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WO2015054366A1 - Plaque frontale pour stomie comprenant un réservoir d'adhésif pour stomie - Google Patents

Plaque frontale pour stomie comprenant un réservoir d'adhésif pour stomie Download PDF

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Publication number
WO2015054366A1
WO2015054366A1 PCT/US2014/059664 US2014059664W WO2015054366A1 WO 2015054366 A1 WO2015054366 A1 WO 2015054366A1 US 2014059664 W US2014059664 W US 2014059664W WO 2015054366 A1 WO2015054366 A1 WO 2015054366A1
Authority
WO
WIPO (PCT)
Prior art keywords
stoma
faceplate
reservoir
assembly
inlet opening
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/US2014/059664
Other languages
English (en)
Inventor
Bettakeri S. UDAYAKUMAR
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.)
Hollister Inc
Original Assignee
Hollister Inc
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 Hollister Inc filed Critical Hollister Inc
Publication of WO2015054366A1 publication Critical patent/WO2015054366A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • A61F5/443—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices having adhesive seals for securing to the body, e.g. of hydrocolloid type seals, e.g. gels, starches, karaya gums
    • 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
    • A61F5/4404—Details or parts
    • 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

Definitions

  • the present disclosure relates to a faceplate for ostomy appliances, and more particularly to a faceplate including adhesive reservoir.
  • An ostomy appliance or system is a medical device or prosthetic that provides a means for collecting waste from a stoma typically created as a result of a surgical procedure to divert a portion of the colon or small intestine.
  • One type of ostomy appliance is a pouch that is attached to a user around the stoma or the peristomal area.
  • a pouch is permanently attached to a faceplate on the opposite side of a skin barrier.
  • the skin barrier is typically formed from a hydrophilic adhesive material that can provide a seal between the user's skin and the pouch.
  • the pouch system is attached to a user via the skin barrier.
  • a two-piece system also includes a faceplate and a pouch.
  • a two-piece system includes a pair of coupling rings, one of which is fixedly attached to a faceplate assembly, while the other is attached to a pouch assembly.
  • the coupling rings are configured to mate with each other, such that the pouch assembly can be securely attached to the faceplate assembly by engaging the coupling rings together.
  • the faceplate assembly is first attached to a user via a skin barrier, and the pouch assembly is secured to the faceplate via the coupling rings.
  • a two-piece pouch system allows a user to remove and replace the pouch without removing the faceplate that is adhered to user's skin. This can help to reduce the discomfort and irritation associated with removing skin barrier adhesive or gel from the user's skin.
  • the faceplate is replaced with a new unit after 3 to 4 days of wear.
  • An ostomy pouch may be configured as a drainable pouch including a draining outlet to allow a user to empty pouch content as it gets filled with stoma output, which can be reused after closing the draining outlet.
  • An ostomy pouch may also be configured as a closed pouch, which is discarded after it is filled with stoma output.
  • a faceplate includes an inlet opening to receive a stoma.
  • stoma effluent leakage can weaken the seal between a skin barrier and user's skin, and can irritate the peristomal skin causing skin damage and infection. Peristomal skin irritation and infection can be difficult to cure and expensive. Stoma effluent leakage can also result in accidents and user embarrassment.
  • efforts have been made to provide a faceplate that can fit and seal around a stoma outer wall to reduce stoma effluent leakage.
  • stoma effluent leakage remains as a serious problem for ostomates.
  • any improvements to reduce the risk of stoma leakage are of great importance to ostomates.
  • the present disclosure according to various embodiments provides an improved faceplate which seals around a stoma outer wall and its base to reduce the risk of leakage.
  • a faceplate assembly including a reservoir containing a sealing material for sealing around a stoma outer wall and mucocutaneous junction at the stoma base is provided according to various embodiments.
  • the reservoir may contain a sealing material, such as an adhesive or a sealing gel for sealing around a stoma outer wall and mucocutaneous junction at the stoma base to reduce the risk of stoma effluent channeling under a skin barrier and damaging the peristomal skin.
  • the faceplate assembly can also include a removable sealant holder, which is configured to operate with the adhesive reservoir to contain the sealing material, and allow the sealing material to come in contact with a stoma outer wall as a user withdraws the sealant holder from the faceplate assembly.
  • a faceplate assembly for an ostomy pouch system may include a faceplate, a skin barrier, and a reservoir for containing a sealing material or adhesive.
  • the faceplate may include an inlet opening, a first surface and a second surface.
  • the skin barrier may be displaced on the second surface.
  • the reservoir may be arranged proximate the inlet opening and extend away from the second surface.
  • the reservoir may be configured to contain a sealing material for sealing around a stoma outer wall and expose the sealing material when a stoma is received through the inlet opening.
  • the reservoir may be defined by a collar, which may be attached to the faceplate and extend from the second surface.
  • the collar may be formed from a soft flexible film, and may have an accordion-like or bellows-like shape.
  • the faceplate assembly may also include a sealant holder, which may be removably arranged in the inlet opening.
  • the sealant holder may include a head plate, a cylindrical wall and a center opening.
  • the reservoir may be defined between the collar and the cylindrical wall.
  • the center opening, head plate and cylindrical wall may have a generally circular shape.
  • the sealant holder may be arranged in the inlet opening, such that the head plate seats on the faceplate about the inlet opening and the cylindrical wall is arranged adjacent the reservoir.
  • a plurality of troughs which have an accordion-like or bellows-like shape, may be defined between the cylindrical wall and the collar, thereby forming the reservoir.
  • the reservoir may be filled with an adhesive or sealing gel, such as hydrophilic mucoadhesives or a waxy material, for sealing around a stoma outer wall. Once applied around the stoma, the adhesive or sealing gel may remain in place around the stoma outer wall throughout the course of use and effectively prevent stoma effluent from channeling under the skin barrier and damaging the peristomal skin.
  • the center opening of the sealant holder may be configured to receive a stoma. Further, the sealant holder may be configured such that the sealing material for sealing around a stoma outer wall is exposed as the sealant holder is withdrawn from the inlet opening and allow the sealing material to come in contact with the stoma to seal around the stoma outer wall and its base.
  • the faceplate assembly may be used for a two-piece ostomy appliance.
  • the faceplate may include a first coupling ring mounted on the first surface, which is configured to secure a pouch assembly by engaging with a second coupling ring mounted on the pouch assembly.
  • the faceplate assembly according to any of the above discussed embodiments may be used for a one-piece ostomy appliance, in which a pouch may be fixedly attached to the second surface of the faceplate.
  • a method of attaching an ostomy appliance to a user includes a step of providing a faceplate assembly including a faceplate, a skin barrier, and a reservoir.
  • the faceplate may include an inlet opening, a first surface and a second surface.
  • the skin barrier may be displaced on the second surface.
  • the reservoir may be arranged proximate the inlet opening and extend away from the second surface.
  • the reservoir may contain a sealing material for sealing around a stoma outer wall and mucocutaneous junction at the stoma base.
  • the method also includes steps of placing the faceplate assembly on a user such that the reservoir is arranged around a stoma outer wall, and exposing the stoma sealing material in the reservoir to allow the stoma sealing material to seal around the stoma. Further, the method includes a step of adhering the skin barrier to a peristomal skin.
  • the faceplate assembly may also include a removable sealant holder arranged in the inlet opening.
  • the removal sealant holder may include a cylindrical wall and a center opening.
  • the step of exposing the stoma sealing material may include withdrawing the removable sealant holder from the inlet opening to expose the stoma sealing material.
  • the method may also include a step of pushing the sealant holder against the stoma to raise the stoma through the center opening of the sealant holder to facilitate sealing around a recessed stoma outer wall and its base.
  • FIG. 1 is a perspective illustration of a two-piece ostomy system including a pouch assembly and a faceplate assembly including an adhesive reservoir and a removable sealant holder according to an embodiment
  • FIG. 2 is a cross sectional view of the faceplate assembly of
  • FIG. 1 taken along line A—A;
  • FIG. 3 is a perspective view of the removable sealant holder of
  • FIG. 2; [0021] FIG. 4 is a perspective view of sealant holder according to a different embodiment
  • FIG. 5 is a cross sectional view of a one-piece drainable ostomy pouch system including a reservoir assembly according to an embodiment
  • FIG. 6 is a cross sectional view of a one-piece disposable ostomy pouch system including a reservoir assembly according to a different embodiment.
  • FIG. 1 is an illustration of a two-piece ostomy system 10 according to an embodiment.
  • the two-piece ostomy system 10 includes a pouch assembly 12 and a faceplate assembly 14.
  • the pouch assembly 12 includes a collection pouch 16 which may be formed of a body side panel 18 and an outer panel 20, which are sealed together around their periphery 22.
  • the pouch 16 may include an open neck portion 24 at the pouch's lower end, which may be provided with closure means, such as a suitable clamp for maintaining the pouch in a closed condition.
  • closure means such as a suitable clamp for maintaining the pouch in a closed condition.
  • the neck portion 24 may be omitted entirely and the panels 18, 20 may be sealed around the full periphery of the pouch 16.
  • the pouch assembly 12 may also include a first coupling ring 26, which may be secured to the body side panel 18 of the pouch 16 by heat sealing or any other suitable means.
  • the faceplate assembly 14 generally includes a faceplate 30, a second coupling ring 32, a skin barrier 34, a reservoir 36, and a removable sealant holder 38.
  • FIG. 2 is a cross sectional illustration of the faceplate assembly 14 taken along line A— A.
  • the faceplate 30 may be formed of a gas-permeable, water-resistant microporous material.
  • the faceplate 30 is highly flexible, so that is will conform readily to body contours and body movements, and relatively strong and durable.
  • the skin barrier 34 may be formed of a suitable pliable and tacky material capable of engaging and adhering to the peristomal skin. Such barrier materials are well known in the art.
  • the skin barrier 34 may be formed of a medical-grade pressure sensitive adhesive that can adhesively secure the faceplate assembly 14 to a patient's skin in the peristomal region.
  • the second coupling ring 32 may be mounted on the faceplate
  • the first coupling ring 26 and the second coupling ring 32 are configured to mate with each other, such that the pouch assembly 12 may be mechanically secured to the faceplate assembly 14 when the coupling rings 26, 32 are engaged together.
  • the faceplate assembly 14 also includes an inlet opening 40 for receiving a stoma 52, which may be sized to fit around a stoma outer wall 54.
  • the reservoir 36 is arranged proximate the inlet opening 40 and configured to contain a material 50 for sealing around the stoma outer wall 54.
  • the reservoir 36 is defined by an accordion-like or bellows-like collar 37, which may be attached to the faceplate 30. As shown in FIG.
  • accordion-like or bellows-like troughs 42 are defined between the collar 37 and the removable sealant holder 38, in which a material for sealing around the stoma outer wall 54, such as a suitable adhesive, sealant, or sealing gel, may be contained.
  • a material for sealing around the stoma outer wall 54 such as a suitable adhesive, sealant, or sealing gel, may be contained.
  • the accordion-like collar 37 may be formed using a suitable soft flexible film.
  • FIG. 3 is an illustration of the sealant holder 38 according an
  • the sealant holder 38 includes a cylindrical wall 44, a circular head plate 46, and a center opening 48.
  • the sealant holder 38 is arranged in the inlet opening 40, such that the circular head plate 46 seats on the faceplate 30 about the inlet opening 40, and the cylindrical wall 44 is displaced adjacent the collar 37, such that the accordion-like troughs 42 are formed between the collar 37 and the cylindrical wall 44.
  • a material suitable for sealing around the stoma outer wall 54 may be filled in the accordion troughs 42.
  • a biocompatible adhesive or sealing gel such as a mucoadhesive or a waxy material.
  • Other biocompatible materials that do not get mushy or fall apart when exposed to stoma effluent during use, such as a silicone formulation, may also be suitable.
  • An adhesive or sealing gel may be loaded into the accordion-like troughs 42 during manufacturing of the faceplate assembly 14, or by a user prior to donning the faceplate assembly 14.
  • tissue adhesives and gels may be used to fill the reservoir 36.
  • the sealant holder 38 may be configured to operate with the accordion-like collar 37 to contain an adhesive in the accordion-like troughs 42, and prevent the accordion-like troughs 42 from prematurely collapsing during manufacturing, shipping and handling prior to donning of the faceplate assembly 14.
  • the faceplate assembly 14 is placed on a user, such that the center opening 48 of the sealant holder 38 is arranged over the stoma outer wall 54.
  • the sealant holder 38 pushes the sealant holder 38 against the stoma 52, the stoma 52 is raised through the center opening 48.
  • a recessed stoma can be pushed out and raised through the center opening 48 to facilitate sealing of the recessed stoma.
  • the sealant holder 38 is slowly withdrawn from the inlet opening 40, which exposes an adhesive or sealant contained in the accordion-like troughs 42, allowing the adhesive or sealant to come in contact with and seal around the stoma outer wall 54.
  • the adhesive in the accordion-like troughs 42 is fully exposed to the stoma outer wall 54 to provide a good seal around the stoma 52 and its base to isolate the stoma 52 from the surrounding peristomal skin without blocking the stoma orifice.
  • Some users may prefer pulling the sealant holder 38 and pressing the skin barrier 34 against the peristomal skin almost simultaneously or in small sequential steps. For example, a user may pull the sealant holder 38 little and push the skin barrier 34 little, and repeat these steps until the sealant holder 38 is completely removed and the skin barrier 34 is secured on the peristomal skin.
  • the pouch assembly 12 is attached to the faceplate assembly 14 by engaging the coupling rings 26, 32.
  • a reservoir in this embodiment is defined by the accordion-like collar, in other embodiments, a reservoir can be formed in different shapes to contain a stoma sealing material. Further, a sealant holder may come in different shapes and sizes. For example, a sealant holder may be generally oval shaped.
  • a one-piece pouch system may also include such a reservoir.
  • FIG. 5 is a cross sectional illustration of a one-piece drainable pouch system including a reservoir assembly according to an embodiment.
  • the one-piece pouch system 100 includes a pouch 102, a skin barrier 104, and a reservoir assembly 106.
  • the pouch 102 is a drainable pouch including a drain opening 130.
  • the reservoir assembly 106 is arranged proximate an inlet opening 108 defined in the pouch 102.
  • the reservoir assembly 106 may include a sealant holder 110, an accordion-like or bellows like collar 112, and accordion-like or bellows-like troughs 114 defined between the sealant holder 110 and the collar 112.
  • the troughs 114 may be filled with a material for sealing around a stoma outer wall, such as a mucoadhesive, a gel material, or a biocompatible material which does not get mushy or fall apart when exposed to stoma effluent during use.
  • FIG. 4 is an illustration of the sealant holder 110.
  • the sealant holder 110 may include a cylindrical wall 116, a circular head plate 118, and an opening 120 defined in the head plate 118 and extending through the cylindrical wall 116.
  • the cylindrical wall 116 may be attached to the circular head plate 118 along a snap-off joint 122.
  • the cylindrical wall 116 may also include a bottom surface 124, on which one or more opening may be provided for equalizing pressure to prevent vacuum suction effect when cylindrical wall 116 portion is snapped off and removed after a stoma has been received through the cylindrical wall 116.
  • the sealant holder 110 may also be provided with a string 128 for pulling and removing the cylindrical wall 116 portion of the sealant holder 110.
  • the snap-off joint 122 is a weak joint configured to break and detach the cylindrical wall 116 portion from the circular head plate 118 upon a pulling force.
  • a user can press the skin barrier 104 against the base of a stoma to attach the one-piece pouch system 100, wherein the stoma is received through the opening 108 and through the cylindrical wall 116. If needed, the user can push the sealant holder 110 against the peristomal area to facilitate placement of the stoma through the cylindrical wall 110. Once the stoma is received through the sealant holder opening 108, the user can access the string 128 through the opening 130 and pull the string 128 to snap off and detach the cylindrical wall 116 portion of the sealant holder 110, thereby exposing the stoma sealing material in the troughs 114 to seal around the stoma outer wall.
  • FIG. 6 is a cross sectional illustration a disposable one-piece pouch system 200 including a reservoir assembly 206 according to an embodiment.
  • the disposable one-piece pouch system 200 and the reservoir assembly 206 are similar to the drainable one-piece pouch system 100 and the reservoir assembly 106 except a pouch 202 is closed pouch without a drain opening.
  • a string 228 of a sealant holder 210 is attached to a bottom portion 230 of the pouch 202.
  • a user may snap off a cylindrical wall portion 216 of the sealant holder 210 by pulling the bottom portion of the pouch 202 to expose a stoma sealing material in troughs 214.
  • the cylindrical wall portion 216 may be formed from a softer or less rigid material than the sealant holder 38, 110 of the previously described embodiments to minimize discomfort of a user from the cylindrical wall portion 216 remaining in the pouch 202 during use.
  • a softer material suitable for the cylindrical portion 216 is silicone.
  • the cylindrical wall portion 216 may also be formed from a material that becomes softer when exposed to stoma output, such as polyvinyl alcohol (PVOH).

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

Abstract

L'invention concerne un ensemble plaque frontale pour des systèmes de poche pour stomie. L'ensemble plaque frontale comprend un réservoir destiné à contenir un matériau de scellement étanche pour un scellement étanche ou une adhésion autour d'une paroi externe d'une jonction cutanéo-muqueuse et de stomie au niveau de la base de stomie. La plaque frontale peut également comprendre un organe de retenue de matériau de scellement étanche amovible, qui est configuré pour exposer le matériau de scellement étanche de stomie lorsqu'un utilisateur retire l'organe de retenue de matériau de scellement étanche de l'ensemble plaque frontale. En outre, l'organe de retenue de matériau de scellement étanche amovible peut faciliter le soulèvement et le scellement étanche d'une stomie renfoncée.
PCT/US2014/059664 2013-10-08 2014-10-08 Plaque frontale pour stomie comprenant un réservoir d'adhésif pour stomie Ceased WO2015054366A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201361888304P 2013-10-08 2013-10-08
US61/888,304 2013-10-08

Publications (1)

Publication Number Publication Date
WO2015054366A1 true WO2015054366A1 (fr) 2015-04-16

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PCT/US2014/059664 Ceased WO2015054366A1 (fr) 2013-10-08 2014-10-08 Plaque frontale pour stomie comprenant un réservoir d'adhésif pour stomie

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112601508A (zh) * 2018-06-01 2021-04-02 奥斯托福姆有限公司 造口术袋
CN114504424A (zh) * 2022-01-06 2022-05-17 浙江大学医学院附属第一医院 一种防漏液型造口袋

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3805789A (en) * 1971-11-26 1974-04-23 A Marsan Hermetically sealed sealing means and appliance for ostomy conditions
US5125916A (en) * 1991-04-04 1992-06-30 Ras Partnership Stoma cap
FR2816202A1 (fr) * 2000-11-07 2002-05-10 Bernard Huet Dispositif d'aide a la mise en place d'un support de poche stomique et poche stomique
US20100114044A1 (en) * 2007-04-09 2010-05-06 Cramer Kathryn E Adhesive body fitment for ostomy appliane
US20120277700A1 (en) * 2011-04-28 2012-11-01 Flowcheck Medical Devices, Llc Ostomy device

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3805789A (en) * 1971-11-26 1974-04-23 A Marsan Hermetically sealed sealing means and appliance for ostomy conditions
US5125916A (en) * 1991-04-04 1992-06-30 Ras Partnership Stoma cap
FR2816202A1 (fr) * 2000-11-07 2002-05-10 Bernard Huet Dispositif d'aide a la mise en place d'un support de poche stomique et poche stomique
US20100114044A1 (en) * 2007-04-09 2010-05-06 Cramer Kathryn E Adhesive body fitment for ostomy appliane
US20120277700A1 (en) * 2011-04-28 2012-11-01 Flowcheck Medical Devices, Llc Ostomy device

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112601508A (zh) * 2018-06-01 2021-04-02 奥斯托福姆有限公司 造口术袋
CN114504424A (zh) * 2022-01-06 2022-05-17 浙江大学医学院附属第一医院 一种防漏液型造口袋

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