Conduit Fixation Device

Abstract

A conduit fixation device for fixing a conduit, such as a medical conduit, is disclosed. The device has a body defining a channel for receiving the conduit and two arrays of fins extending from opposite sides of the channel and oriented at an acute angle relative to a longitudinal direction along the channel. The arrays of fins are oriented in opposite directions. A conduit inserted into the channel elastically deforms at least ends of the fins, and friction between the fins and the conduit provides resistance to longitudinal movement of the conduit along the channel, i.e., "tensile resistance," in either direction.

Description

[Technical field]

[0001] The present invention relates to the field of attachment of conduits, particularly for use in clinical settings, and in particular the attachment of catheters, intravascular lines and the like, to a patient. [Background technology]

[0002] Medical treatments commonly involve injecting or withdrawing fluids from a patient by connecting fluid lines to body cavities, such as the chest, abdomen, skull, or other body lumen, such as a vein, artery, spinal cord, urethra, or intestine.

[0003] For example, intravenous (IV) lines are used to administer medications, administer or replace plasma, and rehydrate patients, while fluids may be removed through urinary or enteral catheters, and surgical drains may be placed within cavities during or after surgery to drain contents and facilitate recovery.

[0004] A patient or body part may remain relatively mobile while fluid lines are attached, and a patient may forget or be unaware of fluid lines, especially during extended treatments or upon regaining consciousness. Additionally, clinical settings may be crowded with additional fluid lines and medical equipment, and clinicians may frequently need to work in close proximity to fluid lines, electrical conduits, and the like. Thus, unplanned removal of lines from patients is a common problem that can reduce quality of care and lead to adverse clinical outcomes.

[0005] Unintentional removal of fluid lines, even for low-cost medications and fluids, can lead to wastage losses, extended treatment times, and patient discomfort. It has also been known that removed lines can leave needles or other medical implements in the patient's body that require imaging or surgical procedures to remove. Furthermore, in some settings, the consequences of unintentional line removal can be serious or even fatal, especially in emergency and surgical settings.

[0006] A number of techniques are commonly used to secure fluid or other lines and isolate the entry point from forces acting on the line.

[0007] Adhesives or tapes can be used to secure fluid lines. This technique is easily adaptable to different types or diameters of lines, but hair, sweat, or other fluids can weaken the adhesion to the patient's skin and achieve limited pulling resistance at best. These measures must be constantly renewed, and over time, the adhesive or tape can cause skin irritation. In some cases, pulling out and removing the fluid line can cause pain and injury.

[0008] Devices are also known that mechanically hold the line in a holding device to isolate the line from the entry point. In using such devices, attachment to the line is also at least to some extent independent of attachment to the patient.

[0009] For example, the urinary catheter stabilization device Statlock (Bard Medical, Crawley, UK) has an adhesive pad that is applied to the patient's skin, to which is attached a molded retainer for the catheter. The cap latches shut over the catheter to hold it in place. However, the retainer is sized to hold a catheter of a particular diameter and has limited resistance to longitudinal forces applied to a catheter held in the device.

[0010] Braidlock (Braidlock Ltd, Warrington, UK) uses a braided sheath to hold a catheter or IV line, which narrows under tension at the neck to resist longitudinal forces on the line. Braidlock can only accommodate a limited range of line diameters, and the line must be inserted or removed through the braided sheath, making it difficult to install, remove, or replace IV lines.

[0011] US Patent No. 5,399, 674 describes a medical fixation device that also accommodates only a limited range of line diameters in an open channel or groove flanked by flexible "blades". The blades are arranged at an angle to the channel to provide at least some resistance to pulling the conduit or line in one direction. The device can be used as a conduit guide to aid in the routing of the conduit in a clinical setting, but near the entry point, additional stabilization of the line is required. US Patent No. 5,399, 674 describes a device that includes two opposing rows of resilient clamping elements in a housing and a guide channel extending therebetween. The clamping elements extend perpendicular to the channel, which limits the surface area that contacts the conduit. The perpendicular orientation of the clamping elements further limits the amount of tensile resistance that can be provided to the conduit in the channel. [Prior art documents] [Patent documents]

[0012] [Patent Document 1] International Publication No. 2005 / 051472 [Patent Document 2] International Publication No. 2017 / 013114 Summary of the Invention [Problem to be solved by the invention]

[0013] Thus, a need remains to address one or more of the deficiencies found in existing fluid line retention and conduit retention in general. [Means for solving the problem]

[0014] According to one aspect of the present invention, a body defining a channel for receiving a length of conduit extending along the channel; an array of elastically deformable fins disposed along the channel extending from at least a first side of the channel and an opposite second side of the channel; each fin having an orientation extending at an acute angle relative to a longitudinal direction along the channel, and each of the fins having a common orientation relative to the longitudinal direction along the channel; A conduit fixation device is provided comprising:

[0015] The body may further comprise a retention mechanism to resist or prevent lateral movement of the conduit out of the channel.

[0016] In use, a conduit, such as an IV line, catheter, or the like, may be placed into the channel and held therein against lateral removal from the channel by the retention mechanism. The device has a particularly compact configuration and can be advantageously secured in a variety of locations with minimal interference with other equipment, patient clothing, and the like.

[0017] A conduit inserted into the channel will typically elastically deform at least the ends of the fins slightly, and friction between the fins and the conduit provides resistance to longitudinal movement of the conduit along the channel, i.e., "tensile resistance." In effect, the fixation device isolates the conduit extending distally from the fixation device from forces applied to the fixation device and the conduit extending proximally therefrom, and vice versa. The fixation device thereby reduces the risk of fracture of the entry point into the patient of the conduit or associated medical device.

[0018] The angled orientation of the fin array maintains the orientation of the fins when the conduit is inserted into the channel in use, such that the fins provide greater "pulling resistance" (resistance to longitudinal movement of the conduit relative to the fixation device) in one longitudinal direction than in the other. The fins are elastically deformable to accommodate various conduit diameters. The angled orientation of the fins further increases the contact area between the conduit and each of the elastically deformed fins, further facilitating pulling resistance.

[0019] Pull resistance is provided by engagement of the conduit with multiple fins along the length of the conduit, thus distributing forces along the conduit, which can limit the risk of the conduit becoming "stuck" (i.e., pinched or partially or completely blocked), particularly when used with flexible or compressible conduits.

[0020] It will be appreciated that in a clinical setting, forces applied to a retained conduit may have longitudinal (i.e., axial) and transverse components relative to the conduit, and the elastically deformable fins can deform to accommodate such forces in various directions while reducing the likelihood of the conduit breaking or pinching.

[0021] That is, the fins are angled relative to the longitudinal direction along the channel such that each fin defines an acute angle on one side of the fin and an obtuse angle on the other side of the longitudinal direction, where the acute angle is directed toward one or the other of the proximal or distal ends of the channel.

[0022] Each fin has a free end adjacent the channel and a fixed end further from the channel than the free end.

[0023] The orientation of the fin refers to the direction from the free end to the fixed end of the fin when the fin is in an undeformed configuration. The fin may be straight between the fixed and free ends such that the orientation between the fixed and free ends extends along the length of the fin. The fin may be as disclosed in more detail below.

[0024] It will be appreciated that in use, when a conduit is inserted into the channel, the fins will undergo some elastic deformation and the overall orientation of the fins may change, typically at a more acute angle relative to the longitudinal direction of the channel, and / or the fins may bend or deform. The degree of deformation may also change when a force is applied between the conduit fixation device and the conduit in use. For example, a curvature may be introduced into at least a portion of the fin, and the degree of curvature may be changed. The fins in use may also be compressed or stretched during use. The fins may be deformed to different degrees in different regions of the fins, for example to accommodate the cross-sectional shape of the conduit inserted into the channel.

[0025] The fixed end of the fin may be directly or indirectly coupled to the body. The fixed end may be generally fixed relative to the body. By generally fixed, we mean that the fixed end forms part of an elastically deformable structure, such as a molding disclosed below, which can accommodate slight deformations and therefore movements of the fixed end during use.

[0026] The fin may be joined (directly or indirectly) to the body along some or all of the length of the fin, although it will be appreciated that at least a portion of the free end furthest from the body remains unjoined.

[0027] In some embodiments, the or each fin is bonded to the body only at a fixed end. During use, such fins may be deflected and / or elastically deformed to accommodate a conduit within a channel. Fins that are not bonded along a length (or entire length) of the fin from the free end may be deflected to accommodate a variety of different sized conduits.

[0028] An "array of fins" refers to a plurality of fins, typically equally spaced, along at least a portion or all of the length of a channel, where the fins are on opposite sides of the channel and have a common orientation relative to the longitudinal direction along the channel. The orientation is defined relative to the longitudinal direction with respect to the direction of the acute angle the fins form with respect to the channel. The angle at which fins that share a common orientation extend from the channel may vary along the array, or the angles of all fins in the array may be the same, at least in the undeformed state. The array can include any number of fins, pairs of opposing fins, or opposing fins staggered along opposite sides of the channel. The array of fins may include the same or different numbers of fins on opposite sides of the channel. For example, along each side of the channel, the array of fins may include 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 15, or in some embodiments more fins along the channel. A channel may include 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 15, or in some embodiments more, fins along a side of the channel provided in one or more arrays. The length of the fins within a fin array can vary along the channel and / or on opposite sides of the channel, for example, to define curved or convoluted channels as described herein.

[0029] Proximal and distal refer to directions or positions relative to the conduit in use. The proximal end of a medical conduit typically extends from a device or container (such as a fluid container). The distal end of a medical conduit typically extends from a point of entry into a patient's body cavity (such as the patient's vasculature) or a point of contact with the patient (e.g., a sensor placed on or near the patient) in use.

[0030] In some embodiments, the fixation device comprises a first array of fins having a first orientation relative to a longitudinal direction along the channel and a second array of fins having an opposite second orientation relative to the longitudinal direction along the channel.

[0031] Thus, in another aspect of the invention, a body defining a channel for receiving a length of conduit extending along the channel; a first array of elastically deformable fins disposed along the channel extending from at least a first side of the channel and an opposite side of a second of the channel; and a second array of elastically deformable fins disposed along the channel extending from at least a first side of the channel and an opposite side of the second of the channel; each fin having an orientation extending at an acute angle relative to a longitudinal direction along the channel; each of the fins in the first array has a first orientation relative to the longitudinal direction along the channel, and each of the fins in the second array has an opposite second orientation relative to the longitudinal direction along the channel. A conduit fixation device is provided.

[0032] The first array may extend along a portion of the length of the first channel, and the second array may extend along a portion of the length of the second channel.

[0033] At least a portion of the first array and at least a portion of the second array may extend along a shared portion of the length of the channel, and the first array and the second array may extend along the same portion of the length of the channel.

[0034] The first array of fins may extend on a side of the first channel and a side of the second channel, and the second array may extend on a side of the third channel and optionally a side of the fourth channel. The first array of fins may extend around a first portion (circumferential or circumferential) of the channel, and the second array of fins may extend around a second portion of the channel. The first and second portions together may define the entire circumference or periphery of the channel.

[0035] The array of fins may extend from a third channel side and optionally a fourth channel side, the third side and the fourth side being orthogonal to the first side and the second side.

[0036] The array of fins may extend from the first, second, third and optionally fourth channel sides along at least a portion of the length of the channel, and in some embodiments along the entire length of the channel. The array of fins may extend substantially the entire periphery of the channel along at least a portion or all of the length of the channel.

[0037] Thereby, the fixation device may be able to withstand a wide range of force directions applied to a retained conduit in use.

[0038] In another aspect, the present invention provides a method for producing a composition comprising: a body defining a channel for receiving a length of conduit extending along the channel; an array of elastically deformable fins disposed along the channels extending from at least a first said channel side and an opposing second said channel side, and a third said channel side and optionally a fourth said channel side, the first side and the second side being orthogonal to the third side and the fourth side; each fin having an orientation that extends at an acute angle relative to a longitudinal direction along the channel; and each of the fins having a common orientation relative to the longitudinal direction along the channel. A conduit fixation device is provided.

[0039] The array of fins may extend from the sides of the first, second, third and fourth channels along at least a common portion of the length of the channels, or in some embodiments along the entire length of the channels.

[0040] The device may include a first array of fins and a second array of fins. The first array of fins may extend along a portion of the length of the first channel. The second array of fins may extend along a portion of the length of the second channel.

[0041] The first array and the second array may extend along a common (or entire) portion of the length of the channel, or at least a portion of the first array and at least a portion of the second array may extend along different portions of the channel.

[0042] Along at least a portion of the length of the channel, the first array and the second array may together define said array extending from the first, second, third and optionally fourth sides of the channel. That is, a given array may comprise a first subarray and a second subarray. Along at least a portion of the length of the channel, the first subarray and the second subarray may be generally continuous around the channel.

[0043] In some embodiments, the first fin array and the second fin array may close around the conduit in use.

[0044] In some embodiments, the retention feature comprises at least a portion of the array of fins. For example, the second array may form part of a lid or closure and be operable to close around the conduit when the lid or closure is closed.

[0045] In some embodiments, the two fin arrangements may be combined in a "clamshell" type or miter arrangement.

[0046] The first fin array may have the same or a different orientation as the second fin array.

[0047] In some embodiments, the channel is straight.

[0048] In some embodiments, the channels are curved or convoluted along at least a portion of the length of the channel. As disclosed herein, the channels may comprise curved or convoluted void paths.

[0049] A flexible conduit, such as an IV line, may be placed in the curved or convoluted channel.

[0050] In use, the curvature of the channel may supplement the tensile resistance of the device: tension applied to the conduit in the longitudinal direction (i.e., at least one component of force is applied along the length of the conduit) acts to straighten the path of the conduit along the channel, which presses the conduit against a portion of the fin and acts to further elastically deform, thereby increasing the static friction between the fin and the conduit.

[0051] A channel may have a single curvature. A channel may have two or more curvature directions. For example, in some embodiments, a channel may be generally S-shaped or may have one or more undulations. In some embodiments with two or more curvature directions, the channel extends along a plane. That is, the two or more curvatures are aligned. In some embodiments with two or more curvature directions, the channel has two or more curvature orientations and does not extend along a plane. For example, a first curvature along the channel may extend in a first plane, and a second curvature along the channel may extend along a second plane, the second plane being at an angle (e.g., perpendicular) to the first plane.

[0052] Curved, such as a curved channel or curved void path, refers to a channel or path that includes at least one bend. A curved channel or curved void path can include one or more radii of curvature. Convoluted refers to a channel or path that includes at least two bends in generally opposite but not necessarily coplanar directions along its length. For example, a convoluted channel or path can be generally serpentine or S-shaped. The curvature of the channel can be defined by the free ends of the fins (e.g., the length of the fins can vary along the channel). Alternatively or additionally, the curvature of the channel can be defined by one or more ribs, as disclosed below.

[0053] In some embodiments, the body comprises an inner portion and a support portion disposed laterally outward of the inner portion along at least a first channel side and a second channel side, the inner portion defining the channel and comprising an array of elastically deformable fins, the inner portion may include one or more fin components as disclosed herein, and the fin components may be removable, movable, or reconfigurable.

[0054] In some embodiments, the support portion may comprise a material having a first stiffness, and at least the fins of the inner portion may comprise a material having a second, lower stiffness.

[0055] According to another aspect, the conduit fixation device comprises: A body having an inner portion and a support portion; the inner portion defines a channel for receiving a length of conduit extending along the channel; the inner portion comprises an array of elastically deformable fins disposed along the channel extending from at least a first side of the channel and an opposite second side of the channel; each fin has an orientation extending at an acute angle relative to a longitudinal direction along the channel, each of the fins having a common orientation relative to the longitudinal direction along the channel; the support portion is disposed laterally outward of the inner portion along at least a first side of the channel and an opposite second side of the channel; the support portion comprises a material having a first stiffness and the fins of at least the inner portion comprise a material having a second, lower stiffness. It has a main body.

[0056] That is, the first and second materials may be selected to optimize the performance of the fixation device: a lower stiffness (Young's modulus) elastic material may be used for the fins (or the entire inner portion) to facilitate elastic deformation and allow the fins to better conform to the shape and contour of the conduit in use, while a higher stiffness material may be used by the support portion to resist transmission of such elastic deformation outward.

[0057] The entire support portion and / or the entire inner portion may be formed of the first material or the second material, respectively.

[0058] The first material may be a different material than the second material, or may be the same material or type of material, but processed differently, for example to change the density or morphology of the material.

[0059] The inner portion may be bonded, for example, between or within the support portions. The inner portion and the support portions may be formed separately and bonded together during manufacture.

[0060] The inner portion and the support portion may be removably coupled to one another, for example to allow an inner portion having an appropriate size or configuration of channel void paths and / or fin elasticity for a particular purpose to be used or selected with a single configuration of support portion.

[0061] In some embodiments, the inner portion is molded into the support portion. For example, the support portion and the inner portion may be co-molded.

[0062] The support portion can include or define a recess, and the inner portion can be located within the recess. The support portion can define a proximal and / or distal end of the channel. For example, the support portion can define a recess (e.g., a box or enclosure for the inner portion), and the channel can extend through an opening or recess in a wall of the recess.

[0063] As disclosed herein, at least the fins of the inner portion include or are constructed from an elastomeric material or other resiliently deformable material.

[0064] The support portion, or at least a portion thereof, may be rigid or semi-rigid. By semi-rigid, it is meant that the support portion has some flexibility but is rigid enough to resist the forces exerted through the fins when deformed by the conduits in the channels. The support portion may include or be formed from a molded or machined plastic material, such as, for example, polypropylene, acrylonitrile butadiene styrene (ABS), or polycarbonate.

[0065] In any aspect or embodiment disclosed herein, opposing fins may be longitudinally aligned with one another or longitudinally offset from one another on alternating sides of the channel.

[0066] The fixation device of any of the aspects or embodiments disclosed herein may be adapted to limit inversion or deviation of the fins when, in use, a longitudinal force is applied between the fixation device and the conduit in the channel in the same orientation as the fins. Such adaptation may further improve tension resistance.

[0067] The ends of the fins in the fin array that contact the conduit in use may be joined along one or both sides of the array.

[0068] The fixation device may comprise one or more barriers or ribs extending along at least a portion of the channel between ends of the fins extending from the channel to opposite sides of the channel, particularly in embodiments in which the fins of the fin array have free ends, said ribs or barriers extend partially between the free ends.

[0069] The ribs or barriers may be rigid or semi-rigid along at least a portion of the length of the channel.

[0070] The ribs may be elastically deformable along at least a portion of the length of the channel, such as at least the proximal and / or distal ends of the channel. Elastically deformable ribs may reduce the risk of bending or kinking of the conduit. An array (or sub-array) of fins may also extend partially between the free ends of another array of fins to perform a similar function.

[0071] The ribs or barriers may at least partially define the void pathways.

[0072] The device may comprise a plurality of ribs or barriers, for example an array of fins may extend from a side of a first channel and an opposing side of a second channel, and ribs may extend between the fins from a side of a third channel and optionally a side of a fourth channel.

[0073] The ribs or barriers may define curved or convoluted channels.

[0074] The rib or barrier may, for example, comprise part of the body, or the support and / or the lid.

[0075] Some embodiments may include one or more reconfigurable ribs or barriers, which may be operably coupled to a button or slider, or a movable wall, for example, as disclosed herein, so that the extent to which the rib or barrier extends between the fins of the array can be reconfigured to provide some degree of adjustment of the pull resistance of the device.

[0076] The fixation device can comprise a plurality of fin arrays. For example, a first array can extend from a first and second side of at least a portion of the length of the channel, and a second array of fins can extend from an orthogonal third channel side and optionally a fourth channel side. Alternatively or additionally, the fixation device can comprise a first array of fins and a second array of fins oriented in different directions relative to a longitudinal direction along the channel, as disclosed herein.

[0077] The fixation device may comprise a plurality of fin components constituting the array or arrays and defining the channel or channels. It will be appreciated that the arrays and channels of the fixation devices disclosed herein may be constructed using a variety of fin components. For example, an array of fins may comprise a plurality of parts, e.g., each part defining a fin on one side of a channel, or each part defining a fin that extends partially around a channel. The array of fins may be formed as a single unit, in some embodiments, e.g., by molding. Conversely, a given fin component may define at least a portion of an array of multiple fins.

[0078] In relation to any aspect of the embodiments disclosed herein, the fin array can have a variety of configurations, such as:

[0079] When the fins are in an undeformed state (when no conduits are present within the channels), the channels may define void paths, i.e., transverse to the channels, the channels may define gaps between opposing fins (e.g., between fins on a first channel side and a second channel side).

[0080] The width (lateral) of the void passage may define the minimum diameter of a conduit that may be fixed within the fixation device. The minimum diameter may be, for example, at least 105%, 110%, 120% or 130% of the width of the void passage.

[0081] In a cross-section through the channel (i.e., looking longitudinally along the channel), when the fin is undeformed, the void path may be square or rectangular, i.e., the opposing fin ends define two, three or four sides of the void path that is square, rectangular or diamond shaped in cross-section.

[0082] The void passages may be circular, elliptical or polygonal in cross section, i.e., the ends of the fin array facing the channel may define part (usually half or more) of a circle, ellipse or polygon.

[0083] Other cross-sectional shapes of the void pathways are possible, for example, the ends of the opposing fins may be provided with a curvature or lip to at least partially assist in engaging, enveloping and / or retaining the conduit within the channel in use.

[0084] Each fin in the fin array may have a fixed end that is generally fixed relative to the body (except for slight movement that occurs during elastic deformation of the fin component in use in some embodiments) and a free end that is moveable relative to the body to accommodate a conduit inserted into the channel.

[0085] An angle can be defined between the fixed end and the free end. In an undeformed state, the angle of the fins can be, for example, between about 10 degrees and about 85 degrees, between about 20 degrees and about 80 degrees, between about 30 degrees and about 75 degrees, or between about 45 degrees and about 70 degrees. The angle can be about 5, 10, 15, 30, 45, 50, 55, 60, 65, 70, or 80 degrees. In an undeformed state, the angle of each fin of the fin array relative to the length of the channel can be substantially the same.

[0086] In some embodiments, the angle of the fins in the fin array may vary along the channel, for example, if the channel is curved or convoluted, adjacent fins may be substantially parallel to one another and the angle relative to the curved or convoluted channel may vary along the length of the channel.

[0087] It will be appreciated that when a conduit is inserted into a channel, with the fin in a deformed state, the angle between the orientation of the fin and the orientation of the channel may change, and the amount of change in angle will depend on the diameter and flexibility of the conduit, and furthermore may be non-uniform along the channel.

[0088] In an undeformed state, the fins of the fin array may be substantially straight between their fixed and free ends. In some embodiments, in an undeformed state, the fins of the fin array are curved, J-shaped, or otherwise non-straight between their fixed and free ends. Such a configuration may, in some embodiments, provide an increased surface area of ​​contact between the fins and the conduit during use.

[0089] The fins may comprise any suitably resilient material, including, for example, resilient plastic or elastomeric materials such as silicone, closed cell neoprene, polyurethane, polystyrene, polyolefins, and other materials known to those skilled in the art for use in medical applications. The fins may comprise a resilient component and a coating component. For example, a coating or surface treatment (e.g., a roughened or alternatively smooth surface, or a "sticky" coating such as a polyurethane coating) may be selected to more effectively frictionally engage a particular type of conduit, such as an IV line.

[0090] The fins may comprise multiple resilient materials. For example, a portion of the fin (e.g., a lip or other formation that cups around or over the conduit to retain the conduit in the channel against lateral removal from the channel in use) may comprise or be formed of a more resilient (i.e., stiffer) material to aid in retaining the conduit in the channel.

[0091] The elasticity of the fin may vary along its length, for example increasing from the free end to the fixed end.

[0092] Materials may be selected to have suitable solvent and temperature resistance for cleaning, as is known in the art.

[0093] The elasticity of the fins can be selected for a particular purpose based on typical tensile forces expected to act between the conduit and the fixation device in normal use. The required load can be related, for example, to the weight of the equipment or device through which the conduit extends. For example, for fixation of an IV line, it is desirable that the fixation device can at least isolate the IV line entry point into the vein from the drop of the fluid bag. Such bags (saline, plasma, etc.) usually contain about 1 liter of aqueous liquid. Thus, a fixation device may be required to isolate the conduit (e.g., a drain) distal to the device from longitudinal forces of about 1-10 N, about 1-5 N, about 1-3 N, or about 1.5-3 N applied between the device and the retained IV line, i.e., the conduit proximal to the device.

[0094] In some embodiments, greater load resistance may be anticipated, such as the use of heavier equipment, such as surgical drainage devices weighing approximately 10, 20, 30, 40, 50, 60 or 80 kg, or in some cases more. Thus, a fixation device may be required to isolate the distal conduit (e.g., a drain) of the device from longitudinal forces of about 10-200 N, about 50-150 N, or about 70-100 N, or about 10, 20, 30, 40, 50, 60 or 80 N, or in some cases more, exerted on the proximal conduit of the device.

[0095] It will be appreciated that the fixation device will block longitudinal forces but may allow some movement of the conduit within the channel, for example, the permitted range of such movement may be about 20 mm, 15 mm, or 10 mm, or less, under a given longitudinal force.

[0096] The retention mechanism functions to retain the conduit within the channel against lateral movement out of the channel.

[0097] The retention feature may comprise a narrowed entrance to the channel defined by the body. The narrowed entrance may comprise a width less than the width of a conduit that the fixation device is sized to use, such that, in use, the body is deflected to temporarily widen the opening and / or the conduit is squeezed to fit through the channel. The narrowed entrance may be less than the width of the void path of the channel.

[0098] The retention feature may include a closure that traverses or covers at least a portion of the channel For example, the retention feature may comprise one or more straps that can be releasably secured across the channel.

[0099] In some embodiments, the retention mechanism comprises a lid or cover for attachment over at least a portion of the length of the channel. The lid may be hinged to the body, for example by an active hinge, and secured by latches, clips, or other suitable fastening means. The lid may be removably attached over at least a portion of the length of the channel. The cover may be attached by any suitable fastening means, such as clips, latches, etc.

[0100] The retention mechanism may be coupled to the support portion.

[0101] The support portion may comprise a retention feature, for example in an embodiment having a fin extending around a side of the third channel and optionally a side of the fourth channel, or around the perimeter of the channels, the retention feature may comprise a lid or closure over the channels, in some embodiments the lid or closure comprises a fin component or multiple fin components.

[0102] A lid or closure forming part of the support portion may, for example, comprise an insert portion comprising the above-mentioned array of fins that, in use (when the lid or closure is placed over the channel), extends from a side of the third channel.

[0103] In embodiments in which the support portion comprises a material having a first stiffness and at least the fins of the insert portion comprise a material having a second, lower stiffness, the lid or cover may comprise a material having the first stiffness.

[0104] In some embodiments, the fixation device is reconfigurable.

[0105] The reconfigurable fixturing device may be capable of reconfiguration, such as changing the angle of at least a portion of the fin relative to the channel, changing the width of the void path along at least a portion of the length of the channel, changing the curvature of the channel, or changing the orientation of at least a portion of the fin, between at least a first configuration and a second configuration.

[0106] The support portion and / or the inner portion may be reconfigurable.

[0107] Reconfiguration can adjust the tensile resistance that the device applies to a conduit held in the channel, the direction of the tensile resistance that the device applies to a conduit held in the channel, or the size of the channel (and therefore the diameter of the conduit that can be held therein).

[0108] The body (e.g., a support portion thereof) may include a button or slider for changing the configuration of the fixation device. The button or slider may be operable to transition the device between the first and second configurations.

[0109] In use, the conduit may be loaded into the channel when the device is in the first configuration and then the device may be transitioned to the second configuration.

[0110] The curvature of at least a portion of the channel can be altered by transitioning the device between a first configuration and a second configuration.

[0111] In the first configuration, the channel may be straight. In the second configuration, the channel may be curved. Transitioning from the first configuration to the second configuration may increase the curvature of at least a portion of the channel.

[0112] Transitioning from the first configuration to the second configuration can reduce a width of the void path of the channel along at least a portion of the length of the channel.

[0113] The transition between the first and second configurations can be accomplished by pressing a button or moving a slider (e.g., a tilt slider) to move all or a portion of the fins laterally relative to the channel. All or a portion of the fins relative to a first channel side and a second channel side can be deflected laterally to impart a curvature to the channel or change the curvature of the channel.

[0114] Arrangements for laterally biasing the fins can be conveniently provided within the support as disclosed herein: buttons or sliders can bias the movable inner wall of the support part laterally and / or longitudinally, or can prevent or limit lateral movement of the support part.

[0115] The slider may be laterally or longitudinally movable and may be coupled or engaged to at least one of the fins. For example, at least a portion of the fin may be engaged or coupled to said movable portion along at least a portion of the length of the channel along a side of the first channel and / or the second channel. The movable wall portion, button or slider may be coupled or engaged to one or more fin components.

[0116] Moving the slider can reconfigure the angle of the associated fins during use. For example, the conduit may be held within the channel when the fixation device is in a first configuration, and the slider may be operable to move the device to a second configuration. The ends of the fins engaged to the conduit remain in substantially the same position in both configurations, while the ends of the fins coupled to the slider move longitudinally, thereby changing the angle. The fins coupled to the slider can be transitioned between a first configuration in which they are generally perpendicular to the channel, and a second configuration in which the fins are at an angle to the channel, as disclosed herein.

[0117] By varying the angle of the fins, the orientation of the relative fins can be changed.

[0118] The button or slider may be indexed and have at least two index positions defined by a first configuration and a second configuration.

[0119] The fixation device is reconfigurable by removing and replacing one or more fin components. For example, in some embodiments, one or more arrays may each comprise or consist of a removably coupled fin component, such that the device may be reconfigurable by removing a fin component and reattaching it with the fins reversed in orientation. This may facilitate, for example, using fin components of different sizes, elasticities, air passage profiles, curvatures, etc., within a given body. This may reduce the chance of error and / or improve efficiency in clinical settings where placement of the device on a patient or equipment is sensitive.

[0120] The fixation device may include one or more rotatable fin components. The one or more fin components may be rotatably coupled to the body or support portion. The fixation device can be reconfigured by rotating the one or more fin components to reverse the orientation of its fins.

[0121] By varying the orientation of the fin components, the orientation of the fin array can be selected, and the maximum tensile resistance that the array provides can be selected.

[0122] In some embodiments, the device may be comprised of two or more arrays, at least one of which is reconfigurable to change the orientation of its fins, thereby allowing the fixation device to selectively provide substantially equal tensile resistance in both longitudinal directions (relative to the channel) or to provide greater tensile resistance in a selected longitudinal direction.

[0123] The fixturing device may include a first channel and a second channel, and in some embodiments may include three or more channels.

[0124] The fixturing device may include multiple bodies, each body defining a channel.

[0125] The fixturing device may include a body defining a number of channels.

[0126] The first channel and the second channel may extend generally parallel to one another.

[0127] The first channel and the second channel may share a common first end and / or a common second end.

[0128] In some embodiments, the first channel comprises a first array of fins and the second channel comprises a second array of fins, and the first and second arrays may be in different orientations, such that an orientation of the fixation device may be selected.

[0129] In some embodiments, the first channel comprises a first array of fins and the second channel comprises two second arrays of fins oriented in opposite directions relative to the length of the second channel, and the conduits may be inserted to selectively provide tensile resistance in a single direction, or in both directions.

[0130] The two or more channels may extend end to end. In some such embodiments, the fixation device comprises a bifurcated channel arrangement, i.e., the device comprises a main channel extending at one end thereof and extending into the first and second channels. Each of the main channel, the first channel, and the second channel may comprise an array of fins, or an array of multiple fins, in any combination or orientation order.

[0131] Moreover, the device can include two pairs of first and second channels, each pair sharing a common first end and / or second end, thereby providing various pathways for the conduit.

[0132] Thus, the degree of tensile resistance that the device provides to a conduit fixed in each direction can be selected with greater resolution.

[0133] Additionally or alternatively, a multi-channel fixation device may comprise channels with multiple widths of void pathways, or may comprise an array of multiple resilient fins, such that in use, a particular pathway may be selected to accommodate a particular diameter or flexibility of a conduit.

[0134] The fixation device may further comprise an external attachment for attaching the fixation device to a patient or structure, the external attachment being coupled to the body.

[0135] The external attachment may comprise, for example, a band or strap for attachment to a patient's limb. The external attachment may include a garment or part of a garment, such as a vest, undergarment, limb cover, etc. The external attachment may include an adhesive portion, for example in the form of a tape or adhesive patch or strip, that may be attached to the patient's skin or clothing, or to a structure, such as a fixture or trolley. The external attachment may include a releasable fastener, such as a clip or hook-and-loop fastener component.

[0136] The external attachment for attaching the device to the patient may consist of an adjustable band or strap. Adjustability may be provided by any suitable means, such as hook and loop fasteners, buckles, ratchets, or strings.

[0137] The body may be (optionally releasably) attached to, or at least partially embedded in, or surrounded by, the external fitting. For example, the external fitting may comprise a plastic or elastomeric material and the body, or at least a supporting portion thereof, may be of a harder material, such as a polypropylene material, and may be at least partially embedded in or surrounded by the plastic / elastomeric material of the external fitting.

[0138] The body may be connected to an external attachment via, for example, one or more clips, fasteners, loops, or the like.

[0139] The body may be removable from the external fitting, for example for cleaning. The body and external fitting may be integral, for example formed from a single material.

[0140] The choice of materials for the fixation device or its components may depend on the clinical setting. Those skilled in the art will appreciate that in some situations, such as surgical or emergency applications, the device may be adapted for single use. However, other applications, such as those requiring longer term use of the device, may require material selection that takes into account patient comfort, cleaning of the device and / or sterilization and reusability of the device.

[0141] In some embodiments, the fixation device or one or more components thereof are advantageously made from a wipe-clean material. A wipe-clean material is a material having a substantially non-porous surface. Examples include plastic or elastomeric materials, such as silicone, closed-cell neoprene, polyurethane, polystyrene, polyolefins, and other such materials known to those skilled in the art for use in medical applications. The fixation device can comprise a washable or sterilizable fabric, such as a plastic or elastomeric coated fabric.

[0142] In some embodiments, the fixturing device, or one or more components thereof, are made from a recyclable material, such as a thermoplastic material, or a biodegradable material, such as a biodegradable plastic material, such as cellulosic or other plastic materials based on plant-derived polymers or resins, which are known in the art.

[0143] One or more components of the fixturing device may be molded (i.e., formed by molding, such as compression molding or injection molding). For example, the fin component, one or more parts of the body, the external fittings may be molded.

[0144] One or more components of the fixation device may be overmolded or co-molded with one or more additional components, for example, the support portion and the inner portion may be co-molded and the external fitting may be overmolded around at least a portion of the body.

[0145] The fixation device or its components may be provided with an anti-pathogenic (such as anti-bacterial, anti-fungal or anti-microbial) coating or may be impregnated with an anti-pathogenic component, of which many are known in the art, including metal colloid compositions such as those based on silver or copper, quaternary ammonium compositions or polymers, biguanide polymers, and many others.

[0146] The fixation device or its components may be provided with a luminescent coating or may be impregnated with a luminescent pigment or dye, which may, for example, aid in locating the fixation device at night or in low light conditions, or may serve as a reminder to the patient that they are still wearing the fixation device.

[0147] The invention, in another aspect, extends to a medical system including a medical conduit secured to a fixturing device in accordance with the aspects and embodiments disclosed herein, where the conduit extends along the length of a channel of the fixturing device.

[0148] The conduit may be flexible, semi-flexible or rigid.

[0149] The conduit may be a fluid line, such as an IV line, a venous line, an arterial line, or a drain. The conduit may be a gas line, for example for delivering anesthesia or oxygen. The conduit may be an electrical or optical conduit, such as extending from a monitoring device (e.g., a compartment monitor, an electrical or optical sensor, etc.) applied externally or transcutaneously to the patient.

[0150] The conduit may be flexible and urged into a curved or convoluted path by an arrangement of fins.

[0151] The fixation device of the medical system may further include an external attachment.

[0152] An external device is attached or attachable to a patient or structure, for example, to a limb, head, neck or torso of a patient, or to the surroundings such as a trolley or bed frame, etc. A fixed device can be attached to a stand such as an IV stand, an ICP monitoring stand, etc.

[0153] The medical system may include two or more conduits (of the same or different types or diameters) secured to the fixation device and extending along respective channels.

[0154] Further alternative or optional features of the fixation device correspond to other aspects or embodiments of the fixation device disclosed herein.

[0155] In another aspect, Providing a fixation device according to aspects and embodiments disclosed herein; Inserting a conduit laterally into the channel; A method of securing a conduit is provided, comprising:

[0156] The method may include manipulating a retention mechanism, which may be, for example, by fastening a strap over the channel or closing a lid.

[0157] The method may include reconfiguring the fixation device between at least a first configuration and a second configuration, i.e., to change the angle of at least a portion of the fins relative to the channel, to change the width of the void path along at least a portion of the length of the channel, to change the curvature of the channel, or to change the orientation of at least a portion of the fins.

[0158] The fixation device can be reconfigured before or after inserting the conduit into the channel. The fixation device can be reconfigured before or after manipulating the retention mechanism.

[0159] The method may include urging the flexible conduit into a curved or convoluted path.

[0160] The method may include attaching an external attachment to the patient or structure.

[0161] The external attachment may comprise a band or garment and the method may include wrapping the band around the patient's limb or other body part or threading the patient's limb or body part through or within the external attachment.

[0162] The external attachment may comprise an adhesive tape and the method may include placing the fixation device on the patient or on a garment and applying the adhesive tape over a portion of the fixation device. The external attachment may comprise an adhesive surface and the method may include preparing or exposing the adhesive surface and applying it to the patient.

[0163] The external attachment may comprise a clip or clamp and the method may include attaching said clip or clamp to the patient's clothing, a bed frame, or the like.

[0164] The method may include attaching an external fitting before and / or after securing the conduit to the fixation device.

[0165] It will be appreciated that the method may include securing two or more conduits to the fixation device. Two or more conduits may be secured simultaneously. In some embodiments, one or more conduits may be attached at different times relative to one or more other conduits. For example, in some situations, a clinician may return to the patient and secure and / or remove conduits, for example to replace an IV drip.

[0166] The method may include removing the conduit from the fixation device. Removal may be accomplished by reversing the fixation methods disclosed herein. Removal may be accomplished, for example, by disrupting one or more of said straps, e.g., by severing one or more of said straps to release the conduit or conduits.

[0167] In another aspect, the invention relates to the use of the fixation device disclosed herein to fix a conduit, such as a medical conduit, to a patient, for example, proximate an entry point, such as a cannula entry point.

[0168] It will be understood that the further and optional features of each aspect of the invention correspond to the further and optional features of any other aspect of the invention. The methods disclosed herein may, for example, include using any feature of the fixation devices or medical systems disclosed herein, and the fixation devices and medical systems may include any apparatus necessary for carrying out the methods.

[0169] "Lateral," "longitudinal," and related terms refer to an orientation or direction with respect to a channel, void path therethrough, or conduit, as the case may be. For example, with respect to a conduit, the longitudinal direction is generally along the axis of the conduit, or along the length of a curved conduit. The channel may extend from a first end to a second end of the body, and the longitudinal direction with respect to the channel may be generally between the first and second ends. The longitudinal direction may be defined along any portion of a curved or convoluted channel. Similarly, a "lateral" direction may be defined at an angle to the longitudinal direction. For example, the transverse direction may be generally radial to the axis of the conduit, or generally perpendicular to the longitudinal direction of the channel. When referring to a longitudinal or "tensile" force applied to a conduit, it refers to a force applied to the conduit relative to the fixation device (i.e., a force that may result from either movement), at least one component of which is parallel to the conduit.

[0170] As used herein, the term "comprising" or "including" refers to an apparatus or method that includes the features mentioned above and optionally further features. The term "comprising" or "including" also encompasses an apparatus or method that consists only of the recited features.

[0171] Although the present invention has been described primarily in the context of fixation devices, systems, and methods for medical applications, fixation devices may also be provided for use with other types of conduits and in other environments where routing, fixation, and tension isolation of cables is desired, such as electrical conduits, rope applications, braided cables, etc. Thus, references herein to medical conduits and the like should not be considered limiting.

[0172] Exemplary embodiments are described with reference to the following drawings: [Brief description of the drawings]

[0173] [Figure 1(a)-(b)] 1(a) and 1(b) are perspective views showing an example of a conduit fixation device. [Figure 1(c)] FIG. 1(c) is a plan view of the device of FIG. 1(b) with a conduit fixed within the channel. [Diagram 2] FIG. 2 is a top view of another example of a conduit fixation device having a medical conduit disposed within a channel. [Figure 3(a)-(b)] 3(a) and 3(b) are perspective views of the device of FIG. 2 in two respective configurations. [Figure 4(a)-(b)] 4(a) and 4(b) are perspective views of a further example of a reconfigurable fixation device in each of two configurations. [Figure 5(a)-(c)] FIG. 5(a) is a perspective view of a conduit fixation device with a convoluted channel, and FIGS. 5(b) and 5(c) show fixation devices with a flexible conduit positioned along the convoluted channel. [Figure 6(a)-(b)] 6(a) and 6(b) show plan and cross-sectional end views of a conduit fixation device with a lid and an array of fins around the channel. [Figure 7] FIG. 7 shows a fixation device having two channels. [Figure 8] FIG. 8 shows a fixation device having two channels. [Figure 9] FIG. 9 shows a fixation device with a branched channel arrangement. [Figure 10] FIG. 10 illustrates a reconfigurable fixation device. [Figure 11] FIG. 11 illustrates a reconfigurable fixation device. [Figure 12] FIG. 12 illustrates a reconfigurable fixation device. [Figure 13(a)-(c)] 13(a)-(c) show a fixturing device having a body defining ribs between an array of fins. [Figure 14(a)] FIG. 14(a) is a perspective view of a fixation device having convoluted channels with multiple curved orientations. [Figure 14(b)-(c)] 14(b) and 14(c) are exploded perspective views of the insertion portion of the fixation device of FIG. 14(a). DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0174] 1(a) shows a fixation device 100 for fixating conduits, particularly medical conduits. The device 100 has a body 102 defining a channel 104. The channel includes elastically deformable fins 106 extending from a first channel side 107a and a second channel side 107b. The device 100 is shown with the fins in an undeformed state.

[0175] The fins each have an orientation that extends at an acute angle α with respect to a longitudinal direction L along the channel. The angle α is generally measured along the length L of said fin 106 from the fixed end 106a to the free end 106b. Each of the fins 106 has a common orientation; that is, the acute angle α of each fin between a line defining the fin's orientation extending from the free end 106b and the fixed end 106a of each fin, and the longitudinal direction L of the channel, generally points in a similar manner with respect to the longitudinal direction L (i.e., toward the same proximal end 108p or distal end 108d of the channel).

[0176] In use, a conduit such as an IV line or catheter is placed within the channel, and the dimensions of device 100, and in particular the width of channel 104, may be selected such that the conduit elastically deforms at least the ends of the fins, and friction between the fins and the conduit provides resistance to longitudinal movement of the conduit along the channel, i.e., "tensile resistance."

[0177] In use, the fixation device isolates conduits extending distally from the fixation device, and vice versa, from forces applied between the fixation device and conduits extending proximally from the device, thereby reducing the risk of fracture of the entry point of the conduit or associated medical device into the patient.

[0178] The angled fins provide more "pulling resistance" distally (direction D). When the conduit is pulled in direction D, the ends of the fins 106 will drag to some extent due to friction and compress, or further compress and increase engagement with the conduit. When pulled in direction P, there is some friction (and therefore pulling resistance) between the conduit and the fins, but the friction between them tends to stretch the fins and sharpen the acute angle α, reducing fin deformation.

[0179] The fins are capable of deflecting and elastically deforming to accommodate various conduit diameters.

[0180] It will be appreciated that in a clinical setting, forces applied to a retained conduit may have longitudinal and lateral components relative to the conduit (i.e., axial direction), and the elastically deformable fins can deform to accommodate such forces in various directions while reducing the likelihood of the conduit breaking or pinching.

[0181] The resiliency or other properties of the fins (such as surface texture or material), the length and / or width of the channels may be selected for a particular purpose.

[0182] The fins 106 in the array are parallel to one another (when undeformed) and each make the same angle relative to the length of the channel, although in alternative embodiments disclosed herein, the angle relative to the channel may vary along the channel.

[0183] In the illustrated embodiment, the body 102 includes a support portion 110 and an inner portion 112. The support portion is laterally outboard of the inner portion, and in the illustrated example, the support portion defines a recess having a depression 110a at the end of the channel 104. As described in more detail below, in some embodiments, the inner portion may be removable. In other embodiments, the inner portion is not removable and may, for example, be glued or molded into the support portion.

[0184] The support portion 110 is molded from a relatively hard, inflexible plastic material, such as polypropylene. The inner portion 112, which contains the array of fins 106, is molded from a resiliently deformable material having a lower stiffness, such as medical grade silicone. In the illustrated embodiment, the entire inner portion (including the fins) is molded from a single material, although in alternative embodiments multiple materials can be used, with at least the fins 106 having a lower stiffness than the outer support portion 110.

[0185] The inner portion 112 is removable from the support portion 110 allowing the device 100 to be reconfigured with different inner portions 112 .

[0186] The inner and support portions can be provided with different stiffnesses to optimize their stiffness, for example the fins can be made with a relatively low stiffness so that they can better conform and grip the conduit, while the support portion provides overall resistance to channel expansion.

[0187] The fixation device 100 also includes a base 120 having slots 122 that serve as external attachments for attaching the fixation device to a patient or structure using bands or straps (not shown) threaded through the slots. The base 120 is co-molded with the body 102 in the illustrated embodiment.

[0188] Optionally, a strap can be routed over the open top surface of channel 104 and act as a retention feature on the channel to prevent the conduit from being pulled laterally out of the channel. In an alternative embodiment, device 100 alternatively includes a lid or flap (not shown) that is operable to close over the channel and act as a retention feature.

[0189] FIG. 1(b) shows another fixation device 200. Features in common with the fixation device 100 are given similar reference numerals with an increment of 100. Unlike the fins 106 of the device 100 (which are straight in the direction from the fixed end 106a to the free end 106b when the fins are in the undeformed configuration as shown), the fins 206 of the device 200 are "J-shaped", i.e. curved towards the free end 206b. The free end 206b of the fin 206 thus forms an angle with the longitudinal direction L of the channel that is more acute than the angle α1 of the fixed end 206a. The orientation of the fin (angle α defined between a line extending between the fixed end and the free end and the orientation L of the channel) is also smaller (i.e. more acute) than the angle α1. In the illustrated embodiment, the free end 206b is approximately aligned with the longitudinal direction L of the channel. In use, the J-shaped fin 206 can provide a larger contact surface area with the conduit. This is illustrated in FIG. 1( c ), which shows the device 200 with a conduit 224 disposed within the channel 204 . The fins 206 elastically deform relative to the conduit 224 such that a surface area near each free end 206 b of the fins 206 contacts the conduit 224 .

[0190] Other non-straight configurations are possible, such as a gentle curve or a twist midway along each of the fins.

[0191] The fins of devices 100, 200 are shown in an undeformed configuration. As shown, the free ends 106b, 206b of opposing fins (for the first channel side and the second channel side) do not touch such that the channels define a void path between the free ends of the opposing fins.

[0192] 2 shows another fixation device 300. Features in common with device 100 are given similar reference numerals incremented by 200.

[0193] The fixation device 300 has an array of first fins 306 extending along a portion of the first channel 304 and an array of second fins 356 extending along a portion of the second channel 304. Each of the fins in the arrays 306, 356 is elastically deformable and extends at an acute angle α with respect to the longitudinal direction of the channel 304.

[0194] A length of conduit 324 is shown disposed within the channel, with a number of fins 306 , 356 elastically deforming to accommodate and retain the conduit 324 within the channel 304 .

[0195] The first array of fins 306 has a first orientation and is oriented in a direction P toward the proximal end 308p of the channel. The second array of fins 356 has an opposite second orientation and is oriented in a direction D toward the distal end of the channel. Thus, the device 300 provides tensile resistance to the conduit in both directions by additionally compressing one or the other of the first array of fins 306 or the second array of fins 356 when a longitudinal tension is applied to the conduit.

[0196] It will be understood that device 300 can be used in either orientation, and the terms proximal and distal are used for descriptive purposes only, i.e., in use, end 308d of the channel may, for example, face proximally.

[0197] Device 300 may optionally include further body features as described above in relation to device 100.

[0198] In one embodiment, the device 300 is reconfigurable and comprises removable first and second inner portions 312a, 312b. During use, one of the inner portions 312a, 312b can be removed and reinserted into the support portion 310 with the orientation of the fins reversed, whereby the device 300 is reconfigured to have two arrays of fins 306, 356 oriented in the same direction. Figures 3(a) and 3(b) show how the device 300 can be reconfigured in this manner.

[0199] The device 300 also includes outer buttons 326, one or both of which can be depressed inwardly from a predetermined extended position (shown) to a predetermined depressed position (not shown) to impart a curvature to the channel or at least increase the compression of the array of second fins 356 against the conduit 324. Reconfiguration of the channel curvature or width / compression of the conduit can provide additional pulling resistance in some circumstances. The effective narrowing of the channel 304 by depressing one or both buttons 326 can also allow the device 300 to be used with a wider range of conduit diameters.

[0200] The button may be coupled to a support portion 310 and may optionally include a deflectable inner wall portion (not shown) to apply an inward force along the length of the channel 304, generally as disclosed herein.

[0201] The fixation device 400, in some embodiments, may include an open support portion 410 to facilitate rotation of the second inner portion 412b about a co-molded pin or protrusion 428 that is placed within an opening 430 in the support portion 410, as shown in Figures 4(a) and 4(b).

[0202] Further components of the base portion, such as a fixation mechanism or external attachments, may be removably attached to the body during use to allow rotation or reconfiguration of the device 300, 400.

[0203] Another fixation device 500 is shown in Figure 5(a). Features in common with device 100 are given similar reference numerals incremented by 400.

[0204] The device 500 has a body 502 having a support 510. The body 502 (particularly an inner portion 512 thereof) defines a convoluted channel 504. As shown, in the undeformed configuration of the fin array 506, the channel 504 is convoluted and includes two curves along its length. In certain applications, particularly when using flexible conduits such as IV lines, tension applied longitudinally to the conduit acts to straighten the conduit along the channel, and the curved channel 504 supplements the tensile resistance of the device 500 as the conduit presses against the fins on either side of the curve of the channel 504. Thus, the fins undergo further elastic deformation, increasing friction between the conduit and the channel.

[0205] Additionally, curved or convoluted paths can better accommodate conduits of various diameters. This is illustrated in Figures 5(b) and 5(c), which show thin IV line 524n and thick IV line 524w, respectively, secured within channel 504. In the illustrated embodiment, thin IV line 524n is a 3 mm diameter line and thick IV line 524w is a 6 mm diameter line. The curvature allows at least a portion of fin 506 to engage the thin conduit and provide adequate pulling resistance.

[0206] It will be appreciated that fixation devices according to the present invention can be configured to accommodate flexible conduits of different diameters, or a smaller or wider range of conduit diameters. For example, 10mm or 15mm fluid conduits may be used and a given fixation device may be adapted to accommodate both diameters.

[0207] 6(a) and 6(b) are plan and cross-sectional end views of another conduit fixation device 600. Features in common with device 100 are labeled with similar reference numerals, incremented by 500.

[0208] The device 600 has a body 602 that defines a channel 604. In the illustrated embodiment, the channel is straight, although curved or convoluted embodiments are also contemplated. The device also includes a base 620 having a slot 622 therein, which functions as an external attachment as described above.

[0209] The body 602 comprises an outer support portion 610 including a lower portion 610a and a lid portion 610b joined via an active hinge 611. Each portion 610a, 610b of the support portion 610 defines a cavity into which are attached lower and upper inner portions 612a, 612b, respectively, which are less rigid (e.g., made from silicone).

[0210] The lower inner portion 612a defines a first subarray of fins 606a. The upper inner portion 612b defines a second subarray of fins 606b. The first subarray and the second subarray comprise fins oriented in the same direction as each other.

[0211] As shown in FIG. 6(b), each of the subarrays of fins 606a, 606b includes a semicircular cross-sectional cut (when viewed along the channel) from each pair of opposing fins such that when the lid 610b is closed, the subarrays 606a, 606b come together to define an array of fins 606 that extends around the channel.

[0212] In cross section, when the lid 610b is closed (latched via latch 619) and the fins are undeformed, the array 606 defines a channel having a circular cross-section of void passage 605. As disclosed herein, void passages having other cross-sections are also contemplated.

[0213] 7 and 8 show a device 700, 800 having a body 702, 802 that defines two channels.

[0214] The device 700 has a first channel 704a and a parallel second channel 704b. The first channel 704a has two arrays of oppositely oriented fins 706a and 706b, generally as described above for device 300. The second channel 704b has an array of a single fin 706c, generally as described above for device 100. This device 700 allows a user to select a channel for the conduit 724 between when high pulling resistance is required in one direction and when pulling resistance is required in both directions. The two conduits may be used simultaneously.

[0215] In alternative embodiments, the device may alternatively or additionally comprise channels of different widths, channels having fins of different stiffness, etc., or combinations of such options.

[0216] The device 800 has a first channel 804a and a second channel 804b that share a common proximal end 808p and a distal end 808d. The channels are curved. The second channel 804b has two oppositely oriented fin arrays 806a, 806b. The first channel 804b has a single fin array 806c. A conduit 824 can be routed along either channel.

[0217] The fixation device 900 of Figure 9 has a bifurcated channel arrangement, comprising a main channel 904 that branches into a first channel 904a and a second channel 904b that share common proximal and distal ends. The first and second channels include fins arranged in opposite directions to each other, providing an opportunity for selection of the path of the flexible conduit during use.

[0218] FIG. 10(a) shows a reconfigurable fixation device 1000 having a convoluted channel 1004. The device 1000 has a first channel portion having an array of first fins 1006a extending from a first side and an opposing second side, and a second channel portion having an array of second fins 1006b extending from an orthogonal third side and an opposing fourth side. The device 1000 has a support portion having a lower portion 1010a defining a recess that accommodates a first inner portion 1012a comprising the first array 1006a. A further recess accommodates the lower components of the second array 1006b. The upper portion 1010b hinged to the lower portion 1010a accommodates the upper components of the second array 1006b and also serves as a retention mechanism when the upper and lower portions are closed around a conduit in use. As shown in the cross-sectional view of FIG. 10(b), the support portion 1010 includes a slider 1060 with a button 1062 connected to a movable wall portion 1066 via a neck 1064 and extending outside the support portion. The neck extends through a slot 1068, whereby the button may be operable to move the wall portion 1066. The wall portion is received within a recess 1070 adjacent to a first array 1006a defined in the support portion 1010. Adjacent to a second array 1006b, a recess is defined between the second array 1006b and the support portion 1010. Movement of the wall portion 1066 adjusts the length of the second array (top) that can move within the recess, and therefore to some extent the force applied by the second array 1006b to the conduit in the channel 1004 in use.

[0219] In some applications, the slider can move the second array 1006b into and out of engagement with the conduit, providing the user with the option to reconfigure the device to have strong tensile resistance in a single direction or in two directions. This can be convenient, for example, to adjust the position of the conduit and optimize its placement without having to open the lid 1010b. For example, some procedures may require precise advancement of the conduit, but withdrawing the conduit may be harmful. An example of this would be advancing a catheter into an artery, such as the femoral artery, toward the heart to control aortic bleeding, in which case the device can be used to ensure that the catheter is not pushed back out of the artery during the procedure, which could be life-threatening. Once the conduit is properly positioned, the device can be reconfigured to provide "bidirectional" tensile resistance.

[0220] 11(a) and 11(b) show another fixation device 1100 with convoluted channels 1104. The body 1102 defines a first array 1106 and a second array 1156 oriented in opposite directions. The device 1100 is reconfigurable between two configurations as shown. The body consists of an outer support part 1110 with a slider 1160 and a button 1162 connected via a neck (not visible) to an internal button (not visible) of the support part. The internal button abuts a movable wall part 1166 that flexes from a pivot 1167. Movement of the slider in a slot 1168 slides the internal button closer (FIG. 11(b)) or further away (FIG. 11(a)) from the pivot 1167 relative to the movable wall part 1166, thereby adjusting the degree of inward flexure of the wall part 1166. Wall portion 1166 abuts inner portion 1112 and thus provides adjustment to the width of channel 1104 (i.e. its gap path) and, in use, the degree of force applied between fin 1106 and the conduit within the channel, in the region of the channel adjacent wall portion 1166. Again, as noted above, without removing the conduit from the device, the device can be reconfigured to provide pulling resistance in one direction during use and additional pulling resistance in the opposite direction once the placement of the conduit is finalized.

[0221] 12(a)-12(c) show another example of a reconfigurable fixation device 1200. The device 1200 has a straight channel 1204 with an array of first fins 1206 extending from opposing first channel sides 1207a and second channel sides 1207b. The fins 1206 form part of an elastically deformable insert portion 1212a within a cavity in the lower portion 1210a of the support portion 1210. The fins of the array 1206 are oriented in a direction D.

[0222] The support portion 1210 also includes a lid 1210b. The lid 1210b includes a slider 1260 with a button 1262 that extends outside the support portion and is connected to a movable wall portion 1266 via a neck 1264. The neck extends through a slot 1268, which allows the button to be operated to move the wall portion 1266. A second array of fins 1256 is attached to the movable wall portion and extends from a third side 1207c of the channel along a portion of the length of the channel when the lid 1210b is closed.

[0223] When the conduit 1224 is inserted into the channel 1204 and the lid 1210b is closed over the lower portion 1210a, the fins of the first array 1206 engage the conduit 1224 and elastically deform relative to the conduit 1224, providing greater tensile resistance to a longitudinal force applied between the conduit 1224 and the device 1224 in direction D compared to the tensile resistance to a force applied in direction P.

[0224] When button 1260 is in its forward-most position in direction P within slot 1268, fins 1256 elastically deform to orient in direction P, i.e., opposite to the orientation of the fins in first array 1206a, as shown.

[0225] When button 1260 is moved to the distal end of the slot (as far as it can in direction D), the fixed end of fin 1206b is pulled along with the movable wall portion such that the orientation of fin 1206b reverses. Compressive forces within the fin bias button 1260 to one or the other of these two positions.

[0226] In this manner, the arrangement of second fins 1256 of device 1200 is reconfigurable to adjust the contribution of the fins 1256 to the overall tensile resistance of the device in each direction.

[0227] FIG. 13(a) shows a conduit fixation device 1300 in which a body 1302 includes a support portion 1310 having a lower portion 1310a and an upper portion 1310b in the form of a lid. An insert portion 1312 comprising an array of fins 1306 is disposed within a recess defined by the lower portion 1310a. The fins extend from a side 1307a of the first channel 1304 and an opposing side 1307b of the second channel 1304, the channels including void pathways between the free ends 1306b of the fins 1306.

[0228] The void pathway is also bounded on orthogonal third and fourth sides by lower rib 1380a and upper rib 1380b, which can be seen most clearly in FIG. 13(b), which shows the body with insert portion 1312 removed. In the illustrated embodiment, the ribs are co-molded with the support portion 1310 of the body and are rigid. In alternative embodiments, elastically deformable ribs, or ribs having elastically deformable portions, can be provided as disclosed herein.

[0229] The ribs 1380a, 1380b engage where the free ends 1306b of the fins 1306 extend between the fins, thereby inhibiting eversion or prolapse of the fins 1306. The ribs may also facilitate the use of more compliant, less elastic materials in the construction of the fins, which in some applications may be advantageous in providing the necessary pulling resistance without undue compression and risk of pinching or obstructing the conduit.

[0230] In an embodiment of the bottom 1310a and lid 1310b, the ribs 1380a, 1380b are of a constant depth so that the channel 1304 is straight and the void path has a rectangular cross-section.

[0231] 13(c) shows an alternative support portion 1310' having an alternative lower portion 1310c and upper lid portion 1310d for use with the same insert portion 1312. The support portion 1310' has undulating ribs 1380c and 1380d that undulate in third and fourth directions relative to the channel. The lower rib 1380c has a proximal valley 1381p and a distal peak 1382d, while the upper rib 1380d has a complementary proximal peak 1382p and distal valley 1381d.

[0232] Thus, the channels 1304 are planar in the vertical plane (defined between the fins) and undulate in and out of the horizontal plane through the device 1300 .

[0233] 14(a)-14(c) show a fixation device 1400 having a convoluted channel 1404 with multiple curvature directions.

[0234] The device 1400 has a body 1402 with a base 1420 and slot 1420 that function as an external attachment, as described above. The body 1402 has a lower support portion 1410a attached to a top lid portion 1410b via an active hinge (not visible in FIG. 14(a)) and securable over the channel by a latch 1419.

[0235] A first insert portion 1412a molded from an elastic material is positioned within a recess in the lower support portion 1410a and includes an array of opposing first fins 1406a and second fins 1456a extending from a side 1407a of the first channel 1404 and a side 1407b of the second channel 1404.

[0236] In a plane H parallel to the first and second directions (ie, horizontally through the device 1400 in the illustrated orientation), the channel 1404 has three bends along its length and is convoluted.

[0237] The device 1400 also includes a second insert 1412b having a lower portion 1413a and an upper portion 1413b that fit into the lower support portion 1410a and the lid 1410b, respectively. The second insert 1412b defines an array of opposing third fins 1406b and an array of fourth fins 1456b that extend from a third channel side 1407c that is perpendicular to the first and second sides and an opposing fourth channel side 1407d, respectively.

[0238] 14(b) and 14(c) are exploded perspective views of the first and second insertion portions; The channels 1404 include gap paths between the free ends of the various fins, and the fins of the third array 1456a and the fourth array 1456b are shown extending partially in the direction of plane V (vertical in the illustrated orientation) between the free ends of the first array 1406a and the second array 1456a.

[0239] Similar to ribs 1380c and 1380d of device 1300, the free ends of the third array and the free ends of the fins of the fourth array, viewed parallel to plane H, define complementary undulations. As a result, in plane V parallel to the third and fourth directions, channel 1404 is also convoluted, having three bends along its length.

[0240] It should further be noted that the free ends of the first array and the second array are generally longitudinally aligned with the free ends of the third array and the fourth array, such that the third array and the fourth array act to inhibit eversion or deflection of the fins of the first array and the fins of the second array during use. In the illustrated embodiment, the third array of fins and the fourth array of fins are generally shorter than the fins of the first array and the fins of the second array and are therefore less prone to deflection.

[0241] It will be understood that vertical, horizontal, top and bottom, and other terms relating to orientation, refer to the relative orientation of various features of the devices disclosed herein, e.g., with respect to the orientation of the device as depicted in the drawings, and such terms are not to be construed as limiting the orientation of the device or features in use.

[0242] It will be understood that any of the various features discussed above (with respect to retention mechanisms, external attachments, etc.) may be provided in connection with any example or embodiment. Additionally, the various features disclosed in connection with any example or embodiment (such as, but not limited to, means for reconfiguration, channel shapes, sizes, lids / closures, construction methods or materials, arrangements and subarrangements, etc.) may also be provided in further combinations with each other.

Claims

1. a body defining a channel, a body for receiving a length of conduit extending along the channel; a first array of elastically deformable fins disposed along the channel and extending from at least a first side and an opposite second side of the channel; a second array of elastically deformable fins disposed along the channel extending from at least a first side and an opposite second side of the channel; Equipped with each fin having an orientation extending at an acute angle relative to a longitudinal direction along the channel; each of the fins in the first array having a first orientation relative to the longitudinal direction along the channel and each of the fins in the second array having an opposite second orientation relative to the longitudinal direction along the channel; the first array extends along a first portion of the length of the channel and the second array extends along a second portion of the length of the channel; Conduit fixation device.

2. 10. The conduit fixation device of claim 1, wherein the channel is curved or convoluted along at least a portion of the length of the channel.

3. the body comprising an inner portion and a support portion disposed laterally outward of the inner portion along at least the first and second sides of the channel, the inner portion defining the channel and comprising the array of elastically deformable fins; 3. The conduit fixation device of claim 1 or 2, wherein the support portion comprises a material having a first stiffness and the fins of at least the inner portion comprise a material having a second, lower stiffness.

4. the medial portion and the support portion are removably coupled to one another; or 4. The conduit fixation device of claim 3, wherein the inner portion is co-molded into the support portion and / or the support portion comprises or defines a recess and the inner portion is located within the recess.

5. the fins of at least the inner portion include or consist of an elastomeric material, such as silicone; and / or wherein the support portion, or at least a portion thereof, is rigid or semi-rigid and formed from a molded or machined plastic material such as polypropylene.

6. 3. The conduit fixation device of claim 1 or 2, wherein the body further comprises a retention mechanism for resisting or preventing lateral movement of the conduit out of the channel.

7. 3. The conduit fixation device of claim 1 or 2, wherein the channels define void paths between opposing fins when the fins are in an undeformed state.

8. 3. The conduit fixation device of claim 1 or 2, wherein in an undeformed state, the fin is substantially straight between its fixed end and its free end; or the fin is curved or J-shaped between its fixed end and its free end.

9. 3. The conduit fixation device of claim 1 or 2, wherein the conduit fixation device is reconfigurable between at least a first configuration and a second configuration, such as by changing the angle of at least some of the fins relative to the channel, by changing the width of the void path along at least a portion of the length of the channel, by changing the curvature of the channel, or by changing the orientation of at least some of the fins.

10. 10. The conduit fixation device of claim 9, wherein the conduit fixation device is reconfigurable by removing and replacing one or more fin components.

11. The conduit fixation device of claim 1 or 2, comprising a first channel and a second channel.

12. 3. The conduit fixation device of claim 1 or 2, further comprising an external attachment for attaching the conduit fixation device to a patient or a structure, the external attachment being coupled to the body.

13. 3. A medical system comprising a medical conduit secured to the conduit-securing device of claim 1 or 2, wherein the conduit extends along the length of a channel of the conduit-securing device.

14. Providing a conduit fixation device according to claim 1 or 2; Inserting a conduit laterally into the channel; 10. A method for securing a conduit, comprising:

15. 15. The method of claim 14, comprising operating a retention mechanism by securing a strap over the channel or closing a lid over the channel.

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