Multi-lumen catheter

Abstract

A multi-lumen vascular access catheter (1) comprises a catheter body (10) with a plurality of lumen, and a plurality of extension tubes (30) each extending from an interface (20) with the catheter body, each extension tube being in fluid communication with one of the plurality of lumen of the catheter body. The extension tubes have a circumferential cross-section comprising a first portion formed of transparent material and a second portion formed of a coloured material, providing axially extending stripes, providing unimpeded viewing of fluids inside the extension tube whilst also ensuring easy identification.

Description

[0001] Multi-Lumen Catheter

[0002] Field of Invention

[0003] The present invention relates to multi-lumen catheter. In particular, but not exclusively, embodiments relate to multi-lumen vascular access catheter, for instance, for use as a central venous catheter (CVC).

[0004] Background

[0005] Multi-lumen catheters have a plurality of lumen combined into a single catheter body to provide separate, and parallel, paths for the delivery (or drawing) of fluids such as medicaments or blood. Such catheters are known with a variety of number of lumens, for example commonly being available with 2, 3, 4, 5, 6 or 7 lumens. At least some of the lumen may have different diameters and / or flow characteristics. The catheter is inserted into the body with the distal tip located at a delivery location and the proximal end outside of the body at an insertion location to which connections can be made. A common form of multi-lumen catheter is a central venous catheter which, in use, is inserted along a vein (typically in the chest, neck or arm) and generally extends to a major vein above the heart. Each lumen has an opening, usually, proximal to the distal end of the catheter body, with openings typically positioned at different locations along the catheter body. The proximal end of a multi-lumen catheter typically has an interface portion, such as a hub or manifold which provides a fluid connection to each lumen. The interface commonly includes a fixation feature (for example fixation wings) to allow the external portion of the catheter to be secured to a patient's skin, close to the insertion location.

[0006] Extension tubes typically extend from the interface and terminate with connectors, for example luer lock type connectors, to allow the connection of medical devices. As each lumen of a multi-lumen catheter may have a specific diameter and / or delivery location, it is necessary to ensure that the extension lines are labelled to ensure correct selection in use. It is known to include or provide clip-on tags on the extension tubes for identification. Optionally, extension tubes may include printed text information indicating which lumen they relate to. To further improve identification of the correct extension line and lumen the applicant has developed the Altius (RTM) range of central venous catheters which include colour-coded extension tubes.

[0007] The applicant has now identified further improvements which may provide a user- friendly arrangement which meets the needs of clinical practitioners.

[0008] Summary of Invention

[0009] According to a first aspect of the invention, there is provided a multi-lumen catheter comprising a catheter body extending from a proximal end to a distal end (a tip of the catheter body) and having a plurality of lumen, each lumen extending from the proximal end to an opening proximal to the distal end. A plurality of extension tubes each extend from an interface with the proximal end of the catheter body (at a distal end of the extension tubes) to a connector at a proximal end. Each extension tube is in fluid communication with one of the plurality of lumen of the catheter body. At least one extension tube has a circumferential cross-section comprising a first portion formed of transparent material and a second portion formed of a coloured material.

[0010] The applicant has recognised that some users are deterred from using coloured extension tubes due to a preference for transparent lines. Transparent lines allow the clinician to clearly observe and monitor the fluid passing through the tube. Accordingly, the applicant has identified that it would be advantageous to provide extension tubes which are formed of distinct portions which enable the provision of both a transparent portion and a colour coded portion in each extension tube. Thus, embodiments provide both a window for viewing the fluid in the tube and an unambiguous, immediate, means of tube identification. By "transparent" it will be understood that the material has a lower opacity than the coloured material, sufficient to allow a clinician to see from outside through the tube wall thickness to discern whether or not fluid is passing through the tube.

[0011] For catheters with a low number of extension tubes, such as 3, 4 or 5 extension tubes, only one or fewer than the number of extension tubes may comprise a colour coded portion.

[0012] In some embodiments, each extension tube has a circumferential cross-section comprising a first portion formed of transparent material and a second portion formed of a coloured material.

[0013] By circumferential cross-section, it is understood that, viewed in a section, the wall of a tube provides a structure enclosing the lumen, wherein part of the wall - a first portion - is transparent, and another part of the wall - a second portion - is opaque, or less transparent than the first part. Alternatively, or in addition, the first portion may be transparent and tinted in one of several colours, and the second portion may be opaque. Likewise, the first portion may be transparent and colourless, to be practically clear, and the second portion may be transparent and tinted in one of several colours. The different colours of the different extension tubes are understood to be sufficiently different from each other to be distinctive.

[0014] In some embodiments, the or each second portion that is formed of a coloured and / or opaque material are inward-facing, towards the centre of a bundle of extension tubes. Thereby, the transparent and / or clear portions are outward-facing. In this manner, the respective coloured and / or opaque portions may provide a backwall blocking view of other tubes behind, which may help to make fluid flow better discernible.

[0015] In some embodiments, the first (transparent) portion may provide an axially extending window. Thus, the first portion may allow the clinician to observe fluid passing along the length of the extension tube and into the catheter body. The first and second portions may each extend continuously along the length of the extension tube. Accordingly, in embodiments the cross-section comprising a first portion formed of transparent material and a second portion formed of a coloured material may extend along the full axial length of each extension tube. The extension tube may have a substantially uniform cross-section extending from (at or proximal to) the interface to (at or proximal to) the connector.

[0016] The second (coloured) portion may extend axially in a non-linear direction, for example the second portion having a serpentine or helical path along the extension tube. In other embodiments the second portion may comprise an axially extending stripe. An axially extending stripe may provide good unimpeded viewing of the fluid whilst also ensuring easy identification. The axially extending stripes may be of uniform width along the axial extension of the extension tube. However, the invention is not necessarily limited to uniform stripe widths, for instance in some embodiments some degree of variation may be tolerated and / or desired.

[0017] The portions may be considered sectors of the extension tube. In other words the portions may be generally defined by a circumferential arc extending between two radial planes (which intersect at approximately the central axis of the tube). Alternatively, the portions may be defined in a percentage amount of the circumference, particularly as a percentage of the outer circumference or perimeter measured perpendicularly to the tube extension. As a further option, the portions may be defined as relative ratios. E.g. a 25% stripe and 75% window may correspond to a 90° sector stripe and 270° window, and may likewise correspond to a 1:3 stripe- to-window ratio. It will be appreciated that typically the extension tube comprises an annular wall surrounding a central (circular) bore. The extension tube may, therefore, be a cylindrical tube, however may sometimes be deformed or of a material allowing some degree of deformation.

[0018] In some embodiments, the second (coloured) portion comprises a plurality of second portions. For example, two diametrically opposed second portions could be provided with interposed first portions. However, for simplicity and convenient viewing it may be desirable to have a majority of the cross section formed of the first portion's transparent material. In embodiments, the first portion may extend around a major sector of the extension tube. It will be appreciated that a major sector is a sector with a central angle of at least 180°, or 50% (% of the outer perimeter of the extension tube). In some embodiments the first portion may extend around a major sector with a central angle of at least 270°, or 75%.

[0019] In some embodiments, the second portion may extend around a minor sector having a central angle which is no greaterthan 45°, or 12.5%. The second portion may extend around a minor sector having a central angle which is no less than 36°, or 10%, or no less than 10°, or 2.8%.

[0020] In some embodiments, the second portion extends around a minor sector having a central angle which is no greater than 180°, 170°, 160°, 150°, 145°, 140°, 130°, 120°, 110°, 100°, 90°, 85°, 80°, 75°, 70°, 65°, 60°, 55°, 50°, 45°, 40°, 35°, 30°, 25°, or 20°.

[0021] In some embodiments, the second portion extends around a minor sector having a central angle which is no less than 10°, 15°, 20°, 25°, 30°, 35°, 40°, 45°, 50°, 55°, or 60°.

[0022] In some embodiments, the second portion covers, measured in a plane perpendicular to the extension tube, no more than 90%, 85%, 80%, 75%, 60%, 55%, 50%, 45%, 40%, 35%, 30%, 25%, or no more than 20% of the outer perimeter of the extension tube.

[0023] In some embodiments, the second portion covers, measured in a plane perpendicular to the extension tube, no less than 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, or no less than 75% of the outer perimeter of the extension tube.

[0024] In some embodiments, the ratio between second portion and first portion is 40:1, 36:1, 30:1, 25:1 20:1, 18:1, 15:1, 10:1, 9:1, 5:1, or 3:1.

[0025] It will be appreciated that the first portion covers the corresponding complementary percentage (to amount to 100%), or angle (to amount to 360°). In some embodiments, the second portion of each of the plurality of extension tubes comprises a distinct colour (i.e. the second portion colour codes the plurality of extension tubes). The connector at the proximal end of each extension tube may also be matched in colour to the colour of the second portion of the same extension tube.

[0026] In some embodiments, one or more, or each extension tube, is provided with a clamp, which may be matched in colour to the colour of the second portion of the same extension tube to which the clamp is attached.

[0027] The connector at the proximal end of each extension tube may be of any convenient form and it will be appreciated that several standard forms of connector are readily available. The use of standard connectors is convenient for compatibility and ease of use. For example, the connectors may be Luer lock connectors.

[0028] In some embodiments, two or more, or all, of the plurality of extension tubes have different axial lengths. At least some of the plurality of extension tubes may have different diameters and / or flow characteristics.

[0029] In some embodiments, the first and second portions may comprise co-moulded polymers. The polymers may be constituted by polyurethane. For example, the first and second portions may be co-extruded to form the extension tube. Advantageously co-extrusion may provide an extension tube with a coloured axially extending section without requiring any additional processing steps. A skilled person will be familiar with different methods to manufacture co-extruded tubular sections of different opacity or colour, such as sections including a transparent portion and an opaque portion, and will considerthese can be readily manufactured and cut to length to form an individual extension tube by being bonded or moulded to a connector and interface at each axial end.

[0030] Alternatively, the extension tubes may be formed integrally with the main body of the catheter, wherein lengths of tubes are used to form the main body, e.g. through bundling, fusing, or otherwise attaching them to each other, and other lengths of the same tubes are maintained separate from each other to provide individual extension tubes.

[0031] An appreciation underlying the invention was that suitable materials, such as polyurethane, may be co-extruded in different colours, and / or in different levels of opacity. In this manner, an opaque material may be co-extruded with a transparent material to form a tube with two or more portions. Such different materials may be prominent, as can be imagined, as stripes on the tube surface. The extrusion process will be understood to be controlled within suitable tolerances to ensure the wall thickness of the tube is the same, or practically the same, for the differently coloured, or differently opaque, materials.

[0032] Furthermore, the percentage, or angular extent, of stripes may be chosen as desired, e.g. to provide 75% (270°) transparent window portions and 25% (90°) opaque, coloured portion. As will be appreciated, the ratio of transparent to opaque portions may be varied. In initial trials, it was considered that a relatively thin coloured stripe is effective in allowing a tube to be readily identified, while allowing the window portion to be relatively larger, e.g. at a ratio of, for example, 1:9 (10% indicator stripe, 90% window), 1:5 (16% indicator stripe, 84% window), 1:4 (20% indicator stripe, 80% window), 1:3 (25% indicator stripe, 75% window), 1:2 (33% indicator stripe, 66% window), or 1:2 (50% indicator stripe, 50% window), or even 3:1 (75% indicator stripe, 25% window), and other ratios between such values.

[0033] In some embodiments, the plurality of extension tubes is provided by extension portions attached to the catheter body.

[0034] In some embodiments, at least two of the plurality of lumen of the catheter body have different flow characteristics, and the extension tubes are matched to the flow characteristics. An appreciation underlying the development of the invention was that the extension tubes need to be matched to lumen of the main catheter body. It will be understood that the lumen of the catheter body have predetermined flow characteristics. The exact flow property is not necessarily required for an understanding of the invention, however the flow characteristics can vary, for instance, due to internal lumen diameter, or due to number and size of distal openings. To provide an illustrative example, two lumen of otherwise same length and diameter may comprise a different number of distal openings. This may affect, for instance, a rate of drug delivery, depending on which lumen is used.

[0035] In some embodiments, the flow characteristics of at least two lumen of the catheter body differ at least in part due to different lumen diameters or different lumen crosssections.

[0036] In some embodiments, the flow characteristics of at least two lumen of the catheter body differ at least in part due to number of outlet openings.

[0037] In some embodiments, the flow characteristics of at least two lumen of the catheter body differ at least in part due to distance of outlet openings from catheter tip.

[0038] In some embodiments, of at least two lumen of different outlet configuration (such as number of openings and / or distance from catheter tip) have the same lumen diameter or the same lumen cross-section.

[0039] Different lumen with same cross-section or diameter may, therefore, have different flow characteristics.

[0040] The second portion of the extension tubes, i.e. the portion providing a colour coding, may be matched to the flow characteristics of the corresponding lumen in the catheter body. To this end, extension tubes with similar or identical geometry, for instance extension tubes with same wall thickness and / or inner lumen diameter, may be matched to the respective lumen of the main body. In some embodiments, at least one of the extension tubes is labelled with information indicating its flow characteristics. In some embodiments, at least one of the extension tubes is labelled with information indicating the flow characteristics of the lumen of the catheter body to which it is attached.

[0041] In addition to the second portion (providing a coloured stripe), the extension tubes may be provided with a label, such as printed text, indicating the flow characteristics of the lumen.

[0042] It will be appreciated that the extension lines are connected to the catheter body in a permanent manner in which they cannot be removed without destruction of the connection. Thereby, it can be avoided that extension lines are swapped in the product.

[0043] According to another aspect of the invention there is provided a catheter kit comprising a multi-lumen catheter of an embodiment and a guidewire. The catheter kit may further comprise an introducer needle. The catheter kit may further comprise a dilator. The catheter kit may further comprise a guidewire introducer syringe. The catheter kit of embodiments may be provided in a sterile package. The sterile package may comprise a transparent window showing at least a portion of one or more of the striped extension tubes.

[0044] According to another aspect of the invention there is provided a method of manufacturing a multi-lumen catheter according to any one of the embodiments of the first aspect. The method may comprise multiple steps to form any one or more features described in relation to one or more of the embodiments of the first aspect. For instance, the method may comprise forming, or providing, a multi-lumen main body for a catheter. The method may comprise providing one end with a tip, and / or providing one or more, or each, of the lumen with an arrangement of one or more outlets. The method may comprise forming, or providing, a plurality of extension lines comprising one or more features described in relation to one or more embodiments of the first aspect. The method may comprise attaching the extension lines to the corresponding lumen structure of the main body. Attaching the extension lines may comprise using an alignment tool, such as a mandrel, to match a lumen of the main body with a corresponding extension line. The extension lines may be formed with, and / or provided with, features described in relation to one or more embodiments of the first aspect.

[0045] Whilst the invention has been described above, it extends to any inventive combination of the features set out above or in the following description or drawings.

[0046] Description of the Drawings

[0047] Embodiments of the invention may be performed in various ways, and embodiments thereof will now be described by way of example only, reference being made to the accompanying drawings, in which:

[0048] Figure 1 shows a central venous catheter in accordance with an embodiment;

[0049] Figure 2 is a detailed view of the extension tubes of the catheter of figure 1;

[0050] Figure 3A shows a radial cross section of the extension tubes of figure 2;

[0051] Figure 3B shows a schematic end view of a hub of a main body;

[0052] Figure 4 shows a three-dimensional schematic representation of an axially extending section of an extension tube in accordance with figure 2; and

[0053] Figure 5 shows a catheter kit in accordance with an embodiment.

[0054] Detail Description of Embodiments

[0055] Throughout the present description it will be noted that the terms "proximal" and "distal" are used and it will be understood that such terms are made with reference to the in-use orientation of the device from the perspective of the clinician. In other words, any proximal directions or features are those which are closest to the user and furthest from the tip of the catheter. Any distal directions or features are those which are furthest from the user and closest to the tip of the catheter. It will be appreciated that catheters are generally elongate tubular devices and, as such, the terms axial, radial and circumferential are used herein and intended to be broadly understood as general geometric terms. The axial direction is aligned along the length of the device (or portion thereof). It will, however, be noted that components of embodiments need not conform to a strict circular form and as such references to these general directions do not exclude irregular or non-circular tubes, sections or profiles.

[0056] An example of a multi-lumen catheter 1 in accordance with an embodiment is shown in figure 1. The illustrated catheter 1 is a central venous catheter, commonly referenced as CVC, and is an example of a vascular access catheter. The catheter 1 generally comprises a catheter body 10, a hub 20 and a plurality of extension tubes 30 each ending with a connector 40.

[0057] The catheter body 10 extends from a tip 12, at its distal end, to a proximal end 14 which interfaces with the hub 20. Within the body 10, a plurality of lumen are formed which each separately extend from the hub 20 to an outlet, for example outlets 15, at or close to the tip 12. It will be appreciated that such multi-lumen catheter may include a variety of shapes and sizes of lumen, for example with lumen of specific diameters or flow characteristics intended for particular purposes in use. As such, the lumen of the body 10 may define multiple different diameter channels and / or some channels having the same diameter (for example a multi-lumen catheter body could include a single size "1", size "2", and size "4" lumen and two size "3" lumen) to allow for differing flow rates through the catheter body 20. Some lumen may have the same diameter, but different outlets 15, providing different flow characteristics to lumen of otherwise same diameter. The outlets 15 of one lumen may differ from the outlets 15 of another (one or more) lumen by number of outlets 15 per lumen, shape, distance from the tip 12, or location along the main body 10, etc. For instance, two lumen of some diameter may have different number of outlet holes and thereby have different flow rates. The lumen may be integrally formed with the catheter body 10 (for example through an extrusion process). Alternatively, the lumen may be formed from discreet tubular sections which are bundled together (and bonded, fused, moulded or otherwise secured) to form the final multi-lumen catheter body 10. The catheter body 10 may be formed of a variety of known biocompatible materials such as polyurethane. A skilled person will be familiar with suitable materials used in the production of central venous catheters. The tube structures making up the lumen of the main body may be of unitary colour.

[0058] In use, the catheter body 10 is typically inserted axially along a vein (in the case of a CVC) until the tip 12 is located in a suitable location. When in position, the openings or outlets 15 for each lumen may correspond to different arterial locations. The proximal end 14 of the catheter body remains outside of the body close to the insertion site.

[0059] The hub 20 is the interface between the catheter body 10 and the extension tubes 30. The hub 20 provides a fluid connection between each of the lumen in the catheter body 10 and its corresponding extension tube 30. It may be appreciated that a variety of interface / hub configurations are known, and the present invention is not intended to be limited to any specific hub arrangement. The hub 20 may include or be located proximal to at least one fixation wing 22 which allows the hub to be secured to a patient's skin close to the insertion location. Although the illustrated embodiment shows a winged hub for a catheter, other types of hubs may be used, and it will be appreciated that the invention is not necessarily limited to a particular hub type. In some embodiments, the tubes making up the main catheter body 10 are unitary with the extension tubes 30, the main catheter body 10 being a portion in which the extension tubes are bundled. However, the tubes 30 are not necessarily unitarily formed with the main body in all embodiments. It was found during the development of embodiments that, during manufacture, attaching the extension tubes 30 to an already-formed main body 10, i.e. a preformed main body 10, provides a greater degree of freedom to match the extension tubes to the flow characteristics of the corresponding lumen in the main body 10. For instance, the tube structures providing the lumen of the main body may be made of a single-colour material. The tube structures forming the lumen of the main body may all have the same colour. The tube structures forming the lumen of the main body may have different colours wherein each individual tube structure has one colour. The tube structures of the main body may be opaque, without transparent window-providing material.

[0060] The extension tubes 30a-30e are generally shown in figure 2. Each extension tube 30 extends from a distal end 32 which interfaces with the hub 20 (and is in fluid communication with a single lumen of the catheter body 10) to a proximal end 34 which is connected to and carries a connector 40a-40e, respectively. A variety of standard connector types are readily available, and it is desirable to use a connector which is widely compatible. It will be appreciated that it several different embodiments may be offered using different connector types. The connectors 40 may be luer lock devices and in some embodiments may for example be luer-safe connectors which include an automatic clamp action. The axial length of each of the extension tubes 30a-30e may differ which helps provide improved access to each individual connector 40a-40e during use. To help identification of each extension tube the connectors 40a-40e may be individually colour coded as shown schematically by the patterned markings in Figure 2. A detachable clamp 50a-50e is also usually provided with the catheter 1 and the clamps 50 may be colour coded to match their respective connector 40. While the invention is not limited to the use of specific colours, typical opaque colours used in catheters include white, purple, blue, red, black, brown, green. Certain colours or colour combinations may be required, reserved or prohibited, as the case may be, for regulatory reasons or convention, however it will be appreciated that the invention is not technically limited to specific colours.

[0061] In accordance with embodiments of the invention each extension tube 30a-30e comprises a first portion 36 formed of (here) transparent material and a second portion 38 formed of (here) a coloured material of different opacity than the transparent material. The arrangement of the two portions 36 and 38 is best seen in the cross-sectional view (through A-A of figure 2) shown in figure 3A and the schematic three-dimensional view of figure 4. Both portions 36 and 38 co-extend axially along the full length of the extension tube. Accordingly, it can be appreciated that the body of the extension tube 30 can be considered to be a primarily transparent tube with a coloured, axially extending, stripe defined by the second portion 38. The portions 36 and 38 meet at radial edges r ( r in figure 3A) which constitute a boundary between the two portions. Depending upon the manufacturing method and / or manufacturing tolerances, there may be a small transition region around the edges of the portions 36 and 38 where the materials overlap. The tube may be formed by coextruding the first 36 and second 38 portions such that the portions are integral and structurally substantially non-distinct. An exemplary material for surgical catheters is polyurethane, although a skilled person will be aware of a wide range of suitable materials, such as silicone.

[0062] As can be noted in figure 3A, the first, transparent, portion 36a-36e extends around a major sector of the annulus which defines the wall of the extension tubes 30. The first, transparent, portion 36a-e is a sector with a central angle y of approximately 270°, or around 75% of the circumference (measured in a plane perpendicular to the tube). The second, coloured, portion 38a-e is a minor sector having a central angle of approximately 90°, or around 25% of the circumference (measured in a plane perpendicular to the tube). This provides a particularly effective window (formed by transparent portion 36) to observe fluid flow through the bore of the tubes whilst still providing an easily visible identification stripe (formed by portion 38). In this embodiment, all the extension tubes use substantially the same sector proportions, or percentage surface area, respectively, but it will appreciated that this is not essential and may for example be varied depending upon the identification colour (for example some colours may be sufficiently visible in a narrower stripe) and the intended use (for example the degree to which visual inspection of the fluid flow is likely to be required). It can be noted that the colours of the second portions 38a-38e (as shown by the patterned markings in figure 3A) matches the colour of the corresponding connector 40a-40e, although a colour matching is not necessarily a requirement of all embodiments. It is believed that a relatively thin opaque colour stripe, e.g. of about 5% of the circumference, may suffice to be readily discernible from different directions due to refractive effects of the transparent tube portion. While figure 3A shows lumen of circular cross-section, a circular cross-section is not necessarily a requirement of all embodiments. Some embodiments may have a noncircular cross-section, such as a semi-circular or "D" shaped cross-section, or other geometries.

[0063] Figure 3B illustrates, schematically, an end view of a main body 10, in the region of the hub 20. For the purpose of the present disclosure, the hub 20 comprises, or provides, an outer wall 21 surrounding five lumen 22a, 22b, 22c, 22d,22e of the main body 10. The five lumen 22a-22e may each provide different flow characteristics, such as different flow rate, or delivery outlet location along the main body. At least two, or all, of the lumen 22a-22e may have similar diameters, e.g. similar or same inner diameter and / or outer diameter.

[0064] To form the multi-lumen catheter, each extension tube 30a-30e is attached to the corresponding lumen 22a-22e, respectively, such that the second portion 38a-38e, respectively, corresponds to the flow characteristics of the main body lumen 22a-22e to which it is attached. Each extension tube 30a-30e, respectively, is attached to a corresponding lumen 22a-22e of same inner cross-section and / or outer cross-section, respectively. For instance, a mandrel arrangement may be used to provide a support when fit in the lumen, to identify the geometry of a lumen, to identify matching lumen of the main body 10 and of the extension tubes 30a-30e. Main body and extension tubes may be supported on the mandrel while being fused. The extension tubes 30a- 30e are attached to their respective lumen locations 22a-22e in a fluid tight manner, thereby to form a continuous flow passage from outlet 15 to connector 40a-40e, respectively. The extension tubes may be provided with a label, e.g. printing, corresponding to the flow characteristics of the extension tubes 30a-30e, respectively. Alternatively, or in addition, one or more, or all, of the extension tubes 30a-30e may be provided with a label, e.g. printing, corresponding to the flow characteristics of the main body lumen 22a-22e to which the respective extension tube 30a-30e is attached. Referring to figure 5, for ease of use, catheters in accordance with embodiments of the invention may be provided as a surgical kit 200. The kit may be provided sealed in a sterile packaging 100, such as a tray, which can be opened in a clinical setting immediately prior to use. The kit may for example include a catheter 1 having a catheter body 20, a hub 20 and extension tubes 30 including connectors 40. The kit may also include one or more of a scalpel 110, a dilator 112, an introducer needle 114, a secondary fixation wing 116, a guidewire introducer syringe 118, and / or a guidewire 120. The connectors 40 may be colour matched to the colour of the opaque portions of the extension tubes. Alternatively, or in addition, the kit may comprise clip-on tags.

[0065] The transparent portions may be clear, colourless material. Alternatively, the transparent portions may comprise or be constituted by tinted windows, having a colour with a relatively high degree of transparency. The colour of the tinted, transparent windows may match the colour of the striped coloured portions on the same extension tube. Alternatively, the colour of the tinted, transparent windows may be selected to enhance visual contrast for fluids for which it is expected to be used.

[0066] Although the invention has been described above with reference to preferred embodiments, it will be appreciated that various changes or modifications may be made without departing from the scope of the invention as defined in the appended claims. For example, whilst preferred embodiments use a continuous stripe of colour for identification of the extension tubes it may be possible to form the coloured portion in a manner which is discontinuous along the axial direction such that a dashed or interrupted stripe is formed.

Claims

Claims1. A multi-lumen vascular access catheter comprising: a catheter body extending from a proximal end to a distal end and having a plurality of lumen, each lumen extending from the proximal end to an opening proximal to the distal end; a plurality of extension tubes each extending from an interface with the catheter body at a distal end to a connector at a proximal end, each extension tube being in fluid communication with one of the plurality of lumen of the catheter body; wherein at least one extension tube has a circumferential cross-section comprising a first portion formed of transparent material and a second portion formed of a coloured material.

2. The multi-lumen catheter of claim 1, wherein each extension tube has a circumferential cross-section comprising a first portion formed of transparent material and a second portion formed of a coloured material.

3. The multi-lumen catheter of claim 1 or 2, wherein the or each second portion formed of a coloured material is inward-facing.

4. The multi-lumen catheter of any one of the preceding claims, wherein the first portion provides an axially extending window.

5. The multi-lumen catheter of any one of the preceding claims, wherein the first and second portions each extend continuously along the length of the extension tube.

6. The multi-lumen catheter of any one of the preceding claims, wherein at least one second portion comprises an axially extending stripe.

7. The multi-lumen catheter of any one of the preceding claims, wherein at least one second portion comprises a helically extending stripe.

8. The multi-lumen catheter of any one of the preceding claims, wherein the first potion extends around a major sector of the extension tube.

9. The multi-lumen catheter of claim 8, wherein the second portion extends around a minor sector having a central angle which is no greater thanl80°, 170°, 160°, 150°, 145°, 140°, 130°, 120°, 110°, 100°, 90°, 85°, 80°, 75°, 70°, 65°, 60°, 55°, 50°, 45°, 40°, 35°, 30°, 25°, or 20°.

10. The multi-lumen catheter of claim 8 or 9, wherein the second portion extends around a minor sector having a central angle which is no less than 10°, 15°, 20°, 25°, 30°, 35°, 40°, 45°, 50°, 55°, or 60°.

11. The multi-lumen catheter of any one of the preceding claims, wherein the second portion covers, measured in a plane perpendicular to the extension tube, no more than 90%, 85%, 80%, 75%, 60%, 55%, 50%, 45%, 40%, 35%, 30%, 25%, or no more than 20% of the outer perimeter of the extension tube.

12. The multi-lumen catheter of any one of the preceding claims, wherein the second portion covers, measured in a plane perpendicular to the extension tube, no less than 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, or no less than 75% of the outer perimeter of the extension tube.

13. The multi-lumen catheter of any one of the preceding claims, wherein the connector at the proximal end of each extension tube matches the colour of the second portion.

14. The multi-lumen catheter of any one of the preceding claims, wherein each of the plurality of extension tubes comprises a distinct colour.

15. The multi-lumen catheter of any one of the preceding claims, wherein one or more, or each of the extension tubes, is provided with a clamp attached to the tube, wherein, optionally, the clamp is colour-matched to the second portion.

16. The multi-lumen catheter of any one of the preceding claims, wherein two or more, or all, of the plurality of extension tubes have different axial lengths.

17. The multi-lumen catheter of any one of the preceding claims, wherein the first and second portions comprise co-moulded polymers, wherein, optionally, the first and second portions are co-extruded.

18. The multi-lumen catheter of any one of the preceding claims, wherein the plurality of extension tubes is provided by extension portions attached to the catheter body.

19. The multi-lumen catheter according to any one of the preceding claims, wherein at least two of the plurality of lumen of the catheter body have different flow characteristics, and wherein the extension tubes are matched to the flow characteristics.

20. The multi-lumen catheter according to claim 19, wherein the flow characteristics of at least two lumen of the catheter body differ at least in part due to different lumen diameters or different lumen cross-sections.

21. The multi-lumen catheter according to claim 19 or 20, wherein the flow characteristics of at least two lumen of the catheter body differ at least in part due to number of outlet openings.

22. The multi-lumen catheter according to any one of claims 19 to 21, wherein the flow characteristics of at least two lumen of the catheter body differ at least in part due to distance of outlet openings from catheter tip.

23. The multi-lumen catheter according to claim 21 or 22, wherein the flow characteristics of at least two lumen of different outlet configuration have the same lumen diameter or the same lumen cross-section.

24. The multi-lumen catheter according to any one of the preceding claims, wherein at least one of the extension tubes is labelled with information indicating its flow characteristics.

25. The multi-lumen catheter according to any one of claims 19 to 23, or according to claim 24 when depending from claim 19, wherein at least one of the extension tubes is labelled with information indicating the flow characteristics of the lumen of the catheter body to which it is attached.

26. A catheter kit comprising a multi-lumen catheter of any preceding claim and a guidewire.

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