WO2009124548A1 - Wound cover device - Google Patents

Wound cover device Download PDF

Info

Publication number
WO2009124548A1
WO2009124548A1 PCT/DK2009/000086 DK2009000086W WO2009124548A1 WO 2009124548 A1 WO2009124548 A1 WO 2009124548A1 DK 2009000086 W DK2009000086 W DK 2009000086W WO 2009124548 A1 WO2009124548 A1 WO 2009124548A1
Authority
WO
WIPO (PCT)
Prior art keywords
cover
collar
tube
device according
preceding
Prior art date
Application number
PCT/DK2009/000086
Other languages
French (fr)
Inventor
Brian Nielsen
Original Assignee
Coloplast A/S
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
Priority to US7110708P priority Critical
Priority to US61/071,107 priority
Application filed by Coloplast A/S filed Critical Coloplast A/S
Publication of WO2009124548A1 publication Critical patent/WO2009124548A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/008Drainage tubes; Aspiration tips
    • A61M1/0088Drainage tubes; Aspiration tips with a seal, e.g. to stick around a wound for isolating the treatment area
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/008Drainage tubes; Aspiration tips
    • A61M1/0086Connectors therefor, e.g. detachable from hand-piece

Abstract

A device connectable to a vacuum source for the use with a wound having a wound surface comprises a flexible cover (2) configured to seal to a patient's skin surrounding the wound or configured to seal to a film dressing. The device further comprises a collar (1) integrally formed with the cover (2) and including a passageway (3) configured to receive a least a portion of a tube in communication with a vacuum source. The cover (2) and the collar (1) may be integrally formed by injection molding. A supportive member (5) may be provided in order to provide mechanical stability to the flexible film cover (2).

Description

WOUND COVER DEVICE

Technical field

The present invention generally relates to the field of negative pressure systems, i.e. suction systems, for removal of fluids from a wound and thus for enhancing wound healing. Such systems may comprise a wound enclosure which is attachable to a wound circumference of a living being to form an enclosure, and a suction source in fluid communication with the enclosure to provide a pressure difference between a negative pressure in the enclosure and an air pressure of an ambient space.

Background of the invention

It has been found that fluid drainage of wounds promotes tissue growth and thereby facilitates a reduced healing time. The treatment has been exercised for many years, and various therapeutic apparatus for providing suction to a wound have been developed.

A wound cover may be fixed in a sealing manner to the skin of a living being so that an enclosure is formed around the wound. The cover is connected to a pump, and suction is applied. The suction forces exudate from the enclosure to a receptacle. Commonly a collar is attached to an adhesive film sealing to the patient's skin surrounding the wound. The collar defines a passageway for receiving a tube to be connected to a suction source. When assembled the collar and the film form an attachment device, which is attachable to the patient's skin, and to which a suction tube is connectable. Attachment of the collar to the adhesive film typically involves the removal of a film-supporting liner covering a backside of the film in the area of the film, in which the collar is to be attached. This step has to be accurately controlled, because a hole is to be cut in the liner only, while the liner is attached to the film, and great care has to be taken that the cut does not extend into the film itself. Once the collar has been positioned on the film, the collar and film are joined by an appropriate process, such as by welding or gluing. Welding presents a particular challenge, because the amount of heat provided must on the one hand be sufficiently high to ensure appropriate local melting of the materials, while on the other hand it must accurately controlled in order not to cause damage to the adhesive on the skin-facing surface of the film. Finally, the suction tube is attached to the collar.

The steps of cutting a hole in the supporting liner covering the film and welding the collar to the film are complicated due to the difficulties in controlling the steps. Moreover, a risk exists that leakages occur in the area, where the collar is attached to the film, and/or in the area where the tube is connected to the collar. Leakages may occur as a result of inappropriate assembly of the parts or due to mechanical impacts, e.g. ruptures inadvertently provided by the patient or physician.

Summary of the invention

It is an object of preferred embodiments of the present invention to provide a wound cover device including an adhesive film and a cup, which is easy and inexpensive to manufacture. It is a further object of preferred embodiments of the invention to provide a wound cover device, which has a reduced risk of leakage.

In a first aspect, the present invention provides a device connectable to a vacuum source for the use with a wound having a wound surface, the device comprising: - a flexible cover configured to seal to a patient's skin surrounding the wound or configured to seal to a film dressing; - a collar integrally formed with the cover and including a passageway configured to receive a least a portion of a tube in communication with a vacuum source. The collar and the cover are preferably formed from one single piece of material, e.g. by injection molding.

In a second aspect the invention provides a method of manufacturing a device connectable to a vacuum source for the use with a wound having a wound surface, the device comprising a flexible cover configured to seal to a patient's skin surrounding the wound or configured to seal to a film dressing, and a collar attached to the cover and including a passageway configured to receive a least a portion of a tube in communication with a vacuum source, the method comprising the step of integrally forming the cover and the collar from one single piece of material, e.g. by injection molding.

It will be appreciated that the difficulties and drawbacks arising from prior art attachment devices may be overcome as the collar is formed integrally with the film. Hence, the cover and the collar may be formed in a single manufacturing step, preferably injection molding, and the risk of leakage is reduced, as the manufacture does not involve mutual attachment of two separate parts.

The cover is preferably provided with an adhesive layer on its skin-side surface for adhering to the patient's skin or to the film dressing.

The tube may or may not form part of the device of the present invention. It may be provided as a separate part, which is securable to the collar by welding, gluing or by a mechanical sealing and locking mechanism. Alternatively, the tube may be integrally formed with the collar and the cover, i.e. preferably injection molded in one single process step together with the collar and the cover.

The tube has a distal end received in the passageway in the collar, and an opposite, proximal end of the tube may be provided with a connector for connecting the tube to a vacuum source or to a further tube. The collar, cover, tube and connector may be formed by two- component injection molding, with the collar, cover and tube being formed from a first material, and the connector being formed from a second material. Hence, the tube may be formed by a flexible, relatively soft material, whereas the connector may be formed by a non-flexible, relatively hard material.

In order to increase the mechanical stability of the film, a supportive member may be provided along an outer circumference of the cover. The supportive member may be integrally formed with the cover, e.g. by injection molding, or it may be provided as a separate member. In the latter alternative, it may be placed in a mold, in which the cover and the collar are injection molded, prior to molding the cover and the collar, whereby the circumference of the cover attaches to the supportive member as the material of the cover solidifies. The supportive member may extended along the entire circumference of the cover, e.g. as a ring or rectangular frame, or only along a portion of the circumference of the cover.

The cover may be tapered towards its outer periphery when seen in cross section, so that the thickness of the film reduces along the outwardly extending radial axis. This configuration may facilitate injection molding of the cover and removal of the molded device from the injection mold.

The materials used for the attachment device may be any soft injection moldable material, e.g. thermoplastic materials. Examples of thermoplastic materials are elastomeric thermoplastics such as SBS (styrene butylene styrene block copolymer) or SEBS (styrene ethylene butylene styrene block copolymer). Alternative materials include curable materials, such as polyurethanes and silicones. In one embodiment the attachment device, i.e. cover and collar, is manufactured from silicone. In yet other embodiments, the cover and the collar are prepared from a material chosen from the group of silicones, vulcanized rubber materials or blends/copolymer thereof.

The hardness of the material may vary throughout the device due to different curing zones (silicone) or as a result of two-component injection molding (thermoplastic elastomers). The shore and thickness of the materials are preferably selected such that it is ensured that liquid may pass through the passageway. The thickness of the tube wall in the collar is preferably between 0.05 and 10 mm, preferably between 0.1 and 5 mm, more preferably between 0.2 and 2 mm. In a particular preferred embodiment the thickness of the tube wall in the collar is between 0.3 and 1 mm.

The tube and collar assembly may be configured in the manner disclosed in international patent publication WO 2007/006306, which is hereby incorporated by reference.

WO 2007/006306 also provides further information on suitable materials and their properties for the access port described therein, which apply equally to the device of the present invention.

The film portion of the device is preferably flexible. It is preferable to use a material that holds a certain degree of moisture permeability in order to allow the skin to breathe. In a preferred embodiment the level of moisture permeability is below 800 g/m2 per day. The thickness of the film is preferably sufficiently low to obtain flexibility and breathability. The thickness of the material covering the intact skin should preferably be below 1 mm, more preferably below 0.5 mm and most preferably below 0.3 mm.

The adhesive used on any the device may be a skin friendly adhesive. In one embodiment of the invention it is a silicone adhesive.

Description of the drawings

Embodiments of the invention will now be further described with reference to the accompanying drawings, in which:

Figs. 1 and 2 show a cross section first embodiment of a device according to the present invention including a supportive member along the periphery of the cover;

Figs. 3 and 4 show further embodiments including no supportive member;

Figs. 5-8 show embodiments including suction tube sections.

Fig. 1 shows an injection molded part comprising a collar 1, a cover film 2, a passageway 3 and a peripheral supportive ring 5. The part shown in Fig. 1 is injection molded from a single piece of material. Fig. 2 shows an attachment device according to the present invention based on the injection molded part of Fig. 1, with an adhesive layer 4 provided on a skin- facing surface of the cover 2. The cover 2 is tapered, i.e. has a decreasing thickness towards its periphery. Figs. 3 and 4 show variations of the embodiment of Fig. 2. More specifically, in the embodiment of Fig. 3, the cover film 2 has a uniform thickness, i.e. no thickness decrease towards its outer periphery. In Fig. 4, the cover film 2 has a decreasing thickness; however the supportive ring 5 has been omitted in this embodiment.

Further embodiments are shown in Figs. 5 and 6, in which the adhesive layer 4 is covered by a removable liner 7. The passageway 3 has a tubular extension 6 forming a suction tube or part thereof for connection to a suction source or a further tube section (not shown). Fig. 7 shows a similar embodiment, in which the cover 2 has a constant, i.e. non-decreasing, thickness.

In the embodiment of Fig. 8, a proximal end of the tube 6 is provided with a connector 8 for connecting the tube 6 to a vacuum source or to a further tube (not shown).

Claims

1. A device connectable to a vacuum source for the use with a wound having a wound surface, the device comprising: - a flexible cover configured to seal to a patient's skin surrounding the wound or configured to seal to a film dressing;
- a collar integrally formed with the cover and including a passageway configured to receive a least a portion of a tube in communication with a vacuum source.
2. A device according to claim 1, wherein the cover and collar are formed by injection molding.
3. A device according to claim 1 or 2, further comprising an adhesive layer on a skin-side surface of the cover for adhering to the patient's skin or to the film dressing.
4. A device according to any of the preceding claims, wherein the tube is integrally formed with the collar and the cover.
5. A device according to any of the preceding claims, wherein the tube has a distal end received in said passageway in the collar, and wherein an opposite, proximal end of the tube is provided with a connector for connecting the tube to a vacuum source or to a further tube.
6. A device according to claim 5, wherein the collar, cover, tube and connector are formed by two-component injection molding, with the collar, cover and tube being formed from a first material, and the connector being formed from a second material.
7. A device according to any of the preceding claims, further comprising a supportive member along an outer circumference of the cover.
8. A device according to claim 7, wherein the supportive member and the cover are integrally formed.
9. A device according to any of the preceding claims, wherein a major portion of the cover has a thickness of less than 0.3 mm.
10. A device according to any of the preceding claims, wherein the cover has a moisture permeability of at most 800 g/m2/day.
11. A device according to any of the preceding claims, wherein a distal portion of the tube received by the collar has a wall thickness of between 0.3 and 1 mm.
12. A device according to any of the preceding claims wherein at least the cover and the collar are prepared from thermoplastic elastomer, such as SBS (styrene butylene styrene block copolymer) or SEBS (styrene ethylene butylene styrene block copolymer).
13. A device according to any of the preceding claims wherein at least the cover and the collar are prepared from a material chosen from the group of silicones, vulcanized rubber materials or blends/copolymer thereof.
14. A device according to any of the preceding claims, wherein the cover, when seen in cross section, is tapered towards and outer periphery thereof, so that the thickness of the film reduces along the outwardly extending radial axis.
15. A method of manufacturing a device connectable to a vacuum source for the use with a wound having a wound surface, the device comprising a flexible cover configured to seal to a patient's skin surrounding the wound or configured to seal to a film dressing, and a collar attached to the cover and including a passageway configured to receive a least a portion of a tube in communication with a vacuum source, the method comprising the step of integrally forming the cover and the collar from one single piece of material.
PCT/DK2009/000086 2008-04-11 2009-04-03 Wound cover device WO2009124548A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US7110708P true 2008-04-11 2008-04-11
US61/071,107 2008-04-11

Publications (1)

Publication Number Publication Date
WO2009124548A1 true WO2009124548A1 (en) 2009-10-15

Family

ID=40638145

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/DK2009/000086 WO2009124548A1 (en) 2008-04-11 2009-04-03 Wound cover device

Country Status (1)

Country Link
WO (1) WO2009124548A1 (en)

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2495009A1 (en) 2011-03-02 2012-09-05 Lohmann & Rauscher GmbH Wound treatment assembly and suction attachment for same
EP2636417A1 (en) 2012-03-05 2013-09-11 Lohmann & Rauscher GmbH Wound treatment assembly and covering device for same
WO2014023501A1 (en) 2012-08-09 2014-02-13 Paul Hartmann Ag Connection device for use in negative pressure therapy for wounds
WO2014023500A1 (en) 2012-08-09 2014-02-13 Paul Hartmann Ag Method for producing a connection device for use in negative pressure therapy for wounds
US9050398B2 (en) 2010-12-22 2015-06-09 Smith & Nephew, Inc. Apparatuses and methods for negative pressure wound therapy
US9320840B2 (en) 2012-10-05 2016-04-26 Luis F. Angel Catheter vacuum dressing apparatus and methods of use
US9327065B2 (en) 2009-12-22 2016-05-03 Smith & Nephew, Inc. Apparatuses and methods for negative pressure wound therapy
EP3117806A1 (en) 2015-07-16 2017-01-18 Lohmann & Rauscher GmbH Wound treatment assembly
EP3120817A1 (en) 2015-07-22 2017-01-25 Lohmann & Rauscher GmbH Wound treatment assembly
USD804014S1 (en) 2010-12-22 2017-11-28 Smith & Nephew, Inc. Suction adapter
US9956329B2 (en) 2008-03-07 2018-05-01 Smith & Nephew, Inc. Wound dressing port and associated wound dressing
US10406036B2 (en) 2009-06-18 2019-09-10 Smith & Nephew, Inc. Apparatus for vacuum bridging and/or exudate collection

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020161346A1 (en) * 2000-11-29 2002-10-31 Lockwood Jeffrey S. Vacuum therapy and cleansing dressing for wounds
US20030212357A1 (en) * 2002-05-10 2003-11-13 Pace Edgar Alan Method and apparatus for treating wounds with oxygen and reduced pressure
US20050148913A1 (en) * 2004-01-02 2005-07-07 Weston Richard S. Reduced pressure wound treatment appliance
WO2007031757A1 (en) * 2005-09-15 2007-03-22 Smith & Nephew, Plc Apparatus
US20070265585A1 (en) * 2006-05-11 2007-11-15 Joshi Ashok V Device and method for wound therapy

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020161346A1 (en) * 2000-11-29 2002-10-31 Lockwood Jeffrey S. Vacuum therapy and cleansing dressing for wounds
US20030212357A1 (en) * 2002-05-10 2003-11-13 Pace Edgar Alan Method and apparatus for treating wounds with oxygen and reduced pressure
US20050148913A1 (en) * 2004-01-02 2005-07-07 Weston Richard S. Reduced pressure wound treatment appliance
WO2007031757A1 (en) * 2005-09-15 2007-03-22 Smith & Nephew, Plc Apparatus
US20070265585A1 (en) * 2006-05-11 2007-11-15 Joshi Ashok V Device and method for wound therapy

Cited By (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9956329B2 (en) 2008-03-07 2018-05-01 Smith & Nephew, Inc. Wound dressing port and associated wound dressing
US10406036B2 (en) 2009-06-18 2019-09-10 Smith & Nephew, Inc. Apparatus for vacuum bridging and/or exudate collection
US10406037B2 (en) 2009-12-22 2019-09-10 Smith & Nephew, Inc. Apparatuses and methods for negative pressure wound therapy
US9999547B2 (en) 2009-12-22 2018-06-19 Smith & Nephew, Inc. Apparatuses and methods for negative pressure wound therapy
US9974695B2 (en) 2009-12-22 2018-05-22 Smith & Nephew, Inc. Apparatuses and methods for negative pressure wound therapy
US9642750B2 (en) 2009-12-22 2017-05-09 Smith & Nephew, Inc. Apparatuses and methods for negative pressure wound therapy
US9327065B2 (en) 2009-12-22 2016-05-03 Smith & Nephew, Inc. Apparatuses and methods for negative pressure wound therapy
US9956389B2 (en) 2010-12-22 2018-05-01 Smith & Nephew, Inc. Apparatuses and methods for negative pressure wound therapy
USD804014S1 (en) 2010-12-22 2017-11-28 Smith & Nephew, Inc. Suction adapter
US9050398B2 (en) 2010-12-22 2015-06-09 Smith & Nephew, Inc. Apparatuses and methods for negative pressure wound therapy
EP2495009A1 (en) 2011-03-02 2012-09-05 Lohmann & Rauscher GmbH Wound treatment assembly and suction attachment for same
DE202013012333U1 (en) 2012-03-05 2016-05-11 Lohmann & Rauscher Gmbh Wound care assembly and covering device therefor
WO2013131638A1 (en) 2012-03-05 2013-09-12 Lohmann & Rauscher Gmbh Wound care arrangement and covering unit therefor
EP2636417A1 (en) 2012-03-05 2013-09-11 Lohmann & Rauscher GmbH Wound treatment assembly and covering device for same
WO2014023501A1 (en) 2012-08-09 2014-02-13 Paul Hartmann Ag Connection device for use in negative pressure therapy for wounds
DE102012214178A1 (en) 2012-08-09 2014-06-12 Paul Hartmann Ag Connection device for use in the negative pressure therapy of wounds
DE102012214175A1 (en) 2012-08-09 2014-06-12 Paul Hartmann Ag A method of making a connector for use in wound wound therapy
WO2014023500A1 (en) 2012-08-09 2014-02-13 Paul Hartmann Ag Method for producing a connection device for use in negative pressure therapy for wounds
US9586000B2 (en) 2012-08-09 2017-03-07 Paul Hartmann Ag Connection device for use in the negative pressure treatment of wounds
US9320840B2 (en) 2012-10-05 2016-04-26 Luis F. Angel Catheter vacuum dressing apparatus and methods of use
EP3117806A1 (en) 2015-07-16 2017-01-18 Lohmann & Rauscher GmbH Wound treatment assembly
EP3120817A1 (en) 2015-07-22 2017-01-25 Lohmann & Rauscher GmbH Wound treatment assembly

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