Substance delivery device

• US 20050245902A1
• Filed: 02/10/2003
• Published: 11/03/2005
• Est. Priority Date: 02/08/2002
• Status: Abandoned Application

• Current Assignee: Advanced Animal Technology Limited
• Original Assignee: Advanced Animal Technology Limited
• Inventors: Cornish, Brian, Oakley, Andrew Philip
• Application Number:
  US10/504,237
• Publication Number:
  US 20050245902A1
• Time in Patent Office: Days
• US Class Current: 604/890.100
• CPC Class Codes: A61D 7/00 Devices or methods for introducing solid, liquid, or gaseous remedies or other materials into or onto the bodies of animals for reproduction or fertilisation A61D19/00 ; devices for implanting pellets, radon seeds or the like A61M37/0069
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008

Abstract

A substance delivery device capable of insertion into a body cavity of an animal, with the delivery device including a body capable of housing a delivery apparatus capable of actively being controlled to autonomously deliver at least one substance into a body cavity of an animal, with the delivery apparatus including dedicated pressure systems to deliver the at least one substance from independent reservoirs via at least one associated outlet, with the at least one substance ranging in form from substantially fluid to substantially solid, with the device also including a programmable control device capable of initiating and regulating delivery of the at least one substance in accordance with a preferred delivery regime, and with the body further including a tail portion adapted to receive retention apparatus external to the animal and capable of effecting retention of the substance delivery device within the body cavity of an animal.

Claims

1. Substance delivery device capable of insertion into a body cavity of an animal, said delivery device including

a body, the body capable of housing a delivery apparatus capable of actively being controlled to autonomously deliver at least one substance into the animal'"'"'s body cavity,

said delivery apparatus including dedicated pressure systems to deliver the substance(s) from independent reservoirs via associated outlet(s), said substance(s) ranging in form from substantially fluid to substantially solid,

the device also including programmable control means capable of initiating and regulating delivery of the substance(s) in accordance with a preferred delivery regime,

the body further including a tail portion adapted to receive retention apparatus external to the animal and capable of effecting retention of the substance delivery device within the body cavity of an animal.

2. Substance delivery device as claimed in claim 1 wherein the body is a substantially hollow receptacle including at least two separate but interconnectable portions, said body being adapted to enclose in a substantially fluid tight manner the at least one independent reservoir and an internal chassis of the device with which the delivery apparatus and control means are associated and said body further adapted to receive the tail portion of the device and to include provision for the outlet(s) of the at least one reservoirs.

3. Substance delivery device as claimed in claim 1 wherein the delivery apparatus includes at least one conduit/reservoir capable of containing the substance, at least one pressure device capable of applying pressure to the conduit/reservoir, and valve means,

wherein the delivery apparatus applies pressure by the pressure device and activation of the valve means causing the substance within the conduit/reservoir to move along the conduit/reservoir to the outlet and in to the cavity and wherein the pressure device includes at least one of a pump, a spring, a plunger.

4. Substance delivery device as claimed in claim 1 wherein the independent reservoirs contain substances in substantially fluid or substantially solid form in a fluid tight manner, said reservoirs including any one or a combination of substantially flexible, collapsible, and rigid portions and adapted to release the substance in whole or part in accordance with activation of the delivery apparatus.

5. Substance delivery device as claimed in claim 1 wherein the outlet(s) are adapted to enable delivery of the substances in either or both substantially fluid and substantially solid form during operation of the delivery apparatus, said outlets including at least one of sealing means and restricting means to effect control of release of the substances as required.

6. Substance delivery device as claimed in claim 1 wherein the programmable control means for initiating and regulating delivery of the substance(s) is electric in operation and includes:

a power source,

a microprocessor able to run software for determining and controlling the delivery of a dose by the substance delivery device according to a pre-determined delivery regime,

a printed circuit board including components for effecting operation of either or both resistors and an electromagnetic coil in response to the software being run by the microprocessor, their operation resulting in autonomous delivery of at least one substance from at least one reservoir in accordance with the aforesaid predetermined delivery regime, and

a switch to activate the substance delivery device and/or initiate timing of the delivery of the substance(s) in accordance with the aforesaid predetermined delivery regime.

7. Substance delivery device as claimed in claim 1 wherein the preferred delivery regime includes delivery of substances in any one of:

regulated doses,

at specific concentrations, and

at specific intervals over a predetermined period of time to effect a desired physiological response in an animal for which it is intended to be used.

8. Substance delivery device as claimed in claim 7 in which a desired physiological response includes at least one of:

synchronizing oestrus for effecting controlled breeding programs,

the control of parasites,

affecting growth, and

altering nutritional status.

9. Substance delivery device of claim 7 in which the delivered substance includes at least one of:

a. an oestrogen or oestrogen derivative,

b. prostaglandin or a prostaglandin derivative,

c. progesterone or progesterone derivative,

d. a hormone other than an oestrogen, prostaglandin, or progesterone or derivatives thereof,

e. a vitamin, mineral, or nutritional supplement,

f. a medicine,

g. a parasiticide or insecticide,

h. a prophylactic agent; and

i. a carrier compound, preparation, or solution.

10. Substance delivery device as claimed in claim 1 wherein the range of form of the substances includes liquids of varying viscosities, pastes, gels, powder, granules, capsules/tablets, gases.

11. Substance delivery device as claimed in claim 1 wherein the said tail portion includes a substantially elongate shaft portion and an angled distal portion, said shaft portion being adapted to engage the body of the device and said angled distal portion adapted to receive the retention means;

said tail portion being configured to facilitate insertion and withdrawal of the device in to and from the body cavity of said animal.

12. Substance delivery device as claimed in claim 1 wherein the retention apparatus external to the animal for effecting retention of the substance delivery device within the animal includes, at one distal end, a portion adapted to engage the tail portion of the substance delivery device and, at the opposite end, a portion adapted to engage an exterior surface of the animal.

13. Substance delivery device as claimed in claim 1 wherein the body cavity of an animal includes any one of the ear, the buccal cavity, the vagina, the rumen, and the rectum.

14. Substance delivery device as claimed in claim 1 wherein the operation of delivery apparatus and programmable control means together cause controlled delivery of the at least one substance from the device to the animal in accordance with the preferred delivery regime, in predetermined quantities, for predetermined dose duration, at predetermined times to achieve desired concentrations of the substance in the animal to effect a desired outcome.

15. Substance delivery device as claimed in claim 14 wherein the at least one substance is delivered autonomously in situ to the animal in either or both substantially solid form and substantially fluid form.

16. Substance delivery device as claimed in claim 1 wherein the substance delivery device insertable into an animal'"'"'s body cavity is adapted to be used at least as an intra-vaginal, intra-rumenal, or intra rectal substance delivery device.

17. Substance delivery device as claimed in claim 16 wherein where the substance delivery device is an intra-vaginal delivery device the substance delivery device is adapted to deliver formulated hormones in regulated doses at specific times in accordance with a predetermined delivery regime into the anterior vagina of an animal to synchronize oestrus for purposes including effecting controlled breeding programs.

18. Substance delivery device as claimed in claim 17 wherein synchronizing oestrous to effect controlled breeding enables fixed time blanket insemination in either cycling or non-cycling animals, including cows.

19. Substance delivery device as claimed in claim 17 wherein the formulated hormones delivered in regulated doses at specific times in accordance with a predetermined delivery regime include four separate hormonal treatments formulated to effect the desired outcome when delivered in precisely the required dose and at the exact time during a specific treatment period.

20. Substance delivery device as claimed in claim 19 wherein the treatment period includes delivery of the hormone formulation treatments over either nine days or eleven days.

21. Substance delivery device as claimed in claim 17 wherein the delivery device is adaptable to deliver a range of formulations into other areas of the animal'"'"'s body to control or synchronize other body functions or cycles.

22. Substance delivery device as claimed in claim 1 wherein the retention apparatus is adapted to maintain the substance delivery device in situ within the period over which the device is required to deliver the substance(s) from the substance delivery device.

23. Substance delivery device as claimed in claims 16 wherein where the substance delivery device is an intra-vaginal delivery device the retention apparatus is adapted to accommodate the peristaltic nature of the smooth muscle of the anterior vagina and effect retention of the device during the period the device is inserted in the animal.

24. Substance delivery device as claimed in claim 2 wherein the at least two separate, but inter-connectable portions of the body include an anterior front portion at the leading end of the device and a posterior rear portion at the trailing end of the device, when the device is inserted into the animal.

25. Substance delivery device as claimed in claim 24 wherein the front portion of the body is substantially elongate and cylindrical in shape, having a substantially uniform cross-sectional profile, said configuration being dictated by the internal components of the device housed therein including the number of substance formulations and form of the substances to be delivered, the number and structural configuration of reservoirs required to house the formulations, the delivery apparatus (both type and quantity) required to deliver the formulations, the number and location of the outlets for the substances, the control means for effecting the delivery regime of the formulations.

26. Substance delivery device as claimed in claim 24 wherein the rear portion is a substantially ovoid cylinder and being of substantially wider diameter and substantially shorter than the front portion said configuration being dictated by the internal components of the device housed therein including the number of substance formulations and form of the substances to be delivered, the number and structural configuration of reservoirs required to house the formulations, the delivery apparatus (both type and quantity) required to deliver the formulations, the number and location of the outlets for the substances, the control means for effecting the delivery regime of the formulations.

27. Substance delivery device as claimed in claim 24 wherein the configuration of the body portions is determined by one or more of the cavity structure, the physiology of the animal into which the device is being inserted, the process for which the device is being used and the length of time the device is to be retained in the animal.

28. Substance delivery device as claimed in claim 24 wherein the front body portion includes a substantially thinner, indented portion coinciding with an activation switch of the control means to allow an operator to activate the control means of device externally by depressing the switch through the thinner body wall before the device is inserted into the animal.

29. Substance delivery device as claimed in claim 28 wherein the substantially thinner, indented portion of the front body portion also improves operator visibility of the internal components of the device, including either or both a light emitting diode (LED) display and an indicator light, to indicate activation of the control means.

30. Substance delivery device as claimed in claim 24 wherein the front portion of the body is further adapted to include orifices/apertures that form the outlet(s) associated with reservoirs dedicated to containing separate substances and from which the substances in the reservoir(s) are delivered, even though the reservoir for the particular substance may not necessarily be encased by the front body portion.

31. Substance delivery device as claimed in claim 30 wherein a reservoir also operates as a conduit.

32. Substance delivery device as claimed in claim 30 wherein the front portion is further adapted to receive a nose cap portion substantially at the leading distal end, said nose cap portion being adapted to include a plurality of outlet orifices.

33. Substance delivery device as claimed in claim 32 wherein the nose cap portion includes hinged, releasable sealing means to enable delivery of the substances from the reservoirs when required in accordance with the delivery regime.

34. Substance delivery device as claimed in claim 33 wherein the sealing means when sealed provides a substantially fluid tight seal to each of the substance reservoirs.

35. Substance delivery device as claimed in claim 33 wherein release of the releasable sealing means occurs in conjunction with a controlled operation of the delivery pressure devices associated with each reservoir allowing the contents of the substance reservoirs to be expelled from the reservoirs/conduits and delivered into the animal.

36. Substance delivery device as claimed in claim 2 wherein the rear body portion encloses at least one substance reservoir for housing one or more substances in substantially fluid (including pastes or gels), substantially solid (including powder or capsules/tablets) or substantially gaseous form.

37. Substance delivery device as claimed in claim 36 wherein where the at least one substance reservoir(s) when housing a substance in substantially fluid form is adapted to be collapsible.

38. Substance delivery device as claimed in claim 37 wherein where the reservoir is collapsible a breather hole is included in a rear portion of the body to enable air pressure within the device to equilibrate as the collapsible reservoir is emptied during delivery of the substance.

39. Substance delivery device as claimed in claim 36 wherein the rear portion is further adapted to receive a distal end of a shaft of the tail portion.

40. Substance delivery device as claimed in claim 39 wherein the distal end of the shaft of the tail portion is received into a recess in the rear body portion during assembly of the device and provides a secure anchor point for attachment of the retention apparatus to the device.

41. Substance delivery device as claimed in claim 40 wherein the rear body portion is adapted to be strengthened via a series of ridges to provide more rigidity to the rear portion, for supporting either or both reservoir(s) and the tail portion.

42. Substance delivery device as claimed in claim 24 wherein the front and rear body portions are interconnectable via complementary configured interlocking recesses and protrusions molded into the body portions.

43. Substance delivery device as claimed in claim 24 wherein the body portions are adapted to improve the ease with which the substance delivery device is able to be inserted into and withdrawn from a passage or body cavity of an animal, and without causing damage and/or discomfort to the animal via a substantially smooth external finish in conjunction with a substantially cylindrical shape.

44. Substance delivery device as claimed in claim 2 wherein the chassis of the device serves as the internal skeleton of the device to which other internal components are attached, including at least three reservoirs located at variable locations within the body of the device, electronic control means including a printed circuit board and energy source and valve and delivery pressure systems for the reservoirs.

45. Substance delivery device as claimed in claim 44 wherein the body includes at least two portions, the chassis slots into the front portion of the body via a locating lug and is retained in place via a spring/resilient system which forces the chassis against the front body section, and via sealing means including O-ring(s).

46. Substance delivery device as claimed in claim 45 wherein the O-rings are adapted to cause a fluid-tight seal to prevent moisture from the animal'"'"'s cavity accessing the internal working mechanism including the electronics of the device, particularly where the body includes venting holes to allow atmospheric pressure to equilibrate delivery of substances from collapsible reservoirs and in doing so allow animal fluids into the device.

47. Substance delivery device as claimed in claim 11 wherein the substantially internal shaft portion of the tail portion is positioned in situ internally of the cavity and the angled distal portion at an outer distal end of the shaft is positioned adjacent the entrance of the cavity and includes the engaging means adapted to receive a portion of the retention apparatus to be located externally of the cavity.

48. Substance delivery device as claimed in claim 47 wherein the external distal portion is angled at a right angle to the shaft.

49. Substance delivery device as claimed in claim 47 wherein the tail portion for use with the delivery device to be inserted into the vagina of a cow includes a substantially elongate shaft that extends from the rear of the body of the device by a distance of approximately 126 mm, is substantially circular in a cross-section and is approximately 14 mm in diameter along its length and wherein the external distal portion is angled at right-angles to the shaft and extends for approximately 12 mm to barbed engaging means capable of engaging with a portion of the retention apparatus.

50. Substance delivery device as claimed in claim 49 wherein the right angled distal portion located at the outer distal end of the tail is further adapted to determine the depth of insertion of the device as the right-angled distal portion is located adjacent the vulval lips of the animal.

51. Substance delivery device as claimed in claim 49 wherein the substantially elongate shaft is adapted to limit the delivery device being dislodged or expelled from the anterior vagina of the animal, to minimize internal pressure against the vaginal wall while the device is in situ, ensures that the device remains in the correct orientation and location while in situ, ensures minimal trauma to the animal during insertion and removal and avoids the need for an applicator to insert the device into the animal.

52. Substance delivery device as claimed in claim 51 wherein the substantially elongate shaft is configured to include substantially straight, spiraled, curved, helical and/or include undulating portions along all or part of its length, and/or be extendible telescopically, to enable it to be adapted to complement a range of sizes of body cavities and/or the physiology associated with different body cavities of different animals into which the delivery device may be inserted.

53. Substance delivery device as claimed in claim 49 wherein the tail of the device contributes to retention of the device within the animal'"'"'s cavity particularly where the cavity is the vagina, using an internal connecting portion between the retention apparatus and the device.

54. Substance delivery device as claimed in claim 11 wherein the tail serves as the applicator for the device by enabling an operator inserting the device to hold the tail at the time of insertion of the device and to use it to guide and deliver the device to a correct location within the animal.

55. Substance delivery device as claimed in claim 11 wherein the tail serves to facilitate withdrawal of the device when the functional utility of the device has been exhausted by an operator pulling on the tail portion which when further assisted by pressure exerted by the walls of the passage or the opening to the body cavity enables the device to be withdrawn with minimum discomfort to the animal.

57. Substance delivery device as claimed in claim 11 wherein the distal end of the shaft of the tail portion is attached to the rear portion of the body of the device by any one of:

a) being rigidly fixed into the rear portion of the body of the device;

b) being molded onto the body of a device; and

c) being press-fitted into an aperture in the rear portion of the body.

58. Substance delivery device as claimed in claim 57 wherein distal end of the shaft of the tail portion is attached to the rear portion of the body of the device such that when also connected to the retention apparatus the orientation of the tail is predetermined and ensures the device has the same orientation within the cavity in all instances.

59. Substance delivery device as claimed in claim 57 wherein the tail is adapted to be located in the chassis of the device.

60. Substance delivery device as claimed in claim 57 wherein when the distal end of the shaft of the tail portion is press-fitted into the aperture in the rear portion of the body the distal end is secured in place via protrusions, including barbs, which positively engage the body.

61. Substance delivery device as claimed in claim 58 wherein the tail portion is adapted to be detachable from the body of the device and/or be re-usable.

62. Substance delivery device as claimed in claim 49 wherein the tail includes an exterior surface adapted to be smooth so as minimize abrasion or trauma with the target animal, and to ensure that any animal excrement, mucous or body fluid does not bond or bind to the tail once inserted and while in situ, whilst also being dependent on the internal conditions of the body cavity into which the device is inserted, and the corresponding shaft strength required.

63. Substance delivery device as claimed in claim 11 wherein to facilitate use of the tail portion for insertion or withdrawal of the substance delivery device into the vaginal body cavity of an animal the tail portion is substantially rigid to enable the shaft of the tail portion to withstand stress without the shape of the shaft becoming distorted.

64. Substance delivery device as claimed in claim 63 wherein to provide a substantially rigid tail portion, the tail portion is manufactured from thermoplastics materials including a glass component of between 5% to 40%.

65. Substance delivery device as claimed in claim 64 wherein the tail portion includes a glass content of less than 25% for use when greater flexibility of the tail portion is required in the insertion of the device, or for use when the retention of the device in the animal for the length of time required to effect delivery of the substances into the animal may be less crucial.

66. Substance delivery device as claimed in claim 64 wherein the tail portion includes a glass content of greater than 33% where a more rigid tail portion is required and it is not crucial for a smooth surface finish to the exterior molding of the tail portion.

67. Substance delivery device as claimed in claim 64 wherein the tail portion is used in conjunction with an intravaginal delivery device, the preferred glass to thermoplastics ratio is 33% glass to 66% nylon to provide a rigid, tail portion with minimal flexibility.

69. Substance delivery device as claimed in claim 12 wherein an external point of attachment of the retention apparatus on the animal is dependent on the animal'"'"'s behavioral characteristics.

70. Substance delivery device as claimed in claim 69 wherein an external point of attachment of the retention apparatus on naturally passive animals including cows is located on the animal'"'"'s back.

71. Substance delivery device as claimed in claim 69 wherein an external point of attachment of the retention apparatus on naturally inquisitive animals, including pigs, is in the vicinity of the vulval area, relying on the animal'"'"'s reluctance to allow other animals to touch that area to minimize the likelihood of another animal pulling off, or chewing the retention apparatus.

72. Substance delivery device as claimed in claim 12 wherein the retention apparatus includes a patch and strap arrangement.

73. Substance delivery device as claimed in claim 72 wherein the strap is substantially elongate and resilient and adapted to attach at one distal end to the angled portion of the tail rod and including the patch at the outer free distal end of the strap.

74. Substance delivery device of claims 72 and claim claim 72 in which the patch for an intra vaginal device is attached to the back of the animal and the strap is under sufficient tension at the time of insertion of the device into the animal'"'"'s vagina to maintain the device in the animal but without the angled distal portion of the tail portion rubbing against and causing trauma to the animal'"'"'s vulval commissure.

75. Substance delivery device as claimed in claim 74 wherein the patch when adapted to be attached to the back of the cow is approximately 55 mm-60 mm in diameter.

76. Substance delivery device as claimed in claim 75 wherein patch is attached to the animal'"'"'s back via adhesive applied to either or both the patch and the surface of the animal.

77. Substance delivery device as claimed in claim 76 wherein patch includes a roughened surface to accentuate bond between the strap and the cow when the adhesive is applied and the patch is glued to the animal.

78. Substance delivery device as claimed in claim 74 wherein the strap tension, the tail dimensions and attachment of the patch to the animal'"'"'s back minimizes occurrence of expulsion of the device from the animal via muscular peristalsis or accidental removal from the vagina.

79. Substance delivery device as claimed in claim 71 wherein the retention apparatus includes any one of a cap, diaphragm or similar means that applies suction or adhesion around the vulval region and retains the device in situ.

80. Substance delivery device as claimed in claim 53 wherein the retention apparatus is integral with the tail.

81. Substance delivery device as claimed in claim 9 wherein the hormones delivered in regulated doses at specific times in accordance with a predetermined delivery regime include two formulations of estradiol, one of prostaglandin and a progesterone formulation.

82. Substance delivery device as claimed in claim 81 wherein the formulations of estradiol and prostaglandin are delivered from the delivery device via a plurality of delivery apparatus adapted to deliver required single-unit doses at a specific time.

83. Substance delivery device as claimed in claim 81 wherein the formulation of progesterone is delivered from the delivery device via at least one delivery apparatus adapted to deliver a continuous dosing to replicate the naturally occurring situation in the animal.

84. Substance delivery device as claimed in claim 83 wherein the delivery apparatus used to provide continuous dosing of a progesterone formulation includes a collapsible reservoir.

85. Substance delivery device of claim 84 in which the continuous dosing of a progesterone formulation from a collapsible reservoir is achieved by either or both:

active delivery of specific doses from the delivery apparatus at controlled predetermined time intervals, and

passive delivery through controlled dissolution in accordance with a predetermined delivery regime.

86. Substance delivery device as claimed in claim 85 wherein the progesterone available in at least one of a substantially liquid, powdered, or tablet form.

87. Substance delivery device as claimed in claim 86 wherein where the progesterone is adapted for delivery in to the animal'"'"'s body cavity via one or more of:

being dissolved in a carrier solution in readiness for delivery;

or

the carrier solution is stored separately from the progesterone until prior to release of the formulation into the animal, when the carrier solution is introduced to the progesterone with the dissolved final formulation released into the animal;

or

the carrier solution is stored separately from the progesterone until release of the formulation into the animal, when the carrier solution is introduced to the progesterone with mixing occurring at the time of release;

or where the progesterone is in powdered or tablet form;

or

dissolution in the animal'"'"'s body fluids.

88. Substance delivery device as claimed in claim 87 wherein where progesterone is used in the formulation the carrier solution includes a solvent comprising either or both water and an alcohol to make soluable the progesterone, to facilitate transfer of the hormone across membranes, particularly in substantially aqueous environments of a body cavity, such as the vagina.

89. Substance delivery device as claimed in claim 9 wherein the carrier compound, preparation, solution is included to facilitate the transfer of insoluble, or partially soluble substances across water-soluble membranes and includes chemical compounds capable of forming inclusion complexes.

90. Substance delivery device as claimed in claim 89 wherein at least one chemical compound capable of forming inclusion complexes for transferring insoluble, or partially soluble substances across water-soluble membranes includes cyclodextrin.

91. Substance delivery device as claimed in claim 86 wherein the progesterone is delivered in a substantially fluid form activation of the pressure device of the delivery apparatus effects delivery of the progesterone as a continuous series of pulsatile doses from the reservoir in accordance with the predetermined delivery regime.

92. Substance delivery device as claimed in claim 3 wherein the pressure applied to cause movement of the substance(s) being delivered from the reservoir to the outlet of the substance delivery device is an expulsive force.

94. Substance delivery device as claimed in claim 86 wherein the progesterone is delivered in a substantially solid form activation of the pressure device of the delivery apparatus effects delivery of the progesterone within the reservoir to an outlet of the substance delivery device where the surface of the progesterone is subjected to passive dissolution by fluids in the cavity.

95. Substance delivery device as claimed in claim 3 wherein tension pressure is applied to either or both the reservoir and the substance to effect movement of the substance(s) being delivered from the reservoir to the outlet of the substance delivery device.

97. Substance delivery device as claimed in claim 3 wherein the pressure device is activated by a power source, including a battery.

98. Substance delivery device as claimed in claim 84 wherein the collapsible reservoir containing the progesterone is maintained under positive pressure by means of a spring force applied to the posterior end of the reservoir such that the substance is always presented to the inlet of a pump to which the bellows reservoir is attached, regardless of the attitude of the device, used to effect continuous programmed series of pulsatile doses of the progesterone.

99. Substance delivery device as claimed in claim 84 wherein the collapsible reservoir containing the progesterone is maintained under positive pressure by means of a spring force applied to the posterior end of the reservoir such that the substance is always presented to an outlet of the reservoir, regardless of the attitude of the device, when used to effect continuous passive doses.

100. Substance delivery device as claimed in claim 98 wherein to provide delivery of the progesterone solution as a continuous programmed series of pulsatile doses according to command, pressure is applied to the posterior end of the collapsible reservoir by a seal and spring such that a valve is opened for a specific period of time to allow some of the contents of the reservoir to fill a small delivery cavity and whereby pressure from repeated operation of the valve effectively drives the fluid to the outlet.

101. Substance delivery device as claimed in claim 100 wherein the pump is operated by means of a magnetic core that is forced to stroke when a electromagnetic coil, within which the magnetic core is housed, is energized, such that the core activates a release mechanism allowing a predetermined quantity of solution to enter the pump with the positive pressure in the reservoir ensuring the progesterone solution enters the pump and is expelled from the outlet under pressure.

102. Substance delivery device as claimed in claim 84 wherein the reservoir is adapted to collapse via the inclusion of annular rings that enable the reservoir to concertina when even spring pressure is applied at the posterior end of the reservoir thereby effecting movement of the substance along the reservoir.

103. Substance delivery device as claimed in claim 102 wherein the posterior end of the reservoir is further adapted to effect even collapsing via reinforcing means thereby minimizing racking, implosion from the posterior end of the reservoir, or uneven dosing or output from the device.

104. Substance delivery device as claimed in claim 91 wherein the reservoir contain progesterone in substantially fluid form the quantity of fluid required to fill the reservoir optimally ranges between 12 ml and 42 ml with the reservoir being varyingly configured to accommodate the fluid.

105. Substance delivery device as claimed in claim 104 wherein the fluid contained in the reservoir is directed towards the anterior end of the reservoir when the reservoir collapses, and towards valve means also located at the anterior end of the reservoir.

106. Substance delivery device as claimed in claim 105 wherein the bellows is adapted to be connected directly to the valve means.

107. Substance delivery device as claimed in claim 106 wherein the valve means includes a central aperture, a seal positioned to seal the aperture and a valve ring to lock the seal in a fixed position.

108. Substance delivery device as claimed in claim 107 wherein the collapsible reservoir is substantially tapered adjacent the valve means to effect maximum delivery of the progesterone in fluid form to the valve means and to minimize residual progesterone in the reservoir at the end of the dosing regime.

109. Substance delivery device as claimed in claim 108 wherein the seal of the valve means is sealed via a spring applied against the rear of the reservoir effecting pressure from the progesterone fluid against the seal thus keeping the valve closed at all times while the valve is not being operated, yet during operation of the valve means the seal provides the energy to push the progesterone fluid to the outlet.

110. Substance delivery device as claimed in claim 109 wherein the valve means is a metering valve system operating on a reversed magnetic polarity principle, including either a moving or a fixed armature capable of being magnetized, or a rare earth magnet and an actuator pin which opens the valve means, a coil member capable of being magnetized, tension apparatus, and a chamber capable of receiving a substance from a conduit/reservoir.

111. Substance delivery device as claimed in claim 110 wherein the valve means comprises a mild steel bobbin with an attached seal, which moves on a horizontal plane when a surrounding coil member capable of being activated, is energized creating a solenoidal effect resulting in the moving armature sealing against the stationary armature, thus reversing the polarity of a rare earth magnet providing energy to the valve means and momentarily opening the seal between the valve and a bulkhead, allowing fluid to travel through a narrow conduit to an outlet of the device, with deactivation of the coil member enabling the moving armature to move away from the fixed armature.

112. Substance delivery device as claimed in claim 111 wherein the coil member is a copper coil located substantially adjacent to the chassis to provide the energy to the magnet upon activation.

113. Substance delivery device as claimed in claim 111 wherein the metering valve system is adapted to create a chamber within the conduit, such that movement of the moving armature towards and away from the fixed armature enables some of the substance which has passed into this chamber to move along the conduit to the outlet, thereby operating as a pump.

114. Substance delivery device as claimed in claim 110 wherein the valve system includes a rare earth magnet and an actuator pin which opens the valve at the time of activation of the coil member the polarity of the rare earth magnet is reversed causing the magnet to strike the actuator pin which in turn opens the seal on the valve arrangement.

115. Substance delivery device as claimed in claim 112 wherein activation of the coil member is controlled by the operation of a software program for a controlled duration to enable fluid to travel past the actuator pin into the magnet chamber and towards the outlet.

116. Substance delivery device as claimed in claim 113 wherein the progesterone formulation is in contact with the magnet during delivery.

117. Substance delivery device as claimed in claim 114 wherein the actuator pin is configured to complement the interior dimensions of the valve means to ensure that the seal is opened for a predetermined period at each stroke of the pin.

118. Substance delivery device as claimed in claim 117 wherein the dimensions of the actuator pin against the interior dimensions of the valve means and the distance the pin travels are determine the actual amount of fluid dosed at each stroke.

119. Substance delivery device as claimed in claim 118 wherein the dimensions of the actuator pin are capable of being variably selected according to the amount of fluid to be dosed.

120. Substance delivery device as claimed in claim 119 wherein variation to the amount of fluid to be dosed is achievable by varying any one or more of:

the actuator pin dimensions,

the frequency of dose firing,

the duration of opening,

the outlet dimensions,

the viscosity of the formulation,

the spring energy available to the progesterone reservoir,

the quantity of fill in the progesterone reservoir,

the strength of the magnetic field surrounding the rare earth magnet, and

the strength of the rare earth magnet.

121. Substance delivery device as claimed in claim 120 wherein variation to the amount of fluid to be dosed is achievable by varying the dimensions of the actuator pin by any one of:

lengthening the fine point of the pin which strikes the seal thereby opening the seal further to enable more fluid to be dosed at each stroke of the pin, and

shortening the body of the pin such that the magnet has to travel further and a longer lag time in opening of the valve occurs.

122. Substance delivery device as claimed in claim 115 wherein the outlet for progesterone delivery is located substantially adjacent the valve means for ensuring active delivery of the progesterone formulation to the target area within the body cavity.

123. Substance delivery device as claimed in claim 122 wherein the outlet includes a reducing-diameter outlet providing sufficient resistance to the progesterone fluid to effect one or more of:

a positive “

squirt of formulation”

,

control over the flow and quantity of progesterone formulation delivered at any one time, and

consistency of small-dose outputs on an accurate basis.

124. Substance delivery device as claimed in claim 123 wherein the reducing-diameter outlet is reduced through three reductions from 1 mm, to 0.7 mm, to 0.5 mm on the external surface of the body of the device to provide a back pressure on the valve means to cause active expulsion as the fluid leaves the device.

125. Substance delivery device as claimed in claim 124 wherein the device is an intravaginal device the progesterone formulation is actively expelled from the device to clear the device and any mucous naturally accumulating around the device in the anterior vagina.

126. Substance delivery device as claimed in claim 82 wherein to minimize the effects of the accumulation of mucous and to ensure a formulation is optimally presented in the cavity for transfer across the vaginal mucosa, the delivery apparatus for the single-unit doses are adapted to be a plunger-type delivery system to expel the single unit doses some distance and with some force from the device.

127. Substance delivery device as claimed in claim 126 wherein the single-unit doses of formulation are delivered as any one or more of a tablet, a capsule, or liquid formulation of varying viscosity.

128. Substance delivery device as claimed in claim 127 wherein for controlling oestrus in cattle, a plurality of doses of oestradiol and prostaglandin in individual solid capsules are contained within three single dose conduits located in the anterior of the delivery device with at least one pressure device associated with each conduit.

129. Substance delivery device as claimed in claim 127 wherein for controlling oestrus in cattle, a plurality of doses of progesterone in individual solid capsules, relying on passive dissolution within the animal'"'"'s vagina, are also optionally contained within single dose conduits with at least one pressure device associated with each conduit.

130. Substance delivery device as claimed in claim 128 wherein the at least one pressure device of the unit doses includes a plunger that operates between a pre-delivery position and a fired position.

131. Substance delivery device as claimed in claim 130 wherein when the plunger is in a pre-delivery position the plunger is held under tension until released.

132. Substance delivery device as claimed in claim 130 wherein when the plunger is in a fired position the plunger fully extends to the front of the device.

133. Substance delivery device as claimed in claim 131 wherein when the plunger is released heat is applied to a portion of the plunger which melts such that a spring associated with the plunger propels the plunger along the conduit which in turn applies pressure to the unit dose causing it to be expelled under force from the unit dose conduit.

134. Substance delivery device as claimed in claim 133 wherein the heat required to melt the plunger is provided by any one of energy sources within the substance delivery device including battery energy, or energy sources in the surrounding environment including kinetic, chemical, or thermal energy.

135. Substance delivery device as claimed in claim 129 wherein the individual unit dose conduit also includes a nose cap to provide fluid seal.

136. Substance delivery device as claimed in claim 135 wherein the nose cap is resiliently hinged to the body of the device in at least one location around its perimeter.

137. Substance delivery device as claimed in claim 136 wherein the hinge of the nose cap retains the nose cap in place and prevents inadvertent loss of the nose cap after the plunger has fired.

138. Substance delivery device as claimed in claim 1 wherein the pressure devices are either capable of causing the flow of substance through the conduit, and/or capable of causing release of the substance from the conduit without back flow.

140. Substance delivery device as claimed in claim 1 wherein the control means controls delivery of the substances from the reservoirs by triggering activation of the delivery apparatus in accordance with a predetermined regime.

141. Substance delivery device as claimed in claim 140 wherein the control means is reprogrammable to effect at least one of:

recalibration of the triggering of the delivery apparatus,

regulation of delivery via altering the size of the dose, the timing and/or the duration of the dose, and

responding to environmental changes around the substance delivery device in response to feedback from sensors around the substance delivery device.

142. Substance delivery device as claimed in claim 141 wherein the sensors determine when the environment is ideal for the introduction of a substance into the body of the animal thus enabling the microprocessor to control the delivery apparatus to introduce the substance.

143. Substance delivery device as claimed in claim 142 wherein the sensors determine factors in the body fluid surrounding the substance delivery device and/or delivery apparatus, such as temperature, acidity, viscosity or even odor which act as physiological indicators that may be more accurate than a calendar date for determining when certain substances should be introduced into the animal.

144. Substance delivery device as claimed in claim 6 wherein the switch is activated by:

depression of the switch manually at the time of insertion of the device into the cavity for a preprogrammed time, and

activation, control and programming from a remote source by electronic signaling means.

145. Substance delivery device as claimed in claim 144 wherein activation of the switch is confirmed by a flashing LED display.

146. Substance delivery device as claimed in claim 145 wherein electronic signaling means that is external device to the animal for triggering the activation of the switch includes a radio transmitter, an ultrasonic transmitter, or a magnet.

147. Substance delivery device as claimed in claim 141 wherein the microprocessor runs a software program to effect one or more of:

triggering and/or regulating the action of the pumps/pressure devices of the delivery apparatus,

connecting or disconnecting the pumps from the energy source,

controlling operation of the valve means to permit or prevent the flow of substance from the delivery apparatus and/or from the outlets of the substance delivery device, and

effecting supply of power to resistors on the circuit board to effect release of the mechanism for firing the front single-unit doses.

148. Substance delivery device as claimed in claim 147 wherein the microprocessor and associated software effect activation of the release mechanism for the progesterone delivery by the control mechanism energizing the progesterone delivery system by sending an electrical current to the pump, valve, magnet.

149. Substance delivery device as claimed in claim 147 wherein the microprocessor and associated software effects control over the time at which a unit dose is delivered, and over the timing and dose volume of a continuous series of pulsatile doses.

150. Substance delivery device as claimed in claim 151 wherein microprocessor is a four bit microprocessor or an 8 bit single chip microprocessor such as a pic 16c54 or Z8 or Motorola 6805.

151. Substance delivery device as claimed in claim 6 wherein the power source of the control means is a 3 volt specialist lithium power cell.

56. A method of inserting into and withdrawing from a body cavity of an animal a substance delivery device, using the tail of the animal.

68. A method for retaining a substance delivery device within a body cavity of an animal into which the substance delivery device is inserted, via use of retention apparatus means.

93. A method for delivering a substance to an outlet of a substance delivery device including at least one conduit capable of containing the substance, at least one pressure device capable of applying pressure to the conduit/reservoir and valve means, wherein the steps of applying pressure to the conduit/reservoir and valve means, causing the substance within the conduit to move along the conduit to the outlet.

96. A method for delivering a substance to an outlet of a substance delivery device including at least one conduit capable of containing the substance, at least one pressure device capable of applying pressure to either or both the conduit/reservoir and the substance therein, wherein the steps of applying pressure to effect movement of the substance within the conduit to the outlet.

139. A method of introducing a substance into an animal from a substance delivery device substantially as described above, wherein the step of controlling at least one of the operation of the delivery apparatus to effect active introduction of a substance in to a cavity, the time of delivery of one or more substances, the volume of substance delivered on a dose by dose basis.

152. A method of controlling the delivery apparatus of a substance delivery device wherein the step of introducing predetermined amounts of at least one substance at predetermined times into the body of an animal.

153. A method of delivering a substance to a body wherein the step of using a pressure device of the delivery apparatus to apply pressure to the conduit of the delivery apparatus, causing the substance within the conduit to move along the conduit to an outlet and into a body.

154. A method of introducing a substance into an animal wherein the step of controlling the operation of the substance delivery device so that the substance is actively introduced into the animal.

155. A method of introducing a substance into an animal from a substance delivery device, wherein the step of controlling the operation of the delivery apparatus so that the substance is actively introduced into the animal.

156. A method of controlling the delivery apparatus of a substance delivery device, wherein the step of introducing predetermined amounts of substance at predetermined times into the body of an animal.

157. A method of controlling the introduction of a substance into an animal from a substance delivery device, wherein energy sources in the environment surrounding the substance delivery device are utilized.