GB2520356A

GB2520356A - Medical tube securement device

Info

Publication number: GB2520356A
Application number: GB1320423.5A
Authority: GB
Inventors: Andrew Micklethwaite
Original assignee: SPECIALITY MEDICAL DEVICES Ltd
Current assignee: SPECIALITY MEDICAL DEVICES Ltd
Priority date: 2013-11-19
Filing date: 2013-11-19
Publication date: 2015-05-20
Anticipated expiration: 2033-11-19
Also published as: HK1209664A1; GB2520356B; GB201320423D0

Abstract

A medical tube securement device 100 to releasably attach a medical line externally to the skin of a patient. The device comprises a helically coiled main body 110 in which a plurality of helical or spiral turns 101 extend between first and second ends and an anchorage foot 105 extending radially from the main body at a position between the ends for attaching the device to the skin 108. The flexible coiled main body is capable of firstly elongation to grip the tube 109 and secondly compression to allow adjustment of the tube position relative to the device. Underside of the foot may comprise a fixing component such as adhesive or hook and loop. The main-body may be formed from a singularly coiled helix and the foot may be positioned at an axially endmost helical turn. Preferably to affect the friction of gripping the radially inward surface of the helical turns may comprise a coating and possibly a profiled surface of raised patterns. A locking flange may be axially positioned between the helical turns to prevent axial compression of the turns. A medical tube fixing assembly with the tube extending through helical turns and projecting axially beyond the two ends.

Description

Medical Tube Securement Device

Field of invention

The present invention relates to a medical tube securement device and in particular, although not exclusively, to a device configured to secure externally medical tubing to a body part such that the medical tube may be conveniently attached or detached from the securement device independently of any attachment of the device to the body part.

Background art

Commonly, medical patients require the administration of fluids, including medications and the like, or the draining of both medical and biological fluids during treatment.

Typically, medical tubing is used for both supply and extraction of fluids with a catheter or wound drain being typical examples. It is not uncommon for the catheter or wound drain to remain secured to the patient for a number of days, weeks or even months.

Intravenous catheters are introduced into a vein of a patient, typically a forearm or hand, using a needle to pierce the skin. Depending upon the stage of the treatment, the catheter tubing may be temporarily attached to the patient using medical tape. Alternatively a more permanent mechanism for attachment may be used for long term treatment.

Typically, attachment of medical tape at the patient's skin can be problematic due to the risk of contaminants collecting at the tape and the difficulty with removing the tape when required. A number of medical tube attachment devices have been proposed in an attempt to provide both a quick and reliable means of securing a tube to a patient and to provide an attachment that is convenient for removal when the medical tubing is to be changed or is no longer required. Example attachment devices are described in GB 2464932; US 2011/0054409; US 2010/0179481; WO 2013/021160; AU 2011202877; AU 2010246476; AU 2008249520; and US 2005/0215953.

However, existing attachment devices are problematic for a number of reasons. In particular, sudden movement by the patient or accidental movement by medical staff may catch the tubing and dislodge or move it from its intended attachment position at the skin.

Additionally, when it is required to change or remove the attachment device it is often necessary to detach the entire medical tube and to reattach a replacement. If this is repeated at regular intervals, particularly within short time periods, it can cause skin irritation and soreness. Furthermore, the strength of the grip' of the tube by the securement device is not optimised where the device is configured to allow positional adjustment of the tube.

Accordingly, what is required is a medical securement device that addresses these problems.

Summary of the Invention

Accordingly, it is an objective of the present invention to provide a medical tube securement device that is effective to provide secure and robust attachment of the tube externally at the patient and to allow removal and interchange of the seeurement device whilst maintaining attachment of the tubing to the patient. It is a further specific objective to provide an attachment device that is effectively self-locking to the medical tube where a strength of the grip' of the tubing is increased in response to undesirable or unintentional movement (in particular pulling) of the tubing relative to the attachment device. It is a further objective to provide a device that allows positional adjustment of the tubing without compromising the strength of the gripping action.

The objectives are achieved by providing a medical line attachment device that comprises a helically coiled main body and a foot anchorage component in which a plurality of helical turns of the coil are capable of both axial elongation and compression so as to respectively increase or decrease the grip strength (via adjustment of the frictional contact) around the tubing. Such an arrangement is advantageous to allow both convenient positional adjustment of the medical tubing relative to the patient and to significantly enhance the gripping contact between the attachment device and the tubing should the tubing be pulled in any one or two directions relative to the region of attachment of the patient. This achieved by variation of the internal diameter of the helical coil resultant from either compressing the helical turns together to increase the diameter of the helix (by the action of bring the coil ends together axially) or by drawing apart the coil ends axially to decrease the helix internal diameter so as to clamp the device onto and around the medical tube.

Advantageously, by variation of the axial position of the anchorage foot relative to the coil ends, the present device may be configured to be mono-or bi-directional. That is, by positioning the anchorage foot substantially at a mid-axial position any subsequent pulling of the tube in either axial direction will result in one section of the coil (to one side of the anchorage foot) elongating and gripping onto the tube. Alternatively, by positioning the anchorage foot at one end of the coil, the gripping action is provided in one direction only, with movement in the alternate axial direction serving to compress the helical turns and allow the medical tube to move axially within the coil.

The anchorage foot of the subject invention may comprise a suitable medical dressing to secure to the body of a patient. Alternatively, a medical dressing fixation component may be attachable to the anchorage foot to allow intermediate attachment to the medical dressing that is in turn attached to the patient body.

According to a first aspect of the present invention there is provided a medical tube securement device comprising: a helically coiled elongate main body having a first end and a second end, the main body extending through a plurality of helical turns around a longitudinal axis of the device between the first and second ends; an anchorage foot extending radially outward from the main body at a position between the first and second ends or substantially at one of the first and second ends; the device capable of attachment externally to a body part via the anchorage foot such that the coiled elongate main body is capable of being separated from the body part by the anchorage foot; wherein the main body comprises a flexible material such that the helical turns are capable of elongation and compression axially relative to the foot such that when compressed a diameter of the helical turns is increased to allow a medical tube to slide axially within the helically coiled main body and when elongated the diameter of the helical turns decrease such that the main body is configured to grip the medical tube and inhibit axial movement of the tube relative to the device.

Optionally, the device further comprises a fixation component provided at an underside surface of the foot. Optionally, the fixation component comprises hook and loop type fasteners. Alternatively, the fixation component comprises an adhesive. Optionally, the device may comprise an adhesive backed dressing, plaster, bandage, gauze or other fabric or material used for attachment of medical devices to the skin of a patient.

Preferably, the main body is formed as a singularly coiled helix capable of being uncoiled by an unwinding of the helical turns. Advantageously, the device comprises a single foot extending radially outward exclusively from one of the helical turns. Such an arrangement allows the device to be uncoiled from the medical tube so as to allow complete detachment of the tube from the device without having to remove the tube from attachment to the patient.

Optionally, the coiled main body comprises between three to twenty, five to twelve or five to six complete helical turns between the first and second ends.

Optionally, the foot is positioned at an axially endmost complete helical turn of the main body. Optionally, the foot is positioned at an axial mid-region between the first and second ends. Such an arrangement is advantageous to provide a desired mono-or bi-directional action of the securement device as described herein.

Optionally, the main body and the anchorage foot are formed integrally or non-integrally.

Optionally, the anchorage foot and in particular a leg and/or base component may be formed non-integrally with the main body. Optionally, the anchorage foot comprises an integral or non-integral leg and base component.

Optionally, the device comprises any one or a combination of the following materials: a plastic; a thermoplastic; a silicone or silicone based material; an elastomeric material; a polyethylene; a polypropylene; a polyurethane; an elastic material.

Optionally, the device may comprise a coating at a surface of the main body corresponding to the surface orientated radially inward at the helical turns. The coating may be selected to provide a desired level of friction with the tube being effective to either increase or decrease the frictional contact with the tube relative to an uncoated main body. Optionally, axial segments of the main body may be coated at the radially inward facing surface so as to increase or decrease the frictional contact with the tube relative to non-coated regions of the coiled main body. Such an arrangement may be advantageous to increase or decrease the gripping action at discrete axial regions of the coiled body such as the ends or middle sections. Optionally and to affect the grip strength of the coiled main body, the main body may thrther comprise surface profiling provided at a surface of the main body corresponding to the surface that is orientated radially inward at the helical turns.

Optionally, the surface profiling comprises any one of a combination of the following set of: teeth; ridges; bumps; a raised pattem.

Optionally, the device may frirther comprise a locking flange positioned and moveably mounted adjacent the main body and capable of being moved between an engagement position and a disengaged position such that in the engagement position at least a part of the flange is positioned axially between the helical turns to prevent the helical turns compressing together axially. Such an arrangement is advantageous to axially lock the device into clamping engagement around the tube.

According to a second aspect of the present invention there is provided a medical tube securement assembly comprising: a device as claimed herein; and a medical tube extending internally and axially within the helical turns, the tube projecting axially beyond the first and second ends.

Advantageously, an inside diameter of the helical turns is less than an outside diameter of the medial tube. Such an arrangement is effective to provide a desired level of grip of the tube by the coiled main body such that a default condition of mounting a medical tube within the coiled main body is for the main body to grip the tube when at rest.

The present securement device is compatible for use with a variety of medical tubes including, not exclusively, any one of the following set of: a fluid supply tube; a fluid extraction tube; a wound drain; a urinary catheter; an infrision catheter.

Brief descrintion of drawinQs A specific implementation of the present invention will now be described, by way of example only, and with reference to the accompanying drawings in which: Figure 1 is a perspective external view of a medical tube securement device attached to the skin of a patient and clamping in position a medical tube according to a specific implementation of the present invention; Figure 2 is a further perspective view of the attachment device of figure 1 removed from the medical tube and the patient; Figure 3 is a further embodiment of the securement device of figure 2 in which an anchorage foot is located at a different axial position at an elongate helical coil so as to affect the gripping and release mechanism of the device according to a further specific implementation of the present invention; Figure 4 is a perspective view of a further embodiment of the device of figure 1 having a locking flange movable into engagement with the helical coil so as to lock the coil axially according to a further specific implementation of the present invention.

Detailed description of preferred embodiment of the invention Referring to figure 1, the medical tube securement device 100 comprises an elongate main body 110 formed from a substantially planar strip like material having a first end 102 and a second end 103. Main body 110 is formed as a coil and in particular a helix so as to comprise a plurality of helical turns 101 extending axially between first and second ends 102, 103. A single anchorage foot indicated generally by reference 105 extends radially outward from main body 110. Foot 105 comprises a leg 106 positioned radially intermediate main body 110 and a substantially planar base 107. Base 107 is secured to a medical dressing indicated generally by reference 111 having an adhesive underside 112 for attachment to the skin 108 of a patient. Securement device 100 is configured to receive a medical tube 109 inserted through and gripped by the plurality of helical turns 101.

Referring to figure 2, each helical turn 101 is wound around a central longitudinal axis 200 at device 100. Each helical turn 101 comprises an equal outside and inside diameter wherein the inside diameter is defined by a radially inward facing surface 202 and the outside diameter is defined by a radially outward facing surface 203. Each helical turn 101 is spaced apart equally in the axial direction by intermediate gap regions 201. Each gap region 201 is defined axially between an end edge 208 of a first helical turn and an opposed end edge 209 of a neighbouring helical turn 101. Main body 110 comprises a flexible material being for example a low density thermoplastic elastomer such as LD polyurethane.

Leg 106 extends radially outward from the coiled helix (defined by the helical turns 101) and fonns an extension from a single helical turn 101 such that base 107 is radially spaced from main body 110 by the radial length of the single leg 106. Accordingly, main body is capable of both flexing laterally with respect to longitudinal axis 200 and compressing and elongating in the longitudinal axis direction. Base 107 comprises an upper face 205 orientated towards main body 110 and a lower face 204 orientated away from main body 110. Leg 106 is attached at a first end 207 to main body 110 and at a second end 206 to base upper face 205. Base lower face 204 comprises a fixation component to secure foot 105 to dressing 111. According to the specific implementation, face 204 comprises an adhesive.

The material of main body 110 is both flexible and elastic such that the helical body 110 is capable of elastic elongation and compression in a direction of a longitudinal axis 200. In particular, and referring to the embodiment of figure 2 with foot 105 positioned at an axial mid-region of coiled body 110, the securement device is effective to be bi-directional'.

That is, the main body 110 may be divided into a first section 210 extending axially to one side of foot 105 and a second section 211 extending axially to an opposite side of foot 105.

With medical tube 109 accommodated within the helical turns 101 as illustrated in figure 1, an axial pulling force in direction A on tube 109 will cause helical turns 101 within section 211 to compress together to close gaps 201 until edges 208, 209 are brought into contact or near touching contact. This accordingly provides an increase in the inside diameter of each helical turn 101 within section 211 so as to release the frictional contact between the radially inward coil surface 202 and an external surface 104 of the tube 109.

In contrast, the helical turns 101 within the alternate section 210 are pulled with tube 109 so as to elongate the coiled main body 110 and increase the gap regions 201 as edges 208, 209 are drawn ifirther apart axially. This acts to reduce the coil inside diameter, as defined by the radially inward facing surface 202, such that surface 202 clamps onto tube surface 104. The tube 109 is effectively gripped by section 210. As will be appreciated, any movement in the opposite axial direction B will provide the corresponding and opposite axial compression and elongation at sections 211,210.

The present attachment device 100 and in particular the relative magthtude of the gripping force provided by the helical turns 101 may be selectively adjusted by variation of a number of parameters of main body 110 including in particular, but not exclusively: the axial separation distance C between regions D and E of neighbouring helical turns 101; a relative thickness of the strip-like main body 110 as defined between the radially inward and outward facing surfaces 202, 203; the constituent material of main body 110; an axial length F of each helical turn 101 and a relative inside diameter of each helical turn 101 relative to a corresponding outside diameter of tube 109.

According to the preferred embodiment, the axial length F of each helical turn 101 is approximately equal to the axial length of each gap region 201. The relative axial length F of each helical turn 101 and each gap region 201 is selected for optimised frictional contact between the coil inward facing surface 202 and the tube external surface 104.

The present securement device 100 is effective to prevent undesirable and unintentional axial slippage of tube 109 within the device 100 as the helical turns 101 are effective to clamp onto the outside surface 104 in the event of axial pulling or pushing in directions A and B. In addition, device 100 is configured to allow tubing 109 to be axially adjusted relative to the position of attachment to the skin 108. This may be achieved via a user grasping ends 102, 103 and compressing helical turns 101 together axially so as to increase their internal diameter and allow tube 109 to slide axially.

The subject invention is further advantageous in that any lateral movement of tube 109 relative to axis 200 serves to elongate the relevant section 210, 211 and accordingly decrease the helical turn inside diameter thereby increasing the strength of grip of tube 109. By attaching main body 110 at anchorage foot 105 via a single point of attachment (corresponding to leg 106) tube 109 may be conveniently detached from device 100 by uncoiling the helical turns 101 about tube 109 via an unwinding from one or both of main body ends 102, 103.

Figure 3 illustrates a further embodiment of the securement device 100 in which foot 105 is positioned towards or at first end 102. In particular, leg 106 is attached to helical turn 101 at a position of the endmost complete helical turn between positions D and B in the axial direction. In this configuration, substantially the full axial length of main body 110 extends axially from one side of foot 105 and is represented generally by section 300. As detailed with reference to the embodiment of figure 2, with tubing 109 accommodated within the helical turns 101 of the embodiment of figure 3, and the tube pulled in direction A substantially the full axial length of the main body 110 will grip onto the tube surface 104. However, movement in the opposite axial direction B, will cause the entire coil section 300 to compress as the helical turns 101 are drawn together to close axial gaps 201 thereby allowing tube 109 to slide axially within the coiled main body 110. Positional adjustment of tube 109 is therefore possible by convenient manipulation of the main body and/or by a simply pushing or pulling in one of two axial directions. The embodiment of figure 3 therefore is mono-directional in that the axial locking force provided by main body 110 acts in direction A only with adjustment of tube 109 being possible via axial movement in direction B. Figure 4 illustrates a further embodiment of the subject invention having a locking flange 400 positioned laterally to one side of the coiled main body 110 and movable mounted at foot 105. In particular, locking flange 400 comprises a plurality of axially spaced apart cylindrical segments 401 that are mounted and maintained at foot 105 to be aligned at the same axial position as gap regions 201. The segments 401 may be displaced by a pivoting action to close around tube outer surface 104 within each gap region 201 so as to be positioned axially between helical turn end edges 208, 209. In particular, each segment 401 comprises end edges 403, 404 that are positioned axially adjacent the respective end edges 209, 208 of axially adjacent helical turns 101 when flange 400 is locked in position to be coaxial with the coiled main body 110. When moved to this position, the helical turns 101 are prevented from compressing axially together such that the entire coiled main body 110 is locked in position around tube 109. Such an arrangement is advantageous to prevent undesirable release of the locking action of the securement device 100 and to provide a releasable manual lock.

Each segment 401 is mounted on a common support frame 402 that may comprise a flexible stem or strap attached at one end (not shown) to foot 105. Accordingly, segments 401 are capable of pivoting relative to foot 105 via frame 402. Optionally, foot 105 may further comprise a latch component (not shown) for engagement with segments 401 (or extensions attach thereto) so as to retain the segments 401 in the engaged position between helical turns 101.

Claims

Claims 1. A medical tube securement device comprising: a helically coiled elongate main body having a first end and a second end, the main body extending through a plurality of helical turns around a longitudinal axis of the device between the first and second ends; an anchorage foot extending radially outward from the main body at a position between the first and second ends or substantially at one of the first and second ends; the device capable of attachment externally to a body part via the anchorage foot such that the coiled elongate main body is capable of being separated from the body part by the anchorage foot; wherein the main body comprises a flexible material such that the helical turns are capable of elongation and compression axially relative to the foot such that when compressed a diameter of the helical turns is increased to allow a medical tube to slide axially within the helically coiled main body and when elongated the diameter of the helical turns decrease such that the main body is configured to grip the medical tube and inhibit axial movement of the tube relative to the device.
2. The device as claimed in claim I further comprising a fixation component provided at an underside surface of the foot.
3. The device as claimed in claim 2 wherein the flxation component comprises hook and loop type fasteners.
4. The device as claimed in claim 2 wherein the fixation component comprises an adhesive.
5. The device as claimed in any preceding claim wherein the main body is formed as a singularly coiled helix capable of being uncoiled by an unwinding of the helical turns.
6. The device as claimed in any preceding claim comprising a single foot extending radially outward exclusively from one of the helical turns, 7. The device as claimed in any preceding claim comprising between three to twenty complete helical turns between the first and second ends.8. The device as claimed in claim 7 comprising between five to twelve complete helical turns between the first and second ends.9. The device as claimed in any preceding claim wherein the foot is positioned at an axially endmost complete helical turn of the main body.10. The device as claimed in any preceding claim wherein the main body and the anchorage foot are formed integrally.11. The device as claimed in any preceding claim wherein the device comprises any one or a combination of the following materials: * a plastic; * a thermoplastic; * a silicone or silicone based material; * an elastomeric material; * a polyethylene; * a polypropylene; * a polyurethane; * an elastic material.12. The device as claimed in any preceding claim further comprising a coating at a surface of the main body corresponding to the surface orientated radially inward at the helical tunis.13. The device as claimed in any one of claims Ito 11 further comprising surface profiling provided at a surface of the main body corresponding to the surface that is orientated radially inward at the helical turns.14. The device as claimed in claim 13 wherein the surface profiling comprises any one of a combination of the following set of: * teeth; * ridges; * bumps; * a raised pattern.15. The device as claimed in any preceding claim further comprising a locking flange positioned and moveably mounted adjacent the main body and capable of being moved between an engagement position and a disengaged position such that in the engagement position at least a part of the flange is positioned axially between the helical turns to prevent the helical turns compressing together axially.16. A medical tube securement assembly comprising: a device as claimed in any preceding claim; and a medical tube extending internally and axially within the helical turns, the tube projecting axially beyond the first and second ends.17. The assembly as claimed in claim 16 wherein an inside diameter of the helical turns is less than an outside diameter of the medial tube.18. The assembly as claimed in claims 16 or 17 wherein the medical tube is any one of the following set of: * a fluid supply tube; * a fluid extraction tube; * a wound drain; * a urinary catheter; * an inibsion catheter.Amended claims have been filed as follows:-Claims 1. A medical tube securement device comprising: a helically coiled elongate main body having a first end and a second end, the main body extending through a plurality of helical turns around a longitudinal axis of the device between the first and second ends; an anchorage foot extending radially outward from the main body at a position between the first and second ends or substantially at one of the first and second ends; the device capable of attachment externally to a body part via the anchorage foot such that the coiled elongate main body is capable of being separated from the body part by the anchorage foot; wherein the main body is formed as a singularly coiled helix capable of being uncoiled by an unwinding of the helical turns, the main body further comprises a flexible material such that the helical turns are capable of elongation and compression axially relative to the foot such that when compressed a diameter of the helical turns is increased to allow a medical tube to slide axially within the helically coiled main body and when elongated the diameter of the helical turns decrease such that the main body is configured to grip the medical tube and inhibit axial movement of the tube relative to the device.2. The device as claimed in claim 1 further comprising a fixation component provided at an underside surface of the foot.3. The device as claimed in claim 2 wherein the fixation component comprises hook and loop type fasteners.4. The device as claimed in claim 2 wherein the fixation component comprises an adhesive.5. The device as claimed in any preceding claim comprising a single anchorage foot extending radially outward exclusively from one of the helical turns.6. The device as claimed in any preceding claim comprising between three to twenty complete helical turns between the first and second ends.
7. The device as claimed in claim 6 comprising between five to twelve complete helical turns between the first and second ends.
8. The device as claimed in any preceding claim wherein the foot is positioned at an axially endmost complete helical turn of the main body.
9. The device as claimed in any preceding claim wherein the main body and the anchorage foot are formed integrally.
10. The device as claimed in any preceding claim wherein the device comprises any one or a combination of the following materials: * a plastic; * a thermoplastic; * a silicone or silicone based material; * an elastomeric material; * a polyethylene; * a polypropylene; * a polyurethane; * an elastic material.
11. The device as claimed in any preceding claim further comprising a coating at a surface of the main body corresponding to the surface orientated radially inward at the helicai turns.
12. The device as claimed in any one of claims 1 to 10 further comprising surface profiling provided at a surface of the main body corresponding to the surface that is orientated radially inward at the helical turns.
13. The device as claimed in claim 12 wherein the surface profiling comprises any one of a combination of the following set of: * teeth; * ridges; * bumps; * a raised pattern.
14. The device as claimed in any preceding claim further comprising a locking flange positioned and moveably mounted adjacent the main body and capable of being moved between an engagement position and a disengaged position such that in the engagement position at least a part of the flange is positioned axially between the helical turns to prevent the helical turns compressing together axially.
15. A medical tube securement assembly comprising: a device as claimed in any preceding claim; and a medical tube extending internally and axially within the helical turns, the tube projecting axially beyond the first and second ends.
16. The assembly as claimed in claim 15 wherein an inside diameter of the helical turns is less than an outside diameter of the medial tube.

17, The assembly as claimed in claims 15 or 16 wherein the medical tube is any one of the following set of: * a fluid supply tube; * a fluid extraction tube; * a wound drain; * a urinary catheter; * an inifision catheter.