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WO2018100213A1 - Dispositif pour la collecte de résidus chez des patients ayant une stomie d'élimination - Google Patents

Dispositif pour la collecte de résidus chez des patients ayant une stomie d'élimination Download PDF

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Publication number
WO2018100213A1
WO2018100213A1 PCT/ES2017/000149 ES2017000149W WO2018100213A1 WO 2018100213 A1 WO2018100213 A1 WO 2018100213A1 ES 2017000149 W ES2017000149 W ES 2017000149W WO 2018100213 A1 WO2018100213 A1 WO 2018100213A1
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WO
WIPO (PCT)
Prior art keywords
bag
self
patient
expander
fixing
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/ES2017/000149
Other languages
English (en)
Spanish (es)
Inventor
José Ignacio RODRÍGUEZ GARCÍA
José Manuel SIERRA VELASCO
Marta VILLAZÓN SUÁREZ
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Universidad de Oviedo
Original Assignee
Universidad de Oviedo
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
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Publication of WO2018100213A1 publication Critical patent/WO2018100213A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices
    • A61F5/445—Colostomy, ileostomy or urethrostomy devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices
    • A61F5/445—Colostomy, ileostomy or urethrostomy devices
    • A61F5/448—Means for attaching bag to seal ring

Definitions

  • 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 removal stoma).
  • a removal stoma such as a colostomy or ileostomy operation (digestive removal stoma).
  • a removal stoma such as a colostomy or ileostomy operation (digestive removal stoma).
  • a removal stoma such as a colostomy or ileostomy operation (digestive removal stoma).
  • a removal stoma such as a colostomy or ileostomy operation (digestive removal stoma).
  • colostomy bags used for the collection of feces in patients who have undergone surgery and have a digestive s
  • a digestive stoma of elimination 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.
  • ostomla A digestive stoma of elimination
  • the function of the stoma is, therefore, that of allowing feces and gases to go outside.
  • a. External bags The bag is a collection system of feces and gases that is placed around the stoma or opening, necessary because the continence, that is, control over the time of evacuation.
  • the bags whether closed or open, can also be:
  • 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. It does not cause 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.
  • C. Irrigation by colostomy This technique involves the introduction of water at body temperature through the stoma.
  • colostomy bags are usually fixed by an adhesive disc to the skin around the stoma.
  • the bag can be attached to the adhesive disk by a mechanical system that incorporates the "click function". making a sound when both sides fit and giving the user greater security.
  • a ring is used that guides and helps the patient to fix a bag and disk attached to the skin.
  • Patent document ES 2015678 A6 describes a shutter system for patients with terminal colostomy surgery, whose cover has a housing for a check valve, and by means of a shutter like a rubber balloon that can be inflated by air, the closure is achieved.
  • 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 is a device for the collection of waste in patients with elimination 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.
  • 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.
  • the bag comprises a handle at one of its ends and an elastic band at another of its ends.
  • the self-expander comprises at least three flexible sheets, which are deformed under pressure to introduce the device together with the collection bag 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.
  • the self-expander is introduced into the patient's body inside the intestine to perform an endointestinal waste collection.
  • the self-expander comprises a fixed or attachable cover.
  • the fixing means comprise: - An adhesive disc, composed of a sheet adherent to the patient's skin with a connecting ring attachable to a fixing flange.
  • the adhesive disc is normally placed around the osotmia hole.
  • 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.
  • 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.
  • 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.
  • the fixing means do not include adhesive elements to the patient's skin, which also prevents skin disorders, among others.
  • only one cover or retaining ring remains externally.
  • a self-expander that serves as an applicator to insert and remove it from inside the body.
  • the self-expander it is formed by a cylindrical body and three (or more) "legs" in 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.
  • 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 periods of time determined. This ensures that the patient does not feel uncomfortable by not having to carry the stool bag attached to his skin.
  • the system 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. It also has the possibility to self-fix the stoma by shape, in one of the 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.
  • 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 gases to go outside.
  • 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.
  • Fig. 1A a bag fixed by adhesive disk is shown.
  • Fig. 1 B A fastening of a bag based on a belt is shown in Fig. 1 B, which can complement the use of adhesives.
  • 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).
  • 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.
  • 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 in the Fig. 3B you can see a three-dimensional view of the assembly in perspective. In these figures the bag (1) is not represented.
  • Figure Fig. 4 shows some of the components of the device of the invention.
  • 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 colostomphase bags adhere, and to which it can be fixed the device object of this patent.
  • the fixing flange (4) attachable to the adhesive disk (5) capable of being fixed by pressure to the adhesive disk (5) can be seen.
  • a section of an abdominal wall in which an ostomla has been performed can be seen to the left of the figure.
  • Fig. 4B 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).
  • a handle or handle (7) attached to the closed end of the bag (1), which can be folded and attached to the lid (3).
  • an elastic band (8) on the edge, which helps to fix it.
  • Figure Fig. 5 shows the device of the previous figures in different phases of use.
  • Fig. 5A, Fig. 5B, Fig. SC, Fig. SD, Fig. SE, Fig. SF and Fig. 5G the sequence of use of the device is graphically described.
  • the adhesive disc (5) adheres to the patient's skin, around the ostomy hole. Then, as seen in Fig. 5B, the connecting ring or connecting flange (4) is fixed (snap-fit) to the adhesive disk (5).
  • the self-expander (2) and the cover (3) of the self-expander (2) are disposed, and the side of the closed bag (1) is inserted inside both.
  • Fig. SC the self-expander (2) and the cover (3) of the self-expander (2) are disposed, and the side of the closed bag (1) is inserted inside both.
  • 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
  • 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) attached to the same ring, which will never enter the patient's body.
  • 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.
  • 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).
  • the fixing flange (4) of the adhesive disc (5) is released and the ostomy hole is closed with a temporary closure lid while another internal bag is prepared or an external bag is placed.
  • 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.
  • the adhesive disc (5) is dispensed with, among others.
  • the device comprises rotating cams (6) that guarantee closing 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.
  • FIG. 8 the assembly sequence of the self-locking device of Fig. 6 and Fig. 7 is shown.
  • Fig. 8A and Fig. 8B the way of placing the bag (1) on a graph is described.
  • 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.
  • the cover (3) and the self-expander (2) by a turn, they are fixed by way thus guaranteeing the fixation of the device to the patient's body.
  • This example describes a device to be attached to the adhesive discs (5) used with the external commercial bags.
  • 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 depending on the part of the device for which they are used.
  • 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 customization of the device, that is, diameters and lengths of the parts that make up the system can be varied.
  • 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 ostomla, it has been used Nylon as input material 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 manufacturing planes 30%, which guarantees the flexibility required of the self-expanding blades.
  • ABS has been used as input material in the 3D printer.
  • This material has a breaking tension between 22 MPa and 24 MPa, sufficient for the efforts to be supported, and has a low elongation of the order of 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.
  • 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, elongation, ..) are the most appropriate depending on the part of the device for which they are used.
  • 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.
  • 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 used nylon orno 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 manufacturing planes 30%, which guarantees the flexibility required of the self-expanding blades.
  • ABS ⁇ 30 ⁇ has been used as input material in the 3D printer.
  • This material has a breaking tension between 26 MPa and 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 relative position 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.

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  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

Selon l'invention, un dispositif pour la collecte de résidus chez des patients ayant une stomie d'élimination comprend une poche (1) qui est placée à l'intérieur du corps d'un patient présentant une colostomie ou iléostomie et qui collecte les résidus, évitant tous les inconvénients liés aux poches externes. Ledit dispositif comprend aussi un dispositif d'auto-expansion (2) pour insérer la poche (1) et la placer de manière adéquate, et des moyens de fixation au corps du patient. Le dispositif selon l'invention peut être fixé aux adhésifs actuellement utilisés pour la fixation externe des poches chez les patients qui tolèrent l'adhésif sans problème d'irritation de la peau ou encore peut s'auto-fixer à la stomie sous la forme d'une des réalisations préférées. L'invention concerne l'application dans les secteurs où sont conçus, produits et utilisés des dispositifs pour traitements médicaux ou autres thérapies sanitaires de dosage de médicaments ou collecte d'échantillons.
PCT/ES2017/000149 2016-12-01 2017-12-01 Dispositif pour la collecte de résidus chez des patients ayant une stomie d'élimination Ceased WO2018100213A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ES201601046A ES2598557B2 (es) 2016-12-01 2016-12-01 Dispositivo para la recogida de residuos en pacientes con estoma de eliminación
ESP201601046 2016-12-01

Publications (1)

Publication Number Publication Date
WO2018100213A1 true WO2018100213A1 (fr) 2018-06-07

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Family Applications (1)

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PCT/ES2017/000149 Ceased WO2018100213A1 (fr) 2016-12-01 2017-12-01 Dispositif pour la collecte de résidus chez des patients ayant une stomie d'élimination

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ES (1) ES2598557B2 (fr)
WO (1) WO2018100213A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024180473A1 (fr) * 2023-02-27 2024-09-06 Gals Bio Ltd. Dispositif intravaginal avec partie extensible

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0218203A1 (fr) * 1985-10-10 1987-04-15 Irwin R. Berman Obturateur capsulé expansible pour orifice naturel ou artificiel du corps humain
ES2015686A6 (es) * 1989-05-31 1990-09-01 Lopez Hervas Pedro Dispositivo hinchable filtrante para el cierre de colostomias.
WO1996038106A1 (fr) * 1995-05-29 1996-12-05 Coloplast A/S Systeme de collecte de selles
ES2241592T3 (es) * 2000-01-04 2005-11-01 Zassi Medical Evolutions, Inc. Apertura continente para la ostomia.

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0218203A1 (fr) * 1985-10-10 1987-04-15 Irwin R. Berman Obturateur capsulé expansible pour orifice naturel ou artificiel du corps humain
ES2015686A6 (es) * 1989-05-31 1990-09-01 Lopez Hervas Pedro Dispositivo hinchable filtrante para el cierre de colostomias.
WO1996038106A1 (fr) * 1995-05-29 1996-12-05 Coloplast A/S Systeme de collecte de selles
ES2241592T3 (es) * 2000-01-04 2005-11-01 Zassi Medical Evolutions, Inc. Apertura continente para la ostomia.

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024180473A1 (fr) * 2023-02-27 2024-09-06 Gals Bio Ltd. Dispositif intravaginal avec partie extensible

Also Published As

Publication number Publication date
ES2598557A1 (es) 2017-01-27
ES2598557B2 (es) 2017-07-10

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