The disclosure relates generally to a winged capsule device with improvements to better withstand drop impact at cold conditions and geometric stress during bending.
Kexxtone is a controlled release formulation of monensin (as monensin sodium) contained in a plastic capsule equipped with retaining wings. Slowly releasing monensin from an opening at the distal end of the capsule, the capsule will remain effective for an average of 95 days after administration in lactating dairy cattle. The capsule can also be used to dispense other formulations, which may have shorter or longer administration periods, for example in the range of 30-180 days.
To administer monensin, the wings of the winged capsule are folded down along the body of the capsule and then placed in an administration tool. The administration tool containing the winged (folded) capsule is introduced into the animal's mouth, then the administration tool is triggered by pressing a plunger to expel the winged capsule into the pharynx of the animal. The capsule then passes through the esophagus and into the reticulorumen, at which time the wings, which are flexible and resilient, expand to keep the winged capsule in the reticulorumen and prevent regurgitation of the winged capsule by the animal.
The wings are flexible and resilient to enable insertion and self-expansion, and to maintain the capsule in position while also preventing tissue damage. The capsule has a rounded top, or dome, and the wings are attached to the center of the dome. The rounded shape of the dome along a plane traversing the wings, or folding plane, facilitates folding of the wings, therefore the attachment surface, or joint, maintaining a small profile suitable for insertion into the pharynx. The joint may comprise a small amount of material forming a neck between the wings and the surface of the dome.
After manufacture, multiple winged capsules are placed inside packaging, typically a bag. It has been found that in the process of packaging the winged capsule and transporting the bags, wings might bend near the joint past the point of material yield, at which point they no longer recover their functional shape. The bent wings might also break and separate from the bolus. Further, the winged capsules may be subjected to cold conditions during shipping and handling (for example, −20° C. to 0° C.) and as a result may suffer end fractures, particularly after drop impact. The damaged devices must be discarded taking care that they are properly disposed in light of their content. An economical solution is needed to prevent damage to the winged capsules to reduce waste and disposal costs.
Winged capsules sized and configured to deliver a substance to an animal are provided herein. In some embodiments, the winged capsule includes: a capsule having a bottom wall and tubular wall extending from the bottom wall, the tubular wall and the bottom wall defining an inner space adapted to contain the substance, and the bottom wall having an aperture adapted to deliver the substance to the animal; and a capsule retainer including a central wing portion connected to the capsule and wings connected to and extending laterally from the central wing portion along a wing plane, the central wing portion having a maximum central width, wherein each of the wings has a distal end having a distal width and an intermediate portion between the distal end and the central wing portion, the intermediate portion having a width narrowing from a width adjacent the central wing portion to the distal width.
In some embodiments, the winged capsule includes: a capsule having a bottom wall and tubular wall extending from the bottom wall, the tubular wall and the bottom wall defining an inner space adapted to contain the substance, and the bottom wall having an aperture adapted to deliver the substance to the animal; and a capsule retainer connected to the capsule and wings connected to and extending laterally from the central wing portion along a wing plane, wherein the capsule has a top portion adjacent a bottom portion, the bottom portion including the bottom wall, the bottom wall having a flat surface encircling the aperture, and the bottom portion also including an reinforcement section adjacent a radial circumferential edge of the bottom wall and having a thickness greater than a thickness of the bottom wall.
In the drawings, corresponding reference characters indicate corresponding parts, functions, and features throughout the several views. Although the drawings represent embodiments of various features and components according to the present invention, the drawings are not necessarily to scale and certain features may be exaggerated in order to better illustrate and explain the present invention. However, the invention is not limited to the precise arrangements and instrumentalities of the embodiments shown in the drawings.
For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings, which are described below. The embodiments disclosed below are not intended to be exhaustive or limit the invention to the precise form disclosed in the following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art may utilize their teachings. It will be understood that no limitation of the scope of the invention is thereby intended. The invention includes any alterations and further modifications in the illustrated devices and described methods and further applications of the principles of the invention as set forth in the claims.
Some parts described below with reference to the figures are common to multiple embodiments and variations thereof. Throughout the figures the same reference numerals are given to the common parts and the descriptions of the common parts are not repeated for simplicity. Furthermore, unless specifically stated, the depictions of the embodiments and variations thereof are made to scale although the scale can vary between embodiments.
Capsule 14 may comprise two components assembled together—a top portion and a bottom portion. During manufacture of any of the winged capsules described herein, the substance may be inserted into the top portion of capsule 14 and then the bottom portion is affixed to the top portion to retain substance 17 therein. Alternatively, the substance can be inserted through a lateral opening on the wall of the capsule. The top portion is affixed to the neck.
Capsule retainer 18 includes a central wing portion 180, “CP”, having a length CL corresponding to a width of capsule 14, connected to the capsule and wings 182 connected to and extending laterally from the central wing portion along a wing plane. Length CL is measured along a longitudinal extent of wings 182. Capsule retainer 18 may be connected to capsule 14 by neck 16. Capsule retainer 18 comprises a transverse rib 181. Wings 182 extend on either side of transverse rib 181 (shown in
Lateral edge ribs 184 extend from the central wing portion to at least the portion of the wing with the wing tip width, i.e. distal rib portion 184d, with an intermediate portion of the lateral edge rib, 184i, therebetween.
As shown, intermediate longitudinal rib 186 extends as far distally as the distal end of intermediate portion 184i. Intermediate longitudinal rib 186 may be longer or shorter, as desired to obtain a desired flexibility in combination with the wing thickness, shape and material, and the structure of the other ribs. Similarly, a width transition section of the wings can be longer or shorter than shown, although the embodiments shown are preferred embodiments. Particularly when a localized flexure area is provided (described below), the length of the transition section can be reduced, as shown in
In some embodiments, the width transition section of the wings (beginning at the distal edge of the central wing portion and ending as soon as the wing width equals its narrowest width) is at most 70%, 65%, 60% or 50% of the length of the wing extending from the width transition section to the distal tip.
In some embodiments, WC is at least 60% of WT, measured along the same direction. WC may be, more preferably, at least 70%, 80%, and even more preferably at least 85% of WT. If the capsule is cylindrical, the width of the capsule is its diameter, DC, and WT is at least 55% of the diameter, DC, measured along the same direction. WT may be, more preferably, at least 60%, 80%, and even more preferably at least 85% of the diameter, DC. The capsule's cross-section may also be oval or have other shapes.
As already mentioned, thicker ribs at the central wing portion CP (directly over capsule 14) of the retainer enhance strength in areas where utmost flexibility is not required, while thinner ribs distally from the central wing portion provide the necessary flexibility. The dashed lines illustrate the height of intermediate longitudinal ribs 186, 190.
In some variations, ribs at the central wing portion CP and ribs distally from the central wing portion have the same height and/or width and/or cross-section. In the central wing portion the rib cross-section provides strength to prevent folding damage and in the wings the cross-section increases resiliency. The ribs in the wings, e.g. one or more of the intermediate longitudinal rib and the lateral edge ribs, could also have a larger cross-section than the wings in the central wing portion, particularly when the wings are materially narrower than the central wing portion. Alternatively, ribs at the central wing portion CP and ribs distally from the central wing portion have different height and/or width and/or cross-section. Examples with different rib heights were provided above. In those examples, the widths of the ribs could be different, for example the lateral edge ribs could taper to a smaller height while widening to a wider width, thereby. Additional rib variations are exemplified below. The embodiments disclosed with reference to
In some variations, one or more of the intermediate longitudinal rib and the lateral edge ribs can extend to the distal edge ribs, providing additional rigidity to the wings. Optionally, the distal edge ribs have a larger cross-section than the lateral edge ribs, for example a wider cross-section. Additionally, the distal edge ribs could be eliminated by increasing the thickness of the distal tips of the wings, solidifying the space that previously existed between ends of the distal edge ribs, providing raised portions that are not elongate protrusions. The embodiments disclosed with reference to
It should be understood that the term “rib” connotes elongate protrusions that extend from a surface. The term “protrusion” or “raised portions” could be used to denote ribs.
Although capsule 14 is shown having a cylindrical shape, it should be understood that the cross-section of capsule 14 across its longitudinal axis does not have to be circular but can be, for example, oval, rectangular or square, with or without rounded edges in the case of rectangular or square cross-sections.
The wing capsule may be injection molded from materials including substantially polypropylene. Example polypropylene materials include materials with the following characteristics, although other injection molding grade polymers may also be used. These materials are more resilient to flexure than materials used in prior devices and thus help reduce damage.
As used herein, “localized flexure area” refers to an area traverse to a longitudinal aspect of the wings which is sized and configured to flex when the wings are folded, thereby reducing stress on the central wing portion where the neck is attached and preventing stress fractures. In prior devices a high stress location was identified where the central wing portion connects to the neck. The localized flexure area provides a designated bend location, which may be also referred of as a second bend location (the first being the portion where the neck is attached to the central wing section). The localized flexure area can have reduced height ribs, which includes notched ribs (
Referring to
Referring to
As mentioned above,
Referring to
The width of the lateral edge ribs is also wider in and adjacent the central wing portion and narrower at the distal ends. The width of the lateral edge ribs is another variable to determine resistance to flexure. The width may also be constant.
The width of the intermediate longitudinal ribs 202 is also wider in and adjacent the central wing portion and narrower at the distal ends. The width of the intermediate longitudinal ribs is another variable to determine resistance to flexure. The width may also be constant.
As shown in
Referring to
The embodiments and variations described above describe advantageous features of the capsule retainer. Additional advantageous features are provided to prevent breakage of the capsule, particularly if the capsule is dropped. These features can be implemented in any of the winged capsules described with reference to
Referring to
The flat surface section, which may have a constant thickness, may comprise inner surface 143i and outer surface 143o opposite the inner surface, and the reinforcement section may comprise a tapered protrusion extending distally from the outer surface.
The tapered protrusion may be continuous and circular. An example of a continuous tapered protrusion 408 is shown in
A dashed line is shown to represent the flat surface of bottom wall 143 and more clearly depict how reinforcement section 407 extends distally from the flat surface of bottom wall 143.
In a variation of the present embodiment, the continuous radially tapered protrusion comprises a plurality of radially distributed ribs.
Referring to
In an aspect, a winged capsule for delivery of a substance to an animal is provided. The winged capsule includes a capsule having a bottom wall and a tubular wall extending from the bottom wall, the tubular wall and the bottom wall defining an inner space adapted to contain the substance, and the bottom wall having an aperture adapted to deliver the substance to the animal. The winged capsule further includes a capsule retainer including a central wing portion connected to the capsule and wings connected to and extending laterally from the central wing portion along a wing plane, the central wing portion having a maximum central width. Each of the wings has a distal end having a distal width and an intermediate section between the distal end and the central wing portion, the intermediate section having a width narrowing from a width adjacent the central wing portion to the distal width.
In further aspects of the winged capsule, the capsule has an outer cross-section width measured perpendicularly to a longitudinal extent of the wings, where the maximum central width is at least 60% of the outer cross-section width of the capsule. In another aspect, the capsule retainer includes a localized flexure area within the central wing portion of the capsule retainer. In yet another aspect, the capsule retainer comprises a transverse rib in the central wing portion, and extending distally from the transverse rib along the wing plane, lateral edge ribs and an intermediate longitudinal rib between the lateral edge ribs. Further, at least one of the lateral edge ribs and the intermediate longitudinal rib includes a notch within the central wing portion and/or the central wing portion comprises a localized flexure area. Additionally, the localized flexure area comprises reduced height rib portions of the lateral edge ribs and/or the intermediate longitudinal rib and, in an aspect, the reduced height rib portions each has a height which is less than a height of the lateral edge ribs or the intermediate longitudinal rib of the wings and/or the reduced height equals zero. In yet another aspect, the lateral edge ribs and the intermediate longitudinal ribs extend distally from the localized flexure area. Additionally, the central wing portion comprises a transverse rib and the transverse rib includes a cavity, a width of the transverse rib being greater than a diameter of the cavity. Further still, the central wing portion has a length equal to an outer cross-sectional width of the capsule measured along the same direction. In yet another aspect, the winged capsule includes a neck, a width of the neck being smaller than the length of the central wing portion measured along the same direction.
In further aspects, the winged capsule of any one of the preceding aspects, where the capsule has a top portion adjacent a bottom portion, the bottom portion including the bottom wall, the bottom wall having a flat surface section encircling the aperture and having a first thickness, a rounded circumferential edge surface, and a reinforcement section between the flat surface section and the rounded radial edge surface, the reinforcement section having a second thickness greater than the first thickness. Additionally, the flat surface section comprises an inner surface and an outer surface opposite the inner surface, and where the reinforcement section comprises a tapered protrusion extending distally from the outer surface. Further, the tapered protrusion is continuous and circular. Additionally, the tapered protrusion comprises spaced outwardly extending ribs. Further still, each of the ribs includes a tapered section and a substantially flat section connecting the tapered section to the rounded circumferential edge surface. In yet another aspect, the flat surface section comprises an inner surface and an outer surface opposite the inner surface, and where the reinforcement section comprises a radial protrusion extending proximally from the inner surface. Additionally, the radial protrusion extending proximally from the inner surface comprises a first section having the second thickness and a second section extending radially outwardly from the first section and having a third thickness. Further, the first section of the radial protrusion comprises a first flat surface and the second section comprises a second flat surface. Further still, the second flat surface overlaps, longitudinally, a portion of the rounded circumferential edge surface. Also, the third thickness decreases radially outwardly. In another aspect, the top portion includes the tubular wall, and where the tubular wall overlaps, longitudinally, the second flat surface. Also, the tubular wall contacts the second flat surface. In still further aspects, the winged capsule of any one of the aspects above, where the capsule retainer comprises a top surface and a bottom surface opposite the top surface, lateral edge ribs and intermediate longitudinal ribs extending from the top surface, and bottom ribs extending from the bottom surface. Additionally, the bottom ribs are shorter than the lateral edge ribs. Further the bottom ribs are thicker than the lateral edge ribs.
In another aspect, a winged capsule for delivery of a substance to an animal is provided. The winged capsule includes a capsule having a bottom wall and a tubular wall extending from the bottom wall, the tubular wall and the bottom wall defining an inner space adapted to contain the substance, and the bottom wall having an aperture adapted to deliver the substance to the animal. The winged capsule further includes a capsule retainer including a central wing portion connected to the capsule and wings connected to and extending laterally from the central wing portion along a wing plane, a top surface and a bottom surface opposite the top surface, lateral edge ribs and intermediate longitudinal ribs extending from the top surface, and bottom ribs extending from the bottom surface. In further aspects of the winged capsule, the bottom ribs are shorter than the lateral edge ribs. Additionally, the bottom ribs are thicker than the lateral edge ribs.
In further aspects, the winged capsule of any one of the aspects above, where the capsule has a top portion adjacent a bottom portion, the bottom portion including the bottom wall, the bottom wall having a flat surface section encircling the aperture and having a first thickness, a rounded circumferential edge surface, and a reinforcement section between the flat surface section and the rounded radial edge surface, the reinforcement section having a second thickness greater than the first thickness. Further, the flat surface section comprises an inner surface and an outer surface opposite the inner surface, and wherein the reinforcement section comprises a tapered protrusion extending distally from the outer surface. Additionally, the tapered protrusion is continuous and circular and/or the tapered protrusion comprises spaced outwardly extending ribs. Further, each of the ribs includes a tapered section and a substantially flat section connecting the tapered section to the rounded circumferential edge surface. Additionally, the flat surface section comprises an inner surface and an outer surface opposite the inner surface, and wherein the reinforcement section comprises a radial protrusion extending proximally from the inner surface. Also, the radial protrusion extending proximally from the inner surface comprises a first section having the second thickness and a second section extending radially outwardly from the first section and having a third thickness. Further, the first section of the radial protrusion comprises a first flat surface and the second section comprises a second flat surface. Additionally, the second flat surface overlaps, longitudinally, a portion of the rounded circumferential edge surface. Also, the third thickness decreases radially outwardly. Further still, the top portion includes the tubular wall, and wherein the tubular wall overlaps, longitudinally, the second flat surface. Additionally, the tubular wall contacts the second flat surface.
In yet another aspect, a winged capsule for delivery of a substance to an animal is provided. The winged capsule includes a capsule having a bottom wall and a tubular wall extending from the bottom wall, the tubular wall and the bottom wall defining an inner space adapted to contain the substance, and the bottom wall having an aperture adapted to deliver the substance to the animal. The winged capsule further includes a capsule retainer including a central wing portion connected to the capsule and wings connected to and extending laterally from the central wing portion along a wing plane, a top surface and a bottom surface opposite the top surface, and lateral edge ribs and intermediate longitudinal ribs extending from the top surface. Additionally, the capsule has a top portion adjacent a bottom portion, the bottom portion including the bottom wall, the bottom wall having a flat surface section encircling the aperture and having a first thickness, a rounded circumferential edge surface, and a reinforcement section between the flat surface section and the rounded radial edge surface, the reinforcement section having a second thickness greater than the first thickness.
In further aspects of the winged capsule above, the flat surface section includes an inner surface and an outer surface opposite the inner surface, and wherein the reinforcement section comprises a tapered protrusion extending distally from the outer surface. In an additional aspect, the tapered protrusion is continuous and circular and/or the tapered protrusion comprises spaced outwardly extending ribs. Additionally, each of the ribs includes a tapered section and a substantially flat section connecting the tapered section to the rounded circumferential edge surface. Further, the flat surface section comprises an inner surface and an outer surface opposite the inner surface, and wherein the reinforcement section comprises a radial protrusion extending proximally from the inner surface. Further still, the radial protrusion extending proximally from the inner surface comprises a first section having the second thickness and a second section extending radially outwardly from the first section and having a third thickness. Additionally, the first section of the radial protrusion comprises a first flat surface and the second section comprises a second flat surface. Also, the second flat surface overlaps, longitudinally, a portion of the rounded circumferential edge surface. Yet further, the third thickness decreases radially outwardly. Additionally, the top portion includes the tubular wall, and wherein the tubular wall overlaps, longitudinally, the second flat surface. Also, the tubular wall contacts the second flat surface.
Except where a contrary intent is expressly stated, the terms “comprises,” “comprising,” “containing,” and “having” and the like mean “includes,” “including,” and the like, and are generally interpreted to be open ended transition terms. The recitation of components, structures, steps, or the like specifically listed following an open-ended transition term in no way limit such claim to the components, structures, steps, or the like specifically listed. The terms “consisting of” or “consists of” are closed transition terms.
Except where a contrary intent is expressly stated, the terms “first,” “second,” “third,” “fourth,” and the like in the description and in the claims, if any, are used for distinguishing between similar elements and not necessarily for describing a particular sequential or chronological order. It is to be understood that any terms so used are interchangeable under appropriate circumstances such that the embodiments described herein are, for example, capable of operation in sequences other than those illustrated or otherwise described herein. Similarly, if a method is described herein as comprising a series of steps, the order of such steps as presented herein is not necessarily the only order in which such steps may be performed, and certain of the stated steps may possibly be omitted and/or certain other steps not described herein may possibly be added to the method.
Except where a contrary intent is expressly stated, terms are used in their singular form for clarity and are intended to include their plural form.
Occurrences of the phrase “in one embodiment,” or “in one aspect,” herein do not necessarily all refer to the same embodiment or aspect.
While this invention has been described as having designs illustrated by embodiments and examples, the present invention may be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains.
This application is a U.S. National Stage of International PCT Application No. PCT/US2021/016860, filed Feb. 5, 2021, which claims the benefit of and priority from U.S. Patent Application No. 63/045,066, filed on Jun. 27, 2020 and U.S. Patent Application No. 62/971,355, filed on Feb. 7, 2020; the foregoing applications are incorporated herein by reference in their entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US2021/016860 | 2/5/2021 | WO |
Number | Date | Country | |
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62971355 | Feb 2020 | US | |
63045066 | Jun 2020 | US |