WO2012109981A1

WO2012109981A1 - Restraint device

Info

Publication number: WO2012109981A1
Application number: PCT/CN2012/071126
Authority: WO
Inventors: Chung-Hung MA; Sim-Heung YEUNG; Dik-Lam CHEONG; Suet-Kam WONG; Yuet-Sheung YUE; Wai-Yuen KAN
Original assignee: Hospital Authority
Priority date: 2011-02-14
Filing date: 2012-02-14
Publication date: 2012-08-23
Also published as: GB201105856D0; HK1154171A2

Abstract

A restraint device (10, 100, 200, 300) for restraining or limiting movement of the limb of a subject, comprises: an adjustable cuff member (12, 112, 210, 310) having a first end portion (12a, 112a), a second end portion (12b, 112b) and a length greater than the circumference of the limb of the subject to be restrained, said cuff member (12, 112, 210, 310) being flexible so as to allow the cuff member(12, 112, 210, 310) to be wrapped around the limb of the subject such that the first end portion (12a, 112a) extends over the second end portion (12b, 112b) and to form a band having a requisite circumference and a requisite shape around the limb of the subject; a first fixation member for providing initial fixation of the first end portion (12a, 112a) and the second end portion (12b, 112b) relative to each other and initially maintaining the cuff member (12, 112, 210, 310) around the limb of the subject at said requisite circumference and requisite shape; a second fixation member for securing the cuff member (12, 112, 210, 310) at said requisite circumference around said limb, wherein said second fixation member prevents relative movement of the first and second end portion so as to prevent increasing in the requisite circumference and loosening of the cuff member (12, 112, 210, 310) in use; and a fixation member (18, 118) for securing the restrain device (10, 100, 200, 300) to an immovable object; wherein the cuff member (12, 112, 210, 310) is sized and formed from a material so as to oppose constriction on the limb of the subject and oppose alternation in said requisite shape upon securement by the second fixation member.

Description

RESTRAINT DEVICE

FIELD OF THE INVENTION

The present invention relates to a restraint device and, more particularly, to a wrist and ankle restraint device for restraint of a subject. BACKGROUND OF THE INVENTION

Restraint of patients is required for patients who are confused, who are prone to fall, self-harm or harm to others. Such patients may be restrained in a number of ways including drugs and physically by way of restraint devices.

Restraint devices typically comprise a wrist or ankle restraint band which is secured to a patient, and securement member for securing the device and hence the patient to an immovable object, such as a chair, bed, wheel chair or the like.

Devices of the prior art include typical cloth members which may be tied about the extremity of a patient, by way of a knot. Other devices include looped members with wrist or ankle engagement portions which require tying to the patient, buckle-type restraints including a buckle member having apertures at p re-determined spacings requiring a pin member to be placed through the apertures upon a suitable diameter or circumference of the device being determined by a wrapping device around the limb of the patient.

Other devices of the prior art include an adjustable wrist or ankle band member which is first wrapped around the ankle or wrist of a patient and initially secured by way of a hook and loop member, for example, Velcro® and subsequently secured by way of an adjustable buckle and strap member, the bucket member being either a self-locking buckle which locks upon tensioning of the strap or a detachably engageable buckle member again, which is tensioned by way of a strap being looped through the buckle.

Problems and disadvantages of such devices include the necessity of a first carer to immobilize the patient whilst two further carers are required to suitably engage the band member about the wrist or ankle of a patient and secure the band member at a suitable diameter or circumference, followed by securing the device by either a pin through an aperture, or a buckle type member as described above, such a secondary fixation preventing a subject from loosening the band member from the subjects wrist or ankle. The securement member is then attached to the immovable object as described above.

Disadvantages include tightening of the band member about the wrist or ankle of the patient about the patient struggling, which may cause discomfort, bruising, lack of blood circulation, ultimately resulting in harm to the patient. Furthermore, the necessity of three carers to restrain a patient is a significant human resource burden upon a care institution or hospital, or in a private home.

Furthermore, such devices require all three carers to ultimately secure the attachment member to the immovable object, as the length of the attachment member required varies depending upon the anatomical dimensions of the patient and the required immobilization for the patient. Typically, such attachment members consist of strap members extending from the cuff member which are tied of about the immovable object accordingly.

The above disadvantages, in particular, trauma to a patient during securement of the cuff member to the ankle or the wrist of the patient can cause serious discomfort as well as permanent trauma, including dislocation, bruising, a dimmer, skin allergy and abrasion, as well as psychological trauma whilst the subject is undergoing restraint by the carers, as well as subsequently whilst the subject is restrained. OBJECT OF THE INVENTION

Accordingly, it is an object of the present invention to provide a restraint device which substantially ameliorates at least some of the disadvantages as exhibited by those of the prior art.

SUMMARY OF THE INVENTION In a first aspect, the present invention provides a restraint device for restraining or limiting movement of the limb of a subject, the restraint device comprising: an adjustable cuff member having a first end portion, a second end portion and a length greater than the circumference of the limb of the subject to be restrained, said cuff member being flexible so as to allow the cuff member to be wrapped around the limb of the subject such that the first end portion extends over the second end portion and form a band having a requisite circumference and a requisite shape around the limb of the subject; a first fixation member for providing initial fixation of the first portion and the second end portion relative to each other and initially maintain the cuff member around the limb of the subject at said requisite circumference and requisite shape; a second fixation member for securing the cuff member at said requisite circumference around said limb, wherein said second fixation prevents relative movement of the first and second end portions to prevent increase in the requisite circumference and loosening of the cuff member in use; and a fixation member for securing the restrain device to an immovable object; the cuff member is sized and formed from a material so as to oppose constriction on the limb of the subject and oppose alternation in said requisite shape upon securement by the second fixation member.

Preferably, the member provides a preload to urge said first and second end portions in a direction relative to each other, and the cuff member is sized and formed from a material so as to oppose constriction on the limb of the subject and oppose alternation in said requisite shape upon said preload being induced by the second fixation member.

In a preferred embodiment, the reduction in said requisite circumference of the cuff member by movement of the first and second end portions of the cuff member from said preload provided by the second fixation member is opposed by the first fixation member.

More preferably, increase in said requisite circumference is opposed by said first fixation member. More preferably, increase in said requisite circumference is opposed by said second fixation member.

More preferably, the cuff member is sized and formed from said material so as to oppose alteration in said requisite shape of the cuff member upon a load being applied radially outwardly to the cuff member by the limb of the subject in use. The cuff member includes a fabric material, and more preferably a the cuff member is a composite fabric construct. The construct may comprise three layers, an upper layer comprised of knitted polyester, a middle layer comprised as a double layer of polyester spacer, and a third layer comprising knitted cotton. The upper layer is preferably a knitted polyester has a weight in the range of from 50g/m2 to 150g/m2, the middle layer is comprised of a two or more polyester spacer layers each having a thickness in the range of from 1 mm to 3.5mm and a weight in the range of from 200g/m2 to 500g/m2, and the lower layer is a knitted cotton having a weight in the range of from 150g/m2 to 250g/m2. More preferably, the cuff member has a length in the range of from 170mm to

500mm, and a width in the range of from 50mm to 150mm.

Preferably, the cuff member has a length in the range of from 250mm to 400mm, and a width in the range of from 75mm to 125mm.

The first fixation member preferably includes a first and a second complimentary engage portion, said first and second complimentary engagement portions being located at opposed surfaces and opposed ends of the cuff member, and provide adjustable initial fixation so at allow varying requisite circumferences of the cuff member to be provided.

Preferably, the first fixation device is provided in the form of complimentary loop and hook engagement means, such as Velcro® or the like.

The second fixation member preferably includes a first and second complimentary engagement portion, said first and second complimentary engagement portions being located at the same surface and towards opposed ends of the cuff member, and provide adjustable fixation so as to allow varying requisite circumferences of the cuff member to be provided.

Preferably, the first and second complimentary engagement portions are provided as a "snap lock" device, said snap lock device provided locking engagement upon the first and second complimentary engagement portions being urged towards each other, and requiring an external force to release engagement between the first and second complimentary engagement portions. The second fixation member preferably provides adjustable fixation by way of a user operable strap, wherein upon urging of the strap away from the cuff member said preload is induced, and wherein said preload is user operable releasable.

Preferably, the distal end portion of user operable strap and the cuff member have complementary engagement means such that upon fixation of the restrain device to a subject, the user operable strap extends over the second fixation member and is secured to the cuff member. The complementary engagement means is a hook and loop configuration or the like

The fixation member preferably includes an adjustable portion including a user operable strap, wherein upon urging of the strap away from the cuff member the engagement member is shortened in length so as to urge the cuff member towards an immovable object, and wherein the engagement member is user operably releasable. Preferably, complementary engagement means is provided so as to provide for separation and release of the cuff member from the immovable object. The fixation member preferably includes a distal loop configuration, said distal loop configuration providing looped fixation to the immovable object.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the present invention will be explained in further detail below by way of examples and with reference to the accompanying drawings, in which:-

Fig. 1a shows a top view of a schematic representation of the restraint device according to the present invention;

Fig. 1 b shows a bottom view of the restraint device as depicted in Fig. 1 a;

Fig. 1c shows a side view of the restraint device as depicted in Fig. 1 a and Fig. 1 b;

Fig. 2a shows a schematic representation of the device as depicted in Figs. 1 a-1 c in an "in use" configuration;

Fig. 2b shows a top view of the device as depicted "in use" in Fig. 2a;

Fig. 3a shows a top view of an exemplary embodiment of a restraint device according to the present invention; Fig. 3b shows a bottom view of the restraint device as depicted in Fig. 3a;

Fig. 3c shows a perspective view of the restraint device as depicted in Fig. 3a and Fig. 3b partially secured in an "in use" configuration;

Fig. 3d shows the restraint device of Fig. 3c in a further progressive "in use" during fixation;

Fig. 3e shows yet a further perspective view of the restrain device of Fig. 3c and 3d "in use" during fixation;

Fig. 3f shows a further progressive perspective view of the device as depicted in Fig. 3c-3e "in use" progressively during fixation; Fig. 3g depicts the device of Figs. 3a-3f in an "in use" and fixated arrangement;

Fig. 3h shows a referential view of the device as depicted in Figs. 3a-3g, whereby the device is engaged with the limb of a subject;

Fig. 3i shows a referential view of the device as depicted in Figs. 3a-3g, whereby the device is engaged with an immovable object;

Fig. 4a shows a referential view of the device as depicted in Figs. 3a-3g, whereby the device is engaged with the limb of a subject;

Fig. 4b shows a referential view of the device as depicted in Figs. 3a-3g, whereby the device is engaged with the limb of a subject; Fig. 5 shows an enlarged view of a portion of the cuff member of the device as depicted in Figs. 3a-3g;

Fig. 6a shows a further an exemplary embodiment of a restraint device according to the present invention;

Fig. 6b shows the further an exemplary embodiment of Fig 6a in a further configuration; and

Fig. 7 shows a cross-sectional schematic representation an embodiment of a cuff member of a restrain device according to the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring to Figs. 1a-1 c, and Figs. 2a and 2b, there is depicted a schematic representation of a restraint device 10 according to the present invention for illustrative purposes. Figs. 1a-1 c depict the restraint device 10 in a non-use configuration, and Fig. 2a and Fig. 2b depict the restraint device in an "in use" configuration.

The restraint device 10 includes an adjustable cuff member 12 having a first end portion 12a and a second end portion 12b. The cuff member 12, depicted as being of a general elongate shape, has a length greater than the circumference of a limb of a subject to which the restraint device 10 is to be applied, so that upon the cuff member 12 being wrapped about the limb of a subject, the first end portion 12a extends over the second end portion 12b so as to form a band having a requisite circumference and a requisite shape around the limb of the subject. The cuff member 12 is formed from suitable materials and is suitably sized so as to be flexible such that in use, the cuff member may be readily wrapped around the limb of the subject.

A first fixation member is provided, which comprises complimentary engagement portions 14a and 14b, the complimentary engagement portions 14a, 14b being positioned such that upon the cuff member being wrapped about the limb of the subject at a requisite circumference, that is a suitable level of looseness of the restraint device about the limb of the subject, initial fixation is provided at a suitable position. The engagement portions 14a, 14b of the first fixation member provides initial fixation, so as to maintain the cuff at the requisite circumference during application and fixation of the device of the subject.

A second fixation member is provided, comprising complimentary second fixation portions 16a, 16b which secure the cuff member 10 at the requisite circumference around the limb of the subject. Furthermore, the second engagement portions 16a, 16b are adapted so as to be urged towards each other so as to provide a preload to the first and second end portions 12a, 12b of the cuff member 12 in a direction relative to each other so as to prevent increase in the requisite circumference and hence loosening of the cuff member 12b in use, by force exerted by the subject.

When the second engagement portions 16a, 16b of the second fixation member are urged towards each other, resistance to decrease in the requisite circumference of the cuff member 12 is provided by the first fixation engagement portions 14a, 14b, which prevent the first end portion 12a and the second end portion 12b of the cuff member moving relative to each other upon application of the preload as exerted during application of the second fixation member.

The cuff member 12 is provided, and is suitably sized and formed from appropriate materials such that upon wrapping around the limb of the subject, the "in use" shape of the cuff member 12 is of a general circular configuration. Furthermore, the cuff member 12 is provided with suitable flexural and compressive resistance, such that upon urging of the second engagement portions 16a and 16b together, the cuff member substantially resists excessive deformation and compression, such that the requisite general shape of the cuff member as provided as a band around the limb of the subject is not altered, and the limb of the subject does not undergo compression by the cuff member 12 when the preload as provided by the second fixation member is exerted across the end portions 12a, 12b of the cuff member 12.

Those skilled in the art will appreciate that suitable structure, shape, geometry and materials may be selected so as to allow the cuff member to be readily wrapped around the limb of the subject during application to the subject, whilst also providing resistance to excessive deformation upon application of the preload by the second fixation member.

Furthermore, those skilled in the art will appreciate that by maintaining the requisite general shape and circumference of the cuff in use during tightening or preloading and subsequently during restraint, reduces trauma to the subject, including reduction in likelihood of muscular or ligament trauma, reduction in likelihood of fracture of extremities of limbs, reduction in likelihood of vascular trauma, bruising and loss of circulation due to deformation during application of the device to a subject.

Furthermore, the structural and material properties of the cuff member 12, by maintaining the requisite circumference and suitable clearance between the limb of the subject and the inner surface of the cuff member, upon the subject restraining upon the restraint device 10, reduces the likelihood of self-inflicted trauma due to struggling and pressure of the cuff member on the limb of the subject.

In order for the restraint device 10 to restrain the limb of the subject, the restraint device 10 further comprises a fixation member 18 which allows the restraint device 10 to be secured to an immovable object during restraint, such as a chair, a wheel chair, a bed frame or the like.

Referring to Figs. 3a-3i, there is depicted a preferred embodiment of a restraint device 100 according to the present invention. Similarly as described in relation to Fig. 1a-1 c and Fig. 2a, Fig. 3a & 3b, the restraint device 100 comprises an adjustable cuff member 1 12, having a first end portion 112a and a second end portion 112b. In use, as shown in Fig. 3c, the cuff member 1 12 is wrapped back upon itself such that the first end portion 112a overlaps the second end portion 112b, such that the cuff member 112 forms a band of a general circular geometry. As depicted in Fig. 3c-3h, the cuff member 1 12 forms a general circular geometric shape when wrapped back upon itself, and is relatively self-supporting and flexurally resilient so as to be maintained in this general circular arrangement regardless of whether the limb of a patient is within the band formed by the cuff.

Referring to Fig. 3c, the first end portion 1 12a is overlapped the second end portion 1 12b of the cuff member 112 and the cuff member is maintained at a requisite circumference, the requisite circumference being that as required to be suitably placed around the limb of a subject so as to provide sufficient space between the limb and the inner surface of the cuff member 1 12, in a manner as described above. As is shown, complimentary portions 1 14a and 114b of a first fixation member provide initial fixation and secure the first end portion 1 12a and the second end portion 112b of the cuff member 112 at the requisite circumference when the article is wrapped around the limb of a subject. It should be noted that although a limb is not depicted in Figs. 3c-3h, prior to the cuff member 112 being wrapped into the circular configuration, the limb shall be used against the opened cuff member 1 12 and wrapped therein accordingly.

In the present embodiment, the complimentary engagement portions 1 14a, 1 14b are provided as a complimentary hook and loop fixation device, such as Velcro® registered or the like. Such a fixation member allows readily for adjustable initial fixation of the cuff member 1 12 at various points so as to give a requisite circumference suitable for wrapping of the limb of the subject. Furthermore, a first fixation member such as a loop and hook complimentary engagement means allows for rapid fixation as well as rapid release, as well as ease of fixation and ease of release, which is appropriate and advantageous in the whole environment. Referring to Fig. 3e-3g, the second fixation member which comprises complimentary engagement portions 116a and 116b, allows the cuff member 1 12 to be tensioned in a circumferential direction, by a user pulling on the self-locking strap 1 16c which is looped through the second engagement portion 1 16b of the second fixation member in a manner such that upon circumferential opposite tension or movement of the first end portion 1 12a and the second end portion 1 12b of the cuff member 112 so as to increase the circumference and loosen the device, movement is opposed.

Upon the complimentary first and second engagement portions, 1 16a and 1 16b, of the second engagement member being engaged with each other, drawing upon by a user of the strap 1 16c away from the second fixation member urges the complimentary engagement portions 116a, 116b in a direction away from each other and the end portions 1 12a, 1 12 of the cuff member in a direction so as to tighten the band formation of the cuff member 112 accordingly. However, reduction in the requisite circumference for the patient of the cuff member 1 12 is prevented, as the first fixation member provides sufficient fixation such that the preload provided by the second fixation member is opposed, and reduction in the requisite circumference is substantially prevented.

Furthermore, the cuff member 112 is provided with structural and material properties such that upon tightening and tensioning of the strap 1 16, the preload provided by the second fixation member is prevented from substantially altering the shape of the cuff member 1 12, thus preventing tightening of the cuff member around the limb of the subject during secondary fixation of the cuff member 1 12 by the second fixation member 116a, 1 16b. In the present embodiment, the second fixation member is provided by a "clip lock" complimentary engagement means, such means providing the due function of being readily engageable and disengageable by way of biased portions which may be depressed by a user so as to allow immediate release with little effort yet resisted substantial loads in the disengagement direction. Thus, such a device readily sustained the requisite demands of circumferential forces induced across the second fixation member due to the first end portion 1 12a and the second end portion 1 12b being urged away from each other as a result of force induced to the cuff member 1 12 by a subject when effort against the restraint device 100 is applied by the subject. Such a second fixation member must secure the cuff 1 12 to the subject in a manner such that the subject, upon struggling, cannot overcome the interlock force between the first and second portions 116a, 1 16b of the first fixation member.

Furthermore and advantageously, such a second fixation member as depicted in the second embodiment requires a degree dexterity and forces applied to two sides of the member, thus reduces the likelihood of impact of an object on one side of the fixation member disengaging the first portion 116a from the second portion 116b, thus providing suitable security and preventing unwanted release of the device, which could result in harm to the patient and also to others. Such biased fixation members have been shown typically in the art to withstand significant axial strengths, thus providing suitable fixation of the cuff about the limb of a subject.

Referring to Fig. 3i, a referential view of the restraint device 100, when wrapped about the wrist of a subject, in the arrangement and procedure as shown and described in reference to Fig. 3c-3g is provided, which shows the general shape of the cuff member 1 12 being maintained whilst wrapped around the wrist of the subject.

Referring to Fig 3a-3i, the restraint device 100, includes a fixation member 1 18 for securing the device to an immovable object, such as a chair, wheel chair, bed or the like. During restraint of a subject, a subject often may resist application of the device, and rapid restraint of the patient, including application of the cuff member as well as fixation to the immovable object is required. Discussion above in reference to Figs. 1 and 2 is equally applicable in this matter.

In the present exemplary embodiment, the fixation member 1 18 includes a detachable engagement device having complimentary engageable portions, 1 18a as shown in Fig. 3g, 3h and 3i. The fixation member further comprises a loop portion 1 18c.

Referring to Figs. 4a and 4b, there is depicted the loop portion 118c whereby the loop portion is wrapped over a member of the immovable object and looped upon itself, then the complimentary engagement means 1 18a and 118b interlock with each other. A further strap portion 118d, similarly as described with reference to the second fixation member above, allows for rapid adjustment so as to provide a suitable length and securement of restraint to the subject. Referring to Fig. 5, a portion of the cuff member of the present exemplary embodiment is shown, showing the materials from which the cuff member is formed. The cuff member according invention, must exhibit at least the following properties:-

(i) sufficiently flexible so as to be wrapped around the limb of a subject during initial fixation by the first fixation member;

(ii) sufficiently flexurally resilient and axially resilient such that when in the wrapped configuration and upon preload being provided by the second fixation member, the general circular geometric shape of the cuff member is importantly not deformed; (iii) resists deformation and thus reduces the likelihood of trauma to the subject whilst the cuff member is being fitted to the subject at the requisite circumference, which typically allows the insertion of one or two fingers between the cuff and the limb of the subject. Furthermore, as well as reducing the likelihood or instance of trauma during application, by maintaining the general geometry and requisite circumference of the cuff member, during subsequent restraint and used by the patient, the incidents or likelihood of trauma due to compression and tightening, such as limb fracture, skin irritation, vascular disruption, is substantially reduced.

In the present embodiment, the cuff member is formed from the above materials and sizes, which provides the requisite functions of (i), (ii) and (iii) as described above, in accordance with the present invention. In addition to providing the structural and functional requirements of the present invention, the cuff member of the present invention provides a cuff which may be appropriately sized to the body configuration of the subject, provide an enhanced comfort and safety, is non-irritating to the skin of a patient, is readily washable upon being required for cleaning Referring to Figs 6a and 6b, there is depicted a further embodiment of a restraint device 200 according to the present invention. The restraint device as depicted in the present embodiment is similar in the manner which it operates as depicted and described in reference to the restraint device of Figs 3a - 3i.

In addition, the present embodiment includes a further fixation device 218a, 218b, which comprise complimentary hook and loop type engagement mechanisms such that when the cuff member 210 has been formed in the "in-use" loop formation as depicted in Fig 6b, the complimentary engagement means 218a and 218b may be moved towards each other such that the second fixation member 216a, 216b is covered by the strap portion 218, which provides further securement of the restraint device 200 so as to reduce the likelihood of the section fixation member 216a, 216b, being inadvertently unfastened or tampered with by a subject.

Referring to Fig 7, there is shown a schematic cross-sectional representation of a cuff member 310 of an embodiment of the restraint device 300 according to the present invention. As discussed in reference to previous embodiments, the cuff member is suitably constructed and formed from suitable materials so as to provide rigidity and resist compression during application and use of the device 300.

The cuff member 310 is formed from a top layer 312, a middle layer 314 and a bottom layer 316.

Examples of certain materials, geometry and sizing for a cuff member 310 is as follows:

312 Top Layer - 100% knitted polyester,

Weight 110g/m2

314 Middle layer - Double layer

100% polyester spacer,

Thick 2.5 mm / per layer

100% polyester spacer,

weight 350g/m2/layer

316 Bottom Layer - 100% knitted cotton

Weight 190g/m2

However, as will be appreciated by those skilled in the art, numerous and alternate materials, sizes and geometries exist, which alone or in conjunction, provide the requisite functionality as required, without departing from the scope of the invention as described and as claimed.

As will be appreciated by those skilled in the art, other or alternate material sand configuration of the cuff member, as well as the first and second fixation members, without departing from the scope of the invention and the functional requirements thereof. While the present invention has been explained by reference to the examples or preferred embodiments described above, it will be appreciated that those are examples to assist understanding of the present invention and are not meant to be restrictive. Variations or modifications which are obvious or trivial to persons skilled in the art, as well as improvements made thereon, should be considered as equivalents of this invention.

Furthermore, while the present invention has been explained by reference to a preferred embodiment and for restraint of a human subject in general, it should be appreciated that the invention can apply, whether with or without modification, to other or alternate embodiments, without loss of generality.

Claims

1. A restraint device for restraining or limiting movement of the limb of a subject, the restraint device comprising: an adjustable cuff member having a first end portion, a second end portion and a length greater than the circumference of the limb of the subject to be restrained, said cuff member being flexible so as to allow the cuff member to be wrapped around the limb of the subject such that the first end portion extends over the second end portion and form a band having a requisite circumference and a requisite shape around the limb of the subject; a first fixation member for providing initial fixation of the first portion and the second end portion relative to each other and initially maintain the cuff member around the limb of the subject at said requisite circumference and requisite shape; a second fixation member for securing the cuff member at said requisite circumference around said limb, wherein said second fixation prevents relative movement of the first and second end portions so as to prevent increase in the requisite circumference and loosening of the cuff member in use; and a fixation member for securing the restrain device to an immovable object; wherein the cuff member is sized and formed from a material so as to oppose constriction on the limb of the subject and oppose alternation in said requisite shape upon securement by the second fixation member.

2. A restrain device according to claim 1 , wherein member provides a preload to urge said first and second end portions in a direction relative to each other, and the cuff member is sized and formed from a material so as to oppose constriction on the limb of the subject and oppose alternation in said requisite shape upon said preload being induced by the second fixation member.

3. A restrain device according to claim 1 or claim 2, wherein reduction in said requisite circumference of the cuff member by movement of the first and second end portions of the cuff member from said preload provided by the second fixation member is opposed by the first fixation member.

4. A restrain device according to claim 1 , wherein increase in said requisite circumference is opposed by said first fixation member.

5. A restrain device according to claim 1 , wherein increase in said requisite circumference is opposed by said second fixation member.

6. A restrain device according to claim 1 , wherein the cuff member is sized and formed from said material so as to oppose alteration in said requisite shape of the cuff member upon a load being applied radially outwardly to the cuff member by the limb of the subject in use.

7. A restraint device according to any one of the preceding claims , wherein said requisite shape of the cuff member is of a general circular shape.

8. A restraint device according to any one of the preceding claims, wherein the cuff member includes a fabric material.

9. A restraint device according to claim 8, wherein the cuff member is a composite fabric construct.

10. A restraint device according to claim 9, wherein the construct comprises three layers, an upper layer comprised of knitted polyester, a middle layer comprised a polyester spacer, and a lower layer comprising knitted cotton.

1 1. A restraint device according to claim 10, wherein the upper layer is a knitted polyester has a weight in the range of from 50g/m² to 150g/m², the middle layer is comprised of a two or more polyester spacer layers each having a thickness in the range of from 1 mm to 3.5mm and a weight in the range of from 200g/m² to 500g/m², and the lower layer is a knitted cotton having a weight in the range of from 150g/m² to 250g/m².

12. A restraint device according to any one of the preceding claims, wherein the cuff member has a length in the range of from 170mm to 500mm, and a width in the range of from 50mm to 150mm.

13. A restraint device according to claim 12, wherein the cuff member has a length in the range of from 250mm to 400mm, and a width in the range of from 75mm to 125mm.

14. A restrain device according to any one of the preceding claims, wherein the first fixation member includes a first and a second complimentary engage portion, said first and second complimentary engagement portions being located at opposed surfaces and opposed ends of the cuff member, and provide adjustable initial fixation so at allow varying requisite circumferences of the cuff member to be provided.

15. A restraint device according to claim 14, wherein the first fixation device is provided in the form of complimentary loop and hook engagement means.

16. A restraint device according to claim 15, wherein the complimentary loop and hook engagement means is Velcro.

17. A restraint device according to any one of the preceding claims, wherein the second fixation device includes a first and second complimentary engagement portion, said first and second complimentary engagement portions being located at the same surface and towards opposed ends of the cuff member, and provide adjustable fixation so as to allow varying requisite circumferences of the cuff member to be provided.

18. A restraint device according to claim 17, wherein the first and second complimentary engagement portions are provided as a "snap lock" device, said snap lock device provided locking engagement upon the first and second complimentary engagement portions being urged towards each other, and requiring an external force to release engagement between the first and second complimentary engagement portions.

19. A restraint device according claim 17 or claim 18, wherein the second fixation member provides adjustable fixation by way of a user operable strap, wherein upon urging of the strap away from the cuff member said preload is induced, and wherein said preload is user operable releasable.

20. A restraint device according to claim 19, wherein the distal end portion of user operable strap and the cuff member have complementary engagement means such that upon fixation of the restrain device to a subject, the user operable strap extends over the second fixation member and is secured to the cuff member.

21. A restraint device according to claim 20, wherein the complementary engagement means is a hook and loop configuration.

22. A restraint device according to any one of the preceding claims, wherein said fixation member includes an adjustable portion including a user operable strap, wherein upon urging of the strap away from the cuff member the engagement member is shortened in length so as to urge the cuff member towards an immovable object, and wherein the engagement member is user operably releasable.

23. A restraint device according to claim 22, further including complementary engagement means so as to provide for separation and release of the cuff member from the immovable object.

24. A restraint device according to claim 22 or claim 23, wherein the

engagement member includes a distal loop configuration, said distal loop configuration providing looped fixation to the immovable object.