• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    Device for the collection of waste in patients with elimination stoma, comprising a bag (1) that is placed inside the body of a patient with colostomy or ileostomy and that collects the waste, avoiding all the disadvantages of the external bags. It also comprises a self-expander (2) for inserting the bag (1) and placing it properly, and means of attachment to the patient's body. The device of the invention can be attached to the adhesives currently used for securing external bags in patients that tolerate the adhesive without skin irritation problems, or it also has the possibility of self-fusing to the stoma by form in one of the preferred embodiments. Applicable in the sectors in which they design, produce and use devices for medical treatments or other medical therapies for dosing medicines or collecting samples. (Machine-translation by Google Translate, not legally binding)
    公开号:ES2598557A1
    申请号:ES201601046
    申请日:2016-12-01
    公开日:2017-01-27
    发明作者:José Ignacio RODRÍGUEZ GARCÍA；José Manuel Sierra Velasco；Marta VILLAZÓN SUÁREZ
    申请人:Universidad de Oviedo；
    IPC主号:
    专利说明:

    DESCRIPTION

    Device for waste collection in patients with elimination stoma.

    The present invention relates to a self-expanding device for placing a bag inside the body, which collects the waste in a patient who has undergone an intervention with a removal stoma such as a colostomy or ileostomy operation (digestive stoma removal) . It is proposed as an alternative solution against the known external colostomy bags, used for the collection of feces in patients who have undergone surgery and have a digestive stoma of elimination. 10

    The invention is therefore applicable in the sectors in which devices are designed, produced and used for medical treatments or other medical therapies for drug dosing or sample collection, such as in the technical sector of human medicine or animal, or that of chemistry and pharmacy. More specifically, the invention results in application in medical devices for ostomy patients.

    State of the art
     twenty
    A digestive stoma of elimination (ostomy) is a portion of the intestine that goes outside in the abdominal area (through surgery and through a hole), to remove organic waste that for some reason cannot be evacuated through the rectum. There are different types of stomata: in a colostomy the colon is exteriorized and in an ileostomy the ileum, and depending on the part that is exteriorized, the feces will have less than 25 or greater consistency.

    The function of the stoma is, therefore, that of allowing feces and gases to go outside. For the collection of these wastes, there are currently different solutions that help the patient to live a normal life and live with an ostomy, a condition 30 suffered between 2 and 4 per thousand adults in Western countries:

    to. External bags The bag is a collection system of feces and gases that is placed around the stoma or opening, necessary because continence is lost, that is, control over the time of evacuation. Within this type of 35 solutions there are several types of bags:

    • Closed or single use. The lower end is closed so that they cannot be emptied. These bags should be changed every time you want to discard the stool. They are recommended for transverse or 40 descending colostomies since the stool is more solid.

    • Open or of various uses. They have the bottom end open so it can be emptied and closed again. They are used when feces are liquid, that is, in ileostomies and ascending colostomies. You can also use 45 when there are diarrhea.

    The bags, whether closed or open, can also be:

    • One piece. The bag and the adhesive disc are joined in one piece. fifty
    • Of two pieces. The adhesive disc is separated from the bag and remains on the skin while the bag is changed as open or closed.

    b. Plug stopper. It is a device similar to a plug that is inserted into the stoma and does not allow any escape during the time it is applied. No 5 causes noise or smell when carrying a built-in filter, and gives the patient some independence. The maximum time that can remain safely depends on each person. It is not always possible to use it but, when it is, it provides great comfort and security in social relationships.
     10
    C. Irrigation by colostomy. This technique involves the introduction of water at body temperature through the stoma. When water is introduced, as a consequence of the distention of the colon, contractions occur that cause the expulsion of the fecal content. Complete evacuation of the colon leaves the intestine empty and capable of retaining all the fecal material formed until the next irrigation 15 (an average of 48 hours). The same patient can apply it once a professional has shown him how to do it.

    The most used solution for the collection of waste in this type of patients are the aforementioned external bags, which are attached to the patient's body by means of a special adhesive disc. As previously indicated, these bags have different formats but in all of them there are a series of inconveniences arising from the presence of the collection bag on the outside of the body.

    Among these inconveniences, it is worth mentioning, since they are the most traumatizing for the patient, a decrease in the quality of life, especially in relation to body image, difficulties in carrying out certain activities and the recurrent appearance of irritations-eczema peri colostomy due to the contact of the faeces with the skin, due to the difficulties of achieving a perfect coupling of the adhesive disc to the edge of the stoma and that the wastes go outside, or also due to sensitive skins that react in front of the adhesive disc.

    Thus, although most of the bags are fixed with adhesive discs (fig. 1.A), in cases where there is intolerance to it, manufacturers also offer fastening systems based on a kind of belt, which can complement the use of adhesive discs 35, very useful in cases of retraction or sinking of the stoma in the wall (fig. 1.B). This type of belt is also used for the aforementioned irrigation technique.

    In recent years, with the proliferation of such interventions (stomata), a large number of inventions have emerged that revolve around collection systems 40 based on the outer bag and the disc attached to the skin around the stoma, of which we highlight below the most relevant.

    As mentioned, colostomy bags are usually fixed by an adhesive disc to the skin around the stoma. In two-piece devices the bag 45 can be fixed to the adhesive disk by a mechanical system that incorporates the "click function", making a sound when both parts fit together and giving the user greater security. In this sense, in patent document WO 2011/015201 A1, a ring is used that serves as a guide and helps the patient to fix a bag and disk attached to the skin.
     fifty
    Patent document ES 2015678 A6 describes a shutter system for patients operated on terminal colostomy, whose cover has a housing for a check valve, and by means of a plug as a rubber balance that can be inflated by air, closure is achieved.
     5
    In reference document WO 2015/048446 A1, a colostomy bag with a mechanical anchoring system with a ring that rotates a quarter turn, and a manual bag emptying system is described.

    In the reference patent document US 2014/0364823 A1, a controlled discharge ostomy device is described.

    In patent document W02015 / 1864452 A1, a system for fixing the stoma bag to the fixed disc to the skin is described, which has an auxiliary bag that prevents losses. fifteen

    Finally, in the patent document ES 2241592 a continent opening for the ostomy is described, which has the peculiarity that it can be fixed to a stoma for a long-term location (29 days), without the use of adhesives, belts, bandages or revisionist surgical measures, and allows the user to be, in fact, 20 “continent.” The system also allows irrigation or emptying of the ostomy without removing the stoma opening, by using specially designed adapters in combination with the new opening continent.

    All the patents listed focus on the fixation systems of the bags to the 25 discs fixed to the skin and on the problem linked to the possible malfunction of these devices, as well as guaranteeing the safe closure of the stoma, preventing leaks. However, they use external bags and / or need a system with adhesive, not giving the option, on the one hand, the possibility of not carrying the bag externally and, on the other hand, to use a fixing system that may not be based in the use of 30 adhesive discs.

    Description of the invention

    The present invention relates to a device suitable for waste collection in patients with disposal stoma.

    For the purposes of this invention and its description, waste refers to any material that is desired to evacuate from the body of a patient, such as solids, liquids, fluids, gases or other intermediate or compound forms such as mucous membranes, solutions, solutions, etc. An example of a residue is a patient's stool or urine. Another example of a residue is blood, serum, saliva, cerebrospinal fluid or other fluids or fluids produced by a patient or introduced into a patient.

    An object of the invention, therefore, is a device for waste collection in 45 patients with disposal stoma comprising:

    - A bag, with an internal face and an external face, insertable inside the body of a patient and that collects the waste on its internal face.
     fifty
    - A self-expander available on the outer face of the bag, which inserts and expands it inside the patient's body and that is fixed to the patient's body.

    - Means for fixing the self-expander to the patient's body.
     5
    In a preferred embodiment, the bag comprises a handle at one of its ends and an elastic band at another of its ends.

    In another preferred embodiment, the self-expander comprises at least three flexible sheets, which are deformed under pressure to introduce the device together with the collection bag 10 into the patient through the ostomy hole. Once inside the body, they expand to recover their initial shape, facilitating the opening of the bag for the collection of waste. In a possible application, the self-expander is introduced into the patient's body inside the intestine to perform an endointestinal waste collection. fifteen

    In another preferred embodiment, the self-expander comprises a fixed or attachable cover.

    In a more preferred embodiment, the fixing means comprise:
     twenty
    - An adhesive disc, consisting of a sheet adherent to the patient's skin with a connecting ring that can be attached to a fixing flange. The adhesive disc is normally placed around the ostomy hole.

    - A fixing flange attachable to the adhesive disk and the cover. 25

    In another more preferred embodiment, the elastic band of the bag surrounds the fixing flange by fixing one of the ends of the bag during the introduction, use and removal of the bag.
     30
    In another more specific embodiment, the fixing means comprise a self-expander which in turn comprises a attachable cover and cams that move during the coupling of the cover and the self-expander, and which fix the device to the patient's body.
     35
    In another more specific embodiment, the elastic band of the bag surrounds the self-expander fixing one of the ends of the bag during the introduction, use and removal of the bag.

    The device of the invention serves to place a waste collection bag inside the patient's body avoiding all the inconveniences described above in the state of the art, providing a better acceptance of body change and greater comfort.

    In one of the variants of the invention, the fixing means do not include adhesive elements to the patient's skin, which also prevents skin disorders, among others. By this embodiment, only one cover or retaining ring remains externally. To facilitate the placement of the bag, there is a self-expander that serves as an applicator to insert and remove it from inside the body. In a possible materialization of the self-expander, it is formed by a cylindrical body and three (or more) "legs" in 50
    flexible material, and with a shape and a material that gives it the characteristic of being self-expanding.

    The bag is positioned in such a way that the external part of it does not come into contact with the collected material at any time or when it is placed or when it is removed. In this way, irritation of the skin around the stoma is avoided and subsequent manipulation is greatly facilitated.

    The device object of this patent allows its application to the collection of feces in patients with endointestinal stoma. With the device, the bag that collects the feces inside the patient's own intestine can be accommodated, thus allowing there to be no external sign of the colostomy. and can be used instead of an external bag, permanently or for certain periods of time. This ensures that the patient does not feel uncomfortable by not having to carry the stool bag attached to his skin. fifteen

    In another embodiment of the system, this can be attached to commercial adhesive discs that are currently used for securing external bags without modifications thereof. in patients who tolerate the adhesive without skin irritation problems. You also have the possibility to self-fix the stoma by shape, in one of the 20 preferred executions in which cams are used.

    The device presented here consists of formal elements that allow it to be adapted to different sizes of stomata by customizing the device by manufacturing it with additive manufacturing techniques and parametric design. 25

    The invention is applicable in the sectors in which devices are designed, produced and used for medical treatments or other medical therapies for drug dosing or sample collection, and in particular in the health sector and in those patients with stoma, which It has the function of allowing feces and 30 gases to go outside.

    Description of the figures

    Fig. 1 corresponds to the State of the Art (E.T.) and represents several ways of fixing the bags on the body of a person, seen frontally. In Fig. 1A a bag fixed by adhesive disk is shown. A fastening of a bag based on a belt is shown in Fig. 1B, which can complement the use of adhesives.
     40
    Fig. 2 shows an exploded three-dimensional view of the system with the elements that constitute it (except the bag (1) that is not represented here) in the embodiment intended to be used with an adhesive disk (5). Thus, the adhesive disk (5), the fixing flange (4) to the adhesive disk (5), the self-expander (2) based on three flexible sheets and a cover (3) can be seen. Four. Five

    Figure Fig. 3 shows a view of the assembled anterior assembly (that is, with the pieces fitted together). A profile view can be seen in Fig. 3A and a three-dimensional view of the assembly in perspective can be seen in Fig. 3B. In these figures the bag (1) is not represented. fifty
    Figure Fig. 4 shows some of the components of the device of the invention. In Fig. 4A, in the center you can see the disc with adhesive (5), in which the T-shaped flange can be seen, on which the normal external colostomy bags adhere, and to which it can be fixed the device object of this patent. In the same figure, the fixing flange (4) attachable to the adhesive disk (5) capable of being fixed by pressure to the adhesive disk (5) can be seen. In addition, a section of an abdominal wall in which an ostomy has been performed can be seen to the left of the figure. In Fig. 4B the self-expander (2) is appreciated, a piece consisting of at least three flexible sheets with one free end and with the other fixed to a cylindrical body, and a plug (3) can also be seen on the right to the self-expander (2), with a hole through which one of the ends of the bag (1) can pass. Fig. 4C depicts a bag (1) with a handle or handle (7) attached to the closed end of the bag (1), which can be folded and attached to the lid (3). On the open side the bag (1) is an elastic band (8) on the edge, which helps to fix it.
     fifteen
    Figure Fig. 5 shows the device of the previous figures in different phases of use. In Fig. 5A, Fig. 5B, Fig. 5C, Fig. 5D, Fig. 5E, Fig. 5F and Fig. 5G, the sequence of use of the device is graphically described. The figures show a section of an abdominal wall in which an ostomy has been performed.
     twenty
    First, as shown in Fig. 5A and Fig. 5B, the adhesive disc (5) adheres to the patient's skin, around the ostomy hole. Then, as seen in Fig. 58, the connecting ring or connecting flange (4) is fixed (snap-fit) to the adhesive disk (5). Then, according to Fig. 5C, the self-expander (2) and the cover (3) of the self-expander (2) are disposed, and the side of the closed bag 25 (1) is inserted inside both. Next, according to figure Fig. 5D, the side of the opening of the bag (1), which has an elastic ring (8), is fixed to the fixing flange (4), which has shape waits to hold the bag (1), which can be the same that serve to fix the assembly through the closing cover (3) and thus fulfill a double function, or they can be different and specific for the function of fixing the bag (1) by its opening 30

    Then, according to Fig. 5E, with the fingers of the hand, pressure is exerted to close the flexible sheets of the self-expander (2) and the assembly is pushed as shown in Fig. 5F to introduce the bag into the intestine ( 1) and the device through the connecting ring or fixing flange (4), with the mouth of the bag (1) fixed to the same ring, which will never enter the patient's body. As shown in Fig. 5G, once inside, the sheets of the self-expander (2) tend to open the bag against the intestinal walls, facilitating the entry of feces into the part of the bag that is inside the flexible sheets.
     40
    The extraction process is reversed: the self-expander (2) is first released from the connecting ring (4) and the assembly is pulled by the handle (7) located at the closed end of the bag (1). Next, the fixing flange (4) of the adhesive disc (5) is released and the ostomy hole is closed with a temporary closure lid while preparing another internal bag or placing an external bag. Four. Five

    In Fig. 6 and Fig. 7 two three-dimensional models are shown in which the execution of the patent device can be seen with the possibility of self-fixing to the stoma by means of cams (6). The device, like the one described above, comprises a self-expander (2) with three or more flexible sheets. However, in this embodiment, the adhesive disc (5) is dispensed with, among others. The device comprises cams (6)
    swivels that guarantee closure by shape, all in one piece. The rotating cams (6) are pivoting which allows them to close on the inside of the self-expander (2) as the cover (3) is introduced, as can be deduced from Fig. 7. In this figure, it is introduced the cover (3) that, when moving in the self-expander (2), simultaneously pushes the cams (6), which rotate on its point of articulation and already open 5 inside the intestine, obtaining the closure that fixes the device to the body of the patient. In these figures the bag (1) is not represented.

    The assembly sequence of the self-fixing device of Fig. 6 and Fig. 7 is shown in Fig. 8 Thus, in Fig. 8A and Fig. 8B the way of placing the bag (1) is graphically described on the self-expander (2). In Figures Fig. 8C and Fig. 8D it is observed how the bag (1) and self-expanding assembly (2) is introduced first and, later, when the lid (3) is introduced, it activates the self-locking cams (6), guaranteeing thus fixing the device to the patient's body without the need for adhesives. Once inside. the cover (3) and the self-expander (2), by means of a turn, are fixed by way of ensuring the fixation of the device to the patient's body.

    Explanation of preferred embodiment

    For a better understanding of the present invention, the following 20 examples of preferred embodiment are described, described in detail, which should be understood without limitation of the scope of the invention.

    Example 1
     25
    This example describes a device to be fixed to the adhesive discs (5) used with the external commercial bags. In this case a prototype has been built, based on three-dimensional models in .stl format, which were sent to a 3D printer that works with different materials, which allows the choice of the material whose properties (resistance, elongation, ...) are the most appropriate according to part 30 of the device for which they are used.

    In this execution, the use of 3D printers is essential for personalization and adaptation to each particular patient, since by means of the 3D parameterized models of the different system components (see Fig. 2A and Fig. 3A), the 35 customization of the device, that is, diameters and lengths of the parts that make up the system can be varied.

    Specifically, for the self-expander (2) that includes at least three flexible sheets, and whose fundamental characteristic is that they are capable of deforming under pressure so that they can be introduced into the patient through the ostomy hole, it has been Nylon was used as input material in the 3D printer, which guarantees a rupture tension between 44 MPa and 48 Mpa, suitable for the estimated stresses on the device and, more importantly, it has an elongation in one of the planes of 30% manufacturing, which guarantees the flexibility that is required of the sheets of the self-expander.

    For the other parts that make up the device, specifically the fixing means (except for the self-expander), ABS has been used as input material in the 3D printer. This material has a breaking tension between 22 MPa and 50
    24 MPa, sufficient for the efforts to be supported, and has a low elongation of the order of 5%.

    Example 2
     5
    This example describes a device to be fixed to the patient by himself, without the need for the use of commercial adhesive disks normally used. In this case a prototype has been built, based on three-dimensional models in .stl format, which were sent to a 3D printer that works with different materials (ABS, PLA, nylon ...), which allows the choice of the material whose properties (resistance. 10 elongation, ...) are the most appropriate depending on the part of the device for which they are used.

    In this execution, the different system components were materialized using the parameterized models in 3D format (see Fig. 6 and Fig. 7), which allowed the personalization of the device, since in this way diameters and lengths of the parts that make up the system.

    In particular, for the self-expander (2) that includes at least three flexible sheets, and whose fundamental characteristic is that they are capable of deforming under pressure so that they can be introduced into the patient through the hole of the ostomy, it has been used nylon master material of contribution in the 3D printer, which guarantees a breaking tension between 44 MPa and 48 Mpa, suitable for the estimated efforts on the device and, more importantly, it has an elongation in one of the planes of 30% manufacturing, which guarantees the flexibility required of the self-expanding blades.

    For the other parts that make up the device, specifically the fixing means (except for the self-expander), ABS M30i has been used as input material in the 3D printer. This material has a breaking tension between 26 MPa and 30 31 MPa, depending on the construction axis, sufficient for the stresses to be supported, and has a low elongation between 2% and 7%, also depending on the position relative to the axes of construction. This material is especially suitable for medical devices that may be in contact with the skin, as is the case with the fixing means for this execution. 35
    权利要求:
    Claims (8)
    [1]

    1. Device for the collection of waste in patients with elimination stoma comprising:
     5
    - a bag (1) with an internal face and an external face insertable inside the body of a patient that collects the waste on its internal face;
    - a self-expander (2) available on the outer face of the bag (1) that inserts and expands it inside the patient's body and that is fixed to the patient's body; 10 and
    - means for fixing the self-expander (2) to the patient's body.

    [2]
    2. Device according to claim 1 characterized in that the bag (1) comprises a handle (7) at one of its ends and an elastic band (8) at another of its ends.

    [3]
    3. Device according to claim 1 characterized in that the self-expander (2) comprises at least three flexible sheets, which are deformed under pressure to introduce the device together with the collection bag (1) into the patient through the hole of the ostomy, where once inside the body they expand to recover their initial shape, facilitating the opening of the bag (1) for the collection of waste.

    [4]
    Device according to claim 1, characterized in that the self-expander (2) comprises a fixed or attachable cover (3). 25

    [5]
    5. Device according to claim 4 characterized in that the fixing means comprise:
    - an adhesive disc (5), composed of a sheet adherent to the patient's skin with a connecting ring attachable to a fixing flange (4);
    - a fixing flange (4) attachable to the adhesive disk (5) and the cover (3).

    [6]
    Device according to claim 2 and 5 characterized in that the elastic band (8) 35 surrounds the fixing flange (4) by fixing one of the ends of the bag (1) during the introduction, use and removal of the bag (one).

    [7]
    Device according to claim 4, characterized in that the fixing means comprise a self-expander (2) comprising an attachable cover (3) and cams (6) 40 that move during the coupling of the cover (3) and the self-expander (2), and that fix the device to the patient's body.

    [8]
    Device according to claims 2 and 7, characterized in that the elastic band (8) surrounds the self-expander (2) fixing one of the ends of the bag (1) during the introduction, use and removal of the bag (1 ).
    类似技术:
    公开号 | 公开日 | 专利标题
    ES2241592T3|2005-11-01|CONTINENT OPENING FOR OSTOMY.
    ES2606225T3|2017-03-23|Ostomy device with internal seal
    AU2002302096B2|2005-11-17|Pad for use with continent ostomy port
    ES2321510T3|2009-06-08|PROCEDURE AND INSTRUMENT OF FECAL MANAGEMENT.
    JP2020527369A|2020-09-10|Ostomy pouch device
    AU2002352915B2|2008-05-22|Pad for use with continent ostomy port
    US8900116B2|2014-12-02|Inflatable stomal implant
    ES2222762T3|2005-02-01|APPARATUS FOR OSTOMY.
    EP1774929A2|2007-04-18|Overweight control apparatuses for insertion into the stomach
    ES2349132T3|2010-12-28|AN OSTOMY APPARATUS
    BR112014028052A2|2020-10-27|ostomy apparatus, ostomy component sealing system, and method of sealing the stoma in an individual's body.
    ES2619193T3|2017-06-23|Ostomy accessory
    JP5844281B2|2016-01-13|Ostomy device, fluid flow control valve for medical device and ostomy insertion mechanism
    US20110106032A1|2011-05-05|Device for a temporary ileostomy or urostomy closure
    US6350255B1|2002-02-26|Pad for use with a continent ostomy port
    US20200276045A1|2020-09-03|Temporary stoma evacuation device
    US11065145B2|2021-07-20|Sphincter-type intestinal valve
    US20210022909A1|2021-01-28|Medical device for controlling the release of waste content from a subject, uses and method thereof
    EP2869798B1|2021-09-01|Ostomy devices
    ES2598557B2|2017-07-10|Device for waste collection in patients with elimination stoma
    US20120123362A1|2012-05-17|Urostomy bag cover systems
    CN211583749U|2020-09-29|Drainage ostomy bag
    JP6783010B1|2020-11-11|Stoma wearer
    US8192410B2|2012-06-05|Control device for surgical stoma
    ES2232294B2|2006-07-16|FONATORY PROTESIS.
    同族专利:
    公开号 | 公开日
    ES2598557B2|2017-07-10|
    WO2018100213A1|2018-06-07|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    EP0218203A1|1985-10-10|1987-04-15|Irwin R. Berman|Encapsulated expandable closing device for natural or artificial orifice of the human body|
    ES2015686A6|1989-05-31|1990-09-01|Lopez Hervas Pedro|Inflatable filtering device for closing colostomies|
    WO1996038106A1|1995-05-29|1996-12-05|Coloplast A/S|An ostomy collecting system|
    ES2241592T3|2000-01-04|2005-11-01|Zassi Medical Evolutions, Inc.|CONTINENT OPENING FOR OSTOMY.|
    法律状态:
    2017-07-10| FG2A| Definitive protection|Ref document number: 2598557 Country of ref document: ES Kind code of ref document: B2 Effective date: 20170710 |
    优先权:
    申请号 | 申请日 | 专利标题
    ES201601046A|ES2598557B2|2016-12-01|2016-12-01|Device for waste collection in patients with elimination stoma|ES201601046A| ES2598557B2|2016-12-01|2016-12-01|Device for waste collection in patients with elimination stoma|
    PCT/ES2017/000149| WO2018100213A1|2016-12-01|2017-12-01|Device for collecting waste in patients with an elimination stoma|
    [返回顶部]