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    • 专利摘要:
    METHOD AND DEVICE FOR DETECTION AND / OR REFLUX BLOCKING, comprising a naso / orogastric device having a reflux blocking means and comprising a naso / orogastric tube (101) of size and shape to be disposed inside the esophagus so that, at least one distal end is placed in the lumen of a patient’s stomach, at least one elastic esophageal body (103), positioned along the naso / orogastric tube (101), having a pressure-dependent volume of at least one esophageal sensor that detects fluids around at least one segment of the naso / orogastric tube (101), and a pressure regulator that regulates a pressure within the elastic body according to esophageal detection.
    公开号:BR112012018757B1
    申请号:R112012018757-0
    申请日:2011-01-27
    公开日:2020-12-01
    发明作者:Liron Elia；Nir Lilach；Eliahu Eliachar
    申请人:Art Healthcare Ltd；
    IPC主号:
    专利说明:

    [0001] [001] The present application for a patent, in some embodiments thereof, relates to a reflux detection system and method and, more particularly, but not exclusively, to a reflux detection system and method, when a naso / orogastric tube is placed in the esophagus and stomach.
    [0002] [002] Naso / orogastric feeding, such as esophageal, gastric, duodenal and / or enteric feeding is a form of food and / or metabolic support in which nutritional formulas or medications are delivered directly to the gastrointestinal tract, stomach or duodenum. In most cases, nutrient administration is performed using a device or system based on a tube, delivering the nutrient through the patient's pharynx and esophagus directly into the stomach, duodenum or small intestine (jejunum) ). One of the difficulties of naso / orogastric feeding is the increased occurrence of reflux content in the stomach, moving to the patient's pharynx.
    [0003] [003] A common preventive measure against reflux of stomach contents has been to raise the patient's upper body to a semi-recessed position (approximately 45 °), thereby reducing the rise of gastric material to the esophagus into the pharynx and the lungs.
    [0004] [004] A number of naso / orogastric tubes have been developed to operate an esophageal balloon seal against the ascending gastroesophageal content from the stomach to the pharynx. For example, United States Patent No. 4,384,584, filed on October 28, 1981 describes a naso-esophageal catheter that is provided with an inflatable balloon at its distal end, and a signal emitting device is located inside the balloon. so that the location of the distal end of the catheter can be determined when it is inserted into the patient's esophagus. After the catheter has been inserted into the patient's esophagus, the balloon is inflated. Subsequently, a transcervical esophageal catheter is directed through the patient's neck towards the center of the inflated balloon. After the balloon has been punctured, the naso-esophageal catheter is removed and the patient can then be fed with liquid nutrients through the transcervical esophageal catheter.
    [0005] [005] Another example is described in United States Patent Application, Publication Number 2009/0062725, filed on August 29, 2007 describes an enteric feeding unit that reduces the occurrence of gastroesophageal-pharyngeal reflux during feeding includes a pump automated feeding with a feedback sensor for detecting a relative pressure in a patient's stomach and esophagus, and a regulatory system to control and monitor the patient's feeding rate as a function of relative gastroesophageal pressure. The system includes a probe in the stomach, which provides a tight closure of the esophagus. The stomach probe includes a bladder plug for watertight closure of the esophagus, in which the bladder plug is formed of a flexible and / or elastic material. At least one internal bladder cavity is provided for the reception of a fluid medium. A prescribed pressure for the medium in the bladder plug is maintained by an internal lumen that forms the stomach probe, from which an external hose-like lumen extending to the bladder plug is arranged so that between the outer lumen and the internal lumen is formed a channel connected to the interior of the bladder plug cavity disposed in the external lumen by a series of openings. The internal cavity of the bladder plug is connected through a channel formed between the internal and external lumen with a reservoir or equalization vessel appropriately classified for the liquid medium located above the bladder plug and outside the patient. SUMMARY OF THE INVENTION
    [0006] [006] According to some embodiments of the present patent application, a naso / orogastric device having refluxing blocking means is provided. The naso / orogastric device comprises a naso / orogastric tube of size and shape to be disposed within the esophagus so that at least one distal end is placed in the lumen of a patient's stomach, at least one elastic esophageal body, positioned along the naso / orogastric tube, having a pressure-dependent volume, at least one esophageal sensor that detects fluid around at least one segment of the naso / orogastric tube, and a pressure regulator that regulates a pressure within the hair least one esophageal elastic body according to detection.
    [0007] [007] Optionally, at least one esophageal sensor comprises at least one impedance sensor for detecting an impedance change around at least one segment of the naso / orogastric tube.
    [0008] [008] Optionally, the naso / orogastric tube has distal and proximal ends, with at least one esophageal sensor comprising a first esophageal sensor in the vicinity of the distal end and a second esophageal sensor between the distal end and the proximal end.
    [0009] [009] More optionally, the pressure regulator regulates the pressure according to the difference between a first reading of the first esophageal sensor and a second reading of the second esophageal sensor.
    [0010] [0010] More optionally, the first and second readings are impedance change readings.
    [0011] [0011] More optionally, the pressure regulator regulates the pressure according to the time duration of a first detection event of the first reading in relation to a second detection event of the second reading.
    [0012] [0012] More optionally, at least one esophageal sensor comprises at least one impedance sensor for detecting low impedance around at least one segment.
    [0013] [0013] More optionally, the change in impedance is indicative of the presence of a fluid content around at least one esophageal sensor.
    [0014] [0014] Optionally, the naso / orogastric device further comprises an air-conducting tube having a lumen to allow the pressure regulator to change the pressure in at least one elastic esophageal body, the air-conducting tube being connected to a peripheral surface of the tube.
    [0015] [0015] More optionally, the air conducting tube is made of a layer of flexible biocompatible polymer, having a thickness of less than 200 microns.
    [0016] [0016] Optionally, the tube has a first lumen to supply nutrients, microorganisms, water, or medications to the stomach lumen and a second lumen, at least one to inflate and deflate at least one elastic esophageal body.
    [0017] [0017] More optionally, each impedance sensor comprises a plurality of electrodes arranged in a circular shape around the naso / gastric tube.
    [0018] [0018] Optionally, the naso / orogastric device also comprises a pump assembly, controlled by the pressure regulator, in order to regulate the pressure by inflating at least one elastic esophageal body.
    [0019] [0019] More optionally, the pump set comprising an air pressure tank, the pump set increasing the air pressure in the air pressure tank in order to accelerate inflation.
    [0020] [0020] More optionally, at least one elastic esophageal body comprises a plurality of balloons arranged next to each other along the naso / gastric tube.
    [0021] [0021] Optionally, the naso / orogastric device further comprises at least one positioning sensor and a controller that detects the position of at least a portion of the naso / orogastric tube in the esophagus.
    [0022] [0022] More optionally, the positioning sensor, at least one, comprises a threaded thread in a channel along the naso / orogastric tube, the channel having at least one opening along it.
    [0023] [0023] More optionally, a pressure set regulates the pressure according to the location.
    [0024] [0024] More optionally, the controller detects movement according to a change in location, with the pressure regulator reducing the pressure in response to the change.
    [0025] [0025] Optionally, the naso / orogastric device further comprises a connection on a cable having a filter to adjust the air flow from the pressure regulator.
    [0026] [0026] Optionally, at least one esophageal sensor comprises a plurality of threads threaded in a plurality of channels along the naso / orogastric tube, with each channel having at least one opening along it.
    [0027] [0027] According to some embodiments of the present patent application, a method of reflux prevention is provided for at least one tube feeding and esophageal endoscopy of the patient. The method comprises the elimination of a naso / orogastric tube having at least one elastic esophageal body inside the esophagus so that at least one distal end is placed in the lumen of a patient's stomach and at least one elastic esophageal body is placed along a segment of the esophagus, detecting fluid in at least one region along the esophagus, at least in the position around the naso / orogastric tube, between the segment and the stomach, and regulating the pressure within, at least one esophageal elastic body according to detection.
    [0028] [0028] Optionally, the detection comprises an impedance change sensor in at least one region.
    [0029] [0029] More optionally, the regulator comprises the increase in pressure, in order to block the esophagus when the impedance is indicative of the presence of gastric content in the position, at least.
    [0030] [0030] More optionally, the regulator understands the pressure decrease when the impedance is indicative of the absence of gastric content in the position, at least.
    [0031] [0031] Optionally, the distribution comprises an elimination of the elastic stomach body inside the stomach, around the distal end, the regulator comprising the regulation of an additional pressure inside the elastic stomach body in parallel and in correspondence with pressure in order to prevent at least one elastic esophageal body from moving into the patient's pharynx.
    [0032] [0032] According to some embodiments of the present patent application, a naso / orogastric device having reflux blocking means comprising a naso / orogastric tube having a lumen for the delivery of content to the lumen of the stomach of a patient, with at least one reflux blocking means positioned along the naso / orogastric tubes and one having at least one perimeter larger than the perimeter of the naso / orogastric tube and an adjustable structure having at least a state wider than the perimeter of the naso / orogastric tube, and an elastic stomach body at a distal end of the naso / orogastric tube and configured to be inflated by the content so as to have a perimeter larger than the perimeter of the lower esophageal sphincter of the patient.
    [0033] [0033] Optionally, the content comprises a member of a group that includes: nutrients, microorganisms, water and medicines.
    [0034] [0034] Unless otherwise defined, all techniques and / or scientific terms used herein have the same meaning as normally understood by a professional skilled in the art to which the present application for a patent relates. Although methods and materials similar or equivalent to those described herein can be used in practice or in testing the embodiments of the present patent application, the exemplary methods and / or materials are described below. In case of conflict, the patent specification will have control, including definitions. In addition, the materials, methods and examples are illustrative only and are not intended to be necessarily limiting. DESCRIPTION OF THE FIGURES
    [0035] [0035] Some embodiments of the present invention patent application are described here, by way of example only, with reference to the drawings which are attached. With specific reference now to the drawings in detail, it should be noted that the elements indicated are by way of example and for the purpose of illustrative discussion of the embodiments of the present invention patent application. Accordingly, the description taken with the drawings makes it evident to those skilled in the art how the embodiments of the present patent application can be practiced. In the drawings: Figure 1 is a schematic illustration of a portion of a naso / orogastric tube having one or more fluid sensors for detecting a reflux and a controllable reflux blocking device to block the GI content, according to some forms of carrying out the present invention patent application; Figures 2A-2C are exemplary electrodes of exemplary impedance sensors, in accordance with some embodiments of the present patent application; Figure 2D is a schematic illustration of a portion of a naso / orogastric tube having a plurality of balloons to block reflux, according to some embodiments of the present patent application; Figure 3 is a flow chart of a method of reflux blocking when a naso / orogastric device is temporarily disposed in the esophagus, according to some embodiments of the present patent application; Figure 4 is a flow chart of a method of reflux blocking when a naso / orogastric device is temporarily disposed in the esophagus, according to some embodiments of the present patent application; Figure 5, which is a schematic illustration of an exemplary pump assembly, according to some embodiments of the present invention patent application; Figure 6 is a schematic illustration of a portion of the naso / orogastric device described in Figure 1, where an elastic stomach body 701 is attached to the distal end of its naso / orogastric tube, in accordance with some embodiments of the present application. invention patent 101; Figure 7 is a schematic illustration of a portion of a naso / orogastric tube having an external air-conducting tube for inflating an elastic esophageal body thereof, according to some embodiments of the present patent application; Figure 8 is a schematic illustration of a naso / orogastric device, such as the naso / orogastric device described in Figure 1, where one or more position sensors are placed along the naso / orogastric tube of the device, according to some shapes carrying out the present invention patent application; Figure 9A is a cross-sectional illustration of an exemplary naso / orogastric tube, according to some embodiments of the present patent application; Figure 9B is a cross-sectional illustration of an exemplary naso / orogastric tube, with exemplary dimensions, in accordance with some embodiments of the present patent application; Figures 9C and 9D are exemplary openings to allow a fluid sensor and a positioning sensor to function, in accordance with some embodiments of the present patent application; and Figures 10A and 10B are schematic illustrations of an exemplary connector that allows the connection of a naso / orogastric tube to a supply device, a pump set and a controller, according to some embodiments of the present patent application. . DESCRIPTION OF WAYS OF CARRYING OUT THE INVENTION
    [0036] [0036] The present application for a patent, in some embodiments thereof, relates to a reflux detection system and method and, more particularly, but not exclusively, to a reflux detection system and method, when a naso / orogastric tube is placed in the esophagus and stomach.
    [0037] [0037] According to some embodiments of the present patent application, a naso / orogastric device having reflux blocking means is provided which are operated according to the detection of fluids in the esophagus and or around the esophageal sphincter (EEI), for example, using impedance sensors. The naso / orogastric device includes a naso / orogastric tube of size and shape so that it is disposed within the esophagus so that at least one distal end is placed in the lumen of a patient's stomach. Such a naso / orogastric tube can be used for tube feeding and / or esophageal endoscopy. The naso / orogastric device further includes one or more elastic esophageal bodies, such as balloons that are positioned along the naso / orogastric tube and have a pressure dependent volume and one or more esophageal and / or LES sensors that they detect, in use , fluids around segments of the naso / orogastric tube in the esophagus and or in the LES. The fluid sensors are connected to a pressure regulator that regulates the pressure inside the elastic esophageal body according to the fluid detection. For example, the pressure regulator operates a pump set according to the detection.
    [0038] [0038] Optionally, fluid sensors are impedance sensors, each of which includes one or more electrodes, such as ring electrodes, helical electrodes, and / or ribbon electrodes.
    [0039] [0039] According to some embodiments of the present patent application, a naso / orogastric device having a naso / orogastric tube and reflux blocking means, such as a balloon, is connected to a conductive tube of flexible air connected to the peripheral surface of the naso / orogastric tube. Optionally, the conductive tube is part of a flexible sheath that covers the naso / orogastric tube. The flexible sheath has a thickness of between 50 and 150 microns and is designed to hold the peripheral surface of the naso / orogastric tube, therefore, not causing additional discomfort for the patient, when passing through the nasopharynx. As the flexible air conductor tube is enlarged only when it is used to fill the reflux blocking means and how the perimeter of the naso / orogastric tube can be reduced as a result of the extraction of the flexible air conductor tube from its internal lumen, such a naso / orogastric device applies less pressure to the walls of the esophagus when disposed therein than a naso / orogastric device in which the air-conducting tube is placed in the internal lumen. When using such a flexible sheath, the side effects of using a larger gauge tube, such as discomfort, are avoided.
    [0040] [0040] According to some embodiments of the present patent application, a naso / orogastric device having reflux blocking means and an elastic stomach body is provided which is intended to be inflated in the stomach, in order to avoid sliding the reflux blocking means into the pharynx. The naso / orogastric device has a naso / orogastric tube having a lumen to deliver the contents, such as nutrients, microorganisms, water and / or drugs, into the lumen of a patient's stomach; reflux blocking means, such as one or more balloons positioned along the naso / orogastric tube; and having a larger perimeter than the perimeter of the naso / orogastric tube or an adjustable structure that has a wider state than the perimeter of the naso / orogastric tube. The naso / orogastric device further includes an elastic stomach body having a pressure dependent volume at a distal end of the naso / gastric tube. Optionally, the elastic stomach body is inflated by the content distributed so as to have a perimeter larger than the perimeter of the patient's lower esophageal sphincter. Thus, the naso / orogastric tube does not slide out of the patient's body and, therefore, does not raise the reflux blocking medium into the pharynx.
    [0041] [0041] Before explaining at least one embodiment of the present patent application in detail, it should be understood that the present patent application is not necessarily limited in its application with respect to the details of construction and of arrangement of the components and / or methods set out in the following description and / or illustrated in the drawings and / or the Examples. The present application for a patent is capable of incorporating other embodiments or of being practiced or carried out in various ways.
    [0042] [0042] Reference is now made to Figure 1, which is a schematic illustration of a portion of a naso / orogastric device 100 having a naso / orogastric tube 101 one or more fluid sensors 102 for detecting a reflux of the GI content, which can be referred to herein as reflux, and a controllable reflux blocking device 103 for blocking the GI content, according to some embodiments of the present application.
    [0043] [0043] The naso / orogastric device 100 includes a naso / orogastric tube 101 having an internal lumen (not shown) to deliver nutrients, microorganisms, water and / or drugs. The naso / orogastric tube 101 is defined herein as any commonly used naso / orogastric tube, for example, a naso / orogastric tube, a naso-esophageal catheter, a gastric tube, such as a nasogastric tube, a duodenal feeding tube and an enteral feeding tube. The naso / orogastric tube 101 is sized and shaped so that it is disposed inside the esophagus so that a distal end is placed in the lumen of a patient's stomach. Optionally, the naso / orogastric tube 101 comprises a small flexible diameter tube, preferably made of transparent plastic, such as polyvinyl chloride or silicone. The length of the naso / orogastric tube 101 is adjusted to the size of the patient. For example, a naso / orogastric device for adult patients has a naso / orogastric tube 101 over 120 cm long for an 18 Fr tube and a naso / orogastric device for children has a 101 naso / orogastric tube over 40 inches long for a 5 Fr tube.
    [0044] [0044] As mentioned above, the naso / orogastric device 100 further comprises one or more fluid sensors 102 for detecting at least the presence or absence of fluids, such as impedance sensors and / or optical sensors, over the naso / orogastric tube 101. In use, when placed in the esophagus, fluid sensors 102 detect the presence or absence of reflux of gastric contents, for example, as described below.
    [0045] The controllable reflux blocking device 103 includes one or more elastic esophageal bodies, such as balloon catheters, which are positioned along the naso / orogastric tube and have a pressure-dependent volume. To summarize, one or more elastic esophageal bodies are referred to herein as an elastic esophageal body 103. The elastic esophageal body 103 is connected to a distal end of an air-conducting tube 104 that allows to inflate the elastic esophageal body 103. The proximal end the air guide tube 104 is optionally connected to a pump set 105 that inflates the esophageal elastic body 103. Optionally, the esophageal elastic body 103, which is connected to the conductive tube, is connected to the pressure tank which releases the pressure at high speed, using controller 106, and inflates the balloon at high speed, for example, as further described below. Optionally, the esophageal elastic body 103 is connected to another air tube that allows deflation of the esophageal elastic body 103. Optionally, the pump assembly 105 is a bidirectional pump that allows the action of inflating and deflating the esophageal elastic body 103 .
    [0046] [0046] One or more fluid sensors 102 and the pump assembly 105 are connected to a controller 106. Controller 106, which may include a pressure regulator module, operates the pump assembly 105 according to the reading of the pressure sensors fluid 102.
    [0047] [0047] As described above, fluid sensors 102 can be impedance sensors 102. Optionally, each impedance sensor 102 includes one or more electrodes surrounding the naso / orogastric tube 101. Optionally, each impedance sensor 102 includes one or more annular or helical electrodes, as for example, show Figures 2A and 2B.
    [0048] [0048] Optionally, each impedance sensor 102 includes a plurality of parallel strip electrodes that are circularly and divisively placed around a common segment of the naso / orogastric tube 101, for example, as shown in Figure 2C .. Optionally, each electrode covers an area of about 1mm2 and 150mm2. Optionally, 102 impedance sensors between 2 and 20 electrodes are used.
    [0049] [0049] Optionally, the distance between each pair of parallel electrodes is between about 3 mm and about 30 mm.
    [0050] [0050] Optionally, the electrode is made of steel, stainless steel, brass, copper, platinum, silver, gold, aluminum alloys, zinc, nickel, tin, magnesium alloy, bronze, phosphor bronze, conductive polymers and / or any composition and / or any alloy thereof.
    [0051] [0051] Optionally, the electrodes are printed on the peripheral surface of the naso / orogastric tube 101. Optionally, the electrodes are coated with gold, silver, nickel, zinc, tin, copper and / or any composition thereof and / or any alloy of the same.
    [0052] [0052] Optionally, the electrodes are shaped as circular, rectangular and / or triangular spots.
    [0053] [0053] Optionally, one or more fluid sensors 102 are placed in order to detect fluids in the stomach, for example, in the vicinity of the lower esophageal sphincter. In this way, reflux can be detected even before the GI content reaches the esophagus.
    [0054] [0054] Optionally, as described above and illustrated in Figure 2D, the elastic esophageal body 103 includes several balloons. This way, the balloons can be at a lower pressure, putting less pressure on the esophagus. If the GI content passes the first balloon, they are stopped by the second balloon. The space between the balloons intercepts the reflux of the gastric contents without the application of substantial pressure on the esophageal walls.
    [0055] [0055] Reference is now made also to Figure 3, which is a flow chart of a method of reflux blocking when a naso / orogastric device is temporarily disposed in the esophagus, according to some embodiments of the present patent application. .
    [0056] [0056] First, as shown in 201, a naso / orogastric tube with an elastic esophageal body, as shown in 101, 103, is arranged in the esophagus so that at least one distal end of it is in the lumen of a patient's stomach and the elastic esophageal body is placed in a specific segment of the esophagus. Thus, the naso / orogastric tube can be used to administer nutrients, microorganisms, water and / or medications, as described above.
    [0057] [0057] Now, as shown in 202, the presence or absence of GI content in the esophagus is detected, for example, by one or more fluid sensors 102. Optionally, fluid sensors 102 are impedance sensors that detect a change impedance in at least one region along the esophagus, around at least one naso / orogastric tube 101, between the stomach and the esophageal elastic body 103. The detection of GI content in the esophagus, for example, the detection of impedance, is indicative of reflux of gastrointestinal content. Fluid sensor measurements 102 are routed to controller 106.
    [0058] [0058] As shown in 203, controller 106 regulates the pressure inside the esophageal elastic body 103 according to the gastric content detected in the esophagus, for example, according to the detection of an impedance change.
    [0059] [0059] Optionally, the pressure regulator module performs such regulation to allow the esophageal elastic body 103 to be inflated in response to the detection of gastric content in the esophagus and / or around the LES. Optionally, the esophageal elastic body 103 is maintained at low pressure when gastric content is not detected in the esophagus. In such a way, no redundant pressure is applied on the esophageal walls while the naso / orogastric device 100 is used for feeding and / or diagnosing the patient. By avoiding the redundant pressure device in the esophageal walls, esophageal ulcers and other disorders can be avoided.
    [0060] [0060] According to some embodiments of the present patent application, one or more fluid sensors 102 detect the direction of fluids in the esophagus. For example, controller 106 can regulate pressure using its pressure regulator on the esophageal elastic body 103 according to the length of time of a first detection event, such as the detection of a change in impedance by a first fluid sensor 102 with respect to a second detection event, such as a detection of a second impedance change by a second fluid sensor 102. If the first fluid sensor is closer to the stomach than the second fluid sensor and, optionally, the time between the first and the second detection event is within a predefined interval, the readings from the fluid sensors 102 are indicative of the direction of fluids in the esophagus.
    [0061] [0061] According to some embodiments of the present patent application, controller 106 analyzes the fluid content according to the measurements of the fluid sensors 102. For example, a different impedance may be indicative of different compositions of the fluid around fluid sensors 102. For example, while an impedance value and / or the range of impedance values is indicative of saliva, another impedance value and / or the range of impedance values is indicative of gastric content. For example, while gastric contents have a high conductivity and respectively low impedance, air has a low conductivity and respectively high impedance.
    [0062] [0062] Reference is now made also to Figure 4, which is a flow chart of a method of reflux blocking when a naso / orogastric device is temporarily disposed in the esophagus, according to some embodiments of the present patent application. . Blocks 201-203 are as shown in Figure 3. However, a number of additional operations are shown in Figure 4.
    [0063] [0063] Optionally, as shown in 301, after the naso / orogastric tube 101 is disposed in the esophagus, the elastic esophageal body 103 is partially inflated, for example, by about three quarters of a predetermined value. Optionally, pump set 105 is used to fill the elastic esophageal body 103. Optionally, inflation is carried out until a lower pressure, for example, between about 10 mmHg (Torr) and about 40 mmHg is detected by a sensor pressure, for the example of pressure sensor 402 in Figure 5.
    [0064] [0064] Optionally, the minimum diameter of the esophageal elastic body 103 is like the maximum value of the inner diameter of the lower esophageal sphincter in order to prevent sliding into the stomach or up the pharynx and or to prevent gastric reflux from exceeding the esophageal elastic body.
    [0065] [0065] Optionally, as shown in 302, after the naso / orogastric tube 101 is disposed in the esophagus, the pump set 105 is prepared for rapid inflation, optionally with a pressure reservoir, of the esophageal elastic body 103.
    [0066] [0066] Reference is now made also to Figure 5, which is a schematic illustration of an exemplary pump set 105, which is connected, through an air conducting tube 410, to the esophageal elastic body 103, according to some forms of carrying out the present invention patent application. Optionally, pump assembly 105 includes an air container 401, which can be referred to here as an air pressure tank 401, a pressure sensor 402 for estimating the pressure applied to the esophageal elastic body 103 through the esophagus, a valve 403, such as a three-way valve, for diverting air from the air pressure tank 401, either to the elastic esophageal body 103 or out of the naso / orogastric device 100, also used to deflate the balloon, a pressure valve inflation release 404 to control the maintenance of pressure inside 401 and to control balloon inflation. Optionally, controller 106 controls valves 403, 404 and pump 405 and receives information from sensors 402, 406.
    [0067] [0067] In use, for example, in 302, the pump set 105 increases the pressure in the air container 401, optionally, to reach a preset pressure according to the reading of the pressure sensor 406. The pressure built allows inflation of the esophageal elastic body 103. Optionally, the 403 valve allows to reduce the pressure in the esophageal elastic body 103, in order to avoid the creation of esophageal ulcer.
    [0068] [0068] When a reflux is identified, for example, according to the identification of a reflux as shown in 202-203, the elastic esophageal body 103 is inflated, for example, air from the 401 air container. Since the pressure in the air container 401 is high, for example, by 300 mmHg or more, the elastic esophageal body 103 can be inflated in less than one second.
    [0069] [0069] As shown in 303, this process described in blocks 301-302 and 202-203 can be repeated, as long as the naso / orogastric tube 101 is in the esophagus, for example, during one or more tube feeding sessions.
    [0070] [0070] Now, as shown in 304, the elastic esophageal body 103 is deflated before the naso / orogastric device 100 is extracted from the patient's esophagus. Optionally, air is released by opening valve 403, or using pump assembly 105 as a suction pump for deflating the balloon.
    [0071] [0071] Reference is now made to Figure 6, which is a schematic illustration of the naso / orogastric device 100 shown in Figure 1, where an elastic stomach body 701 is attached to the distal end of its naso / orogastric tube 101, according to some embodiments of the present invention application. In use, the distal end of the body of the elastic stomach 701 is placed in the patient's stomach. The elastic stomach body 701 is connected, by means of a filling tube, and optionally a deflation tube, to the pump assembly 105 and / or the other pump. In use, the elastic stomach body 701 is inflated into the stomach. In this way, the elastic stomach body 701 prevents the naso / orogastric tube 101 from sliding into the pharynx. This prevents the elastic esophageal body 103 from sliding towards the lower pharynx, where it can block the trachea and suffocate the patient.
    [0072] [0072] As described above, the naso / orogastric tube 101 can be a naso / orogastric feed tube 101. In such a configuration, the elastic stomach body 701 can be placed on top of one or more of the naso tube feed openings / orogastric 101. In use, the feeding openings are placed in the stomach to allow the patient to be fed. In use, the elastic stomach body 701 is filled with the feed content, such as the feed fluids. The food contents are accumulated in the elastic stomach body 701, increasing its volume so that its diameter is larger than the diameter of the lower esophageal sphincter. Optionally, the elastic stomach body 701 has one or more openings through which the feed content is released. The openings are optionally widened by increasing the volume of the elastic stomach body 701. In such a way, the elastic stomach body 701 is filled before the feed content is released.
    [0073] [0073] Optionally, the elastic stomach body 701, when filled, is used as an anchor for the naso / orogastric feeding tube 101. The weight of the filled elastic stomach body 701 limits the movement of the naso / orogastric feeding tube 101 and prevents it from bending and / or being wrapped in the stomach, and if there are sensors in the stomach, they are submerged within the stomach contents. In this way, the fluid sensors 102 and the elastic esophageal body 103 do not sink into the stomach or esophagus and remain in the esophagus, in order to allow proper functioning, as described above.
    [0074] [0074] According to some embodiments of the present patent application, the elastic esophageal body 103 is inflated by a flexible air conducting tube that is located outside the lumen of the naso / orogastric tube 101, as for example, attached peripheral surface. In such a configuration, the perimeter of the naso / orogastric tube 101 can be reduced since it does not have to contain a conductive lumen to conduct air to inflate the esophageal elastic body 103. It should be noted that as the esophageal elastic body 103 must be inflated relatively quickly in order to block reflux, the perimeter of the conductive lumen must be relatively large, for example, having a diameter of more than 1 millimeter and, therefore, the extraction of it from the naso / orogastric tube 101 has a substantial effect on the perimeter of the naso / orogastric tube 101. For example, reference is now made to Figure 7, which is a schematic illustration of a naso / orogastric tube 101 and an enlargement of its segment that describes an external air conducting tube 501 for filling the esophageal elastic body 103, according to some embodiments of the present patent application. As the external air-conducting tube 501 is used only when the esophageal elastic body 103 is inflated, that is, a short period of no more than a few seconds, it is mostly in an inflated state, not adding practically nothing at the perimeter of the naso / orogastric tube 101. Optionally, the external air-conducting tube 501 is made of a thin layer of polymer, optionally about 80 microns or less. Optionally, the external air-conducting tube 501 forms part of a sheath 502 which is placed over the naso / orogastric tube 101. It should be noted that the naso / orogastric tube 101 may contain an air extraction lumen to remove air from of the esophageal elastic body 103. However, in this way, a lumen can be relatively thin, for example, with a diameter of less than 1 millimeter, the perimeter of the naso / orogastric tube 101 being relatively limited.
    [0075] [0075] Reference is now made to Figure 8, which is a schematic illustration of a naso / orogastric device 800, such as the naso / orogastric device 100 shown in Figure 1, with a plurality of wires from an exemplary positioning sensor 801 it is placed along the naso / orogastric tube, according to some embodiments of the present patent application. In this naso / orogastric device 800, the positioning sensor 801 and the fluid sensor include wires, which are threaded into the naso / orogastric tube 101, for example, in channels that are formed therein. For example, Figure 9A is a cross-sectional illustration of an exemplary naso / orogastric tube having channels 901 for positioning the wires of the positioning sensor 801 and channels 902 for the wires of the fluid sensor 102, which are optionally as the positioning sensor wires 801, threaded along the naso / orogastric tube 101. Figure 9B is a schematic sectional illustration showing the optional and exemplary dimensions of such an exemplary naso / orogastric tube. In order to allow sensors 801, 102 to detect changes in the surrounding intrabody, such as in the esophageal lumen, openings 904, 905, such as cuts, optionally longitudinal, are formed in one or more positions along the channels, optionally at different heights. In use, for fluid sensor wires 102, openings 905 allow direct contact with gastrointestinal fluid in the esophageal lumen. The direct contact allows to detect the change in impedance between different segments of the naso / orogastric tube 101. Optionally, the wires of the fluid sensor 102 are immersed in the naso / orogastric tube 101 so that a direct contact is formed when the gastrointestinal fluids pass through of openings 905. For example, Figure 9C shows an exemplary immersed fluid sensor 102. In this example, a segment of a wire from the fluid sensor 102 remains in the channel, below the opening. In this way, the wires of the fluid sensor 102 are not affected and / or blocked by the inner walls of the esophagus, as for example, with the esophageal sphincter.
    [0076] [0076] In use, for the wires of the positioning sensor 801, the openings 904 allow direct contact with the inner walls of the esophagus, for example, with the esophageal sphincter. Direct contact allows the detection of the impedance level, the change of impedance, and / or the movement around one or more segments of the naso / orogastric tube 101. Optionally, the position sensor 801 detects and monitors the position as described in International Patent Application No. WO2008 / 107872, published on September 12, 2008, which is incorporated herein by reference. Optionally, the wires of the positioning sensor 801 are extracted through the openings 904 so that they project above the surface of the naso / orogastric tube 101. In this example, a segment of a wire of the positioning sensor 801 is extracted, through the opening 904, from your channel. In another example, illustrated in Figure 9D, the wire is threaded through holes in the naso / orogastric tube 101. Thus, the wire segments of the positioning sensor 801 are above the naso / orogastric tube 101 and other segments are below the tube naso / orogastric 101. In this way, direct contact can be established with the internal walls of the esophagus, such as, for example, with the esophageal sphincter.
    [0077] [0077] Optionally, the positioning sensor wires 801 are used to position the naso / orogastric tube 101 in the esophagus, as for example, as described in International Patent Application No. WO2008 / 107872, published on September 12, 2008, which is incorporated by reference.
    [0078] [0078] According to some embodiments of the present patent application, the wires of the positioning sensor 801 are connected and controlled by controller 106. Optionally, controller 106 monitors changes in the positioning of the naso / orogastric tube 101 of according to the impedance reading in the wire of the positioning sensors 801. As each wire can be exposed through an opening that is formed on another height of the naso / orogastric tube 101, a change in the impedance in each wire, indicates that it is established a contact with the wall of the lumens, for example, in the esophageal sphincter. This makes it possible to estimate the location of the naso / orogastric tube 101.
    [0079] [0079] In such configurations, the pressure inside the esophageal elastic body 103 is adjusted according to the changes in the position of the naso / orogastric tube 101. Optionally, the position of the naso / orogastric tubes 101 is monitored to detect a loss and / or an unwanted displacement. In this way, the controller 106 can instruct the pump assembly 105 to reduce the pressure inside the elastic esophageal body 103, when a loss and / or an unwanted displacement is detected. This can be used as a safety mechanism that ensures that if the patient tries to extract the naso / orogastric device 100, when the esophageal elastic body 103 is fully and / or semi-inflated, the pressure in the esophageal elastic body 103 is reduced, optionally urgently, for example, in less than a second.
    [0080] [0080] As described above, the naso / orogastric tubes 101 are defined to conduct the contents to the lumen of a patient's stomach and air to the elastic esophageal body 103. In such a configuration, the naso / orogastric tube 101 includes both an orifice of the first channel 913 for conducting the content, such as feeding, as well as a hole in the second channel 914 for conducting air to the esophageal elastic body 103.
    [0081] [0081] Reference is now made also to Figures 10A and 10B, which schematically illustrate an exemplary connector 920 that allows the connection of the naso / orogastric tube 101 to a supply device and to a pump set and a controller, such as in 105 and 106, according to some embodiments of the present application. The connectors 920 have a hole in the first channel 923 for connecting a supply device to guide the content through the first channel 913 and a hole in the second channel 924 for the connection of the pump set 105 for the conduction of air through the second channel 914 and, optionally, for connecting controller 106 to sensors on channels 901 and 902.
    [0082] [0082] Optionally, the hole in the second channel 924 is connected to channels 901, 902 that accommodate sensors 102, 801. In this way, the naso / orogastric device 100 can be connected through the hole in the first channel 923 to a feeding machine existing and through the hole in the second channel 924 to a dedicated device having controller 106 and pump assembly 105.
    [0083] [0083] Optionally, in order to maintain the sterilization of the pump set 105, the cable that is connected to the orifice in the second channel 924 includes a filter that filters the air conducted through the air channel 914. In such a configuration, if the body esophageal elastic band 103 and / or the air channel leading to it are torn or punctured, gastrointestinal fluids, germs, or other impurities are blocked and prevent contamination of the pump set 105 and / or a tube connecting the set pump 105 with the filter. It should be noted that such a cable allows the use of pump set 105 for a number of patients without the need for redundant sterilization processes. Optionally, in order to maintain the sterilization of the feeding unit, the filter controls the feeding direction through the feeding channel 913. In such a configuration, if the feeding channel 913 is torn or perforated, the gastrointestinal fluids, germs, or other impurities are prevented from contaminating the supply unit or a pipe connecting the supply unit to the filter.
    [0084] [0084] Optionally, caps 930, 931 are detachable to the exemplary connector 920. In Figures 10A and 10B, caps 931, 930 are not connected to connector 920, but supported by a retaining element 932, such as a ribbon flexible. By positioning them in front of the holes in the exemplary 920 connector, sterilization is maintained.
    [0085] [0085] It is expected that, during the life of a patent maturing from this application, many relevant devices and methods will be developed and the scope of the term biocompatible biological material is intended to include all such new technologies a priori.
    [0086] [0086] As the term "about" is used here it refers to ± 10%.
    [0087] [0087] The terms "comprises", "with", "includes", "including", "have" and their conjugates means "including, but not limited to". This term encompasses the terms "consisting of" and "consisting essentially of".
    [0088] [0088] The phrase "which essentially consists of" means that the composition or method may include additional ingredients and / or steps, but only if the additional ingredients and / or steps do not materially alter the basic and innovative characteristics of the claimed composition or method.
    [0089] [0089] As used herein, the singular form "one", "one", "o" and "a" includes references in the plural, unless the context clearly demonstrates otherwise. For example, the term "a compound" or "at least one compound" can include a plurality of compounds, including mixtures thereof.
    [0090] [0090] The word "exemplary" is used here to mean "serve as an example of instance, or illustration". Any embodiment described as "exemplary" should not necessarily be interpreted as preferential or advantageous over other embodiments and / or to exclude the incorporation of features from other embodiments.
    [0091] [0091] The word "optionally" is used here to mean "it is provided in some embodiments and not provided in other embodiments". Any particular embodiment of the present application may include a plurality of "optional" features, unless such features conflict.
    [0092] [0092] Throughout this application, various embodiments of the present invention patent application can be presented in an interval format. It should be understood that the description in interval format is purely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the present application for a patent. Thus, the description of an interval should be considered as having specifically revealed all possible subintervals, as well as individual numerical values within that interval. For example, the description of an interval, such as 1 to 6, should be considered to have specifically revealed subintervals such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., as well as the individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the size of the range.
    [0093] [0093] Whenever a numerical range is indicated in this document, it means that the range is intended to include any quoted numerals (fractional or integral) within the indicated range. The phrases "varying / varies between" a first indication number and a second indication number and "varying / varies from" a first indication number "to" a second indication number are used here interchangeably and are intended to include the first and according to indicated numbers and all fractional and integrals between the same number ranges.
    [0094] [0094] As used herein the term "method" refers to customs, means, techniques and procedures for performing a given task, including, but not limited to, those customs, means, techniques and procedures or known or easily developed to from known ways, means, techniques and procedures by professionals in the arts from the chemical, pharmacological, biological, biochemical and medical industries.
    [0095] [0095] As used herein, the term "treatment" includes revoking, substantially inhibiting, delaying or reversing the progression of a condition, substantially improving the clinical or aesthetic symptoms of a condition or substantially preventing the appearance of the clinical or aesthetic symptoms of a condition .
    [0096] [0096] It is preferable that certain features of the invention, which are, for reasons of clarity, described in the context of the specific embodiments, can also be provided in combination, in a single embodiment. Conversely, various features of the present invention application, which are, for the sake of brevity, described in the context of a simple embodiment, can also be provided separately or in any suitable subcombination or as suitable in any other configuration of the invention. described. Certain characteristics described in the context of various embodiments should not be considered essential characteristics of those embodiments, unless the embodiment is inoperative without such elements.
    [0097] [0097] Although the present application for a patent has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Therefore, it is intended to cover all of these alternatives, modifications and variations that fall within the spirit and broad scope of the attached claims.
    [0098] [0098] All publications, patents and patent applications mentioned in this specification are hereby incorporated in their entirety by reference in the specification, to the same extent as if each individual publication, patent or patent application has been specifically and individually indicated to be here incorporated by reference. In addition, citation or identification of any reference in the present application should not be interpreted as an admission that such reference is available as a prior art with the present application for an invention patent. To the extent that section headings are used, they should not necessarily be construed as limiting. Figures Legend Figure 1 105) Pump Assembly 106) Controller Figure 3 T1) 201 Distribute the tube having an elastic body T2) 202 Detect the presence of the fluid T3) 203 Adjust the pressure in the elastic body Figure 4 T1) 201 Distribute the tube having an elastic body T2) 202 Detect the presence of fluids T3) 203 Adjust the pressure in the elastic body T4) 301 Partially inflate the elastic body T5) 302 Immediate inflation preparations T6) 304 Empty the elastic body before removing it Figures 6 and 8 105 Pump Set 106 Controller
    权利要求:
    Claims (14)
    [0001]
    "NASO / OROGASTRIC DEVICE", with means of reflux blocking, characterized by comprising: a naso / orogastric tube (101), having a feeding channel for conducting the feeding content (913) and at least one opening (905 ) along at least a segment of a lateral surface of said naso / orogastric tube (101), said naso / orogastric tube (101) with size and shape to be disposed inside the esophagus so that at least , said segment is located inside the esophagus and at least one respective distal end is placed in the lumen of a patient's stomach; at least one esophageal elastic body (103) positioned along said naso / orogastric tube (101), having a pressure-dependent volume; at least one esophageal sensor (102) comprising at least one impedance sensor located in at least one said opening (905) and adapted to detect the change in impedance in at least a segment of said nasal tube / orogastric (101) when it has a direct contact with the gastrointestinal fluid (GI) that passes through the opening; and a controller adapted to regulate (106) a pressure within at least one said elastic esophageal body (103), according to said detection.
    [0002]
    "NASO / OROGASTRIC DEVICE" according to claim 1, characterized in that said naso / orogastric tube (101) has distal and proximal ends, at least one said esophageal sensor comprising a first esophageal sensor in proximity to said distal end and a second esophageal sensor between said distal end and said proximal end.
    [0003]
    "NASO / OROGASTRIC DEVICE", according to claim 2, characterized by said controller regulating said pressure according to at least one of a difference between a first reading of said first esophageal sensor and a second reading of said second sensor esophageal and the duration of a first detection event of said first reading in relation to a second detection event of said second reading.
    [0004]
    "NASO / OROGASTRIC DEVICE", according to claim 3, characterized in that said first and second readings are readings of impedance change.
    [0005]
    "NASO / OROGASTRIC DEVICE" according to any one of the preceding claims, characterized in that said impedance sensor (102) comprises a plurality of electrodes arranged in a circular shape around said naso / orogastric tube (101).
    [0006]
    "NASO / OROGASTRIC DEVICE", according to any one of the preceding claims, further comprising a pump assembly (105) controlled by said controller, in order to regulate said pressure by inflating at least one said esophageal elastic body (103), characterized in that the pump assembly (105) comprises an air pressure tank (401), said pump assembly increasing the air pressure in said air pressure tank (401), in order to accelerate said inflation.
    [0007]
    "NASO / OROGASTRIC DEVICE" according to claim 6, characterized in that at least one said esophageal elastic body (103) comprises a plurality of balloons, arranged one after the other, along said said naso / orogastric tube (101 ).
    [0008]
    "NASO / OROGASTRIC DEVICE" according to claim 6, characterized in that it also comprises at least one positioning sensor (801) mounted along said naso / orogastric tube (101) to measure an impedance around the tube naso / orogastric (101) and an adapter controller (106) to detect a location of at least a portion of said naso / orogastric tube (101) in the esophagus.
    [0009]
    "NASO / OROGASTRIC DEVICE" according to claim 8, characterized in that at least one said positioning sensor (801) comprises a threaded wire in said sensor channel along said naso / orogastric tube (101) and extracted through at least one opening of the sensor along said side surface of said naso / orogastric tube (101).
    [0010]
    "NASO / OROGASTRIC DEVICE" according to any one of claims 8-9, characterized in that said controller is adapted to regulate said pressure according to said location.
    [0011]
    "NASO / OROGASTRIC DEVICE" according to any one of claims 8-9, characterized in that said controller (106) detects movement according to a change in said location, said controller reducing said pressure in response to said change.
    [0012]
    "NASO / OROGASTRIC DEVICE" according to any one of the preceding claims, characterized in that it further comprises a connection (914) to a cable, having a filter to adjust the air flow from said pump set.
    [0013]
    "NASO / OROGASTRIC DEVICE" according to any one of the preceding claims, characterized in that at least one said esophageal sensor comprises a plurality of wires (102), threaded in a plurality of channels, along said naso / orogastric tube (101), each said channel having at least one opening along it to allow detection of said change in impedance of at least one said segment.
    [0014]
    "NASO / OROGASTRIC DEVICE", according to any one of the preceding claims, characterized by said controller increasing said pressure, in order to block said esophagus when said impedance indicates the presence of gastric content in at least one segment of the said naso / orogastric tube (101) and / or wherein said controller decreases said pressure when said impedance indicates an absence of gastric content in at least one segment of said naso / orogastric tube (101).
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    同族专利:
    公开号 | 公开日
    JP2013517887A|2013-05-20|
    US20200155420A1|2020-05-21|
    CN102958493A|2013-03-06|
    US9226878B2|2016-01-05|
    US20190133891A1|2019-05-09|
    AU2011210363A1|2012-09-13|
    JP5829624B2|2015-12-09|
    ES2584323T3|2016-09-27|
    CA2788082A1|2011-08-04|
    US20160113843A1|2016-04-28|
    AU2011210363B2|2016-03-10|
    DK2528575T3|2016-08-15|
    EP2528575A1|2012-12-05|
    WO2011092701A1|2011-08-04|
    US11154462B2|2021-10-26|
    CA2788082C|2018-02-20|
    US10548816B2|2020-02-04|
    CN102958493B|2016-06-15|
    EP2528575B1|2016-04-27|
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    法律状态:
    2017-09-19| B15I| Others concerning applications: loss of priority|
    2017-10-24| B12F| Other appeals [chapter 12.6 patent gazette]|
    2019-08-06| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2019-08-20| B06I| Publication of requirement cancelled [chapter 6.9 patent gazette]|Free format text: ANULADA A PUBLICACAO CODIGO 6.21 NA RPI NO 2535 DE 06/08/2019 POR TER SIDO INDEVIDA. |
    2020-04-07| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-08-11| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2020-12-01| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 27/01/2011, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US29894510P| true| 2010-01-28|2010-01-28|
    US61/298,945|2010-01-28|
    PCT/IL2011/000099|WO2011092701A1|2010-01-28|2011-01-27|Method and device of detecting and/or blocking reflux|
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