GB2472268A

GB2472268A - Support for a catheter or drain tube

Info

Publication number: GB2472268A
Application number: GB0913417A
Authority: GB
Inventors: Jason Klein
Original assignee: Salisbury NHS Foundation Trust
Current assignee: Salisbury NHS Foundation Trust
Priority date: 2009-07-31
Filing date: 2009-07-31
Publication date: 2011-02-02
Also published as: GB0913417D0

Abstract

An apparatus for supporting the tube of a drain in the region of the drain tube 50 entering the body of a patient is disclosed, the apparatus comprising a base 4 for securing to the skin of the subject having an opening 10 therein to accept the drain tube 50 and to be aligned with an exit site on a subject; and a tube support assembly disposed on the base, the tube support assembly comprising a support body 22 and retaining means 32 for holding a tube in contact with the support body 22, the support body 22 being arranged to support a tube 50 extending from the exit site on the subject such that the tube extends from the apparatus 2 substantially parallel to the base. The base 4 may be secured to the patient using adhesive and / or sutures.

Description

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 tie the sutures at the *..b . : skin to secure the incisional would tightly around the drain as it emerges from the subject's body. The free ends of the sutured are then wound 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 techniques for securing the drain. 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 retied as tightly around the tubing.

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 : *e** 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 may delay the discharge of the patient from hospital or, at worst, may result in the permanent injury or even 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.

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 o...

of the person applying the sutures and the necessary time to complete the task being * 4. . 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. 0.0

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 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 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 * S..

consequences for the patient. * Is

Further, US 4,516,293 discloses a clamping structure for holding a tube having a base and a wrap-around strap. * S. * S S..,

An adjustable drainage tube holder is disclosed in GB 2,160,776 and comprises a clear flexible mounting plate for attachment to the patient by a suitable adhesive. A collar extends from the mounting plate and is aligned with an aperture in the plate, the collar accepting a tube when in use.

WO 2008/017329 discloses a fixation device for holding a medical instrument, such as a trocar, having a flexible sheet-like member having an aperture and a slot for receiving the instrument.

An access port is disclosed in WO 2007/006306 and comprises a sleeve surrounding an aperture for receiving a tube, a flange portion and a membrane. The access port is described as being suitable for use with a wound care device or a drainage bag.

A cannula skirt is described and shown in US 5215,531 and comprises a generally conical skirt having an opening therein for receiving a cannula. A collar extends from the skirt anti comprises a clamp for fastening the collar around the cannula, once in position.

In general, the known devices for supporting a drain tube or the like once in position in a subject, such as those of the prior art discussed above, while supporting the drain tube, generally require the tube to extend at or close to 90° from the opening in the subject. This can leave the drain tube vulnerable to being inadvertently moved, dislodged and even removed, for example as the subject moves.

us 5,833,666 discloses a catheter fixation assembly for securing a catheter at or adjacent to en exit site on a subject's body. The assembly comprises a resilient member for fixing to the subject and an adjustable clamp. In one embodiment, the *...

: assembly comprises a clamp assembly that allows the catheter to be secured so as * *** to extend along the body of the subject. However, this embodiment of the assembly is required to be fixed to the subject some distance from the exit site or opening in * the subject. This is undesirable.

* ** 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 and to be aligned with an exit site on a subject; and a tube support assembly disposed on the base, the tube support assembly comprising a support body and retaining means for holding a tube in contact with the support body, the support body being arranged in use to support a tube extending from the exit site on the subject such that the tube extends from the apparatus at an acute angle to the skin of the subject.

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 drain tube. The base is formed to provide resistance to lateral forces acting with a component parallel to the skin of the subject to dislodge the drain tube to the side. S...

: 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. A preferred embodiment of the apparatus employs a layer of a suitable adhesive on the surface of the base in contact with the skin of the subject, when the apparatus is in use. Suitable medical grade adhesives for use in contact with the skin of a subject are known in the art and are commercially available.

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. In this way, the base provides a form of dressing around the opening and helps to provide a fluid-tight seal around the exit site in the skin of the subject, in turn helping to prevent infection of the site. The base may be provided with a suitable antiseptic or other agent, such as an antibacterial agent, to assist in preventing infection of the exit site.

The base may be formed from any suitable material. Plastic is a suitable and preferred material, with suitable medical grade plastics being known in the art and available commercially.

As noted, the base comprises an opening therein through which the tube extends. In use, the opening in the base is aligned with the exit site in the skin of the subject, such that the tube extending from the exit site extends directly through the opening in the base of the apparatus. To allow the apparatus to be applied to a tube that is already in position in the subject, the base is preferably provided with a slit I...

: therein extending from the opening in the base to an edge. *S.. * * **..

The base may have any suitable form. Most preferably, the base is a flat * S. member, that is sheet-like, and flexible, to allow the base to conform to the contours of the skin of the subject. The base is preferably formed with a curved or rounded * ,* outer edge, as this is generally more comfortable for the subject and for medical practitioners using and installing the apparatus. The base is most preferably flexible, allowing the base to be bent as required and, if present, allowing the slit in the base to be opened easily to accept a tube. The base is preferably resilient, ensuring that the slit, if present, closes when released.

The region of the base adjacent and/or surrounding the opening may be reinforced, for example by being of a thicker gauge material than the remainder of the base. Alternatively, or in addition thereto, the region of the base surrounding the opening may be of a larger diameter or lateral dimension, to provide increased lateral support in the region surrounding the exit site, If desired, the base may have a smaller diameter or lateral dimension in the portions distal from the opening.

The apparatus further comprises a tube support assembly disposed on the base and extending therefrom. In use, the tube support assembly holds and retains the tube extending from the exit site of the subject. Most preferably, the tube support assembly retains the tube in a substantially fixed and rigid orientation with respect to the base of the apparatus. The tube support assembly comprises a substantially rigid support body and a retaining means for holding the tube against the support body.

The support body is arranged to hold the tube such that it extends away from the apparatus at an acute angle to the skin of the subject. This is in contrast to the devices of the prior art, which generally support the tube in a perpendicular attitude relative to the skin of the subject. Preferably, the tube is supported such that it extends from the apparatus so as to lie along the skin of the subject, more preferably parallel to the base of the apparatus.

The support body may be any suitable structure to provide support to the tube : relative to the base. The support body preferably provides support for the tube such * *** the tube extends in an arc from the opening in the base of the apparatus. More *0 preferably, the support body supports and holds the tube in an arc that extends first * away from the exit site and then returns towards the skin of the subject. In this way, the tube is held to lie along or adjacent the skin of the subject. The support body * *. preferably holds the tube extending from the opening in the base at an angle of less than 90° to the base, more preferably at an angle of less than 70°, still more preferably less than 50° to the base. In a preferred embodiment, the support body holds the tube at an angle of from 25 to 500 to the base, more preferably from 30 to 450 to the base. As noted above, the tube extends from the apparatus substantially parallel to the base of the apparatus. Distal from the opening, the support body preferably holds the tube at an acute angle to the base, more preferably at an angle that is more acute than the angle of the tube extending from the opening. Preferably, the tube is held distal from the opening at an angle of less than 60°, still more preferably less than 45° to the base. In a preferred embodiment, the support body holds the tube at an angleof from 10 to 40° to the base, more preferably from 15 to 35° to the base.

Preferably, the support body is provided with a support surface against which the tube his held by the retaining means. The support surface preferably extends in a curved manner or an arc away from the opening in the base of the apparatus. The radius of curvature of the support surface may be constant along its length. More preferably, the radius of curvature of the portion of the support surface adjacent the opening in the base is less than the radius of curvature of the portion of the support surface distal of the opening. In one preferred embodiment, the support surface is provided with a channel, in particular a channel having an arcuate or V-shaped cross-section, for receiving the tube. The retaining means act to hold the tube in the channel in the support surface.

Preferably, the support body is disposed on the base adjacent the opening in the base. In this way, the support body supports the tube extending from the exit site and through the opening and provides support for the tube at the point it leaves the opening in the base. In a preferred arrangement, the support body has a support surface extending from the opening in the base of the apparatus. The support .. : surface of the support body may extend at an angle to the base, so asto hold the *...

... tube at an angle to the base, as described above. It is further preferred that the *30 support body has a support surface that extends to the base distal from the opening, * most preferably the support surface at or adjacent to the edge of the base. As well as providing support for the tube and a structure to which the tube may be secured, * *. this also advantageously makes the position of the tube more comfortable for the subject. In addition, the drain tube is in a better position to be monitored by nursing staff. Finally, this arrangement, by having the tube extend in an arc, allows the tube to emerge from the subject's body with a much lower risk of kinking and occluding its lumen.

The support body may be of any suitable material. Again, plastic is a particularly preferred material, with suitable medical grade plastics being known in the art and available commercially. The support body may be attached to the base by any suitable means. Preferably, the support body is unitary with the base, for example by having the base and support body moulded or formed as a single component.

As noted above, the apparatus further comprises retaining means for holding the tube in contact with the support body of the support assembly. Any suitable retaining means may be employed. Most preferably, the retaining means are releasable, allowing the tube to be released, for example to adjust its position relative to the subject. Suitable retaining means include clamps, straps or a combination thereof. Suitable clamps and straps are known in the art. Alternatively, or in addition thereto, the support body may be provided with a channel in the support surface, as described above, and formed of a material that is sufficiently resilient to allow the sides of the channel to hold the tube in place on the support body.

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. * ** * S

* S.. a *30 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, for example by being provided with a slit in the base, as described hereinbefore.

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

Embodiments of the apparatus 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 perspective view of one embodiment of the apparatus of the present invention; Figure 2 is a side elevation of the apparatus of Figure 1; Figure 3 is a front elevation of the apparatus of Figure 1 along the line Ill -Ill of Figure 2; Figure 4 is a plan view of the apparatus of Figure 1; and Figure 5 is a diagrammatical representation of the apparatus of Figure 1 in position on a subject and holding a drain tube.

Referring to Figure 1, there is shown an apparatus for retaining a drain tube or the Uke, generally indicated as 2. The apparatus comprises a base 4 formed from a medical grade plastic. The base 4 comprises a flexible, resilient, sheet-like member having a generally elongate form with a first end portion 6 and a second end portion 8. The first end portion 6 is provided with an opening 10 therein and a slit 12 extending from the opening 10 to the edge of the base. As shown in the figures, the *.I' .. : first and second end portions 6, 8 may be characterised as being generally circular, * *** ,* with the diameter of the first end portion 6 being greater than the diameter of the *0 second portion 8. In this way, the base 4 provides increased stability in the region of * the opening 10.

: * The lower surface of the base 4, as viewed in the figures, is provided with a layer of adhesive 14, to allow the base to be adhered to the skin of a subject. The lower surface of the base may also be provided with an agent, such as an antibacterial agent, to assist in preventing infection of the exit site of the subject.

This may be included in the adhesive composition 14.

A support assembly 20 extends from the upper surface of the base 4, as viewed in the figures. As shown, the support assembly 20 comprises a support body 22, the support body being generally elongate and extending longitudinally along the base. A first end 24 of the support body 22 is adjacent the opening 10 in the base.

The second end 26 of the support body 22 is adjacent the edge of the base distal from the opening 10. As shown in Figure 2, the support body 22 comprises a generally arcuate support surface 28 extending from the first end 24 adjacent the opening 10 in the base to the second end 26 adjacent the distal edge of the base 4.

The support surface 28 at the first end 24 adjacent the opening has a first radius of curvature R1 and the support surface 28 at the second end 26 has a second radius of curvature R2, greater than the first. The support surface 28 is provided with a channel 30 therein extending along its length and having a V-shaped cross-section.

The support surface 28 at the first end 24 of the support body extends at an angle to the base of about 45°. At the second end 26 of the support body, the support surface extends at an angle of about 20°.

The support body 22 is provided with straps 32 and strap locks 34 disposed along the length of the channel 30. The straps extend substantially perpendicular to the support surface 28.

The apparatus 2 is shown in use in Figure 5. The apparatus 2 is applied to *S.S * : the skin 40 of the subject with the lower surface of the base 4 contacting the skin *... such that the opening 10 in the base 4 is aligned with the exit site in the skin of the subject. The drain tube 50 extends from the opening in the skin at the exit site * 30 through the opening 10 in the base. The tube 50 is bent to lie along the channel 30 in the support surface 28 of the support body 22 and is held in position by the straps * *. 32. As can be seen in Figure 5, the tube is supported by the apparatus such that it extends away from the distal end of the support body 22 and the apparatus and can lie along the skin of the subject. In this way, the risk of the tube being inadvertently moved or dislodged is significantly reduced, compared with the support devices of

the prior art.

Finally, the apparatus 2 is provided with a plurality of holes or openings 50 in the base 4 in the region of the opening 10. The holes 50 are arranged around the opening 10, as shown for example in Figure 4. The holes 50 are provided for the ends of sutures used to close the opening in the body of the subject. In current practice, the opening in the subject's body is closed using a suture, such as a mattress suture, with the suture being sited in the opening, but not tied at the time the drain is inserted. The holes 50 in the base 4 allow the ends of the suture to be drawn through the base and emerge, without being caught on the underside of the base. *.S * S * S. * S... * S *55 * S. * . S * ** * 55 * S S IS..

Claims

CLAIMS1. 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 and to be aligned with an exit site on a subject; and a tube support assembly disposed on the base, the tube support assembly comprising a support body and retaining means for holding a tube in contact with the support body, the support body being arranged to support a tube extending from the exit site on the subject such that the tube extends from the apparatus at an acute angle to the skin of the subject.
2. The apparatus according to claim 1, wherein the tube is held by the support assembly such that the tube extends from the apparatus substantially parallel to the base.
3. The apparatus according to either of claims 1 or 2, wherein the base is provided with a layer of adhesive on a surface thereof for attaching the apparatus to the skin of a subject.
4. The apparatus according to any preceding claim, wherein the base is provided with an agent to prevent infection of an exit site in a subject.

:.
5. The apparatus according to any preceding claim, wherein the base is provided with a slit extending from the opening in the base to an edge of the base. *.SS * *

* **
6. The apparatus according to any preceding claim, wherein the portion of the base surrounding the opening is of a larger diameter than the remaining portion of the base. * I. * * * **..
7. The apparatus according to any preceding claim, wherein the support body supports the tube extending from the opening at an angle of from 25 to 500 to the base. -
8. The apparatus according to any preceding claim, wherein the support body supports the tube distal from the opening at an angle of from 10 to 40° to the base.
9. The apparatus according to any preceding claim, wherein the support body comprises a support surface, the retaining means holding the tube against the support surface when in use.
10. The apparatus according to claim 9, wherein the support surface extends in an arc away from the opening in the base.
11. The apparatus according to claim 10, wherein the radius of curvature of the support surface adjacent the opening is lower than the radius of curvature of the support surface distal to the opening.
12. The apparatus according to any of claims 9 to 11, wherein the support surface is provided with a channel therein for accommodating the tube.
13. The apparatus according to claim 12, wherein the channel is formed with a V-shaped cross-section.
14. The apparatus according to any of claims 9 to 13, wherein the support surface extends from the opening in the base to adjacent and edge of the base distal : to the opening. S... * . *S*.* *,
15. The apparatus according to any preceding claim, wherein the support body is * . * * 30 unitary with the base.: *
16. The apparatus according to any preceding claim, wherein the retaining means **Ss comprises one or more straps.
17. The apparatus according to claim 16 wherein the or each strap extends perpendicular to the surface of the support body.
18. A drain kit comprising an apparatus as claimed in any preceding claim and a drain tube.
19. The drain kit according to claim 18, further comprising a means for inserting a drain tube into the body of a subject.
20. The use of an apparatus according to any of claims I to 17 for supporting a drain tube on a subject.
21. An apparatus for supporting a drain tube substantially as hereinbefore described having reference to any of Figures 1 to 5. *... * * * ** * *... * * *S.. * S. * . S * S. * *. * S * *SS*