BRPI0804768B1 - stoma occlusion system and implantable stoma occlusion device - Google Patents

Abstract

IMPLANTABLE STOMAS OCCLUSER SYSTEM AND IMPLANTABLE STOMAS OCCLUSER, the object of the present invention, simulates the action of a natural sphincter, producing constriction and lateral displacement of the organ or viscera that will form the stoma in the skin, controllable by the patient. Said system is comprised of: two remote control units (one for daily use by the patient and another for use by a health professional) that control the constriction and opening of the occlusion; and, of an occlusive device that can be implanted in the abdominal wall or pelvic floor, under the skin, at the level of the muscular layer, outside the peritoneal cavity and around the opening of a stoma. The occlusive device is comprised of an electric micromotor (1), bi-directional, coupled to a force transmission system, which produces a tractive force to a constriction tape (5) in order to move it in both directions (open / closed) to a final perimeter between 37.5 mm and 47.5 mm, where the motor (1) and power transmission system are housed inside the protection box, and the constriction tape (5) is arranged so as to surround the periphery of a circular opening, which forms a tunnel in said (...).

Description

FIELD OF THE INVENTION

[001] The present invention relates to an implantable occlusion in ostomized patients, more particularly it refers to a stoma occlusor system and an implantable stoma occlusor system that simulates the action of a natural sphincter, producing constriction and lateral displacement of a hollow organ or viscera, controllable by the patient himself.

TECHNICAL STATUS

[002] Conventional stomas involve a surgical procedure in which an organ, or hollow viscera (stomach, intestines, urinary bladder), is separated in order to provide a deviation of its path, and a portion of the organ is externalized through an incision in the wall abdominal pain of a patient. The anastomosis of the organ to the peritonium and skin of the abdominal wall of a patient is to provide a passage for the matter (feces, urine, food bolus), contained inside, to pass to the outside of the patient's body. The mouth-like terminal of this passage is called "stoma", the Latin term for "mouth".

[003] There are temporary and permanent stomas, and they can be built in any part of the digestive or urinary tract, being more common in the stomach, ileum, descending colon, sigmoid or urinary bladder, having neoplasms as the main cause. For this reason, stomata can be made in any region of the abdomen, but gastrostomies are more frequent in the middle portion of the upper third, ileostomies in the lower right quadrant, vesicostomies in the middle portion of the lower third and colostomies in the lower left quadrant of the abdomen. Other causes of stoma include congenital malformations, diverticulitis, ulcerative proctocolitis, Crohn's disease, Hirschsprung's disease, degenerative diseases, abdominal trauma and parasitic diseases.

[004] Ostomy patients are individuals who, for some reason, have undergone abdominal surgery with the making of a stoma. In this condition, control over the contents of the organ is lost and, without barriers, all material (feces, urine or food cake) that reaches the stoma will be exposed. To deal with this situation, the ostomized patient typically uses polymer bags and utensils on the outside of his body, in order to collect the matter that passes through the stoma, but even with the best of these devices, escapes occur producing noises, odors, complications peristomal skin and patient constraints.

[005] Many efforts have been made to improve the quality of life of ostomates. The most common and oldest ostomy device is the collection bag.

[006] There are many bag systems with different sizes, materials, fixation system, skin barriers, filters, reusable and disposable models, and other accessories to assist patients in their stoma management, such as: those described and shown in US 6,231,553, US 5,961,502, US 5,470,325, US 5,022,693.

[007] Associated with the collection bag system, some patients use the irrigation system, where a quantity of liquid is inserted in the colon and its removal washes and causes the exit of the feces, allowing a long period without elimination of feces and the use of a smaller and discreet collection lid or bag.

[008] The first records that attempted to restore control of the evacuation was the "Colostomy Control Button", dating before the beginning of the fifties and consisting of an expandable rubber plug attached to an aluminum top to close the stoma. Since then, many other attempts have been published, referring to different tools and devices, surgical techniques, passive and active implants, functional electrical stimulation and even the use of 'Smart materials'.

[009] There are more than 25 attempts to resolve the incontinence of a stoma, but no satisfactory solution has appeared.

[010] In addition to the surgical technique and materials used, they can be divided into three major groups: 1) Lids / closure plug: in these devices the lid, with or without the plug, blocks the opening of the stoma and is held in place by skin adhesives, magnetic force, external compression or mechanical fixation. Some of them have odor filters and absorbent materials to control leaks. Patient movements, skin folds, irritation of the peristomal skin and stoma site are severe difficulties with these methods; 2) Internal valves: many surgical techniques have tried to create a valve system with the remaining intestine, or biological or artificial valves. Low pressures inside the colon are not adequate to properly close the valve outlet, stool consistency varies from liquid to solid, and sudden high pressures such as when coughing or in abdominal contraction to get up are not prevented. Surgically created intestinal valves disappeared over time, due to the tissue reorganization process; 3) Inflatable occlusors: the stoma opening is closed by an inflatable ring located around the stoma, under the skin. In the open system, or without a reservoir, the user uses a syringe filled with air or saline to inflate the ring through an external connector, without any pressure control, causing ischemia, skin erosion and explosion. The closed system, or with reservoir, produced good results for urinary incontinence due to the small size of the urinary sphincter and diameters of the urethra, but did not have the same performance in anal incontinence and colostomy. This system consists of three interconnected parts (reservoir, pump and ring) and the pump must be located in the genital area and is manually activated. As it works with preset maximum pressure, the system loses efficiency over time due to the development of fibrous tissues that encapsulate the ring.

[011] An example of an inflatable occlusion can be seen through US patent 7,217,237, which proposes a control circuit and automated occlusion system whose main application is urinary incontinence, although it makes reference to other tubular organs. The system proposed in this US patent 7,217,237 has a number of deficiencies, such as: a high number of items to be implanted (constricting ring, pump / control unit and reservoir) preventing its use in stomata on the abdominal wall; permanent energy consumption to keep the system running, bringing extra care to the patient; the system monitors the pressure inside the occluder's closed hydraulic circuit, which does not represent the pressure actually exerted on the organ under constriction, in addition to eventually detecting local pressure spikes resulting from activities such as sitting, walking, jumping or running, which would generate increases useless and unnecessary pressure increasing the risk of ischemia; the process of fibrosis around the inflatable ring also produces increasing errors in the interpretation of pressure readings, since the pressure of the system must initially overcome the restriction of fibrosis to effectively compress the urethra. In this way, the system would not prevent leakage of urine through coughing, sneezing or sudden increases in pressure in the abdominal cavity, since it is a system that responds after a peak in the increase in the internal pressure of the hydraulic circuit, and the leakage of urine occurs during peak pressure. The required response time would be impossible for a pump-operated hydraulic system. Furthermore, the displacement required to occlude a colostomy or other stoma in the abdominal wall (20 mm to 50 mm in diameter) is much greater than that needed to occlude the urethra (4 mm to 7 mm in diameter).

[012] Also, the prior art reveals gastric rings for bariatric surgery, such as: those disclosed in US patent documents 7,238,191 and US 2005 / 0.143,763.

[013] The object of these patents, although conceptually it is that of a ring that allows constriction, their main application is to reduce the diameter of the stomach and hinder the passage of food, and not the occlusion of the stomach, which constitutes a surgical urgency and it is not desired in bariatric surgery. The rings revealed in the patent documents US 7,238,191 and US 2005 / 0.143,765 have deficiencies such as: they can only be implanted inside a cavity with enough space, in this case, inside the abdominal cavity, making it impossible to implant under the skin for use as anal sphincter, bladder or stoma stoma; the constriction area has a cylindrical profile, generating pressure on a very small area and causing ischemia as in inflatable rings; the implant, to be assembled in the form of a ring, has grooves and cracks in its external structure, which decreases its biocompatibility and stimulates the formation of fibrosis and adhesions in the body, mainly inside the peritoneum.

[014] Although the ring of US 2005 / 0.143.765 is more compact than that of the version of US 7.238.191, the elimination of the rod / antenna that served to house the stretched filiform element decreased its potential constriction capacity, not reaching perimeters necessary for the occlusion of a colostomy.

[015] Other considerations about prior art solutions: at the stoma site there is no efficient muscle for the use of functional electrical stimulation, therefore, loss of energy. In the case of smart materials, specifically shape memory alloys, they are under investigation for medical purposes, but some of their characteristics are limiting, they need energy to stay out of the resting position, the stimulus to activate them it can be harmful to living tissues (high temperatures) and the fatigue resistance is lower than that found in conventional metal alloys.

[016] Thus, the prior art does not satisfactorily resolve the problem of incontinence caused by the stoma.

[017] Considering the anal sphincter as the largest and strongest sphincter in the human body, an occlusion developed and perfected by nature through human evolution, an artificial sphincter should imitate its natural structure as well as possible. In this way, the occlusion should be achieved by a drag component, capable of compressing and displacing the organ axis from its direct position at the opening location. The sphincter should remain closed without energy consumption, producing 40 mmHg to 60 mmHg of compression on the stoma externalization channel, which is sufficient to block many variations in internal pressure. It should not affect the circulation of local blood or cause damage to the internal and external surfaces of the occluded organ. The continence state is considered when no leakage of gas, liquid, mass or solid occurs, eliminating the need for external utensils or special clothes.

BRIEF DESCRIPTION OF THE PRESENT INVENTION

[018] Bearing in mind the prior art, and the problems related to incontinence caused by the stoma, the present invention aims to provide a Stoma Occlusor System and Implantable Stoma Occlusor Apparatus that simulates the action of an anal sphincter, producing constriction and lateral displacement of the colon, or other hollow viscera, controllable by the patient himself.

[019] The system of the present invention is comprised of: an occlusive device that can be implanted in the abdominal wall, under the skin, at the level of the muscular layer, outside the peritoneal cavity and around the opening of a stoma; and, of two modalities of remote control unit that controls the constriction and opening of the occluder and is operable, externally, by the patient or health professional.

[020] Under special conditions, when the stoma is opened in the anal or perineal region, or in cases of fecal or urinary incontinence, the occlusive device may be placed on the pelvic floor, under the skin, at the level of the muscular layer, outside the cavity peritoneal, around the intestine or urethra.

[021] The implantable occlusive device is comprised of a constriction tape activated by means of actuation, comprising: an electric micro-motor associated with a gear system, which produces a traction force adequate to the constriction tape, which is arranged around the opening of a stoma. The constriction tape has a "transport chain" design making it very flexible, strong and light, depending on the choice of appropriate material (metals, polymers or composites). The tape moves in both directions (open / closed) and each element of the "transport chain" works as a 'half-nut' driven by an endless screw. These components of the device are arranged inside a box that can be circular, rectangular, trapezoidal or triangular in shape, always with convex vertices, with a centralized, eccentric or displaced circular opening to one of its vertices, or be from another shape with a circular opening, which houses the constriction tape and through which the organ or viscera that will form the stoma in the skin is passed. This box can be made of stainless steel, titanium, duraluminium, carbon fiber, ultra high molecular weight polyethylene or other resistant and light material. As the implant shell must be very elastic in the constriction part, biocompatible and resistant to the sterilization process, silicone for medical use remains the first option.

[022] In the occlusive device, as described, the electric motor replaces the power of the sphincter muscle and the constriction tape, arranged around the stoma, which is pulled by the motor, replaces the mechanical action of the sphincter muscle.

[023] The apparatus, of the present invention, has a power that allows handling loads of up to 5 Kg and the diameter of the constriction area can be reduced from 40 mm to 12 mm, varying its perimeter from 125 mm to 37.5 mm.

[024] In this way, it is possible to obtain continence for an intraluminal gas pressure greater than 80 mmHg, with a tensile force applied, to the constriction tape, below 50 N in order to obtain a final perimeter between 37.5 mm and 47.5 mm, with the largest offset of the tape being 85 mm.

[025] These parameters are those required for the occlusion of a colostomy and are also sufficient for the other proposed uses (gastrostomy, vesicostomy, ileostomy), since they have smaller diameters, require a lower traction force than that generated by the occluder and the pressure and safety criteria are identical. The only difference is in relation to the diameter in the open position, which will be adjusted to the patient's need, all of which are smaller than 40 mm.

[026] The remote control unit can be connected to the implanted occlusive device through a connector at the skin level connected to a cable under the skin, with an alternative option of a wireless, inductive transcutaneous system.

[027] The control unit has an ergonomic shape, is small, portable, like a mobile phone, has few and simple controls, easy to operate and understand. It informs the user about the level of constriction, time of the last operation, battery charge and asks to confirm commands when close to the safety limit of constriction or to open the sphincter. Two modalities are needed, one for the adaptation period after tissue restoration and another for the patient's daily use. The first modality is used by trained operators (stoma-therapist, nurse or doctor) to adapt the stoma to the action of the occluder, with progressive levels of constriction and periods of time. This procedure aims to avoid disturbances in the healing process and ischemic conditions around the stoma.

[028] The control unit has five basic commands, as follows: 4) Close command - available only in patient mode, with a single command it will trigger the constriction tape from a zero position (fully open) to the first position continence in a perimeter of 50 mm or another detected during the adaptation period; 5) Close adjustment - available in both modes, it moves the constriction tape reducing the perimeter of the constriction area with regular decreases defined in the control unit, up to the safety limit perimeter of 37.5 mm or pressure of 80 mmHg in the area of constriction. In the professional health modality, it starts from the zero position, and in the patient modality, it works only after the "close command"; 6) Open adjustment - its action is the same as "close adjustment", but in the opposite direction. In both modes, the sequence of this command can reach the zero position, but in the patient mode, it is only available after the "close command"; 7) Open command - in both modes, it activates the constriction tape from any previous position to the zero position. It also resets the control circuit to avoid cumulative errors; 8) Stop command - in both modes it cancels the previous commands. This is necessary in case of misuse of another command or discomfort. The circuit can trigger this command internally when a pressure of 80 mmHg is detected in the constriction area, or when the tape reaches the opening or closing limit.

[029] In the implantable stoma occlusion system, of the present invention, a system for detecting the displacement and position of the constricting tape, including limit switches, is provided.

[030] The Stoma Occlusor Apparatus, built according to the above characteristics, is easy to use and has an acceptable aesthetic appearance, without requiring the use of special accessories or sanitary facilities, it can be conveniently operated by the patient to open or close it it when desired, effectively sealing the stoma channel, and thus allowing the patient to reintegrate into the productive population, since at least eight hours of continence are required for social and leisure activities, or a night's sleep, providing feeling of freedom, security and comfort. Its durability exceeds the patient's life expectancy, avoiding changes, replacements or periodic maintenance.

BRIEF DESCRIPTION OF THE DRAWINGS

[031] The present invention is now better visualized and indicated in an exemplary, but not restrictive way, through the drawings accompanying the present application, in which:

[032] FIG.01 - shows the block diagram of the second modality of the Control Unit of the Occlusor System of the present invention.

[033] FIG.1A - shows the block diagram of the Occlusor Apparatus of the present invention.

[034] FIG.02 - shows the block diagram of the first modality of the Control Unit of the Occlusor System, of the present invention.

[035] FIG.03 - shows the circuit diagram of another embodiment of the Control Unit of the Occlusor System, of the present invention.

[036] FIG.04 - shows an external view of the first modality of the implantable occlusive device of the present invention, with the area of constriction open.

[037] FIG.05 - shows an external view of the first modality of the implantable occlusive device of the present invention, with the area of constriction closed.

[038] FIG.06 - shows the constructive arrangement of the first modality of the implantable occlusive device of the present invention.

[039] FIG.07 - shows partial section of the constructive arrangement of the first modality of the implantable occlusive device of the present invention.

[040] FIG.08 - shows detail of the constructive arrangement of the first modality of the implantable occlusive device of the present invention.

[041] FIG.09 - shows a top view, in cross-section, of the first embodiment of the occlusive device of the present invention with the occluder in a closed position.

[042] FIG.10 - shows a top view of the second embodiment of the occlusive device of the present invention, with the area of constriction open.

[043] FIG.11 - shows a perspective view of the second modality of the occlusive device, with the constricted area closed.

[044] FIG.12 - shows perspective view of the second embodiment of the occlusive device of the present invention, without cover.

[045] FIG.13 - shows an enlarged view of the detail 'A', shown in FIG.12, of the occlusive apparatus of the present invention.

[046] FI6.14 - shows details of the constructive disposition of the second modality of the occlusive device, with the area of constriction closed.

[047] FIG.15 - sectional view showing the positioning of the implanted occlusive device.

DETAILED DESCRIPTION OF THE INVENTION

[048] The following description will be made as a reference, only as an example of a preferred embodiment of the present invention, not being considered as a limiting form of the "Stoma Occlusor System and Implantable Stoma Occlusor Apparatus".

[049] The stoma occlusion system shown through the block diagram of figures 1, 1A and 2, is comprised of: a) A remote control unit (8), shown in FIG.1, for daily use by the patient, which it comprises: - a power source (23), which can be a battery; - a display (9) showing information data such as: clock, triggered command, tape position, pressure level, and battery charge, request for confirmation of commands when close to the safety limit of constriction, request to open the sphincter, time of the last operation; - a keyboard composed of five control buttons, 'OPEN' (10), 'ADJUST OPEN' (11), 'CLOSE' (12), 'ADJUST CLOSE' (13), and 'TO' (14); - an integrated microcircuit (15), powered by the power source (23), comprising: logic ports (16) that receive the command signals from the buttons (10-14) on the keyboard; a pressure sensor circuit (18) that receives signals from the pressure sensor of the implanted device (6; 6a); a position and displacement sensors circuit (19) that receives signals from the position and displacement sensors (20; 21) of the tape (5) of the implanted occlusive device; and a circuit (17), comprising an internal clock and counters, which receives signals from the logic gates (16), from the command signals of the buttons (10-14) on the keyboard and the signals sent by the pressure sensor circuit (18) and the position and displacement sensors circuit (19), and sends energy and control signals, through the connections (30; 30A), to the electric micromotor (1) of the said occlusive device (6; 6a) implanted, being that the said connections (30; 30A) comprise a connection means (30) that connects the remote control unit (8) to the connection (30A), of the implanted occlusive device, arranged at the skin level. Said integrated microcircuit (15) also sends information data about the functions and operating conditions of the device.

[050] In this mode, the remote control unit (8) activates the implanted occlusion device (6), as follows: - when the "OPEN" button (10) is activated, the integrated microcircuit (15) activates the micromotor ( 1) in order to move the constriction tape from any previous position to the zero position (fully open) and reset the control circuit to avoid cumulative errors; - when the "ADJUST OPEN" button (11) is activated, the integrated microcircuit (15) activates the electric micromotor (1) only if the CLOSE command has already been activated previously. In this case, the micro circuit (15) sends command signals so that the micro motor (1) moves the constriction strip (5) in the opposite direction to the closing, increasing the perimeter of the constriction area (7, 7a) with additions regular values defined in the control unit, so that the sequence of this command makes it possible to reach the zero position; - when the "CLOSE" button (12) is activated, with a single command the integrated micro circuit (15) activates the electric micro motor (1) which moves the constriction strip (5) from a zero position (fully open) to the first position of continence in a perimeter of 50 mm or another detected during the adaptation period; - when the "Adjust Close" button (13) is activated, the integrated micro circuit (15) activates the electric micro motor (1) which moves the constriction strip (5; 5a) reducing the perimeter of the constriction area (7, 7a), with regular decreases defined in the control unit, up to the safety limit perimeter of 37.5 mm or pressure of 80 mmHg in the constriction area, and this command works only after the "close command"; - when the "PARA" button (14) is activated, the micro circuit (15) cancels the previous commands. This command is necessary in case of misuse of another command or in case of discomfort. In addition to this manual command, the integrated microcircuit (15) activates this command internally when a pressure of 80 mmHg is detected in the constriction area or when the tape reaches the opening or closing limit. b) A remote control unit (8 '), shown in figure 2, used by a healthcare professional, which comprises: - a power source (23), which can be a battery; - a display (9) showing information data such as: clock, triggered command, tape position, pressure level, and battery charge, request for confirmation of commands when close to the safety limit of constriction, request to open the sphincter, time of the last operation; - a keyboard composed of four control buttons, 'OPEN' (10), 'ADJUST OPEN' (11), 'ADJUST CLOSE' (13), and 'TO' (14); - an integrated microcircuit (15), powered by the power source (23), comprising: logic gates (16) that receive the command signals from the buttons (10; 11; 13; 14) on the keyboard; a pressure sensor circuit (18) that receives signals from the pressure sensor of the implanted occlusion device (6); a position and displacement sensors circuit (19) that receives signals from the position and displacement sensors (20; 21) of the tape (5; 5a) of the implanted occlusive device; and a circuit (17), comprising an internal clock and counters, which receives signals from the logic gates (16), coming from the command signals of the buttons (10; 11; 13; 14) on the keyboard and the signals sent by the sensor circuit. pressure (18) and the position and displacement sensors circuit (19), and sends energy and control signals, through the connections (30; 30A), to the electric micromotor (1) of the said occlusive device (6) being implanted, that said connections (30; 30A) comprise a connection means (30) that connects the remote control unit (8) to the connection (30A), of the implanted occlusive device, disposed at the level of the skin. Said integrated microcircuit (15) also sends information data about the functions and operational conditions of the device to the display (9).

[051] In this mode, the remote control unit (8 ') activates the implanted occlusive device, as follows: - when the "OPEN" button (10) is activated, the integrated microcircuit (15) activates the micromotor (1) in order to move the constriction tape from any previous position to the zero position (fully open) and reset the control circuit to avoid cumulative errors; - when the "ADJUST OPEN" button (11) is activated, the micro circuit (15) sends command signals so that the micro motor (1) moves the constriction strip (5) in the opposite direction to the closing, increasing the perimeter the constriction area (7, 7a) with regular increments defined in the control unit, so that the sequence of this command can reach zero position; - when the "Adjust Close" button (13) is activated, the integrated micro circuit (15) activates the electric micromotor (1) to move the constriction tape (5) reducing the perimeter of the constriction area (7, 7a) with regular decreases defined in the control unit, up to the safety limit perimeter of 37.5 mm or pressure of 80 mmHg in the constriction area, this command being initiated from the zero position; - when the "PARA" button (14) is activated, the microcircuit (15) cancels the previous commands. This command is necessary in case of misuse of another command or in case of discomfort. In addition to this command being manual, the integrated microcircuit (15) activates this command internally when a pressure of 80 mmHg is detected in the constriction area or when the tape reaches the opening or closing limit. - an occlusive device (6; 6a) implantable in the patient's abdominal wall or pelvic floor, under the skin, at the level of the muscle layer (B), outside the peritoneal cavity (D) and around the opening of a stoma (C) , which is comprised of: a box (6; 6a) for protection and support of axles, which houses inside it an electric micromotor (1; 1a), a set of gears (2,3; 2a, 3a), and a constricting tape (5; 5a) arranged in a circular opening (7; 7a) of the box (6; 6a); the electric micromotor (1; 1a) receives control signals from the integrated microcircuit (15), from the remote control unit (8; 8 '), and drives a set of gears (2,3; 2a, 3a), from in order to pull or not the constrictor tape (5; 5a) that surrounds the stoma, and whose position and displacement will be monitored by the position and displacement sensors (20, 21) that, together with the pressure sensor (22), send the their respective signals to the logic gates (16) of the control unit (8; 8 '), through the respective pressure (18) and position and displacement (19) circuits, so that, for a limit intraluminal pressure of 80 mmHg, the force transmission system produces a tractive force, below 50N, with a ribbon displacement of up to 85 mm, reaching a final perimeter between 37.5 mm to 47.5 mm inside the said circular opening (7) . The implanted occlusive device has a mini connector (30A) disposed at the skin level. This connector is connected to a thin cable, placed under the skin, and has an external connection structure coated with durapatite (hydroxyapatite), to allow the integration of soft tissues and the sealing around it, and has internal lines to emit energy, send the operating command signals for the micromotor (1) of the occlusive device (6) and receive signals from the position and displacement sensors (20, 21) and pressure (22).

[052] As an alternative way, the activation of the occlusive device can be via the transcutaneous inductive system, which has a receiving antenna at the end of the connection cable, also under the skin, and an external inductive antenna, responsible for the transfer of energy and command signals for the electric motor of said implantable device.

[053] The remote control unit of the system of the present invention can be realized by other embodiments, such as, for example, the one shown in figure 03. In the circuit shown in this figure 03, internal meters are provided that serve to inform and adjust the number of steps required for the engine to perform a function. There are two counters, one for the ADJUSTMENT functions (open / close) that needs fewer steps, and another for the CLOSE function, with a greater number of steps. The signals coming from the counters are represented by (BO1-1, B01-2, B01-3) and (B02-1, B02-2, B02-3). The OPEN function does not use the counters, as you must carry out as many steps as necessary until the occluder is fully opened. The signals from the counters and command keys ('OPEN', 'ADJUST OPEN', 'CLOSE', 'ADJUST CLOSE', 'OPEN LIMIT', 'CLOSE LIMIT' and 'TO') are used on logic gates and actuate four set / reset switches (CI13). Each of these starts one of four multivibrators (CI16), which receive the internal clock operating frequency. The "Clock" or internal clock provides the frequency of steps per second at which the engine will work. Thus, the commands (CW / CCW, STEP, LOAD 1 and LOAD 2, Down 1 and Down 2) are generated to use in the Stepper motor controller (L297, commercial use) that will provide the output signals of the phases motor, passing through a power controller Cl (L298N also for commercial use), which allows adjusting the motor supply voltage. These two CI's are not represented.

[054] The implantable occlusive device, used in the control system mentioned above, as shown in figures 04 - 09, is comprised of: a) an electric micromotor (1), bidirectional, as an actuator, mainly stepper motors, coupled to a system of force transmission, which produces a tractive force to a constriction tape (5) causing said tape (5) to move in both directions (open / closed), and in its displacement in the closed direction, to to obtain an intraluminal gas pressure of up to 80 mmHg, a tensile force below 50N is applied, so that the constriction tape reaches a final perimeter between 37.5 mm and 47.5 mm, with a maximum displacement of 85 mm; b) a protection box (6) and axle support for the internal components, in a triangular shape, formed by a block of ultra high molecular weight polyethylene (UHMWPE), with a maximum length of 98.5 mm, maximum height of 33 mm and maximum weight of 194g, it has concave vertices and contains a circular opening (7), in the form of a tunnel, arranged in one of the vertices. Inside this box (6) are housed, in a compartment, the micromotor (1), the power transmission system (2, 3) and an endless screw (4), and, in a channel formed in the box, a part of the constriction tape (5), which is made of polytetrafluoroethylene (PTFE), metal or polymer, which is arranged parallel and in communication with the endless screw, allowing it to be pulled / pushed by the endless screw towards said circular opening (7) of the box (6), where the other end of the ribbon is fixed close to the opening of the channel, so that the middle portion of the ribbon (5) is freely arranged surrounding the inner periphery of said circular opening (7 ) thus allowing the closing of the circular opening (7) as well as its reversal, as figures 04, 05, 07 and 09 show, and also, on said tape (5) is a layer of silicone (5b). The outer surface of said protection box must be compatible with a silicone rubber coating, and in the area of constriction, the silicone must deform to follow the displacement of the tape transport chain (5).

[055] The gear system of the occlusive device, of the present invention, has two main objectives: to change the rotation of the shaft and to increase the torque.

[056] Figures 06 and 07 show the force transmission system, of the first modality of the occlusive device, of the present invention, which is comprised of a gear system (2), formed by: two nylon sprockets (1 : 1.28), coupled to the micromotor shaft (1), which are coupled to a worm-gearwheel system (1: 6.5), finished in bronze, responsive to an axis change of 90 °, connected to an endless screw (4), which is a 3/8 'Whitworth' steel screw with a bronze nut (4 ') (1:14), to convert rotation into linear displacement. Its total linear displacement is equal to 35.5 mm, and with the width of the nut, the length of the screw is 43 mm. As can be seen from figures 07 to 09, the position and displacement sensor (21) is positioned in order to detect the end of the tape (5), inside the box, when the constriction area is fully open, and the position and displacement sensor (20) is positioned close to the ribbon entrance in the circular opening (7).

[057] In this way, inside the said circular opening (7) of the protection box (6), the organ or viscera is inserted, which will form the stoma (C) in the skin, allowing the tape (5) to surround the said organ closing it or opening it, as can be seen through figures 4, 5 and 15.

[058] Figures 10 to 14 show a second embodiment of the occlusive device. In this modality, as shown in figures 12 to 14, the box of the occlusive device, also built by a single piece in polyethylene (UHMWPE), presents itself in the shape of a ring (6a) containing a rectangular compartment (6d) with curved edges , located in part of its external periphery, and, in its internal periphery, next to this compartment (6d), there is a communication opening for a semicircular channel (6c) formed next to the opening (7a) of the ring, so that its smaller diameter wall forms a semicircular element (6f) that starts fixed to the box (6a), on the opposite side to the compartment (6d), and ends right after the communication opening of the compartment (6d) with its end ( 6e) in the form of a tooth. Said compartment (6d) houses the micromotor (1a) and the power transmission system, comprising a satellite power transmission system (2a) and a second gear transmission system (3a) in such a way that the endless screw (4a) is arranged parallel to the opening or communication window for the channel (6c) which houses the constriction tape (5a). The constriction tape similar to a conveyor belt (5a), made of polytetrafluoroethylene (PTFE), metal or polymer, is arranged in such a way as to surround said periphery of the circular opening (7a) of the box (6a), with one of its ends fixed to the end (6e) of the element (6f) and another free end disposed inside the channel (6c), so that the endless screw (4a) pulls or pushes its free end, allowing the perimeter of the opening to constrict circular (7a) or its reversal, and still, being placed on said tape (5a) a layer of silicone (5b). As can be seen in figure 12, the position and displacement sensor (20) is positioned in order to detect the end of the tape (5a), inside the channel, when the constriction area is fully open, and the position / offset (21) is positioned close to the ribbon inlet in the circular opening (7a). It can also be seen, through figure 14, that the pressure sensor (22) is arranged on the surface of the end (6e) of the element (6f), which faces the interior of the circular opening (7a).

[059] The gear system, used in the second modality, shown in figures 12 to 14, is a planetary gear system with 3.8 g in weight, 8 mm in diameter and 12.3 mm in length. To optimize the internal space and allow the transmission of the gears, two reduction gears (3a) (with 13/19 teeth, module 0.25) allow the worm to work in parallel to the motor, giving the appropriate final torque. Thus, the apparatus of this second modality is 50% lighter (maximum weight of 100g), 60% thinner (maximum thickness of 12 mm) and 40% smaller than the apparatus of the first modality shown in figures 4 to 9.

[060] Thus, the device of both modalities, when implanted, is arranged around the opening of a stoma, allowing it to be opened or closed in a controlled manner. The positioning of the implanted occlusive device (6a) can be seen through figure 15, which shows the device (6) implanted in the patient's abdominal wall arranged around the stoma (C), under the subcutaneous tissue (A), at the level muscle layer (B), outside the peritoneal cavity and around the opening of a stoma (C).

[061] In both modes described above, the box can also be made of titanium, duraluminium, carbon fiber or other resistant and light material. As the implant shell must be very elastic in the constriction part, biocompatible and resistant to the sterilization process, silicone for medical use remains the first option.

[062] The constriction tape (5; 5a) has a "conveyor belt" design making it very flexible, strong and light, and is tensile, non-elastic, thin, and has a smooth surface with a low coefficient friction to preserve the silicone coating. It moves in both directions (open / closed) and each element of the "conveyor belt" works as a half-nut moved by the endless screw, as can be seen in figures 12 and 14. On the opposite side of the " conveyor belt ", the area of constriction, where the stoma will be located, does not touch the stoma because a layer of silicone (5b) will be between them and, on its other side, has lines or teeth to be pushed by the endless screw. When the screw pushes the 'mat', the free end slides into a groove (6c), allowing for an increase in linear displacement without requiring extra space. Said constriction tape (5; 5a), which is continuous, can also be of the mat or chain type, made of metal, polymer, plastic, ceramics or composites, it has components such as fillets, grooves or grooves, which are attached to the worm threads. The displacement in one direction causes a reduction in the size of this circular opening (7; 7a) of the box, functioning as an artificial sphincter, occluder or valve. In the opposite direction, the opening occurs allowing the contents of the occluded organ to escape.

[063] In this way, the constriction device can produce gas continence, for a pressure of 80 mmHg, with an average displacement of the constriction tape of 75 mm, and a tensile force below 40 Newtons.

[064] It is observed that the electric micromotor, like the actuators, mainly stepper motors, from a mechanical point of view, is considered simple, strong, durable, with little or no need for maintenance, easy to cool and with a good ratio of size / torque / energy. It also has a residual torque that helps to brake the mechanical system, even when the engine is not energized.

[065] The stoma occlusion system and implantable stoma occlusion apparatus of the present invention can lead to a whole range of new products and applications. Although it was idealized and designed to improve stoma continence, its operational principle and design can be adapted to other situations, whenever the temporary obstruction of a tubular structure is desired, representing no harm to patients and improving their quality of life.

[066] Changes in the design of the present invention may allow its use in urinary and fecal incontinence where the natural tract is preserved, but the sphincter fails.

Claims (20)

1. "STOMAS OCLUSOR SYSTEM", of the type that uses electromechanical devices, such as micromotor, constriction tape, remote control unit and graphical user interface, whether professional or the patient himself, this interface is of the type display and a keyboard, in addition electronic circuit and power source, characterized by: - remote control unit (8), used by the patient, comprising: - a keyboard composed of five control means: 'ABRE' (10); 'ADJUST OPEN' (11); 'FECHA' (12); 'CLOSED ADJUSTMENT' (13); 'TO' (14); - an integrated microcircuit (15) which, when activated by one of the control means (10-14) and based on the signals received from the pressure sensing devices (22), the position (20) and the displacement (21) of the tape of constriction (5; 5a) of the device (6; 6a), sends energy and sends control signals to the micromotor (1; 1a) of the occlusive device (6; 6a), and, sends data of information of the device to the display ; the power and control signals being sent, via a connection device, to a connection device (30A) disposed under the skin and connected to a thin cable of internal lines to emit energy and send the operational command signals for the micromotor (1; 1a) of the occlusive device (6; 6a); and - remote control unit (8 '), used by a health professional, comprising: - a keyboard composed of four control buttons:' ABRE '(10); 'TO' (14); 'ADJUST OPEN' (11); 'CLOSED ADJUSTMENT' (13); - an integrated microcircuit (15) which, when activated by one of the control means (10; 11; 13; 14) and based on the signals received from the pressure (22), position (20) and displacement sensing devices ( 21) from the constriction tape (5) of the device (6), sends energy and sends control signals to the micromotor (1) of the occlusive device (6) and sends data, from the device information to the display; the power and control signals being sent, via a connection device, to a connection device (30A) disposed under the skin and connected to a thin cable of internal lines to emit energy and send the operational command signals for the micromotor (1) of the occlusive device (6); - an occlusive device, implantable in the patient's abdominal wall or pelvic floor, under the skin, at the level of the muscle layer, outside the peritoneal cavity and around the opening of a stoma, which is comprised of: - a protective box (6 ) and axle support, which houses a bi-directional electric micromotor (1), which activates a power transmission system, according to the said command signals received from the remote control unit, and which has an opening circular (7) through which the organ or viscera that will form the stoma in the skin passes; - a constriction tape (5), arranged so as to surround the inner periphery of the circular opening (7) of the box (6), which is pulled by an endless screw (4) of the power transmission system, in order to to slide freely on the surface of said circular opening (7) in both directions (open / closed), the position of the constriction tape being determined by the position and displacement (20; 21) and pressure (22) sensors, that send their respective signals to the logic gates (16) of the microcircuit, so that, for an intraluminal pressure of 80 mmHg, the force transmission system produces a tractive force, below 50N, with a greater displacement of the tape up to 85 mm, in a final perimeter between 37.5 mm to 47.5 mm, inside said circular opening (7; 7a). 2) Implantable “stoma-blocking apparatus”, of the system defined in claim 1, characterized by a protective box (6) and axle support, implantable in the patient's abdominal wall, under the skin, at the level of the muscular layer, outside the peritoneal cavity and around the opening of a stoma, which houses a bi-directional electric micromotor (1), which activates a power transmission system, according to command signals received from the remote control unit, and which it has a circular opening (7) through which the organ or viscera that will form the stoma in the skin passes; the protection box is coupled to a device for receiving operational command signals, disposed at the patient's skin level, through a thin cable, disposed under the skin, which has internal lines to transmit energy and the command signals operational for the micromotor (1); and a constriction tape (5), arranged so as to surround the inner periphery of the circular opening (7) of the box (6), which is pulled by an endless screw (4) of the power transmission system, in order to to slide freely on the surface of said circular opening (7) in both directions (open / closed), the position of the constriction tape being controlled by a remote control unit based on opening and closing sensors (20, 21 ) and pressure (22), so that, for an intraluminal pressure of 80 mmHg, the force transmission system produces a tensile force on the constriction strip (5), below 50N, with a greater displacement of the tape of 85 mm, in a final perimeter between 37.5 to 47.5 mm inside said circular opening (7). 3) “STOMAS OCLUSOR APPLIANCE”, implantable, according to claim 2, characterized in that the position and displacement sensor (21) is positioned in order to detect the end of the tape (5), inside the box, when the the constriction area is completely open, and the position and displacement sensor (20) is positioned close to the ribbon entrance in the circular opening (7). 4) “STOMAS OCCLUSING APPLIANCE”, implantable, according to claim 3, characterized in that the device for receiving operational command signals, disposed at the level of the patient's skin, is a mini connector. 5) "STOMAS OCCLUSING APPLIANCE", implantable, according to claim 3, characterized in that the device for receiving operational command signals, disposed at the level of the patient's skin, is a receiving antenna disposed at the end of the cable that is under the skin. 6) “STOMAS OCLUSOR APPLIANCE”, implantable, according to claim 4 or 5, characterized in that for an intraluminal pressure of 80 mmHg occurs, the micromotor (1) activates the force transmission system in order to produce a force of tension, below 40 N, so that the constriction tape (5) moves to a final perimeter between 37.5 and 47.5 mm inside said circular opening (7). 7) "STOMAS OCLUSOR APPLIANCE", implantable, according to claim 3 or 4, characterized in that the box (6), for protection and support of axes, is built by a single piece, in a triangular shape and with curved vertices, having a circular opening (7), in the form of a tunnel, arranged at one of its vertices, and having inside it a compartment, to house the micromotor (1), the power transmission system (2, 3) and a screw worm (4), which is in communication with a channel to accommodate part of the constriction tape (5), in order to be positioned in parallel with the worm screw (4), with the opposite part of the tape (5 ) is fixed to the box, close to the opening of the channel, with the middle part of the ribbon arranged freely surrounding the inner periphery of said circular opening (7), so that when the endless screw (4) pulls or pushes it, the stoma passage is open or closed. 8) "STOMAS OCCLUSING APPLIANCE", implantable, according to claim 7, characterized in that the box (6) has a maximum length of 98.5 mm, a maximum height of 33 mm and the occlusive device has a weight of 194 g. 9) "STOMAS OCLUSOR APPLIANCE", implantable, according to claim 7 or 8, characterized in that the force transmission system, disposed inside the box (6), is comprised of a gear system (2), formed by: two nylon sprockets (1: 1.28), coupled to the micromotor shaft (1), which are coupled to an endless screw-sprocket system (1: 6.5), finished in bronze , responsive to a 90 ° axis change, connected to an endless screw (4), which is a 3/8 'Whitworth' screw, steel, with a bronze nut (1:14) (4 '), to convert rotation to linear displacement. 10) "STOMAS OCCLUSING APPLIANCE", implantable, according to claim 9, characterized in that the micromotor (1) is a bidirectional stepper motor. 11) "STOMAS OCLUSOR APPLIANCE", implantable, according to claim 10, characterized in that the worm screw of the power transmission system has a length of 43 mm. 12) "STOMAS OCCLUSING APPLIANCE", implantable, according to claim 3 or 4, characterized in that the box (6a), for protection and support of axes is built by a single piece, in the form of a ring containing a compartment ( 6d), located in part of its external periphery, where the micromotor (1a) and the power transmission system (2a; 3a) are housed, in such a way that the endless screw (4a) is arranged in parallel to an opening of communication between the compartment and the inner periphery of the ring, and that the constriction tape (5a) is arranged to surround the periphery of said circular opening (7a) of the ring, with one of its ends fixed inside the opening circular (7a) and another free end inside a channel (6c), so that the endless screw (4a), of the force transmission system, pull or push the constriction tape, allowing the perimeter of the opening to constrict circular (7a) or its reversal. 13) "STOMAS OCCLUSING APPLIANCE", implantable, according to claim 12, characterized in that the power transmission system (2a, 3a) is a power transmission system by satellite gears (2a) and a transmission system of toothed wheel force (3a). 14) “STOMAS OCLUSOR APPLIANCE”, implantable, according to claim 13, characterized in that the opening and closing sensor (20) is positioned, in the box (6a) next to the channel (6c), close to the end of the tape in the interior of the channel, when the constriction area is in an open position; the opening and closing sensor (21) is positioned close to the entrance of the constriction tape (% a) in the channel (6c) of the box (6a), and the pressure sensor is positioned on the inner surface of the end (6e) of the channel (6c). 15) "STOMAS OCLUSOR APPLIANCE", implantable, according to claim 14, characterized in that the box (6a) has a maximum thickness of 12 mm and has a weight of 100g. 16) “STOMAS OCCLUSING APPLIANCE”, implantable, according to claim 15, characterized in that the force transmission system is comprised of a planetary gear system (2a), with 3.8 g in weight, 8 mm in diameter and component 12.3 mm long, coupled to the micromotor axis (1a) in order to drive two reduction gears (3a) (with 13/19 teeth), which are coupled to the axis of the endless screw that is arranged in parallel to the micromotor (1a). 17) “STOMAS OCCLUSING APPLIANCE”, implantable, according to claim 16, characterized in that the gears (2a) of the force transmission system are made of metal. 18) “STOMAS OCLUSOR APPLIANCE”, implantable, according to claim 11 or 17, characterized in that the constriction tape (5; 5a) is a thin tape with two faces, being that: one of its faces has a design of "transport chain" and each element of the "transport chain" works as a half nut moved by the endless screw (4; 4a); and its opposite face is smooth with a low coefficient of friction facing the constriction area, where the stoma will be located. 19) “STOMAS OCCLUSING APPLIANCE”, implantable, according to claim 18, characterized in that the box (6; 6a) is made of polyethylene (UHMWPE), with an external protective surface compatible with a silicone rubber coating, and in the constriction area, the silicone coating must deform to follow the displacement of the transport chain. 20) "STOMAS OCCLUSING APPARATUS", according to claim 18, characterized in that the tape (5; 5a) is made of polytetrafluoroethylene (PTFE), metal or polymer.

Images