Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
  • A61M16/06—Respiratory or anaesthetic masks
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61D—VETERINARY INSTRUMENTS, IMPLEMENTS, TOOLS, OR METHODS
  • A61D7/00—Devices or methods for introducing solid, liquid, or gaseous remedies or other materials into or onto the bodies of animals
  • A61D7/04—Devices for anaesthetising animals by gases or vapours; Inhaling devices
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M15/00—Inhalators
  • A61M15/009—Inhalators using medicine packages with incorporated spraying means, e.g. aerosol cans

Definitions

• 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.
• 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.
• the mask is made out of a semi-rigid material (eg., sheet polycarbonate) and is provided in various sizes for use with different sized animals.
• 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.
• This mask-type adrninistration of medicaments has proven to be a generally effective method for medicament delivery.
• the masks are bulky and take up significant volume when carried around by a veterinarian, or other provider.
• the semi-rigid structure of such masks makes it necessary to provide a set of various sized masks in order to be able to provide masks for correspondingly sized animals.
• many of those masks are provided with tubes, and the like, for insertion deep into the animal's nostrils. The latter type of mask is particularly difficult to clean making it difficult to use it for more than one animal at a time without cross-contamination.
• Such improved mask should be (a) collapsible to a relatively small volume form for ease and convenience in transport; (b) adaptable for use with different sized animals; and (c) easily cleaned, to permit re-use with the same or different animals.
• the present invention is a drug or medicament, delivery device for fitment to 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 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.
• the mask of the invention is particularly adaptable to accommodate size variation in animals,
• the drug delivery mask of the invention is adapted for removable fixture to the appropriate portion of the head of the animal such as the front of the head (it, a portion of the face), the nostril or the muzzle.
• the mask includes two or more telescopable sections, which are coupled together. Each section includes a relatively inflexible ring ⁇ fining an associated first contour, and each has a relatively flexible skirt extending from its ring to a distal edge. The distal edge of the skirt defines an associated second contour.
• the rings of the mask are nestable, forming a succession of monotonically decreasing sized rings from a largest ring to a smallest ring.
• each ring fits inside the next larger ring in the succession, although in some forms two adjacent rings in the succession may be same size, and may not nest with each other.
• the second contour of a skirt of each ring in the succession is substantially the same as, and is joined to, the first contour of the next ring of the succession.
• the various joined sections may be formed (such as by molding) as a unitary structure.
• 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.
• 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).
• An airborne medicament interface adapter extends from the skirt of the smallest ring.
• the medicament interface adapter is adapted to couple that skirt to a medicament dispenser.
• the medicament dispension is breath-activated but may be user (eg, 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 mask also includes an animal interface adapter extending from the largest ring.
• 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).
• 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.
• the animal interface adapter may be in the form of a stretchable, nominally conic-frustxum shaped elastic sheet, extending from the largest ring.
• the sheet may be stretched as the largest ring is moved over the nostril or muzzle of the animal.
• 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 sections of the mask are formed by molding as a unitary structure, made from one of the group consisting of a thermoplastic elastomer, high density polyethylene, low density polyethylene, polypropylene and silicone rubber.
• a thermoplastic elastomer high density polyethylene, low density polyethylene, polypropylene and silicone rubber.
• the rings may be circular, elliptical or some other closed shape.
• the respective rings may have a C-shaped cross-section, to impart a relatively inflexible characteristic, with its associated skirt extending from one end of the C and the distal edge of the skirt from the next ring being joined to the other end of the C.
• the skirts may be a material to impart a relatively flexible characteristic.
• Various dimensions and geometries may be used in keeping with the invention.
• Fig. 1 shows in exploded diagrammatic form, a drug delivery mask in accordance with the invention
• Fig.2A shows in diagrammatic form, an exemplary drug delivery mask of the invention, in an open state as it might be deployed over the head of an animal;
• Fig.2B shows a sectional view of the mask of Fig, 2A along the lines 2A-2A;
• Fig.2C shows an enlarged sectional view of a portion of the mask contained in circle 2C ⁇ Fig.2B;
• Fig. 3A shows in cKagrarnrnatic form, the mask of Fig.2, in a small volume, closed, or collapsed, form, as it might be configured for storage or transport;
• Fig.3B shows a section view of the mask of Fig.3A along the lines 3A-3 A
• Fig. 3C shows a section view, similar to Fig. 3B, of a portion of another drug delivery mask in accordance with the invention
• Fig. 4A shows a mask of the invention positioned over the nostril of an animal
• Fig. 4B shows a mask of the invention, positioned over the muzzle of an animal
• Fig. 5 shows in diagrammatic form, an exemplary drug delivery mask of the invention, in an open state as it might be deployed over the head of a small human child;
• Fig. 6 shows in cHagrarnmatic form, an exemplary drug delivery mask of the invention, in an open state as it might be deployed in collapsible form over the nose of a small human child;
• Fig.7 shows in diagrammatic form, an exemplary drug delivery mask of the invention, in an open state as it might be deployed over the head of a human adult;
• Fig. 8A shows a perspective view of another drug delivery mask i accordance with the invention.
• Fig. 8B shows an end plan view of the mask of Fig. 8 A
• Fig. 8C shows a sectional view of the mask taken along line 8C--8C of Fig. 8B;
• Fig. 8D shows a side elevation view of the mask of Fig, 8 A
• Fig. 8E shows a sectional view of the mask taken along line 8E--8E of Fig. 8D;
• Fig. 8F shows an enlarged sectional view of a portion of the mask contained in circle 8F of Fig. 8E;
• Fig. 8G shows an enlarged sectional view, similar to Fig. 8F, of another mask
• Fig. 8H shows an enlarged sectional view, similar to Fig. 8F, of another mask.
• Fig. 9 shows a sectional view of a further drug delivery mask in accordance with the invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS
• An exemplary drug delivery mask 110 embodying the present invention for use with dogs, horses, humans and other mammals is shown in diagrammatic form in Fig. 1.
• the mask 110 is shown in exploded form to illustrate the various components which in a fully formed mask are a unitary structure.
• FIG.2A, 2B, 3A and 3B A similar mask 110 is shown in Figs.2A, 2B, 3A and 3B.
• the mask 110 is a unitary structure.
• Figs. 2A and 2B show the mask 110 ⁇ n an open state, having a bell or similar shape, as it might be deployed over the nostril or muzzle of an animal in use.
• Figs.3 A and 3B show mask 110 in a small volume, closed, or collapsed, state, as it might be configured to permit convenient transport or storage.
• the mask 110 includes a sleeve 10 extending along a central axis A" between an airborne medicament interface 20 and an animal interface adapter 30.
• the sleeve 10 includes four sections 12, 14, 16, and 18 extending along the central axis "A".
• Each of the sections includes a relatively inflexible ring Ri defining an associated first contour, having a relatively flexible skirt Si extending therefrom to a distal edge DEL
• the distal edge DEi defines a second contour, where "i" - 1, 2, 3
• the rings Rl, R2, R3, R4 of assemblies 12, 14, 16, and 18 form a monotonically decreasing succession of circular rings, from the largest ring Rl to the smallest ring R4.
• the succession is monotonic in that the individual rings in the succession are successively smaller, although in other embodiments, a ring may be the same (but not larger than) its next (in the succession) neighbor.
• each ring in the illustrated embodiment is sufficiently larger than the next ring (in the succession) so that the smaller ring fits within, i.e., nests, with its neighbor.
• the distal edge DEi of each ring Ri is the same size as the contour defined by next smaller ring R in the succession; that is, DEI is the same size as R2, DE2 is the same size as R3 and DE3 is the same size as R4.
• the distal edge of each skirt of sections 12, 14, and 16 is joined to the ring of the respective one of neighboring sections 14, 16, and 18.
• the mask is made from a soft, supple material having good memory.
• the rings and skirts are made from plastics, for example, one of the group consisting of thermoplastic elastomers, high density polyethylene, low density polyethylene, polypropylene, and silicone rubber.
• the thermoplastic may be of the type sold under the trademarks Elastolene, Evoprene, Pebax or Santoprene. With such materials, the mask 110 is easily washable for use with a number of animals in kennels or stables, with no risk of cross-contamination.
• 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 mask 110 is a unitary structure formed by molding for example, high densiry polyethylene.
• the thickness of the material forming mask 110 is in the range 0.12-0.15 cm, although other thicknesses may be used depending on the desired flexibility.
• the rings are circular and are relatively inflexible. As shown best in Fig.2C, the rings are C-shaped in cross-section having an outer diameter 0.5cm.
• the skirt for a ring extends from one end of the C and the distal edge of the skirc of the next larger ring is coupled to the other end of the C.
• Other forms of rings may be used, for example, solid rings having a circular or ellipitcal or other shaped cross-section.
• the skirts are relatively flexible.
• the adjacent ones of sections 12, 14, 16 and 18, are joined together DEl-to-R2, DE2-to-R3, and DE3-to-R4.
• the entire structure 110 is formed in a single step with a molding process.
• the molding process may comprise rotational molding, blow molding or injection molding, for example.
• the mask 110 can alternatively be made by vacuum forming. Many acceptable methods of forming the mask 110 can be used.
• the airborne medicament interface 20 which is generally cylindrical, extends from the distal end DE4 of skirt S4 of section 14.
• the interface 20 may be formed from the same material as the skirt S4 or another compatible material.
• the interface 20 is integral with, and merely an extension of the skirt S4.
• the end 2QA of interface 20 opposite to the end joined to skirt S4 is shaped to couple to, or receive, an external aerosolizing medicament dispenser 25.
• the dispenser 25 is schematically represented as an aerosol dispenser, with its effluent plume directed to the interior of interface 20.
• the dispenser 25 may be a metered dose breath-actuated or user-(e.g., veterinarian) operated inhaler and may be a dry powder or aerosol dispenser.
• the device 25 includes an output structure which directs airborne medicaments to the interior of mask 110.
• the animal interface adapter 30 extends along axis "A" from ring Rl.
• the interface 30 is in the form of a tapered sheet 32.
• the sheet 32 can be in the form of a conic-frustrum shaped shroud made of an easily stretchable elastic material.
• the sheet 32 is adapted to provide a substantial (although not necessarily total) pneumatic seal between ring Rl and the nostril or muzzle of an animal.
• the interface 30 may optionally include a stretchable elastic or otherwise adjustable strap 34 extending from or near opposite sides of ring Rl, to permit secure fixture of mask 110 to the head of an animal,
• the mask 110 Wth the configuration of mask 110 as shown, where the extension assemblies 12, 14, 16, 18 and interfaces 20 and 30 form a unitary structure, the mask 110 is usable in two states; a first or open state where the various sections 12, 14, 16, IS are "telescoped” out to form a mask for fitment to an animal, and in a second or collapsed state to establish a low volume structure convenient for storage or transport.
• Figs. 2A and 2B illustrate the open state for mask 110
• Figs. 3A and 3B illustrate the collapsed state for mask 110.
• the mask 110 is also usable in an intermediate or partially open state, wherein at least two of the various sections are "telescoped” out to form a mask for fitment to an animal and where one of the rings forms the necessary seal to the animal.
• Fig.3C shows another mask 111 according to the present invention, especially adapted for use in an intermediate state.
• the mask 111 of Fig. 3C is similar to the mask 110 of Figs. 1 through 3, such that elements that are the same have the same reference numerals.
• the skirts Si and S3 of the mask 111 of Fig. 3C are provided with a greater length (along the axis "A"), such that when the mask 111 is in an intermediate or partially open state the folded skirt S2 extends beyond the ariirnal interface 30.
• Fig. 4A shows an animal 40 (horse) with the mask 110 positioned over one of its nostrils.
• Fig. 4B shows an animal 50 (dog) with the mask positioned over the muzzle of the animal.
• the mask When applied to large animals, in particular to horses, the mask is preferably positioned over one nostril only. It has been found in practice, that a horse has sufficient vacuum in one nostril when it breathes in (without having to block up the other nostril) to effect the suitable medicament flow from delivery device 25.
• 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.
• Typical illnesses include COPD, asthma, allergy, etc...
• suitable drugs include ⁇ -agonists or antagonists, steroids eg., beclomethasone, fluticasone or budesoni e, anri- cholinergics e.g., ipratropium bromide, etc... .
• Therapeurically effective formulations and dosages to be administered using the devices described herein are well known to practitioners. One of skill will appreciate that practitioners may opt to alter dosages and/or formulations to fit a particular patient/animal needs.
• FIG. 5 An exemplary drug delivery mask 110 showing the use of the invention for humans 40, is shown in diagrammatic form in Figs. 5 and 6.
• the mask of Fig. 5 includes all the characteristics described above but is especially adapted for human use.
• the mask 110 is a unitary structure.
• Fig.5 shows the mask 110 in an open state, having a bell or similar shape, as it might be deployed over the nostrils and mouth of a small child 40 in use.
• the dispenser 25 may be a metered dose breath- actuated or user-(ag., care giver) operated inhaler and may be a diy powder or aerosol dispenser.
• the sheet 32 can be in the form of a conic-frustum shaped shroud made of an easily stretchable elastic material and/or highly flexible material. The sheet 32 is adapted to provide a substantial (although not necessarily total) pneumatic seal between ring Rl and the nostrils and/or mouth of a human 40.
• the interface 30 may optionally include a stretchable elastic or otherwise adjustable strap 34 extending from or near opposite sides of ring Rl, to permit secure fixture of mask 110 to the front of the face (mouth and/or nostrils) of a human 40.
• the mask may fit over either the nostrils or the mouth separately. It should be understood, however, that the mask 110 can be used without the strap 34 or with a different type of strap(s).
• Fig. 6 illustrates the mask 110 used in a partially open form, where one of the rings Rl forms the necessary seal around the nose of a human 40. In this way, a single mask 110 may accommodate various sizes of the front of the face (mouth and/or nostrils) of a human 40.
• Fig.7 shows a human 50 (human adult or elderly person) with the mask 110 positioned over the nostrils and mouth of the human 50.
• the mask 110 in this figure may also fit over either the nostrils or the mouth separately.
• the device 25 may be used for any drug formulation that may be advantageously administered to the lung or nasal passages in a human 50 or 40, to cure or alleviate any illness or its symptoms.
• Typical illnesses include COPD, asthma, allergy, alt...
• suitable drugs include ⁇ -agonists or antagonists, steroids e,g,, beclomethasone, fluricasone or budesonide, anti-cholinergics e.g., ipratropium bromide, etc.. .
• the doses for children may be the same or similar to those used to treat adult diseases or may be increased or decreased or given in multiple applications as dependant on the size of the human.
• Figs. 8A-8E show an additional mask 210 according to the present invention.
• the mask 210 is similar to the mask 110 of Figs. 1 through 3, such that elements that are the same have the same reference numerals.
• the rings Rl, R2, R3, and R4 of the mask 210 each have a four-sided cross-section transverse to the axis "A" instead of a C- shaped cross-section.
• the cross-section of the ring R3 of Fig. 8F is a trapazoid that extends transversed to the axis "A".
• the rings Ri can each have alternative cross-sections including a re ⁇ angular cross-section that extends transversed to the axis "A" as shown in Fig. 8G, or a re ⁇ angular cross-section that extends at an angle to the axis "A” as shown in Fig. 8H.
• Many variations of the ring Ri are possible trader the scope of the present invention.
• Fig.9 shows a further mask 310 according to the present invention.
• the mask 310 is similar to the mask 110 of Figs. 1 through 3, such that elements that are the same have the same reference numerals.
• the sleeve 10 of the mask 310 does not include the different multiple rings and skirts of the mask 110 of Figs. 1 through 3.
• the mask 310 is, in effect, a more simple embodiment of the present invention, and includes the airborne medicament interface adapter 20, the mammal interface adapter 30, and the relatively flexible sleeve extending along the axis "A" between the medicament interface adapter and the mammal interface adapter.
• the sleeve 10 has a cross se ⁇ ional monotonically increasing between the medicament interface adapter and the mammal interface adapter.
• Example I Pediatric Use of the Drug Delivery Mask To illustrate the effectiveness of a representative embodiment of the invention, the device shown in Fig. 2 is used to administer various medications to a group of human patients between the age of 0-17.
• the mask In the case of medications requiring pulmonary or nasal absorption, the mask is held in place over the nostrils and/or the mouth and against the face of the patient being treated.
• the mask In the case of medications specifically requiring nasal absorption the mask is placed over both nostrils (see Figure 6).
• blood plasma analysis will reveal concentrations levels of the administered medications consistent with pulmonary absorption.
• effe ⁇ ive delivery will be confirmed by observing an ascer ainable improvement in the patients symptoms.

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• Health & Medical Sciences (AREA)
• Veterinary Medicine (AREA)
• Life Sciences & Earth Sciences (AREA)
• Public Health (AREA)
• Anesthesiology (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Pulmonology (AREA)
• Hematology (AREA)
• Emergency Medicine (AREA)
• Wood Science & Technology (AREA)
• Zoology (AREA)
• Medicinal Preparation (AREA)

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• 2001
  • 2001-05-16 CA CA002409039A patent/CA2409039C/en not_active Expired - Fee Related
  • 2001-05-16 WO PCT/GB2001/002221 patent/WO2001087396A1/en active IP Right Grant
  • 2001-05-16 AU AU5654701A patent/AU5654701A/xx active Pending
  • 2001-05-16 EP EP01929867A patent/EP1284773A1/de not_active Withdrawn
  • 2001-05-16 AU AU2001256547A patent/AU2001256547B2/en not_active Ceased

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