NZ573656A - Stomach held bolus string for animal dosing - Google Patents

Abstract

A treatment device 1, in particular to be swallowed by animals to treat intestinal parasites and worms, includes a plurality of discrete solid treatment devices 2, 3, 4, each in the form of a mini-bolus with a head 6 and a tail 7 shaped so that each mini-bolus can be partially nested together with adjacent boluses when the boluses are linked together by a flexible material 5 so that the treatment device forms a single articulated object that can be articulated in a plurality of different orientations. The boluses can be held together by a string passing through a hole through the body of each bolus or a tape along the sides of the boluses.

Description

James & Wells Ref: 129969/47 PATENTS FORM NO. 5 Fee No. 4: $250.00 PATENTS ACT 1953 COMPLETE SPECIFICATION After Provisional No: 573656 Dated: 8 February 2010 TREATMENT DELIVERY DEVICE WE Bomac Research Limited, a New Zealand company having its registered office at Wiri Station Road, Manukau, Auckland, New Zealand hereby declare the invention for which I/We pray that a patent may be granted to me/us, and the method by which it is to be performed to be particularly described in and by the following statement: 1 James & Wells Ref: 129969/47 TREATMENT DELIVERY DEVICE TECHNICAL FIELD The present invention relates to a treatment delivery device, and a method of using same. Reference throughout this specification shall now be made to the treatment 5 delivery device as being a form of bolus used to deliver a substance to animals. However, it should be appreciated that the principles of the present invention could apply to other types of treatment delivery devices.

BACKGROUND ART In the animal health industry it is common practice to deliver a substance such as 10 medicaments, nutritional supplements and essential elements to an animal over a period of time. This can be achieved by a number of means, for example, sub-dermal implants, encapsulated feed additives and suppositories.

One of the most common means by which a bulk substance is delivered is via a bolus.

Boluses are typically delivered intraruminally and contain substances required to be delivered over a period of time in large doses, such as zinc (for facial eczema), micro-organisms to act on gut flora, and anthelmintics.

A bolus usually includes a treatment substance, a binder and often a densifier which ensures that the bolus has sufficient weight to sit in the stomach of the animal as it 20 releases the treatment substance at a predetermined rate.

Predetermined rates may be determined by a number of means. In some types of boluses, an external coating that breaks down is provided, thus exposing the 2 James & Wells Ref: 129969/47 treatment substance/binder to the rumen fluids. The external coating in some versions is wax, and in others an alloy.

While boluses are very effective in delivering a treatment substance to the gut of the animal, the introduction of the bolus to the animal can be difficult to achieve.

For example, boluses are required to be: a) of sufficiently large volume to deliver the amount of treatment substance required, and b) densely compacted in order to allow for the slow delivery of the treatment substance, and c) heavy so that the bolus can remain within the rumen.

As a consequence of these criteria, boluses cannot be readily swallowed by the animal to be treated, in contrast to other treatment delivery devices such as tablets or liquid drench. Further, the bolus is required to be deposited in the bottom of the rumen for it to be effective.

A possible solution to this problem has been the development of a bolus applicator. A bolus applicator is generally comprised of a long tube having at one end a trigger connected to a bolus release, and at the other end, a bolus retainer. In order to insert a bolus into an animal, the tube is inserted down the animal's throat until in position that the bolus can be released and dropped into the animal's rumen.

As can be appreciated, to deliver boluses to animals in such a manner requires considerable skill, particularly when animals are not prone to remaining still during the administration process. 3 James & Wells Ref: 129969/47 Unfortunately, it is relatively common for animals to be hurt during the administration process, even to such a degree that the animals can die as a result. For example, it is relatively common for the bolus to not enter the rumen, but instead be injected accidentally through the back of the animal's oesophagus.

It is obviously desirable if there could be provided a better method of administration of treatment substances to animals.

It is an object of the present invention to address the foregoing problems or at least to provide the public with a useful choice.

All references, including any patents or patent applications cited in this specification 10 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 15 that any of these documents form part of the common general knowledge in the art, in New Zealand or in any other country.

It is acknowledged that the term 'comprise' may, under varying jurisdictions, be attributed with either an exclusive or an inclusive meaning. For the purpose of this specification, and unless otherwise noted, the term 'comprise' shall have an inclusive 20 meaning - i.e. that it will be taken to mean an inclusion of not only the listed components it directly references, but also other non-specified components or elements. This rationale will also be used when the term 'comprised' or 'comprising' is used in relation to one or more steps in a method or process.

Further aspects and advantages of the present invention will become apparent from 4 James & Wells Ref: 129969/47 the ensuing description which is given by way of example only.

DISCLOSURE OF THE INVENTION According to one aspect of the present invention there is provided a treatment device, wherein the device includes: a number of discrete solid treatment devices linked to each other, wherein each discrete solid treatment device is a mini-bolus, and a flexible material linking the mini-boluses, characterised in that each mini-bolus is configured with a head and a tail, wherein the heads and tails of 10 adjacent mini-boluses are shaped and spaced such that the treatment device is in the form of a single articulated object, the object being able to be articulated in a number of orientations.

According to another aspect of the present invention there is provided a discrete solid treatment device for use with a treatment device as substantially as described above, characterised in that the discrete solid treatment device is configured with an aperture passing through its interior, such that a flexible material can be passed through the interior of the discrete 15 solid treatment device, and wherein the discrete solid treatment device is a mini-bolus, wherein each mini bolus has a head and a tail, wherein the heads and tails of adjacent mini-boluses are shaped and spaced such that the treatment device is in the form of a single articulated object, the object being able to be articulated in a number of orientations.

James & Wells Ref: 129969/47 According to another aspect of the present invention there is provided a method of delivering a full dose of a solid treatment substance internally to a non-human animal, the method including the step of: a) delivering to the animal a number of linked discrete solid treatment devices in a treatment device, wherein the accumulative total of the discrete solid treatment devices contain the full dose of treatment substance required, and wherein the solid treatment devices are mini-boluses, the method characterised by the additional step of: b) configuring the treatment device such that each mini bolus has a head and a tail, wherein the heads and tails of adjacent mini-boluses are shaped and spaced such that the treatment device is in the form of a single articulated object, the object being able to be articulated in a number of orientations.

It should be appreciated that for efficient farming methods or general application methods that it will be desired to provide the full dose of treatment substance internally to an animal in a single administration.

However, as described in the prior art, considerable problems occur when one solid treatment device is used. The principle behind the present invention is to effectively provide a number of discrete solid treatment devices, the sum total of which provides the full amount of treatment substance.

These discrete solid treatment devices, when linked together, form a single articulated treatment device such that the treatment device has a degree of flexibility 6 James & Wells Ref: 129969/47 allowing the treatment device to bend at least at an angle commensurate with the curvature of the oesophagus of the animal to be treated.

For ease of reference, the discrete solid treatment devices shall now be referred to as mini-boluses, although this should not be seen as limiting.

Mini-boluses may be delivered by a number of means. In one embodiment of the present invention a bolus applicator may be used, but with a retention device 5 configured to be able to hold a number of the smaller boluses.

Thus, when the bolus applicator is within the animal, pulling the trigger would not cause a singular solid length of bolus to extend out, which may inadvertently penetrate the oesophagus of the animal. Instead, a smaller length bolus, formed from a plurality of linked mini-boluses, would emerge and drop out of the retention 10 device before it could reach or be forced into the oesophagus. Thus, pulling the trigger will cause a sequential dropping of mini-boluses into the animal's stomach.

One aspect of the present invention includes a bolus applicator configured to hold multiple mini-boluses.

The mini-boluses should be understood to be linked and spaced from each other 15 using a flexible material in such a way that the linked mini-boluses create a treatment device in the form of a single articulated object.

For example, the mini-boluses may be linked using a strip of flexible material such as a tape placed along an external surface of the boluses to hold the boluses together. As the tape is flexible, the boluses are able to move with respect to each other. Thus, 20 on application of the present invention to the animal, the bolus would bend or otherwise naturally re-orientate itself if it meets an obstruction such as the back of the 7 James & Wells Ref: 129969/47 animal's oesophagus.

The tape may come in various forms and, for example, may be paper or cellulose. Naturally, the tape will be made of a physiologically acceptable material to the animal, and preferably can disintegrate within the animal's digestive system.

Persons skilled in the art will appreciate that it is likely that the application of the tape on one side of the mini-boluses could lead to the treatment device only being able to flex in one orientation. Therefore, care would be needed when aligning the bolus within the bolus applicator and the bolus applicator relative to the animal.

In other embodiments of the present invention, the flexible material may be a length 10 of string or the like temporarily bonded or fixed to the external surface of the mini-boluses. This may allow the device to flex in a number of different orientations, although it will be recognised that, as with the use of tape, the placement of the string may limit the ability of the device to flex in some orientations. In both instances, this may be offset to some degree by increasing the spacing between each mini-bolus.

In this embodiment of the invention, the flexible and/or bonding material will be made of a physiologically acceptable material to the animal.

In some embodiments of the present invention, the mini-boluses may be formed and moulded with the flexible material partially or fully embedded in each mini-bolus. As the mini-boluses erode due to contact with rumen material, this gradually frees the 20 flexible material and allows the mini-boluses to separate in the rumen.

The separation of the mini-boluses in the rumen often has a useful side effect in that the now separated mini-boluses may knock against each other in the rumen. This can accelerate the disintegration rate of the mini-boluses. 8 James & Wells Ref: 129969/47 In preferred embodiments of the present invention, the articulation may be provided by a length of flexible material such as a string being passed through an aperture in the interior of each of the mini-boluses to link them together in a single articulated device.

In preferred embodiments, the string is positioned along the central axis of the mini-boluses so that they are aligned to provide the least possible width that may hamper ease of application to the animals.

It should be noted that by having the flexible length of material internal to the boluses, rather than external - greater degrees of flexibility are possible with the bolus being 10 able to articulate in many directions, as opposed to some embodiments of the present invention in which the flexible material is positioned off-centre such that orientation of the device may be limited to certain directions.

It should be understood that each mini-bolus is provided with a head and tail.

In preferred embodiments of the present invention, each mini-bolus has an elongate, 15 capsule like shape such that the head and tail may be easily defined by the user.

In preferred embodiments of the present invention, at least one end of each mini-bolus is essentially rounded so that if there is any contact with the soft tissue of the animal's oesophagus or throat, there is less chance of penetration or other injury to the animal. The rounded end of each mini-bolus should be understood to be the head 20 of the mini-bolus.

In preferred embodiments of the present invention, the tail of the mini-bolus is concave, such that it is complementary to the rounded head of the mini-bolus. Persons skilled in the art will appreciate that the head of each mini-bolus partially 9 James & Wells Ref: 129969/47 nestles in the tail of the neighbouring or adjacent mini-bolus (except of course the leading mini-bolus).

Having rounded heads and concave tails of the mini-boluses shaped such they are complementary means that the device can be articulated in a number of different 5 orientations. Persons skilled in the art will appreciate that other shaped configurations may be used for the heads and tails of the mini-boluses so long as they shaped such that risk of penetration or injury to the soft tissue of the oesophagus is minimal.

The spatial separation of each mini-bolus from its adjacent mini-bolus is intended to 10 be such that each mini-bolus loosely abuts and bears against the adjacent mini-bolus. This allows the treatment device to remain in a substantially whole but flexible form. This also allows the treatment device to be packaged as compactly as possible but without risk of entangling the mini-boluses.

It should be appreciated that increasing the spatial separation of adjacent mini-15 boluses may increase the overall degree of articulation of the device so long as each mini-bolus is able, to a degree, to bear upon its neighbouring mini-bolus. This means the device essentially remains a single articulated object.

If the mini-boluses were spatially separated from each other such that they no longer bear against each other, the flexible material that links the mini-boluses may collapse 20 or otherwise allow the bunching, agglomeration or entanglement of the mini-boluses. The device cannot be said to be a single articulated object. This may complicate the delivery of the treatment device or affect dissolution rates of the mini-boluses if they were to become entangled in the rumen.

In preferred embodiments of the present invention, each mini-bolus is identical in size James & Wells Ref: 129969/47 and shape, regardless of whether it is the lead mini-bolus, one of the middle mini-boluses or the last mini-bolus. It will be appreciated that this means the mini-boluses can be formed from a single bolus or tablet moulding for ease of manufacture and assembly.

Any number of mini-boluses may be used in accordance with the present invention. However, the inventor has determined that a treatment device formed from approximately four mini-boluses provides the degree of flexibility, for safe delivery to the animal, and size, for the required dissolution within the rumen.

It is envisaged that the mini-boluses will be of similar composition to the traditional 10 larger boluses. However, different surface area to volume ratios may arise as a consequence of having mini-boluses rather than a large bolus. This may mean that alternate coating designs may be used, for example greater thickness, less solubility and so forth.

In an alternative embodiment of the present invention, there is provided a solid 15 treatment device which has a degree of flexibility allowing the device to bend at least at an angle commensurate with the curvature of the oesophagus of the animal to be treated.

For example, the binder in the bolus manufacture may contain sufficient plasticizer such that the bolus can bend if it encounters an obstruction such as the back of the 20 oesophagus.

It should be appreciated that the present invention has a number of advantages over the prior art.

The present invention allows for a typical dosing regime to be implemented by being 11 James & Wells Ref: 129969/47 able to insert in one application a device that delivers the full amount of treatment required into the rumen of animals.

The use of discrete boluses, whether articulated or not with respect to each other, overcomes the previous problem of risk of penetration or other injury to the soft tissue 5 of the oesophagus of the animal being treated.

Likewise, the alternative embodiment of the present invention of a flexible bolus, whether through using tape or string on multiple boluses or use of a plasticizer, also addresses this problem.

BRIEF DESCRIPTION OF THE 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: Figure 1 is a diagrammatic side view of one embodiment of the present invention; and Figure 2 is a diagrammatic side view of another embodiment of the present invention; and Figure 3 is a diagrammatic side view of yet another embodiment of the present invention.

BEST MODES FOR CARRYING OUT THE INVENTION With respect to the figure, there is illustrated a solid treatment device generally indicated by arrow 1 in accordance with one embodiment of the present invention. The solid treatment device (1) will now be referred to as a bolus. 12 James & Wells Ref: 129969/47 The illustrated bolus (1) is comprised of three discrete mini-boluses (2, 3, 4) which are attached together by a length of flexible material in the form of string (5) passing through an aperture (not shown) along the central axis of each mini-bolus (2, 3, 4).

Each mini-bolus (2, 3, 4) is comprised of substantially the same material as would 5 normally be used with a traditional larger bolus for the same treatment. However, the number of mini-boluses (2, 3, 4) is such that the total amount of treatment substance contained within in them is equivalent to a larger treatment bolus.

The string (5) is made of medical grade material and passes through the central longitudinal axis of the mini-boluses (2, 3, 4) to align them. The string (5) is either 10 made of a biodegradable product which will dissolve within the rumen of the animal (not shown) or of a composition that can be readily passed through the digestive tract of the animal.

Each mini-bolus (2, 3, 4) has a head (6) and a tail (7). The head (6), which is rounded to minimise risk of penetration of the soft tissue of the oesophagus of the 15 animal (not shown) being treated, is complementary to the tail (7) such that each mini-boluses (2, 3, 4) partially nestles in the adjacent mini-bolus.

The combination of the flexible string (5) and the mini boluses (2, 3, 4) enables the bolus (1) to flex in a number of directions. Thus, administration of the bolus (1) into the animal (not shown) is less likely to cause harm as the bolus (1) will flex as soon 20 as it meets an obstruction.

Turning now to Figure 2, an alternative embodiment of the invention (8) is illustrated, in which the flexible material is a length of adhesive tape (9) attached to the exterior surfaces of the mini-boluses (10, 11, 12). In this embodiment, the flexing of the bolus favours the side of the bolus (8) to which the tape is attached. 13 James & Wells Ref: 129969/47 Similarly, the embodiment of the invention (13) illustrated in Figure 3 has a limited degree of flex due to the position of the flexible material (14). In this embodiment, the flexible material is string (14) which has been embedded in the mini-boluses (15, 16, 17) as they have been moulded.

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. 14

Claims (13)

Received at IPONZ on 4 May 2012 James & Wells Ref: 129969/47 WHAT l/WE CLAIM IS:

1. A treatment device, wherein the treatment device includes: a plurality of discrete solid treatment devices linked to each other, wherein each discrete solid treatment device is a mini-bolus, and flexible material linking the mini-boluses, characterised in that each mini-bolus is configured with a head and a tail, wherein the heads and tails of adjacent mini-boluses are spaced and configured to be at least partially nested such that the treatment device is in the form of a single articulated object, the object being able to be articulated in a plurality of different orientations.

2. A treatment device as claimed in claim 1 wherein the head of each mini-bolus is rounded.

3. A treatment device as claimed in either claim 1 or claim 2 wherein the tail of each mini-bolus is concave.

4. A treatment device as claimed in any one of claims 1 to 3 wherein the flexible material is string.

5. A treatment device as claimed in any one of claims 1 to 3 wherein the flexible material is a length of plastic.

6. A treatment device as claimed in any one of claims 1 to 3 wherein the flexible material is a length of adhesive tape.

7. A mini-bolus for use with the treatment device as claimed in any one of claims 1 15 Received at IPONZ on 4 May 2012 James & Wells Ref: 129969/47 to 4, characterised in that the mini-bolus is configured with an aperture passing through its interior, such that a flexible material can be passed through the interior of the mini-bolus, wherein the mini bolus has a head and a tail, wherein the head and tail is configured to be complementary to each other such that in use, the head of the mini-bolus is at least partially nested in the tail of an adjacent mini-bolus, such that the treatment device is in the form of a single articulated object, the object being able to be articulated in a plurality of different orientations.

8, A discrete solid treatment device as claimed in claim 7 wherein the head of each discrete solid treatment device is rounded.

9, A discrete treatment device as claimed in either claim 7 or claim 8 wherein the tail of each discrete solid treatment device is concave.

10, A method of delivering a full dose of a solid treatment substance internally to a non-human animal, the method including the step of: a) delivering to the animal a plurality of linked discrete solid treatment devices in a treatment device, wherein the accumulative total of the discrete solid treatment devices contain the full dose of treatment substance required, and wherein the solid treatment devices are mini-boluses, the method characterised by the additional step of: b) configuring the treatment device such that each mini bolus has a head and a tail, wherein the heads and tails of adjacent mini-boluses are 16 Received at IPONZ on 4 May 2012 James & Wells Ref: 129969/47 spaced and configured to be at least partially nested such that the treatment device is in the form of a single articulated object, the object being able to be articulated in a plurality of different orientations.

11. A treatment device substantially as herein described with reference to and as illustrated by the accompanying figures.

12. A discrete solid treatment device substantially as herein described with reference to and as illustrated by the accompanying figures.

13. A method of delivering a full dose of a solid treatment substance internally to a non-human animal substantially as herein described with reference to and as illustrated by the accompanying figures. 17