Source: https://russianpatents.com/patent/250/2503469.html
Timestamp: 2020-06-05 03:46:15
Document Index: 186409397

Matched Legal Cases: ['art 208', 'art 208', 'art 208', 'art 208', 'art 208', 'art 208', 'art 208', 'art 208', 'art 208', 'art 208', 'art 222', 'art 208', 'art 208', 'art 208', 'art 208', 'art 210', 'art 208', 'art 208', 'art 208', 'art 208', 'art 208', 'art 508', 'art 604', 'art 604', 'art 604', 'art 604', 'art 604', 'art 610', 'art 610', 'art 610', 'art 610', 'art 720', 'art 720', 'art 720', 'art 738', 'art 738', 'art 744', 'art 744']

Systems and methods for anesthetising of ear tissues
A61F11/08 - internal, e.g. earplugs
This application will require the priority claimed in the prior application for patent U.S. registration number 61/085360, "SYSTEMS AND METHODS ANESTESIOLOGIA TISSUE of the EAR", case No. 021120-001300US patent attorney, dated July 31, 2008, the contents of which are incorporated herein by reference.
The present invention relates to methods and systems for drug delivery by electrophoresis. More specifically, the present invention relates to new and effective methods and systems for drug delivery by electrophoresis for anestesiologia tissue of the ear.
Electrophoresis is a method of drug delivery through biological membrane, such as skin or when performing certain surgical operations on the ear, the eardrum (BP). Under the action of low-level electric current charged on the same solution containing the medicinal substance, when electrophoresis is the repulsion of ions of medicinal substances and their transport through the skin or other membrane. Earlier in surgery of the ear, attempts were made use of electrophoresis for anestesiologia (or "call numbness") BP before the introduction through her tube for the treatment of chronic inflammation of the middle ear. In the line is the use of electrophoresis BP drug solution is injected into the ear canal and with the electrode through the solution to an electric current, thus, transported anaesthetic substance through the PSU. The possibility of application of devices and systems electrophoresis prior art is limited, as they are not suitable for every patient. Devices of the prior art, generally not capable of tightly holding the medicinal solution in the ear canal, therefore, during the procedure of electrophoresis, the patient will need to bounce back and tilted his head. When using currently known methods of electrophoresis, the patient should almost motionless to be in a half upright position with tilted his head for 5-15 minutes until the electrophoresis procedure does not provide adequate anesthesia BP, which can be particularly difficult for children. In addition, the use of known systems allows you to perform the anesthesia only one ear at a time, so the anesthesia by electrophoresis both BP of the patient is relatively long and causes discomfort.
Known attempts liquid delivery for electrophoresis to PSU using an ear swab designed to hold the liquid in the outer ear canal. For example, see U.S. patent No. 5674196 issued by Donaldson et al. However, earplugs such as those described in Donaldson, and other currently known earplugs, which have several disadvantages. For example, most ear swabs is designed to prevent fluid in the ear canal, and not to hold the liquid inside passage. Currently known and described previously earplugs in most cases not sufficiently correspond to the curved anatomy of the external ear canal and, therefore, do not provide a snug fit in ear canal at least some (and in some cases all) patients. Thus, existing earplugs are usually not able to hold the fluid inside the ear canal, which significantly impedes or prevents delivery of anaesthetic substances by electrophoresis, if the patient is in the upright position. Moreover, the previously described earplugs intended for use in the electrophoresis procedure, do not solve problems such as the formation of bubbles in the drug solution for electrophoresis, which can inhibit the interaction between electrode and solution.
Based on the above, it is preferable to have improved devices and systems for medicinal electrophoresis eardrum. Ideally, such devices and systems will allow you to enter an anesthetic substance by the method of electrophoresis of the patient, finding the Musya in a vertical position. Also ideally, such devices and systems will provide simultaneous electrophoresis BP on both sides. At least some of these problems can be solved by various embodiments of the present invention.
In one aspect of the present invention electrophoresis system for anestesiologia tympanic membrane of an ear of a patient can include ear swab at least one flexible sealing element and the electrode. Ear swab may have a distal portion, a proximal portion, a tube connecting the distal and the proximal portion, and a side opening located on the handset or on the proximal part. The tube may have lower relative stiffness than the distal and proximal parts, the smaller the relative rigidity allows the tube to repeat the curves of the ear canal. A flexible sealing element may be connected to the tube of the ear pad, and its shape allows tightly clogging the ear canal. The electrode may include an electrode tip and an elongated stem, and may be movably installed inside the tube of the ear pad, and the electrode tip has a size that allows you to place it in the distal part and move it inside the tube.
In one of the embodiments ear swab which may include a side opening, communicates with a tube that allows air and / or liquid out of the tube. In one of the embodiments, the distal part is hard compared with the tube. In one of the embodiments, the distal portion may include a sealing ring, which forms a tight connection with the electrode tip in the extended position. In one of the embodiments the outer diameter of the electrode tip may be greater than the inner diameter of the sealing ring and the sealing ring can be flexible, allowing the tip of the electrode to enter the ring for forming an airtight seal. In one of the embodiments of the proximal part can be hard. In one of the embodiments the proximal portion may include a fitting Luer. In one embodiment, the implementation of at least one flexible sealing element may have the shape of the umbrella, where the open end of the sealing element facing toward the proximal end of the ear pad. In one embodiment, the implementation of at least one flexible sealing element may include a distal sealing element and the proximal sealing element, and the diameter of the proximal sealing element may be greater than the diameter of the distal sealing element. In one embodiment, the status is of each of the flexible sealing elements may be in the form of an umbrella, where the open end of each of the sealing element facing toward the proximal end of the ear pad. In one of the embodiments, the electrode can be easily deformable. In one of the embodiments the electrode may include a lumen. In one embodiment, the exercise system may include a headset connected to the proximal part of the ear pad. The ear hook includes a curved element, covering the part of the ear and prevents displacement of the ear swab after placing it in the ear. In one of the embodiments the system may further include an ear swab and an additional electrode for delivery of fluid to electrophoresis to the eardrum of the other ear of the person or animal. In one embodiment, the exercise system may include your headset connecting an ear swab and additional ear swab, when they entered into the ear cavities of the patient.
In one aspect of the invention, the system for delivery of a substance to electrophoresis to the eardrum of the ear of the person or animal may include an elongated flexible tube with a proximal part and a distal part, the first flexible sealing element having the shape of an umbrella and tightly seal the ear canal, the second flexible sealing element having the shape of an umbrella and tightly seal the ear canal, the tube is distal increasing rigidity, placed in the distal part of the elongated tube distal of the sealing element, the fitting Luer, coupled with the proximal part of the tube and having a side opening in communication with the main lumen of the tube and the electrode. The flexible tube may include a main lumen passing inside it. The distal portion may include an inner edge at the distal end of the distal portion, and a sealing element located proximally relative to the inner edge. An elongated tube is flexible and able to bend, adapting to the shape of the ear canal. The first flexible sealing element may be integrated with an elongated tube and positioned on its outer surface with an offset from the distal part of the elongated tube. A second flexible sealing element may be integrated with an elongated tube and positioned on the outer surface proximally relative to the first sealing element. The tube with the distal increasing rigidity prevents deformation of the distal portion of an elongated tube. The electrode may include an elongated barrel. The electrode tip may have a diameter that exceeds the diameter of the elongated shaft. The electrode can move within the lumen of the tube of the ear swab from venutolo position, in which the Jew is the awn can pass through the tube around the electrode, in the extended position, in which the electrode tip is placed inside the distal part of the elongated tube between the inner edge and the sealing element, forming a tight seal.
In one aspect of the present invention a method of anestesiologia tympanic membrane of an ear of the patient by the method of electrophoresis may include delivery of a solution containing an anaesthetic substance in the ear canal of the patient, the introduction of the device for electrophoresis in the ear canal filled with a drug solution containing an anaesthetic agent, removing excess solution containing an anaesthetic substance through the lumen during insertion of the electrode and his stay in the first position, movement of the electrode from the first position to the second position and the inclusion of the electrode in the second position. The device for electrophoresis may include an electrode capable of moving within the lumen from the first position to the second position. The first position of the device for electrophoresis makes it possible to extract excess air or solution from the ear canal. The device for electrophoresis in the second position seals the ear canal.
In one of the embodiments of the method further may include a control electrode moving from the first position to the second state is through acoustic and (or) tactile feedback. In one of the embodiments, the method may include repeating the steps of the method for the second ear of the patient. In one embodiment, the implementation of the patient's head can be laid back and tilted in delivery of drug solution into the ear canal, while activation of the electrode, it can remain in a vertical position. In one of the embodiments, the method may include repeating the steps of the method for the second ear of the patient, in this case, before or during activation earplugs are connected with a headset worn on the head of the patient. In one of the embodiments, the method may include the deformation of the electrode to give it a shape corresponding to the shape of the external ear canal.
In one aspect of the present invention a method of anestesiologia tympanic membrane of an ear of the patient by the method of electrophoresis may include delivery of a solution containing an anaesthetic substance in the ear canal of the patient, the introduction of the device for electrophoresis in the ear canal and activation of the electrode. The device for electrophoresis may include an electrode placed inside the lumen. The device for electrophoresis can tightly hold the medicinal solution containing an anaesthetic substance, and simultaneously withdraw the excess lekarstvennayaforma, containing an anaesthetic substance, past the electrode and through the seal within the lumen.
In one of the embodiments, the method may include repeating the steps of the method for the second ear of the patient. In one of the embodiments, the patient may be in a position sideways during delivery and in a vertical position during activation. In one of the embodiments, the method may include the deformation of the electrode to give it a shape corresponding to the shape of the external ear canal.
In one aspect of the present invention set to perform anestesiologia tympanic membrane of an ear of a human or animal by electrophoresis method may include ear swab and controller. Ear swab may include a distal portion, a proximal portion and a tube extending from the distal portion to the proximal portion, at least one flexible sealing element extending from the outer surface of the tube and located closer to the distal than proximal end, and an electrode. The tube may have lower relative stiffness than the proximal and distal parts of the ear pad. The electrode may include an elongated shaft and a tip electrode having a diameter that exceeds the diameter of the elongated shaft. The electrode can be moved inside the tube of the ear swab from vtyanutoj the provisions in which the liquid can pass through the tube around the electrode, extended position, in which the electrode tip is in contact with the inner surface of the tube, preventing the flow of fluid through the pipe. The controller can be electrically connected to the electrode.
In one of the embodiments set may further include an ear swab for the second ear of the patient and an additional electrode for additional ear swab. In one embodiment, the implementation of the controller can be connected to the electrode and the additional electrode. In one embodiment, the implementation of the set can include your headset for placement on a patient's head, and holding electrodes and ear swabs. 31. In one embodiment, the implementation of the set can include a sufficient amount of the medicinal solution to ensure anestesiologia eardrum both ears of the patient by electrophoresis. In one of the embodiments, the kit may include a device for drug delivery, delivering the drug solution into the ear canal of the patient.
For a more complete understanding of the nature and advantages of various aspects and embodiments of the invention it is necessary to refer to the following description and the accompanying figures. Each predstavleniya are included solely for illustrative and descriptive purposes, and is not intended to limit the scope of embodiments of the present invention.
Figure 1A presents a view of the outer ear from the front.
Figure 1B presents the partial image in the context of the outer, middle and inner ear.
In figures 2A-2C are presented in the context of system anestesiologia tympanic membrane made in accordance with various embodiment of the invention.
Figure 2D presents a perspective view of the distal end of the ear tampon made in accordance with one embodiments of the invention.
Figure 2E presents a side view of the ear tampon made in accordance with one embodiments of the invention.
In figures 2F and 2G are side systems anestesiologia tympanic membrane made in accordance with various embodiment of the invention.
Figure 2H shows the system in action, in accordance with one embodiments of the invention.
In figures 3A-3C presents a partial image in the context of system anestesiologia eardrum in action, in accordance with various embodiment of the invention.
The figure 4 shows the set anestesiologia the eardrum, in accordance with one of the in the of the ways of carrying out the invention.
Figure 5A shows a front view of a flexible sealing element made in accordance with one embodiments of the invention.
Figure 5B presents a side view of the flexible sealing element made in accordance with one embodiments of the invention.
Figure 5C shows a front view of a flexible sealing element made in accordance with one embodiments of the invention.
Figure 5D presents a side view of the flexible sealing element made in accordance with one embodiments of the invention.
In the figure 5E presents a perspective view of a flexible sealing element made in accordance with one embodiments of the invention.
Figure 5F shows a front view of a flexible sealing element made in accordance with one embodiments of the invention.
Figure 6A shows a front view of the ear tampon, including the temples, in accordance with one embodiments of the invention.
Figure 6B shows a front view of the ear tampon, including the temples, in accordance with one embodiments of the invention.
Figure 6C shows a front view of an ear swab, including ear hook, in use, in accordance with one variant of domestic the invention.
Figure 6D presents a side view of the integrated ear liner made in accordance with one embodiments of the present invention.
In figures 6E and 6F are front integrated ear in use, in accordance with various embodiment of the invention.
Figure 7A presents a perspective view of the ear tampon made in accordance with one embodiments of the invention.
Figure 7B presents a perspective view extended parts for use in the ear swab in accordance with one embodiments of the invention.
Figure 7C presents the view in the context of extended parts for use in the ear swab in accordance with one embodiments of the invention.
In figures 7D-7I shows in perspective advanced parts for use in the ear swab, in accordance with various embodiment of the invention.
In the figure 7J shows the image disassembled advanced parts for use in the ear swab in accordance with one embodiments of the invention.
Figure 8A presents a side view of the extended ear tampon made in accordance with one embodiments of the invention.
Figure 8B presents in the d side of the extended ear tampon in use, in accordance with one embodiments of the invention.
Figure 9A presents a view in section of a tampon foam made in accordance with one embodiments of the invention.
Figure 9B presents a view in cross section of cylinder foam made in accordance with one embodiments of the invention.
Figure 10A shows a view in cross section of the port medical mirror, made in accordance with one embodiments of the invention.
Figure 10B presents a view in cross section of an alternative distal port in accordance with one embodiments of the invention.
Figure 10C presents a perspective view of an alternative distal port in accordance with one embodiments of the invention.
In figures 10D and 10E shows the port medical mirror in use, in accordance with one embodiments of the invention.
In figures 10F-10H shows the port medical mirror in use, in accordance with one embodiments of the invention.
In figures 11 and 12 shows a simplified support structure worn on the head of the patient and support system electrophoresis, in accordance with various ASU is estline of the invention.
Figure 1A shows the outer ear. The outer ear includes the main element, known as the ear or auricle 100. The outer ear acts as a funnel, directing the sound into the inner ear. The main elements of the ear are the tip 102, the auricle 104, the antihelix 106, curl 108, rook 110, a triangular hole 112, external auditory meatus 114, tragus 116, proteomelab 118.
The figure 1B shows the image in terms of the inner and outer parts of the ear. The auricle 100, as shown, is connected with the outer auditory passage 118, or ear canal. Ear canal 118 is depicted as a relatively direct way, but in fact the passage, as a rule, has a more curved, tortuous structure. Ear canal 118 connects the middle ear 120, which includes the tympanic cavity 122. Middle ear 120, in turn, is connected with the inner ear 124. Tympanic cavity 122, as a rule, holds air cavity behind the outer part, called the eardrum. In the case of infection of the middle ear 120 inside the tympanic cavity 122 accumulates the liquid. Fluid accumulation causes of human infection of the middle ear pain. Middle ear infections are common in young children. To alleviate the suffering by drum puncture the membrane for evacuation of the liquid, this manipulation is known as tympanotomy. Before the procedure tympanopuncture the patient undergoes General anesthesia, but this anesthesia is not preferred due to the high cost and health risks. The preferred alternative in this case is local anesthesia of the tympanic membrane by means of drug delivery by electrophoresis. Thus, the patient can be awake during the operation. The devices and methods of local anestesiologia eardrum disclosed in co-assigned application for U.S. patent No. 11/962073 and 11/749,729, the content of which is fully incorporated herein by reference.
Figure 2A presents electrophoresis system 200 for anestesiologia tympanic membrane made in accordance with one embodiments of the invention. The system 200 includes earplugs 202 and the electrode 206. Ear swab 202 may include a flexible sealing element 204, the distal portion 208, the proximal portion 210 and receiver 212, which connects these two parts. Tube 212 is more flexible in relation to bending than the distal part 208 and the proximal portion 210. This is a distinct advantage, because ear canal usually is a winding passage, it is necessary that th is would be the distal part 208 and the proximal portion 210 located at the opposite ends of this winding passage. Ear swab 202 should preferably be bent and adapted to form a tortuous passage, without blocking the tube 212. In an alternative embodiment, the ear pad 202 may be pre-bent and formed so that its shape corresponds to the shape of the tortuous passage of the ear canal. To obtain the desired flexibility ear swab 202 may be made of a flexible polymeric material, such as silicone.
The distal portion 208 may include a rigid member 214. Rigid element 214, in General, may be in the form of a cylinder or tube, and having an inner edge 216 which prevents the exit of the electrode from the distal part 208. Rigid element 214 may be made of metal or polymer, which increases the structural strength of the distal part 208. Due to the rigid element 214, the distal part 208 has a higher hardness than the tube 212, thus, the distal portion 208 retains its shape when passing through the winding passage. Rigid element 214 may be associated with distal part 208 or molded into it. In an alternative embodiment, the rigid element 214 is integrated with the distal part 208 and is part of the wall thickness is greater than the wall thickness of the tube 212.
The distal portion 208 may further comprise a sealing ring 218. The o-ring 218 is sealed to Zach who Olivet electrode 206 inside the distal part 208. The sealing ring may be associated with distal part 208 or molded into it, or alternatively it can be integrated between the distal part 208 and the tube 212. The o-ring 218 may be performed in such a way as to pass the liquid in the case, if it experiences a pressure higher than atmospheric, for example pressure, which occur when the introduction of a system 200 in the cavity of the ear filled with fluid. For example, the o-ring 218 may be made in the form of double seal opening in the proximal direction. During testing it was found that 2.2 cm H2O is the best option for the threshold pressure of the sealing ring.
The proximal portion 210 may be stiffer than the tube 212, so that the shape of the proximal portion 210 is maintained during the introduction to the winding passage. The proximal portion 210 may include a side opening 220. Side opening 220 is designed for removing excess fluid from the ear cavity, fluid is withdrawn from the proximal portion 208 and through the tube 212. In an alternative embodiment, a side opening 220 may be positioned on the tube 212. The proximal portion 210 may include a fitting Luer with airtight gasket 222 for connection with the electrode 206, as shown in the figure. The proximal part of viewlocity which may be scabrose part 222 for connection with the tube 212. In an alternative embodiment, the proximal portion 210 may be integrated with the tube 212 and save stiffness due molded inserts, which add rigidity, or thick-walled sections.
Flexible sealing elements 204 are used for forming a sealed connection between the system 200 and the ear canal. Flexible sealing elements 204, as a rule, have an elasticity that is able to deform to take the shape of the ear canal, forming a tight seal. The figure shows two flexible sealing element 204, however, be sure you only need one, and can be used multiple items. The first flexible sealing element 204a may be made in the form of an umbrella oval shaped and integrated into the tube 212 and the distal portion 208, as shown in the figure. In an alternative embodiment, the flexible sealing elements 204 may have a pyramid (triangular or triangular shape. It is established that the ear canal, as a rule, has an oval or triangular shape in cross section. Preferably, between the first flexible sealing element 204a and the most distal part of the system 200, there was a drain 226. The outlet 226 provides additional space in the ear cavity for air bubbles, thus preventing the formation of air pockets in the distal part 208. Second upl is tausi element 204b may be larger than the first sealing element, and can be integrated into the receiver 212, as shown in the figure.
In an alternative embodiment, the flexible sealing elements 204 may include adhesive elements contributing to the formation of a tight connection between the sealing surface elements 204 and ear canal. For example, the adhesive layer can be applied on external (i.e. facing the channel surface of the first sealing element 204a and (or) the second sealing element 204b. An adhesive layer may be covered with a protective tape, which must be removed before the introduction of the device into the ear canal. For these purposes, can be used in various adhesives, for example, temperature-dependent, which at room temperature have reduced stickiness, and when heated in the process of introducing into the ear canal become extremely sticky. Temperature-sensitive adhesive composition suitable for placement and re-placement in complex anatomical structure of the ear to reduce discomfort to the patient. Ear swab 202 can be cooled using a cold compress, which reduces the stickiness and remove the ear pad 202. Examples of adhesive elements can serve as: laying Eakin Cohesive® production CovaTec, Inc. and napkin Pre-Po® production Landec Labs, Inc. In the alternative the option can be used temperature-sensitive adhesive composition, having a high viscosity at body temperature and low viscosity when heated to a temperature above body temperature. In this embodiment, for heating use a warm compress to reduce the stickiness and remove the ear pad 202.
The electrode 206 includes the electrode tip 228, an elongated shaft 230 and the proximal coupling element 232. The electrode tip 228 may have a cylindrical shape corresponding to the interior space of the distal part 208. The electrode tip 228, usually has the form of contributing to the formation of an airtight seal inside the distal portion 208 between the inner edge 216 and the sealing ring 218. The electrode tip 228 also has a size that enables its movable inside the tube 212. The electrode tip 228 is preferably made of silver (purity of 99.9%). It is established that the electrode tip of sterling silver 228, which may be covered with oxidized layer simplifies the procedure of electrophoresis. In devices of the prior art was used electrodes made of stainless steel or gold, which are often caused electrolysis fluid electrophoresis, for example, lidocaine, decreased pH, causing discomfort to the patient. The silver electrode can reduce electrical energy is Liz and reduces thus, the discomfort. In an alternative embodiment, the electrode tip 228 may have a silver coating deposited on another metal, for example stainless steel.
The electrode tip 228, as shown, is made of metal and formed into a cylinder, however, in alternative embodiments, the implementation of the tip electrode 228 may have other configurations, with increased surface area to facilitate electrophoresis. For example, can be used multiple strands of silver wire, grouped like a brush. In another embodiment, there can be several concentric lipotropic different diameters. In another embodiment, may be used silver mesh, arranged similarly to the metal sponge. In another embodiment, can be used tip pressed from the polymer matrix, with a relatively large surface area (e.g., sponge) and gold or silver plating or sputtering. In another embodiment, can be used a woven material with a metallic coating with external insulation or without it, depending on size. In another embodiment, can be used cylindrical body from the inner cells of the distal. Another is ariante implementation may use a coil of silver foil. In another embodiment, can be used tip with notches adapted in size (i.e., smaller diameter) and having open sides. In another embodiment, as the electrode, in the form of a tube or wire, can be used elongated shaft 230 with the proximal seal in the tube 212. In another embodiment, can be used weight with many petals or branches (for example, in the form of a flower), integrated into the surface of the flexible sealing element 204. In another embodiment, can be used soft, stretchy tank with a dielectric outer surface and an inner surface with a silver coating, the distal protruding beyond the distal part 208. In another embodiment, may be used one or more cameras, the surfaces of which have a metallic coating, in the distal part 208. In another embodiment, the electrode tip 228 may have holes and (or) textured surface (e.g., cross-strokes, potraviny, sandblasted) to increase surface area. In another embodiment, the electrode tip 228 may include several types of metals, where one metal (e.g. zinc) plays the role of a sacrificial anode. In other variations is the implementation can be used conveyor (i.e., flexible strip with a metallic coating, which can be used to supply clean electrode surface during the operation. In another embodiment, the receiver 212 may include cleaning elements, which during the rotation cleans the surface of the electrode, providing, thus, a clean surface of the electrode during the operation. In another embodiment, the electrode tip 228 may have a protective coating that prevents corrosion.
The electrode tip 228 can be attached to the elongated shaft 230 by soldering or welding. An elongated shaft 230 can be made of the same material as the electrode tip 228. An elongated shaft 230 may further include a lumen to allow fluid. An elongated shaft 230 preferably should be flexible, allowing the user to pre-attach the elongated barrel shape before the introduction of the system 200 in ear canal. Ear swab 202 may also be inserted before the electrode 206 and, thus, the electrode 206 may have a shape corresponding to the shape of the pre-inserted and deformed accordingly ear swab 202. The shape of the proximal coupling element 232 allows you to form a tight seal with the proximal part 210. The proximal connector, the first element 232 also has electrical connection with the wire 234, what provides the power supply to the electrode 206.
Figure 2B shows the electrophoresis system 200 in the first position, in accordance with one embodiments of the invention. The figure shows the electrode 206, where the electrode tip 228 is in the proximal position within the tube 212. In the first position, the distal part 208 and tube 212 form a channel for the fluid. In the first position, fluid can pass through the distal part 208 and out through the opening 220, as indicated by the arrow.
Figure 2C shows the electrophoresis system 200 in the second position, in accordance with one embodiments of the invention. Electrode 206 is shown with the electrode tip in the distal position within the distal part 208. The electrode 206 may be firmly pressed through the seal ring 218, while you hear a click. Thus, the electrode 206 may be moved from the first position to the second position with an audible confirmation. In the second open position the distal part 208 is closed and no longer forms with the tube 212 channel for the fluid. In an alternative embodiment, the seal ring 218 can pass fluid when the fluid pressure inside the ear canal will exceed the threshold.
Figure 2D shows an alternative implementation of the system electropho is Asa 200. In this embodiment, as the outlet 226 and the distal part 208 include many located on one straight line of holes 236, which are placed proximally over the inner edge 216. The figure shows four holes 236, however, in alternative embodiments, the implementation may be more or fewer holes. Holes 236 may be of any suitable size, for example, in one embodiment, each of the holes may have a diameter approximately equal to 0.64 mm (0.025 inches). Holes 236 contribute to the reduction of the volume occupied medicinal solution and open the large surface area of the electrode tip 228, which, in turn, can reduce the voltage required for the procedure of electrophoresis. During electrophoresis the electrode tip 228 gradually corrode and, thus, requires electrophoresis system more voltage as the electric efficiency of the tip of the electrode is reduced. Experimentally during cadaver testing, it was found that holes 236 10 minutes can reduce the amount of voltage by approximately two thirds, compared with the system 200 without holes 236. Thus, the presence of holes 236 prevents dips and surges in the system. Por the shafts voltage - moments when electrophoresis system does not meet the needs of corroded electrode tip 228 in voltage, and thus, the procedure of electrophoresis may be unexpectedly interrupted. The voltage spikes can cause the patient discomfort.
Figure 2E shows an alternative implementation of the electrophoresis system 200. In this embodiment, system 200 is essentially the same as described above, however, to the distal end of the system 200 is attached to the reservoir 238. The reservoir 238 may be made of soft material, such as thin polymer or woven material. Outside the tank 238 may be covered with a sticky substance, such as the compositions described in this document. Organic residues, such as flakes of skin or ear sulfur, can break away from its place in the process of introducing the system and (or) in the process of electrophoresis. Residues may accumulate on the electrode system 200 and, thus, reduce the active surface area of the electrode. During use, the system is introduced into the cavity of the ear, and the reservoir 238 stick to the surfaces of the ear canal, leading to the tympanic cavity 122. For expansion tank 238 in ear cavity can be used tube, such as a cotton cushion, or expanding foam or spray. In some embodiments, the implementation of the reservoir 238 depict is to place a bottle with double walls. The reservoir 238 prevents the accumulation of organic residues on the electrode, creating a physical barrier between the ear canal and the electrode. The tank can also reduce the loss of medicinal solution, as it prevents the absorption of the medicinal solution in the walls of the ear canal.
In figures 2F-2H are shown alternative embodiments of the system for electrophoresis 200. In these embodiments, the implementation of the system 200 is essentially the same as described above, however, the flexible electrode 240 extends beyond the distal end of the system 200. Flexible electrode 240 may include a dielectric side 242 and the conductive side 244 with a plot of the open metal (e.g. silver). Flexible electrode 240 may be made of a flexible polymer, such as polymid, coextruding with a metal strip. Flexible electrode 240 may be made in the form of a separate tape, curved in the form of a loop, where the inner side of the loop is part of the open metal. Alternatively, we can use several tapes, as shown in the example flexible electrode 246 in figure 2G. The length of extension of the flexible electrode 240 is configured according to the specific anatomy of the patient. In practice, the flexible electrode 240 may interact with the ear canal, as shown in figure 2H, not you whom they shock, as the conductive side 244 is not in contact with the surface of the ear canal. Flexible electrode 204 may deviate from the surface of the ear canal due to its flexible properties. Flexible electrode 240 provides a large surface area of the electrode, thereby increasing the effectiveness of the procedure of electrophoresis. A large area of the electrode surface also helps reduce the formation of bubbles in the drug solution.
In figures 3A-3C shows how to use electrophoresis system 200 for anestesiologia tympanic membrane of an ear of a patient, in accordance with one embodiments of the invention. The figure shows the ear 300 patients in cross section. Initially, the patient takes the position lying on its side so that the ear, requiring surgical intervention, were at the top. Then the fluid electrophoresis 302 is injected into the ear canal, as shown in the figure. After that, the ear pad 304 is inserted into the filled ear canal plugging fluid for electrophoresis inside the ear canal. In General, the ear pad 304 is executed in accordance with the described herein options for implementation. If necessary, the ear pad 304 may be impregnated with a liquid for electrophoresis 302 before the introduction of the tampon into the ear canal.
Figure 3B shows the introduction of electr is Yes 306 into the ear pad 304. The electrode 306 may be flexible, and if necessary, can be pre-bent before the introduction. The electrode 306 may make a distinct noise when introduced into the ear pad 304, feeding, thus, the user sound signal indicating proper installation. After final installation of the electrode 306, the pressure inside the ear canal increases and excess fluid 308 drained from the swab, so the fluid pressure immediately balanced with the atmospheric pressure, as shown in the figure. This is an advantage, as even a slight rise in pressure can cause severe pain in the inflamed ear. After insertion of the electrode 306 to him is energized to start the treatment of the patient. The outer ear may also be processed, as described in this document.
In an alternative embodiment, the first position implies a partial introduction of the electrode 306 in ear swab 304, for example, when the electrode tip 228 is placed in the tube 212, during the initial introduction into the ear canal. After placing the ear pad electrode 304 306 can be moved from the first position to the second position (i.e., operating position when it is fully positioned inside of the ear pad 304.
In another alternative embodiment, the implementation of the population electrode 306 can be completely introduced into the ear swab 304 before the introduction of the tampon into the ear canal. After the introduction of the ear pad 304 in ear canal pressure in the ear cavity increases, and simultaneously the pressure is discharged through the seal in the ear pad 304, which removes excess fluid, when the pressure exceeds the set threshold. The advantage of this variant implementation is that the user does not need to move the electrode when the ear pad is located in the cavity of the ear.
Figure 3C shows the ear and, accordingly, the patient is in an upright position. The device 304 includes a drain 310 from the electrode, causing air bubbles 312 to move to the specified position. The outlet 310 prevents the accumulation of air bubbles directly or partly on the electrode, which can lead to partial or complete loss of treatment efficiency. The presence of the outlet 310 is an advantage, as it allows the use of a system 200 in an upright position, and thus allows the treatment of both ears at the same time.
In an alternative embodiment, the patient may be in a vertical position before the introduction of fluid electrophoresis 302 or ear swab 304. First, the ear canal is entered ear swab 304 with fully adjustable electrode 306. In this embodiment, the electrode 306 includes a separate lumen for filling the ear canal. Liquid for electronic is roporta 302, fill the ear canal, is injected through the electrode 306. After filling the ear canal fluid electrophoresis 302 pressure in the ear cavity increases, and simultaneously the pressure is discharged through the seal in the ear pad 304. Thus, excess liquid is displayed when the pressure exceeds the set threshold. The advantage of this variant implementation is that, if necessary, the fluid can fill both one and both ears simultaneously, the patient may be in a vertical position.
In an alternative embodiment, after placement of the device 304 may be proximally imposed sealing material, as shown in figure 3C. As the sealing material can be used soft pliable material, for example, bone wax (such as beeswax, paraffin or isopropyl). The sealing material may be used singly or as a hermetically attached element device 304, for example, in the structure proximally (e.g., between the sealing element 204b and a side opening 220 on figa) posted by disk. The sealing material becomes plastic when heated to body temperature. In practice, the sealing material can push through and give it the appropriate form in the ear or anatomical on the spine of the outer ear after proper placement of the device 304, as shown in figs. The sealing material may take the form corresponding to the form of the complex anatomy of the outer ear, and to provide a secure fit. The sealing material also provides an airtight seal that allows you to use the device 304 a bit smaller, which, in turn, provides a more rapid and less traumatic introduction of the device into the ear canal as the primary seal in this case is formed by the sealing material, and not by device 304.
Alternatively, in place of or in combination with the sealing material can be used a fabric patch. Tissue patch may have the form of a disk and to be hermetically attached to the device 304 as proximally (e.g., between the sealing element 204b and a side opening 220 on figa) posted by the disk. Tissue patch may include an adhesive material, such as a temperature-dependent formulations described herein. Alternatively, the fabric plaster may contain conventional adhesive composition, such as used in a transparent adhesive bandages Nexcare™ Tegaderm™ production 3M, Inc. In practice, the fabric plaster can push through and give it the appropriate form in the ear or anatomical cavity of the outer ear after proper placement of the device is the STV 304, as shown in figs. Fabric patch can provide as tight seal and secure fit. Thus, tissue patch also allows you to use the device 304 with a size smaller than standard.
The figure 4 shows a set of 400 to anestesiologia tympanic membrane of an ear of the patient by the method of electrophoresis, in accordance with one embodiments of the invention. Set 402 includes a system substantially similar to the devices described in this document. Each system 402 includes ear pad 404 and the electrode 406. As shown, ear swabs can be of different sizes. Set 400 also includes a controller 408, which includes a return electrode 410 is electrically compatible with the system 402. The controller 412 provides a power supply system 402 for the procedure of electrophoresis. Examples of compatible controllers shown in co-assigned application for U.S. patent, previously incorporated herein by reference, No. 11/962063.
In figures 5A and 5B are front and side, respectively, of the flexible sealing element 500, made in the form of an umbrella, in accordance with one embodiments of the invention. A flexible sealing element 500 includes an integrated fin 502, or spokes. With integrated ribs 502 other cha the tee 504 flexible sealing element 500 can be thinner, than the part having the ribs, thus, a flexible sealing element 500 easily deformed. Thus, the device, which includes a flexible sealing element 500, for example, the system 200 may provide an airtight seal inside the ear canal with less effort than the sealing element, does not have integrated ribs 502. In an alternative embodiment, the integrated fin 502 may be located on the inner part of the flexible sealing device 500.
In figures 5C and 5D are front and side, respectively, of the flexible sealing element 506 in accordance with one embodiments of the invention. A flexible sealing element 506 has a cut out portion 508. The cut out portion 508 are thin layers of material. Cut part 508 thinner than the remaining portion 510 of the flexible sealing element 506, and thus, a flexible sealing element 506 easily deformed. Thus, the device, which includes a flexible sealing element 506, for example, the system 200 may provide an airtight seal inside the ear canal with less effort than the sealing element, having cut out portions 508. In an alternative embodiment, the cut portion 508 may be located on the inner part of the flexible sealing device 506.
On the figures the x 5E and 5F shows in perspective and in front, accordingly, the flexible sealing element 510 in accordance with one embodiments of the invention. A flexible sealing element 506, as shown, has the shape of a pyramid or triangle. A flexible sealing element 506 has three sides, creating a tight seal of the ear canal. The cross-sectional shape of the ear canal is not round, but generally triangular. Thus, a flexible sealing element 510 tightly and effectively forms a tight seal inside the ear canal.
In figures 6A and 6B are rear and side, respectively, of the ear swab 600 in accordance with one embodiments of the invention. Ear pad 600 includes a main portion 602, which may include a tubular element and at least one flexible sealing element, as broadly described in this document. Ear swab also includes the behind the ear part 604. In previous devices as locking mechanism ear swabs were used design headphone type. Such devices of the prior art cause inconvenience or discomfort to the user (particularly small children), and as a result the patient has violated the procedures for electrophoresis. The behind the ear part 604 may be made of a flexible polymer such as silicone, and may also b is to be integrated with the ear pad 600. The behind the ear part 604 may also include a frame construction made from a flexible polymer wrapped around the rod (e.g., wire). The rod can be easily deformable, so that the ear hook 604 could be arranged in a shape corresponding to the profile of a specific ear. Alternatively, the rod may be elastic, allowing a constant force acts not on the outer ear, and the ear pad 600.
Figure 6C shows an ear swab 600 in use, in accordance with one embodiments of the invention. The behind the ear part 604 wraps around the leg curl 606 ear. The behind the ear part 604 has advantages compared with other designs of the prior art, as it has a relatively low weight and does not interfere with the patient.
Figure 6D presents a side view of the integrated ear pad 608, made in accordance with one embodiments of the present invention. Ear pad includes a main portion 610, which, in turn, includes power supply and control unit. The control unit functions as a control unit 412 in figure 4. The main part 610 may include control buttons for starting and stopping procedures of electrophoresis. The main part 610 may include one or more adhesive pads. An earmold 608 also includes a flexible bridge 612, having bent the th profile. Flexible bridge 612 can be made of a flexible polymer, such as rubber, and may have a flexible metal rod. Ear swab 614 may have a swivel connection with a flexible bridge 612. Ear swab 614, in General, can have the same design as earplugs described in this document. The cable 616 departs from the main part 610 and attached to the return electrode 618. The return electrode 618 may include a latch to attach to other return electrode.
Figure 6E shows the integrated ear liner 608 in use, in accordance with one embodiments of the invention. The main part 610 may be placed, as shown, with the curl, and can be taped to the patient's skin. Flexible bridge 612 wrapped around the curl, and the ear pad 614 is inserted into the ear canal. Integrated ear liner 608 supports ear swab 614, preventing unwanted shifting and creating a constant reference force, providing a tight seal. By adjusting the flexible bridge 612 can increase or decrease the reference force. Ear swab 614 can be rotated, thus, integrated ear liner 608 can be used on both ears. The return electrode 618 may be glued to the skin of the patient to provide feedback electrical the CSOs path for the control unit. Because integrated ear liner 608 includes an integrated control unit, the patient can freely move during the procedure.
Figure 6F shows the integrated ear pad 620 to use, in accordance with one embodiments of the invention. Integrated ear liner 620 has a design similar to the design ear pad 608 in figure 6D, however, the control unit 622 is placed separately from the lining of the return electrode. Integrated ear liner 620 also includes a flexible body 624, which completely covers the curl of the ear. Flexible body 624 may be made of a flexible polymer, such as rubber, and may have a flexible metal rod. Flexible body 624 can be adjusted depending on the anatomy of the ear to prevent unwanted displacement, and to provide continuous support efforts, forming a tight seal.
Figure 7A shows an ear swab 700 in accordance with one embodiments of the invention. Different areas of the anatomy of the ear have different levels of electrical resistance. The electric current is preferably passes through a region with a low resistance. For example, the eardrum has a lower resistance compared to the cartilaginous areas in the ear canal. You must prevent is ratite unwanted electrical contact with the areas with the greatest resistance it is also necessary to limit the magnitude of the delivered current to provide a comfortable condition of the patient. The location of the electrode as close as possible to the eardrum contributes to the achievement of a positive result, as it reduces the overall delivery path of the current. However, as we know, the ear canal has a winding structure, therefore, to place the electrode as close as possible to the eardrum, not touching other areas in the cavity of the ear, is quite difficult. Ear swab 700 solves these problems.
Ear pad 700 includes a sealing body 702 for a tight fit ear pad 700 in the ear canal. The design of the sealing body 702 similar in design to the other ear swabs described in this document. The sealing body 702 may have gaps and holes to fill the ear canal, or not to have any. Ear pad 700 includes an insulating body 704, passing through the thickness of the sealing body 702. The extended portion 706 of the insulating body 704 comprises an electrode 708. The presence of the extended portion 706 is an advantage, as it electrode 708 extends beyond the sealing body at a sufficient distance and in the process is closer to the eardrum. The distal portion 706 may also come into contact with areas of the ear canal, providing, however, the centrifugal what Yu electrode 708.
In figures 7B and 7C shows in perspective and in cross-section, respectively, of an alternative execution of the extended portion 710, which can be used, for example, with an ear swab 700 presented on figure 7A. The extended portion 710 has a plurality of longitudinal sections 712, which provide fluid access to the inner electrode 714. The extended portion 710 may be made of hypotrophy, trimmed and covered with an outer insulating layer. The presence of the extended part is an advantage since it reduces the number of required parts, and reduces the density of the electric current through the use of a relatively large surface area for the electrode 714. As installed, the reduced density of the electric current more comfortable procedure for the patient. Alternatively, the convex portion 710 may be omitted, and also can be used more or less longitudinal sections 712, as shown in the figure.
Figure 7D presents a perspective view of an alternative execution of the extended portion 710, which can be used, for example, with an ear swab 700 presented on figure 7A. The extended portion 710 includes an insulating areas 716a, 716b and the electrode 718. The electrode 718 may be made of Chinese alloy, such as alloy Titus is Nickel. Thus, when the contact electrode 716a with portions of the ear canal electrode 718, as needed, can easily change direction. The electrode 718 may be longer than shown in the figure, and may include a few insulating sections 716b for further extension of the electrode 718 and placing it next to the tympanic membrane.
In the figure 7E presents a perspective view of an alternative execution of the extended part 720, which can be used, for example, with an ear swab 700 presented on figure 7A. Elongated portion 720 has a design based on hypotrophy similar to that shown in figures 7B and 7C. The extended part 720 includes many drilled holes 722, which provide the contact of the liquid with the inner electrode 724, which is shown in the figure the shaded areas. The extended part 720 may be made of hypotrophy, trimmed and covered with an outer insulating layer.
In the figure 7F presents a perspective view of an alternative execution of the extended portion 726, which may be used, for example, with an ear swab 700 presented on figure 7A. The extended portion 726 may be in the form of easily deformable but resilient basket. At the contact of the extended portion 726 with portions of the ear canal it can easily change direction. The extended portion 728 is the C of the outer insulating material 728 and the inner conductive portion 730. The extended portion 726 may be made of Chinese material, such as an alloy of titanium, Nickel, and have a thin proportions, for example, less than 0.127 mm (0.005 inches).
In the figure 7G presents a perspective view of an alternative execution of the extended portion 732 that can be used, for example, with an ear swab 700 presented on figure 7A. The extended portion 732 includes an outer insulating element 734 and several electrodes 736. Several electrodes 736 are within the insulating element 734. The advantage of this configuration is that it significantly increases the area of the conductive surface and, thus, contributes to the reduction of the density of electric current. Thanks to this configuration, during this procedure, electric current is directed distally towards the eardrum.
In the figure 7H presents a perspective view of an alternative execution of the extended part 738, which can be used, for example, with an ear swab 700 presented on figure 7A. The extended part 738 is similar to the extended part, presented in figure 7F. However, the electrodes 742 are isolated until the most distal point, as shown in the figure. Thanks to this configuration, during this procedure, electric current is directed distally towards the drum re is the PMC.
On the figures 7I and 7J shows in perspective and in a disassembled state, respectively, of an alternative execution of the extended part 744, which may be used, for example, with an ear swab 700 presented on figure 7A. The extended part 744, as shown, is made in the form of a coil, which, in turn, includes a multi-layer construction. The multilayer structure includes an outer insulating element 746, conductive element 748 and the inner insulating element 750. The inner insulating element 750 has openings 752, expose the conductive element 750. The extended portion 744 may be made of pre-coated flat wire, which then latches 752 on one side and which is then minimized accordingly.
In figures 8A and 8B presents a side view and a view in working condition, respectively, extended ear tampon made in accordance with one embodiments of the invention. Ear swab 800 includes an outer expandable portion 802 and the expander 804. The outer expandable portion 802 and the extender can be connected to each other inside the ear swab near the distal end, as shown in the figure. The expander 804 moves within the expandable part and can be pulled proximally to zastavi the ü outer expandable portion to expand and take the second configuration, as shown in figure 8B. The outer expandable portion 802 may be made of a soft polymer, for example, of silicone. The advantage of this configuration is that it just adapts to the anatomy of the ear the patient, and allows you to penetrate as deeply as possible.
Figure 9A shows the device foam 900 in accordance with one embodiments of the invention. The device foam 900 includes an electrode 902 and a perforated tube 904 attached to the electrode 902. Swab foam 906 surrounds the electrode 902. Swab foam 906 may have a cylindrical or conical shape, and may be made of foam with open cells. Electrode 902 may be made of malleable metal (e.g. silver) single or stranded wire or solid or perforated tube, and may include isolation 908, leading from the proximal end of the perforated tube 904. An electrical connector (not shown) can be connected to the proximal end of the electrode 902. The perforated tube 904 may be made of flexible and dielectric or conductive material, and, in General, has sprocket holes along the entire length. The device foam 900 may also include additional TP is the following elements (not shown) and / or adhesive elements, as described herein. In practice, the swab foam 906 compress injected into the ear canal, and then let go, giving him the opportunity to deal and to be compacted in the ear canal. The medicinal solution can be introduced into the ear canal before the introduction of the tampon foam 900, or after insertion of the tampon due to the structure of the swab foam 902, which has open cells. Due to the porosity of the swab foam medicinal solution can penetrate the entire length of the perforated tube 904, thus increasing the surface area of the electrode through perforated holes in the perforated tube 904. The porosity of the swab foam also prevents the increase in pressure during the procedure of electrophoresis.
Figure 9B shows the balloon device foam 910 in accordance with one embodiments of the invention. Balloon device foam 910 includes an electrode 912. The electrode 912 may be made of malleable metal (e.g. silver) single or stranded wire or solid or perforated tube. In one of the embodiments the electrode 912 may include an outer lumen (not shown), which may be made of block copolymers of polyethers with inorganic salts (e.g. the R, Pebax® 55D)whose inside diameter is approximately 1.5 mm to 0.060 inches)and an external diameter of approximately 1.8 mm (0,072 inches). An electrical connector (not shown) can be connected to the proximal end of the electrode. The electrode 912 may also include a distal end with extended insulator surrounding the lived many wires. Swab foam 914 surrounds the electrode 912. Swab foam 914 may be made of foam with open cells. A suitable material is a polyurethane foam based on polyether (EC85HDE) density of 80.1 g/l (5 lb/ft3), production Foamex Innovations, Inc. Swab foam may be of cylindrical shape with an outer diameter of 5-15 mm and an inner diameter of 2.5 mm In the present embodiment, the external diameter of 8.3 mm 11 mm Swab foam may have a different shape, for example conical. Swab foam placed in a tank with double wall 916. Tank with double walls 916 may be made of pliable, propagative or unyielding material. In one of the embodiments tank with double walls 916 may be performed by applying a silicone coating by immersion in an appropriate form that is suitable for these purposes, the silicone coating is MED10-6400 production NuSil Technology LLC. The cylinder Fe is inimi walls 916 may be glued to the side of the electrode 912, and then partially inverted for forming a double wall. Then, in the space between the walls is introduced swab foam 914. The distal portion of the balloon 916 can be connected to the retractable connecting element 918, such as a T-shaped connector 88207 company Qosina Corp.
In practice, the retractable connecting element 918 is vacuum, which causes the swab foam 914 to shrink. Then the balloon device foam 910 is inserted into the ear canal. Thereafter, the vacuum is stopped, which causes the expansion of the foam 914. Advanced foam 914 puts pressure on the bladder with double walls 916 in contact with the walls of the ear canal, thereby tightly plugging the drug solution inside the ear canal. Tat for inflating the balloon is not used positive air pressure, the danger of rupture of the container no. For re-compression foam 914 and facilitate easy removal of the swab from the ear re-apply the vacuum.
Figure 10A presents the port medical mirror 1000, made in accordance with one embodiments of the invention. Port medical mirror 1000 may have a generally conical shape. Port medical mirror 1000 can be made of polymer and metal alloy. Port medical mirror 1000 can bitunicate flexible or rigid. Port medical mirror 1000 may include a proximal port 1002, which has a detachable connection with the distal port 1004. The proximal port 1002 can be connected to the distal port 1004 by planting with weak interference fit or by means of a threaded connection. The inner pad 1006 may be removable and hermetically connected to the distal port 1004. The inner pad 1006 includes an electrode 1008, made in the form of a loop, as shown in figure 2F. However, the electrode 1008 may generally take the form of any electrode from among those described in this document. The inner pad 1006 may include sealing elements (not shown), the design of which is similar in design to other sealing elements described in this document. The distal port 1004 may include an adhesive layer 1010, which can be executed like any adhesive composition as described herein. An adhesive layer 1010 can also be made on the basis of soft silicone mastic, adhesive sealant, used in pouch bags, expanding foam, dental impression material, gel, bone wax, gas-permeable cement or silicone sealant.
Figure 10B shows an alternative distal port 1012, made in accordance with one embodiments of the invention. Distalen the th port 1012 is executed similarly to the distal port 1004, however, the distal port 1012 includes an electrode surface 1014. Electrode surface 1014 may be made in the form of a layer of metal, such as silver, United with the inner surface of the distal port 1004. The inner pad 1016 may be removable and hermetically connected to the distal port 1012. The inner pad 1016 may include a contact surface 1018, which forms an electrical contact with the electrode surface when the inner pad 1016 is connected with the distal port 1004.
Figure 10C shows an alternative distal port 1020 made in accordance with one embodiments of the invention. The distal port 1012 is executed similarly to the distal port 1004, however, the distal port 1012 is connected with a tampon with many movable electrode 1022. The movable electrodes 1022 have increased flexibility and increased surface area. The movable electrodes 1022 may include insulating and conductive areas of open metal.
In figures 10D and 10E shows the port medical mirror 1000 in use, in accordance with one embodiments of the invention. Manipulation of the port medical mirror 1000 can be performed by using the proximal port 1002. The enlarged diameter of the proximal port 1002 allows you to perform manipulations in the contain the port medical mirror 1000 with your fingers. Port medical mirror can be adjusted to provide visualization of the eardrum. An adhesive layer 1010 at the distal port 1004 provides a tight seal and fixation between the distal port 1004 and ear canal. After placement of the port medical mirror 1000 in the optimum position proximal port 1002 can be detached from the distal port 1004. Then the distal port 1004 can be filled with a medical solution, and the inner pad 1006 may be introduced into the distal port 1004. After completion of electrophoresis to the inner pad 1006 electrical current is applied.
In figures 10F-10H shows the port medical mirror 1000 in use, in accordance with one embodiments of the invention. Port medical mirror 1000 includes an alternative distal port 1012 with the electrode surface 1014. The distal port 1012 already placed in the ear canal and the proximal port 1002 is extracted, in accordance with figures 10D and 10E. The distal port 1012 can be filled with a medical solution, and an inner pad 1016 may be inserted into the distal port 1012. After completion of electrophoresis to the inner pad 1016 electrical current is applied.
The figure 11 shows a simplified support structure 1100 worn on the head of the patient ACC is accordance with one embodiments of the invention. Simplified support structure 1100 is worn on the head of the patient when the patient is conscious and in a vertical position. The support structure 1100 is designed to maintain one or more systems described herein, at the level of the ears of the patient E. As you can see in figure 11, the support structure 1100 is composed of several elements arranged on the same axis, namely, the first body 1110 in contact with the first ear, a second body 1110 in contact with the second ear, and the element covering the patient's head and held between the first and second body. Using headphones, shown in figure 11, can connect any earplugs, made in accordance with the principles of the present invention.
The figure 12 shows a simplified support structure 1200 worn on the head of a patient in accordance with one embodiments of the invention. The support structure 1200 is made by analogy with glasses and is wearing a similar way. Earplugs 1210 attached to the support structure 1200 with the help of hinges and held inside the ear canals with the help of support structure 1200. Earplugs 1210 can be performed by analogy with any ear swabs from among those described in this document. Supporting instrukciya 1200 can prevent unwanted movement and to provide a sealing force against the ear swabs 1210. The support structure 1200 may include adjustable elements for adjustment of the width and length, depending on the anthropometric data of the individual patient. The support structure 1200 may include a display panel such as an LCD panel, which can provide a video preview for the patient. Earplugs 1210 may also include speakers, providing the patient audio data.
The present invention can be embodied in various specific forms that do not contradict its basic principles. These additional embodiments of covered by the scope of the present invention, which is disclosed in the accompanying claims.
1. The system of delivery of a substance to electrophoresis to the eardrum of the ear of a person or animal, the system includes:
ear swab, consisting of:
the distal part;
the proximal part;
tube extending from the distal portion to the proximal portion, where the tube has a lower hardness compared to the proximal and distal part of the ear swab;
at least one flexible sealing element extending from the outer surface of the tube and located closer to the distal than the proximal end; and
electrode consisting of:
the elongated barrel; and
the tip of the electrode, obladaeshchim diameter compared to the elongated shaft, where the electrode is moved inside the tube of the ear swab from venutolo position, in which fluid can pass through the tube around the electrode, extended position, in which the electrode tip is in contact with the inner surface of the tube, preventing the flow of fluid through the pipe.
2. The system according to claim 1, in which the ear pad further includes a side opening that communicates with a tube that allows air and / or liquid from the tube.
3. The system according to claim 1, in which the distal part is hard compared with the tube.
4. The system according to claim 1, in which the distal portion includes a sealing ring, which protects the electrode tip in the extended position.
5. The system according to claim 4, in which the outer diameter of the tip of the electrode is larger than the inner diameter of the sealing ring and the sealing ring is flexible, allowing the tip of the electrode to enter the ring for forming an airtight seal.
6. The system according to claim 1, in which the proximal portion is rigid.
7. The system according to claim 6, in which the proximal portion includes a fitting Luer.
8. The system according to claim 1, in which at least one flexible sealing element has the shape of the umbrella, where the open end of the sealing element facing toward the proximal end of the ear pad.
9. The system according to claim 1, in which the at least one flexible sealing element includes a distal sealing element and the proximal sealing element, and the diameter of the proximal sealing element is greater than the diameter of the distal sealing element.
10. The system according to claim 9, in which each of the sealing elements has the shape of the umbrella, where the open end of each of the sealing element facing toward the proximal end of the ear pad.
11. The system according to claim 1, in which the electrode is easily deformable.
12. The system according to claim 1, in which the electrode includes a lumen.
13. The system according to claim 1, further comprising a headset connected to the proximal part of the ear swab, ear hook includes a curved element, covering the part of the ear, and prevents the displacement of the ear swab after placing it in the ear.
14. The system according to claim 1, further comprising additional ear swab and an additional electrode for delivery of fluid to electrophoresis to the eardrum of the other ear of the person or animal.
15. System 14, additionally including your headset connecting an ear swab and additional ear swab, when they entered into the ear cavities of the patient.
16. System for delivery of a substance to electrophoresis to the eardrum of the ear of a person or animal, the system includes:
an elongated flexible tube with a proximal part and a distal part, including the main lumen passing inside it, distillate includes an inner edge at the distal end of the distal portion and the sealing element, located proximally relative to the inner edge, where the elongated tube is flexible and able to bend, adapting to the shape of the ear canal;
the first flexible sealing element having the shape of an umbrella and tightly seal the ear canal, the first sealing element is integrated with the elongated tube and is located on its outer surface with an offset from the distal portion of an elongated tube; a second flexible sealing element having the shape of an umbrella and tightly seal the ear canal, the second flexible sealing element is integrated with the elongated tube and is located on the outer surface proximally relative to the first sealing element; a tube with a distal increasing rigidity, placed in the distal part of the elongated tube distal of the sealing element, the tube with the distal increasing rigidity prevents deformation of the distal portion of an elongated tube; fitting Luer, coupled with the proximal part of the tube and having a side opening in communication with the main lumen of the tube; and an electrode, consisting of:
the elongated shaft; and a tip electrode having a larger diameter compared with an elongated stem, where the electrode is moved inside the tube of the ear swab from venutolo provisions to the torus fluid can pass through the tube around the electrode, in the extended position, in which the electrode tip is placed inside the distal part of the elongated tube between the inner edge and the sealing element, forming a tight seal.
17. How anestesiologia tympanic membrane of an ear of a human or animal by the method of electrophoresis, the method includes: delivery of a solution containing an anaesthetic substance in the ear canal of a patient; introducing external auditory meatus of the ear swab for electrophoresis connected to the electrode located in the first position inside the ear swab, where the lumen of the ear pad is open from the distal opening to the proximal exit port of the fluid when the electrode is in the first position; removing excess solution containing an anaesthetic substance through the lumen of the ear pad; moving the electrode from the first position to the second position inside the ear swab for forming a sealed the seal between the electrode and the inner wall of the lumen ear swab; and the inclusion of the electrode for applying current to the medicinal solution in the outer ear canal.
18. How anestesiologia tympanic membrane of an ear of a human or animal by the method of electrophoresis, the method includes:
delivery of a solution containing an anaesthetic substance in the outer with whowas passage of a patient; introduction in the external auditory meatus of a patient, the device for electrophoresis, the device for electrophoresis includes ear swab having a lumen and an electrode placed inside the lumen, where the introduction of the device provides a tight seal between the device and the outer auditory passage, therefore, the drug solution is retained in the cavity of the outer ear canal and excess drug solution simultaneously displayed by the electrode and through the lumen of the ear swab; and the inclusion of the electrode for applying current to the drug solution.
19. Set for electrophoresis to perform anestesiologia tympanic membrane of an ear of a human or animal by electrophoresis, and the set includes:
tube extending from the distal portion to the proximal portion, where the tube has a lower relative stiffness than the proximal and distal parts of the ear swab;
at least one sealing element extending from the outer surface of the tube and located closer to the distal than the proximal end; and
electrode, including:
the tip electrode having a larger diameter compared with an elongated stem, where the electrode is moved inside t the skirts ear swab from venutolo provisions in which the liquid can pass through the tube around the electrode, extended position, in which the electrode tip is in contact with the inner surface of the tube, preventing the flow of fluid through the tube; and
a controller, electrically connected to the electrode.
20. Set according to claim 19, further including:
additional ear swab for the second ear of the patient; and
an additional electrode for additional ear swab, where the controller connects to the electrode and the additional electrode.
21. Set according to claim 19, further including your headset for placement on a patient's head, and holding electrodes and ear swabs.
22. Set according to claim 19, further comprising a sufficient amount of the medicinal solution to ensure anestesiologia eardrum both ears of the patient by electrophoresis method.
23. Set by article 22, additionally comprising a device for drug delivery in order to deliver the medicinal solution into the ear canal of the patient.
Method of treating intracranial small-volume haematomas // 2496536
SUBSTANCE: invention concerns medicine, namely neural diseases, neurosurgery, traumatology. A neck surface is exposed to autoresonant red emission in a projection of carotid sinus at wave length 0.63-0.66 mcm, power 24-26 mWt for 7-10 minutes and to infrared emission at wave length 0.87-0.89 mcm, power 9-10 Wt for 10-15 minutes. That is followed by pharmacological neuroprotection by intranasal electrophoresis with neuroprotective preparation at current intensity 0.5-2.0 mA for 15-20 minutes. The treatment is started from the third post traumatic day. The first therapeutic day required the exposure to red laser light followed by a 15-20-minute pause and the intranasal electrophoresis in the morning with the exposure to red laser light in the evening. On the second therapeutic day, the exposure to red laser light is performed in the morning, and in the evening the same is followed by a 15-20-minute pause and the intranasal electrophoresis. The treatment is conducted within 14-20 days.
EFFECT: method enables reducing the length of traumatic intracranial haematoma resolution ensured by the synergetic effect of the red and infrared laser light and therapeutic preparations.
Physiotherapeutic electrode apparatus // 2495686
SUBSTANCE: invention relates to medicine and medical equipment, namely to apparatuses used in oncology and physiotherapy. The apparatus comprises two electrodes mounted in cavities of dielectric cup-shaped body connected to a UHF unit, each body of which is provided with an additional mesh electrode of a graphitised electrically conductive cloth with a lining adjoining thereto and impregnated with a drug substance. The mesh electrode is shaped and sized after the main electrode; it is parallel to the main electrode, separated therefrom with a dielectric lining and connected to a DC power source. An outer surface of each body comprises equispaced ribs with through holes flushes for flexible lightguide in the number of 4 to 10, assembled in a common cable and connected to a laser light source generating laser light to cover the tumour from both sides.
EFFECT: using the invention enables extending the physiotherapeutic functions of the UHF hyperthermia apparatuses.
Method of treating allergic rhinitis // 2494774
SUBSTANCE: invention refers to medicine, namely physiotherapy, otorhinolaryngology. The method involves the endonasal drug administration by electrophoresis. For electrophoresis, two paired U-cathodes are placed around the right and left ears. The drug preparations are administered by a wet nonwoven material. The endonasal electrodes (anodes) are wrapped with the nonwoven material of surface density 40-60 g/m2. The material of the one electrode is coated with a composition of sodium alginate and hydrocortisone, while another one - with a composition of sodium alginate and mexidol in a therapeutically effective amount. The nonwoven material of the surface density 160-180 g/m2 of the form congruent to the electrodes is laid under the U-cathodes. The material is coated with the composition of sodium alginate and urea in a therapeutically effective amount. The procedures are daily. The nonwoven material is kept after the procedure for another 10 - 20 minutes. The therapeutic course is 5-10 procedures.
EFFECT: method provides the comfortable procedure ensured by the soft plastic form of the non-woven material, mucus absorbability from the nasal passages onto the sodium alginate, improved nasal breathing, loss of the conductive component with the objective hearing improve.
Apparatus to suppress disease-causing microbes // 2489178
SUBSTANCE: invention refers to medical equipment, namely to apparatuses to suppress disease-causing microbes. The apparatus comprises a handle, a head and a voltage source, wherein the handle has a conductor in its middle part used as a negative terminal being in contact with the body. The head comprises a positive terminal consisting of silver which is able to release positive ions into body tissue when the electrical circuit is getting closed. The voltage source is integrated into the apparatus.
EFFECT: using the apparatus enables reducing the number of disease-causing microbes on the human body for a long time with no drug treatment involved.
Device and methods for improved multiple per os delivery of biologically active substances and for prevention of local irritation // 2485982
SUBSTANCE: group of inventions refers to medicine. The nasal drug delivery directly to patient's brains is ensured by a conductor for therapeutic electrophoresis coupled with a device for the drug delivery. A controller adjusts an electrical charge fed to the conductor for therapeutic electrophoresis. The conductor for therapeutic electrophoresis can be introduced in each nasal cavity. The given conductor is preferentially enclosed in a tube used for the nasal drug delivery. A cleaning solution may be also delivered into the nasal cavity after the treatment for the purpose of relieving an irritation following therapeutic electrophoresis.
EFFECT: group of inventions enables a more safe procedure of the drug delivery with total delivery control ensured.
Method of treating diabetic polyneuropathy // 2483763
SUBSTANCE: invention refers to medicine, particularly physiotherapy, and may be used for treating diabetic polyneuropathy. What is involved is a phototherapy by Bioptron-compakt III apparatus. A lamp is placed at 5 cm from an abdominal wall surface above a projection of a pancreas. A light beam containing different wave lengths within the range of 400 nm to 34000 nm are used. The power flow density is 40 mWt/cm2, the optical energy flow density is 2.4 J/cm2, the length is 4 minutes. Then, the lamp is placed at 5 cm from a surface of a back above spines on a projection of the segments T7-T9 pravertebrally from both sides for 2 min from each side. Thereafter, the lamp is placed at popliteal spaces at 5 cm to be exposed in turn for 2 min on each side. A total length of one procedure is 12 minutes, daily; the therapeutic course is 10 procedures. On the same day, an electrophoresis session is conducted through a temporary spacer with 1% placenta hydrolysate by means of Potok-1 apparatus. The current intensity is 10-15 mA, the length is 20 min. The electrodes are placed as follows: a Y-electrode (+), each of 160 cm2 is placed paravertebrally in an interscapular region at a small distance from each other, a Y-electrode (-), each of 150 cm2 is placed on gastrocnemius muscles. The therapeutic course comprises 10 daily procedures.
EFFECT: method enables recovering all the types of sensitivity within lower extremities, the functional state of the pancreas and the carbohydrate and fat metabolic processes ensured by anti-inflammatory, anti-oedema and adaptive effects.
Method of endodontic nanoimpregnation treatment of pulpitis, apical and marginal dental periodontitis // 2481803
SUBSTANCE: invention relates to medicine, namely to therapeutic dentistry, and is intended for treatment of pulpitis, apical and marginal dental periodontitis. Drug processing of root canal is carried out. Canal is dried. After that, root canal of tooth is filled with liquid No 1 - solution of subacid magnesium fluoric silicate from composition of "Dentin-hermetising liquid". Active needle electrode of device for carrying out electro- or depot phoresis is introduced into canal and transcanal electrophoretic introduction of ions, contained in liquid, into dentin tubes of tooth root is performed. Amount of electricity, passing through tissues of tooth root tissues, constitutes from 1 to 5 mA X min, with current value from 0.1 to 1 mA. After that root canal is dried with air and electrophoresis of liquid No 2 - alkaline suspension of highly-dispersive calcium hydroxide from composition "Dentin-hermetising liquid" is carried out at the same parameters as the first liquid. Root canal is dried with air and filled by traditional method.
EFFECT: method makes it possible to reduce number of complications and increase efficiency of treatment of pulpitis, apical and marginal periodontitis due to deep transcanal electrophoretic fluoridation of tooth root dentin.
Headband-free hearing protector, and method for hearing protection // 2489998
SUBSTANCE: group of inventions refers to medicine. According to the first version, a hearing protector for passive sound decay in a particular ear canal of an individual comprises a shoulder, a liner element and a press pad. A neck and press plate extend from the shoulder. The neck has a projecting leg. The liner element covers the leg. The press pad is coupled with the press plate. The press pad and liner element comprises a flexible polymer material. According to the second version, the hearing protector for passive sound decay in the particular ear canal of the individual comprises a neck element partially covering an element attached to a human's ear, press plate, flexible pad "НСП" attached to the auditory pathway, and elastomer press pad. The partially covering element extends from the neck element. The press plate extends from the neck or shoulder. The flexible pad "НСП" attached to the auditory pathway covers the neck at least partially. The elastomer press pad covers the press plate at least partially.
EFFECT: inventions provide comfort for a great number of users and possibility to remove the device from the ear without contaminating it with a hand.