Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1998-12-09
2002-03-05
Lewis, Kim M. (Department: 3761)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C123S184550, C606S119000
Reexamination Certificate
active
06352524
ABSTRACT:
The present invention relates to active delivery devices and related procedures.
More particularly the invention relates to devices or inserts (hereafter “devices”) capable of delivering a substance from the device into a surrounding environment whatever that may be. Such delivery will be as a fluid from a storage reservoir for such fluid or its precursor.
Unlike passive diffusion devices of this type the present invention is directed to a device which can achieve an active expression of the fluid from a storage reservoir for such fluid or its precursor and preferably with control of the continuous or intermittent reduction of the volume of the reservoir which achieves the active expression and preferably with a low passive release incidence to any active release incidence and also preferably with a low passive release incidence during any period of no active release.
The environment of any such release may vary.
Such environments include body cavities, plant beds, loci of pest movement, liquid surrounds (eg fish tanks), etc.
The reason for the preferred characteristics will now be described by reference to non-restrictive examples of such use.
As a first example the invention may relate to active delivery devices locatable in a body cavity of an animal to actively release a substance (eg. useful by intra-vagina insertion of synchronising the oestrus of animal or by intraruminal delivery of releasing desired agents into a ruminant).
When one considers the mating of animals, it is useful for farmers to synchronise the oestrus of animals whether they be cattle beasts (whether for dairy or beef purposes) sheep, goats, horses, or the like where artificial insemination is practised. By way of example, in relation to cattle beasts, in a normal 365 day year 282 days on average is taken up of the year with the gestation period itself. With approximately 30 days to recover after delivery of its progeny each cow therefore has an average of only two and a half cycles if there is to be a timely management of the herd. Thus it is important over that remaining period of less than 53 days to ensure each cow in a herd becomes pregnant.
The traditional method of mating dairy cows with bulls is now largely superseded by the use of artificial insemination procedures which offers the prospect of rapid herd improvements although bulls are still presented to the herd frequently to catch those animals that have not conceived by the artificial insemination procedure should they comes into oestrus within a designated time.
There is therefore a great advantage attached to bringing such herd animals into oestrus simultaneously so as to make it easier to ensure effective usage of the artificial insemination procedure and subsequently to enable still within the “window” a further prospect of artificial insemination of those animals synchronistically brought to oestrus that have not already conceived.
BACKGROUND OF THE INVENTION
Various means of achieving such a management of the synchronisation of the coming into oestrus of cows (whether heifers or lactating cows) and even sheep and goats has been disclosed in the art which includes the livestock improvement publication of this company (1995 edition) made available to interested parties by this company trading as INTERAG™ in respect of its intra vaginal Eazi-Breed™ CIDR® product line.
The disclosures in the aforementioned publication, the full contents of which are here included by way of reference, ensures to date the best procedure applicable (at least to New Zealand herds) of cattle beasts to ensure a timely conception of a herd without a significant downgrading of the fecundity of the herd.
As used herein the term “synchronise” or the derivatives thereof in respect of the onset of oestrus of an animal is not restricted to exact synchrony but rather relates to a period of time usually measured in days over which the synchrony occurs.
Initial attempts using intra vaginal devices from which progesterone could be leached simply had the effect of preventing oestrus until after they were withdrawn thereby deriving some synchrony in the onset of oestrus thereafter during a period when a heifer or lactating cow is able to cycle. This lead to a three day spread in the synchrony after a 12 to 15 day insertion of the intra vaginal progesterone containing device.
Subsequent efforts to confine the period of the synchrony lead to such a progesterone containing intra vaginal device being inserted shortly after, simultaneously with or shortly before the administration (usually intra vaginally) of an oestradiol. For instance the use of a CIDR® intra vaginal device as referred to the aforementioned publication simultaneously with a capsule containing ten milligrams of oestradiol and the retention of the CIDR® intra vaginal device in the animal for ten days led shortly thereafter to a three day synchrony onset of oestrus period.
More recently that last mentioned procedure has been refined for heifers to provide a two day period of synchrony with an 80% of the herd onset of oestrus within the first day. In this refined procedure at about day 6 of the 10 day insertion period a prostaglandin is injected.
The aforementioned procedures are now described in the art. Also described in the art are insemination procedures. It is also known to use substantial repeats of the procedure within the available cycling period referred to so that there is at least one additional prospect of conception by artificial breeding within an appropriate economic window.
With all such procedures however the longer the period of the presence of the progesterone containing intra vaginal device in an animal (about 15 days is the optimum for tightness of the synchronisation) there is a corresponding diminishment in the fertility of individual animals in the herd owing to the effect over time on the follicle development to the fertilisable egg stage. The use of the oestradiol changes follicle growth pattern. Hence with its use an optimisation of the fecundity prospects for the herd can be achieved by better balancing the tightness of the synchronisation (with longer insertion) against the loss of fertility (with longer insertion).
A cost factor arises in the adoption of such procedures as a farmer is faced with the costs of the intra vaginal progesterone containing device as well as the use of the oestradiol and/or prostaglandin materials additionally used. This ignores also the economic cost of the artificial breeding materials themselves.
The intra vaginal progesterone containing devices hitherto used in New Zealand and to a large extent elsewhere are typified by the CIDR® product of this company depicted hereinafter in
FIGS. 1 and 2
being a variable geometry device for vaginal insertion and retention which comprises a structural frame of a metal or appropriate plastics material (eg. nylon) encased in a progesterone impregnated plastics material (eg. silicone) from which the material can leach in the vaginal environment and from which it can be timely withdrawn by appropriate means (eg; a string, tail or a tool) to allow the animal to progress into oestrous shortly after the removal. Reference should be made to New Zealand Patent Specification No. 207341 (U.S. Pat. No. 4,678,463). Hereinafter the aforementioned device will be referred to by its registered trademark CIDR®.
The prior art CIDR™ devices of this company are intra vaginal passive delivery systems to be used in cattle for the control of oestus. Two major uses are in the treatment of anoestrus and synchrony. Other uses include its role in embryo transfer and treatment of cystic ovaries.
Another product available in the market place of this kind is another variable geometry device and such a device is depicted hereinafter in FIG.
3
. Such a device is a helical coil capable of being helically tightened and which is retainable in its helical form in the animals vagina. The device includes a withdrawal cord and carries a gelatine capsule which includes oestradiol so that there can be co-administration of the progesterone to be released over
Bunt Craig Robert
Burggraaf Shane
Rathbone Michael John
Interag
Jacobson & Holman PLLC
Lewis Kim M.
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