MXPA99005093A - Sphincterian-reservoir device - Google Patents

Abstract

La presente invención se refiere a un dispositivo protésico que suple las funciones de (esfinter-reservorio del tracto intestinal (esfínter anal y recto sigmoides) y urinario. El dispositivo es una prótesis que se encuentra unido al tracto intestinal o urinario mediante un procedimiento quirúrgico en forma permanente y lo pone en contacto con el ambiente extracorporeo, esto es, evita la construcción de un estoma y sus complicaciones. Modifica por completo el concepto de estoma. El objetivo de esta invención es mejorar la calidad de vida de los paciente que tienen o requieran un estoma en forma definitiva o que presentan disfunción importante del esfínter anal y/o urinario.

Description

Sphincter reservoir device. Description. The present invention relates to a prosthetic device which supplies the sphincter-reservoir functions of the intestinal and urinary tract, that is, the function of the anal and urinary sphincter, and the reservoir function of the urinary bladder and the sigmoid rectum in the human being. The device is permanently and imperviously bound to the intestinal and / or urinary tract and is placed in the human body (abdominal or pelvic cavity) by means of a surgical procedure. Its usefulness is to equip people who have partial or total dysfunction of the urinary and / or anal sphincter, as well as partial or total dysfunction of the reservoir function of the urinary bladder and the recto-siogmoid of a new sphincter prosthetic mechanism and / or reservoir that supplies these functions.

The "Reservoir-Sphincteric Prosthetic Device" (DRE) is a structure of biocompatible material that connects the intestinal tract with the extracorporeal environment, transports, stores and expels the urine and / or intestinal material that the carrier produces. That is, it replaces the functions of the anal and / or urinary sphincter, as well as the container function of the sigmoid bladder and rectum.

The DRE is constituted by the following elements mainly: 1. Union Element (EU) 2. Basic Structure (EB) 3. Reservoir (R) 4. Sphincter Mechanism (ME) 5. Sensor System (SS) 6. Voiding Mechanism (MV) 7. Aesthetic Element (EE) 8. Fixing element (EF) 1. Union element. The binding element is made of biocompatible material (whether rigid, semi-rigid, flexible or a combination of them), its function is to link the living tissue (intestinal and / or urinary tract) with the basic structure of the DRE.

The joining element (Biocompatible material), is located at the end of the receiver appendix (AR), tubular structure of the basic structure and protrudes from this structure by a few cm, the joining element is in permanent continuity with the material that constitutes The basic structure is used by the surgeon to perform the union between the DRE and the intestinal and / or urinary tract by means of a surgical procedure. The joining element may be of the same material as the basic or different structure; 2. Basic Structure The EB is the framework of the DRE, is made of biocompatible material, which can be rigid, semi-rigid or flexible, or that some of its parts are rigid, others semi-rigid and other flexible. Its shape and dimensions depend on the physiological functions that it supplies (reservoir and / or sphincter), the age of the carrier, the site of the body where it is installed (abdominal cavity, pelvic cavity, etc.), or of the supplying organ, between others The main function of the EB is: a) Serve as an interface between the intestinal and / or urinary tract and the outside of the body. b) Serve as a container, means of fixation and support to the rest of the elements that make up the DRE. c) Serve as a means of fixation between the totality of the DRE and the structures of the body.

The basic structure can be divided into two main types based on the physiological functions that the DRE supplies: The sphincter function only as shown in the figure is the sphincter and reservoir function as a whole as shown in figure 2.

The EB of a DRE that substitutes the sphincter function (valvular) only as shown in figure 1, is constituted by a cylinder (tubular structure), which at one of its ends we find the union element (UE), I which As already mentioned, it will be attached to the intestinal and / or urinary tract and at its other extreme we will find the aesthetic element (EE). Inside this tubular structure we will find next to the joining element a proximal unidirectional valve (sphincter mechanism) and another valve, close to the aesthetic element, or no valvular element. 1 The EB will only be a tubular structure, that in one of its ends (receiving appendix) it would find continuity with the EU, being able to be this one of 0.2 to 10 cm. On the internal surface of the EB we will find a fixing element (EF) to hold the sphincter mechanism, this fixing mechanism is a copy, a thread, bellows, pressure, or some other mechanism, is part of the basic structure, in such a way that the unidirectional valve can be removed and repositioned easily, as another possibility the sphincter mechanism can be part of the EB.

The EB will pass through the abdominal wall or perineum to the outside of the body, this end of the BS, which is tubular (outer appendix), will have the fixation means for the aesthetic element and / or for another valvular mechanism, this being the element Fixation part of the EB, the aesthetic element (EE) may be removed and repositioned by the user to evacuate intestinal material and / or urine, may be by means of pressure, bellows, thread, or other suitable.

On the external surface of the EB and in continuity with it will be the external fixation element which fixes the whole device to the structures of the body.

The size, shape, diameter, and length of the EB will depend on the characteristics of the patient, the organ to which the DRE is communicated and the place where it is implanted, among other factors.

When the DRE supplies the function of both sphincter and reservoir as shown in figure 2, unlike a DRE that only supplies the sphincter function as shown in figure 1, it requires a container, a mechanism for emptying and other elements, for this reason the EB is different. This type of EB binds to living tissue in the same way as tubular EB, through a tubular structure and through the EU. This tubular structure that is part of the EB and that is attached to the container (constituent part of the EB that contains the reservoir) we will call it "receptor appendage" (AR), this has as function to be in continuity with the EU and to be fixed to the intestinal and / or urinary tract. In another point of the EB and being constituent of it is another tubular structure (outer appendage, AE) which has the function of traversing the aponeurotic, muscular layers and the skin to put the DRE in contact with the extracorporeal medium.

The dimensions and shape of the container will be determined by the same factors mentioned above: Age, location, function, etc., as well as the position of the receiving appendix and the outer appendix between them and in relation to the container.

The container is a volumetric structure (hollow) constituent part of the EB that contains the reservoir, is made of biocompatible material, can be rigid, semi-rigid, or flexible, or have a combination of materials. It is in continuity with the recipient appendix and the outer appendix, that is, the EB of a DRE that supplies the sphincter-reservoir function of the intestinal and / or urinary tract, is a framework of biocompatible material consisting of two tubular structures ( appendices) and a container, which contains and serves as a fixation to the reservoir, the sphincter mechanism, the sensor system, the emptying mechanism and the rest of the elements.

The recipient appendix found the EU that is in permanent continuity with the EB, close to the EU (0.2, 2.0 cm), we found in the interior of the receiving appendix the fixation or anchoring of the proximal unidirectional valve (VUP), part of the sphincter mechanism, as mentioned above the fixing means may be of different types: pressure, bellows, thread, etc., so that the VUP can be removed easily, this mechanism of fixation must ensure that the material that crosses the VUP does not present escape to the container, but is stored in the reservoir. In the outer appendix (A Ext), tubular structure, we will find two fixing elements or devices that form the EB one for the distal unidirectional valve (VUD) and another more external for the aesthetic element (EE). The one destined for the VUD will have the same characteristics as the one mentioned for the VUP. The one that will fix the aesthetic element, may be pressure, bellows, thread, etc., must comply with the characteristic of withdrawing and repositioning easily in such a way that it does not suffer any deformation, due to constant use.

The BS will have various devices or fixation elements for the other DRE systems and mechanisms, these fixation means or devices will depend on the different types of sensor systems, emptying mechanisms, reservoirs, sphincter mechanisms, etc. that are used and are part of the DRE; The forms, dimensions, structures and materials of the EB will vary depending on these same factors. 3. Reservoir (R) The reservoir is a flexible impermeable material bag, whose main function is to receive and store the intestinal and / or urinary material, coming from these organs respectively. It is located inside the container (EB) and is fixed to the receiving appendix on one side and the outer appendix on the other. The reservoir can be attached to the sphincter mechanism (VUP and VUD), that is, the bag can contain the two valves that constitute the esfmterian mechanism and be placed and removed together, therefore, these two elements would be fixed at the same site in the EB. A second possibility is that there are separate fixation devices, different in the BS, intended to fix the bag (reservoir) and the sphincter mechanism (VUP and VUD) separately. In this same sense the sensor mechanism can be included in the reservoir; pressure sensors, distensibility sensors, electrical, of any others, can be included in the walls of the bag and be extereorizados and replaced at the same time of the replacement of the reservoir. 4. Sphincter Mechanism (ME) The sphincter mechanism is formed of a system of valves that can be made of different materials (plastic, silicone, metal, etc.) or a combination thereof.

The sphincter mechanism is characteristically constituted by a unidirectional valve proximal to the DRE binding site with the intestinal and / or urinary tract (VUP), within the lumen of the recipient appendix a few millimeters from the EU and another unidirectional valve that is located near the point where the DRE crosses the corporal structures towards the outside in the light of the outer appendix (VUD), a few millimeters from the fixation site of the aesthetic element. Both valves are fixed to the EB by means of a clamping mechanism that can be pressure, bellows, thread, etc. Allows valves to be removed easily from the outside. The function of the VUP is to allow the passage of intestinal material or urine that comes from the organ communicated with the DRE through the EU, without this material penetrating the container, but only flows into the reservoir and prevents reflux into the organ lumen. as the pressure inside the reservoir increases. The VUP can be in continuity with the bag that forms the reservoir, is fixed in the same place in the EB and therefore can be removed and placed at the same time, another possibility is that the VUP has an anchor site in the EB by separated from the reservoir and it is only removed independently.

The VUD is a unidirectional valve that is made with the same materials as the VUP, is fixed to the EB by a mechanism that allows its replacement easily. This valve, due to its proximity to the outside and to be the access route to the reservoir from the outside, has its own characteristics that differentiate it from the VUP. This valve has the function of preventing the passage of material that is in the reservoir towards the outside of the body, however, this impediment to emptying the reservoir, will be controlled, voluntarily by the user through the mechanism of draining the DRE, that is, the VUD will be in close relation to the emptying mechanism. The VUD as well as the VUP may be in continuity with the bag that forms the reservoir and have a fixation site with the EB of the whole set, or separately. Finally, the VUD is also closely related to the sensor system.

. Sensor System (SS) The sensor system (SS) has the function of detecting the state in which the reservoir is located (full or empty) and alerting the DRE user to this information.

The SS can fulfill the function of establishing the degree of filling of the reservoir by means of one or several of the following factors: The pressure inside the reservoir. The pressure in the space that exists between the wall of the bag that forms the reservoir and the EB container. The degree of distension of the bag that forms the reservoir. The pressure exerted on the VUP or on VUD. The pressure exerted on the reservoir. The distance between a specific site of the reservoir wall and another specific site on the wall of the container. The contact of the reservoir with the wall of the container. The level of the material inside the reservoir.

The function of the SS to detect the filling state of the reservoir, will allow the necessary use of microsensors: Tires, pressure, electrical, mechanisms, etc., which will be located depending on the case of EB, in the reservoir, in the VUP , in the VUD, or in some other element of the DRE according to the case and will be transported by these structures as required.

The function of notifying or alerting the reservoir filling conditions to the DRE carrier may be by electrical stimuli in the skin surrounding the aesthetic element, or may carry this stimulus to the sensory nerve roots in the sacral plexus by microelectrodes, or in mechanical form and pressure transmission of the interior of the reservoir on a device that is on the surface of the aesthetic element. 6. Vacuuming Mechanism (MV) The function of the emptying mechanism is to evacuate the material that is inside the reservoir. It must act in coordination with the SS, and with the VUD to achieve its objective. The evacuation mechanism can be of different types: Mechanical, Electrical, Pneumatic and Mixed. Mechanical.- The contents of the reservoir can be evacuated manually and mechanically by the same DRE carrier or somebody by introducing a probe into the reservoir and irrigating it, in this case the VUD will have to allow the passage of the probe without this fact losing its ability to prevent the exit of the material contained in the reservoir after the removal of the probe.

The contents of the reservoir can be evacuated by compressing it by means of a device that is fixed in the EB, being able to be: bellows, piston, etc. and powered by an electric or pneumatic mechanism.

Pneumatic.- By insufflation of air in the space between the reservoir and the container from the outside by the action of a hand pump or other, this will cause increased pressure, in this space and on the reservoir producing the output of its content towards the site of least pressure. In this case, the VUD will allow the contents of the reservoir to exit at a pre-established pressure.

The elements that make up the emptying mechanism, as well as the sensor system, will be included in the rest of the elements that constitute the DRE, mainly in the EB. 7. - Aesthetic Element The Aesthetic Element is a plastic cap, which is fixed in the outer part of the outer appendix of the EB and has the function of occlude the entrance to the DRE and take care of the aesthetics of the carrier, so it must be the same skin color of this one. Another function that fulfills is to serve as input to the interior of the DRE of other systems that are part of DRE, such as DD, MV, among others, in addition on its external surface can host some part of the SS that the carrier can see easily. 8. - Fixing element (EF) This element has the function of serving as a fixation point between the whole of the DRE and the bodily structures that they decide to use for their fixation is on the outer surface of the basic structure and forms part of it the EF can be an extension of the EB, or be of another biocompatible material that is attached to it.

Claims (17)

Claims Having described the present invention, this is considered a novelty, for which the content of the following clauses is claimed:

1) Sphincter reservoir prosthetic device, which fulfills the functions of the spinal-reservoir of the intestinal and / or urinary tract in humans, which is attached to the intestinal and / or urinary tract permanently and imperviously inside the body human; the device is a structure of biocompatible material, which transports, stores and expels urine and / or intestinal material that the carrier produces, characterized because it consists of the following elements: a) Binding element, which is in continuity with the tissue parts I live and with the basic structure; b) Basic structure, is the framework of the reservoir-sphincter device, when the device only supplies the sphincter function, the basic structure is constituted by a cylinder (tubular structure), the basic structure constitutes at one of its ends, the receiving appendix where we find the element of union, close to this we find the mechanism of fixation or anchoring of the proximal unidirectional valve, which can be held by means of a system of thread, bellows, pressure; at the other end of the basic structure we find the outer appendix, where the aesthetic element is located, and the unidirectional distal valve (only allows drainage), with similar characteristics as the first, these valves may be fixed to the basic structure, or may be replaced; between the receiver and the outer appendix is the container, which is a volumetric structure, inside or forming part of the basic structure are: c) Reservorio, is a bag of flexible waterproof material, whose function is to receive and store the materials coming from the intestinal and / or urinary tract, it is fixed to the receiving appendix on one side and the outer appendix on the other, being able to be united the reservoir to the unidirectional valve proximal and to the distal unidirectional valve, permanently so that it may be removed jointly with the reservoir, and the valves, or the reservoir and valves may be removed separately, depending on the fixation system; d) Sphincter Mechanism, the mechanism is formed by the valves: one of them, located in the receiver appendix near the joining element and the other, in the outer appendix, valve close to the aesthetic element, both valves attached to the basic structure, allow the passage of waste substances to the reservoir or to the outside, valves may be removed when they suffer some deterioration from the outside, or failing that, when they are fixed to the reservoir remove them in the company of all the elements that are in it; e) Microsensors, detect the filling state of the reservoir which can be: pneumatic, pressure, electrical, mechanisms, which will be installed in the basic structure, in the reservoir, in the valves, these microsensors will have the function of transmitting stimuli to the skin surrounding the aesthetic element in order to alert the wearer of the filling level of the reservoir, or to carry the stimuli, to the sensory nerve roots in the sacral plexus by microelectrodes, mechanically or by pressure on a device located on the surface of the aesthetic element; f) Emptying Mechanism, mechanism that acts through the interaction of the rest of the systems that make up the device, whose objective is to evacuate the material that is in the reservoir, this can be carried out by a system ) mechanically, that is, a probe will be introduced through the outer appendix, into the reservoir, through the unidirectional distal valve, draining the contents of the reservoir by means of water irrigation, or by compressing the reservoir by a device that is fixed in the basic structure, can be by means of a bellows, piston, driven by a pneumatic or electric system b) Pneumatic, by means of insufflation of air between the reservoir and the container from the outside, g) Aesthetic element is fixed in the outer appendix of the basic structure, serves as cap, looks after the aesthetics of the carrier, h) Fixing elements, fix the reservoir-sphincter device, to the body structure, fixation is achieved by means of extensions of the basic structure.

2) Reservoir-sphincter prosthetic device, in accordance with clause 1, characterized in that the union with human living tissue is permanent and impermeable, being located in the receiving appendix, protruding from this structure a few millimeters or centimeters, in addition to being part of the reservoir device sphincter.

3) Sphincter reservoir prosthetic device, in accordance with clauses 1 and 2, characterized in that the device, give it shape and dimensions according to the physiological functions that it supplies, that is, reservoir and / or sphincter, and the supplying organ.

4) Sphincteric reservoir prosthetic device in accordance with clauses 1 to 3, characterized in that the reservoir-sphincter device is permanently implanted from the connecting element to the outer appendix.

5) Prosthetic-sphincter prosthetic device, in accordance with clauses 1 to 4, characterized in that the basic structure is a frame, in which it is attached to the joint element, located in the receiving appendix and to the aesthetic element, located in the outer appendix and between these is located the container that is a hollow structure.

6) Prosthetic-sphincter prosthetic device, with clause 5 characterized in that in the receiving appendix and outer appendix the clamping elements are located, which fix the reservoir and valvular system by means of pressure, thread, bellows, etc. The unidirectional valves proximal or distal respectively, whose function is to allow the passage of waste substances to the reservoir to subsequently drain them.

7) Reservoir-sphincter prosthetic device, in accordance with clauses 5 and 6, characterized in that the valves, when connected to the reservoir by a mechanical system, can be removed from the outside.

8) Prosthetic-sphincter prosthetic device, in accordance with clauses 1 to 7, characterized in that the basic structure of the sphincter reservoir device passes through the musculoaponeuratic section and the rest of the layers to the outside of the body.

9) Prosthetic-sphincter prosthetic device, in accordance with clauses 1 to 8, characterized in that the reservoir is located inside the basic structure, whose function is to store substances produced by the carrier, the reservoir is a flexible waterproof bag .

10) Reservoir-sphincter prosthetic device, in accordance with clauses 1 to 9, characterized in that inside the basic structure is located the sphincter mechanism, which is formed by a unidirectional valve proximal and a distal, which allow the step of substances in one direction in order to drain them outwards.

11) Reservoir-sphincter prosthetic device, in accordance with clauses 1 to 10, characterized in that inside the basic structure are located the sensor systems, found in the same basic structure, in the reservoir, in the valves; the sensors can be pneumatic, pressure, electrical, mechanisms and the projection of the stimulus will be towards the aesthetic element or take this stimulus to the sensory nerve roots in the sacral plexus through microelectrodes.

12) Reservoir-sphincter prosthetic device, in accordance with clauses 1 to 11, characterized in that the filling degree of the reservoir can be measured by: pressure inside the reservoir, degree of distension of the pouch that forms the reservoir, pressure in the valves, by contact of the reservoir with the wall of the container, level of material inside the reservoir.

13) Prosthetic-sphincter prosthetic device, in accordance with clauses 1 to 12, characterized in that the emptying mechanism acts in combination with the sensor system and with the distal and proximal unidirectional valve, evacuates the contents of the reservoir, achieved by means of of a mechanical, electrical, pneumatic or combination of them.

14) Reservoir-sphincter prosthetic device, in accordance with clauses 1 to 13, characterized in that the esthetic element is located in the outer appendix, this is a stopper, prevents waste substances from escaping, which can subsequently be drained.

15) Reservoir-sphincter prosthetic device, in accordance with clauses 1 to 14, characterized in that the aesthetic element gives the wearer a good appearance.

16) Reservoir-sphincter prosthetic device, in accordance with clauses 1 to 15, characterized in that the reservoir can be exchanged with all its parts or only some parts through the outer appendix.

17) Reservoir-sphincter prosthetic device, in accordance with clauses 1 to 15, characterized in that the sphincter reservoir device consists of prolongations in order to be able to support it to the body structure.