Note: Descriptions are shown in the official language in which they were submitted.
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IMPROVEMENTS IN AND RELATING TO RETENTION APPARATUS
Tla CHNICAL FIELD
This invention relates to improvements in and relating to retention apparatus.
It is envisaged the retention apparatus will be most commonly used to retain a
substance
delivery device in a passage or body cavity of an animal.
In particular, the retention apparatus will be most commonly used in
situations for retaining
a substance delivery device in a body cavity that can be readily accessed,
such as the
vagina, uterus, rectum, and so forth.
The retention apparatus is designed to maintain the substance delivery device
in said cavity
for predetermined periods to enable substances in the delivery device to be
delivered into
the animal in a manner (controlled or otherwise) over the required period of
time.
Such substance delivery devices may be used to control the release of
substances into the
animal for controlling parasites, release of nutritional supplements, for
vaccines, for
controlling reproduction and/or growth and so forth as part of a programme
involving
chemical and/or hormonal intervention.
BACKGROUND ART
A range of retention apparata is available in the prior art for use in
retaining associated
apparatus in or on an animal for a required time period. The retention
apparatus may be
included on or be attachable to the apparatus.
Retention apparata for retaining a device within a passage or body cavity of
an animal may
be fully (along with the device) or partially inserted into the animal. To
facilitate insertion
of the device and retention apparatus the retention apparatus may be
compressible. Once
inserted, the retention apparatus typically resumes its uncompressed
configuration thereby
retaining the device to which it is attached within the animal's body cavity.
Such retention apparata may be an integral part of the device as with
compressible helical
coils, or the devices may include multiple lobes or arms affixed to a device.
The latter
types of retention apparata rely on the ability to fold the lobes or arms onto
each other to
facilitate insertion of the device into the body cavity of the animal.
Alternately the lobes or
arms may be flexed or hinged to a position where they are substantially in
line with the
device to which they are attached for easy insertion of the device into the
animal's body
cavity. Once inserted the compressed coil, lobes or arms spring open to retain
the device
inside the animal's body cavity.
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However, a number of problems exist with the use of such retention apparata.
For
example, apparatus that expands once inserted into the body cavity of an
animal can
a) cause irritation to the walls of the cavity and discomfort to the animal.
Whilst
retention apparata allow retention of the device within the animal's body
cavity,
movement of the device within the cavity is also typically permitted. This
movement can lead to internal irritation of the cavity (and cervix if the
cavity is
the vagina of the animal)and cause discomfort to the animal,
b) impact detrimentally on the flow of the animal's internal body secretions,
c) be difficult to extract from the animal's body cavity once the functional
utility of
the device to which they are attached has been exhausted, and
d) be problematic to insert into the animal's body cavity in the first
instance due to
the nature of the material from which the retention apparatus are made and
therefore
e) require a separate applicator to facilitate insertion of the device and the
retention
apparatus into the animal's body cavity, and.
f) often be suitable only for use in small body cavities
Alternatively, in some prior art retention systems, the retention apparatus
may itself be
impregnated with, or contain, the substances required to be delivered into the
animal's
body cavity. With time, secretion of the substance into the body cavity can
effectively
reduce the surface area of the retention apparatus and in turn reduce the
ability of the
retention apparatus to retain the substance delivery device in the animal's
body cavity.
Accordingly, muscular contractions of the walls of the animal's body cavity
may force the
device and its retention apparatus out of the animal's body cavity before
complete delivery
of the substances) has been achieved. Therefore, the effectiveness of the
substance
delivery device may be severely limited.
Systems requiring the use of applicators to insert the devices and their
retention apparatus
into the body cavity of the animal also have a number of disadvantages. The
applicators
may be complex, bulky, and costly to manufacture, or may increase the time
taken for
insertion of a substance delivery device into an animal.
It would therefore be advantageous to have a retention apparatus capable of
being used
with a device for insertion into an animal's body cavity that:
(a) effectively retains that device within the cavity for the required period:
and
(b) enables the delivery device to be easily inserted and removed; and yet
{c) does not detrimentally impact on the normal body processes (such as by
impeding
S,5 flow of body secretions and so forth) by its mere physical presence; and
(d) is suitable for use with devices to be inserted into body cavities such as
the vagina,
uterus and rectum (principally); and
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(e) can be used without causing undue physical discomfort to the animal; and
(f) can easily be adapted for use with a range of animal species,
(g) does not require a specialised applicator.
It is an object of the present invention to address the foregoing problems or
at least to
provide the public with a useful choice.
Further aspects and advantages of the present invention will become apparent
from the
ensuing description, that is given by way of example only.
Tlrcrr.n~jlRR OF INVENTION
According to one aspect of the present invention there is provided retention
apparatus
capable of retaining a substance delivery device within a body cavity of an
animal into
which the substance delivery device is inserted, the retention apparatus
including
positioning apparatus capable of maintaining the substance delivery device in
a preferred
position within the body cavity of an animal, and
restraining apparatus capable of hindering unwanted removal of the positioning
apparatus
and the substance delivery device from the animal's body cavity,
characterised in that at least a portion of the restraining apparatus is
attached in a preferred
location on the external surface of the animal's body via attachment means.
According to another aspect of the present invention there is provided
retention apparatus
substantially as described above wherein at least a portion of the positioning
apparatus is
inserted into the animal.
According to another aspect of the present invention there is provided
retention apparatus
substantially as described above wherein the positioning apparatus also
includes engaging
apparatus capable of engaging with either or both a portion of the restraining
apparatus and
the substance delivery device.
According to another aspect of the present invention there is provided
retention apparatus
substantially described above wherein the restraining apparatus is comprised
of resilient
material capable of being stretched to effect the required tension to maintain
the positioning
apparatus and the substance delivery device substantially within the animal's
body.
According to another aspect of the present invention there is provided
retention apparatus
substantially described above wherein the restraining apparatus includes a
substantially
elongate portion and a substantially expanded portion.
According to another aspect of the present invention there is provided
retention apparatus
substantially described above wherein the attachment apparatus is a contact
adhesive
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capable of being applied to either one or both of the expanded portion of the
restraining
apparatus and the external surface of the animal's body.
In this specification unless the context otherwise states, the term
positioning apparatus
shall mean and refer to any apparatus that is capable of positioning the
substance delivery
device in a preferred position within an animal's body cavity.
For ease of reference the positioning apparatus shall now be referred to as a
tail rod.
However, it should be appreciated that use of this term is not to be seen as
limiting.
The term restraining apparatus in this specification shall mean (unless
otherwise stated) any
apparatus capable of maintaining at least the tail rod in the required
position within the
animal's body cavity whilst specifically hindering the ability of the tail rod
and the
substance delivery device attached thereto to work out of the animal's body
cavity when
the animal is engaged in normal daily activities and/or bodily functions. The
animal's
activities include but are not limited to normal walking or running movements,
mounting of
the animal by another animal, defecation, urination, muscular activity within
the animal's
body cavity into which the substance delivery device has been inserted, and
the production
by the animal of secretions such as mucus that could operate to lubricate the
entry to the
animal's cavity and facilitate expulsion of the substance delivery device and
the tail rod
from the cavity.
For ease of reference the term restraining apparatus shall now be referred to
as the tail. It
should be appreciated however that use of this term is not intended to limit
the
specification.
The term attachment means in the specification shall mean unless otherwise
stated, any
apparatus or means of attachment capable of fastening, affixing or joining the
restraining
apparatus on to or around the external surface of the animal's body.
For ease of reference, the means of attachment shall now be referred to as an
adhesive.
However, it should be appreciated that this term is not intended to limit the
use of any other
suitable means of attachment or apparatus capable of performing the required
function as
stated above.
The substance delivery device referred to in the specification substantially
includes a body
(or sheath) capable of substantially enclosing all of the components of the
substance
delivery device. The applicant has described a preferred embodiment of the
substance
delivery device in New Zealand Patent Specification No. 304150. However, any
suitable
substance delivery device may be used with the present invention.
The substance delivery device preferably is used to deliver at least one
therapeutic agent
into the animal. The therapeutic agent can include either or both one or more
chemicals and
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hormonal substances. For example the substance delivery device may be used to
deliver
nutrients, vaccines, breeding hormones, growth hormones, anti-parasitic
treatments and so
forth. Administration of the agents being achieved by insertion of the
substance delivery
device into an animal's body cavity, and release of the agents therefrom and
into the
animal.
In preferred embodiments of the present invention, the tail rod is a
substantially solid and
rigid rod. A solid rod is preferred to ensure the rod is sufficiently strong
enough to
withstand wear and tear, particularly when used in the larger domestic animals
such as
horses and cows.
However, in some species of animals, hollow rods may also be suitable.
In preferred embodiments, the tail rod is a single unit. However, in other
embodiments the
tail rod may be comprised of two or more sections attached to each other to
obtain the
required length, as needed for the particular animal with which the
positioning apparatus is
used.
The tail rod is preferably rod shaped to provide a smooth outer surface, free
of angles or
corners that may otherwise cause physical discomfort to the animal or result
in irritation of
the linings of the animal's body cavity or passages by such sharp edges. In
addition, the
round rod shape contributes to the ease of insertion of the tail rod into the
animal's
cavity/passage.
2p Preferably the dimensions of the tail rod are specific to the species of
animal with which
the tail rod (and the substance delivery device attached to it) is used. In
addition, there may
be variations in the dimensions of the tail rod for use with animals within
the same species
due to the age, sex and/or breeding status of the animal into which the tail
rod and the
substance delivery device are to be inserted. For example, when the substance
delivery
device is being used as an intravaginal device for cows, the dimensions of the
tail rod will
be specifically (and therefore varyingly) designed for older dairy cows, first
mated heifers,
beef cows and early post-partem dairy cows and so forth. As can be
appreciated, the
vaginal canal can differ depending on age of the animals within the same
species, and also
differs between species.
Similarly, where the tail rod may be used with a substance delivery device for
insertion
into different body cavities (such as the rectum), again the length of the
tail rod will
understandably vary.
In particular, where the tail rod is used with an intravaginal substance
delivery device, the
length of the tail rod is critical for ensuring the device is inserted past
the pelvic bone of the
animal. For example, trials with the retention apparatus having a tail rod
inserted at
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IOOmm into the vaginal cavity of mature cows resulted in rotation and
expulsion of the
device. By comparison, having the tail rod inserted 150mm into the vaginal
cavity ensured
greater retention of both the tail rod and the substance delivery device
within the animal.
In preferred embodiments of the present invention the tail rod is made from
substantially
rigid material. The applicant has found that use of some polyurethane PVC
materials
provide too much flexibility to the rod, enabling the rod to be worked out of
the animal's
body cavity and leading to expulsion of the entire system by the animal.
However, it must
be appreciated that materials used for the tail rods (and the substance
delivery device body)
should pose no physiological danger to, cause no allergic reactions in and
cause minimal
discomfort to the animal.
In addition, the tail rod is preferably configured to include an elongate
straight portion. The
substantially elongate straight portion is designed to facilitate insertion of
the tail rod into
the animal's body cavity without causing undue discomfort to the animal.
However, an
undulating elongate portion may be preferred for use in some cavities and/or
passages, or
with some animals to ensure optimum retention inside the animal.
The length of the elongate portion is such that it ensures and the attached
substance
delivery device is also inserted into the animal's body cavity to the required
depth.
The tail rod also includes a substantially angled portion at one of its distal
ends. This
angled portion may operate as a stop to complete insertion of the rod within
the animal's
cavity/passage. The angled portion operating as a stop by pressing against the
outside of
the animal adjacent to the cavity/passage entrance. The length of the angled
portion may
vary depending on the overall anatomy of the animal with which the positioning
apparatus
is used. In addition, this angled portion of the rod may vary in configuration
when it is
used as a stop, to ensure better co-operation of the surface of the angled
portion against the
animal.
As appreciated, the overall configuration of the tail rod facilitates
retention of it and the
attached substance delivery device within in the animal's body cavity.
The opposite distal end (opposite in the angled portion) of the tail rod, is
substantially
straight. The substance delivery device may be fixedly or removably attached
to this
straight, distal, end of the substantially elongate straight portion.
Fixed attachment may be achieved by heat moulding the substance delivery
device to the
end of the substantially elongate portion. However, in preferred embodiments,
the tail rod
is fixed to the substance delivery device via a one-way engaging system, such
as a bayonet
system or press fitting system that operates to fix the tail rod to the
substance delivery
device in a non-removable manner.
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In yet other embodiments, the substance delivery device and the tail rod may
be moulded in
one piece to obviate problems of the substance delivery device becoming
detached from the
tail rod.
Alternatively, in other embodiments, the substance delivery device may be
removably
attached to the tail rod to enable the tail rod to be used repeatedly, simply
by replacing an
expended substance delivery device with a new one.
Such removable attachment of the substance delivery device to the tail rod may
be effected
through engaging a complementarily configured section at the end of the
substantially
elongate portion of the tail rod with a corresponding section on the substance
delivery
device. Such configuration could include a threaded, bayonet or other suitable
system.
Alternately, a portion of the substance delivery device may simply be inserted
into the end
of the tail rod and pinned in position. For example, insertion of a locking
pin into an
appropriately located aperture on the external surface of the tail rod which
can be aligned
with a similarly located aperture on the inserted portion of the substance
delivery device.
As can be appreciated, any suitable arrangement for attaching the tail rod to
the substance
delivery device may be employed with this invention as required.
The substantially angled distal end of the tail rod is preferably configured
to receive a
portion of the restraining apparatus. For ease of reference the restraining
apparatus shall
now be referred to as a tail. However, use of this term is not to be seen as
limiting.
In preferred embodiments, the substantially angled portion includes a series
of barbs
integrally moulded into the tail rod. These projecting barbs are capable of
being received
into, or are capable of receiving, a complementarily configured portion of the
tail.
The arrangement is designed to be a quick fit system to enable easy attachment
and removal
of the tail onto and from the tail rod. However, it can be appreciated that in
other
embodiments of the present invention, any suitable means of attaching the tail
to the
substantially angled portion of the tail rod may be used with this invention.
In addition, in some embodiments it may be preferred that the tail rod and the
tail be a
single structure ready for attachment to the substance delivery device.
Alternatively, the entire combination of the tail, tail rod and substance
delivery device may
be moulded in one piece for devices that are to be thrown away after use. On
the other
hand, individual tails, tail rods and substance delivery devices may be
preferred where re
use of the individual sections is required or desired.
In preferred embodiments of the present invention the tail includes a
substantially elongate
portion and a substantially expanded portion. The expanded tail portion is
located towards
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one distal end of the elongate portion of the tail, whilst the other distal
end the elongate
portion is configured to attach (either fixedly or removable) to the angled
portion of the tail
rod.
For ease of reference, the substantially elongate portion shall be referred to
as a strap and
the substantially expanded portion shall be referred to as a patch. However,
it should be
appreciated that the use of either of these terms is not intended to limit the
scope of the
specification.
Preferably, the length of the strap is dictated by the species of animal with
which the_
retention apparatus is being used. In addition, the length will also be
dictated by the age
and sex of the particular animal.
Similarly, the width of the strap is also dictated by a number of factors
including the ability
of the strap to perform the required function in relation to the retention
apparatus without
interfering with the normal bodily functions of the animal, or causing undue
discomfort to
the animal.
In addition, the tail is required to be made of substantially flexible
material. The material is
preferably sofdsupple enough to be able to be moulded to conform to the
external shape of
the animal against which the strap rests again without interfering with the
bodily functions
of the animal and without causing unnecessary discomfort to the animal.
Preferably, the restraining apparatus is also made of resilient material
capable of being
stretched to effect the tension required to maintain the tail rod and
substance delivery device
within the animal's body cavity whilst also being firmly attached at a
suitable location to
the exterior surface of the animal's body.
Preferably therefore, the tail is made of a rubber material of a particular
formulation to
provide the required resilience, flexibility and durability, without causing
any adverse
physiological reactions in (such as allergic reactions) or physical discomfort
to the animal
with which it is used.
However, any suitable material may be adapted for use with the invention. For
example,
early prototypes included plastic and/or metal wires capable of being bent to
conform to
and be moulded against the animal's body. However, wires, whilst capable of
being used,
have limitations in terms of their resilience.
In some embodiments, the tail is made from layers of the preferred rubber
material that is
laminated. Preferably the strap includes a greater number of laminated layers
than the
patch. Multiple layers can increase the strength of and contribute to the
required resilience
of the strap. The patch is preferably thinner to enable the patch to be
flexible enough to be
secured to the animal's external surface by the attachment apparatus.
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In preferred embodiments however, the tail is injection moulded using the
specific rubber
material to produce a tail in which the stem is substantially thicker than the
patch (which
essentially looks like a paddle), but where the entire tail is produced in one
procedure.
Alternately, the tail may be stamped/cut from sheet material having the
required properties
and thickness in the strap and patch areas.
The resilience of the material is also such that it is capable of being
stretched to effect the
required tension when the strap is attached to the animal. Yet at the same
time the strap is
flexible enough to enable the strap of the tail to be moulded to conform to
the shape of the
animal's external body surface without interfering with the animal's normal
bodily
functions. For example where the retention apparatus is used with an
intravaginal device,
the tail is moulded to conform to the shape of the cow without interfering
with the function
of the cow's tail, or with the animal's defecation or urination. In addition,
the tail is able to
fit closely to the perineum to prevent faecal matter from gaining ingress to
the vaginal
cavity.
As can be appreciated, whilst the tail is required to be made of substantially
resilient and
flexible material, it is preferable that the material demonstrate a firm
elasticity to prevent
over-stretching of the tail. Over-stretching of the tail could enable the tail
rod to rotate and
be expelled from the animal's body cavity.
In preferred embodiments of the present invention, the patch is required to be
of a
sufficient surface area to ensure secure attachment of the tail to the
animal's body.
Accordingly, the patch of the tail is substantially circular. The applicant
has experimented
with a range of shapes for the patch portion of the tail, and whilst other
shapes may be
used, the circular patch is preferred. This overall configuration of the patch
has been
found to be critical to the success of attachment of the patch to the external
surface of the
animal's body.
The dimensions of the strap and/or patch may also be adjustable to enable the
tail to be
used on animals of different ages, sexes and so forth. For example, the tail
used for cows
may be different to that used for heifers or young stock, and so forth.
Therefore, to
accommodate the differing requirements, the patch and strap may be two
separate portions
that may be joined together as required. Such an embodiment may also include
adjustment
apparatus to facilitate adjustment of the tail for use with a particular
animal. Alternatively,
one-piece systems may also include such adjustment apparatus.
In addition, the material of the tail is required to be sufficiently strong to
obviate against the
tail breaking/snapping. The substantially thicker strap contributes to
providing the required
strength.
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In preferred embodiments of the present invention where the retention
apparatus is used for
an intravaginal, intrarectal and so forth substance delivery device, the patch
is preferably
attached in the region of the animal's tail but to one side of the animal's
backbone.
Preferably the point of attachment is located between the backbone and the pin
bone
(ischium) of an animal, such as a cow. This positioning enables the tail to be
attached to
the animal's external surface whilst providing sufficient tension to maintain
the tail rod in
the body cavity without the retention apparatus interfering with other bodily
functions of
the animal such as urination and so forth (depending upon the cavity into
which the
substance delivery device is inserted).
In preferred embodiments of the present invention, the patch is attached to
the external
surface of the animal's body by the means of attachment. Preferably the means
of
attachment is an adhesive.
In preferred embodiments, the means of attachment is a contact adhesive that
is fast curing
and capable of being used on animals with minimal (if any) detrimental effects
or
discomfort. Accordingly, the contact adhesive is anti-allergenic,
physiologically safe and
so forth.
In addition, the adhesive is one that is preferably capable of attaching the
patch to the
animal's external surface irrespective of the animal's hair or fur type, or
length. However,
attachment of the patch to the animal's external surface may be affected by
external
conditions, such as material on which the animal beds down, or rolls in. Where
the
ground or bedding material is dusty and/or sandy, the animal's body may need
to be
shaved in the region where the patch is to be attached. Optionally, the area
may also be
cleaned with a suitable fluid (such as a solvent, or a burst of air, and so
forth), to further
reduce the amount of material on the animal's skin that may affect the ability
of the patch to
adhere the thereto. However, there are typically no long term effects of
attaching the patch
by adhesive to the animal's skin, as regrowth of hair prevents permanent
damage to the
skin from adhesives, when the patch is removed.
The applicant has trialled a range of adhesives such as MULTIGRASST""
(supplied by
Bostik) and KAMART"" with varying degrees of success. However, the preferred
adhesive
is adapted to meet the applicant's objectives which are to use an adhesive
compatible with
both the animal and the preferred material used for the patch, whilst also
providing a very
fast cure.
One of the advantages of using the preferred contact adhesive in the
attachment of the tail to
the external surface of the animal is that the substance delivery device can
be inserted into
the animal's body cavity and the retention apparatus secured in place with
minimal time and
effort but with maximum retention of the substance delivery device in the
animal's body
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cavity for the period required to complete the program of treatment of the
animal with the
appropriate therapeutic agent.
The application of the adhesive to the patch and/or the animal may vary
however,
depending upon the type and length of the animal's hair or fur. In any
situation a
successful patch/animal bond is essential.
Accordingly, the adhesive may be applied to the animal only, the patch only,
the patch and
the animal and so forth. Where applied only to the animal or only to the
patch, the patch is
temporarily pressed on to the attachment area, removed, left for a short
period and then re-_
applied to the attachment area to enable the adhesive to bond.
The adhesive may be pre-applied to the patch during manufacture of the
retention
apparatus. The adhesive may then be covered by a removable material to prevent
the patch
sticking to objects before required. At the time the patch is to be applied to
the animal the
material is peeled from the surface of the patch to expose the adhesive, ready
of use.
It can be appreciated that different adhesives, or means of attachment of the
patch to the
animal may be required depending on the species of animal with which the
retention
apparatus is used. For example, attaching the patch to animals with woollen
coats may
pose different problems than where the patch is attached to animals with hair,
and so forth.
Accordingly, the patch may be secured via other means. For example, contact
tapes,
bubble patches containing adhesive that is released when the bubbles are burst
(on contact
with the animal, or when pressure is applied), and so forth may be used.
The present invention has been developed specifically for retaining a
substance delivery
device in the body cavity of an animal by employing restraining apparatus
capable of being
attached between the back bone and the ischium (pin bone) of a domestic
animal. Trials on
cows suggest the invention will be equally effective in all cow types. This
concept has
been developed to remedy observed deficiencies in other retention systems for
such
substance delivery devices.
Systems that include villi, lobes or arms for retaining the substance delivery
device within
the body cavity of an animal have been found to be deficient. For example,
typical villi
systems generate the production of significant quantities of mucus, that have
been
observed at the time of removal of the device.
In addition, plugs of mucus may also be found following the removal of the
device from
(for example) the vaginal cavity. Where such substance delivery devices have
been used
intravaginally, mucus production is due to the interaction of the villi with
the sensitive
vaginal mucosa and from irritation of the cervix by the front of the device.
In addition,
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villi systems whilst retaining the device intravaginally, nevertheless enables
the device to
move backwards and forward within the vagina.
The production of large quantities of mucus and occasionally blood is
typically due to the
substance delivery device contacting and irritating the cervix. The production
of large
quantities of mucus (and blood) is unacceptable, as it indicates undesirable
interference to
the animal by the device.
The present retention system is designed to reduce mucus production, as it is
less invasive
and provides less opportunity for the device to contact the cervix and
therefore reduces
interference of the cervix by the device.
To achieve maximum effectiveness of the retention apparatus, the depth of
insertion of the
tail rod, the location of the patch on the animal, the patch/animal bond, and
the tightness of
the tail strap are all important factors, as is minimal trauma to the animal
at any stage during
the treatment programme (when the substance delivery device is infra animal).
BRIEF DESCRIPTION OF DRAWINGS
Further aspects of the present invention will become apparent from the
following
description that is given by way of example only and with reference to the
accompanying
drawings in which:
Fi~u~ is a diagrammatic side view of the restraining apparatus in accordance
of
one preferred embodiment of the present invention, and
~p F~'gure 2a is a diagrammatic plan view of the restraining apparatus in
accordance
with one preferred embodiment of the present invention, and
F' a a is a diagrammatic cross-sectional view through the strap of the
restraining
apparatus in accordance with one preferred embodiment of the present
invention, and
Figure 3a is a diagrammatic side view of the restraining apparatus in
accordance
with another preferred embodiment of the present invention, and
i re is a diagrammatic cross sectional view through the distal end of the
restraining apparatus configured to receive or be attached to the
positioning apparatus of the retention apparatus in accordance with one
3p preferred embodiment of the present invention, and
F~,g_ures 4. 5 are diagrammatic bottom and top plan views respectively of the
restraining
apparatus in accordance with another preffered embodiment of the present
invention, and
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F~ure,~s 6a. 6b are diagrammatic side views of the positioning apparatus of
the retention
apparatus in accordance with one preferred embodiment of the present
invention, and
Figure 6c is a diagrammatic top plan view of the positioning apparatus in
accordance
with one preferred embodiment of the present invention, and
Figures 6d. 6e are diagrammatic representations of the angled distal portions
of the
positioning apparatus, configured to engage with the substance delivery
device and the restraining apparatus, respectively, in accordance with one
preferred embodiment of the present invention, and
F, inure 7 is a diagrammatic representation of an early prototype of the
retention
apparatus attached to a substance delivery device in accordance with
another embodiment of the present invention, and
Figure 7b is a diagrammatic representation of a preferred embodiment of the
retention apparatus attached to a substance delivery device.
~5 ~FST MODES FOR CARRYING OUT TIiE~NVENTION
With reference to the diagrams by way of example only there is provided
retention
apparatus, generally indicated by arrow 1, as shown in Figures 1 through 7 for
retaining a
substance delivery device (generally indicated by arrow 2) within a body
cavity of an
animal (not shown) into which the substance delivery device (2) is inserted.
The retention apparatus ( I ) includes positioning apparatus, generally
indicated by arrow 3.
The positioning apparatus (3) is capable of maintaining the substance delivery
device (2) in
a preferred position within the body cavity of the animal.
The retention apparatus ( 1 ) also includes restraining apparatus, generally
indicated by
arrow 4, for hindering removal of the positioning apparatus (3) and the
substance delivery
device (2) from the animal's body cavity.
The retention apparatus ( 1 ) also allows for a means of attachment,
(generally indicated by
arrow 5) for attaching a portion of the restraining apparatus (4) in a
preferred position on
the external surface of the animal's body.
The substance delivery device (2) is configured to be inserted into an
animal's body cavity
to release therapeutic agents) into the animal, for a pre-determined period.
The substance
delivery device (2) is represented in Figures 6c and 7. However, it should be
appreciated
that the structural configuration of the substance delivery device (2) can
vary.
As can be seen in Figure 7 the substance delivery device (2) is substantially
integrally
attached to the positioning apparatus or tail rod (3). In Figure 6a the
substance delivery
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device (2) can be adapted such that the tail rod (3) may be fixedly or
removably attached to
the substance delivery device (2).
The tail rod (3) is appropriately dimensioned in terms of width and length to
enable the
substance delivery device (2) to be inserted into the animal's body cavity to
a depth that
prevents the tail rod (3) and the substance delivery device (2) from rotating
and being
expelled from the animal's body cavity during the animal's normal bodily
functions (such
as muscular contractions) and/or general physical activities (such as bulling
in cows and so
forth).
As shown in Figures 6a-a the tail rod (3) is a substantially circular rod with
an elongate
portion (6) and a substantially angled portion (7). The substance deliver
device (2) is
attached to the appropriately configured distal end (8) of the substantially
elongate portion
(6) of the tail rod (3), whilst the substantially angled portion (7) is
configured at (9) to
receive a portion of the restraining apparatus or tail (4).
The tail rod illustrated is substantially circular and smooth to facilitate
easy insertion of the
substance delivery device (2) and the tail rod (3) into the animal's body
cavity without
causing undue irritation to the walls of the body cavity or the entry passage,
or cause
undue discomfort to the animal, during the insertion, withdrawl or retention
period.
The tail rod (3) in Figure 7 also includes flexible joints (10) to enable the
tail rod (3) to
conform to the required shape to facilitate configuration of the tail rod (3)
for the animal
with which it is used.
Figure 7 representing an earlier prototype illustrates, the restraining
apparatus or tail (4)
comprising a wire tail (16) and a plastic tail (17), both of which are fed
through the tail rod
(3). However, later preferred embodiments of the tail {4) as illustrated in
Figures 1-5
inclusive, are made of a substantially resilient and flexible rubber material
to enable the tail
(4) mould to the external surface of the animal as required to enable the tail
{4) to
effectively restrain the tail rod (3) and the substance delivery device (2)
from being
expelled from or working out of the animal's body cavity.
The tail (4) includes a strap ( 11 ) and a patch ( 12). The strap ( 11 ) is
substantially elongate,
the length being dictated by either or both the species of animal with which
it is to be used
and the age of the animal. The patch ( 12) is substantially circular and
substantially thinner
than the strap ( 11 ) portion of the tail (4) (as shown in Figures 1 through
5).
The dimensions and/or configuration of the patch (12) are critical to ensuring
successful
attachment of the patch (12) to the external surface of the animal's body.
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The patch ( 12) is positioned towards one distal end ( 13) of the strap ( 11
). The opposite
distal end ( 14) of the strap is configured at ( 18) to complement and be
attached to the
configured distal end (9) of the tail rod (3).
In use, the retention apparatus (1) is either integral with the substance
delivery device (2)
or is attached to the substance delivery device (2) for use.
It should be appreciated that the substance delivery device (2), the tail rod
(3) and the tail
{4) may be either moulded in one piece. Alternatively, one or more of the
substance
delivery device (2), the tail rod (3) and the tail (4) may be separate from or
attached to, an _
adjacent portion depending upon the requirements of the retention apparatus
(1) and the
substance delivery device (2).
For example, where the retention apparatus ( 1 ) and the substance delivery
device (2) are
designed to be discarded after use, all three features may be moulded as one
piece.
Alternately, where the tail rod (3) and/or the tail (4) can be re-used or
interchanged,
accordingly, they are preferably configured to be capable of inter-connection
to the other
apparata.
Figures 1 to 5 illustrate embodiments of the tail (4). Figures 1 and 3b show
the distal end
(14) of the strap where it is configured at (18) to receive an appropriately
configured
portion of the tail rod (3).
Figure 2b further illustrates a cross-sectional view through the strap ( 11 )
having a
preferred configuration. As can be seen, the strap ( 11 ) portion of the tail
(4) differs in
thickness to the patch ( 12).
The means of attachment (5) in preferred embodiments is a preferred contact
adhesive
capable of being used with animals. However, any suitable adhesive may be used
with the
retention apparatus provided it is effective at maintaining contact between
the patch ( 12)
and the external surface of the animal's body throughout the period of
treatment.
Treatment periods may be relatively short (up to a few days) or may be
considerably longer
(several weeks).
While adhesive (5) is the preferred means of attachment, nevertheless, other
embodiments
of the invention may incorporate other attachment apparatus specifically
designed for
different species of animals where adhesive may be unsuitable.
Both the substance delivery device (2) and the tail rod (3) are inserted into
an animal's
body cavity such as the vaginal cavity, the rectal cavity and so forth into
which a
therapeutic agents) is required to be delivered.
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The tail rod (3) is inserted to a depth where it optimally contributes to
maintaining the
substance delivery device (2) within the animal's body cavity. At the same
time the tail rod
(3) may protrude only so far (or not at all) to ensure effectiveness of the
tail (4) - providing
the tail rod (3) does not catch on any part of the cow's anatomy (such as the
tail) or is not
capable of being contacted by another animal or by environmental objects that
may cause
movement of the tail rod (4) and the substance delivery device (2) within the
animal's body
cavity, or may contribute to the substance delivery device being expelled from
the animal's
body cavity.
When the substance delivery device (2) and the tail rod (3) have been inserted
into the
animal's body cavity, the strap (11) of the tail (4) is stretched to create
sufficient tension to
enable the strap ( 11 ) to mould or conform to the shape of the body of the
animal without
interfering with the animal's bodily functions. For example, the strap ( 11 )
is stretched to
provide sufficient tension to maintain the tail rod (3) in position whilst not
impeding the
function of the animal's tail, or the bodily functions of defecation or
urination.
Preferably, where the retention apparatus (1) is used with an intravaginal
device (2), the
strap ( 11 ) of the tail (4) is positioned to sit closely to the animal's
perineum to prevent
faecal matter from gaining ingress to the vaginal cavity.
Preferably, where the substance delivery device (2) and the retention
apparatus (1) is used
to administer therapeutic agents) into the vagina of an animal such as a cow,
the tail (4)
holds the tail rod (3) firm and ensures the intravaginai device (2) remains
securely in the
vagina by ensuring appropriate tension of the strap ( 11 ) and attachment of
the patch ( 12) to
the cow's back between the back bone and the ischium (pin bone).
As can be appreciated, the point of attachment on the animal's external
surface will depend
upon the body cavity with which the substance delivery device (2) and the
retention
apparatus ( 1 ) are used.
The adhesive (5) is then applied to either or both the patch (12) and the
external surface of
the animal's body. After the required period of time to allow the adhesive to
bond with the
surface onto which it has been applied, the patch (12) is then pressed onto
the glue patch
on the animal's body. The patch (12) is held in position for sufficient time
to ensure
bonding between the patch (12) and the animal's body.
It should also be appreciated that the dimensions and configuration of the
substance
delivery device (2), the tail rod (3) and the tail (4), as well as the type of
attachment
apparatus (5) will depend largely upon the species of animal with which the
apparatus is
used. The age and sex of the animal will also be factors to consider.
Similarly, it may be
necessary to use different materials for both the tail rod (3) and the tail
(4) as required to
ensure effectiveness of the retention apparatus ( 1 ) with different species
of animals.
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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.
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