WO2007029065A2

WO2007029065A2 - Wound treatment apparatus and method

Info

Publication number: WO2007029065A2
Application number: PCT/IB2006/002107
Authority: WO
Inventors: Elaine Joy Gundry; Garth O'connor; Malan De Villiers
Original assignee: Southern Cat (Pty) Ltd
Priority date: 2005-08-02
Filing date: 2006-08-02
Publication date: 2007-03-15
Also published as: WO2007029065A3

Abstract

The invention concerns the treatment of a wound (20) on a body part, for example a forearm (28). Treatment apparatus (10) is provided which makes use of an enclosure to enclose the body part. The arrangement is such that a space inside the enclosure is partially occupied by the body part. The enclosure has an inlet (46) through which a gaseous fluid can be fed into the unoccupied portion of the space (77) and an outlet (39.1) through which gaseous fluid can exhaust from the enclosure. In use, gaseous fluid is passed through the unoccupied portion of the space, from the inlet to the outlet, in order to treat the wound. In the preferred embodiment, the enclosure is provided by a flexible, inflatable bag (14) and the operating parameters are such that the passage of the gaseous fluid through the bag maintains the bag in an inflated condition about the body part.

Description

'WOUND TREATMENT APPARATUS AND METHOD"

BACKGROUND TO THE INVENTION

THIS invention relates to a wound treatment apparatus and method.

It is recognized by health care professionals that the healing of bodily wounds can be accelerated by exposing the wound site to flowing air or oxygen together, possibly, with additional treatment agents or medicaments.

It is also recognized that certain types of wound dressing, such as are used on wounds such as burns, ulcers, pressure sores and the like, should be kept moist if they are to perform acceptably. In such cases, a normal procedure would be to spray water or another moistening agent periodically onto the dressing once the latter has been placed over the wound and, if necessary, bound in place by means of a bandage or the like.

The present invention seeks to provide a novel wound treatment apparatus and method in which the above principles are implemented. SUMMARY OF THE INVENTION

According to one aspect of the invention there is provided a wound treatment apparatus comprising an enclosure for operatively enclosing a body part having a wound thereon in a configuration in which a space defined in the enclosure is partially occupied by the body part, the enclosure having an inlet through which a gaseous fluid can operatively be fed into the unoccupied portion of the space and an outlet via which gaseous fluid can operatively exhaust from the enclosure whereby gaseous fluid can be passed through the said unoccupied portion of the space, from the inlet to the outlet, in order to treat the wound.

The term "body part" as used in this specification refers to any part, of the human body which can be enclosed in an enclosure having a single mouth at one end for insertion of the body part, or a sleeve-like enclosure having mouths at opposite ends through which the body part can be extended such that a portion of the body part is accommodated within the enclosure.

The apparatus may particularly serve for treating a body part having a wound, such as a burn wound, ulcer, pressure sore or the like. With the body part enclosed within the enclosure and the wound, or a dressing on the wound, exposed to the space defined in the enclosure, a gaseous fluid suitable for treatment of the wound can be fed into the space and thus into contact with the wound. The gaseous fluid will typically be air or a gaseous mixture including air.

In the preferred embodiment, the enclosure is in the form of a flexible, inflatable bag and the gaseous fluid supply means is operative to pass the gaseous fluid through the bag, from the inlet to the outlet, under sufficient pressure to maintain the bag in an inflated condition about the body part. In such an embodiment, the bag may be transparent to allow visual inspection of the wound environment and it may be disposable after use. According to another aspect of the invention there is provided method of treating a wound on a body part, the method comprising the steps of enclosing the body part in an enclosure having an inlet and an outlet in a configuration in which a space defined in the enclosure is partially occupied by the body part, and passing a gaseous fluid, selected for treatment of the wound, through an unoccupied portion of the enclosure from the inlet to the outlet.

The invention envisages many other features and advantages of the apparatus and method summarized above. Such other features, which are set forth in the appended claims, and advantages are described subsequently.

BRIEF DESCRIPTION OF THE DRAWINGS

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

In the drawings:

Figure 1 diagrammatically illustrates a first embodiment of the invention;

Figure 2 diagrammatically illustrates the embodiment of Figure 1 in use;

Figure 3 diagrammatically illustrates a body part support which can be used in the embodiment of Figures 1 and 2;

Figure 4 diagrammatically illustrates a second embodiment of the invention; and

Figure 5 diagrammatically illustrates a third embodiment of the invention in use. DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

In Figure 1 a body treatment apparatus according to the invention is designated generally by the reference numeral 10. The body treatment apparatus 10 includes a gaseous fluid supply arrangement 12, an enclosure in the form of an inflatable bag 14, a discharge pipe 16 and a discharge container 18.

The bag 14 is made of a transparent, flexible plastics material and has an open mouth 22. The bag has attached to it a gauze seal 24 around the mouth and has also securing means in the form of straps or tapes 26 adjacent the mouth. The purpose of the seal 24 and the straps 26 will be described below.

A body part, typically a part of a limb in the form of either an arm or a leg, can be inserted into the bag 14 through the mouth 22. Figure 2 shows a left forearm 28 inserted into the bag. The mouth 22 is then sealed about the body part by appropriately tying the straps 26.

The bag 14 carries two spaced apart eye formations 30, each defining an irrigation aperture through the wall of the bag. Each eye formation 30 has a closure in the form of a screw cap 31. The bag 14 also has an identical eye formation 32 with a screw cap 33. The screw cap 33 of the eye formation 32 may, in other embodiments, be replaced with a connector 34 for an oxygen supply line (not shown), if required. The eye formation 32 will then define a secondary inlet of the bag 14.

Between the eye formations 30, a slit 36 is defined in the wall of the bag 14. The slit 36 has a slide fastener 38 which, when closed, is substantially air tight. When the slide fastener 38 is open, the slit 36 forms an access aperture for the bag 14.

The bag 14 has also three discharge outlets 39.1, 39.2 and 39.3. The outlets are served by valves 40.1 , 40.2 and 40.3 respectively which allow them to opened and closed as required. The purpose of the outlets and valves will become apparent from the following description.

The bag member 14 also carries suspension formations in the form of lugs 41.1 and 41.2 by means of which it can be suspended from an overhead support structure (not shown).

The gaseous fluid feed arrangement 12 includes dual air pumps 42 and a gaseous fluid supply line 44 extending from the pumps to an 46 adjacent the mouth of the bag. The line 44 has an in-line charcoal air filter 48 and an inline ozone device 50. A suspended plastics bag 52, containing a saline solution, is suspended over the supply line 44 and can feed saline solution into the line under the control of a flow control valve 54. In the line the saline solution may be nebulised or vaporized for incorporation in the gas flow. The bag 52 has a heating lamp 56 for heating the saline solution in the bag.

The arrangement 12 includes also a gaseous fluid supply line 60 which branches from the line 44 and terminates at an irrigator nozzle 62.

The discharge pipe 16 is connected to the valve 40.1. The container 18 is closed by means of a lid 66. The pipe 16 extends through an opening in the lid 66 with its bottom end 68 disposed near the bottom of the container 18 as shown. In operation the container 18 is partially filled with an antiseptic receptor liquid (not shown in Figure 1) with the end 68 of the pipe 16 submerged in the liquid.

The apparatus 10 can include one or more body part supports. A typical one of these supports, designated by the numeral 70, is shown in Figure 3. The support 70 has a dimension, into the plane of the paper in Figure 3, which may be approximately twice that of the vertical height of the support. The support 70 is provided by a foam rubber body 72 the lower surface of which is formed with three arcuate recesses 74. Alongside and between the recesses are adhesive elements 76 which can be used to adhere the support 70 to the inner surface of the bag 14. One possible mode of use of the body treatment apparatus 10 of Figure 1 will now be described with reference to Figures 1 to 3 generally. It will be assumed that the forearm 28 has burn wounds over much of its upper surface, i.e. the surface which is visible in Figure 2.

Before use one or more of the body part supports 70 are adhered to the inner surface of the bag member at positions opposite to the lugs 41.1 and 41.2. Normally, the orientation of the body part supports will be such that the recesses 74 extend from left to right in Figures 1 and 2. The forearm 28 is inserted into the open mouth 22 of the bag member 14 and is rested upon the supports 70 with the wounded upper surface of the forearm facing upwardly such that the lugs 41.1 and 41.2 are situated above the forearm. The mouth 22 of the bag is then secured about the forearm by tying the straps 26 in an appropriate manner, with the gauze seal 24 providing a sealing action.

The bag member 14 can then be suspended from an overhead support by means of the lugs 41.1 and 41.2, typically with the lug 41.1 slightly higher than the lug 41.2.

The line 44 is connected to the inlet 46 of the bag member 14 in the configuration shown, and the pipe 16 is connected to the valve 40.1 with the other valves 40.2 and 40.3 closed. In other configurations, the pipe 16 may be connected to one or other of the valves 40.2 and 40.3, in each case with the other two valves closed.

The pumps 42 are actuated to pump air through the line 44. The filter 48 filters impurities from the air. The air passes through the ozone device 50, which introduces ozone into the air to form a gaseous fluid mixture. The lamp 56 is energized to heat the saline solution in the bag member 52 to a desired temperature. The valve 54 is opened to a required extent so that ■ saline solution is drawn into the gaseous fluid flow in the line 44 and is entrained in that flow, typically in a nebulised or vaporised state. The fluid mixture comprising air, ozone and saline solution in nebulised or vaporized form is accordingly introduced into the bag member 14 through the inlet 46. The inlet pressure is sufficient to maintain the bag 14 in an inflated state. The internal space 77 defined in the inflated bag is partially occupied by the forearm 28. The gaseous fluid circulates through the unoccupied portion of the space 77 from the inlet 46 to the outlet valve 40.1. In so doing the fluid circulates over the wound on the forearm 28 to aid healing thereof.

The slide fastener 38 may be manipulated to open the slit 36 in order to allow access to the wound in order to attend to it as necessary. Any liquid fluids, including any wound exudate, which accumulate in the bag 14 can be drained from the bag through the outlet 39.1. Such fluids, as well as gaseous fluid exhausted through the outlet 39.1 are then discharged through the pipe 16 into the receptor liquid in the container 18. The recesses 74 allow liquid fluids to flow along the bottom of the bag towards the outlet.

Should it be required to irrigate the wound directly with gaseous fluid, a selected one of the caps 31 may be removed from its eye formation 30, whereafter the nozzle 62 can be inserted through or attached to the associated irrigation aperture. The nozzle 62 can then be triggered to dispense gaseous fluid supplied to it through the line 60 directly onto the wound.

Figure 4 shows another embodiment of the invention. Components corresponding to those illustrated in Figures 1 to 3 are indicated by the same reference numerals. In this case the bag 14 is in the form of a sleeve both ends of which are open. The sleeve-like bag in this embodiment is, as before, fitted over a left forearm 28. The opposite ends of the bag, designated 22.1 and 22.2, are similar to the mouth 22 of the bag 14 of the bag and can be sealed about the forearm by means of straps or tapes similar to those described above. With this configuration, which is suitable for use in situations where the wound is situated between the wrist and the elbow, the hand 80 remains free. Figure 5 illustrates another embodiment of the invention, and like components are again indicated by like numerals. In this case, the forearm 28 carries a wound 90 which is to be treated and to which a dressing 92 has been applied. The wound 90 is typically a burn wound, ulcer, pressure sore or the like which is prone to bacterial infection. The dressing in this embodiment is one manufactured and sold under the name Acticoat™ or Acticoat 7™ by Smith & Nephew Healthcare Limited. If necessary, the dressing may be secured in place by means of an external bandage or other fastening means (not shown).

Acticoat™ and Acticoat 7™ dressings carry fine particles of metallic silver which serve as an antimicrobial agent to combat bacterical infection. In the use of such dressings, it is recommended that the dressing be kept moist, both in order to maintain a moist, wound-healing environment and to prevent the dressing from drying out and adhering to the wound site.

In the Figure 5 embodiment, moisture is provided from a container 94 of sterile water. Water from the container 94 is drawn into the line 44 through a line 96 controlled by a valve 98. If necessary the water in the container may be heated by a heating lamp or other heating device 100.

The line 44 may if necessary include a venturi formation designed to generate a low pressure in the air stream to draw the water into the line. The various parameters are such that the water is either nebulised or forms water vapour in the air stream. The air stream is accordingly moistened by the introduction of the sterile water.

The bag 14 includes an outlet 39.1 leading into the line 16 which is, as before, controlled by an outlet valve 40.1. The moistened air stream circulates through the bag from the inlet 46 to the outlet. The pressure of the moistened air stream circulated through the bag is maintained at a level sufficient to inflate the bag in order to form a moistened volume around the forearm 28. In the moist environment which is created in the bag, the dressing 92 is able to perform an efficient antimicrobial action. Water which precipitates out of the air stream in the bag, together with any liquid exudates from the wound 90, are able to leave the bag through the outlet 39.1 and the line 16. Such liquids are, together with the gaseous exhaust from the bag, taken by the line 16 into the container 18, in Figure 5 shown partially filled with a suitable antiseptic liquid 102. The end 68 of the line 16 is located beneath the liquid level 104 such that liquid components entering the container 18 are discharged into the antiseptic liquid while gaseous components bubble up through the liquid to be exhausted beneath the lid 66.

In this embodiment, it is envisaged that the maintenance of a moist environment around the dressing and wound within the bag 14 will accelerate the healing of the wound.

Although specific mention has been made of an Acticoat™ or Acticoat 7™ dressing, it will be understood that the maintenance of a moist healing environment as described can be beneficial in the case of other dressing types as well.

Figure 5 is diagrammatic only, and in addition to the illustrated features, any or all of the other features described above in relation to Figures 1 to 3 may also be incorporated in the apparatus. By way of example, there may be one or more further valved or closable inlets into the bag, corresponding to the formations 30, through which other medicaments or preparations may be introduced into the bag or through which targeted irrigation, as described above, can take place. The irrigation components may be arranged such that the irrigation nozzle(s) can be used for direct irrigation of the wound or a wound dressing by means of the moistened air stream or even directly by the sterile water itself.

There may also be an opening, such as the elongate slit 36, in a side of the bag, typically closed by a sealed slide fastener, to allow access to the wound for the purposes of replacing the dressing and/or bandage or for other wound-related activities.

The bag 14 in Figure 5 may accommodate one or more flexible body part supports, corresponding to the support 70, to support the forearm or other body part comfortably within the bag. It may also have one or more external suspension points, corresponding to the lugs 41.1 and 41.2, by means of which it can be suspended from an elevated structure, thereby to assist in supporting the relevant body part at an appropriate elevation and orientation.

The embodiment of Figure 5 may be further modified by replacing the illustrated bag 14 with a bag, similar to that seen in Figure 4, having two open ends, enabling the bag to be used as a treatment enclosure for a wounded mid-region of a limb or other body part.

Although specific mention has been made of the treatment of a wounded forearm it will be appreciated that the principles of the invention are equally applicable to the treatment of other body parts, for example a leg or even a torso.

The embodiments of the invention described above provide for convenient treatment of certain types of wounds whilst protecting them from infection.

Claims

1.

A wound treatment apparatus comprising an enclosure for operatively enclosing a body part having a wound thereon in a configuration in which a space defined in the enclosure is partially occupied by the body part, the enclosure having an inlet through which a gaseous fluid can operatively be fed into the unoccupied portion of the space and an outlet via which gaseous fluid can operatively exhaust from the enclosure whereby gaseous fluid can be passed through the said unoccupied portion of the space, from the inlet to the outlet, in order to treat the wound.

2.

An apparatus according to claim 1 comprising a gaseous fluid supply means for passing a gaseous fluid through the enclosure from the inlet to the outlet.

3.

An apparatus according to claim 2 wherein the gaseous fluid supply means is arranged to pass air or a gaseous fluid mixture including air into the enclosure through the inlet.

4.

An apparatus according to claim 3 wherein the enclosure is in the form of a flexible, inflatable bag and the gaseous fluid supply means is operative to pass the gaseous fluid through the bag, from the inlet to the outlet, under sufficient pressure to maintain the bag in an inflated condition about the body part.

5.

An apparatus according to claim 4 and comprising an air filter for filtering the pumped air.

6.

An apparatus according to claim 4 or claim 5 and comprising means for introducing ozone into the pumped air.

7.

An apparatus according to any one of claims 4 to 6 and comprising means for introducing a saline solution into the pumped air.

8.

An apparatus according to claim 7 comprising a container for accommodating saline solution, means for heating the saline solution to a suitable temperature, and means for introducing heated saline solution into the pumped air.

9.

An apparatus according to any one of claims 4 to 7 and comprising means for introducing moisture into the gaseous fluid in order to moisten it.

10.

An apparatus according to claim 10 comprising a container for sterile water and means for introducing the sterile water into the gaseous fluid in nebulised or vapour form.

11.

An apparatus according to any one of claims 4 to 10 and comprising irrigation means operative to irrigate the wound directly, through an opening in a wall of the bag, with gaseous fluid.

12.

An apparatus according to claim 11 and comprising at least one closable opening in a side wall of the bag and an irrigation nozzle arranged to receive a flow of the gaseous fluid, the irrigation nozzle being insertable into a selected one of the openings in order to direct the gaseous fluid onto the wound or a dressing on the wound.

13.

An apparatus according to any one of claims 4 to 12 wherein the bag is made of a transparent, flexible plastics material.

14.

An apparatus according to any one of claims 4 to 13 wherein the bag defines a mouth through which the body part can be inserted into the bag and has securing means adjacent the mouth for securing the mouth about the inserted body part.

15.

An apparatus according to claim 14 wherein the bag is dimensioned to receive therein a forearm and hand and the securing means is operative to secure the mouth of the bag around the arm in the vicinity of the elbow.

16.

An apparatus according to any one of claims 4 to 13 wherein the bag is in the form of a sleeve having opposite ends and defines a mouth at each of the ends, such that a body part can be extended through the mouths, with a portion of the body part accommodated within the bag, and securing means adjacent each mouth for securing the adjacent mouth around the body part.

17.

An apparatus according to any one of claims 14 to 16 and comprising, at each mouth, sealing means for establishing a seal between the mouth and the body when the mouth is secured about the body part.

18.

An apparatus according to claim 17 wherein the sealing means comprises a strip of gauze or foam material.

19.

An apparatus according to any one of the preceding claims and comprising at least one body part support inside the enclosure for supporting a body part inserted into the enclosure.

20.

An apparatus according to claim 19 wherein the, or each, body part support is fixed in position within the enclosure and has a recessed, operatively lower side to allow liquid in the enclosure to flow to the outlet.

21.

An apparatus according to any one of the preceding claims and comprising suspension means on the enclosure by means of which the enclosure can be suspended at a suitable orientation.

22.

An apparatus according to any one of the preceding claims and comprising a discharge container and a discharge conduit extending from the outlet to the discharge container for conveying exhausted gaseous fluid, as well as any liquid in the enclosure, from the outlet to the container.

23.

An apparatus according to claim 22 and comprising a valve for controlling the flow of fluid material through the discharge conduit.

24.

An apparatus according to claim 23 wherein the discharge container is, in use, at least partially filled with an antiseptic receptor liquid and the discharge conduit has a discharge end submerged in the receptor liquid.

25.

An apparatus according to any one of the preceding claims and comprising a closable access opening into the enclosure through which access can be gained to a body part in the enclosure.

26.

An apparatus according to claim 25 wherein the access opening is in the form of a slit in wall of the enclosure and a slide fastener is provided to close the slit in a sealed manner.

27.

An apparatus according to any one of the preceding claims and comprising a secondary inlet into the enclosure through which a treatment gas can be introduced into the enclosure.

28.

An apparatus according to claim 27 and comprising means for introducing oxygen into the enclosure through the secondary opening.

29.

A method of treating a wound on a body part, the method comprising the steps of enclosing the body part in an enclosure having an inlet and an outlet in a configuration in which a space defined in the enclosure is partially occupied by the body part, and passing a gaseous fluid, selected for treatment of the wound, through an unoccupied portion of the enclosure from the inlet to the outlet.

30.

A method according to claim 29 comprising the step of passing air or a gaseous fluid containing air through the unoccupied portion of the enclosure.

31.

A method according to claim 30 wherein the enclosure is in the form of a flexible, inflatable bag and gaseous fluid is passed through the bag from the inlet to the outlet under sufficient pressure to maintain the bag in an inflated condition about the body part.

32.

A method according to claim 31 and comprising the step of filtering air in the gaseous fluid.

33.

A method according to claim 31 or claim 32 and comprising the step of introducing ozone into the gaseous fluid.

34.

A method according to any one of claims 31 to 33 and comprising the step of introducing a saline solution into the gaseous fluid.

35.

A method according to claim 34 comprising the steps of heating the saline solution and introducing the heated saline solution into the gaseous fluid.

36.

A method according to any one of claims 31 to 35 comprising the step of introducing moisture into the gaseous fluid in order to moisten it.

37.

A method according to claim 36 wherein sterile water is introduced into the gaseous fluid in nebulised or vapour form.

38.

A method according to either one of claims 36 or 37 and comprising the steps of dressing the wound with a dressing including silver.

39.

A method according to any one of claims 31 to 38 comprising the step of irrigating the wound directly with gaseous fluid liquid through an opening in a wall of the bag.

40.

A method according to claim 39 wherein the bag has at least one closable opening in a side wall thereof, the method comprising the step of inserting an irrigation nozzle into a selected one of the openings, supplying the irrigation nozzle with gaseous fluid and operating the irrigation nozzle to direct the gaseous fluid towards the wound.

41.

A method according to any one of claims 31 to 40 wherein the bag has a mouth through which the body part can be inserted into the bag, the method comprising the step of securing the mouth of the bag around the body part in a generally sealed manner.

42.

A method according to any one of claims 31 to 40 wherein the bag is in the form of a sleeve having opposite ends and defines a mouth at each of the ends, the method comprising the steps of extending the body part through both mouths such that a portion of the body part is accommodated within the bag, and securing both mouths of the bag around the body part in a generally sealed manner.

43.

A method according to any one of claims 29 to 42 and comprising the step of supporting the body part on at least one body part support within the enclosure.

44.

A method according to any one of claims 29 to 43 and comprising the step of suspending the enclosure from a support structure.

45.

A method according to any one of claims 29 to 44 and comprising the steps of providing a discharge container at least partially filled with a receptor liquid and a discharge conduit extending from the outlet to a submerged position in the receptor liquid in the discharge container, and conveying into the receptor liquid, through the discharge conduit, exhausted gaseous fluid from the enclosure as well as any liquid in the enclosure.

46.

A method according to claim 45 and comprising the step of controlling flow through the discharge conduit by means of a valve in that conduit.

47.

A method according to any one of claims 29 to 46 and comprising the step of treating the wound with oxygen introduced into the enclosure through a secondary inlet into the enclosure.