WO2010007413A2

WO2010007413A2 - Wound management device

Info

Publication number: WO2010007413A2
Application number: PCT/GB2009/050842
Authority: WO
Inventors: Damian Daniel David O'neill
Original assignee: Belfast Health And Social Care Trust
Priority date: 2008-07-11
Filing date: 2009-07-13
Publication date: 2010-01-21
Also published as: GB0812729D0; WO2010007413A3

Abstract

A wound management device (1) is provided comprising a tube (5) comprising a first, open, end adapted for connection to a suction device, a second, open, end (15) and a suction portion (17) proximal to the second end, the suction portion having a plurality of openings (19) therein, a collar (7) extending around at least part of the suction portion of the tube, the collar comprising a side wall (21) having a first end (23) and a second, open, end (25) proximal to the second open end of the tube, wherein the tube and the collar define a chamber (31) therebetween which connects the second open end of the collar and the plurality of openings in the suction portion of the tube.

Description

WOUND MANAGEMENT DEVICE

FIELD OF THE INVENTION

This invention relates to a wound management device for managing removal of fluid from a wound, and particularly, but not exclusively, for managing removal of effluent from fistulae and stoma wounds.

BACKGROUND OF THE INVENTION

Stomas are artificial openings in the abdomen wall that are used to collect waste (effluent) from the intestine or bladder. Ileostomies are openings from the small intestine and colostomies are openings from the large intestine.

Fistulae are abnormal connections between two epithelium-lined vessels or organs that do not normally connect. Enterocutaneous fistulae occur between the stomach or intestine (small or large) and the skin surface. In addition, enterocutaneous fistulae cause the leakage of intestinal contents (effluent) through an opening in the skin.

Stoma and wound management appliances may be used to manage the intestinal contents (effluent) released from fistulae and stomas.

Conventional wound appliances are designed to remove small volumes of effluent from fistula and stoma wounds. In patients where large volumes of effluent are produced, removal of the effluent is often not sufficient, and wound appliances often do not adhere adequately to the patient's skin. This results in the effluent coming into contact with the patient's skin, causing damage thereto. Additionally, in patients where the volume of effluent produced is high, the conventional appliances require frequent replacement to avoid prolonged exposure of the skin to the effluent. Prolonged exposure of the skin to moisture can result in maceration (softening of the skin, which leaves it more vulnerable to infection and tearing). In addition, exposure of the skin to intestinal material can cause excoriation (mechanical destruction of the skin) as a result of chemical irritation and proteolysis (enzymatic breakdown of protein in tissues). Further damage to the skin may occur through frequent removal of appliances that are adhered to the skin surrounding the fistula or stoma. Such damage to tissue can result in severe pain requiring treatment with opiate analgesics or other therapeutics.

A further complication in patients with high fluid volume wounds is the difficulty in accurately measuring the volume of their fluid output (required to ensure patients receive adequate fluid replacement).

SUMMARY OF THE INVENTION

The invention provides a wound management device comprising a tube comprising a first, open, end adapted for connection to a suction device, a second, open, end and a suction portion proximal to the second end, the suction portion having a plurality of openings therein, and a collar extending around at least part of the suction portion of the tube, the collar comprising a side wall having a first end and a second, open, end proximal to the second open end of the tube, wherein the tube and the collar define a chamber therebetween which connects the second open end of the collar and the plurality of openings in the suction portion of the tube. In use, the tube and collar are placed proximal to the wound. On operation of the suction device, a negative pressure is provided within the tube and the collar. Fluid in the wound is sucked through the second open end of the tube, along the tube and into an fluid collection unit (preferably having at least 1 litre capacity). Fluid is also sucked through the second open end of the collar into the chamber. The chamber provides connection to the openings in the suction portion of the tube, and fluid is able to flow through the chamber and be sucked through the openings of the suction portion into the tube, and, from there, along the tube and into the fluid collection unit. Provision of the plurality of openings in the suction portion of the tube (in addition to the open end of the tube) allows increased volumes of fluid to be removed from the wound. Provision of the collar around the suction portion of the tube protects the openings of the suction portion from occlusion, for example should the negative pressure produced by the suction device cause a wound appliance used with the device to collapse inwards towards the tube and the collar or should the wound appliance be pressed inwards towards the tube and the collar.

The tube may comprise any type of tube capable of receiving fluid from a wound. Preferably, the tube comprises a flexible material. The tube may comprise a catheter, for example a rubber rectal catheter. The second end of the tube may be tapered. The first end of the tube may have a larger diameter than that of the second end of the tube. The first end of the tube may have a diameter of approximately 1.2cm and a lumen diameter of approximately 0.9cm. The second end of the tube may have a diameter of approximately 0.7cm and a lumen diameter of approximately 0.4cm. The tube may have a length in the region of approximately 40cm. The openings of the suction portion of the tube may be substantially oval in shape, for example approximately 0.5cm by 0.2 cm. The openings of the suction portion of the tube may be substantially circular in shape. The openings of the suction portion of the tube may be axially spaced along the suction portion. Additionally or alternatively, the openings of the suction portion of the tube may be circumferentially spaced around the suction portion. The suction portion may comprise four to six openings.

The collar may extend around all of the suction portion of the tube. The collar may extend up to the second open end of the tube. The collar may extend over the second open end of the tube. Thus the collar may provide protection for the second open end of the tube from occlusion e.g. by a wound appliance.

The first end of the collar may be open. Thus fluid from the wound may flow into the chamber via the first and second ends of the collar. Alternatively, the first end of the collar may form a closure around the tube. Thus the chamber is closed at this end of the collar, which, in some circumstances, may be used to promote flow of fluid through the openings of the suction portion into the tube.

The diameter of the collar may be in the region of approximately 2.5cm with a lumen diameter of approximately 2.1 cm. The diameter of the collar may be approximately three times the diameter of the tube. The collar may have a length in the region of approximately 5cm to approximately 8cm, for example approximately 7cm. The collar may be formed from humidified oxygen tubing.

The side wall of the collar may provide a plurality of openings therein, for example three to five openings. The side wall openings may be axially spaced along the collar. Additionally or alternatively, the side wall openings may be circumferentially spaced around the collar. The side wall openings of the collar may substantially correspond with the openings of the suction portion of the tube. The collar may be corrugated comprising a plurality of radially raised rings axially spaced along the side wall of the collar. The side wall openings of the collar may be provided in the raised rings or between the raised rings or a combination of in and between the raised rings.

Provision of side wall openings in the collar allows fluid to be sucked through these openings into the chamber and from there through the openings in the suction portion of the tube, etc. Provision of the side wall openings in the collar allows further increase in the volume of fluid removed from the wound. Corrugation of the collar may increase resistance of the collar to crushing thereof, for example as a result of negative pressure provided within the collar. Provision of a corrugated collar with side wall openings provided between the raised rings of the corrugation, protects the side wall openings of the collar from occlusion, for example should the negative pressure produced in the device cause a wound appliance used with the device to collapse inwards towards the collar or should the wound appliance be pressed inwards towards the collar.

The collar may not be concentric with at least part of the suction portion of the tube, for example a portion of the side wall of the collar may rest against a portion of the suction portion of the tube. Alternatively, the collar may be substantially concentric with at least part of the suction portion of the tube. The collar may extend around at least part of the suction portion of the tube by attachment of the collar and the tube. The collar and the tube may be formed as one piece. Thus, the wound management device may be provided for use with the collar and the tube forming one part.

The collar may extend around at least part of the suction portion of the tube by positioning of the collar around the tube without attachment of the collar and the tube. Thus, the wound management device may be provided for use with the collar and the tube forming two separate parts.

The wound management device may be adapted for use with a wound appliance for placing around the wound. The wound management device may comprise a wound appliance for placing around the wound.

The wound appliance may comprise a bag-like structure. The wound appliance may comprise an aperture boundary defining an aperture. The aperture boundary may hold the tube within the aperture, such that the second end and the suction portion of the tube are both positioned within the wound appliance. The aperture boundary may be attached to the tube. The aperture boundary may form a substantially airtight seal around the tube. The wound appliance may comprise, or be provided in use with, a second aperture boundary defining a second aperture which boundary is adapted to be placed around the wound. The second aperture boundary may comprise a seal to attach the appliance around the wound. The seal may comprise a plasticine-type substance. The wound appliance may be provided in conjunction with a transparent template for ease of creating a second aperture boundary which substantially corresponds to the wound. The wound appliance may be provided in use with an aperture boundary defining an aperture which is applied around a wound. This allows the wound appliance to be adapted to any particular size and shape of wound. Alternatively, the wound appliance may be provided already comprising an aperture boundary defining an aperture to be applied around a wound.

The wound appliance may comprise a drape-like structure. The wound appliance may drape over the tube, such that the second end and the suction portion of the tube are both positioned between the wound and the wound appliance. The tube may extend under and out of a side portion of the wound appliance. The tube may be attached to the side portion of the wound appliance. The wound appliance may drape over the wound and at least some surrounding thereof.

When the wound management device comprises the tube, the collar and the wound appliance, the tube and collar may be attached together and the tube and wound appliance may be attached together. Thus, the wound management device may be provided for use with the tube, collar and wound appliance forming one part, which may facilitate application of the device to a wound. Alternatively, when the wound management device comprises the tube, the collar and the wound appliance, the tube and collar may be attached together and the wound appliance may be separate from the attached tube and collar. Alternatively, when the wound management device comprises the tube, the collar and the wound appliance, the tube and collar and wound appliance may each be separate from each other. Thus, the wound management device may be provided for use with the tube, collar and wound appliance forming a plurality of parts.

The wound management device may be attached to a portable suction device, a wall mounted suction device or a floor mounted suction device. In the latter case, the suction device may comprise a container suitable for housing the suction device at ground level. The suction device may provide suction at between 50 to 100mm Hg. The first end of the tube of the wound management device may be attached to a perspex tapered tube connection device, connected to a bubble suction tubing in turn connected to the suction device. Alternatively, the first end of the tube of the wound management device may be adapted for direct connection to the suction device.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will now be described by way of example only, with reference to the accompanying drawings, in which

Figure 1 is a schematic representation of an embodiment of a wound management device according to the invention, and

Figure 2 is a schematic representation of the wound management device of Figure 1 attached for use over a wound on an abdomen of a patient.

DETAILED DESCRIPTION OF THE INVENTION

Referring to Figure 1 , in this embodiment, the wound management device 1 comprises a wound appliance 3, a tube 5 and a collar 7.

The wound appliance 3 comprises a bag-like structure, but it will be appreciated that other types of wound appliance, such as a drape, may be used. The wound appliance 3 has a first aperture boundary 9 defining a first aperture. The first aperture boundary 9 holds the tube 5 within the aperture, forming a substantially airtight seal around the tube 5. The wound appliance 3 is provided in use with a second aperture boundary 13 defining a second aperture. In use of the device, the second aperture boundary 13 is placed around a wound. The second aperture boundary 13 comprises a seal to attach the wound appliance 3 around the wound.

The tube 5 comprises a catheter, but it will appreciated that other types of tube may be used. The tube 5 has a first, open, end (not shown) adapted for connection to a suction device, a second, open, end 15 and a suction portion 17 proximal to the second end 15. The first aperture boundary 9 of the wound appliance 3 holds the tube 5 such that the second end 15 and the suction portion 17 of the tube 5 are both positioned within the wound appliance 3 as shown. The suction portion 17 has a plurality of openings 19, for example four to six openings, therein. The openings 19 are oval in shape, are axially spaced along the suction portion and circumferentially spaced around the suction portion and open into the lumen of the tube 5.

The collar 7 is formed from humidified oxygen tubing, but it will be appreciated that other types of tubing may be used for the collar. The collar 7 has a diameter which is larger than that of the tube 5, as shown, for example approximately three times the diameter of the tube. The collar 7 has a length, for example approximately 40cm long, such that it extends around at least part of the suction portion 17 of the tube 5 and in this preferred embodiment extends around all of the suction portion 17 and over the second open end 15 of the tube 5. The collar 7 comprises a side wall 21 having a first end 23 and a second, open, end 25 proximal to the second open end 15 of the tube 5. The collar 7 is corrugated comprising a plurality of radially raised rings 27 axially spaced along the side wall 21 . The side wall 21 has a plurality of oval openings 29 therein, for example four openings, which are provided in/between the raised rings 27 and axially spaced along the collar 7 and circumferentially spaced around the collar 7. The side wall openings 29 may substantially correspond with the openings 19 of the suction portion 17 of the tube 5. In this embodiment, the collar 7 is positioned around the suction portion 17 and second end 15 of the tube 5 such that the collar 7 is substantially concentric with the tube 5. It will be appreciated, however, that the collar may be positioned around the tube such that they are not concentric, for example a part of the side wall of the collar may rest against a part of the suction portion of the tube. In this embodiment, the collar 7 is positioned around the suction portion 17 and second end 15 of the tube 5 by attachment to the tube 5. It will appreciated, however, that the collar may be positioned around the tube without being attached thereto.

As a result of the arrangement of the collar 7 around the suction portion 17 and the second end 15 of the tube, a chamber 31 is defined between the collar 7 and the tube 5. The chamber 31 provides connection between the second open end 25 of the collar 7 and the plurality of openings 19 in the suction portion 17 of the tube 5.

Referring to Figure 2, the wound management device 1 is attached around a wound 40 of the abdomen of a patient. The wound appliance 3 is provided with a transparent template (not shown). This is placed on top of the wound 40 and surrounding area and the wound boundary is marked on the template using, for example, an indelible pen. The template is then reversed and placed onto the wound appliance 3 and the boundary of the wound is engraved by pressure, for example from a ballpoint pen lid or similar item, onto the wound appliance 3. This forms the wound aperture boundary 13 of the appliance 3, and a wound aperture is formed in the appliance 3 by cutting along the wound aperture boundary 13.

The wound management device 1 is placed onto the patient's abdomen, i.e. the wound appliance 3 and tube 5 and the collar 7 are applied as one to the wound 40. The wound aperture boundary 13 of the appliance 3 is placed over the boundary of the wound 40 and sealed thereto such that the wound 40 opens into the bag-like wound appliance 3.. A transparent polyurethane adherent dressing may also be used to ensure any air leaks around the appliance 3 are sealed. The second end 15 of the tube 5 and the second end 25 of the collar 7 are located proximal to a fistula and stoma of the wound preferably at a distal aspect thereof to reduce the opportunity of fluid (effluent) from the fistula and stoma coming into direct contact with the ends of the tube and collar. The collar 7 is preferably placed on a foam-like material (not shown), to alleviate pressure applied by the collar onto the wound. Preferably, a part of the collar which rests proximal to the wound is not corrugated. The openings 19 of the collar 7 may rest on the foam-like material and suck fluid from the material.

The wound management device 1 is then attached to a portable suction device or a floor/wall mounted suction device (not shown). The first end of the tube 5 of the wound management device 1 is attached to a perspex tapered tube connection device (not shown) which is connected to a bubble suction tubing (not shown)which, in turn, is connected to the suction device. The suction device provides suction at between 50- 100mm Hg. The tube 5 is secured to the patient's flank with a transparent polyurethane adherent dressing.

On operation of the suction device, a negative pressure is provided within the tube 5, the collar 7 and the chamber 31 therebetween. Fluid in the wound 40 is sucked through the second open end 15 of the tube 5, along the tube 5 and into a fluid collection unit (not shown). Fluid is also sucked through the second open end 25 of the collar 7 into the chamber 31 . The chamber 31 provides connection to the openings 19 in the suction portion 17 of the tube 5, and fluid flows through the chamber 31 and is sucked through the openings 19 of the suction portion 17 into the tube 5, and, from there, along the tube 5 and into the fluid collection unit. In addition, fluid is sucked through the openings 29 of the side wall 21 of the collar 7 into the chamber 31 and flows through the chamber 31 and is sucked through the openings 19 of the suction portion 17 into the tube 5, and, from there, along the tube 5 and into the fluid collection unit.

Thus it can be seen that multiple paths are provided for removal of the fluid from the wound, which allows increased volumes of fluid to be removed in comparison to conventional wound management devices. Provision of the collar around the suction portion of the tube protects the openings of the suction portion from occlusion by the wound appliance. Provision of the collar around the second open end of the tube protects this from occlusion by the wound appliance. When, as described above, the wound comprises a fistula and stoma, the wound management device allows efficient removal of fistula and stoma effluent from the wound, thus protecting the patient from harmful contact with such effluent.

The wound management device of the invention achieves a sealed fluid drainage system which allows: a) protection of the surrounding skin from harmful fluid (e.g. acidic gastrointestinal effluent), b) collection of the fluid for accurate measurement and subsequent fluid replacement, c) promotion of healing of the wound by achieving a moist bed by continuous topical negative pressure, d) several days between wound management device change, e) control of odour released from the fluid, and f) minimisation of pain caused by damage to the tissue surrounding the wound. In the above-described embodiment, the collar 7 is attached to the tube 5 and the tube 5 is attached to the wound appliance 3, i.e. the wound management device 1 is provided as a pre-assembled, one-piece device. The collar 7 and the tube 5 may be attached by forming them as one piece for example by plastics moulding. As described above, the wound management device 1 , i.e. the wound appliance and tube and collar, are applied as one to the wound.

In an alternative embodiment, the wound management device may be provided as a kit of parts. Each of the wound appliance, tube and collar of this embodiment may be provided separately, and may be assembled together for use of the device. Assembly of the wound appliance, tube and collar may comprise attaching them together. Use of the device may comprise, for example, placing the tube in the wound appliance, placing the collar proximal to the wound and applying the wound appliance and the tube to the wound so that tube locates in the collar, or, alternatively, inserting the collar through an aperture of the wound appliance onto the tube and applying the device to the wound. It will also be appreciated that the wound appliance and the tube may be provided pre-assembled and the collar may be provided separately and be assembled with the tube for use of the device, or the tube and the collar may be provided pre- assembled and the wound appliance may be provided separately and be assembled with the tube and collar for use of the device.

In a further embodiment of the wound management device, the device may be formed from modified conventional, readily available components. For example, a stoma or fistula bag could be modified to receive a catheter, the catheter could be modified to have a suction portion, and a collar could be formed from tubing.

Claims

1 . A wound management device comprising a tube comprising a first, open, end adapted for connection to a suction device, a second, open, end and a suction portion proximal to the second end, the suction portion having a plurality of openings therein, and a collar extending around at least part of the suction portion of the tube, the collar comprising a side wall having a first end and a second, open, end proximal to the second open end of the tube, wherein the tube and the collar define a chamber therebetween which connects the second open end of the collar and the plurality of openings in the suction portion of the tube.

2. A device according to claim 1 , in which the collar extends around all of the suction device and over the second open end of the tube.

3. A device according to claim 1 or claim 2, in which the side wall of the collar provides a plurality of openings therein.

4. A device according to claim 3, in which the openings of the collar substantially correspond with the openings of the suction portion of the tube.

5. A device according to claim 4, in which the collar is corrugated comprising a plurality of radially raised rings axially spaced along the side wall of the collar and the openings of the collar are provided between the raised rings.

6. A device according to any preceding claim, in which the collar is not concentric with at least part of the suction portion of the tube, and a portion of the side wall of the collar rests against a portion of the suction portion of the tube.

7. A device according to any of claims 1 to 5, in which the collar is substantially concentric with at least part of the suction portion of the tube.

8. A device according to any preceding claim, in which the collar extends around at least part of the suction portion of the tube by attachment of the collar and the tube.

9. A device according to any of claims 1 to 7, in which the collar extends around at least part of the suction portion of the tube by positioning of the collar around the tube without attachment of the collar and the tube.

10. A device according to any preceding claim, in which the device is adapted for use with a wound appliance for placing around the wound.

1 1 . A device according to any of claims 1 to 9, in which the device comprises a wound appliance for placing around the wound.

12. A device according to claim 10 or claim 1 1 , in which the wound appliance comprises a bag-like structure.

13. A device according to claim 12, in which the wound appliance comprises an aperture boundary defining an aperture, which aperture boundary holds the tube within the aperture, such that the second end and the suction portion of the tube are both positioned within the wound appliance.

14. A device according to claim 10 or claim 1 1 , in which the wound appliance comprises a drape-like structure.

15. A device according to claim 14, in which the wound appliance drapes over the tube, such that the second end and the suction portion of the tube are both positioned between the wound and the wound appliance.

16. A kit of parts for use as a wound management device, the kit comprising a tube comprising a first, open, end adapted for connection to a suction device, a second, open, end and a suction portion proximal to the second end, the suction portion having a plurality of openings therein, and a collar extending around at least part of the suction portion of the tube, the collar comprising a side wall having a first end and a second, open, end proximal to the second open end of the tube, wherein the tube and the collar define a chamber therebetween which connects the second open end of the collar and the plurality of openings in the suction portion of the tube.

17. The kit of claim 16 further comprising a wound appliance for placing around the wound.