WO2015142667A1 - Stomie et dispositif de support de stomie - Google Patents

Stomie et dispositif de support de stomie Download PDF

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Publication number
WO2015142667A1
WO2015142667A1 PCT/US2015/020560 US2015020560W WO2015142667A1 WO 2015142667 A1 WO2015142667 A1 WO 2015142667A1 US 2015020560 W US2015020560 W US 2015020560W WO 2015142667 A1 WO2015142667 A1 WO 2015142667A1
Authority
WO
WIPO (PCT)
Prior art keywords
outer diameter
wall
device opening
stoma
intermediate wall
Prior art date
Application number
PCT/US2015/020560
Other languages
English (en)
Inventor
April SCHUMMER
Original Assignee
Schummer April
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
Application filed by Schummer April filed Critical Schummer April
Publication of WO2015142667A1 publication Critical patent/WO2015142667A1/fr

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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; Portable urination aids; Colostomy devices
    • A61F5/445—Colostomy, ileostomy or urethrostomy devices

Definitions

  • the present invention is in the technical field of medical support devices. More specifically, the present invention is in the technical field of ostomy pouches and associated de vices.
  • Colostomy procedures involve the removal of a diseased portion of a patient's colon and routing a healthy section through a surgical incision in the lower abdomen (ostomy) where the colon end (stoma) is sutured in place.
  • This procedure exposes the distal end of the healthy colon (stoma) to the exterior of the patient ' s abdomen and allows the passage of feces, urine and other discharge from this point into a collection device, commonly known as a pouch.
  • the surgical positioning of a stoma is individually tailored to a patient, may be on either side of a patient's abdominal wall and typically range in size from 15 mm to 50 mm although this is in no way limiting.
  • these collection pouches are affixed in place by a several-step process, beginning with the attachment of an adhesive plate (known as a barrier) to the abdomen so as to surround the stoma ostomy.
  • a barrier fits securely around the ostomy and inhibits moisture from separating the adhesive from the abdominal skin surface.
  • This adhesive barrier typically contains an interlocking device, called a flange, on the opposite side of the adhesive. The flange attaches to a mating connector on an ostomy pouch.
  • the barrier may include other features like hoops or loops for attachment of additional accessories.
  • a patient attaches an ostomy pouch to the flange of the adhesive connector (barrier) in order to collect voided waste.
  • the stoma is surgically designed to be flushed with the abdomen.
  • support garments and other products and devices are needed in order to allow the patient more control and flexibility for different levels of activity.
  • a typical support garment comprises an elastic band or other compressive material is worn over the barrer/pouch combination in order to maintain the integrity of the seal.
  • This support garment is typically adjustable via straps and elastic bands to meet the needs of individual patients and typically wraps around a patient ' s body at the abdomen and over the barrier/pouch combination to provide additional pressure upon the connection and further maintain the seal.
  • the placement of the belt may not be optimal to the patient, resulting in potential belt slippage and may additionally be uncomfortable and bulky.
  • the belt may pull the barrier off of the skin, resulting in stomal and proximity bleeding and leakage of bodily wastes from the now-defective seal into the patient's clothing, resulting in physical and emotional trauma to the patient.
  • the '589 patent discloses an ostomy appliance that uses an absorbent, tubular body member that itself absorbs drainage from the stoma.
  • a cap member seals off the device and prevents drainage flow out of the device.
  • the body member is not structurally rigid and is pervious to fluid, which allows gas, liquid and solid drainage to be absorbed.
  • the device is intended for use without an external ostomy pouch and for short periods of time when the patient may be a public place and the anticipated amount of drainage from the stoma is small.
  • the present invention comprises a flexible membrane that may take the form of a flat, concave, or convex surface and further comprises a central annulus that allows the passage of feces and other intestinal contents to flow through, and into the attached collection bag.
  • This annulus. or lumen extends through the central portion of the device and extends from one side to form a tube like structure.
  • the annular hollow tube portion of the device is inserted into the lumen of the intestinal stoma and positioned so that the flat, convex, or concave perimeter o the device covers and supports the stoma end of the protruding intestine.
  • This structure creates a needed "depth” that provides strength in the structure to always allow discharge to be eliminated from the stoma to the collection pouch, which is needed to allow the stoma to function as intended.
  • the depth of the device provides and keeps the integrity of the invention and the stoma in its proper condition.
  • the device has a perimeter that mates within the inner perimeter of a flange located on the non- adhesive side of the barrier.
  • the collection pouch is then placed over the device/barrier assembly and attached to the assembly via interconnecting flanges or other mating devices.
  • a compressive garment e.g., a belt, band or corset-type device
  • a compressive garment may then be affixed over the devicc//barrier/pouch combination to provide further support and confidence to the patient.
  • the advantages of the present invention include, by way of example and without limitation, the prevention of protrusion of an intestinal stoma through a surgically-created ostomy.
  • FIG. 1 is a perspective drawing of an exemplary embodiment of the invention.
  • FIG. 2 is a sectional view of through plane 2-2 of FIG. I .
  • FIG. 3 is a representative illustration of a surgically-created ostomy with associated stoma.
  • FIG. 4 shows the attachment device used in FIG. 3.
  • FIG. 5 is an enlarged view of window 4 shown in FIG. 3.
  • FIG. 6 is a perspective drawing of the embodiment of the invention in relation to an ostomy pouch.
  • FIG. 7 is a sectional side view of the embodiment in use with a patient.
  • FIG. 8 is an enlarged view of window 8 shown in FIG. 7.
  • FIG. 9 is a sectional view of a second embodiment o the invention. DETAILED DESCRIPTION OF CERTAI EMBODIMENTS
  • the illustrated embodiment 100 comprises an elastic, deformable material such as silicon, rubber or the like and which is impervious to fluid.
  • the embodiment 100 comprises an open cylinder containing a central annulus, or lumen 130 proportioned so that a first end 120 may be inserted into the lumen of a stoma projecting from the patient's abdominal wall.
  • the first end 120 includes a cylindrical wall 122 that defines a first device opening 124 of the embodiment 100.
  • the first device opening 124 is large enough to allow passage of fecal matter and other waste, preferably being at least five millimeters in diameter.
  • An opposing, large-diameter second end 1 10 is sized so as to rest on the stomal end wall and so seal the stoma.
  • the second end 1 10 includes an annular surface 103 and cylindrical surface 104 adjacent to the annular surface 103.
  • the second end 1 10 includes an inner cylindrical surface 126 that defines a second device opening 128.
  • a longitudinal axis 102 extends between the first and second device openings 124. 128.
  • the depth between the annular surface 103 and the first opening 124 is 1.2 inches.
  • the diameter of the annular surface 103 is 1.7 inches.
  • An intermediate wall 132 is longitudinally positioned between the ends 1 10, 120.
  • the intermediate wall 132 is continuously-curved and symmetrical around the axis 102.
  • the wall 132 has a maximum diameter adjacent to the second end 1 10 and tapers to a minimum diameter adjacent to the cylindrical wall 122.
  • the inner cylindrical surface 126, the cylindrical wall 122, and the intermediate wall 132 define the lumen 130.
  • the cylindrical surface 104 has a diameter sized so as to insert within the receiving hole of a barrier and is secured when the ostomy pouch is attached to the barrier via clips or other devices known to persons of skill in the art.
  • the positioning of the embodiment 100 between the stomal end and an ostomy pouch maintains longitudinal pressure on the stoma toward the abdominal cavity, thereby preventing stomal protrusion.
  • the device/barrier/pouch combination may be further secured by means of an elastic type band or belt that is applied over the combination and around the patient's abdomen, providing additional pressure to maintain the proper positioning of the stoma and further prevent protrusion of the bowel.
  • FIG. 3 illustrates a typical stoma 210, which is the surgically- created portion of bowel extending through the abdominal wall of a patient 212.
  • the bowel contents are directed through the stomal opening and into an ostomy pouch that receives fecal matter.
  • a major problem that is addressed by the instant device is that often the stomal end protrudes through a hole in the barrier and into the pouch, causing severe pain and discomfort.
  • patients who require an ostomy pouch to collect fecal matter through a stoma often experience emotional and psychological distress and may be reticent to go into public for fear that the loss of control of bowel movements and the associated smell and leakage will cause embarrassment.
  • the instant device while controlling the protrusion of the stomal end. additionally provides additional confidence to such an afflicted individual.
  • FIG. 4 shows an attachment device 340 (barrier) for an ostomy pouch that is affixable to a patient via adhesive pad 213 and provides a means of securing an ostomy pouch.
  • the attachment device 340 has a flange
  • an annular portion 333 of the adhesive pad 213 defines a second circular aperture 345 that has a smaller diameter than, and is adjacent to, the aperture 344. Together, the apertures 344, 345 provide a passage through the attachment device 340.
  • the illustrated embodiment 100 is shown being inserted into the functional position.
  • the attachment device 340 is affixed to the patient 212 via adhesive pad 213 around the stoma 210, which terminates in a distal end wall 312.
  • the device 100 is inserted into the lumen 214 of the stoma 210 so that the lumen 130 of the device 100 becomes continuous with the lumen 214 of the stoma 210.
  • the device is constructed of materials such as latex, rubber or other fluid-impervious materials, which give the device a natural deformability or flexibility to maintain a tight seal with the lumen 214 of the stoma 210.
  • the large-diameter second end 1 10 of the device 100 is sized so as to rest against the distal end wall 312 of the stoma 210 and the annular portion 333 of the adhesive pad 213.
  • the cylindrical surface 104 of the end 1 10 is attached to the flange 342 with an interference fit with the cylindrical surface 346.
  • a collection device 420 includes an ostomy pouch 426 having an interior volume 428, an opening 430 to the volume 428. and a flange 432 adjacent to the opening 430 and engagcable with the flange 342 of the attachment device 340.
  • the device 100 is held in place and positioned to provide pressure on the stoma 210, thereby preventing the stomal protrusion through the attachment device 340 and into the pouch interior 428.
  • the device 100 in use the device 100 extends through the ostomy 600 of the patient 212 and in contact with the stoma 210 and the annular portion 333 of the adhesive pad 213.
  • the adhesive pad 213 is adhered to the skin surface 602 of the patient 212 in the abdom inal region.
  • the large-diameter second end 1 10 of the device 100 is radially within the flange
  • the distal end wall 312 of the stoma 210 is in contact with the device 100.
  • the flange 432 of the collection device 420 is engaged with the flange 342 of the attachment device 340.
  • a flow path is established from the lumen 214 of the stoma 210 to the pouch interior 428.
  • the annular portion 333 of the adhesive pad 213 has a smaller diameter than the flange 342, longitudinal movement of the device 100 toward the abdomen is inhibited by contact of the second end 1 10 with the annular portion 333.
  • This compressing and decompressing causes a "sucking" action that promotes discharge of fluid from the stoma 210 into the pouch 426 and thus inhibits radial-outward flow through the various components and onto the skin surface 602 beneath the adhesive pad 213.
  • fluid that may have accumulated in spaces 604 radially between the device 100 and the stoma wall may be drawn first backward toward the abdomen and then into the first device opening 124.
  • FIG. 9 shows a second embodiment 700 of the invention. which comprises an elastic, deformablc material such as silicon, rubber or the like and further comprises of an open cylinder containing a central lumen 730 proportioned so that one end 720 may be inserted into the lumen of a stoma projecting from the patient's abdominal wall.
  • an elastic, deformablc material such as silicon, rubber or the like
  • an open cylinder containing a central lumen 730 proportioned so that one end 720 may be inserted into the lumen of a stoma projecting from the patient's abdominal wall.
  • the first end 720 includes a cylindrical wall 722 that defines a first device opening 724 of the embodiment 700.
  • the first device opening 724 is again preferably at least five millimeters in diameter.
  • An opposing, large-diameter second end 710 is sized so as to rest on the stomal end wall and so seal the stoma.
  • the second end 710 includes an annular surface 703 and cylindrical surface 704 adjacent to the annular surface 703.
  • the second end includes an inner cylindrical surface 726 defining a second device opening 728.
  • a longitudinal axis 702 extends between the first and second device openings 724, 728.
  • An intermediate wall 732 is longitudinally positioned between the ends 710, 720.
  • the intermediate wall 732 is cylindrical and symmetrical around the axis 702.
  • the second end 710 is sized so as to rest on the stomal end wall and so seal the stoma. In this configuration, the contents of the bowel are free to travel through the device lumen 730 and into a containment pouch.
  • the second end 710 is further sized so as to insert within the receiving hole of a barrier and is secured when an ostomy pouch is attached to the barrier via clips or other devices known to persons of skill in the art.
  • the positioning of the device between the stomal end and the ostomy pouch maintains longitudinally-inward pressure on the stoma, thereby preventing stomal protrusion.
  • the device 700 is made of a flexible material
  • longitudinal pressure (i.e., pressure in a direction parallel to the axis 702 ) of the stoma 210 against part of the intermediate wall 732 may cause a longitudinal compressing and decompressing of the intermediate wall 732 resulting from the natural movement of the patient.
  • This compressing and decompressing causes a "sucking" action that promotes discharge of fluid from the stoma into the pouch 426 and thus inhibits radial-outward flow through the various components and onto the skin surface of the patient.
  • fluid that may have accumulated in spaces radially between the device 700 and the stoma wall may be drawn first backward toward the abdomen and then into the device opening 724.

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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

L'invention concerne un dispositif pour inhiber une saillie pour stomie, qui comprend une première extrémité ayant un premier diamètre externe et une première ouverture de dispositif; une seconde extrémité ayant un second diamètre externe plus grand que le premier diamètre externe, la seconde extrémité ayant une surface cylindrique interne et une seconde ouverture de dispositif; un axe longitudinal s'étendant entre la première ouverture de dispositif et la seconde ouverture de dispositif; une paroi cylindrique co-terminale avec la première extrémité, la paroi cylindrique ayant un axe colinéaire avec l'axe longitudinal; une paroi intermédiaire longitudinale entre la paroi cylindrique et la seconde extrémité, la paroi intermédiaire ayant un diamètre externe maximal plus grand que le premier diamètre externe et plus petit que le second diamètre externe; la surface cylindrique interne, la paroi cylindrique et la paroi intermédiaire définissant au moins une partie d'une lumière s'étendant entre la première ouverture de dispositif et la seconde ouverture de dispositif; et le dispositif étant fabriqué à partir d'un matériau imperméable aux fluides.
PCT/US2015/020560 2014-03-16 2015-03-13 Stomie et dispositif de support de stomie WO2015142667A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201461953904P 2014-03-16 2014-03-16
US61/953,904 2014-03-16

Publications (1)

Publication Number Publication Date
WO2015142667A1 true WO2015142667A1 (fr) 2015-09-24

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3884235A (en) * 1974-04-16 1975-05-20 Mohammad Ajaz Sami Urinary collection device
US4701169A (en) * 1983-12-19 1987-10-20 Craig Medical Products Ostomy appliance with improved attachment means
US5653701A (en) * 1995-06-12 1997-08-05 Desert Shield Trust Ostomy support belt
US6350255B1 (en) * 1998-02-25 2002-02-26 Zassi Medical Evolutions, Inc. Pad for use with a continent ostomy port
US20100174253A1 (en) * 2007-06-12 2010-07-08 Convatec Technologies Inc. Ostomy Appliance
US8388586B2 (en) * 2007-02-22 2013-03-05 Convatec Technologies, Inc. Seal for an ostomy appliance
US8821464B2 (en) * 2009-07-14 2014-09-02 Stimatix Gi Ltd. Disposable ostomy assemblies

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3884235A (en) * 1974-04-16 1975-05-20 Mohammad Ajaz Sami Urinary collection device
US4701169A (en) * 1983-12-19 1987-10-20 Craig Medical Products Ostomy appliance with improved attachment means
US5653701A (en) * 1995-06-12 1997-08-05 Desert Shield Trust Ostomy support belt
US6350255B1 (en) * 1998-02-25 2002-02-26 Zassi Medical Evolutions, Inc. Pad for use with a continent ostomy port
US8388586B2 (en) * 2007-02-22 2013-03-05 Convatec Technologies, Inc. Seal for an ostomy appliance
US20100174253A1 (en) * 2007-06-12 2010-07-08 Convatec Technologies Inc. Ostomy Appliance
US8821464B2 (en) * 2009-07-14 2014-09-02 Stimatix Gi Ltd. Disposable ostomy assemblies

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