Medical sleeve

The invention provides a device adapted to assist the sterilization of a limb surface, comprising a flexible tubular sleeve, closed at one end, shaped and sized so as to loosely fit, in use, around the limb of a patient whose limb surface is to be sterilized. The sleeve bas limb-sealing means, located close to or at each end of the sleeve, and each capable of forming, in use, a seal between the sleeve and the limb of a patient. The device is particularly suitable to assist in de-contamination of limbs prior to surgery thereon.

This application is a national phase of International Application No. PCT/GB2005/000561 filed Feb. 17, 2005 and published in the English language.

FIELD OF THE INVENTION

The invention relates to a device to assist the application of preparations such as antimicrobial agents, medicaments and cosmetics to the surface of a user's limb. The device is particularly suitable to assist in decontamination of limbs prior to surgery thereon.

BACKGROUND TO THE INVENTION AND PRIOR ART KNOWN TO THE APPLICANT

The decontamination and sterilisation of skin is one of the most important parts of any surgical operation. Since the work of Pasteur, Lister, Semmelweiss and others, we have known that bacteria cause infection. As a consequence of their work, a variety of methods are now routinely used to reduce the bacterial count on the surface of the skin prior to surgical procedures.

Standard techniques employed to this end include: skin depilation (i.e. removal of hair) immediately prior to surgery; removal of any visible contamination; washing of the skin with soap and water; painting of the skin with an anti-microbial agent.

This last part of the preparation before surgery (i.e. the use of an anti-microbial agent) is often known amongst surgeons as the ‘skin prep’. It is this procedure that has turned surgery from a life-threatening procedure into the safe procedure it is today. Prior to the introduction of skin prep, mortality rates from wound infection could be as high as 40%. Following the introduction of skin preparation, the infection rate from bacteria residing on the skin has fallen to almost unrecordable levels.

However, the introduction of more complex surgery, and especially joint-replacement surgery, where the presence of foreign material in the body potentiates the infection, has led to a reassessment of skin preparation.

It is known that anti-microbial agents such as iodine, chlorhexidine and alcohol need time in contact with the skin to kill the bacteria. It is also known that there is a reservoir of skin-associated organisms that reside in the sweat glands and hair follicles of the body. Therefore, a skin preparation agent that stays on the skin for a period of time prior to surgery will be more effective in reducing the bacterial count. Furthermore, if the agent forms a film on the skin which is retained throughout the operation, then this is also of benefit.

A common technique for application of the anti-microbial agent is as follows: the surgeon or the surgeon's assistant is supplied with a bowl containing the skin preparation fluid, and something for applying the agent. This usually comprises a swab or a piece of sponge held in a pair of locking forceps. For preparation of the abdomen or chest, this is usually excellent. The area to be cleaned is roughly flat, does not need to be moved, and is clearly visible to the surgeon.

For structures such as the arm and leg, the situation is more difficult. As the skin prep is carried out after anaesthesia has commenced, the limb must be held in the air by an assistant. It is not possible to clearly see the entire surface of limb. In particular, toes and fingers are difficult to prepare. The person who holds the limb is ‘non-sterile’—i.e. has not been through the de-contamination procedures carried out by surgeons and their assistants—and so has to transfer the support of the limb to the sterile surgical team. This whole procedure takes a significant amount of time and can be prone to contamination. If a tourniquet is being used, then the anti-microbial agent can seep under the tourniquet and cause contact burns.

Whilst lifting of an arm is not too difficult, lower limbs have considerable weight and may have to be supported whilst the limb is cleaned. As a result, the non-sterile member of the team initially supporting the limb may have to support it at arm's length to allow the surgical team access to the limb. This can be dangerous, not only for the patient, if the leg is dropped, but also to the person holding the limb, and can result in back strain and other similar injuries.

Whilst these problems, and the solutions provided by the current invention, are described in terms of human surgical procedures, they clearly have parallels in the veterinary field.

Furthermore, whilst the invention relates primarily to problems associated with the application of anti-microbial agents to limbs, there are similar problems in associated areas for which the invention has considerable application. For example, it is often required to apply other agents such as medicaments, depilants (hair-removal agents) and cosmetic preparations such as artificial tanning solutions to limbs of users, without undue contact of the agent with the hand of the person applying it. Furthermore, these agents may need to be left in contact with the skin for some length of time without the agent drying or coming into contact with, for example, clothes, furniture or other parts of the body. The invention also has application as temporary wound-dressing, for example in the treatment of burns, and allows wound inspection following surgery or during ward rounds. Prior art known to the applicant comprises former patent applications GB 2276323, WO 03/090598, DE 29913123U1 and, U.S. Pat. No. 6,276,364 and U.S. Pat. No. 5,592,953

It is an object of the present invention to attempt a solution to these problems.

SUMMARY OF THE INVENTION

The invention provides a device adapted to assist the sterilisation of a limb surface, and comprising: a flexible tubular sleeve, closed at one end, shaped and sized so as to loosely fit, in use, around the limb of a patient whose limb surface is to be sterilised; and respective limb-sealing means, each located close to or at a respective end of said sleeve, and each capable of forming, in use, a seal between the sleeve and the limb of a patient.

Preferably, at least one of the limb-sealing means comprises a perforated, elastic diaphragm. This type of limb-sealing means has a particular advantage over eg. a simple drawstring arrangement or elasticated cuff in that the elastic diaphragm can stretch to accommodate the varying diameters of a patient's limb without either the need to adjust the drawstring, or the possibility of an ineffective seal between an elasticated cuff and a patient's limb.

In any embodiment of the invention it is also preferable that at least one of the limb-sealing means comprises a substantially frustoconical portion. Not only can this arrangement assist in the insertion of a patient's limb into the limb-sealing means, but it may also be used to position the limb-sealing means, before use, away from contamination.

In any aspect of the invention, the limb-sealing means are preferably constructed so as to create a wiping action when slid, in use, along a patient's limb. This feature is particularly advantageous as it serves to remove any excess fluid that has been applied to a patient's limb before the commencement of surgery.

In any aspect of the invention, both ends of the said sleeve are advantageously initially closed. By closing both ends of the sleeve, it is possible to produce the device in a sterile fashion and to maintain that sterility during storage. Additionally the sleeve may be provided as part of a sterile pack.

In any aspect of the invention, the sleeve of the device is preferably substantially transparent. By this means, it is possible for an operator or a user to see the limb whilst applying fluid such as an anti-microbial formulation. This enables the user to ensure that the fluid is spread evenly over the limb and reaches all exposed parts, such as between the fingers and toes.

In any aspect of the invention, it is preferable that at least one of any sealed end of the sleeve is perforated, nicked, weakened or otherwise adapted to assist opening of that sealed end. In the surgical context, it is advantageous to be able to open an end of the sleeve quickly and without use of cutting means such as scissors or a scalpel. This avoids risk of injury to the patient and contamination of surgical or other instruments.

In any aspect of the invention, it is advantageous that the device further comprises at least one tab or loop to assist pulling the sleeve, in use, along a patient's limb. When used in the field of pre-surgical limb sterilisation, it is important not to re-introduce any contamination onto the patient's limb following the ‘skin prep’. By providing tabs or loops, especially at the end closest to the extremity of the limb, a surgeon or surgeon's assistant can pull the sleeve along the limb and avoiding contact with the sterilised skin surface. As well as flexible tabs or loops, such a loop could advantageously comprise a rigid ring, large enough to pass over a patient's limb, to facilitate pulling the sleeve along the limb. Such means to assist pulling the sleeve may be advantageously located at either or both ends of the sleeve to assist the two pulling actions envisaged: firstly to pull a first end over the limb to enclose it; and secondly to pull the send end up to meet the first end, thereby exposing the treated skin.

In any aspect of the invention, it is advantageous for the device to further comprise fastening means to hold the two ends of the sleeve close together whilst the sleeve is positioned on a patient's limb. In use, and as illustrated and described below, the two ends of the sleeve may be brought together on a patient's limb causing the sleeve to adopt a bunched configuration. Provision of fastening means, such as adhesive tape, a stud type fastening or even a simple tie fastening allows the operator to maintain the sleeve in that configuration without it slipping back down the patient's limb.

In any aspect of the invention, it is preferable that the device has an easily rupturable container of sterilising agent inside (in use) the sleeve. It is particularly advantageous to provide such a container within the sleeve as it will remove the need for an operator to have contact with the sterilising agent (or other medicament or cosmetic preparation) during the application process. Furthermore, this allows a pre-metered dose of sterilising agent to be provided thus ensuring that sufficient material is used.

In any aspect of the invention, it is advantageous that the sleeve further comprises a valve arrangement to allow egress of air from within the sleeve whilst the sleeve is positioned on a patient's limb. In one such aspect, the valve would be a one-way valve, to allow air to escape from between the patient's limb and the sleeve, in use, so facilitating e.g. moving both ends of the sleeve to a common point on the limb (to expose the skin surface) without the sleeve “ballooning” due to trapped air. In another such aspect, the valve arrangement would comprise a simple tap arrangement to allow air to escape from, or to be introduced into the sleeve. For situations requiring aseptic conditions, the valve arrangement may be provided with a air filter suitable for removing airborne contaminants such as bacteria. In this arrangement, therefore, the sleeve may be inflated or deflated at will. In this way, the relative proximity of the sleeve and the patient's skin may be controlled: by inflating the sleeve, it is held away from the skin, allowing improved inspection of e.g. wounds; by deflating the sleeve, it may be repositioned more easily, and may be used to apply pressure to the patient's limb, or to dressings or medicaments applied thereon.

Preferably a limb sealing means is provided which is sized and shaped to be extendable beyond an opening formed by removal of the sealed end of the device.

Preferably at least one of the limb sealing means adapts to fit limbs of differing circumference without the need to cut sections from the device.

Preferably a resealable portal is provided.

In a second broad aspect, the invention provides a device adapted to assist the sterilisation of a limb surface, and comprising:a flexible tubular sleeve, closed at one end, shaped and sized so as to loosely fit, in use around the limb of a patient whose limb surface is to be sterilised; and respective limb-sealing means, each located close to or at a respective end of said sleeve, and each capable of forming, in use, a seal between the sleeve and the limb of a patient and incorporating a perforated elastic diaphragm.

In a third broad aspect, the invention provides a device adapted to assist the sterilisation of a limb surface, and comprising:a flexible tubular sleeve, closed at one end, shaped and sized so as to loosely fit, in use around the limb of a patient whose limb surface is to be sterilised;and respective limb-sealing means, each located close to or at a respective end of said sleeve, and each capable of forming, in use, a seal between the sleeve and the limb of a patient and wherein the sleeve is substantially transparent.

In a fourth broad aspect, the invention provides a device adapted to assist the sterilisation of a limb surface, and comprising:a flexible tubular sleeve, closed at one end, shaped and sized so as to loosely fit, in use around the limb of a patient whose limb surface is to be sterilised;and respective limb-sealing means, each located close to or at a respective end of said sleeve, and each capable of forming, in use, a seal between the sleeve and the limb of a patient and wherein at least one of any sealed end of the sleeve is perforated, nicked, weakened or otherwise adapted to assist opening of that sealed end.

In a fifth broad aspect, the invention provides a device adapted to assist the sterilisation of a limb surface and comprising:a flexible tubular sleeve, closed at one end, shaped and sized so as to loosely fit, in use around the limb of a patient whose limb surface is to be sterilised;and respective limb-sealing means, each located close to or at a respective end of said sleeve, and each capable of forming, in use, a seal between the sleeve and the limb of a patient and wherein a valve arrangement is provided to allow egress of air from within the sleeve whilst the sleeve is positioned on a patient's limb.

In a sixth broad aspect, the invention provides a device adapted to assist the sterilisation of a limb surface and comprising:a flexible tubular sleeve, closed at one end, shaped and sized so as to loosely fit, in use around the limb of a patient whose limb surface is to be sterilised;and respective limb-sealing means, each located close to or at a respective end of said sleeve, and each capable of forming, in use, a seal between the sleeve and the limb of a patient and a limb sealing means which is sized and shaped to be extendable beyond an opening formed by removal of the sealed end of the device.

In a seventh broad aspect, the invention provides a device adapted to assist the sterilisation of a limb surface and comprising:a flexible tubular sleeve, closed at one end, shaped and sized so as to loosely fit, in use around the limb of a patient whose limb surface is to be sterilised;and respective limb-sealing means, each located close to or at a respective end of said sleeve, and each capable of forming, in use, a seal between the sleeve and the limb of a patient and wherein at least one of the limb sealing means adapts to fit limbs of differing circumference without the need to cut sections from the device.

In an eighth broad aspect, the invention provides a device adapted to assist the sterilisation of a limb surface and comprising:a flexible tubular sleeve, closed at one end, shaped and sized so as to loosely fit, in use around the limb of a patient whose limb surface is to be sterilised;and respective limb-sealing means, each located close to or at a respective end of said sleeve, and each capable of forming, in use, a seal between the sleeve and the limb of a patient and wherein a re-sealable portal is provided.

Included within the scope of the invention is a device substantially as described herein with reference to and as illustrated by any appropriate combination of the accompanying drawings.

EMBODIMENTS OF THE INVENTION

FIG. 1is a schematic plan of the device, shown generally as1, comprising a flexible tubular sleeve2made of a flexible, transparent, plastics material. The sleeve is closed at one end3and open at the other end4. Close to each end of the sleeve there is a limb-sealing means comprising a drawstring6located within a channel5, which surrounds the sleeve2. The sleeve2fits loosely around the limb of a patient and each of the limb-sealing means may be operated by means of the drawstrings6to form a seal, in use, between the sleeve2and the limb of a patient.

FIGS. 2 and 3illustrate a design for an embodiment of the limb-sealing means, comprising a perforated, elastic diaphragm.FIG. 2illustrates a sheet of elastic material7, such as rubber, which has a perforation/hole8in the centre. The dashed line9indicates where to fold the sheet7, and the dashed lines10illustrate where to subsequently seal and trim the sheet7.FIG. 3illustrates a plan view of the folded, sealed and trimmed sheet7forming a frustoconical limb-sealing means, generally indicated as11, with a hole8.

FIG. 4illustrates a way in which a limb-sealing means may be incorporated into a sleeve. There is illustrated, in part, a sleeve2with a sealed end3. Such a sleeve may conveniently be manufactured from a heat-sealable plastics material. Located within the sleeve is a frustoconical member12of a similar plastics material that may be heat-sealed to the sleeve around its periphery, indicated generally by13. At the smaller end of this member12is located a limb-sealing means11(as illustrated inFIG. 3) which may be sealed to the frustoconical member12where they meet, generally indicated by14.

FIG. 5illustrates another, preferred, embodiment of the invention, generally indicated as15. The device comprises a flexible, transparent sleeve2with a closed end3and an open end4. Located at the open end4is a limb-sealing means11of the frustoconical, elastic diaphragm type as discussed above. A second limb-sealing means11is located toward the sealed end3of the sleeve2. The sealed end3is weakened, by perforation16, to assist opening of the sealed end3. The device further comprises loops17attached to the sleeve2and close to the initially sealed end3.

FIG. 6illustrates the embodiment ofFIG. 5in which the frustoconical limb-sealing means11are shown in their everted configuration, after having opened the initially sealed end3and pulled the sleeve2over the limb of a patient (not shown) in a left to right direction in the illustration.

FIG. 7illustrates an embodiment of the invention further comprising fastening means18attached to the sleeve2. In this embodiment, the fastening means18comprise self-adhesive tags, attached to the sleeve2, each having a peel-off protective strip19over the adhesive. In this embodiment, three such tags are provided. The second limb-sealing means of this embodiment is not illustrated inFIG. 7for sake of clarity. Also illustrated inFIG. 7is a valve arrangement27to allow control of air movement in and out of the sleeve when it is positioned on a patient's limb.

Use of the Device

FIGS. 8 to 12illustrate an embodiment of the device in use on the arm of a patient.

FIG. 8illustrates an embodiment of the device20in position around the arm21of a patient. The arm passes through the first limb-sealing means22into the interior of the sleeve2. The second limb-sealing means23is, at this stage, not surrounding the arm21. Within the sleeve2is located a sachet of skin-sterilisation fluid24.

InFIG. 9, the sachet24has been opened to release its contents25which now be spread over the surface of the arm21. This process may be carried out by, or with the assistance of the patient, or by the surgeon's assistant alone. The transparent nature of the sleeve2enables the fluid to be seen and helps to ensure that it is spread over the entire surface, especially between the fingers26.

FIG. 10illustrates the stage where the arm of the patient21has been pushed through the second sealing means23into the space between that sealing means23and the sealed end3of the sleeve2. The spent sachet24of sterilising fluid has also been passed into this section of the sleeve2ready for disposal.

The patient may conveniently be anaesthetised at this stage.

FIG. 11illustrates the stage when the initially sealed end3has been opened by means of perforations16(illustrated inFIG. 10), leaving a now open end25. In this state, the sleeve2will adopt a generally bunched configuration26.

FIG. 12illustrates the final situation where the sleeve2has been pulled up to the top of the arm21, thus exposing the sterile skin ready for surgery. In this configuration, the sleeve2is in its bunched configuration26and the two limb-sealing means,22and23, are close together. It is at this stage that the fastening means (not illustrated) are particularly useful in maintaining the sleeve2in this configuration. The wiping action of the limb-sealing means23when pulled from its position shown inFIG. 11to that shown inFIG. 12removes excess sterilising fluid from the surface of the arm21.

The operation may now commence. At this stage, or after surgery, the whole device may be removed from the patient's arm by cutting and can be disposed with.

FIGS. 13aand13billustrate an embodiment of the invention wherein a port, or opening,31is provided in the tubular sleeve2. The port31is sealed by the application of a suitable adhesive which is affixed to the sleeve2around the port31and to which a suitably shaped piece of waxed paper or other material32to which the adhesive will form a temporary and reversible bond is affixed. The port31thus provides a facility for the introduction of a liquid such as a sterilisation fluid or medicament (as appropriate) through the port, following the insertion of a user's limb into the limb sealing means11at the open end4of the sleeve2. The combination of an appropriate adhesive and the waxed paper32allows the port31to be opened and re-sealed as required.

A block of suitable absorbent material as indicated by55, such as sponge, may be included in the interior of the sleeve2to absorb any excess fluid (or other medicament) which remains once a user has spread the skin sterilisation fluid over a limb. Alternatively the skin sterilisation fluid may be provided in the form of a thixotropic agent which is initially a gel which becomes a liquid when spread on the patient's arm; the re-gelling of the agent then prevents unwanted flow of liquid.

In another embodiment of the invention, the frustoconical member12, as shown inFIG. 4, is replaced with a rectangular shaped member41, as shown inFIGS. 14aand14b, to which is attached a rectangular shaped limb sealing means42which incorporates a perforation/hole48. The rectangular shaped member41is sized such that when a user inserts their hand or foot through the hole48in the limb sealing means42, following the use of a sterilising solution within the sleeve2and removal of the sealed end3by means of the perforations16, the user's hand or foot extends beyond the open end25of the sleeve2. In this way, when the sleeve is pulled up to the top of the arm, contact between the unsterilised end25of the sleeve2and the sterilised arm is avoided.

FIG. 15illustrates the rectangular shaped member41and limb sealing means42prior to their insertion and attachment to the tubular sleeve2. The rectangular shaped member41incorporates a central cut-out section indicated by the line47. The limb sealing means42is attached to the member41by any suitable means such as heat welding, use of adhesive or double sided adhesive tape such that the hole48is aligned over the cut-out section. The rectangular shaped member41and attached limb sealing means42are initially folded along the line A-A to give the configuration shown inFIG. 16and the adjacent faces of the member41are heat welded to each other along the lines51A and51B. The outer faces of the member41are then heat welded to the sleeve along the line52as indicated onFIGS. 14aand14bsuch that the member41is located an appropriate distance from the location of the perforations16. During this latter heat welding process the inner faces of the sleeve not separated by the member41are also welded to each other to form two seals53. In use once a user's leg or hand has been inserted through the second limb sealing means42any liquid present in the main compartment54of the sleeve is retained there by the seals53in combination with the rectangular shaped member41, the limb sealing means42and associated relevant seals.

Whereas the sleeve2of the present embodiment is produced from a transparent material the member41is preferably manufactured from a semi-opaque material, such that the member41and associated limb sealing means42can be easily distinguished from the sleeve2thus making it easier for the sleeve to be placed on the limb of a patient.

The limb sealing means42may be made of any suitable elastomeric material, although the thermoplastic rubber sold under the trade mark Kraton in sheet form has been found to be particularly suitable for this purpose. Kraton® is a polymer which while retaining elastic properties when stretched, does not rapidly return to its original shape. The material sold under the trade mark Elastoflex is also suitable. Thus when the limb sealing means42is stretched by a user inserting a limb, a seal is formed around the limb by the Kraton® but it is not a tight seal that would otherwise act as a tourniquet and so the limb sealing means provided adapt to fit limbs of differing circumference without the need to cut sections from the device.