Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-09-29
2002-06-04
Mendez, Manuel (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S048000
Reexamination Certificate
active
06398774
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to an equine intranasal delivery system for the delivery of cold-adapted equine viruses. The invention also includes both apparatus and methods for the intranasal delivery of various materials, compositions or medicaments to both humans and animals. Generally, the invention provides basic technology for the delivery of various compositions to target locations.
There are many advantages to intranasal administration of medications and other compositions which include, among others, a direct route to the blood stream, avoidance of hepatic first pass metabolism, bioavailability, ease and convenience, and proximity to the central nervous system. See Y. W. Chien et al.,
Anatomy and Physiology of the Nose
, Nasal Systemic Drug Delivery, Chapter 1, 1-26, 1989. Various types of compositions, therapeutics, prophylactics or otherwise, may be delivered intranasally including, but not limited to, topical anesthetics, sedatives, hypnotics, analgesics, ketamines, opiates, glucagons, vaccines, anti-nausea and motion sickness medications, antihistamines, antihypertensive drugs, psychoactive medications, antibiotics, and hormones. See, as examples, M. R. Nott et al.,
Topical Anaesthesia for the Insertion of Nasogastric Tubes
, European Journal of Anaesthesiology, 12(3), May 1995; R. J. Henry et al,
A pharmacokinetic Study of Midazolam in Dogs: Nasal Drop Versus Atomizer Administration
, Journal of the American Academy of Pediatric Dentistry, 20(5), 321-326, 1998; J. Lithander et al.,
Sedation with nasal Ketamine and Midazolam for Cryotherapy in Retinopathy of Prematurity
, British Journal of Ophthalmology, 77(8), 529-530, 1993; F. E. Ralley,
Intranasal Opiates: Old Route For New Drugs
, Canadian Journal of Anesthesiology, 36(5) 491-493, 1989; B. Haneberg et al,
Intranasal Administration of Mengiococcal outer membrane vesicle vaccine induces persistent local Mucosal Antibodies and Serum Antibodies with Strong Bactericidal Activity in Humans, Infection and Immunity
, 66(4), 1334-1341, 1998; B. K. Wager et al,
A Double Blind Placebo
-
Controlled Evaluation of Intranasal Metoclopramide in the Prevention of Postoperative nausea and Vomiting
, Pharmacotherapy, 16(6), 1063-1069 1996; and J. Q. Wang, et al.,
An Experimental Study on Nasal Absorption of Gentamycin in Dogs
, Chinese Medical Journal, 107(3), 219-221, 1994.
Specifically with respect to live virus vaccines, it has been shown that they are often too pathogenic for use as immunogens for either humans or animals as described in U.S. Pat. No. 3,953,592. Attempts to vaccinate against viral infection With inactivated virus, however, may not offer effective protection and can produce undesirable side effects as indicated in U.S. Pat. No. 3,953,592; R. Belshe et al,
Immunization of Infants and Young Children with Live Attenuated Trivalent Cold
-
Recombinant Influenza A H
1
N
1
, H
3
N
2
, and B Vaccine
, The Journal of Infectious Disease, Volume 165, 727-732, 1992; K. M. Nelson et al.,
Local and Systemic Isotype
-
specific Antibody Responses to Equine Influenza Virus Infection Versus Conventional Vaccination
, Vaccine, Volume 16, Number 13, 1998. Injection of equids with inactivated viruses may cause, for example, inflammatory reactions at the site of injection. See Mumford et al.,
Serological Methods for Identification of Slowly
-
Groweing Herpesviruses Isolated from the Respiratory Tract of Horses
, Equine Infectious Disease IV, 49-52, 1978; Mumford et al.,
Consultation on Newly Emerging Strains of equine Influenza,Vaccine
11, 1172-1174, 1993. It has also been shown that protective responses to viral infection are not limited to the production of antibodies but that a local antibody system and an interferon production mechanism operate at the primary site of infection in the nasal passage membranes as disclosed by U.S. Pat. No. 4,132,775; T. Tomoda et al.,
Prevention of influenza by the Intranasal Administration of Cold
-
Recombinant, Live
-
attenuated Influenza Virus Vaccine: Importance of Interferon
-&ggr;
Production and Local IgA Response
, Vaccine, Volume 13, Number 2, 185-190, 1995; and Holmes, Lamb, Coggins, et al,
Live Temperature Sensitive Equine
-2
Influenza A Virus Vaccine: Production and Eficacy in Experimental Ponies
, Equine infectious disease VI, 253-258, 1992.
As such, intranasal delivery of the above mentioned compositions has become a preferred route of administration for both inactivated viruses as described by U.S. Pat. No. 3,953,592, and cold-adapted live virus vaccines which are inhibited from replication in the range of the normal body temperature but do replicate at lower temperatures, such as perhaps, associated with the mucosae of the upper respiratory tract as disclosed by U.S. Pat. No. 3,927, 208; Maassab, et al.,
Biologic and Immunologic Characteristics of Cold
-
Adapted Influenza Virus
, Journal of Immunology. 102, 728-732, 1969; and Keitel et al.,
Trivalent Attenuated Cold
-
Adapted Virus Vaccine: Reduced Viral Shedding and Serum Antibody Responses in Susceptible Adults
, The Journal of Infectious Disease, Volume 167, 305-311, 1993. Intranasal delivery of compositions has also been effective for certain reassortant cold-adapted viruses which may also possess a dominant interference phenotype which may inhibit the growth of the corresponding wild-type strains and other heterologous viruses as disclosed by U.S. Pat. Nos. 4,683,137 and 4,693,893.
Due to the increased use of intranasal delivery of various compositions, including inactivated and cold-adapted live viruses, in both humans and animals, there is corresponding demand in the marketplace for intranasal apparatus and methods of intranasal delivery which address existing problems, and which are especially acute with respect to equids including, for example, horses, ponies, or exotic equids such as zebra which may be part of a zoological collection, or otherwise.
A significant problem with intranasal delivery of compositions is interspecies and intraspecies anatomical variation. With regard to one aspect of these differences, it is evident from casual observation that the gross morphology of bovine species present a shorter nasal passage then, for example, equid species. An inflexible intranasal administrator, for example, may be adequate for intranasal delivery of a composition or dose to a bovine where the intranasal administrator need only tranverse a short distance in the bovine nasal passage, however, such an inflexible device may not be suitable for equids where the intranasal administrator may have to traverse several inches within the nasal passages of an equid.
A related problem with intranasal delivery of compositions in equids as opposed to bovine, for example, is the presence of a false nostril (nasal diverticulum) as described by Klaus, Dieter, Budras,
Anatomy of the Horse an Illustrated Text
, 2nd edition, Mosby-Wolfe, London, 1994. The nasal diverticulum presents two problems with regard to intranasal delivery in equids although other species may have anatomical structures which present equivalent difficulties. First, an intranasal probe for equids must be designed such that the user has an immediate means of determining if the delivery aperture of the intranasal probe has properly entered the nasal passage or if the intranasal probe has inadvertently entered the nasal diverticulum. The second problem associated with the nasal diverticulum is that the type of cells which line the nasal diverticulum are not the same type of cells which line the nasal passage of the upper respiratory tract. Delivery of compositions, including the delivery of cold-adapted live viruses, to the type of cells which line the nasal diverticulum may not provide therapy because such cells may not be susceptible to such compositions, or cold adapted live viruses. While the nasal diverticulum provides a remarkable example of the necessity of coordinating therapeutic compositions with an anatomical location having cells susceptible to a particular composition or dose, dose-location coordination may be an impo
Penner Steven J.
Sebring Randal W.
Heska Corporation
Mendez Manuel
Santangelo Law Offices P.C.
LandOfFree
Intranasal delivery system does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Intranasal delivery system, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Intranasal delivery system will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2976538