that rotation of blinding cap 10 relative to syringe barrel 12 does not facilitate rotation of needle shield 8 or at least does not facilitate complete concurrent rotation needle shield 8. For example, the inner diameter of chamber 96 can be larger than the outer diameter needle shield 8 so that needle shield 8 does not directly contact sidewall 102 of body 90. More specifically, needle shield 8 and sidewall 102 of body 90 can be spaced apart by an open space having a distance that is at least or less then 1 mm, 2 mm, 3 mm or 5 mm or is in a range between any two of the foregoing. One of the benefits of having chamber 96 larger than needle shield 8 is that blinding cap 10 can be easily secured over a variety of different sizes and shapes of needle shields without risk of interference by the needle shields. Alternatively, needle shield 8 can bias or sit directly against sidewall 102 of body 90. Needle shield 8 can also be securely held within chamber 96 of blinding cap 10 so that rotation of blinding cap 10 relative to syringe barrel 12 causes concurrent rotation of needle shield 8. This can be caused by direct frictional engagement between needle shield 8 and sidewall 102 of body 90. Alternatively, to help facilitate engagement between blinding cap 10 and needle shield 8, a flexible material, adhesive or the like can be positioned within chamber 96 of blinding cap 10 that will ensure a secure frictional engagement or adhesive engagement between sidewall 102 of blinding cap 10 and needle shield 8 when needle shield 8 is disposed within chamber 96.
With reference to
To administer the dosage within syringe 6, seal 172 is first broken by manually rotating syringe barrel 12 and blinding cap 10 in opposite directions or rotating one while the other is held stationary. This rotation causes seal 172 to tear along perforation line 174. Next, once seal 172 is broken, blinding cap 10 is pulled distally relative to syringe 6/syringe barrel 12. In so doing, flange 84 (
It is appreciated that seal 172 is optional and can be eliminated. For example, where no seal 172 is used and it is desired to administer the dosage within syringe 6, blinding cap 10, as shown in
It is appreciated that blinding cap 10 can have a variety of different configurations. For example, it is not necessary that body 90 and sleeve 92 have a cylindrical configuration. In alternative embodiments, each could have a transverse cross section that is elliptical, oval, polygonal or have other configurations. Furthermore, in the above discussed embodiment, with reference to
Depicted in
Depicted in
Depicted in
Because sleeve 92A of blinding cap 10C will step out from syringe barrel 12 during use, a different configuration and placement of a seal can be used, if desired. For example, in contrast to using seal 172 (
Depicted in
Depicted in
Hinge 182 is depicted as a living hinge that is concurrently molded with cap portions 70A and 70B so that cap portions 70A and 70B and hinge 182 form a single, continuous, unitary member as opposed to separate member that are connected together. However, in other embodiments alternative hinge configurations can be used. Furthermore, in the depicted embodiment, hinge 182 is a single hinge that extends along the length of first sidewall portion 124A and second sidewall portion 124B.
In an alternative embodiment, two or more spaced apart hinges can be formed along first sidewall portion 124A and second sidewall portion 124B. For example, depicted in
In a further alternative embodiment, in contrast to forming hinge 182 or hinges 182A and 182B between first sidewall portion 124A and second sidewall portion 124B, hinge 182 or hinges 182A and 182B could also be formed between first distal end wall portion 130A and second distal end wall portion 130B.
Finally, depicted in
The present invention 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. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.
This application is a continuation of U.S. application Ser. No. 16/261,200, filed Jan. 29, 2019, which claims the benefit of Provisional Application No. 62/627,418, filed Feb. 7, 2018, which are incorporated herein by specific reference.
| Number | Name | Date | Kind |
|---|---|---|---|
| 8998855 | Hudson et al. | Apr 2015 | B2 |
| 9545480 | Hunkeler et al. | Jan 2017 | B2 |
| 11077242 | Locati | Aug 2021 | B2 |
| 20120238961 | Julian | Sep 2012 | A1 |
| 20130204197 | Bicknell et al. | Aug 2013 | A1 |
| 20130281938 | Ekman et al. | Oct 2013 | A1 |
| 20150238704 | Evans et al. | Aug 2015 | A1 |
| 20160144122 | Locati et al. | May 2016 | A1 |
| Entry |
|---|
| European Search Report dated Jul. 15, 2019, issued in European Application No. 19155429.4, filed Apr. 9, 2019. |
| Number | Date | Country | |
|---|---|---|---|
| 20210308363 A1 | Oct 2021 | US |
| Number | Date | Country | |
|---|---|---|---|
| 62627418 | Feb 2018 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16261200 | Jan 2019 | US |
| Child | 17354435 | US |
