WO2016056926A1

WO2016056926A1 - A substance delivery device

Info

Publication number: WO2016056926A1
Application number: PCT/NZ2015/050173
Authority: WO
Inventors: Michael John Rathbone
Original assignee: Ulti Pharmaceuticals Limited
Priority date: 2014-10-09
Filing date: 2015-10-09
Publication date: 2016-04-14

Abstract

The present disclosure relates to a substance delivery device, particularly for intravaginal delivery of a substance to an animal. The device includes a first elongate member and a second elongate member, wherein each of the first and second elongate members has a first end and a second end. The device has a pivotal connection between the first elongate member and the second elongate member, with the device is configured such that the distance between the respective first ends decreases when the distance between the respective second ends increases. In use, the device is placed into the vaginal tract of the animal - more particularly, positioned such that the first ends are positioned within the vagina of the animal, and the second ends are within the vestibule of the animal.

Description

A SUBSTANCE DELIVERY DEVICE

STATEMENT OF CORRESPONDING APPLICATIONS

This application is based on the Provisional specification filed in relation to New Zealand Patent Application Number 626321, the entire contents of which are incorporated herein by reference.

TECHNICAL FIELD

This invention relates to a substance delivery device. More particularly, but not exclusively, it relates to a device for insertion into, and retention within, the vagina of an animal for intra-vaginal delivery of a substance.

BACKGROUND ART

Drug delivery inserts are used extensively in many animal species for many medical treatments, for example estrous control. However, although considerable research has been invested in the design of intra vaginal estrous control devices for pigs, there remains room for improvement in this regard.

Pigs have highly muscular vaginas, with intra-vaginal inserts designed for use with other animals such as cows and sheep generally being expelled from a pig's vagina on contraction of the vagina. It has proved very difficult to design an insert that will be retained within the vagina of pigs. Camels also have highly muscular vaginas, and the same problems have been found in developing an intra vaginal insert suitable for use by camels.

Previous inserts developed specifically for pigs, such as that seen in United States Patent No. 6444224, often include projections or barbs that are used to retain the insert within the vagina. However these can cause unwanted damage to the vaginal mucosa.

It is therefore desirable to provide an intra vaginal device offering higher rates of retention inside the vagina of animals such as pigs or camels for extended periods of time, with a reduced likelihood of causing damage to the vaginal mucosa. It is an object of the present invention to address the foregoing problems or to at least provide the public with a useful choice.

All references, including any patents or patent applications cited in this specification are hereby incorporated by reference. No admission is made that any reference constitutes prior art. The discussion of the references states what their authors assert, and the applicants reserve the right to challenge the accuracy and pertinency of the cited documents. It will be clearly understood that, although a number of prior art publications are referred to herein, this reference does not constitute an admission that any of these documents form part of the common general knowledge in the art, in New Zealand or in any other country. Throughout this specification, the word "comprise", or variations thereof such as "comprises" or

"comprising", will be understood to imply the inclusion of a stated element, integer or step, or group of elements integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps.

Further aspects and advantages of the present invention will become apparent from the ensuing description which is given by way of example only.

SUMMARY

According to an exemplary embodiment of the present disclosure there is provided a substance delivery device, including: a first elongate member and a second elongate member, wherein each of the first and second elongate members has a first end and a second end; and a pivotal connection between the first elongate member and the second elongate member, wherein the device is configured such that the distance between the respective first ends decreases when the distance between the respective second ends increases. According to an exemplary embodiment of the present disclosure there is provided a method of delivering a substance to a non-human animal, including: placing a substance delivery device substantially as herein described into the vaginal tract of the animal. The inventor has identified that the substance delivery device may have particular application to animals having a vaginal tract in which the vestibule and vagina, together with the hymeneal ring, are approximately hourglass in shape, and the vaginal musculature of the animal is sufficient to expel objects placed within it. For example, in an embodiment, the non-human animal may be a swine. In an exemplary embodiment, the non-human animal may be a camel. However, it should be appreciated that this is not intended to be limiting, and the animal may be any suitable non-human animal, particularly a mammal, in which it is desirable to deliver a substance intra-vaginally.

The pivotal connection should be understood to be any means capable of acting as a fulcrum between the elongate members such that they may pivot relative to each other. The pivotal connection may be, for example, a hinge. However, it should be appreciated that this is not intended to be limiting, as other forms of pivotal connection are contemplated - for example a living hinge between the first elongate member and the second elongate member.

In an exemplary embodiment the pivotal connection may be located at a position along the elongate members between the respective first and second ends of the first and second elongate members. Reference will herein be made to the device having a first portion, which should be understood to mean the portions of the first and second elongate members between the respective first ends and the pivotal connection. Similarly, reference to a second portion should be understood to mean the portions of the first and second elongate members between the pivotal connection and the respective second ends. Reference to the width of the first and second portions should be understood to mean the distance between surfaces on the first and second elongate members facing away from each other. It should be appreciated that both of the first and second portions will have an open width and a closed width.

In an exemplary embodiment at least one of the portions of each of the first elongate member and the second elongate member may be arch-shaped. Reference to arch-shaped should be understood to mean a shape produced by an elongate member rising along its length from a plane to a peak, before falling back towards the plane. It should be appreciated that while the arch-shape may be produced with curves, this is not intended to be limiting, and the arch shape may be produced by a series of linear lengths with angular junctions.

In such an embodiment, the distance between the first and second elongate members may increase to a widest point between the respective end and the pivotal point, before tapering again, from both directions. Therefore, when the device is within the vagina, contraction of either the vagina or vestibule areas to bear on either the first portion or second portion of the elongate members cause the distance between either the respective ends to decrease - i.e. close. This in turn causes a levering action to increase the distance between the opposite ends - i.e. open - to bear against the vaginal tract and retain the device in the vagina.

In an exemplary embodiment, both the first and second portions of the first and second elongate members may be arch-shaped. It is envisaged that this may assist with both insertion and extraction of the device - with the arch-shape of both portions producing a taper at each end to assist with pushing (and pulling) of the device. In a further exemplary embodiment, at least one portion of each elongate member may be substantially recurved. In an exemplary embodiment, at least one of the elongate members between the pivotal connection and the second end may include a reverse curvature. Reference to a reverse curvature should be understood to mean a shape in which a curve transitions to another curve in the opposite direction - occasionally referred to as an "S" curve, although it should be appreciated that the reverse curvature may be less pronounced than in the letter "S".

In an exemplary embodiment, the first portions of the first and second elongate members may taper towards the first ends. This should be understood to mean that the distance between the first ends of the first and second elongate members may decrease relative to the maximum distance between the first portions. This may be beneficial for ease and of inserting the insert into the vagina. It may also help avoid damaging the mucosa in the vagina by streamlining the insert.

In an exemplary embodiment the device may also include an intermediary member, located between the first elongate member and the second elongate member. It is envisaged that this intermediary member may increase the surface area for carrying the substance to be delivered to the animal - as will be described further below. In an exemplary embodiment the intermediary member may be substantially planar, in order to reduce the extent to which it limits the pivotal movement of the first elongate member or the second elongate member.

The elongate members, and the intermediary member in exemplary embodiments, may collectively be referred to herein as a frame of the substance delivery device. It should be appreciated that reference to preferred properties or features of the frame is not intended to limit variation between each of the members included in the frame in all embodiments. In an exemplary embodiment, the device may include a strap extending between the respective second portions of the first and second elongate members. It is envisaged that the strap may be flexible along its length, while resisting tensile forces - i.e. stretching - as in the case of a cable tie, for example. A removal device including an engaging portion - for example, a hook - may be engaged with the strap, with pulling of the removal device pulling the second portions together as well as in the direction of the pulling action.

In an exemplary embodiment each of the second portions may include an anchor point for securing the strap thereto.

In an exemplary embodiment, the intermediary member may include an aperture for guiding the strap between the respective second portions.

It should be appreciated that the various dimensions of the device may be determined to suit the intended animal with which the device is to be used. For example, the dimensions may be determined based on the type of animal, the age of the animal, or the parity status of the animal.

In an exemplary embodiment in which the device is configured for use with a gilt (i.e. a young swine who has not yet farrowed), the length of the first portion may be within the range of 75 mm to 90 mm. In an exemplary embodiment the length of the first portion may be within the range of 78 mm to 85 mm. It should be appreciated that useful ranges may be selected between any of these values (for example, about 75 to about 85, about 75 to about 80, about 80 to about 90, about 80 to about 85, or about 85 to about 90 mm). In an exemplary embodiment in which the device is configured for use with a gilt, the length of the second portion may be within the range of 55 mm to 100 mm. In an exemplary embodiment the length of the second portion may be within the range of 55 mm to 65 mm. It should be appreciated that useful ranges may be selected between any of these values (for example, about 55 to about 95, about 55 to about 90, about 55 to about 85, about 55 to about 80, about 55 to about 75, about 55 to about 70, about 55 to about 60, about 60 to about 100, about 60 to about 95, about 60 to about 90, about 60 to about 85, about 60 to about 80, about 60 to about 75, about 60 to about 70, about 60 to about 65, about 70 to about 100, about 70 to about 95, about 70 to about 90, about 70 to about 85, about 70 to about 80, about 70 to about 75, about 75 to about 100, about 75 to about 95, about 75 to about 90, about 75 to about 85, about 75 to about 80, about 80 to about 100, about 80 to about 95, about 80 to about 90, about 80 to about 85, about 85 to about 100, about 85 to about 95, about 85 to about 90, about 90 to about 100, about 90 to about 95, or about 90 to about 100 mm). In an exemplary embodiment in which the device is configured for use with a gilt, the open width of the first portion may be within the range of 35 mm to 50 mm. In an exemplary embodiment the open width of the first portion may be within the range of 35 mm to 45 mm. It should be appreciated that useful ranges may be selected between any of these values (for example, about 35 to about 45, about 35 to about 40, about 40 to about 50, about 40 to about 45, or about 45 to about 50 mm).

In an exemplary embodiment in which the device is configured for use with a gilt, the closed width of the first portion may be within the range of 20 mm to 30 mm. In an exemplary embodiment, the closed width of the first portion may be in the order of 24 mm to 26 mm. It should be appreciated that useful ranges may be selected between any of these values (for example, about 20 to about 28, about 20 to about 26, about 20 to about 24, about 20 to about 22, about 22 to about 30, about 22 to about 28, about 22 to about 26, about 22 to about 24, about 24 to about 30, about 24 to about 28, about 26 to about 30, about 26 to about 28, or about 28 to about 30 mm).

In an exemplary embodiment in which the device is configured for use with a gilt, the open width of the second portion may be within the range of 20 mm to 50 mm. In an exemplary embodiment, the open width of the second portion may be within the range of 25 mm to 40 mm. It should be appreciated that useful ranges may be selected between any of these values (for example, about 20 to about 45, about 20 to about 40, about 20 to about 35, about 20 to about 30, about 20 to about 25, about 25 to about 50, about 25 to about 45, about 25 to about 40, about 25 to about 35, about 25 to about 30, about 30 to about 50, about 30 to about 45, about 30 to about 40, about 30 to about 35, about 35 to about 50, about 35 to about 45, about 35 to about 40, about 40 to about 50, about 40 to about 45, or about 45 to about 50 mm).

In an exemplary embodiment in which the device is configured for use with a gilt, the closed width of the second portion may be within the range of 20 mm to 35 mm. In an exemplary embodiment, the closed width of the second portion may be within the range of 26 mm to 30 mm. It should be appreciated that useful ranges may be selected between any of these values (for example, about 20 to about 32, about 20 to about 30, about 20 to about 28, about 20 to about 26, about 20 to about 24, about 20 to about 22, about 22 to about 35, about 22 to about 32, about 22 to about 30, about 22 to about 28, about 22 to about 26, about 22 to about 24, about 24 to about 35, about 24 to about 32, about 24 to about 30, about 24 to about 28, about 24 to about 26, about 26 to about 35, about 26 to about 32, about 26 to about 30, about 26 to about 28, about 28 to about 35, about 28 to about 32, about 28 to about 30, about 30 to about 35, about 30 to about 32, or about 32 to about 35 mm). Again, it should be appreciated that the dimensions discussed in relation to exemplary embodiments potentially used with gilts is not intended to be limiting to all embodiments. For example, the inventor anticipates that the closed width of the first portion in embodiments configured for sows or for camels may be substantially that projected for use with gilts. However, in an exemplary embodiment in which the device is configured for use with a sow, the closed width of the second portion may be within the range of 40 mm to 75 mm. In an exemplary embodiment in which the device is configured for use with a camel, the closed width of the second portion may be within the range of 30 mm to 65 mm.

The frame may be made of any material but in an exemplary embodiment may be made of plastics material. The plastics material may be degradable or non-degradable. The plastics material may be a thermoplastic. For example, the frame may be formed from a polymer such as a polyethylene, polypropylene, starch-like polysaccarides such as Mater-Bi, polycaprolactone, poly glycolide, poly lactide, polyurethane, rubber, silicone, ethylene vinyl acetate, nylon, or combinations thereof. Specific examples of potentially suitable polymers include polyamide (Nylon), low-density polyethylene, high- density polyethylene, polypropylene, polycarbonate, polyester, polyacrylonitrile, polyolefin, acrylate such as polymethyl methacrylate), polyvinyl chloride, polyvinyl fluoride, polymethacrylate, high impact polystyrene, polystyrene, polysulfone, polybutadiene, polyaryletherketone, polyethylene terephthalate (PET), polyglycolic acid, polyclatic acid, polylactic-co-glycolic acid, polycaprolactone, starches, polybutylene succinate, poly p-dioxanone, poly-3-hydroxybutyrate, or a combination thereof.

In an exemplary embodiment, at least one of the members of the frame may be skeletal. Reference to a frame member being skeletal should be understood to mean that the frame includes a number of openings or spaces - particularly in order that fluid might pass through said openings. In an exemplary embodiment, the surface area of the frame may be less that the area of the openings. As described further below, this skeletal configuration may assist with increasing the surface area of the substance carrier exposed to the vaginal tract. It should be appreciated that exemplary embodiments of the substance delivery device described herein may be used to carry the substance for delivery to the animal by a number of means.

In an exemplary embodiment the frame may be configured to a have at least one carrier member secured to it, the carrier member impregnated by the substance. Securing of the carrier member may be achieved using any suitable means known in the art - for example, through use of fasteners, or an adhesive. According to an exemplary embodiment of the present disclosure there is provided a method of manufacturing a substance delivery device substantially as herein described, the method including: securing a carrier member impregnated with the substance to be delivered to at least one of the first elongate member and a second elongate member. However, it should be appreciated reference to use of a distinct carrier member is not intended to be limiting. For example, the frame itself may act as a carrier medium of the substance, with the material from which the frame is made being impregnated with the substance.

According to an exemplary embodiment of the present disclosure there is provided a method of manufacturing a substance delivery device substantially as herein described, the method including: impregnating at least one of the first elongate member and a second elongate member with the substance to be delivered.

In another exemplary embodiment, the frame may be coated by a carrier medium impregnated by the substance.

According to an exemplary embodiment of the present disclosure there is provided a method of manufacturing a substance delivery device substantially as herein described, the method including: coating at least one of the first elongate member and a second elongate member with a carrier medium impregnated with the substance to be delivered.

The at least one carrier member may be of any suitable configuration and structure for impregnation by the substance. For example, in an exemplary embodiment the carrier member may be a sheet or pad having a thickness of about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7 or 0.8 mm, and useful ranges may be selected between any of these values.

In an exemplary embodiment the at least one carrier member may be made of a polymer. In an exemplary embodiment the polymer may be selected from a non-degradable thermoset polymer, a non-degradable thermoplastic polymer, a biodegradable polymer or a combination thereof. For example the polymer may be formed from silicone, ethylene vinyl acetate, polycaprolactone, natural (latex) rubber, styrene-butadiene rubber, polyurethane, polyamide (Nylon), low-density polyethylene (LDPE), high-density polyethylene (HDPE), polypropylene, polycarbonate, polyester, polyacrylonitrile, polyolefin, acrylic such as polymethyl methacrylate, polyvinyl chloride, polyvinyl fluoride, polymethacrylate, high impact polystyrene, polystyrene, polysulfone, polybutadiene, polyarylehetherketone, polyethylene terephthalate (PET), polyglycolic acid, polylactic acid, polyclatic- co-glycolic acid, starches, polybutylene succinate, poly p-dioxane, poly-3-hydroxybutyrate, or a combination thereof.

In an exemplary embodiment the substance includes at least one active agent. The at least one active agent may be any substance, whether therapeutic or medicinal, suitable for intra vaginal delivery. For example the active agent may be selected from : a natural or synthetic hormone, an antibiotic, antifungals or antivirals, a peptide or protein, an antiparasitic, an anti-inflammatory, minerals, vitamins, trace elements, growth promotants, and any combination thereof.

In an exemplary embodiment, where the active agent is a hormone, the hormone may be selected from progesterone, estradiol and testosterone. Where the active agent is an antibiotic, it may be selected from, for example: penicillins, cephalosporins, macrolides, fluoroquinolones, sulphonamides, tetracyclines, glycylcyclines, aminoglycosides, carbapenems, or a combination thereof. Where the active agent is an anti-inflammatory it may be selected from, for example: non-steroidal antiinflammatory drugs (NSAIDs), such as aspirin, ibuprofen, naproxen, aceclofenac, diclofenac, acetmetacin, dexibuprofen, ketoprofen, dexketoprofen, fenoprofen, flurbiprofen, etodolac, sulindac, indometacin, nebumetone, tiaprofenic acid, meloxicam, selective cyclo-oxygenase-2 (COX-2) inhibitors such as celecoxib, rofecoxib, etoricoxib or a combination thereof.

In an exemplary embodiment the substance may include at least one release rate modifier. In some embodiments the release rate modifier may be selected from inert fillers such as calcium carbonate, salts such as sodium chloride, pore forming substances such as water soluble salts, oils such as arachis and liquid paraffin, and surface active agents such as sodium lauryl sulphate.

The carrier medium - for example the at least one carrier member - may contain 1, 5, 10, 15, 20, 25, 30, 35, 40 45, 50, 55, 60, 65 or 75% by weight of the active agent, and useful ranges may be selected between any of these values. It should be appreciated that in embodiments having a plurality of carrier members, the active agent may be the same or different, and/or the same or different % by weight.

On insertion of the device, the carrier medium is exposed to the fluids within the vaginal tract to release the substance - and more particularly the active agent. The structure of the delivery device as herein described responds to the contraction and release of the vestibule and vaginal muscles to expand the respective portions of the device, and thereby reduce the likelihood of the device being expelled from the vaginal tract until a desired dwell time is achieved. BRIEF DESCRIPTION OF DRAWINGS

Further aspects of the present invention will become apparent from the following description which is given by way of example only and with reference to the accompanying drawings in which:

FIG. 1 is a perspective view of an exemplary substance delivery device;

FIG. 2A is a side view of an exemplary first elongate member of the substance delivery device;

FIG. 2B is a side view of an exemplary second elongate member of the substance delivery device;

FIG. 2C is a perspective view of an exemplary intermediate member of substance delivery device;

FIG. 2D is a perspective view of a skeletal frame of the substance delivery device, including the first and second elongate members and the intermediate member;

FIG. 3 is a perspective view of exemplary removable substance carriers of the substance delivery device;

FIG. 4 is an exploded perspective view of the substance delivery device;

FIG. 5 is a side view of the substance delivery device;

FIG. 6A is a first view of the substance delivery device inserted into the vaginal tract of a female swine;

FIG. 6B is a second view of the substance delivery device inserted into the vaginal tract;

FIG. 6C is a third view of the substance delivery device inserted into the vaginal tract;

FIG. 7A is a side view of an exemplary embodiment of the substance delivery device, including a strap, in an open state, and

FIG. 7B is a side view of an exemplary embodiment of the substance delivery device, including a strap, in a closed state. DETAILED DESCRIPTION

FIG. 1 illustrates a substance delivery device 100. The device 100 is configured for insertion into an animal's vaginal tract, and may herein be referred to as an intravaginal insert. The device 100 has a first end 102 from which the device 100 is inserted, and a second end 104 from which the device is pushed during insertion, or pulled during extraction.

The device 100 includes a first elongate member 106 and second elongate member 108, pivotally connected by a pin 110. An intermediary member 112 is positioned between the first elongate member 106 and the second elongate member 108, having a tab 114 with a tab aperture 115.

Substance carrier members in the form of sheets 116, 118, 120a, and 120b may be secured to the first and second elongate members 106, 108 and intermediary member 112, respectively.

Referring to FIG. 2A, the first elongate member 106 has a first end 200 and a second end 202, with a central barrel portion 204 of the pivotal connection located there between. The first elongate member 106 includes a first portion 206 between the first end 200 and the central barrel portion 204, and a second portion 208 between the central barrel portion 204 and the second end 202. The first portion 206 - particularly the outer face indicated by the "206" marking - is arch-shaped. The second portion 208 is also arch-shaped, although the second portion 208 also has a reverse curvature along its length.

It may be seen in FIG. 2B that the second elongate member 108 substantially mirrors the first elongate member 106: having a first end 210, a second end 212, and an outer barrel portion 214 located there between defining a first portion 216 and a second portion 218.

The intermediary member 112, as seen in FIG. 2C, includes a front portion 220a and a rear portion 220b, joined by intermediary barrel portions 222 which fit between the central barrel portion 204 and the outer barrel portion 214 of the first and second elongate member 106 and 108 respectively to provide a barrel for the pin 110. The intermediary member 112 is skeletal in construction, having a plurality of contained openings 224. A plurality of fastener bosses 226 are provided for securing the sheets 120 and 120b of FIG. 1 to the intermediary member 112. While not clearly seen in FIG. 2A or 2B, the first and second elongate members 106, 108 have a similar structure. As seen in FIG. 2D, the first elongate member 106, the second elongate member 108, and the intermediary member 112 may be secured by the pin 110, to collectively provide a frame 228 of the device 100.

FIG. 3 shows the substance carrier sheets 116, 118, 120a and 120b (collectively indicated by numeral 300) in isolation from the frame 228 of the device 100.

Each of the sheets 300 may be manufactured by molding a mixture of a polymer and the substance (including the active agent to be delivered). The polymer forms a matrix in which the active agent is retained, with exposure to fluids within the vaginal tract releasing the active agent from the matrix. The delivery in this manner allows release of the active agent over a period of time, which can be controlled by manipulating the amount, concentration of active agent and the size of the sheets 300.

The at least one active agent may be any substance, whether therapeutic or medicinal, suitable for intra vaginal delivery. For example the active agent may be selected from: a natural or synthetic hormone, an antibiotic, antifungals or antivirals, a peptide or protein, an antiparasitic, an anti-inflammatory, minerals, vitamins, trace elements, growth promotants, and any combination thereof. Where the active agent is a hormone, the hormone may be selected from, for example, progesterone, estradiol and testosterone. Where the active agent is an antibiotic, it may be selected from, for example: penicillins, cephalosporins, macrolides, fluoroquinolones, sulphonamides, tetracyclines, glycylcyclines, aminoglycosides, carbapenems, or a combination thereof. Where the active agent is an antiinflammatory it may be selected from, for example: non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, naproxen, aceclofenac, diclofenac, acetmetacin, dexibuprofen, ketoprofen, dexketoprofen, fenoprofen, flurbiprofen, etodolac, sulindac, indometacin, nebumetone, tiaprofenic acid, meloxicam, selective cyclo-oxygenase-2 (COX-2) inhibitors such as celecoxib, rofecoxib, etoricoxib or a combination thereof.

The total surface area of the sheets 300, particularly where the device 100 is configured for use hormone treatment in swine, may be in the order of 170 cm² to 220 cm². It should be appreciate that this is not intended to be limiting, but is described for illustrative purposes. FIG. 4 shows the skeletal construction of the first elongate member 106, the second elongate member 108, and the intermediary member 112 - and thus double sided exposure of the sheets 116, 118, 120a, and 120b to increase the effective surface area. It should be appreciated that while the mechanism for carrying and delivering the substance is described and illustrated as being manufactured separately in sheet form and secured to the frame 228, this is not intended to be limiting. For example, the frame 228 itself could be made of a polymer impregnated with the substance, or coated with a polymer impregnated with the substance.

Table 1 below outlines potential dimensions of exemplary embodiments of the device 100, developed for trial use with gilts. The dimensions are illustrated in FIG. 5, in which 'A' is the length of the first portion, 'B' is the length of the second portion, 'C is the open width of the first portion, 'D' is the closed width of the first portion, Έ' is the open width of the second portion, and 'F' is the closed width of the second portion.

Table 1:

It should be appreciated that these values are not intended to be limiting to all embodiments of the present disclosure, but are provided for illustrative purposes. Initial trials of embodiment IV indicate that the open width of the second portion (Έ') may be unsuitable in some cases due to difficulty with insertion.

FIG. 6A, 6B, and 6C illustrate the positioning of the substance delivery device 100 within the vaginal tract 600 of a female swine, the tract 600 including: the vulva entrance 602, the vestibule 604, the hymeneal ring 606, the vagina 608, and the cervical entrance 608.

In FIG. 6A, the device 100 is inserted from its first end 102 by pushing against the tab 114, until the pivot pin 110 is positioned approximately in line with the hymeneal ring 606.

In such a position, contraction of the vagina 608 about the first potions 206 and 216 of the device 100 pushes them together, simultaneously opening second portions 208 and 218 to bear against the walls of the vestibule 604 and resist expulsion from the vaginal tract 600 - as seen in FIG. 6B.

Conversely, as illustrated in FIG. 6C, contraction of the vestibule 604 about the second portions 208 and 218 of the device 100 causes the opening of the first potions 206 and 216 to resist passage through the hymeneal ring 606.

Without user intervention, the device 100 is thereby retained until the desired dwell time is achieved for sufficient release of the active agent, and the user manipulates the device 100 to extract it. FIG. 7A and FIG. 7B illustrate an exemplary feature and method for removal of the device 100. In FIG. 7A it may be seen that a strap 700 is secured between anchor points 702 and 704 of the respective second portions 208 and 218 of the first and second elongate members 106 and 116, and threaded through the tab aperture 115 of the tab 114. The strap 700 is flexible along its length, while resisting tensile forces - i.e. stretching - as in the case of a cable tie, for example. The length of the strap 700 is such that the second portions 208 and 218 are permitted to open to a desired width to retain the device 100 in the vestibule 604 (as seen in FIG. 6B).

Referring to FIG. 7B, a removal hook 706 is hooked onto the strap 700. Pulling the hook 706, and therefore strap 700, draws the second portions 208 and 218 together, until a point where the device 100 itself is pulled by the hook 706 to extract the device. As well as providing a convenient catch point for the hook 706, drawing the second portions 208 and 218 together assists with bringing the device 100 through the vulva entrance 602.

The entire disclosures of all applications, patents and publications cited above and below, if any, are herein incorporated by reference. Reference to any prior art in this specification is not, and should not be taken as, an acknowledgement or any form of suggestion that that prior art forms part of the common general knowledge in the field of endeavour in any country in the world.

The invention may also be said broadly to consist in the parts, elements and features referred to or indicated in the specification of the application, individually or collectively, in any or all combinations of two or more of said parts, elements or features.

Where in the foregoing description reference has been made to integers or components having known equivalents thereof, those integers are herein incorporated as if individually set forth.

It should be noted that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications may be made without departing from the spirit and scope of the invention and without diminishing its attendant advantages. It is therefore intended that such changes and modifications be included within the present invention.

The invention may also be said broadly to consist in the parts, elements and features referred to or indicated in the specification of the application, individually or collectively, in any or all combinations of two or more of said parts, elements or features. Aspects of the present invention have been described by way of example only and it should be appreciated that modifications and additions may be made thereto without departing from the scope thereof as defined in the appended claims.

Claims

CLAIMS:

1. A substance delivery device, including: a first elongate member and a second elongate member, wherein each of the first and second elongate members has a first end and a second end; and a pivotal connection between the first elongate member and the second elongate member, wherein the device is configured such that the distance between the respective first ends decreases when the distance between the respective second ends increases.

2. A substance delivery device as claimed in claim 1, wherein the pivotal connection is located at a position along the elongate members between the respective first and second ends of the first and second elongate members.

3. A substance delivery device as claimed in claim 2, wherein each of the first elongate member and the second elongate member includes a first member portion between the first end and the pivotal connection, and a second member portion between the pivotal connection and the second end.

4. A substance delivery device as claimed in claim 3, wherein at least one of the first and second member portions is arch-shaped.

5. A substance delivery device as claimed in claim 4, wherein both the first and second portions of the first elongate member and the second elongate member are arch-shaped.

6. A substance delivery device as claimed in any one of claims 3 to 5, wherein at least one of the first and second member portions has a reverse curvature.

7. A substance delivery device as claimed in any one of claims 3 to 6, including a flexible strap extending between the respective second member portions of the first and second elongate members.

8. A substance delivery device as claimed in any one of claims 1 to 7, wherein at least one of the first elongate member and the second elongate member is skeletal.

9. A substance delivery device as claimed in any one of claims 1 to 8, including an intermediary member located between the first elongate member and the second elongate member.

10. A substance delivery device as claimed in claim 9, wherein the intermediary member is substantially planar.

11. A substance delivery device as claimed in any one of claims 1 to 10, wherein the substance delivery device is made of a material impregnated with the substance to be delivered.

12. A substance delivery device as claimed in any one of claims 1 to 10, wherein at least one of the first elongate member and the second elongate member are coated by a carrier medium impregnated with the substance to be delivered.

13. A substance delivery device as claimed in any one of claims 1 to 10, including at least one carrier member impregnated with the substance to be delivered, and secured to at least one of the first elongate member and the second elongate member.

14. A substance delivery device as claimed in any one of claims 10 to 13, wherein the substance includes at least one hormone.

15. A method of delivering a substance to a non-human animal, including: placing a substance delivery device as claimed in any one of claims 11 to 14 into the vaginal tract of the animal.

16. A method as claimed in claim 15, wherein placing the substance delivery device includes positioning the substance delivery device such that the first ends are positioned within the vagina of the animal, and the second ends are within the vestibule of the animal.

17. A method as claimed in claim 16, wherein placing the substance delivery device includes positioning the device such that the position of the pivotal connection is substantially aligned with the hymeneal ring of the animal.

18. A method as claimed in any one of claims 15 to 17, wherein the animal is a swine.

19. A method as claimed in claim 18, wherein the animal is a gilt.

20. A method as claimed in any one of claims 14 to 16, wherein the animal is a camel.