GB2456325A

GB2456325A - Apparatus for supporting a drain tube

Info

Publication number: GB2456325A
Application number: GB0800466A
Authority: GB
Inventors: Jason Klein
Original assignee: Salisbury NHS Foundation Trust
Current assignee: Salisbury NHS Foundation Trust
Priority date: 2008-01-11
Filing date: 2008-01-11
Publication date: 2009-07-15
Also published as: GB0800466D0

Abstract

The apparatus comprises a base 22 for securing to the skin of the subject having an opening therein to accept the drain tube, a collar 32 extending from the base having a passage 34 and clamping means external to the passage in the collar for tightening the collar around the drain tube when in place within the passage. The apparatus may comprising a slit 36 extending from an edge of the base through the base and the collar to the opening in the base and the passage in the collar, whereby the base and collar may be opened along the line of the slit to allow the base and collar to be extended around the drain tube. The apparatus may also comprise a plurality of lateral mounting portions 28 which in use may extend to hold the collar away from the skin (figs 5 and 6).

Description

I

SUPPORT FOR A DRAIN OR THE LIKE AND METHOD OF USING THE SAME

The present invention relates to a device for supporting a drain or other line in place in the human or animal body, including but not limited to a support for a drain in place in the chest cavity of the subject.

It is very common in many procedures to treat the human or animal body that a line is inserted into the body to deliver or remove fluids. A drain is commonly employed to remove fluid, including both liquids and gases, from within the body as part of many procedures, including both surgical and emergency procedures. The drain typically comprises a flexible tube having a proximal end for extending into the body, the proximal end being provided with one or more openings to assist fluid to enter the tube. The distal end of the tube is typically left extending from the body and is connected, by a suitable connection means, to a reservoir which both acts as an air lock and allows for the collection of the drained fluids. The drain is inserted into the body through an appropriately formed and positioned opening. For example, a chest drain, such as a drain to remove fluids from the pleural cavity, is inserted into an incision made between two ribs. Two or more such drains may be installed in a patient in close proximity, if a large portion of the body requires fluids to be drained.

Although the incisional apertures may be close at the skin surface the proximal ends of the drains may be relatively distant within the body.

In order to secure the drain in position and prevent its inadvertent removal from the body of the patient, the commonly applied technique is to insert one or two sutures into the skin of the subject adjacent the incision and to wind the free end of the suture tightly around the portion of the drain tube extending from the opening.

These ends of the suture are tied several times along the length of the tube.

Provided the sutures are properly applied and tightly tied, this has proven to be an effective method for securing a drain in the patient.

However, although the commonly applied techniques can result in a secure drain, a number of significant problems remain with existing drain technology. First, with the aforementioned practice of using sutures to secure the drain in place, it is difficult to move the drain, for example to reposition the drain once inserted and secured. If the drain needs to be moved, there are two options open to the clinician.

The better option is to cut the sutures, reposition the drain, and apply fresh sutures, to secure the drain in the new position. Often a clinician is tempted to loosen the knots securing the drain, reposition the drain and then attempt to re-secure it again.

This is rarely secure again as the knots can never be as tight around the tubing again.

The need to move or reposition a drain often arises where a drain is inserted into the patient without access being available to the region being drained. In the case of a chest drain, it is a comparatively simple matter to insert and locate a drain in position when the chest cavity has been opened, for example for conducting a surgical procedure. When such an opening exists, the surgeon can properly locate the proximal end of the drain tube, before closing the patient. This is not possible when a drain is to be installed without such access internally to the region to be drained. In such cases, an incision is made, a drain tube is inserted into the approximate region to be drained, and the patient is imaged using x-ray techniques to identify the location of the drain tube internally. If the drain tube does not have its proximal end located properly, as is often the case, the drain should be loosened by removing the sutures and repositioned. As will be appreciated, this is a time consuming and may be an uncomfortable procedure for the patient, despite appropriate use of analgesic and local anaesthetic agents.

Second, it has happened that drains have been inadvertently removed from :" patients during patient movement. Drains are used in conscious patients and comatosed and sedated patients. Whenever a patient moves there is a risk that the patient will not be fully aware of the drain and its collection system. It does happen that patients have trapped the drain or tugged at the drain when moving and in so doing have tested the security of attachment to the body of the patient. Patients that are critically ill or injured or have undergone major operations are often sedated or comatosed. These patients often have several lines and drains. Turning the patient in bed to prevent pressure sores developing can be difficult and puts any drains at risk. It is even more difficult to move these patient if they need to be returned to theatre for an urgent operation or moved to have an urgent investigation. It takes several nurses, doctors and porters to move these patients safely. The more lines and drains that a patient has, the more likely that one will be inadvertently caught on the patient's bed or other surrounding equipment, and so will be accidentally dislodged or even pulled out.

Depending on the importance of the function of the drain, the outcome of a drain being dislodged or unintentionally removed can be devastating for the patient.

This will often delay the discharge of the patient and at worst may result in the death of a patient.

To replace a drain in a patient in an emergency is stressful for the doctor and nurses involved. It puts the patient at risk of the complications of the insertion of a new drain and creates a new incisional wound which provides a new risk of infection.

For conscious patients, the insertion of a drain is often an uncomfortable and sometimes painful procedure despite appropriate use of analgesia and local anaesthetic agents.

Accordingly, it would be most advantageous if the risk of inadvertant removal of a drain was minimised by the provision of a universally secure system of attachment that could be used by all clinicians from senior surgeons to junior doctors.

* ***** * S Further, as noted above, when carried out properly the use of sutures to secure a drain tube can be effective. However, this procedure is reliant upon the skill of the person applying the sutures and the necessary time to complete the task being available. It is often the case that a drain must be installed on an emergency basis, giving the medical practitioner only a very short time to complete the installation.

Accordingly it would be most useful if a quicker and more reliable means for securing a drain could be found One attempt to address some of the problems discussed above is disclosed in US patent application publication No. US 2006/0025723. This document concerns an antibacterial chest tube, surgical drain, port or access line securing device. The device comprises a main body portion or base of a generally oval shape. A plurality of holes are formed in the periphery of the base to allow the device to be secured to the skin of a patient by means of sutures. The device comprises a tubular element extending from the surface of the base, the tubular element and the base defining a generally tubular bore extending therethrough for accepting a drain tube or the like.

The tubular element may extend perpendicular from the base or at an angle to the perpendicular. The device comprises a means for securing a drain tube or the like within the tubular element. US 2006/0025723 discloses several different embodiments of the securing means. In a first design, a pair of locking screws are provided, which extend through threaded bores in the tubular element and can be tightened to grip the outer surface of the drain tube within the tubular element. In an alternative arrangement, the tubular element is provided with an inflatable inner collar, which may be inflated using liquid or gas, to grip the drain tube and hold it in position within the bore of the tubular element.

The device of US 2006/0025723 suffers a number of drawbacks. First, the device is complex to manufacture and use, having a complex structure, in particular when employing the inflatable inner collar. Second, the use of locking screws can e*' result in crushing or puncturing of the drain tube, if overtightened. Further, the device must be in place around the drain tube before the procedure to insert the drain tube "20 is begun. Otherwise the device must be slid over the drain after its insertion. This leads to a delay in achieving the airlock of the closed draining system. This airlock is needed to ensure that air and fluid may only flow out of the drain rather than back into the body cavity. Movement of fluid into the body can have disastrous *.* consequences for the patient.

Accordingly, there is a need for an improved device for supporting and securing a drain tube at the point of entering the human or animal body.

In a first aspect, the present invention provides an apparatus for supporting the tube of a drain in the region of the drain tube entering the body of a subject, the apparatus comprising: a base for securing to the skin of the subject having an opening therein to accept the drain tube; a collar extending from the base; a passage extending through the collar and aligned with the opening in the base for receiving the drain tube; and clamping means external to the passage in the collar for tightening the collar around the drain tube when in place within the passage.

The apparatus of the present invention provides a simple construction that is easy both to manufacture and use. In particular, with the clamping means being external to the collar, the passage through the collar and the opening in the base are unobstructed and provide a clean, simple passage for the drain tube. This in turn allows the tube to be easily released, repositioned and re-secured without the risk of damage to the tube, for example due to overtightening or by being punctured.

The apparatus is suitable for use with the tube of a drain, for example a chest drain or the like. However, the apparatus may be used to support and retain in position any other tube or line that is inserted into the human or animal body, whether for introducing fluids into the body or removing fluids therefrom. Accordingly, while the present invention will be described in relation to the support of drain tubes in general and of chest drains in particular, the scope of the invention is to be construed accordingly.

*. .. . The apparatus comprises a base. The base may be any suitable shape or configuration. The primary functions of the base are to provide a connection between the apparatus and the skin of the subject and to provide support and **. orientation for the collar and the drain tube. The base is formed to provide resistance :45 to lateral forces acting with a component parallel to the skin of the subject to dislodge the drain tube to the side. Preferred configurations for the base are described hereinafter.

In addition to providing resistance to lateral or sideways forces, the base provides a means for securing the apparatus to the skin of the subject. The base may be secured to the skin by any suitable means. As discussed above, one preferred method of securing the skin is by sutures. Accordingly, the base may comprise one or, more preferably a plurality, of holes or openings therethrough, to allow the apparatus to be attached to the skin by sutures. Alternatively, the base may comprise one or more slots, slits, tabs or projections, again for use with sutures to secure the base to the skin of the subject. As an alternative to, or in addition to, sutures, the base may be secured to the skin by an adhesive. The adhesive may be applied directly to the base to adhere the base to the skin. Alternatively, the base may be secured to the skin by means of adhesive tape.

The base has an opening formed therein to accept a drain tube or the like, such that the base may be secured to the skin of the subject around a drain tube inserted into the body of the subject, with the drain tube extending from the body through the opening in the base.

The apparatus further comprises a collar extending from the base. The collar may extend perpendicular to the base. In one preferred embodiment, the collar extends at an angle of less than 90. to the base. In particular, the collar extends at an angle of from 10 to 80 to the base, more preferably at an angle of from 20 to 70 to the base. A particularly preferred range of angles for the collar to extend is from to 65 to the base, with an angle of from 45 to 60 being especially preferred. * S.

:.:: By having the collar extend at an angle to the base, as described, the drain w20 tube may be more efficiently positioned, allowing the patient greater freedom to move and be moved, without risking inadvertently changing the position or orientation of the drain. In this respect, the collar may be in a fixed orientation with respect to the base, for example by having the base and collar formed as a single component.

Alternatively, the collar may be mounted to the base in a manner that allows collar to * : * 5 rotate with respect to the base, thereby allowing the orientation of the collar to be varied.

The collar may have a constant internal and/or external diameter along its length. A constant internal diameter along the length of the collar is preferred, in order to provide the maximum support to the drain tube, when in position in the collar. The external diameter of the collar may be constant along the length of the collar. Alternatively, the collar may be tapered, such that the external diameter is greater at the end of the collar adjacent the base and less at the free end of the collar.

The collar has a passage therethrough, aligned with an opening through the base, to accept a drain tube. In one embodiment, the collar is generally tubular in form, having an enclosed bore extending along substantially its entire length.

Alternatively, the collar may have one or more openings therein. The collar should extend sufficiently around the exterior of the drain tube to ensure that it is securely held and supported when properly located in the passage through the collar. It is preferred that the collar comprises at least a portion that extends substantially or entirely around the drain tube, when the drain tube is in position in the passage, to grip and hold the drain tube in place.

The collar is aligned with the base such that a drain tube can extend through the opening in the base and through the passage in the collar.

The apparatus further comprises means for clamping the collar around the drain tube. The clamping means are external to the passage through the collar. In this way, the path of the drain tube through the passage in the collar is ensured to be * .* unobstructed and to allow free movement of the drain tube through the passage, :.:: when the clamping means are released. This allows the apparatus to be easily installed, as well as allowing the drain tube to be released and refastened, for example when it is required to reposition the drain tube in the subject.

The clamping means may be any suitable means that allow the drain tube within the passage of the collar to be held by a clamping action of the collar. In one embodiment, the clamping means is provided by an inherent bias in at least a portion of the collar, such that the collar is biased to a clamping position around the drain tube. In particular, the collar may comprise one or more clamping portions that are inherently biased inwards, towards the drain tube, and act to hold the drain tube in place within the passage of the collar. The clamping portions may be moved against the bias, to release the drain portion. In such a case, the clamping portions are most preferably provided with means, such as a tab, shoulder or the like, to allow the user to urge the clamping portions open against the bias, to release the drain tube.

Alternatively, the apparatus may be provided with clamping means on the exterior of the collar, which act to crush the collar against the drain tube within the passage. In such a case, the collar should be of a material that is sufficiently flexible and resilient to be clamped against the outer surface of the drain tube. Suitable clamping means are known in the art for acting on the exterior of the collar. An example of simple clamping means include one or more ties, preferably releasable, which are tightened around the exterior of the collar to compress it against the drain tube. More complex clamping means include sprung clips and over-centred clips, both of known design.

As noted, the clamping means may be an inherent property of the collar itself.

Alternatively, or in addition thereto, the apparatus may comprise clamping means applied to the collar. The exterior of the collar may be provided with means to retain the clamping means in position around the collar. For example, the collar may comprise one or more protrusions or ridges to retain the clamping means in position on the collar. Alternatively or in addition thereto, the collar may comprise one or more grooves formed therein, within which the clamping means may partially or wholly lie.

The apparatus may be formed from any suitable material, provided that the material is safe for contact with the skin of the subject. Suitable materials are known S.....

* in the art and include a wide range of metal and plastic materials. It is preferred to have the apparatus formed from a material that is transparent, in particular to form at *: *::* least the collar from a transparent material, to allow the drain tube within the collar to be visible to the medical practitioner. A transparent material will also allow the incision in the body of the subject and the point of entry of the drain tube to be more clearly visible, as these are likely to be partially or wholly obscured or covered by the apparatus when in use. Any infection, bleeding or leakage at the site of the incision, for example, may therefore be identified at an early stage.

In one embodiment, the apparatus comprises the base and collar, such that the apparatus is placed around a drain tube, with the drain tube passing through the bore n the collar and the opening in the base, before the drain tube is inserted into the subject. Once the drain is in place, the apparatus is moved along the drain tube, the base secured to the skin of the patient, as aforementioned, and the collar clamped around the drain tube adjacent the entry of the drain tube into the body of the subject. However, a drawback of this arrangement is that the medical practitioner installing the drain must remember to locate the apparatus around the drain tube before the tube is inserted into the subject. In an emergency situation, for example, this may be overlooked. Accordingly, a preferred embodiment of the apparatus of the present invention is one that can be applied to the subject with the drain tube already in situ.

In one aspect of the present invention, in order to allow the apparatus to be applied around a drain tube, or the like, after installation, the base and collar comprise a slit or opening therein, allowing the apparatus to be opened and wrapped around the exterior of the drain tube. The apparatus may then be moved or slid along the drain tube into contact with the skin of the subject around the incision and entry point of the drain tube and secured thereto, as hereinbefore described.

Accordingly, in a further aspect, the present invention provides an apparatus * * for supporting the tube of a drain in the region of the drain tube entering the body of a subject, the apparatus comprising: **** a base for securing to the skin of the subject having an opening therein to accept a drain tube; I.....

* a collar extending from the base; and a passage extending through the collar and an opening in the base for *:*:: receiving the drain tube; * 25 the apparatus further comprising a slit extending from an edge of the base * through the base and the collar to the opening in the base and the passage in the collar, whereby the base and collar may be opened along the line of the slit to allow the base and collar to be extended around the drain tube.

The apparatus comprises a base and a collar, which are preferably as hereinbefore described. In order to allow the apparatus to be extended around a drain tube, a slit or opening is provided in the base extending from an edge of the base to the opening in the base. The slit or opening extends through the collar.

References herein to a slit are to be taken as indicating any suitably sized opening allowing the apparatus to be applied to and extended around a drain tube or the like, with the drain tube being in place extending into the body of the subject.

In one embodiment, the apparatus is provided with a simple slit in the base and the collar. The material of construction of the base and the collar are sufficiently flexible and resilient for the slit to be opened to accept the drain tube to enter the passage in the collar and the opening in the base in a lateral direction from the edge of the base. Alternatively, the slit is a wider opening, closer in width to the diameter of the drain tube to be accommodated, allowing the apparatus to be of a more rigid construction while still enabling a drain tube to be slid into and out of the passage in the collar in a lateral direction.

In order to facilitate the opening of the slit to accommodate the drain tube, the opposing side of the collar to the slit may be provided with a hinge. The hinge may be formed as part of the collar, for example a longitudinal portion of reduced thickness. Alternatively, a hinge assembly may be applied to or incorporated into the collar, to allow the lateral entry into the passage to be enlarged to accept the drain tube. Suitable hinge constructions are known in the art.

As noted, the apparatus comprises a base. One function of the base is to allow the apparatus to be attached to the skin of the subject in the region of the * incision into which the drain tube extends. The base may have any suitable form and shape. In one embodiment, the base is provided with a shape that allows two apparatus to be located side by side, in order to support two adjacent drain tubes.

This may be required, for example, in the case of a subject that has substantial fluid S.....

* in the chest cavity, requiring two drains to be installed to remove the fluid, typically an upper chest drain and a lower chest drain.

However, in an alternative embodiment, the base is provided with lateral portions extending from the collar. The base comprises sufficient laterally extending portions to provide support for the drain tube and a resistance to lateral forces acting on the drain, which may have a tendency to dislodge or inadvertently remove the drain.

Accordingly, in a further aspect, the present invention provides an apparatus for supporting the tube of a drain in the region of the drain tube entering the body of a subject, the apparatus comprising: a base for securing to the skin of the subject having an opening therein for receiving a drain tube; a collar extending from the base; and a passage extending through the collar aligned with the opening in the base for receiving the drain tube; wherein the base comprises a plurality of lateral mounting portions, the lateral portions being sufficient in number and disposed around the collar in a position to provide the apparatus with a resistance to lateral forces when the lateral mounting portions are secured to the skin of the subject.

The lateral mounting portions are disposed around the collar and act to prevent the collar from tilting or tipping under the action of lateral forces, which may dislodge the drain tube within the subject. The lateral mounting portions comprise means to fix the base to the skin of the subject. For example, the lateral mounting portions may each comprise one or more holes to allow the mounting portion to be fixed to the skin by one or more sutures. Alternatively, or in addition, the lateral mounting portions may comprise an adhesive layer on the surface to contact the skin. As a further alternative, the lateral mounting portions may be formed so as to * allow a length of adhesive tape to be applied across the portion and affixed to the skin. * .*

In general, the lateral mounting portions should lie in at least two lateral lines S.....

* extending through the collar, with the resistance to lateral forces being greater as the angle between the two lateral lines increases. In one embodiment, the base comprises at least three lateral mounting portions. If three lateral mounting portions are provided, they are most preferably arranged equilaterally around the collar. In an alternative arrangement, the base comprises at least four lateral mounting portions.

For example, the base may be in the form of a cross, having four laterally extending mounting portions. Alternatively, the base may be in the form of a star having five or more limbs. In a further alternative, the lateral mounting portions may be portions of a larger shape, for example a circular or rectangular base, with the circle or rectangle being large enough to allow the lateral mounting portions to provide the required degree of lateral stability.

In general, the base may be formed to lie flat against the skin of the subject.

However, this may compromise the incision in the tissue of the patient through which the drain tube is inserted. In particular, this may allow the incision to become infected and prevent the infection from being noticed and/or treated. An alternative arrangement is to provide the base with a plurality of lateral portions extending from the base, such that the free ends of the lateral portions contact the skin of the subject, when the apparatus is in use, and hold the collar at a distance from the subject's skin.

Accordingly, in a further aspect, the present invention provides an apparatus for supporting the tube of a drain in the region of the drain tube entering the body of a subject, the apparatus comprising: a base for securing to the skin of the subject having an opening therein for receiving a drain tube; a collar extending from the base; and a passage extending through the collar aligned with the opening in the base S. ... 20 for receiving the drain tube; wherein the base comprises a plurality of lateral mounting portions, each *...S.

* lateral portion having a support portion at its free end for contacting the skin of the subject, the lateral mounting portions being arranged such that, when the apparatus * .. is in use, the collar is held at a distance from the skin of the subject. *.

S....' * The lateral mounting portions should be sufficient in size and/or number to hold the collar away from contact with the skin of the subject in a secure manner.

This ensures that the incision through which the drain tube enters the body of the subject is open to the air and is open to inspection and, if required, treatment.

The lateral mounting portions may be sufficient in number and spaced apart to provide the resistance to lateral forces mentioned above.

Each lateral mounting portion has a support portion at its free end for contacting the skin of the subject. This support portion may be of any suitable form to support the apparatus and the drain tube, when in use, and to allow the apparatus to be secured to the skin of the subject. Suitable techniques for securing the support portion to the skin of the subject are described hereinbefore and include providing one or more holes, slits or openings in the support portion to allow sutures to be used to secure the apparatus. In one preferred arrangement, the support portion extends at an angle to the lateral mounting portion so as to lie flat against the skin of the subject when in use. In this arrangement, the lateral mounting portion may be regarded as a leg' extending from the region of the collar with a foot' at its free end for attaching to the skin of the subject.

In a further aspect, the present invention provides a drain kit, the drain kit comprising a drain tube for insertion into the body of a subject and an apparatus as hereinbefore described.

The kit may comprise one or more means for inserting the drain tube into the body of the subject through a suitable incision. Such means are known in the art and commercially available. * .** **

In a still further aspect, the present invention provides a method of inserting a *.*** * drain into the body of a subject, the method comprising: inserting a drain tube into the body; locating a support apparatus around the drain tube in the region of the entry * of the drain tube into the body, the support apparatus comprising a base having an * opening therein to accommodate the drain tube and a collar extending from the base with a passage therethrough aligned with the opening in the base, the collar being located around the drain tube such that the drain tube lies within the passage in the collar, the method comprising applying the support apparatus around the drain tube after the drain tube has been inserted into the body of the subject by means of a slit extending through the base and the collar of the support apparatus; securing the base of the apparatus to the skin of the subject adjacent the drain tube; and clamping the collar around the drain tube.

The support apparatus may be an apparatus as hereinbefore described.

As noted, the apparatus may be located around the drain tube before the tube is inserted into the body of the subject. However, more preferably, the apparatus is of a form that allows it be extended around the drain tube after the tube has been inserted and then affixed.

Further, the present invention provides the use of an apparatus as hereinbefore described for supporting a drain tube or the like.

Embodiments of the present invention will now be described, by way of example only, having reference to the accompanying drawings, in which: Figure 1 is a diagrammatic representation of a drain assembly in place in the chest of a subject; Figure 2 is perspective side view of a support apparatus according to one * *$ ** embodiment of the present invention; **** * S. Figure 3 is a plan view of the support apparatus of Figure 2 along the line Ill -I.....

* Ill; * *. Figure 4 is a cross-sectional view of the support apparatus of Figure 2 in *2* place on a subject with a drain in place and supported; ****.* * S Figure 5 is a cross-sectional view of the support apparatus of a further embodiment of the present invention; and Figure 6 is a perspective view of the support apparatus of Figure 5 along the line VI -VI, with a drain tube in place in the apparatus.

Embodiments of the present invention will be described and shown in relation to surgical drains. However, it is to be understood that this is merely illustrative and that the present invention may be applied to any similar lines that are used to deliver fluid to or remove fluid from the body of a subject.

Referring to Figure 1, there is shown a human subject, generaHy indicated as 2, having a chest 4. A drain assembly, generally indicated as 10, is shown in place in the subject 2. The drain assembly 10 comprises a drain tube 12, of generally conventional design, extending into the chest cavity of the subject (indicated by a dotted line in Figure 1). The drain tube 12 terminates in a conventional connection 14, by which it is connected to a flexible drain line 16, again in conventional manner.

A support apparatus according to one embodiment of the present invention, generally indicated as 20, is shown secured to the skin of the subject adjacent the point of entry of the drain tube 12 into the chest cavity.

The support apparatus 20 is shown in more detail in Figures 2, 3 and 4. The apparatus comprises a base 22. The base 22 comprises a central, generally circular portion 24, through which an opening 26 extends, to receive a drain tube. The base 22 further comprises four lateral portions 28a to 28d, equally spaced around the circumference of the central portion 24 and extending generally radially therefrom.

*: The lateral portions 28a to 28d extend sufficiently far from the central portion 22 and O are spaced around the central portion so as to provide a uniform lateral support and rigidity to the support when in place, and allowing it to resist lateral forces that may * distort or dislodge the drain tube, when in situ. The embodiment shown in Figures 2 to 4 comprises four lateral portions. It will be appreciated a higher or lower number * *. of lateral portions may be provided, with the requirement that they are of a size and *25, distribution to provide resistance to lateral forces that may be applied to the support when in use. With lateral portions of the design shown in the figures, a minimum of three equally spaced portions will be required to provide the required stability and resistance.

Each lateral portion 28a to 28d is provided with two holes 30 therethrough, allowing each portion to be attached to the skin of the subject by. sutures.

Alternatively, or in addition thereto, the surface of the lateral portions to contact the skin may be provided with an adhesive layer, and/or adhesive tape may be applied over each portion to secure the support 20 to the skin of the subject.

The support apparatus 20 further comprises a tubular collar 32 extending from the surface of the central portion 22, such that in use the collar 32 extends away from the skin of the subject when the support apparatus is attached as hereinbefore described. The collar 32, as shown in the figures, is a complete tube. However, it is to be understood that the collar may take other configurations, such as a partial tube or a tube with openings therein, provided that the function of the collar to grip and support a drain tube is maintained. The collar 32 has a bore 34 extending therethrough, providing a passage for a drain tube, as described below. The collar 32 may extend perpendicular to the base 22. However, the collar 32 more preferably extends at an angle to the perpendicular, as shown in the figures. The angle of the tube shown in the figures is 45° to the base 22. The collar 32 is positioned such that the bore 34 is aligned with the opening 26 in the central portion 24 of the base 22.

A split 36 extends along the length of the collar 32 and across the central region 24 of the base, such that both the opening 26 in the base 22 and the bore 34 of the collar may be opened by appropriate flexing of the support apparatus. In this way, the apparatus may be applied around a drain tube or the like. Tabs 38 are * ** ..* provided on each of the central portion 24 of the base 22 and the collar 32 on * *** adjacent opposing sides of the split 36. The tabs 38 allow a user to grip the support apparatus to aid flexing and opening.

* * S.. * S

A clamp 40 extends around the end portion of the collar 32 and comprises a * ,. strap 42 and a lock 44. The clamp 40 is operable to tighten the collar 32 around a drain tube present in the bore 34. The clamp 40 may be released to allow the collar S.., *I * and base to be opened. A single clamp 40 is shown in the figures. However, two or more similar clamps may be provided around the collar, if required to adequately retain and support a drain tube.

The use of the support apparatus 20 is illustrated in Figure 4. In use, a drain tube 100 of known design is installed in the subject according to conventional procedures, involving making an incision in the skin 102 of the subject and inserting the drain tube through the incision and locating it in the required position. The portion of the drain tube bOa beneath the skin 102 of the subject is indicated by a dotted line in Figure 4. Once the drain tube 100 has been properly positioned, the support apparatus 20 is opened along the slit 36 and applied around the shaft of the drain tube 100. The apparatus 20 may be applied to the drain tube before installation, by sliding the apparatus along the tube from a free end. However, this is not required. Once located around the drain tube 100 with the tube extending along the bore 34 in the collar 32 and through the opening 26 in the base 22, the apparatus is moved along the drain tube 100 to the position shown in Figure 4 with the base 22 in contact with the skin 102. Sutures 104 are applied through the holes 30 in the lateral portions 28 of the base 22 to secure the support apparatus to the subject.

Finally, the or each clamp 40 is tightened to secure the collar 32 around and firmly grip the drain tube 100.

Should the drain tube 100 need to be repositioned, as is often the case, it is not necessary to remove the support apparatus 20, as is the case with known devices. Rather, the clamp 40 is loosened, allowing the drain tube to slide through the apparatus. Once the drain tube is in the new position, the clamp 40 is *::: retightened. S...

Referring to Figures 5 and 6, there is shown an alternative arrangement of the :40 apparatus of the present invention, generally indicated as 200. The apparatus comprises a base 202 having a generally flat central portion 204 from which extend four generally flat lateral portions 206a, b, c and d. A leg portion 208a, b, c and d extends substantially perpendicular from the end of each later portion 206a, b, c and : d and terminates in a foot 210a, b, c and d, each foot extending perpendicular to the * 25 respective leg portion away from the centre of the base 202 and substantially parallel with the central portion 204 of the base. Each foot 210a, b, c and d is provided with two holes 212 therethrough, to allow the foot to be secured to the skin of the subject by means of sutures 214, as shown in Figure 6.

The apparatus 200 further comprises a collar 220 having a central longitudinal bore 222 therethrough, extending from the base 202. The bore 222 in the collar 220 aligns with an opening 224 in the central portion 204 of the base. The collar 220 extends at an angle a to the base 202. The collar 220 has a generally tapered outer form, with the collar being widest at its junction 224 with the base 202.

The bore 222 in the collar 220 is of constant diameter throughout its length. Two grooves 226a and bare formed in the external surface of the collar in the region adjacent the base 202, and provide a means for locating a clamp around the collar.

A slit 225 (shown in Figure 6) extends through the central portion 204 of the base 202 and the collar 220, allowing the bore 222 in the collar to be opened to receive a drain tube. The slit is held closed in use by the clamp located by the grooves 226a and b in the external surface of the collar.

The apparatus 200 is shown in use in Figure 6, secured to the skin of a subject over an incision 300 and with a drain tube 302 extending through the bore 222 in the collar 220 and into the subject through the incision. * ** * * * * ** **** * * **.* *

****** * * * ** * S * * ** **SS*. * S

Claims

1. An apparatus for supporting the tube of a drain in the region of the drain tube entering the body of a subject, the apparatus comprising: a base for securing to the skin of the subject having an opening therein to accept the drain tube; a collar extending from the base; a passage extending through the collar and aligned with the opening in the base for receiving the drain tube; and clamping means external to the passage in the collar for tightening the collar around the drain tube when in place within the passage.

2. The apparatus according to claim 1, wherein the base comprises one or more holes, openings, slits or slots therethrough for securing the apparatus to the skin of a subject by means of suturing. * **

3. The apparatus according to either of claims I or 2, wherein the collar extends perpendicular to the base.

4. The apparatus according to either of claims I or 2, wherein the collar extends at an angle to the perpendicular to the base. * S. * S S * **

5. The apparatus according to claim 4, wherein the collar extends at an angle of from 20 to 70°, preferably from 30 to 65°, more preferably from 45 to 60° to the base.

6. The apparatus according to any preceding claim, wherein the collar is in fixed orientation with respect to the base.

7. The apparatus according to claim 6, wherein the collar and the base are formed as a single component.

8. The apparatus according to any preceding claim, wherein the collar comprises at least a portion that, in use, extends entirely around the drain tube.

9. The apparatus according to claim 8, wherein the collar is generally tubular in form, the passage being formed by the bore of the tube.

10. The apparatus according to any preceding claim, wherein the collar is tapered, with the widest portion of the collar being adjacent the base.

11. The apparatus according to claim 10, wherein the passage through the collar has a uniform diameter along its length.

12. The apparatus according to any preceding claim, wherein the clamping means are provided, at least in part, by an inherent bias in the collar.

* *.

13. The apparatus according to any preceding claim, wherein the clamping :::::: means comprises one or more straps extending around the outer surface of the collar. *70

* S S. .4 *

14. The apparatus according to any preceding claim, wherein the collar is of a transparent material. * .* * a S * S.

15. The apparatus according to claim 14, wherein the collar and the base are of a transparent material.

16. The apparatus according to any preceding claim, wherein the apparatus may be applied around a drain tube after the drain tube has been installed in the subject.

17. The apparatus according to claim 16, comprising one or more slits allowing the opening in the base and the passage in the collar to be extended around the shaft of a drain tube.

18. The apparatus according to claim 17, wherein a single slit extends across the base and along the collar.

19. The apparatus according to either of claims 17 or 18, wherein the base and collar are each provided with a hinge to facilitate opening of the apparatus.

20. The apparatus according to any preceding claim, wherein the base comprises a plurality of lateral portions extending laterally from the collar.

21. The apparatus according to claim 20, wherein the lateral portions are disposed around the collar to provide resistance to lateral forces.

22. The apparatus according to claim 21, wherein the base comprises at least three lateral portions.

23. The apparatus according to claim 22, wherein the base comprises at least four lateral portions, spaced equally around the collar. S...

24. The apparatus according to any of claims 2Oto 23, wherein the lateral :410 portions extend so as to hold the collar away from the skin of the subject when the apparatus is in use.

25. An apparatus for supporting the tube of a drain in the region of the drain tube entering the body of a subject, the apparatus comprising: a base for securing to the skin of the subject having an opening therein to accept a drain tube; a collar extending from the base; and a passage extending through the collar and an opening in the base for receiving the drain tube; the apparatus further comprising a slit extending from an edge of the base through the base and the collar to the opening in the base and the passage in the collar, whereby the base and collar may be opened along the line of the slit to allow the base and collar to be extended around the drain tube.

26. An apparatus for supporting the tube of a drain in the region of the drain tube entering the body of a subject, the apparatus comprising: a base for securing to the skin of the subject having an opening therein for receiving a drain tube; a collar extending from the base; and a passage extending through the collar aligned with the opening in the base for receiving the drain tube; wherein the base comprises a plurality of lateral mounting portions, the lateral portions being sufficient in number and disposed around the collar in a position to provide the apparatus with a resistance to lateral forces when the lateral mounting portions are secured to the skin of the subject.

27. A drain kit comprising a drain tube for insertion into the body of a subject and an apparatus as defined in any preceding claim.

28. A method of inserting a drain into the body of a subject, the method * ** comprising: :::::: inserting a drain tube into the body; locating a support apparatus around the drain tube in the region of the entry of the drain tube into the body, the support apparatus comprising a base having an opening therein to accommodate the drain tube and a collar extending from the base with a passage therethrough aligned with the *:*::* opening in the base, the collar being located around the drain tube such that the drain tube lies within the passage in the collar, the method comprising applying the support apparatus around the drain tube after the drain tube has been inserted into the body of the subject by means of a slit extending through the base and the collar of the support apparatus; securing the base of the apparatus to the skin of the subject adjacent the drain tube; and clamping the collar around the drain tube.

29. A support apparatus for a drain substantially as hereinbefore described having reference to the Figures 1 to 4 or Figures 5 and 6.

30. A drain kit substantially as hereinbefore described.

31. A method of inserting a drain into the body of a subject substantially as hereinbefore described having reference to the accompanying figures. * Is * 5 * * SS 5.. * S S... *

S..... * S * .. * . . * *5

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