WO2021058669A1

WO2021058669A1 - A device and method for preventing infections during the drying off of livestock

Info

Publication number: WO2021058669A1
Application number: PCT/EP2020/076767
Authority: WO
Inventors: Colin Sutherland; Joseph O'reilly
Original assignee: Colin Sutherland; Oreilly Joseph
Priority date: 2019-09-24
Filing date: 2020-09-24
Publication date: 2021-04-01
Also published as: GB201913741D0; GB2590890A

Abstract

The device includes a sealing balloon (100) and an associated delivery syringe device (120). The sealing balloon (100) has a proximal end (102) which has an opening, and, a distal end (104) which is sealed. Two O-rings (106a, 106b) are located on the sealing balloon (100), Whilst the sealing balloon (100) is mounted on the delivery syringe device (120), the O-rings (106a, 106b) are maintained in an expanded state by the delivery syringe device (120) which allows the sealing balloon (100) to be inflated whilst it is mounted on the delivery syringe device (120). When the O-rings (106a, 106b) have been released from the delivery syringe device (120), they will dose into their contracted state thus sealing off the sealing balloon (100) and maintaining the sealing balloon (100) in an inflated state if it is already inflated. The delivery syringe device (120) comprises a delivery syringe (122) and an elongate balloon-mounting lance (124). The delivery syringe (122) comprises a plunger (126), finger grips (128) and a nozzle (130). The nozzle (130) preferably comprises a male luer connector. The elongate balloon-mounting lance (124) has a complementary co- operating female luer connector.

Description

“A Device and Method for Preventing Infections During the Drying Off of

Livestock”

Introduction

This invention relates to a device and method suitable for preventing or at least mitigating against, infections from occurring in livestock, and in particular dairy cows, during their drying off period.

There are approximately 270 million dairy cows in the world. Best practice for the management of milk production is to provide a drying off period to each dairy cow. This will facilitate good milk production after the drying off period has finished.

The drying off period is the period of time which a dairy cow is not milked. Typically the drying off period will last for sixty days. During this time, the dairy cow will cease lactating. The mammary gland of the dairy cow requires such a non-lactating period, or dry period, prior to calving in order to optimise the production of milk in the lactation period which follows on from calving.

The dry period is measured from the time when milk removal is ceased, which is known as milk stasis, until the subsequent calving. As mentioned above, it will normally last for sixty days but can be in the region of forty to seventy days depending on circumstances.

The normal procedure to dry off a cow is to withdraw all grain and reduce the water supply several days before the dry period is to be commenced. The effect of withdrawing all grain and water is that there will be a drastic reduction in the milk production during that time. Milking is then halted about 45 to 50 days before expected date of parturition.

Dairy cows can suffer from different types of infections, such as mastitis and this affects the milk production and milk quality. Mastitis in dairy cows is estimated to cost the industry approximately €3.5 billion per annum. There are two types of mastitis: contagious mastitis (staphylococcus aureus bacteria) and environmental mastitis (streptococcus uberis bacteria). The presence of the bacteria can occasionally show up as clotting in the milk, but this is not always the case and infections in milk produced and shipped from a farm may only be caught at a later stage, which is of a large cost to the farmer and to the industry generally.

There are different action plans which have been developed over time for avoiding mastitis infections and managing mastitis infections which have developed. These action points include hygienic teat management, where the teats of livestock are disinfected on a regular basis and the equipment coming into contact with the teats is also disinfected regularly. This prevents the spread of infections. A further action point relates to diligent and prompt milk recording which will assist in identifying mastitis in dairy cows at an early stage and thus allow treatment using antibiotics. Chronically infected dairy cows may have to be culled in order to manage the mastitis infections. Whilst all of the above action points are important in the avoidance, management and treatment of mastitis infections, it will be appreciated that dry cow therapy (which is the treatment of dairy cows during their drying off period) is most important. This is due in part to the fact that 80% to 70% of mastitis infections occur during the drying off period and therefore effective mastitis infection avoidance and prevention during the drying off period will greatly assist in managing the infection.

The present invention is directed towards this dry cow therapy and in particular a device for use for dry cow therapy. Dairy cows have a natural defence to mastitis infections which could occur during the drying off period. This natural defence develops at the beginning of the drying off period but it can take up to 10 days after the drying off period has commenced in order for the natural defences to take full effect. The natural defence take effect through closure of a sphincter muscle in a teat canal of the teat being dried off and also through the development of a keratin plug (wax like substance) in the teat cistern of the teat being dried off. During this time period where the natural defences have not yet taken effect but the drying off period has begun, mastitis infections can easily develop in the teat so it is desirable to have a therapy method which has a more immediate effect than the natural defences which the dairy cow can produce. One such more immediate effect, known from the prior art, is to use a sealant to block the teat cistern at the commencement of the drying off period. Such sealants are already sold on the market and typically an application syringe will contain approximately 4g of an intra-mammary infusion. When the drying off period is to commence, the teat is disinfected and then the sealant is applied into the teat cistern. A farmer will usually be the person to apply the sealant into the teat cistern. It is a little bit troublesome and difficult to apply the sealant correctly. The sealant is injected from a syringe through teat canal and into the teat cistern. In order to ensure that the sealant remains in the teat cistern, and does not travel too far up into the gland cistern where it is ineffective against preventing intra-mammary infections (IMI), the person applying the sealant must use the correct pressure on the syringe and pinch off one end of the teat cistern (adjacent a cisternal ringfold). The farmer must squeeze the sealant delivering syringe with just enough force to ensure that the sealant will travel up through the teat canal and into the teat cistern up to the pinched off point in the teat cistern, but not further. Use of excessive force would cause the sealant to push past the pinch off point at the top of the leaf cistern and enter the gland cistern, where it is less effective.

When one considers that a farmer will likely have to apply a large number of sealants to their herd of dairy cows, it is easy to contemplate how the misapplication of the sealant will occur. As the application of the sealant into the teat is somewhat awkward and requires some time to be taken over it, it can be easily seen how a farmer would look to complete the task quickly by rushing it and misapplying the sealant. Misapplied sealant can enter the gland cistern where it is less effective at preventing mastitis infections and/or can easily fall out of the teat cistern at a later stage if a sufficient amount is not injected into the teat cistern. The misapplication of the sealant is easily done as it is contrary to the manner in which farmers have been applying other mastitis prevention and treatment to the teats. The application of the sealant must be done differently to the application of a normal dry cow antibiotic. The normal dry cow antibiotic is typically injected completely through the teat cistern and into the gland cistern where it acts against the infection, and farmers will therefore be used to applying the antibiotic to their dairy cows in this fashion.

A further problem with using sealants is that the sealants are not easily removed when it is time to terminate the drying off period for the dairy cow. The sealant, which will have formed into a hardened mass of sealant material, must be squeezed out through the teat canal. It is common for the sealant to break up when it is being removed. As the sealant must be removed fully to ensure that it does not contaminate any milk produced subsequently, if the sealant breaks up during its removal, it becomes very difficult and time consuming for the farmer to spend additional time working on the teat to ensure that the sealant has been fully removed from the teat.

Throughout this specification, the term “dairy cow” shall be understood to encompass any type of cow which could benefit from sealing off of their teat - it may not be strictly limited to lactating cows. Indeed, the present invention is equally envisaged to be easily applicable to other types of livestock which have teats that need to be temporarily sealed and/or orifices which need to be temporarily blocked. It is a goal of the present invention to provide a device and method of use of same that overcomes at least one of the above mentioned problems.

Summary of the Invention

According to the invention there is provided a sealing balloon suitable for insertion into a teat cistern of a dairy cow in order to seal the teat cistern when the sealing balloon is inflated, the sealing balloon including an elongate tubular body having an internal blind bore with an opening at one end and being closed at the other end, the body having a non-inflatable neck portion and an inflatable head portion; the opening being at a free inner end of the neck portion, and a valve mounted on the neck portion which is operable to seal the neck portion.

In one embodiment of the invention the head portion is movable between a collapsed position of similar diameter to the neck portion and an expanded position of greater diameter than the neck portion.

In another embodiment the head portion is adapted to substantially fill a teat cistern when inflated in use within the teat cistern.

In another embodiment the valve is a non-return valve for delivery of balloon expansion fluid into the tubular body.

In another embodiment the valve is mounted within a valve housing, a connector on the valve housing for connection to a balloon inflation device for the head portion of the body, the body being mounted on the valve housing at an outlet of the valve.

In another embodiment an insertion lance is mounted centrally within the body, having an outer end attached to an outer end of the head portion and a free inner end,

In another embodiment the valve comprises at least one O-ring mounted on the neck portion which extends around and clamps the neck portion, urging the neck portion towards a pinched closed position. In another embodiment the O-ring is positioned on the neck portion to correctly locate the head portion within a teat cistern when the O-ring engages an outer end of the teat canal.

In another embodiment the body further includes a second inflatable portion on the neck portion spaced-apart from the head portion.

In another embodiment anti-microbial material is provided on an exterior of the neck portion The present invention is directed to a sealing balloon suitable for insertion into a teat cistern of a dairy cow in order to seal the teat cistern when the sealing balloon is inflated. The present invention is further directed to such a sealing balloon, the sealing balloon comprising a non-inflatable neck portion and an inflatable head portion; the non-inflatable neck portion comprises a lower opening at a proximal end of the neck portion and an upper opening at a distal end of the neck portion; the inflatable head portion comprises a lower opening at a proximal end of the head portion and an upper seated end at a distal end of the head portion; the lower opening of the head portion being connected to the upper opening of the neck portion so as to allow a gas to pass through the neck portion into the head portion in order to inflate the inflatable head portion; wherein, the neck portion comprises at least one O-ring which is located adjacent the lower opening of the neck portion and which is biased towards a contracted state which is suitable for closing the neck portion of the sealing balloon so as to maintain the head portion of the sealing balloon in an inflated state.

The advantage of providing the sealing balloon in this manner is that the O-ring can be used to close off the inflated sealing balloon. The O-ring will sit around the non- inffatable neck portion of the sealing balloon and may be stretched into an expanded state so as to allow a gas to pass through the non-inflatabie neck portion of the sealing balloon when the O-ring is in its expanded state. However, once the O-ring is released from this enforced expanded state, it will be biased to shrink into a contracted state such that it will close off the sealing balloon and maintain the inflated head portion of the sealing balloon in an inflated state.

In a further embodiment, the non-inflatable neck portion comprises a substantially tubular shape. In a further embodiment, the inflatable head portion comprises a substantially tubular shape. In a further embodiment, the inflatable head portion is substantially spherocylindrical in shape. The spherocylindrical shape is seen to be particularly advantageous for fitting the inflatable head portion within the teat cistern of a teat to be sealed off.

In a further embodiment, the inflatable head portion comprises a substantially tubular shape in its deflated state and in its inflated state, such that a diameter of the tubular shape of the inflatable head portion in its deflated state is approximately equal to a diameter of the tubular shape of the non-inflatable neck portion, and, a diameter of the tubular shape of the inflatable head portion in its inflated state is greater than the diameter of the tubular shape of the non-inflatable neck portion. The advantage of providing the diameter of the tubular shape of the inflatable head portion in its deflated state is approximately equal to a diameter of the tubular shape of the non-inflatable neck portion is to allow the deflated sealing balloon to be easily inserted into the teat of the dairy cow. Subsequently, a portion of the sealing balloon can be inflated to seal off the teat cistern whilst a portion of the sealing balloon remains protruding from the teat canal of the teat to facilitate removal of the sealing balloon from the teat,

In a further embodiment, the diameter of the tubular shape of the inflatable head portion in its inflated state is in the range of three times to five times greater than the diameter of the tubular shape of the inflatable head portion in its deflated state.

The present invention is further directed towards a delivery syringe device suitable for mounting a sealing balloon as claimed in any preceding claims, wherein, the delivery syringe device comprises a delivery syringe and an elongate balloon- mounting lance, whereby, the elongate balloon-mounting lance comprises a female luer connector at one end and the delivery syringe comprises a male luer connector, The advantage of providing the elongate balloon-mounting lance is that the elongate balloon-mounting lance can be used to mount the sealing balloon and can assist in inserting the deflated sealing balloon into the teat.

In a further embodiment, the elongate balloon-mounting lance is tapered.

In a further embodiment, the elongate balloon-mounting lance comprises a free end which opposes the female luer connector end and the elongate balloon-mounting lance tapers inwardly towards the free end of the elongate balloon-mounting lance. The present invention is further directed towards an elongate balloon-mounting iance suitable for mounting a sealing balloon as claimed in any preceding claims, wherein, the elongate balloon-mounting Iance, whereby, the elongate balloon- mounting lance comprises a female luer connector at one end and a free end which opposes the female luer connector end, and, the elongate balloon-mounting lance tapers inwardly towards the free end of the elongate balloon-mounting Iance.

The present invention is further directed towards a method of sealing a teat of a dairy cow using a sealing balloon, wherein, the method comprises the steps of: inserting the sealing balloon, in its deflated state, partially into a teat cistern of the teat of the dairy cow using an elongate balloon-mounting lance which is also partially inserted into the teat of the dairy cow; inflating the sealing balloon within the teat cistern of the teat of the dairy cow by passing a gas through the elongate balloon-mounting lance; and, removing the elongate balloon-mounting lance from the teat of the dairy cow so as to leave the inflated sealing balloon partially within the teat cistern of the teat of the dairy cow.

In a further embodiment, the sealing balloon comprises non-inflatable neck portion and an inflatable head portion, and the method step of inflating the sealing balloon within the teat cistern of the teat of the dairy cow comprises inflating the inflatable head portion within the teat cistern of the teat of the dairy cow.

In a further embodiment, the method step of removing the elongate balloon- mounting lance from the teat of the dairy cow comprises leaving a part or all of the non-inflatable neck portion of the sealing balloon protruding from the teat of the dairy cow to facilitate removal of the sealing balloon from the teat cistern of the teat of the dairy cow.

In a further embodiment, the method step of opening the non-inflatable neck portion of the sealing balloon comprises the method step of removing at least one O-ring from the neck portion; whereby the O-ring is located adjacent a lower opening of the neck portion and the O-ring is suitable for closing the neck portion of the sealing balloon so as to maintain the head portion of the sealing balloon in an inflated state.

In a further embodiment, the method step of inserting the sealing balloon, in its deflated state, partially into a teat cistern of the teat of the dairy cow comprises inserting the inflatable head portion of the sealing balloon into the teat cistern and leaving a section of the non-inflatable neck portion protruding from the teat of the dairy cow.

The advantage of leaving a section of the non-inflatable neck portion protruding from the teat of the dairy cow is that the sealing balloon can be relatively easily removed from the teat it is placed within. As the seating balloon is made of one material and will be deflated for removal, it is highly unlikely to break up and therefore the farmer can be assured that the sealing balloon will be removed in its entirety from the teat and thus avoid any possibility of contamination of subsequent milk produced from that teat,

In a further embodiment, the method comprises the further step of removing an O- ring located on the sealing balloon in order to facilitate the deflation of the sealing balloon so that the sealing balloon may be removed from the teat cistern of the teat of the dairy cow.

Detailed Description of Embodiments

The invention will be more clearly understood from the following description of some embodiments thereof, given by way of example only, with reference to the accompanying drawings, in which:

Figure 1 is a perspective view of a deflated sealing balloon in accordance with the present invention, mounted on a delivery syringe device; Figure 2 is a perspective view of the sealing balloon of Figure 1, in its inflated state, mounted on the delivery syringe device;

Figure 3a is a diagrammatic view of an udder of a dairy cow; Figure 3b is a diagrammatic detail view of a teat of a dairy cow;

Figure 4 is a perspective view of a sealing balloon of Figure 1 being removed from the delivery syringe device; Figure 5a is a side view of a delivery syringe with a male fuer connector;

Figure 5b is a perspective view of an elongate balloon-mounting lance having a female luer connector; Figure 6a is a perspective view of a sealing balloon in accordance with the present invention, in its deflated state;

Figure 6b is a perspective view of the sealing balloon of Figure 6a, in its inflated state;

Figure 7a is a diagrammatic view of the delivery syringe device of Figures 5a and 5b, inserting the sealing balloon of Figure 6a into a teat cistern of a dairy cow, in accordance with one use of an aspect of the present invention;

Figure 7b is a diagrammatic view of the delivery syringe device of Figure 7a inflating the sealing balloon of Figure 7a in the teat cistern of the dairy cow;

Figure 7c is a diagrammatic view of the delivery syringe device of Figure 7a being removed, after having inflated the sealing balloon of Figure 7a in the teat cistern of the dairy cow;

Figure 7d is a diagrammatic view of the delivery syringe device of Figure 7a fully removed from the teat cistern of the dairy cow, leaving the inflated sealing balloon of Figure 7a in the teat cistern of the dairy cow;

Figure 7e is a diagrammatic view of the sealing balloon of Figure 7a being deflated in the teat cistern of the dairy cow; Figure 7f is a diagrammatic view of the sealing balloon of Figure 7a, fully deflated, being removed from the teat cistern of the dairy cow;

Figure 8 is a schematic illustration of another sealing balloon apparatus according to the invention; and

Figure 9 is a schematic illustration of a further sealing balloon apparatus of the invention.

Referring to Figure 1 , there is provided a delivery syringe device mounting a sealing balloon in accordance with the present invention. The sealing balloon is indicated generally by reference numeral 100. The delivery syringe device is indicated generally by reference numeral 120 and forms a balloon inflation device. The sealing balloon 100 comprises a proximal end indicated generally by reference numeral 102 which has an opening, and, a distal end which is indicated generally by reference numeral 104 which is sealed. In the present embodiment, two O-rings 106a, 106b are located on the sealing balloon 100. In the present embodiment, there is a distal O-ring 106a and a proximal O-ring 106b. It will be appreciated that in alternative embodiments, one or more O-rings may be used in place of the two O- rings 106a, 106b shown in the present embodiment The O-rings 106a, 106b are self-sealing O-rings 106a, 106b which are dimensioned and manufactured to close into a contracted state and create an air-tight seal for the sealing balloon 100. As shown in Figure 1 , whilst the sealing balloon 100 is mounted on the delivery syringe device 120, the O-rings 106a, 106b are maintained in an expanded state by the delivery syringe device 120. Keeping the O-rings 106a, 106b in an expanded state allows the sealing balloon to be inflated, whilst it is mounted on the delivery syringe device 120. When the O-rings 106a, 106b have been released from the delivery syringe device 120, they will close into their contracted state thus sealing off the sealing balloon 100 and maintaining the sealing balloon 100 in an inflated state if it is already inflated.

The delivery syringe device 120 comprises a delivery syringe 122 and an elongate balloon-mounting lance 124. The delivery syringe 122 comprises a plunger 126, finger grips 128 and a nozzle 130, as are all known in the art. The nozzle 130 preferably comprises a male luer connector. Such luer connectors are generally push-luer connectors or lock-luer connectors and are generally known in the art; either can be used in conjunction with the present invention. The elongate balloon- mounting lance 124 has at its inner end 132 which engages the nozzle 130 a complementary co-operating female luer connector. It will be appreciated that the male and female luer connectors may be located vice versa, such that the nozzle 130 comprises a female luer connector and the elongate balloon-mounting lance 124 comprises a male luer connector. Figure 2 shows the sealing balloon 100 in its inflated state. The sealing balloon 100 comprises a non-inflatable neck portion 200 and an inflatable head portion 202. The O-rings 106a, 106b are positioned on the non-inflatable neck portion 200, adjacent the proximal end 102 of the sealing balloon 100. It will be appreciated that the elongate balloon-mounting lance 124 mounts the sealing balloon 100 and at the same time, stretches the O-rtngs 106a, 106b into an expanded state. Once the sealing balloon 100 is released off the elongate balloon-mounting lance 124, the Cu- rings 106a, 106b will act to contract on the neck portion 200, forming a substantially air-tight seal or stop valve so as to close off and seal the sealing balloon 100.

Figure 4 shows a sealing balloon 100 of the present invention being removed from the delivery syringe device 120. The distal end of the elongate balloon-mounting lance 124 is shown being removed from the opening at the proximal end 102 of the sealing balloon 100. The O-rings 106a, 106b will contract as this happens to close the neck portion 200..

Returning to Figure 2, when the sealing balloon 100 is mounted on the elongate balloon-mounting lance 124, as mentioned above, the elongate balloon-mounting lance 124 will hold the O-rings 106a, 106b in an expanded state. The elongate balloon-mounting lance 124 comprises a central axial through passage which allows a gas or fluid from the delivery syringe 122 to be passed through the elongate balloon-mounting lance 124 and into the sealing balloon 100, causing the inflatable head portion 202 of the sealing balloon 100 to be inflated. The operation of the present invention will be discussed in greater detail with reference to Figures 7a-7f

The sealing balloon 100 is designed to be inserted into a teat cistern of a teat of a dairy cow, and inflated so as to seal off the teat cistern. In this manner, by sealing off the teat cistern, the potential for the dairy cow to contract an infection during the drying off period is significantly reduced.

Looking at Figure 3a, the anatomy of a dairy cow's udder 300 is shown. The udder 300 supports a plurality of teats 302. Each teat comprises a teat cistern 304 which is connected to a gland cistern 306. Milk ducts 308 feed into the gland cistern 306.

Turing to Figure 3b, the anatomy of a single teat 302 is shown in greater detail and it can be seen that within the teat 302, a teat canal 310 forms the outlet of the teat 302. There is a sphincter muscle 312 around the teat canal 310 which controls the opening of the teat canal. This sphincter muscle forms part of a dairy cow’s natural defence against mastitis infections during a drying off period, but can take up to 10 days to close off the teat 302. A cisternal ringfold 314 is located intermediate the teat cistern 304 and the gland cistern 306. When using a sealant from the prior art, a farmer would need to pinch off the teat 302 adjacent this cisternal ringfold 314.

It will be appreciated that the object of the present invention is to seal the teat cistern 304 so as to prevent a mastitis infection from developing in the gland cistern 306, the milk ducts 308 and/or the teat cistern 304.

Referring now to Figure 5a, there is provided a delivery syringe, indicated generally by reference numeral 122, as is well known in the art. The delivery syringe 122 comprises a tubular body 500 housing the plunger 126. Finger grips 128 extend outwardly from the tubular body 500 at one end of the tubular body 500 at an outer end of the body 500 adjacent the plunger 126. The tubular body 500 transitions at an inner end of the body 500 into a tapered nozzle 130 which locates a luer connector 502. The luer connector 502 may be a male luer connector or a female luer connector and the luer connector 502 may be a push-luer connector or a lock-luer connector, as described supra.

A further important aspect relating to the present invention is the use of the elongate balloon-mounting lance 124 which mounts the sealing balloon 100 of the present invention. The elongate balloon-mounting lance 124 is shown in Figure 5b. The elongate balloon-mounting lance 124 mounts the sealing balloon (not shown in Figure 5b) and assists with inserting at least the inflatable head portion of the sealing balloon into a teat 302 to be sealed off. The elongate balloon-mounting lance 124 comprises a luer connector 504. As above, the luer connector 504 may be a male luer connector or a female lure connector, and, the luer connector may be a push-luer connector or a lock-luer connector. The luer connector 504 of the elongate balloon-mounting lance 124 will act in a complementary co-operating fashion with the luer connector 502 of the delivery syringe 122 to mount the elongate balloon-mounting lance 124 on the nozzle 130. The luer connector 504 is connected to an intermediate tapering portion 506 which in turn is connected to an elongate tubular lance portion 508. The elongate lance portion 508 is tapered inwardly towards its distal end indicated generally by reference numeral 510. A through channel extends between the luer connector 504, which has open ends, and the distal end 510 of the elongate lance portion 508. In this manner, a gas or fluid may be pushed through the elongate balloon-mounting lance 124. It will be appreciated that when the elongate balloon-mounting lance 124 is attached to the delivery syringe 122, depressing the plunger 126 into the tubular body 500 of the delivery syringe 122 will cause a gas/fluid present in the tubular body 500 of the delivery syringe 122 to be expelled out of the distal end 510 of the elongate balloon-mounting lance 124. When the sealing balloon 100 is mounted over the elongate lance portion 508 of the elongate balloon-mounting lance 124, pressing the plunger 126 into the tubular body 500 of the delivery syringe 122 will cause the sealing balloon 100 to be inflated. The elongate balloon-mounting lance 124 may be preferably made using a moulded plastics material.

It is anticipated that approximately 5ml of a fluid/gas may be expelled from the delivery syringe device 120 through the distal end 510 of the elongate balloon- mounting lance 124 in order to inflate the sealing balloon 100. Various different types of gases and fluids are envisaged to be used, as discussed further hereinafter.

Turning now to Figures 6a and 6b respectively, the sealing balloon 100 is shown in its deflated state and inflated state respectively. The sealing balloon 100 comprises an open proximal end 102 and a sealed distal end indicated generally by reference numeral 104. The open proximal end 102 is preferably flanged. The sealing balloon 100 is elongated and comprises a similar diameter continuously along its longitudinal axial length, when in its deflated state. The sealing balloon 100 comprises a non- inf!atable neck portion 200 and the inflatable head portion 202. The diameters of the non-inflatab!e neck portion 200 and an inflatable head portion 202 will be similar when the inflatable head portion 202 is in its deflated state. The inflatable head portion 202 is located adjacent the sealed distal end 104 of the sealing balloon 100 and the non-inflatable neck portion 200 is located adjacent the open proximal end 102 of the sealing balloon 100 Grooves 600 for accepting the O-rings 106a, 106b are provided on the non-inflatable neck portion 200 of the sealing ring 100,

The O-rings 106a, 106b are of standard construction, such that they are substantially toroidal in shape. The O-rings 106a, 106b are so dimensioned and constructed of an appropriately flexible material that the O-rings 106a, 106b will be stretched into an extended state when the sealing balloon 100 is mounted on the elongate balloon- mounting lance 124, and, will return into a contracted stale when the sealing balloon 100 is released from the elongate balloon-mounting lance 124, When the sealing balloon 100 is mounted on the elongate balloon-mounting lance 124, the O-rings will be stretched over and around the circumference of the elongate balloon-mounting lance 124 When the sealing balloon 100 is released off from its mounting on the elongate balloon-mounting lance 124, the O-rings 106a, 106b will contract to form an air-tight seal around the non-inflatable neck portion 200 of the sealing balloon 100.

The non-inflatable neck portion 200 and the inflatable head portion 202 are substantially tubular in shape. When the inflatable head portion 202 is deflated, it will have a dimeter which is similar to, such as to be approximately equal to, the diameter of the non-inflatable neck portion 200, taking account of a slight tapering along the longitudinal axis of the sealing balloon 100, where said tapering causes the proximal open end 102 to be wider in diameter than the seated distal end 104. In its inflated state, the inflatable head portion 202 of the sealing balloon 100 is dimensioned to form a sealing fit within a teat cistern 304 of a teat 302 In a preferred embodiment, the inflatable head portion 202, when inflated, will be substantially spherocylindrical in shape. A spherocylinder is also known as a capsule shape. The spherocylinder is envisaged to comprise a diameter which is in the range of 3 to 5 times the dimeter of the inflatable head portion 202 when it is deflated. The sealing balloon 100 is envisaged to be constructed of any elastic polymer based material. For example, the sealing balloon 100 may be constructed from polyvinyl chloride (PVC), nylon, polyether block amide such a Pebax® , polyurethane, ChronoPrene™, latex, rubber, polyethylene terephthalate or any combination thereof. In yet a further embodiment, whilst the disclosure of the present invention is predominately focussed on the use of an inflatable balloon, it will be appreciated that a self-expanding technology such as nitinol stent-like structures, or similar, may be used in place of a sealing balloon which has an inflatable head portion. A self- expanding head portion would be used in the stead of the inflatable head portion. A non-inflatable, or in this case, a non-self-expanding portion, would still be used. A sheath or such like may be used to maintain the self-expanding head portion in a contracted state, until the self-expanding head portion was in the teat cistern and was permitted to expand so as to form a seal within the teat.

With reference to Figures 7a to 7f, wherein like parts previously described have been assigned the same reference numerals, the use of the sealing balloon 100 and the delivery syringe device 120 are now described.

It is foreseen to package a single delivery syringe 122 with a plurality of sealing balloons 100 pre-mounted on a plurality of elongate balloon-mounting lances 124. In this way, a user will firstly connect the luer connector of the elongate balloon- mounting lance 124 to the luer connector of the delivery syringe 122 so as to form the delivery syringe device 120 with the sealing balloon 100 mounted thereon.

As shown in Figure 7a, the distal end of the sealing balloon 100 is then inserted through the teat canal 310 of a teat 302 such that the inflatable head portion 202 of the sealing balloon 100 will be positioned within the teat cistern 304. The distal O-ring 106a will be positioned on the non-inflatable neck portion 200 of the sealing balloon

100 at a location which will allow the distal O-ring 106a to act as a stopper, or indicator, for the user/farmer. Once the distal O-ring 106a comes into abutment with an exterior lip of the teat canal 310, the user can stop inserting the sealing balloon 100 mounted on the elongate balloon-mounting lance 124 into the teat 302. It wilt be appreciated that the location of the distal O-ring 106a on the non-inflatable neck portion will be selected so as to match with the average teat dimensions of a dairy cow.

Looking now at Figure 7b, it is shown that the inflatable head portion 202 of the sealing balloon 100 is inflated once it is within the teat cistern 304. Inflating the inflatable head portion 202 of the sealing balloon 100 is achieved by pressing down the plunger on the delivery syringe device 120. The delivery syringe 122 may be filed with air or a fluid such as an anti-bacterial fluid. This is advantageous should the sealing balloon 100 fail when inside the teat cistern 304. In a preferred embodiment, the inflated head portion 202 will take the form of a spherocylinder when inflated as this resembles the shape of the teat cistern which it is sealing off. In particular, the diameter of the spherocylinder, when inflated fully, shall be selected to be large enough to extend across the majority of teat cisterns in dairy cows. In a preferable embodiment, the dimeter of the spherocylinder will be in the range of 3mm to 7mm, and is preferably 5mm. In a preferable embodiment, the longitudinal length of the spherocylinder will be in the range of 7mm to 12mm, and is preferably approximately 9mm. It will be understood that alternatively shaped inflatable head portions, such as cylindrical shapes, spherical shapes, ring shapes and so on, are also foreseen to be utilised. The overall longitudinal length of the sealing balloon, when inflated shall be in the range of 17mm to 27mm, and is preferably approximately 23.5mm.

The inflatable head portion 202 or the entire sealing balloon 100 may be coated in an antibacterial fluid or an alternative fluid which may ease insertion into the teat cistern 304 and/or prevent infection within the teat 302.

As seen in Figures 7c and 7d, the sealing balloon 100 is removed from its mounting on the elongate balloon-mounting lance 124 when a user pulls the delivery syringe device 120 away from the teat 302. The expansion of the sealing balloon 100, and in particular the inflatable head portion 202 of the sealing balloon 100, within the teat cistern 304 prevents the sealing balloon 100 from being pulled out from the teat 302 as the delivery syringe device 120 is being pulled out from the teat 302. Once the elongate balloon-mounting lance 124 has been withdrawn past the location of the distal O-ring 108a on the non-inflatab!e neck portion 200, the distal O-ring 106a will contract and form an air-tight seal around the non-inflatabie neck portion 200. Likewise, as the elongate balloon-mounting lance 124 is withdrawn further, and the elongate balloon-mounting lance 124 has been withdrawn past the location of the proximal O-ring 106b on the non-inflatable neck portion 200, the proximal O-ring 106b will contract and form a second air-tight seal around the non-inflatable neck portion 200. The use of two O-rings 106a, 106b is for redundancy in the present invention, and it will be appreciated that just one may be used.

As seen in Figure 7d, the sealing balloon 100 is then left with the inflatable head portion 202 inside the teat cistern 304 of the teat 302 and thus seals off the teat cistern 304 in this manner. This greatly reduces the possibility of the teat cistern becoming infected. The sealing balloon 100 is inserted into the teat cistern 304 at the commencement of the drying off period. A part of the non-inflatable neck portion 200 is left protruding from the teat canal 310 of the teat 302. This will facilitate the removal of the sealing balloon 100 in due course.

When it is desired to remove the sealing balloon 100, which will usually be at the end of the drying off period, the O-rings 106a, 106B are pulled off or cut off and this will allow the sealing balloon 100 to deflate as shown in Figure 7e. In Figure 7f, with the sealing balloon 100 fully deflated, the sealing balloon 100 has been removed from the teat cistern 304 of the teat 302.

Referring now to Figure 8 another seating balloon device according to the invention is shown and indicated generally by the reference numeral 10, The device 10 has an elongate tubular body 11 with an internal blind bore 12 and an opening 13 at one end, the other end 14 being dosed. The body 11 has a non-inflatable neck portion 15 and an inflatable head portion 16. A one-way valve 17 is mounted on the neck portion 15. The valve 17 is mounted within a valve housing 18. A luer connector 19 on the valve housing 18 connects to the delivery syringe 122 as previously described. A funnel 20 extends outwardly from the valve housing 18. An inner end 21 of the neck portion 15 is bonded to the outer end of the funnel 20. An insertion lance 22 is mounted centrally within the body 11 having an outer end 25 attached to an inside face of the outer end 26 of the head portion 16. This facilitates deployment of the body 11 through the teat canal 310 to locate the inflatable head portion 16 within the teat cistern 304. An inner end 28 of the insertion lance 22 is free. The drawing shows the head portion 16 partially inflated. Prior to inflation the head portion is tightly sheathed against the lance 22 to facilitate insertion through the teat canal 310 into the teat cistern 304. When the head portion 16 is inflated within the teat cistern 304 the valve housing will hang down outside the teat 302 and the syringe 122 is disconnected from the luer connector 19,

If desired an anti-microbial coating may corer an exterior of the neck portion or a silver band could encircle the neck portion. Various other valve arrangements are possible which allow injection of inflating fluid into the head portion 16.

Figure 9 shows another sealing balloon device 30 having a second inflatable portion 31 spaced-apart from the inflatable head portion 16. This second inflatable portion locates against the outer end of the teat canal 310 upon insertion and inflation of the device 30 in use.

It will be appreciated that the use of the term "non-inflatable" throughout the preceding specification should be interpreted as being difficult to inflate, rather than strictly not inflatable. The non-inflatable neck portion 200 may inflate slightly when a fluid is delivered into the sealing balloon 100, but the amount of inflation will be marginal or almost imperceptible to the human eye.

The terms "comprise" and "include", and any variations thereof required for grammatical reasons, are to be considered as interchangeable and accorded the widest possible interpretation.

It will be understood that the components shown in any of the drawings are not necessarily drawn to scale, and, like parts shown in several drawings are designated the same reference numerals.

It will be further understood that features from any of the embodiments may be combined with alternative described embodiments, even if such a combination is not explicitly recited hereinbefore but would be understood to be technically feasible by the person skilled in the art.

The invention is not limited to the embodiments hereinbefore described which may be varied in both construction and detail within the scope of the appended claims.

Claims

1. A sealing balloon suitable for insertion into a teat cistern of a dairy cow in order to seal the teat cistern when the sealing balloon is inflated, the sealing balloon including an elongate tubular body having an internal blind bore with an opening at one end and being closed at the other end, the body having a non-inflatabie neck portion and an inflatable head portion; the opening being at a free inner end of the neck portion, and a valve mounted on the neck portion which is operable to seal the neck portion.

2. The sealing balloon as claimed in claim 1, wherein the head portion is movable between a collapsed position of similar diameter to the neck portion and an expanded position of greater diameter than the neck portion.

3. The sealing balloon as claimed in claim 1 or claim 2, wherein the head portion is adapted to substantially fill a teat cistern when inflated in use within the teat cistern. 4. The sealing balloon as claimed in any one of the preceding claims, wherein the valve is a non-return valve for delivery of balloon expansion fluid into the tubular body.

5. The sealing balloon as claimed in any one of the preceding claims, wherein the valve is mounted within a valve housing, a connector on the valve housing for connection to a balloon inflation device for the head portion of the body, the body being mounted on the valve housing at an outlet of the valve. 6. The sealing balloon as claimed in any one of the preceding claims, wherein an insertion lance is mounted centrally within the body, having an outer end attached to an outer end of the head portion and a free inner end.

7. The sealing balloon as claimed in any one of claims 1 to 4, wherein the valve comprises at least one 0-ring mounted on the neck portion which extends around and clamps the neck portion, urging the neck portion towards a pinched closed position 8, The sealing balloon as claimed in claim 7, wherein the O-ring is positioned on the neck portion to correctly locate the head portion within a teat cistern when the O-ring engages an outer end of the teat canal.

9. The sealing balloon as claimed in any one of the preceding claims, wherein the body further includes a second inflatable portion on the neck portion spaced-apart from the head portion.

10. The sealing balloon as claimed in any one of the preceding claims, wherein anti-microbial material is provided on an exterior of the neck portion

11. The sealing balloon as claimed in any one of the preceding claims, wherein, the non-inflatab!e neck portion comprises a substantially tubular shape.

12. The sealing balloon as claimed in any one of the preceding claims, wherein, the inflatable head portion comprises a substantially tubular shape.

13. The sealing balloon as claimed in claim 12, wherein, the inflatable head portion comprises a substantially tubular shape in its deflated state and in its inflated state, such that a diameter of the tubular shape of the inflatable head portion in its deflated state is approximately equal to a diameter of the tubular shape of the non-inflatable neck portion, and, a diameter of the tubular shape of the inflatable head portion in its inflated state is greater than the diameter of the tubular shape of the non-inflatable neck portion. 14. The sealing balloon as claimed in any one of the preceding claims, wherein, the diameter of the tubular shape of the inflatable head portion in its inflated state is in the range of three times to five times greater than the diameter of the tubular shape of the inflatable head portion in its deflated state.

15. A delivery syringe device suitable for mounting a sealing balloon as claimed in any one of the preceding claims, wherein, the delivery syringe device comprises a delivery syringe and an elongate balloon-mounting lance, whereby, the elongate balloon-mounting lance comprises a female luer connector at one end and the delivery syringe comprises a male luer connector.

16. The delivery syringe device as claimed in claim 15, wherein, the elongate balloon-mounting lance is tapered.

17. The delivery syringe device as claimed in claim 16, wherein, the elongate balloon-mounting lance comprises a free end which opposes the female luer connector end and the elongate balloon-mounting lance tapers inwardly towards the free end of the elongate balloon-mounting lance.

18. The elongate balloon-mounting lance suitable for mounting a sealing balloon as claimed in any one of claims 15 to 17, wherein the elongate balloon-mounting lance comprises a female luer connector at one end and a free end which opposes the female luer connector end, and, the elongate balloon-mounting lance tapers inwardly towards the free end of the elongate balloon-mounting lance.

19. A method of sealing a teat of a dairy cow using a sealing balloon, wherein, the method comprises the steps of: a) inserting the sealing balloon, in its deflated state, partially into a teat cistern of the teat of the dairy cow, and b) inflating the sealing balloon within the teat cistern of the teat of the dairy cow by injecting a fluid into the balloon.

20. The method of claim 19 wherein the method comprises the steps of: a) inserting the sealing balloon, in its deflated state, partially into a teat cistern of the teat of the dairy cow using an elongate balloon-mounting lance which is also partially inserted into the teat of the dairy cow; b) inflating the sealing balloon within the teat cistern of the teat of the dairy cow by passing a gas through the elongate balloon- mounting lance; c) removing the elongate balloon-mounting lance from the teat of the dairy cow so as to leave the inflated sealing balloon partially within the teat cistern of the teat of the dairy cow. 21. The method of sealing a teat of a dairy cow as claimed in claim 20, wherein, the sealing balloon comprises non-inflatable neck portion and an inflatable head portion, and the method step of inflating the sealing balloon within the teat cistern of the teat of the dairy cow comprises inflating the inflatable head portion within the teat cistern of the teat of the dairy cow.

22. The method of sealing a teat of a dairy cow as claimed in claim 20, wherein, the method step of removing the elongate balloon-mounting lance from the teat of the dairy cow comprises leaving the non-inflatable neck portion of the sealing balloon protruding from the teat of the dairy cow to facilitate removal of the sealing balloon from the teat cistern of the teat of the dairy cow at a later time.

23. A method of sealing a teat of a dairy cow as claimed in claim 22, wherein, the method step of opening the non-inflatable neck portion of the sealing balloon comprises the method step of removing at least one O-ring from the neck portion; whereby the O-ring is located adjacent a lower opening of the neck portion and the O-ring is suitable for closing the neck portion of the sealing balloon so as to maintain the head portion of the sealing balloon in an inflated state.

24. The method of sealing a teat of a dairy cow as claimed arty of claims 20 to 23, wherein, the method step of inserting the sealing balloon, in its deflated state, partially into a teat cistern of the teat of the dairy cow comprises inserting the inflatable head portion of the sealing balloon into the teat cistern and leaving a section of the non-inflatable neck portion protruding from the teat of the dairy cow.

25. A method of sealing a teat of a dairy cow as claimed any of claims 20 to 24, wherein, the method comprises the further step of removing an O-ring located on the sealing balloon in order to facilitate the deflation of the sealing balloon so that the sealing balloon may be removed from the teat cistern of the teat of the dairy cow.