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EP-4248921-B1 - A MEDICAL DEVICE WITH AN OPENING SYSTEM

EP4248921B1EP 4248921 B1EP4248921 B1EP 4248921B1EP-4248921-B1

Inventors

  • JONES, JAMES DONALD
  • OBERHOLTZER, GARY

Dates

Publication Date
20260513
Application Date
20161014

Claims (10)

  1. A medical device (1) with an opening system comprising: a. opposing walls (2, 3) having a cavity therebetween, the walls (2, 3) joined along their peripheries, and tapering to an outlet opening (8) at the proximal end (7) of the device; b. a deformable reinforcing member (18, 9, 29) on one exterior surface of said opposing walls (2, 3), near the outlet opening (8), said reinforcing member (18, 9, 29) having two lateral edges deformable by manual application of pressure to said lateral edges, so as to radially distend the outlet opening (8); and c. a first fastener (13, 20) and a second fastener (17, 21) attached to opposing exterior surfaces of said opposing walls (2, 3), wherein one of said first (13, 20) and second fastener (17, 21) is near the outlet opening (8); wherein the outlet is flexible and foldable from an opened condition to a closed condition by one or more folds, and wherein the first (13, 20) and second fastener (17, 21) are capable of forming a linkage when said outlet is in the closed condition; characterised in that the lateral edge of the reinforcing member (18, 9, 29) is notched.
  2. The medical device (1) of claim 1, further comprising a system for securing the device in the closed condition, the system comprising: d. a security flap (14), wherein said flap (14) is attached to one exterior surface of said opposing walls (2, 3), distal to the opening (8) of the outlet with respect to said deformable reinforcing member (18, 9, 29), wherein a portion of the flap (14) extends freely from said one exterior surface of said opposing wall to which the flap (14) is attached; e. a third fastener attached to one exterior surface of said opposing pouch walls (2, 3), and f. a fourth fastener attached to the freely opened portion of the security flap (14), wherein said third and fourth fastener can form a linkage when said outlet is in the closed condition.
  3. The medical device (1) of claim 2, wherein at least one of the first, second, third and fourth fasteners is a hook and loop fastener.
  4. The medical device (1) of claim 1, wherein the first fastener (13, 20) is attached to the deformable reinforcing member (18, 9, 29) having two lateral edges and is deformable by manual application of pressure to said lateral edges, so as to controllably distend the outlet opening (8).
  5. The medical device (1) of claim 1, wherein the second fastener (17, 21) is attached to the deformable reinforcing member (18, 9, 29) having two lateral edges and is deformable by manual application of pressure to said lateral edges, so as to controllably distend the outlet opening (8).
  6. The medical device (1) of claim 2, wherein at least one of the first (13, 20), second (17, 21), third, and fourth fasteners differs in shape with respect to any other fastener.
  7. The medical device (1) of claim 2, wherein at least one of the first (13, 20), second (17, 21), third, and fourth fasteners differs in size with respect to any other fastener.
  8. The medical device (1) of claim 1, wherein the first (13, 20) and second fasteners (17, 21) form a linkage after at least two folds of the outlet.
  9. The medical device (1) of claim 1, wherein the third and fourth fasteners form a linkage after at least two folds of the outlet.
  10. The medical device (1) of any one of the preceding claims, wherein the medical device (1) is an ostomy pouch.

Description

FIELD OF THE INVENTION Disclosed within are opening systems for medical devices. The medical device is for collecting, storing and/or disposing of bodily fluids or waste. In certain embodiments, the medical device is an ostomy bag or pouch. BACKGROUND OF THE INVENTION Medical devices and ostomy pouches for the removal and storage of bodily fluids are used by many patients every day. Conditions that affect the bladder and digestive system can lead to the necessity of an ostomy, which is a temporary, or permanent, surgical creation of an opening, or stoma, from a part of the body such as the bladder or intestines to the outside of the body. There are many different types of ostomy such as colostomy, ileostomy or urostomy. US 2011/028924 A1 discloses a drainable ostomy pouch. The ostomy pouch includes a collection portion and a drain chute portion extending from the collection portion. The ostomy pouch has a discharge opening for permitting emptying of contents from the pouch. The drain chute is foldable between an open condition in which the drain chute portion is extended from the collection portion, and a closed condition in which the drain chute portion is folded towards the collection portion. At least one flap retains the folded drain chute portion. JP 2013 086808 A generally discloses a packing bag which can prevent liquid substances accommodated therein from splattering out of an opening when opening the bag. US 2005/131360 A1 relates to a drainable ostomy pouch comprising a first and a second flexible stiffening strips of relatively stiff material such as PET, nylon, high density polyethylene or low density polyethylene extending immediately adjacent to and along a drainage opening of the ostomy pouch. The pouch further comprises a Velcro strip on one wall and a Velcro strip on a flap of the ostomy pouch for securing a coil comprising the first and second stiffening strips rotated upwards three times. US 2004/049837 A1 discloses a drainable ostomy pouch having an outlet. Reinforcing members at the outlet are deformable by application of manual pressure at their ends to distend the outlet. The lateral edges of the reinforcing members may be offset, which encourages the reinforcing members to consistently bend away from each other. A peelable distributed mechanical engagement fastener secures the outlet in a folded condition. The fastener parts are hook-hook type plastic extrusions, and provide a snap-engagement. A security flap is foldable under the outlet when in its folded condition. US 2003/191441 A1 generally relates to a disposable cover for enclosing the outlet spout of a drainable stoma pouch. SUMMARY OF THE INVENTION The present invention provides for improved methods to easily and reliably drain bodily waste from a reusable and drainable medical device such as an ostomy pouch. The features disclosed herein may permit users with limited dexterity and strength to manipulate, open and seal the drainable pouch. Disclosed herein are medical devices, including ostomy pouches, comprising a closable opening for the storage, removal and sanitary disposal of waste and bodily fluids. In one embodiment is described a medical device with an opening system comprising (a) opposing walls having a cavity therebetween, the walls joined along their peripheries, and tapering to an outlet opening; (b) first and second deformable reinforcing members attached to opposing exterior surfaces of said opposing walls, wherein each reinforcing member has two lateral edges deformable by manual application of pressure to said lateral edges, so as to radially distend the outlet opening, wherein the first and second deformable reinforcing members are offset from each other along a longitudinal axis; and (c) first and second fasteners; wherein the outlet is flexible and foldable from an open condition to a closed condition by one or more folds. In some embodiments, the medical device with an opening system further comprises (d) a system for securing the device in the closed condition, the system comprising: a security flap, wherein said flap is attached to the same exterior surface of one of said opposing walls as the second reinforcing member, distal to the opening of the outlet with respect to the second reinforcing member, wherein a portion of the flap extends freely from the exterior surface of the opposing wall on which the flap is attached; and wherein the first fastener is attached to the same exterior surface of one of said opposing walls as said first reinforcing member, distal to the opening with respect to said first reinforcing member, the second fastener is attached to the freely opened portion of said security flap, and wherein the first fastener and the second fastener are capable of forming a linkage when the outlet is in the closed condition. In some embodiments, at least one of the first and second fasteners is a hook and loop fastener. In some embodiments, the first deformable reinforcing member is near the o