Patent Application
20070272169
The invention relates to the delivery of drugs to animals, and more particularly to devices for enabling the delivery of drugs or medicaments to animals for pulmonary or nasal absorption via the mouth and or nose.
The deliver of a drug or a medicament to an animal, and in particular a mammal, such as a human, a dog or a horse, for pulmonary or nasal absorption is desired in many circumstances. Direct application, such as by a spray or aerosol delivery device, or a dry powder delivery device, is difficult due to movements of the animal. To enable such application of medicaments, in the prior art, an elongated, generally cup-shaped “mask” is often provided, having a relatively large open base end for fitment over an animal's nostril or muzzle and having a medicament administration port opposite that base end. Typically, the mask is made out of a semi-rigid material (e.g., sheet polycarbonate) and is provided in various sizes for use with different sized animals.
In use in the prior art, an appropriate sized mask is selected, and the open base end is positioned over the animal's nostril or muzzle, preferably with a friction fit at the open base end. The size of the open end is such that at least a rough seal is established between the open end of the mask and the animal's nostril or muzzle. When the mask is so positioned, medicament is delivered at the medicament administrative port, for example by spray, aerosol delivery device, or dry powder medicament delivery device, either breath-activated or user-driven. As the animal breathes, the medicament is drawn into one (or both) nostril(s), or in the mouth and into the lungs or the nasal passages.
However, when the animal breathes in the medicament through the mask, the animal's head may move in different directions, and because of the rigid connection between the medicament administration port of the mask and the medicament dispenser, the medicament administration port of the mask may come apart from the medicament dispenser, that, in turn, causes interruption or termination of the medicament supply to the animal. The interruption or termination of the medicament supply may cause serious damage to the animal's health.
Moreover, the semi-rigid structure of the prior art masks fail to provide a substantially seal between the interior region of the mask and the animal's face. That may cause insufficient or incorrect amount of medicament taken by the animal.
Therefore, there is a need for an improved mask for delivering drugs to animals for pulmonary or nasal absorption via the mouth and/or nose. Such improved mask should have flexible connection between the medicament administration port of the mask and the medicament dispenser, and have an improved seal manner between the mask and the animal.
The present invention is a drug or medicament delivery device for fitting with the appropriate portion of the head of the animal such as the front of the head or over one nostril for the effective delivery of drugs or medicaments, for pulmonary or nasal absorption. The device is in the form of a mask. The mask includes an airborne medicament interface adapter adapted to couple to a medicament dispenser in a sealed manner, an animal interface adapter adapted to establish a substantial seal between the animal interface adapter and the animal, and a relatively flexible sleeve extending along a longitudinal axis between the medicament interface adapter and the animal interface adapter. The medicament interface adapter extends along a reference axis and is coupled to the sleeve with a ball-and-socket coupler.
The ball-and-socket coupler preferably includes a hollow socket member and a hollow ball member. The hollow socket member preferably includes a partially spherical inner surface characterized by radius R, defining an interior socket region disposed about and extending along the longitudinal axis from a distal end of the sleeve toward the medicament adapter. The socket member is contiguous with one of the medicament interface adapter and the sleeve, preferably the sleeve. The hollow ball member includes a partially spherical outer surface characterized by a radius equal to or slightly less than R. An inner surface of the hollow ball member defines an interior region extending along the reference axis of the medicament interface adapter from the medicament interface adapter toward the distal end of the sleeve. The ball member is contiguous with the other of the medicament interface adapter and the sleeve.
The partially spherical outer surface of the hollow ball member is captively held by the partially spherical inner surface of the hollow socket member, permitting relative movement of the ball member with respect to the socket member, whereby the reference axis of the medicament interface adapter may be selectively angularly offset or aligned with the longitudinal axis in response to relative motion of the ball member with respect to the socket member.
In a preferred form, the hollow socket member is contiguous with the sleeve and the hollow ball member is contiguous with the medicament interface adapter.
In yet another preferred embodiment, the ball member extends between two opposite ends, a first end from which medicament interface adapter extends, and a second end. An elongated tubular element extends along the reference axis from the second end of the ball member toward the animal interface adapter to an end disposed near the animal interface adapter. The medicament interface adapter, the hollow ball member, and the tubular element form a continuous inner passageway from a medicament interface defined by the medicament interface adapter to the end of the tubular element. The end of the tubular element is intended to be inserted into or against the animal's nostril or mouth, when the animal interface adapter is pressed against the animal's face, to further ensure that substantially all medication dispensed within the medicament interface adapter is delivered to the animal's nostril.
The tubular element preferably includes two sections, a first section coupled to the second end of the ball member, and a second section coupled to the first section. The medicament interface adapter, the ball member, and the first section of the tubular element are preferably manufactured integrally. The second section is preferably flexible, and most preferably, is bellows-shaped, such that the length of the tubular element and the direction of the end of the tubular element can be adjusted by compressing or expanding the bellows-shaped second section. The direction of the tubular element also can be adjusted by rotating the ball member with respect to the socket member. The tubular element preferably has a cylindrical shape, but alternative shapes, such as conical shapes, also can be used, and the diameter of the tubular element can vary along the length of the tubular element.
In a further preferred embodiment, the sleeve further comprises at least one annular relatively compliant seal member extending from an inner circumference of the sleeve. In one preferred form, the seal member is a toroidal tube, defining a closed interior region filled with gas. In another preferred form, the seal member is a sealing skirt made of relatively compliant material. The sealing skirt preferably extends toward the animal interface adapter. In use, when the animal interface adapter is pressed against the animal's face, the annular compliant seal member provides a further seal around the animal's nostril or muzzle.
The airborne medicament interface adapter is adapted to couple the sleeve to a medicament dispenser. Preferably, the medicament dispenser is breath-activated but may be user (e.g., care giver) actuated. The medicament dispenser may be in the form of a dry powder medicament dispenser, or in aerosol dispenser. Alternatively, a user-actuated spray dispenser may be used.
The animal interface adapter is adapted to provide a substantial (although not necessarily complete) pneumatic seal between the animal interface adapter and the appropriate portion of the head of the animal (e.g., the front of the head of a small child, the nostril or the muzzle of any animal such as cats, dogs or horses). By way of example, the animal interface adapter may be in the form of a thin or tapered flexible sheet, which when pressed against the area around the appropriate portion of the head, forms at least a rough seal. As a further example, the animal interface adapter may be in the form of a stretchable, nominally conic-frustum shaped elastic sheet, extending from a proximal end of the sleeve. In the elastic form, the sheet may be stretched as the largest ring is moved over the nostril or muzzle of the animal. In some forms, an elastic or otherwise adjustable strap extends from the animal interface adapter, where the strap may be placed around the back of an animal's head to secure the mask in place.
The sleeve, which extends between the medicament interface adapter and the animal interface adapter, preferably has a unitary bell shape structure and has a step-like lateral surface. In an alternative form, the sleeve has a straight conical lateral surface. The sleeve preferably has a cross section monotonically increasing between a relatively small distal end and a relatively large proximal end.
In one preferred embodiment of the present invention, the sleeve is a cone-like structure extending along the longitudinal axis between the animal interface adapter and the medicament interface adapter, and defining an interior region. The cone-like structure includes a set of rings having diameters, which monotonically decrease from the animal interface adapter to the medicament interface adapter, each of the rings including a flexible skirt extending therefrom, each skirt having a monotonically decreasing diameter. The sleeve may further include at least one relatively compliant seal member, each extending from an inner circumference of an associated one of the rings into the interior region. The sleeve may further include a plurality of radially distributed struts extending externally from the sleeve and coupling at least one ring to the skirt of the next larger ring.
In another preferred embodiment, the mask is collapsible to permit use in a full or partially open state, and to permit easy and convenient transport in a collapsed or closed state. In a collapsed condition, a relatively small ring of the sleeve is fitted or nested into the next relatively large ring. In a preferred form, the mask of the invention is particularly adaptable to accommodate size variation in animals.
The present invention is intended for use with any animal, which may experience the benefits of the invention. Foremost among such animals are those, which are difficult to control or cannot be made to cooperate in the delivery of drugs or medicaments via conventional delivery devices. Hence, the term “animal” is used to designate patients such as infants, children, physically or mentally disabled patients, as well as any other animal (e.g., a dog, a cat or a horse).
For a fuller understanding of the nature and the objects of the invention, reference should be made to the following detailed description and the accompanying drawings in which the reference numerals refer to like elements and in which:
An exemplary drug delivery mask 110 embodying the present invention for use with dogs, horses, humans and other mammals is shown in
An animal interface adapter 30 is formed at the relatively large proximal end 12. An airborne medicament interface adapter 20 extending along a reference axis B is coupled to the relatively small distal end 14 by a ball-and-socket coupler 60, which includes a hollow socket member 62 and a hollow ball member 64. In
The hollow ball member 64 includes a partially spherical outer surface characterized by a radius equal to or slightly less than R. An inner surface of the hollow ball member 64 defines an interior region extending along the axis B from the medicament interface adapter 20 toward the distal end 14 of the sleeve 10. The ball member 64 is preferably contiguous with the medicament interface adapter 20.
The partially spherical outer surface of the hollow ball member 64 is captively held by the partially spherical inner surface of the hollow socket member 62, permitting relative movement of the ball member 64 with respect to the socket member 62, whereby the axis B of the medicament interface adapter may be selectively angularly offset or aligned with the longitudinal axis A, along which the socket 62 and the sleeve 10 extend, in response to relative motion of the ball member 64 with respect to the socket member 62. The partially spherical outer surface of the ball member 64 is preferably frictionally coupled to the partially spherical inner surface of the socket member 62, such that the relative orientation of the ball member 64 and the socket member 62 is maintained constant until a relative force is applied between the ball member 64 and the socket member 62 above a predetermined threshold force F. One of, or both of the partially spherical outer surface of the ball member 64 and the partially spherical inner surface of the socket member 62 have a frictional texture to effect the frictional coupling between the two surfaces.
In an alternative form as shown in
The medicament interface adapter 20 is shaped to couple to, or receive, an external aerosolizing medicament dispenser 25. In
The device 25 may be used for any drug formulation which may be advantageously administered to the lung or nasal passages in an animal, to cure or alleviate any illness or its symptoms. Many medicaments, bioactive active substances and pharmaceutical compositions may be included in the dosage forms of the present invention. Non-limiting examples of classes of drugs contemplated for use include ace-inhibitors, acne drugs, alkaloids, amino acid preparations, anabolic preparations, analgesics, anesthetics, antacids, antianginal drugs, anti-anxiety agents, anti-arrhythmias, anti-asthmatics, antibiotics, anti-cholesterolemics, anti-coagulants, anti-convulsants, anti-depressants, anti-diabetic agents, anti-diarrhea preparations, antidotes, anti-emetics, anti-histamines, anti-hypertensive drugs, anti-inflammatory agents, anti-lipid agents, anti-manics, anti-nauseants, anti-nauseants, anti-neoplastics, anti-obesity drugs, anti-parkinsonism agents, anti-psychotics, anti-pyretics, anti-rheumatic agents, anti-spasmodics, anti-stroke agents, anti-thrombotic drugs, anti-thyroid preparations, anti-tumor drugs, anti-tussives, anti-ulcer agents, anti-uricemic drugs, anti-viral drugs, appetite stimulants or suppressants, biological response modifiers, blood modifiers, bone metabolism regulators, cardiovascular agents, central nervous system stimulates, cerebral dilators, cholinesterase inhibitors, contraceptives, coronary dilators, cough suppressants, decongestants, dietary supplements, diuretics, DNA and genetic modifying drugs, dopamine receptor agonists, endometriosis management agents, enzymes, erectile dysfunction therapies, erythropoietic drugs, expectorants, fertility agents, gastrointestinal agents, homeopathic remedies, hormones, hyper- and hypo-glycemic agents, hypercalcemia and hypocalcemia management agents, hypnotics, immunomodulators, immunosuppressives, ion exchange resins, laxatives, migraine preparations, motion sickness treatments, mucolytics, muscle relaxants, neuromuscular drugs, obesity management agents, osteoporosis preparations, oxytocics, parasympatholytics, parasympathomimetics, peripheral vasodilators, prostaglandins, psychotherapeutic agents, psycho-tropics, stimulants, respiratory agents, sedatives, smoking cessation aids, sympatholytics, systemic and non-systemic anti-infective agents, terine relaxants, thyroid and anti-thyroid preparations, tranquilizers, tremor preparations, urinary tract agents, vasoconstrictors, vasodilators, and combinations thereof.
In some embodiments of the invention, the dosage form for use with the invention comprises anti-inflammatory agents suitable for inhalation administration. Such anti-inflammatory agent may include, for example, bronchodilators and steroids. Representative β2-adrenergic receptor agonist bronchodilators include, without limitation, salmeterol, formoterol, bambuterol, albuterol, terbutaline, pirbuterol, bitolterol, metaproterenol, isoetharine, isoproterenol, fenoterol, or procaterol. Non-limiting anti-inflammatory steroids contemplated for use with the invention include budesonide, beclomethasone, fluticasone, and triamcinolone diacetate. Additional anti-inflammatory agents contemplated include ipatropium bromide and sodium cromoglycate.
Therapeutically effective formulations and dosages to be administered using the devices described herein are well known to practitioners. One of skill in the art will appreciate that practitioners may opt to alter dosages and/or formulations to fit a particular patient/animal needs.
The animal interface adapter 30 extends along axis A from the relatively large proximal end 12 of the sleeve 10. The animal interface adapter 30 is preferably manufactured integrally with the sleeve 10, as shown in
Referring to
In one preferred embodiment, as shown in
In one preferred form, the sleeve 10 is fully collapsible and can be folded into a relatively small volume, as shown in
The sleeve 10 of the mask 110 may further includes at least one annular-shaped relatively compliant seal member extending from an inner circumference of the sleeve 10.
In another alternative form, as shown in
The tubular element 90 also can be manufactured with different original length to use with different animals. In the embodiment shown in
As shown in
In general, the sleeve 10 and the animal interface adapter 30 are preferably made from a soft, supple material having good memory. By way of example, the sleeve 10 and the animal interface adapter 30 are made from plastics, for example, one of the group consisting of thermoplastic elastomers, high density polyethylene, low density polyethylene, polypropylene, and silicone rubber. By way of example, the thermoplastic may be of the type sold under the trademarks Elastolene, Evoprene, Pebax or Santoprene. With such materials, the mask is easily washable for use with a number of animals in kennels or stables, with no risk of cross-contamination. It is also envisioned that the mask can be made from materials other than plastic, such as a rubber, synthetic rubber, silicone, soft nylons, or can include support materials, such as fibers or a cloth material, such as canvas, contained within the plastic or rubber to provided strength and durability.
The hollow socket member 62 and the hollow ball member 64 are preferably made from a rigid material, or at least the outer surface of the ball member 64 and the inner surface of the socket member 62 are rigid, allowing relative rotary movement of the ball member 64 with respect to the socket member 62. The medicament interface adapter 20 and the first section 92 of the elongated tubular element 90 are preferably made from rigid material and are manufactured integrally with the hollow ball member 64. The second bellows-shaped section 94 is preferably made from a semi-rigid or flexible material.
While the claimed invention has been described in detail and with reference to specific embodiments thereof, it will be apparent to one of ordinary skill in the art that various changes and modifications can be made to the claimed invention without departing from the spirit and scope thereof. Thus, for example those skilled in the art will recognize, or be able to ascertain, using no more than routine experimentation, numerous equivalents to the specific substances and procedures described herein. Such equivalents are considered to be within the scope of this invention, and are covered by the following claims.
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/US04/30823 | 9/20/2004 | WO | 4/9/2007 |
| Number | Date | Country | |
|---|---|---|---|
| 60503983 | Sep 2003 | US |
