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Methods for reducing pain and drug delivery devices. RU patent 2513219.

Methods for reducing pain and drug delivery devices. RU patent 2513219.
IPC classes for russian patent Methods for reducing pain and drug delivery devices. RU patent 2513219. (RU 2513219):

A61P23/02 - Local anaesthetics
A61M11/06 - of the injector type
A61K31/167 -
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FIELD: medicine.

SUBSTANCE: group of inventions refers to medicine, and may be used in treating the patients suffering headaches and facial pains. There are presented versions of a drug delivery device comprising an injector a first end of which is left outside patient's nasal passages. Another end of the injector comprises one or more holes for spraying a drug upwards, and/or to the side, and/or to the front towards a sphenopalatine ganglion, an input device interacting with a patient's nostril and comprising a canal for receiving the injector. Additionally, the device can comprise a handle connected to the input device and provided for receiving the canal of the input device. The injector can move between a storage position before the interaction, and an interaction position related to the interaction. There are also presented versions of the method of using the above device that involve introducing the injector through the nasal passage into median and/or posterior and/or inferior region in relation to the patient's sphenopalatine ganglion, and spraying the drug.

EFFECT: group of inventions provides faster and more effective headache and facial pain relief by safe and accurate drug delivery of the therapeutic substances blocking the sphenopalatine ganglion.

49 cl, 4 dwg, 30 ex

 

A group of inventions described here refers essentially to devices and methods of delivery of medicines, in particular, though not exclusively, to the introduction of drugs to control the pain associated with headaches, facial pain, etc.

Common ways of treatment of pain associated with headaches and facial pain, not as safe and effective as it is desirable. For example, nonsteroidal anti-inflammatory drugs (NSAID), such as brand drugs SOKH-2 should be used rarely and not long because they can cause ulcers and heart attacks - deficiency, which is then followed by the inefficiency of the impact of these drugs on a large number of patients. The use of drugs is also undesirable because of their ability to cause dependence. Additionally, the use of drugs on the basis of tryptamine, which include, but are not limited to, sumatriptan (marketed under the brand name IMITREX F. GlaxoSmithKline), and zolmitriptan (marketed under the trade name ZOMIG F. AstroZeneca), it is undesirable due to high costs and potentially high toxicity of these drugs.

One method that is used to control the pain associated with headaches and facial pain, known as ONG blockade. In this case, the anesthetic is applied to basic-sphenopalatine ganglion (ONG) patient trained health worker, which usually enters the applicator with cotton tip moistened with anesthetic, in nostril patient to inflict anesthetic on ONG. Using the average nasal sink as an anatomical landmark, moistened applicator with cotton end jostle up essentially blind (successful implementation depends on the qualifications and experience of the physician). It is clear that the effectiveness and safety of this procedure leaves much to be desired. In addition, the efficacy and safety of ordinary ONG blockades significantly reduced in the long existing but erroneous belief, widespread among doctors that ONG is located behind the top turbinate that is not true.

The volume of the invention shall be determined exclusively attached claims and is not limited in any way by the statements set forth in this summary.

The first way to relieve pain, the patient provides for the introduction of the injector through the nasal passage of the patient in the region, essentially, middle, or rear, and/or lower in relation to the basic-nubnmu the ganglion of the patient and the injection of a drug through the injector up, and/or sideways, and/or towards basic-nubnmu the ganglion.

The first device for the delivery of medication to a patient in need of it, contains (a) injector, consisting of the first end, designed so that it remains outside nasal passage of the patient, and the second end, is made so that he entered into the nasal passage of the patient; and (b) an input device is designed so that it interfaces with the nostrils of the patient and included the bypass channel, made for the reception of the injector with the opportunity slip.

A second device for delivery of medication to a patient in need of it, contains (a) injector containing the first end, made to stay outside nasal passage the patient, the other end, are made so as to enter the nasal passage of the patient, and the bypass channel, continuing from the first end of the second end and executed so that it could enter a drug where the other end of the injector contains one or many holes, made to spray drug upwards, sideways and forward in the direction of major-nubnmu the ganglion; (b) an input device, designed to interact with the nostrils of the patient and contains the channel, made for the reception slidable injector, the first section with this form that corresponds to the inner part of the nostrils, and the second section containing rounded bump and essentially flat opposite direction, where the cross-sectional area of the first section is greater than the cross-sectional area of the second section; and (C) the handle connected to the device input and includes a guide (the guide), made so that she could hold a bypass channel input device. The handle is made so that she could move to the side of the patient's face so that the movement of arms back in the input device is operated in cooperation with the nostrils of the patient. Injector able to move between the position of storage prior to interaction and cooperation in accordance with the interaction, in which the position of the interaction is located in the middle of the back, and below basic-palatal of the cyst.

The second way to relieve pain, the patient provides the delivery of medicaments up, and/or sideways, and/or towards basic-nubnmu the ganglion using the described device.

BRIEF DESCRIPTION OF DRAWINGS

Figure 1 - side view in the device section for delivery of medication to a patient in need of this before putting the unit into the nostril of the patient, in accordance with the described principles.

Figure 2 - view from above in the section of the device shown in figure 1, along the line 2-2.

Figure 3 - side view in the section of the device shown in figure 1, after input unit has entered into cooperation with the nostrils of the patient in accordance with the described principles.

On Figure 4 - side view in the section of the device shown in figure 1, after input unit has entered into cooperation with the nostrils of the patient and after the injector was transferred from the storage positions in provision of interaction, with the consequence that the other end of the injector is up, sideways and in advance of the primary nubnmu the ganglion.

Figure 5 - look at the section head man in the middle line, where ONG 2 shows in the correct anatomical position behind the middle turbinate 4.

DESCRIPTION OF INVENTION

Here are presented and described previously unknown and highly effective ways pain in a patient, essentially, but not exclusively, headaches, facial pain and the like, and convenient devices that allow easy management of medicines in accordance with these methods. As shown below, describes the methods and devices allow you to apply the medication up, and/or sideways, and/or towards basic-nubnmu the ganglion of the region, in essence, located in the middle, and/or rear, and/or below basic-palatal of the cyst. Methods and devices can provide the patient and the doctor is a safe and effective way to create ONG blockade, in essence, such that can be used by the doctor and/or directly to the patient without the help or guidance of a qualified medical personnel.

It is assumed that used the phrase "in the direction of major-nubnmu the ganglion" and similar phrases used in relation to the delivery of the drug, include myself ONG and pterygopalatine fossa, which is located ONG and basically-palatal hole.

As an introduction figure 5 shows look at the section head man in the middle line, which correctly determined the location ONG 2, behind the middle turbinate 4, not behind the front turbinate 6 or the top 8 of the nasal cavity near the lattice plates ethmoid 9, as mistakenly believed by many doctors. In addition, the correct location ONG 2 actually shifted sideways from the plane of the drawing, in other words, ONG is not in a two-dimensional plane is a cross-section, as well as wrongly was considered by many doctors.

In the US Patent US №4,886,493, Jordan Yee describes the process of execution ONG blockade, in which a tube is inserted in the nostril of a patient with the purpose of delivering drugs to the pterygopalatine fossa, which is located ONG. Unfortunately, as shown in Figure 3 of US Patent US №4,886,493, the location of the pterygopalatine fossa (18) was incorrectly identified as being behind the top of the nasal shell in x-y - plane, available in a straight line from the nostrils through the tube (11). As a result of this misunderstanding, in addition to the expected decrease of performance which may result from the delivery of medicines not to the right place, the end (13) device Yee pass dangerously close to the weak lattice plates ethmoid bone. Because vinyl lattice ethmoid bone resembles a sieve and is due to the frontal lobes of the brain, dangerous to enter anesthetics in the immediate vicinity of this record, as they can easily penetrate the frontal share.

In the US Patent US №6,491,940, ed. Bruce, Levin described an alternative procedure to perform ONG blockade. Unlike patent Yee described above, the US patent US №6,491,940 B1 recognizes lateral displacement ONG, because it describes curved rather than straight body (100), where does the anesthetic. Unfortunately, as the patent Yee, patent Levin refuses to admit that the correct location ONG - behind the middle turbinate, not at the top of the nasal cavity, as shown in Figa patent Levin and as described there (for example, paragraph 72, lines 20-22). Thus, as in the case of Patent Yee, the process described in the patent Levin, again, makes the device delivery anesthetic in dangerous proximity lattice record ethmoid with all possible risks and the resulting decrease in effectiveness.

ONG (also known as sphenopalatine ganglion) is the largest group of neurons on the outer side of the cranial cavity and is located in the pterygopalatine fossa, the dimensions of which are about 1 cm wide and about 2 cm in height. Pterygopalatine fossa limited front rear wall of the maxillary sinus, rear - medium plate wing-shaped ridge, the middle perpendicular record of the hard palate and ahead of the sphenoid sinus. Side pterygopalatine fossa reported with apex in the hollow (nienawisci the hole).

ONG inside the pit is located behind the middle turbinate and juts out for a few millimeters (from 1 to 5 mm) deep into the side of the nasal mucosa. ONG has a complex nerve centre and a lot of communications (connections). ONG is separated from the upper branches of the trigeminal nerve in the pterygopalatine fossa pterygopalatine nerves and is located in the middle of the maxillary branches when viewed in sagginale plane. Back ONG connected with nerve pterygoid channel (velievym nerve). Himself ONG has diverging branches and forms the top, rear, side nasal and pharyngeal nerves. In the tail part of a ganglion (ONG) is in close connection with larger or smaller nebnye nerves.

ONG has a nervous, motor and autonomic components (elements). Nerve fibers rise from the maxillary nerve, pass through ONG and distributed through the nasal membranes, soft palate and some parts of the throat.

It is also believed that some amount of motor nerves included in nerve trunks. Vegetative innervation ONG more complex. Sympathetic component (element) begins with the preganglionarnah sympathetic fibers going from the upper part of the thoracic spinal cord, forming white connective branches, passing through the sympathetic ganglia, where the preganglionarnah fibers form a synapse (connect) with postganglionarnyh fibers. Postganglionarnyh fiber is then attached to the nerves carotid artery before branching and passing through a deep rocky nerves and nerve wing-shaped channel. Postganglionic nerves pass through ONG towards the lacrimal glands and mucous membrane of the nose and palate.

ONG usually considered parasympathetic functions. Parasympathetic component (element) ONG has its preganglionarnah the origin in the upper stimulate salivation centers, then passes through the area of the facial nerve (VII) until the formation of a large rocky nerve for the formation of nerve pterygoid channel, which ends in ONG. Inside ONG preganglionarnah fiber connect (create synapsis) and their postganglionarnae cells and continue on the mucous membrane of the nose, and one branch goes together with maxillary nerve to the lacrimal gland.

Despite the above description and regardless of the currently existing theories about anatomy ONG, resulting from the use of devices and methods, described below, can be achieved safe and effective pain relief. Although an approximate 10, will be described with reference to Figure 1-4, it should be understood that this is an indicative device merely illustrative and alternative designs can similarly be used for delivery of medicaments in accordance with the principles described here. It should be understood that the elements and details of the various approximate devices, described below, can be combined in various ways to produce new variations, which also extends to the area of this teaching. Drawings and the description below presents only as illustrative material and are not intended to limit the scope of the claims or its equivalents.

Figure 1-4 below shows the approximate unit 10 for delivery of medication to a patient who needs it. The device 10 includes injector 12, which includes the first end 29, made to stay outside nasal passage of the patient, and the other end 30, made so as to enter the nasal passage of the patient. The device 10, also contains an introduction to device 18, made with the possibility to interact with the nostrils of the patient and contains the channel 48, made for the reception slidable injector 12. Injector 12 able to move between the storage position (see figure 1)prior to the interaction of the input unit 18 from the nostrils of the patient, and the regulation of interaction (see figure 4) respectively for interaction input devices with 18 nostrils of the patient. However, after the initial interaction input devices with 18 nostrils patient injector 12 it is desirable to transfer, at least for the time in storage position (see figure 3)until it intends set of interaction (see figure 4) under the leadership of a user. In some embodiments, the provision of interaction of the injector 12 is in the middle and/or lower ONG. In other variants position interaction injector 12 is in the middle, below and behind ONG what is best shown in figure 4.

As used here, the phrase "storage" and "regulations of interaction", each aimed to cover many provisions within the selected range. For example, in some embodiments, the degree to which the injector 12 is inserted into the nostril first patient (for example, child, will be different from the extent to which the injector 12 is inserted into the nostril second patient (for example, an adult male). Despite this, the phrase "the position of the interaction", seeks to cover the ways the exact position of the injector 12 inside the nostrils, any of which is correctly regarded as secondary, and/or rear, and/or lower in relation to the ONG. In some embodiments, the injector 12 not able to slip inside the input unit 18, but rather fixed in position to be at the middle and/or lower ONG after the interaction, input unit 18 from the nostrils of the patient. In other variants, injector 12 not able to slip inside the input unit 18, but rather fixed in position to be in the middle, behind and below ONG after the interaction, input unit 18 from the nostrils of the patient.

Injector 12 contains tubular section 24 (the so-called pipe-Cobra, named for its ability to expand), which includes the channel 22, passing from the first end 29 second late 30's and is designed in such a way that it was administered drug. Some versions of tubular section 24 has an outside diameter of approximately 5 mm, and a channel with inner diameter of approximately 2 mm Throughout this description sizes and distances, such as data diameters should just strictly be considered as demonstration and in no way limited and/or fixed. There are significant differences in the sizes and distances specified in this description that will be understandable to a specialist.

In some embodiments, the other end of the 30 injector 12 includes the jet 28 with nozzles 34, in which there are one or many of 36 holes, made with the possibility to spray medication up, and/or sideways, and/or towards ONG. In some versions of the jet 28 performed with the ability to spray medication side and/or up towards ONG, and other variants of the nozzle 28 performed with the ability to spray medication side, up and down toward ONG.

In some versions of the jet 28 creates an angle pointing upwards at the end of the second 30 injector 12. In some versions of the jet 28 takes place in the side, front and top directions under angle, components from about 45 degrees to about 60 degrees to create the possibility of adaptation to anatomy of different patients, in which ONG is on the side of the cavity behind the middle turbinate. In some versions of the jet 28 has a length ranging from about 2 mm to about 5 mm In some embodiments, the injector 12 is designed so that it can be to configure handedness, for example, in some embodiments, the injector 12 is designed to interact with the left nostril of the patient, while in other variants injector 12 is designed to interact with the right nostril patient (this path left-injector in General complements the right path injector).

Input unit 18 may be sent in nostril to create a horizontal way, essentially parallel to the bottom of the nasal cavity or the base of the nose, thus, input unit 18 held on the bottom of the nasal cavity in the position of the median to the lower nasal sink. This function is self-input unit 18 facilitates fast and accurate use of the device by the patient without having to resort to the manual on the part of medical personnel. In some versions of the input unit 18 creates long path length between about 1.5 cm to about 2 cm in nostril. After input device installed 18 steadily in the nose, the tip of the nose is usually directed upwards. Tubular section 24 of the injector 12 may then be partially or fully retracted before the end of the nostrils. In order to adjust to the slightly curved form of the internal anatomy of the nose, channel 48, which is located tubular section 24, may be slightly curved towards the corresponding nostrils on from about 5 to about 20 degrees. After tubular section 24 of the installed position, the treatment can then be submitted to ONG through the jet 28 to achieve the desired effect lock ONG. In some embodiments, the device is equipped with an additional 10 secure a rigid support for restrictions continue for advancement in nostril injector 12.

As is well shown in figure 1, 3 and 4, input unit 18 contains the first section 44, and the second section 38. In some versions of the area of the cross section of the first section 44 more than the area of the cross section the second section 38. In some embodiments, the first section 44 usually concave and has a loop made 46 thus, to repeat, form the inner part of the nostrils and, essentially, to match it. Some versions narrow the second section 38 is rounded bump 39 and reverse side of 40, with essentially flat surface 42. Channel 48 input unit 18 accepts made with the possibility of sliding tubular section 24 of the injector 12 and in some versions it has a diameter ranging from about 6 mm to about 7 mm In some embodiments, the second section 38 input unit contains 18 interacting with nostrils the end, which stretches on from about 1 cm to about 3 see some of the options of the first section 44 input unit 18 stretches on from about 2 cm to about 3 see some of the options of input unit 18 designed in such a way as to be able settings handedness, for example, in some versions of the input unit 18 is designed to interact with the left nostril of the patient, while in other types of input device 18 is made so that to interact with the right nostril patient (the left-hand path input devices generally complement the loop right input devices).

Some versions of the device next 10 includes container 14, connected with the first end 29 and channel 22 injector 12, which is made with the ability to hold the 16 medication (for example, anesthetic). Some options, as shown in figure 1, 3 and 4, 14 container fixed on the rod 26, with the bottom section 31, which in some ways has an outside diameter of essentially the same as tubular section 24. The lower section 31 can be stretched in an outward direction and/or up and/or angle from the end of the first 29 injector 12 and in some versions to connect with upper section 32, which has a larger diameter, is designed to fit the exhaust pipe 33 container 14. Similarly, the lower section 31 of the upper section 32 may be stretched in an outward direction and/or up and/or angle.

In some embodiments, the container 14 promptly connected, mounted or otherwise attached to the upper section 32 of the rod and fully or partially filled medication 16. After the 14 container is provided in interaction with the channel 22 injector 12, 16 medication can be served on the tube section 24 and released through one or more holes 36 nozzles 28. Container 14 can be made of plastic, metal or similar and may be susceptible to compression (compressible) and/or pressure to facilitate the delivery of medication to the channel 22. In some embodiments, the container 14 is replaced by the input hole (not shown) so that the drug could be entered through the front hole in the upper section 32, using the device of administration, such as syringe.

Some versions of the device next 10 includes additional handle 20, connected with the rear section of the input unit 18 in the immediate vicinity of the first section 44. Handle 20 includes upward groove 50, which creates guide (channel) 52, is designed to accommodate and together with the channel 48 input unit 18 to be able to take slidable tubular section 24 of the injector 12. In some versions of the guide 52 has a depth and width ranging from about 6 mm to about 7 mm Handle 20 made with the possibility of movement towards the person of the patient so that the reverse movement of the handle 20 led input unit 18 in cooperation with the nostrils of the patient.

Injector 12, input unit 18 and handle 20 can be made of any materials, including, but not limited, flexible, rigid or semi-rigid polymer materials (e.g. plastics, rubber and so on), metals and their alloys, etc. and their combinations. In some embodiments, the injector 12 runs from flexible plastic, input unit is 18 elastomeric and/or elastic plastic or rubber handle 20 is made of plastic. In some cases, one or more injector 12, input unit 18 and handle 20 are made of such material that you perform a one-time and/or biodegradable.

While the approximate 10, described above, may be used to deliver drug up, and/or sideways, and/or towards basic-nubnmu the ganglion of the patient, in accordance with the principles set out in this description, alternative structures can as well be used for the implementation of such delivery the same way.

Solely as an example, injection cone with curved section at one end, is designed to be entered in nostril patient, similar to corner the jet 28, located on the second end of the 30 injector 12, can be placed inside, essentially, cylindrical (for example, having the form of a pen or cigars). Injection cone can be made of flexible or semi-rigid material, e.g. plastic, so that he could remain essentially in line or nesehnuti position when in position storage inside but it is easy to take a curved shape, being extended from the chassis to bring in a position interaction. In such a device one or more inner surface of the outer casing is intended for straightening or suspend completely or partially, given curvature injection cone until the moment when the pressure cone will be placed in the position of interaction, then the curvature of the cone is restored. Some versions of at least one site of injection cone (for example, end, intended for production of medicaments), if necessary, can be extensible (for example, when the air, oxygen, and/or other gases, and/or medications are passed through the cone under pressure).

Through apply one or more of the index mark (marking) on the cylindrical case described above, the user can easily determine the direction of curvature injection cone, installed inside, for example by rotation of the body around and education of the arc in 360 degrees user you may choose any desired direction spray for delivery of the drug by injection cone. A simple rotation of the housing the direction of the spray can gradually change on a continuous arc from 0 degrees to 360 degrees inclusive. In developing one end of the chassis can be equipped by the end of Luara made with the possibility to interact with the syringe containing the drug. Alternatively, an end of the building, designed in such a way that it remains outside the nostrils may be equipped with a partition or a similar membrane through which the drug can be introduced into injection cone contained in it.

Many other modifications of devices of delivery described here, as well as alternative structures, is also provided for use in the measure in which they simply allow us to deliver medication up, and/or sideways, and/or towards basic-nubnmu the ganglion of the patient in accordance with this technology. As an example plot device, intended for introduction into the nostril of the patient (for example, the site injector 12 above), can be made of any therapeutically acceptable plastic material (for example, plastics, metals, metal alloys and so on), capable to accept and save desired the form when using (for example, to increase or decrease the curvature of the angular nozzles 28, installed on the second end of the 30 injector 12). This function may be desirable, for example, when a physician wants to precisely adjust the geometry of the device to be used by the patient in the clinic.

Way to relieve pain, the patient in accordance with this doctrine includes the delivery of medicaments up, and/or sideways, and/or forward in primary nubnmu the ganglion of the patient with use of these devices. In some versions of the medication is served on the side and/or up towards ONG. In other types of medication is served to the side, up and down toward ONG.

In some embodiments, the way to relieve pain, the patient includes (a) enter injector 12 through the nasal passage of the patient in the region, being located in the middle, and/or rear, and/or lower ONG patient; and (b) delivery of drug injector 12 upwards, and/or sideways, and/or towards ONG. In some embodiments, the injector 12 is inserted through the nasal passage of the patient in the region, essentially, located in the middle and/or lower ONG, while in other variants injector 12 is injected into the area, essentially, in the middle, below and behind ONG. In some versions of the medication is served to the side and/or up towards ONG, while in other types of medication is served to the side, up and down toward ONG. In some embodiments, the injector has 12 other end 30, equipped with one or more 36 holes, through which the drug is sprayed in the direction of ONG.

Anesthetics, which may be used in accordance with the options described here include but are not limited to, embukai, amalasan, Americain, benoxinate, ethoxyquin, mefenamic, Balakan, butamben, butanilicaine, Butylin, butokukai, certican, cocaethylene, cocaine, cycloketocain, dibucaine, dimeticon, dimethocaine, depardon, declinin, akhonin, acagnin, ethyl of aminobenzoate, ethyl chloride, etidocaine, P-ealain, eurosin, fenscoman, tomochin, exiscan, gidroksiprolin, hydroxytyramine, isobutyl p-aminobenzoate, laurencin mesilat, levocska, lidocaine, meperidine, mepivacain, marilyin, metabolicescoe, methyl chloride, mortician, Narain, oktanain, artokhin, oxethazaine, paradoxical, penagain, phenol and-pipecoloxylidide, piperocaine, piridoksin, polidocanol, primaxin, Samaritan, prilocaine, proparacaine, proparacaine, probiotan, proposition, pseudomaquis, Perrotin, quinine urea(quinine), isokan, ropivacaine, salicil-alcohol, tetracaine, Tolkein, trimekain, veratridine, salamin etc. and combinations thereof, and all their optical and/or stereoisomers and all their salts, used in pharmacology.

Some versions of the drug includes an anesthetic, selected from the group, which includes benzocaine, tetracaine, ropivacaine, lidocaine, water, physiological solution and their combinations. Some versions of the drug includes water and/or physiological solution, having a temperature lower than about 10 C, and other options below than about 5 degrees C. some versions of the drug includes a combination consisting of a benzocaine, tetracaine and ropivacaine. Some versions of the drug includes an anesthetic, consisting of approximately 14% benzocaine, about 2% of tetracaine and about 1% of ropivacaine of the total weight of anesthetic.

In some embodiments, the mixture of benzocaine, tetracaine and ropivacaine is used to achieve rapid impact ONG blockade, as well as lasting effect of anesthesia, thereby reducing the need for repeated applications of drugs and minimise any potential complications, depending on the dose and/or side effects. Benzocaine, which is pretty effective in the local application and its toxic dose of more than 200 mg, is the start time of about 30 seconds and duration from about half to about one hour. Benzocaine provides near-instant start anesthesia and may enhance absorption of local anesthetics when mixed with them. Ropivacaine whose toxic dose of 175 mg, usually begins to act slowly, but it lasts from about two to about six hours. Ropivacaine provides advanced conduction anesthesia and long anesthesia. Tutrakan is a very strong local anesthetic with rapid onset and duration from about half an hour and one hour. when mixing tetracaine with ropiwakaina, the duration of anesthesia exceeds 6 hours.

In some versions of the medication used in accordance with this invention, served in the container 14 (shown in figure 1, 3 and 4) as a compressed or aerosolization mixture. Medication additionally contains preservatives, liquid carrier and/or other inert ingredients and additives that would be understandable to a specialist.

The number of drug, submitted in accordance with this invention can easily be determined by a specialist and will vary depending on factors such as the quality and/or concentration of medication, the patient's age, condition and/or the sensitivity to the drug, etc. In some embodiments, the dose of anesthetic ranges from about 0.1 QC (critical concentration) to about 1.0 RC. In some embodiments, the dose of anesthetic is about 0.5 QC.

Methods and devices described herein are intended for use in the treatment of all types of States to which it is desirable introduction of medicaments up, and/or sideways, and/or towards ONG patient. Approximate condition that can be treated thus, include, but are not limited, basically-palatal neuralgia, trigeminal neuralgia, including glossofaringealnaya neuralgia, migraine with or without aura, headaches under pressure, headaches, including chronic headaches, paroxysmal hemicrania, verhneportovay neuralgia, atypical facial pain ganglionit ciliary site, vasomotor rhinitis, deep depression, fibromyalgia, etc. and their combinations.

Convection process for creating ONG blockade used to treat a wide range of diseases, and the described methods and devices intended for use in the treatment of all of them. Typical diseases include pain and/or discomfort associated with mythicism spasm, vascular spasm, neuralgia, reflex sympathetic dystrophy, chronic low back pain of various etiologies (e.g. muscular, discogenic, arthritis and other), pain in the external perevalnom cartilage, mandibular tooth pain, glossodynia, pain in the ear (in cases inflammation Evstafieva pipes) and damage to the middle ear, secondary ear pain caused by cancer of the larynx, the pain caused laryngeal tuberculosis, spasm of the face and upper respiratory tract, syphilis headache, headache with malaria, paroxysmal headache, atrial scotoma, dysmenorrhea, intercostal pain (neuralgia), gastric pain, nausea and diarrhea, myalgia cervical muscles, sciatica, temporomandibular neuralgia, touch facial neuralgia, pain upper teeth, pain associated with the removal of the tooth, a sensation of a foreign body in the throat, a permanent itch, the external ear canal, herpes ear deny, impaired taste, atypical facial pain, neuralgia of the trigeminal nerve, cervical arthritis, dysfunctional-muscle pain-facial syndrome, peripheral neuropathy, neuralgia after shingles, fractures associated with osteoporosis, lumbosacral stretching (voltage), and various other arthritic conditions, etc. and their combinations, but are not limited. Further definitions for which there are described here devices and methods include control of sudden fits of anger, removal of depression, etc., but are not limited.

The term "set" refers to the set of materials that are used in the application of the method in accordance with this invention. Such kits may include one or more of the device and/or its elements, including, but not limited to, an exemplary devices described above, and, further, to include one or more of the drug to use them, including, but not limited to, one or more anesthetic mentioned above.

In some embodiments, the set includes the injector and/or input device, each of which is designed to interact with the left nostril of the patient. In some embodiments, the set includes the injector and/or input device, is designed to interact with the right nostril patient. In some embodiments, the set includes the injector and input unit, is designed to communicate with the left nostril of the patient and to the right. Additionally may be interchangeable arms to attach either to the right or to the left input device. In other embodiments, the handle itself is configured handedness, and a separate arm can be provided for each driver input unit and left input devices.

In some versions it is expected the presence of the device into a fully assembled, while in other variants assembling is required. In some embodiments, the device provides a set that includes injection cone with curved section on one of his all made for introduction into the nostril of a patient in pressure cone is located inside essentially cylindrical (for example, having the form of a pen or cigars) the body, for example, as described above. In some cases, one or many elements of the device are disposable and, optionally, biodegradable.

A drug that is included in the kit can include a single agent or a lot of reagents. Approximate used medications in accordance with this technology include, but are not limited to those mentioned above. Medicines can be presented in a Packed form in one or in separate containers, depending on their cross-reactivity and stability and, in liquid or in dried form they are in. The number and proportion of any reagents are presented in a set can be chosen in such a way as to ensure optimum results for your application.

The medicines included in the set that can be delivered in any type of containers so that the intensity of the actions of the various components, essentially, was preserved, while the components themselves slightly absorbed or change as a result of interaction with the container material. To an acceptable containers include, but are not limited, ampoules, bottles, tubes, bottles, vials, syringes, bags and envelopes (for example, covered with foil (foil)), etc. Containers can be made from any acceptable material, including, but not limited to, glass, organic polymers (for example, polycarbonate, polystyrene, polyethylene etc), ceramics, metal (for example, aluminum, metal alloys (e.g., steel), cork, etc. Additionally containers can have one or more sterile available port (for example, for access by means of a needle), for example, can be represented by a partition. The preferred materials for partitions include rubber and polymers, including but not limited, for example, poly-tetrafluoroethylene species, which is sold under the brand name TEFLON F. DuPont (Wilmington, Del.). Additionally containers may contain two or more compartments, separated by walls or membranes, which can be removed with the aim of mixing.

Sets in accordance with the present invention can also be supplied with other elements, known in the art and/or which may to be desirable from commercial or user point of view, for example empty syringes, tubes, gauze pads, disinfectants, cleaning solutions, how to create ONG blockade and/or Assembly, use and/or cleaning the unit, etc. and their combinations.

In some embodiments, the instructions may be attached to one or more element of the device and/or containers (e.g. bottles) or to a larger container, which is packaged one or more element of the set for transportation. Instructions can also be presented as separate attachments, called advertising insert in the package. Instruction materials accompanying the sets that can be printed (for example, on paper) and/or submitted on electronic media (e.g. floppy disk, CD-ROM, DVD-ROM, zip disk, in the form of videos, audio recordings, etc). Alternatively, the instructions may be in the form of the user's guide on the web-site (for example, specified by the manufacturer or distributor of the set) and/or through e-mail.

The following examples show the features described here devices and methods and is provided only as illustrative material. They are not intended to restrict the claims or its equivalents.

EXAMPLES 1-30

The above device and/or methods were applied for the treatment of 30 patients suffering from chronic headaches, such as the attacks of headaches and headaches caused by pressure. The results of this test amazing and unexpected. To illustrate the result of applying the methods described above was, at least, the pain reduction by 90% and 100% efficiency ONG blockade in 100% of patients. The pain began to diminish in a time interval of about 30 seconds to 60 seconds, and the duration ranged from about 4 to about 24 hours. Each ONG blockade carried out by the use of only 0.5 CC or less of the mixture anesthetics, including benzocaine, tetracaine and ropivacaine in the amounts described above. Have at least 10 patients the duration of time the treatment of pain, in accordance with this technology, lasted for up to 24 hours. In General, it was agreed extremely effective control of headache. Patients were able to return to work and to avoid the use of toxic drugs in almost 100% cases.

Described here devices and methods applicable to the majority of patients over the age of 15 years in 95% of the population irrespective of the growth of the patient's weight, sex, and race. In addition, although currently it is believed that these devices and methods will primarily be used to treat people the same devices and methods can also be used to treat all types of patients (not people). Any patient with nostrils (for example, other mammals, such as primates, dogs, cats, pigs, horses, cows, etc., and not mammals), can also be subjected to treatment (for example, a veterinarian) in accordance with the principles outlined here.

In General described the devices and methods of ensuring safe and more effective aid in the treatment of pain associated with headaches, facial pain, etc. Devices and methods for cost-effective and can easily be applied to patients qualified medical staff, as well as by the patients without the guidance of a health care worker for the implementation of reliable and replicable drug delivery to the destination point. In some of the options described here devices and methods can be used by patients themselves twice in an hour or on request.

During operation auxiliary handle 20 10 devices described here can move towards the person of the patient up until input unit 18 will not enter and will not settle down tightly and comfortable in nostril patient to lift the nose of the patient so that it was directed upwards and slightly back. After that injector 12 can be pushed back towards the nose of the patient to move tubular section 24 and nozzle 28 in the rear, while the nozzle 28 will not be located in the middle, and/or behind, and/or directed to ONG, in the middle and/or sent forward some options, and in the middle, directed forward and behind the others. After this medicine, for example anesthetic may be injective and sprayed through the holes 36 nozzles 28 up, and/or sideways, and/or towards ONG with the aim of relieving pain, sideways and/or up in some variants and to the side, up and forward in other variants. When appropriate anesthetic is sprayed on ONG, can be achieved fast and long vasoconstriction (narrowing) of the blood vessels belonging to the same side of the head or brain, resulting in effective management of pain.

See detailed description and the accompanying drawings are presented only for explanation and example, and are not intended to limit the invention as described in the accompanying claims. Many variants of the present invention will be applied by the specialists in this area without departing from the essence of the present invention, which is outlined in the attached claims.

1. Way to relieve pain associated with headaches and/or facial pain in a patient, including: introduction injector through the nasal passage of the patient in the region essentially middle, or rear, and/or lower relative to the basic-palatal ganglion of the patient; and the delivery of drug injector up, and/or sideways, and/or towards basic-nubnmu the ganglion.

2. The method according to claim 1 in which the region is essentially the middle and lower against major nubnmu the ganglion.

3. The method according to claim 1, wherein the area is essentially a middle, bottom, and rear in relation to the basic-nubnmu the ganglion.

4. The method according to claim 1 in which the drug is served sideways and upwards towards basic-nubnmu the ganglion.

5. The method according to claim 1 in which the drug is served to the side, up and down toward basic-nubnmu the ganglion.

6. The method according to claim 1, wherein the area is essentially a middle, bottom, and rear in relation to the basic-nubnmu the ganglion and in which the drug is served to the side, up and down toward basic-nubnmu the ganglion.

7. The method according to claim 1, wherein the pain include headache, facial pain or their combination.

8. The method according to claim 1, wherein the injector provides the first end, made to stay outside nasal passage and the other end made to enter into the nasal passage.

9. The method of claim 8, in which the drug is served from the other end of the injector.

10. The method of claim 9, in which the other end contains one or many holes through which the drug is sprayed in the direction of major-nubnmu the ganglion.

11. The method of claim 10, wherein is the drug contains an anesthetic.

12. The method according to claim 11, in which the anesthetic selected from the group consisting of benzocaine, tetracaine, ropivacaine, lidocaine and their combinations.

13. The method according to claim 11, in which the anesthetic contain benzocaine, tetracaine and ropivacaine.

14. The method indicated in paragraph 13, in which the anesthetic contains about 14% of benzocaine, about 2% of tetracaine and about 1% of ropivacaine by weight, of the total weight of anesthetic.

15. The method according to claim 1, wherein the injector slidable taken into input unit and in which the introduction of the injector provides: interaction input unit from the nostrils of the patient so that the area of the nose of the patient rises when interacting with introductory device; and slip injector out of storage in a position to deal after input device interacts with the nostrils, in which provision of interaction of the injector is in the middle, and/or behind, and/or lower in relation to major nubnmu the ganglion.

16. The method indicated in paragraph 15, in which the position of the interaction of the injector is in the middle and lower in relation to major nubnmu the ganglion.

17. The method indicated in paragraph 15, in which the position of the interaction of the injector is in the middle, below and behind in relation to major nubnmu the ganglion.

18. The device for the delivery of medication to a patient in need of it, containing: injector containing the first end, made to stay outside nasal passage of the patient, and the other end made to enter into the bow of the patient, and the other end of the injector contains one or many of the holes, made to spray drug up, and/or sideways, and/or towards basic-nubnmu the ganglion, and input device, designed to interact with the nostrils of the patient, and contains the channel, made for the reception of the injector.

26. The device A.25, additionally contains a channel connected to the first by the end of the injector, in which the channel is designed to accept a syringe containing the drug.

27. The device p, additionally contains the container in the message with the first end of the injector, and the container is made to the contents of the medicine.

28. The device according to item 27, in which the container is made of compressed so that the drug in the container moved into the channel as a result of compression.

29. The device b, in which the container is under pressure.

30. The device p in which input device contains the first section and the second land plot and in which the area of the cross section of the first section bigger than the area of the cross section of the second leg.

31. The device according to article 30, where the first section has the following form, which is made to match the internal shape of the nostrils.

32. The device p in which the second section contains rounded bump and essentially flat opposite direction.

33. The device p, additionally contains a handle that is connected with inlet device.

34. The device p in which the handle contains a guiding device, made for the reception of the channel input devices.

35. The device according to clause 34, in which the handle is made to move towards the person of the patient, so that the movement of the arm ago led input unit in cooperation with the nostrils of the patient.

36. The device p in which the injector is made to interact with the left nostril of the patient.

37. The device p in which input device made with the possibility of interaction with the left nostril of the patient.

38. The device p in which the injector is made to interact with the right nostril patient.

39. The device § 38, in which input device is made with the possibility to interact with the right nostril patient.

40. The device p, in which, by interaction input unit from the nostrils is provided horizontal path essentially parallel to the base of the nose of the patient in the medial position to the lower nasal sink patient.

41. The device p in which input device so designed as to be supported by the bottom of the nasal cavity of the patient.

42. How to use the device on p for delivery of medication to the patient, including: interaction input unit from the nostrils of the patient; moving injector in provision of interaction; and the spread of the drug in the direction of major-nubnmu the ganglion through a nozzle at the second end of the injector.

43. Way to relieve pain associated with headaches, facial pain in a patient, including: delivery of medicaments up, and/or sideways, and/or towards basic-nubnmu the ganglion using the device according to p.

44. The method according to item 43, in which the drug is served sideways and upwards towards basic-nubnmu the ganglion.

45. The method according to item 43, in which the drug is delivered to the side, up and down toward basic-nubnmu the ganglion.

46. The method according to item 43, in which the patient is suffering from status selected from the group consisting of: basic-palatal neuralgia, trigeminal neuralgia, glossofaringealnaya neuralgia, migraine, migraine with aura headache, migraine without aura headache, headache due to pressure, paroxysmal headache, chronic paroxysmal headache, paroxysmal of hemicrania, verhneportovay neuralgias, facial pain, atypical facial pain, ganglionitis ciliary site, vasomotor rhinitis, deep depression, fibromyalgia, and their combinations.

47. The method according to item 43, which results from the use of this method is the increasing penetration of the drug through gemeentelijke barrier.

48. The method according to item 43, in which pain is a headache, facial pain or their combination.

49. The device for the delivery of medication to the needy in this patient, containing: injector containing the first end, made to stay outside nasal passage of the patient, the other end, are made so as to enter the nasal passage of the patient, and the channel continuing from the first end of the second end and made so as to take the medication, in which the other end of the injector contains one or many of the holes, made to spray drug upwards, sideways and forward in the direction of major-nubnmu the ganglion; input device, made to interact with the nostrils of the patient and contains the channel, made for the reception of the injector with the opportunity slip, first section, having a form corresponding to the shape of the inside of the nostrils, and the second section containing rounded bump and essentially flat back the direction in which the cross-sectional area of the first section is greater than the cross-sectional area of the second section; and the handle is connected to an input device, and contains the guide is made for reception of the channel input devices; this grip is made to move in towards the person of the patient, so that the movement of the arm ago led input unit in cooperation with the nostrils of the patient; the injector can move between the storage position, previous interaction and provision of interaction corresponding to the interaction; and where provision of interaction is in the middle, back, and lower in relation to major nubnmu the ganglion.

 

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