![]() Device for monitoring, warning and removal of stool in patients with elimination ostomy (Machine-tra
专利摘要:
Device for the supervision, warning and removal of stool in patients with elimination ostomy, which is composed of a cylindrical body (1), which is attached to the abdomen of the patient and its active end of the intestine. This cylindrical body (1) is provided with a vent filter (2) for intestinal gases and an elastic bag (9) both replaceable. A retention plug (3) maintains the stool in the patient's intestine, and by means of a pressure sensor coupled to the retention plug (3), the accumulation of stool is monitored, which, when reaching the stipulated values, activates an alarm signal in the patient to evacuate the waste, removing the retention cap (3) and leaving the content momentarily in the elastic bag. Once unloaded, the elastic bag (9) with the waste is removed and a new one is replaced, the same being necessary or not with the gas vent filter (2), which will depend on its wear. (Machine-translation by Google Translate, not legally binding) 公开号:ES2804033A1 申请号:ES201900127 申请日:2019-08-01 公开日:2021-02-02 发明作者:Martinez Raúl Martinez 申请人:Martinez Martinez Raul; IPC主号:
专利说明:
[0002] Device for monitoring, warning and removal of stool in patients with elimination ostomy [0003] Technical sector [0005] The present invention describes a permanent or temporary device that monitors the accumulation of feces in the intestine of an ostomy patient by means of a pressure sensor and warns when its evacuation is necessary. Its main peculiarity compared to other patented devices is that it is surgically installed using stitches or another alternative method to the abdominal wall and the patient's stoma, so that it does not require bags outside the body. The improvements over other devices is to reduce the different conditions derived from current methods and to hide the aesthetic appearance of the stoma in the patient's abdomen, which currently generates great psychological problems. [0007] The device of the invention is composed of a cylindrical body, adhered to a fixation mesh to the patient's abdomen, an extensible cylindrical elastic bag (condom) and a vent filter for evacuating gases with active filters to avoid odors, both interchangeable and disposable. , retention cap with safety by overpressure, with sensor for stool detection and warning for bowel emptying by vibration, sound signal or wirelessly to mobile device. [0009] Background of the invention [0011] Today digestive stomata are practiced on patients with different pathologies such as colorectal tumors, inflammatory bowel diseases such as ulcerative colitis or Crohn's disease, hereditary diseases such as familial adenomatous pollinosis and traumatic accidents that can affect the rectal and urogenital areas due to name some of the most common. [0013] In general, they are defined as the exteriorization of the colon (colostomy), the ileum (ileostomy) and ureters (urostomy) through the abdominal wall, suturing it to the patient's skin, thus creating an artificial outlet (stoma), with the object of collecting waste produced by the human body in a device. They are usually designs based on a bag or device adhered by adhesive to the abdomen, which will vary in shape depending on the type of ostomy. [0015] All these methods usually lead to one of these types of conditions: [0017] • Skin irritation: It frequently appears on the periostomal skin, observing signs of redness and skin abrasions. It is caused by humidity, chemical and physical irritations, inadequate hygiene and allergic reactions. [0019] • Stenosis: It is produced by narrowing in the stoma orifice, due to strangeness or irritations at the stoma outlet. [0021] • Hernia: Failure of the abdominal wall, protruding both the ostomy and the skin around it, so it is convenient to use girdles to control abdominal pressure and avoid physical efforts and weight gain. [0022] • Retraction: Stoma sinking into the abdominal cavity. [0024] • Prolapse: It is the protrusion of the intestinal loop on the cutaneous plane of the abdomen through the orifice of the stoma. [0026] • Granulomas: Appearance or growth of small fleshy masses in the mucosa of the stoma. [0028] • Poor location of the stoma: Causes difficulty in adapting stool collection devices. [0030] As a consequence of this problem, the ostomy patient has a slow recovery accompanied by a high level of anxiety. [0032] In relation to the possible improvements to the system used for ostomy patients, different devices have been designed that focus on the systems for fixing the bags to the patient's abdomen, some of which reference to patent documents may be WO2011 / 015201 A1, ES 2015678 A6 , WO 2015/048446 A1, US 2014/0364823 A1, WO2015 / 1864452 A1, or ES 2241592, all related to external bags and only document ES2598557B2, refers to a self-expanding device for placing a bag inside the body, that collects waste in a patient who has undergone an intervention with a removal stoma such as a colostomy or ileostomy operation (digestive removal stoma). [0034] This concept differs from the device described in this invention, as it is fixed by suture to the abdomen and intestine of the patient in the same surgical intervention of the colostomy or later. The dilation capacity of the intestine is used, which, through a sensor and its electronic circuit powered by a rechargeable battery, monitors and detects the excessive accumulation of stool, which will cause an alarm for the patient to open the device and fill the elastic bag or condom attached. [0036] Explanation of the invention [0038] The invention whose purpose is to evacuate the feces of a patient from the large or small intestine, through this device, which will be located at a suitable point on the patient's abdomen, is described below. The design of the device aims to be as concealed as possible, in contrast to the rest of the body to avoid rejection of the patient's physical appearance, and by means of a bag inside the device, the feces will be collected in a simple way and with the greatest asepsis possible. . Once the bag is removed, it is discarded along with the stool and a new one will be placed in the part of the device enabled for it. [0040] It is made up of a cylindrical body that is designed at one end for hermetic contact with the large intestine (visceral side), and the other end to discharge the feces has certain characteristics to incorporate the elastic bag (condom), the filter venting and anti-odor, and the retention plug. [0042] The end of the cylindrical body on the visceral side is designed so that the large intestine can be attached by means of stitches or an alternative method to this device and its part called the fixation disc, so that there is no danger of feces leaking to the outside (towards the visceral peritoneum), being able to withstand the peristaltic movements of the intestine and the muscular tensions originating in the patient's abdomen. [0043] On the other hand, the end, in contact with the environment and flush with the patient's skin, is designed so that the cylindrical body is fixed: [0044] • Retention cap with overpressure safety that contains pressure sensor, supervision and alarm or wireless communication, and battery. [0045] • Anti-odor vent filter. [0046] • Elastic bag or condom. [0047] Around the cylindrical body and attached to it, it has a mesh fixation disc with the same characteristics as those used for inguinal hernias, designed to withstand abdominal stress and which present the least possible rejection in this type of surgical intervention. This disc is attached by sutures or alternative method to the abdominal tissue and to the edges of the skin tissue to keep the device of the invention fixed. The edges of the skin tissue around the cylindrical body are folded inwards, forming together with the device a hole for the exit of the patient's feces. The retention cap is designed with a housing for an O-ring that closes against the elastic bag (condom) and this in turn against the internal part of the cylindrical body. This O-ring has two functions: [0048] • Withstand normal intestinal pressures to keep the plug closed. [0049] • Opening due to overpressure of the intestine due to an excessive accumulation of feces inside and that have not been evacuated for any reason. When the retention cap is opened, the stool remains lodged in the elastic bag type condom. The patient has to remove the elastic bag by pulling it from its holding part to the cylindrical body of the device, next to the slot where the end of the bag is housed. [0050] The retention cap has the necessary electronic elements, so that the patient is notified by means of a sound, vibration or alarm via wireless connected to a mobile device. Therefore, it contains a pressure sensor necessary to capture intestinal pressure at all times, which, through an electronic circuit powered by a rechargeable battery, is capable of monitoring intestinal pressure, differentiating whether it is peristaltic movements or an excessive filling of the intestine. by faeces, which will mean a warning by means of the indicated alarm and integrated into the electronic circuit. [0051] In the cylindrical body of the device, it has also been designed to incorporate an anti-odor vent filter, a system for the evacuation of intestinal gases with active carbon fabric filters to prevent odors and breathable fabric to prevent the escape of liquids to the outside. This mechanism is disposable and can be changed each time the elastic condom bag is removed. [0052] The elastic bag can be similar to the male condom used, made of latex to the extent that the patient is not allergic or other materials such as polyurethane if so. To facilitate the removal of the elastic bag at its closed end, a small properly adhered thread is added so that the patient can stretch the bag once the retention cap has been removed. [0053] The retention cap has a concentric smaller cap to be able to exchange the sensor's rechargeable battery. [0054] The materials with which the invention can be built must be biocompatible with the human body, which should meet the following requirements: [0055] • Impervious to body fluids. [0056] • Biologically compatible. [0057] • Inert, so as not to provoke an inflammatory or foreign body reaction. [0058] • Be chemically stable. [0059] • Have adequate resistance. [0060] • Not carcinogenic. [0061] • Sterilizable. [0062] • Do not cause allergy or hypersensitivity. [0063] • Implanted is rapidly infiltrated by connective tissue. [0064] Description of the drawings [0065] Fig. 1 presents the exploded view of the device designed in the invention and whose parts are numbered as follows; cylindrical body (1), vent filter (2) with breathable activated carbon membranes, elastic bag (9) of feces, mushroom (7) for concentration of sensor pressures, support of pressure sensor (6) with electronic circuits , cylinder (8) for power and rechargeable battery connections, stool elastic bag retention cap (3), closing O-ring (5), battery cap (4) for battery removal. [0066] Fig. 2A shows the cylindrical body (1) in 3D view from the end in contact with the intestine and the following parts are distinguished: [0067] o Fixation disc (12) in a transverse plane to the cylindrical body adhered thereto and manufactured with mesh for inguinal hernia, and which is attached by means of sutures to the abdomen and to the end of the active intestine of the patient, serving to hold the assembly. [0068] o Visceral end of the cylindrical body in contact with the intestine, visceral side, which has inlet and outlet fixation holes (11) on the outside of the cylindrical body (1) and which is fixed by suture thread to the internal part of the intestine at its active end from which the feces exit, in addition to two sealing grooves (17) to prevent internal displacement of the feces in this space. [0069] o Insertion slot (14) of vent filter (2) on the visceral side and that performs the closure against the cylindrical body (1). [0070] o Retention groove (13) of the elastic bag (9), on the side of the end of the cylindrical body (1) that protrudes from the skin plane. [0072] In Fig. 2B the cylindrical body (1) is shown seen from the end that protrudes from the cutaneous plane of the patient to fix the rest of the parts of the device of the invention. This side has a retention groove (13) for the elastic bag (9), an insertion groove (14) of the vent filter, whose vented gases are expelled through the outlet window (18), an interior groove (15 ) and an internal stop (16) on the cylinder body. (1) for adjusting and closing the O-ring (5) and the retaining plug (3). [0074] Fig. 2C shows in longitudinal section through the center of symmetry, the cylindrical body (1) at whose visceral end it has fixing holes (11) and sealing grooves (17), which is inserted into the stoma connected with points of suture in its internal part and in the fixation disc (12), which is also attached to the subcutaneous tissue. Protruding from the cutaneous plane, the parts described in Fig. 2B can be seen. [0076] Fig. 3 shows the vent filter (2) that is housed in an insertion slot (14) in the inner part of the cylindrical body (1) and whose function is to vent intestinal gases with an active carbon filter. to avoid odors and breathable fabric to avoid intestinal fluid flows. It can have several uses and can be exchanged for a new one when the patient sees that it is obstructed or odors are increasing. For the design of this part of the device, it has been taken into account that it is easily removable once inserted into the cylindrical body (1) of the device of the invention, by means of the lateral guides with adjustment flanges (21) at one of the ends and at the other end with sealing lips (24). The gases are vented through the internal hole of the filter (22) and the lower openings (23) that communicate the interior of the intestine with the exterior of the patient's body. [0078] Fig. 4A shows the cross section of the vent filter (2) along the AA plane indicated in Fig. 4B, in which the disposition of the breathable membrane (27) and the activated carbon filter (26) can be seen . The lower openings (23) are also observed for the entry of gases from the intestine to the filter and the protection against the entry of remains greater than 3 mm in diameter (25). [0080] Fig. 5A shows the exploded view of the retaining cap (3) and pressure sensor assembly with their respective parts. In the retention cap (3) it has a finger (31) for opening it and in the O-ring groove (33) the O-ring (5) is housed, which closes against the elastic bag (9) and in turn with the cylindrical body (1). The inside of the retention plug (3) is hollow to contain the pressure sensor and on the chamfer (32) a small battery plug (4) closes, with adjustment edges (42) and a finger (41) whose function is to be able to extract the rechargeable battery from the sensor. This battery cap (4) can also be used to be replaced by other types of silicone caps that can hide the visible part of the device of the invention with the patient's skin. On the other hand, in the left part of this figure you can see the pressure sensor that comprises several parts, the mushroom (7) that is in contact with the elastic bag (9) and receives the pressure from the interior of the intestine and that has Some clamping edges (72) to be fixed to the sensor support (6) that contains the electronic circuits necessary for the measurement, supervision and treatment of the pressure signal received with the power connections to the rechargeable battery found in the cylinder (8), which has a position base (81) for insertion in the sensor support (6). The base of the sensor support (6) has radial grooves (61) to give flexibility to this cantilever, and the cylindrical part has adjustment lugs (62). [0081] In Fig. 5B and Fig. 5C two different views of the retaining cap (3) and pressure sensor assembly are shown once assembled and its parts coupled. As can be seen in the figures indicated, the pressure sensor is made up of the mushroom (7) that is mounted on the sensor support (6) inside which are the electronic circuits and the cylinder (8) that carries the rechargeable battery. Both are housed within the hollow cylindrical part of the retention plug (3). In Fig. 5C, the design of the pressure concentrator (71) of the mushroom (7) is seen. [0083] In Fig. 5D, it is shown how the elastic bag (9) is wrapping the entire assembly of the retention cap (3) and pressure sensor. The open end (90) presents a winding of the elastic bag (9) as a retention edge (91) that is embedded in the retention groove (13) of the cylindrical body (1) indicated above in Fig. 2B. The blind end of the elastic bag (93) presses the mushroom (7) of the pressure sensor, which is designed on the basis of finite element calculations (FEM) to concentrate the pressures in a certain section so that the electronic sensor that is located on the sensor support (6), transmit its pressure signal to a microcontroller inside it. This, and the rest of the electronic circuits for the sound, vibratory or wireless warning of the set, are powered by the rechargeable battery arranged in the cylinder (8). In this way, and adjusting each case, in general knowing that the pressure of the peristaltic movements of the large intestine is around 30 mmHg in amplitude, it is considered that a pressure in amplitude greater than 40 mmHg, can be considered intestine ready to evacuate already It will also depend on the duration and frequency of these pressures. It will be necessary to remove the retention plug (3) to empty the stool, which will be retained in the elastic bag held by the retention slot (13). The retention cap is designed so that if the detection system does not work or the patient has a sensory loss problem, from an internal pressure of 60 mmHg it will automatically open, leaving the stool in the elastic bag. [0085] In Fig. 6A a possible elastic bag (9) is shown longitudinally sectioned and almost extended and in which the most important parts of it can be seen, such as the open end (90), the central part (92) that it folds over itself and the blind end that is in contact with the sensor and transmits the pressure inside the intestine (93), to which a small thread adheres to facilitate its extraction when removing it (94). [0087] Fig. 6B shows an internal view of the elastic bag (9) sectioned longitudinally before installing it in the cylindrical body (1), being collected in its central part (92) like an accordion, and with the retention edge ( 91) of the same elastic material as the rest of the bag. The part in contact with the sensor (93) is also observed, together with the thread to assist the extraction of the bag (94). [0089] Fig. 7A shows the assembly of the device of the invention assembled in 3D perspective from the side that connects to the active intestine of the patient and represented with the elastic bag (9) sectioned longitudinally so that the inside of the composite device can be seen by: the mushroom (7) of the pressure sensor in contact with the elastic bag (9), pressure sensor support (6), and the inner bottom of the retention plug (3). In contact with the interior of the intestine is also the gas vent filter (2) that is located in the upper internal part of the cylindrical body (1) and that connects it with the external environment of the patient. [0090] In Fig. 7B the assembly of the device described is shown in 3D perspective from the point of view external to the body of the patient without placing the retention cap (3), on which side the vent filter (2) is placed, and the elastic bag (9). Here you can see the exit window (18) of the intestinal gases in the cylindrical body (1) once they have passed through the vent filter (2). The retention groove (13) for fixing the elastic bag (9) and another interior groove (15) for adjusting the O-ring of the retention plug (3) can also be seen. As can be seen, the vent filter (2) cannot be removed without first removing the elastic bag (9). Surrounding the cylindrical body (1) and attached to it is the fixation disc (12) made of mesh for inguinal hernias which is attached to the abdomen, and which has been represented by a flat disc with small holes. [0092] In Fig. 7C the assembly of the invention is presented with the same view as Fig. 7B, but with the retention cap (3) and the battery cap (4) located in their position when the device is operative. In these, the respective claws (31) and (41) can be seen, which allow a better extraction of the caps when it is necessary to remove them. [0094] Finally, two representations are made, in Fig. 8A frontal position of a male patient in which the outer part of the cylindrical body (1), the retention cap (3) and the battery cap (4) can be seen. In Fig. 8B a female patient is represented in a lateral position in which the cylindrical body (1) protrudes minimally. [0096] Preferred embodiment of the invention [0098] An embodiment example is set forth below and should not be understood as the only way to manufacture the invention described or the materials used in the example. [0100] Example: [0102] The first prototypes have all been manufactured by 3D printing, using PLA filament, due to its good mechanical characteristics and because it does not emit harmful gases during printing. Once desired designs have been achieved, other biomaterials have been used that could give the invention sufficient durability and reduce possible rejection problems in patients who could have the device implanted. [0104] It can be manufactured in a biomaterial such as polytetrafluoroethylene (PTFE), polypropylene (PP), or any material used today in biomedical applications, whose properties allow its use in this invention. [0106] The part that should be more durable is the cylindrical body (1) of Fig. 2A, 2B or 2C, since it will be sewn (attached) to the patient's body, so it has been chosen to manufacture it in PP material (polypropylene) , since it will have contact with visceral parts of the patient's body and it is required that it not present rejection. This part has been made by injection into a previously made metal mold. For the fixation disc (12) that is considered part of the cylindrical body (1), and that will be attached by sutures (or alternative method) to the patient's abdomen, a prefabricated mesh woven in the same PP material has been used, which is used in surgical operations for inguinal hernias. This is embedded in the body of the cylinder due to the fact that the metal mold is divided into two parts by a cross-section through the same plane of the fixing disc (PP mesh), and that allows it to be inserted so that a part is attached to the cylindrical body. the PP has cooled. [0108] The vent filter (2), the mechanical parts of the pressure sensor, the retention plug (3) and the battery plug (4), all have been manufactured by 3D printing in ABS for its great resistance and to meet the biocompatibility requirements up to 30 days in the body. Subsequently, two fabrics were manually introduced to the vent filter: one made of activated carbon and breathable Goro-tex fabric with 0.5 mm2 holes, both glued with Loctite 401 to the vent filter (2). A standard nitrile rubber O-ring (5) has been used to they met the design characteristics of the retention plug (3). For the electronic elements of the pressure sensor, a resistive sensor FSR 402 has been used that is installed under the mushroom (7), supported on the sensor support (6), inside which is located the PIC18f2525 microcontroller, with surface mounting components The necessary SMDs, a buzzer and a mini vibration motor, all of them powered by a 5 Vdc lithium battery found in the cylinder (8), and which will perform the functions indicated in the invention.
权利要求:
Claims (8) [1] 1. Device for monitoring, warning and removal of feces in patients with elimination ostomy, characterized in that it is made up of: • A cylindrical body (1) prepared to be attached to the active end of the intestine (stoma) and to the abdomen of the patient. • Retention plug (3) attachable to the cylindrical body (1). • Ventilation filter (2) for intestinal gases that can be attached to the cylindrical body (1). • Elastic bag (9) for collection of feces fixed by the open end (90) to the cylindrical body (1). [2] 2. Device for monitoring, warning and removal of feces in patients with elimination ostomy, according to claim 1, characterized in that the cylindrical body (1) comprises a transverse fixation disk (12) made of flexible mesh, capable of being sewn to the abdomen of the patient subcutaneously and end of the stoma. [3] 3. Device for monitoring, warning and removal of feces in patients with elimination ostomy, according to claim 1, characterized in that the cylindrical body (1) comprises a visceral end capable of being sewn to the active end of the patient's intestine. [4] 4. Device for monitoring, warning and removal of feces in patients with removal ostomy, according to claim 1, characterized in that the cylindrical body (1) has sealing grooves (17) and holes for fixation (11) for sealing to the active end of the patient's intestine. [5] 5. Device for monitoring, warning and removal of feces in patients with removal ostomy, according to claim 1, characterized in that the cylindrical body (1) comprises an insertion slot (14) to install the outlet vent filter (2) of intestinal gas through it. [6] 6. Device for monitoring, warning and removal of stool in patients with elimination ostomy, according to claim 1, characterized in that the cylindrical body (1) comprises a stool outlet end with retention groove (13) for fixing the elastic bag (9), and inner groove (15) to fit the O-ring (5) and inner stop (16) to place the retention plug (3) in the cylindrical body (1). [7] 7. Device for monitoring, warning and removal of stool in patients with elimination ostomy, according to claim 1, characterized in that the retention plug (3) contains a pressure sensor, supervision and warning of stool evacuation (6, 7, 8), powered by rechargeable battery. [8] 8. Device for monitoring, warning and removal of feces in patients with elimination ostomy, according to claim 6, characterized in that an O-ring (5) is installed in the retention cap (3), pressed when mounting in the bag elastic (9) and in the cylindrical body (1).
类似技术:
公开号 | 公开日 | 专利标题 US20170281397A1|2017-10-05|Seal for controlled evacuation ostomy appliance ES2301931T7|2012-06-14|ADAPTER, COVER AND CONNECTOR FOR OSTOMY BAGS. ES2241592T3|2005-11-01|CONTINENT OPENING FOR OSTOMY. US4781176A|1988-11-01|Implantable device US8900116B2|2014-12-02|Inflatable stomal implant US5108430A|1992-04-28|Implantable reservoir adapted to receive and store structural devices therein US20190015241A1|2019-01-17|Ostomy pouching device US10813787B2|2020-10-27|Ostomy management device JP3231717U|2021-04-22|Medical device that controls excretion from the subject, its use and method US4969902A|1990-11-13|Implantable device EP3375416B1|2020-05-13|Sphincter-type intestinal valve BRPI0817872B1|2019-10-15|TREATMENT SYSTEM FOR A PATIENT PRESENTING AN INTESTINAL DISORDER ES2291502T3|2008-03-01|AN OSTOMY APPARATUS ES2804033B2|2021-12-13|Device for monitoring, warning and removal of stool in patients with elimination ostomy US8221368B2|2012-07-17|Apparatus for use with ostomy devices providing protection and sound attenuation of a stomal aperture CN111818885A|2020-10-23|Device for use with surgically formed lumen ES2598557B2|2017-07-10|Device for waste collection in patients with elimination stoma CN216021614U|2022-03-15|Medical device for controlled release of waste content from a subject's external stoma and ostomy bag WO2020174497A1|2020-09-03|Intestinal waste management system AU2011247843B2|2014-06-26|Seal for controlled evacuation ostomy appliance JP2013176512A|2013-09-09|Body fluid sucking pump, and body fluid sucking collecting device using this pump WO2015142667A1|2015-09-24|Ostomy and stoma support device
同族专利:
公开号 | 公开日 ES2804033B2|2021-12-13|
引用文献:
公开号 | 申请日 | 公开日 | 申请人 | 专利标题 US20120136324A1|2009-07-14|2012-05-31|Stimatix Gi Ltd.|Ostomy containment device| EP2856985A1|2010-05-02|2015-04-08|B.Braun Medical SAS|Disposable ostomy cap| US20170360592A1|2015-02-09|2017-12-21|Tencar Inc.|Ostomy appliance|
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申请号 | 申请日 | 专利标题 ES201900127A|ES2804033B2|2019-08-01|2019-08-01|Device for monitoring, warning and removal of stool in patients with elimination ostomy|ES201900127A| ES2804033B2|2019-08-01|2019-08-01|Device for monitoring, warning and removal of stool in patients with elimination ostomy| 相关专利
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