WO2019077188A1

WO2019077188A1 - Continent colostomy device

Info

Publication number: WO2019077188A1
Application number: PCT/ES2018/070682
Authority: WO
Inventors: Francisco Javier PÉREZ LARA
Original assignee: Servicio Andaluz De Salud
Priority date: 2017-10-18
Filing date: 2018-10-18
Publication date: 2019-04-25
Also published as: ES1196036Y; ES1196036U

Abstract

The invention describes a device (1) for a continent colostomy, which can be installed inside the abdominal wall (PA) of a patient and comprises: an inflatable element (2) with a longitudinal central hole (21) for the passage of the large intestine (IG), which passes through a stoma (E) of the patient, said element being configured to switch between a deflated configuration in which the central hole (21) has a first diameter, and an inflated configuration in which the central hole (21) has a second diameter smaller than the first diameter; a reservoir (3) for storing fluid, connected to the inflatable element (2); and a drive pump (4) for driving the fluid between the reservoir (3) and the inflatable element (2), to cause said inflatable element (2) to switch between the deflated and inflated configurations.

Description

DEVICE FOR CONTINENT COLOSTOMY DESCRIPTION OBJECT OF THE INVENTION

The present invention belongs in a general way to the field of medicine, and more particularly to the devices used in the closure of an ostomy, such as for example a colostomy.

The object of the present invention is a new device designed to improve the sealing of a conventional plug for colostomy.

BACKGROUND OF THE INVENTION

An ostomy is an operation performed in order to create a stoma for an organ or viscera located at a point other than the natural orifice of excretion. The term "stoma" means "mouth" or "opening", so an ostomy provides a new way out to the outside for the organ or viscera in question. There are different types of ostomies, although the most frequent is the colostomy. A colostomy involves connecting the large intestine to the wall of the abdomen, creating a stoma through which the severed end of the large intestine is connected to allow the exit of the stool. The realization of a colostomy is motivated by the elimination of the colon and possibly a section of large intestine due to ailments such as cancer.

A colostomized patient should collect stool in a leaky bag through the stoma located in his abdomen. However, the stoma created does not have a sphincter, as it does in the anus, and for that reason stools can come out at any time. This forces the patient to a very frequent care and attention of the state of the stoma, which constitutes an important discomfort.

To solve this problem, there are currently obturator devices particularly designed to temporarily seal the stoma and thus simulate the function performed in the anus by the sphincter. Figs. 1A and 1B show an example of shutter (100) of this type. The obturator (100) essentially comprises a plug (101) provided with a central stem (102). The plug (101) has a generally circular and essentially flat shape, and is designed to adhere to the patient's skin covering the stoma (E) formed in the abdominal wall (PA). The central stem (102) is lubricated to facilitate its introduction through the stoma (E) and has an expansion mechanism at its distal end (102a). This expansion mechanism can be of the inflatable type. Alternatively, it can work thanks to the use of materials that swell when coming into contact with body fluids. In any case, as shown in Figs. 2A-2C, once the central stem (102) is introduced through the stoma (E) and its distal end (102a) protrudes from the inner side of the abdominal wall (PA), said distal end (102a) expands. Thanks to this, the obturator (100) is anchored in the stoma (E) and prevents the undesired exit of the feces, which are stored inside the large intestine (IG).

This type of obturators (100) ostensibly improve the quality of life of colostomized patients, providing them with a certain ability to contain feces that gives them autonomy. However, sometimes the pressure exerted by the feces from inside the large intestine (IG) causes loss of stool. These losses can find a way out through the stoma (E) by the sides of the distal end (102a) of the central stem (102) and appear below the plug (101), causing problems for the patient.

Therefore, there is still a need in the art for improved obturators that are capable of ensuring that the colostomy is watertight.

DESCRIPTION OF THE INVENTION

The present invention describes a new device for continent colostomy that solves the above problems thanks to the fact that, when used in combination with a conventional obturator of the type described above, ostensibly improves the sealing of the closure. This device allows opening and closing of the exit of the stoma at will of the patient thanks to an inflatable element that can pass between a swollen configuration in which the closure provided by the conventional obturator is completely watertight and a deflated configuration in which the patient You can remove the obturator to empty the contents of the large intestine.

The device for continent colostomy of the present invention, which is installable inside the abdominal wall of a patient, basically comprises the following elements: an inflatable element, a reservoir of fluid, and a pump of impulsion. Next, each of these elements is defined in more detail. a) Inflatable element This is an inflatable element comprising a longitudinal central hole configured for the passage of the large intestine that passes through the patient's stoma. The longitudinal direction refers in this context to the main direction of a central axis of the hole, which when installed will coincide with a direction perpendicular to the skin of the patient along which the stoma extends. Therefore, this inflatable element is arranged around the stoma, housed inside the abdominal wall, so that the large intestine and the stoma itself pass through said longitudinal central orifice. The inflatable element is configured to alternate between a deflated configuration where the central hole has a first diameter and a swollen configuration where the central hole has a second diameter smaller than the first diameter. Note that, in this context, the term "diameter" does not necessarily have to refer to a strictly circular diameter, but refers generically to the transverse dimension of the orifice of the inflatable element. In other words, when the inflatable element swells, the central orifice narrows and compresses the tissues that pass through it. The central orifice of the inflatable element further comprises a longitudinal groove for receiving the blood vessels of the large intestine. In effect, the blood vessels that supply blood to the large intestine extend along it in an essentially longitudinal direction of the intestine itself. Excessive pressure on these blood vessels could make it difficult to irrigate the end portion of the intestine connected to the stoma, which could cause necrosis and other related problems. The longitudinal groove of the central orifice of the inflatable element houses the blood vessels of the intestine so that, when the inflatable element passes into its swollen configuration and pressure is exerted on the walls of the end of the large intestine connected to the stoma, said blood vessels are not compressed in excess and irrigation can continue to reach all parts of said end of the large intestine.

In a particularly preferred embodiment of the invention, the longitudinal central orifice has a shape whose cross-section gradually tapers in the longitudinal direction from an inner, wider end to an outer, narrower end. For example, the central hole could have an essentially conical shape, so that when the inflatable element is housed inside the abdominal wall of the patient around the stoma the outer end, located on the outer side of the stoma, would be narrower than the inner end, located on the inner side of the stoma. This allows the support of the expanded distal end of the obturator stem against said second end of the inflatable element to be improved to prevent the likelihood of leakage, since as the accumulated stool in the intestine exerts pressure on the expanded distal end of the obturator, it it enters and fits more and more into the conical central hole, thus increasing the tightness of the closure.

In principle, the inflatable element can be configured in any way provided it has the characteristics described in the previous lines. In a preferred embodiment of the invention, the inflatable element may comprise a single inflatable cavity, for example of essentially toroidal or cylindrical shape. In another particular embodiment of the invention, the inflatable element may comprise several inflatable cavities interconnected with each other. This second particular embodiment has the advantage that the central hole could have a straight prism shape naturally endowed with several longitudinal grooves suitable for receiving the vessels of the large intestine. b) Reservoir of fluid It is a reservoir of fluid storage connected to the inflatable element. The connection can be carried out by means of a conduit or the like through which the fluid stored in the reservoir could pass, depending on the needs of the patient, from the reservoir to the inflatable element and vice versa. The reservoir will have a suitable shape for implantation under the skin of the patient in an area of the abdomen close to the position of the stoma. The fluid used will normally be saline. c) Drive pump

The impulse pump allows the fluid between the reservoir and the inflatable element to be urged for the purpose of alternating said inflatable element between the deflated configuration and the inflated configuration. The pump may be located, for example, in a conduit that interconnects the reservoir with the inflatable element. The pump, which will also be lodged under the skin of the patient in an area of the abdomen close to the position of the stoma, will be manually operated by the patient himself in a simple manner.

The drive pump may further include a blocking valve that helps prevent the return of fluid stored in the inflatable element when in its swollen configuration, which allows the fluid to be retained inside the inflatable element in its swollen configuration.

The operation of this device for continent colostomy would be fundamentally the following. First, by means of a simple surgical operation, the proposed device is installed under the skin of the patient. The inflatable element, in its deflated configuration, is disposed housed inside the abdominal wall so as to surround the stoma to which the end of the large intestine is connected. The inflatable element is in communication, through an interconnecting conduit, with the reservoir also installed under the patient's skin in a place close to the stoma in the abdomen of the patient. The delivery pump is also housed under the patient's skin at some intermediate point of the interconnecting conduit between the reservoir and the inflatable element. Once the device of the invention is installed, the patient can start to use it in combination with a conventional obturator. For this, a conventional obturator of the type described above is available in the stoma. The conventional obturator is formed by an essentially flat cap, which covers the outer end of the stoma and the surrounding skin, and a lubricated stem with an expandable distal end that is inserted along the stoma orifice.

In this situation, the patient acts through his skin on the delivery pump to pass the inflatable element from the deflated configuration to the inflated configuration. As a result, the orifice of the inflatable element passes from the first diameter to the second, smaller diameter, thus compressing the inner walls of the stoma against the outer walls of the stem of the conventional obturator. As a consequence, the distal end of said plug stem, which is in the expanded position, is trapped in a more secure manner against the second end, or inner end, of the inflatable element. Furthermore, the actual pressure exerted by the faeces during the use of this device tends to increase the strength of the support of the expanded distal end of the obturator stem against the inflatable element, thereby tending to improve the sealing of the achieved closure.

BRIEF DESCRIPTION OF THE FIGURES

Figs. 1 a and 1 b show respective perspective views of a colostomy obturator according to the prior art respectively with the distal end of the stem before and after the expansion.

Figs. 2a-2c show a sequence of operations for the installation of a colostomy obturator according to the prior art. Figs. 3a and 3b show respective schematic views of an example of device for colostomy respectively in deflated configuration and in swollen configuration according to the present invention.

Figs. 4a and 4b show an alternative example of an inflatable element according to the present invention. Figs. 5a and 5b show an alternative example of an inflatable element according to the present invention. Figs. 6a-6c show a sequence of operations representative of the operation of a device example according to the present invention.

PREFERRED EMBODIMENT OF THE INVENTION The present invention is described below with reference to the attached figures. Figs. 3a and 3b show the device (1) for colostomy of the present invention respectively in its deflated and inflated configuration. As can be seen, the device (1) is formed by an inflatable element (2), a reservoir (3) of fluid, and a pump of impulsion (4).

The inflatable element (2) in this example is formed by a single cylindrical inflatable cavity having a central hole (21) of essentially constant cross section of circular shape. The orifice (21) reduces its diameter when the inflatable element (2) passes from the deflated configuration shown in Fig. 3a to the inflated configuration shown in Fig. 3b. A longitudinal groove (22) of substantially semicircular cross section runs through the inner wall of the central hole (21) from the first end of the inflatable element (2) (the upper end according to the position of the figure) to the second end of the element (2). ) inflatable (the lower end according to the position of the figure). This groove (22) is designed to house in its interior the blood vessels that irrigate the large intestine in order not to compress them excessively during the use of the device (1).

A conduit in which the impulse pump (4) is arranged connects the inflatable element (2) with the reservoir (3). Both the reservoir (3) and the impulse pump (4) are represented schematically by parallelograms, although they obviously have a cornered shape suitable for implantation under the skin of the patient's abdomen. The reservoir (3) can be made of an elastic material and usually contains a fluid such as saline or the like. The impulse pump (4) is of reversible operation, so that it can drive the fluid initially contained in the reservoir (3) both in the direction of inflation of the inflatable element (2) (to the right according to the position of the figure) to pass the device (1) to the inflated configuration shown in Fig. 3b, as in the direction of deflation of the inflatable element (2) (to the left according to the position of the figure) to pass the device (1) to the deflated configuration shown in Fig. 3a.

Figs. 4a and 4b show an alternative example of inflatable element (2) formed by three inflatable cavities of straight prismatic shape of approximately oval or rectangular section with rounded edges that are connected along one of their generatrices. As a consequence of this configuration, the central hole (21) has a substantially constant cross section of approximately triangular shape provided with three vertices that can exert the function exerted by the groove (22) in the device (1) of Figs. 3a and 3b. When the three cavities swell, their size increases and as a consequence the cross section of the central hole (21) is reduced.

Figs. 4a and 4b show another alternative example of inflatable element (2) formed by two inflatable cavities of straight prismatic shape of essentially elongated and curved section that are connected along the guidelines located at the respective ends of said elongated shape. The central hole 21 has in this case an essentially constant cross section of elongated shape. When the two cavities swell, their size increases and as a consequence the cross section of the central hole (21) is reduced.

Figs. 6a-6c show a sequence of operations for the use of a device (1) according to the invention. The device (1) of this concrete example comprises an inflatable element (2) formed by a single cavity provided with a central hole (21) of decreasing cross section from a wider inner end (the lower end according to the position of the figure) towards a narrower outer end (the upper end according to the position of the figure). That is, the central hole (21) has an approximately conical shape for the reasons that will be explained later in this document. Before using the device (1) of the invention, a surgical operation is performed simple to install the inflatable element (2), initially in its deflated configuration, inside the abdominal wall (PA) of the patient. The installation is performed by ensuring that the blood vessels of the end of the large intestine (GI) are housed within the groove (22) (not shown in Figs 6a-6c). The reservoir (3) and the delivery pump (4) are also installed under the skin of the patient in the area of the abdomen near the stoma (E) (these elements are not shown explicitly in Figs 6a-6c).

Once the device (1) is installed, the patient places a conventional obturator (100) in the stoma (E): introduces the stem (102) through the stoma (E) until the cap (101) is stuck on the skin of the patient on the outside of the stoma (E); then, the expandable distal end (102a) of the stem (102) expands, either by contact with the patient's fluids or through some other mechanism. The conventional obturator (100) is therefore installed in the conventional manner in the stoma (E). This situation is represented in Fig. 6a.

Starting from this situation, the patient operates the delivery pump (4) housed under the skin of his abdomen to pass the inflatable element (2) from its deflated configuration to its swollen configuration. As a consequence, the cross section of the central hole (21) decreases appreciably, compressing the end of the large intestine (IG) connected to the stoma (E), as well as the stem (102) of the conventional obturator (100). The vessels of the large intestine (GI), lodged in the groove (22), are not compressed in excess. The compression achieved by inflating the inflatable element (2) significantly increases the sealing of the closure provided by the shutter (100). This situation is shown in Fig. 6b.

Moreover, when feces accumulate in the large intestine (GI) cavity adjacent to the stoma, they can exert a certain pressure on the closure provided by the conventional obturator (100). In case the device (1) of the present invention is not used, it is possible that the faeces find an exit path along a space between the walls of the stem (102) and the lateral walls of the stoma (E) , with the disadvantages that this represents for the patient. On the contrary, when the device (1) of the invention is used, the pressure exerted by the faeces tends to displace the expanded distal end (102a) of the stem (102) of the conventional obturator (100) in the vertical direction according to the figure. Since in that In the direction of the cross-section of the central hole (21) gradually tapers, the consequence is that the greater the pressure exerted by the feces, the more strongly the distal end (102a) is fitted inside the central hole (21), and The more tight the closure is.

Claims

Device (1) for continent colostomy installable inside the abdominal wall (PA) of a patient, characterized in that it comprises:

- an inflatable element (2), comprising a longitudinal central hole (21) for the passage of the large intestine (IG) passing through the stoma (E) of the patient, where the central hole (21) comprises a longitudinal groove (22) to house the blood vessels of said large intestine (IG), and where the inflatable element (2) is configured to alternate between a deflated configuration where the central hole (21) has a first diameter and a swollen configuration where the central orifice (21) ) has a second diameter smaller than the first diameter;

- a reservoir (3) for storage of fluid connected to the inflatable element (2); Y

- a driving pump (4) for driving the fluid between the reservoir (3) and the inflatable element (4) for the purpose of alternating said inflatable element (2) between the deflated configuration and the inflated configuration.

Device (1) according to claim 1, wherein the longitudinal central hole (21) has a shape whose cross-section tapers gradually from an inner end to an outer end.

Device (1) according to claim 2, wherein the longitudinal central hole () has an essentially conical shape.

Device (1) according to any one of the preceding claims, wherein the inflatable element () comprises a single inflatable cavity.

Device (1) according to claim 4, wherein the inflatable element (2) has an essentially toroidal or cylindrical shape.

6. Device (1) for colostomy according to any of claims 1-3, wherein the inflatable element (2) comprises several inflatable cavities interconnected with each other.

Device (1) according to any of the preceding claims, wherein The driving pump (4) further comprises a blocking valve to prevent the return of the fluid stored in the inflatable element (2) when it is in its swollen configuration.