Delivery devices and their use

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

Reexamination Certificate

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Details

C604S141000, C604S891100

Reexamination Certificate

active

06450991

ABSTRACT:

TECHNICAL FIELD
The present invention relates to improvements in and/or relating to delivery devices and their use.
Delivery devices such as those utilised to deliver medicaments, supplements and/or other agents into a body cavity (eg; vagina, rumen, etc). Delivery of substances into the rumen of a ruminant whilst a delivery device is retained in the rumen is well known.
BACKGROUND OF THE INVENTION
Generally such intra ruminal devices take the form of a device or bolus capable ofbeing inserted into the rumen by an appropriate applicator to be retained over at least the delivery period by either
(a) retention means of variable geometry, e.g. deployable wings or the like, or
(b) retention means reliant upon density.
Known for ruminal delivery are devices capable of providing either a continuous (even if not strictly constant) or a pulsed delivery. In the later category are such devices as those reliant upon galvanic action to provide periodic exposure to a fresh reservoir of the dry or fluid composition of or containing the agent to be released.
Agents to be delivered into a ruminant intra ruminally are well known. Their function ranges from that of providing protection against bloat, agents to render more efficient the uptake of food, agents adapted to deal with mineral or vitamin deficiencies, agents to deal with attacks by pests (whether internal or external, etc).
The present invention relates to an active device which does not rely upon the environmental conditions of the device within the rumen of an animal once administered and which is active in a controlled way in its release profile.
Devices of this type are known. For example, in U.S. Pat. No. 4564363 of Smith Kline Beecham Corporation (the full content of which is hereby here included by way of reference) there is disclosed a multi reservoir bolus type device providing for a delayed release of the contents of at least one reservoir under the control of an electrically detonatable squib.
The present invention relates to a device of this kind having a plurality of separately controllable dischargeable reservoirs in a device which is either a density or variable geometry type retention device for intra ruminal insertion.
It is an object of the present invention to provide a viable body cavity delivery device (eg; intra ruminal bolus or device) capable of timed release of multiple reservoirs of agent to be released (whether the same or different) and irrespective of whether or not such quantities to be released at different times are the same or different or are to delivered at different rates or in different quantities. An alternative object is to at least provide the public with a useful choice in respect of active release devices for body cavity (eg; the rumen) insertion. A still other object is to provide a squibless active delivery system.
BRIEF SUMMARY OF THE INVENTION
Accordingly in a first aspect the present invention consists in a device for actively releasing material(s) intra ruminally comprising or including
a housing having a plurality of reservoirs each having an outlet from said housing,
material(s) to be released in each of said reservoirs,
closure means for at least some of said outlets to protect the material(s) from passive release,
an electrolytic cell for each of said reservoirs having closure means, each electrolytic cell being capable when activated of generating a gas which will cause by displacement of the material(s) of its respective reservoir sufficient displacement of or change to the closure means of that reservoir thereby to allow release of the material(s), and
means to activate selectively each electrolytic cell.
Preferably the device is an intra ruminal device.
Preferably said electrolytic cell of each reservoir is capable through the generation of the gas of expressing at least some of the material(s) out of the outlet of the reservoir.
Preferably the gas of at least some reservoir acts indirectly on the material(s).
Preferably the gas of at least one reservoir acts of material displacement means selected from
(i) a piston or plunger arrangement, and
(ii) a collapsible bladder or deformable membrane type arrangement.
Preferably said means to activate selectively each electrolytic cell includes a timer and/or logic means capable of delaying the activation of at least one of the electrolytic cells to thus delay the active release of the materials.
Preferably at least one of said closure means is a cap or the equivalent.
Preferably at least one of said closure means is tethered to said housing.
Preferably a film or foil material, or laminate thereof, provides, at least in part, a closure means for at least one of said reservoirs.
Preferably said film or foil is rupturable to allow the active release of the material(s) of the respective reservoir.
Preferably said electrolytic cell of at least one of said reservoirs is capable of being activated so as to provide a timed release of the materials within the respective reservoir.
Preferably said battery is capable of powering the electrolytic cells.
Preferably a switch is provided to energise the device whereupon, at an appropriate time or times, at the control of said means to activate each electrolytic cell, there is an appropriate energising of a particular electrolytic cell and thereafter the active release of the material(s) of the particular reservoir.
Accordingly in another aspect the present invention may broadly be said to consist in an intra ruminal device consisting of, comprising or including
a housing having a plurality of reservoirs each having an outlet from said housing,
closure means for at least some of said outlets,
material(s) to be released from each reservoir in each of said reservoirs,
material displacement means to reduce the volume of each such reservoir, such material displacement means being selected from
(i) a piston or plunger arrangement, and
(ii) a collapsible bladder or deformable membrane type arrangement,
electrolytic cells, each dedicated to one of said reservoirs, and each positioned to generate, when activated, a gas which by action on said material displacement means will cause the closure means of its reservoir to allow access of the material(s) (in use) to ruminal fluids(s) and/or membrane(s), and
means to activate selectively each electrolytic cell.
Preferably said means to activate selectively each electrolytic cell includes a timer and/or logic means capable of delaying the activation of at least one and preferably several of the electrolytic cells to thus delay the active release of the materials into the rumen (in use) of the respective reservoirs.
Preferably a piston or plunger arrangement is provided in each reservoir and each reservoir is in the form of a barrel of any appropriate cross section for the piston or plunger. Preferably however the cross section is circular.
Preferably the closure means is rupturable or sufficiently movable or deformable at said outlets by the material or materials of the particular reservoir under the action of gas on its material displacement means to achieve the release effect of the hitherto at least substantially sealed material(s).
Preferably said device includes as part of said means to activate a battery capable of powering the electrolytic cells.
Preferably a switch is provided to energise the device whereupon at an appropriate time or times, at the control of said means to activate each electrolytic cell, there is an appropriate energising of a particular electrolytic cell and thereafter the active release of the material(s) of the particular reservoir.
Preferably the arrangement involves the provision of at least one reservoir which substantially immediately makes its materials available (irrespective of whether or not its reservoir requires closure means to be dislodged, ruptured or otherwise affected and irrespective of whether or not there is any active release from such a reservoir under the action of a said material displacement means).
Preferably rumen retention has
(i) a density which will result in rumen retention,
(ii) a variable geometry retention

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