WO2020248019A1

WO2020248019A1 - A device for supplying a tensioning force, an assembly and method for the same

Info

Publication number: WO2020248019A1
Application number: PCT/AU2020/050595
Authority: WO
Inventors: Jason FAIRCLOUGH
Original assignee: Kangaroo Medtek Pty Ltd
Priority date: 2019-06-13
Filing date: 2020-06-12
Publication date: 2020-12-17

Abstract

A device comprising an attachment portion with a first face and a second face. The first face includes at least one adhesive area arranged to retain a patient's digit, and a fastening portion provided to the attachment portion. The fastening portion is arranged to supply a tensioning force to tension the patient's digit.

Description

A device for supplying a tensioning force, an assembly and method for the same

Related Applications

[001] This Application claims priority from Australian Provisional Patent Application No. 2019902065, the entire contents of which are incorporated herein by reference.

Technical Field

[002] The present invention generally relates to a device, assembly and method for supplying a tensioning force, and more particularly to a device, assembly and method for supplying a tensioning force to a patient's digit, limb or joint.

Background

[003] The performance of surgical operations and the process of recovery from hand and wrist injuries presents numerous challenges to clinicians due to the complex and delicate structure of such areas. Likewise, many of these challenges also apply to surgical operations on feet and the process of recovery from foot injuries. One such challenge is the control of, and positioning of, the various digits of a patient's hand or foot during surgical operations and/or post-operation procedures.

[004] Current solutions use an extension sleeve device to retain the fingers of a patient, where an extension sleeve, also known as a finger trap device, is a self-tightening cylindrical tube of a helically wound or braided threads of nylon or similar such materials. Initially, the diameter of the tube is sized to be smaller than the diameter of the patient's finger so that when the finger is inserted inside the tube, the braids of the tube are compressed and the diameter of the tube increases. Once the patient's finger is inserted inside the extension sleeve device, attempting to withdraw the patient's finger from the tube pulls at the braids which tightens the tube around the patient's finger. Once the patient's finger is retained by the tube, the extension sleeve may be hung from a stand. Alternatively, the extension sleeve may be positioned or tensioned in certain ways to articulate the patient's finger into a specific position. However, this solution relies the diameter of the tube being just slightly smaller than the diameter of the patient's finger.

[005] It is common for the extension sleeve to be produced in a very limited number of sizes, and is often used with a "one size fits all" approach. This situation proves very problematic for the treatment of people with smaller or larger than average finger dimensions, for example children. Further, each person's finger dimensions vary with each finger, so that use of the extension sleeve does not enable to same tight grip on all of the patient's fingers. This commonly results in a patient's fingers falling out of the extension sleeve during surgery or therapy, which as would be appreciated, could potentially result in further injury to the patient.

[006] The preferred embodiments of the present invention seek to address one or more of these disadvantages.

[007] The reference in this specification to any prior publication (or information derived from the prior publication), or to any matter which is known, is not, and should not be taken as an acknowledgment or admission or any form of suggestion that the prior publication (or information derived from the prior publication) or known matter forms part of the common general knowledge in the field of endeavour to which this specification relates.

Summary

[008] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.

[009] In a first aspect embodiment, there is a device comprising an attachment portion with a first face and a second face, the first face including at least one adhesive area arranged to retain a patient's digit, a fastening portion provided to the attachment portion, said fastening portion being arranged to supply a tensioning force to tension the patient's digit.

[010] In other particular, but non-limiting, forms there is provided an embodiment where the device further includes an elastically deformable connector that connects the fastening portion to a supply of tension. [Oi l] According to yet further optional aspects, provided by way of example only, the attachment portion includes an aperture that extends from the first face to the second face.

[012] In other particular, but non-limiting, forms there is provided an embodiment where the fastening portion includes a catch portion connected to a shank portion wherein the shank portion is arranged to pass through the aperture and the catch portion is arranged to be unable to pass through the aperture.

[013] In an embodiment, the shank portion is arranged to retain the connector.

[014] In a further embodiment, the shank portion is arranged to be loop shaped.

[015] According to yet further optional aspects, the device further includes a connector that connects the fastening portion to a supply of tension.

[016] In an embodiment, the connector includes at least one length adjustment device.

[017] In a further embodiment, the at least one length adjustment device includes a button toggle.

[018] In an embodiment, the connector includes a connector sheath that is slideable along the length of the connector.

[019] In yet another embodiment, the connector sheath is arranged to locate between the fastening portion and the at least one length adjustment device.

[020] In a further embodiment, the connector includes a locking clip.

[021] In yet another further embodiment, wherein the connector sheath is arranged to locate between the fastening portion and the locking clip.

[022] In an embodiment, the length of elastically deformable material includes a loop of elastic cord that is retained by the shank portion. [023] According to yet further optional aspects, the locking clip includes two angled slots arranged to receive and retain the loop of elastic cord.

[024] In other particular, but non-limiting, forms there is provided an embodiment where the second face is non-adhesive.

[025] In a further embodiment, the attachment portion is at least partially comprised of a flexible and hypoallergenic material.

[026] In yet another embodiment, the attachment portion is formed in a shape selected from the group comprising, rectangle, square, oval, triangle, dog bone, rounded square.

[027] In an embodiment, there is provided an assembly for use on a patient's hand in accordance with any one of the preceding claims, wherein the assembly includes at least one device arranged to be removably attached to a splint.

[028] In other particular, but non-limiting, forms there is provided an embodiment where the splint includes at least one fastener, such that the fastening portion of the at least one device is connected under tension to the at least one fastener.

[029] According to yet further optional aspects, the splint includes a semi rigid body located to support at least one finger of the patient's hand.

[030] In another embodiment, the assembly includes a pocket of a flexible material arranged to receive the body.

[031] In a second aspect, there is provided an attachment portion with a first face and a second face, the first face including at least one adhesive area, the attachment portion including an aperture which is sized and located to receive and retain a fastening portion that fastens to the attachment portion at a first end and fastens to a connector a second end.

[032] In another aspect, there is provided a method of supplying tension to a patient's digit, the method comprising the steps of; connecting the fastening portion to an attachment portion; passing a connector through a shank aperture provided to the fastening portion; adhering the attachment portion to the patient's digit, such that the fastening portion is secured to the patient's digit; connecting the connector to a supply of tension.

[033] According to yet further optional aspects, the step of adhering the attachment portion to the patient's digit further comprising adhering an adhesive first face of the attachment portion to the patient's digit.

[034] In a further embodiment, the method includes repeating each of the steps for a plurality of the patient's digits.

Brief Description of Figures

[035] Example embodiments are apparent from the following description, which is given by way of example only, of at least one non-limiting embodiment, described in connection with the accompanying figures.

[036] Figure 1 illustrates a side view of an embodiment of the present invention.

[037] Figure 2 illustrates a low perspective view of an embodiment of the present invention.

[038] Figure 3 illustrates of a top view of an embodiment of the present invention.

[039] Figure 4 illustrates a perspective view of an embodiment of the present invention.

[040] Figure 5 illustrates a low perspective view an embodiment of the present invention.

[041] Figure 6 illustrates a top view of an embodiment of the present invention.

[042] Figure 7 illustrates an embodiment of the present invention in a non-limiting example of use.

[043] Figure 8 illustrates a top view of an embodiment of the present invention.

[044] Figure 9 illustrates a top view of an embodiment of the present invention. [045] Figure 10 illustrates a side view of an embodiment of the present invention.

[046] Figure 11 illustrates a detailed view of Area B of Figure 10.

[047] Figure 12 illustrates a top view of an embodiment of the present invention.

[048] Figure 13 illustrates a top view of an embodiment of the present invention in a non limiting example of use.

[049] Figure 14 illustrates a bottom view of an embodiment of the present invention in a non-limiting example of use.

[050] Figure 15 illustrates an embodiment of the present invention in a non-limiting example of use.

[051] Figure 16 illustrates an embodiment of the present invention in a non-limiting example of use.

Detailed Description

[052] The following modes, given by way of example only, are described in order to provide a more precise understanding of one or more embodiments. In the figures, like reference numerals are used to identify like parts throughout the figures.

[053] Referring to Figures 1 to 3, an embodiment of a device 100 is provided, the device 100 comprising an attachment portion 102 with a first face 104 and a second face 106. The first face 104 and the second face 106 are on opposing sides of the attachment portion 102 relative to one another. The first face 104 and the second face 106 are arranged to enable the attachment portion 102 to attach the device 100 to the digit of a patient.

[054] In an embodiment, the faces 104 and 106 of the attachment portion 102 may be at least partially comprised of a flexible or stretchable material. Moreover, the stretchable material of the attachment portion 102 may be stretchable in along one or more axes. To control such stretchability, at least one face of the attachment portion 102 may include a portion of non-stretchable material. For example, as shown in Figure 2, a strip of flexible but non-stretchable material 103 may be provided to the first face 104 along the axis A-A to limit the elastic deformation experienced by the attachment portion 102 along axis A-A when in use. Alternatively, although not shown, an embodiment may be provided where the strip of non-stretchable material 103 may extend perpendicular to axis A-A, or may be provided to the second face 106.

[055] In an embodiment, the non-stretchable material and attachment portion 102 may be formed from the same type of material the attachment portion 102 and having a single axis of stretchability (i.e. an axis along which the material is stretchable). In such an embodiment, the non-stretchable material may be attached to the attachment portion 102 at an orientation so that the axis of stretchability of the non-stretchable material does not align with axis of stretchability of the attachment portion 102, which limits the stretchability of the attachment portion 102 where the non-stretchable material is located.

[056] Further, the stretchable material of the attachment portion 102 and/or the non- stretchable material of the non-stretchable portion may be made from a hypoallergenic material. Within the context of the specification, the term hypoallergenic is defined as meaning that something is relatively unlikely to cause an allergic reaction. Further, such materials may also be breathable, at least partially water or soil resistant and/or be capable of undergoing sterilising procedures, for example using a gamma radiation device.

[057] In an embodiment, the attachment portion 102 may be formed in a variety of shapes to suit the size, shape and of type of digit or to suit the level of tension required to be supplied to the digit. Accordingly, the attachment portion 102 may be of a shape selected from the group comprising, rectangle, square, oval, triangle, dog bone, rounded square. For example, as shown in Figure 3, the attachment portion 102 is approximately "dog bone" shaped, such that it forms a shape that may be described as having two rounded wider shaped ends extending from a narrower middle region.

[058] In an embodiment, the first face 104 may include at least one adhesive area 108, where the at least one adhesive area 108 may be arranged to cover at least a portion of the first face 104 of the attachment portion 102. Alternatively, the at least one adhesive area 108 may be arranged to cover all of the first face 104 of the attachment portion 102 or indeed may be provided to a portion of the first face 104 in a pattern or arrangement that enables more effective attachment and/or removal of the attachment portion 102 to the digit of the patient. The at least one adhesive area 108 may include an adhesive provided to an area of the first face 104. The adhesive may be a hypoallergenic adhesive, at least partially water resistant and/or be capable of undergoing sterilising procedures, for example using a gamma radiation device. Further, the at least one adhesive area 108 may be temporarily covered by one or more removable backing portions (not shown) that protect the adhesive until the device is ready to be used, at which time the backing portions are removed and the device is attached to the patient.

[059] In an embodiment, the attachment portion 102 may include one or more grip portions (not shown) where the one or more grip portions are provided to the outer edge of the attachment portion 102. For example, the one or more grip portions may be sections of the boundary or periphery of the first face 104 that do not include any adhesive areas. The one or more grip portions allow a patient or clinician to easy grab and pull the one or more grip portions to enable easy removal of the attachment portion 102 from the patient's digit. The one or more grip portions may be provided at discreet positions on the first face 104 or include a continuous section around the periphery of the first face 104 of the attachment portion 102.

[060] In one embodiment, the attachment portion 102 may include an aperture 110 that extends though the attachment portion 102. The aperture 110 may be arranged to pass through the attachment portion 102 from the first face 104 to the second face 106 and be sized, shaped and located to receive and retain a fastening portion 112. The fastening portion 112 may be connected or fastened to a second end of a connector 114. A first end of the connector 114 is connected to a device or arrangement that provides a tensioning force. In other words the fastening portion 112 and attachment portion 102 connects the patient's digit to the connector 114, which then connects the patient's digit to a tensioning force.

[061] Within the specification, the term digit is taken to mean a finger, thumb or toe. As such, the examples of the invention as described in relation to a patient's fingers and hands may also find application in use for a patient's feet. Further, the phase "supplying a tensioning force" is taken to mean that the first end of the connector 114 is subjected to a pulling force transmitted axially though the device 100.

[062] For example, the supply of the tensioning force may be supplied by one end of the device 100 being fixed and the other end of the device 100 being pulled. Alternatively, the device 100 may be fixed to a stationary structure at a relatively higher position compared to the patient the weight of the user's limb being supported by the structure and device provides a tensioning force. In such an example, the structure may be in the form of traction brace, device, rig, mechanism, or another such device capable of providing and regulating a supply of a tensioning force. An example of such a structure is shown in Figure 11, which is discussed in further detail later in the specification. In a further example, the tensioning force may be supplied by the attachment of springs or other such devices to the patient or the device to increase the tensioning force. Alternatively, the tension force may be supplied by pulling the connector 114 of the device 100 with the patient's hand being maintained in a fixed position, for example, by reducing the length of the connector 114, which may be connected to the device 100 and patient at one end and connected to a splint at the other end. An example of such an arrangement is also described in further detail later in the specification.

[063] In an embodiment, the connector 114 may comprise a length of elastically deformable material. For example, the connector 114 may include a length of elastic cord. Once the length of elastically deformable material has been passed through the fastening portion 112, then ends of the length of elastically deformable material connector 114 may be joined together to form a loop of elastically deformable material. In an embodiment, the open ends of the length of elastically deformable material may be joined by tying the ends together or by attaching them together by means of a mechanical fastener, such as but limited to a clip or toggle clip. Alternatively, chemical adhesives and the use of heat fusing the ends together may also be used to attach the ends together.

[064] Referring to Figures 4 and 5, an example of the fastening portion 112 is provided. In an embodiment, the fastening portion 112 includes a catch portion 116 connected to a shank portion 118. The catch portion 116 is shaped and sized relative to the aperture 110 so that the catch portion 116 is unable to pass through the aperture 110 when in use on a patient. For example, the catch portion 116 may be round, square, circular, domed or otherwise shaped such that the catch portion 116 cannot pass through the aperture 110. Alternatively or additionally, the catch portion 116 may be sized larger relative to the aperture 110 such that the catch portion 116 cannot pass through the aperture 110.

[065] As shown in Figures 4 and 5, the catch portion 116 may be of a smooth-edged cylinder shape with a domed recess 115 formed on a face of the catch portion 116 that is distally located relative to the shank portion 118. When attached to a patient's digit, the domed recess 115 is arranged to receive the tip of the patient's digit, and as such, improve useability and patient comfort. In an embodiment, the fastening portion 112 may be described as functioning similar to a button fastener.

[066] In an embodiment, the shank portion 118 is arranged to pass through the aperture 110 and connect to the connector 114. The shank portion 118 may include a shank aperture 117 that is arranged to receive and retain the connector 114. In an embodiment, as shown in Figure 4, the connector 114 may be formed in a loop through the shank aperture 117. The shank aperture 117 may be formed with a "key-hole" arrangement to enable easy connection and retention of the connector 114. In one example, as shown in Figure 4, the shank aperture 117 is approximately rectangular shaped and the shank portion 118 includes a channels 119 on either side that extend from the shank aperture 117 extending along the shank portion 118 in the direction moving away from the catch portion 116. When assembling the device, the connector 114 is passed through the shank aperture 117 and is received and retained by the channels 119. In another embodiment, the shank portion 118 may be formed from a loop of rigid material to enable easy attachment of the fastening portion to the connector 114.

[067] In an alternative embodiment, the connector 114 may be a single, non-looped length of elastic cord. The connector 114 may be connected to the shank 118 through an eye, which is a fixed loop formed at the end of the cord. The eye may be formed by using a clamp or ferrule 130. The ferrule 130 may be made from metal or plastic. Alternatively the other means such as heat fusing, tying, adhesive bonding, or splicing may be used as would be understood by a person skilled in the art. In such an embodiment, a connector sheath 120 (described further below) may be arranged to cover the ferrule 130 to provide support and to prevent the patient from any injuries caused by rubbing against the metal or plastic ferrule 130. [068] In a further embodiment, the connector 114 may further include a connector sheath 120 that is slideable along the length of elastically deformable material. An example of the connector sheath 120 is best shown in Figure 1. The connector sheath 120 may also be arranged to fit over the shank portion 118 such that when the connector sheath 120 is moved along the connector 114 and over the shank portion 118, the connector sheath 120 forms a tight fit over the connector 114 and the fastening portion 112, which acts to hold the arrangement together. For example, by pushing the lengths of the connector 114 into the channels 119.

[069] Moreover, in yet another embodiment, the connector 114 may also include a locking clip 122, of which an example thereof is described with reference to Figure 6. The connector sheath 120 may be arranged to locate between the fastening portion 112 and the locking clip 122. The locking clip 122 may be arranged to engage with the connector 114 at a location that maintains the connector sheath 120 and the fastening portion 112 together. For example, as shown in Figure 6 the connector 114 comprises length of elastically deformable material formed in a loop with two side lengths 126, the side lengths being retained by the shank portion 118 where they meet. The locking clip 122 may include two slots 124 that are arranged to receive the two side lengths 126 of the connector 114. The two slots 124 may be arranged to extend towards or away from each other at an angle to improve the locking function of the locking clip 122.

[070] Due to the flexible nature of the attachment portion 102, the device 100 can be adhered to the patient's digit in any way that enables a sufficiently strong adherence of the device 100 to the digit and comfort of the patient. For example, this may include wrapping the attachment portion 102 around the patient's finger. Additionally, this also allows any adhesive areas 108 to be adhered to either the finger or to the second face 106 so that the device 100 does not become unintentionally stuck to another object whilst in use.

[071] Once firmly attached to the patient's digit, the device 100 may then be used to subject the digit to a tensioning force. As can be seen in Figure 7, a tensioning force can be applied to the patient's finger by pulling on the connector 114. In the example shown, the tensioning force is applied to the finger in order to realign a malrotated finger. [072] In a further embodiment, the connector 114 may include at least one length adjustment device. The at least one length adjustment device may include fasteners, toggles, stops, locking clips (similar to locking clip 122) and other such devices. Referring to Figure 8, an example embodiment is provided, where the at least one length adjustment device may include a toggle 128, otherwise known as a cord lock. The toggle 128 may include a cord button toggle, a bean toggle, bell cord stopper or other type of cord lock. The toggle 128 enables for the length of the connector 114 to be easily adjusted. For example, as shown in Figure 1, a toggle 128 is provided to each side of the loop of connector 114, whereby, the toggle 128 is arranged to adjust the length of the connector 114. This facilitates improved control of both the position of the finger and the tensioning force provided to the finger. In an alternative embodiment, the connector 114 may be fed twice such that four threads of the connector 114 pass through the toggle 128 to form an adjustable loop on the second end (i.e. the connector 114 forms a double loop).

[073] In another embodiment, the at least one length adjustment device may include a silicone, rubber or plastic stop 132 that may be slideably positioned along the length of the connector 114. The stop 132 may be arranged to provide a tight fit with the connector 114, such that the stop 132 is in a fixed location along the connector 114. For example, the stop 132 may be positioned along the length of the connector 114 just behind the connector sheath 120 to maintain the connector sheath 120 in position. Alternatively, referring to Figure 14, the stop 132 may be positioned so that it changes the length of the connector 114 to adjust the tensioning force.

[074] Referring again to Figure 14, an embodiment may also include an end stop 134, where the end stop 134 is arranged at a fixed location at the end of the connector 114 to retain the end of the connector 114 to prevent fraying or undue wear and/or to prevent any stops 132, toggles 128 or connector sheaths 120 arranged along the length of the connector 114 to accidently slide off the connector 114.

[075] Referring now to Figures 9 to 14, embodiments are provided illustrating an assembly 136 for use on a patient's hand. The embodiments shown are provided as examples only in order to demonstrate the workings of the invention. As such, the examples provided are understood to be non-limiting. The assembly 136 may include at least one device 100 arranged to be removably attached to a splint 138. The splint 138 may include at least one fastener 140 to enable the connector 114 to be removably connected to the splint 138. The at least one fastener 140 may include a button, Velcro™ clip, snap fastener or other similar devices that enable the connector 114 to be removably connected to the splint 138.

[076] Referring to Figures 9 to 11, the splint 138 may further include a body 144. The body 144 may be formed from different layers of material to provide both structural integrity and comfort. For example, as shown in Figure 10 and 11, the body 144 may include an inner layer of a semi-rigid and plastically deformable material 137, such as aluminium, thermoplastics (such as but not limited to Polypropylene), composites including carbon fibre or other such materials. The term semi-rigid and plastically deformable is defined as meaning that the material 137 is a material that is at least semi rigid and capable of being deformed and retaining the deformed shape (for example a thin layer of aluminium). The body 144 may also include at least one outer layer of a malleable material 139 that may include foam, neoprene, fabrics, plastics, rubber or silicon.

[077] In an embodiment, the various layers may be sandwiched together by means of chemical adhesives or mechanical fasteners. Alternatively, the outer layers of malleable material 139 may also be arranged to fully encapsulate the inner layer of rigid material 137. For example, encapsulating the layer of the semi-rigid material 137 within an integral outer layer of silicon or malleable plastic. The outer layers of malleable material 139 may be formed in a generally rectangular shape (similar to the shape of the pocket 142 shown in Figure 12) that encompasses the shape of the semi-rigid material 137 shown in Figure 9 to prevent any sharp edges of the semi-rigid material 137 from harming the patient.

[078] Referring again to Figure 9, an example of the semi-rigid material 137 is provided. The semi-rigid material 137 may be formed in a generally rectangular shape with a plurality of slots and tabs provided along the periphery. That is, the arrangement of two slots 141 spaced apart from one another forms a tab 143 betwixt them. The plurality of slots and tabs 145 and 147 are arranged to enable the body 144 to be deformed to conform to the limb of a patient. For example, the semi-rigid material 137 enables the body to be bent into a half-cylindrical shape to receive a patient's forearm and wrist and the plurality of slots and tabs 145 and 147 enable for the body 144 to be bent at an angle to accommodate the relative angle between a patient's wrist and hand and their forearm, which is best shown in Figure 16.

[079] In the example shown, the semi-rigid material 137 may include a plurality of slots and tabs 145 and 147 located along the intervals of the horizontal sides of the semi-rigid material 137, the horizontal sides being those that extend parallel to axis B-B. In an embodiment, each of the plurality of slots may be the same or of varying depth (extending along an axis perpendicular to axis B-B) or width (extending along an axis parallel with axis B-B) relative to any other of the plurality of slots. Further, the plurality of slots may be located to form tabs of varying width. For example, the plurality of slots indicated at 145 are deeper than the plurality of slots indicated at 147. Further, the plurality of slots indicated at 145 are positioned so that the tabs indicated at 145 are wider than the tabs indicated at 147.

[080] Further, the semi-rigid material 137may also include one or more slots 149 and tabs 152 along one or both vertical sides of the semi-rigid material 137, the vertical sides being those that extend perpendicular to axis B-B, where the one or more slots 149 may be the same or of varying depth (extending along an axis parallel with axis B-B) or width (extending along an axis perpendicular with axis B-B) relative to any of the other one or more slots 149. The slots 149 may be arranged to receive the connector 114 and maintain the connector 114 and device 100 in alignment with the digit of the patient.

[081] In an embodiment, the plurality of slots along the horizontal sides 145 and 147 may be of greater relative width compared to the width of the one or more slots 149 along the vertical sides. Further, the one or more tabs 152 along the vertical sides may be of greater width relative to the tabs on the horizontal sides indicated at 145 and 147.

[082] Alternately, the slots 145, 147 and 149 formed along the periphery of the semi-rigid material 137 may be formed using smoother indentations instead of slots and tabs, for example forming a wave-like or bubble-like shaped peripheral area of the semi-rigid material 137 and/or malleable material 139. An example of this variation is provided in Figure 16. [083] In another embodiment, the semi-rigid material 137may include a recess 154, which may align with a patient's thumb to enable articulation of the thumb when the assembly 136 is provided to a patient's hand. Alternatively, the body 144 may include a thumb portion 133 that may be formed by the semi-rigid material 137 and/or the malleable material 139 as shown in Figure 12.

[084] In an embodiment, , the body 144 may further include tensioning apertures 156 that may be used along with one or more fasteners 140 that are receivable within said tensioning apertures 156 to aid in the attachment of the second end of the connector 114 of the device 100 in the formation of the assembly 136.

[085] In an embodiment, the splint 138 may also include a pocket of a flexible material 142 arranged to receive the body 144. The pocket 142 may be made of various fabrics, including breathable and water and soil resistant fabrics and may include various straps or Velcro™ fastener portions to attach the splint 138 to the patient's hand, such as straps 158 as shown in Figure 14. Further, at least one side of the pocket 142 may include a zipper or other such fastener to enable the body 144 (including the outer layer of malleable material 139 and the inner layer of semi-rigid material 137) to be received and retained within the pocket 142. In an alternate embodiment, the outer layer of malleable material 139 may be replaced by the pocket 142, such that the body 144 includes only the inner layer of semi rigid material 137 that is received and retained within the pocket 142. In such an embodiment, the pocket 142 is arranged to encompass any sharp edges of the semi-rigid material 137 to prevent harm to the patient.

[086] Referring to Figures 13 and 14, an example of the assembly 136 including the splint 138, including the body 144 received within a pocket of a flexible material 142, and including the device 100 in use on a patient's finger. Further, referring to Figure 16, another example of the assembly 136 including the splint 138, including the body 144 (without the pocket), and including the device 100 in use for a wrist embodiment where the assembly further includes straps 158, the straps being also shown in Figure 14, which support a patient's wrist or hand in a fixed position.

[087] In another embodiment, the body 144 may be of reduced size and modified shape to support one or more of the patient's fingers or toes (opposed to a whole hand or wrist or foot) in a particular position (not shown). Correspondingly, the pocket of a flexible material 142 may also be sized and shaped to correspond with the size and shape of the body 144 in such an embodiment.

[088] Referring again to Figure 15, there is provided a further embodiment wherein the device 100 is provided to a patient's hand. In the embodiment shown, four of the patient's fingers are connected to a tension rig 148, with each finger being retained by a device 100.

[089] In the example shown, the fastening portion 112 includes a ring, such as a keyring or split ring that may be connected to the tension rig 148. Each of the devices 100 are connected by a connective element 150 that is provided to the tension rig 148. The connective element 150 may be metallic or elastic, and the length of the connective element 150 may be variable. As such, the connective element 150 may replace the connector 114 in some embodiments. However, as would be understood by the person skilled in the art, the devices 100 may be connected in a variety of other arrangements, such as individually connecting the devices 100 to the tension rig 148 using elastic, plastic or other such materials. Various connective fixtures such as shackles, oval, D or S shaped carabiners 160, rings 162, and other such devices may also be used to connect the devices 100 to the connective element 150. The above embodiments shown are provided as examples only in order to demonstrate the workings of the invention. As such, the examples provided are understood to be non-limiting.

[090] An assembly 136 such as that described above, may find application in numerous methods of treatment, such as but not limited to treatment of a finger fracture, finger dislocation, limited finger motion, and/or a finger extensor tendon injury like mallet finger or hammer finger, as the assembly 136 would enable treatment of such an injury by maintaining the injured finger in a straight position. Further, the assembly also enables the finger to be arranged in a state of skeletal traction.

[091] In an embodiment, there is provided a method of supplying tension to a patient's digit. The method may include a step of assembling the device 100, where the clinician attaches the fastening portion 112 to the attachment portion 102 by passing the shank portion 118 of the fastening portion 112 through the aperture 110 in the attachment portion 102 until the catch portion 116 rests against the first surface 104 and is unable to further pass through the aperture 110. Then, a free end of the connector 114 is passed through the aperture 117 in the shank portion 118 and formed into a loop. The clinician may also feed the connector 114 through the connector sheath 120 and may further add at least one length adjustment device along the length of the connector 114.

[092] The method may also comprise the steps of arranging a fastening portion to axially align with the patient's digit. This may involve a clinician placing the catch 116 of the fastening portion on the tip of a patient's finger or toe.

[093] The clinician may then adhere the attachment portion to the patient's digit such that the fastening portion is secured to the patient's digit. The clinician then adheres the adhesive first face 104 of the attachment portion 102 to the patient's digit. This may involve removing any backing provided to the at least one adhesive section 108 so that the adhesive surface of the at least one adhesive section 108 may be placed against the patient's skin thereby attaching the attachment portion 102 to the patient's digit. Manual manipulation of the attachment portion 102 may be required to securely adhere the attachment potion 102 to the patient in a comfortable manner and so that the attachment portion 102 adheres evenly to the patient's digit. For example, in reference to Figure 2, the clinician may first arrange attachment portion 102 such that it is folded along an axis perpendicular to axis A-A and pressing the adhesive portions to the skin of the patient's digit. Any extraneous or overlapping portions of the at least one adhesive area 108 that is able to be connected to the patient's skin may be adhered to parts of the second face 106 in a wrapping or twisting manner.

[094] The clinician may then connect the connector 114 to a supply of tension. This may be in the form of traction brace, device, rig or mechanism, a splint or another structure or device capable of providing and regulating a supply of a tensioning force. This may include the attachment of springs or other such devices to increase the tensioning force. Alternatively, tightening or loosening the connector 114 may also provide a means to adjust the tensioning force.

[095] In an embodiment, the method may further include repeating each of the steps for a plurality of the patient's digits such that a limb of the patient is suspended. That is, the clinician may attach the device 100 to each of a patient's fingers or toes in order to suspend the patient's hand or foot, or indeed their arm or leg.

[096] Optional embodiments may also be said to broadly include the parts, elements, steps and/or features referred to or indicated herein, individually or in any combination of two or more of the parts, elements, steps and/or features, and wherein specific integers are mentioned which have known equivalents in the art to which the invention relates, such known equivalents are deemed to be incorporated herein as if individually set forth.

[097] In the foregoing description of preferred embodiments, specific terminology has been resorted to for the sake of clarity. However, the invention is not intended to be limited to the specific terms so selected, and it is to be understood that each specific term includes all technical equivalents which operate in a similar manner to accomplish a similar technical purpose. Terms such as "horizontal" and "vertical", and the like are used as words of convenience to provide reference points and are not to be construed as limiting terms.

[098] Although a preferred embodiment has been described in detail, it should be understood that modifications, changes, substitutions or alterations will be apparent to those skilled in the art without departing from the scope of the present invention.

[099] Throughout this specification and the claims which follow, unless the context requires otherwise, the word“comprise”, and variations such as“comprised”,“comprises” or“comprising”, will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps. Further, as used herein, a, an, the, at least one, and one or more are used interchangeably, and refer to one or to more than one (i.e. at least one) of the grammatical object. By way of example,“an element” means one element, at least one element, or one or more elements.

Advantages

[0100] The embodiments described herein provide a novel means of providing a tensioning force to retain the patient's digit for surgery or when undergoing treatment when the movement of the digit is restricted. [0101] The device provides a highly effective means of retaining a digit without the risk that the digit may come loose during surgery. Further, grip portions enable easy removal of the device from the digit of the patient.

[0102] Further, the device also removes the requirement to have multiple sized extension sleeves as the device is able to accommodate every possible sized finger. Further, as the devices are for a single use, they provide a more sanitary and convenient option than reusable extension sleeves.

[0103] Moreover, the device enables for a digit to be secured in a splint and under traction simultaneously. Further, the embodiments describe allow for multiple digits, a hand, a wrist or a foot of a patient's to be secured and supported under tension.

Claims

The following claims or points describe various embodiments or aspects:

1. A device comprising;

an attachment portion with a first face and a second face, the first face including at least one adhesive area arranged to retain a patient's digit,

a fastening portion provided to the attachment portion, said fastening portion being arranged to supply a tensioning force to tension the patient's digit.

2. The device in accordance with claim 1, wherein the device further includes an elastically deformable connector that connects the fastening portion to a supply of tension.

3. The device in accordance with claim 1 or 2, wherein the attachment portion includes an aperture that extends from the first face to the second face.

4. The device in accordance with claim 3, wherein the fastening portion includes a catch portion connected to a shank portion, wherein the shank portion is arranged to pass through the aperture and the catch portion is arranged to be unable to pass through the aperture.

5. The device in accordance with claim 4, wherein the shank portion is arranged to retain the connector.

6. The device in accordance with any one of claims 2 to 5, wherein the connector includes at least one length adjustment device.

7. The device in accordance with claim 6, wherein the at least one length adjustment device includes a button toggle.

8. The device in accordance with any one of claims 2 to 7, wherein the connector includes a connector sheath that is slideable along a length of the connector.

9. The device in accordance with claim 8 when dependant on claim 6, wherein the connector sheath is arranged to locate between the fastening portion and the at least one length adjustment device.

10. The device in accordance with any one of the preceding claims, wherein the second face is non-adhesive.

11. The device in accordance with any one of the preceding claims, wherein the attachment portion is at least partially comprised of a flexible and hypoallergenic material.

12. The device in accordance with any one of the preceding claims, wherein the attachment portion is formed in a shape selected from the group comprising, rectangle, square, oval, triangle, dog bone, rounded square.

13. An assembly for use on a patient's hand in accordance with any one of the preceding claims, wherein the assembly includes at least one device arranged to be removably attached to a splint.

14. The assembly in accordance with claim 13, wherein the splint includes at least one fastener, such that the fastening portion of the at least one device is connected under tension to the at least one fastener.

15. The assembly in accordance with any one of claims 13 or 14, wherein, the splint includes a semi rigid or rigid body arranged to support at least one finger of the patient's hand.

16. The assembly in accordance with claim 15, wherein the assembly includes a pocket of a flexible material arranged to receive the body.

17. A device comprising;

an attachment portion with a first face and a second face, the first face including at least one adhesive area, the attachment portion including an aperture which is sized and located to receive and retain a fastening portion that fastens to the attachment portion at a first end and fastens to a connector a second end.

18. A method of supplying tension to a patient's digit, the method comprising the steps of; connecting a fastening portion to an attachment portion;

passing a connector through a shank aperture provided to the fastening portion; adhering the attachment portion to the patient's digit, such that the fastening portion is secured to the patient's digit;

connecting the connector to a supply of tension.

19. The method in accordance with claim 18, the step of adhering the attachment portion to the patient's digit further comprising adhering an adhesive first face of the attachment portion to the patient's digit.

20. The method in accordance with any one of claims 18 or 19, the method including repeating each of the steps for a plurality of the patient's digits.